Abstract: An extravascular nerve cuff that is configured to hold a leadless, integral, implantable microstimulator. The nerve cuff may include a cuff body having a pocket or pouch for removably receiving the implantable device within. The nerve cuff can be secured around the nerve such that the electrodes of the device are stably positioned relative to the nerve. Furthermore, the nerve cuff drives the majority of the current from the stimulation device into the nerve, while shielding surrounding tissues from unwanted stimulation.

Abstract: Methods for treating eating disorders and for reducing a risk associated with developing an eating disorder in patients via therapeutic renal neuromodulation and associated systems. Renal sympathetic nerve activity can be attenuated to improve a patient's eating disorder status or risk of developing an eating disorder. The attenuation can be achieved, for example, using an intravascularly positioned catheter carrying a therapeutic assembly configured to modulate the renal sympathetic nerve.

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: A computer-assisted imaging and localization system assists the physician in positioning implants and instruments into a patient's body. The system displays overlapping images—one image of the surgical site with the patient's anatomy and another image showing the implant(s) or instrument(s). The overlapping image of the implant/instrument is moved over the static image of the anatomy as the implant/instrument is moved. The moving image of the implant/instrument can be an unaltered image or an image altered to intensify or mitigate the anatomical or non-anatomical aspects of the moving image. Sliding these images over one another helps the surgeon in positioning devices or instruments with a high degree of accuracy and with a limited number of additional x-rays.

Abstract: Systems and methods for the treatment of gastroesophageal reflux disease (GERD) include at least one electrically stimulating electrode coupled to a pulse generator. Individuals with GERD are treated by implanting a stimulation device within and/or proximate the patient's lower esophageal sphincter, gastric fundus, or other nearby gastrointestinal structures and applying electrical stimulation to the patient's lower esophageal sphincter and/or fundus, in accordance with certain predefined protocols. Electrical stimulation provided by the disclosed systems results in an increase in the length of the high pressure zone of the LES and/or modulation of the receptive relaxation response of the fundus to decrease gastric pressure, creating a longer barrier to the reflux of gastric contents or increasing functional lower esophageal pressure respectively, thereby treating GERD.

Abstract: Systems and methods for the treatment of gastroesophageal reflux disease (GERD) include at least one electrically stimulating electrode coupled to a pulse generator. Individuals with GERD are treated by implanting a stimulation device within and/or proximate the patient's lower esophageal sphincter, gastric fundus, or other nearby gastrointestinal structures and applying electrical stimulation to the patient's lower esophageal sphincter and/or fundus, in accordance with certain predefined protocols. Electrical stimulation provided by the disclosed systems results in an increase in the length of the high pressure zone of the LES and/or modulation of the receptive relaxation response of the fundus to decrease gastric pressure, creating a longer barrier to the reflux of gastric contents or increasing functional lower esophageal pressure respectively, thereby treating GERD.

Abstract: There is provided a method for controlling a flow of intestinal contents in the intestinal passageway of a patient's intestines. The method comprises gently constricting (i.e., without substantially hampering the blood circulation in the intestinal tissue wall) at least one portion of the intestinal tissue wall to influence the flow in the intestinal passageway, and stimulating the constricted wall portion to cause contraction of the wall portion to further influence the flow in the intestinal passageway. The method can be used for restricting or stopping the flow in the intestinal passageway, or for actively moving the fluid in the intestinal passageway, with a low risk of injuring the intestines.

Abstract: A flexible microwave catheter, including a flexible coaxial cable having an inner conductor, an inner dielectric coaxially disposed about the inner conductor, and an outer conductor coaxially disposed about the inner dielectric, at least one feedpoint defining a microwave radiating portion of the flexible coaxial cable, a mesh structure having a collapsed configuration and an expanded configuration and disposed about the microwave radiating portion of the flexible coaxial cable, wherein the mesh structure expands radially outward from the flexible microwave catheter thereby positioning the at least one feedpoint at the radial center of the mesh structure.

