Methods of deploying a mitral heart valve

Patent metadata

Field	Value
Publication number	US-9861478-B2
Application number	US-201615076107-A
Country	US
Kind code	B2
Filing date	Mar 21, 2016
Priority date	May 12, 2011
Publication date	Jan 9, 2018
Grant date	Jan 9, 2018

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.

First claim

What is claimed is:

1. A method for preparing and deploying a prosthetic mitral valve with reduced suture entanglement, the method comprising:
opening a storage jar having a bottom portion and a jar lid attached thereon by detaching the jar lid from the bottom portion, the bottom portion containing a prosthetic mitral valve having an inflow end, an outflow end, and a flow axis therebetween, the valve further 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, wherein detaching the jar lid from the bottom portion automatically activates a commissure constriction mechanism to flex the commissure post tips inward;
removing the valve from within the storage jar;
threading an array of implantation sutures pre-installed at a mitral valve annulus through a sewing ring of the valve;
advancing the valve along the array of implantation sutures until the sewing ring contacts the mitral valve annulus, the valve being advanced with the commissure posts leading and the commissure post tips flexed inward to reduce entanglement between the implantation sutures and the commissure posts;
tying down the implantation sutures;
de-activating the commissure constriction mechanism to permit the commissure posts to flex outward.

2. The method of claim 1 , wherein a valve holder is attached to the inflow end of the valve and the valve is stored in the storage jar with the inflow end oriented toward the jar lid, and wherein the step of removing the valve from within the storage jar comprises attaching a delivery handle to the valve holder.

3. The method of claim 2 , wherein the commissure constriction mechanism is connected to the valve holder, and wherein the valve holder is attached to the sewing ring and detaching the valve holder from the sewing ring causes de-activation of the commissure constriction mechanism.

4. The method of claim 2 , wherein the commissure constriction mechanism comprises a commissure constriction rod configured to translate axially relative to the valve holder and positioned with a distal end thereof adapted to hold a trefoil arrangement of attachment sutures spanning the commissure post tips in a tented arrangement, thereby flexing the commissure posts radially inward, and wherein unscrewing the jar lid from the bottom portion advances the commissure constriction rod axially from a proximal position out of contact with the trefoil arrangement of attachment sutures to a distal position in contact with the trefoil arrangement of attachment sutures.

5. The method of claim 4 , wherein the commissure constriction rod includes opposed lockout pawls on cantilevered fingers that flex inward during passage through the valve holder and spring outward underneath the valve holder to maintain the commissure constriction rod in the deployed position.

6. The method of claim 2 , 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, the method including removing an assembly of the valve holder, valve, holder clip, and packaging sleeve from the storage jar, detaching the packaging sleeve from the holder clip, and detaching the holder clip from the valve holder.

7. The method of claim 2 , 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, 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, the method including removing an assembly of the valve holder and valve from the storage jar by pulling it through the two flexible halves of the holder clip.

8. The method of claim 7 , wherein a valve holder is attached to the inflow end of the valve and the valve is stored in the storage jar with the inflow end oriented toward the jar lid, and wherein the valve holder has a central aperture, and the commissure constriction mechanism comprises a commissure constriction rod configured to translate axially relative to the valve holder and positioned with a distal end thereof adapted to hold a trefoil arrangement of attachment sutures spanning the commissure post tips in a tented arrangement, thereby flexing the commissure posts radially inward, the commissure constriction rod having the female threaded nut therein, wherein unscrewing the jar lid from the bottom portion rotates the male threaded member which in turn axially advances the female threaded nut and commissure constriction rod axially from a proximal position out of contact with the trefoil arrangement of attachment sutures to a distal position in contact with the trefoil arrangement of attachment sutures.

9. The method of claim 1 , including structure attached to the jar lid that activates the commissure constriction mechanism when detaching the jar lid from the bottom portion.

10. The method of claim 9 , wherein the structure attached to the jar lid includes a male threaded member projecting downward from the jar lid, and the commissure constriction mechanism includes a female threaded nut that the male threaded member engages, wherein detaching the jar lid from the bottom portion comprises unscrewing the jar lid from the bottom portion.

11. A method for preparing and deploying a prosthetic mitral valve with reduced suture entanglement, the method comprising:
opening a storage jar having a bottom portion and a jar lid attached thereon by detaching the jar lid from the bottom portion, the bottom portion containing a prosthetic mitral valve having an inflow end, an outflow end, and a flow axis therebetween, the valve further 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, wherein a valve holder is attached to the inflow end of the valve and the valve is stored in the storage jar with the inflow end oriented toward the jar lid, and wherein a holder clip held within the jar retains the valve holder suspended in the jar, wherein the holder clip has a central aperture that retains the valve holder suspended over a cavity within the storage jar bottom portion, the holder clip comprising two flexible halves that mesh together along a mid-line so as to resist downward movement of the valve holder but flex upward to permit the valve holder and valve to be axially pulled upward free of the holder clip, and wherein the step of removing the valve holder and valve from the storage jar comprises removing an assembly of the valve holder and valve from the storage jar by pulling it through the two flexible halves of the holder clip,
activating a commissure constriction mechanism to flex the commissure post tips inward, the commissure constriction mechanism comprising a commissure constriction rod configured to translate axially relative to the valve holder and positioned with a distal end thereof adapted to hold a trefoil arrangement of attachment sutures spanning the commissure post tips in a tented arrangement, thereby flexing the commissure posts radially inward, the commissure constriction mechanism activated by rotating a first threaded member engaged with a second thre

Assignees

• Edwards Lifesciences Corp

Inventors

• Murad Michael C
• Karapetian Emil
• Adzich Wesley V

Classifications

• A61F2220/0075

  sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable · CPC title

• A61F2250/001

  for adjusting a diameter · CPC title

• A61F2/2409

  Support rings therefor, e.g. for connecting valves to tissue (annuloplasty rings A61F2/2442) · CPC title

• A61F2/2412

  with soft flexible valve members, e.g. tissue valves shaped like natural valves · CPC title

• A61F2230/0006

  circular · CPC title