Abstract: Methods for preparing and using collagen extracts and collagen scaffolds are provided. Additionally methods and related kits for the repair of articular tissue using the collagen material are provided.

Abstract: A method for forming a porous implant suitable for a cavity from which tissue has been removed includes incorporating a gas or a pore forming agent into an alginate solution; transferring the alginate solution with the gas or the pore forming agent into a solidified body mold having a desired shape with an outer surface; removing the water from the solidified body; and subjecting the solidified body to a conversion solution to convert the outer surface to a less soluble alginate creating a composition comprising the outer surface having less soluble alginate and a core having more soluble alginate.

Abstract: Methods for preparing and using collagen extracts and collagen scaffolds are provided. Additionally, methods and related kits for the repair of articular tissue using the collagen material are provided.

Abstract: An encapsulation device system for therapeutic applications such as but not limited to regulating blood glucose. The system may comprise an encapsulation device with a first oxygen sensor integrated inside the device and a second oxygen sensor disposed on an outer surface of the device, wherein the sensors allow for real-time measurements (such as oxygen levels) related to cells (e.g., islet cells, stem cell derived beta cells, etc.) housed in the encapsulation device. The system may also feature an exogenous oxygen delivery system operatively connected to the encapsulation device via a channel, wherein the exogenous oxygen delivery system is adapted to deliver oxygen to the encapsulation device.

Abstract: Methods and compositions for the biological repair of cartilage using a hybrid construct combining both an inert structure and living core are described. The inert structure is intended to act not only as a delivery system to feed and grow a living core component, but also as an inducer of cell differentiation. The inert structure comprises concentric internal and external and inflatable/expandable balloon-like bio-polymers. The living core comprises the cell-matrix construct comprised of HDFs, for example, seeded in a scaffold. The method comprises surgically removing a damaged cartilage from a patient and inserting the hybrid construct into the cavity generated after the foregoing surgical intervention. The balloons of the inert structure are successively inflated within the target area, such as a joint, for example. Also disclosed herein are methods for growing and differentiating human fibroblasts into chondrocyte-like cells via mechanical strain.

Abstract: A method of producing a catalyst material with nano-scale structure, the method comprising: introducing a starting powder into a nano-powder production reactor, the starting powder comprising a catalyst material; the nano-powder production reactor nano-sizing the starting powder, thereby producing a nano-powder from the starting powder, the nano-powder comprising a plurality of nano-particles, each nano-particle comprising the catalyst material; and forming a catalyst precursor material from the nano-powder, wherein the catalyst precursor material is a densified bulk porous structure comprising the catalyst material, the catalyst material having a nano-scale structure.

Abstract: A system operating in an environment having an ambient pressure, the system comprising: a reactor configured to combine a plasma stream, powder particles and conditioning fluid to alter the powder particles and form a mixture stream; a supply chamber coupled to the reactor; a suction generator configured to generate a suction force at the outlet of the reactor; a fluid supply module configured to supply the conditioning fluid at an original pressure; and a pressure regulation module configured to: receive the conditioning fluid from the fluid supply module, reduce the pressure of the conditioning fluid from the original pressure to a selected pressure relative to the ambient pressure regardless of any changes in the suction force at the outlet of the reactor, and supply the conditioning fluid at the selected pressure to the supply chamber.

Abstract: A method of removing slag formed during laser cutting a hypotube may include flowing cooling gas into a laser nozzle, directing flow of the cooling gas onto an external surface of the hypotube, and injecting cooling fluid into an inner lumen of the hypotube at a velocity. Flowing the cooling gas and injecting the cooling fluid may at least partially remove slag from the external surface of the hypotube.

Abstract: A pre-assembled orthopaedic implant adapted for improved gas sterilization. The implant includes a first component adapted for assembly with a second component such that a mating surface of the first component is in close proximity with a mating surface of the second component. At least one gas conduit associated with the mating surface of the first component facilitates a sterilizing gas to penetrate into and dissipate from the interface defined by the mating surfaces.

Abstract: A method of processing bone material using supercritical fluids is disclosed. The method comprises placing the bone material in a processing chamber, adding supercritical fluid to the processing chamber, pulsing the supercritical fluid in the processing chamber, and rinsing the bone material. A processing system for processing bone material using supercritical fluids in accordance with the present invention comprises a processing chamber for housing the bone material, a vat for storing a processing fluid, a pump, a heating element, a flow path, a tank, and a solvent port.

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: Initiator polymers having an initiator group and a ligand group are provided. The initiator polymers are capable of specifically binding to a receptor on a surface. Using a macromer system, the initiator polymers are useful for the formation of a polymeric matrix on the surface of a material. In particular, initiator polymers are provided that have specificity to pancreatic ? cells and can be used to encapsulate cells for transplantation and the treatment of diabetes.

