Abstract: A first value of an electrical stimulation parameter of an electrical stimulation therapy that resulted in a first physiological response for a patient is identified. The electrical stimulation therapy is delivered at least in part through a lead that is implanted inside the patient. Based on the first value, a limit of a second value of the electrical stimulation parameter that should result in a second physiological response for the patient is determined. An actual second value of the electrical stimulation parameter that actually resulted in the second physiological response for the patient is identified. Based on a comparison of the limit of the second value and the actual second value, an implantation of the lead is evaluated.

Abstract: A topical nerve stimulator patch and system are provided including a dermal patch; an electrical signal generator associated with the patch; a signal receiver to activate the electrical signal generator; a power source for the electrical signal generator associated with the patch; an electrical signal activation device; and a nerve feedback sensor.

Abstract: A system for controlling urination in a patient includes an implantable controller and an external device. The implantable controller includes circuitry and electrodes for stimulating the pudenal nerves in order to control urination. In addition, the implantable controller includes sensors for determining information on bladder fullness and for transmitting such information to an external device which is used for controlling the implanted controller. The external device will display when bladder filling exceeds a safe threshold level, allowing the patient and a caregiver to take appropriate steps to allow the patient to urinate.

Abstract: Described herein are methods for treating a subject suffering from or at risk for a condition mediated by an inflammatory cytokine cascade, by electrically or mechanically stimulating vagus nerve activity in an amount sufficient to inhibit the inflammatory cytokine cascade.

Abstract: A nerve activity blocking system (100) includes a blocking electrode (102) configured to generate a blocking electrical signal that blocks, at least in part, an action potential propagating through a nerve system of a body. using a low frequency alternating current. The blocking electrical signal prevents propagation of the action potential by overriding another electrical signal controlling an organ of the body.

Abstract: A medical device and method for determining a dose of insulin to be administered for glycemic control is provided, wherein the dose is stepwise adapted. The method includes determining a blood glucose value, receiving glycemic event information in respect to a predetermined glycemic event, wherein the predetermined glycemic event occurred within a predetermined time interval, receiving a previously adapted dose value stored in a storage unit, and setting an alert based on at least the blood glucose value, the glycemic event information and the previously adapted dose, wherein the alert indicates that the blood glucose value and the predetermined glycemic event are not in a specified relation to the previously adapted dose value.

Abstract: An electrical stimulation system includes a stimulator having at least one electrode and a power supply. The electrode is connectable to the power supply, and the power supply delivers electrical stimulation energy in the form of a capacitive discharge voltage through the stimulator and electrode to tissue proximate a target anatomy to induce an observable response in the target anatomy during a medical procedure.

Abstract: Devices, systems, and techniques for mitigating error from gesture input are disclosed. A system may receive an indication of a first gesture input, determine that the first gesture input is an indicator gesture input, and, responsive to the determination that the first gesture input is the indicator gesture input, enter a gesture control mode during which the system is configured to control one or more actions related to a medical procedure. Only during the gesture control mode, the system may receive an indication of a second gesture input associated with the medical procedure and, responsive to receiving the indication of the second gesture input, control, based on the second gesture input, at least a portion of the medical procedure. Additionally, or alternatively, the system may employ other error mitigation techniques for gesture input related to medical procedures.

Abstract: A medical apparatus for a patient comprises an implantable system. The implantable system comprises a first implantable device comprising: at least one implantable functional element configured to deliver stimulation energy to tissue of the patient; and an implantable controller configured to provide a stimulation waveform to the at least one implantable functional element, the stimulation waveform comprising one or more stimulation parameters. The apparatus is configured to randomly vary at least one of the one or more stimulation parameters. Methods of providing stimulation energy with randomly varying stimulation parameters are also provided.

Abstract: The present specification discloses devices and methodologies for the treatment of transient lower esophageal sphincter relaxations (tLESRs). Individuals with tLESRs may be treated by implanting a stimulation device within the patient's lower esophageal sphincter and applying electrical stimulation to the patient's lower esophageal sphincter, in accordance with certain predefined protocols. The presently disclosed devices have a simplified design because they do not require sensing systems capable of sensing when a person is engaged in a wet swallow and have improved energy storage requirements.