Abstract: Devices and methods are provided for forming and securing a tissue plication. More particularly, the devices and methods of the present invention can be used to create multiple tissue folds on an anterior and posterior wall of a stomach cavity to reduce the volume thereof. In one aspect, a method of gastric volume reduction is disclosed that includes advancing a tissue acquisition and fixation device endoscopically into a stomach, manipulating the device to form a first fold of tissue on an interior surface of an anterior wall of the stomach, and manipulating the device to form a second fold of tissue on an interior surface of a posterior wall of the stomach, where the second fold is not attached to the first fold.

Abstract: A method of implanting electrically conductive leads in the gastrointestinal musculature for stimulation of target tissues involves an endoscopic approach through the esophagus. An endoscope is inserted into the esophagus of a patient. The mucosal surface of the anterior esophagus is punctured in the region encompassing the lower esophageal sphincter (LES). A tunnel is created through the submucosa and exits at the muscularis propria, adventitia, or serosal side of the stomach. The lead is navigated further to the anterior abdominal wall. A first end of the lead remains within the gastrointestinal musculature while a second end of the lead is positioned just outside the anterior abdominal wall. The first end of the lead comprises at least one electrode. An implantable pulse generator (IPG) is implanted and operably connected to the second end of the lead to provide electrical stimulation to target tissues.

Abstract: An implantable medical electrical lead for electrical stimulation of body tissue that includes at least one shape memory polymer portion that has a first configuration and a second configuration, wherein the second configuration is obtained upon exposure of the shape memory polymer portion to a transition stimulus, and wherein the second configuration of the modifiable portion exhibits a greater resistance to movement of the lead within the body tissue than does the first configuration; and at least one electrode configured to provide electrical stimulation of body tissue, wherein the lead has a proximal end and a distal end. Systems and kits as well as methods of utilizing the leads of the invention are also included.

Abstract: A method of laparoscopically implanting an electrically stimulating lead proximate the lower esophageal sphincter (LES) of a patient includes delivering the lead through a port of a laparoscope inserted into the abdominal cavity of the patient through an incision in the abdominal wall. The stimulating electrode is implanted in or proximate the muscularis layer of the lower esophageal wall to treat esophageal reflux disease (GERD). The lead includes a needle and suture at its distal end for pulling the electrode into the muscular wall of the LES. Clips are applied to the suture attached to the distal end of the lead to prevent retrograde movement of the electrode. The lead also includes an anchoring member for anchoring the portion of the lead proximal to the electrode. The method and lead used with the method allow the surgeon to work within the confined anatomy present at the gastroesophageal junction and prevents backwards movement and dislodgment of the electrode.

Abstract: In one aspect, an ingestible, electrical device, comprises one or more electrodes comprising a biocompatible conducting material and a biocompatible insulating material; a generator connected to the one or more electrodes; and an outer casing enclosing the one or more electrodes and the generator, the outer casing configured to dissolve in an aqueous environment of the organism; wherein the one or more electrodes have a first form factor when enclosed in the outer casing and a second form factor following a dissolution of the outer casing, the first form factor is a form factor that is collapsed an increased amount relative to an amount that the second form factor is collapsed, and the second form factor is a form factor that is collapsed a decreased amount relative to an amount that the first form factor is collapsed.

Abstract: An implantable medical system includes an implantable medical device (IMD) and an electrode coupleable to the IMD. The electrode is operative to deliver a first electrical signal from the IMD to a neural structure. The system includes a sensor coupleable to the IMD. The sensor is operative to sense a physiological parameter. The physiological parameter may include at least one of a neurotransmitter parameter, a neurotransmitter breakdown product parameter, a neuropeptide parameter, a norepinephrine parameter, a glucocorticoid (GC) parameter, a neuromodulator parameter, a neuromodulator breakdown product parameter, an amino acid parameter, and a hormone parameter. The IMD includes a controller operative to change a parameter of the first electrical signal based upon at least one sensed physiological parameter to generate a second electrical signal and to apply the second electrical signal to the neural structure.

