A method for manufacturing a heart valve using bioprosthetic tissue that exhibits reduced in vivo calcification. The method includes applying a calcification mitigant such as a capping agent or an antioxidant to the tissue to specifically inhibit oxidation in tissue. Also, the method can be used to inhibit oxidation in dehydrated tissue. The capping agent suppresses the formation of binding sites in the tissue that are exposed or generated by the oxidation and otherwise would, upon implant, attract calcium, phosphate, immunogenic factors, or other precursors to calcification. In one method, tissue leaflets in assembled bioprosthetic heart valves are pretreated with an aldehyde capping agent prior to dehydration and sterilization.

The present invention relates to methods for adhering tissue surfaces and materials and biomedical uses thereof. In particular the present invention relates to a method for adhering a first tissue surface to a second tissue surface in a subject in need thereof, comprising the steps of adsorbing a layer of nanoparticles on at least one of the tissue surfaces, and approximating the surfaces for a time sufficient for allowing the surfaces to adhere to each other. The present invention also relates to a method for adhering a material to a biological tissue in a subject in need thereof, comprising the steps of adsorbing a layer of nanoparticles on the surface of the material and/or the biological tissue and approximating the material and the biological tissue for a time sufficient for allowing the material and the biological tissue to adhere to each other.

Thin, biocompatible, high-strength, composite materials are disclosed that are suitable for use in medical devices, such as a prosthetic valve for regulating blood flow direction. In one aspect, the leaflet material maintains flexibility in high-cycle flexural applications, making it particularly applicable to high-flex implants such as a prosthetic heart valve leaflet. The leaflet material includes a coating of a non-elastomeric TFE-PMVE copolymer.

An implantable medical product and method of use for substantially reducing or eliminating harsh biological responses associated with conventionally implanted medical devices, including inflammation, infection and thrombogenesis, when implanted in in a body of a warm blooded mammal. The bioremodelable pouch structure is configured and sized to receive, encase and retain an electrical medical device therein and to allow such device to be inserted into the internal region or cavity of the pouch structure; with the pouch structure formed from either: (a) first and second sheets, or (b) a single sheet having first and second sheet portions. After receiving the electrical device, the edges around the opening are closed by suturing or stapling. The medical device encased by the bioremodelable pouch structure effectively improves biological functions by promoting tissue regeneration, modulated healing of adjacent tissue or growth of new tissue when implanted in the body of the mammal.

Inventive concepts relate generally to the field of implantable urological devices, and more particularly to compositions that inhibit crystallization of urine components. Described are implantable urological devices including a surface and a crystallization inhibitor composition, the crystallization inhibitor composition including: (a) an inhibitor of urine component crystallization in combination with a biodegradable polymer, or a polyalkene homopolymer or copolymer, or (b) a biodegradable polymer that includes an inhibitor of urine component crystallization, wherein the crystallization inhibitor composition provides controlled release of the inhibitor of urine component crystallization from the surface of the device into a subject. Methods of making the implantable urological devices are also described.

Methods for treating a bioprosthetic tissue are described herein. The methods comprise contacting the bioprosthetic tissue with at least one nucleophile and/or at least one electrophile in the presence of a catalytic system comprising at least one or a combination of a fluoride-based salt, a cesium-based salt, a potassium-based salt, a rubidium-based salt, or a carbonate-based salt. The methods may be used to alter functional groups on biological tissue which represent actual and potential calcium binding sites and also processes for cross-linking bioprosthetic tissue. Both processes may be used in conjunction with known fixative techniques, such as glutaraldehyde fixation, or may be used to replace known fixative techniques.

Some embodiments of the disclosure provide a decellularized heart valve (DHV) composite, a preparation method of the DHV composite, and a use of the DHV composite. In some examples, the preparation method of the DHV composite includes the following steps: S1, conducting a reaction I on a DHV with a copper chloride-dopamine hydrochloride mixed solution to obtain a copper ion-modified DHV; and S2, conducting a reaction II on the copper ion-modified DHV with a GDF11 solution to obtain the DHV composite. In other examples, the present disclosure provides a use of the DHV composite in preparation of a tissue-engineered heart valve (TEHV). In further examples, the TEHV is a heart valve (HV) with remodeling and regeneration capabilities.

The present invention relates to a process for sterilizing implantable biomaterials. In particular, the invention relates to a process for sterilizing collagen-containing implantable biomaterials and storage thereafter.

A treatment for bioprosthetic tissue used in implants or for assembled bioprosthetic heart valves to reduce in vivo calcification. The method includes applying a calcification mitigant such as a capping agent or an antioxidant to the tissue to specifically inhibit oxidation in tissue. Also, the method can be used to inhibit oxidation in dehydrated tissue. The capping agent suppresses the formation of binding sites in the tissue that are exposed or generated by the oxidation and otherwise would, upon implant, attract calcium, phosphate, immunogenic factors, or other precursors to calcification. In one method, tissue leaflets in assembled bioprosthetic heart valves are pretreated with an aldehyde capping agent prior to dehydration and sterilization.

Methods of preparing calcification-resistant bioprosthetic tissue include providing fresh biological tissue, cross-linking the tissue, treating the cross-linked tissue with an alcohol for a time sufficient to allow the alcohol to be diffused into the tissue, and treating the alcohol-treated fixed tissue with a polyol for a time sufficient to allow fluid in the tissue to be replaced by the polyol. The methods may include sterilizing the cross-linked tissue in a solution including propylene oxide or peracetic acid either before or after the alcohol treatment step; or drying the alcohol/polyol-treated, cross-linked tissue, sterilizing the dried tissue by exposure to ethylene oxide or peracetic acid, and storing the sterilized tissue in a dry, ambient environment. The treated tissue may be a tissue component for a bioprosthetic valve, a valve assembly for a bioprosthetic valve or a fully assembled bioprosthetic valve incorporating the tissue.