Abstract: A prosthetic heart valve has leaflets made of a thin and flexible material. The side edges of adjacent leaflets are sewn together so as to form a substantially tubular valve structure having an in-flow end and an out-flow end. Each of the leaflets is adapted to flex inwardly into and out of engagement with another leaflet so as to close and open the valve in response to force by blood pressure. The leaflets are configured so that a portion of the inner face of each leaflet is in a facing relationship with a portion of the inner face of an adjacent leaflet.

Abstract: A method for treating fixed biological tissue inhibits calcification of the biological tissue following implantation thereof in a mammalian body. The method includes placing the biological tissue in contact with glutaraldehyde and then heating the glutaraldehyde. Alternatively, methods other than heating (e.g., chemical or mechanical means), for effecting polymerization of the glutaraldehyde may also be utilized. Alternatively, the tissue may be heat treated prior to fixing thereof. Alternatively, methods other than glutaraldehyde may also be used for fixing the tissue. The biological tissue may be so treated at any time prior to implantation thereof in a mammalian body.

Abstract: Valved prostheses are described with crosslinked leaflets. At least one of the leaflets has a shape corresponding to a contoured surface. The leaflets are individually attached to the prostheses. Furthermore, in some embodiments, the leaflets do not comprise native leaflet tissue. Methods for forming tissue heart valve prostheses can comprise assembling a plurality of leaflets configured to open and close the valve in response to pressure differentials. Each of the plurality of leaflets is preformed individually when at least partially crosslinked in contact with a contoured surface. The individual crosslinked leaflets can be selected and matched for assembly into a valve. In general, the tissue, when it is crosslinked, has a size and shape approximately the size of a single human heart valve leaflet.

Abstract: A tubular prosthetic semilunar or atrioventricular heart valve is formed by cutting flat, flexible leaflets according to a pattern. The valve is constructed by aligning the side edges of adjacent leaflets so that the leaflet inner faces engage each other, and then suturing the leaflets together with successive stitches along a fold line adjacent the side edges. During operation, when the leaflets open and close, the leaflets fold along the fold line. Distal tabs extend beyond the distal end of each leaflet. The tab portions of adjacent leaflets are folded over each other and sewn together to form commissural attachment tabs. The commissural tabs provide commissural attachment points to accommodate sutures and the like in order to secure the tab to a vessel wall, if a semilunar valve, and papillary muscles and/or chordae tendineae, if an atrioventricular valve.

Abstract: A method is disclosed for using tubular material to replace a semilunar heart valve (i.e., an aortic or pulmonary valve). To create such a replacement valve, the native valve cusps are removed from inside an aorta or pulmonary artery, and the inlet end of a tubular segment is sutured to the valve annulus. The outlet (distal) end of the tube is either “tacked” at three points distally, or sutured longitudinally along three lines; either method will allow the flaps of tissue between the suture lines to function as movable cusps. This approach generates flow patterns that reduce turbulence and closely duplicate the flow patterns of native semilunar valves. An article of manufacture is also disclosed, comprising a sterile biocompatible synthetic material which has been manufactured in tubular form, by methods such as extrusion or coating a cylindrical molding device, to avoid a need for a suture line or other seam to convert a flat sheet of material into a tubular shape.

Abstract: The invention provides a replacement heart valve which contains an acellular matrix as a structural scaffold. The scaffold is seeded with isolated myofibroblasts and/or endothelial cells prior to implantation into a recipient mammal.

Abstract: A method an apparatus for limiting longitudinal stretch during fixation of a harvested aortic root including valve leaflets and the product produced. The apparatus includes an inflow plug inserted into the inflow section of the aortic root and having an apertured tube or cannula extending through the valve leaflets to an outflow plug inserted into the outflow section of the aortic root. Apertures in the tube are located on either side of the valve leaflets and the tube is coupled to a fluid inlet, preferably located on the outflow plug. The outflow plug is slidable relative to the tube and is provided with an engagement mechanism such as a setscrew for fixing the location of the outflow plug relative to the tube and the inflow plug. After assembly of the aortic root to the apparatus, the fluid inlet is coupled to a source of defined pressure and the root is inflated.

Abstract: A supportless atrioventricular valve intended for attaching to a circumferential valve ring and papillary muscles of a patient comprising a singular flexible membrane of tissue or synthetic biomaterial, wherein a minimally invasive delivery system is provided through a percutaneous intercostal penetration and a penetration at the cardiac wall into a left atrium of the heart.

