Devices and Methods for Stimulating Nerves
A device positioned in the vagina includes a sensor. The sensor data is used to determine whether a condition is met or exists to trigger a therapeutic response by the device. A device for stimulating nerves adjacent the vagina includes a nerve stimulating element coupled to a main body. The nerve stimulating element is positioned and designed to stimulate the vesical, Frankenhauser's and/or inferior hypogastric plexuses. The device may reside in the vaginal fornices. An implant is also provided which has a nerve stimulating element in contact with a uterosacral ligament. The device positioned in the vagina may be used to charge a power source for an implant, which may be a capacitor.
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The present application is a continuation of U.S. application Ser. No. 15/029,252, filed Apr. 14, 2016, which is a 371 of PCT/US2014/061209, filed Oct. 17, 2014 which are all hereby incorporated by reference. The present application is also a continuation of U.S. application Ser. No. 15/008,758, filed Jan. 28, 2016, which is a continuation of U.S. application Ser. No. 14/101,336, filed December 9, 2013 (now U.S. Pat. No. 9,248,285), which is a continuation-in-part of U.S. application Ser. No. 14/056,937, filed Oct. 17, 2013 (now U.S. Pat. No. 9.381,351), which is a continuation-in-part of U.S. application ser. No. 13/913,390, filed Jun. 8, 2013 (abandoned), which is a continuation-in-part of U.S. application Ser. No. No. 13/844,472, filed March 15, 2013 (now U.S. Pat. No. 8,914,111), which is a continuation-in-part of U.S. application Ser. No. 13/492,855, filed Jun. 9, 2012 (now U.S. Pat. No. 8,788,040), which are all hereby incorporated by reference.
BACKGROUNDMillions of women suffer from increased urinary urgency, frequency, incontinence, incomplete bladder emptying and irritative bladder conditions. There are two main types of incontinence, urge incontinence and stress incontinence, which have different physiological causes and different treatment options. Many women suffer from mixed incontinence, having both conditions.
Stress incontinence is largely the result of weakened ligaments, pelvic floor tissue and vaginal support, ultimately allowing the urethra to drop open in the setting of increased intraabdominal pressure. The process leading to stress incontinence is primarily mechanical and is associated with supportive tissue under the distal anterior vaginal wall. Strengthening the pelvic floor and supporting the urethra and/or bladder neck are safe and effective treatments for stress incontinence.
Urinary urgency, frequency, urge incontinence, incomplete bladder emptying, and nocturia represent a more complex process that is greatly neurologically mediated. Urinary urgency is marked by a strong, and often uncomfortable, urge to void that is difficult to suppress. Urge incontinence is defined by involuntary leakage of urine in the setting of urgency. The conditions noted above and other irritative bladder conditions may result from abnormal sensitivity of autonomic bladder nerves that prematurely communicate “fullness” to the central nervous system. These conditions may also result from erroneous nerve function in the central nervous system that allows the bladder to empty at inappropriate times. The underlying cause of these problems may be multifactorial. Ultimately, it is the autonomic nervous system that communicates bladder sensation, discomfort, or “fullness” and coordinates bladder filling and emptying.
Incomplete bladder emptying or urinary retention may result from inappropriate autonomic nerve signaling to the urethra and/or bladder. Some medical treatments are aimed at altering autonomic signal to the urethra, such that urethral tone is lessened. Others work by increasing bladder muscle tone by activating autonomic receptors in the bladder to cause a bladder contraction.
Many treatments of irritative bladder conditions are aimed at modifying nerve signaling between the bladder and the central nervous system. The goal is to affect both the afferent signals to the central nervous system that signal irritation, urgency, pressure or a sense of fullness and/or the efferent nerve signal that can trigger a rise in bladder pressure, cause discomfort, or leakage. Autonomic nerves transmit these signals. Treatment for urinary urgency, frequency, nocturia and urge incontinence is multifaceted, attempting to affect nerve signaling with behavioral, dietary, medical and physical therapies.
Urinary urge incontinence medications attempt to inhibit bladder contractions by disrupting signals between the autonomic nerves and the urinary tract. These drugs are not adequately effective for the majority of patients and also have significant systemic side effects that limit usage. Discontinuation rates at 6 months are well over 50% due to the high cost, lack of adequate effectiveness, and side effects. There are also contraindications to use, most of which are conditions affecting the elderly population that desires treatment for lower urinary tract symptoms.
An aggressive pelvic floor physical therapy regimen incorporating education, lifestyle, and dietary changes along with pelvic floor exercise training can be a reasonably effective treatment for urgency, frequency and urge incontinence in some patients. It is not clear how well exercise alone works to control urge related symptoms, as a large portion of the benefit gained from physical therapy is the result of education, cognitive-behavioral techniques, diet and lifestyle change. Patients are not often compliant beyond the short term, as the regimen can be costly, time consuming and difficult to comply with over time.
The goal of most pelvic floor exercises is to strengthen the muscles of the pelvic floor and increase nerve “tone.” These exercises activate the somatic nerves in order to cause pelvic floor muscle contraction. This is primarily a treatment for stress incontinence. A pelvic floor muscle contraction can secondarily affect autonomic nerves to the bladder via a spinal cord reflex arc. These exercises may dampen the signal to urinate or prevent leakage. They do not necessarily prevent the more common overactive bladder symptoms that occur before one has time to perform a contraction, such as a spontaneous sense of urgency or waking at night to void. It has been shown that urinary urgency alone, without leakage, is more bothersome to patients than urinary leakage alone. Effective treatment needs to prevent the spinal cord from perceiving inappropriate sensations in the first place.
Neuromodulation of autonomic nerves has become a useful treatment method for lower urinary tract symptoms, such as urgency, frequency, incontinence, incomplete bladder emptying, irritative symptoms, incomplete bladder emptying, fecal incontinence and related conditions. One technique involves an implanted stimulation lead over the S3 nerve root. It can be a successful treatment for patients who have failed other treatments.
Although use of the surgical implant over the S3 nerve root has been successful, the treatment has drawbacks. The main disadvantage is that the device requires surgical implantation of small electrical leads through a foramen in the sacrum and a stimulator device within the soft tissue above the gluteus maximus. Implantation typically requires two surgical procedures, exposure to radiation, and often requires additional surgery to revise or remove the components. It has also been reported that over 25% of patients will require surgical revision of either the implanted battery or lead to manage complications. Additionally, the current surgical implant often needs to be removed for some types of MRI. The device is also extremely expensive. In general, patients prefer less effective alternative therapies, as they often do not think bladder symptoms warrant surgery or they are not comfortable with the idea of a surgical implant.
Another drawback of the conventional surgical implant is that the stimulation occurs at the level of the nerve root, so somatic fibers traveling in the S3 nerve root are also stimulated before they branch off into somatic nerves. These nerves can cause the patients to feel vulvar, vaginal, anal and lower extremity muscle contractions or tingling. Still another limitation of the implantable stimulator is that the same one, or occasionally two, nerve roots are available and subject to all of the stimulation. As a result, the nerve becomes less responsive due to habituation rendering the lead less effective or ineffective. This phenomenon has been well established. Due to these many drawbacks, including risk of surgery, complications associated with the implant, cost, reduced effectiveness over time, and somatic symptoms associated with the implanted S3 sacral nerve modulator, this treatment has not been widely adopted despite its effectiveness.
The existing non-surgical electrical stimulation therapies include devices that are positioned in the vagina thereby avoiding some drawbacks of the surgical implant. However, these devices are often less effective and have their own drawbacks. Many conventional devices positioned in the vagina direct electrical impulses in the lower or distal vagina and/or adjacent to the pelvic floor. Electrical signals are sent through the vagina to paravaginal tissue, targeting nerves adjacent the pelvic floor muscles or the muscles themselves. The goal suggested by these conventional methods is generally to stimulate nerves adjacent the pelvic floor and to increase pelvic floor tension. Many of these therapies attempt to treat stress incontinence and/or simulate pelvic floor exercises. Yet, bladder filling, emptying and sensation are mediated by autonomic nerves, not somatic nerves. The inventor believes that these devices and therapies are often not as effective at treating urinary urgency, incontinence, nocturia, incomplete bladder emptying or other lower urinary tract symptoms as an implanted sacral nerve modulator because they do not sufficiently isolate stimulation to autonomic nerves.
A major limitation of these vaginal stimulation devices for treating most irritative urinary tract symptoms is that they indiscriminately send electrical impulses to both somatic and some distal autonomic nerve fibers adjacent to the lower and mid-vagina. They also often target somatic nerves, such as the pudendal nerve and its distal branches. The somatic nerves do not directly control bladder filling, emptying, or sensation. Activation of somatic nerves can cause increased pelvic floor tension, discomfort, and pain associated with pudendal nerve activation. Such conditions may actually contribute to urinary urgency, frequency and voiding dysfunction. Somatic nerves are quite sensitive, so the electrical impulses can be perceived even at low intensity, thereby limiting the full range of treatment protocols or precluding therapy altogether.
Thus, the inventor believes that the problem with present neuromodulation treatment methods is that they either require surgical implantation or, for vaginally inserted devices, the stimulation does not adequately target important autonomic nerve structures yet influences muscles and somatic nerves in the lower vagina providing less effective therapy for autonomically mediated urinary tract symptoms and contributing to undesirable side effects. Furthermore, the conventional implanted sacral nerve root therapies stimulate somatic nerves (although there are also autonomic—parasympathetic fibers near this location) and provide therapy to a very focal portion of a nerve, thereby contributing to habituation. These factors may provide less effective therapy for autonomically mediated urinary tract symptoms and contribute to undesirable side effects. Thus, optimal therapy would stimulate the autonomic nerves that mediate signal between the urinary tract and the central nervous system and/or end organ while avoiding activation of the pelvic floor and associated somatic nerves. Optimally, neuromodulation would be delivered directly to the autonomic nerves at the “gateway” between the urinary tract and the spinal cord while avoiding pelvic floor muscle and nerve activation.
The present invention is also directed to systems and methods for altering and improving (reducing) sympathetic tone. The autonomic nervous system maintains homeostasis and functional control of most organs in the body. The sympathetic arm of the system mediates the “fight or flight” response associated with a stress state, generally via norepinephrine, otherwise known as “adrenaline.” The sympathetic system is responsible for preparing animals for immediate action. The parasympathetic arm maintains organ function at rest. It is theorized that survival of early organisms was quite dependent on the ability to quickly adjust from rest (grazing) to extreme physical activity (fleeing a predator). This transition requires immediate coordination of many organs, glands and nerves that increase cardiac output, optimize respiratory function, increase skeletal muscle contractility, alter blood flow distribution, adjust visual depth perception, and trigger rapid-fire thinking. When the sympathetic tone is high, organs are operating at an extreme capacity, which is not healthy over time.
Outside of acute stress, organisms need to maintain a fine balance between the sympathetic and parasympathetic tone. In modern times humans are not often fleeing life-threatening danger. However, we tend to live in a chronic state of stress. Naturally, the sympathetic nervous output is upregulated in a chronic stress state. Chronic stress contributes to persistently elevated sympathetic tone, which has deleterious effects on most organs of the body. For example, the heart is very sensitive to even modest increases in circulating epinephrine. Chronic exposure to increased epinephrine levels results in a rise of blood pressure and heart rate that can contribute to many forms of heart disease, including arrhythmias, coronary artery disease, valvular dysfunction and heart failure. Alterations in cerebral blood flow resulting from stress, influenced by the sympathetic nervous system, can result in migraine headaches.
Metabolism is greatly affected by increased sympathetic tone, via increased release of cortisol. Cortisol is an adrenal hormone that alters metabolism of glucose, bone, muscle, adipose (fat) cells and connective tissue. Cortisol acts locally and systemically to mobilize metabolic resources for a stress response related action. Chronically elevated circulating cortisol levels can have serious and deleterious consequences including insulin resistance/diabetes, decreased bone formation (osteoporosis), inhibited collagen production (poor tissue quality and wound healing), decreased protein synthesis (atrophy), increased gastric acid secretion (ulcers and gastrointestinal bleeding), altered renal function (electrolyte imbalances), impaired hippocampal function (decreased learning ability and dampened memory retrieval), along with increased epinephrine sensitivity in blood vessels (hypertension). Cortisol also weakens the immune response by inhibiting T cell proliferation, which results in vulnerability to infection and cancer.
Stress and elevated sympathetic tone is also associated with increases in circulating inflammatory mediators, mainly Interleukin-6, which promote systemic inflammation. Inflammation is responsible for autoimmune conditions affecting nearly every organ in the body. Examples include dermatologic conditions (eczema), atherosclerosis (coronary artery disease and stroke), gastrointestinal (ulcerative coltis or Crohn's disease), lupus, arthritis, allergic reactions, pericarditis, myocytis, cataracts, pain conditions, interstitial cystitis, vasculitis, glomerulopathies, multiple sclerosis, iritis, asthma, and cancer. Pain is associated with inflammation and stress. Increased mortality has been associated with chronic exposure to increased stress and Interleukin-6 levels.
Many people simply maintain an elevated sympathetic tone, regardless of their stress level. Normal blood pressure and heart rate in healthy and relaxed people varies within a normal range, for example. Central obesity contributes to increased sympathetic output, regardless of stress level or cardiovascular health.
The role of autonomic imbalance in leading to poor cardiovascular health, and in causing heart failure, is increasingly being recognized. Research shows elevated inflammation in heart failure patients, with inflammation linked to left ventricular dysfunction. Poor autonomic tone is related to arrhythmia and increased heart rate.
The current approaches to delivering autonomic modulation are based on implanted devices. Even monitoring devices for recording heart rhythms that do not deliver stimulation, are often implanted under the skin, requiring a procedure. By contrast, the present invention provides for both monitoring of heart rhythms (rate and waveform) and delivery of autonomic neuromodulation by vaginally-inserted and self-retained systems and methods, complemented by wireless transmission of data from a user's existing personal device which may act as a controller.
Ultimately, lowering sympathetic tone can improve specific disease states and overall health. Current approaches to decrease sympathetic tone include exercise, weight loss, relaxation techniques, meditation and cognitive behavioral therapies. These approaches are not always effective, achievable or sustainable.
The present invention is directed to improved systems and methods for stimulating nerves. The present invention is also specifically directed to systems and methods for altering sympathetic tone. The present invention allows monitoring and sensing, diagnosis, and/or therapeutic treatment of numerous medical conditions.
SUMMARYThe present invention provides devices and methods for targeting autonomic nerves while minimizing transmission of stimulus to pelvic floor muscles and non-target nerves, specifically, somatic nerves adjacent to the lower or mid-vagina. The present invention is positioned to stimulate autonomic plexuses and autonomic nerves at the “gateway” between the lower urinary tract and the spinal cord while avoiding pelvic floor muscle and nerve activation. In specific embodiments and methods, the present invention targets the inferior hypogastric plexus (or pelvic plexus), left and right Frankenhauser's plexus (or Lee's plexus) and the vesical plexus. These plexuses may, of course, be called by other names such as Lee's plexus as another name for Frankenhauser's plexus without departing from the invention. Furthermore, the Frankenhauser's plexus refers to both left and right Frankenhauser's plexuses collectively. Unless otherwise specified, use of Frankenhauser's plexus or plexuses shall mean both plexuses.
In one aspect of the present invention, a device for stimulating nerves is positioned in the upper half of the vagina, and in specific embodiments in the vaginal fornices, so that the stimulus intended for the target nerves does not adversely influence non-target somatic nerves, such as the pudendal nerve or its branches, adjacent to the distal or lower half of the vagina. Reducing side effects and possible urinary tract symptoms due to stimulating somatic nerves are thereby avoided in accordance with the present invention.
The present invention treats urologic, gynecologic, colorectal and pain conditions in women with neuromodulation of nerves via electrical stimulation (and other modalities) delivered by a unique, self-retained, indwelling vaginal device that resides in the fornices of the vagina (or uppermost portion of the vagina in women without a cervix) and targets specific autonomic plexuses which communicate with associated nerves traveling to and from genitourinary and pelvic structures. The neuromodulation of the present invention stimulates the nerve plexuses to change a signal transmitted by the nerve plexuses to the associated autonomic nerves. The wide range of functions served by these autonomic nerves allows the present invention also to address sympathetic tone, cardiovascular function, sexual dysfunction, and other medical conditions. Similarly, the wide range of communication to and from autonomic nerves allows the present invention to affect organs well beyond the genitourinary and pelvic region itself.
Referring to
Importantly, the vagina terminates at the level of the pericervical ring around the uppermost portion of the cervix, just below the uterosacral ligament USL insertions. The recesses of the most proximal, or uppermost, aspect of the vagina that surround the cervix are called the vaginal fornices VF. The pelvic floor PF surrounds the lower portion of the vagina near the vaginal opening, making the “floor” of the pelvic cavity. The inferior hypogastric plexus IHP is a web-like plexus adjacent to the posterior and lateral cervix at the level of the uterocervical junction and the uterosacral ligament USL insertions, just proximal to the posterior vaginal fornix. Inferior hypogastric plexus IHP fibers also cover the distal uterosacral ligaments and possibly reside in the lower or under-portion of the cardinal ligament just anterior to the USL. For reference, the IHP is generally referred to as a singular structure in the literature, but anatomic studies suggest significant concentrations of these ganglia may be distributed bilaterally, as described above. For purposes of this description and application the IHP, when used herein, will refer to the IHP and any lateral extensions around the cervix or most proximal aspect of the vagina.
Autonomic nerve fibers travel from the IHP around the cervix to the vesical plexus, which communicates with autonomic fibers to innervate the bladder. Some autonomic fibers travel from the IHP to the posterior-lateral aspect of the cervix to right and left Frankenhauser's plexuses FP (also known as Lee's or the uterovaginal plexuses). Frankenhauser's or Lee's plexuses send some nerves upward to innervate the uterus and some nerves inferiorly to innervate the vagina, cervix, urethra, and clitoris. Both of these plexuses may be important in controlling urinary tract function. Autonomic fibers travel between the IHP and the middle rectal plexus to innervate the distal rectum.
Surgical removal of the cervix can result in injury to the hypogastric nerves, IHP, Frankenhauser's plexuses and/or the vesical plexuses. These structures often heal and function well post-operatively. However, they can sustain permanent injury and exhibit chronically altered function resulting in chronic urinary tract conditions and other forms of pelvic organ dysfunction.
As mentioned above, autonomic nerves and somatic nerves have different functions. Autonomic nerves control visceral, internal organ function and some types of pain. The bladder and urethra are innervated by autonomic nerves. Somatic nerves mediate voluntary muscle activity, body movement, and somatic sensation. The pudendal nerve PN and its distal branches mediate voluntary pelvic floor function and some distal vaginal, urethral, anal and genital sensation. The nerve types also have different distributions. For example, autonomic nerves traveling to and from the pelvic organs enter via a proximal and central approach, just above the top of the posterior vagina in the center of the pelvic cavity. The somatic nerves travel to the pelvic floor from an inferior and lateral approach. A problem with prior art devices placed in the vagina is that they stimulate, usually intentionally, somatic nerves adjacent the pelvic floor such as the pudendal nerve and its branches.
Autonomic nerves are responsible for signaling visceral organ or peritoneal pain, such as that caused by endometriosis, dysmenorrhea, interstitial cystitis, irritable bowel syndrome, adhesions and other conditions. Autonomic nerves also influence how visceral organs respond to somatic pain and can be a source of referred pain in a somatic distribution. Autonomic sensation may be transmitted by autonomic (or visceral) sensory fibers, not necessarily sympathetic or parasympathetic fibers.
In an embodiment, the present invention is an indwelling, removable, programmable, stimulation device that is positioned in the fornices of the vagina, thereby optimally targeting autonomic plexuses of the pelvic organs and the distal aspect of the hypogastric nerves. This device will deliver electrical stimulation (and support other therapies, such as application of a magnetic field, medication, or ultrasound) to the plexuses and associated nerves at the autonomic gateway between the pelvic organs and the central nervous system, mainly at the left and right hypogastric nerves, inferior hypogastric plexus, left and right Frankenhauser's plexuses, the vesical plexus and possibly the middle rectal plexuses. Stimulation of these plexuses and distal hypogastric nerves changes a signal sent by these plexuses and nerves to their associated efferent and afferent nerve fibers.
