Implantable medical device including a conductive fixation element

• US 7,765,012 B2
• Filed: 11/30/2006
• Issued: 07/27/2010
• Est. Priority Date: 11/30/2006
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Gerber, Martin T.
• Primary Examiner(s): MANUEL, GEORGE C
• Application Number:
  US11/606,626
• Publication Number:
  US 20080132981A1
• Time in Patent Office: 1,335 Days
• Field of Search: 607116-118
• US Class Current: 607/116
• CPC Class Codes: A61N 1/0534 Electrodes for deep brain stimulation
• CPC Class Codes: A61N 1/0536 Preventing neurodegenerative response or inflammatory reaction
• CPC Class Codes: A61N 1/0558 Anchoring or fixation means therefor
• CPC Class Codes: A61N 1/36082 Cognitive or psychiatric applications, e.g. dementia or Alzheimer's disease

Abstract

A system comprises an implantable medical device and an actively deployable clip attached to the implantable medical device to restrict movement of the implantable medical device once the clip is deployed within a body of a patient. The clip includes an electrically conductive portion. The implantable medical device may be implanted proximate to any suitable tissue site within the patient, and in one embodiment, the implantable medical device is implanted proximate to an occipital nerve or a trigeminal nerve of the patient.

Claims

1. A system comprising:

an implantable medical device defining a longitudinal outer surface;

a stimulation electrode extending at least partially around the longitudinal outer surface of the implantable medical device; and

a wire fixation element disposed along the longitudinal outer surface of the implantable medical device, wherein only a portion of the fixation element is electrically conductive, the portion being configured to at least one of deliver electrical stimulation to a target tissue site within a patient or sense a physiological parameter from the target tissue site, wherein the fixation element is actively deployable from a first shape to a second shape to resist substantial movement of the implantable medical device from the target tissue site, and wherein the stimulation electrode and the portion of the fixation element are configured to be activated independent of one another.

2. The system of claim 1, wherein the second shape has an outermost dimension of at least about two millimeters.

3. The system of claim 2, wherein the outermost dimension of the second shape is between about two millimeters and about five millimeters.

4. The system of claim 1, further comprising a retainer that retains the fixation element in the first shape, wherein the retainer releases the fixation element for deployment to the second shape in response to manipulation of the retainer.

5. The system of claim 4, wherein the retainer is at least one of a sheath or a device defining a cavity configured to receive the fixation element, the device comprising a frangible seam covering the cavity and a seam breaker member at least partially embedded in the frangible seam.

6. The system of claim 1, wherein the first shape is a substantially straight shape.

7. The system of claim 1, wherein the second shape is a substantially curvilinear shape.

8. The system of claim 7, wherein the second shape is a spiral shape.

9. The system of claim 1, wherein the stimulation electrode comprises a first stimulation electrode and the implantable medical device is a lead comprising at least the first stimulation electrode, and wherein at least a portion of the electrically conductive portion of the fixation element is a second stimulation electrode of the lead.

10. The system of claim 9, wherein the second stimulation electrode is a cuff electrode configured to wrap around at least one of an occipital nerve or a trigeminal nerve of the patient.

11. The system of claim 9, further comprising an electrical stimulation generator coupled to the lead, the fixation element being configured to deliver electrical stimulation from the electrical stimulation generator to the tissue site within the patient.

12. The system of claim 9, wherein the fixation element comprises a first fixation element located between the distal end of the lead and the first stimulation electrode, the system further comprising a second fixation element located between a proximal end of the lead and the first stimulation electrode.

13. The system of claim 9, wherein the lead further comprises a third stimulation electrode adjacent to the first stimulation electrode, the third stimulation electrode extending at least partially around the longitudinal outer surface of the lead body, wherein the fixation element is located between the first and third stimulation electrodes.

14. The system of claim 1, wherein the fixation element is attached to a distal end of the implantable medical device.

15. The system of claim 1, wherein the fixation element comprises one of an elastic material or a shape memory material.

16. The system of claim 1, wherein the implantable medical device comprises an electrical stimulation generator.

17. The system of claim 1, wherein the longitudinal outer surface of the implantable medical device is round and the electrode extends at least partially around a circumference of the longitudinal outer surface.

