EXPANDABLE MEMBER FOR VENOUS LEAD FIXATION

• US 20080183267A1
• Filed: 01/25/2007
• Published: 07/31/2008
• Est. Priority Date: 01/25/2007
• Status: Active Grant

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Johnson, Eric T., Soltis, Brian D., Tockman, Bruce A., D'Aquanni, Peter J., Smith, Gayla A.
• Granted Patent: US 7,662,132 B2
• Time in Patent Office: Days
• US Class Current: 607/127
• CPC Class Codes: A61N 1/057 Anchoring means; Means for fixing the head inside the heart
• CPC Class Codes: A61N 2001/0585 Coronary sinus electrodes

Abstract

The present invention is directed to a cardiac lead for delivery to the left side of a patient'"'"'s heart including a self-expanding fixation method positioned over the distal portion of the lead. The self-expanding fixation member is capable of automatically expanding from a collapsed state to an expanded state upon deployment at a target site in a cardiac vessel. the fixation member is configured such that in the expanded state it is biased to a side of the lead body.

Claims

1. A cardiac lead comprising:

a conductive lead body including a proximal end, a distal end, and a lumen extending there between;

at least one electrode located on the lead body;

a preformed, self-expanding helical fixation member positioned over a distal portion of the lead body, the fixation member including a distal end fixed to the lead body and a proximal end slideably adjacent to the lead body, the fixation member being preformed such that in an expanded configuration it is biased to a side of the lead body.

2. The cardiac lead according to claim 1, wherein the self-expanding helical fixation member comprises a wire or coil extending over a length of the distal portion ranging from about 0.05 inches to about 1.5 inches in the expanded configuration.

3. The cardiac lead according to claim 1, wherein the self-expanding fixation member is in a collapsed configuration during insertion into a patient'"'"'s vasculature.

4. The cardiac lead according to claim 1, wherein the fixation member comprises a material having a Young'"'"'s Modulus ranging from about 12 to about 29 Msi.

5. The cardiac lead according to claim 1, wherein the fixation member is made from a material comprising Nitinol, nickel-titanium alloy, titanium, polyurethane, 316 SS, MP35N, platinum, platinum alloy, a biocompatible polymer, a bio-resorbable polymer, or combinations thereof.

6. The cardiac lead according to claim 1, wherein the fixation member comprises a wire or a coil having an outer diameter ranging from about 0.005 to about 0.007 inches.

7. The cardiac lead according to claim 1, wherein in the expanded configuration the self-expanding fixation member has an effective diameter ranging from about 4 to about 8 millimeters.

8. A cardiac rhythm management system for delivering therapy to a heart, the system comprising:

a conductive lead body including a proximal end, a distal end, and a lumen extending there between, the lead body being configured to allow passage of a guiding member through the lead lumen;

at least one electrode located on the lead body;

a pulse generator electrically coupled to the proximal end of the lead body;

a pre-formed, self-expanding helical fixation member positioned over a distal portion of the lead body, the fixation member including a distal end fixed to the distal end of the lead body and a proximal end slideably adjacent to the lead body, the fixation member being preformed such that in an expanded configuration it is biased to a side of the lead body; and

a delivery sheath for deploying the self-expanding fixation member to a target site in a coronary vessel.

9. The cardiac rhythm management system according to claim 8 further comprising a guiding member for guiding the lead through a patient'"'"'s vasculature.

10. The cardiac rhythm management system according to claim 8, wherein the self-expanding helical fixation member comprises a wire or coil extending over a length of the distal portion ranging from about 0.05 inches to about 1.5 inches in the expanded configuration.

11. The cardiac rhythm management system according to claim 8, wherein the self-expanding fixation member comprises a wire or a coil having an outer diameter ranging from about 0.005 to about 0.007 inches.

12. The cardiac rhythm management system according to claim 8, wherein the self-expanding fixation member comprises a material having a Young'"'"'s Modulus ranging from about 12 to about 29 Msi.

13. The cardiac rhythm management system according to claim 8, wherein in the expanded configuration, the self-expanding fixation member has an effective diameter ranging from about 4 to about 8 millimeters.

14. A lead for placement in a coronary vessel of a human heart, the lead comprising:

a conductive lead body having a proximal end, a distal end, and a lumen extending there between;

at least one electrode operatively coupled to the lead body; and

a fixation means for securing the distal end of the lead body in the coronary vessel, the fixation means having a distal end fixed to the distal end of the lead body and a proximal end slideably adjacent to the lead body.

15. The lead according to claim 14, wherein the fixation means comprises a spiral, helical, or corkscrew-shaped wire.

16. The lead according to claim 14, wherein the fixation means is capable of expanding from a collapsed configuration to an expanded configuration upon deployment in a coronary vessel.

17. The lead according to claim 14, wherein when the fixation means expands from a collapsed configuration to an expanded configuration, the fixation means is biased to a side of the lead body.

18. The cardiac lead according to claim 14, wherein the fixation means comprises a material having a Young'"'"'s Modulus ranging from about 12 to about 29 Msi.

19. The cardiac lead according to claim 14, wherein fixation means comprises a wire or a coil having an outer diameter ranging from about 0.005 to about 0.007 inches.

20. The cardiac lead according to claim 14, wherein the fixation means has a preformed shape.