Devices and Methods for Preparing A Transcatheter Heart Valve System

• US 20140277403A1
• Filed: 03/12/2013
• Published: 09/18/2014
• Est. Priority Date: 03/12/2013
• Status: Active Grant

• Current Assignee: Medtronic Vascular Galway Limited (Medtronic Plc)
• Original Assignee: Medtronic Vascular Galway Limited (Medtronic Plc)
• Inventors: Peter, Stephen
• Granted Patent: US 9,333,077 B2
• Time in Patent Office: Days
• US Class Current: 623/2.11
• 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 2/2412 with soft flexible valve members, e.g. tissue valves shaped like natural valves check valves with flexible valve members in general F16K15/14
• CPC Class Codes: A61F 2/2415 Manufacturing methods
• 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 2/9522 Means for mounting a stent or stent-graft onto or into a placement instrument

Abstract

Devices and methods for preparing a transcatheter heart valve system. The device includes a housing, sealing apparatuses and a port. The housing forms a chamber sized to receive a prosthetic valve and a portion of a delivery device. During use, the prosthesis is seated in the chamber, and the sealing apparatuses operated to seal the chamber about the delivery device. Air bubbles in a liquid delivered through the delivery device and to the chamber are removed from the system via the port, thereby flushing the system. Further, the device is manipulated to permit loading of the prosthesis into the delivery device in an air bubble-free environment.

Claims

1. An assembly for loading and delivering a stented prosthetic heart valve, the assembly comprising:

a delivery device including;

a tube terminating at a distal end and defining a lumen,

a shaft disposed within the lumen and connect to a tip, the tip located distal the distal end; and

a valve loading device selectively connected to the delivery device, the valve loading device including;

a housing forming a chamber and terminating at opposing, first and second ends, wherein an opening to the chamber is defined at each of the first and second ends,

a first sealing apparatus associated with the first end and configured to selectively sealingly engage the tip,

a second sealing apparatus associated with the second end and configured to selectively sealingly engage the tube,

a port open to the chamber;

wherein the assembly is configured to provide a flushing state in which a stented prosthetic heart valve is located within the chamber and the valve loading device is assembled to the delivery device such that air bubbles entrained in a liquid delivered to the chamber can be removed via the port.

2. The assembly of claim 1, wherein the assembly is configured to provide a delivery state in which the stented prosthetic heart valve is collapsed within the tube and the valve loading device is removed from the delivery device.

3. The assembly of claim 1, wherein the assembly is configured to provide a loading state in which an entirety of the stented prosthetic heart valve is collapsed within the tube and one of the first and second sealing apparatuses is sealingly engaged with the delivery device.

4. The assembly of claim 3, wherein a maximum diameter of the chamber is greater than a diameter of the lumen, and further wherein the assembly is configured to incrementally compress the stented prosthetic heart valve in transitioning from the flushing state to the loading state.

5. The assembly of claim 1, further comprising a vacuum instrument configured to generate a vacuum pressure in the chamber via the port.

6. The assembly of claim 1, wherein the port is located adjacent the first sealing apparatus such that in the flushing state, the port is distal the tube.

7. The assembly of claim 6, wherein the housing defines a prosthesis segment extending from the second end and a neck segment extending from the prosthesis segment to the first end, and further wherein the prosthesis segment defines an expanding diameter in a direction of the first end for receiving the stented prosthetic heart valve, and even further wherein the neck segment has a tapering diameter in a direction of the first end, the port being located along the neck segment.

8. The assembly of claim 1, wherein the valve loading device further includes a check valve assembled to the port.

9. The assembly of claim 1, wherein the housing includes first and second housing portions, the first housing portion being releasably mounted to the second housing portion.

10. A valve loading device for flushing and loading a transcatheter heart valve system including a stented prosthetic heart valve and a delivery device, the valve loading device comprising:

a housing forming a chamber and terminating at opposing, first and second ends, wherein an opening to the chamber is defined at each of the first and second ends;

a first sealing apparatus associated with the first end and configured to selectively sealingly engage the delivery device;

a second sealing apparatus associated with the second end and configured to selectively sealingly engage the delivery device; and

a port open to the chamber;

wherein the device is configured to retain a stented prosthetic heart valve within the chamber and for assembly to the delivery device such that air bubbles entrained in a liquid delivered to the chamber can be removed via the port.

11. The valve loading device of claim 10, wherein the housing defines a prosthesis segment extending from the second end and a neck segment extending from the prosthesis segment to the first end, and further wherein the prosthesis segment defines an expanding diameter in a direction of the first end for receiving the stented prosthetic heart valve, and even further wherein the neck segment has a tapering diameter in a direction of the first end, the port being located along the neck segment.

12. The valve loading device of claim 10, wherein the valve loading device further includes a check valve assembled to the port.

13. The valve loading device of claim 10, wherein each of the first and second sealing apparatuses includes a Tuohy-Borst valve.

14. The valve loading device of claim 10, further comprising a vacuum instrument configured to generate a vacuum pressure in the chamber via the port.

15. A method of preparing a transcatheter heart valve system, including a delivery device and a stented prosthetic heart valve, for the performance of a transcatheter valve implantation procedure, the method comprising:

seating a stented prosthetic heart valve within a chamber defined by a housing of a valve loading device, the housing extending between opposing, first and second ends and defining an opening to the chamber at the each of the first and second ends;

connecting a first component of a delivery device to the stented prosthetic heart valve;

sealing the first and second openings relative to the delivery device;

dispensing a liquid through the delivery device and into the chamber;

creating a negative pressure in the chamber to remove air bubbles entrained in the liquid;

capturing the stented prosthetic heart valve within the delivery device; and

removing the valve loading device from the delivery device.

16. The method of claim 15, wherein the delivery device further includes a tube defining a lumen and a shaft disposed within the lumen, the shaft connect to a tip located distal the tube, and further wherein the step of sealing the first and second openings includes establishing a seal at the tip and a seal at the tube.

17. The method of claim 16, wherein the first component is a coupling body, carried by the shaft and configured to mate with a corresponding component of the stented prosthetic heart valve.

18. The method of claim 17, wherein the step of capturing the stented prosthetic heart valve within the delivery device includes:

releasing the seal at the tip; and

retracting the shaft relative to the tube to draw the stented prosthetic heart valve into the lumen.

19. The method of claim 16, wherein the stented prosthetic heart valve is configured to be reversibly collapsible from a natural arrangement to a collapsed arrangement, and further wherein:

following the step of loading the stented prosthetic heart valve within the chamber and during the step of dispensing a liquid, at least a portion of the stented prosthetic heart valve is distally beyond the tube and has a diameter greater than a diameter of the lumen; and

following the step of capturing the stented prosthetic heart valve within the delivery device, the stented prosthetic heart valve is retained in the collapsed arrangement, including an entirety of the prosthetic heart valve having a diameter not greater than a diameter of the lumen.

20. The method of claim 15, wherein the loading device further includes a port open to the chamber, and further wherein the step of establishing a negative pressure in the chamber includes operating a vacuum instrument connected to the port, the port being located distal the stented prosthetic heart valve.

21. The method of claim 15, wherein the housing includes first and second housing section, and further wherein the step of seating the stented prosthetic heart valve within the chamber includes:

loading the stented prosthetic heart valve within the second housing section, including the first housing section being separated from the second housing section; and

assembling the first housing section to the second housing section to complete the chamber.