Abstract: A film frame for an IOL has been developed which has the advantages of being lightweight, non-irritating, easily surgically implanted, aesthetically pleasing, and containing plate haptics. This IOL works in the anterior or posterior chamber of the eye for phakic or aphakic lenses and especially in the anterior chamber for phakic refractive lenses where thinner is better and long-term stability is required. This deformable IOL frame is a haptic system based on a high modulus harder material shaped skeletal frame or plate haptic assembled with low modulus softer elastomeric hinged zones. The rigid frame or haptic in combination with the soft hinges will ensure that the lens is ideally situated in the anterior chamber angle of the eye. Additionally, the soft elastomer can be extended to provide for a softer atraumatic contact point or ‘toe’ in the eye tissue.

Abstract: The present invention facilitates the use of the rapid manufacturing systems in the manufacture of prosthetic limb sockets by providing a substantially flat and strong distal attachment plate or base for the deposition of the fused-deposition-modeling materials thereon. The present invention also provides a method for fabricating a socket of a prosthetic limb which comprises the steps of: (a) providing a substantially flat distal attachment plate, where the attachment plate includes a coupling mechanism carried thereon for coupling a prosthetic upright assembly thereto; and (b) repeatedly depositing layers of solidifying material to the proximal surface of the attachment plate, controlled, at least in part, according to the dimensions of the patient's residual limb, so as to form a socket for receiving the patient's residual limb.

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: An intravascular flow modifier and vascular reinforcement for treatment of aneurysms is formed of a single loop of wire formed into a series of transverse loops and longitudinal connecting sections to configure an essentially cylindrical reinforcement device that still allows, if desired, access to the neck of an aneurysm for insertion of embolic coils and the like.

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: There are numerous medical situations involving deficiencies of living bone or periodontal tissue and where increase of living bone or periodontal tissue mass is desired. Methods are described wherein a configured, shell-like device that is capable of being penetrated by living cells and tissues, is implanted into the body of a mammal in such a way as to establish a space, the space being at least partly, bounded by the device. The configuration of the device is such that the configuration of the established space is essentially the same as the configuration of living bone or periodontal tissue that is desired for treatment of the tissue deficiency. At least one protein from the Transforming Growth Factor-Beta Superfamily of proteins is placed within the established space for the purpose of stimulating the growth of living bone or periodontal tissue within the established space. A kit for the generation of living bone or periodontal tissue, comprised of the components mentioned above, is also disclosed.

Abstract: Disclosed herein is processed dermis graft for use in orthopedic surgical procedures. Specifically exemplified herein is a processed dermis graft comprising one or more bone blocks having a groove cut into the surface thereof, wherein said groove is sufficient to accommodate a fixation screw. Also disclosed is a method of processing dermis that results in a dermis derived implant suitable to replace a tendon or ligament in a recipient in need thereof. Other compositions and applications of a dermis derived implant, and methods of manutacture and use, are disclosed.

Abstract: The invention provides an article of manufacture comprising a substantially non-immunogenic ligament or tendon xenograft for implantation into humans. The invention further provides a method for preparing a ligament xenograft by removing at least a portion of an ligament from a non-human animal to provide a xenograft; washing the xenograft in saline and alcohol; subjecting the xenograft to at least one treatment selected from the group consisting of exposure to ultraviolet radiation, immersion in alcohol, ozonation, freeze/thaw cycling, and optionally chemical crosslinking. In addition to or in lieu of the above treatments, the methods include a cellular disruption treatment and glycosidase digestion of carbohydrate moieties of the xenograft followed by treatment of carbohydrate moieties of the xenograft with capping molecules. The invention also provides articles of manufacture produced by one or more of the above-identified methods of the invention.

Abstract: Using animal tissues as starting materials, a method is described for producing extracellular matrix particulates. The invention includes an embodiment wherein the matrix particulates are applied to collagen scaffolds, which can be seeded with living cells or the particulates may alone be seeded with living cells. Further, the invention encompasses bonding the particulates to collagen foams, or collagen threads made into fabrics or to foams combined with threads. The particulates, with or without scaffolding, can be used as tissues for grafting or as model systems for research and testing. The invention also encompasses the spinning of threads on which the matrix particulates are components and the freeze drying of foams to whose surfaces the matrix particulates are attached.

