Abstract: The present invention discloses a fistula formation-inducing material having a property of forming a fistula wherein cells are exposed on at least a portion of the fistula luminal surface. This material can be inserted into a living body, using a hollow tubular member, as desired. As a result, there is provided a fistula formation-inducing material which allows the formation of a fistula, reliably lined by host cells, in a living body.

Abstract: An implant valve for implantation in a blood vessel is comprised of a flexible tube and a hollow, substantially cylindrical support with a casing, expandable in diameter from an initial position to an implantation position. The support extends substantially coaxially over a part of the length of the tube along the inner wall of the tube. The casing of the support cooperates with the inner wall of the tube such that, in the implantation position, a first part of the tube can be formed into a rigid shell, which can be clamped substantially coaxially along the inner wall of a blood vessel. A second, axially contiguous part of the tube can then form a flexible, tubular valve body, which can extend substantially clear in the blood vessel. In an advantageous embodiment, the flexible tube comprises a vein turned inside out and the ends of the tube are connected to form a ring embracing the support.

Abstract: The invention provides method of fabricating a scaffold comprising a fluidic network, including the steps of: (a) generating an initial vascular layer for enclosing the chamber and providing fluid to the cells, the initial vascular layer having a network of channels for fluid; (b) translating the initial vascular layer into a model for fluid dynamics analysis; (c) analyzing the initial vascular layer based on desired parameters selected from the group consisting of a characteristic of a specific fluid, an input pressure, an output pressure, an overall flow rate and combinations thereof to determine sheer stress and velocity within the network of channels; (d) measuring the sheer stress and the velocity and comparing the obtained values to predetermined values; (e) determining if either of the shear stress or the velocity are greater than or less than the predetermined values, and (f) optionally modifying the initial vascular layer and repeating steps (b)-(e).

Abstract: A multilayer composite vascular access graft and a method of constructing such a graft are disclosed. The mcVAG has improved performance characteristics, which include desirable handling characteristics such as ease of suturing, kink resistance and the ability to serve as a cannulation route soon after the implant procedure.

Abstract: A tissue graft is disclosed that includes a decellularized umbilical vessel having a luminal surface and an ablumenal surface, wherein the decellularized umbilical vessel is prepared by an automated dissection process. The decellularized umbilical vessel has not been substantially cross-linked. In one method of use, the decellularized umbilical vessel is capable of having at least one cell type seeded at least a portion of at least one of the luminal and ablumenal surfaces thereof. A process of preparing the tissue graft, methods of using the tissue graft, and kits which contain the tissue graft are also disclosed.

Abstract: A method of harvesting a target vessel includes creating a first incision, inserting a light source into a vessel through the first incision, the vessel located next to the target vessel, using the light source to illuminate a portion of the vessel, locating the target vessel from outside the vessel using the illuminated portion of the vessel, and dissecting at least a portion of the target vessel from surrounding tissue. A method that involves a target vessel includes inserting a light source into a vessel that is located next to the target vessel, providing light inside the vessel using the light source, and using light transmitted through a wall of the vessel to illuminate the target vessel or tissue next to the target vessel.

Abstract: The present invention relates to a method of preparing a tissue graft material. The invention also relates to a multipurpose tissue graft material and to methods of using same as a replacement for vascular and non-vascular tissue.

Abstract: Apparatus and methods for seeding an implantable medical device, such as a vascular prosthesis, with cells, such as endothelial cells, are described. The invention supports techniques for seeding a luminal surface of the device with axial centrifugation. Cells are introduced in suspension into the lumen of the device. The introduction of the cells may occur after a blood centrifugation product, such as platelet-poor plasma, is applied to the luminal surface. After the cells are introduced, the device is then subjected to centrifugation around a longitudinal axis defined by the lumen. Axial centrifugation causes the cells to concentrate toward and adhere to the luminal surface. Shortly after axial centrifugation, the seeded device can be presented for implantation in a patient. The implantable medical device may be inserted into a protective sleeve prior to seeding the device with cells, and the sleeve may or may not be removed prior to implantation.

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: This invention relates to a method for preparing a drug-eluting stent using a chemical vapor deposition, the method comprising modifying the surface of a biodegradable polymer with nanostructures through a plasma-assisted chemical vapor deposition so as to improve drug-loading capability and drug elution rate.

Abstract: A method for preparing a scaffold material for use in the prosthesis therapy is disclosed. The method comprises (a) lyophilizing a segment of native soft tissue of mammalian origin, heating the lyophilized tissue at a temperature of 100-200° C., and incubating the tissue with elastase to selectively remove elastin leaving the extracellular components mainly comprised of collagen.