Abstract: The present specification discloses devices and methodologies for the treatment of achalasia. Individuals with achalasia are treated by implanting a stimulation device within the patient's lower esophageal sphincter and applying electrical stimulation to the patient's lower esophageal sphincter, in accordance with certain predefined protocols. The presently disclosed devices have a simplified design because they do not require sensing systems capable of sensing when a person is engaged in a wet swallow and have improved energy storage requirements.

Abstract: Methods and devices are provided for activating brown adipose tissue (BAT). Generally, the methods and devices can activate BAT to increase thermogenesis, e.g., increase heat production in the patient, which over time can lead to weight loss. In one embodiment, a medical device is provided that activates BAT by electrically stimulating nerves that activate the BAT and/or electrically stimulating brown adipocytes directly, thereby increasing thermogenesis in the BAT and inducing weight loss through energy expenditure.

Abstract: A stimulator device for controlling waste storage for a subject, having one electrode placed in proximity to a portion of each of the right and left pudendal nerves, which contains efferent fibers that, when stimulated, produce contraction of the urethral or anal sphincter. The stimulator device having a pulse generator connected to electrodes, bilaterally, to provide stimulation for each electrode to stimulate pudendal efferent axons. The pulse generator adapted to provide a first type of stimulation to cause waste to be stored within the subject. The pulse generator adapted to provide a second type of stimulation, different from the first type of stimulation, to allow waste to be voided from the subject by blocking nerve impulses that accompany sphincter dyssynergia. An input device to allow an end user to select the first type of stimulation, the second type of stimulation, or no stimulation. Variations of the concept are disclosed.

Abstract: A topical nerve stimulator patch and system are provided including a dermal patch; an electrical signal generator associated with the patch; a signal receiver to activate the electrical signal generator; a power source for the electrical signal generator associated with the patch; an electrical signal activation device; and a nerve feedback sensor.

Abstract: Methods for electrical modulation of inflammation or serum TNF levels in a subject.

Abstract: Systems and methods are provided for neuro stimulation. In one implementation, a system is provided that includes a stimulator introduced into tissue at a target location and a central controller that communicates wirelessly with the stimulator. The stimulator includes a power system that receives wireless energy transmission, and an electrode system that transmits an electrical pulse for stimulating the target location. The central controller includes a power system that wirelessly delivers power to the stimulator, a communication system that wirelessly communicates with the stimulator, and a processing system that controls the power system and the communication system. The central controller may instruct the stimulator to transmit one or more electrical pulses to the target location to affect an endocrine function (e.g., affect the glucose level of a patient).

Abstract: A device for treating obesity of a patient, the device comprising: at least one operable stretching device implantable in the patient and adapted to stretch a portion of the patient's stomach wall, and an implantable control unit for automatically controlling the operable stretching device, when the control unit and stretching device are implanted, to stretch the stomach wall portion in connection with the patient eating such that satiety is created.

Abstract: According to one aspect, an implantable medical device may include an anchor assembly configured to anchor the medical device to a body lumen. The implantable medical device may also include a capsule. The capsule may include a pH sensor. The pH sensor may be configured to measure a pH of contents within the body lumen. The capsule may also include a power source, a controller, and an impedance sensor. The impedance sensor may be configured to measure an impedance within the body lumen.

Abstract: A balloon dissector includes a cannula, an expandable bladder, and a cord. The cannula defines a lumen between proximal and distal ends. The expandable bladder is configured to expand when fluid is injected into the lumen and includes an inner surface, a proximal base, and a retainer. The proximal base is selectively coupleable to the distal end of the cannula in a sealing relationship. The retainer is positioned on the inner surface of the expandable bladder. The cord includes a first end, a second end, and a central portion. The one end of the cord extends from the proximal end of the cannula. The cord extends through the lumen of the cannula and through the retainer of the bladder returning into the lumen. The cord configured to draw the expandable bladder into the lumen after the expandable bladder is expanded.

