• 专利附录
  • 专利说明
  • 权利要求
  • 类似技术
  • 同族专利
  • 引用文献
  • 法律状态
  • 优先权
    • 专利摘要:
    perfusion system to perfuse into an organ. an perfusion system for passing liquid through an organ comprises: a perfusion fluid circuit arranged to circulate perfusion fluid through the organ; a substitute organ arranged to be connected to the circuit in place of the organ so that the circuit can circulate fluid through the substitute organ; and organ detection means arranged to distinguish between the presence of the organ in the circuit and the presence of the substitute organ in the circuit. the sensing means may comprise one or more pressure sensors.
    公开号:BR112014011356B1
    申请号:R112014011356-4
    申请日:2012-11-08
    公开日:2021-06-15
    发明作者:Stuart Brian William Kay；Sebastien Antoine Yves Cuvelier；Jonathan Richard Oakley；Peter John Friend；Leslie James Russel；Constantin-C Coussios；David George Robinson；Philip David Canner；Peter Alan Salkus
    申请人:Organox Limited；
    IPC主号:
    专利说明:

    FIELD OF THE INVENTION
    [001] The present invention relates to perfusion systems for bodily organs, in particular human organs, such as liver, pancreas, kidney, small intestine, but also other organs including non-human organs. BACKGROUND OF THE INVENTION
    [002] It is known, for example, from EP 1 168 913 to provide a system for extracorporeal organ perfusion in which a human or non-human organ can be preserved, for example, prior to transplantation into a patient. The system typically comprises a reservoir for perfusion fluid, which may be blood or another perfusion solution, and a circuit for circulating the fluid through the organ. SUMMARY OF THE INVENTION
    [003] The present invention provides a perfusion system for perfusing an organ, the system comprising a perfusion fluid circuit for circulating perfusion fluid through the organ, adjusting device for adjusting the content of at least one component in the fluid, measuring device for measuring the content of said at least one component in the perfusion fluid, and control device arranged for controlling the adjustment device. For example, the control device can be arranged to control the adjustment device in order to keep said measured content within a target range. In some cases this may be above a minimum target level, or below a minimum target level, or between upper and lower target limits.
    [004] The content can be a relative content or a proportion, for example it can be a percentage, and it can be measured by mass, or by volume, or by mole percent.
    [005] The at least one component can be at least one of: oxygen; carbon dioxide; and a nutrient such as glucose.
    [006] Where the at least one component comprises oxygen, the adjustment device may comprise oxygen addition device arranged to add oxygen to the fluid. For example, it might comprise an oxygenator.
    [007] Where the at least one component comprises carbon dioxide, the adjustment device may comprise carbon dioxide extraction device arranged to extract carbon dioxide from the fluid. This can be arranged to supply air, or another gas, which can absorb or extract carbon dioxide from the fluid. This function can be performed by an oxygenator that also delivers oxygen, or it can be performed by a separate device or system.
    [008] The at least one component may comprise at least one of, or both of: oxygen and carbon dioxide, in which case the system may further comprise nutrient measuring device arranged to measure the content of at least one nutrient in the fluid . The system may comprise a nutrient supply. The system may comprise a nutrient addition device arranged to add the nutrient to the fluid, for example, from supply. The control device can be arranged to control the nutrient addition device to add the nutrient if the nutrient content falls below a target range.
    [009] The system may comprise a thermometer arranged to measure the temperature of the fluid. The system may comprise thermal adjustment device arranged to adjust the temperature of the fluid. The control device can be arranged to control the thermal adjustment device to keep the fluid temperature within a target range.
    [010] The system can comprise an analysis duct through which the fluid can flow. The measuring device can be arranged to measure the fluid in the analysis duct. For example, the analysis duct can connect two parts of the circuit that will experience different pressures from each other during perfusion. This will tend to cause some of the fluid to flow through the analysis duct during perfusion. For example, the analysis duct may have an upstream end connected to the organ's upstream circuit, and a downstream end connected to the organ's downstream circuit.
    [011] The measuring device can be arranged to operate during organ perfusion. The control device can be arranged to operate during organ perfusion to maintain target range or ranges.
    [012] The control device may include a memory arranged to store at least one boundary of said range, or at least one of said ranges. The control device can be arranged to compare the measured content with said at least one threshold. This can enable you to determine when the measured grade is outside the target range.
    [013] The system may comprise a user interface arranged to enable a user to input at least one boundary of said range, or of at least one of said ranges. The user interface can also be arranged to indicate the content of at least one of the fluid's components.
    [014] The system may comprise organ detection device arranged to detect the presence of the organ in the circuit. The system may further comprise a substitute organ arranged to be connected to the circuit in place of the organ so that the circuit can circulate fluid through the substitute organ. Where the system includes organ detection device, the organ detection device can be arranged to distinguish between the presence of the organ in the circuit and the presence of the substitute organ in the circuit.
    [015] In fact, the present invention further provides a perfusion system for passing liquid in an organ, the system comprising: a perfusion fluid circuit arranged to circulate perfusion fluid through the organ; a substitute organ arranged to be connected to the circuit in place of the organ so that the circuit can circulate fluid through the substitute organ; and organ detection device arranged to detect the presence of the organ, or the substitute organ, or both, in the circuit. The organ detection device can thus be arranged to distinguish between the presence of the organ in the circuit and the presence of the substitute organ in the circuit.
    [016] The organ detection device may comprise at least one pressure sensor arranged to measure the pressure of the perfusion fluid at at least one point in the circuit. The organ detection device can be arranged to measure the difference in pressure between two points in the circuit. The organ sensing device may comprise a pressure sensor arranged to measure the pressure of perfusion fluid flowing towards the organ. The organ sensing device may comprise a pressure sensor arranged to measure the pressure of perfusion fluid flowing away from the organ. Alternatively, or moreover, the organ sensing device may comprise a flow meter arranged to measure the fluid flow rate at at least one point in the circuit. The organ detection device can be further arranged to receive data regarding the speed of a pump in the circuit, and to use this data in determining whether the organ or the substitute organ is present in the circuit.
    [017] The control device can be arranged to operate in two different modes, one of which is a preparation mode suitable for preparing the system for perfusion of an organ, and one of which is a perfusion mode suitable for perfusion of an organ. organ. The control device can be arranged, in both modes, to control the content of at least one component of the perfusion fluid. The control device can be arranged to control fluid flow in the perfusion circuit in a different way in each of the two modes. For example, in one mode the fluid can be pumped at a constant speed.
    [018] The system may comprise a bubble detection device arranged to detect bubbles in the fluid during perfusion.
    [019] In fact the present invention further provides a perfusion system comprising a circuit to circulate perfusion fluid through the organ, control device arranged to control the flow of fluid throughout the perfusion circuit, and bubble detection device arranged to detect the presence of bubbles in the fluid.
    [020] The control device can be arranged to respond to bubble detection by the bubble detection device. For example, the control device can be arranged to respond to the detection of bubbles by producing a warning output, such as when displaying a warning. Alternatively, or in addition, it can be arranged to respond by reducing the flow of fluid through at least a part of the circuit, or to the organ, optionally shutting it down completely, for example, by partially or completely closing a valve. flux control. The flow control valve can be arranged to control fluid flow from a reservoir to the organ.
