Abstract: A method of treating a sphincter that provides an expandable basket structure with a first energy delivery device. The basket structure is introduced in a sphincter. The first energy delivery device is advanced from the basket structure into an interior of the sphincter. Sufficient energy is delivered from the first energy delivery device to create a desired tissue effect in the sphincter. Thereafter, the basket structure is removed from the sphincter.

Abstract: Systems and methods manipulate a support structure to form a composite lesion in a tissue region at or near a sphincter. The support structure carries an array of electrodes attachable to a source of energy capable of heating tissue when transmitted by the electrodes. The systems and methods advance the electrodes to penetrate the tissue region and form, when the energy is transmitted, a first pattern of lesions. The systems and methods retract the electrodes, and shift the position of the electrodes, either rotationally, or axially, or both rotationally and axially. The systems and methods advance the electrodes a second time to form, when the energy is transmitted, a second pattern of lesions either rotationally or axially or both rotationally and axially shifted from the first pattern of lesions. The first and second patterns of lesion together comprise the composite lesion.

Abstract: A self-propelling device (1) is adapted to travel through a passage (3) having walls containing contractile tissue, the device (1) comprising a body (2) and at least one contractile tissue-stimulating means for stimulating the walls to urge the device selectively in both a forward direction (7). The stimulating means may be electrodes (5,8), and the passage can be the gut of an animal or human. The device is particularly useful as an enteroscope.

Abstract: An implantable medical or intramuscular lead system, such as for use as a gastric lead, and method of use in which electrodes along the lead are imbedded in tissue. The system includes a clip having two arms biased to a closed position clamping the lead. The arms of the clip are movable against the bias to an open position allowing the clip to be moved along the length of the lead, or the clip to be attached or removed in the lateral direction. The system facilitates implantation of the lead in tissue, and may be particularly suited for minimally invasive implantation, such as laparoscopically.

Abstract: A method of forming a composite lesion pattern in a tissue region

Abstract: An improved process using electrostimulation for treating obesity, especially morbid obesity, and other syndromes related to motor disorders of the stomach is provided. The improved method of this invention provides electrostimulation on the lesser curvature of the stomach, preferably on the lower or distal end of the lesser curvature, which provides improved control of obesity and other syndromes related to motor disorders of the stomach. In one embodiment, the process employs stimulation of the lesser curvature at a rate of about 2 to about 14 pulses/minute with each pulse lasting about 0.5 to about 4 seconds such that there is a pause of about 3 to about 30 between the pulses. Preferably, the pulse rate is about 12 pulses/minute with each pulse lasting about 2 seconds with a pause of about 3 seconds between pulses. Preferably, the pulse amplitude is about 0.5 to about 15 milliamps. More preferable, each pulse consists of a train of micro-bursts with a frequency of about 5 to about 100 sec−1.

Abstract: An apparatus to treat a sphincter includes a catheter means including a catheter means distal portion means. An energy delivery device means is coupled to the catheter means and includes a tissue piercing distal end. The energy delivery device means is configured to pierce a sphincter exterior surface, advance a sufficient distance in an interior of the sphincter to a tissue site, deliver energy to the tissue site and create controlled cell necrosis of the sphincter in order to reduce a frequency of sphincter relaxation. A cable means is coupled to the energy delivery device means.

Abstract: A screening test is used on a patient to determine if pancreatic secretion is responsive to stimulation. The screening test compares measurements of a pancreatic indicator both before and after natural stimulation. The pancreatic indicator is measured before natural stimulation and then the patient's pancreas is naturally stimulated. After waiting a time period from when the natural stimulation began, the pancreatic indicator is once again measured. The difference between the pancreatic indicator measured before ingesting the meal and the pancreatic response indicator measured after ingesting and waiting a time period is calculated and a decision is made whether the patient has a pancreatic condition suitable for treatment with electrical stimulation. Additionally, an efficacy test is used to evaluate the efficacy of employing electrical stimulation to treat a pancreatic condition.

