Abstract: A mitral annuloplasty ring that has a saddle shape with an upward bow in both an anterior segment and a posterior portion, with the upward bow being more pronounced in the anterior segment. The ring defines a closed ring body with a rounded isosceles triangular shape and the anterior segment along a long side. The posterior portion bulges outward to create a minor-major axis dimension ratio of between about 3.3:4 to 4:4. An inner ring body is made of a generally rigid material such as titanium that will substantially resist distortion when subjected to the stress imparted thereon after implantation in the mitral valve annulus of an operating human heart. The outward and upward posterior bow of the annuloplasty ring corrects for pathologies associated with mitral valve prolapse, as seen with Barlow's syndrome for instance, in which the leaflets tend to be elongated or floppy.

Abstract: A prosthetic heart valve sewing ring that is highly compatible with surrounding tissue by being made of a material that has physical properties similar to the surrounding tissue. The present invention provides an “iso-elastic” sewing ring, or one having an elasticity similar to that of soft tissue. Exemplary materials include silicone, polyurethane, polyurethane copolymers, rubber, and other hemocompatible and biocompatible thermoplastic elastomers. The material may have an elastic modulus between about 100 to 5000, up to 10,000 psi, and more preferably between 200 to 2000 psi, a tensile strength between about 5000 and 60,000 psi, and more particularly between about 5000 to 50,000 psi, and a tensile elongation between about 100 to 3000%, preferably between about 100 to 1000%. The sewing ring may be a fiber mat, monolithic, or may have a reinforcing fiber embedded therein to help prevent suture pull-out.

Abstract: A heart valve prosthesis can be formed with a harvested tissue heart valve and a sewing rim that extends outwardly from the annulus of the harvested heart valve for easier attachment of the prosthesis. The heart valve prosthesis can further include a belt that extends along the annulus to provide further support to the valve annulus. A single piece of pericardial tissue can be used to form the sewing rim, belt and a collar that envelopes the edge of the annulus. The harvested heart valve prosthesis can have the diameter of its annulus adjusted using pledgeted suture prior to the application of additional support structures such as the belt, sewing rim and collar.

Abstract: A mitral annuloplasty ring that has an outward and an upward posterior bow. The ring defines a closed, modified oval shape with a minor-major axis dimension ratio of between about 3.3:4 to 4:4. The ring is made of a material that will substantially resist distortion when subjected to the stress imparted thereon when the ring is implanted in the mitral valve annulus of an operating human heart. As a result, the annuloplasty ring corrects for pathologies associated with mitral valve prolapse, or Barlow's syndrome, in which the leaflets tend to be elongated or floppy.

Abstract: Suturing rings and methods of use thereof facilitating initial implantation of new and replacement of dysfunctional tissue or mechanical heart valve mechanisms supported by the suturing ring are disclosed. The suturing ring annulus is adjustable to receive and engage the valve frame of the heart valve mechanism within the annulus. An interlocking mechanism applies restraint to fix the adjusted suturing ring annulus engaged against the valve frame to support the heart valve mechanism during chronic implantation. Sutures affixing the suturing ring to the valvar rim can be routed and entrapped between the suturing ring annulus and the valve frame when the suturing ring is restraint is applied. The restraint is released to replace a dysfunctional heart valve mechanism and reapplied when a new heart valve mechanism is fitted into the annulus.

Abstract: Pannus-resisting implantable medical devices comprise one or more antimicrobial reservoirs, each such reservoir incorporating antimicrobial substances in predetermined distributions for timed release in vivo. Predetermined distributions of antimicrobial substances incorporated in antimicrobial reservoirs are achieved through use of fluid solvent carriers, which may comprise supercritical fluid solvents. Precipitation of antimicrobial substances from such solvent carriers in predetermined distributions is accomplished through evaporation and/or application of heating, cooling or decreased ambient pressure to the solvent carriers.

Abstract: 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.

