Apparatus and methods for delivery of transcatheter prosthetic valves

• US 9,526,611 B2
• Filed: 10/29/2014
• Issued: 12/27/2016
• Est. Priority Date: 10/29/2013
• Status: Active Grant

• Current Assignee: Tendyne Holdings Inc. (Abbott Laboratories Incorporated)
• Original Assignee: Tendyne Holdings Inc. (Abbott Laboratories Incorporated)
• Inventors: Tegels, Zachary J., Vidlund, Robert M.
• Primary Examiner(s): Woo, Julian W
• Application Number:
  US14/527,382
• Publication Number:
  US 20150119978A1
• Time in Patent Office: 790 Days
• US Class Current: 1/1
• CPC Class Codes: A61B 50/00 Containers, covers, furniture or holders specially adapted for surgical or diagnostic appliances or instruments, e.g. sterile covers drapes specially adapted for instruments A61B46/10
• CPC Class Codes: A61B 50/30 Containers specially adapted for packaging, protecting, dispensing, collecting or disposing of surgical or diagnostic appliances or instruments for wound clamps A61B17/10; for ligaturing clips A61B17/122; packages or dispensers for surgical gloves or finger-stalls A61B42/40
• CPC Class Codes: A61F 2/0095 Packages or dispensers for prostheses or other implants for intraocular lenses A61F2/1691; for dental surgery A61C19/02
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2/9517 handle assemblies therefor
• CPC Class Codes: A61F 2230/0067 conical
• CPC Class Codes: A61F 2250/0039 differing in diameter
• CPC Class Codes: A61F 2250/0062 Kits of prosthetic parts to be assembled in various combinations for forming different prostheses

Abstract

In some embodiments, an apparatus includes a catheter assembly and a handle assembly that can be removably coupled to the catheter assembly. A valve holding tube defines a lumen configured to receive a prosthetic mitral valve in a compressed configuration and can be removably coupled to a distal end portion of the handle assembly. The valve holding tube can be received within a hub of the catheter assembly when coupled to the handle assembly. The actuator when actuated is configured to cause the tensioning unit to travel along a traveler strap of the catheter assembly moving the handle assembly distally such that a distal end of an elongate shaft of the handle assembly moves the prosthetic mitral valve distally out of the valve holding tube and out a distal end of the sheath such that the prosthetic mitral valve is free to move to a biased expanded configuration.

Claims

1. An apparatus, comprising:

a catheter assembly including a sheath, a hub and a traveler strap;

a handle assembly including an actuator, a tensioning unit coupled to the actuator, and an elongate shaft, the handle assembly configured to be removably coupled to the catheter assembly; and

a valve holding tube defining a lumen configured to receive a prosthetic mitral valve in a compressed configuration, the valve holding tube configured to be removably coupled to a distal end portion of the elongate shaft of the handle assembly,

a distal end portion of the valve holding tube configured to be received within an interior region of the of the hub when the valve holding tube is coupled to the elongate shaft of the handle assembly, and

the actuator, when actuated, configured to cause the tensioning unit of the handle assembly to travel along the traveler strap and move the handle assembly distally such that a distal end of the elongate shaft moves the prosthetic mitral valve distally out of the valve holding tube and out a distal end of the sheath such that the prosthetic mitral valve is free to move to a biased expanded configuration.

2. The apparatus of claim 1, wherein the valve holding tube includes o-rings configured to engage an interior wall of the hub of the catheter assembly to prevent distal movement of the valve holding tube when the tensioning unit travels along the traveler strap and the handle assembly is moved distally.

3. The apparatus of claim 1, wherein the traveler strap engages the tensioning unit with a friction fit.

4. The apparatus of claim 1, wherein the traveler strap includes a plurality of teeth configured to engage teeth on a strap mount of the tensioning unit.

5. The apparatus of claim 1, wherein the actuator is coupled to the tensioning unit with a pawl that moves a strap mount to form a ratchet mechanism.

6. The apparatus of claim 1, wherein the valve holding tube has a length between about 12 cm and about 38 cm.

7. The apparatus of claim 1, wherein the valve holding tube has a length between about 60 cm to about 150 cm.

8. The apparatus of claim 1, further comprising:

a dilator device configured to be removably received at least partially through the lumen of the sheath and interior region of the hub such that a tapered distal end portion of the dilator device is disposed outside a distal end of the sheath, the tapered distal end portion of the dilator device configured to pass through an epicardial surface of the heart and through the mitral annulus when the sheath is inserted into the heart.

