Heart valve holders and handling clips therefor

• US 20040138741A1
• Filed: 12/19/2003
• Published: 07/15/2004
• Est. Priority Date: 07/27/2000
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Stobie, Robert, Ekholm, C. Roger, Newborg, Steve, Jackman, Jerry L., Ton-That, Cuong
• Granted Patent: US 7,819,915 B2
• Time in Patent Office: Days
• US Class Current: 623/2.11
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation

Abstract

An improved holder, system and method for implanting a tissue-type prosthetic heart mitral valve that constricts the commissure posts of the valve and allows the user to detach the handle of the holder prior to withdrawing the holder itself. The ability to remove the handle allows a surgeon greater access to suturing the prosthetic valve to the mitral annulus. The holder may include two relatively movable plates, one of which attaches to the valve sewing on the inflow end of the valve ring and the other which attaches via sutures to the valve commissures on the outflow end. Separation of the plates places the sutures in tension and constricts the commissures. An adjusting member or adapter is interposed between the handle and holder to enable separation of the two plates and removal of the handle. The adjusting member or adapter may be packaged with the valve and holder combination, or may be sold as a separate unit, possibly with the handle, so that prior art holders can be retrofit. Removable storage and handling clips secure the holder and heart valve assembly within a storage jar during transportation. A kit of a number of identical storage and handling clips and holders for different diameter tissue-type prosthetic heart valves may be provided.

Claims

1. A kit of storage and handling clips and heart valve holders for different diameter tissue-type prosthetic heart valves, the heart valves each having an inflow end and an outflow end and a flow axis therebetween, each valve including an annular sewing ring at the inflow end, the kit comprising:

a set of holders each adapted to attach to the sewing ring at the inflow end of a valve and having a generally planar portion including a plurality of tangs radiating from a central body to cover a portion of the sewing ring, the tangs being radially dimensioned to correspond to the diameter of the respective sewing ring, and each holder including a plurality of peripheral notches in the planar portion; and

a plurality of identical storage and handling clips each having structure for engaging the peripheral notches in any one of the holders.

2. The kit of claim 1, wherein the planar portion of each holder is generally triangular in shape with the tangs at the apices and one of the peripheral notches located adjacent each tang.

3. The kit of claim 2, wherein the planar portion of each holder includes three generally linear sides extending between the apical tangs so as to form the triangular shape, wherein each linear side is interrupted by a clip-engaging peripheral notch.

4. The kit of claim 1, wherein each clip comprises a disk portion and a handle pivotally attached to one side thereof.

5. The kit of claim 4, wherein the disk portion is generally C-shaped and the clip is molded of a polymer.

6. The kit of claim 4, wherein the handle is formed by a semi-circular strip pivotable with respect to the disk portion such that it lies generally parallel to the plane of the disk portion until pulled upward by a user.

7. The kit of claim 6, wherein the clip is molded of a polymer with the ends of the semi-circular handle being attached to the disk portion by living hinges.

8. The kit of claim 1, wherein each clip comprises a disk portion with the structure for engaging the peripheral notches including fingers extending generally axially from one side thereof.

9. The kit of claim 8, wherein each finger includes an inwardly directed pawl shaped to engage a corresponding peripheral notch.

10. The kit of claim 8, wherein there are three peripheral notches in each holder and three fingers on each clip, the fingers and notches being evenly spaced around a common axis of the holder and clip and equidistantly radially-spaced from the axis.

11. A kit of handling clips and heart valve holders for different diameter prosthetic heart valves, the heart valves each having an inflow end and an outflow end and a flow axis therebetween, the kit comprising:

a set of differently-sized holders each adapted to attach to a heart valve at the inflow end thereof and being radially dimensioned to correspond to the diameter of the respective heart valve; and

a plurality of handling clips all having identically-sized structure for coupling the clip to any one of the holders.

12. The kit of claim 11, wherein each holder has a generally planar portion including a plurality of tangs radiating from a central body and a plurality of peripheral notches for receiving the structure for coupling the clip, wherein the planar portion of each holder is generally triangular in shape with the tangs at the apices and one of the peripheral notches located adjacent each tang.

13. The kit of claim 12, wherein the planar portion of each holder includes three generally linear sides extending between the apical tangs so as to form the triangular shape, wherein each linear side is interrupted by a clip-coupling peripheral notch.

14. The kit of claim 11, wherein each clip comprises a disk portion and a handle pivotally attached to one side thereof.

15. The kit of claim 14, wherein the disk portion is generally C-shaped and the clip is molded of a polymer.

16. The kit of claim 14, wherein the handle is formed by a semi-circular strip pivotable with respect to the disk portion such that it lies generally parallel to the plane of the disk portion until pulled upward by a user.

17. The kit of claim 16, wherein the clip is molded of a polymer with the ends of the semi-circular handle being attached to the disk portion by living hinges.

18. The kit of claim 11, wherein each clip comprises a disk portion with the structure for coupling to the holder including fingers extending generally axially from one side thereof.

19. The kit of claim 18, wherein each finger includes an inwardly directed pawl shaped to engage a corresponding peripheral notch provided in the holder.

20. The kit of claim 18, wherein there are three peripheral notches in each holder and three fingers on each clip, the fingers and notches being evenly spaced around a common axis of the holder and clip and equidistantly radially-spaced from the axis.