Abstract: The invention relates to bioreactors having an enclosed chamber, a sheet growth module, a rollable mandrel, and a clamp for holding the sheet to the mandrel for rolling for the manufacture of a tissue engineered blood vessel (TEBV). The TEBV is made from a cultured fibroblast sheet rolled into a multilayer vessel which has sufficient burst strength to withstand physiological blood pressure without the inclusion of smooth muscle cells or synthetic scaffolding.

Abstract: A method for securing a compliant scaffold to an outer surface of a vascular graft includes positioning the scaffold radially about an elongated support tube which includes first and second radially outwardly flared end portions respectively defining first and second open ends of the support tube. The method further includes pulling the vascular graft through a lumen of the support tube, and axially deploying the scaffold over the first end portion of the support tube and into compliant contact with the outer surface of the vascular graft.

Abstract: A bone graft forming guide for providing a bone graft and a method of forming a bone graft. The guide includes a main body including a holder for holding a graft material and guide containing a pattern generally corresponding to the desired shaped of the bone graft. The forming guide may include a hole guide containing a plurality of hole guides arranged in a pattern generally corresponding to the desired shape of the bone graft. The forming guide may further include a cutting guide containing a pattern corresponding to the desired shape of the bone graft.

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: A joint and method for producing a joint in an endovascular graft. In one embodiment, a flap of a flexible material portion of an endovascular graft is folded about a portion of an expandable member to form a loop portion. The flap is secured in the loop configuration so that tensile force on the expandable member is transferred into a shear force on the fixed portion of the flap.

Abstract: Methodology for using laser machining techniques to modify a tissue for use in a medical device. In a representative mode of practice, relatively low energy laser machining is used to thin down at least a portion of a valved jugular vein. The thinned down vein may then be sutured to, or otherwise integrated with, a corresponding stent to make a percutaneous heart valve.

Abstract: A dermal tissue transplantation system combining a tissue particle harvester, a tissue particle collector, and a chambered dressing. The system provides a harvester capable of harvesting tissue from a donor site on the order of about 100 microns. The integrated tissue particle collector provides a means for collecting the harvested tissue for in situ cultivation in a chambered dressing at the wound site.

Abstract: The present technology is related to the field of sterilization and decellularization of allografts or xenografts, specifically to processes that achieve effective removal of the cells contained within a vascular tissue matrix and an effective reduction in potential harmful organisms to create grafts suitable for human implantation. In some embodiments, vascular grafts, vascular tissue and/or blood vessels are contacted with cleaning solution under conditions suitable conditions to reduce immune reaction in patients. More specifically, the present technology is directed to sterilization and decellularization of vascular grafts.

Abstract: Described are expanded collagenous materials and methods for their preparation and use. Certain expanded collagenous materials can be prepared by treating a first collagenous material with an alkaline substance under conditions effective to expand the first collagenous material, and recovering the expanded material. Expanded materials can exhibit beneficial persistence and tissue generation characteristics when implanted, and can be used in the formation of highly porous medical implant bodies which can be compressed to fractions of their original volume and will thereafter substantially recover their original volume.

Abstract: Devices and methods for bone marrow aspiration, storage, and the combining of harvested marrow with biomaterials, therapeutic agents or medical devices are provided for the treatment or assessment on a variety of diseases or injuries. In a preferred embodiment, the invention includes aspiration of marrow into a cartridge to minimize bacterial contamination and clotting while facilitating handling, storage or the combining of harvested material with biomaterials, therapeutic agents or medical devices.

Abstract: The present invention provides for compositions and methods for the preservation of tissues and organs ex vivo and in situ. In addition, the present invention provides for kits that may be used in the preparation of the solutions of the present invention. The present invention also provides a device for perfusing tissues and organs with the solutions of the present invention.

Abstract: A temporary bioabsorbable-radiopaque marker for use on an implantable endoprosthesis. The bioabsorbable-radiopaque marker is adapted to be disposed on or adjacent an implantable endoprosthesis in a body lumen for a predetermined amount of time until the bioabsorbable and radiopaque materials are absorbed or dispersed in the body.

Abstract: Disclosed are cellulose-based pliable, porous and non-porous prosthesis structures that can be formed to various geometries such as thin films, membranes, hollow tubes, heart valves, including an aortic heart valve. Also disclosed are methods for preparing a cellulose-based porous prosthesis structure.

