Sulzer Carbomedics Inc.

Carbomedics Inc.

Mark A Moore

Richard E Phillips, Jr

Chandrashekhar Prabhakar Pathak

David T Cheung

Brian K McIlroy

Richard E Philips, Jr

C P Pathak

Joseph Andrew Chinn

Joseph A Sauter

R Michael Casanova

Chandrashenkhar P Pathak

Gerald L Mechanic

Melanie D Robinson

L Diane Bruce

Ruth L Russell

Method of cross-linking tissue with a bis-maleimide compound

A method is provided for producing antimicrobial, antithrombogenic medical devices. The method employs an antimicrobial treatment process wherein an antimicrobial agent is dissolved in an appropriate solvent and the resulting solution is contacted with a portion of a medical device of interest. The antimicrobial treatment process is advantageously performed without the need for additional compounds to facilitate antimicrobial agent uptake into the device. The method further comprises an antithrombogenic treatment process wherein antithrombogenic agents or materials are applied or otherwise associated with at least some portion of the medical device.

Method for producing antimicrobial antithrombogenic medical devices

A method for treating biomaterial is provided in which a biological tissue, typically after being cross-linked, is contacted with an anticalcification treatment solution under condition effective to render the biomaterial resistant to in vivo calcification upon implantation in a host animal. The anticalcification treatment solutions comprise higher alcohol solutions, a polyol solutions and/or a polar aprotic organic solvent solutions.

Anticalcification treatments for fixed biomaterials

A method extracting lipids from tissue samples, particularly collagenous tissue samples for use in preserving the tissue samples, is disclosed. The product of the method of extracting the lipids is also disclosed. Extraction is accomplished by immersing the tissue sample in a medium which is an aqueous solution of a salt and a sugar that is buffered to maintain pH and which has a high (greater than about 4500 mosm) osmolality.

Method for extracting lipids from tissue samples using high osmolality storage medium and product

A method for treating biological tissue is provided in which a cross-linked biological tissue containing free aldehyde groups is reacted with a suitable neutralization agent in order to chemically block the aldehyde groups from reactivity toward cellular proteins. Also provided is the cross-linked biological tissue so produced which is substantially free of reactive aldehyde groups and, as a result, exhibits reduced toxicity and improved biocompatibility.

Method for treating cross-linked biological tissues

This invention relates, in general, to a process for cross-linking and stabilizing proteinaceous material, and in particular, to a process for oxidizing collagenous material, by oxidizing the tissue. The invention also relates to the resulting cross-linked product. The method comprises immersing the material to be cross-linked in a solution comprising compounds designed to generate the radical species singlet oxygen or other oxidizing intermediates without the addition of an external energy source. Immersing collagen containing tissue in a solution comprising an oxidizing agent and sufficient dissolved oxygen, under controlled conditions of pH and temperature, provides a cross-linked and stabilized collagen containing tissue that resists chemical and enzymatic degradation.

Oxidative stabilization of collagen containing materials

A method for cross-linking biological tissue is provided which uses as a cross-linking agent a low molecular weight, substantially monomeric polyfunctional aldehyde formed in situ or just prior to cross-linking. The polyfunctional aldehyde is essentially free of the undesirable heterogeneous polymeric species that result from polyfunctional aldehyde self-reactivity. Also provided is biological tissue that is cross-linked with a substantially monomeric glutaraldehyde.

Blocked functional reagants for cross-linking biological tissues

Collagen-containing tissue is cross-linked to provide tissue suitable for use in production of bioprosthetic devices. A cross-linking agent is used having an aliphatic component containing about 8 to 40 carbon atoms and two collagen-reactive groups such as isocyanate, epoxy or n-hydroxysuccinimide. The cross-linking agent may be produced by dimerizing fatty acids, and modifying carboxylic acid group of the fatty acids before or after dimerization to contain collagen-reactive groups. The cross-linked tissue has desirable mechanical and biocompatibility features and a reduced susceptibility to calcification.

Cross-linking tissue with a compound having a C.sub.8 to C.sub.40

The disclosed invention relates to the process of fixating tissue to obtain tissue for bioprosthetic applications. The fixating process comprises exposing the tissue to a fluid comprising activated difunctional or polyfunctional acids that can react with amino groups in tissue under mild conditions. Activating moieties include disuccinimidyl moieties, n-hydroxy disuccinimidyl moieties, sulfo-disuccinimidyl moieties, and mixtures thereof. The acid is preferably aliphatic difunctional or polyfunctional acids, more preferably a naturally occurring aliphatic difunctional or polyfunctional acids. Even more preferred is an acid consisting of glutaric, suberic acid, sebacic acid, tartaric acid, or mixtures thereof. The activated difunctional or polyfunctional acids are esters comprising the difunctional or polyfunctional acids and the activating moieties.

Tissue crosslinking for bioprostheses using activated difunctional or

This invention relates to tanning biomaterial to obtain calcification resistant biomaterial with good mechanical properties for bioprosthetic applications. The biomaterial of the invention is obtained by tanning tissue by any method except by oxidation, and then at a later time tanning the tissue by any of the oxidative fixation methods. The process was shown to provide beneficial results with the most frequently used fixation process, which involves fixating tissue with glutaraldehyde. Tissue fixated with glutaraldehyde and then by oxidative fixation has a lower calcification potential than does glutaraldehyde-only tanned tissue and has mechanical properties more similar to glutaraldehyde tanned tissue than to oxidative stabilized tissue. In particular, a process is described where tissue is fixed with glutaraldehyde followed by photoxidation.

Non-calcific biomaterial by glutaraldehyde followed by oxidative fixation

The present invention provides an iodine-based solution, and a method of using that solution, which sterilizes tissue implants without denaturing the proteins in the implant and without inducing calcification of the implant in vivo. Preferably, the tissue implants sterilized using the present invention are fixed without using glutaraldehyde. Most preferably, the tissue implants are fixed by photooxidation.

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Austin, TX, United States of America

Mark A Moore