阅读说明：本技术 具有氧生成的器官运送器 (Organ transporter with oxygen generation ) 是由 C·P·斯坦曼 D·克拉维茨 A·R·费伯 R·洛克沃德 R·H·蒙森 E·D·夏普洛 于 2013-07-08 设计创作，主要内容包括：一种用于灌注容器(50)中的器官(20)或组织的设备(10)包括：灌注回路,其用于灌注该器官或组织；氧合器(100),其用于氧合循环通过灌注回路的灌注液；以及氧供应装置(102),其包括氧浓缩器和/或氧发生器并且被构造成将氧供应至氧合器。氧发生器或浓缩器优选地实时制备氧以将氧合提供至灌注液,但也可以被制备和存储。所制备的氧优选地具有比空气中的氧浓度高的浓度。氧发生器可通过分解水来供应氧。氧浓缩器可以是借助于变压吸附或借助于固态氧泵浓缩氧的装置。(An apparatus (10) for perfusing an organ (20) or tissue in a container (50) comprising: a perfusion circuit for perfusing the organ or tissue; an oxygenator (100) for oxygenating a perfusion fluid circulating through the perfusion circuit; and an oxygen supply device (102) comprising an oxygen concentrator and/or an oxygen generator and configured to supply oxygen to the oxygenator. The oxygen generator or concentrator preferably produces oxygen in real time to provide oxygenation to the perfusate, but may also be produced and stored. The produced oxygen preferably has a concentration higher than the oxygen concentration in the air. The oxygen generator may supply oxygen by decomposing water. The oxygen concentrator may be a device that concentrates oxygen by means of pressure swing adsorption or by means of a solid state oxygen pump.)

1. An apparatus for perfusing an organ or tissue, the apparatus comprising:

a perfusion circuit for perfusing the organ or tissue with a liquid perfusate;

an oxygenator for oxygenating perfusate that is recirculated through the perfusion circuit, wherein the perfusate oxygenated by the oxygenator has previously been circulated through a basin for holding an organ or tissue;

an oxygen supply configured to supply oxygen to the oxygenator, the oxygen supply including at least one selected from an oxygen concentrator and an oxygen generator, wherein the oxygen supply is external to and separate from the remainder of the apparatus;

a roller pump configured to circulate the liquid perfusion fluid through the perfusion circuit; and

a coolant container configured to cool the organ or tissue;

wherein the oxygen is not stored in the device.

2. The apparatus of claim 1, wherein the oxygen supply device is an oxygen generator that supplies oxygen by decomposing water.

3. The apparatus according to claim 1, wherein the oxygen supply device is an oxygen concentrator that supplies oxygen by concentrating oxygen by means of pressure swing adsorption.

4. The apparatus of claim 1, wherein the oxygen supply is an oxygen concentrator comprising a solid state oxygen pump.

5. The apparatus of claim 1, wherein the oxygen supply device is configured to supply oxygen by activating an oxygen supply source having a relatively low oxygen concentration and outputting oxygen having a higher concentration relative to the oxygen supply source.

6. The apparatus of claim 5, wherein the oxygen supply device is configured to operate where the oxygen supply source is air.

7. The apparatus of claim 6, wherein the air is compressed air.

8. The apparatus of claim 6, wherein the air is ambient air.

9. The apparatus of claim 5, wherein the oxygen supply is configured to operate where the oxygen supply source is water.

10. The apparatus of claim 5, further comprising a container for storing the oxygen supply.

11. The apparatus of claim 5, further comprising:

a bubble trap disposed within the perfusion circuit downstream of the oxygenator with respect to a direction of perfusion liquid flow.

12. The apparatus of claim 1, wherein the apparatus does not include an oxygen storage device.

13. The apparatus of claim 1, wherein the apparatus is transportable and weighs less than 90 pounds.

14. The apparatus of claim 1, wherein the apparatus is configured to disinfect or prevent contamination of the oxygen supplied by the oxygen supply device.

