System and method for placing a medical electrical lead

• US 20020072737A1
• Filed: 04/17/2001
• Published: 06/13/2002
• Est. Priority Date: 12/08/2000
• Status: Abandoned Application

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Sommer, John Louis, Soukup, Thomas M., Dahl, Roger, Zytkovicz, Duane, Sundquist, Steve, Thornton, Arnold, Belden, Elisabeth Lacy
• Application Number:
  US09/836,017
• Publication Number:
  US 20020072737A1
• Time in Patent Office: Days
• US Class Current: 606/34
• CPC Class Codes: A61N 1/0563 specially adapted for defibrillation or cardioversion
• CPC Class Codes: A61N 2001/0578 having means for removal or extraction

Abstract

A system and method for deploying a lead in a cardiac chamber, a cardiac vein, or a coronary artery of a patient is disclosed. The system includes a delivery device such as a guidewire having an electrode retention member at the guidewire distal end to engage an electrode assembly. The guidewire is adapted to be inserted into the inner lumen of an introducer sheath so that the electrode retention member extends beyond the distal tip of the introducer. The electrode assembly is then coupled to the electrode retention member of the guidewire. The introducer includes means at the distal end adapted to engage the proximal end of the electrode assembly that is mounted on the guidewire. This allows the introducer to push the electrode assembly and the guidewire through the vasculature to a predetermined point of implant. The introducer may then be utilized to dislodge the electrode assembly from the guidewire at the predetermined implant site before the guidewire and introducer are withdrawn. In one embodiment, the guidewire includes a steerable distal tip to allow the assembly to be readily maneuvered to the implant site. The electrode retention member may be rotatably mounted on the guidewire so that the guidewire steerable distal tip is free to rotate through the curves of a patient'"'"'s vascular system without requiring rotation of the electrode assembly. According to one aspect of the invention, the guidewire and introducer may be readily coupled to a previously-implanted electrode assembly so the electrode may be re-located at a second implant site.

Claims

1. A system for delivering an electrode assembly to an implant site, comprising:

a delivery device having an electrode retention member to couple to the electrode assembly; and

an introducer having an inner lumen sized to receive the delivery device, the introducer further having a distal tip adapted to mate with the electrode assembly when the electrode assembly is retained by the electrode retention member and the delivery device is located within the inner lumen, wherein the introducer is adapted to transfer the electrode assembly and the delivery device to the implant site.

2. The system of claim 1, wherein the delivery device includes a steerable distal tip.

3. The system of claim 2, wherein the steerable distal tip is coupled to a deflection wire extending to a proximal portion of the delivery device.

4. The system of claim 2, wherein the steerable distal tip is manually shapeable.

5. The system of claim 1, wherein the distal tip of the introducer is adapted to selectively disengage the electrode assembly from the electrode retention member.

6. The system of claim 1 wherein the electrode retention member is independently rotatable with respect to the delivery device.

7. The system of claim 6, wherein the delivery device includes a grooved portion, and wherein the electrode retention member is coupled to the grooved portion.

8. The system of claim 6, wherein the electrode retention member is a plug member capable of forming a press fit with the electrode assembly.

9. The system of claim 1, wherein the electrode retention member is a shaped distal tip portion of the delivery device capable of forming a press fit with the electrode assembly.

10. The system of claim 6, wherein the electrode retention member includes multiple radially-extending bristles capable of forming a press fit with the electrode assembly.

11. The system of claim 1, wherein the electrode retention member is an inflatable member.

12. The system of claim 1, wherein the introducer includes a sheath and a coil disposed within the sheath to prevent kinking of the introducer.

13. The system of claim 1, wherein the introducer is splittable.

14. The system of claim 1, wherein the introducer includes a proximal region, a distal region, and fluoroscopic member included within the distal region.

15. The system of claim 1, wherein the inner lumen is sized to receive a lead extending from the electrode assembly.

16. The system of claim 1, wherein the introducer includes a proximal section and a grooved member located at the proximal section, the grooved member adapted to engage a lead coupled to the electrode assembly.

18. The method of claim 17, wherein the electrode assembly has been previously implanted at a first implant site within the patient'"'"'s body, wherein method c.) is performed by coupling the electrode assembly to the electrode retention member at the first implant site, and wherein method d.) is performed to locate the electrode assembly at a second implant site.

19. The method of claim 17, wherein method c.) includes engaging the electrode assembly to the electrode retention member with a press fit.

20. The method of claim 17, wherein method d.) includes the method of steering the introducer, the delivery device, and the electrode assembly to the point of implant using the delivery device.

21. The method of claim 20, wherein the method of steering includes the method of deflecting a distal tip of the delivery device by applying tension to a pull-wire attached to the distal tip of the delivery device.

22. The method of claim 20, wherein the method of steering includes the method of rotating a preformed distal tip of the delivery device.

23. The method of claim 22, wherein the method of rotating including rotating the preformed distal tip of the delivery device independently of the electrode retention member.

24. The method of claim 17, wherein the coupling method c.) occurs outside of the patient'"'"'s body.

25. The method of claim 17, wherein the coupling method c.) includes the method of mating a distal end of the introducer with the electrode assembly.

26. The method of claim 17, wherein the coupling method c.) further includes introducing a lead coupled to the electrode assembly through the inner lumen of the introducer.

27. The method of claim 17, wherein the coupling method c.) further includes attaching a lead coupled to the electrode assembly to a coupling member located on an exterior surface of the introducer.

28. The method of claim 17, and further including the method of splitting the introducer to remove the introducer from the patient'"'"'s body.

29. The method of claim 17, wherein the electrode retention member is inflatable, and wherein the coupling method c.) includes inflating the electrode retention member to engage the electrode assembly.

17. A method of placing an electrode assembly within a living body, including the methods of:

a.) providing a delivery device having a proximal section, a distal section, and an electrode retention member located within the distal section;

b.) advancing the delivery device through an inner lumen of an introducer so that the electrode retention member extends beyond a distal end of the introducer;

c.) coupling the electrode assembly to the electrode retention member;

d.) applying a push force to the introducer to transfer the introducer, the delivery device, and the electrode assembly to a point of implant in the patient'"'"'s body; and

e.) employing the introducer to dislodge the electrode assembly from the electrode retention member.

30. A method of utilizing a delivery device having a distal end positioned within a body to deploy an electrode assembly within the body, including the methods of:

a.) coupling the electrode assembly to a proximal end of the delivery device;

b.) coupling an introducer to the proximal end of the delivery device at a position proximal to the electrode assembly;

c.) mating a distal end of the introducer with a proximal end of the electrode assembly;

d.) applying a push force to the introducer to transfer the distal end of the introducer and the electrode assembly to a predetermined location within the body; and

e.) withdrawing the introducer from the body.

31. The method of claim 30, wherein the delivery device is a previously-placed lead.

32. The method of claim 30, wherein method a.) includes the method of advancing the delivery device through a lumen of the electrode assembly.

33. The method of claim 30, wherein method c.) includes the method of mating a tapered member at the distal end of the introducer to the proximal end of the electrode assembly.

34. The method of claim 30, and further including the method of repeating methods a.) through d.) to deliver a second electrode assembly to a second predetermined location with the patient'"'"'s body.

35. The method of claim 30 wherein method d.) includes the method of steering the introducer to the second predetermined location within the patient'"'"'s body using at least one pull-wire.

36. The method of claim 30, wherein method e.) includes the method of splitting the introducer to remove the introducer from the delivery device.

37. The method of claim 30, wherein the electrode assembly includes at least one defibrillation electrode.

38. The method of claim 30, wherein the electrode assembly is for use in a multipolar pacing application.