Edwards Lifesciences Corporation

Cuong Ton-That

Robert Stobie

Jerry L Jackman

C Roger Ekholm

Steve Newborg

Hung Ly Lam

Son Van Nguyen

Roger C Ekholm

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.

Heart valve holders and handling clips therefor

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.

Method for retrofitting a heart valve holder

A donor heart valve sizer and method of sizing to increase the quality and yield of, and decrease the expense of fabricating, prosthetic heart valves. The sizer includes an axially-extending sizing portion sized to fit within the lumen of a donor heart valve. The sizing portion may be conical such that a resistance to further insertion is felt when the exterior of the sizing portion contacts the annulus of the valve. A measuring bracket attached to the sizing portion includes a scale aligned with the sizing portion that indicates the final expected valve size based on the position of the fresh donor valve on the sizing portion. The measuring bracket includes regions of acceptable valve sizes, and may also include regions of unacceptable valve sizes. A method of sizing includes utilizing the sizer in the slaughterhouse to reduce the overall number of valves shipped to the valve assembly facility to obtain a particular valve size. The sizer and method are particular useful for sizing xenograft valves, especially porcine aortic valves. The sizing portion may be made of polytetrafluoroethylene, and have an included taper of approximately 4&deg;.

Fresh donor heart valve sizer and method of use

Heart valve holder for constricting the valve commissures and methods of use

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Irvine, CA, United States of America

Cuong Ton-That