Abstract: A stentless atrioventricular valve intended for attaching to a circumferential valve ring and papillary muscles of a patient comprising a singular flexible membrane of tissue or synthetic biomaterial, the valve having a sewing ring, an anterior cusp and a posterior, wherein the anterior cusp and said posterior cusp are an integral part of a continuum from the singular membrane without sutured commissure between remote ends of the cusps and wherein texture elements secured at edge portions of the cusps configured to extend the texture elements for connection to papillary muscles in a ventricle cavity when the sewing ring is sutured to an atrioventricular junction of a patient heart.

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 is directed to methods for obtaining heart valves from a donor animal that have a reduced tendency to cause inflammation when implanted into a human patient. The valves produced by this method should be less likely to undergo post-surgical degeneration.

Abstract: Tools can be used to assist with the implantation of heart valve prostheses, especially stentless aortic heart valve prostheses. In some embodiments, a heart valve prosthesis includes a plurality of flexible leaflets; a commissure support and a plurality of fasteners inserted into the inner surface of the commissure support and protruding from the outer surface of the commissure support. The fasteners comprise an elongated portion and a tip at an end of the elongated portion. In other embodiments, a heart valve prosthesis includes a plurality of flexible leaflets and a reinforcement secured to an inner surface of a valve commissure support. The reinforcement has an aperture. The heart valve prosthesis and fastener components can be placed into kits. The fasteners can be used to perform improved implantation procedures.

Abstract: A method for treating fixed biological tissue inhibits calcification of the biological tissue following implantation thereof in a mammalian body. The method includes placing the biological tissue in contact with glutaraldehyde and then heating the glutaraldehyde. Alternatively, methods other than heating (e.g., chemical or mechanical means), for effecting polymerization of the glutaraldehyde may also be utilized. Alternatively, the tissue may be heat treated prior to fixing thereof. Alternatively, methods other than glutaraldehyde may also be used for fixing the tissue. The biological tissue may be so treated at any time prior to implantation thereof in a mammalian body.

Abstract: A semilunar stentless valve is formed entirely of biological tissue, and has a plurality of leaflets that are joined to form an annulus and coapt to form a one-way valve. The leaflets open fully to minimize obstruction. A narrow rim of tissue is provided over commissures where the leaflets join and around a base of the valve for a sewing ring. The valves can be sutured to heart tissue wall in a single suture row.

Abstract: A system and method to facilitate thickness measurement of bio-material workpiece, preferably a sheet, and to topographically map the sheet into similar thickness zones for later use. In particular, the system may include a three-axis programmable controller for manipulating a bio-material workpiece with respect to a thickness measurement head. The measurement head may include a plurality of sensors for simultaneous measurement of a plurality of points, with the sensors being adapted to contact the sheet or not. A robust human-machine interface is also provided for process control, preferably including a touch-screen monitor. A marking head may be provided for marking the zones or otherwise indicating the thickness in different areas. Two platens are desirably used in parallel for increased thoughput; the workpiece on one platen may be measured while the other is marked. The system and method are especially suited for assessing and marking pericardial tissue for forming heart valve leaflets.

Abstract: 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.

Abstract: A novel durable prosthetic heart valve compatible with implantation in a human natural heart valve annulus. The prosthetic heart valve comprises a tubular heart valve which in function resembles a human heart valve, but which is formed of either synthetic or biologic material. The present valve is capable of structurally complying with annular deformation during each heartbeat. Valve embodiments comprise aortic, mitral, tricuspid, and pulmonic implantable valves. Valves can be selectively impregnated with a group of biologically active substances consisting of antibiotics, bactericidal agents, anticoagulant medications, endothelial cells, genetic material, growth factors or other hormonal or biologically active substances. Use of non-thrombogenic biocompatible materials in the valve which mimics operation of a natural heart valve essentially eliminates the need for long term administration of anticoagulants.

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.

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.

Abstract: A method of cutting material for use in an implantable medical device employs a plotted laser cutting system. The laser cutting system is computer controlled and includes a laser combined with a motion system. The laser precisely cuts segments out of source material according to a predetermined pattern as designated by the computer. The segments are used in constructing implantable medical devices. The cutting energy of the laser is selected so that the cut edges of the segments are melted to discourage delamination or fraying, but communication of thermal energy into the segment beyond the edge is minimized to avoid damaging the segment adjacent the edge.

Abstract: A multiple-sided medical device comprises a closed frame of a single piece of wire or other resilient material and having a series of bends and interconnecting sides. The device has both a flat configuration and a second, folded configuration that comprises a self-expanding stent. The stent is pushed from a delivery catheter into the lumen of a duct or vessel. One or more barbs are attached to the frame of the device for anchoring or to connect additional frames. A covering of fabric or other flexible material such as DACRON, PTFE, or collagen, is sutured or attached to the frame to form an occlusion device, a stent graft, or an artificial valve such as for correcting incompetent veins in the lower legs and feet. A partial, triangular-shaped covering over the lumen of the device allows the valve to open with normal blood flow and close to retrograde flow.

