WO2021156460A1 - Organ transport apparatus - Google Patents

Organ transport apparatus Download PDF

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Publication number
WO2021156460A1
WO2021156460A1 PCT/EP2021/052842 EP2021052842W WO2021156460A1 WO 2021156460 A1 WO2021156460 A1 WO 2021156460A1 EP 2021052842 W EP2021052842 W EP 2021052842W WO 2021156460 A1 WO2021156460 A1 WO 2021156460A1
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WO
WIPO (PCT)
Prior art keywords
body part
fluid
outer container
perfusion
inner container
Prior art date
Application number
PCT/EP2021/052842
Other languages
French (fr)
Inventor
Terence Gourlay
Original Assignee
The University Of Strathclyde
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by The University Of Strathclyde filed Critical The University Of Strathclyde
Publication of WO2021156460A1 publication Critical patent/WO2021156460A1/en

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Classifications

    • A—HUMAN NECESSITIES
    • A01—AGRICULTURE; FORESTRY; ANIMAL HUSBANDRY; HUNTING; TRAPPING; FISHING
    • A01N—PRESERVATION OF BODIES OF HUMANS OR ANIMALS OR PLANTS OR PARTS THEREOF; BIOCIDES, e.g. AS DISINFECTANTS, AS PESTICIDES OR AS HERBICIDES; PEST REPELLANTS OR ATTRACTANTS; PLANT GROWTH REGULATORS
    • A01N1/00—Preservation of bodies of humans or animals, or parts thereof
    • A01N1/02—Preservation of living parts
    • A01N1/0236—Mechanical aspects
    • A01N1/0242—Apparatuses, i.e. devices used in the process of preservation of living parts, such as pumps, refrigeration devices or any other devices featuring moving parts and/or temperature controlling components
    • A01N1/0247—Apparatuses, i.e. devices used in the process of preservation of living parts, such as pumps, refrigeration devices or any other devices featuring moving parts and/or temperature controlling components for perfusion, i.e. for circulating fluid through organs, blood vessels or other living parts
    • A—HUMAN NECESSITIES
    • A01—AGRICULTURE; FORESTRY; ANIMAL HUSBANDRY; HUNTING; TRAPPING; FISHING
    • A01N—PRESERVATION OF BODIES OF HUMANS OR ANIMALS OR PLANTS OR PARTS THEREOF; BIOCIDES, e.g. AS DISINFECTANTS, AS PESTICIDES OR AS HERBICIDES; PEST REPELLANTS OR ATTRACTANTS; PLANT GROWTH REGULATORS
    • A01N1/00—Preservation of bodies of humans or animals, or parts thereof
    • A01N1/02—Preservation of living parts
    • A—HUMAN NECESSITIES
    • A01—AGRICULTURE; FORESTRY; ANIMAL HUSBANDRY; HUNTING; TRAPPING; FISHING
    • A01N—PRESERVATION OF BODIES OF HUMANS OR ANIMALS OR PLANTS OR PARTS THEREOF; BIOCIDES, e.g. AS DISINFECTANTS, AS PESTICIDES OR AS HERBICIDES; PEST REPELLANTS OR ATTRACTANTS; PLANT GROWTH REGULATORS
    • A01N1/00—Preservation of bodies of humans or animals, or parts thereof
    • A01N1/02—Preservation of living parts
    • A01N1/0236—Mechanical aspects
    • A01N1/0242—Apparatuses, i.e. devices used in the process of preservation of living parts, such as pumps, refrigeration devices or any other devices featuring moving parts and/or temperature controlling components

Definitions

  • the present invention relates to an apparatus, system and method for transporting a body part, such as an organ and/or tissues, of a subject.
  • a body part such as an organ and/or tissues
  • the present invention relates to an apparatus and method for preserving a body part intended for transplantation, e.g., an organ and/or tissues, during transportation thereof.
  • organ transplantation has become a common medical procedure.
  • kidney transplantation has become the treatment of choice for patients suffering from end-stage renal disease (ESRD) providing superior quality of life, longer patient survival, and reduced health care costs when compared to dialysis [Wolfe 1999, Tonelli 2011 , Rana 2015].
  • ESRD end-stage renal disease
  • organ transplantation is the only effective therapy for patients with end-stage disease the treatment of choice for patients suffering from end-stage renal disease (ESRD) providing superior quality of life, longer patient survival, and reduced health care costs when compared to dialysis [Wolfe 1999, Tonelli 2011 , Rana 2015].
  • a number of techniques have been used over time to store, preserve and/or transport organs and/or tissues, for example, kidneys, prior to transplantation.
  • Static Cold Storage (SCS) SCS involves flushing the procured organ with preservation solution at 0-4 °C, then immersing it into preservation solution at the same temperature until transplantation, resulting in decreased cellular metabolism [Jing 2018]
  • MP Machine Perfusion
  • Hypothermic Machine perfusion which is typically performed at 0-8 °C and is based on the concept that oxidative energy production by mitochondrial electron transport is sustained at hypothermic temperatures (Jing 2018), Normothermic Machine Perfusion (NMP) which is performed at 35-38 °C is a method of perfusing organs under physiologic conditions to maintain metabolic activity and viability [Jing 2018],
  • Subnormothermic Machine Perfusion which is performed at 20-34 °C and thus is a midway approach between HMP and NMP that provides oxygenated perfusate at warm but not physiological conditions [Berendsen 2012, Bral 2018], and
  • Controlled Oxygen Rewarming which is performed at 8-20 °C and is an alternative organ perfusion method involving a slow, gradual rise in the perfusate temperature [Kath2018, Jing 2018].
  • HOPE Hypothermic Oxygenated Perfusion
  • Fral 2018 Hypothermic Oxygenated Perfusion
  • Persufflation which delivers humidified, gaseous oxygen directly to the organ via its vasculature
  • an apparatus for transporting and/or preserving a body part comprising: an inner container configured to receive a body part and a receiving fluid; an inlet configured to connect the body part to a perfusion device; and a heating device configured to heat and/or control or regulate temperature of at least a portion of the body part and/or of the receiving fluid.
  • body part will be herein understood as comprising an organised tissue structure such as an internal or external organ or part of an organ, e.g. kidney, liver, heart, lung, pancreas, gallbladder, spleen, etc, and/or an organised tissue structure including for example a face or part thereof, skin graft, or the like.
  • an organised tissue structure such as an internal or external organ or part of an organ, e.g. kidney, liver, heart, lung, pancreas, gallbladder, spleen, etc, and/or an organised tissue structure including for example a face or part thereof, skin graft, or the like.
  • the receiving fluid may be a receiving liquid.
  • the receiving fluid may comprise, may consist essentially of or may consist of blood.
  • the blood may comprise the subject’s own blood, a donor’s blood, and/or blood obtained from a blood bank, e.g. blood of a compatible blood type.
  • the receiving fluid may comprise, may consist essentially of or may consist of a physiologically acceptable fluid such as plasma, serum or a saline or isotonic solution.
  • the body part e.g. organ and/or tissue, may be provided and/or preserved in a protective environment.
  • this may allow temperature regulation or control of the body part via the medium of the receiving liquid.
  • the heating device configured to heat and/or control or regulate the temperature of at least a portion of the body part by heating and/or controlling or regulating the temperature of the receiving fluid.
  • the temperature of at least a portion of the body part may be controlled or regulated indirectly via the receiving fluid.
  • the heating device may be or may comprise a heat pad.
