System and method for positioning implantable medical devices within coronary veins

• US 8,734,397 B2
• Filed: 01/22/2009
• Issued: 05/27/2014
• Est. Priority Date: 03/31/2000
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Spear, Stanten C., Kelley, James F., Gardeski, Kenneth C., Seraj, Mohmoud K., Chan, Eric K. Y.
• Primary Examiner(s): PEFFLEY, MICHAEL F
• Application Number:
  US12/357,810
• Publication Number:
  US 20090131873A1
• Time in Patent Office: 1,951 Days
• Field of Search: 606/41, 606 48- 50, 604/160, 604/161, 604/164
• US Class Current: 604/164.04
• 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 extending from a proximal end to a distal end defining an inner lumen, wherein the sheath comprises;

a shaft section,

a distal section distal to the shaft section at the distal end of the sheath, wherein the distal section comprises a soft tip extending from a transition location along the distal section to the distal end of the sheath, the soft tip being distal to, and softer than, the shaft section, wherein the soft tip has a length ranging from about 0.15 cm to about 0.35 cm and is formed of material having a hardness ranging from about 25 D to 35 D (Shore),

a slittable braid extending along the shaft section and at least a portion of the distal section, the slittable braid terminating at a distal end thereof approximately at the transition location, and

an internal liner adjacent at least a portion of the inner lumen and extending along the shaft section and terminating within the distal section of the sheath beyond the distal end of the slittable braid, wherein the soft tip of the distal section extends beyond the internal liner to the distal end of the sheath; 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 comprises an electrophysiology catheter.

3. The system of claim 1, 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 pie 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 1, wherein the internal liner is formed of a lubricious material.

9. The system of claim 8, wherein the lubricious material is selected from the group consisting of PolyTetraFluoroEthylene (PTFE), PolyVinylDieneFluoride (PVDF), and High-Density PolyEthylene (HDPE).

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

11. The system of claim 10, wherein the inner diameter is approximately 0.096 inches.

12. The system of claim 11, wherein the shaft section of the steerable catheter has an outer diameter of less than 0.093 inches.

13. The system of claim 12, wherein the shaft section and the distal tip section are formed of a polymer tubing.

14. The system of claim 13, wherein the shaft section is formed of PEBAX tubing having a hardness ranging from approximately 55 D to 72 D (Shore).

15. The system of claim 14, wherein the shaft section has a length ranging from approximately 43 to 62 cm.

16. The system of claim 15, wherein the distal section is formed of PEBAX tubing having a hardness ranging from approximately 25 D to 35 D (Shore).

17. The system of claim 1, wherein the distal section has a length ranging from approximately 1.5 to 3.5 cm.

18. The system of claim 17, wherein the distal section includes a flourovisible marker band.

19. The system of claim 1, wherein the sheath further includes a transition section that is distal to the shaft section and proximal to the distal section, the transition section being softer than the shaft section and harder than the soft tip.

20. The system of claim 19, wherein the transition section is formed of PEBAX tubing having a hardness ranging from approximately 35 D to 40 D (Shore).

21. The system of claim 20, wherein the transition section has a length ranging from about 2.25 and 5.5 cm.

22. The system of claim 21, wherein at least one of the shaft section, the transition section, and the distal section includes a radiopaque filler material.

23. The system of claim 1, wherein the shaft section further comprises:

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.

24. The system of claim 1, wherein the distal section further comprises:

a distal segment,

the soft tip being distal to, and softer than, at least a portion of the distal segment.