Implantable medical elongated member with in situ formed fixation element

• US 20080103578A1
• Filed: 10/31/2006
• Published: 05/01/2008
• Est. Priority Date: 10/31/2006
• Status: Abandoned Application

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Gerber, Martin T.
• Application Number:
  US11/591,433
• Publication Number:
  US 20080103578A1
• Time in Patent Office: Days
• US Class Current: 607/149
• 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
• CPC Class Codes: A61N 1/057 Anchoring means; Means for fixing the head inside the heart

Abstract

An implanted elongated member, e.g., a medical lead or catheter, includes one or more conduits that deliver a solidifying substance to an outer surface of the distal portion of the elongated member via one or more exit ports. The solidifying substance is cured in situ from moisture in the surrounding tissue, UV light or some other curing method. The solidifying substance helps secure the elongated member to a target tissue site. The solidifying substance may form fixation structures that extend away from the elongated member, form an adhesive bond between the elongated member and the tissue, or inflate a balloon element that that engages with the adjacent tissue.

Claims

1. An apparatus comprising:

an elongated member having a proximal end and a distal end;

at least one electrode disposed closer to the distal end of the elongated member than the proximal end of the elongated member;

at least one exit port defined by a longitudinal outer surface of the elongated body;

at least one conduit within the elongated member that is in fluid communication with the at least one exit port; and

a solidifying substance delivered by the at least one conduit to tissue within a patient, the solidifying substance extending outward from the at least one exit port of the elongated body to form a fixation element.

2. The apparatus of claim 1, wherein the tissue comprises a first tissue, the first tissue being proximate to a second tissue, and wherein the second tissue is a therapy delivery site.

3. The apparatus of claim 1, wherein the longitudinal outer surface of the elongated member defines multiple exit ports disposed at a plurality of locations along the longitudinal outer surface of the elongated member, and wherein the at least one conduit is in fluidic communication with at least two of the multiple exit ports.

4. The apparatus of claim 3 wherein the multiple exit ports are disposed at several locations around a circumference of the longitudinal outer surface of the elongated member.

5. The apparatus of claim 1, wherein the at least one exit port comprise a first exit port located between the at least one electrode and the proximal end of the elongated member, and a second exit port located between the at least one electrode and the distal end of the elongated member.

6. The apparatus of claim 1, wherein the at least one electrode comprises an array of electrodes, and wherein the at least one exit port is located between two electrodes of the array of electrodes.

7. The apparatus of claim 1, wherein the solidifying substance is an adhesive that secures the elongated member to the tissue of the patient.

8. The apparatus of claim 7 wherein the adhesive is at least one of a cyanoacrylate or a fibrin glue that cures upon exposure to moisture.

9. The apparatus of claim 1, wherein the solidifying substance forms a fixation structure extending away from the exit port.

10. The apparatus of claim 1, further comprising a balloon element mounted to the elongated member, wherein the balloon element covers the at least one exit port.

11. The apparatus of claim 10, wherein the solidifying substance inflates the balloon element.

12. The apparatus of claim 11, wherein the balloon element is formed to define a predetermined shape within the tissue once inflated by the solidifying substance.

13. The apparatus of claim 1, wherein the solidifying substance comprises a first fluid and a second fluid that are combined near the at least one exit port to solidify outside of the elongated member.

14. The apparatus of claim 13, wherein the conduit comprises a first conduit to deliver the first fluid and a second conduit to deliver the second fluid.

15. The apparatus of claim 1, wherein the solidifying substance is cured by energy delivered to the solidifying substance through the at least one conduit within the elongated member.

16. The apparatus of claim 1, wherein the solidifying substance is liquefied by energy delivered to the solidifying substance through the at least one conduit within the elongated member.

17. A method comprising:

inserting an elongated member into a patient, wherein the elongated member comprises at least one exit port defined by a longitudinal outer surface of the elongated member, and at least one conduit within the elongated member that is in fluidic communication with the at least one exit port;

positioning the elongated member adjacent to a tissue of the patient; and

delivering a solidifying substance to the at least one exit port via the at least one conduit, wherein the solidifying substance interfaces with the tissue through the at least one exit port.

18. The method of claim 17, wherein upon delivering the solidifying substance to the at least one exit port via the at least one conduit, the solidifying substance interfaces with the tissue at multiple locations along the longitudinal outer surface of the elongated member.

