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

• US 9,987,487 B2
• Filed: 04/11/2017
• Issued: 06/05/2018
• 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): Stice, Paula J
• Application Number:
  US15/485,031
• Publication Number:
  US 20170216589A1
• Time in Patent Office: 420 Days
• 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 electrically stimulating hormone producing cells (HP-cells) in the intestinal tract of a patient to secrete a glucose regulating hormone (GR-hormone), the method comprising:

delivering a device to the intestinal tract of the patient to electrically stimulate the HP-cells in the intestinal tract; and

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 with normal peristaltic contraction of the intestinal tract wherein the electrical signal includes a first wave form and a second waveform, the first wave form configured to stimulate the HP-cells without causing a peristaltic contraction the determination of such made by sensing a pressure of the intestinal wall on the device.

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 pressure is sensed by a pressure sensor associated with the device.

11. The method of claim 1, wherein delivering the device to the intestinal tract comprises ingesting the device.

12. The method of claim 11, wherein the device comprises a swallowable capsule.

13. The method of claim 11, wherein the ingestion of the device is coordinated with a ingestion of food.

14. The method of claim 11, wherein the device is ingested during a selected time period before, during or after the ingestion of food.

15. The method of claim 14, wherein the time period is selected to coordinate the stimulation of the HP-cells with the absorption of nutrients from the food into a blood stream.

16. The method of claim 11, wherein the device travels through the intestinal tract to stimulate HP-cells at any location where they are found in the intestinal tract.