Abstract: A method of treating a biological tissue that enables dry storage of said tissue is disclosed. In one embodiment, the method comprises contacting the biological tissue with a non-aqueous treatment solution comprising a polyhydric alcohol and a C1-C3 alcohol and removing a portion of the treatment solution from the solution-treated biological tissue. Also disclosed is biological tissue prepared using the above process and prosthetic devices made with such tissue.

Abstract: An implantable valve prosthesis including a frame defining a lumen extending between a proximal frame end and a distal frame end and a leaflet positioned within the lumen and having a distal edge attached to the frame and a proximal edge free of the frame. The leaflet includes a first and a second slit extending distally from the proximal edge and defining a free portion of the leaflet between the first and second slits. The leaflet is movable between a position that allows fluid flow in an antegrade direction and a second position that restricts flow in a retrograde direction.

Abstract: A surgical sutureless valve that is attached to a stent frame for delivery to a location in a patient using percutaneous implantation devices and methods.

Abstract: A method of implanting a prosthetic valve in a stenosed aortic valve via a catheterization technique. A balloon catheter is advanced into a patient's vasculature and a balloon is expanded within the stenosed aortic valve to push aside the calcified leaflets. The prosthetic valve is then introduced into a patient's vasculature through an 18 French arterial introducer. After advancement through the femoral artery and aorta, the prosthetic valve is radially expanded for implantation in the dilated aortic valve. The prosthetic valve includes a compressible and expandable frame and a valvular structure made with pericardial tissue. The prosthetic valve further includes an internal cover fastened to an internal surface of the frame between an inlet end of the frame and the valvular structure.

Abstract: Methods for the conditioning of bioprosthetic material employ bovine pericardial membrane. A laser directed at the fibrous surface of the membrane and moved relative thereto reduces the thickness of the membrane to a specific uniform thickness and smoothes the surface. The wavelength, power and pulse rate of the laser are selected which will smooth the fibrous surface as well as ablate the surface to the appropriate thickness. Alternatively, a dermatome is used to remove a layer of material from the fibrous surface of the membrane. Thinning may also employ compression. Stepwise compression with cross-linking to stabilize the membrane is used to avoid damaging the membrane through inelastic compression. Rather, the membrane is bound in the elastic compressed state through addition cross-linking. The foregoing several thinning techniques may be employed together to achieve strong thin membranes.

Abstract: A treatment for bioprosthetic tissue used in implants or for assembled bioprosthetic heart valves to reduce in vivo calcification. The method includes applying a calcification mitigant such as a capping agent or an antioxidant to the tissue to specifically inhibit oxidation in tissue. Also, the method can be used to inhibit oxidation in dehydrated tissue. The capping agent suppresses the formation of binding sites in the tissue that are exposed or generated by the oxidation and otherwise would, upon implant, attract calcium, phosphate, immunogenic factors, or other precursors to calcification. In one method, tissue leaflets in assembled bioprosthetic heart valves are pretreated with an aldehyde capping agent prior to dehydration and sterilization.

Abstract: An intraparietal reinforcing device is designed to be integrated into a biological valvular prosthesis consisting of a biological cardiac valve having a valve plane formed by leaflets attached laterally to an external wall along commissurae. The device can be placed in the organic tissue of the valve, and includes a base and a stabilizing part mounted thereon. The device can be inserted inside the external wall of the valve to reinforce the valve's structure and to maintain the valve's shape after implantation. The stabilizing part includes at least two intraparietal shafts, designed to be inserted into the valve tissue and positioned on the base so that, once the device is put in place on the valve, they are displaced laterally to the intersection point of the intersection line of the external wall with the commissurae and of the valve plane. A biological prosthesis may be provided with such a device.