Abstract: An apparatus is disclosed for differentially treating a medical device. One portion of the device is treated with a first fluid and a separate portion is treated with a second fluid. The second fluid generally is substantially different from the first fluid. The first fluid can be contacted with an flow region of the medical device. The apparatus can include a conduit system, where fluid flowing through the conduit system flows through the flow region. Sheet material can be treated differentially on the opposite surfaces of the sheet. The medical device can include vascular tissue.

Abstract: A prosthetic heart valve has leaflets made of a thin and flexible material. The side edges of adjacent leaflets are sewn together so as to form a substantially tubular valve structure having an in-flow end and an out-flow end. Each of the leaflets is adapted to flex inwardly into and out of engagement with another leaflet so as to close and open the valve in response to force by blood pressure. The leaflets are configured so that a portion of the inner face of each leaflet is in a facing relationship with a portion of the inner face of an adjacent leaflet.

Abstract: Methods are disclosed for producing a prosthesis by at least partially cutting a material segment with a beam. The cutting is preferably controlled by a process control unit to cut the material segment along a pattern to generate a target image and size. In some embodiments, the material segment includes a tissue segment separated from an organism. An apparatus for cutting tissue comprises a tissue segment, a support platform, a beam generator and a process control unit. The beam generator is oriented to direct a beam at the tissue segment supported by the support platform. The process control unit is operably connected to the support platform. The improved cutting approaches can be used in the formation of heart valve prostheses.

Abstract: 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.

Abstract: A process of applying thermal energy using a controlled regimen is described to reduce the size of biological xenograft and allograft heart and vascular tissue, particularly heart valves, which are used for implants by applying a controlled regimen of thermal energy, and the related implant products, apparatuses and systems. In a particular embodiment, a xenograft or allograft heart valve experiences size reduction and fits the size requirements of a recipient into whom the heart valve is being implanted.

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 semilunar stentless valve is formed entirely of biological tissue, and has a plurality of leaflets that are joined to form an annulus and coapt to form a one-way valve. The leaflets open fully to minimize obstruction. A narrow rim of tissue is provided over commissures where the leaflets join and around a base of the valve for a serving ring. The valves can be sutured to heart tissue wall in a single suture row.

Abstract: A patch prosthesis includes at least one cusp extending from a length of an associated valve wall. An elongated sheet of biocompatible material is attached to the valve wall, such that a portion of the elongated sheet extends beyond an inflow end of the cusp. A measurement system may be employed to measure the size of a patient's native cusp(s), which measurement may be utilized to select a patch prosthesis having an appropriately sized cusp.

Abstract: A prosthesis is formed from a substrate with an associated attraction compound. The attraction compound binds viable precursor cells to the substrate. Thus, the substrate forms a synthetic tissue supporting viable cells once the substrate is contacted with a solution containing viable precursor cells. Preferred precursor cells differentiate into fibroblasts or into endothelial cells.

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: An anatomically designed atrioventricular valve is made of biologically compatible synthetic membrane or biological membrane of autologous, homologous or heterologous origin. A single piece of the selected membrane material is trimmed so as to form two unequal sheaths similar to the normal anterior and posterior mammalian mitral valve leaflets with a wide upper base to be sutured to the host's mitral annulus. These two leaflets are prolonged and tapered into two thin bands to be connected to the papillary muscles serving as replacements for the natural marginal chordae tendinae of the normal mitral valve. The two lateral sides of the membrane are joined to form a truncated cone with a wider upper circular base and a narrow extremity formed by the thin chordal bands. A set of sutures are placed between selected points at the base of the cone and the two thin prolongations serving as replacements for the strut or stay basal chords of the natural mitral valve.

Abstract: A supported bioprosthetic heart valve is provided. The valve includes a stent and a bilogical valve member. The stent has an annular frame defined by a support rail. The support rail is formed to define a triad of axially-projecting circumferentially-spaced commissure posts, each post having an inverted U-shaped configuration and a pair of legs. Each of the pair of legs has an upper end and a lower end. The lower end of each leg merges smoothly with the lower end of a leg of an adjacent commissure post. A sleeve having an inflow end and an outflow end is fitted around the annular frame. The biological valve member is defined by a tubular wall and three leaflets, the three leaflets being attached to the tubular wall and axially converging along three commissures. The biological valve member has a shape which fits the contour of the support rail and is disposed under the support rail. The biological valve member is sutured to the support rail and the outflow end of the sleeve.