Abstract: An electrical stimulation lead for a target nerve includes a sleeve having an inner surface and an outer surface, the inner surface defines a nerve channel. A longitudinal slit extends from the outer surface to the nerve channel and along an entire length of the sleeve. A width of the slit retains the target nerve within the nerve channel when the sleeve is closed and releases the target nerve when open. A plurality of electrodes are disposed on the inner surface of the sleeve. A flexible transition element electrically couples a lead body to the plurality of electrodes. Upper and lower sections of the sleeve rotates about a common hinge line (e.g., like a clam shell) located directly opposite the longitudinal slit. The material along the common hinge line remains “elastic” when the sleeve is moved from closed to open, and vice-versa.

Abstract: An implantable device coupled with an integrated circuitry, is operable to receive signals representing a human body action. The implantable device may be further operable to authenticate the signals. Responsive to authenticating the signals, the implantable device may be further operable to perform a device action associated with the implantable device. The implantable device may include a medical device that detects physical conditions of a body.

Abstract: The present invention provides a system for delivering a time-varying stimulation field to a subject. In the system, a power source, a control component and a transmission component operate as a stimulation field generator to provide a predetermined time-varying stimulation field to up-regulate or down-regulate an expression level of human genes. The present invention also provides a wearable apparatus for delivering the time-varying magnetic field to mammalian cells associated with bone formation in a subject. The wearable apparatus contains the stimulation field generator in a housing. The resulted modification on gene regulation of these genes and mammalian cells promotes the retention, repair of and reduction of compromised mammalian cartilage, bone, and associated tissue.

Abstract: According to various method embodiments, a person is indicated for a therapy to treat a cardiovascular disease, and the therapy is delivered to the person to treat the cardiovascular disease. Delivering the therapy includes delivering a vagal stimulation therapy (VST) to a vagus nerve of the person at a therapeutically-effective intensity for the cardiovascular disease that is below an upper boundary at which upper boundary the VST would lower an intrinsic heart rate during the VST.

Abstract: Provided is a urination disorder treatment device which easily confirms with high accuracy whether it is appropriately used or not. In the urination disorder treatment device, a control portion compares a stimulation pulse 58 by a pair of body-surface electrode pads with a detection pulse 60 of a toe to judge whether a nerve passing through the sacral bone or the vicinity of the sacral bone is appropriately stimulated by the stimulation pulse 58 or not. Further, the detection pulse 60 is generated by reactions of the tibial nerve and/or the peroneal nerve extended up to the tiptoe which are connected to the nerve passing through the sacral bone or the vicinity of the sacral bone by way of the ischiadic nerve.

Abstract: Methods of evaluating homeostatic capacity of a subject are provided. Aspects of the methods include obtaining dynamic biometric data from the subject and evaluating the homoeostatic capacity of the subject from the obtained dynamic biometric data. Also provided are devices configured for use in practicing the methods. The methods and devices described herein find use in a variety of applications, e.g., health monitoring applications, treatment applications, dynamic diagnostic applications, etc.

Abstract: Methods, systems, and apparatus for electrically stimulating a smooth muscle. The method includes generating a continuous pulse train signal having pulses and pulse intervals between the pulses, the pulses and the pulse intervals being generated at a pulse frequency. The method also includes modulating the continuous pulse train signal at a modulation frequency to match dynamics of intracellular calcium ion oscillations in the smooth muscle. The method also includes entraining a group of cells of the smooth muscle by applying the modulated continuous pulse train signal to the group of cells of the smooth muscle to increase an oscillation frequency of the calcium ion oscillations.

Abstract: GI tract treatment and monitoring devices configured for temporary implantation in the GI tract and non-invasive removal via natural body processes are disclosed. Methods of implantation, treatment and monitoring with disclosed devices are also disclosed. Devices include bio-active fixation that allows removal from the body by natural processes after a time that may be engineered in the fixation elements. In some embodiments, devices are configured to be implanted on GI tract tissue and transmurally migrate into the GI tract to be passed from the body. In other embodiments, devices are configured for placement within the GI tract via a delivery tube such as an NJ/NG tube. Embodiments include stimulation devices for treating conditions such as ileus and sensors for monitoring GI leaks and/or biological or chemical markers for various GI tract conditions.

