Apparatus and method for expanding a stimulation lead body in situ

• US 6,442,435 B2
• Filed: 05/21/2001
• Issued: 08/27/2002
• Est. Priority Date: 04/30/1998
• Status: Expired due to Fees

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Schendel, Michael J., Schallhorn, Richard, Rise, Mark T., King, Gary W.
• Primary Examiner(s): Evanisko, George R.
• Application Number:
  US09/862,104
• Publication Number:
  US 20010023367A1
• Time in Patent Office: 463 Days
• Field of Search: 607/116, 607/117, 607/119, 607/122
• US Class Current: 607/117
• CPC Class Codes: A61M 2209/045 for filling, e.g. for filling reservoirs
• CPC Class Codes: A61M 2210/0693 Brain, cerebrum
• CPC Class Codes: A61M 2210/1003 Spinal column
• CPC Class Codes: A61M 5/14276 specially adapted for implantation
• CPC Class Codes: A61M 5/1723 using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00
• CPC Class Codes: A61N 1/05 for implantation or insertion into the body, e.g. heart electrode A61N1/06 takes precedence
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/0558 Anchoring or fixation means therefor
• CPC Class Codes: A61N 1/056 Transvascular endocardial electrode systems

Abstract

An implantable lead is provided with at least one extendable member to position therapy delivery elements, which may be electrodes or drug delivery ports, after the lead has been inserted into the body. The lead may formed as a resilient element which is contained in a retainer tube that may be removed to permit the lead to deploy. Alternatively, a non-resilient lead may be provided with a slotted retainer tube. A series of mechanical linkages for expanding and retracting the lead within the human body may be actuated with various mechanisms. A control system may be provided for closed-loop feedback control of the position of the extendable members. The invention also includes a method for expanding an implantable lead in situ.

Claims

1. An implantable medical device comprising:

at least one implantable lead for providing delivery of therapy to a body comprising an elongate central portion having an axis, the implantable lead further comprising at least one extendable member having an end, the extendable member depending from the central portion and being adapted to assume a range of positions, including a compact position, in which the end is disposed in close proximity to the central portion, and an extended position, in which the end is disposed at a location distal from the central portion, the implantable lead further comprising at least one therapy delivery element disposed on the extendable member for delivering therapy to the body, and

means for position adjustment of the extendable member throughout the range of positions at any time in situ after surgical implant, wherein the means for position adjustment of the extendable member comprises a component operatively connected to the extendable member and adapted to be operatively connected to a needle passed through a patient'"'"'s skin to cause movement of the extendable member by one of movement of the needle or adjustment of a fluid inside the component using the needle.

2. The implantable medical device of claim 1, further comprising an inert and flexible film over a space between extendable members or between an extendable member and the elongate central portion.

3. The implantable medical device of claim 1 wherein the central portion has at least one part that rotates and wherein the rotation of the at least one part of the central portion that rotates results in a coiling or uncoiling of the extendable member around the central portion.

4. The implantable medical device according to claim 1, wherein the extendable member incorporates a resilient material to urge the extendable member towards the extended position.

5. The implantable medical device according to claim 1, further comprising a central passage in the central portion for accommodating a centering stylet to stabilize and center the implantable lead.

6. The implantable medical device according to claim 1, comprising two or more therapy delivery elements and wherein the extendable member is adapted to be folded in a manner that the therapy delivery elements are disposed one on top of the other in the compact position.

7. The implantable medical device according to claim 1, wherein the extendable member is formed as a series of telescoping elements.

8. The implantable medical device according to claim 7, wherein the telescoping elements are provided with therapy delivery elements thereon.

9. The implantable medical device according to claim 1, wherein the extendable member comprises a transverse extendable member adapted to bend to a compact position in which the extendable member extends in a direction substantially parallel to the axis of the central portion and wherein the extendable member is adapted to extend in an extended position at an angle of 90 degrees or less to the axis of the central portion, and the implantable medical device further includes a linkage assembly to cause movement of the extendable member.

10. The implantable lead of claim 9, wherein the transverse extendable member is resilient.

11. The implantable medical device of claim 1 wherein the component further comprises a linkage assembly comprising at least one actuating member operatively connected to the extendable member to cause movement of the extendable member with movement of the at least one actuating member.

12. The implantable medical device of claim 11 wherein the at least one actuating member moves in a direction substantially parallel to the axis of the central portion.

13. The implantable medical device of claim 11 wherein the linkage assembly further comprises a rack gear and a pinion gear, the rack gear being operatively connected to the at least one actuating member to cause movement of the extendable member.

14. The implantable medical device of claim 13 wherein the rack gear is operatively connected to the at least one actuating member and adapted to be operatively connected to a needle to move the at least one actuating member with movement of a needle adapted to be passed through the skin.

15. The implantable medical device of claim 11 wherein the linkage assembly further comprises a hydraulic cylinder, the hydraulic cylinder being operatively connected to the at least one actuating member to cause movement of the extendable member.

16. The implantable medical device of claim 15 wherein the hydraulic cylinder is operatively connected to the at least one actuating member and adapted to be operatively connected to the needle.

17. The implantable medical device of claim 11 wherein the linkage assembly further comprises a rotational shaft and gear mechanism operatively connected to the at least one actuating member to cause movement of the extendable member.

18. The implantable medical device of claim 17 wherein the rotational shaft is operatively connected to the at least one actuating member and adapted to be operatively connected to the needle to move the at least one actuating member with movement of a needle adapted to be passed through the skin.

19. The implantable medical device of claim 11, wherein the extendable member is formed as a series of telescoping elements.