Abstract: A method for preparing a pre-loadable biological heart valve capable of rapid rehydration includes performing a cross-linking treatment, wherein a biological valve is cross-linked by soaking in an aqueous glutaraldehyde solution; performing a hydrophilic treatment, wherein the biological valve is soaked in a solution containing a hydrophilic molecule and a condensing agent, to allow the hydrophilic molecule to be immobilized on the biological valve by chemical grafting; and performing a drying treatment, wherein the biological valve after the hydrophilic treatment and the cross-linking treatment is dried to obtain the pre-loadable biological heart valve capable of rapid rehydration.

Abstract: A method is provided for preparing pericardial tissue that is used for a bioprosthetic heart valve assembly. According to this method, pericardial tissue is harvested from a host animal and then cleaned. The cleaned tissue is then fixed using glutaraldehyde. After fixation of the tissue, the residual antigenic components are removed to preserve the tissue structural integrity for its long-term performance. In addition, higher concentrations of alcohol are used to reduce the tissue bioburden, and at the same time to dehydrate the tissue followed by preserving the tissue with glycerol so as to mitigate glutaraldehyde-storage related issues for the bioprosthetic heart valve.

Abstract: A fabric and a leather product in which collagen fiber bundles form a network structure has a base yarn woven layer, and also has collagen fiber bundles. The collagen fiber bundles sheathed in the base yarn woven layer protrude on the surface of the base yarn woven layer, and the protruding collagen fiber bundles and their branches are interwoven to form a network structure, where a part of the branches in the collagen fiber bundle is sheathed on the base yarn so that at least one end of the branch protrudes from the base yarn braided layer. Leather products may include these fabrics and leather surface layers.

Abstract: A system for harvesting bone material from a bone may include a rotary cutter defining a rotary cutter longitudinal axis extending between a rotary cutter proximal end and a rotary cutter distal end. The rotary cutter may have a drive shaft configured to receive input torque, and an osteochondral cutter configured to cut the tissue and receive the tissue material in response to rotation of the osteochondral cutter under pressure against the tissue. The system may further include a bone port defining a bone port longitudinal axis extending between a bone port proximal end and a bone port distal end. The bone port may have a bone port cannulation sized to closely fit over the osteochondral cutter. At least one of the bone port proximal end and the bone port distal end may be securable to the tissue. A stratiform tissue graft may be delivered through the bone port.

Abstract: A surgical balloon composed of an aseptically recovered umbilical cord vessel is provided. Methods of preparing a balloon and methods of using the same are also provided.

Abstract: This invention relates to the field of surgical implants, and in particular to a method of treating biomedical material, and more particularly bioprosthetic heart valves and tracheas, to mitigate calcification when implanted in a mammalian body.

Abstract: A vascular graft for treatment of diseased or damaged blood vessels is disclosed. The graft comprises a sheet of acellular tissue matrix with an intact basement membrane. The graft is formed by wrapping the sheet into a tube and securing the edges of the sheet together. The acellular tissue matrix facilitates tissue ingrowth and remodeling of the graft with host cells.

Abstract: The present application is directed to the field of implants comprising soft tissue for use in implantation in humans. The soft tissue implants of the present application are preferably obtained from xenograft sources. The present application provides a chemical process that neutralizes, removes or substantially reduces antigens from and sterilizes and/or strengthens xenograft implants. The present techniques yield soft tissue implants having superior structural, mechanical, and/or biochemical integrity. The present application is also directed to processes for treating xenograft implants comprising soft tissues such as tendons and ligaments, and to implants produced by such processes.

Abstract: A surgical balloon composed of an aseptically recovered umbilical cord vessel is provided. Methods of preparing a balloon and methods of using the same are also provided.

Abstract: Bioprosthetic tissues are treated by immersing or otherwise contacting fixed, unfixed or partially fixed tissue with a glutaraldehyde solution that has previously been heat-treated or pH adjusted prior to its contact with the tissue. The prior heat treating or pH adjustment of the glutaraldehyde solution causes its free aldehyde concentration to decrease by about 25% or more, preferably by as much as 50%, and allows a “stabilized” glutaraldehyde solution to be obtained at the desired concentration and pH for an optimal fixation of the tissue at high or low temperature. This treatment results in a decrease in the tissue's propensity to calcify after being implanted within the body of a human or animal patient.