Abstract: Embodiments of the invention provide apparatus, systems and methods for facilitating introduction of a urinary drainage catheter (UDC) into the urinary tract (UT). One embodiment provides a UDC including electrodes for delivering high frequency current to a patient's pudendal nerves to relax the urinary sphincter (US) before passing the UDC therethrough so as reduce the resistance force on the UDC and discomfort to the patient. The electrodes can comprise at least one pair of bipolar electrodes and may be flexible so as to bend and flex within the urethra. The UDC includes one or more lumens including a drainage lumen and an inflation lumen for inflating an anchoring device on the UDC. The UDC can include a pressure sensor to assess relaxation of the US. The UDC may include a second set of electrodes and irrigation lumen for relaxing the US and flushing the urethra with the UDC in place.

Abstract: Devices and methods are provided for a leadless implantable medical device (LIMD) comprising a housing. An electrode is disposed on the housing. An electronics circuit is disposed in the housing and is configured to sense cardiac signals, and/or generate and deliver pacing signals to the electrode. A transceiver circuit is disposed in the housing, and is configured to communicate wirelessly with an external device. A fixation antenna electrically separate from the electrode is disposed on a distal portion of the housing and is electrically coupled to the transceiver circuit, and configured to operate as an antenna for communication between the transceiver circuit and the external device.

Abstract: Nerve stimulation systems and methods are disclosed for providing modulation of nerve targets in the lower limbs typically at or below the knee. For example, transcutaneous electrical nerve stimulation (TENS), percutaneous nerve stimulation, and implantable stimulation systems and methods are disclosed for providing stimulation to the saphenous nerve (SAFN). Additionally, systems and methods are provided for co-stimulating the posterior tibial nerve (PTN) and SAFN in combination with unique stimulation, and with control and display of OAB therapy protocols for multiple sites. Systems and methods of treatment can provide for management of usage and compliance monitoring, obtain and operating upon patient input responses to queries and management of payments and permissions related to provision of therapies for various disorders. Monitoring of usage and compliance can be managed both locally and remotely from a user. Stimulation provided in combination with a passive implantable component is also disclosed.

Abstract: A system for controlling urination in a patient includes an implantable controller and an external device. The implantable controller includes circuitry and electrodes for stimulating the pudenal nerves in order to control urination. In addition, the implantable controller includes sensors for determining information on bladder fullness and for transmitting such information to an external device which is used for controlling the implanted controller. The external device will display when bladder filling exceeds a safe threshold level, allowing the patient and a caregiver to take appropriate steps to allow the patient to urinate.

Abstract: Systems and methods are described that provide a dynamic reporting functionality that can identify important information and dynamically present a report about the important information that highlights important findings to the user. The described systems and methods are generally described in the field of diabetes management, but are applicable to other medical reports as well. In one implementation, the dynamic reports are based on available data and devices. For example, useless sections of the report, such as those with no populated data, may be removed, minimized in importance, assigned a lower priority, or the like.

Abstract: A method for inducing a cellular or hormonal response includes using a wave-generating device to emit sound waves through an individual's skin and onto a target organ, and vibrating the target organ or a portion thereof at a frequency in resonance with the sound waves. The sound waves have a frequency of less than 200 Megahertz (MHz).

Abstract: Systems and methods for the treatment of bladder conditions using direct electrical pacing are provided. The systems and methods generally apply high-frequency pacing stimuli directly to the bladder wall, from one or more of the inner and outer bladder surfaces.

Abstract: An example of a system may include a stimulator and at least one controller. The stimulator may be configured to deliver nerve stimulation to capture a first set of axons in a nerve and to deliver depletion block stimulation to capture a second set of axons in the nerve, where the second set is a subset of the first. The depletion block stimulation may include a series of pulses at a depletion pulse frequency within a range between about 100 Hz to about 1 kHz, and the nerve stimulation may include a series of pulses at a stimulation pulse frequency within a range of about 0.25 Hz to about 50 Hz. At least a portion of the nerve stimulation and at least a portion of the depletion block stimulation may be delivered to be effective in providing a nerve block while delivering nerve stimulation.