Abstract: We disclose ultrafine-grained titanium. A coarse-grained titanium billet is subjected to multiple extrusions through a preheated equal channel angular extrusion (ECAE) die, with billet rotation between subsequent extrusions. The resulting billet is cold processed by cold rolling and/or cold extrusion, with optional annealing. The resulting ultrafine-grained titanium has greatly improved mechanical properties and is used to make medical implants.

Abstract: In order to bypass a restriction in a parent vessel, a first site in a branch vessel branching from the aorta is accessed intraluminally. An occlusion is formed at the first site, and the aperture is formed in the branching vessel, intraluminally, proximal of the first site. An aperture is formed in the parent vessel distal of the restriction, and a lumen is formed which communicates between the branching vessel proximal of the occlusion, and the parent vessel distal of the restriction.

Abstract: An intervertebral implant having a composite wedge/dowel configuration is provided. The intervertebral implant includes a central body portion and a pair of radially extending wings. The radially extending wings can be tapered from a first end of the implant to the second end of the implant along an axis parallel to the longitudinal axis of the central body portion. Alternately, the radially extending wings can be tapered along an axis transverse to the longitudinal axis of the cylindrical body portion or along any other axis between parallel and transverse to the longitudinal axis. A throughbore or plurality of throughbores extend from a top surface of the implant through the implant to a bottom surface of the implant. The implant may be formed from a cortical ring cut from the diaphysis of a long bone by milling the top and bottom surfaces of the cortical ring to form the substantially central body portion and the tapered radially extending wings.

Abstract: A prosthesis and a method of making a prosthesis having a needle containment and support structure that minimizes needle point plowing and/or needle scoring and inhibits delamination of the support structure during cannulization of the prosthesis. The prosthesis includes a first tube of expanded polytetrafluoroethylene (ePTFE), a polymer membrane, preferably ePTFE, positioned about the exterior surface of the first tube, and at least one support structure wound along a winding axis about the membrane to form axially spaced-apart ridges on the membrane. The support structure is a bead, filament, or similar structure that is wound about the exterior surface in a helical or spiral pattern to form the spaced apart-ridges. Alternatively, a plurality of spaced support rings can be employed to form the ridges. The ridges are preferably spaced apart a distance effective to direct a needle to a puncture site at an angle that inhibits needle plowing and hole enlarging, approximately less than 1.

Abstract: The present invention relates to a support structure/membrane composite device which includes a support structure, such as a radially expandable stent, a porous non-textile polymeric membrane adjacent to said stent and a thermoplastic anchor means attaching said stent to said porous non-textile polymeric membrane. The porous non-textile polymeric membrane is preferably made from expandable fluoropolymer materials. The anchoring means is a thermoplastic material which is dissolvable at the interface between the support structure and membrane by a suitable solvent which wets the membrane surface and deposits the thermoplastic material within the pores of the membrane. Methods of preparing the device are also disclosed.

Abstract: An improved permanently implantable breast tissue prosthesis comprising angularly and immutably attached base and dome envelopes wherein the base envelope is of a substantially triangular shape and the dome envelope is of a substantially discoid shape, each envelope having a shell defining an inner fluid containable chamber and an outer textured surface to be in direct contact with breast tissue and a valve formed as a part of a wall in base and dome envelopes, the valve facilitating the introduction, containment or removal of fluid within the containable chamber of each envelope.

Abstract: A method for forming a temporary orthopedic implant used in an orthopedic surgical procedure. The method includes mixing bone cement during a surgical procedure. An appropriately sized cement mold is selected which is translucent and includes an input port. The cement mold is filled with bone cement to form the temporary implant. A surgeon determines that the cement mold is fully filled by viewing through the translucent cement mold. The surgeon further fills the cement mold by directing a nozzle within the input port of the cement mold. The cement mold may further be pierced to relieve any air pockets formed in the cement mold. The temporary implant is then subsequently implanted into a patient. The temporary implant may also include a re-enforcement member included into the temporary implant.

