Abstract: An implant device comprising an electrode for electrical stimulation of the pancreas, the device being adapted to be inserted into the pancreas, and to change at least one of its properties after being inserted into the pancreas, so that it will cause less irritation to the pancreas than before changing said property.

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: An implantable restriction system having an antenna capable of being readily and predictably movable to achieve a desired orientation that is effective to communicate with an external device is provided. The antenna can be movably coupled to a housing such that the antenna can float and/or move freely with respect to the housing. The housing can be part of a gimbal element or another component of the system. The antenna can include a weight or a magnetic element to help it achieve the desired orientation. Methods for transcutaneously communicating with an implantable restriction device are also provided.

Abstract: An implantation device for releasably holding implantable microstimulators can be used to guide one or more microstimulators to any site within the gastrointestinal tract for implantation. The device can further releasably hold one or more ligation clips for securing the one or more microstimulators in place within the implantation site(s) and/or for closing an incision in which a microstimulator is implanted. The device can be employed using open, laparoscopic, and endoscopic techniques.

Abstract: The present invention relates to a medical device (2) for electrical stimulation. The device comprising an implantable elongated lead system (20) having a distal end (21) and a proximal end (22), the lead system comprises one or more electrical conductors (23) for connection to one or more electrodes (24). The one or more electrical conductors are wound along a length axis (25) of the lead system with a plurality of windings, and wherein the density of windings is non-uniformly distributed along the length axis. In an embodiment, the medical device is in the form of a deep brain stimulation (DBS) device.

Abstract: A system, device, and method for placing a capsule for sensing one or more parameters of a patient by anchoring the capsule to a tissue at a specific site and releasing the capsule from the device, using a single actuator operated during a single motion. As an example, a delivery device may anchor the capsule to the tissue site and release the capsule from the delivery device during a single motion of the actuator. This allows a user to place the capsule by interacting with only a single actuator through one type of motion, thus making delivery of the capsule more reliable and user-friendly.

Abstract: Gastric stimulation devices, systems and methods are provided, particularly for stimulating a gastric organ having an internal cavity. Such devices and systems are typically implanted outside of the gastric organ while the environment of the internal cavity is probed and monitored by one or more sensors. The sensor information may be used to affect the stimulation signals provided to the gastric organ by the devices and systems. Such feedback integration assists in providing treatments and stimulation programs that are tailored to the needs of the individual patient.

Abstract: An endoluminal treatment device and method includes introducing an endoluminal device into a lumen of a patient and engaging a wall of the lumen with an implant device. The implant device can be a drug delivery device or medical device.

Abstract: Devices and methods are provided for treatment of tissue in a body lumen with an electrode deployment device. Embodiments typically include a device with a plurality of electrodes having a pre-selected electrode density arranged on the surface of a support. The support may comprise a non-distensible electrode backing that is spirally furled about an axis and coupled to an expansion member such as an inflatable elastic balloon. In some embodiments, the balloon is inflated to selectively expose a portion of the electrode surface while maintaining the electrode density.

Abstract: The disclosure is directed to techniques for delivering electrical stimulation therapy 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: Systems and methods that treat disorders of the gastrointestinal tract by applying one or more treatment agents to tissue at or near the region where abnormal neurological symptoms or abnormal tissue conditions exist. The treatment agent is selected to either disrupt the abnormal nerve pathways and/or to alleviate the abnormal tissue conditions. The treatment agent can include at least one cytokine and/or at least one vanilloid compound to evoke a desired tissue response. The systems and methods can be used a primary treatment modality, or as a neoadjuvent or adjuvant treatment modality.

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: Techniques are described that allow an implantable device to sense gastric data and activity data from a patient, and estimate the patient's amount of energy consumed and energy expended based on the sensed data. A system provides feedback to the patient, a family member, or a doctor about the patient's energy consumed, energy expended, and net energy. The data may be provided in table or graphical format, and may show daily or weekly energy balance data or may show a trend of the daily or weekly energy data. The patient may receive feedback by an implanted alert module that provides and audio alert or a vibration alert. In addition, data acquired by the system may be used to adjust the patient's stimulation therapy parameters.

Abstract: A method is provided, including placing first and second electrodes (90) at respective first and second sites of a duodenum (40) of a subject, and activating the electrodes (90) to increase a blood insulin level of the subject. Other embodiments are also described.

Abstract: A method for treating at least one of a plurality of disorders characterized at least in part by vagal activity includes positioning an electrode around a body organ innervated by the vagus. An electrical signal is applied to the electrode to modulate vagal activity. The electrical signal is applied at a frequency selected for the signal to create a neural conduction block to the vagus with the neural conduction block selected to at least partially block nerve impulses on the vagus. The application of the electrical signal is discontinued. The application of the signal and the discontinuing of the signal are repeated with durations of the discontinuing and the application selected to treat the disorder.