Abstract: An annuloplasty ring having a three-dimensional discontinuous form generally arranged about an axis with two free ends that are axially offset. The ring is particularly suited for repair of the tricuspid valve, and more closely conforms to the annulus shape. The ring is more flexible in bending about radially extending axes than about the central axis. The ring may have an inner structural support covered by a pliable sleeve and/or a fabric tube. The structural support may have a varying cross-section, such as a C-shaped cross-section in a mid-section between two free ends and a rectangular cross-section at the free ends. A deliver template having a mounting ring with about the same shape as the ring facilitates implant, and may be releasably attached to a delivery handle. The deliver template may include a plurality of cutting guides for releasably attaching the annuloplasty ring thereto while presenting maximum outer surface area of the ring.

Abstract: A prosthetic heart value assembly comprising a prosthetic heart valve and a fixation band. The fixation band comprises a tubular frame and a tube. The tubular frame comprises longitudinally-extending members having hooks on their distal ends and fixation means on proximal ends, and a stabilizing laterally-extending member. The tube is positioned inside the longitudinally-extending members, a distal end of the tube being everted over the hooks. A sewing cuff is formed in the tube. The prosthetic valve is secured to the fixation band by suturing a prosthetic valve sewing cuff to a fixation band sewing cuff. The prosthetic valve and fixation band are advanced to the valve's seat. The fixation band's hooks are passed through the wall of the everted tube and into surrounding tissue and the fixation band's fixation means are deployed.

Abstract: A sewing ring (12) has a diameter commensurate with a diameter of a removed mitral valve. Skirts (44, 46) of mesh or net material extend downward from the sewing ring and line the walls of an associated vessel (58). Basal chordae simulating structures (34, 36) in the form of elongated strips of mesh or netting, rods, or the like extend from the skirt to an underside of each of two valve leaflets (14, 16). Marginal chordae simulating structures (30, 32) extend between each leaflet and the basal chordae simulating structure. The sewing ring (12) is stitched to an open end of a vessel and inner ends of the basal chordae simulating structure are stitched or stapled (50, 52) to associated papillary musculature (54, 56). In this manner, the papillary muscles assist in controlling the timing and control of the mitral valve.

Abstract: A sewing ring for prosthetic heart valves that is connected and configured to pivot outward. A biocompatible fabric covering surrounds at least a portion of the sewing ring, and the ring may be exclusively connected to a stent with the fabric. The sewing ring may be generally planar and of uniform thickness, or may be of varying thickness. The fabric may be used to encompass both the stent and the sewing ring, and may be a single piece. A seam may be provided in the fabric as a discrete pivoting line. The sewing ring may be convertible between bi-stable positions. The ring may extend outward in a frusto-conical shape so as to enable inversion between a position facing the inflow end of the valve and a position facing the outflow end of the valve. The sewing ring may have a compliant insert having a celled construction defined by outer walls and inner ribs. A method of implantation, and a method of assembly of the heart valve is also provided.

Abstract: The present invention provides a prosthetic heart valve that includes biologically active agents that retard or prevent the infiltration of fibrous tissue (“pannus”) from the host into the structure of the prosthetic valve. Preventing or decreasing the overgrowth of the prosthetic valve by pannus reduces the complications associated with the implantation and use of prosthetic heart valves.

Abstract: The present invention provides a suture-terminating device comprising a central body having at least one surface, a plurality of flanges extending radially from the surface and defining at least one grove therebetween, each flange having at least one aperture axially aligned and spaced away from the base wall, at least one removable member disposed within each aperture, and at least one spring disposed adjacently to the surface and maintained in its activated state by contact with a removable member disposed within the aperture. The grove has a base wall and at least one sidewall. The spring, while in its active state, is positioned adjacent to and spaced from the base wall, defining a gap of sufficient size to permit the passage of at least one suture therethrough. The surgeon actuates the device by withdrawing the removable member from the aperture, thus permitting the spring to return to its resting state within the grove.

