System and method for positioning implantable medical devices within coronary veins

• US 10,328,243 B2
• Filed: 05/21/2014
• Issued: 06/25/2019
• 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:
  US14/283,303
• Publication Number:
  US 20140343549A1
• Time in Patent Office: 1,861 Days
• 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, wherein the braid is formed of stainless steel, wherein the braid has an ultimate tensile strength of between approximately 200 and 250 kilo-pounds per square inch (ksi), wherein the braid has a pic count of between 35 and 55 pics per inch, and further wherein the braid is formed of a wire having a diameter of approximately 0.002 inches; 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 electrophysiology catheter.

3. The system of claim 1, and further comprising an internal liner adjacent at least a portion of the inner lumen.

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

5. The system of claim 4, wherein the lubricious material is selected from the group consisting of PolyTetraFluoroEthylene (PTFE), PolyVinylDieneFluoride (PVDF), and High-Density PolyEthylene (HDPE).

6. A sheath apparatus for receiving a steerable catheter to position implantable medical devices within the coronary sinus or a branch vein thereof, wherein the sheath apparatus comprises a substantially straight slittable sheath extending from a proximal end to a distal end defining an inner lumen, wherein the slittable 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;

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, wherein the braid is formed of stainless steel, wherein the braid has an ultimate tensile strength of between approximately 200 and 250 kilo-pounds per square inch (ksi), and further wherein the braid has a pic count of between 35 and 55 pics per inch;

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.

7. The sheath apparatus of claim 6, wherein the internal liner is formed of a lubricious material.

8. The sheath apparatus of claim 7, wherein the lubricious material is selected from the group consisting of PolyTetraFluoroEthylene (PTFE), PolyVinylDieneFluoride (PVDF), and High-Density PolyEthylene (HDPE).

9. The sheath apparatus of claim 6, wherein the inner lumen has an inner diameter ranging from about 0.86 to 0.106 inches.

10. The sheath apparatus of claim 6, wherein the slittable braid comprises one or more strands formed of a material more radio-dense than the other strands of the slittable braid.

11. The sheath apparatus of claim 10, wherein the one or more strands of a material more radio-dense are more visible under fluoroscopy than the other strands of the slittable braid.

12. The sheath apparatus of claim 10, wherein the one or more strands of a material more radio-dense provide a profile of the sheath when viewed under a fluoroscope.