Abstract: A method of preparing a fixed biological tissue includes, shaping the biological tissue, cross-linking the biological tissue, sterilizing the biological tissue, and inactivating prions in the biological tissue.

Abstract: The present invention describes a cardiac prosthetic system (400) comprising: an anchoring conduit (200) having a harbour (415), the harbour including a first releasably engaging component (515); a temporary valve (305) and a heart valve prosthesis (420) having a second releasably engaging component (445) enabled to be securely coupled and uncoupled from the first releasably engaging component (515) of the harbour (415).

Abstract: A vessel preparation and preservation kit supports a blood vessel during processing for use in bypass graft surgery. The device comprises a clamshell base having first and second trays latchable in a closed condition and pivotable to an open condition. The first tray has a series of open slots on an interior surface, wherein each slot extends substantially transverse to the longitudinal axis of the clamshell base. A first fixture has a first plate positionable in any selected one of the slots, a first fitting for holding a first end of the blood vessel, and a fluid supply needle for inserting into the first end of the blood vessel. A second fixture has a second plate positionable in any selected one of the slots a predetermined distance from the first fixture and having a second fitting for holding a second end of the blood vessel. A liquid-retaining foam is mounted in the second tray to immerse the prepared blood vessel in liquid to preserve it by putting the trays in the closed condition.

Abstract: A device for preparing small intestines of a vertebre is provided. The device includes a body for cooperation with the small intestines. The body defines an external periphery of the body. The device further includes means for longitudinally slitting the small intestines. The means for longitudinally slitting the small intestines is operably associated with the body. The device further includes means for despooging the small intestines in juxtaposition with said body.

Abstract: A vascular connector includes a main tube having a channel for fluid flow therethrough and opposed ends adapted to be connected to a vascular structure; and at least one inlet tube having a channel for fluid flow therethrough, a proximal end intersecting the main tube, and a distal end adapted to be connected to a vascular structure.

Abstract: The invention relates to heart valve xenografts from transgenic pigs having a disruption of an ?1-3 galactosyl transferase nucleic acid sequence and use of the xenografts for treating a patient.

Abstract: The present invention is a natural, cell-free tissue replacement that does not require difficult or extensive preparation made by washing tissue replacement in a solution including one or more sulfobetaines and an anionic surface-active detergent and washing the tissue replacement in serial solutions of the buffered salt to remove excess detergent. The natural, cell-free tissue replacement may be a nerve graft that supports axonal regeneration, guides the axons toward the distal nerve end and/or is immunologically tolerated. Other forms of the invention are a composition and kit prepared by the method of making a native, cell-free tissue replacement. The present invention may be modified for use in diagnostic, therapeutic, and prophylactic applications.

Abstract: A tissue illumination system and a method for harvesting a section of a blood vessel from a patient's body for further use. The tissue illumination system includes a light catheter inserted into a lumen of the blood vessel section to illuminate the vessel section and vessel side branches with an intensity which is visible to the physician from an exterior of the vessel section.

Abstract: The invention is directed to apparatus and methods for seeding an implantable medical device, such as a vascular prosthesis, with cells, such as endothelial cells. The invention supports techniques for seeding a luminal surface of the device with axial centrifugation. Cells are introduced in suspension into the lumen of the device, and the device is subjected to centrifugation around a longitudinal axis defined by the lumen. Axial centrifugation causes the cells to concentrate toward the luminal surface. Shortly after axial centrifugation, the seeded device can be presented for implantation in a patient.

Abstract: A device for assisting in a vascular procedure is provided that includes a handle and one or more legs that are operable to move in response to a force being applied to the handle. The legs are operable to extend and to contract in order to manipulate a conduit. In a more particular embodiment, the device can be used in conjunction with a stand operable to receive the conduit such that the conduit can be removed from the stand by the device. The stand may include one or more graduations that indicate the size of the conduit once it is positioned on the stand.

Abstract: An animal model for hyperpigmentations in which the formation of hyperpigmentations in human skin is faithfully simulated is provided. An animal model for hyperpigmentations, wherein a black person's skin is grafted onto a non-human animal, is provided.