Abstract: The new valve has a ring (1) with grooved (10) upper stents (2), three for trileaflet valves. The ring has a threaded mesh (6) stretching across stents. An outer sewing ring (4) placed on a gutter (3) on the outer surface of the ring fixes to native valve. The stent has grooves (10) to prevent sliding of mesh. The valve is sterilized and packed safely. The pericardium is cut by a levered cutter (7) with a handle, a middle fulcrum and the cutting cusp shaping (8) surfaces cutting desired size & shape cusps (5). The cusps are sutured to the mesh on indicated coloured threads. The valve is tested for leaks. The valve holder (9) holds the cusp mounted valve in suturing to native valve ring. The sewing ring of the valve is sutured to native valve annulus and the valve holder is removed. The valve opens with a big central lumen and closes with no leak.

Abstract: An anatomically approximate prosthetic heart valve includes dissimilar flexible leaflets, dissimilar commissures and/or a non-circular flow orifice. The heart valve may be implanted in the mitral position and have one larger leaflet oriented along the anterior aspect so as to mimic the natural anterior leaflet. Two other smaller leaflets extend around the posterior aspect of the valve. A basic structure providing peripheral support for the leaflets includes two taller commissures on both sides of the larger leaflet, with a third, smaller commissure between the other two leaflets. The larger leaflet may be thicker and/or stronger than the other two leaflets. The base structure defines a flow orifice intended to simulate the shape of the mitral annulus during the systolic phase. For example, the flow orifice may be elliptical.

Abstract: Described are percutaneous vascular valves (11) free of attached support structures and deployment systems (31) and methods for providing attachment of the valves within a vascular vessel.

Abstract: A prosthetic valve assembly for implantation within a native aortic valve using a catheterization technique. The prosthetic valve assembly includes a collapsible and expandable metallic frame. The frame is constructed to resist the recoil forces of the native aortic valve. The frame may be formed with a concave profile. A valvular structure made with pericardial tissue is sewn to the frame for permitting blood flow in one direction. An internal cover is provided along an internal surface of the frame and provides a sleeve which prevents blood from passing through gaps in the frame.

Abstract: The invention provides for bioengineered or tissue engineered heart valves that are more efficiently recellularized and/or have a decreased inflammatory potential. The heart valves are generally decellularized and then recellularized using autologous cells wherein the valves are subjected to pulsatile motion during the recellularization process. Tissue engineered heart valves subjected to the pulsatile motion are characterized by having at least 20% of the cells that remain on or in said previously decellularized tissue two weeks after the recellularization process are located below or interior to the basement membrane of said tissue. A method of making bioengineered tissues having these characteristic is also disclosed. Further provided is a bio-assay and related method for determining the inflammatory potential of a tissue.

Abstract: Methods of reducing retrograde fluid flow through a valve within a body vessel are provided. The methods can include the steps of identifying a valve exhibiting an undesirable amount of retrograde fluid flow within a body vessel, such as a venous valve or a heart valve, and providing a means for reducing the retrograde fluid flow. A medical device providing a desired amount of retrograde fluid flow can be modified after permitting the medical device to remain in a body cavity for a remodeling-effective time period. The implanted medical device can be modified by subsequently reducing the amount of retrograde fluid flow permitted across the implanted prosthetic valve within the body vessel.

Abstract: Medical devices for implantation in a body vessel are provided. Each medical device comprises a main body, a valve, and a vessel engaging member. The vessel engaging member is disposed on an outer surface of the main body. Kits including a plurality of vessel engaging members for use with one or more valve members are also provided. The vessel engaging members have varying radial dimensions, allowing assembly of medical devices having varying radial dimensions. Methods of treating a patient using medical devices according to the invention are also provided.