15. A method of perfusing an organ or tissue using the apparatus of claim 1, the apparatus being a portable organ perfusion apparatus, the method comprising:

producing oxygen from a device comprising at least one selected from an oxygen concentrator and an oxygen generator;

supplying the oxygen to a liquid perfusate to oxygenate the perfusate when the oxygen is being prepared; and

perfusing the organ or tissue with an oxygenated perfusate that has previously been circulated through a basin for holding the organ or tissue,

wherein the concentration of oxygen is higher than the concentration of oxygen in air, and the perfusate is recirculated,

the oxygen is prepared in situ on the portable organ perfusion apparatus, wherein the oxygen is not stored in the portable organ perfusion apparatus.

16. The method of claim 15, wherein the device is an oxygen concentrator and the oxygen is produced from air by pressure swing adsorption.

17. The method of claim 15, wherein the device is an oxygen generator and the oxygen is produced from water.

18. The method of claim 15, wherein the device is an oxygen concentrator and the oxygen is prepared from air by means of a solid state oxygen pump.

19. The method of claim 15, wherein the oxygen is produced by starting an oxygen supply source having a relatively low oxygen concentration and outputting the oxygen having a higher concentration relative to the oxygen supply source.

20. The method of claim 19, wherein the oxygen supply source is air.

21. The method of claim 20, wherein the air is compressed air.

22. The method of claim 20, wherein the air is drawn from the ambient atmosphere.

23. The method of claim 15, wherein the oxygen is produced from water.

24. The method of claim 15, wherein the oxygen is disinfected or purified.

25. A method of perfusing an organ or tissue using the apparatus of claim 1, the apparatus being a transportable perfusion apparatus, the method comprising:

producing oxygen by a process comprising at least one selected from pressure swing adsorption, water splitting, and pumping oxygen by means of a solid state oxygen pump;

supplying the prepared oxygen to a liquid perfusate to oxygenate the perfusate;

perfusing the organ or tissue with an oxygenated perfusate that has previously been circulated through a basin for holding the organ or tissue; and

recirculating the perfusate;

the process is carried out using the transportable perfusion apparatus, wherein the oxygen is not stored in the transportable perfusion apparatus.

26. The method of claim 25, wherein the oxygen is supplied as the oxygen is produced.

27. A method of perfusing an organ or tissue using the apparatus of claim 1, the apparatus being a portable perfusion apparatus, the method comprising:

preparing oxygen in situ on the portable perfusion apparatus;

oxygenating a liquid perfusion fluid in the portable perfusion apparatus with the prepared oxygen;

perfusing an organ or tissue with an oxygenated perfusate that has previously been circulated through a basin for holding the organ or tissue; and

recirculating the perfusate;

wherein the oxygen is not stored in the portable perfusion apparatus.

28. The method of claim 27, wherein the oxygen is produced by a process comprising at least one selected from pressure swing adsorption, water splitting, and pumping oxygen by means of a solid state oxygen pump.

Technical Field

Related art areas include organ and tissue perfusion apparatuses that are capable of maintaining and/or restoring the viability of an organ or tissue and preserving the organ or tissue for diagnosis, treatment, storage, and/or transport.

Background

For convenience, as used herein, the term "organ" should be understood to mean an organ and/or tissue, unless otherwise indicated.

The goal of organ perfusion apparatus is to simulate the conditions of the human body such that the organ remains viable prior to use in research, diagnosis, treatment or transplantation. Many times, organs need to be stored and/or transported between facilities. The goal of maintaining and restoring organs during perfusion is to reduce ischemia and reperfusion injury. The increased storage period in normal or near normal functional states also provides certain advantages, for example, the organ can be transported a greater distance and there is increased time for testing, processing and evaluation of the organ.

In maintaining an organ in a near ideal environmental and physiological state, it is known to provide an oxygenated perfusate to the organ. U.S. patent No.6,673,594, which is incorporated herein by reference in its entirety and in which the present invention may be used, discloses, for example, a configuration in which an organ is provided with a perfusate that is oxygenated by means of gaseous oxygen provided to an oxygenation membrane.

