SYSTEM AND METHOD FOR POSITIONING IMPLANTABLE MEDICAL DEVICES WITHIN CORONARY VEINS

• US 20090131873A1
• Filed: 01/22/2009
• Published: 05/21/2009
• Est. Priority Date: 03/31/2000
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Chan, Eric K.Y., Gardeski, Kenneth C., Kelley, James F., Spear, Stanten C., Seraj, Mohmoud K.
• Granted Patent: US 8,734,397 B2
• Time in Patent Office: Days
• US Class Current: 604/164.130
• CPC Class Codes: A61B 18/1492 having a flexible, catheter-like structure, e.g. for heart ablation A61B18/1477 takes precedence
• CPC Class Codes: A61B 2017/22038 with a guide wire
• CPC Class Codes: A61B 2018/00386 Coronary vessels
• CPC Class Codes: A61M 2025/0042 Microcatheters, cannula or the like having outside diameters around 1 mm or less
• CPC Class Codes: A61M 2025/0047 the inner layer having a higher lubricity
• CPC Class Codes: A61M 2025/0081 Soft tip
• CPC Class Codes: A61M 2025/0161 wherein the distal tips have two or more deflection regions
• CPC Class Codes: A61M 2025/0681 Systems with catheter and outer tubing, e.g. sheath, sleeve or guide tube
• CPC Class Codes: A61M 2025/1052 for temporarily occluding a vessel for isolating a sector
• CPC Class Codes: A61M 2025/1079 having radio-opaque markers in the region of the balloon
• CPC Class Codes: A61M 25/005 with embedded materials for reinforcement, e.g. wires, coils, braids
• CPC Class Codes: A61M 25/0051 made from fenestrated or weakened tubing layer
• CPC Class Codes: A61M 25/0054 with regions for increasing flexibility
• CPC Class Codes: A61M 25/008 Strength or flexibility characteristics of the catheter tip
• CPC Class Codes: A61M 25/0138 having flexible regions as a result of weakened outer material, e.g. slots, slits, cuts, joints or coils
• CPC Class Codes: A61M 25/0141 having flexible regions as a result of using materials with different mechanical properties
• CPC Class Codes: A61M 25/0147 with movable mechanical means, e.g. pull wires
• CPC Class Codes: A61M 25/0668 splittable, tear apart
• CPC Class Codes: A61N 1/056 Transvascular endocardial electrode systems
• CPC Class Codes: A61N 2001/0578 having means for removal or extraction
• CPC Class Codes: A61N 2001/0585 : Coronary sinus electrodes

Abstract

An improved system and method for placing implantable medical devices (IMDs) such as leads within the coronary sinus and branch veins is disclosed. In one embodiment, a slittable delivery sheath and a method of using the sheath are provided. The sheath includes a slittable hub, and a substantially straight body defining an inner lumen. The body comprises a shaft section and a distal section that is distal to, and softer than, the shaft section. A slittable braid extends adjacent to at least a portion of one of the shaft section and the distal section. In one embodiment of the invention, the sheath further includes a transition section that is distal to the shaft section, and proximal to the distal section. The transition section is softer than the shaft section, but stiffer than the distal section.

Claims

1. A system for positioning implantable medical devices within the coronary sinus or a branch vein thereof, comprising:

a substantially straight slittable sheath having an inner lumen, a shaft section, and a distal section that is distal to, and softer than, the shaft section, the sheath further including a slittable braid adjacent to at least a portion of at least one of the shaft section and the distal section; and

a steerable catheter having a shaft adapted to be inserted within the inner lumen of the sheath.

2. The system of claim 1, wherein the steerable catheter is an EP catheter.

3. The system of claim 2, wherein the braid is formed of stainless steel.

4. The system of claim 3, wherein the braid has an ultimate tensile strength of between approximately 200 and 250 kilo-pounds per square inch (ksi).

5. The system of claim 4, wherein the braid has a pic count of between 35 and 55 pics per inch.

6. The system of claim 5, wherein the braid is formed of a wire having a diameter of approximately 0.002 inches.

7. The system of claim 6, wherein the wire is type-304 vacuum melt stainless steel wire.

8. The system of claim 7, and further comprising an internal liner adjacent at least a portion of the inner lumen.

9. The system of claim 8, wherein the internal liner is formed of a lubricious material.

10. The system of claim 9, wherein the lubricious material is selected from the group consisting of PolyTetraFluoroEthylene (PTFE), PolyVinylDieneFluoride (PVDF), and High-Density PolyEthylene (HDPE).