Abstract: Apparatus for stimulating neuromuscular tissue of the gastrointestinal tract and methods for installing the apparatus to the surface of the neuromuscular tissue. A pair of electrodes are supported by an electrode attachment member having a distal surface configured for attachment to the surface of the neuromuscular tissue. The electrodes are supported adjacent the distal surface to provide an interface between the electrodes and the surface of the neuromuscular tissue. The electrode attachment member may be flexible to pass through a laparoscopic surgical access opening in a compacted form and then returned to an uncompacted form for attachment to the surface of the neuromuscular tissue by the use of staples or sutures.

Abstract: A system and method for treating gastrointestinal and other disorders via electrical stimulation of plural portions of a patient's gastrointestinal tract uses an implantable control module, sensors attached to various structures of the gastrointestinal tract, and electrodes also attached to various structures of the gastrointestinal tract. Signals received from the sensors are analyzed to identify events in the gastrointestinal system, and electrical stimulation is applied to structures of the gastrointestinal tract, in sequence, to restore normal function or achieve other clinically desirable results.

Abstract: A medical device is provided comprising a capsule for introduction into a bodily lumen. The capsule can include a balloon filled with a conductive fluid, or a mechanism for actuating wings supporting electrodes. An umbilicus can attach to the trailing end of the capsule. A control unit controls propulsion of the capsule through the bodily lumen.

Abstract: An electrical device utilized to control the body weight of a medically overweight human being comprises of at least two electrical leads for implanting on the fundus of the stomach. An electrical generator/controller (pacemaker) generates and regulates the frequency and degree of electrical stimulation. The device can be used surgically, laproscopically, and/or endoscopically.

Abstract: Apparatus for stimulating neuromuscular tissue of the gastrointestinal tract and methods for installing the apparatus to the neuromuscular tissue. Four electrodes are supported by an electrode assembly for attachment to the neuromuscular tissue. The electrodes are oriented substantially equidistantly with respect to the tissue and provide an electrical interface with the neuromuscular tissue. The pulse generator is provided with a switching matrix, and may stimulate the tissue in a time-varying manner by selecting pairs of electrodes and altering the polarities thereof while stimulating the tissue.

Abstract: A device, system and 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 device, system and 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.

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: This invention relates to an implant device which is designed and adapted use in laparoscopic surgery. This implant device is especially adapted for electrostimulation and/or electrical monitoring of endo-abdominal tissue or viscera. The implant device has an elongated body having on, or near, its distal end a flexible attachment member which can be folded back on to the elongated body and attached to the elongated body thereby forming a closed loop around the tissue of interest. By “looping” around or through the tissue of interest, the attachment member and the elongated body are securely attached to the tissue and will resisted displacement even in cases where the tissue is subject to vigorous, periodic peristaltic movement within the body (e.g., digestive organs).

Abstract: An apparatus to treat a sphincter includes an energy delivery device support member. An energy delivery device is coupled to the energy delivery support member. The energy delivery device has a configuration that controllably produces lesions of a sufficient size and number in the sphincter to create a selectable tightening of the sphincter.

Abstract: Systems and methods manipulate a support structure to form a composite lesion in a tissue region at or near a sphincter. The support structure carries an array of electrodes attachable to a source of energy capable of heating tissue when transmitted by the electrodes. The systems and methods advance the electrodes to penetrate the tissue region and form, when the energy is transmitted, a first pattern of lesions. The systems and methods retract the electrodes, and shift the position of the electrodes, either rotationally, or axially, or both rotationally and axially. The systems and methods advance the electrodes a second time to form, when the energy is transmitted, a second pattern of lesions either rotationally or axially or both rotationally and axially shifted from the first pattern of lesions. The first and second patterns of lesion together comprise the composite lesion.

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: The invention relates to medicine specifically to medical technology, and concerns electrical gastro-intestinal tract and mucous membrane stimulators. The electrical gastro-intestinal tract stimulator comprises a casing (1) with electrodes and in the form of a medicinal capsule containing a power source (4), a control unit (5) of which M outputs are connected to M electrodes (3), a device (6) for receiving signals from internal organs and/or an external transmitter, to (1-N) outputs of which are connected (1-N) inputs of the control unit (5). The electrical stimulator can contain P additional electrodes (7) provided with a coating of microelements or medicinal preparations and connected to P separate outputs of the control unit (5). The electrical stimulator can also contain a signal transmitter (10) designed to transmit signals from the device (6) for receiving signals from internal organs and/or external transmitter and control unit (5) to an external receiver for medical observation and monitoring.