19. The method of claim 18, wherein the multiple locations are located around a circumference of the longitudinal outer surface of the elongated member.

20. The method of claim 17, further comprising curing the solidifying substance to adhere the elongated member to the tissue of the patient.

21. The method of claim 17, further comprising forming at least one fixation structure with the solidifying substance, the at least one fixation structure extending away from the at least one exit port.

22. The method of claim 17, further comprising inflating at least one balloon element covering the at least one exit port with the solidifying substance into a shape that secures the elongated member to the tissue of the patient.

23. The method of claim 17, wherein the solidifying substance comprises a first fluid and a second fluid, the method further comprising curing the solidifying substance via one of interaction between the first fluid and the second fluid or delivering energy to the first and second fluids through the at least one conduit within the elongated member.

24. The method of claim 17, further comprising liquefying the solidifying substance via delivering energy to the solidifying substance through the at least one conduit within the elongated member.

25. The method of claim 17, wherein the tissue is at least one of a sacral nerve, a pudendal nerve, a spinal cord, and an occipital nerve.

26. The method of claim 17, wherein inserting the elongated member into the patient comprises introducing an introducer proximate to a peripheral nerve of the patient.

27. The method of claim 26, wherein inserting the introducer proximate to the peripheral nerve comprises positioning the introducer substantially transversely across an occipital nerve.

28. The method of claim 17, wherein the elongated member comprises at least one of a lead comprising an electrode or a catheter.

29. The method of claim 17, further comprising coupling the elongated member to a medical device, the medical device delivering a therapy to the tissue via the elongated member.

30. The method of claim 29, wherein the medical device is at least one of a neurostimulator, a sensor or a fluid delivery device.

31. The method of claim 17, further comprising explanting the elongated member from the tissue of the patient by disengaging the solidifying substance from the tissue.

32. The method of claim 31, wherein disengaging the solidifying substance from the tissue comprises introducing a solvent into the conduit to liquefy or soften the solidifying material.

33. A system comprising:

a medical lead comprising;

an elongated member having a proximal end and a distal end and a longitudinal outer surface that defines at least one exit port;

at least one stimulation electrode disposed closer to the distal end than the proximal end;

at least one conduit within the elongate member that is in fluidic communication with the at least one exit port; and

a solidifying substance delivered by the at least one conduit to tissue within a patient, the solidifying substance extending outward from the at least one exit port of the elongated body to form a fixation element; and

an electrical stimulator that delivers electrical stimulation therapy to a patient via the at least one stimulation electrode of the medical lead.

34. The system of claim 33, wherein one of the at least one conduits is in fluidic communication with multiple exit ports disposed at several locations around a circumference of the longitudinal outer surface of the elongated member, and wherein the solidifying substance is an adhesive that secures the medical lead to the tissue of the patient.

35. The system of claim 33, wherein the solidifying substance forms a fixation structure extending away from the at least one exit port.

36. The system of claim 33, further comprising at least one balloon element mounted to the lead body that covers the at least one exit port, wherein the solidifying substance inflates the at least one balloon element.

37. A system comprising:

a medical lead comprising;

an elongated member having a proximal end and a distal end;

at least one exit port defined by a circumferential outer surface of the elongated body; and

at least one conduit within the elongated member that is in fluid communication with the at least one exit port; and

a fluid delivery device in fluid communication with the at least one conduit that delivers a solidifying substance to tissue within a patient such that the solidifying substance extends outward from the longitudinal outer surface of the elongated member to form a fixation element.

38. The system of claim 37, wherein the medical lead further comprises at least one electrode disposed closer to the distal end than the proximal end.

39. The system of claim 37, wherein the medical lead further comprises a therapy conduit within the elongated member that delivers at least one of a pharmaceutical agent, insulin, a pain relieving agent or a gene therapy agent to a target tissue of the patient.

40. The apparatus of claim 37, wherein the solidifying substance is an adhesive that secures the elongated member to the tissue of the patient.

41. The apparatus of claim 37, wherein the solidifying substance forms a fixation structure extending away from the exit port that secures the elongated member to the tissue of the patient.

42. The apparatus of claim 37, further comprising a balloon element mounted to the elongated member to cover the exit port, wherein the solidifying substances inflates the balloon element.