Abstract: The present invention contemplates compositions and methods for the treatment of vascular grafts both ex vivo and in vivo. Ex vivo treatment comprises completely removing a vessel (i.e., vein or artery) from the body and treating with the compositions of the present invention. In vivo treatment comprises treating the vessel in vivo without removing the vessel completely from the body (albeit one or both ends of the vessel may be closed off in order to focus the treatment in the desired area and/or avoid systemic treatment). In one embodiment, at least a portion of the smooth muscle cells of a vessel (e.g., vein or artery) are transfected ex vivo or in vivo with a vector capable of expressing at least one phosphatase. In a preferred embodiment, smooth muscle cells are transfected with adenovirus vector comprising the gene encoding PTEN.

Abstract: The invention relates to a method for placing a flexible jacket 3 on a natural vessel section 5, in particular a vein, to a device for placing a flexible jacket 3 in accordance with said method, and to an auxiliary instrument 1 for use in said method. The method comprises the following steps: pushing the jacket 3 onto a tubular application aid 2, filling the vessel section with a fluid, introducing, in particular pulling, the filled vessel section 5 into the application aid 2, the filling of the vessel section and the introduction of the vessel section 5 into the application aid 2 being carried out with the assistance of a tubular auxiliary instrument 1, and pulling the application aid 2 and the tubular auxiliary instrument 1 apart while at the same time pulling the vessel section 5 out of the application aid 2 and depositing the jacket 3 on the surface of the vessel section 5.

Abstract: A method for inhibiting restenosis is described. The method comprises implanting a stent in a patient's vasculature and simultaneously delivering a restenosis-inhibiting medicine to the treatment site by adjuvant therapy.

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 form a confluent monolayer on the hybrid vascular graft.

Abstract: A method and apparatus for bi-directionally dissecting and harvesting a vessel includes a dissector device that is at least temporarily secured to a harvester device.

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 include a pressure/flow system having an external flow loop system for generating a flow loop, a specimen having a region arranged in the flow loop, and a controller, where the pressure/flow system is capable of adjusting at least two dynamic conditions at the region or a diameter of the specimen. Embodiments of methods can prepare a hybrid carotid bypass graft intended for implantation into a mammal by placing the hybrid carotid bypass graft in a system embodiment according to the invention prior to implantation of the hybrid carotid bypass 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 the specimen holder. Embodiments of methods can coat a hybrid hemodialysis access graft or a hybrid femoral artery bypass graft with a confluent monolayer of endothelial cells by immobilizing a plurality of endothelial cells on the hybrid hemodialysis access graft or the hybrid femoral artery bypass graft and placing the hybrid graft in a system embodiment according to the invention under conditions effective to promote the endothelial cells to form a confluent monolayer on the hybrid 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 prepare a hybrid hemodialysis access graft or a hybrid femoral artery bypass graft intended for implantation into a mammal by placing the hybrid graft in a system embodiment according to the invention prior to implantation of the hybrid 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 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 promote endothelialization of a hybrid hemodialysis access graft or a hybrid femoral artery bypass graft by placing the hybrid hemodialysis access graft or the hybrid femoral artery bypass graft in a system embodiment according to the invention under conditions effective to promote stem cells to form a confluent monolayer on the hybrid 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 hemodialysis access graft or a hybrid femoral artery bypass graft following implantation into a mammal's body by placing the hybrid hemodialysis access graft or the hybrid femoral artery bypass graft in a system embodiment according to the invention prior to implantation of the hybrid 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 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 form a confluent monolayer on 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 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 endothelial cells to form a confluent monolayer on the surface of the hybrid vascular graft.

Abstract: A method of yielding a functional human hybrid coronary bypass graft is provided. The method includes conditioning a hybrid synthetic tubular structure having stem cells and/or endothelial cells on at least one surface to yield the functional human hybrid coronary bypass graft. Specifically, the method includes placing the hybrid synthetic tubular structure in a system capable of producing three dimensional dynamic conditions for a sufficient time to yield said functional human hybrid coronary bypass graft.

Abstract: A dural graft is provided having improved stiffness characteristics relative to conventional dural substitutes. The dural graft can be formed from a collagen material having a stiffness between about 0.1 pounds per inch (lb./in.) and 0.25 lb./in. Relative to the collagen material forming conventional dural graft substitutes, the decreased stiffness of the collagen material of the present dural graft can provide the graft with a relatively improved or increased pliability. As a result of the increased pliability, the dural graft can sufficiently conform to a curvature of a tissue surface to which it is applied, such as the curved surface of a meningeal membrane. The reduced stiffness of the collagen material can also provide for a relatively improved or increased flexibility or elasticity of the dural graft. The increased flexibility of the dural graft minimizes tearing of the graft when handled or manipulated during an implantation procedure.

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.