  • heating device There may be provided one heating device or a plurality of heating devices.
  • the heating device may be or may comprise an electric heating device, e.g. an electric heat pad.
  • the heating device may be battery powered, which may improve portability of the device and/or may provide continuous power and durable autonomy.
  • the electric heating device may comprise one or more solid state heating elements, e.g. Peltier devices, which may improve the accuracy of the temperature control or regulation.
  • the heating device may be or may comprise a chemical heat device, e.g., a chemical heat pad. This may further improve portability but may offer lower power or autonomy.
  • the heating device may be configured to heat and/or to control or regulate the temperature of the receiving fluid, e.g. blood.
  • the heating device may be provided on a surface, e.g. an outer surface of, the inner bag.
  • the inner container e.g. an outer surface thereof, may comprise at least one packet configured to receive one or more heating devices.
  • a/the heating device may be attached, e.g. by adhesive or attaching means such as clips or the like, to the inner container, e.g. to an outer surface thereof.
  • the inner container may be configured to allow heat transfer from the heating device through the inner container.
  • the inner container may be made of a thin material, such as a plastic film or sheet.
  • the inner container may be transparent, which may allow visual monitoring of the body part.
  • the apparatus may further comprise an outer container configured to receive at least a portion of the inner container.
  • the inner container e.g. inner bag
  • the body part may be protected from potential damage.
  • the inner bag containing the body part may be conveniently removed from the outer bag, while still being maintained in a sealed environment.
  • the outer container may be made of a transparent material, e.g. plastic. This may help visual monitoring of the body part.
  • The/a heating device may be configured to heat and/or to control or regulate the temperature of the receiving fluid, e.g. blood.
  • The/a heating device may be provided on a surface, e.g. an outer surface of, the outer container. In such instance the/a heating device may be configured to heat and/or to control or regulate the temperature of the receiving fluid, e.g. blood, through the outer container.
  • the outer container e.g. an outer surface thereof, may comprise a pocket configured to receive a/the heating device.
  • a/the heating device may be attached, e.g. by adhesive or attaching means such as clips or the like, to the outer container, e.g. to an outer surface thereof.
  • the inner container may define an inner chamber.
  • the inner chamber may comprise and/or may at least be partially filled with a/the receiving fluid.
  • the outer container may define an outer container receiving chamber configured to receive the inner container.
  • the outer container may comprise or may at least partially be filled with an outer container fluid, e.g. an outer container liquid, such as a saline solution.
  • an outer container fluid e.g. an outer container liquid, such as a saline solution.
  • the outer container fluid may be provided within the outer container receiving chamber.
  • the inner container may be at least partially provided within the outer container fluid, e.g. saline solution, in the outer container receiving chamber.
  • the outer container fluid may be provided within a portion of the outer container distinct from the outer container receiving chamber.
  • the outer container may comprise or may define an annular space or volume configured to receive or hold the outer container fluid.
  • the annular space or volume may define the outer container receiving chamber.
  • the outer container may comprise an outer wall defining an outer surface of the outer container and/or of the annular space.
  • the outer container may comprise an inner wall defining an inner surface of the annular space and/or defining the outer container receiving chamber. In such instance, in use, the inner container may be at least partially provided inwards of the outer container receiving chamber, and may be at least partially surrounded by the annular space and/or the outer container fluid therein.
  • temperature of the body part may be regulated and/or controlled by controlling the temperature of the outer container fluid, e.g. saline solution, which in turns may control and/or regulate the temperature of the receiving fluid, e.g. blood, in the inner container.
  • the outer container may be configured to allow heat transfer from the/a heating device through the outer container.
  • the outer container may be made of a thin material, such as a plastic film of sheet.
  • heat transfer between the heated outer container fluid and the inner container receiving fluid may occur through a single solid barrier (the inner container) which may therefore optimise heat transfer.
  • heat transfer between the heated outer container fluid and the inner container receiving fluid may occur through two solid barriers (the inner wall of the of the annular space the outer container, and the inner container wall) which may therefore be less effective in terms of heat transfer between the outer container fluid and the inner container receiving fluid, but may improve safety and may reduce risks of contamination of the inner container receiving fluid and thus of the body part.
  • the outer container may be transparent, which may allow visual monitoring of the body part.
  • the inner container may comprise a/the inlet configured to connect the body part to a perfusion device.
  • the body part may be perfused, e.g. continually or intermittently.
  • a/the body part may be cannulated after harvesting.
  • An/the inlet cannula may be connected to a/the inlet to allow perfusion of the body part.
  • body parts which may involve connection to an open perfusion system (e.g., inlet only) include faces, skin grafts, etc.
  • the inner container may comprise an outlet configured to connect the body part to a perfusion device.
  • the body part may be perfused, e.g. continually or intermittently, for example using a closed perfusion system or circuit.
  • a/the body part may be cannulated after harvesting.
  • An/the outlet cannula may be connected to a/the outlet to allow perfusion, e.g. closed perfusion, of the body part.
  • body parts which may involve connection to a closed perfusion circuit include kidneys, livers, hearts, etc.
  • the inlet may permit flow of perfused fluid from the perfusion device to the body part.
  • the outlet may permit flow of fluid from the body part to the perfusion device.
  • the apparatus may comprise a drainage reservoir which may configured to collect or receive a material, e.g. a fluid, produced by the body part.
  • a drainage reservoir which may be configured to collect or receive urine.
  • the drainage reservoir may comprise or may be a urine collector.
  • the provision of a drainage reservoir, e.g. urine collector may permit assessment of the state of the body part.
  • the provision of a urine reservoir may allow monitoring the function of a kidney via urine production, and/or may allow monitoring the health level of a kidney by measuring the amount or volume of urine produced and/or by testing the urine produced, for example by performing a colourimetric assessment and/or a quantitative analysis of the urine in the drainage reservoir.
  • the apparatus may be connectable to, or may comprise, the perfusion device.
  • the perfusion device may comprise:
  • a pump arranged to circulate a fluid though the perfusion device and/or to the inlet;
  • the perfusion device may further comprise a fluid reservoir, e.g. a blood reservoir, which may supply fluid, e.g. blood to the inlet and/or to the oxygenator.
  • a fluid reservoir e.g. a blood reservoir
  • the fluid reservoir e.g. a blood reservoir
  • the perfusion circuit may form part of the perfusion circuit.
  • the perfusion device may further comprise an additional fluid reservoir.
  • the additional fluid reservoir may be configured to provide an additional fluid to the perfusion system or circuit. For example, when the body part is a kidney, loss of fluid from the perfusion circuit due to urine production may be compensated by feeding a fluid, e.g., blood or an isotonic fluid, to the perfusion system or circuit.
  • a fluid e.g., blood or an isotonic fluid
  • the apparatus may comprise or may be associated with a weight measuring device.
  • the weight measuring device may comprise a cantilever load cell.
  • the weight measuring device e.g., cantilever load cell, may be configured to measure the weight of the apparatus or to measure and/or detect a change in the weight of the apparatus, in use. This may help determine, regulate and/or control the amount, e.g. weight, of additional fluid from the additional fluid reservoir required to compensate for any loss of fluid in the perfusion circuit, for example due to urine production by a/the kidney.
  • the apparatus and/or the perfusion system may comprise at least one fluid flow sensor.
  • the at least one fluid flow sensor may comprise at least one ultrasonic Doppler fluid flow sensor, and may be attached, e.g. clipped, to a conduit, e.g. a tube, of the perfusion system or circuit.