    [021] The bubble detection device can also be arranged to measure the fluid flow rate in the perfusion circuit. The bubble detection device comprises an ultrasound transducer. The bubble detection device can be arranged to determine both whether bubbles are present in the fluid and the fluid flow rate by synchronizing ultrasound transmissions and detections.
    [022] The system may comprise measuring device arranged to measure the amount of fluid secreted by the organ or leaked from it. For example, the fluid can be bile from a liver, ascites from a liver, urine production from the kidney, or any other excretion from any organ.
    [023] The system may further comprise a drainage pit arranged to collect the segregated or leaked fluid. The measuring device can be arranged to measure the volume of fluid entering the drainage shaft. The system can be arranged to record and display the amount of fluid that is secreted or leaked. For example, the control device may include part of the measurement device, and may be arranged to calculate and record the total fluid volume, or the fluid flow rate, or both, and may record these values at regular intervals during perfusion. to monitor the organ. The controller can be arranged to generate a display of all or part of this information. The controller can be arranged to modify its control of at least one component of the system in response to measured volume or measured flow rate. For example, it can be arranged to vary the speed, or the average speed, or the duty cycle, of a pump that is arranged to pump fluid from the sump.
    [024] The system can further comprise a support shelf on which at least some of the components of at least one of the perfusion circuit, the adjustment device and the control device are mounted. The system can further comprise a transport system on which the support rack can be mounted. The transport system may include a cover arranged to cover the support rack and the components mounted thereto. The transport system can include a base with wheels. The transport system can be arranged to support the support rack in the transport position, or in an operative position that is elevated relative to the transport position.
    [025] Some embodiments of the present invention can provide a perfusion system in which one or more of the following functions are automated: detection of an organ in the circuit for perfusion; detection of perfusion fluid in the circuit; control of fluid pressure in the circuit during perfusion; fluid temperature control in the circuit during perfusion; and control of one or more nutrients in the perfusion fluid during perfusion. The system, therefore, can be fully automated.
    [026] Some embodiments of the invention provide a system that is portable.
    [027] Some modalities can be arranged to be powered by battery and power lines.
    [028] The present invention further provides a method of passing liquid into an organ, the method comprising circulating perfusion fluid through the organ, measuring the content of at least one component in the perfusion fluid, and adjusting the content of said at least a component in the fluid in order to maintain said measured content within a target range. The content can be a relative content or a proportion, for example it can be a percentage, and it can be measured by mass, or by volume, or by mole percent. The at least one component can be at least one of: oxygen, carbon dioxide and a nutrient such as glucose. The measurement or adjustment can be performed using any system according to the invention as described above.
    [029] Preferred embodiments of the present invention will now be described by way of example only with reference to the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS
    [030] Figure 1 is a schematic diagram of an infusion system according to an embodiment of the invention;
    [031] Figure 2 is an enlargement of part of Figure 1;
    [032] Figure 3 is a schematic diagram of an oxygenator forming part of the system in Figure 1;
    [033] Figure 3a is a diagram of a combined flowmeter and bubble detector according to an embodiment of the invention and forming part of the system of Figure 1;
    [034] Figure 4 is a schematic diagram of an oxygen concentrator forming part of the system in figure 1;
    [035] Figure 5 is a diagram similar to Figure 2 showing a liver connected to the system of Figure 1;
    [036] Figure 6 is a diagram of the system of Figure 1 modified for perfusion of a single inlet and single outlet organ, such as a pancreas or kidney;
    [037] Figures 7a, 7b and 7c are perspective views of the system of figure 1 mounted on a mobile transport system according to an embodiment of the invention;
    [038] Figures 8a, 8b and 8c are perspective views of the system of figure 1 mounted on a mobile transport system according to a further embodiment of the invention;
    [039] Figures 9a, 9b, 9c and 9d are perspective views of the system of figure 1 mounted on a mobile transport system according to a further embodiment of the invention; and
    [040] Figure 10 is a perspective view of the system of figure 1 mounted on a mobile alternative additional transport system. DESCRIPTION OF PREFERRED MODALITIES
    [041] Referring to figures 1 and 2, an infusion system according to an embodiment of the invention generally comprises a sling 10 in which an organ can be supported, a fluid reservoir 12, an oxygenator 14 and a perfusion circuit 16 arranged to circulate fluid between the reservoir, the organ and the oxygenator during perfusion. A controller 18 is arranged to control the operation of the system as will be described in more detail below.
    [042] The sling 10 is molded plastic or other suitable material and designed to be compatible in order to enable non-traumatic organ support while providing a degree of shock absorption during transport. The sling 10 has a perforated base 19 through which fluids leaking from the organ can flow out, and side walls 20 extending upward from the base 19, and a flap 22 extending around the top of the side walls 20. A fluid drainage pit 24 which, where the organ is a liver, forms an ascites drainage pit, is located under the sling 10, and comprises a concave base 26 which tapers down to a drainage hole 28 which is formed at its lowest point. The drainage shaft 24 is arranged to receive fluid leaking through the base 19 of the sling. The drainage shaft 24 also comprises side walls 30 which extend upwards from the base 26, around the side walls 20 of the sling, and have a flange 32 around its top that supports the flap 22 of the sling 10. A removable cover 34, which is molded plastic, fits over the top of the sling 10 and has a flap 36 around its lower edge that fits against the flap 22 of the sling.
    [043] The sling 10 is supported within an organ container 40 that has the ascites drainage well 24 and a bile drainage well 42 supported on its base 44, and in this mode formed integrally with it. Organ container 40 has sidewalls 46 extending upward from its base 44 and a removable cover 48. Bile drainage pit 42 is approximately twice as deep as ascites drainage pit 24 and a It is generally narrow and tubular in shape, and extends downwardly from the base 44 of the container 40 with its flap 52 flush with the flange 32 of the ascites drain 24 and the flap 22 of the sling.
    [044] The bile drainage pit 42 is formed in two parts, an upper part 42a and a lower part 42b, both of which are integral with the base 44 of the organ container. The lower part 42b has a bile inlet port 54 formed at its side, towards its upper end 56, and a bile overflow port 58 formed at its upper end. A bile outlet port 60 is formed in the base 44 of the organ container near the top of the bile drainage well, with an upper connector 60a for connecting via a cannula to the liver, and a lower connector 60b for connecting to a bile measuring system 62. The bile measuring system 62 is arranged to measure the volume of bile secreted by the liver before allowing it to flow into the bile drainage well 42.
    [045] As can be seen more clearly in Figure 2, the bile measuring system 62 comprises a bile receiving duct 64 having its upper end connected to the lower connector 60b, and its lower end connected to a connector in the form of a T 66, a bile outlet duct 68 having its upper end connected to connector 66 and its lower end connected to bile drainage well inlet port 54, and an overflow duct 70 having its lower end connected to connector 66 and its upper end connected to an additional port 69 formed in the base 44 of the container. An overflow tube 72 connects the top of the additional port 69 to the bile overflow port 58 at the top of the bottom 42b of the drain well. A liquid level sensor 74 is arranged to measure the fluid level in the overflow duct 70 and to send a signal indicative of the fluid level to the controller 18. In this embodiment the liquid level sensor 74 is arranged to detect when the liquid level in the overflow duct 70 reaches a predetermined height, and to send a signal indicative of this to the controller 18. A flow control valve, which in this embodiment comprises a throttling valve 76, in the bile outlet duct 68 is switchable between a closed state in which it closes the outlet duct 68 so that bile can accumulate in the metering system 62 and an open state in which it allows bile to be drained from the metering system 62 to the bile drainage well 42. Controller 18 is arranged to control flow control valve 76.