At this location the neuromodulation signal will have more effect than if it were distributed distal to the plexuses, such as with current devices that stimulate and reside lower in the vagina. With more distally stimulating devices some aberrant nerve signal arising above the stimulation site can travel, for example, between the urinary tract and the plexuses or hypogastric nerve above the stimulation site. The same limitations can hinder the effects of the current devices in treating gynecologic, colorectal and pain conditions as well. The device of the present invention, on the other hand, is positioned in the vaginal fornices or upper-most portion of the vagina thereby optimizing stimulation to the autonomic nerves and plexuses that control the sensation and function of the pelvic organs, including the bladder.
In a preferred embodiment, a ring-like device with an electrode, or a plurality of electrodes, will reside in the fornices, adjacent to the plexuses that surround the cervix. The device will also be able to target the junction between the left and right hypogastric nerves (that travel to and from the IHP along the uterosacral ligaments) and the IHP. An advantage of the present invention is that positioning the device in the fornices allows access to the collection of plexuses (vesical, inferior hypogastric plexus, and Frankenhauser's plexus) and the hypogastric nerves simultaneously with a single device.
The device may also have bilateral pairs of electrodes: right and left anterior, right and left anterior-lateral, right and left posterior-lateral, and right and left posterior leads. Any individual electrode or grouping of electrodes may be programmed to work with or independently of any other electrode or grouping of electrodes as described in further detail below. Bilaterality allows great flexibility of use. Each patient has an individual distribution of autonomic nerves and plexuses and some may have a dominant side. Alternating between right and left sides may also be important for any given patient to reduce habituation. Stimulation regimens may be customized for each patient.
The position of the device is essential to its unique ability to stimulate the target autonomic plexuses in the pelvis. For example, the posterior electrodes are adjacent to the IHP, the posterior-lateral electrodes are adjacent to left and right Frankenhauser's plexuses, the anterior electrodes are adjacent to the vesical plexus and the anterior-lateral electrodes are adjacent to the fibers approaching and leaving the vesical plexus. The anterior-lateral electrodes and posterior-lateral electrodes may ultimately reside adjacent to the vesical plexus or IHP respectively, depending on normal variant distribution of nerves and plexuses in an individual patient. As noted above, some IHP or hypogastric nerve fibers may travel along the undersurface of the cardinal ligament, just anterior to the USL. The posterior or posterior-lateral sets of electrodes may stimulate the autonomic fibers in the IHP or nerve fibers leaving or approaching the IHP that affect autonomic communication with the middle rectal plexus and/or autonomic rectal nerves. They may also affect signaling of the left and right hypogastric nerves as they approach and leave the IHP along the distal end of the uterosacral ligaments USL.
There will be multiple embodiments that optimize the direction of signal to the target structures and/or contact with the tissue. For example, in an embodiment the ring will have a flared and/or curved rim to increase electrode contact with the vaginal wall and adjacent nerves. Another embodiment may have protruding tabs extending from the ring to maintain position and/or more effectively direct current to the target nerves or plexuses. The device may also have a marker or positioning feature in order to maintain proper orientation relative to a midline. There may also be a feature available to optimize the transmission of electrical signal across the vaginal wall.
By directing signals to the peri-cervical plexuses and nerves, stimulation is directed to autonomic nerves while minimizing, and possibly eliminating, stimulation of somatic nerves and pelvic floor muscles. This is an essential distinction of the present invention from current devices. Because the device will reside in the fornices, or uppermost portion of the vaginal apex in some women, it will be well proximal to the somatic sensory nerve distribution. This will allow the patient to wear the device without awareness, making continuous treatment regimens possible. Such continuous regimens may be difficult with conventional devices residing lower in the vagina. Convenience of use, privacy, and comfort may increase compliance and, therefore, treatment success using the devices and methods of the present invention.
The device being described is able to work unilaterally, bilaterally, anteriorly, posteriorly and/or laterally as a single device that is easily placed and removed. With the device of the present invention the stimulation sites may also be changed or rotated. For example, a stimulation regimen may alternate between the rightward then leftward aspect of the IHP or vesical plexus, right and left Frankenhauser's plexus, or the junction or intersection between the right and left hypogastric nerves and the IHP. The feature allows increased flexibility with treatment regimens, giving certain plexuses or nerves rest while stimulating others.
The device of the present invention will also be able to target vastly more autonomic signals traveling to and from the pelvis. This may make it more effective at treating global pathologic problems, such as chronic pelvic pain. For example, a patient with severe pelvic pain may require continuous circumferential stimulation while a patient with overactive bladder may only need to target therapy to a single plexus.
As such, the device of the present invention permits the patient to receive individualized therapy. After initial placement, each patient's symptoms, response to treatment and any side effects may be monitored. A regimen will be customized based on her response to therapy. The device is programmable and the patient will be able to have adjustments to her regimen as desired. The plurality and laterality of electrodes allows a wide variety of stimulation opportunities.
For example, an overactive bladder patient may do well with the electrodes adjacent to the IHP stimulating 30 minutes daily. A patient with side effects to signaling of the IHP, say constipation, may prefer use of the anterior leads near the vesical plexus. If a patient has a blunted response after a long course of use, a good option could be to stimulate only the right anterior leads for a week and then rest the associated nerves while stimulating the leftward nerves of the vesical plexus during the following week. An interstitial cystitis/painful bladder syndrome patient may benefit from stimulating the vesical plexus and one or both of Frankenhauser's plexuses simultaneously to treat both bladder pain and urgency.
A patient with a spinal cord injury may do better with signaling the IHP continuously to control high levels of aberrant signal. This could afford treatment of fecal and urinary incontinence. Another patient may benefit from activating Frankenhauser's to treat non-obstructive urinary retention.
A woman suffering from dysmenorrhea (pain with menstruation) may only need the posterior-lateral leads active in order to stimulate Frankenhauser's plexuses and avoid dampening signal to and from the rectum or bladder. She could use the device five days a month. One patient with chronic pelvic pain may require continuous circumferential stimulation. Another may only require therapy targeted to the plexuses on one side allowing the rectal and bladder signals to function normally on the contralateral side. One therapeutic goal will be to find the least amount of signal required to treat each patient.
Achieving the therapeutic goal of finding the appropriate amount of treatment will often be based on monitoring and sensing, as well as diagnostic functions. Monitoring a patient via a set of sensors provides baseline data, variations from that baseline, comparison with normal ranges, monitoring of treatment regimens, and a variety of other data analytic functions. Such monitoring and sensing of bodily parameters can be the basis for diagnosis by either software in the device itself, other devices with which it communicates, clinicians treating the patient, the patient herself, or any combination. Therapy can be triggered automatically, based on data from the monitoring and diagnostic functions, triggers related to such data, pre-set software programs, patient input, clinician input, or any combination.
In this way, therapy may be intermittent, continuous, or not delivered at all, based on the monitoring and sensing, as well as diagnosis, of the data about the patient's condition. This ability to integrate monitoring, diagnosis, and therapy in a flexible way is a significant advantage of the methods and devices described herein.
While the above discussion has discussed the example of therapy delivered primarily via electrical energy based on electrodes, this is meant only as an example. There are a broad range of modalities (as also mentioned above) supported by the methods and devices described herein, especially as the monitoring and sensing, as well as diagnostic, functions extend well beyond monitoring and diagnosing nerves. A wide range of physical, biological, chemical, and other parameters can be measured and provide input into potential therapy for both the user and her physicians. Furthermore, this data can be communicated to, compared with, combined with, and triangulated wirelessly with information from other devices, allowing even greater flexibility.
Specific aspects of the present invention are now described. The device has a nerve stimulating element positioned on an exterior surface of a body for contact with the exposed or internal surface of the vagina. The nerve stimulating element may stimulate nerves in any suitable manner including provision of one or more emitting elements, which emit electrical energy, ultrasound energy, a drug, a magnetic field or other suitable stimulus. In a specific embodiment, the nerve stimulating element may be one or more electrodes, which deliver electrical energy to stimulate adjacent plexuses, nerves and associated autonomic nerve fibers. The nerve stimulating element may include a sensor or sensors to measure physiological parameters or may communicate with such sensors.
As mentioned above, many conventional devices contribute to side effects from stimulating somatic nerves adjacent to the distal or lower half of the vagina. These devices also often describe intentionally stimulating pelvic muscles and somatic nerves. The present invention avoids drawbacks associated with these devices by providing a device which has all of the nerve stimulating elements positioned in the proximal half of the vagina and may have the entire device positioned in the proximal half of the vagina. To this end, the present invention provides nerve stimulating elements that are positioned close to the target plexuses. These nerves travel close to the proximal end of the vagina and have branches, which are typically no more than 2 cm from the exposed surface of the vagina and, as such, the preferred embodiments are described with the nerve stimulating element being no more than 3 cm from the target nerve plexus or nerve. Stated another way, the nerve stimulating element may be positioned no more than 3 cm from the uterosacral ligaments which are positioned adjacent the target plexuses. Stated still another way, the nerve stimulating element is positioned to stimulate the vesical plexus, left and right Frankenhauser's plexus, left and right hypogastric nerves, and/or inferior hypogastric plexus without intervening nerves, and in particular without intervening somatic nerves. Stated still another way, the nerve stimulating element may be positioned to contact the exposed surface of the vagina closer to the left or right hypogastric nerve, vesical plexus, Frankenhauser's plexuses, or the inferior hypogastric plexus, than to the pelvic floor. Stated yet another way, the nerve stimulating element (and in some embodiments all nerve stimulating elements) is positioned within 3 cm from a proximal end of the vagina, proximal to a distal end of the cervix, or proximal to the midpoint between the proximal and distal ends of the vagina. Finally, the entire device may be positioned proximal to a midpoint between the proximal and distal ends of the vagina or within 5 cm from the proximal end of the vagina.
The device may also include a plurality of nerve stimulating elements to stimulate the left and right sides of the target nerve plexuses and/or nerves either simultaneously or independently. Providing independent nerve stimulating elements on the left and right sides of the target plexuses and nerves permits tailoring the therapy for the user and condition being treated. Furthermore, the laterality of treatment regions may be changed periodically to reduce habituation thereby permitting stimulation of the same plexus from different approaches.
The main body of the device may form a closed loop having a central opening with the cervix positioned in the central opening. Although the main body extends completely around the cervix, the main body may extend only partially around the cervix. To this end, the main body may extend around at least 120 degrees, or even 270 degrees, around the cervix relative to the cervical axis. For example, the main body may be C-shaped or U-shaped. In another aspect of the present invention, the nerve stimulating elements (such as the electrodes) are spaced apart at least 120 degrees, or even 180 degrees, relative to the cervical axis (or the central axis when the cervix is absent) so that the target nerve plexuses may be stimulated independently (or simultaneously) as described herein with a single device on opposite sides of the cervix. Of course, the nerve stimulating element(s) may be positioned only along a posterior or anterior half of the vaginal canal for targeted use as described herein rather than spaced around the periphery of the device.
The present invention may be useful in stimulating and altering autonomic nerve function for treatment of urinary urgency, frequency, incontinence, incomplete bladder emptying, pain and other pelvic visceral organ dysfunction, such as fecal incontinence. The devices and methods are designed to deliver therapy, an example being electrical stimulation, to specific plexuses that mediate autonomic communication between the visceral pelvic organs and the central nervous system. The device will also alter the signal from visceral pain nerves.
The indications for use include those referred to below. In addition, alteration of autonomic nerve signal may be used to treat cardiovascular conditions, such as hypertension, bradycardia, tachycardia and other dysrhythmias. Beneficial effects of this treatment may include altering autonomic tone, thereby treating chronic stress related conditions, such as gastritis, inflammatory conditions (such as asthma, inflammatory bowel diseases, atherosclerosis and arthritis), headaches, diabetes and anxiety. An example of integration of monitoring, diagnosis, and treatment is monitoring of heart rate and waveform to support, when necessary, control of heart rate via autonomic nerve stimulation/modulation.
The present invention is also directed to modulating the peripheral autonomic nervous system to alter, and ultimately reduce, systemic sympathetic tone. The autonomic nervous system functions as a circuit. Modulation of the signal of the autonomic plexuses surrounding the cervix and uppermost aspect of the vagina, namely the inferior hypogastric plexus (IHP), Frankenhauser's plexuses (L and R) and the vesical plexuses (L and R), may alter systemic sympathetic discharge throughout the sympathetic chain. Stimulation of the superior hypogastric plexus (SHP) may have a similar effect and may be included in this group of plexuses. Stimulation of these plexuses may influence the sympathetic tone of individual organs differentially. Alternatively, this therapy may influence the sympathetic tone of some, but not all organs under the control of the autonomic nervous system. In one aspect of the present invention, at least three of the plexuses are stimulated in accordance with methods and systems of the present invention.
The current invention will decrease sympathetic tone thereby protecting organs (such as the heart and vascular system) from deleterious effects of chronically increased sympathetic stimulation (via hormones, neurotransmitters, chemicals) and/or mitigate systemic disease processes influenced by sympathetic outflow, such as inflammation and immunosuppression.
In one aspect of the present invention, a battery-operated nerve stimulating device (which includes a handheld programmable and wireless controller) is designed to be positioned in the vagina and specifically the vaginal fornices. An embodiment may also include a version wherein the device and controller are connected via a cable without departing from the scope of the invention. The controller may record information regarding previous stimulation regimens, impedance, patient responses to therapy and other information. The information stored by the controller can be transferred to a computer or other device to review and analyze. The controller may also recommend stimulation regimens, based on patient response to past treatments or standard regimens known to be therapeutic.
Use of the information is therefore extremely flexible, based on the device's ability to operate independently or in conjunction with other devices. Data can be provided by sensors on the device itself, and/or by other medical and computing devices with which the controller and the device communicate. Data analysis can be completed by the device itself, by the controller, and/or by other medical and computing devices.
The devices and methods distribute therapy to autonomic plexus targets in the central pelvis while avoiding somatic nerves, general paravaginal nerves and the pelvic floor muscles. Unlike other vaginal neuromodulation devices, the electrodes are positioned in the most cephalad aspect of the device to optimize distribution of therapy above the vault of the vagina. Multiple embodiments are designed to assure adequate coverage of the plexuses. For example, versions include a torus-like, a truncated pyramidal frustum and truncated cone. Variations will include devices with and without a central opening, as the later may be beneficial for women without a cervix.
The devices of the present invention may be shaped to cause the apical vagina to widen and elevate, thereby bringing the vaginal wall closer to the target plexuses. The shape of the device also induces tenting of the vagina around the surface of the device. This layering of the vagina over the nerve stimulating elements optimizes contact between these elements and the vaginal wall. These embodiments cause a modest increase in vaginal wall tension and decreased resistance within the vaginal wall, thereby providing a more predictable interface between the nerve stimulating elements (such as electrodes) and the target structures.
The nerve stimulating elements generally conform to the contour of the device to maintain consistent proximity and contact with the vaginal wall. This feature may assure treatment of the entire plexus and plexus associated nerves that travel peripheral to the cervix and/or apex of the vagina. This also facilitates stimulation of pain nerves, both visceral and autonomic, traveling to and from adjacent visceral organs, within the preperitoneal tissue or associated with the peritoneum.
The invention may also provide surface features designed to optimize stimulation of the targets. In one embodiment, the device surface may have an undulating exterior surface with peaks, or raised areas, between valleys or recesses. The raised areas protrude into the vaginal wall to create a seal between recesses. Each recess will contain at least one nerve stimulating element and may also include a conductive material.
An embodiment will provide variations of a form-fitting, externally applied and absorbable ring-like insert. The insert includes a plurality of electrically conductive areas coupled to a substrate with the plurality of electrically conductive areas being separated by non-conductive areas. The substrate may form a closed loop with the electrically conductive areas positioned at spaced apart locations on the closed loop. The substrate may dissolve within the body to leave the conductive areas positioned within recesses in the main body of the device. The conductive areas may include a gel, such as a hydrogel, or a porous material having a flowable conductive material contained in the pores (such as a hydrogel or saline). The porous material may be a resilient foam element or any other suitable biocompatible porous element. The substrate may also include an elastic band that secures the insert to the device.
Once the insert is applied to the device the conductive areas will reside within the recesses and the exposed substrate will cover the external surface of the device ultimately providing a smooth outer contour.
The device may also include a reservoir (or reservoirs) of a conductive, flowable material (such as a hydrogel or saline). The reservoir is a part of or coupled to the main body of the device and is further fluidly coupled to one or more recesses. The conductive, flowable material may be automatically drawn into the recess. For example, the recess may include a porous element that draws the flowable material automatically out of the reservoir and into the recess. Alternatively, mechanical, chemical, thermal, electrical or hydrogen driven means may be used to force the flowable material out of the reservoir.
The insert(s) and/or the reservoir(s) may also be used to deliver any compatible substance or flowable material in a controlled fashion. For example, a drug may be delivered in a time-released fashion, based on data correlation with other data provided by the device and/or other medical or computing devices with which the device wirelessly communicates, or on demand from a signal provided from the controller. Clearly, both the propitious location of the device and its communication integration allow for great flexibility in use of inserts and reservoirs.
The insert(s) and reservoir(s) can collect as well as dispense compatible substances and flowable materials. Collecting such materials when the device is positioned in the body allows data from the materials to be included in the broader data monitoring, sensing, and diagnostic functions. The ease of removing the device, changing insert(s), and re-inserting the device allow data from materials collected to be easily analyzed externally as well.
The physical characteristics of the devices described herein may also help maintain proper orientation. As mentioned previously, the device may include recesses, which form peaks and valleys that help the device maintain the same position and limit rotation. The truncated pyramid and truncated cone shapes may help to drape the vagina in a similar fashion over the device. The torus shaped embodiment is designed to prevent dislocation, by virtue of the smooth outer circumference. The design will facilitate the vagina to conform to the shape and envelope the device so that when pressure is exerted on the upper vagina the vagina and device move as a unit. The device may also be able to alert the user when the battery is weak. The device may communicate with the handheld controller and a flashing light and/or audible alarm will notify the user. The device may also mechanically pulse and/or send stimulation so that the patient is alerted.
To comprehensively treat the peripheral pelvic visceral plexuses the system of the present invention may include a vaginal positioned device with multiple nerve stimulating elements that may operate independently to create multiple potential circuits with an implant. The vaginal device allows delivery of therapy through different plexuses via multiple current pathways, as 2 or more groupings of electrodes (one vaginal device and one or more implants) triangulate therapy and provide selective stimulation of target plexuses and associated nerves. Thus, the system being disclosed offers open circuit stimulation (for a single electrode) and closed circuit and selective stimulation, which may be directed by the user or health care provider.
The advantage of selective stimulation is the opportunity to employ multiple treatment pathways and potential regimens so that therapy may be individualized. For example, a user with pelvic pain may benefit from modulating nerve signals via Frankenhauser's plexus. She or her healthcare provider may activate the circuit between the vaginal electrodes in the posterior aspect of the vaginal device (near Frankenhauser's plexus) and one or more of the implants, depending on whether she desires unilateral or bilateral treatment. A patient with significant urinary urgency may benefit from creating a circuit between the vesical plexus by activating the stimulating elements on the anterior aspect of the vaginal device and the implant. A patient with fecal incontinence or fecal urgency may favor simply stimulating the IHP via the uterosacral implants with or without input from the vaginal device. The vaginal device allows increased flexibility of use, such that therapy may be tailored to each woman's symptoms and response to therapy.
Another advantage of the vaginal component and its ability to select and control the delivery of energy through different tissue and nerve pathways is minimization and possibly prevention of habituation. The vaginal component stimulating elements afford right/left and anterior/posterior electrodes as discussed herein. Targeting specific structures also avoids unnecessary stimulation of unintended targets. This feature will minimize side effects. Stimulating as few visceral and autonomic pelvic nerves as necessary may decrease habituation associated with pelvic plexuses, interneuron and the central nervous system stimulation. Focused therapy will require less current and ultimately less energy use, which favors prolonged battery-life.
The vaginal device and/or controller records data regarding treatment regimens, including start and end time, nerve stimulating elements used, resistance, current, frequency, disruption of therapy and any changes made to a regimen. In real time the user will be able to record subjective and objective information, which will be used to adjust and tailor future regimens to her specific needs. For example, if she has a good response to a certain regimen she may note it at the end of a day or predetermined assessment period. In this case, the regimen will be maintained or she may opt to decrease stimulation intensity towards the threshold of benefit. She may also note when she experiences a side effect. She may also record information about her menstrual cycle and be reminded of ovulation, and her last menstrual period, such that therapy is avoided in the luteal phase, if desired.
