Thermedics Inc.

Thermo Electron Corporation

Other

Polymedica Industries, Inc.

Cardiotech International, Inc.

Polymedia Industries, Inc.

Michael Szycher

Jonathan L Rolfe

Donald J Dempsey

Andrew M Reed

Donald Dempsey

Alan Edwards

Jacob Leidner

David G Cook

Jon M Potter

This invention provides a modified catheter/indwelling device biomaterial that provides both immediate, and long-term microbiocidal effects on otherwise antibiotic-resistant strains of microorganisms. The material, which exhibits good mechanical performance characteristics for medical devices, is composed of a hydrophobic polyurethane (PU), a hydrophilic polyethylene vinyl acetate (PEVA) as an option, a soluble silver salt and a sparsely-soluble silver salt. The hydrophobic polyurethane provides the good physical properties, the PEVA the hydrophilicity necessary to allow some water ingress into the catheter, the soluble silver salt for an immediate burst effect, and the sparsely-soluble silver salt for sustained-release over many months postimplantation. Alternatively, the sparsely soluble silver salt can be silver iodate and is combined with silver sulfadiazine. Chlorhexidine can also be included in the material.

Antimicrobial material and method for making the same

This invention provides a modified catheter biomaterial that provides both immediate, and long-term microbiocidal effects on otherwise antibiotic-resistant strains of microorganisms. The material, which exhibits good mechanical performance characteristics for medical devices, is composed of a hydrophobic polyurethane (PU), a hydrophilic polyethylene vinyl acetate (PEVA), a soluble silver salt and a sparsely-soluble silver salt. The hydrophobic polyurethane provides the good physical properties, the PEVA the hydrophilicity necessary to allow some water ingress into the catheter, the soluble silver salt for an immediate burst effect, and the sparsely-soluble silver salt for sustained-release over many months postimplantation.

Filament-reinforced biomedical devices, and methods of making them.

Biocompatible devices

A biocompatible, biodurable polycarbonate polyurethane with internal polysiloxane segments and devices made therefrom.

Hydrolytically-and proteolytically-stable polycarbonate polyurethane

A sheet-form composite suitable as a spyrosorbent wound dressing and exhibiting differential moisture vapor transport rate properties is disclosed. The sheet-form composite includes a hydrophilic, monolithic film layer characterized by having a differential ratio of wet to dry moisture transport rate greater than 1 and a dry moisture transport rate greater than about 2,600 g/m.sup.2 /24 hrs. This film layer is laminated to a hydrophilic exudate transport layer. The exudate transport layer can itself be, or can further include, a hydrophilic pressure sensitive adhesive applied in a continuous or discontinuous pattern. The sheet-form composite has a moisture vapor transport rate of greater than 2,000 g/m.sup.2 /24 hrs when dry, and a wet to dry moisture vapor transport rate ratio in the range of about 1.5 to about 10.

Spyrosorbent wound dressings for exudate management

Polyurethane products having long-term biostability in combination with a low modulus of elasticity and a high ultimate tensile strength and other desireable mechanical properties which are particularly useful as leads for implantable pacemakers, as vascular grafts, as mammary prostheses, and as other products which are intended to be placed within the body of a mammal for extended periods with no substantial degradation of the product. The polyurethanes are prepared from the reaction of an organic diisocyanate, preferably an aliphatic or cycloaliphatic diisocyanate with polycarbonate glycol chained extended with diol, diamine or a mixture of diamine and alkanolamine.

Biostable polyurethane products

A non-toxic hydrophilic polyurethane elastomer having less than about 0.5% by weight extractables and which is curable in the absence of heat is disclosed. The elastomers are prepared from suitable hydrophilic polyurethane oligomers in combination with suitable ultraviolet light absorbers which become chemically bound into the elastomer during the polymerization (curing) thereof and thus become essentially non-extractable therefrom.

Hydrophilic polyurethane elastomers

A perfume patch comprising a fragrance-emitting member having a fragrance dispersed within an ultra-thin polyurethane membrane. A layer of pressure sensitive adhesive is applied to adhere the member to a surface. The polyurethane is formed from a diisocyanate, a macroglycol, and an acrylyl chain terminator to which a photoinitiator and a fragrance oil are added prior to curing. A barrier layer may be applied by an adhesive or other suitable means to prevent migration of the fragrance oil to the adhesive so that no residue of adhesive remains on the surface. The perfume patch preferably includes a support for the fragrance-emitting member for ease in application and handling.