Abstract: A stent manufactured for treating internal tubular organs, typically for treating a blood vessel, in which the stent has a sufficient diametral shrinkage ability and an ability for returning back to the original diameter thereof.

Abstract: The present invention facilitates the use of the rapid manufacturing systems in the manufacture of prosthetic limb sockets by providing a substantially flat and strong distal attachment plate or base for the deposition of the fused-deposition-modeling materials thereon. The present invention also provides a method for fabricating a socket of a prosthetic limb which comprises the steps of: (a) providing a substantially flat distal attachment plate, where the attachment plate includes a coupling mechanism carried thereon for coupling a prosthetic upright assembly thereto; and (b) repeatedly depositing layers of solidifying material to the proximal surface of the attachment plate, controlled, at least in part, according to the dimensions of the patient's residual limb, so as to form a socket for receiving the patient's residual limb.

Abstract: A method of making a biodegradable polymeric implant comprising the steps of aseptically mixing at least one monomer with at least one catalyst to form a polymerization mixture, injecting the polymerization mixture into a sterile mold, and polymerizing and/or cross-linking the polymerization mixture in the sterile mold to form a sterilized biodegradable polymeric implant. Additives may be included in the polymerization mixture as needed.

Abstract: The present invention provides a novel apparatus for measuring the shape of various parts of anatomy, and alternatively capturing and digitizing an image of the part for the purpose of creating prosthetic or orthotic devices. Also provided are methods of measuring anatomical profiles involving physical contact with the body parts, and methods of manufacturing internal or external prosthetic and orthotic articles which mimic natural body parts in texture and motion characteristics, and in some cases, appearance.

Abstract: A method for producing an expandable stent includes steps of: (i) selectively removing portions of a solid tubular wall having a diameter substantially the same as that of the stent in a second, expanded position to define multiple sections of the porous surface connected to one another by a series of axially disposed connecting members; (ii) radially compressing the stent by applying a radially inward force on the multiple sections and the connecting members such that the multiple sections have a diameter substantially the same as that of the stent in the first, compressed position; and (iii) removing the connecting members between the multiple sections to produce the stent in the first position.

Abstract: The present invention is a specialized implant having opposed surfaces for engaging each of the vertebral bodies adjacent a disc space into which the implant is implanted. The surface comprises arrayed projections having at least one forward facing facet directed at least in part toward the leading end of the implant and at least one rearward portion directed at least in part toward the opposite trailing end of the implant. Each of the forward facet and rearward portion has a length and a slope. The length of the forward facet is longer than the length of the rearward facet. The slope of the rearward facet is steeper than the slope of the forward facet. The surface projections also have opposed side facets directed generally toward the sides of the implant. The side facets are located between the forward facet and rearward facet and converge toward each other in a direction away from the base of the surface projections.

Abstract: Making a stent in accordance with information regarding tubular living-body tissue of each individual for treating such as aneurysm.

Abstract: A system for molding a tissue or substitute tissue product in a mold having an exterior surface, and an interior surface, wherein at least one portion of the interior surface is porous and whose pores are in continuous communication with the exterior surface, and wherein said mold can be fabricated using solid free-form fabrication techniques is disclosed.

Abstract: An intraocular multifocal lens has no definite line between near, far, and/or intermediate power lens areas, and substantially no distortion. A human or animal can use the lens with no need for it to translate. The lens preferably has substantially circular, substantially concentric, lens areas in order from the center, far, intermediate, and near. The multifocal zone preferably is about 2.5-3.5 mm in diameter for all adults. The lens can be made by mechanically acting on a single vision lens (having a predetermined near prescription) using a spinner shaft mounting the lens, and a rotating dish covered by a taut fabric.

Abstract: A process and product comprising collagen and demineralized bone particles. The product may contain a maximum of 20% by weight inorganic materials. The product may densified by compression. Additional osteogenic factors, mitogens, drugs or antibiotics may be incorporated therein. Inorganic materials may be bound to the organic matrix via precoating with a calcium or hydroxyapatite binding protein, peptide or amino acid. The materials also display long lasting drug release characteristics.

