Apparatus and method for maintaining and/or restoring viability of organs
First Claim
1. A method of maintaining and/or restoring the viability of at least one organ subjected to a period of ischemia, comprising:
- perfusing said at least one organ with a first medical fluid at a first temperature to at least one of maintain and restore pre-ischemia ATP and enzyme levels in the organ, wherein the first medical fluid contains oxygen in an amount effective to cause the organ'"'"'s mitochondria to at least one of maintain and restore pre-ischemia ATP levels in the organ.
1 Assignment
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. In perfusion, organ perfusion pressure is preferably controlled in response to a sensor disposed in an end of tubing placed in the organ, by a pneumatically pressurized medical fluid reservoir, providing perfusion pressure fine tuning, overpressurization prevention and emergency flow cut-off. In the hypothermic mode, the organ is perfused with a medical fluid, preferably a simple crystalloid solution containing antioxidants, intermittently or in slow continuous flow. The medical fluid may be fed into the organ from an intermediary tank having a low pressure head to avoid organ overpressurization. Preventing overpressurization prevents or reduces damage to vascular endothelial lining and to organ tissue in general. Viability of the organ may be automatically monitored, preferably by monitoring characteristics of the medical fluid perfusate. The perfusion process can be automatically controlled using a control program.
-
Citations
224 Claims
-
1. A method of maintaining and/or restoring the viability of at least one organ subjected to a period of ischemia, comprising:
perfusing said at least one organ with a first medical fluid at a first temperature to at least one of maintain and restore pre-ischemia ATP and enzyme levels in the organ, wherein the first medical fluid contains oxygen in an amount effective to cause the organ'"'"'s mitochondria to at least one of maintain and restore pre-ischemia ATP levels in the organ. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43)
-
44. A method of at least one of maintaining and restoring the viability of at least one organ subjected to a period of ischemia, comprising:
-
perfusing said at least one organ with a first medical fluid at a first temperature to at least one of maintain and restore pre-ischemia energy levels in the organ; and
perfusing the organ with a second medical fluid at a second lower temperature to at least one of store and transport the organ. - View Dependent Claims (45, 46, 47, 48)
-
-
49. A method of perfusing an organ, comprising:
perfusing said organ utilizing at least one medical fluid reservoir in communication with a pressure source and a fluid pathway connected to the reservoir and connectable to the organ, wherein the reservoir and pathway are configured to perfuse the organ at a perfusion pressure controlled at least in part by varying the pressure provided to the reservoir by the pressure source, wherein the reservoir is a flexible container and the pressure source comprises a cuff disposed around the container. - View Dependent Claims (50)
-
51. A method of perfusing an organ, comprising:
perfusing an organ utilizing at least one medical fluid reservoir, a fluid pathway connected to the reservoir and connectable to the organ and a stepper motor-activated cam valve disposed on the fluid pathway, wherein the perfusion pressure is controlled at least in part by the stepper motor-activated cam valve.
-
52. A method of perfusing an organ, comprising:
perfusing an organ utilizing at least one medical fluid reservoir in communication with a gravity pressure head tank and a fluid pathway connected to the pressure head tank and to the organ, wherein the pressure head tank and pathway are configured to perfuse the organ at a perfusion pressure controlled at least in part by the gravity pressure head.
-
53. A method of perfusing an organ, comprising:
-
perfusing an organ with a medical fluid;
collecting medical fluid that has passed through the organ;
passing the collected medical fluid through a sensor that senses fluid characteristics indicative of organ viability; and
determining whether an organ remains viable based on said sensed fluid characteristics. - View Dependent Claims (54, 55)
-
-
56. A method of transporting and storing an organ, comprising, in sequence:
-
a. perfusing said organ at a normothermic temperature to repair damage from warm ischemia;
b. perfusing said organ at a hypothermic temperature;
c. at least one of transporting and storing said organ at a hypothermic temperature; and
d. perfusing said organ at a normothermic temperature to repair damage from the hypothermic transport or storage of step c. - View Dependent Claims (57, 58, 59, 60, 61, 62, 63, 64)
-
-
65. Apparatus for perfusing at least one organ, comprising:
-
at least one flexible medical fluid reservoir;
a pressure cuff disposed around the at least one flexible medical fluid reservoir; and
a fluid pathway connected to the reservoir and connectable to the organ, wherein the organ perfusion pressure is controlled at least in part by varying the pressure provided by the pressure cuff. - View Dependent Claims (66, 67, 68, 69)
-
-
70. Apparatus for perfusing at least one organ, comprising:
-
at least one medical fluid reservoir;
a fluid pathway connected to the reservoir and connectable to the organ; and
a stepper motor-activated cam valve disposed on the fluid pathway, wherein the organ perfusion pressure is controlled at least in part by the stepper motor-activated cam valve. - View Dependent Claims (71)
-
-
72. Apparatus for perfusing at least one organ, comprising:
-
at least one medical fluid reservoir;
a gravity pressure head tank in fluid communication with the at least one medical fluid reservoir; and
a fluid pathway connected to the pressure head tank and connectable to the organ, wherein the organ perfusion pressure is controlled at least in part by the gravity pressure head.
