# US 8,788,034 B2 · Single-pulse activation of the cholinergic anti-inflammatory pathway to treat chronic inflammation

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- Number: US 8,788,034 B2
- Document ID: US8788034B2
- Status: Granted
- Kind: B2
- Application number: 13/467,928
- Filed: 2012-05-09
- Published: 2012-11-15
- Granted: 2014-07-22
- Earliest claimed: 2011-05-09
- Assignees: SetPoint Medical Corporation
- Applicants: Jacob A. Levine; Michael A. Faltys
- Inventors: Jacob A. Levine; Michael A. Faltys
- Web page: https://patentgrep.com/patent/US8788034B2

## CPC

- A61N 1/36053: {adapted for vagal stimulation (A61N1/36114 takes precedence)}
- A61N 1/3606: {adapted for a particular treatment}
- F04C 2270/0421: Controlled or regulated
- 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)
- F04C: ROTARY-PISTON, OR OSCILLATING-PISTON, POSITIVE-DISPLACEMENT MACHINES FOR LIQUIDS (engines F03C); ROTARY-PISTON, OR OSCILLATING-PISTON, POSITIVE-DISPLACEMENT PUMPS

## Abstract

Described herein are methods and systems for applying extremely low duty-cycle stimulation sufficient to treat chronic inflammation. In particular, described herein are single supra-threshold pulses of electrical stimulation sufficient to result in a long-lasting (e.g., >4 hours, greater than 12 hours, greater than 24 hours, greater than 48 hours) inhibition of pro-inflammatory cytokines and/or effects of chronic inflammation. These methods and devices are particularly of interest in treatment of inflammatory bowel disease (IBD).

## Claims

### Claim 1

A system for treating chronic inflammation in a patient, the system comprising:
an implantable microstimulator configured to apply a low duty-cycle stimulation to a vagus nerve, wherein the low duty-cycle stimulation provides no more than a single supra-threshold pulse every four hours; and
a controller configured to set a dose for the microstimulator wherein the dose comprises the single supra-threshold pulse followed by an off-period of at least four hours, wherein the single supra-threshold pulse is configured to reduce a level of inflammation in the patient.

### Claim 2 (depends on 1)

The system of claim 1, wherein the off-period is at least 24 hours.

### Claim 3 (depends on 1)

The system of claim 1, wherein the off-period is at least 48 hours.

### Claim 4 (depends on 1)

The system of claim 1, wherein the single supra-threshold pulse has a pulse amplitude of less than 5 mA.

### Claim 5 (depends on 1)

The system of claim 1, wherein the single supra-threshold pulse has a pulse amplitude of less than 3 mA.

### Claim 6 (depends on 1)

The system of claim 1, wherein the single supra-threshold pulse has a pulse amplitude of less than 2 mA.

### Claim 7 (depends on 1)

The system of claim 1, wherein the single supra-threshold pulse is biphasic.

### Claim 8 (depends on 1)

The system of claim 1, wherein the chronic inflammation is intestinal inflammation.

### Claim 9 (depends on 1)

The system of claim 1, wherein the chronic inflammation is inflammatory bowel disease.

### Claim 10 (depends on 1)

The system of claim 1, wherein the chronic inflammation is Crohn's disease.

### Claim 11

A method of treating chronic inflammation in a patient, the method comprising:
implanting a microstimulator; and
applying only a single supra-threshold stimulus pulse from the microstimulator to the vagus nerve followed by an off-time of at least 4 hours; and
reducing a level of inflammation in the patient.

### Claim 12 (depends on 11)

The method of claim 11, wherein the off-time is at least 24 hours.

### Claim 13 (depends on 11)

The method of claim 11, wherein the off-time is at least 48 hours.

### Claim 14 (depends on 11)

The method of claim 11, wherein the single supra-threshold stimulus pulse has a pulse amplitude of less than 5 mA.

### Claim 15 (depends on 11)

The method of claim 11, wherein the single supra-threshold stimulus pulse has a pulse amplitude of less than 3 mA.

### Claim 16 (depends on 11)

The method of claim 11, wherein the single supra-threshold stimulus pulse has a pulse amplitude of less than 2 mA.

### Claim 17 (depends on 11)

The method of claim 11, wherein the single supra-threshold stimulus pulse is biphasic.

### Claim 18 (depends on 11)

The method of claim 11, wherein the chronic inflammation is intestinal inflammation.

### Claim 19 (depends on 11)

The method of claim 11, wherein the chronic inflammation is inflammatory bowel disease.

### Claim 20 (depends on 11)

The method of claim 11, wherein the chronic inflammation is Crohn's disease.