Abstract: The present invention provides methods of treating a gastrointestinal condition. In some embodiments, the method generally includes administering a chemical or electrical stimulus to an artery of the gastrointestinal vasculature of the subject, a vein of the gastrointestinal vasculature of the subject, a nerve supplying an artery of the gastrointestinal vasculature of the subject, and/or a nerve supplying a vein of the gastrointestinal vasculature of the subject, wherein the chemical or electrical stimulus is effective for treating a gastrointestinal condition.

Abstract: Methods for providing therapy related to urological disorders. Particular embodiments of this technology relate to stimulation of lumbar spinal targets either alone or in combination with a sacral target or targets. In embodiments spinal roots are stimulated by partially or fully implanted stimulators to treat symptoms by producing bladder inhibition relative to that which occurs prior to stimulation. Embodiments also disclose improving nerve stimulation, including lumbar nerve root stimulation, using methods termed enhanced transcutaneous electrical stimulation (eTENS) since these enhance the inhibition or excitation of neural tissue.

Abstract: The present specification discloses devices and methodologies for the treatment of GERD. Individuals with GERD may be treated by implanting a stimulation device within the patient's lower esophageal sphincter and applying electrical stimulation to the patient's lower esophageal sphincter, in accordance with certain predefined protocols. The presently disclosed devices have a simplified design because they do not require sensing systems capable of sensing when a person is engaged in a wet swallow, have improved energy storage requirements, enable improved LES function while concurrently delivering additional health benefits, and enable improved LES function post stimulation termination.

Abstract: In one aspect, wireless gastrointestinal stimulations are described herein. In some embodiments, a system described herein comprises at least one transmitter and at least one stimulation device. The transmitter can include a signal generator operable to generate an electromagnetic signal, a first antenna operable to broadcast the electromagnetic signal, and an energy source. The at least one stimulation device is operable to deliver a pattern of electrical pulses to a gastrointestinal tissue comprising a muscle, and the stimulation device includes a circuit board having a circumference, at least one second antenna wrapped around the circumference of the circuit board, the at least one second antenna being configured to receive the electromagnetic signal and to generate an electrical current from the electromagnetic signal, and at least one electrode operable to deliver the electrical current to the muscle.

Abstract: Methods and devices are provided for activating brown adipose tissue (BAT). Generally, the methods and devices can activate BAT to increase thermogenesis, e.g., increase heat production in the patient, which over time can lead to weight loss. In one embodiment, a medical device is provided that activates BAT by electrically stimulating nerves that activate the BAT and/or electrically stimulating brown adipocytes directly, thereby increasing thermogenesis in the BAT and inducing weight loss through energy expenditure.

Abstract: A method may include, using an electrode lead(s) having a proximal end and a distal end and comprising spaced apart electrodes carried by the distal end, positioning the electrodes adjacent nerves in a patient; using a subcutaneous lead connector plug comprising a housing electrically connected to the proximal end of the electrode lead(s) and defining a lead connection port(s) and an anchor point(s), positioning the housing along with the proximal end of the electrode lead(s) inside the patient; connecting the anchor point(s) to tissue beneath the patient's skin and, using a first generator lead having a distal end and a proximal end, plugging the distal end of the first generator lead into the lead connector port(s); and connecting the proximal end of the first generator lead to a first neural stimulation generator, and operating the first neural stimulation generator to provide electrical stimulation to the nerves via the electrodes.

Abstract: A wearable device for suppressing appetite or hunger in a patient includes a microprocessor, electrical stimulator and at least one electrode configured to deliver electrical stimulation to the epidermis, through a range of 0.1 mm to 10 mm or a range of 0.1 mm to 20 mm of the dermis, of a T2 frontal thoracic dermatome to a T12 frontal thoracic dermatome or meridian of the patient and/or front or back, C5-T1 dermatome across the hand and/or arm, and/or the upper chest regions. The device includes a pad, in which the electrode is disposed, for secure placement of the device on a skin surface of a patient. The device is adapted to provide electrical stimulation as per stimulation protocols and to communicate wirelessly with a companion control device configured to monitor and record appetite patterns of the patient. The control device is also configured to monitor, record, and modify stimulation parameters of the stimulation protocols.

