Prosthetic heart valve packaging and deployment system

• US 8,869,982 B2
• Filed: 12/15/2010
• Issued: 10/28/2014
• Est. Priority Date: 12/18/2009
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Hodshon, Fred, Pintor, Rafael, Yambao, August, Gautam, Abhishek, Campbell, Louis A., Farhat, Lawrence, Huntley, Tammy, Kalam, Faisal, Oba, Travis, Zeng, Qinggang
• Primary Examiner(s): Bui, Luan K
• Assistant Examiner(s): ORTIZ, RAFAEL ALFREDO
• Application Number:
  US12/969,238
• Publication Number:
  US 20110147251A1
• Time in Patent Office: 1,413 Days
• Field of Search: 206/438, 206/210, 206/363, 623/900, 623/2, 623/2.41, 623/2.11, 534/67
• US Class Current: 206/438
• 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 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• 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 2/2418 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 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable

Abstract

Packaging for prosthetic heart valves including an assembly for securely retaining a heart valve within a jar and facilitating retrieval therefrom. The assembly includes a packaging sleeve that fits closely within the jar and has a clip structure for securing a valve holder. Contrary to previous designs, in one embodiment the valve holder is directed downward into the jar, and the valve is retained with an inflow end upward. The valve may have flexible leaflets, and a leaflet parting member on the end of the shaft extends through the leaflets and couples with the valve holder. The assembly of the packaging sleeve, valve, and holder can then be removed from the jar and a valve delivery tube connected with the holder, or to the leaflet parting member. The packaging sleeve may be bifurcated into two halves connected at a living hinge to facilitate removal from around the valve/holder subassembly. The packaging system facilitates attachment of the valve delivery tube for use in a quick-connect valve implant procedure.

Claims

1. A packaging sleeve formed from a single molded component for securing a prosthetic heart valve within a jar, comprising:

a generally planar clip having a peripheral edge and an entry slot leading therefrom to a central docking aperture wider than the entry slot, the clip being defined by two substantially similar halves pivotally connected together at a living hinge at the peripheral edge of the clip opposite from the entry slot;

a plurality of lower legs extending downward from the clip that together elevate the clip above and generally parallel to a flat surface on which the sleeve is placed;

a plurality of upstanding posts having longer lengths than the legs and projecting upward from the clip, at least one post being provided on each of the two halves of the clip; and

a plurality of axial ribs extending upward from the clip, at least some of which are distributed around an approximately semi-circular reinforcing wall.

2. The sleeve of claim 1, wherein the clip halves are generally semi-circular with contoured inner edges defining the entry slot, the entry slot forming an increasing gap from the docking aperture radially outward.

3. The sleeve of claim 1, wherein there are two upstanding posts that project upward from the peripheral edge of the clip at locations that are approximately diametrically opposite around the clip.

4. The sleeve of claim 1, wherein the upstanding posts extend upward from the clip to a height of between about 60-80% of the overall axial sleeve height.

5. The sleeve of claim 1, wherein the axial ribs align generally radially around the central docking aperture.

6. The sleeve of claim 1, wherein each of the lower legs extends downward from the peripheral edge of the clip and includes a main wall portion with a slight curvature conforming to the peripheral edge, and an axial rib projecting outward from the main wall portion.

7. A packaged prosthetic heart valve assembly, comprising:

a jar having a closed bottom and an open top end closed with a lid, the jar having an axial depth greater than the lid;

a prosthetic heart valve having an inflow end and an outflow end;

a valve holder that holds the valve during delivery attached to the valve with at least one suture, wherein the valve holder is attached to the prosthetic heart valve with the at least one suture that passes through fabric in the valve and across a cutting guide in the holder to enable the holder to be pulled free from the valve when the suture is severed; and

a packaging sleeve sized to fit closely within the jar and rest on the bottom thereof, the sleeve having structure to which the valve holder removably couples such that the holder is located below the prosthetic heart valve when stored within the jar.

8. The assembly of claim 7, wherein the packaging sleeve comprises at least two components, one of the components being a generally planar clip and the other component circumscribing the clip and extending substantially the entire axial height of the jar between the bottom and the lid.

9. The assembly of claim 7, wherein the packaging sleeve comprises a single molded component having a plurality of lower legs extending downward from a generally planar clip that together elevate the clip above and generally parallel to the jar bottom, and a plurality of upstanding posts having longer lengths than the legs projecting upward from the clip into proximity with the jar lid, and the structure to which the valve holder removably couples is a central docking aperture of a generally planar clip that has an entry slot open to the central docking aperture.

10. The assembly of claim 7, wherein the packaging sleeve is defined by two substantially similar halves pivotally connected together at a living hinge at the peripheral edge of the sleeve.

11. The assembly of claim 7, wherein the structure to which the valve holder removably couples is a central docking aperture of a generally planar clip from which a plurality of axial ribs extend upward and emanate generally radially from the central docking aperture, and wherein the valve holder includes a central hub and legs projecting radially outward therefrom, wherein at least one of the axial ribs interferes with rotation of one of the valve holder legs when the valve holder is positioned in the central docking aperture to prevent rotation of the holder relative to the clip.

12. The assembly of claim 7, wherein the packaging sleeve includes at least one axial anti-rotation rib projecting outward from its periphery, and the jar includes at least one rail projecting inward from an inner wall that interferes with movement of the anti-rotation rib to limit rotation of the sleeve within the jar.

