Abstract: A surgical procedure according to which a moldable material is positioned over a defect and over an area of the anatomy surrounding the defect so that the moldable material takes the shape of the area. After the moldable material forms a mold, a graft is placed on the mold; and cut to conform to a dimension of the defect.

Abstract: Hybrid synthetic grafts and embodiments of systems and methods for producing hybrid vascular grafts that can yield implantable grafts that combine synthetic grafts with living cells. Embodiments of systems can include a pressure/flow loop subsystem having an external flow loop system coupled to a specimen holder, where the pressure/flow loop subsystem is capable of adjusting at least two dynamic conditions in the specimen holder or a diameter of a specimen in the specimen holder. Embodiments of methods can promote endothelialization of a hybrid lower limb artery bypass vascular graft by placing the hybrid lower limb artery bypass vascular graft in a system embodiment according to the invention under conditions effective to promote stem cells to differentiate into endothelial cells on a surface of the hybrid lower limb artery bypass vascular graft.

Abstract: Hybrid synthetic grafts and embodiments of systems and methods for producing hybrid vascular grafts that can yield implantable grafts that combine synthetic grafts with living cells. Embodiments of systems can include a pressure/flow loop subsystem having an external flow loop system coupled to a specimen holder, where the pressure/flow loop subsystem is capable of adjusting at least two dynamic conditions in the specimen holder or a diameter of a specimen in the specimen holder. Embodiments of methods can coat a hybrid graft with a confluent monolayer of endothelial cells by immobilizing stem cells on a hybrid carotid bypass vascular graft, placing the hybrid graft in a system embodiment according to the invention under conditions effective to promote the stem cells to form a confluent monolayer on the surface of the hybrid vascular graft and in an environment to promote the stem cells to differentiate into endothelial cells.

Abstract: Hybrid synthetic grafts and embodiments of systems and methods for producing hybrid vascular grafts that can yield implantable grafts that combine synthetic grafts with living cells. Embodiments of systems can include a pressure/flow loop subsystem having an external flow loop system coupled to a specimen holder, where the pressure/flow loop subsystem is capable of adjusting at least two dynamic conditions in the specimen holder or a diameter of a specimen in the specimen holder. Embodiments of methods can prepare a hybrid lower limb artery bypass vascular graft intended for implantation into a mammal by placing the hybrid lower limb artery bypass vascular graft in a system embodiment according to the invention prior to implantation of the hybrid lower limb artery bypass vascular graft into the mammal.

Abstract: Hybrid synthetic grafts and embodiments of systems and methods for producing hybrid vascular grafts that can yield implantable grafts that combine synthetic grafts with living cells. Embodiments of systems can include a pressure/flow loop subsystem having an external flow loop system coupled to a specimen holder, where the pressure/flow loop subsystem is capable of adjusting at least two dynamic conditions in the specimen holder or a diameter of a specimen in die specimen holder. Embodiments of methods can promote endothelialization of a hybrid carotid bypass vascular graft by placing the hybrid carotid bypass vascular graft in a system embodiment according to the invention under conditions effective to promote endothelial cells to form a confluent monolayer on the surface of the hybrid vascular graft.

Abstract: Hybrid synthetic grafts and embodiments of systems and methods for producing hybrid vascular grafts that can yield implantable grafts that combine synthetic grafts with living cells. Embodiments of systems can include a pressure/flow loop subsystem having an external flow loop system coupled to a specimen holders where the pressure/flow loop subsystem is capable of adjusting at least two dynamic conditions in the specimen holder or a diameter of a specimen in the specimen holder. Embodiments of methods can coat a hybrid carotid bypass vascular graft with a confluent monolayer of endothelial cells by immobilizing a plurality of endothelial cells on the hybrid carotid bypass vascular graft and placing the hybrid carotid bypass vascular graft in a system embodiment according to the invention under conditions effective to promote the endothelial cells to form a confluent monolayer on the surface of the hybrid vascular graft.

Abstract: Hybrid synthetic grafts and embodiments of systems and methods for producing hybrid vascular grafts that can yield implantable grafts that combine synthetic grafts with living cells. Embodiments of systems can include a pressure/flow loop subsystem having an external flow loop system coupled to a specimen holder, where the pressure/flow loop subsystem is capable of adjusting at least two dynamic conditions in the specimen holder or a diameter of a specimen in the specimen holder. Embodiments of methods can promote endothelialization of a hybrid carotid bypass vascular graft by placing the hybrid carotid bypass vascular graft in a system embodiment according to the invention under conditions effective to promote stem cells to differentiate into endothelial cells on a surface of the hybrid carotid bypass vascular graft.