    [046] The controller 18 is arranged to measure the rate at which bile is secreted by the liver when closing the choke valve 76 so that bile accumulates in the outlet duct 68, and then in the bile receiving duct 64 and in the bile duct overflow 70. When the level sensor 74 detects that the bile has reached the predetermined level, it is arranged to send a signal to the controller 18 which responds by opening the throttling valve 76, for example, for a predetermined period, to allow it to the bile is drained out of the metering system and into the drainage pit, and then closes the valve again so that bile can start to accumulate in the metering system again. The controller 18 is also arranged to record in memory the times at which the bile reaches the predetermined level, and for this reason the times at which the measuring system is filled. This information, together with the known volume of the system when it is filled to the predetermined level, allows the rate at which bile is segregated over time to be monitored. For example, controller 18 can be arranged to calculate a flow rate each time valve 76 is opened from the known volume of the system and the time interval between valve opening and previous valve opening. This flow rate can be displayed on GUI 17 and is updated each time a new flow rate calculation is written. Alternatively controller 18 can be arranged to store this flow rate information in memory so that flow rate data for the complete perfusion process can be stored and then output or displayed via GUI 17. As a further alternative, the controller may not perform any calculations, but may generate output that varies with flow rate, and the GUI can be arranged to respond to the output by generating a display, such as a line graph, which is indicative of the flow rate. , for example, by having axes marked appropriately. It will be appreciated that, for organs other than the liver, this measurement system can be arranged to measure other fluids leaking or being excreted by the organ during perfusion, and to record and display the measured volume. For example, the organ could be a kidney and the fluid could be urine.
    [047] Referring again to Figure 1, an ascites duct 80 is connected at one end to the drainage hole 28 at the bottom of the ascites drainage shaft 26 and at the other end to an ascites return port 82 at the top of fluid reservoir 12. The ascites duct 80 has a central part 80a which is the lowest part of the duct 80, being below the level of the ascites drainage well 26 as well as below the level of the reservoir 12. A pump for ascites 84 is provided in the central portion 80a of the ascites duct 80 to pump ascites from the drainage well 26 back to the reservoir 12. An ascites measuring tube 86 extends vertically upwards from the central portion 80a of the ascites duct , adjacent and upstream of the pump 84, and has a fluid level sensor 88 therein. This level sensor 88 is arranged to detect, and produce a signal, when fluid in the measuring tube 86 reaches a predetermined level which is below the base 19 of the sling 10, and in this embodiment indicated above the drain port 28 in the drain well. of ascites. The fluid level sensor 88 is connected to the controller 18 which receives the signals from it, and for this reason can detect when the level of ascites in the drainage well reaches a predetermined level. In response to this the controller 18 is arranged to activate the pump for ascites 84, for example, for a predetermined time to reduce the level of ascites in the drainage pit 26. The speed of the pump 84 may be variable and the controller 18 may be arranged to control the pump speed, or the pump service ratio, or the average pump speed, based on the measured fluid level. In other embodiments the ascites level sensor can be placed within the sump 26. In fact, any system suitable for measuring the volume of accumulated ascites can be used as a feedback to control the operation of the pump 84. For example, a sensor A pressure gauge located near pump 84 could be used to measure accumulated ascites volume. In still other embodiments the ascites pump 84 can be arranged simply to operate for fixed periods without measuring ascites volume.
    [048] In a modification to this modality, there is an additional ascites level sensor in addition to sensor 88 so that the sensors can detect when the ascites level reaches higher and lower levels. Controller 18 is arranged to turn on the ascites pump 84 when ascites is detected as reaching the upper level, and to turn off the ascites pump 84 when the ascites level drops to the lowest level. The controller is then arranged to record the timing each time the pump is turned on, and this provides an indication of the total ascites volume and ascites flow rate during perfusion. This information can be stored and displayed on GUI 17 in the same way as bile measurements. The speed of the pump 84 can be variable and the controller 18 can be arranged to control the speed of the pump, or the pump service rate, or the average pump speed, based on the measured fluid level. It will be appreciated that, for other organs, this measurement system can be used to measure the total volume or flow rate of other fluids leaking or being excreted by the organ during perfusion. This measurement can also be provided with only one ascites level sensor as shown in figure 1, for example, if the pump 84 is arranged to operate until it has pumped all the ascites that is upstream of the pump 84, which can be assumed to be a fixed volume.
    [049] The perfusion circuit 16 further comprises a first fluid supply duct 100, which when used for perfusion of a liver forms a portal vein duct, a second fluid supply duct 102, which when used for perfusion from a liver forms a hepatic artery duct, and a fluid removal duct 104, which when used for perfusion from a liver forms an inferior vena cava (IVC) duct. The system and its operation will now be described for perfusion of a liver, but it will be appreciated that it can be used equally for other organs, in particular single inflow and single outflow organs such as the kidney, small intestine or pancreas if arranged according to the alternative configuration in Figure 6 . Portal vein duct 100 has one end connected to an outlet port 106 in the fluid reservoir and the other end attached to a portal vein connector 108. Portal vein duct 100 extends through a port 110 in sidewall 46 of the organ container 40 such that the portal vein connector 108 is located within the container. A flow control valve 112, in the form of a throttling valve, having a variable degree of opening, is provided in portal vein duct 100 and is connected to controller 18. Controller 18 is arranged to vary the degree of opening of the throttling valve 112 to control the rate of fluid flow from reservoir 12 to the portal vein of a liver. A portal vein flow sensor 113 is provided in portal vein duct 100 and is arranged to produce a signal indicative of the rate of fluid flow in portal vein duct 100. The output of flow sensor 113 is connected to controller 18 which for this reason it can monitor the flow rate in the portal vein duct. Controller 18 is also arranged to determine from the signal from flow sensor 113 when fluid flow from the reservoir is stopped because the reservoir is empty. In response to the detection of an empty reservoir the controller 18 is arranged to close the flow control valve 112 to prevent air from reaching the organ and to enable replenishment of the volume of perfusion fluid within the reservoir. The flow sensor in this mode is also arranged to act as a bubble detector, arranged to produce a signal indicative of the presence of air bubbles in the fluid in portal vein duct 100. Controller 18 is arranged to close the flow control valve flow 112 in bubble detection in the same mode as when a completely empty reservoir based on fluid flow is detected. The hepatic artery duct 102 has one end connected to a first outlet port 114 of the oxygenator 14 and the other end attached to a hepatic artery connector 116. The hepatic artery duct 102 extends through a port 118 in the sidewall 46 of the organ container 40 such that the hepatic artery connector 116 is located within the container. The IVC duct 104 has one end attached to an IVC 120 connector, which is located within the container 40, and extends outwardly through a port 122 in the base 44 of the organ container 40, the other end of which is connected to a port. inlet 124 of the oxygenator 14. A pump 123 is provided in the IVC duct 104 having its inlet connected by a part of the IVC duct 104 to the IVC 120 connector, and its output connected to the inlet port 124 of the oxygenator 14. The pump 123 is arranged to pump fluid from the IVC duct 104 into the oxygenator 124. The pump 123 is a variable speed pump and is connected to and controlled by the controller 18. An IVC flow sensor 125 is arranged to measure the fluid flow rate in the IVC duct 104 and is arranged to produce a signal indicative of the fluid flow rate in the vena cava duct 104. The output of the flow sensor 125 is connected to the controller 18 which for this reason can monitor the flow rate in the IVC 104 duct.
