Percutaneous tibial nerve stimulator

• US 9,498,633 B2
• Filed: 06/06/2014
• Issued: 11/22/2016
• Est. Priority Date: 06/16/2011
• Status: Active Grant

• Current Assignee: Advanced Uro-Solutions, LLC (Medtronic Plc)
• Original Assignee: Advanced Uro-Solutions, LLC (Medtronic Plc)
• Inventors: Laing, Brent D., Green, John
• Primary Examiner(s): Lavert, Nicole F
• Application Number:
  US14/298,207
• Publication Number:
  US 20140288613A1
• Time in Patent Office: 900 Days
• Field of Search: 607 39- 41, 607/59
• US Class Current: 1/1
• CPC Class Codes: A61N 1/0456 Specially adapted for transcutaneous electrical nerve stimulation [TENS]
• CPC Class Codes: A61N 1/0502 Skin piercing electrodes
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/36017 with leads or electrodes penetrating the skin
• CPC Class Codes: A61N 1/37247 User interfaces, e.g. input or presentation means
• CPC Class Codes: G06Q 20/22 Payment schemes or models
• CPC Class Codes: G16H 20/30 relating to physical therapies or activities, e.g. physiotherapy, acupressure or exercising

Abstract

A method for treating incontinence includes positioning a transcutaneous electrode on skin of a patient adjacent a stimulation site; inserting a leading end of a percutaneous needle electrode through the skin adjacent the stimulation site, the percutaneous needle electrode including a lead wire disposed opposite the leading end; securing a neurostimulator unit to the transcutaneous electrode such that the neurostimulator unit is electrically coupled to the transcutaneous electrode with no lead wire disposed between the neurostimulator unit and the transcutaneous electrode, the neurostimulator unit including a pulse generator; connecting the lead wire of the percutaneous needle electrode to the neurostimulator unit for electrically coupling the needle electrode to the neurostimulator unit; and activating the pulse generator such that current pulses traverse the stimulation site by passing between the transcutaneous electrode pad and the percutaneous needle electrode.

Claims

1. A method comprising:

applying an integrated neurostimulator unit and transcutaneous electrode pad to skin adjacent a stimulation site of a patient such that the electrode pad is disposed on an outer surface of the skin and there is no lead wire disposed between the neurostimulator unit and transcutaneous electrode pad, the neurostimulator unit including a pulse generator;

electrically coupling a percutaneous electrode having a leading end for inserting adjacent a tibial nerve of the patient to the neurostimulator unit;

inserting the leading end of the percutaneous electrode into the skin adjacent the tibial nerve of the patient; and

activating the pulse generator such that current pulses traverse the tibial nerve by passing between the transcutaneous electrode pad and the percutaneous electrode, the current pulses configured to treat incontinence.

2. The method of claim 1 wherein the transcutaneous electrode pad includes an attachment mechanism and the neurostimulator unit includes a corresponding attachment mechanism, wherein the applying step further includes electrically coupling the neurostimulator unit to the transcutaneous electrode by securing the neurostimulator unit attachment mechanism to the electrode pad attachment mechanism.

3. The method of claim 1 wherein the integrated neurostimulator unit and transcutaneous electrode pad is applied adjacent an ankle of the patient.

4. The method of claim 1 wherein the neurostimulator unit includes a display for displaying operating information.

5. The method of claim 1 further comprising:

providing a handheld unit operable to communicate with the neurostimulator unit; and

controlling operation of the neurostimulator unit with the handheld unit.

6. The method of claim 5 wherein the handheld unit is operable to communicate wirelessly with the neurostimulator unit.

7. The method of claim 1 further comprising:

providing a computer system operable to communicate with the neurostimulator unit; and

controlling operation of the neurostimulator unit through the computer system.

8. The method of claim 7 wherein the computer system is operable to communicate wirelessly with the neurostimulator unit.

9. A method comprising:

positioning a transcutaneous electrode on skin of a patient adjacent a tibial nerve;

inserting a leading end of a percutaneous needle electrode through the skin adjacent the tibial nerve, the percutaneous needle electrode including a lead wire disposed opposite the leading end;

securing a neurostimulator unit to the transcutaneous electrode such that the neurostimulator unit is electrically coupled to the transcutaneous electrode with no lead wire disposed between the neurostimulator unit and the transcutaneous electrode, the neurostimulator unit including a pulse generator;

connecting the lead wire of the percutaneous needle electrode to the neurostimulator unit for electrically coupling the needle electrode to the neurostimulator unit; and

activating the pulse generator such that current pulses traverse the tibial nerve by passing between the transcutaneous electrode pad and the percutaneous needle electrode, the current pulses configured to treat incontinence.

10. The method of claim 9 wherein the transcutaneous electrode includes an attachment mechanism and the neurostimulator unit includes a corresponding attachment mechanism, wherein the securing step further includes electrically coupling the neurostimulator unit to the transcutaneous electrode by securing the neurostimulator unit attachment mechanism to the transcutaneous electrode attachment mechanism.

11. The method of claim 9 wherein the transcutaneous electrode is positioned adjacent an ankle of the patient.

12. The method of claim 9 wherein the neurostimulator unit includes a display for displaying operating information.

13. The method of claim 9 further comprising:

providing a handheld unit operable to communicate with the neurostimulator unit; and

controlling operation of the neurostimulator unit with the handheld unit.

14. The method of claim 13 wherein the handheld unit is operable to communicate wirelessly with the neurostimulator unit.

15. The method of claim 9 further comprising:

providing a computer system operable to communicate with the neurostimulator unit; and

controlling operation of the neurostimulator unit through the computer system.

16. The method of claim 15 wherein the computer system is operable to communicate wirelessly with the neurostimulator unit.