By reviewing the treatment regimen (including current, frequency of stimulation, active electrodes and duration of therapy) employed during the time the side effect was experienced, she and her healthcare team will be able to change the stimulation setting or redirect therapy to another target structure altogether. The user may record experiences via free text, respond to periodic questions or via standardized questionnaires and bladder diaries available in the software. All data will be recorded and downloadable to computers and portable devices, such as phones. The user's personal device (such as a phone) may reprogram the controller and alter the regimen. If the patient desires and consents, this objective, subjective and regimen data may be transmitted electronically for remote assessment by healthcare providers or for research purposes.
The controller of the vaginally positioned device may also communicate instructions to the device such as selecting a stimulation regimen, including which electrodes are active, the amount of current, pulse characteristics, and duration of therapy. The control system of the vaginal device will also maintain information about the stimulation regimens employed, resistance, current, power usage and other information related to the stimulation. The hand held controller may also record subjective and objective input from the user.
In another aspect of the present invention, the present invention seeks to modulate the peripheral autonomic nervous system to alter, and ultimately reduce, systemic sympathetic tone. The autonomic nervous system functions as a circuit. Modulation of the signal of the autonomic plexuses surrounding the cervix and uppermost aspect of the vagina, namely the inferior hypogastric plexus (IHP), superior hypogastric plexus (SHP), Frankenhauser's plexuses (L and R) and the vesical plexuses (L and R), may alter systemic sympathetic discharge throughout the sympathetic chain. Stimulation of these plexuses may influence the sympathetic tone of individual organs differentially. Alternatively, this therapy may influence the sympathetic tone of some, but not all organs under the control of the autonomic nervous system. In one aspect of the present invention, at least three of these plexuses are stimulated in accordance with methods and systems of the present invention.
The current invention will decrease sympathetic tone, thereby protecting organs (such as the heart and vascular system) from deleterious effects of chronically increased sympathetic stimulation (via hormones, neurotransmitters, chemicals) and/or mitigate systemic disease processes influenced by sympathetic outflow, such as inflammation and immunosuppression.
In another aspect of the present invention, an implant with a nerve stimulating element is implanted and preferably secured to a uterosacral ligaments. The implant, like the vaginal devices, modulates the action of nerves and treats conditions by altering the signals of autonomic nerve plexuses, their associated nerves and nerve endings and potentially interneurons and central nervous systems nerves and processes via one or more nerve stimulating implants. The implant may be used independently, together with other implants, or in combination with the vaginally positioned devices of the present invention. The vaginal device may also stimulate the anatomic structures described either by creating a circuit with the implanted electrodes or independently. In another aspect of the present invention, at least two implants are secured to the same uterosacral ligament.
The vaginal device may include the controller and power source to deliver therapy to the inferior hypogastric plexus (or pelvic plexus), left and right Frankenhauser's plexus (or Lee's plexus), vesicle plexuses (L and R) and even the superior hypogastric plexus. These plexuses may, of course, be called by other names such as Lee's plexus as another name for Frankenhauser's plexus without departing from the invention. Furthermore, the Frankenhauser's plexus refers to both left and right Frankenhauser's plexuses collectively. Unless otherwise specified, use of Frankenhauser's plexus or plexuses shall mean both plexuses.
The present invention treats urologic, gynecologic, sexual, colorectal, and pain conditions in women with neuromodulation via electrical stimulation (and other modalities), (including heat, ultrasound, and medication). The implant and indwelling vaginal device deliver therapy to specific autonomic plexuses that communicate with nerves traveling to and from genitourinary and pelvic structures. The neuromodulation of the present invention stimulates the nerve plexuses to alter signal transmitted by the nerve plexuses and associated autonomic nerves between the pelvic organs and the central nervous system.
For reference (
Importantly, the vagina terminates at the level of the pericervical ring (known by other names) around the uppermost portion of the cervix, just below the uterosacral ligament USL insertions. The recesses of the most proximal, or uppermost, aspect of the vagina that surround the cervix are called the vaginal fornices VF. The pelvic floor PF surrounds the lower portion of the vagina near the vaginal opening, making the “floor” of the pelvic cavity. The inferior hypogastric plexus IHP is a web-like plexus adjacent to the posterior and lateral cervix at the level of the uterocervical junction and the uterosacral ligament USL insertions, just proximal to the posterior vaginal fornix. Inferior hypogastric plexus IHP fibers also cover the distal uterosacral ligaments and possibly reside in the lower or under-portion of the cardinal ligament just anterior to the USL. For reference, the IHP is generally referred to as a singular structure in the literature, but anatomic studies suggest significant concentrations of these ganglia may be distributed bilaterally, as described above. For purposes of this description and application the IHP, when used herein, will refer to the IHP and any lateral extensions around the cervix or most proximal aspect of the vagina.
Autonomic nerve fibers travel from the IHP around the cervix to the vesical plexus, which communicates with autonomic fibers to innervate the bladder. Some autonomic fibers travel from the IHP to the posterior-lateral aspect of the cervix to right and left Frankenhauser's plexuses FP (also known as Lee's or the uterovaginal plexuses). Frankenhauser's or Lee's plexuses send some nerves upward to innervate the uterus and some nerves inferiorly to innervate the vagina, cervix, urethra, and clitoris. Both of these plexuses may be important in controlling urinary tract function. Autonomic fibers travel between the IHP and the middle rectal plexus to innervate the distal rectum.
In one embodiment of the present invention, the implant has a nerve stimulating element, such as an electrode, which is positioned around and/or through one or both uterosacral ligaments, adjacent to the inferior hypogastric plexus, Frankenhauser's plexus or the superior hypogastric plexus. The implant may also be secured to other structures, such as pubocervical fascia or the external vaginal wall, without departing from the scope of the invention. The therapy is designed to also treat the autonomic nerves traveling around the pericervical and apical vaginal fascia/connective tissue to visceral pelvic organs and the vesicle plexuses.
In one embodiment, the implant is generally cylindrical in shape with tapered ends. The implant may include a throughhole to accommodate the uterosacral ligament. The nerve stimulating element may be between 0.5 and 5.0 cm long and up to 2 cm wide. The outer surface of each implant is made of a biocompatible and insulating material to which the nerve stimulating elements are attached. The implant has a power source, such as a battery, which powers the implant. The battery may be rechargable and recharged remotely through tissue as is known in the art. For example, the charger may be positioned in the vagina and, in particular, positioned within the vaginal fornices VF.
The size and shape of the device is designed to provide an optimal surface area for stimulation of an autonomic plexus and associated nerves. The nerve stimulating element may be a relatively small microstimulator when treating a somatic nerve or nerve junction, such as a dorsal nerve ganglion. Autonomic nerves plexuses, on the other hand, are broader, so the nerves coalesce more diffusely thereby possibly necessitating a larger nerve stimulator. Broader distribution of therapy may be important for treatment success.
In another aspect of the present invention, the nerve stimulating element pierces the ligament. The uterosacral ligaments contain autonomic nerves as they travel to and from plexuses from the visceral pelvic organs. The implant may have two or more nerve stimulating elements (such as electrodes) in contact with the uterosacral ligament and positioned in series along the ligament. When an implant is secured to each uterosacral ligament, the implants may send current between the bilateral uterosacral ligament implants, thereby increasing the amount of therapy provided to the IHP and broadening the distribution of therapy.
The control system of the vaginally positioned device may communicate with the control system of implant(s) to coordinate stimulation (such as simultaneous or independent stimulation). The control systems may communicate with one another using the nerve stimulating elements to transmit and receive electrical impulses through tissue. Alternatively, the control system may generate radiofrequency signals, which are received by the control system of the implant.
The controller of the vaginally positioned device may also be used to control and send stimulation instructions to the implant either directly or indirectly via the vaginal device. The controller is configured to communicate control information (such as duration and intensity of stimulation) to the control system of the vaginal device. The controller may transmit a stimulation instruction to the device, which then transmits the stimulation instruction to the implant.
The devices, systems and methods of the present invention stimulate target nerves and plexuses while avoiding adversely influencing non-target somatic nerves, such as the pudendal nerve or its branches, adjacent to the distal or lower half of the vagina. Reducing side effects and possible urinary tract symptoms due to stimulating somatic nerves are thereby avoided in accordance with the present invention.
In addition to other treatments describe herein, the present invention may be used to treat any one or more of the following conditions: urinary urgency, frequency, nocturia, urge incontinence, stress incontinence of urine, loss of urine without sensory awareness, overflow incontinence, bladder pain, urethral pain, urethral syndrome, urethral stricture, urinary hesitancy, protracted urinary stream, pelvic floor dyssynergia, interstitial cystitis, dysuria, overactive bladder, incomplete bladder emptying, urinary retention, hesitancy, dysmenorrhea, pelvic pain, pelvic venous congestion syndrome, endometriosis, irritable bowel syndrome, constipation, fecal urgency, fecal incontinence, rectal pain, pain with defecation, anal pain, sexual dysfunction, and abnormal heart rhythm. Of course, numerous aspects of the present invention may be practiced for a different condition without departing from the scope of the invention.
The details of one or more embodiments of the invention are set forth in the accompanying drawings and the description below. Other features, objects, and advantages of the invention will be apparent from the description and drawings, and from the claims.
For the purpose of defining the invention, various terms are now defined for use herein with reference to
As used herein, the shape of the vaginal canal VC defines a central axis CA. A cervical axis CVA extends through and is aligned with the cervical canal CC. The cervical axis CVA is also an axis of symmetry, as closely as can be approximated with the anatomy, for the cervix extending through the cervical opening or cervical canal. A midpoint between the proximal and distal ends of the vagina (or the vaginal canal) is determined herein using the midpoint of the central axis. The central axis CA may, of course, have a relatively complex shape so long as the central axis CA generally defines and follows the orientation and shape of the vaginal canal VC. The proximal end of the vagina (and vaginal canal) is defined by the uppermost portion of the vagina. For example, a proximal portion of the vagina or vaginal canal extending 3 cm from the proximal end of the vagina includes the vagina extending 3 cm from the uppermost (proximal) end.
The vaginal fornices VF, as used herein, refers to a space or recess between the cervix and the adjacent vaginal wall. Specifically, the space is positioned between the exposed surface ES of the vaginal canal VC and an exposed surface of the cervix C and further bounded by a plane P extending perpendicular to the cervical axis CVA and passing through distal end of the cervix C. The vaginal fornices VF may be thought of as a somewhat torus-shaped space but, of course, varies from patient to patient.
Referring now to
In a specific embodiment, the nerve stimulating elements 6 may be one or more electrodes 16 that deliver electrical energy to stimulate adjacent nerves as described below. As used herein, it is understood that use of “electrode” or “emitting element” herein shall be interchangeable with the term nerve stimulating element, and vice versa, as applicable. Thus, aspects of the invention described or claimed specifically in relation to the electrodes 16 or nerve stimulating element 6 are equally applicable to the other and such substitution is expressly incorporated here. Furthermore, the application of electrical stimulus is sufficient to change the signals transmitted by the target nerves and plexuses described below. In this manner, neuromodulation of the target nerves is achieved.
Similarly, aspects of the invention described or claimed in relation to electrodes or nerve stimulating elements will encompass sensing electrodes and related sensing elements, without distinguishing whether electrodes are emitting electrodes or sensing electrodes, nor whether a sensor is integrated with or simply communicates with a nerve stimulating element. In order to determine whether and how much and/or when to deliver neuromodulation or other therapysuch information coming from the nerve stimulating element itself as well as from sensors will be described in greater detail below.
The electrodes 16 are coupled to a control system 18 which in turn is coupled to a power source 19 such as a battery 20. The device 2 may include a battery charger 22 or may be charged transcutaneously as is known in the art. Of course, an advantage of the present invention is that the device 2 may easily be removed, charged and repositioned which cannot be accomplished with conventional surgically placed devices. The device 2 may also include an external controller 24 which may operate the device remotely when the device 2 is in place. The battery charger 22 may also be a controller for programming the device 2 in accordance with methods described herein. A few prior art devices which describe suitable control systems, controllers and battery charging systems are described in U.S. Pat. Nos. 7,729,772, 7,813,809 and 8,165,692 which are hereby incorporated by reference. The controller 24 (and charger 22) may control the duration, frequency, intensity and stimulation protocol as described herein and in the patents incorporated above. The controller 24 may also be incorporated or applied to another suitable personal electronic device, such as a cellphone, programmable watch, tablet, laptop, electronic calendar/organizer or any other suitable personal programmable electronic device, without departing from the scope of the invention. If the controller 24 is incorporated into a personal electronic device the necessary control software can be downloaded and updated as a conventional application. The controller 24 may take advantage of the ability of the personal electronic device to communicate wirelessly with the device 2 (and other devices described below).
The main body 4 of the device 2 forms a closed loop having a central opening 26 with the cervix C positioned in the central opening 26. The main body 4 may be substantially circular or may have substantially straight sides 28 as shown in
The device 2 of the present invention may be positioned partially or entirely within the vaginal fornices VE The nerve stimulating element 6 (and in some embodiments all of the nerve stimulating elements 6) contacts the exposed surface of the vagina 10 proximal to the distal end 46 of the cervix.
The main body 4 has an elongate cavity 48 (see
Referring to
Referring now to
Although the above description presents distinct electrode 16 pairings, it is understood that any of the electrodes 16 may be grouped together by the control system 18 for generating nerve stimulus. For example, the two electrodes 16 on opposite sides of the marker 81 may be used to stimulate the inferior hypogastric plexus along the midline 85 rather than preferentially on the left or right sides. In another example, the left hypogastric nerve (and the junction of this nerve and the IHP) may be stimulated using the LPE2 and the LPLE1 electrodes while the right hypogastric nerve (and the junction of this and the IHP) may be stimulated using the RPE2 and the RPLE1 electrodes. Although the independent stimulation of different regions of the same plexus has been described with respect to left and right sides of the midline of a particular target plexus, the stimulation may take place at any two different regions of the same plexus rather than simply left and right sides as described in further detail below.
Although only one electrode 16 is used on each side of the circuit described above, two or more electrodes 16 may be used to create either side of the electrical circuit rather than using only one for each side as described above. In another aspect of the present invention, the device 2 may include at least twelve electrodes 16 and in the preferred embodiment sixteen electrodes 16. The nerve stimulating element 6 may be formed by any two electrodes 16 (or groups of electrodes 16) and, thus, the device 2 could easily have at least twenty nerve stimulating elements formed by sixteen electrodes 16 by grouping electrodes together, and “skipping” over one or two electrodes 16 (or more) to form the electrode pair rather than using adjacent electrodes 16 to form the pair. An advantage of forming at least twenty different nerve stimulating elements 6 the device 2 may provide greater flexibility of treatment, reduce habituation and targeting different sides of the same plexus at different times as described herein. Skipping electrodes 16 to form a particular nerve stimulating element 6 will increase a spacing between the electrodes 16 (compared to adjacent pairs of electrodes 16) thereby providing the ability to potentially alter the depth of penetration of the stimulus. The control system 18 is configured to independently actuate each of the nerve stimulating elements 6. In this manner, the device 2 of the present invention may operate in at least twenty different modes with each mode being represented by a distinct nerve stimulating element 6 formed by a unique group of electrodes 16 in any manner described herein. Thus, the present invention not only is able to target numerous plexuses with a single device but each of these plexuses may be stimulated in a variety of independent modes. For example, the IHP may be stimulated with the four posterior electrodes 16 (LPE1, LPE2, RPE1, RPE2) in at least four modes (or stated another way by forming at least four different nerve stimulating elements) to stimulate the IHP. In fact, the four posterior electrodes 16 may form at least eight different modes (or stated another way by forming at least eight different nerve stimulating elements 6) to stimulate the IHP by simply grouping electrodes 16 in the manner described herein (adjacent pairs, skipping one, skipping two, grouping two or more electrodes on one side of the circuit or on both sides of the circuit). In this manner, different regions or portions of the same plexus may be stimulated. Of course, the regions stimulated will have overlapping portions but use of different electrode 16 configurations described herein will create different stimulus patterns and regions. Although the device 2 of the present invention may form numerous independent nerve stimulating elements 6, simultaneous actuation may produce fewer nerve stimulating elements 6 (such as eight when using sixteen electrodes 16), nevertheless, the device 2 still may form far more nerve stimulating elements 6 for independent actuation as described herein. The nerve stimulating elements 6 are also preferably formed by more than mere modification of power, frequency or another parameter for the same nerve stimulating element 6. As such, the nerve stimulating element 6 may each have a unique position in that the electrodes 6 are grouped, paired or otherwise organized in a unique manner for each of the nerve stimulating elements 6 formed. As such, each nerve stimulating element 6 formed has a unique position even if a grouping or pair share one or more electrodes 6 so long as the groups or pairings are not identical. Each unique position provides a different focus unlike a single nerve stimulating element that can only change power, frequency or some other characteristic while leaving the stimulation pattern substantially the same.
Although numerous nerve stimulating elements 6 may be formed with the electrodes 16 forming numerous different nerve stimulating elements, in some aspects of the invention the device 2 may have at least four, or at least eight, nerve stimulating elements 6 as described above. Each of the nerve stimulating elements 6 may be actuated independently (or simultaneously, of course) to stimulate different regions of tissue (although these regions may overlap). In another aspect of the invention, the nerve stimulating elements 6 are advantageously distributed around the main body 4 to independently stimulate the various target plexuses. To this end, the device 2 may include at least three nerve stimulating elements 6 which are angularly spaced at least 70 degrees from adjacent nerve stimulating elements relative to the cervical axis CVA or central axis of the main body 4 CAB. If more regions are targeted, the device 2 may include at least four nerve stimulating elements which are angularly spaced at least 50 degrees from adjacent nerve stimulating elements relative to the cervical axis CVA or central axis of the main body 4.
Although the nerve stimulating element 6 has been described with respect to pairs of electrodes 16, the nerve stimulating element 6 may be formed by a single element or even a single electrode 16 without departing from the scope of the invention. For example, a single piezoelectric element may be used to deliver ultrasound energy or the device 2 may include a single electrode 16 with the other electrode carried by another element (even an implantable element) without departing from the scope of the invention.
As mentioned above, many conventional devices introduced into the vagina suffer from the drawback that they often stimulate somatic nerves since these devices are typically positioned in the distal (lower) half of the vagina. These devices also often intend to stimulate pelvic muscles, which may lead to further disadvantages described herein. The present invention avoids these drawbacks by positioning the device 2 in the proximal half of the vagina and, in some embodiments, may have all of the nerve stimulating elements 6 (or electrodes 16) in the proximal half of the vagina. To this end, the present invention provides nerve stimulating elements 6 that are positioned close to the target plexuses; the vesical plexus, left and right Frankenhauser's plexuses, the inferior hypogastric plexus and the intersection of junction between the inferior hypogastric plexus and the left and right hypogastric nerves. These nerve plexuses travel close to the proximal end of the vagina as shown in
The electrodes 16 are also oriented and organized so that they will form nerve stimulating elements 6 that will generally direct stimulus proximally. To this end, the electrodes 16, and the nerve stimulating elements 6, are organized so that a proximal surface 13 are at the same longitudinal position relative to the central axis of the body CAB and the cervical axis CA. Although the electrodes 16 and nerve stimulating elements are preferably oriented in this manner, they may be longitudinally separated without departing from numerous aspects of the present invention. For example, the electrodes 6 (and in one aspect all of the electrodes 16 or nerve stimulating elements 6) may be longitudinally spaced so that the proximal surface 13 of the electrodes 6 (and the nerve stimulating element 6 formed by the electrodes 16) relative to the central axis of the body CAB or the cervical axis CVA by no more than one cm.
Referring now to
Referring to
The device may also be used to stimulate the vesical plexus together with either the Frankenhauser's plexus or with the inferior hypogastric plexus (or both). The vesical plexus may be stimulated independently or simultaneously with one or both of the other two plexuses. In another aspect, an anterior side may be stimulated simultaneously or independently with a posterior side.
As can be appreciated, the present invention provides the ability to target more than one plexus and, alternatively, the same plexus from a different position. For example, a plurality of nerve stimulating elements 6 are positioned to stimulate the same plexus for each of the plexuses described herein. Switching to different stimulating elements 6 may reduce habituation and/or provide other therapeutic benefits. Furthermore, the user may simply select, based on efficacy determined by the user, which of the areas is most beneficial for the particular treatment. Of course, a computer-controlled algorithm may also be used to target particular areas due to set parameters or from feedback data. The control system 18 may control the device 2 to stimulate a target plexus with a first nerve stimulating element 6 for a first period of time, then stimulate the target plexus with a second nerve stimulating element 6 for a second period of time and independent of the first nerve stimulating element 6. In this manner, habituation may be addressed without changing the target plexus but changing the position of stimulation by changing the nerve stimulating element. Of course, the target plexus(es) may also be changed from any one (or more) of the target plexuses described herein to another target plexus(es) to address habituation or as otherwise desired.
