MEANS TO SECURELY FIXATE PACING LEADS AND/OR SENSORS IN VESSELS

• US 20080077220A1
• Filed: 09/22/2006
• Published: 03/27/2008
• Est. Priority Date: 09/22/2006
• Status: Active Grant

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Reddy, G. Shantanu
• Granted Patent: US 7,865,249 B2
• Time in Patent Office: Days
• US Class Current: 607/131
• CPC Class Codes: A61N 1/057 Anchoring means; Means for fixing the head inside the heart
• CPC Class Codes: A61N 1/0573 chacterised by means penetrating the heart tissue, e.g. helix needle or hook
• CPC Class Codes: A61N 2001/0578 having means for removal or extraction

Abstract

According to embodiments of the present invention, a cardiac lead system adapted for fixation to a vessel including an expandable fixation mechanism adapted to engage an inner surface of the vessel and a lead member comprising an anchor structure at distal end, the anchor structure configured to removably engage with fixation mechanism. Such anchor structure may be helical, and may removably engage fixation mechanism upon rotation or an application of torque, and may be extendable and/or retractable. Fixation mechanism may be polymer coated weave and/or mesh to trap anchor structure. Lead member and/or fixation mechanism may include electrodes and/or sensors, and lead member may include L-shape, S-shape, spiral, and/or sinusoidal shape for positioning of electrodes and/or sensors or for facilitated engagement of anchor structure. A guide wire attached to fixation mechanism during deployment may, prior to detachment, serve to guide lead member to a target site at fixation mechanism.

Claims

1. A cardiac lead system adapted for fixation to a vessel, the system comprising:

an expandable fixation mechanism having an expanded position adapted to engage an inner surface of the vessel; and

a lead member having a proximal end and a distal end, the distal end comprising a helix structure,

wherein the helix structure is configured to removably engage the fixation mechanism by rotation of the helix structure into the fixation mechanism.

2. The system of claim 1, wherein the helix structure comprises a single-coil configuration.

3. The system of claim 1, wherein the inner surface of the vessel is a first inner surface, wherein the fixation mechanism comprises:

an outer surface adapted to engage the first inner surface;

a second inner surface; and

a net connecting at least two points along the second inner surface, and

wherein the helix structure is configured to removably engage the fixation mechanism by rotation of the helix structure into the net.

4. The system of claim 1, wherein the inner surface of the vessel is a first inner surface, wherein the fixation mechanism comprises:

an outer surface adapted to engage the first inner surface; and

a second inner surface comprising a coating of polymer, and

wherein the helix structure is configured to removably engage the fixation mechanism by rotation of the helix structure into the coating of polymer.

5. The system of claim 4, wherein the coating of polymer is a polymer weave structure.

6. The system of claim 4, wherein the coating of polymer is a polymer mesh structure.

7. The system of claim 4, wherein the coating of polymer is a first coating of polymer, the outer surface comprising a second coating of polymer between the fixation mechanism and the first inner surface.

8. The system of claim 7, wherein the helix structure is electrically active, wherein the second coating of polymer includes at least one gap, wherein the fixation mechanism further comprises at least one electrode configured to contact the first inner surface through the at least one gap, wherein the fixation mechanism comprises a metallic structure in contact with the at least one electrode, and wherein the helix structure is configured to removably engage the fixation mechanism by rotation of the helix structure into the metallic structure through the first coating of polymer.

9. The system of claim 4, wherein the polymer is selected from the group consisting of:

DACRON®

, expanded polytetrafluoroethylene, and Teflon®

.

10. A cardiac lead system adapted for fixation to a vessel, the system comprising:

an expandable fixation mechanism having an expanded position adapted to engage an inner surface of the vessel; and

a lead member having a proximal end and a distal end, the distal end comprising an anchor structure,

wherein the anchor structure is configured to removably engage the fixation mechanism.

11. The system of claim 10, wherein the fixation mechanism is a stent.

12. The system of claim 10, wherein the anchor structure comprises a helical configuration.

13. The system of claim 12, wherein the anchor structure protrudes longitudinally from the lead member, and wherein the anchor structure is configured to removably engage the fixation mechanism by rotating the anchor structure into the fixation mechanism.

14. The system of claim 10, wherein the anchor structure comprises a configuration selected from the group consisting of:

a hook configuration, a tine configuration, a barb configuration, and a corkscrew configuration.

15. The system of claim 10, wherein the lead member comprises at least one electrode.

16. The system of claim 15, wherein the at least one electrode is a multiplicity of electrodes, and wherein each of the multiplicity of electrodes is spaced at an interval along the lead member.

17. The system of claim 16, wherein at least a portion of the lead member comprises a substantially sinusoidal shape to permit the multiplicity of electrodes to contact the inner surface of the vessel at different locations.

18. The system of claim 10, wherein the fixation mechanism is electrically conductive and comprises at least one electrode in contact with the inner surface, and wherein the anchor structure is electrically active.

19. The system of claim 10, wherein the anchor structure is extendable from within the lead member.

20. The system of claim 19, wherein the anchor structure is retractable back into the lead member.

21. A method for non-destructive anchoring of a cardiac lead member to a coronary vessel, the method comprising:

passing a first guide wire into the coronary vessel;

deploying the stent structure over the first guide wire and into the coronary vessel, the stent structure having a second guide wire attached at a target site;

expanding the stent structure to engage an inner surface of the coronary vessel;

deploying a lead member over the second guide wire to the target site, the lead member comprising an anchor structure; and

attaching the anchor structure to the stent structure.

22. The method of claim 21, further comprising detaching the second guide wire from the stent structure.

23. The method of claim 21, wherein the anchor structure is helical, wherein the fixation mechanism comprises a polymer coating, and wherein attaching the anchor structure to the stent structure comprises rotating the anchor structure into the fixation mechanism through the polymer coating.

24. The method of claim 23, wherein rotating the anchor structure comprises rotating the anchor structure in a first direction, the method further comprising:

removing the anchor structure from the stent structure by rotating the anchor structure in a second direction opposite the first direction.

25. The method of claim 21, wherein the lead member includes a proximal end and a distal end, the method further comprising:

providing the distal end with a tendency to assume an L-shape or an S-shape absent stylet reinforcement;

providing a stylet configured to reinforce the distal end in a substantially straight configuration during deployment of the lead member over the guide wire; and

removing the stylet from the distal end to permit the distal end to assume an L-shape or an S-shape prior to attachment of the anchor structure to the stent structure.