Edwards Lifesciences Corporation

Baxter International Inc.

Ralph Kafesjian

Hung Ly Lam

Than Nguyen

Van Le Huynh

Xiaoming G Guo

Diana Nguyen-Thien-Nhon

Robert Stobie

Jianbo Zhou

Carlos M Romero

Myron Howanec, Jr

Adrian Benton James

Andrzej Skoskiewicz

Robert Ian Lister

Aaron Ernesto Sklar

Banny Banerjee

Delos M Cosgrove, Iii

Can B Hu

Keith E Myers

David W Wieting

Myron J Howanec

Delos M Cosgrove

Myron Jr Howanec

An improved holder and method for implanting a tissue-type prosthetic mitral heart valve that prevents suture looping and ma y also constrict the commissure posts of the valve. An upstanding or shaft member axially positioned on the holder causes the lengths of attachment sutures to extend axially beyond the commissure post tips to create a tent and prevent looping of any of an array of pre-implanted sutures around the tips during deployment of the valve. The shaft member may be axially movable such that it can be initially retracted and then actuated just prior to valve deployment. The shaft member may have notches on its distal tip for capturing the attachment sutures, which are crossed over along the valve axis to ensure engagement by the notches. The attachment sutures may be strands or filaments, or may be wider bands of flexible biocompatible material. If bands are used, they desirably cover the commissure post tips to further help prevent suture looping thereover. The flexible lengths of material extend directly between commissures of the valve, or may extending radially inward from each commissure to a central upstanding member.

Heart valve holder and method for resisting suture looping

An improved holder and method for implanting a tissue-type prosthetic mitral heart valve that prevents suture looping and may also constrict the commissure posts of the valve. An upstanding or shaft member axially positioned on the holder causes the lengths of attachment sutures to extend axially beyond the commissure post tips to create a tent and prevent looping of any of an array of pre-implanted sutures around the tips during deployment of the valve. The shaft member may be axially movable such that it can be initially retracted and then actuated just prior to valve deployment. The shaft member may have notches on its distal tip for capturing the attachment sutures, which are crossed over along the valve axis to ensure engagement by the notches. The attachment sutures may be strands or filaments, or may be wider bands of flexible biocompatible material. If bands are used, they desirably cover the commissure post tips to further help prevent suture looping thereover. The flexible lengths of material extend directly between commissures of the valve, or may extending radially inward from each commissure to a central upstanding member.

Prosthetic heart valve suture rings having a suturable annulus of a compliant internal member and a cloth covering. Three evenly spaced upwardly opening depressions formed on an internal circumference of the suturable annulus receive downwardly-directed cusps of a stent structure of the heart valve. The suture ring may include a silicone sponge waffle annulus having a walled lip on an inner circumference thereof. The lip is contoured to include the three depressions, and a ring washer mounts on the annulus surrounding the walled lip for added stiffness.

Contoured heart valve suture rings

The present invention provides methods for preparing tissue for incorporation into xenografts and bioprosthetic devices. The methods of the invention make use of supercritical fluids to remove infectious materials and chemical agents from tissues, as well as to permeate a tissue with a chemical agent (e.g. tanning, cross-linking, and bioactive agents).

Supercritical fluid extraction process for tissue preparation

An improved holder, system and method for implanting a tissue-type prosthetic mitral heart valve that prevents suture looping and may also constrict the commissure posts of the valve. 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 or similar expedient to the valve commissures on the outflow end. Separation of the plates places the sutures in tension and constricts the commissures. The sutures may be strands or filaments, or may be wider bands of flexible biocompatible material. If bands are used, they desirably cover the commissure post tips to further help prevent suture looping thereover. The flexible lengths of material extend directly between commissures of the valve, or may extending radially inward from each commissure to a central upstanding member. Desirably, a slide is created by the flexible lengths of material adjacent each commissure post, for example by crossing over suture filaments at or radially inward from the commissure posts. If an upstanding member is used, the lengths of suture extend axially beyond the commissure post tips to create a tent that wards off sutures that otherwise might loop around the tips during advancement of the valve along an array of pre-implanted sutures.

