Co-radial lead with extendable/retractable fixation mechanism and apparatus therefor

• US 20070038280A1
• Filed: 08/12/2005
• Published: 02/15/2007
• Est. Priority Date: 08/12/2005
• Status: Active Grant

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Knapp, Christopher, Laroche, Walter, Bodner, Jeffrey
• Granted Patent: US 7,983,764 B2
• Time in Patent Office: Days
• US Class Current: 607/128
• CPC Class Codes: A61N 1/0573 chacterised by means penetrating the heart tissue, e.g. helix needle or hook

Abstract

A lead assembly comprises a lead body extending from a lead proximal end portion to a lead distal end portion with at least one conductor disposed therein. A lead lumen extends within the lead body and is dimensioned and configured to removably and rotatably seat a driver therein. The driver includes a driver body extending from a driver proximal end to a driver distal end and having a stylet or guidewire lumen disposed therein. An extendable and retractable active fixation mechanism is disposed at the lead distal end portion. The active fixation mechanism is actuatable by rotation of the driver. In one example, the at least one conductor includes a first conductor and a second conductor, in which the first conductor is co-radial with the second conductor. In another example, the driver distal end includes a portion extractably engagable with the lead distal end portion.

Claims

1. A lead assembly, comprising:

a lead body extending from a lead proximal end portion to a lead distal end portion, the lead body including at least one conductor disposed therein;

an extendable and retractable active fixation mechanism disposed at the lead distal end portion;

a lead lumen extending within the lead body from the lead proximal end portion to at least an active fixation mechanism proximal end;

a driver removably and rotatably seatable within the lead lumen, the driver including a stylet or guidewire receiving lumen therein; and

the active fixation mechanism actuatable by rotation of the driver.

2. The lead assembly as recited in claim 1, wherein the at least one conductor includes a first conductor and a second conductor, the first conductor is co-radial with the second conductor.

3. The lead assembly as recited in claim 1, wherein the lead lumen is formed, at least in part, by the at least one conductor.

4. The lead assembly as recited in claim 1, wherein a driver distal end includes a portion detachably matable with the active fixation mechanism proximal end.

5. The lead assembly as recited in claim 1, wherein a driver distal end includes a portion extractably engagable with the lead distal end portion.

6. A lead assembly, comprising:

a lead body extending from a lead proximal end portion to a lead distal end portion, the lead body including two or more co-radial conductors disposed therein;

an extendable and retractable active fixation mechanism disposed at the lead distal end portion;

a lead lumen extending within the lead body from the lead proximal end portion to at least an active fixation mechanism proximal end;

a driver removably and rotatably seatable within the lead lumen, the driver including a stylet or guidewire receiving lumen therein and a driver distal end; and

the driver distal end including a portion detachably matable with the active fixation mechanism proximal end.

7. The lead assembly as recited in claim 6, wherein the active fixation mechanism is actuatable by rotation of the driver.

8. The lead assembly as recited in claim 6, wherein the lead lumen is formed, at least in part, by the two or more co-radial conductors.

9. The lead assembly as recited in claim 6, wherein a driver proximal end includes a portion couplable with a rotation facilitating tool.

10. The lead assembly as recited in claim 6, wherein a driver distal end includes a portion extractably engagable with the lead distal end portion.

11. A driver comprising:

a driver body removably and rotatably seatable within a lead lumen, the driver body extending from a driver proximal end to a driver distal end and having a stylet or guidewire receiving lumen disposed therein;

the driver distal end including a portion detachably matable with an extendable and retractable active fixation mechanism; and

the driver proximal end including a portion couplable with a rotation facilitating tool.

12. The driver as recited in claim 11, wherein the driver distal end includes a portion extractably engagable with the active fixation mechanism.

13. The driver as recited in claim 11, wherein the driver body is composed, at least in part, of one or a combination of polyethylene terephthalate, polyimide, polyethylene tetrafluoroethylene, polytetrafluoroethylene, or polyurethane.

14. The driver as recited in claim 11, wherein the driver body is composed, at least in part, of a coiled wire or a braided metal wire.

15. A method of manufacturing a lead assembly, the method comprising:

forming a lead body extending from a lead proximal end portion to a lead distal end portion, including forming a lead lumen disposed within the lead body;

disposing an extendable and retractable active fixation mechanism at the lead distal end portion; and

forming a longitudinally extending removable and rotatable driver, including forming a stylet or guidewire receiving lumen therein and a driver distal end portion detachably matable with a proximal end of the active fixation mechanism.

16. The method as recited in claim 15, further comprising inserting the driver within the lead lumen.

17. The method as recited in claim 15, wherein forming the lead lumen includes positioning two or more co-radial conductors within the lead body.

18. The method as recited in claim 15, wherein forming the driver includes forming a driver proximal end portion couplable with a rotation facilitating tool.

19. The method as recited in claim 15, further comprising inserting a stylet into the stylet or guidewire receiving lumen.

20. The method as recited in claim 15, wherein forming the driver includes forming a driver distal end portion extractably engagable with the lead distal end portion.

21. A method of installing a lead, the method comprising:

introducing a lead assembly into a subject, the lead assembly including,

a lead body having a lead proximal end portion, a lead distal end portion, and a lead lumen therein, and

a driver removably and rotatably disposed within the lead lumen, the driver including a stylet or guidewire receiving lumen therein;

extending or retracting an active fixation mechanism disposed at the lead distal end portion, including detachably mating a driver distal end with an active fixation mechanism proximal end; and

removing the driver from the lead lumen.

22. The method as recited in claim 21, wherein extending or retracting the active fixation mechanism includes selectively rotating a driver proximal end in a first direction or a second direction.

23. The method as recited in claim 22, wherein rotating the driver proximal end in the first direction affects extension of the active fixation mechanism from the lead body.

24. The method as recited in claim 22, wherein rotating the driver proximal end in the second direction affects retraction of the active fixation mechanism within the lead body.

25. The method as recited in claim 22, wherein rotating the driver proximal end includes coupling a rotation facilitating tool to the driver proximal end.

26. The method as recited in claim 21, further comprising inserting a stylet into the stylet or guidewire receiving lumen.

27. A method of extracting a lead from a subject, the method comprising:

introducing a driver into a lead lumen, the driver including,

a driver body having a driver proximal end, a driver distal end, and a stylet or guidewire receiving lumen therein, and

a stylet disposed within the stylet or guidewire receiving lumen;

retracting an active fixation mechanism disposed at a lead distal end portion, including rotating the driver proximal end in substantially a single direction; and

extracting the lead from the subject.

28. The method as recited in claim 27, wherein rotating the driver proximal end in substantially the single direction affects extractable engagement of the driver distal end with an active fixation mechanism proximal end.

29. The method as recited in claim 27, wherein extracting the lead from the subject includes engaging the driver distal end with the lead distal end portion, and applying an extraction force to the driver proximal end.