Abstract: A valve prosthesis (9) for implantation in the body by use of catheter (11) comprises a stent made from an expandable cylinder-shaped thread structure (2,3) comprising several spaced apices (4). The elastically collapsible valve (4) is mounted on the stent as the commissural points (5) of the valve (6) is secured to the projecting apices (4). The valve prosthesis (9) can be compressed around the balloon means (13) of the balloon catheter (11) and be inserted in a channel, for instance in the aorta (10). When the valve prosthesis is placed correctly the balloon means (13) is inflated thereby expanding the stent and wedging it against the wall of the aorta. The balloon means is provided with beads (14) to ensure a steady fastening of the valve prosthesis on the balloon means during insertion and expansion. The valve prosthesis (9) and the balloon catheter (11) make it possible to insert a cardiac valve prosthesis without a surgical operation comprising opening the thoracic cavity.

Abstract: A new aortic root replacement graft or apparatus is disclosed and method for making and using same. The graft or apparatus includes a substantially straight and uniform cylindrical conduit having an outwardly flared end section so that a diameter of the cylindrical section is less than a diameter of a distal end of the flared end section.

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 stentless bioprosthetic valve includes at least one piece of biocompatible material comprising a bi-leaflet conduit having a proximal end and a distal end. The proximal end defines a first annulus for suturing to the valve annulus. The conduit includes first and second leaflets that mimic the native leaflets and extend between the conduit ends. The distal end defines a second annulus at which the first and second leaflets terminate. The conduit further includes first and second pairs of prosthetic chordae projecting from the leaflets at the second annulus. One of the first pair of prosthetic chordae extends from the first leaflet and has a distal end for suturing to a papillary muscle and the other of the first pair of prosthetic chordae extends from the first leaflet and has a distal end for suturing to another papillary muscles.

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 cardiovascular prosthetic valve includes a cuff having a distal end and a proximal end. An inflatable structure is coupled to the cuff and has at least one inflatable channel that forms a toroidal structure. A valve is coupled to the cuff; the valve configured to permit flow in a first axial direction and to inhibit flow in a second axial direction opposite to the first axial direction. In one arrangement, the distal end of the cuff has a non-circular cross-section with respect to the flow and the non-circular cross-section is configured to affect the performance of an adjacent valve. In another arrangement, the cuff includes an anchor moveable from a first position to a second position. In another arrangement, control wires are coupled to the cuff.

Abstract: A treatment for bioprosthetic tissue used in implants or for assembled bioprosthetic heart valves to reduce in vivo calcification. The method includes applying a calcification mitigant such as a capping agent or an antioxidant to the tissue to specifically inhibit oxidation in tissue. Also, the method can be used to inhibit oxidation in dehydrated tissue. The capping agent suppresses the formation of binding sites in the tissue that are exposed or generated by the oxidation and otherwise would, upon implant, attract calcium, phosphate, immunogenic factors, or other precursors to calcification. In one method, tissue leaflets in assembled bioprosthetic heart valves are pretreated with an aldehyde capping agent prior to dehydration and sterilization.

Abstract: A prosthetic valve for placement within a body passage includes at least two valve leaflets made from a first layer of either peritoneal fascia tissue or pleural tissue. Support structure is attached to the first layer to provide structural support for the valve leaflets. A method for producing the prosthetic valve is also provided.

Abstract: A heart valve prosthesis having a plurality of leaflets encircling a flow opening and of size to coapt to form a valve, each leaflet having a free outflow edge at the outflow end of the leaflet, wherein the free outflow edge forms a convex (relative to the leaflet) curve in the plane of the leaflet, and methods for forming such a valve. A stentless heart valve prosthesis suitable for replacement of the aortic root comprising an outer wall and a plurality of leaflets positioned inside the outer wall, encircling a flow opening and of size to coapt to form a valve, wherein the outer wall and leaflets are formed from material other than natural valve material, and methods of forming such a valve prosthesis.

Abstract: A method of making a replacement heart valve device whereby a fragment of biocompatible tissue material is treated and soaked in one or more alcohol solutions and a solution of gluteraldehyde. The dried biocompatible tissue material is folded and rehydrated in such a way that forms a two- or three-leaflet/cusp valve without affixing of separate cusps or leaflets or cutting slits into the biocompatible tissue material to form the cusps or leaflets. After the biocompatible tissue material is folded, it is affixed at one or more points on the outer surface to the inner cavity or a stent.