Abstract: Systems and methods apply a selected treatment agent or agents into contact with tissue at or in the region of a dysfunctional sphincter (in the case of GERD, fecal incontinence, or other dysfunctional sphincter disorders) to affect improved sphincter barrier function and/or to disrupt abnormal nerve pathways. The treatment agent can include at least one cytokine and/or at least one tissue bulking agent 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 applied as a supplementary treatment before, during or after a primary intervention.

Abstract: A sphincter treatment apparatus includes an energy delivery device introduction member including a plurality of arms. Each arm has distal and proximal sections. The distal sections of the arms are coupled as are the proximal sections of the arms. The energy delivery device introduction member is configured to be introduced in the sphincter in a non-deployed state, expand to a deployed state to at least partially expand the sphincter. A plurality of energy delivery devices are coupled to the energy delivery device introduction member. At least a portion of the plurality of energy delivery devices are controllably introducible from the energy delivery device introduction member into the sphincter.

Abstract: The invention provides an apparatus and system for ablation of body structures or tissue in the region of the rectum. A catheter is inserted into the rectum, and an electrode is disposed thereon for emitting energy. The environment for an ablation region is isolated or otherwise controlled by blocking gas or fluid using a pair of inflatable balloons at upstream and downstream locations. Inflatable balloons also serve to anchor the catheter in place. A plurality of electrodes are disposed on the catheter and at least one such electrode is selected and advanced out of the catheter to penetrate and ablate selected tissue inside the body in the region of the rectum. The electrodes are coupled to sensors to determine control parameters of the body structure or tissue, and which are used by feedback technique to control delivery of energy for ablation or fluids for cooling or hydration.

Abstract: A method of treating a sphincter provides a sphincter electropotential mapping device with at least one of a mapping electrode or a treatment electrode. The sphincter electropotential mapping device is introduced into at least a portion of the sphincter, the lower esophageal sphincter, stomach, the cardia or the fundus. Bioelectric activity causing a relaxation of the sphincter is detected and energy is delivered from either the mapping electrode or the treatment electrode to treat the bioelectric activity.

Abstract: A disposable article to be fitted to a wearer having an external anal sphincter muscle, the external anal sphincter muscle having a basal electrical activity. The disposable article preferably comprises a sensor or sensor system operatively connected to the article wherein the sensor is adapted to detect changes in the electrical activity of the wearer's external anal sphincter muscle that correlates to an impending elimination of bodily waste and to provide a signal to the wearer, a caregiver or an element of the article notifying the wearer, caregiver or element of the article of the impending event.

Abstract: Electrode assemblies actively cool mucosal surface tissue at or near a sphincter while applying energy through an electrode to ohmically heat tissue beneath the surface. The applied energy creates one or more lesions, or a prescribed pattern of lesions, below the mucosal surface. Natural healing of the subsurface lesions leads to a physical tightening of the sphincter and/or adjoining tissue to treat sphincter dysfunction. The active surface cooling preserves and protects the mucosal surface against thermal damage. Furthermore, electrode assemblies can deliver a therapeutic material to the tissue region independent of or as an adjunct to lesion formation. The therapeutic material can comprise, e.g., a tissue ablating chemical; or a drug, such as a tissue growth factor, or a fibrosis inducer, or a fibroblast growth factor, or a sclerosant; or a tissue bulking agent; or an exotoxin.

Abstract: Systems and methods manipulate a support structure to form a composite lesion in a tissue region at or near a sphincter. The support structure carries an array of electrodes attachable to a source of energy capable of heating tissue when transmitted by the electrodes. The systems and methods advance the electrodes to penetrate the tissue region and form, when the energy is transmitted, a first pattern of lesions. The systems and methods retract the electrodes, and shift the position of the electrodes, either rotationally, or axially, or both rotationally and axially. The systems and methods advance the electrodes a second time to form, when the energy is transmitted, a second pattern of lesions either rotationally or axially or both rotationally and axially shifted from the first pattern of lesions. The first and second patterns of lesion together comprise the composite lesion.