Abstract: An implantable intraluminal device includes a multilayer composite tubular device supporting one or more stents between the layer thereof and a method of making such a device is disclosed. A first porous elongate tube includes an exterior surface and an interior luminal surface. A radially expandable member is disposed about the exterior surface of the first tube. A second porous elongate tube is disposed concentrically over the first tube and is secured thereto so that the radially expandable member is longitudinally immobilized therebetween.

Abstract: A process is disclosed for producing osteoinductive bone using a controlled-flow apparatus. The present apparatus allows for the controlled extraction of undesirable constituents from a body tissue. The present invention provides for the demineralization of ground bone particles or pieces of cancellous or cortical bone which permits the controlled and reproducible demineralization of bone to produce bone which is maximally osteoinductive. It has been demonstrated that ground cadaveric bone which is demineralized to a residual calcium level approximating 2% by dry weight of bone is optimally osteoinductive as assayed using in vivo and in vitro assays of osteoinductivity. The present controlled-flow apparatus includes one or more solution containers which supply solutions to be pumped into one or more vessels filled with tissue samples to be extracted. Solvent outflowing from the vessels can be monitored for pH, calcium ion concentration or conductivity as a basis for determining when extraction is complete.

Abstract: The invention involves a bioprosthetic article including a biocompatible material having at least one bound exogenous storage structure, the storage structures having collectively greater than about 0.5 mg metal cations per gram of biocompatible material. The calcification inhibitors preferably decrease calcium deposition by greater than 95% relative to untreated tissue. The calcification inhibitors are bonded to the bioprosthetic material preferably at a pH between about 6.0 and 8.5.

Abstract: A filler material for a surgically implantable prosthesis comprised of a synthetic triglyceride having a viscosity substantially greater than that of naturally occurring triglycerides is provided. The triglyceride composition is formed of saturated alkyl chains to reduce or limit the potential for oxidation of the alkyl chains to form peroxide groups which adversely affect the biocompatibility of the filler material and the implant. Preferably, the filler material has a viscosity substantially the equivalent of a normal human breast. The synthetic triglyceride filler material may also have a lower viscosity which is a liquid at room temperature for use in inflatable devices. Prostheses containing filler material having the desired viscosity and antioxidation characteristics are also provided as well as a method for preparing the filler material.

Abstract: The present invention provides a method for producing an anterior cruciate ligament ex vivo. The method comprises seeding pluripotent stem cells in a three dimensional matrix, anchoring the seeded matrix by attachment to two anchors, and culturing the cells within the matrix under conditions appropriate for cell growth and regeneration, while subjecting the matrix to one or more mechanical forces via movement of one or both of the attached anchors. Bone marrow stromal cells are preferably used as the pluripotent cells in the method. Suitable matrix materials are materials to which cells can adhere, such as a gel made from collagen type I. Suitable anchor materials are materials to which the matrix can attach, such as Goinopra coral and also demineralized bone. Optimally, the mechanical forces to which the matrix is subjected mimic mechanical stimuli experienced by an anterior cruciate ligament in vivo.

Abstract: A process for producing a ceramic composite having a porous network. The process includes providing a photocurable ceramic dispersion. The dispersion consists of a photocurable polymer and a ceramic composition. The surface of the dispersion is scanned with a laser to cure the photocurable polymer to produce a photocured polymer/ceramic composition. The photocured composition useful as a polymer/ceramic composite, or the polymer phase can be removed by heating to a first temperature that is sufficient to burn out the photocured polymer. It is then heated to a second temperature that is higher than the first temperature and is sufficient to sinter the ceramic composition to produce a purely ceramic composition having a porous network. Preferably and more specifically, the process uses a stereolithographic technique for laser scanning. The process can form a high quality orthopedic implant that dimensionally matches the bone structure of a patient.

Abstract: Methods are provided for preparing a replacement graft for use in repairing a damaged ligament. The methods include harvesting the graft material, shaping it accordingly, assembling the graft by attaching sutures to the ends, and packaging the graft in a sterile container.

