Responsive gastric stimulator

• US 20050065571A1
• Filed: 09/23/2004
• Published: 03/24/2005
• Est. Priority Date: 05/01/2001
• Status: Active Grant

• Current Assignee: IntraPace, Inc.
• Original Assignee: IntraPace, Inc.
• Inventors: Imran, Mir A.
• Granted Patent: US 7,702,394 B2
• Time in Patent Office: Days
• US Class Current: 607/41
• CPC Class Codes: A61B 2017/00004 (bio)absorbable, (bio)resorbable or resorptive
• CPC Class Codes: A61B 2017/00017 Electrical control of surgical instruments
• CPC Class Codes: A61B 2017/00026 Conductivity or impedance, e.g. of tissue
• CPC Class Codes: A61B 2017/00084 Temperature
• CPC Class Codes: A61B 2017/00477 Coupling A61B2017/0046 takes precedence
• CPC Class Codes: A61F 2005/0016 comprising measuring means
• CPC Class Codes: A61F 5/0026 Anti-eating devices using electrical stimulation
• CPC Class Codes: A61M 2025/0233 specifically adapted for attaching to a body wall by means which are on both sides of the wall, e.g. for attaching to an abdominal wall
• CPC Class Codes: A61M 2025/028 having a mainly rigid support structure
• CPC Class Codes: A61M 25/02 Holding devices, e.g. on the body
• CPC Class Codes: A61N 1/36007 of urogenital or gastrointestinal organs, e.g. for incontinence control
• CPC Class Codes: A61N 1/36085 Eating disorders or obesity
• CPC Class Codes: A61N 1/372 Arrangements in connection with the implantation of stimulators

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.

Claims

1. A gastric stimulation device comprising:

an implantable housing;

electronic circuitry contained within the housing;

at least one stimulating electrode electrically coupled to the electronic circuitry and configured to be electrically coupled to a stomach of a subject; and

a sensor configured to sense a parameter indicative of a condition of a subject;

a responsive element in communication with the sensor and configured to receive information corresponding to the parameter sensed by the sensor;

wherein said electronic circuitry is configured to deliver electrically stimulating signals through the at least one stimulating electrode to the stomach, said electrically stimulating signals selected to cause an interference with innate peristalsis of the stomach; and

wherein the responsive element is configured to control delivery of the electrically stimulating signals in response to sensing the parameter sensed by the sensor.

2. The gastric stimulation device of claim 1 wherein the parameter sensed corresponds to ingestion of material by the subject.

3. The gastric stimulation device of claim 2 wherein the sensor comprises a temperature sensor.

4. The gastric stimulation device of claim 2 wherein the sensor comprises a pH sensor.

5. The gastric stimulation device of claim 1 wherein the parameter sensed corresponds to whether or not the subject is sleeping.

6. The gastric stimulation device of claim 4 wherein the responsive element is configured to turn off electrically stimulating signals when the subject is sleeping.

7. The gastric stimulation device of claim 1 wherein the parameter sensed corresponds to a state of wakefulness of the subject.

8. The gastric stimulation device of claim 1 wherein the parameter sensed corresponds to muscle contractions of the stomach.

9. The gastric stimulation device of claim 8 wherein the sensor comprises a pressure sensor.

10. The gastric stimulation device of claim 8 wherein the sensor comprises a strain gauge.

11. The gastric stimulation device of claim 1 wherein the sensor comprises a pressure sensor and the parameter sensed corresponds the peristalsis of the stomach.

12. A method for creating a sensation of satiety in a subject comprising the steps of:

providing at least one stimulating electrode electrically coupled to a stomach of the subject;

providing a sensor coupled to the subject;

sensing a parameter indicative of an existence of a condition of the subject;

stimulating the stomach of the subject to interfere with innate peristalsis of the stomach based at least in part on whether or not the parameter is sensed.

13. The method of claim 12 wherein the condition of the subject is a condition of the stomach.

14. The method of claim 12 wherein the condition of the subject corresponds to a state of wakefulness.

15. The method of claim 12 wherein the condition of the subject corresponds to a subject'"'"'s activity level.

16. The method of claim 12 wherein the step of stimulating the stomach of the subject comprises stimulating the subject'"'"'s stomach to interfere with innate electrical potentials of the subject'"'"'s stomach.

17. The method of claim 12 wherein the step of providing a sensor comprises providing a pressure sensor;

wherein the step of sensing a parameter indicative of an existence of a condition comprises sensing a pressure within the stomach indicating existence of a predetermined threshold of stomach muscle contractions.

18. The method of claim 12 wherein the step of providing a sensor comprises providing a temperature sensor;

wherein the step of sensing a parameter indicative of an existence of a condition comprises sensing temperature within the stomach indicating ingestion of a substance.

19. The method of claim 12 wherein the step of providing a sensor comprises providing a strain gauge;

wherein the step of sensing a parameter indicative of an existence of a condition comprises sensing strain within the stomach indicating existence of a predetermined threshold of stomach muscle contractions.

20. The method of claim 12 wherein the step of providing a sensor comprises providing a light source and an optical sensor;

wherein the step of sensing a parameter indicative of an existence of a condition comprises sensing light within the stomach indicating presence of ingested material in the stomach.

