IP Library Granted Patent US 9,403,002
Granted Patent B2
US 9,403,002 · App. 14/599,350 · Granted Aug 2, 2016

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

Inventors: Mir A. Imran (Los Altos Hills, CA); Mir Hashim (Fremont, CA); Emily Arnsdorf (Mercer Island, WA)
Assignee: Rani Therapeutics, LLC
A61N1/36007A61K38/26A61N1/05A61N1/37217A61N1/0507A61N1/0509A61N1/06
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Quick Facts
Patent No.
US 9,403,002
App. No.
14/599,350
Granted
Aug 2, 2016
Kind
B2
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 (45)

1. A method for stimulating hormone producing cells (HP-cells) in the intestinal tract of a patient to secrete a glucose regulating hormone (GR-hormone), the method comprising:

ingesting a swallowable device configured to travel through the intestinal tract and electrically stimulate the HP-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 HP-cells in the intestinal tract to secrete the GR-hormone 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 HP-cells comprise K-cells or L-cells.

4. The method of claim 1 , wherein the secreted GR-hormone comprises an incretin or GLP-1.

5. The method of claim 1 , further comprising:

modulating a release of insulin in the patient responsive to the secreted GR-hormone.

6. The method of claim 5 , wherein the insulin release is modulated by the electrical stimulation of the HP-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 GR-hormone.

8. The method of claim 1 , further comprising:

suppressing an appetite level of the patient responsive to the secreted GR-hormone.

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 HP-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 10 , wherein the second waveform occurs substantially non-concurrently with the first waveform.

13. The method of claim 10 , 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 19 wherein a time period is selected to coordinate the stimulation of the HP-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 hormone producing cells (HP-cells) in the intestinal tract of a patient to secrete a hormone which modulates a release of insulin, the method comprising:

ingesting a swallowable device configured to travel through the intestinal tract and electrically stimulate the HP-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 HP-cells in the intestinal tract to secrete the hormone without causing a peristaltic contraction of a small intestine; and

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

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 hormone comprises an incretin or GLP-1.

27. The method of claim 24 , further comprising:

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

28. The method of claim 24 , further comprising:

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

29. The method of claim 24 , wherein the HP-cells comprise K-cells or L-cells.

30. A method for stimulating hormone producing cells (HP-cells) in an intestinal tract of a patient to secrete a hormone 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 HP-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 HP-cells in the intestinal tract to secrete the hormone without causing a peristaltic contraction of the small intestine; and

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

Assignments (2)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jul 24, 2025
From: INCUBE LABS, LLC
To: ALVA THERAPEUTICS, INC.
Reel/Frame 071827/0672 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Feb 18, 2016
From: IMRAN, MIR A.; HASHIM, MIR; ARNSDORF, EMILY
To: INCUBE LABS, LLC
Reel/Frame 037765/0671 →
Continuity (5)
Continuation 14273917 · May 9, 2014
Continuation 14179215 · Feb 12, 2014
Division 12849574 · Aug 3, 2010
Provisional Application 61273389 · Aug 3, 2009
Related Publication 20150174400A1 · Jun 25, 2015