Abstract: A radially expandable support body is enveloped within a cocoon. In a preferred construction, the support is a stent, and a tube of polymeric material, e.g., polytetraeluoroethylene (PTFE), passes through the interior of the stent body and is turned back upon itself over the stent to form a cuff. The assembly is then heated and the outer layer contacts and coalesces with the inner layer, closely surrounding the stent body within a folded envelope having a continuous and seamless end. In one embodiment, an end portion of the tube is expanded before folding back over the-stent. The end portion, which becomes an exterior surface of the finished product, thus acquires a greater degree of porosity. Each end of the central tube may be so expanded, and folded back to seal all surfaces and both ends. The stent body itself may be a ring, or a short series of spaced-apart rings, or a wire or web, or a sheet possessing a number of apertures extending entirely through the sheet.

Abstract: A variety of new ways can be used for associating antimicrobial elemental metal with a medical article. The associated antimicrobial metal reduces the risk of infection associated with the medical use of the medical article. New medical articles are produced by some of these new approaches. Some of the methods involve ways of adjusting the dissociation rate of associated elemental metal such that desired degrees of antimicrobial activity can be achieved over selected periods of time.

Abstract: A method for improving the radial enlargeability and other properties of tape-reinforced tubular vascular graft formed of sintered fluoropolymer(s), such as expanded, sintered PTFE. Broadly, the method comprises the step of radially shrinking the reinforcement tape layer of the graft, or the entire tape-reinforced graft, after sintering thereof. Such radial shrinkage of the reinforcement tape layer, or of the entire graft, renders the graft subsequently radially enlargeable by more than 5%, without tearing or breaking of the reinforcement tape layer of the graft. Radially enlargeable grafts of the present invention may be combined with various types of stents or anchoring systems, to form endovascular graft devices which are transluminally insertable and implantable within the lumen of a host blood vessel.

Abstract: A method and system for molding a tissue or substitute tissue product in a mold having an exterior surface, and an interior surface, wherein at least one portion of the interior surface is porous and whose pores are in continuous communication with the exterior surface, and wherein said mold can be fabricated using solid free-form fabrication techniques is disclosed.

Abstract: A method and system for molding a tissue or substitute tissue product in a mold having an exterior surface, and an interior surface, wherein at least one portion of the interior surface is porous and whose pores are in continuous communication with the exterior surface, and wherein said mold can be fabricated using solid free-form fabrication techniques is disclosed.

Abstract: A stent for placement in a body lumen is fabricated by forming a tube having an un-deployed diameter sized for the tube to be placed on a deployment balloon and advanced through a body lumen to a deployment site. The tube is expandable upon inflation of the balloon to an enlarged diameter sized for the tube to be retained within the lumen at the site upon deflation and withdrawal of the balloon. The tube has a stent axis extending between first and second axial ends of the tube. The tube has an exterior surface and an interior surface. The tube is polished to polish the exterior surface to a smooth surface finish and with at least a portion of the interior surface having a rough surface finish rougher than the surface finish of the exterior surface.

Abstract: A prosthetic implant to replace damaged or diseased bone, especially in the maxillofacial region, is produced by producing a digital representation of the region of interest by CAT scan, using the data to create a model by stereolithography, and using the data also to produce the implant by CNC machining. The implant is an entire replacement extracts excised surgically, without need for reconstructing bone or soft tissue.

Abstract: An article (e.g., in the form of an implantable medical article) in the form of a support material bearing an intermediate layer consisting of a functional silicone polymer formulation, the intermediate layer having photoimmobilized thereon a target compound. In another aspect, a method of fabricating an article including the steps of providing a support material, applying an intermediate layer and photoimmobilizing a target compound onto the intermediate layer, and optionally, reforming the support material into a final desired article.

Abstract: New methods for producing intraocular lenses (IOLs) include a combination of steps which provide outstanding pull strength between the fixation member of the IOL and the optic of the IOL without requiring the lens body region of the fixation member to have enlarged anchor structures. In one embodiment, the present methods include providing an optic member having a recess; providing a fixation member having a lens bonding region free of enlarged anchor structures; placing the lens bonding region into the recess; and thereafter doing at least one of reducing the size of the recess and increasing the cross-sectional area of the lens bonding region. The lens bonding region of the fixation member is thereby secured to the optic member.

