Implantable medical lead including a directional electrode and fixation elements along an interior surface

• US 7,684,873 B2
• Filed: 02/14/2007
• Issued: 03/23/2010
• Est. Priority Date: 10/31/2006
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Gerber, Martin T.
• Primary Examiner(s): Manuel; George
• Assistant Examiner(s): Wieland; Robert N
• Application Number:
  US11/706,146
• Publication Number:
  US 20080103574A1
• Time in Patent Office: 1,133 Days
• Field of Search: 607/122, 607/125, 607/126, 607/117, 607/116
• US Class Current: 607/116
• CPC Class Codes: A61N 1/0534 Electrodes for deep brain stimulation
• CPC Class Codes: A61N 1/0536 Preventing neurodegenerative response or inflammatory reaction
• CPC Class Codes: A61N 1/0558 Anchoring or fixation means therefor
• CPC Class Codes: A61N 1/36017 with leads or electrodes penetrating the skin
• CPC Class Codes: A61N 1/3605 Implantable neurostimulators for stimulating central or peripheral nerve system

Abstract

An implantable medical elongated member includes a first outer surface portion and a second outer surface portion extending around at least ten percent of an outer perimeter of the elongated member. A fixation element extends a distance from the first outer surface portion of the implantable medical elongated member. A longitudinally-extending section of the second outer surface portion proximate to a distal end of the elongated member is substantially devoid of any fixation elements that extend the distance from second outer surface portion. In some embodiments, the longitudinally-extending section of the second outer surface portion is substantially devoid of any exposed electrodes.

Claims

1. An implantable medical lead comprising:

a lead body defining an outer surface comprising;

a first outer surface portion; and

a second outer surface portion extending around at least ten percent of an outer perimeter of the lead body;

a fixation element extending a distance from the first outer surface portion, wherein a longitudinally-extending section of the second outer surface portion proximate to a distal end of the lead body is substantially devoid of any fixation elements that extend the distance from the second outer surface portion; and

at least one directional electrode coupled to the lead body, wherein the directional electrode directs electrical stimulation in a direction in which the fixation element extends from the first outer surface portion, and wherein the longitudinally-extending section of the second outer surface portion is substantially devoid of any exposed electrodes.

2. The implantable medical lead of claim 1, wherein the at least one electrode comprises a ring electrode extending around the outer perimeter of the lead body, and the implantable medical lead further comprises electrical insulation covering a subsection of the at least one electrode residing within the longitudinally-extending section of the second outer surface portion.

3. The implantable medical lead of claim 2, wherein the subsection of the at least one electrode is a first subsection and the electrical insulation comprises a first piece of electrical insulation, and the implantable medical lead further comprises a second piece of electrical insulation covering a second subsection of the at least one electrode residing within the first outer surface portion of the lead body.

4. The implantable medical lead of claim 3, wherein the first and second pieces of electrical insulation are substantially contiguous.

5. The implantable medical lead of claim 2, wherein the electrical insulation comprises an electrically insulating mask.

6. The implantable medical lead of claim 2, further comprising a sheath configured to receive the lead body, wherein the sheath comprises the electrical insulation.

7. The implantable medical lead of claim 1, wherein the at least one electrode comprises at least one electrode segment extending around less than one hundred percent of the outer perimeter of the lead body.

8. The implantable medical lead of claim 7, wherein the at least one electrode comprises at least two substantially axially aligned electrode segments.

9. The implantable medical lead of claim 1, wherein the longitudinally-extending section of the second outer surface portion is substantially devoid of any electrodes.

10. The implantable medical lead of claim 1, wherein the at least one electrode is exposed along the entire first outer surface portion of the lead body.

11. The implantable medical lead of claim 1, wherein the fixation element is a first fixation element and the implantable medical lead further comprises a second fixation element substantially axially aligned with the first fixation element, wherein the at least one electrode is exposed along the first outer surface portion of the lead body between the first fixation element and the second fixation element.

12. The implantable medical lead of claim 1, wherein the fixation element is a first fixation element extending a first distance from the first outer surface portion of the implantable medical lead, and the implantable medical lead further comprises a second fixation element extending a second distance from the second outer surface portion of the implantable medical lead, wherein the first distance is greater than the second distance.

13. The implantable medical lead of claim 1, wherein the distance is a first distance, and the implantable medical lead further comprises an adhesive along at least a subsection of the second outer surface portion of the implantable medical lead, the adhesive extending a second distance from the second outer surface portion of the implantable medical lead, and the second distance being less than the first distance.

14. The implantable medical lead of claim 1, wherein the longitudinally-extending section of the second outer surface portion proximate to the distal end of the lead body is substantially devoid of any fixation elements.

15. The implantable medical lead of claim 1, wherein the first and second outer surface portions have substantially equal sizes.

16. The implantable medical lead of claim 1, wherein the lead body has a circular cross-section defining a first quadrant of the outer surface, a second quadrant of the outer surface, a third quadrant of the outer surface, and a fourth quadrant of the outer surface, and the fixation element extends from at least one of the first, second or third quadrants, and the fourth quadrant of the outer surface is devoid of any fixation elements that extend the distance from the outer surface.