  • the pump may be controllable.
  • the pump e.g. pump power, may be controllable and/or adjustable based on the measured fluid flow, e.g. blood flow.
  • the apparatus may comprise or may be associated with a combined and/or integrated oxygenating device and temperature control device.
  • the combined and/or integrated oxygenating device and temperature control device may provide not only fluid, e.g. blood, recirculation to the body part, but may also provide blood oxygenation thus providing the metabolic needs of the body part.
  • the provision of a temperature control device capability may also help further regulate and/or control the temperature of the body part.
  • the combined and/or integrated blood oxygenating device and temperature control device may further comprise a pump.
  • the pump may comprise or may be the pump of the perfusion device used for pumping and/or circulating the fluid, e.g. blood.
  • a combined or integrated pumping, blood oxygenating device and temperature control device for example as described in PCT Application Publication No. WO 2012/013925 (Gourlay), the content of which is incorporated herein by reference in its entirety.
  • the perfusion device may further comprise a blood treatment unit.
  • the blood treatment unit may be configured to alter, e.g. to remove, certain components of the blood.
  • the blood treatment unit may be configured to remove one or more components of the blood that are susceptible of inducing or suppressing an inflammatory response in the subject.
  • the blood treatment unit may comprise a filtration element.
  • the blood treatment unit may comprise an element, e.g. a filtration element, capable of removing cytokines.
  • the perfusion device may comprise a blood sterilisation unit.
  • the blood sterilisation unit may be configured to remove or kill pathogenic components in the blood.
  • the blood sterilisation unit may be a light sterilisation unit, which may be configured to emit or pass radiation through the blood, e.g. UV radiation, or a High Intensity Narrow Spectrum (HINS) light.
  • HINS High Intensity Narrow Spectrum
  • the perfusion system may further comprise at least one oxygen sensor for measuring oxygen levels within the fluid, e.g. blood.
  • the at least one oxygen sensor may comprise a colourimetric sensor.
  • the perfusion device may further comprise a control unit which may control or interact with the pump so as to be capable of regulating the flow of fluid through the perfusion system of circuit.
  • the control unit may comprise a user interface which may display, e.g. flow rate, oxygen levels, and/or air bubble levels.
  • the user interface may comprise a screen, e.g. an LCD touchpad screen.
  • the user interface and/or control unit may be connected to the perfusion device.
  • control unit may be in communication with the at least one flow sensor.
  • the control unit may comprise an automated mode in which the control unit may automatically control and/or adjust the pump flow rate when fluid flow is outside a predetermined range.
  • control unit may comprise a manual mode in which a user may manually control and/or adjust the pump flow rate, e.g. though the user interface, when the fluid flow is outside a range of predetermined flow rates.
  • control unit and/or the user interface may further comprise an alarm and/or warning display, e.g. visual or sound display, which may be in communication with, e.g. the at least one oxygen sensor, the at least one bubble detector, and or the at least one fluid flow sensor.
  • an alarm and/or warning display e.g. visual or sound display, which may be in communication with, e.g. the at least one oxygen sensor, the at least one bubble detector, and or the at least one fluid flow sensor.
  • the at least one oxygen sensor may trigger activation of the alarm and/or warning display when the at least one oxygen sensor detects that oxygen levels in the fluid are outside a predetermined range.
  • the at least one bubble detector may trigger activation of the alarm and/or warning display when the at least one at least one bubble detector detects that air bubble levels in the fluid flow are above a predetermined level.
  • the at least one fluid flow sensor may trigger activation of the alarm and/or warning display when the at least one flow sensor detects that fluid flow rate are outside a predetermined range.
  • control unit may be remotely accessible by BluetoothTM technology, Wi-Fi technology and the like.
  • a user may be able to control and/or operate the control unit remotely.
  • a system for transporting and/or preserving a body part comprising: an inner container configured to receive a body part and a receiving fluid; an inlet configured to connect the body part to a perfusion device, wherein the body part is cannulated to the inlet; a heating device configured to heat and/or control or regulate temperature of at least a portion of the body part and/or of the receiving fluid; and a perfusion device connected to the inlet and configured to perfuse the body part.
  • the system may comprise an outlet.
  • the body part may be cannulated to the outlet.
  • the perfusion device may be connected to the outlet and may be configured to perfuse the body part.
  • the inlet may permit flow of perfused fluid to the body part.
  • the outlet may permit flow of fluid from the body part to the perfusion device.
  • the system may comprise or may be provided in a housing.
  • the housing may be configured to hold and/or store one or more elements of the perfusion system and/or of the apparatus.
  • the housing may comprise one or more support elements configured to support, connect to or receive one or more of:
  • any element of the system that be provided as a flexible part e.g. a bag, may be stored in a safe and protective environment.
  • One or more elements of the perfusion system may also be provided within and/or secured or attached to the housing, e.g. to one or more inner walls thereof, e.g. oxygenator, pump(s), tubes or cannulae, etc.
  • a method of transporting and/or preserving a body part comprising: providing a body part in an inner container, the inner container containing a receiving fluid; connecting the body part to an inlet configured to be connected to a perfusion device; and controlling and/or regulating the temperature of the receiving fluid by a heating device.
  • the method may comprise controlling and/or regulating the temperature of the body part by controlling and/or regulating the temperature of the receiving fluid.
  • the method may comprise perfusing the body part.
  • the method may comprise connecting the body part to an outlet configured to be connected to the perfusion device.
  • the method may comprise providing the inner container, e.g., inner bag, at least partially within an outer container, e.g., outer bag.
  • the method may comprise controlling and/or regulating the temperature of outer container.
  • the method may comprise controlling and/or regulating the temperature of an outer container fluid.
  • the method may comprise controlling and/or regulating the temperature of the body part and/or of the receiving fluid by controlling and/or regulating the temperature of the outer container fluid.
  • Figure 1 a perspective view of an apparatus according to a first embodiment of the present invention
  • Figure 2 a perspective view of an inner container of the apparatus of Figure 1 ;
  • Figure 3 a perspective view of a first side of an outer container of the apparatus of Figure 1 ;
  • Figure 4 a perspective view of a second side of an outer container of the apparatus of Figure 1 ;
  • Figure 5 a perspective view of the inner container of Figure 1 , holding an organ
  • Figure 6 a perspective view of the apparatus of Figure 1 , holding an organ
  • Figure 7 a perspective view of a system according to a second embodiment of the present invention, including the apparatus of Figure 1 ;
  • Figure 8 a perspective view of the system of Figure 7, holding an organ;
  • Figures 9-10 a perspective view and close up view of an embodiment of the outer container of Figure 3, including a cantilever load cell;
  • Figure 11 a perspective view of a housing for the system of Figure 7, including a housing;
  • FIGS 12-13 perspective views of the system of Figure 7, including the housing of Figure 11.
  • FIG. 1 there is shown a perspective view of an apparatus, generally designated 10, according to a first embodiment of the present invention.
  • the apparatus 10 includes an inner container 30 (shown separately in Figure 2) configured to receive a body part 40 (as illustrated in Figures 5-6) and a receiving fluid 37.
  • the apparatus 10 has an inlet 31 configured to connect the body part 40 to a perfusion device 50.
  • the inlet 31 is connected to organ 40, in this embodiment a kidney, via inlet cannula 35, to allow a perfusion fluid to be circulated from the perfusion system 50 to the kidney 40.
