Abstract: A prosthetic heart valve having an elastomeric stent with an annular base and a plurality of apertures or holes circumferentially spaced around the base for receiving a suture. Flexible polymeric leaflets are molded over the stent. Polymeric material surrounds the apertures, leaving a central opening in each aperture. The base may be a frustro-conical ring. A sewing ring is mounted on the heart valve by suturing the ring through the apertures. Apertures or holes may also be provided by extending an area covered by woven material around all or part of the circumference of the base.

Abstract: A packaging for an implantable medical device such as a heart valve wherein the implantable medical device is immersed in a liquid medium. The packaging comprises a jar and a lid assembly having a seal and a ridge therebetween, the ridge being adapted to contact the seal. At least one circumferential leg is interposed between the lid assembly and the jar. The leg maintains a predetermined spacing between the lid and the jar and may be loaded in compression. The lid assembly may comprise a lid and an overcap. The overcap may turn independently of the lid and may apply compressive pressure to the lid over the ridge and seal. The lid and overcap may be coupled together by, for example, mating snap hooks. At least one of the lid or overcap may have a plurality of snap hooks. At least one of the plurality of snap hooks may be of different length than other of the snap hooks, whereby an asymmetric force may be applied to the lid when the overcap is loosened from the jar.

Abstract: A method is provided for producing antimicrobial, antithrombogenic medical devices. The method employs an antimicrobial treatment process wherein an antimicrobial agent is dissolved in an appropriate solvent and the resulting solution is contacted with a portion of a medical device of interest. The antimicrobial treatment process is advantageously performed without the need for additional compounds to facilitate antimicrobial agent uptake into the device. The method further comprises an antithrombogenic treatment process wherein antithrombogenic agents or materials are applied or otherwise associated with at least some portion of the medical device.

Abstract: A stent includes an elongated stent member having a plurality of post members. Each post member includes a pair of opposite sides. A first end of each post member includes an arcuate apex interconnecting the opposite sides. A second end of each post member has an open end. The opposite sides are angled to converge toward each other at the second end. The second end of each post member is connected to an adjacent post member by a stent portion. Each opposite side and each stent portion converge at an angle of less than 90°. The opposite sides are angled to converge toward each other at the second end.

Abstract: A method for treating biomaterial is provided in which a biological tissue, typically after being cross-linked, is contacted with an anticalcification treatment solution under condition effective to render the biomaterial resistant to in vivo calcification upon implantation in a host animal. The anticalcification treatment solutions comprise higher alcohol solutions, a polyol solutions and/or a polar aprotic organic solvent solutions.

Abstract: A method for manufacturing a prosthetic heart valve. An elastic valve body and at least one leaflet are formed on a mold. The leaflet has a free edge which is formed by the mold without cutting the leaflet at the free edge.

Abstract: A polymer heart valve has a leaflet with a base geometry of a cylinder for simplicity and effective opening. A helical swept surface is added to the top of the cylinder to enhance stable coaption. The heart valve includes a plurality of flexible leaflets. Each leaflet includes a top portion and a bottom portion. The bottom portion is an axial section of a cylinder having an axis and a radius. A first section of the top portion is a surface defined by a first arc having a first radius swept along a first helix. The first arc is tangent to the axial section of the cylinder. A second section of the top portion is a surface defined by a second arc having a second radius swept along a second helix. The second arc is tangent to the axial section of the cylinder. The second helix is a left-handed helix having the same radius and axis as the cylinder.

Abstract: A method and apparatus for inspecting heart valves. The method comprises projecting an actual image of a heart valve onto an image receiver, providing target data corresponding to a desired heart valve, comparing the actual image to the target data using a microprocessor, and determining whether the actual image matches the target data. The apparatus comprises a light source, a image receiver, a holder adapted to support a heart valve between said light source and the image receiver such that an actual image of the heart valve is received at the image receiver, a microprocessor in electronic communication with the image receiver. The microprocessor has access to target values for the regions of interest and compares the actual values in each region of interest to the target values to produce an output pass/fail signal.

Abstract: This invention provides an antimicrobial annuloplasty rings, and methods for making the same, wherein the annuloplasty rings have a desired degree of initial rigidity to facilitate ease of handling during implantation but which becomes flexible some time after implantation. The annuloplasty ring contains a relatively rigid insert enclosed by a fabric sheath, the insert being at least partly comprised of a biodegradable material. Following surgical implantation of the annuloplasty ring, the rigid insert component of the ring, upon exposure to blood and/or other physiological fluids, undergoes a controlled biodegradation which decreases its rigidity, thereby increasing the flexibility of the implanted annuloplasty ring. Furthermore, at least some portion of the annuloplasty ring of the invention has incorporated therein one or more antimicrobial agents in a manner which reduces the likelihood of device infection following implantation.

Abstract: This invention provides an antithrombogenic annuloplasty rings, and methods for making the same, wherein the annuloplasty rings have a desired degree of initial rigidity to facilitate ease of handling during implantation but which becomes flexible some time after implantation. The annuloplasty ring contains a relatively rigid insert enclosed by a fabric sheath, the insert being at least partly comprised of a biodegradable material. Following surgical implantation of the annuloplasty ring, the rigid insert component of the ring, upon exposure to blood and/or other physiological fluids, undergoes a controlled biodegradation which decreases its rigidity, thereby increasing the flexibility of the implanted annuloplasty ring. Furthermore, at least some portion of the annuloplasty ring has incorporated into or onto its structure one or more antithrombogenic agents or materials in a manner which reduces the likelihood of thrombosis following implantation.