Abstract: One aspect of the present invention is a method of producing a decellularized composite tissue bioscaffold for musculoskeletal tissue interface reconstruction by physicochemically treating a musculoskeletal tissue interface isolated from allogeneic sources. In certain embodiments, such musculoskeletal tissue interfaces can also be isolated from xenogeneic sources. The method comprises treatment of the interface with detergents, chemical oxidants and ultrasonic energy, and wash steps in between to remove residual detergents as well as oxidants. The resulting bioscaffold may be freeze-dried or lyophilized, sterilized and aseptically packaged for subsequent use.

Abstract: A method of reducing phospholipid concentration in biological tissue. The biological tissue is immersed in an isopropyl alcohol solution for an effective period of time. After the effective period of time, the biological tissue has a phospholipid concentration that is at least 10 percent by weight less than an initial phospholipid concentration of the biological tissue.

Abstract: Aqueous composition containing a) at least one compound containing carbamoylsulphonate groups and b) at least one nonionic alkoxylated polyol containing ester groups and having an HLB value of at least 13 (b1) and/or alkylglycoside (b2).

Abstract: Bioimplants and methods of making the bioimplants are provided. The bioimplants comprise biological tissues having conjugated thereto adjunct molecules. The biological tissues are sterilized with a chemical sterilizing agent, such as a water soluble carbodiimide. The processes of making the bioimplants include a process in which an adjunct molecule is conjugated to a biological tissue during the sterilization process.

Abstract: A matrix, including epithelial basement membrane, for inducing repair of mammalian tissue defects and in vitro cell propagation derived from epithelial tissues of a warm-blooded vertebrate.

Abstract: Bioprosthetic tissues are treated by immersing or otherwise contacting fixed, unfixed or partially fixed tissue with a glutaraldehyde solution that has previously been heat-treated or pH adjusted prior to its contact with the tissue. The prior heat treating or pH adjustment of the glutaraldehyde solution causes its free aldehyde concentration to decrease by about 25% or more, preferably by as much as 50%, and allows a “stabilized” glutaraldehyde solution to be obtained at the desired concentration and pH for an optimal fixation of the tissue at high or low temperature. This treatment results in a decrease in the tissue's propensity to calcify after being implanted within the body of a human or animal patient.

Abstract: A kind of yarn of animal collagen fiber and the manufacture process thereof, characterized in that the yarn is made of 1-100 WT % of collagen fiber of animal leather, and 0-99 WT % of textile fiber. The yarn of animal collagen fiber is made by the following procedure: choosing raw materials, loosing fiber, assorting, blending, carding, drawing, and twisting, if using the rawhide, the above procedure should add the steps of liming, washing, deliming, tanning and dehydrating. The raw material of the yarn can be the rawhide of any animal, as well as the leftover material or worn-out leather. The yarn has excellent properties, high tensile strength, abrasion resistance, softness, water adsorbent, oil adsorbent, flame-retardant, and can be woven, knitted and braided.

Abstract: Bioprosthetic tissues are treated by immersing or otherwise contacting fixed, unfixed or partially fixed tissue with a glutaraldehyde solution that has previously been heat-treated or pH adjusted prior to its contact with the tissue. The prior heat treating or pH adjustment of the glutaraldehyde solution causes its free aldehyde concentration to decrease by about 25% or more, preferably by as much as 50%, and allows a “stabilized” glutaraldehyde solution to be obtained at the desired concentration and pH for an optimal fixation of the tissue at high or low temperature. This treatment results in a decrease in the tissue's propensity to calcify after being implanted within the body of a human or animal patient.

Abstract: This invention relates to processes of preparing heterogeneous graft material from animal tissue. Specifically, the invention relates to the preparation of animal tissue, in which the tissue is cleaned and chemically cross-linked using both vaporized and liquid cross-linking agents, resulting in improved physical properties such as thin tissue and lowered antigenicity, thereby increasing the ease of delivering the tissue during surgery and decreasing the risk of post-surgical complication, respectively.

Abstract: Non-glutaraldehyde fixation of an organ or a prosthesis for implantation in a mammal is based upon carbodiimide treatment. A solution containing a sterilizing agent, such as EDC, in combination with a coupling enhancer, such as Sulfo-NHS, and a high concentration of a diamine cross linking agent is used. As a result, only minimal surface reduction occurs during fixation, and the resultant products show a dramatic increase in resistance to calcification.