    [050] Each of the connectors 108, 116, 120 is a quick release connector arranged to allow the duct to which it is attached to be connected by means of a cannula to the appropriate vein or artery of the liver, or to a substitute organ 126 which is arranged to complete the perfusion circuit before connecting the actual organ. The substitute organ 126 comprises the two inlet ducts 128, 130 for connection to the portal vein duct 100 and to the hepatic artery duct 102, and an output duct 132 for connection to the IVC duct 104. In this modality, the substitute organ is in the form of a simple Y-shaped connector 134 connecting the two inlet ducts 128, 130 to the outlet duct 132 so that when it is connected to the circuit, fluid can flow through it from the portal vein duct 100 and the duct from hepatic artery 102 to the IVC duct 104.
    [051] The portal vein duct 100, the hepatic artery duct 102, and the IVC duct 104 each have a pressure sensor 136, 137, 138 therein, arranged to measure fluid pressure in duct 100, 102, 104. Each of these pressure sensors 136, 137, 138 is arranged to measure pressure at a point near the respective connector 108, 116, 120, and to produce a signal indicative of pressure at that point. In this embodiment, each of the ducts 100, 102, 104 is divided into two sections and each of the pressure sensors 136, 137, 138 is located in a molded plastic sensor body that also serves to connect the two sections of the duct together. Each of the sensors 136, 137, 138 is located just outside the wall 46 or base 44 of the organ container 40. In each case the duct between the pressure sensor 136, 137, 138 and the connector 108, 116 , 120 is of substantially constant cross-section, so the pressures sensed by sensors 136, 137, 138 are approximately equal to the pressure of fluid flowing into and out of the replacement organ, or the actual organ when it is connected to the circuit.
    [052] The oxygenator 14 has a second outlet port 140 that is connected by a pressure control duct 142 to a pressure control port 144 on the fluid reservoir 12. A flow control valve, in the form of a valve throttling valve 146, having a variable degree of opening, is provided in pressure control duct 142 and is connected to controller 18 so that the controller can vary the degree of opening of throttle valve 146 to thereby control the backflow of fluid from the oxygenator 14 to the reservoir 12. This, together with the speed of the pump 123, is controlled by the controller 18 to control the pressure of fluid flowing into the organ through the hepatic artery duct 102, as well as the pressure of the fluid in the duct of vena cava 104 flowing away from the organ.
    [053] Referring to Figure 3, the oxygenator 14, which is schematically shown, comprises a side-by-side duct 150 arranged to carry fluid from the inlet port 124 to the two outlet ports 114, 140. oxygen 152 has an inlet port 154 for connecting to an oxygen supply and an air supply, and an outlet or vent port 156 for venting oxygen and air from the oxygen chamber. A vent 158 is connected at its lower end to the side-by-side duct 150 and extends upward so that its upper end is approximately flush with the top of reservoir 12. This vent 158 is of the closable type, and is arranged to be opened during filling of the fluid circuit to vent air from the oxygenator, but is closed during perfusion. A permeable membrane 160 between the oxygen chamber 152 and the side-by-side duct 150 allows oxygen in the oxygen chamber 152 to oxygenate the fluid, which may be blood, in the side-by-side duct 150, and allows air in the chamber. of oxygen 152 carry CO2 away from the fluid. A water chamber or duct 162 is also connected to an inlet water port 164 and an outlet water port 166, and is separated from the side-by-side duct 150 by a thermally conductive wall 168. This provides a heat exchanger. heat that allows water, or another suitable thermal control fluid, to be circulated through the oxygenator 14 to control the temperature of the perfusion fluid. A heater 167, such as a Peltier heater, is provided to heat water entering the oxygenator via the water inlet port 164, and a thermometer 169a is provided to measure the temperature of the perfusate flowing out of the oxygenator and into the artery duct liver 102. An additional thermometer 169b is arranged to measure the temperature of the water that is supplied to the heat exchanger. Heater 167 and thermometers 169a, 169b are connected to controller 18 which is arranged to measure and monitor the temperature of the perfusate supplied to the organ and the water supplied to the heat exchanger, and to control the heater 167 in order to maintain the temperature perfusing at a desired level, eg within a target temperature range.
    [054] It will be appreciated that other devices can be used to add oxygen to the perfusate and extract carbon dioxide from it. For example, a bubble maker can be used instead of the type of oxygenator shown in figure 3, which bubbles concentrated oxygen through the perfusate. Also, instead of a device that brings a gas into contact with the perfusate and where the oxygen and carbon dioxide content of the gas is controlled, the system can include separate devices one for each gas.
    [055] Referring to Fig. 3a the flow sensor 113 in portal vein duct 100, as described above, is also arranged to act as a bubble detector. In this mode the flow sensor 113 comprises a housing 300 arranged to be secured around the duct, in this case the portal vein duct 100. Two ultrasound transducers 302, 304 are supported in the housing 300 and arranged so that they are located at one side of the duct. A reflector 306 is supported in housing 300 and arranged to be located on the side of the conduit opposite transducers 302, 304. Transducers 302, 304 are displaced from one another along the conduit in the direction of fluid flow, and angled in such a manner. that when each of them transmits an ultrasound signal it will be reflected by the reflector 304 to the other transducer in such a way that it can be detected. Each transducer 302, 304 is arranged to emit a series of ultrasound pulses, and the timing of the pulses is controlled in such a way that the two transducers 302, 304 emit pulses alternately, with the non-emitting transducer being arranged to detect the pulse emitted after it has been reflected by the reflector 306. The time taken for the ultrasound to travel in each direction between the two transducers is measured, using the emission and detection times, and the detector 145 is arranged to determine the difference between the transmission times in the two transducers. two directions and from this difference calculate the fluid flow rate in conduit 102. If gas bubbles are present in the perfusate, they reflect ultrasound back to the transducer that transmitted it and, in some cases, reflect the ultrasound to the other transducer not transmitting in such a way that they arrive at a different time than those reflected by reflector 304, and generally in much smaller amplitudes. For this reason the bubble detector 145 is arranged to analyze the detection signals from both transducers 302, 304 and to determine from their timing and amplitude when bubbles are present in the perfusate. The ultrasound detector signals can be processed locally in a processor forming part of the bubble detector, so that the processor in the bubble detector sends a simple signal to the controller 18 indicative of the presence of gas bubbles in the perfusate, or the signals detectors can be introduced directly into the controller 18 which can be arranged to analyze them to detect the presence of the gas bubbles by itself.
    [056] In response to detection of gas bubbles the controller 18 can be arranged to produce a warning signal to the GUI which can be arranged to provide a visual or audible warning on receipt of the warning signal. Furthermore, the controller is arranged to stop the flow of perfusate to the organ via the portal vein duct if it determines that gas bubbles are present in the perfusate. Specifically in this case, in response to the detection of bubbles in portal vein duct 100, controller 18 is arranged to close choke valve 112. It is also arranged to fully open choke valve 146 for a fixed period of time, to enable volume replacement inside the reservoir. Following this delay time it is arranged to reopen choke valve 112, and to reset valve 146 in order to achieve the desired blood pressure.
