IMPLANTABLE ELECTRODE, INSERTION TOOL FOR USE THEREWITH, AND INSERTION METHOD

• US 20090024196A1
• Filed: 09/17/2008
• Published: 01/22/2009
• Est. Priority Date: 05/10/2004
• Status: Active Grant

• Current Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Inventors: Thenuwara, Chuladatta, He, Tom Xiaohai, Smith, Lani A., Kuzma, Janusz A.
• Granted Patent: US 8,538,554 B2
• Time in Patent Office: Days
• US Class Current: 607/116
• CPC Class Codes: A61B 17/3468 for implanting or removing devices, e.g. prostheses, implants, seeds, wires devices for implanting seeds A61M37/0069
• CPC Class Codes: A61N 1/05 for implantation or insertion into the body, e.g. heart electrode A61N1/06 takes precedence
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/0558 Anchoring or fixation means therefor

Abstract

An electrode system includes an implantable electrode having at least one electrode contact, an insertion tool, and a technique or method that allows the electrode contact to be positioned within soft tissue at a selected target stimulation site.

Claims

1. An implantable electrode comprising:

an electrode contact at a distal end of the implantable electrode, wherein a distal end of the electrode contact has a conical shape with an arrow-like or needle-like distal point;

a connector plug at a proximal end;

an insulated conductor that electrically connects the connector plug to the at least one electrode contact;

an anchoring tube proximate to the electrode contact with at least one row of flexible barbs protruding therefrom, the anchoring tube, excluding the barbs, having an outer diameter less than an outer diameter of a widest portion of the electrode contact; and

a body portion extending at least from the anchoring tube to the connector plug, wherein the body portion proximal to the anchoring tube has an outer diameter less than the outer diameter of the anchoring tube.

2. The implantable electrode of claim 1, wherein the at least one row of flexible barbs extends longitudinally along the anchoring tube.

3. The implantable electrode of claim 2, wherein the at least one row of flexible barbs comprises two rows of flexible barbs extending longitudinally along the anchoring tube.

4. The implantable electrode of claim 3, wherein the two rows of flexible barbs are located on opposite sides of the anchoring tube.

5. The implantable electrode of claim 1, wherein the at least one row of flexible barbs is disposed in a concentric circle around, and protrudes from, the anchoring tube.

6. The implantable electrode of claim 5, wherein the anchoring tube comprises a collar proximate to the at least one electrode contact and having an outer diameter greater than an outer diameter of another portion of the anchoring tube, wherein at least a portion of the barbs are disposed on the collar.

7. The implantable electrode of claim 1, wherein the anchoring tube comprises a collar proximate to the at least one electrode contact and a second portion proximal to the collar, wherein the at least one row of flexible barbs comprises at least one row of the flexible barbs disposed in a concentric circle around, and protruding from, the collar of the anchoring tube and at least one row of the flexible barbs disposed on the second portion of the anchoring tube.

8. The implantable electrode of claim 7, wherein the collar has an outer diameter greater than an outer diameter of the second portion of the anchoring unit.

9. The implantable electrode of claim 1, wherein the conductor comprises a plurality of thin fibers, each fiber having a diameter of between about 10 to 25 μ

m.

10. The implantable electrode of claim 1, wherein the flexible barbs are formed of plastic or ceramic.

11. A method for implanting an implantable electrode, the implantable electrode having at least one electrode contact at a distal end, a connector plug at a proximal end, and a conductor that electrically connects the electrode contact and the connector plug, wherein the method comprises:

(a) placing the implantable electrode under tension within an insertion tube, with the electrode contact at one end of the insertion tube, and with the connector plug at the other end of the insertion tube, and wherein the insertion tube has a longitudinal slot along its length through which the conductor may pass, but through which the electrode contact and connector plug may not pass;

(b) directing the electrode contact, while held in the insertion tube under tension, through soft tissue to a desired tissue target location;

(c) removing the tension from the implantable electrode held in the tension tube; and

(d) removing the insertion tube from the implantable electrode by passing the conductor through the longitudinal slot, while leaving the electrode contact at the desired target location.

12. The method of claim 11, further comprising tunneling the conductor through soft tissue using a tunneling tool.

13. The method of claim 11, further comprising coupling the connector plug to a neurostimulator.

14. The method of claim 13, wherein the neurostimulator is a microstimulator.

15. The method of claim 11, wherein placing the implantable electrode under tension comprises placing the implantable electrode within the insertion tube which is coupled to a handle, the handle comprising a hook into which the connector plug is placed to apply tension to the implantable electrode.

16. The method of claim 11, wherein the insertion tube comprises a tube wall which defines a central lumen and the longitudinal slot in the tube wall extending from a distal end of the insertion tube.

17. The method of claim 11, wherein the implantable electrode further comprises:

an anchoring tube proximate to the electrode contact with at least one row of flexible barbs protruding therefrom, the anchoring tube, excluding the barbs, having an outer diameter less than an outer diameter of a widest portion of the electrode contact; and

a body portion extending at least from the anchoring tube to the connector plug, wherein the body portion proximal to the anchoring tube has an outer diameter less than the outer diameter of the anchoring tube.

18. The method of claim 17, wherein placing the implantable electrode under tension within the insertion tube comprises aligning at least one row of the flexible barbs with the longitudinal slot of the insertion tube so that the flexible barbs are positioned within the longitudinal slot.

19. The method of claim 17, wherein the insertion tube comprises a second longitudinal slot extending from a distal end of the insertion tube to a position between the distal and proximal ends of the insertion tube.

20. The method of claim 19, wherein the implantable electrode comprises a first row of flexible barbs and a second row of flexible barbs and wherein placing the implantable electrode under tension within the insertion tube comprises aligning the first row of flexible barbs with the longitudinal slot of the insertion tube so that the flexible barbs of the first row are positioned within the longitudinal slot and aligning the second row of flexible bars with the second longitudinal slot of the insertion tube so that the flexible barbs of the second row are positioned within the second longitudinal slot.