Disclosure of Invention

When an organ or tissue is harvested, it may be beneficial to perfuse the organ with an oxygenated perfusate, which may preferably be a liquid perfusate. While the perfusate may be pre-oxygenated, as the organ uses oxygen from the perfusate, the perfusate may require additional oxygen during the perfusion process. It is therefore desirable to provide a perfusion apparatus that can supply oxygen to the perfusion fluid so that the perfusion fluid can be oxygenated during perfusion. However, pre-stored oxygen has disadvantages. For example, pressurized and liquefied oxygen carries a serious flammability risk, which may require considerable design effort to provide adequate safety. Furthermore, considerable logistical effort is required to provide and maintain an adequate supply of compressed or liquefied oxygen to the point of use of the perfusion apparatus. Compressed or liquefied oxygen requires a heavy vessel that must be disconnected when the vessel is emptied. Prolonged oxygenation of the perfusate may require a large container or multiple small containers. In addition, switching containers provides the opportunity to contaminate the device and/or compromise the sterility of the device. Thus, disclosed herein is a perfusion apparatus that provides oxygen prepared in real time to an oxygenated perfusion fluid. Organ perfusion apparatuses capable of preparing oxygen to oxygenate perfusate avoid the hazards of high pressure or liquefied oxygen and also avoid logistical difficulties associated with pre-stored oxygen.

Drawings

Fig. 1 is a schematic view of an organ perfusion apparatus.

Detailed Description

According to an exemplary implementation, a device is provided for preparing oxygen, oxygenating a perfusate using oxygen, and perfusing an organ with the oxygenated perfusate, preferably in real time. The apparatus may include: a perfusion circuit for perfusing an organ or tissue; an oxygenator for oxygenating the perfusion fluid recirculated through the perfusion circuit; and an oxygen supply configured to supply oxygen to the oxygenator. Preferably, the oxygen supply means is at least one selected from an oxygen concentrator and an oxygen generator. As discussed herein, the term "oxygen concentrator" refers to a device that uses a source comprising molecular oxygen and increases the concentration of oxygen relative to the source; and the term "oxygen generator" refers to a device that uses a source other than molecular oxygen to produce oxygen from the source.

One example of an oxygen generator is a device that generates oxygen by decomposing water. Water may be decomposed by applying an electric charge to the water to decompose water molecules into hydrogen and oxygen molecules. Another example of an oxygen generator (which may also be considered to be decomposing water) is an electrochemical device that utilizes a proton exchange membrane to generate oxygen from water, such as disclosed in U.S. patent application publication No.2010/0330547 to Tempelman et al, which is incorporated herein by reference in its entirety. One example of an oxygen concentrator is a device that concentrates oxygen by means of pressure swing adsorption. One example of pressure swing adsorption involves passing pressurized air through an adsorbent material, such as a zeolite or similar molecular sieve, which selectively adsorbs nitrogen while allowing oxygen and argon to pass through the adsorbent material, resulting in a product with an increased oxygen concentration. As another alternative, the oxygen concentrator may be supplied with oxygen by means of a solid state oxygen pump. As used herein, a "solid state oxygen pump" refers to a device that passes only oxygen through a ceramic or similar material by applying an electrical potential that separates oxygen molecules into two oxygen ions, drives the ions across the ceramic, and allows the ions to recombine into oxygen molecules. Thus, oxygen can be extracted from the air, thereby increasing the oxygen concentration. This process drives the ceramic oxygen sensor substantially in reverse.

Oxygen concentrators such as pressure swing adsorption units and solid state oxygen pumps may use oxygen as an input; the air may be stored, compressed, and/or drawn from the surrounding atmosphere prior to use. The apparatus may or may not include a container for storing a source for generating or concentrating oxygen. For example, the apparatus may include a container for storing air, such as a pressurized air tank. Similarly, a water tank may be provided for an oxygen generator that breaks down water.

