Prosthetic heart valve delivery systems and packaging

Patent metadata

Field	Value
Publication number	US-9498317-B2
Application number	US-201113324124-A
Country	US
Kind code	B2
Filing date	Dec 13, 2011
Priority date	Dec 16, 2010
Publication date	Nov 22, 2016
Grant date	Nov 22, 2016

Abstract

Packaging for dry prosthetic tissue heart valves and their delivery systems includes a primary sterile barrier that permits gas sterilization of the tissue implant, and a secondary sterile barrier that also prevents oxidation of the implant during long-term storage. Dry tissue heart valves and their delivery systems are placed within a primary container such as a rigid tray that limits movement of the components therein. The primary container is placed within a secondary container, and the assembly is then sterilized. The outer sterile barrier may include a double seal so that a first gas-permeable seal can be closed for sterilization, after which a second gas-impermeable seal can be closed to seal out any further oxygen contact with the tissue implant. A collapsible delivery handle for a surgical heart valve may be provided which reduces the size of the packaging.

First claim

What is claimed is:

1. A system for packaging a dry tissue heart valve and its delivery system:
a gas-permeable primary container comprising a dry tissue heart valve and a valve delivery system, the dry tissue heart valve having an inflow end and an outflow end, the dry tissue heart valve coupled to a distal end of the valve delivery system, the dry tissue heart valve being oriented such that the outflow end is oriented proximally to the distal end of the valve delivery system and the inflow end is oriented distally from the distal end of the valve delivery system; and
a secondary container sized to receive the primary container, the secondary container being convertible from being gas-permeable to gas-impermeable;
wherein the valve delivery system is configured to be slidably actuated between a collapsed state and an elongated state; and
wherein the dry tissue heart valve coupled to its valve delivery system is packaged in the primary container with the valve delivery system in the collapsed state.

2. The system of claim 1 , wherein the primary container comprises a flexible pouch.

3. The system of claim 2 , wherein the secondary container comprises a flexible pouch.

4. The system of claim 1 , wherein the primary container comprises a relatively rigid tray.

5. The system of claim 4 , wherein the secondary container comprises a relatively rigid tray.

6. The system of claim 4 , wherein the secondary container comprises a flexible pouch.

7. The system of claim 1 , wherein the delivery system includes a collapsible handle.

8. The system of claim 7 , wherein the collapsible handle includes the telescoping sections.

9. The system of claim 1 , wherein the telescoping sections include gas flow apertures open to interior lumens.

10. A method for handling a heart valve comprising: procuring a sterile package containing a prosthetic heart valve comprising an inflow end and an outflow end comprising outflow commissures removably secured to a valve holder, the valve holder including a plurality of legs shaped and dimensioned to mate with the outflow commissures, the prosthetic heart valve being stored in the sterile package without a preservative solution, the holder being coupled to a distal end of a heart valve delivery system comprising a grip section at a proximal end of the heart valve delivery system and a plurality of concentric telescoping sections, the heart valve delivery system having a collapsed state with a first length in which each section fits substantially within a cavity of an adjacent larger section and an elongated state with a second length relatively longer than the first length and the heart valve delivery system being contained in the sterile package in its collapsed state; removing the valve, the valve holder and heart valve delivery system from the sterile package; converting the heart valve delivery system from its collapsed state to its elongated state, including pulling the telescoping sections to lengthen the heart valve delivery system until adjacent telescoping sections lock together and the prosthetic heart valve is advanced distally of the grip section; and wherein all of the telescoping sections but a proximal telescoping section includes outwardly directed sealing sections on proximal ends thereof, and all of the telescoping sections but a distal telescoping section includes an inwardly-directed lip on distal ends thereof and an inwardly-directed circular feature spaced closely from distal ends thereof, wherein converting the heart valve delivery system to the elongated state locks each sealing section in a region between the inwardly-directed lip and the inwardly-directed circular feature of the adjacent telescoping section.

11. The method of claim 10 , wherein the telescoping sections are generally tubular and gradually enlarge in diameter from a distal telescoping section to a proximal telescoping section, and wherein the grip section comprises undulations for receiving fingers of a user.

12. The method of claim 10 , wherein the telescoping sections include interfering lips that prevent any one section from passing completely within another section and that prevent the sections from disengaging past the elongated state.

13. The method of claim 10 , further including elastomeric seals provided between adjacent telescoping sections to provide frictional tightness between the telescoping sections.

14. The method of claim 10 , wherein a distal telescoping section of the heart valve delivery system has a locking head projecting in a distal direction and the valve holder includes a handle coupler extending in a proximal direction and having structure sized and shaped to mate with the locking head of the heart valve delivery system so that the prosthetic heart valve extends distally from the distal telescoping section of the heart valve delivery system, and wherein the locking head is elastomeric and the structure on the handle coupler sized and shaped to mate with the locking head comprises an internal cavity into which the elastomeric locking head closely fits.

15. The method of claim 10 , wherein the prosthetic heart valve is a dry tissue valve and the sterile package contains no liquid preservative.

16. The method of claim 15 , wherein the sterile container includes a primary container and a secondary container, the primary container having a gas-permeable seal that provides a sterile barrier preventing passage of liquid water and providing gas flow passages therewithin around the heart valve, the sealed primary container being placed within the secondary container, the secondary container including a dual seal with a gas-permeable seal inside of a gas-impermeable seal capable of preventing oxygen or water from passing therethrough, the method further including:
removing the gas-impermeable seal from the secondary container and subjecting the sterile container to gas-based sterilization;
removing the gas-permeable seal from the secondary container;
removing the gas-permeable seal from the primary container; and
performing the step of removing the valve, holder and heart valve delivery system from the sterile package.

17. The method of claim 16 , wherein the primary container is a tray having an upper surface and a cavity surrounded by an upper rim and descending downward therefrom, the tray being made of gas-impermeable material, wherein the dry tissue heart valve and its delivery system are placed in the tray cavity.

18. The method of claim 16 , wherein the secondary container comprises a flexible pouch.

19. The method of claim 1 , further comprising a valve holder attached to a distal end of the delivery system, wherein the outflow end of the dry tissue heart valve comprises outflow commissures and the valve holder secures the outflow commissures.

Assignees

• Gautam Abhishek
• Wright Gregory A
• Edwards Lifesciences Corp

Inventors

• Gautam Abhishek
• Wright Gregory A

Classifications

• A61F2/2415

  Manufacturing methods · CPC title

• A61F2/2433

  using balloon catheter · CPC title

• A61F2/2412

  with soft flexible valve members, e.g. tissue valves shaped like natural valves · CPC title

• B65B55/18 Primary

  by liquids or gases (B65B55/14 takes precedence) · CPC title

• A61F2/2418

  Scaffolds therefor, e.g. support stents · CPC title