Ethicon, Gmbh

Stephen C Yeadon

James Constantine Comolli

Robert W Van Holten

Jagdishchandra C Patel

John B Kowalski

Michael C Saylor

A method of sterilizing a polymeric material that is sensitive to radiation. The method includes the steps of applying at least one radiosensitizer to the polymeric material and irradiating the polymeric material with a suitable radiation at an effective dose and time to sterilize the polymeric material. Also disclosed is a method of enhancing the ability of a medical device to withstand sterilization by radiation and a bioabsorbable polymeric medical device.

Sterilization of polymeric materials

A hemostatic device comprising (i) a carrier comprising at least one component selected from the group consisting of hydroxypropyl methylcellulose phthalate, hydroxypropyl methylcellulose acetate succinate, cellulose acetate phthalate; polyvinylacetate phthalate, cellulose acetate phthalate, acetaldehyde dimethylcellulose acetate, polymethacrylate-based polymers, and derivatives, salts, copolymers or combinations thereof; and (ii) thrombin.

Hemostatic device

An apparatus for the irradiation of a radiation sensitive material. The apparatus includes at least one thermally conductive tank for containing a heat transfer medium therein, said at least one thermally conductive tank having a first wall and a second wall in a parallel spaced relationship, said second wall having an outer surface for placing a radiation sensitive material thereon. Also disclosed is a system and method of irradiating a radiation sensitive material.

Apparatus and method for the irradiation of radiation sensitive materials

A method provides for sterilizing with radiation objects which have a low bioburden and which are sensitive to radiation. A dosage of radiation sufficient to ensure sterilization without damaging the object is determined by determining the bioburden upon one or more samples of the objects, determining an estimate of the dose that results in a probability of 0.01 of a surviving microorganism by testing a quantity of samples of the objects at varying dosage levels of radiation, confirming the estimate by testing a quantity of samples of the objects at the dose that was estimated; and calculating a dosage for the sterility assurance level of 10-6 by adding a factor to the dose that was confirmed to result in a probability of 0.01 of a surviving microorganism and wherein the factor is proportional to the dose that yields a probability of 0.01 of a surviving microorganism and inversely proportional to a log of the bioburden.

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Hampton, NJ, United States of America

Stephen C Yeadon