Abstract: A crosslinkable macromer system and related methods of preparing the system and using the system in the form of a crosslinked matrix between a tissue site and an implant article such as a tissue implant or on the porous surface of a prosthetic device. The macromer system includes two or more polymer-pendent polymerizable groups and one or more multifunctional initiator groups. The polymerizable groups and the initiator group(s), when polymer-pendent, can be pendent on the same or different polymeric backbones. The macromer system provides advantages over the use of polymerizable macromers and separate, low molecular weight initiators, including advantages with respect to such properties as nontoxicity, efficiency, and solubility. A macromer system of the invention can be used as an interface between the tissue site and implant article in a manner sufficient to permit tissue growth through the crosslinked matrix and between the tissue site and implant.

Abstract: A cell/tissue culture apparatus for applying a desired tensile stress to a material to be cultivated such as a cell or tissue as a physical stimulation, thereby enhancing acceleration of culture of the material to be cultivated. The cell/tissue culture apparatus comprises a chamber (a culture chamber 8) for circulating a culture fluid (24), a material to be cultivated (a matrix 32) that is placed and cultivated in the chamber, stress generation means (an electromagnetic stretcher 38, an actuator 56) for causing a tensile stress to act on the material to be cultivated from an outside of the chamber, and control means (controllers 50, 60) for causing the tensile stress generated by the stress generation means to intermit as well as undergo gradual increase or gradual decrease. The material to be cultivated can be caused to undergo expansion or contraction by applying and relieving the tensile stress, thereby applying a physical stimulation necessary for the proliferation to the material to be cultivated.

Abstract: The sterilization of biological material of animal or human origin, which is to be used as an implant or transplant, is performed according to a validated sterilization method with a margin of safety of 106 germs by which harmful microorganisms are physically separated and chemically sterilized in four successive steps, initially in an antibiotic, then in deoxicholic acid, then in a surface-active substance and finally in primary alcohol, respectively accompanied by rinsing steps involving an aqueous solution after steps two to four. A bioprosthesis sterilized with a margin of safety>106 germs can be implanted without any further treatment, does not have a tendency towards calcification, and ensures a long service life.

Abstract: The present invention provides processes for fixation of biological tissue and/or post-fixation treatment of such tissue that result in modified tissues with reduced susceptibility to in vitro calcification when used in prosthetic devices. The invention also relates to calcification resistant biological tissue and to methods of using such tissue.

Abstract: An improved method of implanting cells in the body of a patient includes positioning viable cells on a support structure. One or more blood vessels may be connected with the support structure to provide a flow of blood through the support structure. A support structure may be positioned at any desired location in a patient's body. The support structure may be configured to replace an entire organ or a portion of an organ. An organ or portion of an organ may be removed from a body cells and/or other tissue is removed to leave a collagen matrix support structure having a configuration corresponding to the configuration of the organ or portion of an organ. Alternatively, a synthetic support structure may be formed. The synthetic support structure may have a configuration corresponding to a configuration of an entire organ or only a portion of an organ.

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 crosslinkable macromer system and related methods of preparing the system and using the system in the form of a crosslinked matrix between a tissue site and an implant article such as a tissue implant or on the porous surface of a prosthetic device. The macromer system includes two or more polymer-pendent polymerizable groups and one or more initiator groups (e.g., polymer-pendent initiator groups). The polymerizable groups and the initiator group(s), when polymer-pendent, can be pendent on the same or different polymeric backbones. The macromer system provides advantages over the use of polymerizable macromers and separate, low molecular weight initiators, including advantages with respect to such properties as nontoxicity, efficiency, and solubility. A macromer system of the invention can be used as an interface between the tissue site and implant article in a manner sufficient to permit tissue growth through the crosslinked matrix and between the tissue site and implant.

Abstract: The present invention relates to implantable medical devices for the localized delivery of therapeutic agents, such as drugs, to a patient. More particularly, the invention relates to a device having a gradient of water soluble therapeutic agents within a therapeutic agent layer and a mixing layer that allows for controlled release of the therapeutic agents.

Abstract: Novel conjugates of glycosaminoglycans, particularly heparin and dermatan sulfate, and amine containing species and therapeutic uses thereof are described. In particular, mild methods of conjugating heparins to proteins, such as antithrombin III and heparin cofactor II, which provide covalent conjugates which retain maximal biological activity are described. Uses of these conjugates to prevent thrombogenesis, in particular in lung airways, such as found in infant and adult respiratory distress syndrome, and on surfaces in contact with blood are also described.

Abstract: This invention relates to methods of coating the lumenal surface of a blood vessel, or other tissue cavity, and to compositions suitable for use in same.

Abstract: A patterned coating on a prosthesis, for example a stent, and a method for forming the coating are disclosed. Additionally, an apparatus for forming the patterned coating is disclosed.

Abstract: A process for removing contaminants and/or leachables from polymeric materials useful in the manufacture of biocompatible medical devices such as intraocular lenses, corneal inlays and contact lenses using continuous soxhlet extraction.

Abstract: Porous, bioabsorbable scaffolds for tissue engineering of human hair follicles, methods for their manufacture and methods of their use in creating new hair.

Abstract: An intraocular lens, including a lens portion and a means for positioning the lens portion in the eye relative to the cornea of the eye. An outer lens surface of the lens portion is adapted to be altered after the lens portion is positioned in the eye.