An exemplary implementation may include a method of perfusing an organ or tissue. Such a method may include: producing oxygen using at least one device selected from an oxygen concentrator and an oxygen generator; supplying the prepared oxygen to the perfusate to oxygenate the perfusate, preferably while the oxygen is being prepared; and perfusing the organ or tissue with the oxygenated perfusate. Preferably, the oxygen is produced at a concentration higher than the oxygen concentration in the air. Any of the devices discussed above or other devices may be used in the exemplary implementations.

Fig. 1 is a schematic diagram of an exemplary perfusion apparatus 10 for an organ 20. The organ 20 may preferably be a liver, kidney, heart, lung or intestine, but may be any human or animal, natural or engineered, healthy, injured or diseased organ or tissue. The apparatus comprises a basin 30 in which an organ can be placed. The basin 30 may hold a cradle on which the organ 20 is disposed when the organ 20 is in the apparatus 10. The basin 30 may include a first filter 33, which may act as a coarse particle filter. The basin 30 and/or cradle are preferably configured to allow a perfusate bath to be formed around the organ 20. The basin 30 or apparatus 10 may also include a temperature sensor 40 located or focused in or near the cradle. The basin 30 or apparatus 10 may include a plurality of temperature sensors 40, which may provide redundancy in the event of a failure and/or may provide temperature measurements at multiple locations. Preferably, the temperature sensor(s) 40 are infrared temperature sensors. When the organ 20 is disposed in the cradle, the temperature sensor(s) 40 are preferably disposed as close as possible to the organ 20 in order to improve the usefulness and accuracy of the temperature sensors 40, the temperature sensors 40 preferably providing temperature measurements of the perfusate, which may be correlated to the temperature of the organ 20. Alternatively or additionally, temperature sensor(s) 40 may be used to directly measure the temperature of organ 20.

The basin 30 is preferably disposed within a recess of an insulated coolant container 50, the coolant container 50 being capable of holding a cold material such as ice, ice water, brine, etc. The coolant container 50 may be permanently or removably attached to the apparatus 10 or may be an integral, integral part of the apparatus 10. Thus, in use, the organ 20 is disposed in a cradle disposed in the basin 30, the basin 30 being disposed in the coolant container 50. The configuration of the coolant container 50, the basin 30 and the bracket preferably provides a configuration that: which provides cooling to the organ 20 without requiring the contents of the coolant container 50 to contact the organ 20 or the cradle. Although coolant container 50 is described herein as containing ice or frozen water, any suitable cooling medium may be used. Ice or ice water may be preferred as ice is readily available, but it will be appreciated by the skilled person that any suitable cooling medium may be employed, which may be an active cooling medium (e.g. a thermoelectric cooler or a refrigerant circuit) or a passive cooling medium similar to ice or ice water or a combination thereof. The amount of ice or other cooling medium that can be placed within the coolant container 50 should be determined based on the maximum time that cooling will be provided while the organ 20 will be in the apparatus 10.

The cradle may include components configured to fixedly hold the organ 20 in place. Such means may for example comprise a user selectable netting secured to the bracket. The user-selectable netting holds the organ 20 in place while the organ 20 is manipulated or moved. For example, the organ may be held in place with a netting on a cradle while being manipulated (e.g., vasculature trimmed, cannula attached, etc.) prior to being placed in the basin or perfusion apparatus. Similarly, when the organ 20 is moved with the cradle into the basin 30, when the basin 30 is moved into the coolant container 50, and when the apparatus 10 itself is moved during transport, the organ may be held in place.

In the exemplary perfusion apparatus 10 of fig. 1, after passing through the filter 33, the perfusion fluid flows along a first flow path 70, the first flow path 70 including a suitable fluid conduit 72, such as flexible or rigid tubing, a pump 80, a pressure sensor 90, a second filter 34, an oxygenator 100, and a bubble trap 110, each of which is discussed below. In conjunction with one or both of the door flow path 120 and the liver flow path 130 (discussed below), the first flow path 70 may form a recirculated perfusate flow path that provides perfusate to the organ 20 and then recirculates the perfusate.