  • the organ 40 is a kidney.
  • the body part may be an internal or external organ or part of an organ, e.g. kidney, liver, heart, lung, pancreas, gallbladder, spleen, etc, and/or an organised tissue structure including for example a face or part thereof, skin graft, or the like.
  • the inner container 30 also has an outlet 32 connected to the kidney 40 via outlet cannula 36 to allow a perfusion fluid to be circulated from the kidney 40 to the perfusion system 50.
  • the body part being held in the apparatus 10 may not require closed perfusion, and may therefore only be connected to inlet 31 via one of more cannulae to be fed a perfusion fluid. This might apply for example to faces, skin grafts, or the like.
  • the inner container 30 is in the form of a transparent flexible bag, which permits convenient visual inspection of the organ 40 therein.
  • the apparatus 10 also includes a heating device 25 configured to heat and/or control or regulate temperature of at least a portion of the body part 40 and/or of the receiving fluid 37 provided in the inner bag 30.
  • the inner bag 30 is configured to allow heat transfer from the heating device 25 through the inner bag 30.
  • the inner bag 30 is made of a thin plastic film of sheet to allow heat transfer, and is transparent which allows visual monitoring of the body part 40.
  • the apparatus includes an outer container 20 configured to receive the inner container 30.
  • this may provide additional protection for the body part 40 from potential damage, and also may protect the inner bag 30, in use.
  • the heating device 25 is provided on an outer surface of a first side 21 of the outer bag 20.
  • the second side 22 is devoid of a heating device, but it will be appreciated that in other embodiments one or more sides, e.g. both sides 21 ,22, may be provided with one or more heating devices 25.
  • the outer bag 20 is configured to allow heat transfer from the heating device 25 through the outer bag 20.
  • the outer bag 20 is made of a thin plastic film of sheet, and is transparent which may allow visual monitoring of the body part.
  • the receiving fluid 37 in the inner bag 30 is a receiving liquid.
  • the inner bag 30 receiving the kidney 40 is filled or partially filled with blood 37.
  • the kidney 40 is provided and/or preserved in a protective environment and is less likely to suffer damage from e.g., impact, shock, friction, or contact.
  • provision of a receiving liquid 37 in the inner bag 30 allows temperature regulation or control of the kidney 40 via the medium of the receiving liquid 37.
  • the heating device 25 is an electrical heat pad 25 which is powered by battery, which may improve portability of the device and/or may provide continuous power and durable autonomy. It will be appreciated that other forms of portable heating devices may be envisaged, such as a chemical heat device, e.g., a chemical heat pad.
  • the heat pad 25 is attached to first side 21 of outer bag 20 by an adhesive, but it will be appreciated that the heat pad may also be attached to the outer bag 20 by mechanical attaching means such as clips, hook-and-loop devices (e.g. Velcro®) or the like.
  • the outer bag 20 may be provided with a pocket configured to receive the heating device 25.
  • the outer bag 20 defines a receiving chamber configured to receive the inner bag 30 and a heat transfer liquid, here a saline solution.
  • a heat transfer liquid here a saline solution.
  • the outer bag 20 may define a sealed outer chamber filled with an outer liquid, such that the outer chamber and liquid therein define a space configured to receive the inner bag 30.
  • heat transfer may be less effective as it required heat transfer through two solid barriers (the inner wall of the of the annular space the outer bag 20, and the wall of the inner bag 30), this arrangement may improve safety and may reduce risks of contamination of the inner container receiving fluid and thus of the body part 40.
  • the temperature of the body part 40 is regulated and/or controlled by controlling the temperature of the outer bag liquid, which in turns controls and/or regulates the temperature of the receiving fluid 37, e.g. blood, in the inner bag 30.
  • the outer bag 20 is made of a thin plastic film of sheet, and is transparent which may allow visual monitoring of the body part 40.
  • the outer bag may be sealable, and comprise a seal, e.g. a zip lock, to provide a sealed environment for the inner bag 30, in use.
  • a seal e.g. a zip lock
  • the inner bag 30 containing the body part 40 can be conveniently removed from the outer bag 20 as required, e.g. after transport, while still being maintained in a sealed environment.
  • the apparatus 10 also comprises a drainage reservoir 33 which is configured to collect or receive a material, e.g. a fluid, produced by the body part 40.
  • a material e.g. a fluid
  • the drainage reservoir is a urine collector 33 configured to collect or receive urine produced by the kidney 40 via drainage cannula 34.
  • the provision of a urine collector 33 allows assessment of the state of the kidney during transport.
  • the provision of a urine reservoir 33 allows the function of the kidney 40 to be monitored in that production of urine into the urine collector 33 indicated that the kidney functions normally and is therefore viable.
  • the health level of the kidney 40 may also be assessed by measuring the amount or volume of urine produced by the kidney 40 and/or by testing the urine produced, for example by performing a colourimetric assessment and/or a quantitative analysis of the urine in the urine collector 33.
  • Figure 7 there is shown a system 50 for transporting and/or preserving a body part, using the apparatus 10 described in relation to Figures 1 -6.
  • Figure 8 shows the system of Figure 7 with a kidney 40 in the apparatus 10.
  • the system 50 includes the apparatus 10, and a perfusion device 59.
  • the perfusion device 59 is connected to the inlet 31 to feed a perfusion fluid to the kidney 40, and to the outlet 32 to feed the fluid from the kidney 40 back to the perfusion device 59, thus defining a closed perfusion circuit.
  • the perfusion device 59 comprises:
  • a pump 53 arranged to circulate the perfusion fluid from the outlet 32 to the inlet 31 .
  • the pump circulates the perfusion fluid through the oxygenator 51.
  • the perfusion device 59 further comprises a fluid reservoir 52 which supplies the perfusion fluid to the inlet 21 and/or to the oxygenator 51 .
  • the perfusion fluid in the fluid reservoir 52 is blood. Because the system 50 defines a closed perfusion circuit, the fluid reservoir 52 forms part of the perfusion circuit. It will be appreciated that in other embodiments where the perfusion device may not define a closed circuit, e.g., to perfuse organised tissue structures such as skin grafts, a face or part thereof, the pump 53 may feed the perfusion fluid to the inlet 31 via the oxygenator 51 , with no return of perfusion fluid through outlet 32.
  • the perfusion device 59 further comprises an additional fluid reservoir 55.
  • the additional fluid reservoir is configured to provide an additional fluid to the perfusion system 50 via additional pump 56.
  • additional pump 56 For example, when loss of perfusion fluid occurs from the perfusion circuit due to urine production by the kidney 40, such loss of perfusion fluid may be compensated by feeding a fluid, e.g., blood or an isotonic fluid, from the additional fluid reservoir 55 to the perfusion system or circuit via pump 56.
  • a fluid e.g., blood or an isotonic fluid
  • the apparatus 10 is equipped with a cantilever load cell 26.
  • the cantilever load cell 26 is configured to measure the weight of the apparatus 10 or to measure and/or detect a change in the weight of the apparatus 10, in use. This helps determine, regulate and/or control the amount, e.g. weight, of additional fluid from the additional fluid reservoir 55 required to compensate for any loss of fluid in the perfusion circuit, for example due to urine production by the kidney 40.
  • a housing 60 configured to be used in conjunction with the apparatus 10 and/or system 50.
  • the housing 60 is configured to hold and/or store the elements of the perfusion system.
