Swallowable Capsule and Method for Stimulating Incretin Production Within the Intestinal Tract

• US 20110208270A1
• Filed: 08/03/2010
• Published: 08/25/2011
• Est. Priority Date: 08/03/2009
• Status: Active Grant

• Current Assignee: InCube Labs LLC. (In-Cube, Inc.)
• Original Assignee: InCube Labs LLC. (In-Cube, Inc.)
• Inventors: Arnsdorf, Emily, Hashim, Mir, Imran, Mir A.
• Granted Patent: US 8,682,440 B2
• Time in Patent Office: Days
• US Class Current: 607/62
• CPC Class Codes: A61K 38/26 Glucagons
• CPC Class Codes: A61N 1/05 for implantation or insertion into the body, e.g. heart electrode A61N1/06 takes precedence
• CPC Class Codes: A61N 1/0507 Electrodes for the digestive system
• CPC Class Codes: A61N 1/0509 Stomach and intestinal electrodes
• CPC Class Codes: A61N 1/06 for high-frequency therapy
• CPC Class Codes: A61N 1/36007 of urogenital or gastrointestinal organs, e.g. for incontinence control
• CPC Class Codes: A61N 1/37217 characterised by the communication link, e.g. acoustic or tactile
• CPC Class Codes: A61P 3/04 Anorexiants; Antiobesity agents
• CPC Class Codes: A61P 3/10 for hyperglycaemia, e.g. antidiabetics

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.

Claims

1. A swallowable capsule for stimulating L-cells in the intestinal track of a patient, the capsule comprising:

a capsule body having a surface;

the capsule body sized to be swallowed and pass through the intestinal tract of a patient;

at least one pair of electrodes disposed on the capsule body surface for electrically stimulating the L-cells;

at least one sensor coupled to the capsule body for sensing a property of the intestinal track to determine a location of the capsule within the intestinal tract;

a controller coupled to the least one pair of electrodes and the at least one sensor, the controller disposed within the capsule body and configured to receive an input signal from the least one sensor, determine a location of the capsule within the intestinal tract based on the input and generate a waveform outputted to the at least one pair of electrodes, the waveform configured to electrically stimulate L-cells proximate the capsule location to secrete a polypeptide without causing a peristaltic contraction of the intestinal tract; and

a power source coupled to the controller.

2. The capsule of claim 1, wherein the secreted polypeptide is one of incretin or GLP-1.

3. The capsule of claim 1, wherein the controller is configured to initiate generation of the waveform when the capsule reaches a selectable location in the intestinal tract.

4. The capsule of claim 3, wherein the selectable location is the proximate of the small intestine.

5. The capsule of claim 1, wherein the waveform is activated by contact of the capsule with an intestinal wall.

6. The capsule of claim 5, wherein contact is detected by at least one of the least one pair of electrodes or a contact sensor or pressure sensor positioned on the capsule body surface.

7. The capsule of claim 1, wherein a longitudinal axis of the at least one pair electrodes is aligned with respect to a longitudinal axis of the capsule body.

8. The capsule of claim 1, wherein a longitudinal axis of the at least one pair electrodes is aligned with respect to a radial axis of the capsule body.

9. The capsule of claim 1, wherein the at least one pair of electrodes comprise ring shaped electrodes.

10. The capsule of claim 9, wherein the ring shaped electrodes have a coaxial alignment with respect to a longitudinal axis of the capsule body.

11. The capsule of claim 1, wherein the at least one pair of electrodes have a spacing configured to minimize electrical stimulation of tissue subjacent a mucosal layer of the intestinal tract.

12. The capsule of claim 11, wherein the at least one pair of electrodes have a spacing configured to minimize electrical stimulation of tissue more than about 3 to 5 mm subjacent a surface of the mucosal layer of the intestinal tract.

13. The capsule of claim 11, wherein the spacing between the electrodes is in a range between about 0.01 to 0.2 inches.

14. The capsule of claim 11, wherein the spacing between the electrodes is in a range between about 0.05 to 0.2 inches.

15. The capsule of claim 1, wherein the controller includes a signal generator.

16. The capsule of claim 15, wherein the signal generator comprises one of a pulse generator or an H-Bridge.

17. The capsule of claim 15, wherein the signal generator is configured to generate a pulsed signal.

18. The capsule of claim 17, wherein the pulsed signal has a frequency in a range between about 1 to 100 Hz.

19. The capsule of claim 1, wherein the at least one sensor comprises a pressure sensor for sensing a contraction or force of contraction within the intestinal tract.

20. The capsule of claim 1, wherein the at least one sensor comprises a pH sensor for sensing a pH of the intestinal tract or a change in the pH of the intestinal tract as the capsule is moving through the tract.

21. The capsule of claim 1, wherein the at least one sensor comprises a pH sensor and a pressure sensor.

22. The capsule of claim 1, wherein the controller comprises sensor conditioning circuitry for conditioning an input from the at least one sensor.

23. The capsule of claim 22, wherein the conditioning circuitry comprises at least one of a band pass filter, a high pass filter or a low pass filter.

24. The capsule of claim 1, wherein the power source comprises a capacitor, an electrical battery, a lithium battery or a lithium ion battery.

25. The capsule of claim 1, wherein the power source comprises a piezo-electric power source configured to generate electrical power from motion of the capsule though the intestinal tract or mechanical interaction of the capsule with the intestinal tract or the contents of intestinal tract.

26. The capsule of claim 1, wherein the waveform is configured to stimulate L-cells within about 5 cm from the capsule body surface.

27. The capsule of claim 1, wherein the waveform is configured to stimulate L-cells within about 2 cm from the capsule body surface.