Abstract: A reinforcement device for a biological valve includes an arrangement of supports configured to establish a double-trigone geometry in the valve and coupled to a base upon which the valve may be mounted. A plurality of commissural supports establish the geometry of a commissural trigone, and a plurality of intercommissural supports establish the geometry of an intercommissural trigone. A method for reinforcing a biological valve includes using commissural supports in conjunction with intercommissural supports, both sets of supports coupled to a base upon which the valve is mounted.

Abstract: A mono cusped patch for repairing cardiac outflow tract is disclosed in the present invention, which comprises an inner patch, an external supporting patch and a leaflet. An approximate semicircular slit is provided on the inner patch. The inferior border of the leaflet is set between the inner patch and the external supporting patch along the slit. The inner patch, the inferior border of the leaflet and the external supporting patch are stitched together along the slit edge of the inner patch with sutures. The inferior border of the leaflet is fixed between the inner patch and the external supporting patch. According to this special stitching structure, the present invention also provides a valved conduit of good performance.

Abstract: An intraparietal reinforcing device is designed to be integrated into a biological valvular prosthesis consisting of a biological cardiac valve having a valve plane formed by leaflets attached laterally to an external wall along commissurae. The device can be placed in the organic tissue of the valve, and includes a base and a stabilizing part mounted thereon. The device can be inserted inside the external wall of the valve to reinforce the valve's structure and to maintain the valve's shape after implantation. The stabilizing part includes at least two intraparietal shafts, designed to be inserted into the valve tissue and positioned on the base so that, once the device is put in place on the valve, they are displaced laterally to the intersection point of the intersection line of the external wall with the commissurae and of the valve plane. A biological prosthesis may be provided with such a device.

Abstract: A method of treating a biological tissue that enables dry storage of said tissue is disclosed. In one embodiment, the method comprises contacting the biological tissue with a non-aqueous treatment solution comprising a polyhydric alcohol and a C1-C3 alcohol and removing a portion of the treatment solution from the solution-treated biological tissue. Also disclosed is biological tissue prepared using the above process and prosthetic devices made with such tissue.

Abstract: Biomaterial including tissues basically obtained from an animal cornea, in particular, from a fish cornea. A cardiac valve (10) which may envisage at least one cusp (15) made with an organic tissue obtained from this particular biomaterial.

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 process and system for compressing bioprosthetic tissue for use in medical implants. The process involves placing the tissue between two compressive surfaces and applying a force to reduce any nonuniformity of thickness in the tissue, while at the same time reduce the overall thickness. One particularly useful application is the compression of bioprosthetic sheet during the preparation of heart valve leaflets. Bovine pericardium may be compressed to reduce its thickness by about 50%, and then formed into heart valve leaflets. The thinned leaflets have substantially the same absolute strength as those made from uncompressed tissue, and are particular desirable for use in minimally invasive valves which must be compressed into a small profile. The thin tissue enables a reduction in the overall size of the minimally invasive heart valve for delivery. For instance, rolled MIS valves may be reduced in size to as small as 20 mm in diameter.

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. The stitches are placed successively from a proximal in-flow end of each leaflet toward a distal out-flow end. 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 successive stitches terminate proximal of the distal tab portion so that no locked stitches are placed along the distal portion of the fold line. The tab portions of adjacent leaflets are folded over each other and sewn together to form commissural attachment tabs.

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 valvular prosthesis and method of using the prosthesis are disclosed. A valve apparatus is located within a stent apparatus, such that the prosthesis is deformable between a first condition and a second condition, in which the prosthesis has a reduced cross-sectional dimension relative to the first condition, whereby implantation of the prosthesis is facilitated when in the second condition.

