Non-invasive magnetic or electrical nerve stimulation to treat gastroparesis, functional dyspepsia, and other functional gastrointestinal disorders

• US 10,207,106 B2
• Filed: 01/11/2016
• Issued: 02/19/2019
• Est. Priority Date: 03/20/2009
• Status: Active Grant

• Current Assignee: electroCore, Inc.
• Original Assignee: Electrocore, Llc
• Inventors: Simon, Bruce J., Errico, Joseph P., Raffle, John T.
• Primary Examiner(s): Kahelin, Michael W
• Application Number:
  US14/992,398
• Publication Number:
  US 20160121114A1
• Time in Patent Office: 1,135 Days
• CPC Class Codes: A61N 1/0456 Specially adapted for transcutaneous electrical nerve stimulation [TENS]
• CPC Class Codes: A61N 1/205 for promoting a biological process
• CPC Class Codes: A61N 1/36007 of urogenital or gastrointestinal organs, e.g. for incontinence control
• CPC Class Codes: A61N 1/36034 specified by the stimulation parameters
• CPC Class Codes: A61N 1/40 Applying electric fields by inductive or capacitive coupling microwave apparatus A61N5/00; Applying radio-frequency signals
• CPC Class Codes: A61N 2/006 for magnetic stimulation of nerve tissue
• CPC Class Codes: A61N 2/02 using magnetic fields produced by coils, including single turn loops or electromagnets A61N2/12 takes precedence

Abstract

Devices, systems and methods are disclosed for treating or preventing gastroparesis, functional dyspepsia, and other functional gastrointestinal disorders. The methods comprise transmitting impulses of energy non-invasively to selected nerve fibers, particularly those in a vagus nerve. The methods provide damaged interstitial cells of Cajal (ICC) with trophic factors via vagal afferent nerve fibers, thereby reversing ICC damage, and as a consequence improving gastric motility. The methods also increase levels of inhibitory neurotransmitters in the brain so as to decrease neural activity within the area postrema, or they deactivate a resting state neural network containing parts of the anterior insula and anterior cingulate cortex, which will thereby reduce abnormal interoception and visceral hypersensitivity.

Claims

1. A device for treating or preventing at least one of gastroparesis, functional dyspepsia or ileus in a patient comprising:

a housing having an electrically conductive, non-porous interface for contacting an outer skin surface of the patient;

one or more electrodes within the housing;

an electrically conductive fluid within the housing coupling the one or more electrodes to the interface;

an energy source coupled to the one or more electrodes and configured to generate an electric field sufficient to transmit one or more electrical impulses to selected nerve fibers in the patient; and

wherein the one or more electrical impulses is sufficient to modulate the selected nerve fibers to treat or prevent at least one of gastroparesis, functional dyspepsia or ileus in the patient.

2. The device of claim 1, wherein the energy source is located in the housing.

3. The device of claim 1, wherein the energy source comprises a battery and a signal generator coupled to the one or more electrodes within the housing.

4. The device of claim 1, wherein the one or more electrical impulses is transmitted from the one or more electrodes through the electrically conductive fluid within the device and then through the interface.

5. The device of claim 1, wherein the energy source is configured to generate an electric current and to transmit the electric current transcutaneously through the outer skin surface of the patient to generate the one or more electrical impulses at or near the selected nerve fibers.

6. The device of claim 5, wherein the electrical current is transmitted from the one or more electrodes through the electrically conductive fluid within the device and then through the interface.

7. The device of claim 1, wherein the selected nerve fibers are associated with a vagus nerve of the patient.

8. The device of claim 1, wherein the one or more electrical impulses comprises bursts of pulses having a frequency of about 1 to about 100 bursts per second.

9. The device of claim 8, wherein each burst comprises about 2 to 20 pulses.

10. The device of claim 8, wherein the pulses are full sinusoidal waves.

11. The device of claim 8, wherein each pulse has a duration of about 100 to about 1000 microseconds.

12. The device of claim 11, wherein the duration of each pulse is about 200 to about 400 microseconds.

13. The device of claim 1, wherein the one or more electrical impulses generates an electric field at the selected nerve fibers from about 10 to about 600 V/m.

14. The device of claim 13, wherein the electric field is less than 100 V/m.

15. The device of claim 1, wherein the one or more electric impulses generates an electric field at a vagus nerve of the patient above a first threshold for generation of action potentials within A and B fibers of the vagus nerve and below a second threshold for generating action potentials within C fibers of the vagus nerve.

16. The device of claim 1, wherein the housing is a handheld device configured for contacting an outer surface of a neck of the patient.

17. The device of claim 1, wherein the one or more electric impulses generates an electric field at a vagus nerve of the patient above a threshold for generating action potentials within fibers of the vagus nerve responsible for activating neural pathways causing release of inhibitory neurotransmitters within a brain of the patient.

18. The device of claim 17, wherein the inhibitory neurotransmitters comprise at least one of noreprinephrine, serotonin, or GABA.