  • the housing 60 is configured to receive and hold apparatus 10, fluid reservoir 52, and additional fluid reservoir 55.
  • any element of the system 50 that is provided as a flexible part, e.g. a bag, can be stored in a safe and protective environment within the housing 60.
  • the other elements of the perfusion system 60 are also provided within and secured or attached to the housing 60, including oxygenator 51 , pump 53,56 as well as tubes or cannulae (not shown) provided as part of the system 50.
  • Figures 12-13 show the housing 60 with apparatus 10, fluid reservoir 52, and additional fluid reservoir 55 secured inside the housing 60.
  • the housing also has a display 62 to provide a user with information regarding any measured data within the system, e.g. flow, pressure, temperature or the like, and controls 64 to adjust and/or set any preferred parameters, e.g. temperature, flow, pressure, or the like.

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Abstract

An apparatus for transporting and/or preserving a body part (40) comprises an inner container (30) configured to receive the body part and a receiving fluid; an inlet (31) configured to connect the body part to a perfusion device; and a heating device configured to heat and/or control or regulate temperature of at least a portion of the body part and/or of the receiving fluid. The apparatus may further include an outer container (20) to provide additional protection for the body part and the inner container. The inner and the outer container may be made of a plastic film or sheet. The heating device may be a heat pad provided on an outer surface of the inner or outer container. The inner container may further comprise an outlet (32) configured to connect the body part to the perfusion device. A drainage reservoir may also be provided.

Description

Organ Transport Apparatus
Field of invention
The present invention relates to an apparatus, system and method for transporting a body part, such as an organ and/or tissues, of a subject. In particular, though not exclusively, the present invention relates to an apparatus and method for preserving a body part intended for transplantation, e.g., an organ and/or tissues, during transportation thereof.
Background to Invention
Advances in surgical technique, anaesthetic management, and postoperative care mean organ transplantation has become a common medical procedure. For example, kidney transplantation has become the treatment of choice for patients suffering from end-stage renal disease (ESRD) providing superior quality of life, longer patient survival, and reduced health care costs when compared to dialysis [Wolfe 1999, Tonelli 2011 , Rana 2015]. Moreover, in many cases organ transplantation is the only effective therapy for patients with end-stage disease the treatment of choice for patients suffering from end-stage renal disease (ESRD) providing superior quality of life, longer patient survival, and reduced health care costs when compared to dialysis [Wolfe 1999, Tonelli 2011 , Rana 2015].
A number of techniques have been used over time to store, preserve and/or transport organs and/or tissues, for example, kidneys, prior to transplantation.
Static Cold Storage (SCS) SCS involves flushing the procured organ with preservation solution at 0-4 °C, then immersing it into preservation solution at the same temperature until transplantation, resulting in decreased cellular metabolism [Jing 2018]
In contrast to SCS, Machine Perfusion (MP) involves maintaining cellular metabolism in a dynamic physiological environment [Bral 2018]. The benefits of MP are thought to derive from removal of toxic products and the provision of energy substrates [Kaths 2018]. MP can be carried out under different conditions, and can be classified as:
Hypothermic Machine perfusion (HMP) which is typically performed at 0-8 °C and is based on the concept that oxidative energy production by mitochondrial electron transport is sustained at hypothermic temperatures (Jing 2018), Normothermic Machine Perfusion (NMP) which is performed at 35-38 °C is a method of perfusing organs under physiologic conditions to maintain metabolic activity and viability [Jing 2018],
Subnormothermic Machine Perfusion (SNMP) which is performed at 20-34 °C and thus is a midway approach between HMP and NMP that provides oxygenated perfusate at warm but not physiological conditions [Berendsen 2012, Bral 2018], and
Controlled Oxygen Rewarming (COR) which is performed at 8-20 °C and is an alternative organ perfusion method involving a slow, gradual rise in the perfusate temperature [Kath2018, Jing 2018].
Other approaches include Hypothermic Oxygenated Perfusion (HOPE) which provides supplemental oxygen to HMP [Bral 2018], and Persufflation which delivers humidified, gaseous oxygen directly to the organ via its vasculature [Min and Papas 2018]
However, the current techniques tend to be bulky, complex, expensive and/or rely on specialist knowledge or expertise.
It is an object of at least one embodiment of at least one aspect of the present invention to alleviate and/or mitigate one or more problems or disadvantages associated with the prior art.
Summary of Invention
According to a first aspect of the present invention there is provided an apparatus for transporting and/or preserving a body part, the apparatus comprising: an inner container configured to receive a body part and a receiving fluid; an inlet configured to connect the body part to a perfusion device; and a heating device configured to heat and/or control or regulate temperature of at least a portion of the body part and/or of the receiving fluid.
The term body part will be herein understood as comprising an organised tissue structure such as an internal or external organ or part of an organ, e.g. kidney, liver, heart, lung, pancreas, gallbladder, spleen, etc, and/or an organised tissue structure including for example a face or part thereof, skin graft, or the like.
Preferably, the receiving fluid may be a receiving liquid. Typically, the receiving fluid may comprise, may consist essentially of or may consist of blood. The blood may comprise the subject’s own blood, a donor’s blood, and/or blood obtained from a blood bank, e.g. blood of a compatible blood type. Alternatively, the receiving fluid may comprise, may consist essentially of or may consist of a physiologically acceptable fluid such as plasma, serum or a saline or isotonic solution. By providing a receiving liquid, the body part, e.g. organ and/or tissue, may be provided and/or preserved in a protective environment. Advantageously also, this may allow temperature regulation or control of the body part via the medium of the receiving liquid. Thus, in an embodiment, the heating device configured to heat and/or control or regulate the temperature of at least a portion of the body part by heating and/or controlling or regulating the temperature of the receiving fluid. The temperature of at least a portion of the body part may be controlled or regulated indirectly via the receiving fluid.
The heating device may be or may comprise a heat pad.
There may be provided one heating device or a plurality of heating devices.
The heating device may be or may comprise an electric heating device, e.g. an electric heat pad. The heating device may be battery powered, which may improve portability of the device and/or may provide continuous power and durable autonomy. The electric heating device may comprise one or more solid state heating elements, e.g. Peltier devices, which may improve the accuracy of the temperature control or regulation.
The heating device may be or may comprise a chemical heat device, e.g., a chemical heat pad. This may further improve portability but may offer lower power or autonomy.
The heating device may be configured to heat and/or to control or regulate the temperature of the receiving fluid, e.g. blood. The heating device may be provided on a surface, e.g. an outer surface of, the inner bag.
The inner container, e.g. an outer surface thereof, may comprise at least one packet configured to receive one or more heating devices. Alternatively, or additionally, a/the heating device may be attached, e.g. by adhesive or attaching means such as clips or the like, to the inner container, e.g. to an outer surface thereof.
The inner container may be configured to allow heat transfer from the heating device through the inner container. Conveniently, the inner container may be made of a thin material, such as a plastic film or sheet. Advantageously, the inner container may be transparent, which may allow visual monitoring of the body part.
The apparatus may further comprise an outer container configured to receive at least a portion of the inner container. By such provision, the inner container, e.g. inner bag, and/or the body part may be protected from potential damage. Advantageously also, the inner bag containing the body part may be conveniently removed from the outer bag, while still being maintained in a sealed environment.
Conveniently, the outer container may be made of a transparent material, e.g. plastic. This may help visual monitoring of the body part.