Abstract: A treatment method is provided, including identifying a subject as one who is selected to undergo an interventional medical procedure, and, in response to the identifying, reducing a likelihood of a potential adverse effect of the procedure by applying an electrical current to a parasympathetic site of the subject selected from the group consisting of: a vagus nerve of the subject, an epicardial fat pad of the subject, a pulmonary vein of the subject, a carotid artery of the subject, a carotid sinus of the subject, a coronary sinus of the subject, a vena cava vein of the subject, a jugular vein of the subject, a right ventricle of the subject, a parasympathetic ganglion of the subject, and a parasympathetic nerve of the subject.

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: 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: An retaining device for attaching to a contractile organ such as a digestive tract organ or stomach is provided. One aspect may include a lead for stimulating a digestive organ. The device may be an electrical stimulation device configured to deliver electrical signals to the organ.

Abstract: A system and method are disclosed for an implantable gastric stimulation system within the stomach. The stimulation system includes an electronics anchor, electrode lead anchor, implantable pulse generator and external programmer. The electronics anchor is configured to attach to the stomach wall at a first location and the electrode lead anchor configured to attach to the stomach wall at a second location. The electrode lead anchor includes one or more electrodes configured to contact the stomach wall and a flexible lead portion coupled to the one or more electrodes at one end with an the electrical connector portion at the other end. The implantable pulse generator has electronic circuitry and is attached to the electronics anchor; the electronic circuitry is connected to the electrical connector of the electrode lead anchor and can communicate with the one or more electrodes.

Abstract: Method and apparatus for disrupting a gastric vagal nerve in the gastroesophageal region and testing the function and disruption of the vagal nerve. In one example embodiment, a treatment device applies ultrasound at a high energy level, such as high intensity focused ultrasound, to a vagal nerve to disrupt it and then ultrasound at a lower energy level to another portion of the vagal nerve, preferably further from the stomach, so as to stimulate the vagal nerve. Alternative ways to test the function or disruption of the vagal nerve involve using PCP-GABA, a pancreatic polypeptide, pressure changes inside the stomach, the gastric mucusol pH, a dye agent in the stomach, and other tests.

Abstract: A method and apparatus for providing trans-esophageal electrical signal therapy to a portion of a vagus nerve of a patient to treat a medical condition. An implantable medical device comprising at least one electrode is implanted in an inner lumen of the esophagus of the patient. At least one electrode is electrically coupled to the inner lumen of the esophagus. An electrical signal from the IMD is provided to a target portion of the vagus nerve through at least a portion of the wall of the esophagus for treating the medical condition.

Abstract: The disclosure is directed to gastric stimulation programmers, stimulators and methods for controlling delivery of gastric stimulation therapy to maintain the efficacy of the therapy over time. Maintaining the efficacy of gastric stimulation therapy may be possible by implementing one or more anti-desensitization features in a gastric stimulation controller or stimulator. As electrical stimulation therapy is continuously delivered to a patient, the stimulated tissue may become desensitized to the electrical stimulation therapy such that the beneficial effect of the electrical stimulation is diminished. Once desensitization occurs, the affected tissue may not respond favorably to electrical stimulation therapy. Application of one or more anti-desensitization features to control gastric stimulation therapy may reduce or prevent desensitization and effectively extend the efficacy of the therapy over time.

Abstract: A sensor based gastric stimulator system and method for gastric stimulation of a patient employing an implantable gastric stimulator, which includes an information processor, an electrical stimulator circuit, and telemetry circuitry. The implantable stimulator senses intrinsic, gastric electrical activity (slow waves and/or peristaltic waves) and delivers electrical stimulation to intentionally disrupt or disorganize that activity. The stimulation is triggered by (tracks) normal gastric electrical activity and can be delivered with a spatial offset to anticipate the propagating gastric electrical activity or may be delayed temporally to anticipate the next propagating slow or peristaltic wave. The stimulator may be programmed to disrupt/disorganize all or a percentage of the intrinsic, normal gastric electrical activity. The programmer (via radio frequency data link) may non-invasively program stimulation parameters and intervals.

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: A method of using a stimulation device to emit a medium to an appendicular region and/or rectal region of a user for treatment of a gastrointestinal disorder is described. The method includes placing the stimulation device into the appendicular region and/or rectal region, and delivering the medium, wherein the medium stimulates at least a portion of the enteric nervous system. Additionally, apparatus and delivery devices are disclosed.