Perfume patch

A layer or member particularly useful as part of a medical patch such as an anisotropic wound dressing, a transdermal skin patch or an incise medical drape and the processes for forming such a member. The member is comprised of a crosslinked thermoset aliphatic polyurethane elastomer. The elastomer is the reaction product of (1) isophorone diisocyanate, (2) a macroglycol and (3) a chain terminator having both hydroxyl and vinyl functional groups. Polycarbonate glycols or polyetherglycols having a molecular weight of 500-2500 Daltons are preferred macroglycols and isophorone diamine is a preferred chain terminator. In one embodiment, a member or polyurethane layer for use as a wound dressing or an incise medical drape is produced by applying a film-forming solution or dispersion as a thin film to a supporting release paper and treating the film to drive off the liquids and to activate a crosslinker. In another embodiment, a member for an anisotropic medical patch is produced by sandwiching a knitted reinforcing fabric in the elastomer. When used as a transdermal skin patch or a drug dispensing wound dressing, a layer of drug dispensing film containing pharmacoactive agents may be applied to the medical patch, and when appropriate, the medical patch may be coated with a pressure sensitive adhesive.

Medical patches and processes for producing same

An anisotropic wound dressing comprised of a knitted reinforcing fabric which is sandwiched between a crosslinked aliphatic polyurethane. The wound dressing is fabricated by dipping the fabric into a polyurethane-forming coating solution to form a thin film which coates the fibres of the fabric and fills the interstices with a film or layer. The film which coats the fabric is cured by ultraviolet radiation and one side of the film is coated with pressure sensitive adhesive to form a wound dressing. In the most preferred embodiments, the knitted reinforcing fabric is an anisotropic fabric formed with a basic stitch construction to create equally spaced and sized hexagonal interstices. Because of the fabric reinforcement, the resulting oxygen permeable product can be made thin, and yet be anisotropic and strong. The resulting product does not wrinkle easily and holds its shape so it is also easily applied.

Anisotropic wound dressing

A drug releasing system in the form of a medical patch comprised of a drug dispensing polyurethane member as a matrix for a therapeutically effective amount of drug dispersed therein. The polyurethane of the drug dispensing or releasing member is a polyurethane acrylic copolymer which is the reaction product of an oligomer of a diisocyanate, a glycol with a molecular weight between the range of 500-5,000 molecular weight units and an acrylyl chain terminator having a molecular weight between the range of 40-200 molecular weight units cured by actinic radiation. In its preferred embodiment, the foregoing drug releasing or dispensing member is incorporated into a medical patch or drug release system comprised of successive layers of an ultrathin polyurethane substrate, pressure sensitive adhesive, the above-described drug releasing member and optionally a second layer of adhesive. The drug release system of the present invention is biocompatible, oxygen and water vapor permeable, flexible and can incorporate a wide variety of drugs for a controlled, sustained release to the wearer.

Drug release system

The disclosed wound dressings have a drug dispersed throughout a polyurethane matrix that is the reaction product of: (A) An isocyante terminated prepolymer formed by reaction of isophorone diisocyanate and a macroglycol and (B) a monomer containing hydroxyl and vinyl groups. The reaction product is a vinyl terminated polyurethane oligomer which is liquid at room temperature and which may be readily admixed with a pharmacoactive substance and a photosensitizer, formed into a film and cured by exposure to UV light without release of heat. In the most preferred embodiments the foregoing oligomer is codissolved in an organic solvent with a polyurethane polymer which is the reaction product of:

Drug dispensing wound dressing

Reaction product of an aliphatic organic diisocyanate, a high molecular weight polyether polyol (poly tetra methylene ether glycol) and 1,4 butane diol. The resulting polymers have thromboresistant properties, a long flexural life and are extrudable. The polyurethane polymer is ideal for forming transvenous cardiac pacemaker leads, blood bags, intravenous and intra-arterial catheters and tubing, and other shaped devices which must be formed of a blood compatible material.

Extrudable polyurethane for prosthetic devices prepared from a

The actinic radiation cured composition of this invention comprises a polyurethane acrylic copolymer containing a light scattering or fluorescing material. The polyurethane acrylic copolymer is fully cured and is flexible and elastomeric.

Growing community of inventors

Lynnfield, MA, United States of America

Michael Szycher