Apparatus and methods for delivery of transcatheter prosthetic valves

• US 10,363,135 B2
• Filed: 12/22/2016
• Issued: 07/30/2019
• 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:
  US15/388,571
• Publication Number:
  US 20170100248A1
• Time in Patent Office: 950 Days
• 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 and a hub;

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

a valve holding tube defining a lumen configured to receive a prosthetic heart valve in a compressed configuration, the valve holding tube configured to be removably coupled to 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 handle assembly, and

the actuator, when actuated, configured to move the handle assembly distally such that the prosthetic heart valve moves distally out of the valve holding tube and out a distal end of the sheath such that the prosthetic heart 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 handle assembly is moved distally.

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

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

5. The apparatus of claim 1, further comprising:

a dilator device configured to be removably received at least partially through a lumen of the sheath and the 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 a heart valve annulus when the sheath is inserted into the heart.

6. 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 configured to engage a portion of the handle assembly such that when the valve delivery device is actuated, the handle assembly is moved distally and pushes a prosthetic heart 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 heart valve and move the prosthetic heart valve from a biased expanded configuration to a controlled compressed configuration when disposed within the valve loading device.

7. The kit of claim 6, wherein the valve delivery device is configured to be coupled to the valve loading device and configured to be actuated to move a prosthetic heart valve disposed within the valve loading device to an interior of the valve holding tube.

8. The kit of claim 6, further comprising:

a prosthetic heart 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 heart valve configured to assume a biased expanded configuration when unconstrained by the valve holding tube.

9. The kit of claim 6, 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 heart valve annulus when the sheath is inserted into the heart.

10. The kit of claim 6, further comprising:

a prosthetic heart 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 heart 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 heart valve annulus when the sheath is inserted into the heart.

11. The kit of claim 6, 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.

12. A method, comprising:

inserting a prosthetic heart valve into an interior region of a valve loading device while in a biased expanded configuration;

moving the prosthetic heart valve from the biased expanded configuration to a compressed configuration while disposed within the valve loading device;

transferring the prosthetic heart valve while in the compressed configuration from the valve loading device to a valve holding tube;

after transferring the prosthetic heart valve to the valve holding tube, coupling the valve holding tube with the prosthetic heart valve disposed therein in the compressed configuration to a distal end portion of a handle assembly; and

inserting a sheath of a catheter assembly into a heart.

13. The method of claim 12, further comprising:

inserting a distal end portion of the valve holding tube into a lumen of 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 heart valve distally out of the valve holding tube and out a distal end of the sheath and into an atrium of the heart, the prosthetic heart valve configured to move to a biased expanded configuration when uncompressed by the valve holding tube and the sheath.

14. The method of claim 13, 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.

15. The method of claim 12, further comprising:

prior to coupling the valve holding tube to the distal end of the handle assembly, threading a tether coupled to the prosthetic heart 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 heart valve during deployment of the prosthetic heart valve into the heart.

16. The method of claim 15, further comprising:

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

17. The method of claim 12, wherein the valve loading device includes an inner funnel defining the interior region, and an outer funnel configured to be received at least partially within the interior region of the inner funnel, the method further comprising:

after inserting the prosthetic heart valve into the interior region, inserting the outer funnel within the prosthetic heart valve to move the prosthetic heart valve from the biased expanded configuration to a compressed configuration within the valve loading device.

18. The method of claim 17, further comprising:

after inserting the outer funnel within the prosthetic heart valve, inserting a centering tube through a center of the outer funnel and a center of the inner funnel to center the prosthetic heart valve within the interior region of the inner funnel.

19. The method of claim 17, further comprising:

prior to inserting the prosthetic heart valve into the interior region of the inner funnel, threading a tether coupled to the prosthetic heart valve through the inner funnel and coupling the tether to a load assist device coupled between the handle assembly and the valve loading device.

20. The method of claim 19, further comprising:

after coupling the tether to the load assist device, the transferring the prosthetic heart valve includes actuating the handle assembly to pull the prosthetic heart valve via the tether out of the valve loading device and into the valve holding tube.

21. The method of claim 19, further comprising:

after actuating the handle assembly to pull the prosthetic heart valve into the valve holding tube and prior to coupling the valve holding tube to the distal end portion of the handle assembly, decoupling the load assist device from the handle assembly and from the valve loading device.