Heart valve holder that resist suture looping

Improved, adaptable tissue-type heart valves and methods for their manufacture are disclosed wherein a dimensionally stable, pre-aligned tissue leaflet subassembly is formed and its peripheral edge clamped between and attached to an upper shaped wireform and a lower support stent. A variety of adaptable structural interfaces including suture rings, flanges, and conduits may be attached to the support stent with or without an outlet conduit disposed about the wireform to provide a tissue-type heart valve adaptable for use in either a natural heart or in mechanical pumping devices. The methods include forming individual leaflets with a template and using the template to attach the leaflets together to form a tissue leaflet subassembly. The template and leaflets include a straight edge terminating in oppositely directed tabs, and a curvilinear cusp edge extending opposite the straight edge. The template may include a guide slot in its straight edge and the assembly includes aligning two leaflet tabs with the template and passing sutures through the guide slot and through the leaflet tabs. The leaflet subassembly is mated to a wireform with the tabs extending through commissure posts of the wireform. A support stent having an upper surface matching the lower surface of the wireform sandwiches the edges of the leaflet subassembly therebetween. Separated tabs on the leaflet subassembly are passed through the wireform commissures and attached to adjacent stent commissures so as to induce clamping of the leaflet tabs between the stent commissures and wireform commissures upon a radially inward force being applied to the leaflets.

Heart valves and suture rings therefor

Heart valve leaflet selection methods and apparatuses which subject individual leaflets to loads and measure the resulting deflection to more reliably group leaflets of similar physical characteristics for later assembly in prosthetic heart valves. The deflection testing may be accomplished using a variety of test set ups which are designed to impart a load on the leaflet which simulates the actual loading within a heart valve. The results from a number of deflection tests are used to categorize individual leaflets, which data can be combined with other data regarding the characteristics of the leaflet to better select leaflets for assembly into a multi-leaflet heart valve. In one embodiment, the deflection test is combined with an intrinsic load test, and leaflets having similar deflection and intrinsic load values used in the same heart valve. One apparatus for testing the leaflets includes a frame for securing the arcuate cusp of the leaflet while the straight coapting edge remains free, to simulate the actual leaflet mounting configuration within the heart valve prosthesis. The frame may include a lower portion having a recess for the leaflet and plurality of receptor holes around the peripheral edge of the recess, and an upper portion having a plurality of needles which extend downward through the leaflet and into the receptor holes and secure the edges of the leaflet.

Methods of making bioprosthetic heart valves with strain matched leaflets

Cloth-covered stents for tissue heart valves

Apparatus for testing bioprosthetic heart valve leaflets

Method of testing bioprosthetic heart valve leaflets

Methods of tissue heart valve assembly

Multi-leaflet bioprosthetic heart valve

Improved, adaptable tissue-type heart valves and methods for their manufacture are disclosed wherein a dimensionally stable, pre-aligned tissue leaflet subassembly is formed and its peripheral edge clamped between and attached to an upper shaped wireform and a lower support stent. A variety of adaptable structural interfaces including suture rings, flanges, and conduits may be attached to the support stent with or without an outlet conduit disposed about the wireform to provide a tissue-type heart valve adaptable for use in either a natural heart or in mechanical pumping devices.

Tissue heart valves

A solution containing a nonpolymeric epoxy compound for cross linking biological tissues and bioprosthetic materials prepared thereby. The nonpolymeric epoxy compound has the general structural formula:

Nonpolymeric epoxy compounds for cross linking biological tissue and

A mechanical heart valve having one or more leaflets pivotally fitted in a substantially cylindrical shaped valve body formed from a resiliently deformable material. A stiffening member formed from substantially nonresilient material fit about the valve body exterior wall to provide structural integrity to the valve body. Stresses which are normally applied to the heart valve body during the opening and closing of the valve are absorbed or cushioned by the incorporation of a rubber-like body between the stiffening member and the retainer member. Further cushioning is provided by incorporating another rubber-like body in the sewing ring. This second body extends out from the exterior surface of the valve body. Finally, a length of fabric is positioned about the retainer and shock absorbing bodies. This design provides a precisely calibrated rotational torque which allows for optimum orientation of the leaflets by the implanting surgeon.

Growing community of inventors

Newport Beach, CA, United States of America

Ralph Kafesjian