IMPLANTABLE FLEXIBLE CIRCUIT LEADS AND METHODS OF USE

• US 20080140152A1
• Filed: 12/06/2007
• Published: 06/12/2008
• Est. Priority Date: 12/06/2006
• Status: Active Grant

• Current Assignee: St. Jude Medical Luxembourg Holdings SMI S.A.R.L.
• Original Assignee: Spinal Modulation, Inc. (Abbott Laboratories Incorporated)
• Inventors: Hills, Matthew D., Burdulis, Albert G., Kishawi, Eyad, IMRAN, Mir A.
• Granted Patent: US 9,314,618 B2
• Time in Patent Office: Days
• US Class Current: 607/46
• CPC Class Codes: A61N 1/0553 Paddle shaped electrodes, e.g. for laminotomy
• CPC Class Codes: A61N 1/0556 Cuff electrodes
• CPC Class Codes: H05K 1/118 specially for flexible printed circuits, e.g. using folded portions

Abstract

Devices, systems and methods are provided for stimulation of tissues and structures within a body of a patient. In particular, implantable leads are provided which are comprised of a flexible circuit. Typically, the flexible circuit includes an array of conductors bonded to a thin dielectric film. Example dielectric films include polyimide, polyvinylidene fluoride (PVDF) or other biocompatible materials to name a few. Such leads are particularly suitable for stimulation of the spinal anatomy, more particularly suitable for stimulation of specific nerve anatomies, such as the dorsal root (optionally including the dorsal root ganglion).

Claims

1. A method for stimulating a tissue within a body comprising:

positioning a lead comprising a flexible circuit having at least one electrode so that at least one of the at least one electrode is disposed near a dorsal root; and

supplying electrical energy to the at least one of the at least one electrode so as to stimulate at least a portion of the dorsal root.

2. A method of claim 1, wherein the portion of the dorsal root comprises a dorsal root ganglion.

3. A method of claim 1, further comprising advancing the lead through a foramen.

4. A method of claim 1, further comprising advancing the lead through an epidural space.

5. A method of claim 1, further comprising joining the lead with an implantable pulse generator.

6. A method of claim 5, further comprising implanting the lead and the implantable pulse generator wholly within the body.

7. A flexible circuit lead for stimulating a body tissue comprising:

an elongate structure having a distal end configured to be positioned near a dorsal root and a proximal end coupleable with a pulse generator, wherein the structure comprises a dielectric film;

at least one electrode disposed near the distal end; and

at least one conductive trace extending from the at least one electrode toward the proximal end so that stimulation energy is transmittable from the coupled pulse generator to the at least one electrode so as to stimulate the at least a portion of the dorsal root.

8. A flexible circuit lead as in claim 7, wherein the at least one electrode is comprised of a biocompatible conductive metal, alloy or combination of these plated onto the dielectric film.

9. A flexible circuit lead as in claim 8, wherein the biocompatible conductive metal, alloy or combination includes gold, titanium, tungsten, titanium tungsten, titanium nitride, platinum, iridium or platinum-iridium alloy.

10. A flexible circuit lead as in claim 7, wherein the dielectric film has a thickness in the range of approximately 7.5 to 125 μ

m.

11. A flexible circuit lead as in claim 7, wherein the at least one electrode comprises a plurality of electrodes arranged substantially linearly along a longitudinal axis of the distal end.

12. A flexible circuit lead as in claim 7, wherein the at least one electrode comprises a plurality of electrodes arranged substantially linearly along a horizontal axis of the distal end.

13. A flexible circuit lead as in claim 7, wherein the at least one electrode comprises a plurality of electrodes arranged in a substantially circular or arc shape.

14. A flexible circuit lead as in claim 7, wherein the distal end has a pronged shape including at least two prongs.

15. A flexible circuit lead as in claim 8, wherein one of the at least one electrodes is disposed near a tip of one of the at least two prongs.

16. A flexible circuit lead as in claim 7, wherein the distal end is configured to wrap around the body tissue.

17. A flexible circuit lead as in claim 7, wherein the distal end of the elongate structure is passable through a needle.

18. A lead for stimulating a body tissue comprising:

an elongate structure having a proximal end coupleable with a pulse generator and a distal end having two edges which are capable of being positioned in opposition, wherein the distal end includes at least two electrodes which generally oppose each other when the edges are positioned in opposition so as to stimulate the body tissue.

19. A lead as in claim 18, wherein the distal end forms a V-shape or U-shape when the two edges are positioned in opposition which allows the body tissue to be positioned at least partially within the V-shape or U-shape.

20. A lead as in claim 19, wherein the body tissue comprises a dorsal root ganglion.

21. A lead as in claim 18, wherein the distal end comprises two elongate elements, each element having one of the two edges.

22. A lead as in claim 21, wherein the two elongate elements are positionable in linear alignment with a longitudinal axis of the elongate structure.

23. A lead as in claim 18, wherein the distal end has a rounded shape wherein sides of the rounded shape form the two edges.

24. A lead as in claim 23, wherein the sides of the rounded shape curl or fold towards each other to position the two edges in opposition.

25. A lead as in claim 18, wherein the elongate structure comprises a dielectric film.

26. A lead as in claim 25, wherein the dielectric film has a thickness in the range of approximately 7 to 125 μ

m.

27. A lead as in claim 25, wherein the at least two electrodes are comprised of a biocompatible conductive metal, alloy or combination of these plated on the dielectric film.