Abstract: A method of forming an iridium oxide coating on a metal stent to achieve a firmattachment of a thin biocompatible coating of the iridium oxide such that the iridium oxide resists being dislodged from the stent upon expansion thereof in a vessel of the human body during implantation of the stent. The method includes submerging the stent in a coating solution having an adequate concentration of iridium chloride in a suitable liquid vehicle, and subjecting the coating solution with stent immersed therein to combined heating and application of ultrasonic energy at a temperature and energy level and for a time interval sufficient to form a coating of iridium oxide of desired thickness and surface roughness on the underlying metal surface of the stent.

Abstract: A method of specifying the components of an artificial limb, includes the steps of: providing at least one logical unit table arranged to contain data relating to a class of the components; providing a plurality of component records located in the at least one logical unit table, in which each of the component records is arranged to hold data relating to a respective plurality of components of the same class, and in which at least one of the component records relates to a generic component; providing for the at least one generic component record an associated set of specific component records and at least two option lists, each of which lists relates to a defined characteristic of the component of the associated generic component record; in which the user selects an option from each list; and in which a unique specific component record is identified from the associated set thereof that is compatible with each selected option.

Abstract: A method for fixation of biological tissues, and bioprosthetic devices prepared by such method. The method generally comprises the steps of A) fixing the tissue, B) treating the tissue with a mixture of i) a denaturant, ii) a surfactant and iii) a crosslinking agent, C) fabricating or forming the bioprosthesis (e.g., forming the tissue and attaching any non-biological components thereto) and D) subjecting the bioprosthesis to terminal sterilization.

Abstract: The invention provides a substantially non-immunogenic ligament or tendon xenograft for implantation into humans. The invention further provides a method for preparing a ligament xenograft by removing at least a portion of a ligament from a non-human animal to provide a xenograft; washing the xenograft in saline and alcohol; subjecting the xenograft cellular disruption treatment, such as exposure to ultraviolet radiation, immersion in alcohol, ozonation, freeze/thaw cycling, and optionally chemical crosslinking. In addition to or in lieu of the above treatments, the methods include digestion of the carbohydrate moieties of the xenograft with a glycosidase, preferably in a range of about 1 mU/ml to about 1000 U/ml, followed by treatment for sialylation. The invention also provides articles of manufacture produced by one or more of the above-identified methods of the invention.

Abstract: Herein are disclosed devices, particularly medical devices, more particularly implantable medical devices, comprising a first layer of a metal and a short chain silicone terminating with silicon hydride, and a second layer of a silicone polymer. The short chain silicone is bound to the metal, and the silicone polymer is covalently bound via the vinyl group to the silicon hydride group of the short chain silicone. Also disclosed herein is a method for making such devices, involving providing the metal, depositing the short chain silicone, molding the silicone polymer as a silicone prepolymer, and polymerizing the silicone prepolymer to yield silicone polymer covalently bonded to the short chain silicone.

Abstract: A prosthetic bone filler including ceramic granules for use in a living body, the ceramic granules being bonded to each other with a polymeric substance, and having ventilation pores produced as a result of the presence of gaps between the adjacent granules. The prosthetic bone filler is produced by adding the polymeric substance in two portions to the ceramic granules. In addition to good flexibility, the prosthetic bone filler exhibits excellent bio-compatibility.

Abstract: A method whereby one or more occluders are inserted in the housing of a prosthetic heart valve by compressing the housing of the prosthetic heart valve at four discrete locations, thereby causing the housing to deform sufficiently for insertion of occluders between diametrically opposed pivot supports on the inner surface of the housing. The appropriate locations for application of the compressive forces are identified. Compression force is then applied using either pin blocks or v-shaped blocks. One or more occluders are inserted in the pivot supports. The compressive forces are released, allowing the housing to return to its unstressed generally annular shape and securing the occluders in the housing.

Abstract: A method of making a bioprosthetic conduit, comprises the steps of: (a) taking a cylindrical mould, having circumferentially spaced protuberances which extend radially from the axis; (b) curving a layer of a biocompatible sheet material around the cylindrical mould, and joining the opposed edges of the layer together along a longitudinal axis, parallel to the axis of the mould to form a tubular layer; and (c) removing the tubular layer from the mould and turning it inside out to form a cylindrical conduit with sinuses, the conduit being fully fixed by a chemical means; after removal or while still on the mould.