Systems and methods for providing percutaneous electrical stimulation

• US 8,700,177 B2
• Filed: 04/05/2012
• Issued: 04/15/2014
• 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, Rubin, Stuart, Boggs, Joseph W II, Stager, Kathryn W, Bennett, Maria E
• Primary Examiner(s): Gedeon, Brian T
• Application Number:
  US13/440,784
• Publication Number:
  US 20130096641A1
• Time in Patent Office: 740 Days
• Field of Search: 607/2, 607/115, 607149-152
• US Class Current: 607/115
• 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 material disposed between the first side and the second side;

an electrical stimulation device comprising;

a housing having oppositely disposed, substantially planar top and bottom surfaces, wherein the top surface is imperforate;

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;

one or more of a rechargeable battery, an inductive charging circuit adapted to receive an inductive charging signal, and a wireless communication module adapted to receive wireless communications to select or 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 percutenously 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 material disposed between the first side and the second side;

providing an electrical stimulation device comprising;

a housing having oppositely disposed, substantially planar top and bottom surfaces, wherein the top surface is imperforate;

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;

one or more of a rechargeable battery, an inductive charging circuit adapted to receive an inductive charging signal, and a wireless communication module adapted to receive wireless communications to select a stimulation pattern to be generated by the electrical stimulation circuitry;

coupling the electrical stimulation device to the mounting structure;

adhering the patch member to a skin surface of the animal;

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;

delivering the electrical stimulation to the bodily tissue;

observing whether the electrical stimulation at least partially relieved the bodily pain.

4. A method according to claim 3, wherein the bodily pain is bodily pain existing in the body of the patient after an amputation of a body part.

5. A method according to claim 4, wherein the bodily pain did not exist prior to the amputation.

6. A method according to claim 5, wherein the bodily pain existed prior to the amputation, but was absent prior to trauma inflicted upon the body part.

7. A method according to claim 3, wherein implanting the electrode comprises percutaneously inserting the electrode into a patient body.