Apparatus and method for perfusion and determining the viability of an organ
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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. During the period in which the organ is preserved and/or maintained, the organ may be additionally be perfused to obtain data regarding the fluid and/or organ. The data may then be used to ultimately provide information regarding the perfusion efficacy and allow for altering of the perfusion parameters.
Core Innovation
An organ perfusion and diagnostic approach is provided in which an organ is perfused with an oxygen rich fluid to maintain viability while alternating between hypothermic perfusion mode and normothermic perfusion mode. Perfusion pressure and temperature are regulated with controlled, fail-safe perfusion pressure and temperature regulation. Monitoring organ viability uses physiological parameters derived from the perfusate and venous outflow.
The monitored physiological parameters include pressure/flow resistance, pH, pO2, pCO2, lactate, LDH, total protein, T/GST, glucose, base excess, and ionized calcium, and a computer-generated organ viability index is generated. The index supports therapy and transport decisions based on organ viability. The disclosed system also includes an organ diagnostic system for location-specific assessment.
Location-specific microdialysis is performed by placing a probe at or in a specific area of the organ, where dialysate is supplied separately from the perfusing and is not supplied to the entire organ. The probe provides microdialysis at the specific area and uses a semipermeable membrane to deliver dialysate to in-tissue areas and collect returned dialysate for analysis. Outputs are monitored as sensed electrical characteristics and/or sensed chemical characteristics associated only with the specific area.
Claims Coverage
The partial content contains one independent claim. This independent claim covers viability-preserving organ perfusion and area-specific device monitoring using microdialysis supplied separately as dialysate, with sensing outputs limited to only the monitored specific area of the organ.
Area-specific organ characterization using perfusion and microdialysis outputs
Perfusing the organ with an oxygen rich fluid to maintain viability, placing at least one device at or in a specific area of the organ where at least one characteristic of the specific area is monitored, supplying a first medical fluid (dialysate) separately to the at least one specific area of the organ and performing microdialysis at the at least one specific area, and monitoring an output of the device where the output is at least one of a sensed electrical characteristic and a sensed chemical characteristic of only the at least one specific area of the organ.
Overall, the independent claim requires viability-preserving perfusion with oxygen rich fluid, placement of a monitoring device at or in a defined organ area, separate area-only delivery of dialysate for microdialysis at that area, and monitoring of sensed electrical and/or chemical outputs limited to only that specific area.
Stated Advantages
Documented Applications
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