Abstract: Hybrid synthetic grafts and embodiments of systems and methods for producing hybrid vascular grafts that can yield implantable grafts that combine synthetic grafts with living cells. Embodiments of systems can include a pressure/flow loop subsystem having an external flow loop system coupled to a specimen holder, where the pressure/flow loop subsystem is capable of adjusting at least two dynamic conditions in the specimen holder or a diameter of a specimen in the specimen holder. Embodiments of methods can promote engraftment of a hybrid carotid bypass vascular graft following implantation into a mammal's body by placing the hybrid carotid bypass vascular graft in a system embodiment according to the invention prior to implantation of the hybrid carotid bypass vascular graft into the mammal's body.

Abstract: Hybrid synthetic grafts and embodiments of systems and methods for producing hybrid vascular grafts that can yield implantable grafts that combine synthetic grafts with living cells. Embodiments of systems can include a pressure/flow loop subsystem having an external flow loop system coupled to a specimen holder, where the pressure/flow loop subsystem is capable of adjusting at least two dynamic conditions in the specimen holder or a diameter of a specimen in the specimen holder. Embodiments of methods can coat a hybrid graft with a confluent monolayer of endothelial cells by immobilizing stem cells on a hybrid lower limb artery bypass vascular graft, placing the hybrid graft in a system embodiment according to the invention under conditions effective to promote the stem cells to form a confluent monolayer on the surface of the hybrid vascular graft and in an environment to promote the stem cells to differentiate into endothelial cells.

Abstract: A system for preparing a graft vessel for anastomosis includes one or more tools held within a functional package. The package includes a tray and tray top, either or both of which may include one or more features configured to hold the contents of the tray securely therein, and/or may include one or more registration features configured to register one or more items in a desired position in the tray. The package has multiple recesses for holding one or more tools for preparing a graft vessel for anastomosis, and can be sealed and sterilized along with its contents. One of these tools may be a poke-through tool that includes a plurality of membranes within a shell.

Abstract: The disclosure relates to a woven fabric for use in an implantable medical device. The woven fabric comprises shape memory element strands woven with textile strands. At least one of the shape memory element strands has at least one float of at least five textile strands between binding points.

Abstract: Hybrid synthetic grafts and embodiments of systems and methods for producing hybrid vascular grafts that can yield implantable grafts that combine synthetic grafts with living cells. Embodiments of systems can include a pressure/flow loop subsystem having a steady flow system and an external flow loop system coupled to a specimen holder, where the pressure/flow loop subsystem is capable of adjusting at least two dynamic conditions in the specimen holder or a diameter of a specimen in the specimen holder. Embodiments of methods can prepare a hybrid coronary bypass vascular graft intended for implantation into a mammal by placing the hybrid coronary bypass vascular graft in a system embodiment according to the invention prior to implantation of the hybrid coronary bypass vascular graft into the mammal.

Abstract: A method is provided for implanting a valve having at least one valve leaflet within the cardiovascular system of a subject. One step of the method includes preparing a substantially dehydrated bioprosthetic valve and then providing an expandable support member having oppositely disposed first and second ends and a main body portion extending between the ends. Next, the substantially dehydrated bioprosthetic valve is attached to the expandable support member so that the substantially dehydrated bioprosthetic valve is operably secured within the main body portion of the expandable support member. The expandable support member is then crimped into a compressed configuration and placed at a desired location within the cardiovascular system of the subject. Either before or after placement at the desired location, fluid or blood re-hydrates the substantially dehydrated bioprosthetic valve.

Abstract: Devices, systems and methods are disclosed for the formation of an arteriovenous fistula in the limb of the patient. Embodiments include an apparatus for the creation, modification and maintenance of a fistula, including the modification of an existing dialysis fistula; and a method of supplying oxygenated blood to the venous circulation of a patient. A kit of anastomotic implants is described which supports a broad base of patient anatomies and fistula locations. The devices, systems and methods can be used to treat patients with one or more numerous ailments including chronic obstructive pulmonary disease, congestive heart failure, hypertension, hypotension, respiratory failure, pulmonary arterial hypertension, lung fibrosis and adult respiratory distress syndrome.

Abstract: A method for making a bioprosthetic device to reduce post-implantation mineralization of the device is provided. The method comprises providing a collagen-containing material, removing cell debris from the collagen-containing material, crosslinking the material, and removing at least a portion of ester bonds from the crosslinked collagen-containing material. Ester bonds can be removed by exposing the collagen-containing material to hydrolyzing conditions or an enzyme.

