Method of implanting a medical device including a fixation element

• US 20080132982A1
• Filed: 11/30/2006
• Published: 06/05/2008
• 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.
• Granted Patent: US 9,492,657 B2
• Time in Patent Office: Days
• US Class Current: 607/118
• 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 1/0539 Anchoring of brain electrode systems, e.g. within burr hole
• CPC Class Codes: A61N 1/0558 Anchoring or fixation means therefor

Abstract

A system comprises an implantable medical device and an actively deployable clip attached to the implantable medical device that restricts movement of the implantable medical device once the clip is deployed within a body of a patient. In one embodiment, the implantable medical device is a lead and a clip that includes electrically conductive portion is an electrode of the lead. 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 method comprising:

introducing an implantable medical device into a body of a patient;

guiding the implantable medical device to a target tissue site proximate to at least one of an occipital nerve or a trigeminal nerve within the body of the patient; and

actively deploying a fixation element attached to the implantable medical device, 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.

2. The method of claim 1, wherein the implantable medical device comprises an elongated body extending between a proximal end and a distal end, and the method further comprises:

tunneling the proximal end of the elongated body to a therapy delivery source implant site within the patient.

3. The method of claim 1, further comprising:

positioning the fixation element with respect to the at least one of the occipital nerve or the trigeminal nerve such that when the fixation element deploys to the second shape, the fixation element wraps around at least a portion of the at least one of the occipital nerve or the trigeminal nerve.

4. The method of claim 1, wherein actively deploying a fixation element comprises releasing the fixation element from a retainer for deployment to the second shape.

5. The method of claim 4, wherein releasing the fixation element from the retainer comprises withdrawing a sheath or introducer needle from around the fixation element.

6. The method of claim 4, 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 a seam breaker member to break the frangible seam.

7. The method of claim 1, wherein guiding the implantable medical device to the target tissue site comprises positioning the implantable medical device within subcutaneous tissue of the patient superior to the at least one of the occipital nerve or the trigeminal nerve.

8. The method of claim 1, wherein introducing the implantable medical device into the body of the patient comprises:

introducing an introducer needle into the body of the patient superior to a fascia layer; and

introducing the implantable medical device into a lumen of the introducer needle.

9. The method of claim 1, wherein the implantable medical device comprises at least one of a lead comprising at least one electrode or a catheter.

10. The method of claim 1, wherein the implantable medical device comprises an implantable medical lead, and the method further comprises coupling an electrical stimulation generator to the implantable medical lead.

11. The method of claim 1, wherein the implantable medical device comprises an implantable medical lead comprising at least a first electrode and a second electrode, and the method further comprises positioning the first electrode proximate to a first branch of the at least one of the occipital or trigeminal nerves and positioning the second electrode proximate to a second branch of the at least one of the occipital or trigeminal nerves.

12. The method of claim 1, wherein the implantable medical device is a first implantable medical device, the target tissue site is a first target tissue site, and the fixation element is a first fixation element, the method further comprising:

introducing a second implantable medical device into the body of the patient;

guiding the second implantable medical device to a second target tissue site on an opposite side of a midline of the patient; and

actively deploying a second fixation element attached to the second implantable medical device, wherein the fixation element is actively deployable from a third shape to a fourth shape to resist substantial movement of the second implantable medical device from the second target tissue site.

13. The method of claim 1, wherein the second shape is a substantially curvilinear shape.

14. The method of claim 1, wherein the fixation element comprises a first fixation element, the method further comprising deploying a second fixation element attached to a portion of the implantable medical device more proximate than the first fixation element.

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

16. The method of claim 1, wherein the fixation element comprises an electrically conductive portion configured to at least one of deliver electrical stimulation to the target tissue site or sense a physiological parameter from the target tissue site.

17. A method comprising:

introducing an implantable medical device into a body of a patient;

guiding the implantable medical device to a subcutaneous tissue site proximate to at least one of an occipital nerve or a trigeminal nerve within the body of the patient; and

actively deploying a fixation element coupled to the implantable medical device, the fixation element comprising an electrically conductive portion electrically coupled to an electrical conductor disposed within the implantable medical device and configured to deliver electrical stimulation from an electrical stimulation generator to 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 lead body from the tissue site.

18. The method of claim 17, wherein the electrical stimulation generator is located within the implantable medical device.

19. A method comprising:

introducing an implantable medical lead into a body of a patient;

guiding the implantable medical lead to a target tissue site proximate to at least one of an occipital nerve or a trigeminal nerve within the body of the patient; and

actively deploying a fixation element coupled to the lead, the fixation element comprising an electrically conductive portion electrically coupled to an electrical conductor disposed within the lead configured to at least one of deliver electrical stimulation to the target tissue site 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 lead body from the target tissue.

20. The method of claim 19, wherein the portion of the fixation element is a cuff electrode configured to wrap around the at least one of the occipital nerve or the trigeminal nerve of the patient.