Fixation device for coronary venous lead

• US 20060241737A1
• Filed: 04/26/2005
• Published: 10/26/2006
• Est. Priority Date: 04/26/2005
• Status: Active Grant

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Zhang, Yongxing, Tockman, Bruce A., Stockmoe, Scott A., Phillips, Kevin M., Becker, Neil M., Sherman, Cindy L.
• Granted Patent: US 7,477,946 B2
• Time in Patent Office: Days
• US Class Current: 607/126
• CPC Class Codes: A61N 1/057 Anchoring means; Means for fixing the head inside the heart
• CPC Class Codes: A61N 2001/0578 having means for removal or extraction
• CPC Class Codes: A61N 2001/0585 Coronary sinus electrodes

Abstract

In one embodiment, the present invention provides a cardiac lead device including a fixation mechanism slidably attached to the lead such that when the fixation mechanism is expanded into contact with a body lumen, the lead may be moved relative to the fixation mechanism if desired. Such lead movement may be limited by complimentary structure on the lead body and the fixation mechanism that prevents the lead from moving unless sufficient force is applied to the lead.

Claims

1. A cardiac lead system adapted for anchoring in a vessel, the system comprising:

a conductive lead body having a proximal end and a distal end, the lead body defining at least one lead lumen extending between the proximal and distal ends; and

an expandable fixation mechanism having an expanded position adapted to engage an inner surface the vessel, the expandable fixation mechanism being slidably secured to an outer surface of the lead body,

wherein the lead body and fixation mechanism include respectively a first structure and a second structure that are adapted to contact each other to resist a relative longitudinal movement.

2. The system of claim 1 wherein the first structure includes a plurality of stops disposed on the lead body.

3. The system of claim 1 where the first structure includes at least one curve, bend, coil, or ridge on the lead body.

4. The system of claim 3 further comprising a stylet and wherein a diameter of the first structure is adapted to be substantially reduced upon inserting the stylet through the lead lumen.

5. The system of claim 1 wherein the first structure includes at least one protrusion extending radially from the lead body.

6. The system of claim 1 wherein the second structure includes at least one ring which is secured to the fixation mechanism and encircles the outer surface of the lead body.

7. The system of claim 1 wherein the fixation mechanism comprises a stent-like configuration.

8. The system of claim 1 wherein at least a portion of the first or second structure dissolves over a period of time after being contacted with body fluid.

9. The system of claim 1 further comprising a guide having a proximal end and a distal end and including a tubular wall defining a lumen extending between the proximal and distal ends, wherein the cardiac lead is slidable within the lead lumen.

10. The system of claim 9 wherein the fixation mechanism remains compressed when disposed within the lumen of the guide, and expands upon deployment from the lumen of the guide.

11. The system of claim 1 wherein the fixation mechanism is held in a compressed position by a dissolvable material, the material adapted to dissolve upon contacting a body fluid such that the fixation mechanism deploys to the expanded position.

12. A cardiac lead device comprising:

a conductive lead body having a proximal end and a distal end, the lead body defining at least one lead lumen extending between the proximal and distal ends; and

an expandable fixation mechanism having an expanded position adapted to engage an inner surface the vessel, the expandable fixation mechanism being slidably secured to an outer surface of the lead body,

means for compressing the fixation mechanism such that the fixation mechanism is selectively deployable within a body lumen; and

means for resisting the relative movement when the fixation mechanism is secured to the outer surface of the tubular wall of the lead body.

13. The device of claim 12 wherein the means for compressing the fixation mechanism includes a guide having a lumen configured to slidably receive the lead body.

14. The device of claim 12 wherein the means for compressing the fixation mechanism includes a dissolvable material which is adapted to dissolve upon contacting a bodily fluid.

15. The device of claim 12 wherein the means for resisting relative movement includes at least one curve, bend, coil, ridge or protrusion on the lead body.

16. The device of claim 12 wherein the means for resisting relative movement includes at least one ring which is secured to the fixation mechanism and encircles the outer surface of the lead body.

17. A method for implanting a cardiac lead device in a body lumen comprising:

guiding the cardiac lead device into the body lumen, the device including a conductive lead body having a proximal end and a distal end, the lead body defining at least one lead lumen extending between the proximal and distal ends, and

deploying an expandable fixation mechanism from a compressed position to an expanded position such that the fixation mechanism engages an internal wall of the body lumen, the fixation mechanism being secured to an outer surface of the tubular wall of the lead body to provide selective relative movement between the fixation mechanism and the lead body along a longitudinal axis of the lead body.

18. The method of claim 17 further comprising the step of moving the lead body relative to the expanded fixation mechanism.

19. The method of claim 18 wherein the moving step includes the step of inserting a guidewire or stylet into the lead lumen prior to moving the lead body relative to the expanded fixation mechanism.

20. The method of claim 17 wherein the guiding step includes:

implanting an inner guide in the body lumen, the inner guide having a proximal end and a distal end and including a tubular wall defining a lumen extending between the proximal and distal ends; and

guiding the cardiac lead through the inner guide.

21. The method of claim 17 wherein the deploying step includes positioning the fixation mechanism distally of the distal end of the guide catheter and expanding the fixation mechanism.

22. The method of claim 17 wherein the fixation mechanism is held in a compressed position by a dissolvable material, and the fixation mechanism is deployed to the expanded position by contacting the dissolvable material with bodily fluid.

23. The method of claim 17 wherein the guiding step further includes:

initially implanting an outer guide into the body lumen, the outer guide having a proximal end and a distal end and including a tubular wall defining a lumen extending between the proximal and distal ends;

guiding the inner guide through the outer guide; and

guiding the cardiac lead through the inner guide.

24. The method of claim 23 wherein the fixation mechanism is disposed on an outer surface of the tubular wall of the inner guide, and the deploying step comprises positioning the fixation mechanism distally of the distal end of the outer guide, expanding the fixation mechanism, and removing the outer and inner guides such that the fixation mechanism is slidably secure to the lead body.

25. The method of claim 23 wherein the deploying step includes moving the fixation mechanism distally of the distal end of the outer guide and self-expanding the fixation mechanism.

26. The method of claim 23 wherein the moving step includes inserting a tube between the lumen of the outer guide and the inner guide and forcing the fixation mechanism distally of the distal end of the outer guide.

27. The method of claim 23 wherein the deploying step includes expanding the fixation mechanism by balloon inflation.

28. The method of claim 23 wherein the fixation mechanism is held in the compressed position by a dissolvable material, and the deploying step includes contacting the dissolvable material with bodily fluid to expand the fixation mechanism.