11. The system of claim 1, wherein the inner lumen has an inner diameter ranging from about 0.86 to 0.106 inches.

12. The system of claim 11, wherein the inner diameter is approximately 0.096 inches.

13. The system of claim 12, wherein the shaft of the steerable catheter has an outer diameter of less than 0.093 inches.

14. The system of claim 13, wherein the shaft section and the distal tip section are formed of a polymer tubing.

15. The system of claim 14, wherein the shaft section is formed of PEBAX tubing having a hardness ranging from approximately 55 D to 72 D (Shore).

16. The system of claim 15, wherein the shaft section has a length ranging from approximately 43 to 62 cm.

17. The system of claim 16, wherein the distal section is formed of PEBAX tubing having a hardness ranging from approximately 25 D to 35 D (Shore).

18. The system of claim 17, wherein the distal section has a length ranging from approximately 1.5 to 3.5 cm.

19. The system of claim 18, wherein the distal section includes a flourovisible marker band.

20. The system of claim 18, and further including a transition section that is distal to shaft section and proximal to distal section, the transition section being softer than the shaft section and harder than the distal section.

21. The system of claim 20, wherein transition section is formed of PEBX tubing having a hardness ranging from approximately 35 D to 40 D (Shore).

22. The system of claim 21, wherein transition section has a length ranging from about 2.25 and 5.5 cm.

23. The system of claim 22, wherein at least one of the shaft section, the transition section, and the distal section includes a radiopaque filler material.

24. The system of claim 22, wherein the shaft section further includes:

a proximal shaft segment;

an intermediate shaft segment that is distal to, and softer than, the proximal shaft segment; and

a distal shaft segment that is distal to, and softer than, the intermediate shaft segment.

25. The system of claim 24, wherein the distal section further includes:

a soft distal segment;

an intermediate distal segment distal to, and harder than, the soft distal segment; and

a soft tip that is distal to, and softer than, the intermediate distal segment.

26. A method for seating implantable medical devices within the coronary sinus or branch veins, comprising:

a.) providing a slittable sheath having a substantially-straight body defining an inner lumen, wherein the body of the sheath comprises;

a shaft section and a distal section that is distal to the shaft section, the shaft section being formed of a material that is harder than the distal section; and

a slittable braid extending adjacent to at least a portion of one of the shaft section and the distal section;

b.) inserting a steerable catheter within the inner lumen of the sheath;

c.) positioning the steerable catheter and sheath within a body; and

d.) navigating the steerable catheter and the sheath into the coronary sinus.

27. The method of claim 26, wherein step d.) comprises:

advancing a distal end of the steerable catheter beyond a distal end of the sheath;

cannulating the coronary sinus with the steerable catheter; and

advancing the distal tip of the sheath over the distal end of the steerable catheter and into the coronary sinus.

28. The method of claim 27, and further comprising:

withdrawing the steerable catheter from the body;

advancing a balloon catheter within the inner lumen;

obtaining a venogram; and

withdrawing the balloon catheter from the body.

29. The method of claim 27, and further comprising advancing an implantable medical device (IMD) within the inner lumen of the sheath.

30. The method of claim 29, wherein the IMD is a lead.

31. The method of claim 30, wherein the lead has a lumen, and further including loading the lumen of the lead with a navigational device prior to advancing the lead within the inner lumen of the sheath.

32. The method of claim 30, wherein the advancing step includes:

advancing a navigational device within the inner lumen of the sheath; and

advancing the lead over the navigational device.

33. The method of claim 31, wherein the navigational device is selected from the group consisting of a stylet, a guidewire, and a micro-deflection mechanism.

34. The method of claim 33, and further including sub-selecting a branch vein of the coronary sinus.

35. The method of claim 34, wherein the lead and navigational device are used to sub-select the branch vein.

36. The method of claim 34, and further including:

sub-selecting the branch vein with the sheath; and

advancing the lead beyond the distal tip of the sheath.

37. The method of claim 36, and further including withdrawing the sheath and the navigational device from the body.