    [057] In other embodiments, the system may include an additional bubble detector in the hepatic artery duct or the IVC duct. In this case the controller 18 is arranged, when gas bubbles are detected, to stop the pump 123 to stop the flow of fluid through the organ as well as to provide the warning. This enables a user to take precautionary measures, such as allowing the gas bubbles to escape from the perfusate, or even disconnecting the organ and emptying the gas bubbles from the fluid circuit, before restarting perfusion.
    [058] In other embodiments, other types of bubble detector can be used. For example, an ultrasound bubble detector can be used that is not combined with a flow rate sensor, and includes only a single transducer. In that case the flow rate sensor can be supplied separately, and it can be of a different form other than an ultrasound sensor.
    [059] Referring again to Figure 1, a nutrient control circuit 170 comprises a set of syringes 172, in this case four, each containing a respective nutrient, and a nutrient supply duct 174 having a connected end to a separate fluid reservoir 176 and the other end connected to a nutrient inlet port 178 at the top of the main fluid reservoir 12. Each of the syringes 172 is connected to the nutrient supply duct 174 by a respective inlet inlet duct. nutrient 180. A nutrient pump 182 is arranged in nutrient supply duct 174 to pump fluid through nutrient supply duct 176 nutrient supply reservoir to main reservoir 12 via nutrient inlet port 178. Pump 182 and syringes 172 are controlled by controller 18 so that the rate at which each of the nutrients is delivered to reservoir 12 is controlled.
    [060] A small diameter fluid analysis pipeline190 has one end connected to the IVC 104 pipeline, upstream of the pump 123, and in this case downstream of the IVC125 flow sensor, and the other end connected to the depression control pipeline 142. upstream of the pressure control valve 146 so that fluid can flow through the fluid analysis duct 190 from the pressure control duct 142 to the IVC duct 104, bypassing the organ. A measurement system, in this case in the form of a blood gas analyzer (BGA) 192, is arranged to measure various parameters of the fluid flowing through the fluid analysis duct 190. In this embodiment the BGA 192 is arranged to measure the oxygen content and the carbon dioxide content of the fluid flowing through it. Other parameters, including any one or more of temperature, pH, excess base, potassium, glucose, hematocrit, and oxygen saturation, can also be measured and monitored. The BGA 192 is connected to controller 18 and arranged to produce signals, each of which is indicative of the value of one of the parameters it measures, and controller 18 is arranged to receive these signals in such a way that the parameters can be monitored by the controller 18. Signals for this reason include an oxygen level signal and a CO2 level signal in this mode.
    [061] A preactivation bag or reservoir 194 is supported at a level that is above the top of reservoir 12, and connected by a preactivation duct 196 to the perfusion circuit at a preactivation point that is on the vena cava duct 104 at its lowest point 104a. This is also the lowest point of the perfusion circuit 16, which allows the entire circuit 16 to be filled from the bottom, as will be described in more detail below.
    [062] Referring to Figure 4, the oxygen supply to the oxygenator inlet 154 is provided by an oxygen concentrator 200. This comprises a pair of zeolite towers 202, 204, an air inlet 206 arranged to receive gas in the form of air at atmospheric pressure, a compressor 208 arranged at the inlet to compress the inlet air, and a bidirectional switch valve 210 operable to control the inlet air flow to the zeolite towers 202, 204. Each of the towers 202 , 204 has an outlet 212, 214 and these are connected together to form a single oxygen concentrator outlet, which in turn is connected to the oxygenator inlet 154. In use, as compressed air flows through the zeolite towers 202, 204, the zeolite extracts nitrogen from the air which increases the concentration of oxygen in the gas. Nitrogen leaves the towers via vents 216, and the gas leaving the concentrator 200, which comprises concentrated oxygen as well as some nitrogen and traces of other gases, is supplied to the oxygenator inlet 154. A proportional valve 224 at the concentrator outlet oxygen is arranged to control the flow rate of gas, and hence oxygen, from the oxygen concentrator 200 to the oxygenator 14. The proportional valve 224 is connected to the controller 18, and controlled by it, so that the controller can control the rate. oxygen flow rate to the oxygenator 14. The air supply to the oxygenator inlet 154 is provided by an additional compressor 220 which has an inlet 222 arranged to receive air at atmospheric pressure. An additional proportional valve 226 at the output of compressor 220 is connected to and controlled by controller 18 so that the controller can control the air flow rate from compressor 220 to the oxygenator, and hence the carbon dioxide extraction rate .
    [063] In a modification to the arrangement of Figure 4, the second compressor 220 is omitted and the output of the first compressor 208 is connected to both the oxygen concentrator 200 and a separate air duct via the second proportional valve 226 for the inlet of gas oxygenator. The single compressor 208 therefore supplies pressure to the oxygen and air supplies, whose flow rates are independently controlled by their respective flow control valves 224, 226.
    [064] Referring to Figure 5, when the system is operating to pass fluid into a liver, the substitute organ 126 is removed, and the liver 250 to be perfused is placed in a sling 10. The portal vein, hepatic artery , inferior vena cava (IVC) and liver bile duct are cannulated, and the cannulas are connected to portal vein connector 108, hepatic artery connector 116, vena cava connector 120, and outlet port of bile 60 respectively.
    [065] Referring again to figure 1, during perfusion, when the system is operating in a perfusion mode, flow of perfused fluid through the liver is controlled by controller 18 which is arranged to control the pressure in the hepatic artery duct 102 and in the IVC 104 duct to keep them at approximately constant pressures, allowing the liver to regulate the rate of fluid flow through itself. To do this, controller 18 is arranged to monitor the pressure in hepatic artery duct 102 by monitoring the output signal from pressure sensor 137 and the pressure in duct IVC 104 by monitoring the output of pressure sensor 138, and to control the perfusion pump 123 and the throttling valve 146 in the pressure control duct 142 in order to maintain the measured pressures, i.e., the pressure sensor output signals, at the respective established levels, or within their respective ranges.
    [066] The oxygen level in the perfused fluid is also controlled by controller 18 during perfusion. Although much of the oxygenated perfusate from oxygenator outlet 114 flows through hepatic artery duct 102, a small proportion of it is diverted through fluid analysis duct 190 and through BGA 192. The BGA 192 detects the level of oxygen in the perfusate, which is monitored by controller 18. Controller 18 is arranged to control the pressure and flow rate of oxygen supplied by oxygen concentrator 200 to the oxygenator by controlling pump 208 and bidirectional valve 210 of oxygen concentrator 200, in order to control the rate at which perfusate is oxygenated in oxygenator 100. Controller 18 is arranged to maintain the blood oxygen level at a predetermined level or within a predetermined range. The controller 18 has a memory in which a target oxygen content level or range can be stored and the controller is arranged to compare the measured level with the stored level to determine how the oxygen level needs to be controlled. The stored target level can be selected and changed via a user input which in this case is in the form of a graphical user interface (GUI) 17 connected to the controller 18. The GUI 17 is also arranged to display various information including the values of various system operating parameters. These may include oxygen level in the perfusion fluid, carbon dioxide level in the perfusion fluid, temperature of the perfusion fluid, the level of any nutrient in the perfusion fluid, such as glucose.
    [067] The level of carbon dioxide (CO2) in the perfusate is also monitored and controlled by controller 18 during perfusion in a mode similar to oxygen level, with controller 18 continuously using the CO2 level signal from the BGA 192 to measure the CO2 level in the perfusate, comparing it to target levels stored in memory in controller 18, and controlling the air flow control valve 226 to control the air flow rate to the oxygenator 16. The CO2 level target can also be set and adjusted by a user via user input 17.