Abstract: There is described a synthetic aortic conduit formed from two tubular porous layers having a non-bioresorbable sealant, such as SEPs, interposed therebetween. The synthetic aortic conduit can be attached to an aortic valve, such as a xenograft valve, to form an aortic root replacement prosthesis. The synthetic aortic conduit has the advantage that it can be stored in the preservative solutions required for tissue valves without degradation.

Abstract: Methods, apparatuses, computer program products, devices and systems are described that include accepting three-dimensional blood vessel data; applying a sleeve-fitting algorithm to the three-dimensional blood vessel data; and presenting a sleeve-fitting algorithm output in response to said applying the sleeve-fitting algorithm to the three-dimensional blood vessel data.

Abstract: A method of making a stent-graft comprising, providing a radially distensible, tubular stent having opposed open ends comprising an undulating wire helically wound into a plurality of circumferential windings to define stent wall structure having opposed exterior and luminal surfaces, providing a first non-textile, polymeric graft tube, providing a second non-textile, polymeric graft tube, laminating the radially distensible, tubular stent between the first non-textile, polymeric graft tube and the second non-textile, polymeric graft tube, trimming the laminated polymeric graft tube beyond the undulating wire at the open ends, providing a third non-textile, polymeric graft layer; placing the third non-textile, polymeric graft layer over the trimmed over ends, inserting the third non-textile, polymeric graft layer of the tubular stent into the undulating wires; and laminating the third non-textile polymeric graft layer to the first non-textile, polymeric graft tube and the second non-textile, polymeric graft t

Abstract: The present invention generally relates to the conditioning of coated medical devices such as stents. More specifically, the present invention relates to methods for positioning a medical device within an elution media for a predetermined time period to eliminate a burst release from the coating. Under methods and processes of the invention, a medical device target surface may be identified and coated with therapeutic. The coated surface of the medical device may then be positioned within an elution media for a predetermined period of time to release a predetermined amount of coating.

Abstract: The present invention discloses a structural and mechanical model and modeling methods for human bone based on bone's hierarchical structure and on its hierarchical mechanical behavior. The model allows for the assessment of bone deformations, computation of strains and stresses due to the specific forces acting on bone during function, and contemplates forces that do or do not cause viscous effects and forces that cause either elastic or plastic bone deformation.

Abstract: A microprocessor controlled and instrumented bioreactor for conditioning intravascular tissue engineered medical products. One bioreactor design including an integrated pump to provide a relatively small volume of fluid nutrient. The microprocessor control providing measurement and control of the fluid flow and tissue displacement and subsequent determination of material properties. One design includes a flexible joint providing motion of the treated tissue in the axial, bending and torsional direction.

Abstract: A vessel holder supports a blood vessel during processing for use in bypass graft surgery. The holder comprises a base and a first fixture mounted on the base for holding a first end of the blood vessel. The first fixture has a fluid supply needle for inserting into the first end of the blood vessel. A second fixture is mounted on the base a predetermined distance from the first fixture for holding a second end of the blood vessel. The predetermined distance is adjustable for holding the blood vessel under tension. The device reduces labor and time for vessel preparation. With various optional features, the device obtains safer application of pressurized saline solution when testing for leaks, better visualization for inspecting the vessel for surgical use, reliable protection of the vessel from accidental damage, and convenient immersion of the vessel in a bath for preservation until needed in the surgery.

Abstract: A bioprosthetic valve graft comprises a valve frame and valve flaps, the latter acting to open or close a valve aperture to directionally control fluid flow through the bioprosthesis. The bioprosthetic valve graft comprises method for suturelessly attaching a biomaterial suturelessly bonded to the A method for securing a biomaterial to a valve frame includes positioning a flexible valve frame defining an open area on a first major surface of a biomaterial sheet having a peripheral edge, wherein positioning serves to approximate the valve frame and the peripheral edge of the biomaterial sheet to form an at least first bonding locus; and suturelessly bonding the biomaterial to the valve frame at the at least first bonding locus. The method avoids the disadvantages associated with conventional sutures and substantially reduces medical complications in implantations.

Abstract: Methods and systems are described for receiving a parameter relating to a specific patient and for configuring a stent with a flow occlusion portion in response to receiving the parameter relating to the specific patient.

Abstract: Methods and systems are described for receiving a parameter relating to a specific patient, and for customizing one or more attributes of a stent ex situ as an at-least-roughly contemporaneous response to receiving the parameter relating to the specific patient or for customizing one or more junctions of a stent ex situ in response to the received parameter relating to the specific patient.

Abstract: Methods and systems are described for receiving a parameter relating to a specific patient, and for customizing one or more attributes of a stent ex situ as an at-least-roughly contemporaneous response to receiving the parameter relating to the specific patient or for customizing one or more junctions of a stent ex situ in response to the received parameter relating to the specific patient.