Abstract: Devices and methods of non-surgically providing vagus nerve therapy trans-esophageally to treat a variety of medical conditions are disclosed herein. In an embodiment, an implantable medical device comprises a support member having an outer surface. The support member is adapted to engage the inner wall of an esophagus. The IMD also comprises at least one electrode disposed on the outer surface of the support member. The at least one electrode is capable of applying a trans-esophageal electrical signal to the vagus nerve through the wall of the esophagus from the inner lumen thereof. The implantable medical device further comprises a signal generator coupled to the support member and to the at least one electrode. The signal generator causes the at least one electrode to apply an electrical signal to the vagus nerve to treat a medical condition.

Abstract: An apparatus is disclosed for converting excess carbohydrates present in body fluids of a mammal. The apparatus may be placed in the digestive tract of the mammal, or in contact with body fluids such as blood or lymph. The apparatus comprises electrodes for converting monosaccharides to electric energy.

Abstract: Devices and methods of non-surgically providing vagus nerve therapy trans-esophageally to treat a variety of medical conditions are disclosed herein. In an embodiment, an implantable medical device comprises a support member having an outer surface. The support member is adapted to engage the inner wall of an esophagus. The IMD also comprises at least one electrode disposed on the outer surface of the support member. The at least one electrode is capable of applying a trans-esophageal electrical signal to the vagus nerve through the wall of the esophagus from the inner lumen thereof. The implantable medical device further comprises a signal generator coupled to the support member and to the at least one electrode. The signal generator causes the at least one electrode to apply an electrical signal to the vagus nerve to treat a medical condition.

Abstract: The present invention relates to a reflux disease treatment apparatus, apparatus, comprising an implantable movement restriction device that maintains cardia in the correct position and an implantable stimulation device adapted to engage with the cardia sphincter of a patient. The invention further comprises a control device for controlling the stimulation device to stimulate the cardia sphincter. The invention can be combined with various methods for treating obesity, in particular methods that creats satiety by stretching the wall of the stomach or fills out a volume of the stomach.

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 fixation device for holding stimulating electrodes in electrical contact with the wall of a portion of the gastrointestinal tract is provided. In one embodiment, the fixation device includes an expandable member that fixes the electrodes in electrical contact with the gastrointestinal tract wall. Also provided is an implantable device and method for controlling the opening and/or closing of the pylorus. In particular a device and method is provided for stimulating the duodenum to control the closing/and or opening of the pylorus. Finally, a method is provided for treating obesity by controlling the pylorus to retain food in the stomach for a desired period of time, among other things to provide a feeling of-satiety and/or to reduce hunger. One aspect includes controlling the pylorus's contraction by electrical stimulation of the duodenum.

Abstract: An retaining device for attaching to a contractile organ such as a digestive tract organ or stomach is provided. One aspect may include a lead for stimulating a digestive organ. The device may be an electrical stimulation device configured to deliver electrical signals to the organ.

Abstract: An intra-luminal medical device includes a fixation mechanism to attach the medical device to tissue within a body lumen, and a detachment mechanism to permit selective detachment of the medical device from the tissue attachment site without the need for endoscopic or surgical intervention. An electromagnetic device may be provided to mechanically actuate the detachment mechanism. Alternatively, a fuse link may be electrically blown to detach the medical device. As a further alternative, a rapidly degradable bonding agent may be exposed to a degradation agent to detach the medical device from a bonding surface within the body lumen. The medical device may eliminate problems associated with uncertain and inconsistent detachment of intra-luminal medical devices.

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 implantable lead has a lead body construction designed to accommodate loading forces exerted on the lead body during patient movement. The lead body may be sufficiently stretchable to resist forces that could otherwise cause lead failure, axial migration of the electrodes, anchor damage, or tissue damage. Increasing stretchability of a lead body can also increase the vulnerability of the lead body to flex fatigue, buckling fatigue, kinking, and crush. Therefore, the lead described herein includes conductors that comprise coiled wires positioned substantially parallel to a center axis of the lead. The conductors described herein may be coiled around fibers that limit the axial stiffness of the coiled wires to ensure full recovery from axial loading.

Abstract: A device, system and method for electrically stimulating the stomach is provided. A device system and method for attaching a stimulating device to the stomach wall is also provided.

Abstract: An retaining device for attaching to a contractile organ such as a digestive tract organ or stomach is provided. One aspect may include a lead for stimulating a digestive organ. The device may be an electrical stimulation device configured to deliver electrical signals to the organ.

Abstract: A pseudounipolar stimulator lead for anchoring to a digestive organ is provided.

Abstract: Surgical procedures, kits and implants for alleviating human urinary and fecal incontinence are disclosed. Electrical stimulation is provided at one or more locations or positions in relation to or within an anal sphincter muscle comprising an internal anal sphincter surrounding the anus, an external anal sphincter surrounding the internal anal sphincter, a levator ani coupled to the external anal sphincter and perineal floor muscles around the anal orifice to treat or control fecal incontinence. Stimulation electrodes are mounted to one of a mesh patch, a fecal sling or the cuff of an artificial anal sphincter. Tissue anchors may be provided to engage tissue to stabilize mesh patch(es) or the fecal sling. Rectal pressure is detected and employed in controlling delivery of electrical stimulation.