The first filter 33 is preferably a relatively coarse filter (as opposed to the second filter 34). Such a coarse filter may provide a fluid path for preventing large particles, which may be, for example, by-products of an organ or of an organ removed from a donor, from entering and clogging the apparatus 10. The first filter 33 may be an integral part of the basin 30, or the first filter may be disposed elsewhere in the first flow path 70 downstream of the basin 30. For example, the first filter 33 may also be a separate component from the basin 30 or disposed within the fluid conduit 72.

The first flow path 70 may also include a pump 80. The pump 80 may be any pump suitable in connection with perfusion of an organ. Examples of suitable pumps may include manually operated pumps, centrifugal pumps, and roller compaction pumps. If a roller compaction pump is included, the roller compaction pump may comprise a single channel or flow path (where only one tube is compressed by a roller), or the roller compaction pump may comprise a plurality of parallel channels or flow paths (where a plurality of tubes are compressed by a roller). If multiple parallel channels or flow paths are included, the rollers may preferably be arranged out of phase or offset so that the pulses produced by the rollers are out of phase, which may result in a relatively less pulsating fluid flow from the roller compaction pump than would be the case with a single roller. Such multi-channel roller compaction pumps may achieve a constant flow rate or a flow rate with few pulsations, which may be advantageous depending on the type of other components in the flow path and/or the organ being perfused.

The flow path 70 may include a pressure sensor 90. The pressure sensor 90 may preferably be arranged after the outlet of the pump 80 in order to monitor and/or to control the pressure generated at the outlet of the pump by means of a suitable controller 400. The pressure sensor 90 may provide continuous or periodic pressure monitoring.

The flow path 70 may include an oxygenator 100, such as an oxygenator membrane or body, to provide oxygenation to the perfusate. Oxygen may be provided by means of an oxygen generator or oxygen concentrator 102 as shown in fig. 1, which oxygen generator or oxygen concentrator 102 may be separate from the apparatus 10 or integrated into the apparatus 10. For example, the oxygen generator or concentrator 102 may be contained within the apparatus 10, or the oxygen generator or concentrator 102 may be an external device that is connectable to the apparatus to supply oxygen to the apparatus. Oxygen may be generated by any suitable means, some examples of which include pressure swing adsorption by using molecular sieves (e.g., zeolites), by a ceramic oxygen generator (solid state oxygen pump), or by the decomposition of water. Each of the oxygen generators or concentrators 102 discussed above may be adapted to be separate from or integrated with the apparatus 10; however, some devices may be more advantageously adapted for integration or separation. For example, electrochemical oxygen generators can be relatively compact (on the order of a few cubic inches including a water reservoir) and are therefore well suited to being integrated; pressure swing adsorption units, in turn, can be relatively large (due to the size of the adsorbent material vessel and the need for a source of pressurized air, such as a compressor), and are therefore well suited for separations.

The oxygen generator or concentrator 102 preferably produces oxygen in real time to provide oxygenation to the perfusate, but oxygen may also be produced and stored for shorter or longer periods of time depending on the oxygen consumption requirements and the technique selected for producing oxygen. The oxygen generator or concentrator 102 may produce oxygen continuously or non-continuously depending on the requirements of the oxygenated perfusate and/or the type of device used to produce oxygen. The apparatus 10 may be configured such that: there is no oxygen storage for oxygen produced from the oxygen generator or concentrator 102, other than for any residual oxygen contained within the tubing or conduit(s) from the outlet of the oxygen generator or concentrator 102 to the oxygenator 100. In other words, it may be preferred that the device 10 not include any structure specifically configured for oxygen storage. The apparatus 10 may include a device, such as a microbial filter, to ensure the sterility of, or otherwise prevent contamination of, the oxygen supplied to the oxygenator. Preferably, such means are located between the oxygen generator or concentrator 102 and the oxygenator 100, but may also be upstream of the oxygen generator or concentrator 102 or at both locations. Preferably, any means for ensuring the sterility of the oxygen supply or otherwise preventing contamination thereof is a disposable component. As will be appreciated by those of ordinary skill, any suitable means for ensuring the sterility of oxygen or otherwise preventing contamination thereof may be provided in place of the microbial filter.