Abstract: A disposable article to be fitted to a wearer. The disposable article preferably comprises a sensor operatively connected to the article. The sensor is adapted to detect electrical activity in the wearer's smooth colonic muscles, abdominal muscles or the muscles surrounding the bladder or rectum which correlates to an impending elimination of bodily waste and to provide a signal to the wearer, a caregiver or an element of the article of the impending event.

Abstract: The present invention provides systems and methods for selectively applying electrical energy to a target location within the gastrointestinal tract, such as the lower esophageal sphincter (LES). In one aspect of the invention, high frequency voltage is applied between the electrode terminal(s) and one or more return electrode(s) to remove a small tissue segment, channel or hole from the region near or in the LES to shrink the turbinates and prevent swelling, due to the formation of scar tissue as the wound heals. The high frequency voltage may be selected to effect a small amount of thermal damage to the walls of the channel or hole to facilitate the formation of scar tissue without extending this thermal damage beyond the immediate region of the target site. In another aspect, the high frequency voltage is selected to contract collagen fibers within the LES to improve its tone, thereby reducing the frequency of reflux.

Abstract: An implant device specifically for electrostimulation and/or electrical monitoring of endo-abdominal tissue or viscera is provided. The implant device has an elongated body equipped with devices to secure it to the tissue to be treated and two or more electric poles that are electrically connected to an electric connection terminal for connection to a power source to penetrate the tissue to be treated, and quick-release connecting devices to separate the penetration device from the elongated body.

Abstract: Expandable assemblies for treating a tissue region at or near a sphincter comprises a support basket formed from an array of spines. A mechanism flexes the spines to expand and collapse the basket. Electrodes carried by the spines for advancement in a path to penetrate the tissue region upon expansion of the basket. The basket can be formed from a mechanical array of molded, jointed spines, or from an extruded tube having axial slits forming the spines.

Abstract: A sphincter treatment apparatus includes an elongated member having at least one lumen including an inflation lumen and a basket assembly with first and second arms. The basket assembly is coupled to the elongated member and has deployed and non-deployed configurations. An inflatable member is coupled to the elongated member and positioned in an interior of the basket assembly. The inflatable member has deployed and non-deployed states and is coupled to the inflation lumen. In the deployed state, the inflatable member expands the basket assembly to its deployed configuration. A first energy delivery device is positionable in the first arm and advanceable from the first arm to a selected treatment site. A second energy delivery device is positionable in the second arm and advanceable from the second arm to a selected treatment site.

Abstract: A device and method for electrical stimulation of a portion of the gastro-intestinal tract, defining a longitudinal axis. A proximal and at least one distal electrode set are arranged circumferentially about the portion of the gastro-intestinal tract in a plane substantially perpendicular to the longitudinal axis and in axially spaced relationship relative to each other. At least one power source provides an electrical stimulus to the electrode sets sufficient to stimulate the smooth muscle to produce a local circumferential contraction at each electrode set. A timing mechanism phase locks the electrical stimulus such that it is applied to the electrode sets successively and repetitively. The axially spaced relationship between the electrode sets and the timing of the electrical stimulus are selected such that the local circumferential contractions are artificially propagated distally through the portion of the gastro-intestinal tract.

Abstract: There is provided a system and method for directly stimulating the LES of a patient in order to normally maintain it in a closed state, thereby preventing reflux and treating the symptoms of GERD. The stimulation is inhibited in response to patient swallowing, by monitoring esophageal motility and timing out an inhibition period following detection of motility representative of swallowing. The system utilizes an implanted stimulator which is programmed to deliver a train of stimulus pulses to one or more electrodes fixed around the gastro-esophageal junction and connected to the stimulator by one or more leads. The motility sensing is done by a sensor for sensing mechancial wave movement or electrical signals representative of high motility following swallowing. The motility sensor and stimulating electrodes are attached laproscopically, and are preferably carried by a common stent carrier which is sutured around the lower esophagus.

Abstract: A method of treating a sphincter provides a treatment apparatus that includes an expandable device coupled to an introducer distal portion and an energy delivery device. The expandable device includes a first arm and a second arm each with proximal and distal section. The expandable member has a non-deployed configuration and a deployed configuration when the first and second arm distend away from each other. The expandable device is at least partially introduced in the sphincter. At least a portion of the energy delivery device is advanced from the expandable device into an interior of the sphincter. Sufficient energy is delivered from the energy delivery device to create a desired tissue effect in the sphincter. The expandable device is then removed from the sphincter.