    [068] The temperature of the perfusate supplied to the organ is monitored and controlled by the controller 18 which is arranged, during perfusion, to monitor the signal of the perfusate thermometer 169a and the 169b water thermometer and control the water heater 167 to control the temperature of the water flowing in the heat exchanger, and optionally also the flow rate of water flowing through the heat exchanger, to thus maintain the perfusate temperature within a target temperature range. This target range is stored in memory in controller 18 and can be set and adjusted via user input 17.
    [069] The level of each of the monitored nutrients in the perfusate is also monitored and controlled by controller 18 during perfusion in a mode similar to oxygen level, with controller 18 using the BGA 192 nutrient level signal to measure the level of nutrient into the perfusate, comparing it to target levels stored in memory in controller 18, and controlling the appropriate syringe 172 to add the nutrient if the nutrient level drops below a predetermined level. The addition of nutrients will generally be intermittent, so syringe 172 can be controlled simply to add a predetermined amount of the nutrient if the level of nutrient in the perfusate drops below the lowest target level. Alternatively, or in addition, the speed of the nutrient pump 182 may be variable and may be controlled by the controller to vary and control the rate at which nutrients are added to the perfusate. One of the nutrients that can be detected by BGA 192 and controlled in this way is glucose. However, one or more other nutrients can also be controlled in the same way.
    [070] The controller 18 is also arranged to monitor the signal from the bubble detector 113 during perfusion and if it detects the presence of gas bubbles in the perfusate, or more than a minimum bubble content in the perfusate, the controller 18 is arranged to close throttling valve 112 as described above. Controller 18 can also be arranged to display a warning on GUI 17 if bubbles are detected.
    [071] The replacement organ 126 is already connected to the circuit as part of the disposable set, as is the oxygenator 14, and the pump 123. The perfusion circuit is then filled with perfusate. To achieve this, the flow control valves 112, 146 in the portal vein duct 100 and the pressure control duct are opened. A perfusion bag 194 containing perfusate is connected to the upper end of preactivation duct 196. Preactivation bag 194 is then raised to a level that is higher than the top of fluid reservoir 12. This causes perfused fluid from the preactivation bag flows into the perfusion circuit at the preactivation point 104a in the vena cava duct 104, and flows upward through the entire perfusion circuit from that point. As the fluid level in the perfusion circuit rises, this fills the vena cava duct 104, the surrogate organ 126, the hepatic artery duct 102 and the portal vein duct 100, the side-by-side duct 150 of the oxygenator, and the pressure control duct 142, and the reservoir 12, with ports 82, 178 at the top of the reservoir being used to vent air out of the system as it fills. The pumphead can be independently moved and uncapped relative to its drive motor to enable removal of any gas trapped inside the pumphead during filling.
    [072] When the perfusion circuit 16 has been filled, the ascites duct is connected to the ascites return port 82 in the reservoir and the nutrient supply duct 174 is connected to the nutrient supply port 178 in the reservoir, and the vent 158 of oxygenator 14 is closed. The system is then powered on, for example, by a user entering a start command using GUI 17 and it starts running and controller 18 is arranged to control the system as follows. When the system starts operating, both the pressure control valve 146 and the flow control valve 112 in the portal vein duct are opened. Initially, therefore, pump 123 pumps fluid through hepatic artery duct 102, portal vein duct 100, through surrogate organ 126 and through IVC duct 104, also ensuring constant circulation of the perfusion fluid within reservoir 12. Controller 18 it is initially arranged to control the pump 123 to operate at a constant speed and to monitor the pressures in the hepatic artery duct 102 and the IVC duct 104 and compare them. Once the substitute organ 126 is present, the pressure drop across it is low, in particular significantly less than if an actual organ were connected to the circuit, and this enables the controller 18 to detect the presence of the substitute organ from the outputs of the difference between the pressures measured by pressure sensors 136, 138.
    [073] In a modification to this modality, exactly one of the two measured pressures can be used to detect the presence of the surrogate organ 126. For example, the surrogate organ can be determined to be present (or the actual organ to be absent) since that the pressure in the hepatic artery duct remains below a predetermined value. In another alternative modification, the fluid flow rate is measured at at least one point in the circuit, for example, in the fluid removal duct 104 as measured by the flow sensor 125, or in the second fluid supply duct 102, it can be used, by itself or in combination with data defining the speed of pump 123, to determine if organ is present in the circuit. This is because flow rates will be generally lower, and more specifically will be lower for any given pump speed when the organ is present than when it is not. This is because the organ provides greater resistance to fluid flow, which can be measured by measuring the fluid flow rate.
    [074] While the substitute organ is present, and in particular while the controller 18 detects that the substitute organ is present, the controller 18 operates in a preparation mode in which it is preparing the system for connection of the actual organ. In this mode, controller 18 is arranged to control pump 123 so that it pumps fluid through the oxygenator at a constant flow rate, and to monitor and adjust the various fluid parameters, as described above, in order to maintain them within target ranges suitable for perfusion of a real organ. The target ranges for each of the parameters can be entered into the system by a user via GUI 17, or can be set to a default value. The bubble content of the perfusate can also be considered as one of the parameters that are monitored by the controller using the bubble detector 145. When the system is first started it is possible that some gas bubbles are present in the perfusate. The controller 18 is arranged to monitor for its presence and to verify that the bubble content is within a predetermined target range, which is typically uniquely defined by a maximum acceptable value, which may be zero. When the perfusing parameters have reached the target values, the system is ready to connect the real organ. Controller 18 can be arranged to detect arrival at all target ranges or values, and to provide an indication, via GUI 17, that the system is ready.
    [075] To enable connection of the real organ, pump 123 is stopped. GUI 17 allows a user request to be entered for controller 18 to stop pump 123. When this request is received by the controller, the controller is arranged to stop pump 123 in such a way that circulation of the perfusate is stopped. Substitute organ 126 is then disconnected from the circuit, and organ 250 connected to the circuit as shown in figure 5. The controller is arranged, when it receives a 'start' request from a user, entered via GUI 17, to initiate the pump 123 at a constant rate again, and again to monitor the pressures in hepatic artery duct 102 and IVC duct 104 and compare them. Now, as the actual organ 250 provides significant resistance to perfusate flow, a pressure differential will quickly form across organ 250. Specifically, the pressure in hepatic artery duct 102 increases as perfusate is pumped into it, and the pressure in the IVC 104 duct decreases as the perfusate is pumped away from it. When the controller detects that the difference between the pressures in these two ducts reaches a predetermined level, this provides an indication that the actual organ 250 is connected to the circuit and the controller switches to a perfusion mode. In perfusion mode the controller 18 is arranged to control the pressure in the hepatic artery duct 102 and the IVC duct 104, by controlling the speed of the pump 123 and the opening degree of the pressure control valve 146 as described above, to keep them within predetermined target pressure ranges. As mentioned above, the presence of the actual organ can be detected by simply detecting when the pressure in the hepatic artery duct 102 reaches a predetermined level.