The/a heating device may be configured to heat and/or to control or regulate the temperature of the receiving fluid, e.g. blood. The/a heating device may be provided on a surface, e.g. an outer surface of, the outer container. In such instance the/a heating device may be configured to heat and/or to control or regulate the temperature of the receiving fluid, e.g. blood, through the outer container.
The outer container, e.g. an outer surface thereof, may comprise a pocket configured to receive a/the heating device. Alternatively, or additionally, a/the heating device may be attached, e.g. by adhesive or attaching means such as clips or the like, to the outer container, e.g. to an outer surface thereof.
The inner container may define an inner chamber. The inner chamber may comprise and/or may at least be partially filled with a/the receiving fluid.
The outer container may define an outer container receiving chamber configured to receive the inner container.
The outer container may comprise or may at least partially be filled with an outer container fluid, e.g. an outer container liquid, such as a saline solution.
The outer container fluid may be provided within the outer container receiving chamber. In such instance, in use, the inner container may be at least partially provided within the outer container fluid, e.g. saline solution, in the outer container receiving chamber.
The outer container fluid may be provided within a portion of the outer container distinct from the outer container receiving chamber. The outer container may comprise or may define an annular space or volume configured to receive or hold the outer container fluid. The annular space or volume may define the outer container receiving chamber. The outer container may comprise an outer wall defining an outer surface of the outer container and/or of the annular space. The outer container may comprise an inner wall defining an inner surface of the annular space and/or defining the outer container receiving chamber. In such instance, in use, the inner container may be at least partially provided inwards of the outer container receiving chamber, and may be at least partially surrounded by the annular space and/or the outer container fluid therein. When the apparatus comprises an outer container having an outer container fluid, temperature of the body part may be regulated and/or controlled by controlling the temperature of the outer container fluid, e.g. saline solution, which in turns may control and/or regulate the temperature of the receiving fluid, e.g. blood, in the inner container. In such instance, the outer container may be configured to allow heat transfer from the/a heating device through the outer container. Conveniently, the outer container may be made of a thin material, such as a plastic film of sheet.
When the inner container is at least partially provided within the outer container fluid, e.g. saline solution, in the outer container receiving chamber, heat transfer between the heated outer container fluid and the inner container receiving fluid may occur through a single solid barrier (the inner container) which may therefore optimise heat transfer.
When the inner container is at least partially provided inwards of the annular outer container receiving chamber, heat transfer between the heated outer container fluid and the inner container receiving fluid may occur through two solid barriers (the inner wall of the of the annular space the outer container, and the inner container wall) which may therefore be less effective in terms of heat transfer between the outer container fluid and the inner container receiving fluid, but may improve safety and may reduce risks of contamination of the inner container receiving fluid and thus of the body part.
Advantageously, the outer container may be transparent, which may allow visual monitoring of the body part.
The inner container may comprise a/the inlet configured to connect the body part to a perfusion device. By such provision, the body part may be perfused, e.g. continually or intermittently. Typically a/the body part may be cannulated after harvesting. An/the inlet cannula may be connected to a/the inlet to allow perfusion of the body part. Examples of body parts which may involve connection to an open perfusion system (e.g., inlet only) include faces, skin grafts, etc.
The inner container may comprise an outlet configured to connect the body part to a perfusion device. By such provision, the body part may be perfused, e.g. continually or intermittently, for example using a closed perfusion system or circuit. Typically a/the body part may be cannulated after harvesting. An/the outlet cannula may be connected to a/the outlet to allow perfusion, e.g. closed perfusion, of the body part. Examples of body parts which may involve connection to a closed perfusion circuit include kidneys, livers, hearts, etc. In use, the inlet may permit flow of perfused fluid from the perfusion device to the body part. In use, the outlet may permit flow of fluid from the body part to the perfusion device.
Advantageously, the apparatus may comprise a drainage reservoir which may configured to collect or receive a material, e.g. a fluid, produced by the body part. In an embodiment, when the body part is a kidney, the apparatus may comprise a drainage reservoir which may be configured to collect or receive urine. The drainage reservoir may comprise or may be a urine collector. Advantageously, the provision of a drainage reservoir, e.g. urine collector, may permit assessment of the state of the body part. For example, the provision of a urine reservoir may allow monitoring the function of a kidney via urine production, and/or may allow monitoring the health level of a kidney by measuring the amount or volume of urine produced and/or by testing the urine produced, for example by performing a colourimetric assessment and/or a quantitative analysis of the urine in the drainage reservoir.
The apparatus may be connectable to, or may comprise, the perfusion device.
Typically, the perfusion device may comprise:
- a pump arranged to circulate a fluid though the perfusion device and/or to the inlet; and
- an oxygenator to oxygenate the fluid.
Typically, the perfusion device may further comprise a fluid reservoir, e.g. a blood reservoir, which may supply fluid, e.g. blood to the inlet and/or to the oxygenator. In the event of a closed perfusion system or circuit, the fluid reservoir, e.g. a blood reservoir, may form part of the perfusion circuit.
The perfusion device may further comprise an additional fluid reservoir. The additional fluid reservoir may be configured to provide an additional fluid to the perfusion system or circuit. For example, when the body part is a kidney, loss of fluid from the perfusion circuit due to urine production may be compensated by feeding a fluid, e.g., blood or an isotonic fluid, to the perfusion system or circuit.
The apparatus may comprise or may be associated with a weight measuring device. The weight measuring device may comprise a cantilever load cell. The weight measuring device, e.g., cantilever load cell, may be configured to measure the weight of the apparatus or to measure and/or detect a change in the weight of the apparatus, in use. This may help determine, regulate and/or control the amount, e.g. weight, of additional fluid from the additional fluid reservoir required to compensate for any loss of fluid in the perfusion circuit, for example due to urine production by a/the kidney. The apparatus and/or the perfusion system may comprise at least one fluid flow sensor. The at least one fluid flow sensor may comprise at least one ultrasonic Doppler fluid flow sensor, and may be attached, e.g. clipped, to a conduit, e.g. a tube, of the perfusion system or circuit.
The pump may be controllable. The pump, e.g. pump power, may be controllable and/or adjustable based on the measured fluid flow, e.g. blood flow.
Advantageously, the apparatus may comprise or may be associated with a combined and/or integrated oxygenating device and temperature control device. The combined and/or integrated oxygenating device and temperature control device may provide not only fluid, e.g. blood, recirculation to the body part, but may also provide blood oxygenation thus providing the metabolic needs of the body part. The provision of a temperature control device capability may also help further regulate and/or control the temperature of the body part.
The combined and/or integrated blood oxygenating device and temperature control device may further comprise a pump. The pump may comprise or may be the pump of the perfusion device used for pumping and/or circulating the fluid, e.g. blood.
In an embodiment, there may be provided a combined or integrated pumping, blood oxygenating device and temperature control device, for example as described in PCT Application Publication No. WO 2012/013925 (Gourlay), the content of which is incorporated herein by reference in its entirety.
The perfusion device may further comprise a blood treatment unit. The blood treatment unit may be configured to alter, e.g. to remove, certain components of the blood. In an embodiment, the blood treatment unit may be configured to remove one or more components of the blood that are susceptible of inducing or suppressing an inflammatory response in the subject. The blood treatment unit may comprise a filtration element. The blood treatment unit may comprise an element, e.g. a filtration element, capable of removing cytokines.
