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

Abstract: Techniques for the production of flow-oriented collagen gels using hydrodynamics to influence the assembly of collagen fibers. Highly concentrated monomeric solutions of collagen are subjected to shear and extensional flow as they are drawn onto a substrate to induce fibrillogenesis under a high Ph buffer. The produced gel captures the flow induced ordering of molecular collagen upon fibril formation. The depositing or the induction of fibrillogenosis occurs without the application of a magnetic field to the concentration of collagen. These highly oriented 3D scaffolds are capable inducing contact guidance and guiding mammalian cell growth. The collagen fibers mimic the construction of in vivo fibers with the characteristic D-periodicity and the integrin receptors on the fibroblasts respond to this organization. The industrial applications of three-dimensional collagen gels as a biomaterial are widespread from drug delivery to burn repair or tissue engineering system.

Abstract: Techniques for the production of flow-oriented collagen gels using hydrodynamics to influence the assembly of collagen fibers. Highly concentrated monomeric solutions of collagen are subjected to shear and extensional flow as they are drawn onto a substrate to induce fibrillogenesis under a high Ph buffer. The produced gel captures the flow induced ordering of molecular collagen upon fibril formation. The depositing or the induction of fibrillogenosis occurs without the application of a magnetic field to the concentration of collagen. These highly oriented 3D scaffolds are capable inducing contact guidance and guiding mammalian cell growth. The collagen fibers mimic the construction of in vivo fibers with the characteristic D-periodicity and the integrin receptors on the fibroblasts respond to this organization. The industrial applications of three-dimensional collagen gels as a biomaterial are widespread from drug delivery to burn repair or tissue engineering system.

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

Abstract: Described are methods and systems for drying remodelable materials, such that selective regions of the remodelable materials have differing properties. Also described are medical graft products having selective regions of differing material properties. Advantageous remodelable materials include collagenous extracellular matrix material, such as small intestine submucosa.

Abstract: This invention is directed to prosthesis, which, when implanted into a mammalian patient, serves as a functioning replacement for a body part, or tissue structure, and will undergo controlled biodegradation occurring concomitantly with bioremodeling by the patient's living cells. The prosthesis is treated so that it is rendered non-antigenic so as not to elicit a significant humoral immune response. The prosthesis of this invention, in its various embodiments, thus has dual properties. First, it functions as a substitute body part, and second, it functions as bioremodeling template for the ingrowth of host cells.

Abstract: A bioreactor and a method for growing engineered tissue provide facing surfaces in a vessel for containing cell-culture media. The facing surfaces are equidistant and define a gap therebetween while providing substrates for cell tissue growth. By maintaining conditions within the vessel conducive to cell tissue growth and moving the surfaces relative to one another within such cell culture media, tissue growing thereupon is subjected to physiological flow and shear stress, preferably through the use of oscillating motion, and engineered tissue is produced.

Abstract: An actuable truss with ordered or disordered planar or strut elements or pore walls may be seeded with tissue cells, wherein application of a magnetic field may result in mechanical strain on the cells and increased fluid flow in and out of the truss structure. Modified polymers, such as ?-Fe2O3/PLGA, may be used to form actuable scaffolds suitable for tissue engineering. It is also disclosed a device with a trap-door that may be remotely actuated by applying a magnetic field. Such a device may be employed to deliver and control the release of other micro-devices or materials such as drugs to a specific location inside the body of a human or an animal.

Abstract: A hybrid bioreactor for cell culture is disclosed. To simultaneously apply compressive strain for cell differentiation and shear strain for cell proliferation to cells, the hybrid bioreactor includes a plurality of reactor tube assemblies (100), a compressive strain motor (5), a shear strain motor (25), a lower anchor mount (20) having a plurality of toothed anchors (70) to respectively anchor the lower ends of the reactor tube assemblies (100) to the lower anchor mount (20), a ball screw (90) operated in conjunction with the compressive strain motor (5), an upper anchor mount (60) which engages with the ball screw (90) to vertically move upward and downward and having a plurality of compressive strain anchors (80) to anchor the upper ends of the reactor tube assemblies (100) to the upper anchor mount (60), a power transmission unit to transmit the rotating force of the shear strain motor (25) to the toothed anchors (70).

Abstract: Described are medical devices which are or can be used to form tubular medical devices, and related methods. Preferred devices include tubular grafts of biomaterial having lumen walls which present no seam edge that traverses the entire length of the lumen, illustratively including devices having lumen walls which have a discontinuous seam presenting multiple seam edges. Such a device may include a tubular structure formed by inserting a plurality of extensions of a biomaterial sheet through a plurality of corresponding apertures of the sheet.

Abstract: The present invention relates to a process for the production of fibres of an unhydroxylated recombinant collagen polypeptide, and the fibres obtained thereby, as well as to uses of such fibres as a biomaterial.

Abstract: A method of treating a biological tissue including contacting the biological tissue with an aqueous sterilizing solution, and maintaining the aqueous sterilizing solution at a temperature of about 50° C. for a time period of about 1 to 2 days. The method of treating a biological tissue may be utilized as a terminal sterilization step in a method for fixation of biological tissues, and bioprosthetic devices may be prepared by such fixation method. The fixation method may include 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 the terminal sterilization method. The aqueous sterilizing solution may be glutaraldehyde of about 0.625 weight percent buffered to a pH of about 7.4.

