St. Jude Medical, Inc.

Matthew Frank Ogle

Richard F Schroeder

Katherine S Tweden

R Brian Williams

William R Holmberg

M William Mirsch, Iii

Darrin J Bergman

Matthew S Reimink

Donald S Guzik

Andrea L McConico

Sheila Jeanne Kelly

Hallie A Finucane

Paul Edward Ashworth

Peter S Dardi

Wenda C Carlyle

Andrea L Johnson

Daniel Paul McTavish

A polypeptide growth factor is associated with a substrate to promote population of the substrate with endothelial cells. In a preferred approach, the growth factor is associated with the substrate by crosslinking under suitably mild conditions such that the growth factor is active following the crosslinking process. Thus, a prosthesis is formed with growth factor crosslinked to the substrate.

Medical devices with associated growth factors

Improved medical device have an inorganic substrate and a polymer covering at least a portion of the substrate, in which the polymer forms a structure substantially different from the structure of the substrate. Other medical devices include a flexible composite component with an inorganic substrate and a polymer covering at least over a portion of the substrate. The flexible composite component can be bent, at least, about 100 degrees without extending the material beyond its elastic limit. Corresponding methods include applying a polymer onto an inorganic substrate, such that the polymer does not conform to the shape of the substrate.

Medical devices with polymer/inorganic substrate composites

Novel adhesive compositions are described that include an epoxyamine and, preferably, a curing agent. The adhesive composition can be used in surgical settings such as implanting bioprostheses and/or in manufacturing of bioprostheses. Biocompatible substrates can be adhered together by an adhesive bond formed by curing of the epoxyamine adhesive composition.

Biocompatible adhesives

An apparatus is disclosed for differentially treating a medical device. One portion of the device is treated with a first fluid and a separate portion is treated with a second fluid. The second fluid generally is substantially different from the first fluid. The first fluid can be contacted with an flow region of the medical device. The apparatus can include a conduit system, where fluid flowing through the conduit system flows through the flow region. Sheet material can be treated differentially on the opposite surfaces of the sheet. The medical device can include vascular tissue.

Differential treatment of prosthetic devices

Medical devices include biocomatible materials and a plurality of exogenous storage structures. The exogenous storage structures store a therapeutic agent which acts to inhibit restenosis. In some embodiments, the therapeutic agents are radioactive metal ions. In other embodiments, the medical device has an expandable structure with particles of therapeutic agent on its surface. The particles of therapeutic agent are delivered into a region susceptible to restenosis by direct application of the medical device against the adjacent wall.

Medical devices that resist restenosis

Crosslinked tissue is contacted with one or more toxicity reducing solutions to remove cytotoxicity associated with the crosslinking process. In particular, crosslinked tissue can be contacted with an inorganic sulfur-oxygen group to form chemical adducts of aldehydes and the inorganic sulfur-oxygen group. Preferably, the cytotoxicity reduced crosslinked tissue has no residual cytotoxicity. In preferred embodiments, a plurality of toxicity reducing agents are used to detoxify the tissue. Preferred toxicity reducing agents include, for example, inorganic sulfur-oxygen ions, such as bisulfate and thiosulfate, organic sulfates, amines, ammonia/ammonium, and surfactants.

Biocompatible prosthetic tissue

Approaches are described for sterilizing medical and biological articles using sterilizing compositions. The sterilizing compositions include epoxy amine compounds and, optionally, alcohol. The epoxy amine compounds act as antimicrobial agents in the sterilizing compositions. In particular, medical articles can be sterilized and/or stored in the compositions described.

Methods of sterilizing articles

Medical devices are formed from metal/polymer composites that have improved characteristics. The metal/polymer composites have a relatively thick metal coating with an average metal thickness of greater than about 3 microns. The composite has mechanical properties, such as mechanical strength, durability and resiliency, contributed by the metal coating. The metal/polymer composites can be formed by solution based or vapor based approaches.

Medical devices with metal/polymer composites

The invention involves a bioprosthetic article including a biocompatible material having at least one bound exogenous storage structure, the storage structures having collectively greater than about 0.5 mg metal cations per gram of biocompatible material. The calcification inhibitors preferably decrease calcium deposition by greater than 95% relative to untreated tissue. The calcification inhibitors are bonded to the bioprosthetic material preferably at a pH between about 6.0 and 8.5.

Calcification-resistant biomaterials

A variety of new ways can be used for associating antimicrobial elemental metal with a medical article. The associated antimicrobial metal reduces the risk of infection associated with the medical use of the medical article. New medical articles are produced by some of these new approaches. Some of the methods involve ways of adjusting the dissociation rate of associated elemental metal such that desired degrees of antimicrobial activity can be achieved over selected periods of time.

Medical article with adhered antimicrobial metal

Medical articles can include biocompatible material with a deposit of anticalcific elemental metal. The biocompatible material can be tissue, fabric or the like. The biocompatible material can be configured on the medical article such that when the medical article is positioned for its intended use, the biocompatible material is substantially removed from blood flow or is in a low blood flow area effectively removed from vascular blood flow. Gas phase or solution phase methods can be used to deposit the anticalcific elemental metal.

Calcification-resistant medical articles

In general, the invention features a bioprosthetic article including a biocompatible material having at least one bound exogenous storage structure, the storage structure having a quantity of calcification inhibitors releasably bound thereto. The storage structure can be a protein or a synthetic polymer. The calcification inhibitors include metal ions and phosphatase inhibitors generally. Bifunctional metal chelators can be bound to endogenous proteins to deliver metal ions.

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Saint Paul, MN, United States of America

Matthew Frank Ogle