13. The assembly of claim 7, wherein the holder includes a central hub and three legs that extend outward therefrom into contact with three locations on the prosthetic heart valve, and the at least one suture attaching the holder to the valve passes between each holder leg and the corresponding location on the heart valve to secure all three legs to the valve.

14. The assembly of claim 7, wherein the holder further includes a central hub having threading that mates with threading on an element of a delivery system.

15. A packaged prosthetic heart valve assembly, comprising:

a jar having a closed bottom and an open top end closed with a lid, the jar having an axial depth greater than the lid;

a prosthetic heart valve having an inflow end and an outflow end;

a valve holder attached to the valve; and

a packaging sleeve formed from a single molded component sized to fit closely within the jar having a generally planar clip with a peripheral edge and an entry slot leading therefrom to a central docking aperture wider than the entry slot, a plurality of lower legs extending downward from the clip that together elevate the clip above and generally parallel to jar bottom, and a plurality of upstanding posts having longer lengths than the legs projecting upward from the clip into proximity with the jar lid, wherein the valve holder couples to the central docking aperture of the clip such that the holder is elevated from the bottom of the jar and located below the prosthetic heart valve when stored within the jar.

16. The assembly of claim 15, wherein there are only two upstanding posts that project upward from the peripheral edge of the clip at locations that are approximately diametrically opposite around the clip.

17. The assembly of claim 15, further including a plurality of axial ribs extending upward from the clip and emanating generally radially from the central docking aperture, and wherein the valve holder includes a central hub and legs projecting radially outward therefrom, wherein at least one of the axial ribs interferes with rotation of one of the valve holder legs when the valve holder is positioned in the central docking aperture to prevent rotation of the holder relative to the clip.

18. The assembly of claim 15, wherein each of the lower legs extends downward from a peripheral edge of the clip and includes a main wall portion and an axial anti-rotation rib projecting outward from the main wall portion, and the jar includes at least one rail projecting inward from an inner wall that interferes with movement of the anti-rotation rib to limit rotation of the sleeve within the jar.

19. The assembly of claim 15, wherein the clip is defined by two substantially similar halves pivotally connected together at a living hinge at the peripheral edge of the clip opposite from the entry slot.

20. A packaged prosthetic heart valve assembly, comprising:

a jar having a closed bottom and an open top end closed with a lid, the jar having an axial depth greater than the lid;

a prosthetic heart valve having an inflow end and an outflow end;

a valve holder attached to the valve; and

a packaging sleeve having a generally circular periphery as seen from above that fits closely within the jar and an axial dimension that extends substantially the entire axial height of the jar between the bottom and the lid, the packaging sleeve further including a generally planar clip extending radially across the interior of the jar substantially closer to the jar bottom than to the lid, the clip having an entry slot extending from a peripheral edge to a central docking aperture wider than the entry slot, wherein the valve holder couples to the central docking aperture of the clip such that the holder is located below the prosthetic heart valve when stored within the jar.

21. The assembly of claim 20, wherein the packaging sleeve comprises at least two components, one of the components being the generally planar clip and the other component circumscribing the clip and extending substantially the entire axial height of the jar between the bottom and the lid.

22. The assembly of claim 20, further including a plurality of axial ribs extending upward from the clip and emanating generally radially from the central docking aperture, and wherein the valve holder includes a central hub and legs projecting radially outward therefrom, wherein at least one of the axial ribs interferes with rotation of one of the valve holder legs when the valve holder is positioned in the central docking aperture to prevent rotation of the holder relative to the clip.

23. The assembly of claim 20, wherein the sleeve includes at least one axial anti-rotation rib projecting outward from the generally circular periphery, and the jar includes at least one rail projecting inward from an inner wall that interferes with movement of the anti-rotation rib to limit rotation of the sleeve within the jar.

24. The assembly of claim 20, wherein the packaging sleeve comprises a single molded component having a plurality of lower legs extending downward from the clip that together elevate the clip above and generally parallel to jar bottom, and a plurality of upstanding posts having longer lengths than the legs projecting upward from the clip into proximity with the jar lid.

25. A packaging sleeve formed from a single molded component for securing a prosthetic heart valve within a jar, comprising:

a generally planar clip having a peripheral edge and an entry slot leading therefrom to a central docking aperture wider than the entry slot, the clip being defined by two substantially similar halves pivotally connected together at a living hinge at the peripheral edge of the clip opposite from the entry slot;

a plurality of lower legs extending downward from the clip that together elevate the clip above and generally parallel to a flat surface on which the sleeve is placed; and

a plurality of upstanding posts having longer lengths than the legs and projecting upward from the clip, at least one post being provided on each of the two halves of the clip, wherein each of the upstanding posts extends upward adjacent the peripheral edge of the clip and includes a main wall portion having a slight curvature generally tracking the peripheral edge, and an axial reinforcing rib projecting outward from the main wall portion.

26. The assembly of claim 25, wherein each of the lower legs extends downward from the peripheral edge of the clip and includes a main wall portion with a slight curvature conforming to the peripheral edge, and an axial rib projecting outward from the main wall portion.

27. A packaged prosthetic heart valve assembly, comprising:

a jar having a closed bottom and an open top end closed with a lid, the jar having an axial depth greater than the lid;

a prosthetic heart valve having an inflow end and an outflow end;

a valve holder that holds the valve during delivery attached to the valve with at least one suture, wherein the holder further includes a central hub having threading that mates with threading on an element of a delivery system; and

a packaging sleeve sized to fit closely within the jar and rest on the bottom thereof, the sleeve having structure to which the valve holder removably couples such that the holder is located below the prosthetic heart valve when stored within the jar.