Systems and methods for providing percutaneous electrical stimulation

• US 9,339,647 B2
• Filed: 03/14/2014
• Issued: 05/17/2016
• Est. Priority Date: 08/01/2008
• Status: Active Grant

• Current Assignee: SPR Therapeutics, Inc.
• Original Assignee: NDI Medical, LLC
• Inventors: Strother, Robert B., Sakai, Jonathan L., Boggs, Joseph W. II, Stager, Kathryn W., Bennett, Maria E., Rubin, Stuart
• Primary Examiner(s): Wieland, Robert N
• Application Number:
  US14/210,596
• Publication Number:
  US 20140194948A1
• Time in Patent Office: 795 Days
• US Class Current: 1/1
• CPC Class Codes: A61N 1/0456 Specially adapted for transcutaneous electrical nerve stimulation [TENS]
• CPC Class Codes: A61N 1/0492 Patch electrodes A61N1/0412, A61N1/0428 take precedence
• CPC Class Codes: A61N 1/36017 with leads or electrodes penetrating the skin
• CPC Class Codes: A61N 1/36021 for treatment of pain

Abstract

Systems and methods according to the present invention relate to a novel peripheral nerve stimulation system for the treatment of pain, such as pain that exists after amputation.

Claims

1. A system comprising:

a patch member having an adhesive disposed on a first side and a patch mounting structure disposed on a second side, opposite the first side, and an electrically conductive return electrode disposed between the first side and the second side;

an electrical stimulation device comprising;

a housing having oppositely disposed top and bottom surfaces;

a device mounting structure on the bottom surface physically mated with the patch mounting structure;

electrical stimulation generation circuitry disposed at least partially within the housing and configured to deliver electrical stimulation percutaneously;

a rechargeable battery, an inductive charging circuit receiving an inductive charging signal, and a wireless communication module receiving wireless communications to select a stimulation pattern to be generated by the electrical stimulation circuitry;

an electrode electrically coupled to the electrical stimulation generation circuitry and configured to be percutaneously inserted into a patient.

2. A system according to claim 1, wherein the top surface and the bottom surface of the housing are separated by a device thickness, wherein the housing further comprises a perimeter edge extending from the bottom surface and a sloped interface edge connecting the top surface to the perimeter edge along a majority of the perimeter thereof wherein the height of the perimeter edge, measured perpendicular to the top and bottom surfaces, is less than the device thickness.

3. A method of treating bodily pain of an animal comprising the steps of:

providing a patch member having an adhesive disposed on a first side and a patch mounting structure disposed on a second side, opposite the first side, and an electrically conductive return electrode disposed between the first side and the second side;

providing an electrical stimulation device comprising;

a housing having oppositely disposed, top and bottom surfaces;

a device mounting structure on the bottom surface configured to physically mate with the patch mounting structure;

electrical stimulation generation circuitry disposed at least partially within the housing and configured to deliver electrical stimulation percutaneously;

a rechargeable battery, an inductive charging circuit receiving an inductive charging signal, and a wireless communication module receiving wireless communications to select a stimulation pattern to be generated by the electrical stimulation circuitry;

coupling the electrical stimulation device to the mounting structure;

percutaneously implanting an electrode in subcutaneous bodily tissue of the animal;

electrically coupling the electrode to the electrical stimulation generation circuitry;

generating electrical stimulation using the electrical stimulation generation circuitry; and

delivering the electrical stimulation to the bodily tissue percutaneously.

4. A method according to claim 3 further comprising adhering the patch member to a skin surface of the animal.

5. A method according to claim 3 further comprising observing whether the electrical stimulation at least partially relieved the bodily pain.

6. A method according to claim 5, wherein the bodily pain is bodily pain existing in the body of the patient after an amputation of a body part.

7. A method according to claim 6, wherein the bodily pain did not exist prior to the amputation.

8. A method according to claim 7, wherein the bodily pain existed prior to the amputation, but was absent prior to trauma inflicted upon the body part.