Holder and packaging for bioprosthetic heart valve

• US 5,560,487 A
• Filed: 07/29/1994
• Issued: 10/01/1996
• Est. Priority Date: 07/29/1994
• Status: Expired due to Fees

• Current Assignee: Carbomedics Inc. (Snia SpA)
• Original Assignee: Carbomedics Inc. (Snia SpA)
• Inventors: Starr, Stephen
• Primary Examiner(s): Sewell, Paul T.
• Assistant Examiner(s): Laster, Tara L.
• Application Number:
  US08/282,675
• Time in Patent Office: 795 Days
• Field of Search: 206/438, 206/363, 206/583, 206/439, 206/305
• US Class Current: 206/438
• CPC Class Codes: A61B 50/20 Holders specially adapted for surgical or diagnostic appliances or instruments drapes with means to hold surgical instruments A61B46/23; for catheters A61M25/02
• 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 2/2427 Devices for manipulating or deploying heart valves during implantation

Abstract

A heart valve holder and packaging for supporting a bioprosthetic heart valve. The holder is attached to the heart valve, preferably with a single suture, and has a grip for either direct manual manipulation of the heart valve or for the attachment of a removable handle. A clip is provided which attaches to the heart valve holder and suspends the valve holder and the heart valve within a casing or jar. Ethanol or another suitable fluid within the jar protects the heart valve from biologic contamination, while the structure of the heart valve holder and clip protect the heart valve from physical damage. The valve holder, with attached heart valve, and the clip, can be removed from the jar as a single unit, and the clip can be detached from the heart valve holder.

Claims

1. A packaging system for a bioprosthetic heart valve comprising

a container for receiving said heart valve, said container having an interior surface defining a chamber,

a heart valve holder to which said heart valve can be releasably attached,

means for attaching said heart valve to said heart valve holder,

a clip which releasably clasps said heart valve holder for supporting said holder within said container and having a plate with an edge configured to contact said interior surface of said chamber and a first slot for receiving a portion of said heart valve holder, and

a lid removably mounted on said container to selectively enclose said heart valve holder and heart valve within said chamber.

2. The packaging system according to claim 1 wherein said plate further comprises a second slot, co-linear with said first slot, whereby compression of said second slot enlarges said first slot.

3. The packaging system according to claim 2 further comprising a ledge within said chamber for supporting said plate.

4. The packaging system according to claim 3 wherein said heart valve holder comprises post means for connecting with said first slot of said plate.

5. The packaging system according to claim 4 further comprising a handle selectively attached to said heart valve holder.

6. The packaging system according to claim 5 wherein said handle further comprises a bendable shaft.

7. The packaging system according to claim 6 further comprising a casing received within said chamber for providing said ledge within said chamber.

8. The packaging system according to claim 7 wherein said plate further comprises means for griping said plate to compress said second slot.

9. The packaging system according to claim 8 wherein said heart valve holder comprises

a valve holder plate attached to a distal end of said post means, said valve holder plate having

an outer edge, and

a lip extending distally from said outer edge, and

a plurality of arms extending radially outward from said valve holder plate,

means for securing a suture means to a first arm,

means for threading said suture means to at least a last arm, and

means for securing said suture means to at least said last arm.

10. The packaging system according to claim 9 wherein said plurality of arms further comprise at least one middle arm between said first arm and said last arm, each arm having at least two through bores, said middle arm having a scalpel slot for guiding a scalpel to cut said suture means.

11. A heart valve holder to which a bioprosthetic heart valve can be releasably attached, said heart valve holder comprising

post means for manipulating said heart valve holder,

a valve holder plate attached to a distal end of said post means, said valve holder plate having

an outer edge, and

a lip extending distally from said valve holder plate,

a plurality of arms extending radially outward from said outer edge of said valve holder plate,

means for securing a suture means to a first arm,

means for threading said suture means to at least a last arm, and

means for securing said suture means to at least said last arm.

12. The heart valve holder according to claim 11 wherein said plurality of arms further comprise at least one middle arm between said first arm and said last arm, each arm having at least two through bores, said middle arm having a scalpel slot for guiding a scalpel to cut said suture means.

13. A bioprosthetic heart valve and packaging system therefor comprising

a prosthetic heart valve having a central orifice and a circumferential sewing ring,

a container for receiving said head valve, said container having an interior surface defining a chamber and a ledge within said chamber,

a suture means

a heart valve holder to which said heart valve can be releasably attached by said suture means, said heart valve holder having

post means,

a valve holder plate attached to a distal end of said post means, said valve holder plate having

an outer edge, and

a lip extending distally from said outer edge, and

at least a first arm, a middle arm and a last arm, said arms extending radially outward from said valve holder plate, each arm having at least two through bores, said middle arm having a slot for guiding a scalpel to cut said suture means, said suture means being secured in one bore in said first arm, stitched into said heart valve, passed through the other bore in said first arm, along said valve holder plate adjacent said lip, through a first bore in said middle arm, stitched into said heart valve, passed around said middle arm, through another bore in said middle arm, along said valve holder plate adjacent said lip, through a first bore in said last arm, stitched into said heart valve, and secured in another bore in said last arm

a clip which releasably clasps said heart valve holder for supporting said holder within said container, said clip comprising

a plate having an edge configured to contact said ledge of said interior surface of said chamber,

a first slot for receiving a portion of said heart valve holder,

a second slot, co-linear with said first slot, whereby compression of said second slot enlarges said first slot, and

a lid removably mounted on said container to selectively enclose said heart valve holder and heart valve within said chamber.

14. The bioprosthetic heart valve and packaging system according to claim 13 wherein said middle arm further has two bores adjacent said scalpel slot and wherein said suture means passes through said bores adjacent said scalpel slot and across said scalpel slot.

15. In combination, a bioprosthetic heart valve and heart valve holder to which said bioprosthetic heart valve can be releasably attached, said bioprosthetic heart valve having a central orifice and a circumferential sewing ring and said heart valve holder comprising

post means for manipulating said heart valve holder,

a valve holder plate attached to a distal end of said post, said plate having

an outer edge, and

a lip extending distally from said outer edge, and

at least a first arm, a last arm and a middle arm between said first arm and said last arm, each arm having at least two through bores, said middle arm having a scalpel slot for guiding a scalpel, said arms extending radially outward from said valve holder plate,

suture means secured in one bore in said first arm, stitched into said heart valve, passed through the other bore in said first arm, along said valve holder plate adjacent said lip, through a first bore in said middle arm, stitched into said heart valve, passed across said slot in said middle arm, through another bore in said middle arm, along said valve holder plate adjacent said lip, through a first bore in said last arm, stitched into said head valve, and secured in another bore in said last arm.

16. The heart valve and heart valve holder according to claim 15 wherein said middle arm further has two bores adjacent said scalpel slot and wherein said suture means passes through said adjacent bores and across said scalpel slot.

17. The heart valve and heart valve holder according to claim 16 further comprising a handle selectively attached to said heart valve holder.

18. The heart valve and heart vlalve holder according to claim 17 wherein said handle further comprises a bendable shaft.