The flow path 70 may include a bubble trap 110. The bubble trap 110 preferably separates bubbles that may be entrained in the perfusate flow and prevents such bubbles from proceeding downstream and into the organ 20. The bubble trap 110 may also act as an accumulator that reduces or eliminates pulsatility of the flow of perfusion fluid. The bubble trap 110 may initially or through the accumulation of bubbles include a volume of gas such that pressure fluctuations in the perfusate are dampened or eliminated.

The bubble trap 110 may include a vent that allows for purging of gas during a start-up or purge process. The vent may be connected to the purge flow path 140 (which is discussed in detail below) or be part of the purge flow path 140. The vent is preferably opened during the start-up process so that any air or other gas can be purged from the perfusate path 70. Once gas is purged from the perfusate path 70, the vent may preferably be closed. The vent may be closed manually or may be closed automatically by means of a suitable controller 400.

The bubble trap 110 may include a level sensor 112. The level sensor 112 may optionally be used during the purge process to determine when the purge is complete and/or may be used to determine when the purge process needs to be repeated, which may occur after bubbles have been trapped in the bubble trap 110. Additionally, by using the liquid level sensor 112 and the vent, the accumulator function of the bubble trap may be tuned to account for different amplitudes and frequencies of pulsations in the perfusate flow.

The bubble trap 110 may have any number of outlets as desired for a given application of the perfusion apparatus. In fig. 1, the three outlets are shown as being connected to three different flow paths, which may be particularly suitable for perfusion of the liver. When perfusing the liver, the three paths preferably include a portal flow path 120 connected to the portal vein of the liver, a hepatic flow path 130 connected to the hepatic artery of the liver, and a bypass flow path 140 providing a return path to the basin 30. There may also be ports in any flow path that allow fluid to enter the perfusate solution. The port may preferably be located in the bubble trap 110. The port may preferably include a luer type fitting so that a user may extract a small sample of the perfusate for analysis. The port may also be used by a user to apply a substance to the perfusate without opening the basin. While fig. 1 shows a single oxygenator 100 and a single bubble trap 110, one of ordinary skill will appreciate that more than one oxygenator 100 and/or bubble trap 110 may be provided. For example, an oxygenator 100 and a bubble trap 110 may be provided for each of the portal flow path 120 and the hepatic flow path 130. Such a configuration may allow for different levels of oxygenation in each of the portal flow path 120 and the hepatic flow path 130. A single oxygen concentrator or generator 102 may provide oxygen to both the portal flow path 120 and the hepatic flow path 130, or separate oxygen concentrators or generators 102 may be provided for each flow path. If a single oxygen concentrator or generator 102 provides oxygen to both flow paths, suitable valves, such as on-off valves and/or pressure regulators, may control the oxygen supplied to each flow path to be different.

As shown in fig. 1, the portal flow path 120 and the hepatic flow path 130 can optionally include similar or different components, e.g., valves 122, 132; bubble sensors 124, 134; flow sensors 126, 136; flow control clamps 127, 137; and pressure sensors 128, 138. Each similar component may function in a similar manner, and such paired components may optionally be structurally and/or functionally identical to reduce manufacturing costs. The flow sensors 126, 136 may preferably be ultrasonic sensors disposed about the tubing, but any suitable sensor may be used. Ultrasonic sensors may be advantageous because in normal use, such sensors do not contact the perfusate and are therefore not in the sterile path. Such an implementation of the ultrasonic sensor does not require replacement and/or cleaning after use.

