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

• US 6,319,241 B1
• Filed: 04/30/1999
• Issued: 11/20/2001
• 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, Gielen, Frans, Petersen, Daryle
• Primary Examiner(s): Seidel, Richard K.
• Assistant Examiner(s): Hayes, Michael J
• Application Number:
  US09/303,145
• Time in Patent Office: 935 Days
• Field of Search: 604/20-22, 604/31, 604/93, 604/65-67, 604/500, 604/95.01, 604/502-505, 604/890--89, 607/62, 607/116-118, 607/46, 600/372, 600/373, 600/377, 600/378, 128/898, 128/899
• US Class Current: 604/502
• 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

The present invention addresses the problems associated with lead migration, patient movement or position, histological changes, neural plasticity or disease progression. The present invention discloses 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 therapy. The present invention also discloses techniques for non-invasively positioning and re-positioning therapy delivery elements after implant to provide electrical stimulation and/or drug infusion to a precise target. A position control mechanism and/or a position controller are provided for adjusting in situ the position of the therapy delivery elements relative to the targeted tissue of interest. 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 may be 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. A method for providing treatment therapy to a targeted tissue of a patient by means of a therapy delivery device and at least one therapy delivery element coupled to the therapy delivery device, the method comprising the steps of:

(a) implanting in a patient at least one lead having at least one therapy delivery element so that the therapy delivery element lies near the targeted tissue;

(b) coupling a proximal end of the lead to th e impl anted th erapy delivery device;

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

(d) closing all incisions made to implant the therapy delivery device so that the therapy delivery device is completely implanted in the patient; and

(e) adjusting, at any time after the step of closing all incisions, the position of at least one implanted therapy delivery element relative to the targeted tissue.

2. A method as claimed in claim 1, wherein the targeted tissue is neural tissue.

3. A method as claimed in claim 2, wherein the neural tissue is in the spinal cord.

4. A method as claimed in claim 2, wherein the neural tissue is in the brain.

5. A method as claimed in claim 1, wherein the targeted tissue is neural ganglia.

6. A method as claimed in claim 1, wherein the targeted tissue is muscle tissue.

7. A method as claimed in claim 1, wherein the therapy delivery device is a signal generator and the therapy delivery element is an electrode.

8. A method as claimed in claim 7, wherein the step of adjusting includes the step of positioning the electrode laterally from the lead.

9. A method as claimed in claim 7, wherein the step of adjusting includes the step of positioning the electrode from the lead toward or away the targeted tissue.

10. A method as claimed in claim 1, wherein the therapy delivery device is a pump and the therapy delivery element is a catheter.

11. A method as claimed in claim 1, 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.

12. The method as claimed in claim 11, further comprising the steps of:

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

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

13. The method as claimed in claim 1, further comprising the steps of:

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

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