Abstract: Embodiments of the invention provide apparatus and methods for stimulating L cells in the intestinal tract to produce incretins for the treatment of conditions including diabetes and obesity. Many embodiments provide a method and apparatus for the treatment of diabetes by electrically stimulating L-cells to secrete incretins to stimulate or otherwise modulate the production of insulin. Particular embodiments provide a swallowable capsule for stimulating L-cells in the intestinal tract as the capsule moves through the tract. The capsule can include two or more electrodes for providing electrical stimulation to L-cells, a power source for powering one or more components of the capsule, a sensor for sensing the location of the capsule in the intestinal tract; a controller and a waveform generator for generating the electrical signals emitted by the electrodes to stimulate the L-cells to secrete incretins such as GLP-1 to stimulate insulin production for glucose regulation of diabetic conditions.

Abstract: The invention is directed to techniques for stimulating a colon of a patient to relieve chronic constipation. Specifically, a colon stimulation system applies one or more electrical stimuli to the colon of the patient in order to induce peristaltic activity in the colon to relieve chronic constipation. In accordance with the invention, the colon stimulation system induces peristaltic activity in the colon by applying an electrical stimulus to the colon to cause a portion of the colon to contract to a contracted state and removing the electrical stimulus to cause the colon to relax. While in the contracted state, the colon is substantially fully contracted.

Abstract: In general, the disclosure is directed to an implantable neurostimulator and system capable of providing adaptive neurostimulation therapy to alleviate incontinence. The neurostimulator operates according to a set of stimulation parameters stored in memory. During operation, information is obtained from the patient, the implanted neurostimulator, one or more implanted sensors, or some combination thereof. A processor analyzes the information to automatically generate proposed adjustments to the stimulation parameters applied by the neurostimulator. The adjustments provide an adaptive neurostimulation therapy that supports or enhances therapeutic efficacy based on the information.

Abstract: Apparatus and methods are described including identifying a subject as suffering from an impaired body system, the body system being selected from the group consisting of: a cardiovascular system and a renal system. In response thereto, a structure is inserted inside a bladder of the subject, and the bladder is mechanically stimulated with the structure. Other applications are also described.

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

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 medical device is configured to deliver a first stimulation therapy to a patient, and, upon detecting a trigger event, deliver a second stimulation therapy to the patient. In some examples, the first stimulation therapy includes bilateral stimulation in which stimulation is delivered at different times to two lateral sides of the patient and the second stimulation therapy includes substantially simultaneous bilateral stimulation therapy to two lateral sides of the patient. In some examples, the second stimulation therapy may elicit a stronger inhibitory physiological response related to incontinence (e.g., inhibition of bladder contractions) than the first stimulation therapy. The trigger event may include, for example, any one or more of detection of a physiological condition indicative of an increased possibility of an involuntary voiding event or an imminent involuntary voiding event, input from the patient, a predetermined time of day, or expiration of a timer.

Abstract: A method and a multichannel implantable device are described for partial or complete restoration of impaired gastrointestinal motility, or for disturbing and/or partially or completely blocking normal gastrointestinal motility using one or multiple microsystem-controlled channels of circumferentially arranged sets of two or more electrodes which provide externally-invoked synchronized electrical signals to the smooth muscles via the neural pathways.

Abstract: In some examples, a medical device delivers a first electrical stimulation therapy to a patient, and, upon detecting a trigger event, delivers a second electrical stimulation therapy to the patient. In some examples, the first stimulation therapy includes unilateral stimulation or stimulation delivered to both lateral sides of the patient at different times at a stimulation intensity lower than, equal to, or greater than a threshold intensity level for the patient, or bilateral stimulation delivered substantially simultaneously to both lateral sides of the patient, where one lateral side of the patient receives stimulation at an intensity level that is lower than the threshold intensity level and the other lateral side receives stimulation at an intensity level that is greater than or equal to the threshold intensity level. The second stimulation therapy may include substantially simultaneous bilateral stimulation therapy at an intensity level that at or above the threshold intensity level.

Abstract: A gastrointestinal stimulation system includes a remote controlled capsule adapted for positioning in the gastrointestinal tract (GT) of a patient, in which the capsule is secured to the inner wall of the gastrointestinal tract (GT) of a patient by a magnetic coupling system. The capsule is configured to activate at least one chosen area of the patient's GI tract, including when desired, the vagus nerve, thereby facilitating gastro motility or having other interaction with the GI tract, such as monitoring thereof. The remote controlled capsule also may be configured to activate patient's lower esophageal sphincter (LES), stimulating the LES muscle and restoring the barrier between the stomach and the esophagus for treatment of Gastroesophageal reflux disease (GERD). The capsule also may be inserted to the anal canal for treatment of constipation.

