Assessing, maintaining and/or restoring viability of organs/tissues

Inventors

Kravitz, David • Brockbank, Kelvin G. M. • Campbell, Lia H.

Assignees

Lifeline Scientific Inc

Abstract

Methods for ex vivo perfusion of organs (and/or tissues) with a perfusate designed to condition the organ with the desired effect being that upon transplant, said organ, having been administered said perfusate, is less likely to experience delayed graft function, deleterious effects of ischemia/reperfusion injury, including inflammatory reactions, and/or other detrimental responses that can injure the organ or recipient including precipitating or enhancing an immunological reaction from the recipient with the potential of compromising the graft's and/or recipients short teen and/or long term health and proper functionality while monitoring, sustaining and/or restoring the viability of the organ and preserving the organ for storage and/or transport.

Core Innovation

The disclosure addresses a method of determining parameters for maintaining viability of a liver or a kidney in at least one device selected from an organ transporter, perfusion apparatus, cassette, and organ diagnostic apparatus. It starts with procuring a donor liver or a donor kidney that is diseased or injured and in need of treatment in order to be suitable for transplantation. The method then performs processing on the procured organ based on information gathered during preservation, transport, and/or storage in those devices.

A data record is formed by uploading compiled data comprising qualitative and/or quantitative relationships of one or more predetermined biomarkers while livers or kidneys are preserved, transported and/or stored, together with events occurring while livers or kidneys are transported and/or stored, and data related to outcomes of transplantation. A database inquiry is then performed to select a set of biomarkers to monitor for the procured donor liver or kidney. Organ-specific normative ranges are established based on the compiled information contained in the data record.

Using the selected set of biomarkers and comparison to the normative ranges, an organ therapy regimen, perfusion conditions, and a perfusion solution are selected to treat the procured donor liver or kidney, and the processor determines parameters of the perfusion apparatus or at least one different device for maintaining the viability of the treated liver or kidney. The disclosed biomarker relationships include perfusion data from an oxygenated perfusate acquired under hypothermic conditions and relationships among pO2, stability of pO2, oxygen consumption rate, stability of the oxygen consumption rate, and perfusion parameters or conditions, together with events and/or conditions occurring during preservation, transport, and/or storage.

Claims Coverage

The partial content provides one independent claim. It includes four inventive features covering construction of a biomarker-and-outcome data record, selection of biomarkers by database inquiry, comparison to organ-specific normative ranges to choose therapy and perfusion conditions, and processor-determined device parameters to maintain viability. Dependent claims add a suitability/unsuitability outcome tied to a predetermined viability level and a downstream handling pathway for organs deemed unsuitable for transplantation.

Overall, the claim coverage centers on building a data record linking predetermined biomarker relationships and events during preservation, transport, and storage to transplantation outcomes, then using database inquiry and organ-specific normative ranges to select a therapy regimen and perfusion conditions, followed by processor-determined device parameters to maintain viability.

Stated Advantages

Documented Applications

No documented applications found