The perfusion device may comprise a blood sterilisation unit. The blood sterilisation unit may be configured to remove or kill pathogenic components in the blood. The blood sterilisation unit may be a light sterilisation unit, which may be configured to emit or pass radiation through the blood, e.g. UV radiation, or a High Intensity Narrow Spectrum (HINS) light.
The perfusion system may further comprise at least one oxygen sensor for measuring oxygen levels within the fluid, e.g. blood. The at least one oxygen sensor may comprise a colourimetric sensor.
The perfusion device may further comprise a control unit which may control or interact with the pump so as to be capable of regulating the flow of fluid through the perfusion system of circuit.
The control unit may comprise a user interface which may display, e.g. flow rate, oxygen levels, and/or air bubble levels.
The user interface may comprise a screen, e.g. an LCD touchpad screen.
The user interface and/or control unit may be connected to the perfusion device.
Conveniently, the control unit may be in communication with the at least one flow sensor.
The control unit may comprise an automated mode in which the control unit may automatically control and/or adjust the pump flow rate when fluid flow is outside a predetermined range.
Alternatively, or additionally, the control unit may comprise a manual mode in which a user may manually control and/or adjust the pump flow rate, e.g. though the user interface, when the fluid flow is outside a range of predetermined flow rates.
Conveniently, the control unit and/or the user interface may further comprise an alarm and/or warning display, e.g. visual or sound display, which may be in communication with, e.g. the at least one oxygen sensor, the at least one bubble detector, and or the at least one fluid flow sensor.
The at least one oxygen sensor may trigger activation of the alarm and/or warning display when the at least one oxygen sensor detects that oxygen levels in the fluid are outside a predetermined range.
The at least one bubble detector may trigger activation of the alarm and/or warning display when the at least one at least one bubble detector detects that air bubble levels in the fluid flow are above a predetermined level.
The at least one fluid flow sensor may trigger activation of the alarm and/or warning display when the at least one flow sensor detects that fluid flow rate are outside a predetermined range.
Conveniently, the control unit may be remotely accessible by Bluetooth™ technology, Wi-Fi technology and the like. By such provision a user may be able to control and/or operate the control unit remotely. According to a second aspect of the present invention there is provided a system for transporting and/or preserving a body part, comprising: an inner container configured to receive a body part and a receiving fluid; an inlet configured to connect the body part to a perfusion device, wherein the body part is cannulated to the inlet; a heating device configured to heat and/or control or regulate temperature of at least a portion of the body part and/or of the receiving fluid; and a perfusion device connected to the inlet and configured to perfuse the body part.
The system may comprise an outlet. The body part may be cannulated to the outlet. The perfusion device may be connected to the outlet and may be configured to perfuse the body part.
In use, the inlet may permit flow of perfused fluid to the body part. In use, the outlet may permit flow of fluid from the body part to the perfusion device.
The system may comprise or may be provided in a housing. Conveniently, the housing may be configured to hold and/or store one or more elements of the perfusion system and/or of the apparatus. Advantageously, the housing may comprise one or more support elements configured to support, connect to or receive one or more of:
- the apparatus;
- the fluid reservoir; and/or
- the additional fluid reservoir.
By such provision, any element of the system that be provided as a flexible part, e.g. a bag, may be stored in a safe and protective environment.
One or more elements of the perfusion system may also be provided within and/or secured or attached to the housing, e.g. to one or more inner walls thereof, e.g. oxygenator, pump(s), tubes or cannulae, etc.
The features described in relation to the apparatus according to the first aspect may apply in relation to the system according to the second aspect, and are not repeated here merely for brevity.
According to a third aspect of the invention, there is provided a method of transporting and/or preserving a body part, comprising: providing a body part in an inner container, the inner container containing a receiving fluid; connecting the body part to an inlet configured to be connected to a perfusion device; and controlling and/or regulating the temperature of the receiving fluid by a heating device.
The method may comprise controlling and/or regulating the temperature of the body part by controlling and/or regulating the temperature of the receiving fluid.
The method may comprise perfusing the body part.
The method may comprise connecting the body part to an outlet configured to be connected to the perfusion device.
The method may comprise providing the inner container, e.g., inner bag, at least partially within an outer container, e.g., outer bag. The method may comprise controlling and/or regulating the temperature of outer container. The method may comprise controlling and/or regulating the temperature of an outer container fluid. The method may comprise controlling and/or regulating the temperature of the body part and/or of the receiving fluid by controlling and/or regulating the temperature of the outer container fluid.
The features described in relation to the apparatus according to the first aspect or the system according to the second aspect may apply in relation to the method according to the third aspect, and are not repeated here merely for brevity.
Brief Description of Drawings
Embodiments of the invention will now be given by way of example only, and with reference to the accompanying drawings, which are:
Figure 1 a perspective view of an apparatus according to a first embodiment of the present invention;
Figure 2 a perspective view of an inner container of the apparatus of Figure 1 ;
Figure 3 a perspective view of a first side of an outer container of the apparatus of Figure 1 ;
Figure 4 a perspective view of a second side of an outer container of the apparatus of Figure 1 ;
Figure 5 a perspective view of the inner container of Figure 1 , holding an organ;
Figure 6 a perspective view of the apparatus of Figure 1 , holding an organ;
Figure 7 a perspective view of a system according to a second embodiment of the present invention, including the apparatus of Figure 1 ; Figure 8 a perspective view of the system of Figure 7, holding an organ;
Figures 9-10 a perspective view and close up view of an embodiment of the outer container of Figure 3, including a cantilever load cell;
Figure 11 a perspective view of a housing for the system of Figure 7, including a housing;
Figures 12-13perspective views of the system of Figure 7, including the housing of Figure 11.
Detailed Description Of Drawings
Referring to Figure 1 there is shown a perspective view of an apparatus, generally designated 10, according to a first embodiment of the present invention.
The apparatus 10 includes an inner container 30 (shown separately in Figure 2) configured to receive a body part 40 (as illustrated in Figures 5-6) and a receiving fluid 37.
The apparatus 10 has an inlet 31 configured to connect the body part 40 to a perfusion device 50. As best shown in Figures 5-6, the inlet 31 is connected to organ 40, in this embodiment a kidney, via inlet cannula 35, to allow a perfusion fluid to be circulated from the perfusion system 50 to the kidney 40.
In this embodiment, the organ 40 is a kidney. Flowever, in other embodiments, the body part may be an internal or external organ or part of an organ, e.g. kidney, liver, heart, lung, pancreas, gallbladder, spleen, etc, and/or an organised tissue structure including for example a face or part thereof, skin graft, or the like.
In this embodiment, because a kidney is typically perfused via a closed perfusion system 50, and the inner container 30 also has an outlet 32 connected to the kidney 40 via outlet cannula 36 to allow a perfusion fluid to be circulated from the kidney 40 to the perfusion system 50.
It will be appreciated that, in other embodiments, the body part being held in the apparatus 10 may not require closed perfusion, and may therefore only be connected to inlet 31 via one of more cannulae to be fed a perfusion fluid. This might apply for example to faces, skin grafts, or the like.
In this embodiment, the inner container 30 is in the form of a transparent flexible bag, which permits convenient visual inspection of the organ 40 therein.
The apparatus 10 also includes a heating device 25 configured to heat and/or control or regulate temperature of at least a portion of the body part 40 and/or of the receiving fluid 37 provided in the inner bag 30. The inner bag 30 is configured to allow heat transfer from the heating device 25 through the inner bag 30. Conveniently, the inner bag 30 is made of a thin plastic film of sheet to allow heat transfer, and is transparent which allows visual monitoring of the body part 40.