In one aspect, a plurality of devices 2C, 2D, 2E, such as at least three, having different patterns of stimulating elements 6 may be provided as shown in
Referring to
Referring to
In still another aspect of the present invention, the device 2 is now referred to again with reference to
This ability to measure and compare parameters provides numerous additional benefits. The example of measuring impedance can, for example, provide data on blood and tissue. In general, the ability for electrodes to measure as well as deliver energy can provide other data on electrical properties of the tissue and fluids in the environment of the device. Both the ability to acquire measurements at different points in time, and the fact that the device 2 extends further in space than leads of implanted devices, allow for comparisons of parameters by the device. The ability of the device 2 to communicate with other medical and computing devices internal and external to the body extend all of these capabilities. The device 2 can incorporate any of a wide range of other sensors into the nerve stimulating elements or communicate with such sensors elsewhere on the device or on other devices internal or external to the body. Thus, a wide range of parameters can be sensed and monitored, diagnosed, and therapeutically treated. The data integration of such a device worn internally is novel in utilizing multiple sources and extending from sensing, through diagnosis, to therapy.
Referring to
Referring now to
The exterior surface 8G of the main body 4G forms a truncated pyramid having four sides 92 and rounded edges. At least one nerve stimulating element (or at least two) is positioned on each side 92. Alternatively, at least three of the four sides 92 may each have at least two nerve stimulating elements 6G.
The main body 4G includes a recess 80 in which the nerve stimulating element 6G is positioned. The main body 4G may include at least four recesses 80 and at least four nerve stimulating elements 6G each positioned in one of the recesses 80. The main body 4G may also include a non-conductive wall 82 extending between the recesses 80. The wall 82 may be electrically insulated (non-conductive) to isolate the nerve stimulating elements 6G from one another. The wall 82 may also help to contain a conductive material within the recess 80 as explained further below. The main body 4G may also have another wall 84 that extends around the opening 90. The wall 84 may also be a non-conductive material to help isolate the nerve stimulating elements 6G from one another (particularly when electrodes 16 are used) and to contain a conductive material. The wall 84 is positioned between the nerve stimulating elements 6G and a radially inner edge 93 (smaller end) of a central opening 95 in the main body 4G. Another wall 91 is positioned at a radially outer edge 107 (larger end of the opening) of the central opening 90.
The main body 4G may also include a reservoir 94 which contains a flowable substance 96 such as saline or a hydrogel. The reservoir 94 has a lumen 89 fluidly coupled to the recess 80 and a permeable and/or porous structure 98 (depending on application) such as an open cell foam exposed and positioned in the recess 80. The structure 98 has pores 100 that hold the flowable substance 96 which may be electrically conductive (such as saline or a hydrogel). The flowable substance 96 may continue to weep from the structure 98, depending on the physical characteristics of the structure 98, lumen 89 and flowable substance 96, to position the flowable substance 96 in the recess 80 adjacent the nerve stimulating element 6G. The structure 98 may automatically draw the flowable substance 96 from the reservoir 94 thereby automatically replenishing the flowable substance 96 as necessary. Of course, the flowable substance 96 may also be forced from the reservoir 94 without departing from the scope of the invention. The flowable substance may be a conductive substance to enhance electrical contact between the nerve stimulating element 6G and tissue. A fill hole 97 may be used to fill the reservoir 94 as necessary. The reservoirs 94 may each deliver to a single recess 80 but may, of course, deliver to multiple recesses 80 without departing from the scope of the invention. Referring to
Referring to
Referring to
The main body 4J includes a wall 82J extending between recesses 80J. The wall 82J may be electrically insulated (non-conductive) to isolate the nerve stimulating elements 6J from one another. The wall 82J may also help to contain a conductive material 105 within the recess 80J as explained further below. The main body 4J may also have another wall 84J that extends around a smaller end 101 of central opening 90J. The wall 84J may also be a non-conductive material to help isolate the nerve stimulating elements 6J from one another (particularly when electrodes 16 are used) and to contain a conductive material. A lip 103 forms another wall 107 that extends around the larger end (radially outer side) of the central opening 90J thereby surrounding each recess 80J with walls 82J, 84J and wall 107. A conductive material 105 is positioned in the recess. The material 105 may be a soft, pliable, electrically conductive structure such as any of those described herein including a porous material or substance (using saline or a gel such as a hydrogel). In this manner, the conductive material 105 may conform somewhat to the shape of the tissue to enhance contact with tissue and electrical conduction.
Referring to
Referring to
The insert 120 has conductive elements 122 positioned over the nerve stimulating element 6K which may be pliable to conform to tissue and thereby enhance electrical conduction. The plurality of conductive elements 122 are coupled to and separated by non-conductive elements 124 which may also be pliable. The electrically conductive element 122 may be a gel, such as a hydrogel, or a porous material 126 having a flowable material, such as saline, contained in the pores of the porous material 126. To this end, the term electrically conductive shall include porous materials that are not electrically conductive but can conduct electricity when the pores are filled with an electrically conductive material. The non-conductive element 124 may also be a thin layer of material such as a closed cell structure made of a non-conductive material. Alternatively, the non-conductive element 125 may simply be a pliable layer 127 of non-conductive material such as silicone. The pliable nature of the layer 127 may help to conform to tissue to create a barrier to electrical conduction between adjacent nerve stimulating elements 6k. The insert may include a main body 129 that may simply be an elastic band 131 at a radially outer (larger end) of a central opening 133. The band 131 may be coupled to one or both of the non-conductive elements 125 and/or conductive elements 122.
Referring to
Referring to
Referring to
Referring now to
The uterosacral ligament passes through a slot 234 when introduced into the throughhole 227. The implant body 226 is movable from an open position, which permits the uterosacral ligament to enter the throughhole 227 to a locked position which prevents the uterosacral ligament from moving out of the throughhole 227. The locked position may also be provided in any suitable manner such as with a separate structure including as a suture, clasp, cinch, clamp, or a sliding door or gate over the slot 234 without departing from the scope of the invention.
Referring to
The implant 220 also includes a power source 238, such as a battery 240, coupled to the implant body 226. A control system 242 (positioned within the implant body 226) is coupled to the power source 238 and to the nerve stimulating elements in a conventional manner. The battery 240 may be rechargeable (not shown) without departing from the invention and may be charged with a charging device positioned in the vagina in the same position as the device 2 as described in greater detail below.
As mentioned above, the first and third nerve stimulating elements 224, 230 are in contact with the uterosacral ligament which itself is physically connected through various tissue paths to the target plexuses as described herein. Thus, the uterosacral ligament is used to transmit nerve stimuli to the target plexuses and nerves and the anatomic position of the uterosacral ligaments relative to the target areas is advantageous as described above. The nerve stimulating elements on the implant 220 may also be useful for stimulating other nerve plexuses such as the superior hypogastric plexus (SHP) which would be difficult to stimulate using the device 2. The nerve stimulating elements on the implant 220 may also be suitable for delivering stimulation to the middle rectal plexus to treat fecal urge, rectal conditions, and/or incontinence.
Referring to
The implant 220 may also be small enough so that two implants 220 can be positioned adjacent (and even secured) to the same uterosacral ligament. If the implants 220 are separated with one positioned anteriorly on the uterosacral ligament and the other positioned posteriorly (as shown in
The implant 220 may be used by itself, together with additional implants 220, 220A or in conjunction with any of the devices 2, 2A-2N positioned in the vagina described herein and shown in
The implant 220 and the devices 2, 2A-2N may work together to stimulate nerves to modulate the signal of the autonomic plexuses surrounding the cervix and uppermost aspect of the vagina, namely, the inferior hypogastric plexus (IHP), Frankenhauser's plexus (L and R) and the vesical plexuses (L and R). In this manner, the stimulation may alter systemic sympathetic discharge throughout the sympathetic chain. In a specific aspect, the device 2 may have two nerve stimulating elements 6. The two nerve stimulating elements 6 on the device 2 and the nerve stimulating element(s) on the implant 220 together stimulate at least three nerve plexuses from the following list; SHP, IHP, L vesical, R vesical, L Frankenhauser's, and R Frankenhauser's. For example, the implant 220 may stimulate the IHP (or the SHP) while the device 2 has at least one of the nerve stimulating elements 6 stimulating a side of the Frankenhauser's plexus (L or R) and another nerve stimulating element 6 stimulating the other side of the Frankenhauser's plexus relative to the midline 83 (see
The device 2 may also communicate with the implant 220 to coordinate stimulation. For example, various therapies may require simultaneous stimulation while others require independent stimulation. The device 2 and the implant 220 may communicate by simply transmitting and receiving electrical signals through tissue using the nerve stimulating element 6 of the device 2 and the nerve stimulating element of the implant 220. For the purpose of the present invention, “communication” shall require either transmission or receipt of signals or information but does not require both. The controller 24 of the device 2 may be used to communicate with the control system 18 of the device 2 to control, for example, a duration of stimulation and an intensity of stimulation. The controller 24 may also be configured to communicate stimulation instructions for the control system 242 of the implant 220 to the device 2 which then communicates the instructions to the implant 220. Of course, the controller 24 may be configured to communicate instructions directly to the control system of the implant 220 as well. For example, the controller 24 (and/or the implant 220) may generate radiofrequency signals to communicate with one another in a conventional manner.
More than one implant 220 may be delivered and secured to the same uterosacral ligament. Each implant 220 may include all features related to the implants of the present invention. When more than one implant 220 is used, the control systems 242 of the implants 220 may also communicate with one another to coordinate stimulation (such as simultaneous stimulation or independent stimulation). The implants 220 may communicate using electrical signals transmitted to and from the nerve stimulating elements and transmitted through tissue. Alternatively, the nerve stimulating elements (or a separate antenna, not shown) may be used to transmit and receive radiofrequency signals. Of course, any other suitable method of communication between the implants 220 is within the scope of the invention including a physical connection between the implants 220 (such as a filament or wire) although wireless communication is preferred.
Referring now to
A ligament sizer 225 is introduced and the size of the ligament (circumference, diameter and/or thickness) is measured as shown in
The implant 220 may be further secured to the ligament with permanent, monofilament sutures (not shown). Either end of the exposed longitudinal edges of the implant 220 may also include an arrow-like barb (not shown), attached to a fixed length of suture that is projected via an internal mechanism into the receiving opening on the opposing side of the throughhole 227. The arrow-like barb may be relatively large so that it becomes trapped and contained within the implant 220. The proximal and distal sutures may be delivered simultaneously with a fixed suture length. A properly fitted implant 220 will demonstrate two approximately 2-3 mm, exposed sutures on the medial surface. One or more suture(s) may be passed through the ligament to further prevent the implant 220 from traveling or slipping along the ligament. The implant 220 is then retroperitonealized surgically with absorbable suture. The profile of the implant 220 and the suture features are designed to prevent bowel adherence, in the case that the retroperitonealized implants become intraperitoneal.
Referring to
The capacitor 239 may be made of any suitable capacitor materials with more recently developed materials offering high energy densities comparable to a battery. Another advantage of the capacitor 239 is a very high cycle life. One distinct advantage of the capacitor 239 over a rechargeable battery is that the capacitor 239 can be recharged thousands, even tens of thousands, of times. One such material for capacitor 239 is made of layers of graphene and polymer 247. The implant 220B includes an induction element 260, such as an induction coil 262, printed, etched or otherwise deposited or formed on a first flexible substrate 264. The implant 220B has four induction elements 260. A control system 242B is formed on a second substrate 266. The capacitor 239, the control system 242B and an implant body 226 are formed into a roll and bonded together and sandwiched between the nerve stimulating elements 6 to form the implant 220B of
The capacitor 239 may also facilitate design of a smaller implant 220B compared to conventional battery-powered implants since some capacitor materials can be recharged tens of thousands of times and, therefore, the capacitor 239 does not require high storage capacity since it can be reliably recharged thousands of times (unlike batteries which can withstand a much more limited number of recharges). To this end, the capacitor 239 may be sized to provide at least 2 days of power under peak operating conditions, and may be no more than 60 days, under peak operating conditions thereby maintaining a small size. Sizing the capacitor 239 in this manner will facilitate design of smaller implants 220B than a comparable battery-operated implant while also providing longer implant life since the capacitor 239 can be recharged many more times than typical rechargeable batteries.
Referring now to
The implants 220, 220A, 220B may also be recharged with a separate device rather than using the nerve stimulating devices 2, 2A-P. Referring to
Referring again to the devices 2, 2A-P, the following discussion relates to methods and devices for confirming that the device 2, 2A-P is in the proper orientation, that is, that the device 2, 2A-P has not shifted so that the nerve stimulating elements 6 have changed position. The devices 2, 2A-2P are initially positioned by the user in a known starting orientation so that the nerve stimulating elements 6 are positioned adjacent their intended targets for stimulation. The marker 81 (see
As mentioned above, the control system 18P may assess the current orientation of the device 2P automatically and reassign the nerve stimulating elements 6 as necessary without user input. In one aspect, the device 2P may include a sensor 270 coupled to the control system 18P for sensing a parameter, which relates to the orientation of the device 2P. The control system 18P may sample the same parameter periodically to confirm that the device 2P has not moved. As mentioned above, the parameter may be an electrical signal received at one or more nerve stimulating elements 6 and emitted by another nerve stimulating element 6. Alternatively, the parameter may be another electrophysiological parameter such as tissue impedance or may simply be a measure of native electrical activity. Depending upon the particular parameter selected, the control system 18P may also sense and store the parameter relating to the starting or desired orientation for comparison to the parameter sensed for the current orientation.
Referring to
The object 272 may be carried by the controller 24P. The controller 24P is positioned at the predetermined location relative to the body of the user and the control system 18P is used to transmit an instruction to the device 2P to assess the current orientation of the device 2P. To this end, the user simply positions the controller 24P at the predetermined location, such as the belly button, and the controller 24P is then used to transmit an instruction to the device 2P to assess the orientation of the device 2P. The sensor 270 (such as the magnetic sensor) senses the object 272 and determines the orientation of the device based on the sensed data.
The sensor 270 may be a gravity sensor. Similar to other methods described above, the controller 24P initiates assessing device orientation by using the controller 24P to send an instruction to the device 2P to assess the orientation of the device 2P. Prior to sending the instruction to the device 2P, the user first positions herself in a predetermined body position, such as lying flat on her back. The controller 24P is then used to send a signal to instruct the control system 18P of the device 2P to assess the orientation. At this time, the sensor 270 determines the current orientation of the device 2P. The control system 18P may compare the sensor 270 gravity related data for the current orientation to data (either stored data or sensed and saved data) relating to the starting orientation. To this end, the control system 18P may store data relating to the starting orientation in the same manner. The user will assume the predetermined body position, such as lying down, and then uses the controller 24P to instruct the device 2P to use the sensor 270 to obtain sensor data relating to the starting or intended orientation for comparison to the sensor data relating to the current orientation. The sensor 270 and object 272 may also switch positions with the sensor 270 mounted to the controller 24P and the object 272 mounted to the device 2P. For example, the object 272 may simply be a metallic part of the hub 56P and the sensor 270 may be a metallic sensor 270 mounted to the controller 24P. The controller 24P receives information from the sensor 270 to assess the current orientation of the device 2P. The control system 18P transmits a signal to the device 2P to reassign the nerve stimulating elements 6 in accordance with the current orientation of the device 2P if necessary.
Assessing the orientation of the device 2P may also be accomplished by using one or more of the implants 220, 220A, 220B of the present invention like an internal marker or reference point. When the device 2P and implant 220B are used together, the implant 220B may emit a signal detected by the sensor 270 to assess orientation of the device 2P. The device 2P may also use two or more sensors 270 to triangulate the sensor data . Two or more nerve stimulating elements 6 may also be used to sense the electrical activity of one or more of the implants 220B. The device 2P may sense any suitable parameter relating to electrical activity of the implant 220B.
Referring to
As mentioned herein, the nerve stimulating elements 6 may also be sensors (see sensors 270 and accompanying description). For example, when the nerve stimulating elements 6 include conductive electrodes the nerve stimulating elements 6 may be used to obtain ECG data. For this purpose, electrodes on opposing sides of the ring may be selected. Various other sensors have also been previously described in connection with the devices of the present invention and those sensors are also incorporated here.
Embodiments will also provide features designed to optimize data sensing and monitoring, which further permits integration of data sensing with delivery of therapy. Both the device surface and the nerve stimulating elements may contain sensors and/or sensing electrodes for measuring such variables as acoustics, pressure, temperature, flow, acceleration, and pH. Semiconductor and fibre technologies, such as stretched Mylar, may both be used. Thus, the sensors may be of piezoelectric fibers, allowing some, or all, of the surface of the device to provide sensing information, different conductive layers measuring different signals. Capacitive pressure sensing may utilize bioMEMS.
The device 400Q may include additional sensors as now described. A blood pressure sensor 409 extends along the main body 4Q on a side facing the central opening. The blood pressure sensor 409 is in communication with the control system 18Q. The blood pressure sensor 409 may include a material 411, and may be an elongate strip of material 413, that can produce the required pressure information. For example, the material 411 may produce an electrical signal when deformed or produce a change in electrical resistance similar to a strain gauge. Piezoelectric materials, and other materials which convert vibration to an electrical signal, may also be useful for the blood pressure sensor 409 as any other known method of obtaining blood pressure. The blood pressure sensor 409 is coupled to the main body 4Q and may be embedded in a thin-walled portion of the main body 4Q. Furthermore, as will be further explained below, the blood pressure sensor 409 may also be separate from the main body 4Q and in wireless communication with the control system 18Q.
The device 400Q may also include other sensors. For example, a chemical sensor 421 (shown schematically in dotted-line), may sense an ion concentration, a pH or conductivity, for example. Known micro-devices can be incorporated for these uses. Each of these uses is expressly incorporated for the chemical sensor 421. The material is drawn through valve 423 which prevents material from entering under atmospheric pressure. The chemical sensor 421 may lead to a collection 551 as described further below.
The sensor data derived with any of the sensors described herein may be used to determine whether a condition exists that will trigger a corresponding therapeutic response from the device 400Q. For example, the nerve stimulating step using the elements 6 may be altered in response to the condition being met. As used herein, the term sensor may refer to devices that directly measure and transmit raw data or to devices that process the data and perform additional calculations and/or estimations to achieve the “sensor data” without departing from the scope of the invention or meaning of the word “sensor” or “sensor data” as used herein. The sensor data is assessed to determine whether the condition exists to provide a therapeutic response by the control system 18.
The sensor may be provided separate from the main body 4Q and positioned outside the vagina when the main body 4Q is positioned in the vagina. For example, a sensor 425, which may be a blood pressure sensor for example, may communicate raw data to the control system 18Q and is worn on the wrist as shown in
The controller 424Q may include the sensor 423, such as the blood pressure sensor 425, as is known in the art. The controller 424Q may take any form described herein including a device worn on a limb, such as the arm and specifically wrist, and could be worn around the waist by simply lengthening a strap 427. Further, the controller 424Q may be used to control stimulation in any manner described herein. The controller 424Q is in wireless communication with control system 18Q. The sensor 425 may be coupled to at least one of the controller 424Q and to the main body 4Q. When coupled to the controller, the controller 424Q wirelessly communicates with the control system 18Q when the condition is determined to exist. As used herein, transmission of raw data to the control system 18Q shall be sufficient transmission of data when the data ultimately meets the condition warranting therapy in that the data still “controls” actions of the control system 18Q.
The device 400Q may include additional sensors such as a microphone 431. Magnetic actuators 433 are used to expand the main body 4Q, as described below, but may also act as microphones 431 to gather data by essentially listening or monitoring vibrations. For example, the microphone 431 may listen to respiration, heart beat, pulse and other suitable cardiovascular parameters. In a further specific example, the heart beat may be assessed to determine whether an arrhythmia condition exists. The condition could be related to heart rate, blood pressure, heart rate variability or any combination of factors with each factor being “related to” the condition.
The device 400Q may also include an optical sensor 441 which includes an emitter and receiver (not shown) to provide blood flow, pulse and heart rate data among other known values that may be derived from an optical sensor as is known in the art. A temperature sensor 443, in the form of a small wire probe 445, may also provide core body temperature. Other previously mentioned sensors, such as an accelerometer, may also be used here and such uses are expressly incorporated.