17. The implantable medical lead of claim 16, wherein the at least one electrode is exposed within at least one of the first, second or third quadrants of the outer surface, and the fourth quadrant is devoid of any exposed electrodes.

18. The implantable medical lead of claim 16, wherein the fixation element comprises a first fixation element extending a first distance from at least one of the first, second or third quadrants of the outer surface of the implantable medical lead, and the implantable medical lead further comprises a second fixation element extending a second distance from the fourth quadrant of the outer surface, wherein the first distance is greater than the second distance.

19. The implantable medical lead of claim 18, further comprising a third fixation element and a fourth fixation element, wherein the first fixation element extends from the first quadrant of the outer surface, the third fixation element extends from the second quadrant of the outer surface, and the fourth fixation element extends from the third quadrant of the outer surface.

20. The implantable medical lead of claim 1, wherein the second outer surface portion extends around at least twenty-five percent of the outer perimeter of the lead body.

21. The implantable medical lead of claim 1, wherein the fixation element comprises at least one of a tine, a barb, a hook, an adhesive element, a flange, a balloon or a wire-like element.

22. The implantable medical lead of claim 1, wherein the fixation element comprises at least a first fixation element located between the at least one electrode and a proximal end of the lead body and the implantable medical lead further comprises a second fixation element located between the at least one electrode and the distal end of the lead body.

23. The implantable medical lead of claim 1, wherein the at least one electrode comprises an array of electrodes and the fixation element is disposed between two electrodes of the array of electrodes.

24. The implantable medical lead of claim 1, wherein the longitudinally-extending section of the second outer surface portion extends from the distal end of the lead body to a proximal side of the at least one electrode.

25. The implantable medical lead of claim 1, wherein the lead body is a paddle lead body, the first outer surface portion is a first side of the paddle lead body and the second outer surface portion is a second side of the paddle lead body opposite the first side.

26. The implantable medical lead of claim 1, further comprising a visible marker on the lead body to orient the fixation element with respect to an epidermis of the patient or an introducer.

27. An implantable medical lead comprising:

a substantially cylindrical lead body defining an outer surface comprising;

a first outer surface portion; and

a second outer surface portion extending around at least ten percent of an outer perimeter of the lead body;

a fixation element extending a distance from the first outer surface portion; and

at least one directional electrode coupled to the lead body,

wherein a longitudinally-extending section of the second outer surface portion proximate to a distal end of the lead body is substantially devoid of any fixation elements that extend the distance from the second outer surface portion, and

wherein the at least one directional electrode is configured to limit delivery of electrical stimulation to directions radially outward from the first outer surface portion and direct electrical stimulation in a direction in which the fixation element extends from the first outer surface portion.

28. The implantable medical lead of claim 27, wherein the longitudinally-extending section of the second outer surface portion is substantially devoid of any electrodes.

29. The implantable medical lead of claim 27, wherein the at least one electrode comprises an exposed subsection that subtends about 30 degrees to about 270 degrees of the outer perimeter of the lead body.

30. The implantable medical lead of claim 27, wherein the at least one electrode comprises a ring electrode extending around the outer perimeter of the lead body, wherein electrical insulation partially covers a subsection of the ring electrode residing within the second outer surface portion to block electrical stimulation in directions radially outward from the second outer surface portion.

31. The implantable medical lead of claim 27, wherein the at least one directional electrode comprises at least one electrode segment extending around less than one hundred percent of the outer perimeter of the lead body.

32. A method for implanting a medical lead in a patient, the method comprising:

introducing the medical lead into a body of a patient; and

advancing the medical lead to a target therapy delivery site within the body of the patient,

wherein the medical lead defines an outer surface comprising a first outer surface portion and a second outer surface portion extending around at least approximately ten percent of an outer perimeter of the medical lead, the medical lead further comprising at least one directional electrode coupled to the medical lead and a fixation element extending a distance from the first outer surface portion,

wherein the second outer surface portion is substantially devoid of any exposed electrodes,

wherein a longitudinally-extending section of the second outer surface portion proximate to a distal end of the medical lead is substantially devoid of any fixation elements that extend the distance from the second outer surface portion, and

wherein the directional electrode directs electrical stimulation in a direction in which the fixation element extends from the first outer surface portion.

33. The method of claim 32, further comprising orienting the medical lead so that the second outer surface portion faces a superficial direction.

34. The method of claim 32, wherein introducing the medical lead into the patient comprises:

introducing an introducer into the body of the patient; and

introducing the medical lead into a lumen of the introducer.

35. The method of claim 34, wherein introducing the introducer into the patient comprises introducing the introducer superior to a fascia layer.

36. The method of claim 34, wherein introducing the medical lead into a lumen of the introducer comprises aligning the fixation element with a channel defined by the lumen.

37. The method of claim 32, wherein the at least one electrode comprises a ring electrode extending around the outer perimeter of the lead body and partially covered by electrical insulation.

38. The method of claim 32, wherein the at least one electrode comprises at least one electrode segment extending around less than one hundred percent of the outer perimeter of the lead body.

39. The method of claim 32, wherein the target therapy delivery site is proximate to at least one of an occipital nerve or a trigeminal nerve.