Abstract: Acellular matrix grafts are provided with are isolated from natural sources and consist essentially of a collagen and elastin matrix which is devoid of cellular components. The grafts are useful scaffolds which promote the regeneration of muscle tissue and aid in restoring muscle function. Due to their acellular nature, the grafts lack antigenicity. As a result, the acellular matrix grafts can be isolated from autographic, allographic or xenographic tissues.

Abstract: Methods and systems for selection radiation exposure in sterilization of medical devices are disclosed.

Abstract: A system for performing anastomosis between a graft vessel and a target vessel includes a tissue effector that may be configured to deploy a user-selectable number of connectors. The system includes an anvil that enters the wall of the target vessel through an entry hole that is spaced apart from the anastomosis site, and at least one anvil entry hole sealer may be utilized to substantially seal the anvil entry hole upon withdrawal of the anvil. The system may include a shield and a cutter, both of which are movable relative to the anvil, where the shield is configured to protect the graft vessel from the cutter. The cutter may include an incising element movable from a stowed position to an active position.

Abstract: A preserved vessel isolated from a human umbilical cord or placenta and lyophilized for use as an allograft which improves blood supply to human tissue without antigenicity.

Abstract: A system and a method for harvesting a section of a blood vessel from a patient's body for further use. The system includes an expandable hood that creates a workspace for the dissection and removal of the vessel and a telescoping device that has tools at its distal end. The blood vessel is cut at a distal location and a light catheter inserted to illuminate the area of dissection. The system can remove a section of the saphenous vein for use in coronary bypass surgery.

Abstract: A method for stitching thread onto the wall of a tubular medical implant (preferably a graft) employs a sewing machine with an elongate bobbin or a needle on an elongate element, depending on whether it is desired to sew from the outside-in or the inside-out. A motor rotates and translates the implant, which is mounted on a hollow drum, relative to the needle.

Abstract: The invention relates to a preserved, deantigenated tissue matrix of an animal or human hollow organ, e.g. of a blood vessel, of the ureter or urinary bladder, which matrix is autologous, allogenic or xenogenic with respect to a recipient and whose biomechanical properties are not or only slightly impaired by such preservation, which does not include any infectious particles from the donor and is excellently suited for coating with recipient endothelial, epithelial, fibroblast, or muscle cells in order to produce autologous grafts for said recipient. The invention is also directed to a method of producing said tissue matrix and to the use thereof, as well as to the autologous graft produced therefrom, and to the production and use thereof.

Abstract: A fluid flow system for preparing an implantable substrate is provided having a fluid permeable container that is capable of retaining a biocompatible, implantable substrate, and a driver mechanism for subjecting fluid to a constant force to induce a selected, controlled flow rate of the fluid through a substrate disposed in the container. The system can include a fluid reservoir having an inlet and an outlet, and being effective to selectively retain a fluid. The reservoir is preferably disposed upstream of the container. The system can also optionally include a fluid recycling conduit that is effective to recirculate fluid from the container to the reservoir.

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: An apparatus (10) for grafting of a blood vessel (12) and a method of forming the apparatus (10) is provided. The apparatus (10) comprises an expandable support member (16) having inner and outer surfaces (36 and 34). The outer surface (34) of the expandable support member (16) is for engaging and adhering to an inside surface (68) of the blood vessel (12). A layer of biological tissue (14) is attached to the inner surface (36) of the support member (16). The layer of biological tissue (14) has an uninterrupted inwardly facing surface (50) for extending confluently with the inside surface (68) of the blood vessel (12) to provide resistance to thrombosis and platelet deposition.

Abstract: The invention is directed to bioengineered graft prostheses made from two or more superimposed, chemically bonded layers of processed tissue material prepared from cleaned tissue material derived from animal sources. The bioengineered graft prostheses of the invention are prepared using methods that preserve cell compatibility, strength, and bioremodelability of the processed tissue matrix. The bioengineered graft prostheses are used for implantation, repair, or for use in a mammalian host.

Abstract: The present invention relates to a method of making a tissue graft material. The method includes placing body tissue and a blood component in a chamber and extruding the body tissue and blood component from an opening in the chamber to form the tissue graft material.

Abstract: A device and method for removing a generally cylindrical tissue structure such as a blood vessel from the body of a human or animal. The device includes a body portion having distal and proximal ends with at least one lumen extending longitudinally through the body portion. The lumen is sized to accommodate the vessel and at least one tool used in removing the vessel. Means is provided for isolating the vessel from the tools used in the removal procedure.