Abstract: An anticonstipation apparatus, and method, that may include using an implanted stimulus generator that may supply electrical stimuli to the muscles associated with a target portion of the patient's gut, from the esophagus to the anus, through an electrical lead and several pairs of electrodes. The electrical stimuli may be provided to nerves in the autonomic nervous system that are associated with the muscles, or the stimuli may be provided directly to the muscles themselves. The stimuli may be provided sequentially, in a proximal to caudad direction, in order to initiate, enhance or artificially produce peristalsis in the gut's target portion in a proximal to caudad direction. If the gut's target portion is in the descending colon, such stimulation may be coordinated with similar stimulation of the muscles associated with the rectum and anus. A sensor may be provided to detect when the target portion is experiencing constipation.

Abstract: A method of treating a sphincter provides a sphincter electropotential mapping device with a mapping electrode. The sphincter electropotential mapping device is introduced into at least a portion of the sphincter. Aberrant myoelectric activity of the sphincter is detected. Energy is delivered from the sphincter electropotential mapping device to treat the aberrant myoelectric activity of the sphincter.

Abstract: A system is disclosed for enabling telemetry from an auditory prosthesis, illustratively a cochlear prosthesis. An electrode array 10 is used both for delivering electrical stimuli, and for sensing evoked potentials. Preferably a delay is provided between stimulus and measurement, and the sensing electrodes are distinct from the stimulus electrodes.

Abstract: A portable or implantable gastric pacemaker includes multiple electrodes that are positionable on the inner or outer surface of an organ in the gastro-intestinal tract and which are individually programmed to deliver a phased electrical stimulation to pace peristaltic movement of material through the GI tract. The pacemaker will accommodate variations in pulse amplitudes, pulse durations, pulse periods, and relative pulse phasing among the electrodes. Computer control can be used to adjust and vary all stimulation parameters delivered by the electrodes to achieve effective treatment and re-training of an organ for natural pacing. The pacemaker can be programmed with parameters to enhance or accelerate peristaltic movement through the gastric tract or to attenuate the peristaltic movement to treat such conditions eating disorders or diarrhea.

Abstract: An apparatus for aiding in the treatment of cardiac arrest patients which includes a flexible tube having an elongated bladder attached between its opposite ends and a stomach bladder attached to its distal end. Each bladder has a conductive portion which serves as an electrode. Wires are embedded in the sidewall of the tube and connected to each electrode. Passageways formed in the sidewall of the tube and fluid-conveying tubes connected thereto form a fluid path through which a saline solution or a gas passes to fill the bladders. The tube is positioned so that the stomach bladder lies in the fundus of the stomach and the esophageal bladder lies in the posterior to the heart. The stomach bladder is filled and moderate countertraction is applied. Then the esophageal bladder is filled. The esophageal bladder serves as a platform by expanding and hardening the esophagus behind the heart. The heart is then compressed between the sternum and the hardened esophageal bladder, thus enhancing artificial circulation.

Abstract: The process for treating obesity and syndromes related to motor disorders of the stomach of a patient consists in artificially altering, by means of sequential electrical pulses and for preset periods of time, the natural gastric motility of the patient to prevent emptying or to slow down gastric transit.

Abstract: A method of treating patients with compulsive eating disorders includes the steps of detecting a preselected event indicative of an imminent need for treatment of the specific eating disorder of interest, and responding to the detected occurrence of the preselected event by applying a predetermined stimulating signal to the patient's vagus nerve appropriate to alleviate the effect of the eating disorder of interest. For example, the preselected event may be a specified level of food consumption by the patient within a set interval of time, or the commencement of a customary mealtime according to the patient's circadian cycle, or the passage of each of a sequence of preset intervals of time, or the patient's own recognition of the need for treatment by voluntarily initiating the application of the stimulating signal to the vagus nerve. In cases in which the disorder is compulsive eating to excess, the stimulating signal is predetermined to produce a sensation of satiety in the patient.