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: The present invention is directed to a method of regulating gastrointestinal action in a subject using a stimulatory electrode and a sensor to provide retrograde feedback control of electrical stimulation to the GI tract.

Abstract: A medical device, for example, an endoscope or catheter, includes local drug delivery capabilities for selectively delivering at least one drug in vivo. The local drug delivery may occur as the medical device is advanced through tortuous passageways of the patient's body or may occur after the medical device has reached its targeted destination. The medical device includes a drug agent, for example, carried in or on a hydrophilic or hydrogel coating disposed on the outside thereof. When the hydrogel or drug agent receives an appropriate signal, e.g., solution containing a triggering agent or triggering condition, e.g., heat or light, the hydrogel contracts or expands to squeeze out the drug from hydrogel. If electric current is provided as the signal, and the drug agent is charged, the drug agent is released by electrophoretic forces.

Abstract: The disclosure describes a medical lead with a retrieval wire that extends from the proximal end of the lead. The retrieval wire allows a physician to insert the medical lead into a patient and grab the retrieval wire to pull the proximal end of the lead away from the implant site. Upon gaining access to a lead connector on the proximal end of the medical lead, the physician may remove the retrieval wire and couple the lead connector to an implantable medical device that provides stimulation therapy. In this manner the physician may avoid damaging the lead connector when retrieving the medical lead. In addition, the retrieval wire may be used to provide test stimulation to verify correct electrode location. The medical lead may be used to stimulate tissue such as the stomach, small intestine, and the large intestine.

Abstract: A device for treating a tissue region at or near a sphincter including a proximal support, a distal support and an expandable basket having a plurality of spines. The spines have a proximal portion, a distal portion and an intermediate portion therebetween, wherein the spines are movable from a first non-expanded position to a second expanded position wherein in the expanded position the intermediate portion of the spines extends outwardly radially beyond the proximal and distal portions of the spines. A plurality of electrodes are carried by the spines and movable outwardly to an outward position to penetrate tissue for application of energy to the tissue region.

Abstract: Apparatus and methods are provided for the effective and minimally invasive treatment of obesity. In one embodiment, a device for providing therapy to a patient includes an inflatable structure adapted and configured for positioning at least partially within a gastroesophageal (GE) space formed between an inner wall of a phrenoesophageal ligament (POL) and outer walls of the esophagus and cardiac orifice and an electrode structure adapted and configured for positioning at least partially within the GE space. In another embodiment, a method for treating a patient includes introducing an electrode at least partially into a gastroesophageal (GE) space formed between an inner wall of a phrenoesophageal ligament (POL) and outer walls of the esophagus and cardiac orifice and modulating tissue using the electrode.

Abstract: Systems, devices, and methods are described for providing, among other things, devices operable to acquire intestinal microbial flora samples, to map intestinal microbial flora, to identify microbes present in an individual's digestive tract, to delivery intestinal microbial flora compositions, to register a microbial flora collection events, to register microbial flora-seeding events, or the like.

Abstract: A system for designing a therapy or for treating a gastrointestinal disorder or a condition associated with excess weight in a subject comprising at least one electrode configured to be implanted within a body of the patient and placed at a vagus nerve, the electrode also configured to apply therapy to the vagus nerve upon application of a therapy cycle to the electrode; an implantable neuroregulator for placement in the body of the patient beneath the skin layer, the implantable neuroregulator being configured to generate a therapy cycle, wherein the therapy cycle comprises an on time during which an electrical signal is delivered, the electrical signal comprising: a) a set of pulses applied at a first selected frequency of about 150-10,000 Hz, wherein each pulse of the set of pulses has a pulse width of at least 0.01 milliseconds and less than the period of the first selected frequency.