The sensors of the present invention may determine quantitative values or may be used to assess and determine changes in values rather than precise amounts. To this end, the condition may be based, at least in part, upon a baseline condition. Further, this condition may be based on a measurement taken at a prior time. For example, the condition may be determined with the measurement being taken by the same sensor related to the condition at a prior time. In another specific example, the sensor senses the heart beat for a period of time to obtain heartbeat data. The heart beat data is used to determine whether a heart beat variability of the heart beat data meets the condition. The heart beat variability may include a baseline for comparison from previously calculated heart beat variability at a prior time.
In another aspect of the device of 400Q, the device may include the collection reservoir 551 coupled to the main body 4Q. The collection reservoir 551 is configured to hold and collect material, including target material such as a microbe, from the vagina. The material may be assessed by the device 400Q itself. For example, the device 400Q may use the chemical sensor 421, such as a pH sensor. A low-pressure source 556 (at a pressure less than atmospheric pressure) is in fluid communication with the collection reservoir 551 to assist in drawing material into the material reservoir. A regulating valve 555 regulates pressure to control intake of the material into the collection reservoir 551. A small valve, such as a duck-bill valve, (not shown) prevents material from entering the collection reservoir under atmospheric pressure.
In still another aspect, a therapeutic material may also be delivered as now described based upon the sensor data meeting the particular condition. The therapeutic material 459 may be coupled to the main body 4Q of the device 400Q and held in a material reservoir 461. The therapeutic material 459 is delivered to the vagina by repositioning the device 400Q in the vagina once the therapeutic material is coupled to the main body 4Q such as by delivering the therapeutic material 459 into the material reservoir 461, by syringe or the like, or coupling the material reservoir 461 to the main body 4Q when the material reservoir 461 is removable and replaceable.
The main body 4Q includes a first expandable portion 571 to increase a first dimension on the main body 4Q. The main body 4Q has a central axis CA with the first expandable portion 571 increasing the first dimension in a transverse direction to the central axis (or cervical axis CVA). Stated another way, the first expandable portion 571 increases a peripheral length of the main body 4Q when viewed along the central axis CA.
The main body 4Q may also have a second expandable portion 573 which also increases the first dimension, such as the peripheral length, when expanded. Alternatively, the second expandable portion may reduce the size of the central opening 426 when expanded. A third expandable portion 575 may be provided in parallel to the second expandable portion 573 to increase the force exerted. Furthermore, the second and third expandable portions 573, 575 may expand radially inward or outward.
The first, second and third expandable portions 571, 573, 575 are driven by magnetic actuators as is known in the art. The magnetic actuators each have two 579 arms extending to a common cross-member 561 supported by the two arms 579. The cross-members 561 may be embedded in a sidewall of the main body 4Q. A side slot 563 permits the second and third actuators 573, 575 to become slightly recessed to accommodate the opposing motion. Alternatively, the arms 579 may include telescoping elements (not shown) that permit the arms to extend rather than providing the side slot 563. The expandable portions 571, 573, 575 may be used to stretch the vaginal walls, which are believed to have therapeutic effect.
In another aspect of the present invention, the device 400Q may be used to deliver a therapeutic material. The material reservoir 461 containing the therapeutic material 459 may be coupled to the main body 4Q. Any one of the sensors described herein, such as the optical sensor, may be used to obtain sensor data. The sensor data is used to determine whether a condition exists from the data in the sensing step. If so, the therapeutic material 459 may be delivered. For example, the sensor may be a pH sensor, which determines whether a pH condition is met. The control system may control the delivery of the therapeutic material in appropriate amounts based upon, for example, the pH measurement by the pH sensor. One such clinical application for local (intravaginal) drug delivery would involve titrating the dose and delivery of vaginal estrogen to the pH of the vagina in postmenopausal women with atrophic vaginitis. In premenopausal women the vagina is relatively acidic. Healthy vaginal flora is rich with estrogen responsive Lactobacilli. Lactobacilli make lactic acid and keep the vaginal pH approximately 3.8 to 4.5. In menopause the flora changes, as estrogen dependent Lactobacilli fail to thrive. As a result the vaginal pH rises in menopause, generally above 5.0 and potentially to 7.5. 40% of postmenopausal women suffer from atrophic vaginitis symptoms. Vaginal hormone, such as estrogen, is an effective treatment. However, many women are hesitant to use even low dose estrogen out of concern for the known risks. Currently the dosing is not very individualizable, as standard doses are used. The vaginal device described could periodically assess vaginal pH and adjust estrogen dosing and delivery such that the user receives the lowest dose of estrogen required to maintain a healthy vaginal pH. In this manner, the pH of the vagina may be altered with the therapeutic material.
Thus, a few of the numerous applications of the insert and/or reservoir are now briefly provided. pH can be measured by a sensor and a rise in pH treated with dose-controlled estrogen. Cytology collection allows for study of cell biology, and application of therapeutic material. Collection of vaginal flora (that part of the microbiome that inhabits the vaginal cavity) allows for analysis of microbes and delivery of therapeutic material, for example related to infection.
In another embodiment of the closed-loop sensing and treatment of a parameter, the device described may treat systemic parameters. For example, the device may sense blood pressure (measured with a sensor on the controller or on the main body), heart rate or heart rate rhythm and dispense an appropriate amount of therapeutic material to alter that parameter. For example, the therapeutic material being selected to alter at least one of a heart rate and a heart rhythm. The parameters for treatment response would be based on a predetermined and programmed algorithm. The device could sense and interpret parameter response to the drug, assuring that dosing is appropriately titrated to response.
The vaginal wall is permeable via diffusion, paracellular tight junction mediated mechanisms, and receptor or vesicular transport mechanisms. Chemical polymers may also aid in macromolecule delivery through the vaginal wall. Advantages to vaginal delivery of systemic drugs include the absorptive wall, which is more permeable than external skin, has a rich arterial and venous blood supply, and avoids first-pass metabolism.
This ability of the device 2A-P to utilize sensors and other means to assess and automatically adjust orientation based on measured parameters allows for much wider use of sensors by the device to monitor bodily parameters. As mentioned above, sensors on the device 2A-P may be one or more of the nerve stimulating elements or may be independent elements. The sensors used may include some of the sensors mentioned in the above discussion of orientation, but may also include any other sensors, biosensors, and transducers known in the art. These sensors may communicate with other sensors on the device 2A-P itself, with sensors on an object which is independent of or integrated into the controller as described above (that controller being separate from or part of a user's personal device, such as a smartphone), and with sensors on other medical and computing devices. The sensors may include transducers, converting energy between forms.
This ability to compare and communicate sensor data provides numerous advantages. On the one hand, some important parameters are accessible from the location of the device 2A-P in the vaginal fornices, but not accessible from external devices, such as those worn by a user. In other words, the device 2A-P is uniquely positioned in the core of the body. Therefore, the device 2A-P has access to such measurements as core body temperature, and can sense tissue and bodily fluids in its internal bodily environment. On the other hand, there are other parameters measured by the device 2A-P, which can also be measured by other devices positioned internal or external to the body. For example, the user may be wearing a device with sensors, which can make measurements from an external location through the skin. This allows for comparing and triangulating data from device 2A-P to provide information beyond that available from the externally-worn device alone. Device 2A-P can also draw on other historical data. All data sensed by device 2A-P can be integrated into complementary diagnostic and therapeutic functions.
The control systems 242, 242B of the devices 2, 2A-2N and/or the handheld controller 24 may record data regarding treatment regimens including start and end times, nerve stimulating elements used, resistance, current, frequency, disruption of therapy and any changes made to a regimen. The user will also be able to record subjective and objective information, which will be used to adjust and tailor future regimens to her specific needs. For example, if she has a good response to a certain regimen she may note it at the end of a day or predetermined assessment period. In this case, the regimen will be maintained or she may opt to decrease stimulation intensity towards the threshold of benefit.
The user may also note when she experiences a side effect. By reviewing the treatment regimen (including current, frequency of stimulation, active electrodes and duration of therapy) employed during the time the side effect was experienced, she and her healthcare team will be able to change the stimulation setting or redirect therapy to another target structure altogether.
The user may record experiences using the controller 24 or via free text respond to periodic questions or standardized questionnaires and bladder diaries. All data will be recorded and downloadable to computers and portable devices, such as phones. In one aspect, the user's personal device (ie., phone) may reprogram the controller 24 and alter the regimen. If the patient desires and consents, this objective, subjective and regimen data may be transmitted electronically for remote assessment by healthcare providers or for research purposes.
The present invention may be used to treat a number of different conditions such as urge, frequency, nocturia, urge incontinence, stress incontinence, loss of urine without sensory awareness, bladder pain, urethral pain, urethral syndrome, urinary hesitancy, pelvic floor dyssynergia, interstitial cystitis, dysuria, overactive bladder, urinary retention, hesitancy, protracted urinary stream, dysmenorrhea, pelvic pain, pelvic venous congestion syndrome, endometriosis, irritable bowel syndrome, constipation, fecal urgency, fecal incontinence, rectal pain, pain with defecation, and anal pain. The conditions that may be treated extend to sympathetic tone, cardiovascular function, sexual function, and other conditions related to autonomic nerves. Of course, other uses of the present invention may become apparent without departing from the scope of the invention.
The present invention has been described in connection with preferred embodiments but it is understood that numerous modifications could be made to the preferred embodiments without departing from the scope of the invention. For example, the main body could be V-shaped or the nerve stimulating element could be a coil through which a current is passed to induce a magnetic field without departing from numerous aspects of the present invention.
Claims
1. A method of stimulating nerves adjacent a vaginal canal, comprising the steps of:
- positioning a device in the vagina, the device including a main body and a first nerve stimulating element coupled to the main body;
- stimulating nerves adjacent the vaginal canal using the first nerve stimulating element.
2. The method of claim 1, wherein:
- the stimulating step is carried out by stimulating nerves with the first nerve stimulating element sufficiently to change a signal transmitted by the nerves to associated nerves.
3. The method of claim 1, wherein;
- the stimulating step is carried out with the nerves being a first target nerve plexus selected from the group of nerve plexuses consisting of the vesical plexus, the inferior hypogastric plexus and the Frankenhauser's plexuses.
4. The method of claim 1, wherein:
- the positioning step is carried out with the device having a second nerve stimulating element; and
- the stimulating step is carried out with the second nerve stimulating element stimulating a second target plexus selected from the group of nerve plexuses consisting of the vesical plexus, the inferior hypogastric plexus and the Frankenhauser's plexuses, the second target plexus being different from the first target nerve plexus.
5. The method of claim 1, wherein:
- the positioning step is carried out with the nerve stimulating element being positioned to stimulate an autonomic plexus without intervening somatic nerves.
6. The method of claim 1, wherein:
- the positioning step is carried out with the device positioned in the vaginal fornices, the vaginal fornices being a space between the cervix and the vagina and bounded by a plane extending through a distal end of the cervix and perpendicular to a cervical axis, the first nerve stimulating element contacting the surface of the vaginal canal proximal to the distal end of the cervix.
7. The method of claim 1, wherein:
- the positioning step is carried out with a plurality of nerve stimulating elements, wherein all of the nerve stimulating elements are positioned in the vaginal fornices.
8. The method of claim 1, wherein:
- the positioning step is carried out with the main body having a central opening, the cervix being positioned in the central opening and the main body extending around at least 180 degrees of the cervix relative to a cervical axis.
9. The method of claim 1, wherein:
- the positioning step is carried out with the main body extending at least 270 degrees around the cervix.
10. The method of claim 1, wherein:
- the positioning step is carried out with the main body extending completely around the cervix.
11. The method of claim 1, wherein:
- the positioning step is carried out with a second nerve stimulating element, wherein the first and second nerve stimulating elements having proximal surface, wherein the proximal surface of the first and second nerve stimulating elements are longitudinally spaced relative to a cervical axis of the body by no more than 1 cm.
12. The method of claim 1, wherein:
- the positioning step is carried out with at least eight nerve stimulating elements, wherein each nerve stimulating element has a proximal surface, wherein the proximal surface of all eight nerve stimulating elements are longitudinally spaced relative to a central axis of the body by no more than 1 cm.
13. The method of claim 1, wherein:
- the stimulating step is carried out to treat at least one condition from the conditions consisting of urge, frequency, nocturia, urge incontinence, stress incontinence, loss of urine without sensory awareness, bladder pain, urethral pain, urethral syndrome, urinary hesitancy, pelvic floor dyssynergia, interstitial cystitis, dysuria, overactive bladder, urinary retention, hesitancy, protracted urinary stream, dysmenorrhea, pelvic pain, pelvic venous congestion syndrome, endometriosis, irritable bowel syndrome, constipation, fecal urgency, fecal incontinence, rectal pain, pain with defecation, and anal pain.
14. A system for stimulating nerves adjacent a vaginal canal, the system comprising:
- a main body having an exterior surface; and
- a first nerve stimulating element coupled to the main body and positioned on the exterior surface of the main body to contact an exposed surface of a vaginal canal when the main body is positioned in the vaginal canal; and
- a power source coupled to the main body;
- a control system coupled to the power source and the first nerve stimulating element.
15. The system of claim 14, wherein:
- the first nerve stimulating element is configured to stimulate nerves sufficiently to change a signal transmitted by the nerves to associated nerves
16. The system of claim 14, wherein;
- the nerve stimulating element is positioned on the main body to stimulate a first target nerve plexus selected from the group of nerve plexuses consisting of the vesical plexus, the inferior hypogastric plexus and the Frankenhauser's plexuses when the main body is positioned in the vagina.
17. The system of claim 14, wherein:
- the first nerve stimulating element is positioned on the main body so that no intervening somatic nerves are positioned between the first nerve stimulating element and a first target plexus when the main body is positioned in the vagina.
18. The system of claim 14, further comprising:
- at least two nerve stimulating elements, wherein at least one nerve stimulating element is positioned on a left side of a midline and at least one nerve stimulating element is positioned on a right side of the midline.
19. The system of claim 14, further comprising:
- a controller separate from the main body, the controller being positioned outside the body when the main body is positioned in the vagina.
20. The system of claim 19, wherein:
- the controller is configured to communicate with the control system, the controller controlling a duration of stimulation and an intensity of stimulation.
21. The system of claim 14, wherein:
- the main body is sized and shaped to be positioned in the vaginal fornices, the vaginal fornices being a space between the cervix and the vagina and bounded by a plane extending through a distal end of the cervix and perpendicular to a cervical axis, the first nerve stimulating element contacting the surface of the vaginal canal proximal to the distal end of the cervix.
22. The system of claim 14, further comprising:
- a plurality of nerve stimulating elements, wherein all of the nerve stimulating elements are positioned in the vaginal fornices.
23. The system of claim 14, wherein:
- the main body is sized and shaped to be positioned entirely within the vaginal fornices.
24. The system of claim 14, wherein:
- the main body has a central opening in which the cervix is positioned, the main body extending around at least 180 degrees of the cervix relative to a cervical axis when the main body is positioned in the vagina.
25. The system of claim 14, wherein:
- the main body extends at least 270 degrees around the cervix.
26. The system of claim 14, wherein:
- the control system is configured to actuate the first nerve stimulating element to treat a condition from the conditions consisting of urge, frequency, nocturia, urge incontinence, stress incontinence, loss of urine without sensory awareness, bladder pain, urethral pain, urethral syndrome, urinary hesitancy, pelvic floor dyssynergia, interstitial cystitis, dysuria, overactive bladder, urinary retention, hesitancy, protracted urinary stream, dysmenorrhea, pelvic pain, pelvic venous congestion syndrome, endometriosis, irritable bowel syndrome, constipation, fecal urgency, fecal incontinence, rectal pain, pain with defecation, and anal pain.
27. The system of claim 14, wherein:
- the control system includes means for orienting the device about the cervix using the nerve stimulating elements.
28. The system of claim 27, wherein:
- the orienting means includes at least one of the nerve stimulating elements emitting energy and at least one other of the nerve stimulating elements measuring the energy emitted.
29. The system of claim 27, wherein:
- the orienting means is coupled to the control system, the control system recognizing a pattern in a parameter using the nerve stimulating elements, the pattern being used to orient the device about the cervix
30. The method of claim 1, further comprising the step of:
- orienting the device about the cervix using the nerve stimulating elements.
31. The method of claim 1, wherein:
- the positioning step is carried out with the device including a second nerve stimulating element coupled to the main body;
- the stimulating step being carried out with the first nerve stimulating element stimulating nerves adjacent the vagina, and the second nerve stimulating element is positioned to stimulate nerves on an opposing side of the cervix from the first nerve stimulating element when viewed along a cervical axis.
32. The system of claim 14, wherein:
- the main body includes a recess;
- the first nerve stimulating element being positioned in the recess in the main body.
33. The system of claim 32, wherein:
- the main body includes at least four recesses; and
- at least four nerve stimulating elements each positioned in one of the recesses.
34. The system of claim 32, further comprising:
- a plurality of nerve stimulating elements; and
- the main body having a non-conductive wall extending outwardly relative to the recess, the non-conductive wall positioned between adjacent nerve stimulating elements.
35. The system of claim 32, wherein:
- the main body includes a reservoir, the reservoir being fluidly coupled to the recess.
36. The system of claim 14, further comprising:
- a first implant having a first body, a first implant nerve stimulating element coupled to the first body, and a first control system coupled to the first body, the first implant configured to be secured adjacent a uterosacral ligament so that the first implant nerve stimulating element is in contact with the uterosacral ligament.
37. The system of claim 36, wherein:
- the first body has a first throughhole sized to receive the uterosacral ligament.
38. The system of claim 37, wherein:
- the first body is movable from an open position to a locked position, the first body having a slot leading to the first throughhole when the first body is in the open position through which the uterosacral ligament is introduced, the locked position preventing the uterosacral ligament from moving out of the throughhole.
39. The system of claim 38, wherein:
- the slot is reduced in size when the first body moves from the open position to the locked position thereby securing the first body to the uterosacral ligament.
40. The system of claim 38, wherein:
- the first implant nerve stimulating element is positioned within the first throughhole so that the first implant nerve stimulating element is in contact with the uterosacral ligament.
41. The system of claim 36, wherein:
- the first implant includes a first power source coupled to the first body, the first control system being coupled to the first power source and the first implant nerve stimulating element.
42. The system of claim 36, wherein:
- the first implant nerve stimulating element is configured to stimulate nerves sufficiently to change a signal transmitted by the nerves to associated nerves and nerve endings.
43. The system of claim 36, further comprising:
- a second implant nerve stimulating element coupled to the first body, the second implant nerve stimulating element positioned to apply nerve stimulus at a different position along the uterosacral ligament than the first nerve stimulating element when the first body is secured adjacent to the uterosacral ligament.
44. The system of claim 36, wherein:
- the control system communicates with the first control system of the first implant.
45. The system of claim 36, wherein:
- the control system and the first control system communicate to coordinate simultaneous stimulation using the first nerve stimulating element and the first implant nerve stimulating element.
46. The system of claim 36, wherein:
- the control system and the first control system communicate to coordinate independent stimulation using the first nerve stimulating element and the first implant nerve stimulating element.
47. The system of claim 36, wherein:
- the first implant includes a second implant nerve stimulating element.
- the first body has a tubular shape with an outer surface, the second nerve stimulating element being positioned along the outer surface of the first body so that the second nerve stimulating element is in contact with the peritoneum.
48. The system of claim 14, further comprising:
- a second nerve stimulating element coupled to the main body; and
- a third nerve stimulating element coupled to the main body;
- the first nerve stimulating element, the second nerve stimulating element and the third nerve stimulating element being positioned to stimulate at least three nerve plexuses selected from the group of plexuses consisting of SHP, IHP, L vesicle, R vesicle, L Frankenhauser's, and R Frankenhauser's.
49. The system of claim 48, wherein:
- the first nerve stimulating element, the second nerve stimulating element and the third nerve stimulating element coordinate stimulation to alter sympathetic tone.
50. The system of claim 36, wherein:
- the first implant includes a third implant nerve stimulating element coupled to the first body and positioned within the first throughhole so that the third implant nerve stimulating element contacts the uterosacral ligament when the uterosacral ligament is positioned in the first throughhole.
51. The system of claim 50, further comprising:
- a fourth implant nerve stimulating element coupled to the first body and positioned along the outer surface of the first body and spaced apart from the second implant nerve stimulating element.
52. The system of claim 36, further comprising;
- a second implant having a second body with an outer surface, the second implant having a fifth implant nerve stimulating element coupled to the second body.