28. The capsule of claim 1, wherein the waveform is configured to stimulate L-cells within about 1 cm from the capsule body surface.

29. The capsule of claim 1, further comprising:

an accelerometer for sensing motion of the capsule through the intestinal tract, the accelerometer coupled to the controller.

30. The capsule of claim 1, wherein the controller is configured to generate a first and second waveform, the first waveform configured to electrically stimulate L-cells proximate the capsule location to produce a secreted polypeptide without causing a peristaltic contraction of the intestinal tract, the second waveform configured to cause peristaltic contraction of a portion of the intestinal tract proximate the capsule so as to advance the capsule within the intestinal tract.

31. The capsule of claim 30, wherein second waveform is activated responsive to an input indicating that a velocity of capsule motion through the intestinal tract is below a minimum level.

32. The capsule of claim 31, wherein the input is from an accelerometer coupled to the controller.

33. The capsule of claim 30, wherein the first and second waveforms are generated by means of an algorithm electronically stored within the controller or memory resources coupled to the controller.

34. A method for stimulating L-cells in the intestinal track of a patient to secrete a polypeptide, the method comprising:

ingesting a swallowable device configured to travel through the intestinal tract and electrically stimulate L-cells in the intestinal tract;

delivering an electrical signal from the device to an intestinal wall proximate the device, wherein the signal includes a waveform configured to electrically stimulate L-cells in the intestinal tract to secrete the polypeptide; and

electrically stimulating the L-cells to secrete the polypeptide.

35. The method of claim 34, wherein the intestinal wall is the wall of the small intestine.

36. The method of claim 34, wherein the peptide comprises an incretin.

37. The method of claim 36, wherein the incretin comprises GLP-1.

38. The method of claim 36, further comprising:

modulating the release of insulin in the patient responsive to the secreted polypeptide.

39. The method of claim 38, wherein the insulin release is modulated by the electrical stimulation of the L-cells to produce an increase in plasma insulin within 30 minutes of stimulation.

40. The method of claim 34, further comprising:

controlling a blood glucose level of the patient responsive to the secreted polypeptide.

41. The method of claim 34, further comprising:

suppressing an appetite level of the patient responsive to the secreted polypeptide.

42. The method of claim 34, wherein the waveform has a substantially square wave shape.

43. The method of claim 34, wherein the waveform is configured to stimulate the L-cells without substantially causing a peristaltic contraction.

44. The method of claim 34, wherein the waveform includes a first wave form and a second waveform, the first wave form configured to stimulate the L-cells without substantially causing a peristaltic contraction.

45. The method of claim 44, wherein the second waveform is configured to generate a peristaltic contraction of intestinal tissue proximate the device, the method further comprising:

advancing the device within the intestinal tract using the generated peristaltic contraction.

46. The method of claim 45, wherein the second waveform occurs substantially non-concurrently with the first waveform.

47. The method of claim 45, wherein the second waveform is generated responsive to a velocity of the device moving through the intestinal tract.

48. The method of claim 47, wherein the velocity is measured using an accelerometer disposed on or within the device.

49. The method of claim 34, further comprising:

determining a location of the device in the GI tract, wherein the signal is delivered responsive to the location of the device in the intestinal tract.

50. The method of claim 49, wherein the location is the small intestine.

51. The method of claim 49, wherein the location is determined using a sensor.

52. The method of claim 51, wherein the location is determined based on at least one of a sensed pH or sensed pressure applied to the device surface by intestinal wall tissue.

53. The method of claim 34, wherein the ingestion of the device is coordinated with the ingestion of food.

54. The method of claim 53, wherein the device is ingested during a selected time period before, during or after the ingestion of food.

55. The method of claim 54, wherein the time period is selected to coordinate the stimulation of the L-cells with the absorption of nutrients from the food into the blood stream.

56. The method of claim 34, wherein the device comprises a swallowable capsule.

57. The method of claim 34, wherein the device comprises a controller, at least one electrode and a waveform generator.

58. A method for stimulating L-cells in the intestinal track of a patient to secrete an incretin which modulates the release of insulin, the method comprising:

ingesting a swallowable device configured to travel through the intestinal tract and electrically stimulate L-cells in the intestinal tract;

delivering an electrical signal from the device to the intestinal wall proximate the device, wherein the signal includes a waveform configured to electrically stimulate L-cells in the intestinal tract to secrete the incretin without substantially causing a peristaltic contraction of the small intestine or other GI organ;

electrically stimulating the L-cells to secrete the incretin; and

modulating the release of insulin in the patient responsive to the secreted incretin.

59. The method of claim 58, wherein insulin release is modulated by the electrical stimulation of the L-cells to produce an increase in plasma insulin within 30 minutes of stimulation.

60. The method of claim 58, wherein the incretin comprises GLP-1.

61. The method of claim 58, further comprising:

increasing the insulin sensitivity of the patient'"'"'s body tissue responsive to the secreted incretin.

62. The method of claim 58, further comprising:

controlling a blood glucose level of the patient responsive to the secreted incretin.

63. A method for stimulating L-cells in the intestinal tract of a patient to secrete an incretin which suppresses an appetite level, the method comprising:

ingesting a swallowable device configured to travel through the intestinal tract and electrically stimulate L-cells in the intestinal tract;

delivering an electrical signal from the device to the intestinal wall proximate the device, wherein the signal includes a waveform configured to electrically stimulate L-cells in the intestinal tract to secrete the incretin without substantially causing a peristaltic contraction of the small intestine or other GI organ;

electrically stimulating the L-cells to secrete the incretin; and

suppressing the appetite level of the patient in response to the secreted incretin.

64. The method of claim 63, wherein the incretin comprises GLP-1.