Abstract: A sterile implant for treatment of a spinal disc defect comprising an allograft cortical bone demineralized to a Type I collagen having a specific shape which is treated to eliminate osteoinductivity. The implant is lyophilized and compressed into smaller first shape which 20 to 80% from its original shape in at least one dimension and hardened. The implant expanding when hydrated into a second shape having the shape memory of the first shape and expanded in dimensional size from the first compressed shape.

Abstract: A graft prostheses (11), materials and method for implanting, transplanting, replacing, or repairing a part of a patient. The graft prosthesis includes a purified, collagen-based matrix structure removed from a submucosa tissue source. The submucosa tissue source is purified by disinfection and removal steps to deactivate and remove contaminants, thereby making the purified structure biocompatible and suitable for grafting on and/or in a patient.

Abstract: Non-glutaraldehyde fixation of an organ or a prosthesis for implantation in a mammal is based upon carbodiimide treatment. An aqueous solution containing a coupling agent, such as EDC, in combination with a coupling enhancer, such as sulfo-NHS, and a high concentration of a diamine cross-linking agent is used. As a result, only minimal surface reduction occurs during fixation, and the resultant products show a dramatic increase in resistance to calcification.

Abstract: A treatment for bioprosthetic tissue used in implants or for assembled bioprosthetic heart valves to reduce in vivo calcification is disclosed. The method includes preconditioning, pre-stressing, or pre-damaging fixed bioprosthetic tissue in a manner that mimics the damage associated with post-implant use, while, and/or subsequently applying a calcification mitigant such as a capping agent or a linking agent to the damaged tissue. The capping agent suppresses the formation of binding sites in the tissue that are exposed or generated by the damage process (service stress) and otherwise would, upon implant, attract calcium, phosphate, immunogenic factors, or other precursors to calcification. The linking agent will act as an elastic reinforcement or shock-absorbing spring element in the tissue structure at the site of damage from the pre-stressing.

Abstract: A method of preparing an implantable biological device having a first tissue part and a second tissue part includes exposing the first tissue part to a first preparation method and preventing exposure of the second biological tissue part to the first preparation method. Preventing exposure of the second biological tissue part to the first preparation method may be achieved using an embedding technique, a coating technique, a covering technique, or physical isolation. The method may further include exposing the second tissue part to a second preparation method and preventing exposure of the first biological tissue part to the second preparation method. An apparatus for preparing an implantable biologic device includes an enclosure having first and second chambers separated by a partition member wherein a substantial portion of the first tissue part is within the first chamber and a substantial portion of the second tissue part is within the second chamber.

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: A shelf-stable, demineralized, and freeze-dried osteochondral plug comprising cartilage, subchondral bone, and the underlying cancellous bone is provided. Methods of preparing the demineralized osteochondral plug and methods of repairing a defect site are also provided.

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: Adapting crosslinking with triglycidyl amine (TGA) to incorporate the use of a particular type of anti-calcification agent provides a broad-reaching solution to the problem in vivo bioprosthesis calcification. The anti-calcification agent in question includes a polyphosphonate compound that contains a functional group, which serves as a reaction site between the polyphosphonate and a polyepoxide. The functional group is reactive enough to dominate the reaction between the polyphosphonate and the polyepoxide, thereby excluding the chelating oxygen atoms of polyphosphonate from the reaction, protecting their anti-calcification ability. Furthermore, the high reactivity of the functional group allows the polyphosphonate to attach to the polyepoxide more completely, which improves the calcification resistance of bioprosthetic material with which the polyepoxide is crosslinked.

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: Bioprosthetic tissues are treated by immersing or otherwise contacting fixed, unfixed or partially fixed tissue with a glutaraldehyde solution that has previously been heat-treated or pH adjusted prior to its contact with the tissue. The prior heat treating or pH adjustment of the glutaraldehyde solution causes its free aldehyde concentration to decrease by about 25% or more, preferably by as much as 50%, and allows a “stabilized” glutaraldehyde solution to be obtained at the desired concentration and pH for an optimal fixation of the tissue at high or low temperature. This treatment results in a decrease in the tissue's propensity to calcify after being implanted within the body of a human or animal patient.