Abstract: Techniques for remotely titrating a therapy delivered using an implantable medical device system are disclosed. An implantable medical device delivers therapy according to a first program. The system collects patient data relating to at least one of an efficacy of, or side effects resulting from, the delivered therapy, and transmits the patient data to a remote network device. A clinician may then analyze the patient data and determine if changes to the therapy are warranted. The clinician may then transmit a programming change, e.g., a modification to the first program or a new, second program, to the implantable medical device system, and the implantable medical device may deliver therapy according to the changed programming. The process of receiving patient data and modifying the therapy programming may be repeated multiple times until the therapy is adequately titrated, e.g., until the patient data indicates adequate efficacy and/or acceptable side effects.

Abstract: A method of glucose level control, comprising providing at least one electrode adapted to apply an electric field to a pancreas; and applying an electric field to the pancreas using the above-mentioned at least one electrode such that blood glucose levels are significantly reduced and blood insulin levels are not significantly increased.

Abstract: Embodiments of the invention provide apparatus and methods for stimulating L cells in the intestinal tract to produce incretins for the treatment of conditions including diabetes and obesity. Many embodiments provide a method and apparatus for the treatment of diabetes by electrically stimulating L-cells to secrete incretins to stimulate or otherwise modulate the production of insulin. Particular embodiments provide a swallowable capsule for stimulating L-cells in the intestinal tract as the capsule moves through the tract. The capsule can include two or more electrodes for providing electrical stimulation to L-cells, a power source for powering one or more components of the capsule, a sensor for sensing the location of the capsule in the intestinal tract; a controller and a waveform generator for generating the electrical signals emitted by the electrodes to stimulate the L-cells to secrete incretins such as GLP-1 to stimulate insulin production for glucose regulation of diabetic conditions.

Abstract: Methods and systems of treating a patient with pancreatitis pain include providing a stimulator, configuring one or more stimulation parameters to treat pancreatitis pain, programming the stimulator with the one or more stimulation parameters, generating a stimulus configured to treat pancreatitis pain with the stimulator in accordance with the one or more stimulation parameters, and applying the stimulus with the stimulator to one or more stimulation sites in accordance with the one or more stimulation parameters.

Abstract: A method of glucose level control comprising providing at least one electrode adapted to apply an electric field to a pancreas; and applying an electric field to the pancreas using said at least one electrode such that blood glucose levels are significantly reduced and blood insulin levels are not significantly increased compared to a regular insulin response in a same person.

Abstract: The present invention provides systems, apparatus and methods for selectively applying electrical energy to body tissue. A device is provided with an electrode positioned within the interior of an enclosure and a fluid passage coupled to the enclosure for delivery of an electrically conductive fluid such that the electrically conductive fluid. 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. The electrode does not directly contact the tissue of the patient, which reduces the potential for collateral tissue damage or necrosis and/or excessive electric fields in the tissue.

Abstract: A tibial nerve stimulation device including a percutaneous electrode for inserting adjacent a stimulation site of a patient and a neurostimulator unit attachable to a transcutaneous electrode configured to be applied to skin adjacent the stimulation site. The neurostimulator unit includes a pulse generator electrically coupled to the percutaneous needle electrode and transcutaneous electrode and a microcontroller in communication with the pulse generator for monitoring a number of available treatment credits and activating the pulse generator, each available treatment credit corresponding to a treatment session and the pulse generator operable to be activated for performing the treatment session when the number of available treatment credits is at least one. A computer system is operable to communicate with the microcontroller of the neurostimulator unit for receiving a treatment credit request and transmitting the number of treatment credits purchased to the microcontroller of the neurostimulator unit.

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: A method of optimizing the electrical stimulation of a bladder of a patient including selecting a first subset of electrodes from a set of electrodes positioned adjacent to a set of nerves associated with the bladder. The set of electrodes may include one or more electrodes, each of which may be configured to deliver electrical stimulation pulses generated by a stimulator device to the nerves. The method may further include delivering an electrical stimulation pulse through the selected first subset of electrodes and recording at least one parameter of the electrical stimulation pulse after receiving patient feedback.

Abstract: A method for altering operation of a nerve related to a given body condition includes the steps of identifying at least one nerve root of a nerve related to the given body condition; laparoscopically implanting at least one electrode on the nerve root; and operating the electrode to electrostimulate the nerve root and alter operation of the nerve.

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: 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: 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 exemplary method for treating obesity includes an pulse generator configured to deliver electrical energy to a vagal nerve, one or more sensors configured to detect pre-prandial activity and, in response to the detection of pre-prandial activity, a pulse generator configured to deliver electrical energy to the stomach to induce satiety. Various other technologies are also disclosed.

