Techniques for positioning therapy delivery elements within a spinal cord or brain

• US 7,191,018 B2
• Filed: 06/30/2004
• Issued: 03/13/2007
• Est. Priority Date: 04/30/1998
• Status: Expired due to Fees

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Rise, Mark T., King, Gary W., Schendel, Michael, Starkebaum, Warren, Petersen, Daryle, Gielen, Frans
• Primary Examiner(s): LAYNO, CARL HERNANDZ
• Application Number:
  US10/881,239
• Publication Number:
  US 20040236388A1
• Time in Patent Office: 986 Days
• Field of Search: 607116-117, 607119-120, 607122-123, 607125-126, 607128-130
• US Class Current: 607/129
• 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 1/0531 Brain cortex electrodes
• CPC Class Codes: A61N 1/0534 Electrodes for deep brain stimulation
• CPC Class Codes: A61N 1/0539 Anchoring of brain electrode systems, e.g. within burr hole
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/0553 Paddle shaped electrodes, e.g. for laminotomy
• CPC Class Codes: A61N 1/0558 Anchoring or fixation means therefor
• CPC Class Codes: A61N 1/056 Transvascular endocardial electrode systems
• CPC Class Codes: A61N 1/36071 Pain

Abstract

Apparatus and techniques to address the problems associated with lead migration, patient movement or position, histological changes, neural plasticity or disease progression. Disclosed are techniques for implanting a lead having therapy delivery elements, such as electrodes or drug delivery ports, within a vertebral or cranial bone so as to maintain these elements in a fixed position relative to a desired treatment site. The therapy delivery elements may thereafter be adjusted in situ with a position control mechanism and/or a position controller to improve the desired treatment, such as_electrical stimulation and/or drug infusion to a precise target. The therapy delivery elements may be positioned laterally in any direction relative to the targeted treatment site or toward or away from the targeted treatment site. A control system maybe provided for open- or closed-loop feedback control of the position of the therapy delivery elements as well as other aspects of the treatment therapy.

Claims

1. An implantable paddle lead for providing therapy to targeted tissue comprising:

an elongate central portion having a head and an elongate body;

at least one extendable member having an end, the extendable member comprising a movable lateral wing, the extendable member depending from the elongate body of the central portion and being adapted to assume a first position in which the end is disposed in close proximity to the body of the central portion, and a second position, in which the end is disposed from the body of the central portion by the moveable lateral wing, the moveable lateral wing defining a paddle surface; and

at least one therapy delivery element disposed on the elongate central portion and at least one therapy delivery element disposed on the paddle surface for delivering therapy to the targeted tissue.

2. The implantable paddle lead according to claim 1, wherein the extendable member may be extended outwardly from the body of the central portion to position the therapy delivery element toward or away from the targeted tissue.

3. The implantable paddle lead according to claim 1, further comprising a stylet to adjust an extent and/or angle of lateral displacement of the wing from the body of the central portion.

4. The implantable paddle lead according to claim 1, further comprising a stylet to adjust a length of the wing depending from the body of the central portion.

5. The implantable paddle lead according to claim 1, wherein each of the therapy delivery elements disposed on the elongate central portion and the paddle surface comprises an electrode.

6. The implantable paddle lead according to claim 5, wherein the electrode disposed on the paddle surface comprises a recording microelectrode adapted to assist in the placement of the lead at a particular site within a patient.

7. The implantable paddle lead according to claim 1, wherein at least one therapy delivery element disposed on the elongate central portion or the paddle surface comprises a drug infusion section.

8. The implantable paddle lead according to claim 7, wherein each of the therapy delivery elements further comprises an electrode.

9. The implantable paddle lead according to claim 8, wherein at least one electrode comprises a recording microelectrode adapted to assist in the placement of the lead at a particular site within a patient.

10. The implantable paddle lead according to claim 1, comprising means for adjusting the extent to which the extendable member depends from the body of the central portion.

