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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 cre

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.

대표청구항 ▼

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

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 threaded member of the commissure constriction mechanism to cause one of the first or second threaded member to translate axially relative to the valve holder and simultaneously causing the commissure post tips to flex inward;removing the valve holder and valve from 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; andde-activating the commissure constriction mechanism to permit the commissure posts to flex outward. 12. The method of claim 11, wherein the holder clip halves each include a pair of flexible tab extensions and a pair of tab receptacles, one of each on either side of the central aperture, and each tab extension fits closely into a tab receptacle of the other half—with the extensions above the receptacles. 13. The method of claim 11, wherein the first threaded member is a male threaded member, and the second threaded member is a female threaded portion that translates axially relative to the valve holder and causes the commissure post tips to flex inward. 14. The method of claim 11, wherein the first threaded member is a male threaded member on a distal end of a delivery handle, and the second threaded member is a female threaded nut on the valve holder, wherein the male threaded member engages and advances through the female threaded nut on the valve holder and causes the commissure post tips to flex inward. 15. The method of claim 11, wherein the first threaded member is a male threaded worm screw positioned within the commissure constriction rod, and the second threaded member is a female threaded nut on the valve holder, wherein the male threaded worm screw engages and advances through the female threaded nut on the valve holder and causes the commissure post tips to flex inward. 16. The method of claim 11, 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. 17. The method of claim 11, wherein the assembly of the valve holder and valve is removed from the storage jar prior to the step of activating the commissure constriction mechanism. 18. 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 is coupled to and retains the valve holder suspended in the jar,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 threaded member of the commissure constriction mechanism to cause one of the first or second threaded member to translate axially relative to the valve holder and simultaneously causing the commissure post tips to flex inward, wherein activating the commissure constriction mechanism also permits the holder clip to be decoupled from the valve holder;decoupling and removing the holder clip from the valve holder;removing the valve holder and valve from 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; andde-activating the commissure constriction mechanism to permit the commissure posts to flex outward. 19. The method of claim 18, wherein the holder clip has a pair of latches that couple to the valve holder and a central aperture having a lateral opening with inwardly-directed lugs that extend within slots in the valve holder, and lateral removal of the holder clip from the valve holder is prevented by the interference between the lugs and slots until the commissure constriction mechanism has been activated. 20. The method of claim 18, further including an adapter shaped to conform to an inflow side of the valve holder and attached thereto, wherein the valve holder includes at least one suture cutting guide thereon, and wherein the adapter covers a location on the valve holder where attachment sutures to the valve cross over the cutting guide, so as to prevent severing of the sutures prior to detachment of the adapter from the holder.