System and method for lead fixation

• US 8,285,397 B2
• Filed: 09/03/2009
• Issued: 10/09/2012
• Est. Priority Date: 09/16/2003
• Status: Expired due to Fees

• Current Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Inventors: Grandhe, Sarvani
• Primary Examiner(s): Heller, Tammie K
• Application Number:
  US12/553,313
• Publication Number:
  US 20090326628A1
• Time in Patent Office: 1,132 Days
• Field of Search: 607/116, 607/117, 607/122, 607/126
• US Class Current: 607/122
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/0558 Anchoring or fixation means therefor

Abstract

A medical lead includes a pitted, grooved or threaded electrode array tip and a flexible tube or sheath encompassing the electrode array located near the lead tip. In some embodiments, the electrode array adheres to tissue, the tube or sheath adheres to the electrode array at the distal end of the electrode array or the tube or sheath adheres to tissue at the proximal end of the tube or sheath. Embodiments of the tube or sheath may be made from biodegradable material and can include electrode windows spaced along the tube or sheath corresponding to placement of electrode contacts of the electrode array.

Claims

1. A method for implanting a medical lead, the method comprising:

providing a lead having a plurality of spaced-apart electrodes disposed along a distal end of the lead;

using an implantable sheath to encompass at least a portion of each of two or more of the electrodes, but not a distal tip of the lead;

implanting the lead with the implantable sheath, wherein the sheath has biodegradable adhesive that contacts tissue when the sheath is implanted to adhere to the tissue; and

adhering the distal tip of the lead to surrounding tissue using a tissue adhesive applied to the distal tip of the lead.

2. The method of claim 1, further comprising attaching the sheath to the the lead with an adhesive.

3. The method of claim 1, wherein the sheath has at least one electrode window.

4. The method of claim 1, wherein the lead tip has at least one of grooves, pits, and threads.

5. The method of claim 4, further comprising applying the tissue adhesive to the distal tip of the lead for adhering the distal tip to the surrounding tissue.

6. The method of claim 1, further comprising:

removing the lead, while the sheath is left behind in the tissue; and

implanting a second lead into the tissue by inserting the second lead into the implanted sheath.

7. The method of claim 6, wherein removing the lead comprises twisting or rotating the lead to release attachment of the lead to the tissue.

8. The method of claim 1, wherein the lead defines a lumen along a length of the lead, a first opening at the distal tip;

and a second opening at another location on the lead.

9. The method of claim 1, wherein the tissue adhesive applied to the distal tip of the lead is biodegradable.

10. The method of claim 1, wherein the sheath is made of a biodegradable material.

11. The method of claim 1, wherein the sheath is slidably removable from the lead body after implantation.

12. The method of claim 11, further comprising slidably removing the lead body from the sheath after implantation of the lead body.

13. The method of claim 12, wherein slidably removing the lead body from the sheath leaves the sheath substantially intact.

14. The method of claim 1, wherein during implantation the sheath is disposed completely over all of the electrodes covering all of the electrodes entirely.

15. The method of claim 14, further comprising stimulating tissue by passing current through the electrodes to the tissue, wherein the sheath is configured and arranged to allow passage of current through material forming the sheath.

16. The method of claim 1, further comprising stimulating tissue by passing current through the electrodes to the tissue.

17. The method of claim 1, wherein the lead tip is threaded.

18. A method for implanting a medical lead, the method comprising:

providing a lead having a plurality of spaced-apart electrodes disposed along a distal end of the lead, wherein the lead defines a lumen along a length of the lead, a first opening at the distal tip;

and a second opening at another location on the lead;

using an implantable sheath to encompass at least a portion of each of two or more of the electrodes, but not a distal tip of the lead;

implanting the lead with the implantable sheath, wherein the sheath has biodegradable adhesive that contacts tissue when the sheath is implanted to adhere to the tissue; and

after implanting the lead, injecting adhesive into the second opening, through the lumen, and out the first opening to adhere the lead to tissue.

19. The method of claim 18, wherein the lead comprises adhesive disposed on the distal tip and wherein implanting the lead comprises adhering the distal tip of the lead to the tissue when implanted.

20. The method of claim 18, wherein the adhesive injected into the second opening, through the lumen, and out the first opening is biodegradable.