Method of determining that an organ is not suitable for transplantation and using it for testing substances
First Claim
1. A method of determining effects of a substance on at least one organ, comprising:
- restoring and/or maintaining organ viability of the at least one organ, wherein the restoring and/or maintaining of the organ viability includes perfusing the organ with at least one medical fluid during at least one perfusion mode to restore and/or maintain pre-ischemia energy and enzyme levels of the organ;
sensing tissue and/or fluid characteristics indicative of organ viability by a sensor to obtain diagnostic data;
analyzing the diagnostic data to determine whether the at least one organ is suitable to be transplanted; and
based on a determination that the at least one organ is not suitable to be transplanted, further comprising;
perfusing the at least one organ with a first medical fluid to preserve the at least one organ;
contacting the at least one organ with at least one test substance; and
gathering data regarding at least one of the at least one organ, the at least one test substance, and interaction between the at least one organ and the at least one test substance.
2 Assignments
0 Petitions
Accused Products
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.
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Citations
19 Claims
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1. A method of determining effects of a substance on at least one organ, comprising:
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restoring and/or maintaining organ viability of the at least one organ, wherein the restoring and/or maintaining of the organ viability includes perfusing the organ with at least one medical fluid during at least one perfusion mode to restore and/or maintain pre-ischemia energy and enzyme levels of the organ; sensing tissue and/or fluid characteristics indicative of organ viability by a sensor to obtain diagnostic data; analyzing the diagnostic data to determine whether the at least one organ is suitable to be transplanted; and based on a determination that the at least one organ is not suitable to be transplanted, further comprising; perfusing the at least one organ with a first medical fluid to preserve the at least one organ; contacting the at least one organ with at least one test substance; and gathering data regarding at least one of the at least one organ, the at least one test substance, and interaction between the at least one organ and the at least one test substance. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 19)
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18. A method of screening at least one organ, comprising:
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restoring and/or maintaining organ viability of the at least one organ, wherein the restoring and/or maintaining of the organ viability includes perfusing the organ with at least one medical fluid during at least one perfusion mode to restore and/or maintain pre-ischemia energy and enzyme levels of the organ; sensing tissue and/or fluid characteristics indicative of organ viability by a sensor to obtain diagnostic data; analyzing the diagnostic data to determine whether the at least one organ is suitable to be transplanted; and based on a determination that the at least one organ is not suitable to be transplanted, further comprising; perfusing the at least one organ with a first medical fluid to preserve the organ; contacting the at least one organ with at least one test substance; and gathering data regarding at least one of the at least one organ, the at least one test substance, and interaction between the at least one organ and the at least one test substance, wherein the at least one test substance is a bioactive agent.
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Specification