53. The system of claim 51, wherein:
- the second implant includes a second power source coupled to the second body and a second control system coupled to the fifth implant nerve stimulating element.
54. The system of claim 51, wherein:
- the second body of the second implant has a second throughhole, the second body being movable from an open position to a locked position, the second body having a slot leading to the second throughhole so that the uterosacral ligament may enter the throughhole when the second body is in the open position.
55. The system of claim 54, wherein:
- the slot is reduced in size when the second body moves from the open position to the locked position thereby preventing the uterosacral ligament from moving out of the second throughhole.
56. The system of claim 54, wherein:
- the fifth implant nerve stimulating element of the second implant is positioned within the second throughhole so that the fifth implant nerve stimulating element is in contact with the uterosacral ligament when the second body is secured adjacent to the uterosacral ligament.
57. The system of claim 51, further comprising:
- a sixth implant nerve stimulating element coupled to the second body of the second implant, the second body having a generally tubular shape with an outer surface, the sixth implant nerve stimulating element being positioned along the outer surface of the second body.
58. The system of claim 53, further comprising:
- a seventh implant nerve stimulating element coupled to the second body and positioned within the second throughhole so that the seventh implant nerve stimulating element contacts the uterosacral ligament when the uterosacral ligament is positioned in the second throughhole.
59. The system of claim 51, further comprising:
- an eighth implant nerve stimulating element coupled to the second body of the second implant and positioned along the outer surface of the second body spaced apart from the sixth implant nerve stimulating element.
60. The system of claim 51, wherein:
- the first implant and the second implant are sized to be positioned adjacent one another on the same uterosacral ligament.
61. The system of claim 59, further comprising;
- a third implant having a nerve stimulating element configured to be secured to the other uterosacral ligament opposite the uterosacral ligament that the first nerve stimulating element is in contact with.
62. The system of claim 60, further comprising:
- a fourth implant having a nerve stimulating element;
- the third and fourth implants are configured to be secured adjacent the same uterosacral ligament different from the uterosacral ligament that the first nerve stimulating element is in contact with.
63. The system of claim 51, wherein:
- the first implant is configured to be positioned and secured adjacent one uterosacral ligament; and
- the second implant is configured to be positioned and secured adjacent the other uterosacral ligament.
64. The system of claim 63, wherein:
- at least one of the first control system of the first implant and the second control system of the second implant communicates with the other control system to coordinate stimulation using the first and second implants.
65. The system of claim 64, wherein:
- the first and second control systems communicate using the first implant nerve stimulating element and the second implant nerve stimulating element.
66. The system of claim 64, wherein:
- at least one of the first and second control systems communicates with the other control system to coordinate simultaneous application of nerve stimulus by the first implant nerve stimulating element and the second implant nerve stimulating element.
67. The system of claim 64, wherein:
- the first and second control systems communicate to coordinate independent stimulation using the first implant nerve stimulating element and the second implant nerve stimulating element.
68. The system of claim 51, further comprising:
- a controller separate from the main body, the controller being positioned outside the patient's body when the main body is positioned in the vagina,
- the controller being configured to communicate with the control system coupled to the main body.
69. The system of claim 68, wherein:
- the controller is configured to communicate with the control system to control a duration of stimulation and an intensity of stimulation for the first nerve stimulating element.
70. The system of claim 68, wherein:
- the controller is configured to communicate stimulation instructions for the first control system of the first implant to the control system coupled to the main body;
- the control system coupled to the main body being configured to communicate the stimulation instructions to the first control system of the first implant.
71. The system of claim 69, wherein:
- the controller is configured to communicate instructions directly to the first control system of the first implant.
72. The system of claim 36, further comprising:
- a second nerve stimulating element coupled to the main body;
- the first nerve stimulating element, the second nerve stimulating element and the first implant nerve stimulating element being positioned to stimulate at least three nerve plexuses selected from the group of plexuses consisting of SHP, IHP, L vesicle, R vesicle, L Frankenhauser's, and R Frankenhauser's.
73. The system of claim 72, wherein:
- the first nerve stimulating element, the second nerve stimulating element and the first implant nerve stimulating element coordinate stimulation to alter sympathetic tone.
74. The system of claim 36, wherein:
- the first implant nerve stimulating element is positioned to stimulate the IHP.
75. The system of claim 74, wherein:
- the first nerve stimulating element is positioned to stimulate a side of the Frankenhauser's plexus.
76. The system of claim 74, further comprising:
- a second nerve stimulating element coupled to the main body, the second nerve stimulating element being positioned to stimulate the Frankenhauser's plexus on a side opposite from the first nerve stimulating element relative to a midline.
77. The system of claim 74, wherein:
- the first nerve stimulating element is positioned to stimulate a side of the vesicle plexus.
78. The system of claim 74, further comprising:
- a second nerve stimulating element coupled to the first body and positioned to stimulate a side of the vesicle plexus opposite the first nerve stimulating element relative to a midline.
79. The system of claim 51, wherein:
- the first implant nerve stimulating element is positioned to stimulate the SHP.
80. The system of claim 79, wherein:
- the first nerve stimulating element is positioned to stimulate a side of the Frankenhauser's plexus.
81. The system of claim 79, further comprising:
- a second nerve stimulating element coupled to the first body and positioned to stimulate a side of the Frankenhauser's plexus opposite the first nerve stimulating element relative to a midline.
82. The system of claim 79, wherein:
- the first nerve stimulating element is positioned to stimulate a side of the vesicle plexus.
83. The system of claim 82, further comprising:
- a second nerve stimulating element positioned to stimulate a side of the vesicle plexus opposite the first nerve stimulating element relative to a midline.
84. The method of claim 1, further comprising the step of:
- providing a first implant having a first body, a first implant nerve stimulating element coupled to the body, and a first implant control system coupled to the first body.
85. The method of claim 84, further comprising the step of stimulating nerves with the first implant nerve stimulating element.
86. The method of claim 85, further comprising the step of:
- securing the first implant adjacent to a uterosacral ligament so that the first implant nerve stimulating element is in contact with the uterosacral ligament.
87. The method of claim 84, wherein:
- the providing step is carried out with the first body having a throughhole sized to receive the uterosacral ligament.
88. The method of claim 87, wherein:
- the providing step is carried out with the first body being movable from an open position to a locked position, the body having a slot leading to the throughhole when the body is in the open position through which the uterosacral ligament is introduced, the locked position preventing the uterosacral ligament from moving out of the throughhole.
89. The method of claim 88, wherein:
- the providing step is carried out with the first body having a slot which is reduced in size when the body moves from the open position to the locked position thereby securing the first body to the uterosacral ligament.
90. The method of claim 87, wherein:
- the providing step is carried out with the first implant nerve stimulating element positioned within the throughhole so that the first implant nerve stimulating element is in contact with the uterosacral ligament.
91. The method of claim 84, wherein:
- the providing step is carried out with the first implant including a first implant power source coupled to the first body, the first control system being coupled to the first implant power source and the first implant nerve stimulating element.
92. The method of claim 84, wherein:
- the stimulating step is carried out with the first implant stimulating nerves sufficiently to change a signal transmitted by the nerves to associated nerves and nerve endings.
93. The method of claim 84, wherein:
- the providing step is carried out with the first implant having a second implant nerve stimulating element coupled to the first body, the second implant nerve stimulating element positioned to apply nerve stimulus at a different position along the uterosacral ligament from the first nerve stimulating element when the first body is secured adjacent to the uterosacral ligament.
94. The method of claim 84, wherein:
- the providing step is carried out with the control system coupled to the first nerve stimulating element configured to communicate with the control system coupled to the first implant nerve stimulating element to coordinate nerve stimulation using the first nerve stimulating element and the first implant nerve stimulating element.
95. The method of claim 94, wherein:
- the providing step is carried out with the control system configured to communicate with the first control system of the first implant using the first nerve stimulating element and the first implant nerve stimulating element.
96. The method of claim 94, wherein:
- the providing step is carried out with the control system and the first control system configured to communicate to coordinate simultaneous stimulation using the first nerve stimulating element and the first implant nerve stimulating element.
97. The method of claim 94, wherein:
- the providing step is carried out with the control system and the first control system configured to communicate to coordinate independent stimulation using the first nerve stimulating element and the first implant nerve stimulating element.
98. The method of claim 84, wherein:
- the providing step is carried out with the first implant including a second implant nerve stimulating element.
99. The method of claim 98, wherein:
- the providing step is carried out with the first body having an outer surface, the second nerve stimulating element being positioned along the outer surface of the first body so that the second nerve stimulating element is in contact with the peritoneum.
100. The method of claim 98, wherein:
- the providing step is carried out with the first implant including a third implant nerve stimulating element coupled to the first body and positioned within the first throughhole so that the third implant nerve stimulating element contacts the uterosacral ligament when the uterosacral ligament is positioned in the first throughhole.
101. The method of claim 98, wherein:
- the providing step is carried out with the first implant having a fourth implant nerve stimulating element coupled to the first body and positioned along the outer surface of the first body and spaced apart from the second implant nerve stimulating element.
102. The method of claim 84, wherein;
- the providing step is carried out with a second implant having a second body with an exterior surface, the second implant having a fifth implant nerve stimulating element coupled to the second body.
103. The method of claim 102, further comprising:
- securing the second implant to the patient so that the fifth nerve stimulating element is in contact with a uterosacral ligament.
104. The method of claim 102, wherein;
- the securing step is carried out with the first and second implants positioned adjacent the same uterosacral ligament.
105. The method of claim 102, wherein:
- the securing step is carried out with the first implant secured to the patient adjacent one uterosacral ligament and the second implant being secured to the patient adjacent the other uterosacral ligament.
106. The method of claim 102, wherein:
- the providing step is carried out with the second implant including a second control system coupled to the fifth implant nerve stimulating element.
107. The method of claim 102, wherein:
- the providing step is carried out with the second body of the second implant having a second throughhole, the second body being movable from an open position to a locked position, the second body having a second slot leading to the second throughhole when the second body is in the open position.
108. The method of claim 107, wherein:
- the providing step is carried out with the second slot reducing in size when the second body moves from the open position to the locked position thereby preventing the uterosacral ligament from moving out of the second throughhole.
109. The method of claim 107, wherein:
- the providing step is carried out with the fifth implant nerve stimulating element of the second implant positioned within the second throughhole so that the fifth implant nerve stimulating element is in contact with the uterosacral ligament when the second body is secured to the uterosacral ligament.
110. The method of claim 107, wherein:
- the providing step is carried out with the second implant having a sixth implant nerve stimulating element coupled to the second body, the second body having a generally tubular shape with an outer surface, the sixth implant nerve stimulating element being positioned along the outer surface of the second body.
111. The method of claim 107, wherein:
- the providing step is carried out with the second implant having a seventh implant nerve stimulating element coupled to the second body and positioned within the second throughhole so that the seventh implant nerve stimulating element contacts the uterosacral ligament when the uterosacral ligament is positioned in the second throughhole.
112. The method of claim 84, wherein:
- the securing step is carried out with the implant positioned on an anterior side of the uterosacral ligament;
- the positioning step is carried out with the first nerve stimulating element positioned adjacent the vesicle plexus;
- the stimulating step being carried out with the first nerve stimulating element stimulating the vesicle plexus simultaneous with the first implant nerve stimulating element to treat urinary urgency.
113. The method of claim 102, wherein:
- the providing step is carried out with the first implant and the second implant sized to be positioned adjacent the same uterosacral ligament; and
- the securing step is carried out by securing the first and second implants adjacent to the same uterosacral ligament.
114. The method of claim 106, wherein:
- the providing step is carried out with a third implant having a nerve stimulating element configured to be secured adjacent a uterosacral ligament opposite the uterosacral ligament that the first nerve stimulating element is secured adjacent.
115. The method of claim 114, wherein:
- the providing step is carried out with a fourth implant having a nerve stimulating element sized to be secured adjacent the same uterosacral ligament as the third nerve stimulating element
116. The method of claim 115, further comprising the step of:
- securing the third implant and the fourth implant adjacent to the same uterosacral ligament which is different from the uterosacral ligament that the first implant is secured to.
117. The method of claim 1, further comprising the step of:
- providing a second nerve stimulating element and a third nerve stimulating element both coupled to the main body;
- the positioning step is carried out so that the first nerve stimulating element, the second nerve stimulating element and the third nerve stimulating element are positioned to stimulate at least three nerve plexuses selected from the group of plexuses consisting of SHP, IHP, L vesicle, R vesicle, L Frankenhauser's, and R Frankenhauser's; and
- the stimulating step being carried out with the first nerve stimulating element, the second nerve stimulating element and the third nerve stimulating element coordinating stimulation to alter sympathetic tone.
118. The method of claim 106, further comprising the step of:
- communicating information between the first control system of the first implant and the second control system of the second implant.
119. The method of claim 118, wherein:
- the communicating step is carried out with the first and second control systems communicating using at least one nerve stimulating element coupled to the first body and at least one nerve stimulating element coupled to the second body.
120. The method of claim 106, wherein:
- the communicating step is carried out so that at least one of the first and second control systems communicates with the other control system to coordinate simultaneous stimulation with the first implant nerve stimulating element and the fifth implant nerve stimulating element.
121. The method of claim 106, wherein:
- the communicating step is carried out with the first and second control systems communicating to coordinate independent stimulation using the first nerve stimulating element and the fifth nerve stimulating element.
122. The method of claim 106, wherein;
- the communicating step is carried out with a controller separate from the main body, the controller being positioned outside the patient's body when the main body is positioned in the vagina, the controller being configured to communicate control information to the control system.
123. The method of claim 122, wherein:
- the communicating step is carried out with the controller communicating with the control system to control a duration of stimulation and an intensity of stimulation.
124. The method of claim 122, wherein:
- the communicating step is carried out with the controller configured to communicate stimulation instructions for the first implant to the control system coupled to the main body, the control system receiving the stimulation instructions for the first implant from the controller and subsequently communicating the stimulation instructions to the first control system of the first implant.
125. The method of claim 122, wherein:
- the communicating step is carried out with the controller configured to communicate stimulation instructions directly to the first control system of the first implant.
126. The method of claim 84, wherein:
- the providing step is carried out with a second nerve stimulating element coupled to the main body;
- the securing steps are carried out so that the first nerve stimulating element, the second nerve stimulating element and the first implant nerve stimulating element are positioned to stimulate at least three nerve plexuses selected from the group of plexuses consisting of SHP, IHP, L vesicle, R vesicle, L Frankenhauser's, and R Frankenhauser's.
127. The method of claim 126, wherein:
- the stimulating step is carried out with the first nerve stimulating element, the second nerve stimulating element and the first implant nerve stimulating element coordinating stimulation to alter sympathetic tone.
128. The method of claim 126, wherein:
- the securing step is carried out with the first implant nerve stimulating element positioned to stimulate the IHP.
129. The method of claim 128, wherein:
- the securing step is carried out so that the first nerve stimulating element is positioned to stimulate a side of the Frankenhauser's plexus.
130. The method of claim 129, wherein:
- the securing step is carried out so that the second nerve stimulating element is positioned to stimulate the Frankenhauser's plexus on a side opposite the first nerve stimulating element relative to a midline.
131. The method of claim 128, wherein:
- the securing step is carried out so that the first nerve stimulating element is positioned to stimulate a side of the vesicle plexus.
132. The method of claim 131, wherein:
- the securing step is carried out with the second nerve stimulating element positioned to stimulate a side of the vesicle plexus opposite the first nerve stimulating element relative to a midline.
133. The method of claim 126, wherein:
- the securing step is carried out so that the first implant nerve stimulating element is positioned to stimulate the SHP.
134. The method of claim 133, wherein:
- the securing step is carried out so that the first nerve stimulating element is positioned to stimulate a side of the Frankenhauser's plexus.
135. The method of claim 134, wherein:
- the securing step is carried out so that the second nerve stimulating element is positioned to stimulate a side of the Frankenhauser's plexus opposite the first nerve stimulating element relative to a midline.
136. The method of claim 133, wherein:
- the securing step is carried out so that the first nerve stimulating element is positioned to stimulate a side of the vesicle plexus.
137. The method of claim 136, wherein:
- the securing step is carried out so that the second nerve stimulating element is positioned to stimulate a side of the vesicle plexus opposite the first nerve stimulating element relative to a midline.
138. A method of nerve stimulation, comprising the steps of:
- providing a first implant having a first body and a first nerve stimulating element coupled to the first body, the first nerve stimulating element being configured to stimulate nerves;
- forming an access opening in the patient leading to the peritoneum;
- creating an opening in the peritoneum to expose a uterosacral ligament;
- securing the first implant to the patient so that the first nerve stimulating element is in contact with the uterosacral ligament; and
- stimulating nerves using the first nerve stimulating element.
139. The method of claim 138, wherein:
- the securing step is carried out with the first implant secured directly to the uterosacral ligament beneath the peritoneum.
140. The method of claim 138, further comprising the step of:
- sizing the uterosacral ligament before the securing step; and
- selecting the first implant after the sizing step based upon a size of the uterosacral ligament.
141. The method of claim 138, wherein:
- the providing step is carried out with the first implant also having a first power source coupled to the first body and a first control system, the first control system being coupled to the first power source and the first nerve stimulating element.
142. The method of claim 138, wherein:
- the stimulating step is carried out with the first nerve stimulating element configured to stimulate nerves sufficient to change a signal transmitted by the nerves to associated nerves and nerve endings.
143. The method of claim 138, wherein:
- the providing step is carried out with the first implant having a second nerve stimulating element coupled to the first body;
- the securing step being carried out so that the second nerve stimulating element is positioned at a different position along the uterosacral ligament from the first nerve stimulating element.
144. The method of claim 138, wherein:
- the providing step is carried out with the first body having a first throughhole sized to receive the uterosacral ligament.
145. The method of claim 144, wherein:
- the providing step is carried out with the first body being movable from an open position to a locked position, the first body having a slot leading to the first throughhole when the first body is in the open position;
- the securing step being carried out by introducing the uterosacral ligament into the throughhole though the slot and moving the body to the locked position.
146. The method of claim 145, wherein:
- the securing step is carried out with the slot being reduced in size when the first body moves to the locked position thereby securing the first body to the uterosacral ligament.
147. The method of claim 144, wherein:
- the providing step is carried out with the first nerve stimulating element positioned within the first throughhole so that the first nerve stimulating element is in contact with the uterosacral ligament when the first body is secured to the uterosacral ligament.
148. The method of claim 138, wherein:
- the providing step is carried out with the first implant having a second nerve stimulating element, the first body having an outer surface, the second nerve stimulating element being positioned along the outer surface of the first body;
- the securing step being carried out so that the second nerve stimulating element is in contact with the peritoneum.
149. The method of claim 138, wherein:
- the providing step is carried out with the first implant having a third nerve stimulating element coupled to the first body and positioned within the first throughhole so that the third nerve stimulating element contacts the uterosacral ligament when the uterosacral ligament is positioned in the first throughhole.
150. The method of claim 148, wherein:
- the providing step is carried out with the first implant having a fourth nerve stimulating element coupled to the first body and positioned along the outer surface of the first body spaced apart from the second nerve stimulating element.
151. The method of claim 138, wherein:
- the providing step is carried out with a second implant having a second body with an outer surface, the second implant also having a fifth nerve stimulating element coupled to the second body.
152. The method of claim 151, further comprising the step of:
- securing the second implant to the patient so that the fifth nerve stimulating element is in contact with a uterosacral ligament;
- the providing step being carried out with the second implant having a second control system.
153. The method of claim 152, wherein:
- the providing step is carried out with the second implant having a second power source coupled to the second body;
- the second control system being coupled to the second power source and the fifth nerve stimulating element.
154. The method of claim 151, wherein:
- the securing step is carried out with the second implant secured to the patient so that the fifth nerve stimulating element is in contact with the same uterosacral ligament as the first nerve stimulating element.
155. The method of claim 151, wherein:
- the securing step is carried out with the second implant being secured to the patient so that the fifth nerve stimulating element is in contact with a different uterosacral ligament than the first implant is secured to.
156. The method of claim 151, wherein:
- the providing step is carried out with the second body of the second implant having a second throughhole sized to receive the uterosacral ligament.
157. The method of claim 156, wherein:
- the providing step is carried out with the second body being movable from an open position to a locked position, the second body having a second slot leading to the second throughhole, the second body being in the open position to introducing the uterosacral ligament into the second throughhole;
- the securing step being carried out by moving the uterosacral ligament into the second throughhole through the slot and moving the second body to the locked position.
