Sealantium Medical Ltd.

Yotam Schwartz

Orgad Laub

Eran Cohen

A method of production of a tissue sealing patch is disclosed. The method comprises applying a vacuum to a heated work surface; applying a solution of a biocompatible polyurethane polymer to the work surface and spreading it over the work surface with a polymer blade; evaporating the solvent; heating the work surface above the softening temperature of the polymer; spreading powdered tissue sealant material over the polymer film; incorporating the tissue sealant material to a depth of 20-60 &#x3bc;m in the film by pressing on a release sheet placed over the powder and polymer film; removing the release sheet from the adhesive patch material; releasing the vacuum; cooling said work surface; and removing the adhesive patch material from said work surface. The biocompatible polymer preferably comprises PEG-caprolactone-lactic acid units connected by urethane linkages, the PEG having a molecular weight of 3000-3500 amu, and a CL:LA:PEG ratio of 34:2:1.

Method for preparation of tissue adhesive patches

A method for measuring the adhesive strength of a hemostatic tissue patch. Two patches are attached to facing surfaces with a side that would normally seal tissue exposed. Liquid is placed on one of the patches to activate the hemostatic agent, the patches held together long enough to adhere to one another, and then pulled apart. The force necessary to detach them is measured, thereby providing a determination of the adhesive strength of the patch. In contrast to literature methods, the inventive method provides excellent reproducibility.

Method for determining the adhesive force of a hemostatic tissue sealant patch

A method of production of a tissue sealing patch is disclosed. The method comprises casting a polymer film from a biocompatible polyethylene glycol-caprolactone-lactide triblock copolymer (PECALA); softening the polymer film; placing a powdered tissue sealant material on a surface of said polymer film; and, pressing said polymer film to at least partially incorporate the sealant material into said surface of said polymer film. In some embodiments of the invention, the polymer film is created by heating and evacuating a work surface; applying a solution of PECALA to said work surface; adjusting a polymer blade to a predetermined height above said work surface; spreading said solution of PECALA over said work surface with said polymer blade; and evaporating said solvent. The PECALA preferably comprises PEG-CL-LA units connected by urethane linkages, PEG having a molecular weight of between 3000 and 3500 amu, and a CL:LA:PEG ratio of 34:2:1.

Fibrinogen-based tissue adhesive patch

An improved fibrinogen-based tissue sealing patch having a degradation time of less than two weeks is disclosed. The patch comprises a polyethylene glycol-caprolactone-lactide (PEG-CL-LA) triblock copolymer film in which the PEG-CL-LA units are preferably connected by urethane linkages and into a surface of which a fibrinogen-based sealant comprising less than 8 mg/cmfibrinogen and less than 10 IU/cmthrombin has been incorporated. In preferred embodiments, the polymer film comprises PEG having a molecular weight of between 3000 and 3500 and a CL:LA:PEG ratio of 34:2:1. Methods of production and use of the patch are also disclosed.

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Petah Tiqwa, Israel

Yotam Schwartz