Abstract: The present invention relates to decellularized vascular prostheses that are resistant to thrombus occlusion and have a low level of immunogenicity. The vascular prostheses are denuded of cells, and coated with an anti-thrombogenic agent and a growth factor that promotes recellularization and further reduces the immunogenicity. The prostheses have high mechanical strength, resist aneurysm rupture, and allow for secure surgical sutures while maintaining structural integrity. The present invention provides vascular prostheses that are blood vessels, valves or portions of vessels containing valves. The present invention is also useful for coating synthetic vascular stents.

Abstract: A medical device coated with one or more antibodies and one or more layers of a matrix is disclosed. The antibodies or fragments thereof react with an endothelial cell surface antigen. Also disclosed are compositions and methods for producing the medical device. The matrix coating the medical device may be composed of a synthetic material, such as a fullerene, or a naturally occurring material. The fullerenes range from about C60 to about C100. The medical device may be a stent or a synthetic graft. The antibodies promote the adherence of cells captured in vivo on the medical device. The antibodies may be mixed with the matrix or covalently tethered through a linker molecule to the matrix. Following adherence to the medical device, the cells differentiate and proliferate on the medical device. The antibodies may be different types of monoclonal antibodies.

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: The present invention provides an ex vivo vascular remodeling methods and system by which an excised, small diameter blood vessel can be harvested and expanded to provide viable vascular grafts, as demonstrated at the physical and molecular levels, and as optimized in vivo. The tissue-engineered vessels generated by the present invention closely resemble native vessels in terms of structure, histologically, including endothelial coverage and intricate structural components such as the internal elastic lamina, viability (as measured with the MTT assay and TUNEL analysis), and function (vasoactivity, mechanical and biomechanical properties). Thus, the resulting vascular grafts behave in a manner similar to native arteries in terms of mechanical integrity, and provide clinically relevant patency rates when implanted in vivo.

Abstract: The invention relates to a method of treatment of collagenous connective tissue removed from a donor for implant into a recipient which is re-habited or re-colonized by host cells without an immune rejection and inflammatory reaction. After removal from the donor, the tissue is trimmed and thereafter soaked in a cold stabilizing solution having a temperature range of 4 to 10 degrees centigrade. The tissue is then soaked at a predetermined temperature in a polyglycol, salt, hydrogen peroxide, and phosphate buffer first solution of predetermined quantities and concentrations and of sufficient ionic strength to permit ground substances to dissociate such that the collagen fibers remain stable. The tissue is then soaked in an alcohol and water solution at a predetermined temperature for a sufficient period of time to remove the residue of the first solution.

Abstract: It is a general object of the invention to provide a method of effecting repair or replacement or supporting a section of a body tissue using tropoelastin, preferably crosslinked tropoelastin and specifically to provide a tropoelastin biomaterial suitable for use as a stent, for example, a vascular stent, or as conduit replacement, as an artery, vein or a ureter replacement. The tropoelastin biomaterial itself can also be used as a stent or conduit covering or coating or lining.

Abstract: Methods and apparatus are provided for forming a vascular graft in vitro by axially distending a blood vessel to induce growth. The apparatus comprises a chamber containing a tissue culture medium, an inlet cannula, an outlet cannula, and a means for moving the inlet cannula, the outlet cannula, or both, to axially stretch a donor blood vessel secured between the inlet cannula and the outlet cannula in a submerged position in the tissue culture medium, wherein the inlet cannula, the outlet cannula, and the donor blood vessel are secured together to form a conduit through which the tissue culture medium can flow.

Abstract: The invention is directed to methods of making bioremodelable graft prostheses prepared from cleaned tissue material derived from animal sources. The bioengineered graft prostheses of the invention are prepared using methods that preserve cell compatibility, strength, and bioremodelability of the processed tissue matrix. The bioengineered graft prostheses are used for implantation, repair, or use in a mammalian host.

Abstract: A vascular graft comprised of a tubular polytetrafluoroethylene (ePTFE) sheet is provided. The ePTFE sheet has a substantially uniform coating of bioresorbable gel material, for example gelatin, on a surface thereof. The coating minimises bleeding through suture holes in the ePTFE sheet and provides an increase in longitudinal extensibility.

Abstract: Methods and compositions for pre-treatment of lung transplants to reduce susceptibility to post-operative B. cepacia infection are provided. The methods and compositions employ saccharides, particularly dextrans and xylitol, which are applied to the lung transplant before transplantation.

Abstract: A graft is provided with a flexible sheet of graft material to which is sewn a reinforcing wire, preferably of shape-memory alloy. Sewing of the wire is carried out while the sheet is substantially planar, thus by conventional embroidery machines. The sheet is subsequently rolled into a tubular shape.