System and method for lead fixation

• US 7,603,179 B1
• Filed: 09/15/2004
• Issued: 10/13/2009
• 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): Layno; Carl H.
• Assistant Examiner(s): Heller; Tammie K.
• Application Number:
  US10/941,220
• Time in Patent Office: 1,854 Days
• Field of Search: 607115-119, 607122-124, 607/129, 607/133
• 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. An implantable medical lead comprising:

a lead body with a proximal end and a distal end;

an array comprising spaced-apart electrodes disposed along the distal end of the lead body;

a tip at the distal end of the lead body, wherein the tip includes adhesive configured and arranged for contacting tissue and adhering the lead to the tissue when the lead is implanted; and

a unitary, implantable sheath of flexible tubing disposed over at least a portion of the lead body and over at least a portion of each of two or more of the electrodes, wherein the sheath has biodegradable adhesive configured and arranged for contacting tissue and adhering the lead to the tissue when the lead is implanted.

2. The implantable medical lead of claim 1, wherein the adhesive on the tip is biodegradable.

3. The implantable medical lead of claim 1, wherein the tip includes at least one of pits, threads and grooves.

4. The implantable medical lead of claim 3, wherein at least a portion of the tip is threaded.

5. An implantable medical lead comprising:

a lead body with a proximal end and a distal end;

an array comprising spaced-apart electrodes disposed along the distal end of the lead body;

a tip at the distal end of the lead body, wherein the lead body has a lumen along the lead length, which lumen has a first opening at the tip and a second opening at another location of the lead body, wherein adhesive may be injected through the second opening and out through the first opening; and

a unitary, implantable sheath of flexible tubing disposed over at least a portion of the lead body and over at least a portion of each of two or more of the electrodes, wherein the sheath has biodegradable adhesive configured and arranged for contacting tissue and adhering the lead to the tissue when the lead is implanted.

6. The lead of claim 5, further comprising a biodegradable adhesive for injecting through the second opening and out through the first opening.

7. An implantable medical lead comprising:

a lead body with a proximal end and a distal end;

an array comprising spaced-apart electrodes disposed along the distal end of the lead body;

a tip at the distal end of the lead body; and

a unitary, implantable sheath of flexible tubing disposed over at least a portion of the lead body and over at least a portion of each of two or more of the electrodes, wherein the sheath has biodegradable adhesive configured and arranged for contacting tissue and adhering the lead to the tissue when the lead is implanted.

8. The lead of claim 7, wherein the biodegradable adhesive comprises tissue adhesive disposed at the proximal end of the flexible sheath.

9. The implantable medical lead of claim 7, wherein the sheath has electrode windows spaced along the sheath to expose at least one electrode contact of the electrode array.

10. An implantable medical lead comprising:

a lead body with a proximal end and a distal end;

an array comprising spaced-apart electrodes disposed along the distal end of the lead body;

a tip at the distal end of the lead body; and

a unitary, implantable sheath of flexible tubing disposed over at least a portion of the lead body and over at least a portion of each of two or more of the electrodes, wherein the sheath is made from biocompatible, biodegradable material, wherein the sheath has biodegradable adhesive configured and arranged for contacting tissue and adhering the lead to the tissue when the lead is implanted.

11. The implantable medical lead of claim 10, wherein the sheath has electrode windows spaced along the sheath to expose at least one electrode contact of the electrode array.

12. The implantable medical lead of claim 10, wherein the biodegradable material of the sheath is a biodegradable mesh.

13. The implantable medical lead of claim 10, wherein the sheath allows passage of current therethrough to surrounding tissue.

14. The implantable medical lead of claim 10, wherein each of the electrodes is a ring electrode contact.

15. The implantable medical lead of claim 10, wherein the sheath is disposed over at least a portion of each of the electrodes.

16. The implantable medical lead of claim 10, wherein the sheath is disposed completely over all of the electrodes.

17. An implantable neurostimulator lead comprising:

a lead body with a proximal end, a distal end, and a tip at the distal end of the lead body;

a plurality of spaced-apart electrodes disposed along the distal end of the lead body, the electrodes configured and arranged for providing electrostimulation to surrounding tissue when the lead is implanted; and

an implantable sheath disposed over at least a portion of the lead body and over at least a portion of each of two or more of the electrodes, wherein the sheath is slidably removable from the lead body after implantation, wherein the sheath has biodegradable adhesive configured and arranged for contacting tissue and adhering the lead to the tissue when the lead is implanted.

18. The neurostimulator lead of claim 17, wherein the sheath comprises a flexible tubing.

19. The neurostimulator lead of claim 17, wherein the sheath is removable from the lead body and array of electrodes leaving the sheath substantially intact.

20. The neurostimulator lead of claim 17, wherein the sheath is unitary and comprises a plurality of windows aligned with the two or more of the electrodes over which the sheath is disposed.

21. An implantable medical lead comprising:

a lead body with a proximal end, a distal end, and a tip at the distal end of the lead body;

an array comprising spaced-apart electrodes disposed along the distal end of the lead body;

and

a unitary, implantable sheath of flexible tubing disposed over at least a portion of the lead body and over at least a portion of each of two or more of the electrodes, wherein the sheath is removable from the lead body and array of electrodes after implantation of the medical lead, leaving the sheath substantially intact, wherein the sheath has biodegradable adhesive configured and arranged for contacting tissue and adhering the lead to the tissue when the lead is implanted.

22. An implantable medical lead comprising:

a lead body with a proximal end, a distal end, and a tip at the distal end of the lead body;

an array comprising spaced-apart electrodes disposed along the distal end of the lead body;

and

a unitary, implantable sheath of flexible tubing disposed over at least a portion of the lead body and over at least a portion of each of two or more of the electrodes, wherein the sheath is slidably removable from the lead body after implantation, wherein the sheath has biodegradable adhesive configured and arranged for contacting tissue and adhering the lead to the tissue when the lead is implanted.

23. An implantable medical lead comprising:

a lead body with a proximal end, a distal end, and a tip at the distal end of the lead body;

an array comprising spaced-apart electrodes disposed along the distal end of the lead body;

and

a unitary, implantable sheath of flexible tubing disposed over at least a portion of the lead body and over at least a portion of each of two or more of the electrodes, wherein the lead is configured and arranged to allow removal of the lead body and array of electrodes from the sheath, when the lead is implanted in a patient body, leaving the sheath in the patient body, wherein the sheath has biodegradable adhesive configured and arranged for contacting tissue and adhering the lead to the tissue when the lead is implanted.