-
-
73. Apparatus for perfusing at least one organ, comprising:
-
at least one medical fluid reservoir;
a fluid pathway connected to the reservoir and connectable to the organ;
a first heat exchanger in heat exchange communication with the medical fluid reservoir; and
a controller for controlling the first heat exchanger to allow perfusion of the organ with medical fluid at both normothermic and hypothermic temperatures. - View Dependent Claims (74, 75)
-
-
76. Apparatus for holding an organ for at least one of perfusion, storage and transport of the organ, comprising:
-
a portable housing;
an organ supporting surface configured to support an organ while allowing effluent medical fluid to pass therethrough, wherein the portable housing is configured to be received by an organ perfusion device and includes openings configured to allow tubing to pass therethrough and be connected to the organ. - View Dependent Claims (77, 78, 79, 80, 81)
-
-
82. Apparatus for holding an organ for at least one of perfusion, storage and transport of the organ, comprising:
-
a portable housing;
an organ supporting surface;
tubing connectable to the organ to allow perfusion of the organ; and
at least one connection device configured to allow connection of the tubing to tubing of an organ perfusion device. - View Dependent Claims (83, 84, 85)
-
- 86. A perfusion solution kit, comprising a saleable package containing at least one first container holding a first perfusion solution for normothermic perfusion and at least one second container holding a second, different perfusion solution for hypothermic perfusion.
-
98. A control system for controlling perfusion to at least one organ with a medical fluid to maintain viability of the at least one organ, comprising:
-
an input for inputting organ data;
a perfusion selector for selecting one or more types of perfusion modes;
a flow control selector for selecting a type of flow control for each selected perfusion mode;
a controller for controlling flow of the medical fluid based on the selected perfusion mode and flow control;
at least one detector for detecting operating conditions experienced by the medical fluid and organ during perfusion;
a comparator for comparing detected operating conditions with prestored operating conditions and generating a signal indicative of organ viability based on the comparison; and
an indicator for generating a message relating to organ viability based on the signal generated by the comparator. - View Dependent Claims (99, 100, 101, 102, 103, 104, 105, 106, 107, 108, 109, 110)
-
-
111. A method of controlling perfusion of at least one organ with medical fluid, comprising:
-
inputting organ data;
selecting one or more types of perfusion modes;
selecting a type of flow control for each selected perfusion mode;
controlling flow of the medical fluid based on the selected perfusion mode and flow control;
detecting operating conditions experienced by the medical fluid and organ during perfusion;
comparing detected operating conditions with prestored operating conditions and generating a signal indicative of organ viability based on the comparison; and
generating a message relating to organ viability based on the signal generated by the comparator. - View Dependent Claims (112, 113, 114, 115, 116, 117, 118, 119, 120, 121, 122, 123)
-
-
124. A recording medium that stores a control program for use by perfusion system that perfuses at least one organ with a medical fluid, the control program including instructions for:
-
inputting organ data;
selecting one or more types of perfusion modes;
selecting a type of flow control for each selected perfusion mode;
controlling flow of the medical fluid based on the selected perfusion mode and flow control;
detecting operating conditions experienced by the medical fluid and organ during perfusion;
comparing detected operating conditions with prestored operating conditions and generating a signal indicative of organ viability based on the comparison; and
generating a message relating to organ viability based on the signal generated by the comparator. - View Dependent Claims (125, 126, 127, 128, 129, 130, 131, 132, 133, 134, 135, 136)
-
-
137. A method of at least one of maintaining and restoring the viability of at least one organ subjected to a period of ischemia or hypoxia, comprising:
at least one of perfusing and flushing said at least one organ with a first medical fluid at a first hypothermic temperature to reduce or stop catabolic changes. - View Dependent Claims (138, 139, 140, 141, 142, 143, 144, 145, 146, 147, 148, 149, 150, 151, 152, 153, 154, 155, 156, 157, 158, 159, 160, 161, 162, 163, 164, 165, 166, 167, 168, 169, 170, 171, 172, 173, 174, 175, 176, 177, 178, 179, 180, 181, 182, 183, 184, 185, 186, 187)
