Mitral heart valve holder and storage system

• US 8,968,394 B2
• Filed: 05/11/2012
• Issued: 03/03/2015
• Est. Priority Date: 05/12/2011
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Murad, Michael C., Karapetian, Emil, Adzich, W. Vaso
• Primary Examiner(s): Nguyen, Tuan V
• Assistant Examiner(s): IGBOKO, CHIMA U
• Application Number:
  US13/469,975
• Publication Number:
  US 20120290079A1
• Time in Patent Office: 1,026 Days
• Field of Search: 623 21- 211, 623/900, 206/438
• US Class Current: 623/2.11
• 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 2/2427 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
• CPC Class Codes: A61F 2230/0006 circular
• CPC Class Codes: A61F 2250/001 for adjusting a diameter

Abstract

An improved holder and storage system for a tissue-type prosthetic mitral heart valve that constricts the commissure posts of the valve and prevents suture looping. A rod axially movable relative to the holder tensions lengths of attachment sutures that extend between the commissure post tips to create a tent and flex the tips inward, thus helping to prevent looping of any of an array of pre-implanted sutures around the leading tips during delivery of the valve. The holder has a safety mechanism that prevents valve delivery before the rod is deployed. One embodiment automatically deploys the rod upon opening a storage jar. One embodiment permits a delivery handle to directly deploy the rod, while another uses a separate worm screw and coupling. A holder clip that attaches to a packaging sleeve may be formed of flexible members meshed together from which the heart valve and holder are easily pulled free to eliminate a step of decoupling the clip from the sleeve.

Claims

1. A storage assembly for a flexible leaflet prosthetic heart valve that helps prevent suture looping, comprising:

a heart valve having an inflow end and an outflow end and a flow axis therebetween, the valve including a plurality of generally axially-extending flexible commissure posts that end in tips circumferentially-spaced around the outflow end that support occluding flexible leaflets of the valve;

a valve holder that contacts the inflow end of the valve, the valve holder defining a central aperture;

a plurality of attachment sutures each having a first end tied to the valve holder, a middle section that extends from the first end in an outflow direction to one of the commissure post tips, extends to another one of the commissure post tips, and then extends in an inflow direction back to the valve holder, and a second end tied to the valve holder, wherein the middle section crosses the flow axis of the valve between the commissure post tips;

an adapter shaped to conform to an inflow side of the valve holder and attached thereto, the adapter defining a central aperture generally aligned with the valve holder central aperture and having a bridge across the aperture with a threaded nut centered thereon; and

a commissure constriction rod arranged to slide longitudinally through the valve holder aperture and adapter aperture, the rod having a closed bottom end toward the outflow direction and an open top end toward the inflow direction surrounded by a rim larger than the aperture of the valve holder but smaller than the aperture of the adapter, wherein a male threaded member may be screwed through the threaded nut of the adapter until it contacts the closed bottom end of the rod and forces the rod in an outflow direction from an undeployed position into contact with the middle sections of the attachment sutures that cross the flow axis, the rod being movable farther in the outflow direction to a deployed position which places the attachment sutures in tension and accordingly pulls the commissure post tips inward.

2. The assembly of claim 1, wherein both the adapter and valve holder having through holes for receiving attachment sutures that couple the adapter and valve holder together.

3. The assembly of claim 2, wherein the valve holder includes at least one cutting guide thereon, and wherein the adapter covers a location on the valve holder where the attachment sutures to the prosthetic valve cross over the cutting guide, so as to impede detachment of the holder from the valve prior to detachment of the adapter from the holder.

4. The assembly of claim 1, further including a disc-shaped clip that removably couples to the adapter and extends outward from the prosthetic heart valve, a packaging sleeve connected to the clip that substantially surrounds the prosthetic heart valve without touching it, and a storage jar sized to closely receive the packaging sleeve, wherein the packaging sleeve and storage jar include anti-rotation features that limit their relative axial rotation.

5. The assembly of claim 4, wherein the clip defines a central aperture through which the commissure constriction rod slides, wherein the commissure constriction rod includes vertical slots that permit passage of the adapter bridge, and the clip includes inwardly-directed lugs that extend within the vertical slots, wherein the clip can only be removed laterally from the adapter after the commissure constriction rod has reached the deployed position.

6. The assembly of claim 4, wherein the clip comprises two flexible halves that mesh together along a mid-line in a manner that resists downward movement of the valve holder but permits the valve holder and heart valve to be axially pulled upward free of the clip.

7. The assembly of claim 1, wherein the commissure constriction rod includes opposed lockout pawls on cantilevered fingers that flex inward during passage through the valve holder aperture and spring outward underneath the valve holder to maintain the commissure constriction rod in the deployed position.

8. The assembly of claim 7, wherein the commissure constriction rod includes a second set of opposed lockout pawls on cantilevered fingers that flex inward during passage through the valve holder aperture and spring outward underneath the valve holder during movement from the undeployed to the deployed position.