18. The system of claim 1, wherein the stimulation electrode comprises at least one or a ring electrode, a partial ring electrode or a segmented electrode.

19. The system of claim 1, wherein the implantable medical device comprises a lead body comprising a substantially flat paddle-like shape comprising first and second opposing major surfaces, wherein the stimulation electrode and the wire fixation element are disposed on one of the first or second major surfaces.

20. The system of claim 19, wherein the fixation element comprises a first fixation element disposed along the first major surface of the substantially flat paddle-like lead body between the distal end and the stimulation electrode, the system further comprising a second fixation element disposed along the second major surface of the substantially flat paddle-like lead body.

21. The system of claim 19, wherein the fixation element is attached to a distal end of the substantially flat paddle-like lead body.

22. A medical lead comprising:

a lead body defining a longitudinal outer surface;

an electrical conductor disposed within the lead body;

a stimulation electrode extending at least partially around the longitudinal outer surface of the lead body; and

a wire fixation element, wherein only a portion of the wire fixation element is electrically conductive, the portion being electrically coupled to the electrical conductor and disposed along the longitudinal outer surface of the lead body, wherein the fixation element is actively deployable from a first shape to a second shape to resist substantial movement of the lead body from a target therapy delivery site in a patient, and wherein the stimulation electrode and the portion of the fixation element are configured to be activated independent of one another.

23. The medical lead of claim 22, wherein the fixation element is a first electrode and the stimulation electrode comprises a second electrode carried by the lead body.

24. The medical lead of claim 23, wherein the fixation element comprises a first fixation element located distal to the second electrode and the medical lead further comprises a second fixation element located proximal to the second electrode.

25. The medical lead of claim 23, wherein at least one of the first or second electrodes is a sensing electrode.

26. The medical lead of claim 22, wherein the second shape is a substantially curvilinear shape.

27. The medical lead of claim 22, wherein the portion of the fixation element is a cuff electrode configured to wrap around a peripheral nerve of a patient.

28. The medical lead of claim 27, wherein the peripheral nerve at least one of an occipital nerve or a trigeminal nerve of the patient.

29. A method comprising:

implanting an implantable medical device in a body of a patient, the implantable medical device defining a longitudinal outer surface and comprising a stimulation electrode extending at least partially around the longitudinal outer surface; and

actively deploying a wire fixation element disposed along the longitudinal outer surface of the implantable medical device, wherein only a portion of the fixation element is electrically conductive, the portion being configured to at least one of deliver electrical stimulation to a target tissue site within the body of the patient or sense a physiological parameter from the target tissue site, wherein the fixation element is actively deployable from a first shape to a second shape to resist substantial movement of the implantable medical device from the target tissue site, and wherein the stimulation electrode and the electrically conductive portion or the fixation element are configured to be activated independent of one another.

30. The method of claim 29, further comprising releasing the fixation element from a retainer for deployment to the second shape.

31. The method of claim 30, wherein releasing the fixation element from the retainer comprises withdrawing a sheath from around the fixation element.

32. The method of claim 30, wherein the retainer defines a cavity and the retainer comprises:

a frangible seam covering the cavity; and

a seam breaker member at least partially embedded in the frangible seam, the fixation element being disposed within the cavity,

wherein releasing the fixation element from the retainer comprises pulling the seam breaker member to break the frangible seam.

33. The method of claim 29, wherein the stimulation electrode comprises a first stimulation electrode and the implantable medical device comprises a lead comprising at least the first stimulation electrode, wherein the fixation element is a second stimulation electrode of the lead.

34. The method of claim 29, further comprising positioning the fixation element with respect to a nerve of a patient such that when the fixation element deploys to the second shape, the fixation element wraps around at least a portion of the nerve.

35. A system comprising:

an implantable medical device defining an outer surface;

a stimulation electrode extending at least partially around the outer surface of the implantable medical device; and

a fixation element coupled to the implantable medical device, the fixation element comprising an electrically conductive portion configured to at least one of deliver electrical stimulation to a target tissue site within a patient or sense a physiological parameter from the target tissue site,

wherein the fixation element is actively deployable from a first shape to a second shape to resist substantial movement of the implantable medical device from the target tissue site, and

wherein the first shape is a substantially straight shape and the fixation element does not protrude past the outer surface of the implantable medical device when deployed to the second shape.