Abstract: An implantable electrical stimulation lead for the treatment of biological conditions includes a lead body with an electrical connector at one end and a pair of monopolar branches at the other end. The lead body has a length ranging from 390 mm to 490 mm to allow for implantation from an incision site further removed from the final positioning site of the electrodes. The branches have lengths ranging from 50 mm to 120 mm for the both branches. These lengths facilitate successful laparoscopic implantation at sites with confined anatomy, such as, near the gastroesophageal junction. The branches include needles and sutures at their ends for suturing anchors positioned on the branches to surrounding tissue. The needles have curves designed to facilitate maneuvering in confined anatomy. A separate lead includes a suture loop connecting the ends of the first and second branches rather than needles. The loop is used to pull the lead through the working channel of an endoscope.

Abstract: An apparatus to treat a sphincter has a support member. A sphincter electropotential mapping device includes a mapping electrode. The sphincter electropotential mapping device is coupled to the support member and configured to detect aberrant myoelectric activity of the sphincter.

Abstract: A method and apparatus are provided for treating a subject. An electrical signal is applied to at least one stomach site of the subject. The electrical signal is configured to reduce a rise in a blood glucose level of the subject, in order to treat the subject.

Abstract: The present invention is directed to a method of regulating gastrointestinal action in a subject using a stimulatory electrode and a sensor to provide retrograde feedback control of electrical stimulation to the GI tract.

Abstract: An obesity treatment system has a first treatment region sized and configured for deployment in a duodenum and a second treatment region sized and configured for deployment in a stomach. The first and second treatment regions are spaced apart a distance sized and configured to permit simultaneous deployment of the first treatment region in the duodenum and deployment of the second treatment region in the stomach. The first and second treatment regions each carry at least one electrode, which can deliver energy to ablate tissue in and the duodenum.

Abstract: A method of providing an implantable stimulation system to achieve chronic or permanent electrical stimulation of acupuncture points to treat a variety of chronic disorders.

Abstract: Methods and related systems for treating patients suffering from several disorders including bladder dysfunction, erectile dysfunction, and bowel elimination disorders are disclosed and described. The method can include identification of the disorder followed by the step of accessing a pudendal nerve of the patient. A microelectrode array having a plurality of electrodes thereon is inserted into the pudendal nerve of the patient. A controller is electronically associated with the microelectrode array which is programmed to provide selective activation and/or blocking of various muscles using the microelectrodes of the array. The selective stimulation can be tuned to selectively activate or block at least one muscle selected from the group consisting of the external urethral sphincter, the detrusor muscle, the anal sphincter, and the cavernous smooth musculature of the penis.

Abstract: Gastric apparatus is provided, including one or more sensors, adapted to generate respective sensor signals responsive to activity of a gastrointestinal tract of a subject. A control unit is configured with an eating detection threshold selected from the group consisting of: a predetermined threshold, and a threshold determined during a calibration procedure. The control unit is adapted to receive and analyze the sensor signals, and identify an aspect of at least one of the sensor signals indicative of periodic activity of the gastrointestinal tract. The control unit modifies the eating detection threshold responsive to identifying the aspect of the signals that is indicative of the periodic activity, and determines that an eating event has occurred responsive to the modified eating detection threshold and at least one of the analyzed sensor signals. Other embodiments are also described.

Abstract: The present invention is directed to a method of regulating gastrointestinal action in a subject using a stimulatory electrode and a sensor to provide retrograde feedback control of electrical stimulation to the GI tract. The invention is further directed to a method for reducing weight in a subject, again using a stimulatory electrode and a sensor to provide retrograde feedback control of electrical stimulation to the stomach. The invention is further directed to a method of providing electrical field stimulation to a gastrointestinal organ, as well as a method of providing an electrical potential gradient in a gastrointestinal organ. Further provided is a method of stimulating the vagus nerve of a subject. Additionally provided is a method of placing a device in the gastrointestinal tract or wall of a subject from the exterior of the subject, using a needle to insert the device.

Abstract: Instruments for thermally-mediated treatment of a patient's lower esophageal sphincter (LES) to induce an injury healing response to thereby populate the extracellular compartment of walls of the LES with collagen matrices to alter the biomechanics of the LES to provide an increased intra-esophageal pressure for preventing acid reflux. A preferred embodiment is a bougie-type device for trans-esophageal introduction that carries conductive electrodes for delivering Rf energy to walls of the LES (i) to induce the injury healing response or (ii) to “model” collagenous tissues of the LES by shrinking collagen fibers therein.