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: A method for treating morbid obesity in a body of a mammal having a gastrointestinal tract extending through a stomach and a pyloric sphincter and a wall forming the stomach and pyloric sphincter. At least one implant is formed in the wall in the vicinity of the pyloric sphincter to inhibit emptying of the stomach.

Abstract: A physiological state of a patient is detected by at least producing and detecting pressure waves with a free wall of an implantable medical device (IMD) housing. An actuator element may contact the free wall, e.g., a portion of the IMD housing, and cause movement of the free wall that produces a pressure wave within the fluid and tissue of the patient. A detector element contacting the free wall may in turn detect reflected pressure waves received by the free wall. An acoustic module within the IMD may then determine a physiological condition of the patient, e.g., a bladder fullness state, based on the time delay between the transmitted and reflected pressure waves. In some examples in which the IMD also delivers stimulation therapy to the patient, e.g., incontinence therapy, the IMD may also automatically adjust stimulation therapy based on the determined physiological condition.

Abstract: An implantable stimulator(s), small enough to be located near or adjacent to an autonomic nerve(s) innervating urinary and/or gastrointestinal structures, uses a power source/storage device, such as a rechargeable battery. Periodic recharging of such a power source/storage device is accomplished, for example, by inductive coupling with an external appliance. The small stimulator provides a means of stimulating a nerve(s) or other tissue when desired, without the need for external appliances during the stimulation session. When necessary, external appliances are used for the transmission of data to and/or from the stimulator(s) and for the transmission of power, if necessary. In a preferred embodiment, the system is capable of open- and closed-loop operation. In closed-loop operation, at least one implant includes at least one sensor, and the sensed condition is used to adjust stimulation parameters.

Abstract: One aspect of the present disclosure relates to a method for modulating, suppressing or preventing a medical condition in a subject. One step of the method can include positioning at least one electrode on or proximate to at least one of a vidian nerve (VN), a greater petrosal nerve (GPN), a deep petrosal nerve (DPN), or a branch thereof, of the subject. Next, the at least one electrode can be activated to apply an electrical signal to at least one of the VN, the GPN, the DPN, or the branch thereof.

Abstract: A system includes (i) a needle for insertion into a port of an implantable infusion device, and (ii) a receiver apparatus having a port location signal receiver module capable of receiving a signal from the implantable infusion device regarding spatial orientation of the port. The system further includes a processor operably coupled to the receiver apparatus and capable of determining the orientation of the needle relative to the port based on the received signal. The system also includes a display operably coupled to the processor. The processor is configured to cause the display to graphically render trajectory of the needle relative to the port. The port is graphically rendered as a target structure having a reference area. The needle is graphically rendered as an object moveable relative to the target structure. Occupation of the reference area by the object indicates trajectory alignment of the port and the needle.

Abstract: Methods for treating a renal associated condition in a subject are provided. Aspects of the subject methods include paradoxically enhancing renal sympathetic bias in the subject in a manner effective to treat the renal associated condition. Also provided are compositions, kits and systems for practicing the subject methods.

Abstract: Systems and methods are disclosed to stimulate tissue to treat medical conditions involving tissues such as the bone, spine, stomach, nerves, brain and the cochlea. The disclosed invention uses electrical stimulation of the tissue, where vibrational (or acoustic) energy from a source is received by an implanted device and converted to electrical energy and the converted electrical energy is used by implanted electrodes to stimulate the pre-determined tissue sites. The vibrational energy is generated by a controller-transmitter, which could be either implanted or located externally. The vibrational energy is received by a receiver-stimulator, which could be located at or close to the stimulation site.

Abstract: The disclosure is a method of treatment for obesity, in an individual in need thereof comprising positioning stimulatory electrodes in the distal small intestines or ileum, and administering electrical stimulation in trains of pulses or repetitive pulses, where the electrical stimulation is effective, at least in part in, stimulating the vagal afferent and efferent activity, of the distal small intestines or ileum, in the individual. The stimulation of the vagal afferent and efferent activity leads to the regulation of the ileal brake. Specifically, the electrical stimulation is provided in trains of pulses. Also, described is a method of treatment for functional gastrointestinal disease by ileal electrical stimulation. Further this invention provides a method of treatment for an eating disorder comprising administering ileal electrical stimulation effective, at least in part, in stimulating the vagal and sympathetic pathways.

Abstract: Embodiments of the present invention describe a system and method of stimulating nerves during a medical procedure including positioning one or more electrodes in electrical contact with one or more nerves of a patient and electrically stimulating the one or more nerves during a lower urinary, rectal or medical procedure affecting the bowel sufficient to affect one or more of bladder activity, prostate function, incontinence, or pain.