Abstract: The invention, in a first aspect, is an apparatus for holding a flexible annuloplasty ring during implantation. The apparatus comprises a top piece including a bottom surface sized to engage substantially all of the inner diameter of the annuloplasty ring and finished to grip the annuloplasty ring; a bottom piece including a top surface sized to engage substantially all of the inner diameter of the annuloplasty ring and finished to grip the annuloplasty ring; and a haft capable of engaging the top and bottom pieces to clamp the annuloplasty ring therebetween. In a second aspect, the invention is a method of manipulating a flexible annuloplasty ring for implantation. The method comprises disposing the annuloplasty ring between a top piece and a bottom piece; and engaging the top piece and the bottom piece with a haft to clamp the annuloplasty ring between the top and bottom pieces.

Abstract: A bioprosthetic heart valve is disclosed. In a first aspect of the invention, a prosthetic heart valve comprises three mammalian heart valve leaflets, each valve leaflet including a full root length of tissue, the valve leaflets being affixed to one another to define a fluid flow passage, the fluid flow through which may be governed by the valve leaflets. In a second aspect the heart valve comprises a plurality of heart valve leaflets affixed to one another to define a fluid flow passage, the fluid flow through which may be governed by the valve leaflets; and a permanent trimming guide on at least one of the plurality of valve leaflets. In yet a third aspect of the invention, a bioprosthetic heart valve comprises a plurality of assembled parts, wherein the assembled parts are sutured together by hidden and locking stitches.

Abstract: A device for releasably holding and positioning a heart valve prosthesis includes a handle having a first end, a second end and a super elastic shaft interconnecting the first and second ends. A connector is positioned at the second end of the handle and includes a plug portion having a pair of raised members and diametrically opposed guide slots. A low profile pusher-rotator is releasably engaged with the plug portion and includes diametrically opposed guide tabs engaged with the guide slots. A manually flexible release portion of the pusher-rotator includes a pair of engagement members engaged in a snap fit with the raised members. The release portion can be manually distorted to release the engagement members and the raised members for separation of the handle and the pusher-rotator.

Abstract: Vascular grafts, and methods for making the same, are provided. The vascular grafts comprise a graft tissue derived from a biological source that is enclosed within an external synthetic sleeve. The synthetic sleeve has an extended length that is greater than the length of the graft tissue. However, the sleeve is longitudinally compressed such that it has a resting length substantially similar to the length of the graft tissue.

Abstract: A prosthetic cardiac valvular member of flexible material includes a flexible stent member which may be either attached to the cardiac valvular member or molded therein. The stent member is formed by a plurality of adjacent filaments which are bound together by suturing, braiding, jacketing or encapsulating. The prosthetic cardiac valvular member may be either a flexible heart valve or an annuloplasty ring. Post members are formed into the stent member when the stent member is used in the flexible heart valve.

Abstract: A method for treating biological tissue is provided in which a cross-linked biological tissue containing free aldehyde groups is reacted with a suitable neutralization agent in order to chemically block the aldehyde groups from reactivity toward cellular proteins. Also provided is the cross-linked biological tissue so produced which is substantially free of reactive aldehyde groups and, as a result, exhibits reduced toxicity and improved biocompatibility.

Abstract: A valve body assembly for being mounted adjacent an annulus within a heart. A first retainer is attached to the valve body assembly for engaging a first side of the annulus. A second retainer is attached to the valve body assembly and includes a resiliently-deformable retaining member for resiliently engaging a second side of the annulus. The resiliently deformable retaining member is collapsed to a size permitting it to be inserted into through the annulus and positioned adjacent the second side of the annulus. The retaining member is then allowed to expand such that it resiliently engages the second side of the annulus.

Abstract: An implantable prosthetic heart valve comprising: a valve body, a sewing ring assembly surrounding the valve body and comprising at least a fabric collar and preferably also a stiffening ring, and a tubular vascular graft having a proximal end and a distal end. The proximal end of the graft passes between the fabric collar and the valve body, but not between the stiffening ring and the valve body. The proximal end of the graft is preferably retained by a retaining ring that engages a retaining ring in the downstream end of the fabric sleeve.

Abstract: A heart valve prosthesis which incorporates a substantially permanently implantable abutment structure which is surgically attached to a native heart valve annulus through utilization of a resilient metal substructure having an attachment portion which moves into engagement with a native heart annulus upon being released from a retracted orientation. The system employs a positioning instrument which locates the abutment structure and associated heart valve prosthesis at the proper location for releasing the attachment components. Mechanical heart valve components including an occluder function are removably attached to the abutment structure using sutures, such that the valve function itself may be subsequently replaced.

Abstract: A method and apparatus for pre-stressing devices incorporating materials subject to stress softening is disclosed, as well as the resulting device. The method includes fabricating a heart valve with an inflow side and an outflow side. At least a portion of the heart valve includes a material subject to stress softening. The material experiences stress when a pressure differential occurs between the inflow side and the outflow side of the valve. The method includes creating a stress in the material prior to implantation in order to stabilize the stress/strain response of the material prior to implantation.