Apparatus and method for maintaining and/or restoring viability of organs

• US 20110059429A1
• Filed: 11/05/2010
• Published: 03/10/2011
• Est. Priority Date: 09/29/1998
• Status: Active Grant

• Current Assignee: Lifeline Scientific, Inc. (Shanghai Genext Medical Technology Co., Ltd.)
• Original Assignee: Lifeline Scientific, Inc. (Shanghai Genext Medical Technology Co., Ltd.)
• Inventors: Kravitz, David C., Schein, Douglas, Burroughs, Andrew, Owen, Donald R., Fraser, Richard, Brassil, John, Harris, Stanley, Steibel, Dennis J., Isaacs, Dickon, Brockbank, Kelvin G.M.
• Granted Patent: US 8,349,551 B2
• Time in Patent Office: Days
• US Class Current: 435/1.2
• CPC Class Codes: A01N 1/02 Preservation of living parts
• CPC Class Codes: A01N 1/0247 for perfusion, i.e. for circulating fluid through organs, blood vessels or other living parts
• CPC Class Codes: A01N 1/0273 Transport containers A01N1/0268 takes precedence
• CPC Class Codes: G06F 16/955 using information identifiers, e.g. uniform resource locators [URL]
• CPC Class Codes: H04L 67/02 based on web technology, e.g. hypertext transfer protocol [HTTP]

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.

Claims

1. A method of controlling operation of a transporter, comprising:

using a set of controls provided on the transporter to select an operation of the transporter; and

displaying the operation selected;

wherein the operation of the transporter is at least one of priming, washing, error handling, perfusing and idle.

2. The method of claim 1, wherein the controls are manually operated.

3. The method of claim 2, wherein the controls include at least one of a button, a knob, a dial, and a wireless receiver.

4. The method of claim 1, wherein the controls are automatically operated.

5. The method of claim 4, wherein automatic operations are controlled by a monitor within the transporter.

6. The method of claim 1, wherein the operation selected is displayed on a control panel.

7. The method of claim 4, wherein the controls are automatically controlled by the passage of time.

8. The method of claim 4, wherein the controls are automatically operated to transition from one of priming, washing, error handling, perfusing and idle to another of priming, washing, error handling, perfusing and idle.

9. The method of claim 8, further comprising automatically monitoring parameters of the transporter to determine the transition to be made.

11. The method of claim 1, wherein selecting a type of flow control includes selecting between aerobic and anaerobic perfusion for each selected perfusion mode.

12. The method of claim 1, wherein selecting one or more types of perfusion modes includes selecting at least one of hypothermic perfusion, normothermic perfusion, and sequential normothermic and hypothermic perfusion.

13. The method of claim 1, wherein selecting one or more types of perfusion modes includes selecting a plurality of medical fluids at different temperatures.

14. The method of claim 1, wherein selecting one or more types of perfusion modes includes selecting at least one of intermittent perfusion, single pass perfusion, and recirculation perfusion.

15. The method of claim 1, wherein selecting a type of flow control includes selecting flow control based on at least one of perfusate flow rate, perfusate pH, organ inlet pressure and timed sequences.

16. The method of claim 1, wherein detecting operating conditions includes detecting pressure, pH, and oxygen levels.

17. The method of claim 1, further comprising controlling temperature of at least one of the perfusate and the organ with a thermal controller.

18. The method of claim 8, wherein controlling the temperature includes regulating temperature of at least one of the organ container and a perfusate reservoir.

19. The method of claim 8, further comprising sensing a temperature of at least one of an organ, an organ container, and a perfusate reservoir and outputting temperature readings to the thermal controller.

20. The method of claim 1, further comprising setting default settings based on organ type for use in the steps of selecting perfusion mode and flow control.

21. The method of claim 1, including controlling perfusion to a plurality of organs.

22. The method of claim 1, wherein inputting organ data includes inputting data relating to organ type and organ mass.

24. The method of claim 14, wherein the sensed fluid characteristics include pH, pO₂, pCO₂, LDH, T/GST, Tprotein and fluorescent tagged copolymer.

25. The method of claim 14, further comprising recording and/or transmitting to a location different from the location of the organ said sensed fluid characteristics to allow monitoring of the organ'"'"'s viability.

10. A method of controlling perfusion of at least one organ with medical fluid, comprising one or more of:

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 and/or making automatic adjustments to regulate viability based on the signal generated by the comparison.

23. A method of perfusing an organ, comprising:

perfusing an organ with a medical fluid;

collecting medical fluid that has passed at least one of into, through and out of 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.

26. A control system for controlling perfusion of at least one organ with a medical fluid to maintain viability of the at least one organ, comprising:

at least one of

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;

and a controller for controlling flow of medical fluid based on the selected perfusion mode and flow control;

at least one detector for detecting operating conditions experienced by at least one of the medical fluid and the 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 and/or automatically regulating viability based on the signal generated by the comparator.