Implantable electrode, insertion tool for use therewith, and insertion method

• US 8,538,554 B2
• Filed: 09/17/2008
• Issued: 09/17/2013
• Est. Priority Date: 05/10/2004
• Status: Expired due to Fees

• Current Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Inventors: Kuzma, Janusz A., Smith, Lani A., Thenuwara, Chuladatta, He, Tom Xiaohai
• Primary Examiner(s): Schaetzle, Kennedy
• Assistant Examiner(s): LEE, ERICA SHENGKAI
• Application Number:
  US12/212,427
• Publication Number:
  US 20090024196A1
• Time in Patent Office: 1,826 Days
• Field of Search: 607/126, 607/128
• US Class Current: 607/126
• 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. A system for implanting an implantable electrode lead comprising:

an implantable electrode lead, comprising;

a metal electrode contact at a distal end of the implantable electrode lead, 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 metal electrode contact;

a non-conductive 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 metal 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; and

an insertion tool, comprising

an insertion tube defining an outer surface and an interior lumen, wherein the interior lumen is configured and arranged to removably receive at least the body portion, wherein the insertion tube further defines a longitudinal slot extending through the insertion tube from the outer surface of the insertion tube to the interior lumen, wherein the longitudinal slot extends an entire length of the insertion tube and has a width that is greater than the outer diameter of the body portion and less than the outer diameter of the non-conductive anchoring tube; and

a handle comprising a slider and a hook attached to the slider, wherein the hook is configured and arranged to attach to the connector plug and provide a stabilizing force during implantation.

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

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

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

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

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

7. The implantable electrode lead of claim 1, wherein the non-conductive anchoring tube comprises a collar proximate to the metal 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 non-conductive anchoring tube and at least one row of the flexible barbs disposed on the second portion of the non-conductive anchoring tube.

8. The implantable electrode lead of claim 7, wherein the collar has an outer diameter greater than an outer diameter of the second portion of the non-conductive anchoring tube.

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

m.

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

11. The implantable electrode lead of claim 1, wherein the non-conductive anchoring tube is made of polymer.

12. A method for implanting an implantable electrode lead, wherein the method comprises:

providing the system of claim 1;

placing the implantable electrode lead under tension within the insertion tube, with the metal electrode contact at one end of the insertion tube, and with the connector plug at the other end of the insertion tube and attached to the hook of the handle;

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

removing the tension from the implantable electrode lead held in the insertion tube by releasing the connector plug from the hook; and

removing the insertion tube from the implantable electrode lead by passing the insulated conductor through the longitudinal slot, while leaving the metal electrode contact at the desired target location.

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

14. The method of claim 12, further comprising coupling the connector plug, to a neurostimulator.

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

16. The method of claim 12, wherein placing the implantable electrode lead 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.

17. The method of claim 12, 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.

18. The method of claim 17, wherein the implantable electrode lead comprise a first row of flexible barbs and a second row of flexible barbs and wherein placing the implantable electrode lead 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.