Abstract: Apparatus for transcutaneous electrical nerve stimulation in a user, the apparatus comprising: a housing; stimulation means carried by the housing for electrically stimulating at least one nerve; a pair of electrodes releasably mounted to the housing and connectable to the stimulation means for electrical stimulation of the at least one nerve; monitoring means for monitoring user gesture, electrode-skin contact integrity and transient motion; analysis means for analyzing the output of the monitoring means for determining user gesture, electrode-skin contact integrity and transient motion; and control means for controlling the output of the stimulation means in response to the determined user gesture, electrode-skin contact integrity and transient motion.

Abstract: The present disclosure provides systems and methods for programming an implanted device when a patient is remote from a clinician. A system includes a patient programmer configured to be operated by the patient, a clinician programmer configured to be operated by the clinician, and a remote diagnostic server configured to facilitate secure communication between the patient programmer and the clinician programmer, wherein the remote diagnostic server is configured to initiate a secure programming session between the patient programmer and the clinician programmer, receive a proposed stimulation program from the clinician programmer, transmit the proposed stimulation program to the patient programmer, receive an indication from the patient programmer that the patient has accepted the proposed stimulation program, and transmit an alert to the clinician programmer, the alert indicating that the patient has accepted the proposed stimulation program.

Abstract: Devices, methods, computer-readable media, and systems for determining an identity of a food are disclosed. For example, a method may receive at least one property of at least one component in a sample of a food from an intra-oral device including a spectrometer, the at least one property obtained via the spectrometer, compares the at least one property to a plurality of food signatures, and determines the identity of the food based upon the comparing. In another example, a system may include an intra-oral device and a wireless device. The intra-oral device may include a spectrometer for measuring at least one property of at least one component in a sample of a food. The wireless device may include a processor for receiving the at least one property, comparing the at least one property to a plurality of food signatures, and determining the identity of the food based upon the comparing.

Abstract: Systems and methods for treating gastroesophageal reflux disease (GERD) includes minimally invasively implanting a stimulating device in a patient's esophagus in the region proximate the lower esophageal sphincter (LES). The patient is provided with a questionnaire related to his disease via an online service. The questionnaire is accessed on a mobile device, such as a cell phone, or on a computer with network access. The data from the sensors and the answers from the questionnaire are analyzed together by a health care provider using the online service. The data and answers are used to program the stimulating device, via the mobile device or computer, to optimize treatment.

Abstract: Various aspects of the present subject matter provide a device. In various embodiments, the device comprises a port adapted to connect a lead, a pulse generator connected to the port and adapted to provide a neural stimulation signal to the lead, and a signal processing module connected to the port and adapted to receive and process a nerve traffic signal from the lead into a signal indicative of the nerve traffic. The device includes a controller connected to the pulse generator and the signal processing module. The controller is adapted to implement a stimulation protocol to provide the neural stimulation signal with desired neural stimulation parameters based on the signal indicative of the nerve traffic. Other aspects are provided herein.

Abstract: Methods, devices, and systems for monitoring heart rate variability (HRV) are presented. The HRV monitoring systems and devices are adapted to give immediate feedback to the subject concerning their current condition and any pertinent changes in their condition. The HRV monitoring systems and devices detect, analyze, and assess HRV against a pre-determined application or user need. They also have the ability to provide real time notifications based on the system's assessment of a user's heart HRV and changes in the HRV.

Abstract: A non-user controllable electro-therapy device has a housing for a microprocessor, power source, status indicator, activation switch, and one or more channels for electrode contact. Only the activation switch is user-accessible. The microprocessor generates a non-user controllable frequency dependent mixed electrical signal through the electrodes, wherein the mixed electrical signal is a combination of at least two different frequencies, a first frequency having a first minimum and maximum microamp range and a second frequency having a different second minimum and maximum microamp range. The higher of the two frequencies is superimposed on the lower frequency, creating a current intensity window as an envelope along a profile of the lower frequency. The mixed electrical signal is automatically applied for a pre-determined period of time, and amplitude and/or duration and/or frequencies is varied according to a pre-set schedule programmed into a controller coupled to the one or more electrodes.

Abstract: Methods and devices are disclosed that provide therapeutic benefit and treatment for a variety of neurologic and physiologic conditions that include obesity, urinary incontinence, and sensory system disorders.