158. The method of claim 157, wherein:
- the securing step being carried out with the second slot being reduced in size when the second body moves to the locked position.
159. The method of claim 157, wherein:
- the providing step is carried out with the fifth nerve stimulating element positioned within the second throughhole so that the fifth nerve stimulating element is in contact with the uterosacral ligament after the securing step.
160. The method of claim 151, wherein:
- the providing step is carried out with the second implant having a sixth nerve stimulating element coupled to the second body, the sixth nerve stimulating element being positioned along the outer surface of the second body;
- the securing step is carried out so that the sixth nerve stimulating element is in contact with the peritoneum.
161. The method of claim 156, wherein:
- the providing step is carried out with the second implant having a seventh nerve stimulating element coupled to the second body and positioned within the second throughhole;
- the securing step being carried out so that the seventh nerve stimulating element contacts the uterosacral ligament at a spaced apart location from the fifth nerve stimulating element when the uterosacral ligament is positioned in the second throughhole.
162. The method of claim 161, wherein:
- the providing step is carried out with the fifth nerve stimulating element and the seventh nerve stimulating element being positioned at opposite ends of the second throughhole.
163. The method of claim 138, further comprising the steps of:
- sizing the uterosacral ligament; and
- selecting the implant based on the sizing step.
164. The method of claim 163, wherein:
- the sizing step is carried out by taking a first measurement and a second measurement of the ligament at spaced apart locations; and
- the providing step is carried out with the implant having a tapered throughhole;
- the selecting step is carried out with the first and second measurements being used to select the implant so that the tapered throughhole is appropriately sized relative to the uterosacral ligament.
165. The method of claim 152, further comprising the step of:
- communicating information from the first control system to the second control system.
166. The method of claim 165, wherein:
- the communicating step is carried out with the first control system communicating with the second control system using at least one nerve stimulating element coupled to the first body.
167. The method of claim 166, wherein:
- the communicating step is carried out with the second control system communicating with the first control system using at least one nerve stimulating element coupled to the second body.
168. The method of claim 166, wherein:
- the communicating step is carried out with the first control system controlling generation of a radiofrequency signal which is received by the second control system.
169. The method of claim 165, wherein:
- the communicating step is carried out with the first and second control systems coordinating simultaneous nerve stimulation with the first nerve stimulating element and the second nerve stimulating element.
170. The method of claim 165, wherein:
- the stimulating step is carried out with the first and second nerve stimulating elements stimulating the same plexus.
171. The method of claim 165, wherein:
- the communicating step is carried out with the first and second control systems coordinating independent nerve stimulation with the first nerve stimulating element and the second nerve stimulating element.
172. The method of claim 138, wherein:
- the providing step is carried out with the first nerve stimulating element being an electrode.
173. The method of claim 138, wherein:
- the stimulating step is carried out with the first nerve stimulating element stimulating the middle rectal plexus.
174. The method of claim 173, wherein:
- the stimulating step is carried out with the first nerve stimulating element stimulating the middle rectal plexus to treat at least one condition from the list of conditions consisting of fecal urge, bowel disorder, and incontinence.
175. The method of claim 174, wherein:
- the providing step is carried out with a second nerve stimulating element coupled to the first body, the second nerve stimulating element being secured to the patient so that the second nerve stimulating element is positioned to stimulate the IHP;
- the stimulating step being carried out with the first nerve stimulating element stimulating the middle rectal plexus and the second nerve stimulating element stimulating the IHP and middle rectal plexus to treat a rectal condition.
176. The method of claim 138, wherein:
- the stimulating step is carried out with the first nerve stimulating element stimulating a hypogastric nerve.
177. A system for stimulating nerves, comprising
- a first body having an exterior surface;
- a first nerve stimulating element coupled to the first body;
- a first power source coupled to the first body; and
- a first control system coupled to the first power source and the first nerve stimulating element.
178. The system of claim 177, further comprising:
- a second nerve stimulating element coupled to the body, the second nerve stimulating element positioned to apply nerve stimulus at a different position along a uterosacral ligament from the first nerve stimulating element when the first body is secured to the uterosacral ligament.
179. The system of claim 177, wherein:
- the first nerve stimulating element is configured to stimulate nerves sufficiently to change a signal transmitted by the nerves to associated nerves and nerve endings.
180. The system of claim 177, wherein:
- the control system is configured to actuate the first nerve stimulating element at a different time from the second nerve stimulating element.
181. The system of claim 177, wherein:
- the first body has a first throughhole sized to receive the uterosacral ligament.
182. The system of claim 181, wherein:
- the first body is movable from an open position to a locked position, the first body having a slot leading to the first throughhole when the first body is in the open position through which the uterosacral ligament is introduced
183. The system of claim 182, wherein:
- the slot reduces in size when the first body moves to the locked position so that the first body may be secured to the uterosacral ligament in the locked position.
184. The system of claim 182, wherein:
- the first nerve stimulating element is positioned within the first throughhole so that the first nerve stimulating element is in contact with the uterosacral ligament.
185. The system of claim 177, further comprising:
- a second nerve stimulating element;
- the first body having an outer surface;
- the second nerve stimulating element being positioned along the outer surface of the first body.
186. The system of claim 177, further comprising:
- a third nerve stimulating element coupled to the first body and positioned within the first throughhole so that the third nerve stimulating element contacts the uterosacral ligament when the uterosacral ligament is positioned in the first throughhole.
187. The system of claim 185, further comprising:
- a fourth nerve stimulating element coupled to the first body and positioned along the outer surface of the first body spaced apart from the second nerve stimulating element.
188. The system of claim 177, further comprising;
- a second body having an exterior surface; and
- a fifth nerve stimulating element coupled to the second body;
189. The system of claim 188, further comprising:
- a second control system coupled to the second body and the fifth nerve stimulating element.
190. The system of claim 188, further comprising:
- a second power source coupled to the second body.
191. The system of claim 188, wherein:
- the second body has a second throughhole sized to receive a uterosacral ligament.
192. The system of claim 191, wherein:
- the second body is movable from an open position to a locked position, the second body having a second slot leading to the second throughhole, the second body being in the open position for introduction of the uterosacral ligament into the second throughhole through the slot.
193. The system of claim 192, wherein:
- the second slot reduces in size when the second body moves to the locked position to secure the second body to the uterosacral ligament.
194. The system of claim 192, wherein:
- the fifth nerve stimulating element is positioned within the second throughhole so that the fifth nerve stimulating element is in contact with the uterosacral ligament when the second body is secured to the uterosacral ligament.
195. The system of claim 177, further comprising:
- a sixth nerve stimulating element coupled to the second body, the sixth nerve stimulating element being positioned along the outer surface of the second body.
196. The system of claim 177, further comprising:
- a seventh nerve stimulating element coupled to the second body and positioned within the second throughhole so that the seventh nerve stimulating element contacts the uterosacral ligament when the uterosacral ligament is positioned in the second throughhole.
197. The system of claim 195, further comprising:
- an eighth nerve stimulating element coupled to the second body and positioned along the outer surface of the second body spaced apart from the sixth nerve stimulating element.
198. The system of claim 177, wherein:
- the first control system is configured to communicate with the second control system.
199. The system of claim 198, wherein:
- the first control system communicates with the second control system using at least one nerve stimulating element coupled to the first body.
200. The system of claim 199, wherein:
- the second control system also uses at least one nerve stimulating element coupled to the second body for communicating with the first control system.
201. The system of claim 198, wherein:
- the first and second control systems communicate to coordinate nerve stimulation by the first nerve stimulating element and the fifth nerve stimulating element.
202. The system of claim 198, wherein:
- the first and second control systems communicate to coordinate simultaneous nerve stimulation with the first nerve stimulating element and the fifth nerve stimulating element.
203. The system of claim 198, wherein:
- the first and second control systems communicate to coordinate independent nerve stimulation with the first nerve stimulating element and the fifth nerve stimulating element.
204. The system of claim 177, wherein:
- the first nerve stimulating element is an electrode.
205. The system of claim 177, wherein:
- the first nerve stimulating element is configured to stimulate the middle rectal plexus when positioned in contact with a uterosacral ligament.
206. The system of claim 205, wherein:
- the first nerve stimulating element stimulates the middle rectal plexus to treat at least one condition from the list of conditions consisting of fecal urge, bowel disorder, and incontinence.
207. The system of claim 205, further comprising:
- a second nerve stimulating element coupled to the first body, the second nerve stimulating element being secured to the patient so that the second nerve stimulating element is positioned to stimulate the IHP;
- wherein the first and second nerve stimulating elements stimulate the IHP and middle rectal plexus to treat a rectal condition,
- stimulating the IHP and the middle rectal plexus to treat rectal conditions.
208. The system of claim 177, wherein:
- the first nerve stimulating element is configured to be positioned on the uterosacral ligament so that the first nerve stimulating element stimulates the hypogastric nerve.
209. The system of claim 177, wherein:
- the body has a throughhole in which the uterosacral ligament is positioned, the throughhole being tapered.
210. The method of claim 1, further comprising the step of:
- assessing a current orientation of the device;
- the positioning step being carried out with the device positioned in the vaginal fornices, the device also having a control system and a plurality of nerve stimulating elements, the positioning step being carried out to position the device in a starting orientation;
- the assessing step being carried out to determine the current orientation of the device; and
- reassigning the plurality of nerve stimulating elements using the control system based on a change in orientation determined in the assessing step.
211. The method of claim 210, wherein:
- the providing step is carried out with the control system automatically carrying out the assessing step.
212. The method of claim 210, further comprising the step of:
- sensing a parameter related to the starting orientation of the device;
- storing the parameter related to the starting orientation in the control system of the device; and
- the assessing step being carried out with the device sensing the parameter in the current orientation; and
- comparing the parameters from the starting orientation and the current orientation.
213. The method of claim 212, wherein:
- the assessing step is carried out with the parameter being an electrophysiological parameter.
214. The method of claim 213, wherein:
- the assessing step is carried out with the parameter being electrical activity sensed by the device.
215. The method of claim 213, wherein:
- the assessing step is carried out with the first nerve stimulating element being used to sense the parameter.
216. The method of claim 210, wherein:
- the providing step is carried out by providing an object, the device having a sensor configured to sense the object; and
- the assessing step is carried out using the sensor to sense the object.
217. The method of claim 216, further comprising the step of:
- placing the object at a predetermined location relative to the user's body during the assessing step;
- sensing the object with the sensor when the object is in the predetermined position to assess the current orientation of the device.
218. The method of claim 216, wherein:
- the providing step is carried out with the object forming a magnetic field and the sensor being a magnetic sensor.
219. The method of claim 216, wherein:
- the providing step is carried out with the device having a controller that includes the object;
- placing the controller at a predetermined position relative to the user; and
- initiating the assessing step by using the controller to instruct the device to assess the current orientation of the device in the vagina.
220. The method of claim 210, wherein:
- the providing step is carried out with the device including a gravity sensor;
- the assessing step being initiated using the controller while the user is in a predetermined body position, the controller sending a signal to the control system of the device to carry out the assessing step when the user is in the predetermined body position;
- the assessing step being carried out with the gravity sensor transmitting data to the control system relating to the current orientation of the device.
221. The method of claim 210, wherein:
- the providing step is carried out by also providing a first implant having a first body, a first implant nerve stimulating element coupled to the body, and a first implant control system coupled to the first body, the first implant being implanted in the user.
222. The method of claim 221, wherein:
- the assessing step being carried out with the device including a sensor that senses a parameter relating to the first implant.
223. The method of claim 221, wherein:
- the assessing step is carried out with the device sensing electrical activity of the first implant.
224. The method of claim 222, wherein:
- the assessing step is carried out with the control system sensing a starting parameter of the first implant when the device is in the starting orientation, the control system saving the starting parameter and comparing the starting parameter with a current parameter sensed by the sensor when the device is in the current orientation.
225. The method of claim 221, further comprising the step of
- securing the first implant adjacent to a uterosacral ligament so that the first implant nerve stimulating element is in contact with the uterosacral ligament.
226. The method of claim 210, wherein:
- the providing step is carried out with the device having a controller external to the user's body;
- placing the controller at a predetermined body position of the user;
- the assessing step is carried out with the device having a sensor configured to sense the controller during the placing step.
227. The system of claim 14, further comprising:
- a plurality of nerve stimulating elements coupled to the main body;
- the control system includes means for assessing an orientation of the device, the assessing means being configured to assess a current orientation, wherein the control system is configured to reassign the plurality of nerve stimulating elements based on the change in orientation from a starting orientation to the current orientation.
228. The system of claim 227, wherein:
- the control system automatically assesses the current orientation of the device and automatically reassigns the plurality of nerve stimulating elements based on the change from the starting orientation to the current orientation.
229. The system of claim 227, wherein:
- the control system includes a sensor and means for storing a parameter sensed by the sensor relating to the starting orientation of the device.
230. The system of claim 229, wherein:
- the sensor measures an electrophysiological parameter.
231. The system of claim 229, wherein:
- the sensor senses electrical activity in tissue.
232. The system of claim 231, wherein:
- the sensor includes the first nerve stimulating element.
233. The system of claim 227, further comprising:
- an object separate from the device; and
- a sensor coupled to the main body and configured to remotely sense the object.
234. The system of claim 233, wherein:
- the object is positioned at a predetermined location relative to the user when the sensor is used to sense the object.
235. The system of claim 233, wherein:
- the object forms a magnetic field; and
- the sensor is a magnetic sensor.
236. The system of claim 233, further comprising:
- a controller which includes the object, wherein the controller is placed at a predetermined position relative to the user, wherein the controller is used by the user to send a signal to the device to instruct the sensor to sense the object and assess the current orientation.
237. The system of claim 227, further comprising:
- a controller configured to communicate with the control system of the device;
- the control system of the device including a gravity sensor;
- the controller configured to send a signal to the control system to activate the gravity sensor and assess a current orientation of the device.
238. The system of claim 227, further comprising:
- a first implant having a first body, a first implant nerve stimulating element coupled to the body, and a first implant control system coupled to the first body, the first implant being configured to be implanted in the body of the user;
- the control system of the device including a sensor to sense a parameter related to the first implant.
239. The system of claim 238, wherein:
- the sensor is configured with the parameter being related to electrical activity of the first implant.
240. The system of claim 239, wherein:
- the control system of the device compares a current parameter sensed by the sensor with a starting parameter relating to the starting orientation.
241. The system of claim 240, wherein:
- the control system stores the starting parameter which is sensed by the sensor when the device is in the starting orientation, the control system also configured to sense the current parameter and compare the starting parameter with the current parameter to determine the orientation of the device.
242. The system of claim 238, wherein:
- the implant is configured to be secured to a uterosacral ligament.
243. The system of claim 210, further comprising:
- a controller external to the body, the controller being positioning at a predetermined body position; and
- the controller includes a sensor which is capable of sensing at least part of the device in the current orientation when positioned within the vaginal fornices, the controller transmitting a signal to the control system of the device relating to the current orientation, the control system reassigning the plurality of nerve stimulating elements in accordance with the change in orientation of the device from the starting orientation to the current orientation.
244. The method of claim 138, wherein:
- the providing step is carried out with the first implant having a first power source coupled to the first body.
245. The method of claim 244, wherein:
- the providing step is carried out with the first power source being a battery.
246. The method of claim 244, wherein:
- the providing step is carried out with the first power source being a capacitor.
247. The method of claim 246, wherein:
- the providing step is carried out with the capacitor including graphene and polymer.
248. The method of claim 246, wherein:
- the providing step is carried out with the capacitor having layers of graphene and polymer.
249. The method of claim 246, wherein:
- the providing step is carried out with the first implant including a first power source, the first power source being a capacitor and the implant not including a battery.
250. The method of claim 246, wherein:
- the providing step is carried out with the capacitor sized to provide at least 2 days of power under peak operating conditions.
251. The method of claim 246, wherein:
- the providing step is carried out with the capacitor sized to provide no more than 60 days of power under peak operating conditions.
252. The method of claim 84, wherein:
- the providing step is carried out with the first implant having a first power source coupled to the first body.
253. The method of claim 252, wherein:
- the providing step is carried out with the first power source being a battery.
254. The method of claim 252, wherein:
- the providing step is carried out with the first power source being a capacitor.
255. The method of claim 254, wherein:
- the providing step is carried out with the capacitor including graphene and polymer.
256. The method of claim 255, wherein:
- the providing step is carried out with the capacitor including layers of graphene and polymer.
257. The method of claim 254, wherein:
- the providing step is carried out with the first implant not including a battery.
258. The method of claim 254, wherein:
- the providing step is carried out with the capacitor sized to provide at least 2 days of power under peak operating conditions.
259. The method of claim 254, wherein:
- the providing step is carried out with the capacitor sized to provide no more than 60 days of power under peak operating conditions.
260. The system of claim 36, further comprising:
- means for creating a magnetic field coupled to the main body;
- the first implant including a first power source which stores energy, the first implant power source being coupled to the first control system of the first implant, the first implant also having an induction coil positioned within the magnetic field to induce a current therein and charge the first implant power source.
261. The system of claim 260, wherein:
- the first implant power source is a capacitor.
262. The method of claim 284, wherein:
- the providing step is carried out with the device having means for creating a magnetic field coupled to the main body, the first implant having an induction coil and a first implant power source coupled to the induction coil for charging the first implant power source, the induction coil positioned within the magnetic field to induce a current therein to charge the first implant power source.
263. The method of claim 262, wherein:
- the providing step is carried out with the first implant power source being a capacitor.
264. The method of claim 138, wherein:
- the providing step is carried out with the first implant having a first power source coupled to the first body.
265. The method of claim 263, wherein:
- the providing step is carried out with the first power source being a capacitor.
266. The method of claim 265, wherein:
- the providing step is carried out with the capacitor including graphene and polymer.
267. The method of claim 265, further comprising the step of:
- placing a device in the vagina, the device having means for creating a magnetic field;
- the providing step being carried out with the first implant having an induction coil positioned in the magnetic field.
268. The method of claim 263, wherein:
- the providing step is carried out with the first implant not including a battery.
269. The method of claim 265, wherein:
- the providing step is carried out with the capacitor sized to provide at least 2 days of power under peak operating conditions.
270. The method of claim 265, wherein:
- the providing step is carried out with the capacitor sized to provide no more than 60 days of power for operating the first implant under peak operating conditions.
271. The system of claim 177, wherein:
- the first implant has a first power source coupled to the implant control system.
272. The system of claim 271, wherein:
- the first implant power source is a capacitor.
273. The system of claim 271, wherein:
- the first implant power source is a battery.
274. The system of claim 272, wherein:
- the capacitor includes graphene and polymer.
275. The system of claim 271, further comprising;
- a device sized to fit in the vagina, the device having means for creating a magnetic field;
- the first implant having an induction coil positioned in the magnetic field to induce a current therein for charging the first power source.
276. The system of claim 271, wherein:
- the first implant does not include a battery.
277. The system of claim 272, wherein:
- the capacitor is sized to provide at least 2 days of power to operate the first implant under peak operating conditions.
278. The system of claim 272, wherein:
- the capacitor is sized to provide no more than 60 days of power for operating the first implant under peak operating conditions.
279. A method of implanting a nerve stimulator to stimulate a hypogastric nerve, comprising the steps of:
- providing a first implant having a first body, a first nerve stimulating element coupled to the first body, and an implant control system coupled to the first nerve stimulating element;
- forming an access opening in the patient leading to the peritoneum;
- creating an opening in the peritoneum to expose a hypogastric nerve;
- securing the first implant to the patient so that the first nerve stimulating element is in contact with the hypogastric nerve; and
- stimulating the hypogastric nerve using the first nerve stimulating element.
280. A method of charging a power source for an implanted medical device, comprising the steps of;
- providing a device having means for creating a magnetic field;
- positioning the device in the vaginal with the magnetic field creating means positioned in the vaginal fornices;
- activating the magnetic field creating means to create the magnetic field after the positioning step, wherein the magnetic field impinges upon an implanted medical device in the user to charge a power supply coupled to and powering the implanted medical device.
281. A device for charging a power source for an implant, comprising:
- a main body;
- a power source coupled to the main body; and
- means for creating a magnetic field coupled to the main body; and
- a control system coupled to the power source and to the magnetic field creating means.
282. The device of claim 281, wherein:
- the main body is sized and shaped to be positioned in the vaginal fornices.
283. The device of claim 281, wherein:
- the main body is sized and shaped to be positioned entirely within the vaginal fornices.