Valves 122, 132 may be pinch valves used to pinch tubing and reduce or shut off flow, but any suitable valve may be used. Pinch valves may be advantageous because in normal use they do not contact the perfusate and therefore do not need to be replaced and/or cleaned after use.

Preferably, the bubble sensors 124, 134 are ultrasonic sensors disposed about the tubing, but any suitable sensor may be used. Similar to pinch valves, ultrasonic sensors may be advantageous because in normal use they do not contact the perfusion fluid and therefore do not need to be replaced and/or cleaned after use. Rather, the ultrasonic sensor may be disposed in contact with, adjacent to, or around the outer surface of the tubing in order to sense the gas bubbles.

The flow control clamps 127, 137 may be used to fine tune the flow in one or both of the portal flow path 120 and the hepatic flow path 130. Preferably, the organ provides self-regulation to control the amount of flow that exits the bubble trap 110 and is divided between the portal flow path 120 and the hepatic flow path 130. In such self-regulated flow, the pressure sensors 128, 138 provide overpressure monitoring. In the event that the pressure delivered to the organ in either or both of portal flow path 120 or hepatic flow path 130 exceeds a predetermined threshold, apparatus 10 can automatically stop and/or reduce the flow provided by pump 80 to prevent damage to the organ. Additionally or alternatively, the pressure sensors 128, 138 may be used to generate an alarm signal for a user and/or a suitable controller when the pressure approaches a predetermined threshold.

After exiting one or both of the portal flow path 120 and the hepatic flow path 130, the perfusate flows through the organ and returns to the basin 30 to form an organ bath.

The bypass flow path 140 may include a valve 142, and/or sensors such as an oxygen sensor 144 and a pH sensor 146. Preferably, valve 142 is a pinch valve and may have a similar configuration as valves 122 and 132, although any suitable valve may be used. The oxygen sensor 144 and the pH sensor 146 may be used to determine the status of the perfusate. Preferably, the bypass flow path 146 is used only during the purging or priming process, but it may also be used during priming, preferably continuously, to monitor perfusate properties in real time.

Organ perfusion apparatus 10 may also include an accelerometer 150. Preferably, accelerometer 150 is a three-axis accelerometer, but multiple single-axis accelerometers may be used to the same effect. Accelerometer 150 may be used to continuously or periodically monitor and/or record the status of device 10. Monitoring may include monitoring excessive shock and attitude of the device 10. By implementing such monitoring, misuse or potentially inappropriate conditions of the device 10 can be detected and recorded.

The device 10 may include a storage compartment for items other than the organ 20. For example, the device 10 may include a document compartment to store documents and/or charts relating to the organ 20. In addition, the apparatus 10 may include one or more sample compartments. The sample compartment may be configured to store a fluid and/or tissue sample, for example. The sample compartment may advantageously be provided adjacent to the coolant container 50 to provide cooling, which may be similar or identical to the cooling provided for the organ 20.

The apparatus 10 may include one or more tamper evident closures. The tamper evident closure may be used to indicate to a user that the device 10 has been opened at an unauthorized time and/or location and/or by an unauthorized person. The evidence of tampering may prompt the user to perform additional testing, screening, etc. prior to use of the organ 20 and/or the apparatus 10.

The organ transporter is preferably portable to carry organs or tissues from one location to another, and is sized to be carried by one or two persons and loaded into an automobile or small airplane. Perfusion apparatus 10 may preferably be an organ transporter designed to be portable, for example, having dimensions less than 42 inches in length by 18 inches in width by 14 inches in height, and a weight of less than 90 pounds, including the weight of the entire loaded system (e.g., transporter, disposable, organ, ice, and 3 liters of perfusate solution).

Preferred embodiments of the present invention and some variations have been described and shown herein. The terms, descriptions and figures used herein are set forth by way of illustration only and are not meant as limitations. Those skilled in the art will recognize that many variations are possible within the spirit and scope of the invention.