Prognostic testing of organs intended for transplantation
AssigneeBreonics, Inc.
InventorLauren Brasile
Life of this patent
Estimating the term…
Abstract
The present invention discloses a method of prospectively determining whether an organ will function once it is transplanted. A transplantable organ is perfused in an ex vivo warm perfusion system capable of supporting near normal levels of metabolism by the organ. One or more parameters related to organ function are measured and evaluated during perfusion. Measurements of perfused organ function are compared to values indicative of normal organ function to obtain a prediction of whether the organ being perfused will function once it has been transplanted. A method for calculating a viability index based on the parameters evaluated is also disclosed.
Claims26
A method for prospectively determining functional potential of an organ to be transplanted, said method comprising the steps of:
- (a) obtaining a value by measuring a parameter of a fluid derived from an explanted organ, said fluid selected from organ product, circulated perfusate, and a combination thereof;
- (b) comparing the value obtained from said measurement with a range of reference values indicative of normal organ function;
- and
- (c) determining whether or not said value falls within the range of reference values indicative of normal organ function.
A method for prospectively determining functional potential of an organ to be transplanted, wherein said organ is being perfused in a warm preservation system, said method comprising:
- (1) measuring at least one of the following parameters:
- (a) normalization of a perfusion characteristic for the organ;
- (b) extent of damage to the vascular endothelium of the organ;
- (c) level of oxidative capacity of the organ;
- (d) metabolic capacity of the organ;
- and
- (e) an organ-specific parameter of organ metabolism and function;
- (2) comparing the value obtained from said measurement with a range of reference values indicative of normal organ function;
- and
- (3) determining whether or not said value falls within the range of reference values indicative of normal organ function.
A method for determining the severity of ischemic damage to an organ intended for transplant, wherein said organ is being perfused in a warm preservation system, said method comprising:
- (1) measuring at least one of the following parameters:
- (a) normalization of a perfusion characteristic for the organ;
- (b) extent of damage to the vascular endothelium of the organ;
- (c) level of oxidative capacity of the organ;
- (d) metabolic capacity of the organ;
- and
- (e) an organ-specific parameter of organ metabolism and function;
- (2) comparing the value obtained from said measurement with a range of reference values indicative of normal organ function;
- and
- (3) determining whether or not said value falls within the range of reference values indicative of normal organ function.
A method for determining the severity of acute tubular necrosis of a kidney intended for transplant, wherein said kidney is being perfused in a warm preservation system, said method comprising:
- (1) measuring at least one of the following parameters:
- (a) normalization of a perfusion characteristic for the kidney;
- (b) extent of damage to the vascular endothelium of the kidney;
- (c) level of oxidative capacity of the kidney;
- (d) metabolic capacity of the kidney;
- and
- (e) an organ-specific parameter of organ metabolism and function;
- (2) comparing the value obtained from said measurement with a range of reference values indicative of normal kidney function;
- and
- (3) determining whether or not said value falls within the range of reference values indicative of normal kidney function.
A method for determining the extent of damage to vascular endothelium of a transplantable organ comprising:
- (1) determining at least one of the following parameters:
- (a) degree of platelet adherence to the vascular tissue of the organ;
- (b) degree of platelet release from the vascular tissue of the organ;
- and
- (c) degree of platelet activation in the organ;
- (2) determining the normal values for said parameter;
- and
- (3) comparing values from step (1) and values from step (2).
A method for prospectively identifying primary non-function (PNF) in an organ intended for transplant, wherein said organ is being perfused in a warm preservation system, said method comprising:
- (1) measuring at least one of the following parameters:
- (a) normalization of a perfusion characteristic for the organ;
- (b) extent of damage to the vascular endothelium of the organ;
- (c) level of oxidative capacity of the organ;
- and
- (d) metabolic capacity of the organ;
- (2) comparing the value obtained from said measurement with a range of reference values indicative of normal organ function;
- and
- (3) determining whether or not said value falls within the range of reference values indicative of normal organ function.
Dependencies are inferred from the claim text.