# US 11,439,817 B2 · Swallowable capsule and method for stimulating incretin production within the intestinal tract

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- Number: US 11,439,817 B2
- Document ID: US11439817B2
- Status: Granted
- Kind: B2
- Application number: 16/552,570
- Filed: 2019-08-27
- Published: 2019-12-26
- Granted: 2022-09-13
- Earliest claimed: 2009-08-03
- Assignees: InCube Labs, LLC
- Applicants: InCube Labs, LLC
- Inventors: Mir A. Imran; Mir Hashim; Emily Arnsdorf
- Web page: https://patentgrep.com/patent/US11439817B2

## CPC

- A61N 1/36007: {of urogenital or gastrointestinal organs, e.g. for incontinence control}
- A61K 38/26: Glucagons
- A61N 1/05: for implantation or insertion into the body, e.g. heart electrode (A61N1/06 takes precedence)
- A61N 1/0507: {Electrodes for the digestive system}
- A61N 1/0509: {Stomach and intestinal electrodes}
- A61N 1/37217: {characterised by the communication link, e.g. acoustic or tactile}
- A61P 3/04: Anorexiants; Antiobesity agents
- A61P 3/10: for hyperglycaemia, e.g. antidiabetics
- A61N 1/06: for high-frequency therapy
- A61N: ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY (measurement of bioelectric currents A61B; surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body A61B18/00; anaesthetic apparatus in general A61M; incandescent lamps H01K; infrared radiators for heating H05B)
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS

## 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

### Claim 1

A method for stimulating hormone producing cells (HP-cells) in an intestinal tract of a patient to secrete a glucose regulating hormone (GR-hormone), the method comprising:
delivering a swallowable 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 the HP-cells in the intestinal tract to secrete the GR-hormone without causing a peristaltic contraction.

### Claim 2 (depends on 1)

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

### Claim 3 (depends on 1)

The method of claim 1, wherein the HP-cells comprise K-cells or L-cells.

### Claim 4 (depends on 1)

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

### Claim 5 (depends on 1)

The method of claim 1, further comprising: modulating a release of insulin in the patient responsive to the secreted GR-hormone.

### Claim 6 (depends on 5)

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.

### Claim 7 (depends on 1)

The method of claim 1, further comprising: controlling a blood glucose level of the patient responsive to the secreted GR-hormone.

### Claim 8 (depends on 1)

The method of claim 1, further comprising: suppressing an appetite level of the patient responsive to the secreted GR-hormone.

### Claim 9 (depends on 1)

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

### Claim 10 (depends on 1)

The method of claim 1, further comprising sensing pressure within the intestinal tract using a pressure sensor associated with the device.

### Claim 11 (depends on 1)

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

### Claim 12 (depends on 11)

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

### Claim 13 (depends on 11)

The method of claim 11, wherein the ingesting of the device is coordinated with an ingestion of food.

### Claim 14 (depends on 11)

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

### Claim 15 (depends on 14)

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

### Claim 16 (depends on 11)

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

### Claim 17

A method for stimulating hormone producing cells (HP-cells) in an intestinal tract of a patient to secrete a glucose regulating hormone (GR-hormone), the method comprising:
providing a device configured to travel through the intestinal tract and electrically stimulate the HP-cells in the intestinal tract of the patient; 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 the HP-cells in the intestinal tract to secrete the GR-hormone without causing a peristaltic contraction.

### Claim 18 (depends on 17)

The method of claim 17, wherein the intestinal wall is a wall of a small intestine.

### Claim 19 (depends on 17)

The method of claim 17, wherein the HP-cells comprise K-cells or L-cells.

### Claim 20 (depends on 17)

The method of claim 17, wherein the secreted GR-hormone comprises an incretin or GLP-1.