284. The device of claim 281, wherein:
- the main body has a central opening in which the cervix is positioned, the main body extending around at least 180 degrees of the cervix relative to a cervical axis when the main body is positioned in the vagina.
285. The device of claim 284, wherein:
- the main body extends completely around the cervix.
286. The method of claim 1, wherein:
- the positioning step is carried out with a controller separate from the main body, the controller being positioned outside the main body when the main body is positioned in the vagina, the positioning step is carried out with the controller being a personal electronic device.
287. The system of claim 19, wherein: the controller is a personal electronic device.
288. The method of claim 1, wherein:
- the positioning step is carried out with the device having a control system and a sensor in communication with the control system.
289. The method of claim 288, wherein:
- the positioning step is carried out with the sensor being coupled to the main body.
290. The method of claim 288, wherein:
- the positioning step is carried out with the control system configured to determine whether a condition exists in data from the sensor;
- the stimulating step being altered in response to the condition existing.
291. The method of claim 288, wherein:
- the positioning step is carried out with the device including a controller in wireless communication with the control system, the sensor being coupled to at least one of the controller and the main body, the controller being positioned outside the vagina when the main body is positioned in the vagina.
292. The method of claim 291, wherein:
- the positioning step is carried out with the controller configured to determine whether a condition exists in data from the sensor, the controller wirelessly communicating with the control system when the condition exists; and
- the stimulating step being altered by the control system in response to the condition existing.
293. The method of claim 291, further comprising the step of:
- transmitting information wirelessly from the controller to the control system related to data from the sensor.
294. The method of claim 288, wherein:
- the positioning step is carried out with the sensor sensing a cardiovascular parameter.
295. The method of claim 288, wherein:
- the positioning step is carried out with the sensor sensing a respiration.
296. The method of claim 288, wherein:
- the positioning step is carried out with the sensor sensing a temperature.
297. The method of claim 288, wherein:
- the positioning step is carried out with the sensor being an accelerometer.
298. The method of claim 288, wherein:
- the positioning step is carried out with the sensor being a microphone.
299. The method of claim 288, wherein:
- the positioning step is carried out with the sensor converting vibration to an electrical signal.
300. The method of claim 288, wherein:
- the positioning step is carried out with the sensor including a piezoelectric element.
301. The method of claim 288, wherein:
- the positioning step is carried out with the sensor sensing a pulse.
302. The method of claim 288, wherein:
- the positioning step is carried out with the sensor being an optical sensor.
303. The method of claim 288, wherein:
- the positioning step is carried out with the sensor sensing a heartbeat.
304. The method of claim 303, further comprising the step of:
- sensing the heartbeat with the sensor.
305. The method of claim 288, further comprising the step of:
- sensing a blood pressure with the sensor.
306. The method of claim 288, further comprising the step of:
- determining whether a condition exists in data from the sensor; and
- the stimulating step being altered in response to the condition existing from the determining step.
307. The method of claim 288, further comprising the step of:
- sensing with the sensor to obtain data; and
- determining whether a condition exists in the data.
308. The method of claim 307, wherein:
- the stimulating step is altered in response to the condition existing from the determining step.
309. The method of claim 307, wherein: the determining step is carried out by the control system.
310. The method of claim 307, wherein:
- the determining step is carried out by a controller in wireless communication with a control system coupled to the main body; and
- the positioning step being carried out with the controller positioned outside the vagina when the main body is positioned in the vagina.
311. The method of claim 307, wherein:
- the determining step is carried out with the condition being an arrhythmia condition.
312. The method of claim 307, wherein:
- the determining step is carried out with the condition being related to heart rate.
313. The method of claim 307, wherein:
- the determining step is carried out with the condition being based at least in part upon a baseline condition.
314. The method of claim 307, wherein:
- the determining step is carried out with the baseline condition being related to a measurement taken at a prior time.
315. The method of claim 314, wherein:
- the determining step is carried out with the measurement being taken by the sensor at the prior time.
316. The method of claim 307, further comprising the step of:
- sensing the heartbeat using the sensor for a period of time to obtain heartbeat data;
- determining whether a heart beat variability calculated using the heart beat data meets a condition.
317. The method of claim 316, further comprising the step of:
- altering the stimulating step based upon the heart beat variability from the determining step meeting the condition.
318. The method of claim 307, wherein:
- the positioning step being carried out with a control system coupled to the main body, the sensor being coupled to the control system; and
- the determining step is carried out with the control system.
319. The method of claim 307, wherein:
- the positioning step is carried out with the device including a control system coupled to the main body, the device also including a controller positioned outside the vagina when the main body is positioned in the vagina, the controller being in wireless communication with the control system of the device.
320. The method of claim 319, wherein:
- the positioning step is carried out with the controller being carried external to the vagina.
321. The method of claim 319, wherein:
- the positioning step is carried out with the controller being worn.
322. The method of claim 319, wherein:
- the positioning step being carried out with the controller worn on a limb.
323. The method of claim 319, wherein:
- the positioning step being carried out with the controller worn around the waist.
324. The method of claim 1, wherein:
- the positioning step is carried out with the device including a collection reservoir coupled to the main body.
325. The method of claim 324, wherein:
- the positioning step is carried out with the collection reservoir configured to hold material from the vagina.
326. The method of claim 324, further comprising the step of:
- collecting material from the vagina in the collection reservoir.
327. The method of claim 326, wherein:
- the positioning step is carried out with a low pressure source, at a pressure less than atmospheric pressure, being in fluid communication with the collection reservoir to assist in drawing material into the collection reservoir.
328. The method of claim 327, wherein:
- the collecting step is carried out with the material collected in the collection reservoir including a first microbe.
329. The method of claim 324, further comprising the step of:
- assessing the material; and
- the stimulating step being altered in response to the assessing step.
330. The method of claim 324, further comprising the step of:
- assessing the material; and
- selecting a therapeutic material based on the assessing step.
331. The method of claim 330, further comprising:
- coupling the therapeutic material to the main body of the device; and
- delivering the therapeutic material to the vagina by repositioning the device in the vagina with the therapeutic material coupled to the main body.
332. The method of claim 331, wherein:
- the delivering step is carried out with the therapeutic material carried by an insert coupled to the body.
333. The method of claim 331, wherein:
- the delivering step is carried out with the therapeutic material carried in a material reservoir.
334. The method of claim 333, wherein:
- the positioning step is carried out with the material reservoir being removable from the main body.
335. The method of claim 333, further comprising the step of:
- replacing the material reservoir with another material reservoir.
336. The method of claim 333, wherein:
- the positioning step is carried out with the material reservoir being part of a material reservoir module, the material reservoir module including a sensor.
337. The method of claim 335, wherein:
- the positioning step is carried out with the sensor of the reservoir module sensing a concentration of ions.
338. The method of claim 335, wherein:
- the positioning step is carried out with a magnetic actuator forcing material from the material reservoir.
339. The method of claim 335, wherein:
- the positioning step is carried out with the magnetic actuator vibrating the main body.
340. The method of claim 332, wherein:
- the positioning step is carried out with the material reservoir including a valve that prevents fluid from entering the material reservoir.
341. The method of claim 335, wherein:
- the positioning step is carried out with the material reservoir being removable from the main body.
342. The method of claim 1, wherein:
- the positioning step is carried out with the main body having a first expandable portion to increase a first dimension on the main body.
343. The method of claim 342, wherein:
- the positioning step is carried out with the main body having a central axis, the first expandable portion increasing the first dimension in a transverse direction to the central axis.
344. The method of claim 342, wherein:
- the positioning step is carried out with the main body having a central axis, the first expandable portion increasing a peripheral length of the main body when viewed along the central axis.
345. The method of claim 342, wherein:
- the positioning step is carried out with the main body having a central opening, the cervix being positioned in the central opening and defining a cervical axis, the first expandable portion increasing the first dimension in a transverse direction to the cervical axis.
346. The method of claim 342, wherein:
- the positioning step is carried out with the main body having a second expandable portion which also increases the first dimension when expanded.
347. The method of claim 346, wherein:
- the positioning step is carried out with the main body having a central opening, the cervix being positioned in the central opening and defining a cervical axis.
348. The method of claim 347, wherein:
- the positioning step is carried out with the second expandable portion increasing a peripheral length when viewed along the cervical axis.
349. The method of claim 347, wherein:
- the positioning step is carried out with the second expandable portion reducing the size of the central opening when expanded.
350. The method of claim 342, wherein:
- the positioning step is carried out with the first expandable portion reducing the size of the central opening when expanded.
351. A method of delivering a therapeutic material in a vaginal canal, comprising the steps of:
- positioning a device in the vagina, the device including a main body and a first sensor coupled to the main body, the device also including a material reservoir containing a therapeutic material and coupled to the main body;
- sensing data with the sensor;
- determining whether a condition exists from the data in the sensing step; and
- delivering the therapeutic material when the condition exists from the determining step.
352. The method of claim 351, wherein:
- the sensing step is carried out with the sensor sensing an ion concentration.
353. The method of claim 351, wherein:
- the sensing step is carried out with the sensor being a pH sensor producing pH sensor data; and
- the delivering step being carried out with an amount of the therapeutic material being selected based upon the pH sensor data.
354. The method of claim 351, wherein:
- the delivering step is carried out with the therapeutic material including a hormone.
355. The method of claim 351, wherein:
- the delivering step is carried out with the therapeutic material including estrogen.
356. The method of claim 351, wherein:
- the sensing steps is carried out with the sensor being a blood pressure sensor; and
- the delivering step is carried out with the therapeutic material selected to alter the blood pressure.
357. The method of claim 351, wherein:
- the positioning and sensing steps are carried out with the sensor being a a heart beat sensor; and
- the delivering step is carried out with the therapeutic material selected to alter at least one of a heart rate and a heart rhythm.
358. The method of claim 351, wherein:
- the positioning step is carried out with the main body having a central opening, the cervix being positioned in the central opening and the main body extending at least 270 degrees around the cervix.
359. A method of delivering a therapeutic material in a vaginal canal, comprising the steps of:
- positioning a device having a control system in the vagina while a sensor is positioned outside the vagina, the sensor being coupled to a controller which is in wireless communication with the control system of the device, the device including a main body, the main body also having a material reservoir coupled thereto which contains a therapeutic material;
- sensing data with the sensor;
- determining whether a condition exists from the data in the sensing step; and
- delivering the therapeutic material when the determining step determines the condition exists.
360. The method of claim 359, wherein:
- the positioning and sensing steps are carried out with the sensor being a a blood pressure sensor; and
- the delivering step is carried out with the therapeutic material selected to alter the blood pressure.
361. The method of claim 359, wherein:
- the positioning and sensing steps are carried out with the sensor being a a heart beat sensor; and
- the delivering step is carried out with the therapeutic material selected to alter at least one of a heart rate and a heart rhythm.
362. The method of claim 359, wherein:
- the positioning step is carried out with the main body having a central opening, the cervix being positioned in the central opening and the main body extending at least 270 degrees around the cervix.
363. The system of claim 14, further comprising:
- a sensor in communication with the control system.
364. The system of claim 363, wherein:
- the control system is configured to determine whether a condition exists in data from the sensor, the control system altering stimulation with the first nerve stimulating element in response to the condition existing.
365. The system of claim 363, wherein:
- the sensor is coupled to the main body.
366. The system of claim 363, further comprising:
- a controller in wireless communication with the control system, the sensor being coupled to at least one of the controller and to the main body, the controller being positioned outside the vagina when the main body is positioned in the vagina.
367. The system of claim 366, wherein:
- the sensor is coupled to the controller so that the sensor is also positioned outside the vagina when the main body is positioned in the vagina.
368. The system of claim 366, wherein:
- the controller is wirelessly coupled to the control system to transmit information related to data from the sensor.
369. The system of claim 366, wherein:
- the controller is configured to determine whether a condition exists in data from the sensor, the controller wirelessly communicating with the control system when the condition exists; and
- the control system altering stimulation with the first nerve stimulating element in response to the condition existing.
370. The system of claim 363, wherein:
- the sensor senses a cardiovascular parameter.
371. The system of claim 363, wherein:
- the sensor senses a respiration.
372. The system of claim 363, wherein:
- the sensor converts vibration to an electrical signal.
373. The system of claim 363, wherein:
- the sensor includes a piezoelectric element.
374. The system of claim 363, wherein:
- the sensor senses a pulse.
375. The system of claim 363, wherein:
- the sensor is an optical sensor.
376. The system of claim 363, wherein:
- the sensor senses a heartbeat.
377. The system of claim 363, further comprising:
- the sensor senses a heartbeat.
378. The system of claim 363, wherein:
- the sensor being a blood pressure sensor.
379. The system of claim 363, wherein:
- the control system is configured to receive information from the sensor, the control system also configured to determine whether a condition exists in the information from the sensor.
380. The system of claim 379, wherein:
- the control system is configured with the condition being related to heart rate.
381. The system of claim 379, wherein:
- the control system is configured with the condition being related to an arrhythmia.
382. The system of claim 379, wherein:
- the control system is configured with the condition being based at least in part upon a baseline condition.
383. The system of claim 382, wherein:
- the control system is configured with the baseline condition being related to a measurement taken at a prior time.
384. The system of claim 363, wherein:
- the sensor senses a heart beat;
- the control system is configured with the condition being related to a heartbeat variability calculation, the control system configured to calculate a heart beat variability and determine whether the heart beat variability meets the condition.
385. The system of claim 363, further comprising:
- a controller configured to receive information from the sensor, the control system also configured to determine whether a condition exists in the information from the sensor.
386. The system of claim 385, wherein:
- the controller is configured with the condition being related to an arrhythmia.
387. The system of claim 385, wherein:
- the controller is configured with the condition being related to heart rate.
388. The system of claim 385, wherein:
- the controller is configured with the condition being based at least in part upon a baseline condition.
389. The system of claim 388, wherein:
- the controller is configured with the baseline condition being related to a measurement taken at a prior time.
390. The system of claim 385, wherein:
- the sensor senses a heart beat;
- the controller is configured with the condition being related to a heartbeat variability calculation, the control system configured to calculate a heart beat variability and determine whether the heart beat variability meets the condition.
391. The system of claim 385, wherein:
- the controller is positioned outside the vagina when the main body is positioned in the vagina, the controller being in wireless communication with the control system of the device.
392. The system of claim 385, wherein:
- the controller is worn outside the vagina.
393. The system of claim 385, wherein:
- the controller is worn on a limb.
394. The system of claim 385, wherein:
- the controller is worn on the arm.
395. The system of claim 385, wherein:
- the controller is worn on the wrist.
396. The system of claim 385, wherein:
- the controller is worn around the waist.
397. The system of claim 14, further comprising:
- a collection reservoir coupled to the main body.
398. The system of claim 397, wherein:
- the collection reservoir is configured to hold a material from the vagina.
399. The system of claim 398, wherein:
- the collection reservoir is configured to collect and contain material from the vagina.
400. The system of claim 397, further comprising:
- a low pressure source which is at a pressure less than atmospheric pressure, the low pressure source being in fluid communication with the collection reservoir to assist in drawing material into the collection reservoir.
401. The system of claim 398, further comprising:
- means for assessing the material in the vagina and determining whether a condition exists, the assessing means being coupled to the control system.
402. The system of claim 401, further comprising:
- a therapeutic material held by the main body; and
- a material delivery element which delivers the therapeutic material to the vagina when the assessing means determines the condition exists.
403. The system of claim 401, wherein:
- the assessing means includes a sensor coupled to the control system.
404. The system of claim 403, wherein:
- the material delivery element is carried out with the therapeutic material carried by an insert coupled to the body.
405. The system of claim 402, further comprising:
- a material reservoir coupled to the main body which contains the therapeutic material.
406. The system of claim 405, wherein:
- the material reservoir is part of a removable material reservoir module.
407. The system of claim 405, further comprising:
- a sensor coupled to at least one of the material reservoir and the main body.
408. The system of claim 407, wherein:
- the sensor sensing a concentration of ions.
409. The system of claim 407, wherein:
- the sensor sensing a pH of the material.
410. The system of claim 407, wherein:
- the sensor sensing a conductivity of the material.
411. The system of claim 407, wherein:
- the material reservoir module includes a valve that prevents material from entering the collection reservoir under atmospheric conditions.
412. The system of claim 404, wherein:
- the material reservoir being removable from the main body.
413. The system of claim 14, wherein:
- the main body has a first expandable portion to increase a first dimension on the main body.
414. The system of claim 413, wherein:
- the main body has a central axis, the first expandable portion increasing the first dimension in a transverse direction to the central axis.
415. The system of claim 413, wherein:
- the main body has a central axis, the first expandable portion increasing a peripheral length of the main body when viewed along the central axis and when expanded.
416. The system of claim 413, wherein:
- the main body has a second expandable portion which also increases the first dimension.
417. The system of claim 413, wherein:
- the positioning step is carried out with the main body having a central opening, the cervix being positioned in the central opening and defining a cervical axis.
418. The system of claim 417, wherein:
- the first expandable portion of the main body increasing a peripheral length when viewed along the cervical axis.
419. The system of claim 417, wherein:
- the main body has a second expandable portion, the second expandable portion reducing the size of the central opening when expanded.
420. The system of claim 413, wherein:
- the first expandable portion of the main body expands to reduce the size of the central opening when expanded.
421. A system of delivering a therapeutic material in a vaginal canal, comprising:
- a main body;
- a first sensor coupled to the main body, the main body also including a material reservoir containing a therapeutic material and coupled to the main body;
- a control system in communication with the first sensor, the control system determining whether a condition exists from data received from the sensor, the control system configured to release the therapeutic material from the material reservoir when the condition exists.
422. The system of claim 421; wherein:
- the sensor senses an ion concentration.
423. The system of claim 421, wherein:
- the sensor is a pH sensor that produces pH sensor data; and
- the control system selecting the amount of therapeutic material to deliver based on the pH sensor data to alter the pH of the vagina.
424. The system of claim 421, wherein:
- the therapeutic material contained in the material reservoir includes estrogen.
425. The system of claim 421, wherein:
- the sensor is a blood pressure sensor; and
- the therapeutic material selected to alter the blood pressure.
426. The system of claim 421, wherein:
- the sensor is a heart beat sensor; and
- the therapeutic material being selected to alter at least one of a heart rate and a heart rhythm.
427. The system of claim 421, wherein:
- the main body has a central opening, the cervix being positioned in the central opening and the main body extending at least 270 degrees around the cervix.
428. The system of claim 421, wherein;
- the sensor is a pH sensor; and
- the control system delivers a controlled amount of therapeutic material based upon the pH measurement by the pH sensor to alter the pH of the vagina.
429. A system of delivering a therapeutic material in a vaginal canal, comprising:
- a main body;
- a control system coupled to the main body;
- a controller positioned outside the vagina when the main body is positioned in the vagina;
- a sensor in communication with the controller, the controller being in wireless communication with the control system;
- a material reservoir coupled to the main body, the material reservoir containing a therapeutic material;
- the controller being configured to determining whether a condition exists from data from the sensor and communicate with the control system that the condition exists; and
- the control system delivering the therapeutic material when the controller determines that the condition exists.
430. The system of claim 429, wherein:
- the sensor is a blood pressure sensor; and
- the therapeutic material being selected to alter the blood pressure.
431. The system of claim 429, wherein:
- the sensor is a heart beat sensor; and
- the therapeutic material being selected to alter at least one of a heart rate and a heart rhythm.
432. The system of claim 429, wherein:
- the main body having a central opening, the cervix positioned in the central opening and the main body extending at least 270 degrees around the cervix when the main body is positioned in the vagina.
433. The system of claim 263, wherein:
- the sensor is a temperature sensor.
434. The system of claim 263, wherein:
- the sensor is an accelerometer.
435. The system of claim 263, wherein:
- the sensor being a microphone.
436. The system of claim 402, further comprising:
- a magnetic actuator coupled to the material reservoir, the magnetic actuator forcing material from the material reservoir.
437. The system of claim 436, wherein:
- the magnetic actuator is coupled to the main body and configured to vibrate the main body.
438. The system of claim 402, wherein:
- the material reservoir is removable from the main body.
439. The system of claim 438, wherein:
- the therapeutic material includes a hormone.
Type: Application
Filed: Jul 31, 2017
Publication Date: Jun 7, 2018
Applicant: FemPulse, LLC (Incline Village, NV)
Inventors: Alexandra Haessler (Larkspur, CA), Bruo Strul (Portola Valley, CA)
Application Number: 15/665,338