21. The method of claim 20 wherein the step of sensing a parameter indicative of an existence of a condition comprises sensing light within the stomach indicating presence of ingested material of a predetermine composition within the stomach.

22. The method of claim 12 wherein the step of providing a sensor comprises providing a respiration sensor;

wherein the step of sensing a parameter indicative of an existence of a condition comprises sensing a respiration parameter of the subject indicating whether the subject is awake or sleeping and wherein the step of stimulating the stomach comprises stimulating the stomach when the respiration sensor indicates that the subject is awake.

23. The method of claim 12 wherein the step of providing a sensor comprises providing an accelerometer;

wherein the step of sensing a parameter indicative of an existence of a condition comprises sensing motion indicating whether the subject is awake or sleeping.

24. The method of claim 23 wherein the step of sensing a parameter indicative of an existence of a condition comprises sensing at least one motion artifact indicating the subject is awake.

25. The method of claim 23 wherein the step of sensing a parameter indicative of an existence of a condition comprises sensing a respiration parameter.

26. The method of claim 12 wherein the step of providing a sensor comprises providing a pH sensor;

wherein the step of sensing a parameter indicative of an existence of a condition comprises sensing a pH within the stomach indicating presence of ingested material in the stomach.

27. A method of determining a stimulation parameter for stimulating a portion of a gastrointestinal tract comprising the steps of:

providing an electrode electrically coupled to tissue of a gastrointestinal tract;

providing a stimulator coupled to the electrode and configured to deliver an electrical stimulation signal to the portion of the gastrointestinal tract through the electrode;

providing a contractionnsensor in proximity to the electrode;

delivering an electrically stimulating signal to the portion of the gastrointestinal tract through the electrode; and

sensing data corresponding to contraction of the portion of the gastrointestinal tract in proximity to the electrode.

28. The method of claim 27 further comprising the step of adjusting the stimulation to be provided through the electrode in response to data sensed corresponding to the contraction of the portion of the gastrointestinal tract.

29. The method of claim 28 wherein the step of adjusting the stimulation comprises increasing a stimulation parameter in response to sensing data indicating insufficient gastrointestinal tract contraction in response to the stimulation.

30. The method of claim 29 wherein the steps of delivering an electrically stimulating signal, sensing data, and increasing the stimulation parameter are repeated until data is sensed indicating sufficient stomach contraction in response to stimulation.

31. A device for optimizing stimulation to a portion of a gastrointestinal tract comprising:

an electrode configured to be electrically coupled to the portion of the gastrointestinal tract;

a stimulator configured to deliver a stimulation signal to the portion of the gastrointestinal tract through the electrode;

a contraction sensor positioned in proximity to the electrode, wherein the contraction sensor is configured to sense data corresponding to the presence of a contraction of the portion of the gastrointestinal tract resulting from the stimulation signal at the electrode;

wherein the stimulator is configured to adjust the stimulation based on the data corresponding to the presence of a contraction.

32. The device of claim 31 wherein the data corresponding to the presence of a contraction comprises data corresponding to the amount of contraction.

33. The device of claim 31 wherein the stimulator is configured to incrementally increase stimulation until the data corresponding to the presence of contraction reaches a desired amount.

34. The device of claim 31 wherein the stimulator is configured to periodically sense data corresponding to the presence of contraction and to periodically adjust stimulation in response to the data sensed corresponding to the presence of contraction.

35. An implantable gastric sensor comprising:

a sensor configured to be positioned within a stomach and configured to sense information corresponding to a content of the stomach; and

a processor coupled to the sensor configured to receive the information corresponding to the content of the stomach and to determine a property of the content of the stomach.

36. The implantable device of claim 35 wherein the information corresponding to a content of the stomach comprises information corresponding to the presence of food in the stomach.

37. The implantable device of claim 35 wherein the information corresponding to a content of the stomach comprises information corresponding to the composition of food present in the stomach.

38. The implantable device of claim 37 wherein the sensor comprises an impedance sensor, and wherein the information corresponding to a content of the stomach comprises impedance information.

39. The implantable device of claim 37 wherein the sensor comprises an optical sensor, and wherein the information corresponding to a content of the stomach comprises optical information.

40. The implantable device of claim 35 wherein the sensor comprises an optical sensor.

41. The implantable device of claim 35 further comprising:

a responsive element in communication with the processor, the responsive element configured to respond to sensed information corresponding to the content of the stomach.

42. The implantable device of claim 41 further comprising an electrical stimulation device configured to deliver electrical signals to the stomach, and wherein the responsive element is configured to control the electrical stimulation device to deliver electrical signals in response to sensed information corresponding to the content of the stomach.

43. The implantable device of claim 41 wherein the sensed information corresponds to at least one type of food and wherein the responsive element is configured to respond to sensing the presence of the at least one type of food.

44. A gastric stimulation device comprising:

an implantable housing;

electronic circuitry contained in the housing;

at least one stimulating electrode coupled to the electronic circuitry and configured to be electrically coupled to a stomach of a subject and to deliver electrically stimulating signals from the electronic circuitry to the stomach;

a sensor configured to sense information corresponding to a sleeping state of the subject; and

a responsive device configured to prevent delivery of electrically stimulating signals from the electronic circuitry to the stomach when a sleeping state is sensed.