Percutaneous electrode assemblies, systems, and methods for providing highly selective functional or therapeutic neuromuscular stimulation

• US 20070032836A1
• Filed: 10/10/2006
• Published: 02/08/2007
• Est. Priority Date: 02/12/2004
• Status: Abandoned Application

• Current Assignee: NDI Medical, LLC
• Original Assignee: NDI Medical, LLC
• Inventors: Thrope, Geoffrey, Strother, Robert, Mrva, Joseph
• Application Number:
  US11/545,336
• Publication Number:
  US 20070032836A1
• Time in Patent Office: Days
• US Class Current: 607/48
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/32 alternating or intermittent currents applying electric fields by inductive or capacitive coupling A61N1/40; microwave apparatus A61N5/02
• CPC Class Codes: Y10S 128/907 Acupuncture

Abstract

Percutaneous electrode assemblies, systems, and methods make possible the providing of short-term therapy or diagnostic testing by providing electrical connections between muscles or nerves inside the body and stimulus generators or recording instruments carried outside the body. The percutaneous electrodes include a flexible body having an electrically conductive region, a tissue penetrating region, and a percutaneous lead electrically coupled to the electrically conductive region. An anchoring element is positioned on the flexible body to resist movement of the electrically conductive region within tissue. An introducer is sized and configured to receive the flexible body and shield the anchoring element from contact with tissue while the electrically conductive region is placed to a desired position within tissue, and accommodates advancement of the anchoring element beyond the interior lumen for contact with tissue to resist movement of the electrically conductive region placed in the desired position.

Claims

1. A percutaneous electrode assembly comprising

a flexible body including an electrically conductive region, a tissue penetrating region for implantation of the electrically conductive region in a targeted tissue region, and a percutaneous lead electrically coupled to the electrically conductive region,

an anchoring element on the flexible body to resist movement of the electrically conductive region within tissue, and

an introducer having an interior lumen sized and configured to receive the flexible body and shield the anchoring element from contact with tissue while the electrically conductive region is placed to a desired position within tissue, the introducer also being sized and configured to accommodate advancement of the anchoring element beyond the interior lumen for contact with tissue to resist movement of the electrically conductive region placed in the desired position.

2. An assembly according to claim 1

wherein the flexible body is sized to have a diameter not greater than about 0.5 mm.

3. An assembly according to claim 1

wherein the anchoring element comprises a barb.

4. An assembly according to claim 1

wherein the introducer includes an electrically isolated area that correspond to the electrically conductive region of the flexible body.

5. An assembly according to claim 4

wherein the electrically isolated area is electrically coupled to a connector on the introducer to allow the electrically isolated area to be coupled to a stimulating circuit.

6. A method of implanting a percutaneous electrode comprising the steps of

providing a percutaneous electrode with an anchoring element to resist movement of the percutaneous electrode within tissue,

inserting the percutaneous electrode within an introducer that shields the anchoring element from contact with tissue,

implanting the percutaneous electrode while inserted within the introducer, to place the percutaneous electrode in a desired location within tissue, and

withdrawing the introducer to place the anchoring element in contact with tissue, thereby resisting movement of the percutaneous electrode from the desired position.

7. A method according to claim 6

further including, during the implanting step, a step of coupling the percutaneous electrode to a stimulating circuit to provoke a tissue stimulation response to place the percutaneous electrode in the desired location.

8. A method according to claim 6

wherein the introducer includes an electrically isolated area that correspond to the electrically conductive region of the flexible body.

9. A method according to claim 8

wherein the electrically isolated area is electrically coupled to a connector on the introducer to allow the electrically isolated area to be coupled to a stimulating circuit.

10. A method according to claim 9

further including, during the implanting step, a step of coupling the introducer to a stimulating circuit to provoke a tissue stimulation response to place the percutaneous electrode in the desired location.

11. A percutaneous electrode assembly comprising

a flexible body including one or more electrically conductive regions, a tissue penetrating region for implantation of the electrically conductive regions in a targeted tissue region, and a percutaneous lead electrically coupled to the electrically conductive regions, the lead including a conductor for each electrically conductive region,

an anchoring element on the flexible body to resist movement of the electrically conductive region within tissue, and

a flexible introducer having an interior lumen sized and configured to receive the flexible body and shield the anchoring element from contact with tissue while the electrically conductive region is placed to a desired position within tissue, the flexible introducer also being sized and configured to accommodate advancement of the anchoring element beyond the interior lumen for contact with tissue to resist movement of the electrically conductive region placed in the desired position.

12. An assembly according to claim 11

wherein the flexible introducer is sized and configured to accommodate advancement of the flexible body and anchoring element beyond the interior lumen while the flexible introducer is bent.