Abstract: The invention concerns a method of conserving biological prostheses, wherein the method includes the following steps: (a) treating biological prostheses with a solution which contains a mixture of epoxide compounds which are at least in part of different lengths; (b) treating the biological prosthesis treated in accordance with step (a) with an antithrombotic-bearing solution; and (c) possibly storing the prosthesis treated in accordance with step (b) in a sterilising solution. The invention further concerns a biological prosthesis produced in accordance with the method of the invention and a conserving agent.

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 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. The stitches are placed successively from a proximal in-flow end of each leaflet toward a distal out-flow end. 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 successive stitches terminate proximal of the distal tab portion so that no locked stitches are placed along the distal portion of the fold line. The tab portions of adjacent leaflets are folded over each other and sewn together to form commissural attachment tabs.

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: The invention relates to methods of stabilizing glycosaminoglycans in a biological tissue (e.g. a bioprosthetic implant) in conjunction with cross-linking of protein in the tissue. The methods of the invention improve the mechanical integrity of the device and improves its stability in vivo. The invention also includes biological tissues having stabilized glycosaminoglycans and cross-linked proteins and kits for preparing such tissues.

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: In a system for generating tissue by growing cells in a porous and sometimes biodegradable material, a needle punched textile which serves as a scaffold is used for growing any of a variety of anatomical elements, in which the thickness of areas of the anatomical element and thus its strength can be increased by providing layers of mesh which are needled together to form a layerless textile and in which delamination is prevented through the use of the needling. In one embodiment, the needle punched textile is utilized to form a semi-lunar heart valve. In a preferred embodiment for pediatric use, the textile is made from two different biodegradable non-woven meshes. For some adult applications biodegradable meshes are not necessary, thus eliminating the necessity of using two different needled meshes. In one embodiment the needling is done with a single needle which is made to move around the periphery of a mold used in making the scaffold, thus to precisely control the area needled.

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 cusp, 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's heart.

Abstract: A biomaterial useful for bioprostheses such as bioprosthetic heart valves is provided in which the fixed tissue has improved elastic properties. The high elastin-containing biomaterial is further characterized by having anisotropic properties wherein the biological material has a greater stiffness in one direction and a greater elasticity in a cross direction. For instance, the biological material has an elastin content of about 30% by weight. In one embodiment, the biological material is vena cava tissue.

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. The stitches are placed successively from a proximal in-flow end of each leaflet toward a distal out-flow end. 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 successive stitches terminate proximal of the distal tab portion so that no locked stitches are placed along the distal portion of the fold line. The tab portions of adjacent leaflets are folded over each other and sewn together to form commissural attachment tabs.

Abstract: An improved prosthetic mitral valve is provided having advantageous hemodynamic performance, nonthrombogenicity, and durability. The valve includes a valve body having an inflow annulus and an outflow annulus. Commissural attachment locations are disposed adjacent the outflow annulus. An anterior leaflet and a posterior leaflet of the valve are shaped differently from one another. The inflow annulus preferably is scalloped so as to have a saddle-shaped periphery having a pair of relatively high portions separated by a pair of relatively low portions. The anterior high portion preferably is vertically higher than the posterior high portion.

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 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: An apparatus for treating fixed biological tissue to inhibit calcification of the biological tissue following implantation thereof in a mammalian body. The apparatus includes a container for placing the biological tissue in contact with a treatment solution, structure to induce relative tissue/solution movement, and structure to heat the solution. The relative movement may be induced by shaking a container in which the tissue is immersed in the treatment solution, or by stirring the solution within the container. The movement may also be induced by flowing a treatment solution past the tissue to be treated. The tissue may be free to move in the treatment container, or may be restrained from gross movements. The flow may be part of a circulation system having a reservoir, with a heater being provided to heat the treatment solution in the reservoir. Alternatively, a treatment apparatus, including a fluid circulation system if desired, may be enclosed in an incubator.

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 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.