Apparatus and method for determining effects of a substance on an organ

Abstract

An organ perfusion apparatus and method monitor, sustain and / or restore viability of organs and preserve organs for storage and / or transport. Other apparatus include an organ transporter, an organ cassette and an organ diagnostic device. The method includes perfusing the organ at hypothermic and / or normothermic temperatures, preferably after hypothermic organ flushing for organ transport and / or storage. The method can be practiced with prior or subsequent static or perfusion hypothermic exposure of the organ. Organ viability is restored by restoring high energy nucleotide (e.g., ATP) levels by perfusing the organ with a medical fluid, such as an oxygenated cross-linked hemoglobin-based bicarbonate medical fluid, at normothermic temperatures. During the period in which the organ is preserved and / or maintained, various drug research and development may be performed on and / or with the organ. The organ may be perfused with a fluid containing a substance such as a test substance to obtain data regarding the organ, the substance and an interaction of the substance and the organ. The data may then be used to ultimately provide information regarding the drugs efficacy in support of regulatory filings for new drugs.

Description

[0001] This application is a continuation-in-part of U.S. Patent Application No. 10 / 617130 filed on July 11, 2003, which is a divisional application of No. 09 / 645525 filed on August 25, 2000. No. 09 / 645525 is a continuation-in-part of U.S. Patent Application No. 09 / 537180 filed March 29, 2000, which is a continuation-in-part of U.S. Patent Application No. 09 / 162128 filed September 29, 1998 Continuation-in-Part, the entire contents of these patent applications are incorporated herein by reference. technical field [0002] The present invention relates to devices and methods for perfusing one or more organs to monitor, maintain and / or restore the viability of said organs, and / or for transporting and / or storing said organs. The invention also relates to determining whether the organ is a viable candidate for transplantation. In particular, if the organ is not a viable transplant candidate, the invention further relates to perfusing the organ with a fluid to acquire data relating...

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