-
188. A method of at least one of maintaining and restoring the viability of at least one organ subjected to a period of ischemia or hypoxia, comprising:
-
perfusing said at least one organ with a first medical fluid at a first temperature to reduce or stop catabolic changes in the organ; and
perfusing the organ with a second medical fluid at a second temperature to at least one of store and transport the organ. - View Dependent Claims (189, 190, 191, 192)
-
-
193. A method of perfusing an organ, comprising:
perfusing said organ utilizing at least one medical fluid reservoir in communication with a pressure source and a fluid pathway connected to the reservoir and connectable to the organ, wherein the reservoir and pathway are configured to perfuse the organ at a perfusion pressure controlled at least in part by varying the pressure provided to the reservoir by the pressure source, wherein the reservoir is a flexible container and the pressure source comprises a cuff disposed around the container. - View Dependent Claims (194)
-
195. A method of perfusing an organ, comprising:
perfusing an organ utilizing at least one medical fluid reservoir, a fluid pathway connected to the reservoir and connectable to the organ and a variable valve disposed on the fluid pathway, wherein the perfusion pressure is controlled at least in part by the variable valve. - View Dependent Claims (196)
-
197. A method of perfusing an organ, comprising:
perfusing an organ utilizing at least one medical fluid reservoir in communication with a pressure head tank and a fluid pathway connected to the pressure head tank and to the organ, wherein the pressure head tank and pathway are configured to perfuse the organ at a perfusion pressure controlled at least in part by the pressure head.
-
198. A method of perfusing an organ, comprising:
-
perfusing an organ with a medical fluid;
collecting medical fluid that has passed through the organ;
passing the collected medical fluid through a sensor that senses fluid characteristics indicative of organ viability; and
determining whether an organ remains viable based on said sensed fluid characteristics. - View Dependent Claims (199, 200)
-
-
201. A method of transporting and storing an organ, comprising, in sequence:
-
a. perfusing said organ at a mild hypothermic temperature to repair damage from warm ischemia;
b. perfusing said organ at a hypothermic temperature, such as a temperature less than said mild hypothermic temperature of said step a;
c. at least one of transporting and storing said organ at a mild hypothermic temperature, such as a temperature greater than said hypothermic temperature of said step b; and
d. perfusing said organ at a mild hypothermic temperature to repair damage from the hypothermic transport or storage of step c. - View Dependent Claims (202, 203, 204, 205, 206, 207, 208, 209)
-
-
210. Apparatus for perfusing at least one organ, comprising:
-
at least one medical fluid reservoir;
a fluid pathway connected to the reservoir and connectable to the organ;
a first heat exchanger in heat exchange communication with the medical fluid reservoir; and
a controller for controlling the first heat exchanger to allow perfusion of the organ with medical fluid at a first hypothermic temperature and a second hypothermic temperature lower than said first hypothermic temperature.
-
- 211. A perfusion solution kit, comprising a saleable package containing at least one first container holding a first perfusion solution for hypothermic perfusion at a first temperature and at least one second container holding a second, different perfusion solution for hypothermic perfusion at a second temperature lower than said first temperature.
-
223. A control system for controlling perfusion to at least one organ with a medical fluid to maintain viability of the at least one organ, comprising:
-
an input for inputting organ data;
a perfusion selector for selecting one or more types of perfusion modes;
a control selector for selecting a type of control for each selected perfusion mode;
a controller for controlling flow of the medical fluid based on the selected perfusion mode and flow control;
at least one detector for detecting operating conditions experienced by the medical fluid and organ during perfusion;
a comparator for comparing detected operating conditions with prestored operating conditions and generating a signal indicative of organ viability based on the comparison; and
an indicator for generating a message relating to organ viability based on the signal generated by the comparator.
-
-
224. All methods, apparatus and products, and sub-steps and sub-portions thereof, individually and in combination, as shown and/or described herein.
Specification