Abstract: A method and an apparatus for testing the strength of autologous tissue for use in tissue leaflets for constructing artificial heart valves. A strip of tissue is cut adjacent to the edge of the tissue leaflet which is subject to the greatest stress when the tissue leaflet is mounted in the artificial heart valve. The strip of tissue is subjected to a known load produced by a spring to give a go/no go test of tissue strength. The spring is mounted in a generally X-shaped device made up of a generally linear piece having a handle at one end and two generally V-shaped pieces. The centers of all three pieces are joined to one another by a pivot. A spring is attached to the ends of the two generally V-shaped pieces which are closest to each other. The strip of tissue is mounted on the end of the generally linear shaped piece which does not have a handle and the end of the generally V-shaped pieces which is closest to the end of the generally linear piece which is attached to the strip of tissue.

Abstract: A heart valve with a structural stent and radially moveable cusps and commissures. The stent may be of three separate elements, each having a cusp portion and two commissure portions. The commissures may be pivotally or flexibly coupled, and may separate into independent leaflets. A connecting band may be provided that follows the cusps and commissures and extend outwardly. The valve may be connected to the natural tissue along the undulating connecting band. A multi-legged holder having legs alternating between each cusp and commissure may be used for implantation. A method of implantation is also disclosed, as is a system for implanting independent valve leaflets in the native annulus.

Abstract: The invention provides a replacement heart valve which contains an acellular matrix as a structural scaffold. The scaffold is seeded with isolated myofibroblasts and/or endothelial cells prior to implantation into a recipient mammal.

Abstract: A new and unique, optimized, two-dimensional heart valve tissue pattern, valve, and a method of reconstructing a three-dimensional semilunar heart valve, or portion thereof. In one preferred embodiment, the two-dimensional valve tissue pattern, and method of the present invention, comprises a two-dimensional configuration developed and optimized by employing, in part, the anatomy of a three-dimensional human heart valve, and said two-dimensional configuration delimits a two dimensional area that corresponds to the shape of tissue to be used in the repair of at least one leaflet of a circulatory system semilunar valve, wherein the configuration delimits at least one segment, and up to all three segments, of a three segment “trefoil” shape.

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: The present invention is directed to methods for obtaining heart valves from a donor animal that have a reduced tendency to cause inflammation when implanted into a human patient. The valves produced by this method should be less likely to undergo post-surgical degeneration.

Abstract: A method that allows for dry storage of bioprosthetic devices comprising a tissue component is provided. The method comprises the steps of providing a device comprising a chemically cross-linked animal tissue component; treating the tissue component with an aqueous solution comprising a biocompatible, water soluble, organic molecule comprising a plurality of carbon atoms and a plurality of hydroxyl groups for a time sufficient to allow equilibration between the fluids in the interstices of the tissue component and the aqueous solution; and then sterilizing the treated tissue component using a sterilizing gas or ionizing radiation. The present invention also relates to an implantable tissue component that can be stored dry. The tissue component is chemically-fixed and comprises within the interstices thereof a dimensional stabilizer selected from the group consisting of a polyhydric alcohol and derivatives thereof, a water soluble carbohydrate, and a water soluble gum.

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.

Abstract: A method is disclosed for using tubular material to replace a semilunar heart valve (i.e., an aortic or pulmonary valve). To create such a replacement valve, the native valve cusps are removed from inside an aorta or pulmonary artery, and the inlet end of a tubular segment is sutured to the valve annulus. The outlet (distal) end of the tube is either “tacked” at three points distally, or sutured longitudinally along three lines; either method will allow the flaps of tissue between the suture lines to function as movable cusps. This approach generates flow patterns that reduce turbulence and closely duplicate the flow patterns of native semilunar valves. An article of manufacture is also disclosed, comprising a sterile biocompatible synthetic material which has been manufactured in tubular form, by methods such as extrusion or coating a cylindrical molding device, to avoid a need for a suture line or other seam to convert a flat sheet of material into a tubular shape.

Abstract: Medical articles can include biocompatible material with a deposit of anticalcific elemental metal. The biocompatible material can be tissue, fabric or the like. The biocompatible material can be configured on the medical article such that when the medical article is positioned for its intended use, the biocompatible material is substantially removed from blood flow or is in a low blood flow area effectively removed from vascular blood flow. Gas phase or solution phase methods can be used to deposit the anticalcific elemental metal.

Abstract: 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.

Abstract: An apparatus is disclosed for differentially treating a medical device. One portion of the device is treated with a first fluid and a separate portion is treated with a second fluid. The second fluid generally is substantially different from the first fluid. The first fluid can be contacted with an flow region of the medical device. The apparatus can include a conduit system, where fluid flowing through the conduit system flows through the flow region. Sheet material can be treated differentially on the opposite surfaces of the sheet. The medical device can include vascular tissue.