Swallowable capsule and method for stimulating incretin production within the intestinal tract

• US 8,958,879 B2
• Filed: 05/09/2014
• Issued: 02/17/2015
• 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: Imran, Mir A., Hashim, Mir, Arnsdorf, Emily
• Primary Examiner(s): Layno, Carl H
• Assistant Examiner(s): Stice, Paula J
• Application Number:
  US14/273,917
• Publication Number:
  US 20140243921A1
• Time in Patent Office: 284 Days
• Field of Search: 607 40- 41
• US Class Current: 607/40
• 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 method for stimulating incretin-producing cells (IP-cells) in the intestinal tract of a patient to secrete an incretin, the method comprising:

ingesting a swallowable device configured to travel through the intestinal tract and electrically stimulate the IP-cells at any location 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 the IP-cells in the intestinal tract to secrete the incretin without causing a peristaltic contraction.

2. The method of claim 1, wherein the intestinal wall is a wall of the small intestine.

3. The method of claim 1, wherein the IP-cells comprise K-cells.

4. The method of claim 1, wherein the secreted incretin comprises GLP-1.

5. The method of claim 1, further comprising:

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

6. The method of claim 5, wherein the insulin release is modulated by the electrical stimulation of the IP-cells to produce an increase in plasma insulin within 30 minutes of stimulation.

7. The method of claim 1, further comprising:

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

8. The method of claim 1, further comprising:

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

9. The method of claim 1, wherein the waveform has a square wave shape.

10. The method of claim 1, wherein the waveform includes a first wave form and a second waveform, the first wave form configured to stimulate the IP-cells without causing a peristaltic contraction.

11. The method of claim 10, 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.

12. The method of claim 11, wherein the second waveform occurs substantially non-concurrently with the first waveform.

13. The method of claim 11, wherein the second waveform is generated responsive to a velocity of the device moving through the intestinal tract.

14. The method of claim 13, wherein the velocity is measured using an accelerometer disposed on or within the device.

15. The method of claim 1, further comprising:

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

16. The method of claim 15, wherein the location is a small intestine.

17. The method of claim 15, wherein the location is determined using a sensor.

18. The method of claim 17, 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.

19. The method of claim 1, wherein the ingestion of the device is coordinated with a ingestion of food.

20. The method of claim 19, wherein the device is ingested during a selected time period before, during or after the ingestion of food.

21. The method of claim 20, wherein a time period is selected to coordinate the stimulation of the IP-cells with the absorption of nutrients from the food into a blood stream.

22. The method of claim 1, wherein the device comprises a swallowable capsule.

23. The method of claim 1, wherein the device comprises a controller, at least one electrode and a waveform generator.

24. A method for stimulating incretin-producing cells (IP-cells) in the intestinal tract of a patient to secrete an incretin which modulates a release of insulin, the method comprising:

ingesting a swallowable device configured to travel through the intestinal tract and electrically stimulate the IP-cells at any location in the intestinal tract;

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

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

25. The method of claim 24, wherein the insulin release is modulated by the electrical stimulation of the IP-cells to produce an increase in plasma insulin within 30 minutes of stimulation.

26. The method of claim 24, wherein the incretin comprises GLP-1.

27. The method of claim 24, further comprising:

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

28. The method of claim 24, further comprising:

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

29. The method of claim 24, wherein the IP-cells comprise K-cells.

30. A method for stimulating incretin-producing cells (IP-cells) in a intestinal tract of a patient to secrete an incretin which suppresses an appetite level of the patient, the method comprising:

ingesting a swallowable device configured to travel through the intestinal tract and electrically stimulate the IP-cells at any location 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 the IP-cells in the intestinal tract to secrete the incretin without causing a peristaltic contraction of the small intestine; and

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