Abstract: In some examples, electrical stimulation therapy is delivered to support obesity management. The electrical stimulation therapy is configured to cause at least partial gastric distention. Gastric distention tends to induce a sensation of fullness and thereby discourages excessive food intake by the patient. The electrical stimulation therapy may be delivered to the gastrointestinal tract of the patient by electrodes deployed by one or more implantable leads coupled to an electrical stimulator. The electrical stimulator delivers stimulation pulses having a pulse width in a range found to be effective in causing gastric distention.

Abstract: An exemplary method for treating an eating or metabolism disorder includes calling for delivery of energy to the stomach using a pulse train that includes use of pulses with a pulse width less than approximately 20 ms, a duty cycle greater than approximately 20% and a pulse train duration of less than approximately 10 seconds and calling for delivery of energy to a vagal nerve. Various other methods, devices, systems, etc., are also disclosed.

Abstract: A method for treating a sphincter provides a polymer material having a liquid state. The method also provides a catheter having a distal end, a tissue piercing device carried by the distal end, and an energy delivery device coupled to the tissue piercing device. The tissue piercing device has a lumen. The method introduces the catheter into an esophagus and pierces an exterior sphincter tissue surface within with the tissue piercing device. The method advances the tissue piercing device into an interior sphincter tissue site and conveys the polymer material while in a liquid state through the lumen into the interior sphincter tissue site. The method delivers energy to the tissue piercing device to transform the polymer material into a less liquid state within the interior sphincter tissue site, to thereby remodel the sphincter.

Abstract: An exemplary method for treating obesity includes calling for delivery of electrical energy to a vagal nerve, detecting pre-prandial activity and, in response to the detection of pre-prandial activity, calling for delivery of electrical energy to the stomach for a pre-determined amount of time to induce satiety. Various other technologies are also disclosed.

Abstract: Various methods and apparatus for treating a condition associated with impaired glucose regulation in a subject comprising in one embodiment, applying a neural conduction block to a target nerve at a blocking site with the neural conduction block selected to at least partially block nerve pulses. In another embodiment, combinations of down-regulating and or up-regulating with or without pharmaceutical agents are used to treat impaired glucose regulation. In other embodiments, up-regulation or down-regulation of various nerves, such as the vagus and its branches, and the splanchnic is used to modify the production of GLP-1 and GIP, thereby controlling glucose levels. In yet further embodiments, combinations of down-regulating and or up-regulating with or without pharmaceutical agents are used to modify the production of GLP-1 and GIP, to treat impaired glucose regulation.

Abstract: The present invention is directed to a method of stimulating the vagus nerve of a subject.

Abstract: The disclosure provides a method of treatment for obesity, in an individual in need thereof, by administering electrical stimulation at dual sites in the gastrointestinal tract. The electrical stimulations are administered by positioning bipolar stimulatory electrodes in contact with the gastric and dudenol cavities, along afferent vagal neural pathways, in the gastrointestinal tract. The electrical stimulations thus administered, activate the vagal afferents associated with the gastric and dudenol sites in the gastrointestinal tract. The activation of vagal afferents modulates the gastrointestinal peptide satiety hormones. Further, the disclosure provides a method of treatment for eating disorders, in an individual in need thereof, by administering electrical stimulation at dual sites, along afferent vagal neural pathways, in the gastrointestinal tract.

Abstract: Apparatus (450) is provided including an electrode (460) and an implantation tool (458) configured to be passed into an abdominal cavity of a patient, and to insert the electrode into a gastric wall of the patient, generally in parallel to the gastric wall. Other embodiments are also described.

Abstract: A sphincter treatment apparatus includes an energy delivery device introduction member including a proximal end with a first radius of curvature and a distal end with a second radius of curvature. The introduction member is configured to be introduced into the sphincter in a non-deployed state and to be expanded to a deployed state to at least partially expand the sphincter or an adjoining structure. An energy delivery device is coupled to the introduction member. A retainer member is coupled to the energy delivery device introduction member and configured to controllably position the introduction member in an orifice of the sphincter.