9. A storage system for a flexible leaflet prosthetic heart valve that helps prevent suture looping, comprising:

a storage jar having a bottom portion and a lid;

a packaging sleeve that fits closely within the storage jar and defines a hollow inner space;

a disc-shaped clip connected to the packaging sleeve;

a heart valve having an inflow end and an outflow end and a flow axis therebetween, the valve including a plurality of generally axially-extending flexible commissure posts that end in tips circumferentially-spaced around the outflow end that support occluding flexible leaflets of the valve;

a valve holder that contracts the inflow end of the valve and has a central aperture, the valve holder being removable secured to the disc-shaped clip such that the heart valve is suspended within the hollow inner space of the packaging sleeve;

a bridge held stationary with respect to the valve holder and having a threaded nut thereon;

a plurality of attachment sutures each having first and second ends tied to the valve holder and a middle section that extends along two of the valve commissure posts and crosses the flow axis of the valve between the commissure post tips;

a commissure constriction rod arranged to slide longitudinally through the valve holder aperture, the rod having a closed bottom end toward the outflow direction and an open top end toward the inflow direction leading to an interior space;

a worm screw having threads that engage those of the threaded nut and positioned at least partly within the interior space of the commissure constriction rod; and

a screw couple having engagement structure for contacting and rotating a proximal end of the worm screw and being removably attachable to a proximal end of the commissure constriction rod, and wherein the screw couple may be detached from the commissure constriction rod and removed, leaving the worm screw engaged with the threaded nut,

wherein rotation of the screw couple advances the worm screw along the threaded nut until it contracts the closed bottom end of the commissure constriction rod displaces the rod in an outflow direction from an undeployed position until it contacts the middle sections of the attachment sutures on the flow axis connecting the valve holder to the prosthetic heart valve, the rod then being movable farther in the outflow direction to a deployed position which places the attachment sutures in tension and accordingly pulls the commissure post tips inward; and

wherein the bridge and threaded nut are integrally formed with the valve holder; and

wherein the commissure constriction rod is bifurcated by a pair of axial slots which permit passage around the bridge on the valve holder.

10. The system of claim 9, wherein the commissure constriction rod includes opposed lockout pawls that flex inward during passage through the valve holder aperture and spring outward underneath the valve holder to maintain the commissure constriction rod in the deployed position.

11. The system of claim 9, wherein the closed bottom end of the commissure constriction rod has a guide depression formed therein facing the interior space that receives a bottom end of the worm screw.

12. The system of claim 9, further including an adapter sleeve that receives and retains a portion of the screw couple and permits free rotation thereof, the adapter sleeve having a flange for removably attaching to a proximal end of the commissure constriction rod, wherein the screw couple may be rotated from a proximal side of the adapter sleeve.

13. The system of claim 12, wherein the adapter sleeve attaches to the proximal end of the commissure constriction rod with sutures, and wherein the adapter sleeve and screw couple can be removed from engagement with the commissure constriction rod by severing the sutures.

14. The system of claim 9, wherein the screw couple includes internal threading at a proximal end for mating with a male threaded member.

15. A storage system for a flexible leaflet prosthetic heart valve that automatically actuates a commissure constriction mechanism, comprising:

a storage jar having a bottom portion and a lid attached thereon;

a heart valve having an inflow end and an outflow end and a flow axis therebetween, the valve including a plurality of generally axially-extending flexible commissure posts that end in tips circumferentially-spaced around the outflow end that support occluding flexible leaflets of the valve;

a valve holder including a mechanism for pulling the commissure post tips inward; and

structure within the storage jar that actuates the mechanism for pulling the commissure post tips inward solely by detaching the lid from the bottom portion.

16. The system of claim 15, wherein the structure within the storage jar includes a male threaded member projecting downward from the jar lid, and the mechanism for pulling the commissure post tips inward includes a female threaded portion that the male threaded member engages.

17. The system of claim 16, wherein the valve holder contacts the inflow end of the valve and has a central aperture, and the mechanism for pulling the commissure post tips inward includes a plurality of attachment sutures each having first and second ends tied to the valve holder and a middle section that extends along two of the valve commissure posts and crosses the flow axis of the valve between the commissure post tips, and a commissure constriction rod arranged to slide longitudinally through the valve holder aperture, the rod having the female threaded portion therein, wherein the male threaded member forces the rod in an outflow direction from an undeployed position until it contacts the middle sections of the attachment sutures on the flow axis connecting the valve holder to the prosthetic heart valve, the rod then being movable farther in the outflow direction to a deployed position which places the attachment sutures in tension and accordingly pulls the commissure post tips inward.

18. The system of claim 17, wherein the commissure constriction rod includes opposed lockout pawls on cantilevered fingers that flex inward during passage through the valve holder aperture and spring outward underneath the valve holder to maintain the commissure constriction rod in the deployed position.

19. The system of claim 15, wherein the valve holder contacts the inflow end of the valve and has a central aperture, and the mechanism for pulling the commissure post tips inward includes a plurality of attachment sutures each having first and second ends tied to the valve holder and a middle section that extends along two of the valve commissure posts and crosses the flow axis of the valve between the commissure post tips, and a commissure constriction rod arranged to slide longitudinally through the valve holder aperture in an outflow direction from an undeployed position until it contacts the middle sections of the attachment sutures on the flow axis connecting the valve holder to the prosthetic heart valve, the rod then being movable farther in the outflow direction to a deployed position which places the attachment sutures in tension and accordingly pulls the commissure post tips inward.

20. The system of claim 15, further including a packaging sleeve that fits closely within the storage jar bottom portion and a holder clip attached to the top of packaging sleeve, the holder clip having a central aperture that retains the valve holder suspended over a cavity within the packaging sleeve such that the prosthetic heart valve resides within the cavity of the packaging sleeve, and wherein the holder clip comprises two flexible halves that mesh together along a mid-line in a manner that resists downward movement of the valve holder but permits the valve holder and heart valve to be axially pulled upward free of the holder clip.