    [076] With the actual organ 250 present, the controller 18 is arranged to begin measuring the bile volume using the bile measuring system 62 as described above. It is also arranged to initiate drainage of ascites from drainage pit 26, and measure the volume of that ascites, as described above. The controller is also arranged to record the total number of time the bile metering system valve 76 is open and the total number of time the pump for ascites 84 is activated to measure the total bile volume and the total volume of ascites that are produced by the liver during perfusion. It is also arranged to measure the time between each pair of subsequent operations of valve 76, and each pair of subsequent operations of pump 84, and to calculate for each pair of operations an associated bile flow rate, and an ascites flow rate. associated, from the liver.
    [077] It will be appreciated that if an organ other than the liver is connected to the system, each of the bile measurement system and the ascites measurement system can be used to measure different fluids as produced by that organ . For example, they can be used to measure urine coming from a kidney. Also in another embodiment of the system, a metering system that is the same as the bile metering system 62 described above is included in the ascites duct 80 upstream of the pump 84 to provide a more accurate measurement of ascites.
    [078] In yet a further embodiment, the bile measuring system 62 is provided without the rest of the perfusion system described above, and can then be connected to an organ, such as a liver, during surgery, to measure volume or flow rate of fluid produced by the organ during surgery.
    [079] Referring to figure 6, the system in figure 1 can be modified for perfusion of a pancreas, or of another organ with only one vein and one artery that need connection to the perfusion circuit. The only significant modification is that the downstream end of the first fluid supply duct 100 is not connected to the organ, but instead is connected to the fluid removal duct 104 just upstream of the pump 123. The other two ducts are connected to the organ in the same way as to the liver: the second fluid supply duct 102 is connected to the organ for supplying perfusion fluid to the organ, and the fluid removal duct 104 is connected to the organ for carrying perfusion fluid from the organ. When the member is not present, the circuit can be completed using a substitute member 126' which in this case is a simple length of conduit having an inlet end and an outlet end, each of which has a connector thereon in such a way that they can be connected to the second connector 116 and the third connector 120 respectively. System operation in this configuration is the same as that described above with reference to Figure 1, and will not be described again in detail, except that fluid flow from reservoir 12 through first duct 100 simply replaces fluid flowing through pressure relief duct 142 back to the reservoir. For the pancreas the bile drainage pit and measuring system are not used, although any fluid leaking from the organ can still be collected and recirculated using the fluid drainage pit 24.
    [080] Referring to figures 7a, 7b and 7c, in one embodiment the total system of figure 1 or figure 6 is mounted on a support rack 700 which is capable of being housed within a transport trolley 702. The trolley 702 has a substantially flat rectangular base 704 supported on four wheels or casters 705, and four side walls 706 each extending upward from the base and defining a storage volume within the walls. Shelf 700 comprises a vertical sidewall 708, a shelf 710 projecting horizontally from the lower edge of the sidewall, toward one end of the sidewall, and a rectangular support panel 712 that slopes against the other end of the sidewall. Support panel 712 is angled about 30° from the vertical, with its upper end parallel and joined to the upper edge of sidewall 708 and its lower edge spaced from sidewall 708 by a distance equal to the width of shelf 710. The lower part of support shelf 700 for this reason is rectangular with one half being formed by shelf 710 and the other half being the lower open end of a cavity 713 formed between angled support panel 712 and side wall 708. support 700 further comprises a top panel 714 that extends horizontally from the top edge of the sidewall. The top panel 714 and the bottom of the support rack are of equal size and both are arranged to fit the storage volume inside the trolley. The GUI 17 is mounted to the top panel 714 of the support shelf, and can be raised for use as shown in figure 7a or lowered for storage as shown in figure 7b. The system may further comprise a detachable portable display 720 that can be arranged to wirelessly communicate with controller 18 and arranged to display the same information displayed by GUI 17 and to include additional user input to enable a user to input the same data that can be entered via the GUI 17.
    [081] The support rack 700 is mounted within the trolley 702 on a lifting mechanism (not shown) that allows the support rack 700 to be moved between a storage position, or transit configuration, as shown in Figure 7b , wherein the top panel 714 is flush with the top of the trolley walls, and an elevated position, or surgical configuration, as shown in Figures 7a and 7c, wherein the lower portion of the support rack 700 is flush with the top of the trolley walls. As shown in Figures 7a and 7c, one or more oxygen bottles 722 and a battery 724 may be stored within the transport trolley, supported by its base 704, and located so that they are located in cavity 713 within the support rack. 700 when the support stand is in the lowered position.
    [082] Referring to figures 8a, 8b and 8c, in an additional mode the transport is similar to that of figures 7a, 7b and 7c, except that support rack 800 is not connected to trolley 802, but simply rests on the base with wheels 804 when the system is in transit configuration as shown in figure 8b. Also, the support shelf includes a base panel 810 that forms the entirety of the lower end of the support shelf, with a vertical wall 808 extending upwardly from the base panel 810 parallel to its ends and for about half of the length. distance along it. The base panel 810 therefore forms the shelf on one side of the vertical wall 808, and on the other side forms a base below a cavity between the support panel 812 and the center wall, on which the oxygen bottle or others items can be placed. Support panel 812 has its lower edge along one end of base panel 810, and is angled against vertical wall 808. A cover comprises side walls 806 and a top panel 814, and is arranged to fit over the shelf support bracket 800 with its lower edge resting on the 804 trolley in transit configuration. A seal is provided between the cover and the base to seal the transfusion system from the inside. To use the transfusion system, the canopy is simply lifted off the base 804, the canopy 806, 814 is replaced on the base, and the support rack 800 is then supported on the top panel 814 of the canopy as shown in the figure. 8c.
    [083] Referring to figures 9a, 9b, 9c and 9d, in a transport system according to a further embodiment of the invention, the support rack 900 is similar to that of figure 7a, but the trolley 902 is of a design shell-shaped, comprising a wheeled base 904 and two cover sections 906a, 906b, each of which is hinged to the base 904 along a respective side of the base. Each of the cover sections 906a, 906b comprises a side panel 930, the lower edge of which is hinged to the base 904, and two end portions 932 and an upper portion 914. When the cover is closed as shown in Figure 9a, the panels The sides 930 are substantially vertical defining a cavity therebetween, and the parts 914 extend over the top of the cavity to meet each other and the end parts 932 at each end of the cover extend across the side of the cavity to meet with one another. the other. The cavity for this reason is sealed between the two cover sections 906a, 906b and the support shelf can be contained within the cover. To remove the transfusion system from inside the cover, the two cover sections 906a, 906b are opened and the support rack 900 that supports the transfusion system is simply lifted out of the cover, and can be placed, for example, over a table for use.
    [084] Referring to figure 10, a transport system according to a further embodiment of the invention comprises a support rack 1000, a trolley with wheels 1002 and a cover 1006. The trolley 1002 is formed of a frame structure 1002a and a plastic molding 1002b. The molding 1002b rests on part of the frame structure 1002a to form the base 1004 of the trolley, and the part 1002c of the frame structure forms a handle for pushing the trolley that can be folded for easy storage of the trolley. The support rack 1000 is arranged to rest on the base 1004 of the trolley, and comprises a base panel 1010, one half of which forms a shelf 1011 and the other half of which supports a support tower 1013, a face 1012 of the which supports the perfusion circuit 16, reservoir 12, GUI 17, pump 123 and syringes 172. Cover 1006 comprises side walls and a top panel 1014, and is arranged to fit over support rack 1000, and seal against its 1010 base to cover and protect the infusion set. For transport the support rack 1000 is placed on the base of the trolley 1002, and the cover 1006 is placed on it. When the infusion set is to be used, the cover 1006 is removed, and the support rack 1000 with the infusion set mounted thereon is removed from the trolley and placed on a table or similar stand.
