Deployable medical lead fixation system and method

• US 20040059404A1
• Filed: 09/24/2002
• Published: 03/25/2004
• Est. Priority Date: 09/24/2002
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Sommer, John L., Lokhoff, Nicolaas M., Hess, Douglas N., Love, Charles J., Hine, Douglas S., Bjorklund, Vicki L.
• Granted Patent: US 7,107,105 B2
• Time in Patent Office: Days
• US Class Current: 607/126
• CPC Class Codes: A61N 1/056 Transvascular endocardial electrode systems
• CPC Class Codes: A61N 1/057 Anchoring means; Means for fixing the head inside the heart
• CPC Class Codes: A61N 2001/058 Fixing tools

Abstract

An improved medical lead assembly and method of use is provided. The lead assembly includes a lead body, and a spring member positioned adjacent to the lead body. The spring member may be deployed a selectable amount to maintain the lead body in a fixed location within a patient'"'"'s body. The spring member may be an expandable coil, a mesh structure that is similar to a stent, or any other similar device that may be positioned in a low-profile state during a lead implant procedure. After the lead is positioned at a target destination, the spring member may be deployed an amount that is selected based on the characteristics of the surrounding tissue, including vessel size. According to one aspect of the invention, the lead assembly may provide means for facilitating chronic lead extraction.

Claims

1. A lead assembly for implanting within a body, comprising:

a lead body; and

a spring member adjacent to the lead body, the spring member selectively deployable in one of a first deployed state maintaining the lead body in a fixed location relative to the body, and a second deployed state enabling passage of the lead body within the body.

2. The lead assembly of claim 1, wherein the spring member is an expandable coil.

3. The lead assembly of claim 1, wherein the spring member is an expandable mesh.

4. The lead assembly of claim 1, wherein the spring member includes a proximal and a distal end, and further including a collar slidably engaging the lead body and being coupled to any one of the proximal and the distal end of the spring member, the collar adapted to be positioned at a selected location along the lead body to deploy spring member a selectable amount.

5. The lead assembly of claim 2. wherein a portion of spring member is affixed to the lead body, and further including a tubular member coupled to the spring member and slidably engaging the lead body, the tubular member being positionable relative to the lead body to deploy spring member a selectable amount.

6. The lead assembly of claim 5, and further including a removable fixation member to maintain the tubular member at a desired position relative to the lead body.

7. The lead assembly of claim 5, wherein the spring member includes multiple weakened joints each being designed to fracture when sufficient force is exerted on the tubular member, whereby the spring member is separated from the lead assembly.

8. The lead assembly of claim 1, wherein at least a portion of the spring member is formed of a conductive material to serve as an electrode.

9. The lead assembly of claim 1, wherein the spring member is formed, at least in part, of a fluorovisible material.

10. The lead assembly of claim 4, wherein the spring member includes a lumen adapted to receive a stiffening member, the collar being positionable along the portion of the lead body by advancing the stiffening member within the lumen.

11. The lead assembly of claim 4, wherein the collar is coupled to the proximal end of the spring member, and wherein the collar may be moved in a proximal direction relative to the lead body a selectable amount to deploy the spring member.

12. The lead assembly of claim 1, wherein the lead body includes a lumen to receive a stiffening member.

13. The lead assembly of claim 12, wherein the lead body includes a distal end carrying a tip electrode.

14. The lead assembly of claim 1, and further including a tubular member slidably engaging at least a portion of the lead body, and being positionable relative to at least a portion of spring member to maintain the spring member in an unexpanded state.

15. The lead assembly of claim 14, wherein the tubular member may be repositioned relative to the lead body and to the spring member to deploy spring member a selectable amount.

16. The lead assembly of claim 15, and further including a coupling member to maintain tubular member in a desired positioned relative to the lead body.

17. The lead assembly of claim 16, and further including a stopper to restrict movement of the tubular member relative to the lead body.

18. The lead assembly of claim 16, wherein the tubular member may be positioned relative to the lead body and to the spring member to allow spring member to be released from the lead assembly into the body.

19. The lead assembly of claim 5, and further including an extraction device positioned adjacent to the tubular member to deliver energy to tissue affixed to the spring member during chronic removal of the lead assembly.

20. The lead assembly of claim 1, and further including a rotating member rotatably mounted to the lead body and coupled to the spring member, and wherein spring member is deployed by rotating the rotating member a selectable amount relative to the lead body.

21. The lead assembly of claim 20, wherein the spring member is adapted to be wound around, and in relatively close proximity to, the lead body when the spring member is not deployed.

22. A method of positioning a lead assembly within a body, comprising the steps of:

deploying a selectably deployable spring member, located adjacent to and coupled to a lead body of the lead assembly, in a first deployed state enabling passage of the lead assembly within the body;

advancing the lead body to a target location in the body while the spring member is deployed in the first deployed state; and

selectively deploying the spring member in a second deployed state maintaining the lead body at the target location.

23. The method of claim 22, wherein the step of advancing further comprises the step of advancing the lead body through a lumen of a guide catheter.

24. The method of claim 22, wherein the lead body includes a lumen and wherein the step of advancing further comprises the steps of:

inserting a guiding device into the lumen; and

advancing the lead body over the guiding device.

25. The method of claim 24, wherein the lumen extends through a distal end of the lead body, and wherein the lead body is advanced over a guidewire.

26. The method of claim 22, wherein the lead assembly further includes a tubular member slidably engaging the lead body and being coupled to the spring member, and wherein the step of selectively deploying further comprises the step of positioning the tubular member at a selectable positioned relative to the lead body.

27. The method of claim 26, wherein the step of selectively deploying further comprises the step of maintaining the tubular member at a desired position relative to the lead body using a fixation device.

28. The method of claim 27, further comprising the step of detaching the spring member from the lead assembly along a weakened joint of the spring member during a chronic lead removal procedure.

29. The method of claim 22, further comprising the step of delivering an electrical signal to the body through at least a portion of the spring member.

30. The method of claim 22, further comprising the step of viewing at least a portion of the lead assembly under a fluoroscope to determine an amount to deploy the spring member.

31. The method of claim 22, wherein the step of advancing further comprises advancing a stiffening member within a lumen of the spring member.

32. The method of claim 22, wherein the spring member is coupled to a collar that slidably engages the lead body, and wherein the step of selectively deploying further comprises the step of positioning the collar at a selectable position relative to the lead body.

33. The method of claim 22, wherein the lead assembly further includes a tubular member slidably engaging the lead body, and wherein the step of selectively deploying further comprises the step of positioning the tubular member at a selected positioned relative to the spring member to deploy the spring member a selected amount.

34. The method of claim 33, wherein the tubular member is positioned at the selected position relative to the lead body to release the spring member into the body.

35. The method of claim 26, further comprising the step of delivering laser energy to the spring member via an electrode portion of the tubular member to release the spring member from the body during an explant procedure.

36. The method of claim 22, wherein the step of selectively deploying comprises the step of rotating a rotating member, rotatably mounted to the lead body and coupled to the spring member, relative to the lead body to deploy the spring member a selected amount.

37. The method of claim 22, further comprising the steps of:

deploying the spring member from the second deployed state to the first deployed state;

moving the lead body to another location in the body; and

re-deploying the spring member in the second deployed state to maintain the lead body at the other location.