Abstract: The invention is directed to a method of debriding bone including incubating the bone and associated soft tissue, with one or more debriding solutions where the debriding solution may include one or more alkaline solutions. Incubation is optionally carried out with one or more debriding agents including inert dry granular or particulate material including for example beads, and the granular phase of an alkaline agent, including for example granular sodium hydroxide. The incubating may be carried out with agitation. In another embodiment, the medullary canal of the bone is subjected to a positive pressure stream of debriding solution under conditions sufficient to loosen the associated soft tissue from the bone at the interface of the soft tissue and bone. In a further embodiment, the debriding solution is provided as a gel.

Abstract: A method for preparing a soft tissue xenograft includes the steps of removing at least a portion of a soft tissue from a non-human animal to provide a xenograft; washing the xenograft in saline and alcohol: subjecting the xenograft to cellular disruption treatment; and either digesting the xenograft with a glycosidase or glycosidase digestion followed by treatment for sialylation. A soft tissue xenograft for implantation into a human includes a portion of a soft tissue from a non-human animal, wherein the portion has extracellular matrix and substantially only dead cells. The matrix and dead cells have substantially no surface &agr;-galactosyl moieties and have sialic acid molecules linked to at least a portion of surface carbohydrate moieties. Each of the xenografts of the invention has substantially the same mechanical properties as a corresponding native soft tissue.

Abstract: An implant which is particularly suitable for the repair and/or replacement of a skeletal joint, e.g., a vertebral joint, includes a unit of monolithic bone possessing at least one demineralized region exhibiting properties of flexibility and resilience, the demineralized region having diminished or insignificant capacity for promoting new bone growth.

Abstract: An improved fixative for tissue useful for bioprosthetic heart valves is provided. The tissue can have an elastin content and the elastin can be chemically fixed using a phenolic tannin, for example, tannic acid. The fixed elastin component provides greater mechanical durability and improved resistance to biological degradation following implantation. The tannic acid fixation protocol allows for biological material having a high elastin content, for example, about 30% or more. When used in combination with a glutaraldehyde fixative an additive effect can be seen in increased cross-link density and increased resistance to degradation and calcification.

Abstract: A method and apparatus for limiting longitudinal stretch during fixation of a harvested aortic root including valve leaflets and the product produced. The apparatus includes an inflow plug inserted into the inflow section of the aortic root and having an apertured tube or cannula extending through the valve leaflets to an outflow plug inserted into the outflow section of the aortic root. Apertures in the tube are located on either side of the valve leaflets and the tube is coupled to a fluid inlet, preferably located on the outflow plug. The outflow plug is slidable relative to the tube and is provided with an engagement mechanism such as a setscrew for fixing the location of the outflow plug relative to the tube and the inflow plug. After assembly of the aortic root to the apparatus, the fluid inlet is coupled to a source of defined pressure and the root is inflated.

Abstract: A non-crosslinked, decellularized and purified mammalian tissue (e.g., bovine pericardium) having particular use as an implantable resorbable material. The material is treated by alkylating its primary amine groups in a manner sufficient to reduce the antigenicity of the tissue, permitting the treated tissue to be used in vivo and without crosslinking, and in turn, permitting it to be resorbable. The material can be used in surgical repair of soft tissue deficiencies for a certain period of time while the implant itself is gradually remodeled or absorbed by the host. Also provided are a method of preparing such a material, as well as a method of using such a material for surgical repair.

Abstract: There is a need in the tissue treatment arts of methods for effectively mitigating calcification, reducing calcification and reducing phospholipid content of implanted bioprosthetic tissues. The invention provides an effective protocol for preparing biological tissue for incorporation as a bioprosthetic device. Disclosed herein is the discovery that calcification of biological tissue is mitigated and phospholipid content is reduced by including a step in the pre-implantation protocol whereby the biological tissue is treated with a surfactant and cross linking agent in the absence of a denaturant. Furthermore, the biological tissues prepared under this protocol are well suited for use in bioprosthetic devices.

Abstract: The invention provides an article of manufacture comprising a substantially non-immunogenic bone xenograft (X) for implantation into a defect (D) located in a bone portion (10) of a human. The invention further provides methods for preparing a bone xenograft (X) by removing at least a portion of bone from a non-human animal to provide a xenograft (X); washing the xenograft (X) in saline and alcohol; and subjecting the xenograft (X) to at least one of the treatments including exposure to ultraviolet radiation, immersion in alcohol, ozonic, and freeze/thaw cycling. In addition to or in lieu of the above treatments, the methods include a cellular disruption treatment, and digestion of the carbohydrate moieties of the xenograft (X) with a glycosidase followed by treatment for sialylation.