Abstract: A lower esophageal sphincter tightening device for treating gastroesophageal reflux disease which includes an insertion device, an energy source, and an energy transmitting device. The insertion device, by insertion through a body opening, positions the energy transmitting device in the proximity of the lower esophageal sphincter. The energy source generates and transmits energy via the insertion device to the energy transmitting device which directs the transmitted energy onto the lower esophageal sphincter which is comprised largely of collagen. The energy source transmits energy at a level sufficient to cause heating of the sphincter's collagen resulting in a shrinkage of the collagen and a tightening of the sphincter.

Abstract: An ablation catheter system and method of use is provided to endoscopically access portions of the human esophagus experiencing undesired growth of columnar epithelium. The ablation catheter system and method includes controlled depth of ablation features and use of either radio frequency spectrum, non-ionizing ultraviolet radiation, warm fluid or microwave radiation, which may also be accompanied by improved sensitizer agents.

Abstract: Disclosed is a modular system for providing electrical stimulation, in which a first modular electrode section has a contoured back end configured to engage a contoured front end of another electrode section or a tool that may be used to place the first modular electrode section in the patient's body. The contours of the modular electrode section allow the two components to engage with one another so as to prevent their separation in the horizontal plane, and a lead extending from the first modular electrode is configured to engage keels on the top surface of the second electrode portion or tool, with such keels providing a snap-type attachment between the lead and the second electrode portion or tool, such that the two components may be joined together but easily separated from one another through the intentional separation of the lead from the keels on the second electrode portion or tool.

Abstract: Apparatus (18) for treating a human patient, which includes one or more electrode contact surfaces (100), which are configured to be applied to a fundus (22) of the patient. A control unit (90) is configured to drive the one or more electrode contact surfaces (100) to apply an electrical signal to the fundus (22) that chronically improves a blood glucose level of the patient, in order to treat the patient, without calculating an impedance of tissue of the fundus (22) based on a sensed parameter that varies in response to the electrical signal, for detecting eating by the patient or a characteristic of food eaten by the patient. Other embodiments are also described.

Abstract: A responsive gastrointestinal stimulation device is provided where one or more sensors sense data corresponding to a subject or the gastrointestinal tract of a subject and responds to sensing the data by stimulating, adjusting stimulation, or stopping stimulation of the gastrointestinal tract. A stimulation device is also provided to stimulate the gastrointestinal tract to produce a sensation of satiety or to control hunger or food consumption.

Abstract: A method of forming a composite lesion pattern in a tissue region at or near a sphincter comprising providing a catheter having a plurality of energy delivery devices coupled to the catheter. The catheter is introduced at least partially into the sphincter. Energy is delivered from the energy delivery devices to produce the composite lesion pattern. The composite lesion pattern comprises a radial distribution of lesions about the tissue region and a longitudinal distribution of lesions along the tissue region.

Abstract: The invention is directed toward stimulation of a selected tissue layer. A device is attached to a target tissue by applying vacuum pressure to a vacuum cavity of the device and advancing a needle into tissue within the vacuum cavity. The depth on the vacuum cavity is selected to permit deployment at the selected tissue layer. In one embodiment, the invention is directed toward an implantable medical device comprising a device housing defining a vacuum cavity, and a vacuum port for application of vacuum pressure to draw tissue into the vacuum cavity, an electrode that is movable into the vacuum cavity of the device housing to contact at least a portion of the tissue drawn into the vacuum cavity, and a lead comprising at least one conductor coupled to the electrode.

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: Apparatus is provided, including a control unit (310), adapted to be implanted within a patient (324), and a corkscrew-shaped electrode mount (400), adapted to be implanted in a wall of a stomach of the patient. The corkscrew-shaped electrode mount includes first (404) and second (424) electrodes, at respective sites of the electrode mount, and a controller (420), wirelessly coupled to the control unit. Other embodiments are also described.