28. A lead as in claim 18, wherein the distal end is passable through a needle.

29. A system for stimulating a body tissue comprising:

a first elongate structure having first proximal end coupleable with a pulse generator and a first distal end, wherein the first distal end has a first inner surface having a first electrode disposed thereon; and

a second elongate structure having a second proximal end coupleable with the pulse generator and a second distal end, wherein the second distal end has a second inner surface having a second electrode disposed thereon,

wherein the first and second elongate structures are joined so that the first and second electrodes are capable of directing stimulation energy toward each other, and wherein the first and second distal ends are moveable away from each other so as to allow the body tissue to be positioned at least partially therebetween to receive the stimulation energy.

30. A system as in claim 29, wherein the first and second elongate structures are slidably joined.

31. A system as in claim 29, wherein the first distal end is movable by recoil force.

32. A system as in claim 29, wherein the first distal end is attachable to a first obturator which is capable of moving the first distal end.

33. A system as in claim 32, wherein the first obturator is configured to dissect tissue while it moves the first distal end.

34. A system as in claim 32, wherein the first obturator is advanceable from a delivery device so as to advance the first distal end and move the first distal end away from the second distal end.

35. A system as in claim 29, wherein the first elongate structure comprises a dielectric film.

36. A system as in claim 29, wherein the body tissue comprises a dorsal root ganglion.

37. A system as in claim 29, wherein the first elongate structure includes a first contact pad disposed on an outer surface of the proximal end of the first elongate structure, wherein the first contact pad provides electrical connection from the first electrode to the pulse generator.

38. A system as in claim 37, wherein the second elongate structure includes a second contact pad disposed on an outer surface of the proximal end of the second elongate structure, wherein the second contact pad provides electrical connection from the second electrode to the pulse generator.

39. A lead as in claim 29, wherein the distal end is passable through a needle.

40. A flexible circuit lead for stimulating a body tissue comprising:

an elongate structure having a distal end comprising at least one electrode on a dielectric film, wherein the distal end is movable to at least partially surround the body tissue and direct stimulation energy from the at least one electrode toward the body tissue.

41. A flexible circuit lead as in claim 40, wherein the distal end is moveable by curling or uncurling so as to at least partially surround the body tissue.

42. A flexible circuit lead as in claim 40, wherein the distal end is moveable by folding or unfolding so as to at least partially surround the body tissue.

43. A flexible circuit lead as in claim 40, wherein the distal end comprises opposing elements which move toward or away from each other so as to at least partially surround the body tissue.

44. A flexible circuit lead as in claim 43, wherein the opposing elements move independently.

45. A flexible circuit lead as in claim 43, wherein the opposing elements form a V-shape.

46. A flexible circuit lead as in claim 40, wherein the distal end is passable through a needle.

47. A device for stimulating a body tissue comprising:

an elongate shaft having an outer surface; and

a lead having a at least one electrode,

wherein the lead is mounted on the outer surface of the elongate shaft so that the at least one electrode is positionable near a dorsal root for stimulation.

48. A device as in claim 47, wherein the elongate shaft includes a lumen therethrough configured for passage of a stylet.

49. A device as in claim 47, wherein the lead is comprised of an elongate structure comprising a dielectric film.

50. A device as in claim 49, wherein the at least one electrode is comprised of a biocompatible conductive metal, alloy or combination of these plated onto the dielectric film.

51. A device as in claim 47, wherein the at least one electrode comprises a plurality of electrodes positioned so as to wrap at least partially around the elongate shaft.

52. A device as in claim 47, wherein the elongate shaft is configured for implantation in an arrangement so that the at least one electrode is positioned near a dorsal root ganglion.

53. A lead for stimulating a body tissue comprising:

a first elongate structure having a first distal end configured to be positioned near the body tissue and a first proximal end coupleable with a pulse generator, wherein the first elongate structure has a first electrode disposed near the first distal end; and

a second elongate structure having a second distal end, a second proximal end and a second electrode disposed near the second distal end,

wherein the second elongate structure is attached to the first elongate structure in a layered configuration so that stimulation energy is transmittable from the coupled pulse generator to the first and second electrode so as to stimulate the body tissue.

54. A lead as in claim 53, wherein the layered configuration offsets the distal ends.

55. A lead as in claim 53, wherein the first and second electrodes are arranged substantially linearly along a longitudinal axis of the distal end.

56. A lead as in claim 53, further comprising a third elongate structure having a third proximal end, a third distal end and a third electrode disposed near the third distal end, wherein the third elongate structure is attached to the second elongate structure in a layered configuration so that stimulation energy is transmittable from the coupled pulse generator to the third electrode so as to stimulate the body tissue.

57. A lead as in claim 53, wherein at least one conductive trace extends from each electrode toward its respective proximal end

58. A lead as in claim 57, wherein each conductive trace has a shape so that the layered configuration balances the conductive traces.

59. A lead as in claim 57, wherein at least one of the at least one conductive traces has a zig-zag or serpentine shape.

60. A lead as in claim 53, wherein the first elongate structure comprises a dielectric film.

61. A lead as in claim 60, wherein the first electrode is comprised of a biocompatible conductive metal, alloy or combination of these plated onto the dielectric film.

62. A lead as in claim 61, wherein the biocompatible conductive metal, alloy or combination includes gold, titanium, tungsten, titanium tungsten, titanium nitride, platinum, iridium or platinum-iridium alloy.

63. A lead as in claim 53, wherein the distal ends of the layered configuration of elongate structures are passable through a needle.