Implantable medical lead

• US 6,606,521 B2
• Filed: 07/09/2001
• Issued: 08/12/2003
• Est. Priority Date: 07/09/2001
• Status: Expired due to Term

• Current Assignee: Neuropace Inc.
• Original Assignee: Neuropace Inc.
• Inventors: Paspa, Paul M., Boling, C. Lance
• Primary Examiner(s): Getzow, Scott M.
• Application Number:
  US09/901,854
• Publication Number:
  US 20030009207A1
• Time in Patent Office: 764 Days
• Field of Search: 607/115, 607/116, 607/45, 607/134, 607/135, 607/136, 607/137, 607/138, 600/378, 600/373, 600/377, 600/544
• US Class Current: 607/116
• CPC Class Codes: A61N 1/0529 Electrodes for brain stimulation

Abstract

The present invention generally provides an implantable medical lead having markings. The lead is easier to implant and improves the accurate localization of lead electrodes at a specific point of the brain for neurostimulation. Also provided is an implantable medical lead having a removable extension that advantageously provides a minimal length of excess lead protruding from the lead insertion site. The improved lead and method of implantation facilitates use of a neurostimulator device that is implanted directly in a patient'"'"'s cranium.

Claims

1. An implantable lead comprising:

a body having a proximal end and a distal end;

at least one electrode at the distal end;

at least one terminal at the proximal end, the at least one electrode being connected to the at least one terminal; and

a plurality of markings on the body, wherein the markings are proximal of the electrodes.

2. The implantable lead of claim 1 wherein the markings are graduated.

3. The implantable lead of claim 1 wherein the markings are located between the at least one electrode and the at least one terminal.

4. The implantable lead of claim 1 wherein the markings are printed using ion beam assisted deposition.

5. The implantable lead of claim 1 wherein the markings are formed using a silicone-based adhesive with carbon black pigment.

6. The implantable lead of claim 1 wherein the markings are radio-opaque.

7. An implantable lead comprising:

a body having a proximal end and a distal end;

at least one electrode at the distal end;

at least one terminal at the proximal end, the at least one electrode being connected to the at least one terminal; and

a plurality of markings providing an indication of lead position, wherein the markings are proximal of the electrodes.

8. A method of implanting a lead comprising the steps of:

providing a lead having a proximal end and a distal end, the lead having at least one electrode at the distal end connected to at least one terminal at the proximal end, the lead further includes a plurality of markings located between the distal end and the proximal end;

determining an electrode site for stimulation;

providing an insertion site in a patient'"'"'s cranium;

inserting the lead into the insertion site;

positioning the lead at the electrode site; and

providing a visual indication of lead position by the markings on the lead.

9. An implantable lead comprising:

a lead portion having a proximal end and a distal end, the lead portion further including a lead body between the proximal end and the distal end, at least one electrode at the distal end and at least one terminal at the proximal end, the at least one electrode being connected to the at least one terminal, and a plurality of markings on the lead body; and

an extension removably connected to the lead portion, the extension having a proximal end, distal end, and an extension body between the proximal end and the distal end.

10. The implantable lead of claim 9 wherein the markings are radio-opaque.

11. The implantable lead of claim 9 wherein extension includes a plurality of markings on the body of the extension.

12. The implantable lead of claim 11 wherein the markings are radio-opaque.

13. The implantable lead of claim 9 wherein the extension is removably coupled to the lead portion such that the distal end of the extension is removably coupled to the proximal end of the lead portion.

14. The implantable lead of claim 9 wherein the lead portion includes a lumen and the extension includes a lumen, the lumen of the lead portion is interconnected with the lumen of the extension.

15. The implantable lead of claim 9 wherein the extension is more rigid than the lead portion.

16. The implantable lead of claim 9 wherein the at least one terminal of the lead portion is operatively connected to a neurostimulator device that is implanted in a patient'"'"'s cranium.

17. An implantable lead comprising:

a lead portion having a proximal end and a distal end, the lead portion further includes at least one electrode at the distal end electrically connected to at least one terminal at the proximal end; and

an extension removably connected to the lead portion at a break-away zone, the extension having proximal end, a distal end, and a lumen extending therethrough, the lumen of the lead portion being interconnected with the lumen of the extension.

18. The implantable lead of claim 17 wherein the lead portion includes a lumen extending between the proximal end and the distal end of the lead portion.

19. The implantable lead of claim 17 wherein the break-away zone includes a score.

20. The implantable lead of claim 17 wherein the break-away zone includes a weakened area.

21. The implantable lead of claim 17 wherein the break-away zone includes a reduced cross-sectional area of material such that the break-away zone is weakened relative to other portions of the lead portion or extension.

22. The implantable lead of claim 17 wherein the break-away zone includes a visual indicator.

23. The implantable lead of claim 17 wherein the extension has a length between approximately 250 mm and approximately 500 mm.

24. An implantable lead comprising:

a lead portion having proximal end and a distal end, at least one electrode at the distal end and at least one terminal at the proximal end, the at least one electrode being electrically connected to the at least one terminal; and

an extension removably coupled to the lead portion, the extension having a proximal end and a distal end, the extension further including a sleeve portion having a fixed end and a lead portion receiving end, the fixed end being fixed to the distal end of the extension, the lead portion is removably coupled within the lead portion receiving end of the sleeve.

25. The implantable lead of claim 24 wherein the sleeve is split.

26. The implantable lead of claim 24 wherein the extension includes a lumen extending between the proximal end and distal end of the extension.

27. The implantable lead of claim 26 wherein the lead portion includes a lumen extending between the proximal end and distal end of the lead portion, the lumen of the lead portion being interconnected with the lumen of the extension.

28. A method of implanting a lead in a patient'"'"'s brain comprising the steps of:

providing a lead having a lead portion and an extension, the lead portion being removably coupled to the extension, the lead portion having at least one electrode at a distal end electrically coupled to at least one terminal at a proximal end;

determining an electrode site for stimulation;

providing an insertion site in a patient'"'"'s cranium;

inserting a cannula into the patient'"'"'s brain;

inserting the lead into the cannula such that the distal end of the lead portion is inserted first;

positioning the lead at the electrode site;

removing the cannula; and

removing the extension from the lead portion.

29. The method of claim 28 wherein the extension includes a proximal end and a distal end, the extension further including a lumen extending between the proximal end and the distal end, the lead portion further including a lumen extending between the distal end and the proximal end of the lead portion, the lumen of the lead portion being interconnected with the lumen of the extension;

and

further including the step of inserting a stylet into the lumen of the extension and the lumen of the lead portion.

30. The method of claim 29 further including the step of removing the stylet.

31. The method of claim 28 wherein the lead includes markings, the step of positioning the lead at the electrode site includes observing the markings.

32. The method of claim 28 wherein the step of removing the extension from the lead portion includes using a removal tool.

33. The method of claim 28 further including the step of operatively connecting the at least one terminal to a neurostimulator device that is implanted in the patient'"'"'s cranium.

34. An implantable lead comprising:

a lead portion having a proximal end and a distal end, the lead portion further including a lead body between the proximal end and the distal end, at least one electrode at the distal end and at least one terminal at the proximal end, the at least one electrode being connected to the at least one terminal; and

an extension removably connected to the lead portion, the extension having a proximal end, distal end, and a body between the proximal end and the distal end, and wherein the extension and the lead portion have substantially the same diameter.