Abstract: The present invention provides a prosthetic valve and a sewing cuff assembly for attaching the prosthetic valve in a patient's heart. The suture cuff generally includes at least one lock ring and sewing cuff material disposed at least partially around the lock ring. The valve body includes a peripheral groove for receiving the lock ring therein and securing the lock ring thereto. A stiffening ring may be coupled to the peripheral groove or otherwise provided on the valve body.

Abstract: A suture template for facilitating implantation of a prosthetic valve includes a plurality of commissure portions connected to a plurality of cusp portions around an annulus. Each commissure portion has at least one notch and each cusp portion can have an inwardly directed ledge and at least one notch. In one embodiment, the notches open towards the bottom of the suture template. In another embodiment, the notches open towards the top of the suture template.

Abstract: Cardiovascular components such as biocompatible heart valves and annular sewing rings are disclosed, as well as, methods for making the same. The heart valves include biodegradable polymer fiber scaffolds and collagen. Also disclosed are donor aortic heart valves processed without the use of crosslinking chemicals.

Abstract: A heart valve prosthesis has a frame that includes at least one outwardly extending annular flange adjacent to a suturing ring and a band comprising an inwardly extending annular flange that is capable of engagement with the annular flange of the frame. A tortuous path is formed between the annular flange of the frame and the annular flange of the band that can engage and restrain a suture placed between them. One or more split portions or tab portions on the band are adapted to lock the band in engagement with the flange of the frame. Such a device can be used to more easily replace a heart valve by advancing a sutures through a suturing ring on the valve and the valvular rim such that they are brought outward of the flange extending from the frame and then advancing the band over the valve and over the sutures at a proximal, outflow end of the valve until the band engages the flange and captures the sutures between the band and the flange.

Abstract: Suturing rings and methods of use thereof facilitating initial implantation of new and replacement of dysfunctional tissue or mechanical heart valve mechanisms supported by the suturing ring are disclosed. The suturing ring annulus is adjustable to receive and engage the valve frame of the heart valve mechanism within the annulus. An interlocking mechanism applies restraint to fix the adjusted suturing ring annulus engaged against the valve frame to support the heart valve mechanism during chronic implantation. Sutures affixing the suturing ring to the valvar rim can be routed and entrapped between the suturing ring annulus and the valve frame when the suturing ring is restraint is applied. The restraint is released to replace a dysfunctional heart valve mechanism and reapplied when a new heart valve mechanism is fitted into the annulus.

Abstract: 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.

Abstract: A system and method are disclosed for covering a heart valve prosthesis with biological tissue, such as pericardium. In one aspect, the prosthesis includes a stent that is covered with a fabric material. A heart valve is mounted within the stent, such as by sutures securing the heart valve to the fabric covering. One or more sheets of biological tissue are applied to the stented prosthesis so as to cover exposed areas of the fabric material.

Abstract: The present invention provides a heart valve prosthesis device having an occluder, an occluder base and a suture ring, where the occluder base and suture ring have a coating of anti-thrombotic/anti-fibrotic/anti-pannus material on the surface of the occluder base to approximately one-half to two-thirds to the outer peripheral edge of the suture ring, wherein the coating prevents thrombus, fibrosis and pannus from forming on the surfaces it coats. For example, the invention provides an improved heart valve prosthesis device, where the heart valve prosthesis is a mechancical heart valve, or a bioprosthetic heart valve.

Abstract: A suturing ring to attach the body of an implantable heart valve to heart tissue by sutures is composed of a fabric containing an inorganic antimicrobial agent. The fabric can have a material coating the fibers of the fabric in which particles of the agent are embedded. The coating material can be elastomeric and the fabric porous, to improve its flexibility, or non-porous and the fabric ring can be coated with a tissue compatible substance such as collagen. One type of ring has an annular top part to fit over one of top and bottom surfaces of the valve body and defining an opening to the heart valve, a step wall depending from the annular top part to extend along said valve body wall and an outwardly extending flange through which the sutures are to be sewn.