9. A method, comprising:

coupling a valve holding tube to a distal end portion of a handle assembly, the valve holding tube having a prosthetic mitral valve disposed therein in a compressed configuration;

inserting a sheath of a catheter assembly into a heart and extend to the left atrium;

after the inserting the sheath of the catheter assembly, inserting a distal end portion of the valve holding tube into a hub of the catheter assembly; and

actuating the handle assembly such that the handle assembly is moved distally and a distal end of the handle assembly moves the prosthetic mitral valve distally out of the valve holding tube and out a distal end of the sheath and into the left atrium of the heart, the prosthetic mitral valve configured to move to a biased expanded configuration when uncompressed by the valve holding tube and the sheath.

10. The method of claim 9, further comprising:

prior to the coupling the valve holding tube to the distal end of the handle assembly, inserting the prosthetic mitral valve into an interior of a valve loading device such that the prosthetic mitral valve is moved from the biased expanded configuration to the compressed configuration within the valve loading device; and

transferring the prosthetic mitral valve while in the compressed configuration from the valve loading device to the valve holding tube.

11. The method of claim 9, wherein the handle assembly includes an actuator coupled to a tensioning unit, the catheter assembly includes a traveler strap configured to be coupled to the tensioning unit,

the actuating the handle assembly includes actuating the actuator such that the tensioning unit pulls the handle assembly distally along the traveler strap.

12. The method of claim 9, further comprising:

prior to coupling the valve holding tube to the distal end of the handle assembly, threading a tether coupled to the prosthetic mitral valve through a lumen of the handle assembly and through a lumen of a positioning device of the handle assembly, the positioning device configured to hold the tether to control movement of the prosthetic mitral valve during deployment into the heart.

13. The method of claim 12, further comprising:

moving a dial on the positioning device to adjust a tension on the tether extending through the positioning device.

14. A kit, comprising:

a valve delivery device including a catheter assembly, a handle assembly removably couplable to the catheter assembly and a valve holding tube removably couplable to the handle assembly, the catheter assembly including a traveler strap configured to engage a tensioning unit of the handle assembly such that when the valve delivery device is actuated, the handle assembly is moved distally along the traveler strap and pushes a prosthetic mitral valve out of the valve holding tube and out a distal end of the catheter assembly; and

a valve loading device, the valve loading device configured to receive a prosthetic mitral valve and move the prosthetic mitral valve from a biased expanded configuration to a controlled compressed configuration within the valve loading device.

15. The kit of claim 14, wherein the valve delivery device is configured to be coupled to the valve loading device and to move a prosthetic mitral valve disposed within the valve loading device to an interior of the valve holding tube.

16. The kit of claim 14, further comprising:

a prosthetic mitral valve configured to be received within an interior of the valve holding tube in a compressed configuration and to be deployed within an atrium of a heart using the valve delivery device, the prosthetic mitral valve configured to assume a biased expanded configuration when unconstrained by the valve holding tube.

17. The kit of claim 14, further comprising:

a dilator device including a tapered distal end portion, the dilator device configured to be removably received at least partially through a lumen of a sheath of the catheter device such that the tapered distal end portion of the dilator device is disposed outside a distal end of the sheath, the tapered distal end portion of the dilator device configured to pass through an epicardial surface of a heart and through a mitral annulus when the sheath is inserted into the heart.

18. The kit of claim 14, further comprising:

a prosthetic mitral valve configured to be received within an interior of the valve holding tube in a compressed configuration and to be deployed within an atrium of a heart using the valve delivery device, the prosthetic mitral valve configured to assume a biased expanded configuration when unconstrained by the valve holding tube; and

a dilator device including a tapered distal end portion, the dilator device configured to be removably received at least partially through a lumen of a sheath of the catheter device such that the tapered distal end portion of the dilator device is disposed outside a distal end of the sheath, the tapered distal end portion of the dilator device configured to pass through an epicardial surface of a heart and through a mitral annulus when the sheath is inserted into the heart.

19. The kit of claim 14, further comprising:

a sterile package in which the delivery device and the valve loading device can be disposed, the sterile package configured to be sealed with the delivery device and the valve loading device therein.