Container and method for storing and delivering minimally-invasive heart valves

• US 6,723,122 B2
• Filed: 08/30/2001
• Issued: 04/20/2004
• Est. Priority Date: 08/30/2001
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Walsh, Brandon G., Yang, Jibin, Pease, Matthew Lane
• Primary Examiner(s): Prebilic, Paul B.
• Application Number:
  US09/945,392
• Publication Number:
  US 20030045928A1
• Time in Patent Office: 964 Days
• Field of Search: 206/438, 206/397, 206/408, 623/1.11, 623/1.12, 623/1.23, 623/1.24, 623/1.26, 623/2.1, 623/2.11, 623/2.13, 623/2.14, 606/108
• US Class Current: 623/2.1
• 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 2/2415 Manufacturing methods
• CPC Class Codes: A61F 2/9522 Means for mounting a stent or stent-graft onto or into a placement instrument

Abstract

Storage containers for expandable heart valves for minimally invasive valve replacement surgeries are disclosed. The containers permit an expandable valve to be stored in its expanded configuration and then converted to its contracted configuration while still in the container. A mechanism incorporated into the container facilitates the conversion. For example, the container may have a base and a lid, and a crank manipulable from outside. The lid actuates a key within the container that engages the valve to perform the contraction. If the valve is a spirally wound type of expandable valve, the key may be attached to an inner side edge and rotated to wind the valve into a tight spiral. A drain in the container may facilitate removal of a preservative solution so that the valve can be seen during the contraction process, or so that the valve can be rinsed while still within the container.

Claims

1. A storage container for an expandable prosthetic heart valve having both contracted and expanded configurations, comprising:

a container sized to receive the heart valve in its expanded configuration;

a mechanism incorporated into the container and engaging the heart valve operable to convert the heart valve from its expanded configuration to its contracted configuration.

2. The storage container of claim 1, wherein the base has a drain to empty the solution from the container.

3. The storage container of claim 1, wherein the mechanism operable to convert the heart valve from its expanded to its contracted configuration is separable from the base such that the heart valve in its contracted configuration may be removed from the base by manipulating the lid.

4. The storage container of claim 1, wherein the heart valve comprises a generally sheet-like stent body that is spirally-wound about an axis into the contracted configuration and is substantially unwound and at least partly forms a tube centered about the axis in its expanded configuration, the stent body defining a pair of opposed side edges that generally mate in the expanded configuration, wherein the mechanism includes a key attached to a first side edge, and wherein the key rotates to wind the valve from its expanded to its contracted configuration.

5. The storage container of claim 4, wherein the mechanism further includes a clamp releasably attached to the container and to a second side edge of the heart valve opposite the first side edge such that the second side edge is held stationary with respect to the container while the key attached to the first side edge rotates.

6. The storage container of claim 5, wherein the container includes a base and a lid, and wherein the key is rotatably coupled to the lid and the clamp releasably attaches to the base.

7. The storage container of claim 6, wherein the key comprises a shaft passing through the lid and having structure for engaging complementary structure on the first side edge of the heart valve, and the storage container further includes a crank rotatably affixed to the shaft and operable from the exterior side of the lid.

8. The storage container of claim 6, wherein the clamp comprises a dovetail slide and the base includes a complementary channel for receiving the slide, the dovetail slide further including structure for engaging complementary structure on the second side edge of the heart valve.

9. A system for storing and delivering an expandable prosthetic heart valve having both contracted and expanded configurations, comprising:

a prosthetic heart valve comprising a generally sheet-like stent body that is spirally-wound about an axis in the contracted configuration and is substantially unwound and at least partly forms a tube centered about the axis in its expanded configuration, the stent body defining a pair of opposed side edges that generally mate in the expanded configuration;

a plurality of flexible, biocompatible membranes incorporated into the stent body to form heart valve leaflets in the expanded configuration;

a container sized to receive the heart valve in its expanded configuration; and

a mechanism incorporated into the container for winding the heart valve within the container into its contracted configuration.

10. The system of claim 9, wherein the heart valve is a tissue-type valve and the container holds a solution suitable for preserving the leaflets.

11. The system of claim 10, wherein the container includes a base and a lid, and the mechanism incorporated into the container for winding the heart valve within the container is partially incorporated into the lid.

12. The system of claim 11, wherein the base has a drain to empty the solution from the container.

13. The system of claim 11, wherein the mechanism incorporated into the container for winding the heart valve within the container is separable from the base such that the heart valve in its contracted configuration may be removed from the base by manipulating the lid.

14. The system of claim 9, wherein the mechanism includes a key attached to a first side edge of the stent body, wherein the key rotates to wind the valve from its expanded to its contracted configuration.

15. The system of claim 14, wherein the mechanism further includes a clamp releasably attached to the container and to a second side edge of the stent body opposite the first side edge such that the second side edge is held stationary with respect to the container while the key attached to the first side edge rotates.

16. The system of claim 15, wherein the container includes a base and a lid, and wherein the key is rotatably coupled to the lid and the clamp releasably attaches to the base.

17. The system of claim 16, wherein the key comprises a shaft passing through the lid and having structure for engaging complementary structure on the first side edge of the stent body, and the storage container further includes a crank rotatably affixed to the shaft and operable from the exterior side of the lid.

18. The system of claim 16, wherein the clamp comprises a dovetail slide and the base includes a complementary channel for receiving the slide, the dovetail slide further including structure for engaging complementary structure on the second side edge of the stent body.

19. The system of claim 9, further including a clip for holding the heart valve in its contracted configuration.

20. A method of storing and delivering an expandable prosthetic heart valve having both contracted and expanded configurations, the method comprising:

providing a prosthetic heart valve having a contracted configuration sized to be delivered to a site of implantation through a tube and an expanded configuration sized to engage a heart valve annulus;

storing the heart valve in a container in its expanded configuration;

converting the heart valve from its expanded configuration to its contracted configuration while in the container.

21. The method of claim 20, wherein the heart valve is a rolled-type of valve and the step of converting comprises winding the valve from a relatively large spiral to a relatively tight spiral.

22. The method of claim 21, wherein the container includes a base and a lid, and a crank rotatably connected to an inner side edge of the valve, and the step of winding comprises turning the crank to wind the inner side edge of the valve.

23. The method of claim 20, wherein the step of storing includes providing a solution within the container and the method includes draining the solution from the container while the valve remains within the container.

24. The method of claim 23, further including rinsing the valve after draining the solution from the container and while the valve remains within the container.

25. The method of claim 20, wherein the heart valve is a rolled-type of valve and the step of converting comprises spirally winding the valve and maintaining the valve in its wound state using a constraint around the valve.

26. The method of claim 25, further including detaching the heart valve from the storage container after placing the constraint around the valve and mounting the valve on a delivery catheter.