Abstract: A fixation device for holding stimulating electrodes in electrical contact with the wall of a portion of the gastrointestinal tract is provided. The fixation device includes an expandable member that fixes the electrodes in electrical contact with the gastrointestinal tract wall.

Abstract: A method is provided for treating a subject, including applying a current to a site of the subject selected from the list consisting of: a vagus nerve of the subject, an epicardial fat pad of the subject, a pulmonary vein of the subject, a carotid artery of the subject, a carotid sinus of the subject, a vena cava vein of the subject, and an internal jugular vein of the subject.

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: An retaining device for attaching to a contractile organ such as a digestive tract organ or stomach is provided. One aspect may include a lead for stimulating a digestive organ. The device may be an electrical stimulation device configured to deliver electrical signals to the organ. The device may be implanted in the abdomen using a laparoscopic or other method.

Abstract: A gastro-electric stimulation system includes an INS for producing an electrical stimulation signal, at least one medical electrical lead, and at least two electrical contacts. The medical electrical lead has a proximal end and a distal end, the proximal end being connected to the INS, the distal end being adapted for placement in or near a patient's stomach or appropriate nerve or nerve portion. The electrodes are disposed near the distal end of the medical electrical lead, and are electrically connected through the medical electrical lead to the INS to receive the electrical stimulation signal and convey such signal to the selected electrode implant position. The electrical stimulation signal is provided in an amount and manner adapted to increase the pH of the gastric acid in the patient's stomach and/or to decrease the amount of gastric acid produced thereby.

Abstract: A gastrointestinal electrode device is disclosed, comprising an electrode head intended to be implanted in a stomach wall for emission or reception of electrical signals and a flexible cable with an outer isolation layer. The flexible cable is connected to the electrode head for forwarding the electric signals to an external side of the electrode device. The electrode head comprises flexible expandable retention means and at least one electrode contact area arranged to cover at least a part of the outer electrode head area. Further the expandable retention means are automatically expandable from an condition of insertion into an expanded condition for opposing retraction of the electrode via the aperture of insertion, thus making the electrode attachable to the living organ.

Abstract: The present invention provides systems, apparatus and methods for selectively applying electrical energy to body tissue. A device is provided having an enclosure within an outer wall formed from an electrically-permeable material to allow for electrical energy to pass from the interior of the enclosure through the outer wall. The device further includes an electrode positioned within the interior of the enclosure and a fluid passage coupled to the enclosure for delivery of an electrically conductive fluid into the interior of the enclosure such that the electrically conductive fluid couples the electrode with the electrically-permeable section of the outer wall. The conductive fluid allows for the passage of electrical energy from the electrode through the fluid and the outer wall of the enclosure for treatment of tissue on or in a patient.

Abstract: In general, invention is directed to devices and methods for use in laparoscopic surgical procedures in which a medical implant is affixed to or implanted within an exterior surface of a body organ. A system, for example, is described that includes a laparoscopic cannula and a delivery instrument disposed within the cannula to fix a medical implant to an exterior surface of an organ. The delivery instrument has a distal end including a cavity and a vacuum port to draw a portion of the exterior surface of the organ into the cavity. The medical implant is affixed to the portion of the exterior surface drawn into the cavity of the delivery instrument.

Abstract: A method for diagnosing and treating gastric disorders is provided. A functional device resides within the patient?s stomach and is secured to the stomach wall by an attachment device. The functional device may be a sensor for sensing various parameters of the stomach or stomach environment, or may be a therapeutic delivery device. The functional device in one embodiment provides a method for gastric electrical stimulation where stimulating electrodes are secured to the wall of the stomach by the attachment device or otherwise. A preferred device includes: at least one stimulating electrode in electrical contact with the stomach wall; an electronics unit containing the electronic circuitry of the device; and an attachment mechanism for attaching the device to the stomach wall. The functional devices may be programmed to respond to sensed information or signals. An endoscopic delivery system delivers the functional device through the esophagus and into the stomach where it is attached the stomach wall.

Abstract: Techniques are described that allow an implantable device to sense gastric data and activity data from a patient, and estimate the patient's amount of energy consumed and energy expended based on the sensed data. A system provides feedback to the patient, a family member, or a doctor about the patient's energy consumed, energy expended, and net energy. The data may be provided in table or graphical format, and may show daily or weekly energy balance data or may show a trend of the daily or weekly energy data. The patient may receive feedback by an implanted alert module that provides and audio alert or a vibration alert. In addition, data acquired by the system may be used to adjust the patient's stimulation therapy parameters.