    权利要求:
    Claims (7)
    [0001]
    1. A perfusion system for perfusing an organ, the system comprising: a perfusion fluid circuit arranged to circulate perfusion fluid through the organ; and a substitute organ (126, 126') arranged to be connected to the circuit in place of the organ so that the circuit can circulate fluid through the substitute organ; CHARACTERIZED by the fact that the system further comprises organ detection means arranged to distinguish between the presence of the organ in the circuit and the presence of the substitute organ in the circuit, the perfusion system further comprises control means (18) arranged to operate in two different modes, one of which is a mode of perfusion suitable for perfusing an organ and one of which is a mode of preparation, in which the system operates differently from the mode of perfusion, suitable for preparing the system for perfusion of an organ , and the control means is configured to select one of the modes in response to a signal from the detection means.
    [0002]
    2. System according to claim 1, CHARACTERIZED by the fact that the organ detection means comprise a pressure sensor (136, 137, 138) arranged to measure the pressure of the perfusion fluid at a point in the circuit.
    [0003]
    3. System according to claim 2, CHARACTERIZED by the fact that the organ detection means are arranged to measure the difference in pressure between two points in the circuit.
    [0004]
    4. System according to claim 2 or 3, CHARACTERIZED by the fact that the organ detection means comprise a pressure sensor (136, 137, 138) arranged to measure the pressure of perfusion fluid flowing towards the organ , and a pressure sensor (136, 137, 138) arranged to measure the pressure of perfusion fluid flowing away from the organ.
    [0005]
    5. System according to any one of claims 1 to 4, CHARACTERIZED by the fact that the organ detection means comprise a flow meter (125) arranged to measure the fluid flow rate at a point in the circuit.
    [0006]
    6. System according to any one of claims 1 to 5, CHARACTERIZED by the fact that the control means are arranged, in both modes, to control the content of a component of the perfusion fluid, but also to control the flow of fluid in the perfusion circuit in a different way in each of the two modes.
    [0007]
    7. System according to any one of claims 1 to 6, CHARACTERIZED by the fact that it additionally comprises adjustment means for adjusting the content of a component in the fluid, measuring means for measuring the content of said component in the perfusion fluid , and control means arranged to control the adjustment means to maintain said measured content within a target range.
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    同族专利:
    公开号 | 公开日
    ES2681229T3|2018-09-12|
    CA2855337A1|2013-05-16|
    US20170049096A1|2017-02-23|
    WO2013068751A2|2013-05-16|
    WO2013068751A3|2013-08-29|
    BR112014011356A2|2017-06-06|
    CA2855337C|2020-08-18|
    EP2775828B1|2018-05-30|
    CN104039135B|2016-01-20|
    GB2510080A|2014-07-23|
    GB2510080B|2017-09-27|
    CN104039135A|2014-09-10|
    US20140308654A1|2014-10-16|
    EP2775828A2|2014-09-17|
    GB201408214D0|2014-06-25|
    引用文献:
    公开号 | 申请日 | 公开日 | 申请人 | 专利标题
    US5157930A|1991-04-22|1992-10-27|Mcghee Samuel C|Organ preservation apparatus|
    DE19715152A1|1997-04-11|1998-10-15|Udo Prof Dr Franz|Equipment for perfusing limbs to extend live state during transplantation|
    US6642045B1|1997-04-14|2003-11-04|Breonics, Inc.|System for exsanguinous metabolic support of an organ or tissue|
    US6673594B1|1998-09-29|2004-01-06|Organ Recovery Systems|Apparatus and method for maintaining and/or restoring viability of organs|
    GB9908335D0|1999-04-12|1999-06-09|Univ Cambridge Tech|Methods and means for extracorporeal organ perfusion|
    US8128740B2|2003-04-04|2012-03-06|Organ Recovery Systems, Inc.|Device for separating gas from a liquid path|
    US8304181B2|2004-10-07|2012-11-06|Transmedics, Inc.|Method for ex-vivo organ care and for using lactate as an indication of donor organ status|
    DK1942726T3|2006-04-19|2017-04-10|Transmedics Inc|METHODS FOR EX VIVO ORGANIC CARE|
    SE531453C2|2007-07-06|2009-04-07|Xenodevice Ab|Organ evaluation and preservation system|
    US20100143192A1|2008-12-04|2010-06-10|Therox, Inc.|Method and device for combined detection of bubbles and flow rate in a system for enriching a bodily fluid with a gas|DE102011016508A1|2011-04-08|2012-10-11|Sorin Group Deutschland Gmbh|Temperature control device for use in fluid-based hyper / hypothermia systems|
    US10602740B2|2012-07-10|2020-03-31|Lifeline Scientific, Inc.|Organ perfusion apparatus with downstream flow control|
    EP2698176B1|2012-08-13|2017-03-15|Sorin Group Deutschland GmbH|Method and apparatus for disinfection of a temperature control device for human body temperature control during extracorporeal circulation|
    US9956388B2|2014-06-04|2018-05-01|Sonescence, Inc.|Systems and methods for therapeutic agent delivery|
    CN104430302B|2014-12-04|2016-05-18|宋涂润|For preserving the normal temperature filling system of human organ|
    BR112017010520A2|2014-12-12|2017-12-26|Freed Darren|organ perfusion apparatus and method|
    CN104705288B|2015-02-16|2016-09-07|杭州电子科技大学|Subnormal temperature transplant organ vitro intelligent supports System and method for|
    CN104739520B|2015-04-20|2017-06-27|匡仁锐|The control method of medical charging pump and the system using the method|
    CN105379707B|2015-12-16|2017-10-17|浙江大学|Liver normal temperature irrigates repair system|
    EP3487295B1|2016-07-22|2020-11-04|ETH Zürich|Perfusion loop assembly for an ex-vivo liver perfusion|
    ES2675882B1|2017-01-12|2019-04-26|Ebers Medical Tech S L|ORGAN PERFUSION TEAM|
    DE102017217782A1|2017-10-06|2019-04-11|Livanova Deutschland Gmbh|Heating / cooling device for an oxygenator|
    CN110568873A|2019-08-26|2019-12-13|广东顺德工业设计研究院|Online monitoring system for isolated organ perfusion pH|
    CN111658827A|2019-12-22|2020-09-15|西安定华电子股份有限公司|Organ stent preparation device and organ stent preparation method|
    CN111134110A|2019-12-31|2020-05-12|河南省人民医院|In vitro kidney perfusion system|
    法律状态:
    2018-03-27| B06F| Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]|
    2019-07-23| B06U| Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]|
    2020-01-07| B07A| Technical examination (opinion): publication of technical examination (opinion) [chapter 7.1 patent gazette]|
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    优先权:
    申请号 | 申请日 | 专利标题
    GB201119419A|GB201119419D0|2011-11-10|2011-11-10|Organ fluid measurement|
    GB1119419.8|2011-11-10|
    GB1119417.2|2011-11-10|
    GB201119417A|GB201119417D0|2011-11-10|2011-11-10|Organ perfusion systems|
    PCT/GB2012/052781|WO2013068751A2|2011-11-10|2012-11-08|Organ perfusion systems|
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