Implantable flexible circuit leads and methods of use

• US 9,314,618 B2
• Filed: 12/06/2007
• Issued: 04/19/2016
• Est. Priority Date: 12/06/2006
• Status: Expired due to Fees

• Current Assignee: St Jude Medical Luxembourg Holding SMI SARL (Abbott Laboratories)
• Original Assignee: Spinal Modulation, Inc. (Abbott Laboratories)
• Inventors: Imran, Mir A., Burdulis, Albert G., Hills, Matthew D., Kishawi, Eyad
• Primary Examiner(s): Patel, Niketa
• Assistant Examiner(s): Hankins, Lindsey G
• Application Number:
  US11/952,062
• Publication Number:
  US 20080140152A1
• Time in Patent Office: 3,057 Days
• Field of Search: 607/116, 607/117, 607/118, 600/373, 600/377, 600/378
• US Class Current: 1/1
• 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 system for stimulating a dorsal root ganglion, comprising:

a first elongate flexible implantable dielectric structure having a first proximal end and a first distal end, wherein the first distal end has a first elongate inner surface having a first electrode disposed thereon; and

a second elongate flexible implantable dielectric structure having a second proximal end and a second distal end, wherein the second distal end has a second elongate inner surface having a second electrode disposed thereon,

wherein the first and second proximal ends are configured to join along a central longitudinal axis so that the first and second elongate inner surfaces are configured to extend lengthwise along the central longitudinal axis and so that in use stimulating a dorsal root ganglion the first and second electrodes are configured for placement at least partially within a vertebral foramen containing the dorsal root ganglion to direct stimulation energy toward the central longitudinal axis, and

wherein at least one of the first and second distal ends are configured to move away from the central longitudinal axis while the first and second proximal ends are joined so as to allow the dorsal root ganglion to be positioned at least partially between the first and second distal ends to receive the stimulation energy that is directed by the first and second electrodes toward the central longitudinal axis.

2. A system as in claim 1, wherein the first and second elongate structures are slidably joinable.

3. A system as in claim 1, wherein the first distal end is movable by recoil force.

4. A system as in claim 1, wherein the first distal end is attachable to a first obturator which is capable of moving the first distal end.

5. A system as in claim 4, wherein the first obturator is configured to dissect tissue while it moves the first distal end.

6. A system as in claim 4, 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.

7. A system as in claim 1, wherein the first elongate structure and the second elongate structure comprise a dielectric film.

8. A system as in claim 7, wherein the first dielectric film and the second dielectric film has a thickness in the range of approximately 7.5 to 125 μ

m.

9. A system as in claim 7, wherein the first dielectric film and the second dielectric film has a thickness in the range of approximately 0.5-2 mils.

10. A system as in claim 1, further comprising:

a first contact pad and a first conductive trace extending from the first contact pad to the first electrode, a second contact pad and a second conductive trace extending from the second contact pad to the second electrode, wherein the first contact pad and the second contact pad provide electrical connection from the first electrode and the second electrode to an implantable pulse generator.

11. A system as in claim 1, wherein the distal ends are passable through a needle.

12. A system as in claim 1, wherein the first distal end of the first elongate structure includes at least one fold,

wherein the first distal end is configured to pass through a delivery device while in an unfolded position and

wherein the first distal end deploys upon release from the delivery device toward a folded position.

13. A system as in claim 12, wherein the second distal end includes at least one fold, wherein the second distal end is configured to pass through the delivery device while in an unfolded position and wherein the second distal end deploys upon release from the delivery device toward a folded position so that the first and second distal ends deploy by moving away from each other so as to at least partially surround the dorsal root ganglion.

14. A system as in claim 13, wherein the first and second distal ends move independently.

15. A system as in claim 13, wherein the deployed first and second distal ends together form a V-shape.

16. A system as in claim 12, wherein the first and second distal ends are configured to be passable through a needle prior to deployment.

17. A system as in claim 12, wherein the first inner surface faces away from the at least one fold.

18. A system as in claim 17, wherein the first proximal end has at least one contact pad, wherein the at least one contact pad is disposed on an opposite surface of the inner surface and faces the at least one fold.

19. A system as in claim 18, wherein the at least one fold is disposed between the first electrode and the at least one contact pad.

20. A system as in claim 1, wherein the at least one of the first and second distal ends are moveable away from the longitudinal axis by bending or curving.

21. A system as in claim 1, wherein the at least one of the first and second distal ends are moveable away from the longitudinal axis by folding.

22. A system as in claim 21, wherein the biocompatible conductive metal, alloy or combination includes gold, titanium, tungsten, titanium tungsten, titanium nitride, platinum, iridium or platinum-iridium alloy.

23. A system as in claim 1, wherein the first electrode or the second electrode is comprised of a biocompatible conductive metal, alloy or combination of these.