Abstract: A system and method are disclosed for covering a mechanical heart valve with biological tissue to provide a biomechanical heart valve prosthesis. The prosthesis includes a mechanical heart valve having a moveable portion mounted within a generally annular support that permits substantially unidirectional flow of blood therethrough. One or more sheets of a biological tissue material are applied around the support heart valve to provide a sewing ring that includes the biological tissue material.

Abstract: A heart valve having a sewing ring marked by six radially spaced marks. The marks may be spaced at regular intervals around the sewing ring, or they may correspond to asymmetric features of the valve, such as commissures supporting differently sized leaflets. Some of the marks may be placed at a midpoint between adjacent commissures. A template for temporary placement at an implantation site within the patient's heart has six radially spaced marks, corresponding to the marks on the sewing ring.

Abstract: An annuloplasty ring having a three-dimensional discontinuous form generally arranged about an axis with two free ends that are axially offset. The ring is particularly suited for repair of the tricuspid valve, and more closely conforms to the annulus shape. The ring is more flexible in bending about radially extending axes than about the central axis. A deliver template having a mounting ring with about the same shape as the ring facilitates implant, and may be releasably attached to a delivery handle. The deliver template may include a plurality of cutting guides for releasably attaching the annuloplasty ring thereto while presenting maximum outer surface area of the ring. The template may have an outwardly-facing groove to receive and retain the ring.

Abstract: A flexible prosthetic tissue-type heart valve having commissures that are substantially decoupled from a cusp support structure. The valve includes three leaflets having arcuate cusp edges and opposed concave shaped free edges, with outwardly-directed attachment tabs therebetween. A cusp support structure in either one or more pieces attaches to the leaflet cusp edges. Three commissures are each formed partly with an axially-extending insert member to which two adjacent leaflet tabs attach. An inverted V-shaped clip maintains close contact between the adjacent leaflet tabs and provides a stress-relieving clamping action in conjunction with the insert member. The insert member attaches about its lower end to base sections of the cusp support structure, or to an intermediate sewing ring, so that the commissures may pivot about the cusp support structure. The sewing band is scalloped and enables attachment of the valve along the scalloped aortic root so as to couple the valve to the natural motion of the aorta.

Abstract: The present invention provides a prosthetic valve and a sewing cuff assembly for attaching the prosthetic valve in a patient's heart. The suture cuff generally includes at least one lock ring and sewing cuff material disposed at least partially around the lock ring. The valve body includes a peripheral groove for receiving the lock ring therein and securing the lock ring thereto. A stiffening ring may be coupled to the peripheral groove or otherwise provided on the valve body.

Abstract: A heart valve prosthesis can be formed with a harvested tissue heart valve and a sewing rim that extends outwardly from the annulus of the harvested heart valve for easier attachment of the prosthesis. The heart valve prosthesis can further include a belt that extends along the annulus to provide further support to the valve annulus. A single piece of pericardial tissue can be used to form the sewing rim, belt and a collar that envelopes the edge of the annulus. The harvested heart valve prosthesis can have the diameter of its annulus adjusted using pledgeted suture prior to the application of additional support structures such as the belt, sewing rim and collar.

Abstract: A multilayer ingrowth matrix is constructed within well-defined porosity of a prosthetic material. The matrix consists of either proteinaceous or synthetic layers or gradients, or a combination of proteinaceous and synthetic layers or gradients. Each layer within the matrix is designed to achieve a specific function, such as facilitation of ingrowth of a particular cell type or release of a particular growth factor. The well-defined porosity is in the form of either helically oriented, interconnected transmural ingrowth channels, or a porous wall structure containing uniformly shaped pores (i.e. voids) in a very narrow size range, or a combination of channels and pores. This invention allows for uninterrupted ingrowth of connective tissue into walls of a synthetic graft prosthesis made from the prosthetic material. Furthermore, this invention can produce small diameter prostheses having an internal diameter of 6 mm or less.