Abstract: Methods and apparatuses for monitoring and regulating physiological states and functions are disclosed. Several embodiments include application of one or more microelectrode arrays to a dorsal root ganglion for measurement of sensory neuron activity, or stimulation of sensory reflex circuits. The methods and apparatuses can be used, for example, for monitoring or controlling bladder function in a patient.

Abstract: An implantable stimulation device for use in stimulation based treatments for diseases such as GERD or obesity is described. The device is provided with an anchoring unit which upon deployment assumes a shape optimized for the site of deployment. Sensing electrodes and stimulating electrodes in the device are also designed to assume a suitable shape upon deployment. A novel catheter is also provided for easy and expeditious deployment of the device.

Abstract: Systems and methods for treating at least one of a plurality of disorders characterized at least in part by vagal activity.

Abstract: Systems and methods of using a system for treating a gastrointestinal disorder characterized by dysmotility of a gastrointestinal organ.

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: The present specification describes methods and devices using electrical stimulation to modulate lower esophageal sphincter (LES) pressure. The electrical stimulation may be delivered to the LES via one or more electrodes that is placed in contact with the LES tissue. The methods and devices are useful to treat a number of conditions or disease conditions, including for example, gastroesophageal reflux disease (GERD).

Abstract: A therapy system for applying an electrical signal to an internal anatomical feature of a patient includes an implantable component and an external component. The medical device can be checked for safety issues by periodically initiating a sequence of tests of an H-bridge circuit, and, during each test, monitoring a current flow through a sensing resistor electrically connected between a sensing connection of the H-bridge circuit and a ground. Current flow through the sensing resistor indicates that both series electrical switches within at least one of the two pairs of series electrical switches are active during that test.

Abstract: Various implantable medical device embodiments stimulate an autonomic neural target from within a pulmonary artery, and comprise at least one electrode, a power supply, a neural stimulator connected to the power supply, and an anchor structure. The neural stimulator is configured to generate a neural stimulation signal for delivery to the neural stimulation target through the at least one electrode. The anchor structure is configured to chronically and securely implant the neural stimulator, the power supply and the at least one electrode within the pulmonary artery. The anchor structure, the neural stimulator, the power supply and the at least one electrode are configured to be implanted through a pulmonary valve into the pulmonary artery. In various embodiments, the neural stimulator is configured to be operational to implement a neural stimulation protocol when chronically implanted within the pulmonary artery without a wired connection through the pulmonary valve.

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: At least one of a plurality of disorders of a patient characterized at least in part by vagal activity innervating at least one of a plurality of organs of the patient is treated by a method that includes positioning an electrode on a vagus nerve. An electrical signal is applied to the electrode to modulate vagal activity by an amount selected to treat the disorder. In some embodiments, the disorder is bulimia. The signal may be a blocking or a stimulation signal. In some embodiments, the signal is selected to, at least in part, downregulate neural activity on the vagus nerve.

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: Systems and methods are disclosed to stimulate gastrointestinal tissue to treat medical conditions such as eating disorders, gastroparesis, and gastric reflux. The invention uses electrical stimulation of the nerve, where vibrational energy from a source is received by an implanted device and converted to electrical energy and the converted electrical energy is used by implanted electrodes to stimulate the pre-determined gastrointestinal tissue site. The vibrational energy is generated by a controller-transmitter, which could be implanted or located externally. The vibrational energy is received by a receiver-stimulator, which could be located in the various regions on or around the gastrointestinal tissue that needs to be stimulated. The implantable receiver-stimulator stimulates different gastrointestinal tissue to provide the desired therapeutic benefit.

Abstract: A method for altering operation of a nerve related to a given body condition includes the steps of identifying at least one nerve root of a nerve related to the given body condition; laparoscopically implanting at least one electrode on the nerve root; and operating the electrode to electrostimulate the nerve root and alter operation of the nerve.

Abstract: The specification discloses methods and devices for electrically stimulating one or more structures in the gastrointestinal tract. The one or more structures are preferably selected from the upper esophageal sphincter, the esophagus and gastric fundus. The method may involve the step of arranging a plurality of stimulating electrodes adjacent one or more structures which may further include the lower esophageal sphincter, the stomach, the pyloric sphincter, the small intestine, the colon and the vagus. The method and device may further include sensing electrodes to detect change in one or more physiological parameters in the gastrointestinal tract and modulate the stimulating electrodes in response to the change. The device comprises a pulse generator, a power source, a plurality of stimulating electrode set, one or more sensing electrodes and means for varying activity of the stimulating electrodes in response to change detected in the gastrointestinal tract.

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.