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: An apparatus for high-throughput analysis of compound absorption in a controlled environment that closely resembles in-vivo conditions. The apparatus includes at least one tissue-receiving enclosure that is capable of interfacing (e.g., via transfer of fluids, electronically, etc.) with a variety of preparative devices and analytical instrumentation. In some variations, the tissue-receiving enclosure is formed from two housings, which, when engaged, have a capsular shape. The enclosure receives a tissue sample in the form of an un-everted or everted intestinal segment or tubular artificial membrane. The tissue sample is coupled to a generally cylindrical tissue support. The tissue support and the enclosure are axially aligned, and openings at the ends of the enclosure align with openings at the ends of the tissue support. Two feed fittings, one for each end of the enclosure, forcefully mate with the aligned openings in the housing and the tissue support.

Abstract: The objective of the present invention is to provide a collagen material that possesses physical properties to an extent that allows suturing while still maintaining the biochemical properties inherently possessed by collagen, and retains its shape for a certain amount of time even after application to the body; its production process; and, a medical material on which it is based, examples of which include a artificial tube for nerve, artificial tube for spinal cord, artificial esophagus, artificial trachea, artificial blood vessel, artificial valve or alternative medical membranes such as artificial endocranium, artificial ligaments, artificial tendons, surgical sutures, surgical prostheses, surgical reinforcement, wound protecting materials, artificial skin and artificial cornea, characterized by filling or having inside a substance having biocompatibility that can be degraded and absorbed in the body into a matrix of a non-woven fabric-like multi-element structure of collagen fibers having ultra-fine fiber

Abstract: A system for hemodynamic simulation comprises a vessel having properties of a blood vessel, a reservoir containing a quantity of fluid, tubing connecting the vessel and reservoir, and at least one pump for circulating the fluid within the system. Fluid can be tissue culture medium or blood analog fluid, and the vessel may include mammalian cells attached to its inside. A drive system, comprising two reciprocating drive shafts that are coupled by a cam, enables the uncoupling of pulsatile flow and pulsatile pressure to provide independent control over wall shear stress and circumferential strain. The shaft drives two pumps that are 180 degrees out-of-phase and are connected upstream and downstream of the vessel, and effect this uncoupling.

Abstract: A prosthesis, which, when implanted into a mammalian patient, serves as a functioning replacement for a body part, or tissue structure, and will undergo controlled biodegradation occurring concomitantly with bioremodeling by the patients living cells. The prosthesis is treated so that it is rendered non-antigenic so as not to elicit a significant humoral immune response. The prosthesis, in its various embodiments, thus has dual properties. First, it functions as a substitute body part, and second, it functions as bioremodeling template for the ingrowth of host cells.

Abstract: The invention provides compositions and methods for repairing intra-articular and extra-articular tissue including ligament, meniscus, cartilage, tendon, and bone. The method includes contacting the ends of an injured tissue from a patient with a composition. The repair composition includes soluble type 1 collagen, a platelet, and at least one of an extracellular protein and a neutralizing agent.

Abstract: The invention is directed to collagenous tissues which have been treated to remove non-collagenous components such as cells, cellular debris, and other extracellular matrix components, such as proteoglycans and glycosaminoglycans, normally found in native tissues. Treatment of the tissue with alkali, chelating agents, acids and salts removes non-collagenous components from the collagenous tissue matrix while controlling the amount of swelling and dissolution so that the resultant collagen matrix retains its structural organization, integrity and bioremodelable properties. The process circumvents the need to use detergents and enzymes which detrimentally affect the cell compatibility, strength and bioremodelability of the collagen matrix. The collagenous tissue matrix is used for implantation, repair, or use in a mammalian host.

Abstract: A bioremodelable prosthesis for treating a patient with a diseased or damaged organs comprising a first layer that contains acid-extracted fibrillar or non-fibrillar collagen, and a second layer derived from the tunica submucosa of the small intestine that provides structural stability, is pliable and is semi-permeable,pe1 59564443.npc wherein the prosthesis undergoes controlled biodegradation occurring with adequate living cell replacement such that the original prosthesis is replaced by the patient's living cells.

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 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 process for preparing pliable soft tissue specimen which are resistant to cracking and devoid of viable cells includes the steps of treating native soft tissue obtained from a donor by a gradually increasing gradient of aliphatic alcohol or other suitable water miscible polar organic solvent until the last alcohol (or other solvent) solution has at least 25% by volume of the organic liquid. Thereafter, the tissue specimen is treated with a solution containing glycerol or low molecular weight (<1000 D) polyethylene glycol, and polyethylene glycol of a molecular weight between approximately 6,000 to 15,000 D and heparin. Thereafter, the tissue specimen is briefly immersed in aqueous heparin solution, frozen and lyophilized. The tissue specimen is suitable for implantation as a homograft or xenograft, with or without rehydration.

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

Abstract: A method 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: A method of depositing collagen coatings on a metal surface, namely metal stents, by electrodeposition.