Abstract: Cardiovascular components such as biocompatible heart valves and annular sewing rings are disclosed, as well as, methods for making the same. The heart valves include biodegradable polymer fiber scaffolds and collagen. Also disclosed are donor aortic heart valves processed without the use of crosslinking chemicals.

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: A heart valve can be replaced using minimally invasive methods which include a sutureless sewing cuff that and a fastener delivery tool that holds the cuff against the patient's tissue while delivering fasteners to attach the cuff to the tissue from the inside out. The tool stores a plurality of fasteners and is self-contained whereby a fastener is delivered and placed all from inside a vessel. The fasteners are self-forming whereby they do not need an anvil to be formed. Anchor elements are operated from outside the patient's body to cinch a prosthesis to an anchoring cuff of the valve body. The cuff is releasably mounted on the tool and the tool holds the cuff against tissue and drives the fastener through the cuff and the tissue before folding over the legs of the fastener whereby secure securement between the cuff and the tissue is assured. Fasteners are placed and formed whereby fasteners are located continuously throughout the entire circumference of the cuff.

Abstract: A prosthetic heart valve includes an orifice ring adapted to carry blood therethrough. An annular recess is formed in an outer surface of the orifice ring and has first and second axially spaced walls. A sewing cuff is adapted to be coupled to a native tissue annulus of a heart and includes an inner annular cuff portion adapted to conform to the first and second recess walls in the orifice ring. A cuff retaining ring extends around the inner annular fabric portion such that the inner annular cuff portion is positioned between the cuff retaining ring and the annular recess.

Abstract: An apparatus and a method for constructing a heart valve prepared from autologous tissue is disclosed. Three tissue leaflets are held in place with tissue anchors on a tissue mounting frame having an annular base and a plurality of commissure posts extending from the base. An elastomeric sheath rests gently on the tissue leaflets to prevent the leaflets from coming off of the anchor hooks and encloses the leaflets to form valve cusps. The leaflets touch each other on a coaptation line with an angle of approximately 65° C. relative to the commissure post. The heart valves can be constructed intraoperatively in a short time, typically ten minutes. The low coaptation angle and the fact that the leaflets are held in place without being clamped between two unyielding members minimize stress on the tissue.

Abstract: A device for heart valve repair including at least one tension member having a first end and second end. A basal anchor is disposed at the first end of the tension member and a secondary anchor at the second end. The method includes the steps of anchoring the basal anchor proximate a heart valve and anchoring the secondary anchor at a location spaced from the valve such that the chamber geometry is altered to reduce heart wall tension and/or stress on the valve leaflets.

Abstract: A heart valve can be replaced using minimally invasive methods which include a sutureless sewing cuff that and a fastener delivery tool that holds the cuff against the patient's tissue while delivering fasteners to attach the cuff to the tissue from the inside out. The tool stores a plurality of fasteners and is self-contained whereby a fastener is delivered and placed all from inside a vessel. The fasteners are self-forming whereby they do not need an anvil to be formed. Anchor elements are operated from outside the patient's body to cinch a prosthesis to an anchoring cuff of the valve body. The cuff is releasably mounted on the tool and the tool holds the cuff against tissue and drives the fastener through the cuff and the tissue before folding over the legs of the fastener whereby secure securement between the cuff and the tissue is assured. Fasteners are placed and formed whereby fasteners are located continuously throughout the entire circumference of the cuff.

Abstract: Pre-trimmed, cryopreserved homografts and other stentless bioprosthetic heart valves having natural tissue sewing rings formed thereon. The sewing ring may be formed of strip of pericardium or other suitable tissue. Material may be captured between the natural tissue sewing ring and a sub-valvular lip formed on the valve to impart a desired size or shape to the sewing ring. In the case of cryopreserved embodiments of the invention (e.g., cryopreserved human homografts) the sewing ring is attached to the valve by way of a natural tissue suture, biological glue or other attachment component that is capable of undergoing cryopreservation without breaking, excessive weakening, or other changes that prevent it from performing its attachment function.