St. Jude Medical, Inc.

Yi-Ren Woo

Chad Qingshen Cai

XueMei Li

Steven D Kruse

James L Kurk

Michael J Girard

Paul J Fordenbacher

Avrom M Brendzel

Stephen A Petersen

Tanya Shipkowitz

Abhay S Pandit

Stephen A Peterson

Qingsheng Cai

Stephen D Kruse

A prosthetic heart valve has an annular valve-perimeter-shape-defining structure having a radially outer surface. A clip structure is provided on the outer surface. This clip structure is used to attach flexible valve leaflets to the shape-defining structure. One or more retainer members may be used to help hold the leaflets in the clip structure.

Techniques for attaching flexible leaflets of prosthetic heart valves to supporting structures

A prosthetic heart valve of the type that includes a hollow annular stent and a plurality of flexible leaflets that are attached to the stent. One or more fixture structures are used to attach the leaflets to the stent so that sutures do not have to be used for that purpose. The fixture structures preferably extend annularly at least substantially all the way around the valve. Surfaces of the fixture structures that can come into contact with portions of the leaflets that move during use of the valve can be shaped to help beneficially shape those leaflet portions during their movements.

Prosthetic heart valves with flexible leaflets

A prosthetic heart valve includes an annular stent structure having a plurality of annularly spaced stent post regions, a plurality of leaflets that extend radially inward from the stent structure and that include radially outer portions that lie against a radially outer surface of the stent structure, and a clamping structure that is radially outside the other components and that clamps the radially outer portions of the leaflets against the radially outer surface of the stent structures to secure the leaflets to the stent structure. The above-described structural arrangement applies to the stent post regions as well as to other portions of the stent structure.

Prosthetic heart valves with flexible leaflets and leaflet edge clamping

A prosthetic heart valve includes a hydrogel material in its sewing cuff. The hydrogel material may be accompanied by an anticoagulant. If the hydrogel (and/or any included anticoagulant) might react with a packaging solution in which the valve is stored after inclusion of the hydrogel (and any anticoagulant), the hydrogel (and any anticoagulant) may be included in a protective but deliberately frangible pouch in the sewing cuff. After the valve is out of the packaging solution, the pouch can be broken to render the hydrogel (and any coagulant) effective following implantation of the valve in a patient.

Prosthetic heart valves

A synthetic blood vessel graft (e.g., for use with a prosthetic heart valve) includes a mounting cuff adjacent at least one end for facilitating attachment of the graft to another structure (e.g., a sewing cuff of a heart valve). The mounting cuff may be sized and shaped to provide good conformance to the target structure to which it may be attached (e.g., the heart valve sewing cuff). The graft is preferably preclotted. Especially for use with a tissue valve (which must be supplied in a packaging solution that would react with a preclotting agent), the graft is preferably supplied separately from the valve.

Synthetic blood vessel grafts

An implantable prosthesis can be formed from an improved biocompatible material that provides for cellular colonization of the biocompatible material. Specifically, the biocompatible material is a rigid porous material. In embodiments of particular interest, the implantable prosthesis is a mechanical heart valve prosthesis with a rigid occluder. In some embodiments, the rigid occluder is formed from the biocompatible material. A filler comprising a hydrogel or a structural protein can be located within the pores. In some embodiments, a bioactive agent is within the pores. In some embodiments, the rigid occluder is formed from a polymer material, a carbonaceous solid or a ceramic material. The pores can extend through the rigid material.

Valved prosthesis with porous substrate

Improved dip coating methods and mandrels for forming polymer leaflets and valve prostheses generally involve one or more features on the mandrel that facilitate the processing. The mandrel has a top surface and an outer surface comprising a plurality of ridges and contoured surfaces extending to the ridges. An edge on the mandrel separates the top surface and the contoured surfaces, with the mandrel edge corresponding to the free edge of the leaflet. In preferred embodiments, the edge separating the top surface from the contoured surfaces is sharp. The polymer formed on the top surface can be efficiently separated from the remaining portions of the polymer structure to form the free edges of the leaflets.

Mandrel for use in forming valved prostheses having polymer leaflets by dip coating

Implantable vascular devices and implantable cardiovascular devices suitable for contacting a patient's blood or bodily fluids include a polymer substrate that is at least partly coated with a diamond-like carbon coating. The diamond-like carbon coated polymer substrate can be flexible or rigid. Preferred medical devices include heart valve prostheses with leaflets or orifice rings formed from diamond-like carbon coated polymer materials. Preferred approaches for the deposition of the diamond-like carbon coating are performed at low pressures and include ion beam assisted deposition.

Medical article with a diamond-like carbon coated polymer

Valved prostheses include a support structure and a plurality of flexible polymer leaflets connected to the support structure, in which the leaflets have an improved structural design. The support structure has a plurality of commissure supports and scallops between the commissure supports. Generally, the flexible polymer leaflets project away from the support structure at an attachment edge where the leaflets connect to the support structure. In particular embodiments, the leaflets at the attachment edge are at an angle from about 5 degrees to about 85 degrees relative to a plane normal to the valve axis. In some embodiments, the flexible polymer leaflets having a coaptation depth from about 0.3 times the valve radius to about 0.8 times the valve radius. In further embodiments, the flexible polymer leaflets form a valve with a valve height from about one times the valve radius to about 2 times the valve radius and have leaflet lengths at least about 1 millimeter greater than the valve radius.

Polymer leaflet designs for medical devices

A bi-leaflet prosthetic heart valve, comprising an annular body having an upstream edge, a downstream edge and a passageway therebetween includes first and second leaflets pivotally mounted in the annular body. Each leaflet has an upstream edge, a downstream edge and a leaflet length therebetween. First and second pivot axes associated respectively with the first and second leaflets are provided and each leaflet rotates about its respective pivot axes between an open position allowing blood flow through the passageway of the annular body and a closed position blocking blood flow. The valve is configured such that the leaflets have an angle in the naturally open position of more than about 85&deg;.

Leaflet positioning for a mechanical heart valve

A bileaflet heart valve prosthesis includes an orifice body or housing defining an orifice or opening for the passage of blood therethrough. First and second leaflets or occluders are disposed in the orifice and pivotally attached to the orifice body. The first and second occluders pivot about axes between an open position and a closed position, and the axes are non-parallel. The orifice is substantially open when the first and second occluders are in their open positions and substantially closed when the occluders are in their closed position. The bileaflet heart valve may be either a central opening valve, or a side opening valve.

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Woodbury, MN, United States of America

Yi-Ren Woo