Baxter International Inc.

Edwards Lifesciences Corporation

Than Nguyen

Hung Ly Lam

Van Le Huynh

Ralph Kafesjian

Xiaoming G Guo

Delos M Cosgrove, Iii

Alain F Carpentier

Jianbo Zhou

Carlos M Romero

David W Wieting

Richard S Rhee

Can B Hu

Keith E Myers

Aws S Nashef

Minh T Ma

Herbert Chen

Richard M Romley

Ronald A Ness

John C Woodard

Denis Lee

Amir H Abolfathi

Crystal M Cunanan

Robert Stobie

Alexandre Carpentier

Leslie Pathmanaban

Michael J Numamoto

Stephen M Erickson

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

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

An assembly for holding a substantially flexible suture guide of predetermined length in a substantially taut position used to achieve a suture line having a dimension equal to the length of the suture guide, such as the circumference about a heart valve annulus. The assembly includes a rigid suture guide holder having a surface against which the length of suture guide is releasably positioned. The guide holder can have a shape or geometry, such as a circumference or circumferential segment, equivalent to the shape or geometry of the intended suture line. The shape of the guide holder can therefore be selected to hold the suture guide in the shape most advantageous to placing the desired suture line. The assembly further includes a mechanism for releasably binding the suture guide to the surface of the holder and a detachable handle extendibly attached to the holder by means of a lanyard so that the handle can be detached to afford an unobstructed view of the surgical site, but cannot be removed from the surgical site until the holder has also been removed.

Annuloplasty ring delivery system

Cloth-covered stents for tissue heart valves

An assembly for holding a substantially flexible suture guide of predetermined length in a substantially taut position used to achieve a suture line having a dimension equal to the length of the suture guide, such as the circumference about a heart valve annulus. The assembly includes a rigid suture guide holder having a surface against which the length of suture guide is releasably positioned. The guide holder can have a shape or geometry, such as a circumference or circumferential segment, equivalent to the shape or geometry of the intended suture line. The shape of the guide holder can therefore be selected to hold the suture guide in the shape most advantageous to placing the desired suture line. The assembly further includes a mechanism for releasably binding the suture guide to the surface of the holder and a detachable handle extendibly attached to the holder by way of a lanyard so that the handle can be detached to afford an unobstructed view of the surgical site, but cannot be removed from the surgical site until the holder has also been removed.

Annuloplasty ring delivery method

A carrier for heart valves allows the removal of a heart valve from the carrier without manual manipulation. In addition, the carrier minimizes or substantially eliminates leaking of preserving fluid during transportation and storage. The carrier includes ajar, a rinse cage, and a holder to which a heart valve is attachable. The rinse cage includes a first engagement structure, for example, a channel, and the holder includes a second engagement structure, for example, a groove, complementary to the first engagement structure for releasably engaging therewith. A heart valve attached to the holder is disposed or suspended within the rinse cage when the engagement structures are engaged. A heart valve attached to the holder is protected not only when within the jar but also when removed from the jar. The holder has a socket for engaging with a surgical handle used to remove the valve from the jar for rinsing and implantation. The carrier may include apparatus for limiting rotation of the holder relative to the rinse cage and rotation of the rinse cage relative to the jar, which apparatus allows a surgical handle to be securely and firmly attached to the holder with essentially one hand and without removing the valve from the jar. The jar includes a lid that may have a rotatable gasket and a flange. The jar may have an apex-like top surface for making a compressive seal against the gasket when the lid is tightened. The flange may have a vent for allowing gases between the gasket and the lid to escape during sterilization processes of the carrier.

Heart valve carrier and rinse cage

Apparatus for testing bioprosthetic heart valve leaflets

Method of testing bioprosthetic heart valve leaflets

An infra-annular annuloplasty prosthesis is disclosed including a flexibly semi-rigid frame, a portion of which is shaped to conform to the scalloped configuration of the normal circumference of an arterial heart valve annulus. Axially projecting legs spaced circumferentially to correspond to the location of tissue adjacent to the valve commissures are provided for support and anchoring of the annulus-conforming portion to the dense fibrous tissues adjacent each commissure. The prosthesis includes a one-or two-part frame having scalloped upper and lower edges defining peaks and valleys. The upper edge is shaped to follow the contour of the tissue underneath the valve leaflets, and thus supports the leaflets and aortic wall from below. The lower edge is similarly scallop-shaped, but with less pronounced peaks and valleys than the upper edge, and is thus shaped to conform to the aortic annulus shape and provide support directly thereto.

Aortic annuloplasty ring

An expandable annuloplasty ring which may either expand spontaneously, in situ, as the patient grows or be expanded by surgical intervention by balloon dilatation. The distensible annuloplasty ring of the invention may be usable in pediatric patients whose growth, subsequent to surgical implantation of the ring, will necessitate subsequent enlargement of the ring to accommodate growth of the annulus. The ring may include relatively expandable segments to enable the enlargement thereof. The ring segments may include engaging teeth which cooperate with notches or slots formed in the tubes to provide some resistance to ring distention, while preventing collapse of the ring in the opposite direction. The teeth may be of different sizes or shapes to regulate the amount of force needed to expand the ring at different stages of the patient's growth. Alternatively, the adjustable ring includes a solid core of non-elastic material which plastically retains its shape upon natural expansion of the annulus, or after surgical expansion. In one embodiment, segments are coupled together with a discontinuity around the ring periphery. Pivot regions are provided between adjacent segments that, along with the discontinuity, enable the ring to expand upon annulus growth. The discontinuity may be positioned along the anterior side of the ring or around the posterior side. A further version makes use of telescoped segments with no discontinuity. The segments are coupled together with tubular sheaths, and expand without decoupling. A fabric covering may be omitted.

Expandable annuloplasty ring

Methods of tissue heart valve assembly

A ventricular assist device includes a pair of valved conduits and a pumping portion connected by these conduits into the circulatory system of a host patient. The pumping portion and valved conduits are constructed and configured to minimize the number of material-surface transitions which blood must cross in flowing through the device. Also, the valved conduits include porcine xenograft valves, which are externally supported by stenting structure located outside of the blood-contacting flow path of the device. A flexible shape-retaining inner wall member of the valved conduits is impervious to blood, but defines a porous inner surface on which a stable biological interface may form. Also, this inner wall member is shaped with sinuses which do not replicate either the porcine sinuses from which the xenograft valves were taken, or human aortic sinuses. However, the sinuses of the inner wall member are configured to provide effective valve action by the formation of vigorous vortices in the blood flow downstream of these valves, and to avoid the formation of clots on the blood-contacting surfaces of the valved conduits.

Ventricular assist device with minimal blood contacting surfaces

Multi-leaflet bioprosthetic heart valve

Growing community of inventors

Anaheim, CA, United States of America

Than Nguyen