Abstract: The present invention provides an artificial dura mater characterized by comprising at least a sheet of a biodegradable and bioabsorbable synthetic polymer and having a storage modulus at ordinary temperature of from 1×107 to 5×108 (Pa); and a process for producing an artificial dura mater characterized by dissolving a lactide/&egr;-caprolactone copolymer (in a molar ratio ranging from 40/60 to 60/40) in a solvent, filtering the resultant solution and casting the same followed by air drying.

Abstract: Biomedical devices that are to come into contact with living tissue, such as prosthetic and other implants for the human body and the containers used to store and transport them, are together cleaned of non-living, but biologically active organic materials, including endotoxins such as lipopolysaccharides, and assembled into a hermetically sealed package without recontamination. This is achieved by cleaning both the device and package components together in an apparatus, which includes a hermetically sealed chamber, in which they are contacted with atomic oxygen which biocleans them, by oxidizing the biologically active organic materials. The apparatus also includes means for manipulating the device and container and hermetically sealing the cleaned device into the cleaned container to form the package. A calibrated witness coupon visually indicates whether or not the device and container have received enough exposure to the atomic oxygen to have removed the organic materials from their surfaces.

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: Allograft tissue prostheses, as well as tissue valves for replacement of defective heart valves and other tissue-engineered products (TEPs), are effectively sterilized by treatment with a coupling agent known to create amide linkages between amines and carboxylic acids in the presence of a protecting agent. The sterilization treatment preferably employs EDC as a water-soluble coupling agent, plus a water-soluble protecting agent which complexes with potentially reactive amine or carboxyl moieties on the biological tissue, in the optional presence of isopropanol or an equivalent alkanol. One preferred sterilization treatment process uses a buffered aqueous solution where a hydroxymonoamine buffer, such as TRIS plus ethanolamine, provides both the buffering effect and the protecting agents, effectively complexing with potentially reactive carboxyl moieties on the tissue.

Abstract: The present invention comprises a poly (vinyl alcohol) hydrogel construct having a wide range of mechanical strengths for use as a human tissue replacement. The hydrogel construct may comprise a tissue scaffolding, a low bearing surface within a joint, or any other structure which is suitable for supporting the growth of tissue.

Abstract: A biocompatible implant for medical use having a layer of titanium or titanium alloys on its surface. The implant is electrochemically treated by taking it for an anode in electrolyte solution containing calcium ions so as to produce a layer of hydrated oxides or hydrated oxide gels, or is subject to an anodic treatment, and subsequently the implant is subject to another electrochemical surface treatment where the implant in turn is employed as a cathod so as to yield a layer that involves or is adsorbed with calcium ions, thus forming on the implant a hydrated gel layer that has an excellent ability of forming apatite.

Abstract: An improved prosthetic medical device having improved wear resistance and toughness is provided in the present application. A method is provided to selectively cross-link the polymeric matrix comprising the medical device by employing an interrupting means such as a mask, wire mesh or chopper wheel placed in between the medical device and irradiation source. In addition, the medical device may be translated while being irradiated to further effect the selective cross-linking. The present invention also provides for an injection molding process wherein a prosthetic medical device is formed in a single step, then selectively cross-linked.

Abstract: A crosslinkable macromer system and related methods of preparing the system and using the system in the form of a crosslinked matrix between a tissue site and an implant article such as a tissue implant or on the porous surface of a prosthetic device. The macromer system includes two or more polymer-pendent polymerizable groups and one or more initiator groups (e.g., polymer-pendent initiator groups). The polymerizable groups and the initiator group(s), when polymer-pendent, can be pendent on the same or different polymeric backbones. The macromer system provides advantages over the use of polymerizable macromers and separate, low molecular weight initiators, including advantages with respect to such properties as nontoxicity, efficiency, and solubility. A macromer system of the invention can be used as an interface between the tissue site and implant article in a manner sufficient to permit tissue growth through the crosslinked matrix and between the tissue site and implant.

Abstract: A method of sterilizing objects as well as the sterilized objects obtained from the method are disclosed. The method involves contacting an object such as a medical device to be reused with polycationic dendrimer under conditions which result in rendering a conformationally altered protein (e.g. a prion) non-infectious. A disinfecting agent or surgical scrub composition which comprises the dendrimers is also disclosed as are gelatin capsules treated with polycationic dendrimers.

Abstract: Disclosed is a method of enhancing the biocompatibility of a substrate by providing the substrate with a continuous bio-active surface coating. This method includes applying to the substrate a first coating which includes an aqueous dispersion or emulsion of a polymer containing an organic acid functional group and an excess of a polyfunctional cross-linking agent which is reactive with the organic acid groups of the polymer. A continuous bio-active surface coating is then formed over the dried first coating by applying thereover a bio-active agent containing an organic acid functional group or metal salt thereof. The first and second coatings are then dried to covalently bond the organic acid functional groups of the bio-active agent to the polymer through the excess unreacted polyfunctional cross-linking agent.