Abstract: The present invention relates to a process for preparing a biomaterial for tissue repair, which comprises the steps of cross-linking collagen of a collagen-based tissue obtained from a mammal, decellularizing the tissue and freeze-drying the cell-free tissue by employing a cryoprotective solution, and a biomaterial for tissue repair prepared by the said process. The process for preparing a biomaterial for tissue repair of the invention comprises the steps of procuring a collagen-based biological tissue from a mammal; treating the biological tissue with polyepoxy compound to obtain a biological tissue with cross-linked collagen structure; decellularizing the biological tissue thus obtained to give a cell-free tissue; and, immersing the cell-free tissue in a cryoprotective solution containing hyaluronic acid and freeze-drying the said tissue.

Abstract: Biomaterial including tissues basically obtained from an animal cornea, in particular, from a fish cornea. A cardiac valve (10) which may envisage at least one cusp (15) made with an organic tissue obtained from this particular biomaterial.

Abstract: A method of creating an implantation material from biological and tissue engineered biosynthetic and biological tissue of autogenic, allogenic and xenogenic origin suitable for implantation into humans or animals as surgical and vascular prostheses. The resultant material inhibits in vivo calcification and provides a non-porous biomatrix which is impervious to angiogenesis and tissue ingrowth and suitable for the adhesion and retention of transplanted living cells such as endothelial cells, without the need for additional extracellular matrix protein coating. The method, which incorporates a gradual increase in glutaraldehyde concentration from 0% to no more than 5% weight/volume in a pH which is gradually changed from acid to alkaline at room temperature, maintains the micro-architecture and the cellular lining of the material. Additionally flexibility, compliance and haemo-compatibility along with strength and durability can be varied according to the end use.

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: In some embodiments, a method for processing tissue comprises the application of a directional load to modify the properties of the tissue. In particular, the directional force is sufficient to increase the rigidity of the tissue asymmetrically relative to an unaligned tissue equivalently processed without being subjected to a load. In some embodiments, a sufficient directional load is applied to increase the rigidity of the tissue relative to an unaligned tissue equivalently processed that is not subjected to the load, in which the load is applied with a load applicator. A connector transfers the load from the load applicator to the tissue. Selectively aligned tissue having asymmetric mechanical properties can be used to form a prosthetic valve. The leaflets are matched with respect to each of their properties to have improved coaptation relative to corresponding tissue leaflets with symmetrical mechanical properties.

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

Abstract: The invention provides a plasticized bone and/or soft tissue product that does not require special conditions of storage, for example refrigeration or freezing, exhibits materials properties that approximate those properties present in natural tissue, is not brittle, does not necessitate rehydration prior to clinical implantation and is not a potential source for disease transmission. Replacement of the chemical plasticizers by water prior to implantation is not required and thus, the plasticized bone or soft tissue product can be placed directly into an implant site without significant preparation in the operating room.

Abstract: Adapting crosslinking with triglycidyl amine (TGA) to incorporate the use of a particular type of anti-calcification agent provides a broad-reaching solution to the problem in vivo bioprosthesis calcification. The anti-calcification agent in question includes a polyphosphonate compound that contains a functional group, which serves as a reaction site between the polyphosphonate and a polyepoxide. The functional group is reactive enough to dominate the reaction between the polyphosphonate and the polyepoxide, thereby excluding the chelating oxygen atoms of polyphosphonate from the reaction, protecting their anti-calcification ability. Furthermore, the high reactivity of the functional group allows the polyphosphonate to attach to the polyepoxide more completely, which improves the calcification resistance of bioprosthetic material with which the polyepoxide is crosslinked.

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: A method of manufacturing an osteoinductive osteoimplant is provided which comprises the steps of: demineralizing part or all of at least one surface of a monolithic section of cortical bone to a depth of at least about 100 microns; and, configuring the monolithic section of cortical bone to provide an osteoimplant possessing an outer surface possessing at least one demineralized zone and a non-demineralized zone. An implant produced according to the above method demonstrates improved osteoinduction without producing any clinically significant reduction of strength in critical regions of the osteoimplant.

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.