11. A system for providing neurostimulation therapy to targeted tissue comprising in combination:

an implantable paddle lead for providing therapy to a body comprising an elongate central portion having a head and an elongate body, at least one extendable member having an end, the extendable member comprising a movable lateral wing, the extendable member depending from the elongate body of the central portion and being adapted to assume a first position, in which the end is disposed in close proximity to the body of the central portion, and a second position, in which the end is disposed laterally from the body of the central portion by the moveable lateral wing, the moveable lateral wing defining a paddle surface, and at least one electrode disposed on the central portion and at least one therapy delivery element disposed on the paddle surface for providing electrical stimulation to the targeted tissue; and

a signal generator electrically coupled to the electrodes of the implantable paddle lead.

12. The system according to claim 11, further comprising a stylet to adjust an extent and/or angle of lateral displacement of the wing from the body of the central portion.

13. The system according to claim 11, wherein at least one electrode comprises a recording microelectrode adapted to assist in the placement of the lead at a particular site within a patient.

14. A system for providing drug therapy to targeted tissue comprising in combination:

an implantable paddle lead for providing therapy to a body comprising an elongate central portion having a head and a body, at least one extendable member having an end, the extendable member comprising a movable lateral wing, the extendable member depending from the body of the central portion and being adapted to assume a first position, in which the end is disposed in close proximity to the body of the central portion, and a second position, in which the end is disposed laterally from the body of the central portion by the moveable lateral wing, and at least drug infusion section disposed on the extendable member for delivering a drug to the targeted tissue; and

and a pump fluidly coupled to the drug infusion section of the implantable paddle lead.

15. The system according to claim 14, further comprising a stylet to adjust an extent and/or angle of lateral displacement of the wing from the body of the central portion.

16. A method for providing treatment therapy to neural tissue in the brain comprising the steps of:

(a) implanting a paddle lead, the paddle lead comprising a movable lateral wing, the movable lateral wing comprising at least one therapy delivery element;

(b) coupling the therapy delivery element to a therapy delivery device;

(c) operating the therapy delivery device to provide treatment therapy to the targeted tissue via the implanted therapy delivery element; and

(d) adjusting, at any time after the step of implanting, the position of the implanted therapy delivery element relative to neural tissue in the brain by moving the lateral wing.

17. The method as claimed in claim 16, wherein the therapy delivery device comprises a signal generator and the therapy delivery element comprises an electrode.

18. The method as claimed in claim 16, wherein the therapy delivery device comprises a pump and the therapy delivery element comprises a drug infusion section.

19. The method as claimed in claim 16, wherein the step of adjusting includes the step of sensing a condition of a response to the treatment therapy and the step of adjusting is performed in response to the step of sensing.

20. The method as claimed in claim 19, further comprising the steps of:

(e) sensing a symptom indicative of a condition to be treated and generating a sensor signal; and

(f) regulating the operation of the therapy delivery device in response to the sensor signal.

21. The method as claimed in claim 16, further comprising the steps of:

(e) sensing a symptom indicative of a condition to be treated and generating a sensor signal; and

(f) regulating the operation of the therapy delivery device in response to the sensor signal.

22. An implantable paddle lead comprising:

an elongate central portion having a head and an elongate body, the elongate body comprising a first paddle surface;

at least two first and second movable wings, each wing having an end, the wings depending from the elongate body of the central portion and being adapted to assume a first position, in which the ends of the wings are disposed in close proximity to the body of the central portion, and a second position, in which the ends of the wings are disposed laterally from the body of the central portion in generally opposite lateral directions to form a paddle, each moveable lateral wing defining a wing paddle surface; and

at least one electrode disposed on each paddle surface of the elongate body and each wing for delivering stimulation to targeted tissue.

23. The implantable paddle lead according to claim 22, wherein the wings may be extended outwardly from the body of the central portion to position the electrodes disposed on the each wing toward or away from the targeted tissue.

24. The implantable paddle lead according to claim 23, further comprising a stylet to adjust an extent and/or angle of lateral displacement of the wing from the body of the central portion.

25. The implantable paddle lead according to claim 23, further comprising a stylet to adjust a length of the wing depending from the body of the central portion.

26. The implantable paddle lead according to claim 23, wherein at least one electrode on at least one wing comprises a recording electrode.

27. The implantable paddle lead according to claim 23, comprising means for adjusting the extent to which the extendable member depends from the body of the central portion.