In this embodiment, the apparatus includes an outer container 20 configured to receive the inner container 30. Advantageously this may provide additional protection for the body part 40 from potential damage, and also may protect the inner bag 30, in use.
In this embodiment, as best shown in Figures 3-4, the heating device 25 is provided on an outer surface of a first side 21 of the outer bag 20. In this embodiment, the second side 22 is devoid of a heating device, but it will be appreciated that in other embodiments one or more sides, e.g. both sides 21 ,22, may be provided with one or more heating devices 25.
The outer bag 20 is configured to allow heat transfer from the heating device 25 through the outer bag 20. Conveniently, the outer bag 20 is made of a thin plastic film of sheet, and is transparent which may allow visual monitoring of the body part.
Preferably, the receiving fluid 37 in the inner bag 30 is a receiving liquid. In this embodiment, the inner bag 30 receiving the kidney 40 is filled or partially filled with blood 37. By such provision, the kidney 40 is provided and/or preserved in a protective environment and is less likely to suffer damage from e.g., impact, shock, friction, or contact. Advantageously also, provision of a receiving liquid 37 in the inner bag 30 allows temperature regulation or control of the kidney 40 via the medium of the receiving liquid 37.
In this embodiment, the heating device 25 is an electrical heat pad 25 which is powered by battery, which may improve portability of the device and/or may provide continuous power and durable autonomy. It will be appreciated that other forms of portable heating devices may be envisaged, such as a chemical heat device, e.g., a chemical heat pad. The heat pad 25 is attached to first side 21 of outer bag 20 by an adhesive, but it will be appreciated that the heat pad may also be attached to the outer bag 20 by mechanical attaching means such as clips, hook-and-loop devices (e.g. Velcro®) or the like. Alternatively, the outer bag 20 may be provided with a pocket configured to receive the heating device 25.
Conveniently, the outer bag 20 defines a receiving chamber configured to receive the inner bag 30 and a heat transfer liquid, here a saline solution. By such provision, heat transfer between the heated outer bag fluid and the inner bag receiving fluid can occur through a single solid barrier (the inner bag) which may therefore optimise heat transfer.
In an alternative embodiment, the outer bag 20 may define a sealed outer chamber filled with an outer liquid, such that the outer chamber and liquid therein define a space configured to receive the inner bag 30. In such instance, although heat transfer may be less effective as it required heat transfer through two solid barriers (the inner wall of the of the annular space the outer bag 20, and the wall of the inner bag 30), this arrangement may improve safety and may reduce risks of contamination of the inner container receiving fluid and thus of the body part 40.
In use, the temperature of the body part 40 is regulated and/or controlled by controlling the temperature of the outer bag liquid, which in turns controls and/or regulates the temperature of the receiving fluid 37, e.g. blood, in the inner bag 30. To allow heat transfer from the heating device 25 through the outer bag 20, the outer bag 20 is made of a thin plastic film of sheet, and is transparent which may allow visual monitoring of the body part 40.
The outer bag may be sealable, and comprise a seal, e.g. a zip lock, to provide a sealed environment for the inner bag 30, in use.
Advantageously also, the inner bag 30 containing the body part 40 can be conveniently removed from the outer bag 20 as required, e.g. after transport, while still being maintained in a sealed environment.
The apparatus 10 also comprises a drainage reservoir 33 which is configured to collect or receive a material, e.g. a fluid, produced by the body part 40. In this embodiment, when the body part is a kidney 40, the drainage reservoir is a urine collector 33 configured to collect or receive urine produced by the kidney 40 via drainage cannula 34. Advantageously, the provision of a urine collector 33 allows assessment of the state of the kidney during transport. For example, the provision of a urine reservoir 33 allows the function of the kidney 40 to be monitored in that production of urine into the urine collector 33 indicated that the kidney functions normally and is therefore viable. The health level of the kidney 40 may also be assessed by measuring the amount or volume of urine produced by the kidney 40 and/or by testing the urine produced, for example by performing a colourimetric assessment and/or a quantitative analysis of the urine in the urine collector 33. Referring now to Figure 7, there is shown a system 50 for transporting and/or preserving a body part, using the apparatus 10 described in relation to Figures 1 -6. Figure 8 shows the system of Figure 7 with a kidney 40 in the apparatus 10.
The system 50 includes the apparatus 10, and a perfusion device 59. The perfusion device 59 is connected to the inlet 31 to feed a perfusion fluid to the kidney 40, and to the outlet 32 to feed the fluid from the kidney 40 back to the perfusion device 59, thus defining a closed perfusion circuit.
The perfusion device 59 comprises:
- an oxygenator 51 to oxygenate the perfusion fluid; and
- a pump 53 arranged to circulate the perfusion fluid from the outlet 32 to the inlet 31 . The pump circulates the perfusion fluid through the oxygenator 51.
The perfusion device 59 further comprises a fluid reservoir 52 which supplies the perfusion fluid to the inlet 21 and/or to the oxygenator 51 . In this embodiment, the perfusion fluid in the fluid reservoir 52 is blood. Because the system 50 defines a closed perfusion circuit, the fluid reservoir 52 forms part of the perfusion circuit. It will be appreciated that in other embodiments where the perfusion device may not define a closed circuit, e.g., to perfuse organised tissue structures such as skin grafts, a face or part thereof, the pump 53 may feed the perfusion fluid to the inlet 31 via the oxygenator 51 , with no return of perfusion fluid through outlet 32.
The perfusion device 59 further comprises an additional fluid reservoir 55. The additional fluid reservoir is configured to provide an additional fluid to the perfusion system 50 via additional pump 56. For example, when loss of perfusion fluid occurs from the perfusion circuit due to urine production by the kidney 40, such loss of perfusion fluid may be compensated by feeding a fluid, e.g., blood or an isotonic fluid, from the additional fluid reservoir 55 to the perfusion system or circuit via pump 56.
As shown in Figures 9 and 10, the apparatus 10 is equipped with a cantilever load cell 26. The cantilever load cell 26 is configured to measure the weight of the apparatus 10 or to measure and/or detect a change in the weight of the apparatus 10, in use. This helps determine, regulate and/or control the amount, e.g. weight, of additional fluid from the additional fluid reservoir 55 required to compensate for any loss of fluid in the perfusion circuit, for example due to urine production by the kidney 40.
Referring now to Figure 11 , there is shown a housing 60 configured to be used in conjunction with the apparatus 10 and/or system 50. The housing 60 is configured to hold and/or store the elements of the perfusion system. In particular, the housing 60 is configured to receive and hold apparatus 10, fluid reservoir 52, and additional fluid reservoir 55. By such provision, any element of the system 50 that is provided as a flexible part, e.g. a bag, can be stored in a safe and protective environment within the housing 60. In this embodiment, the other elements of the perfusion system 60 are also provided within and secured or attached to the housing 60, including oxygenator 51 , pump 53,56 as well as tubes or cannulae (not shown) provided as part of the system 50.
Figures 12-13 show the housing 60 with apparatus 10, fluid reservoir 52, and additional fluid reservoir 55 secured inside the housing 60. The housing also has a display 62 to provide a user with information regarding any measured data within the system, e.g. flow, pressure, temperature or the like, and controls 64 to adjust and/or set any preferred parameters, e.g. temperature, flow, pressure, or the like.
It will be appreciated that the embodiments of the invention hereinbefore described are given by way of example only and are not meant to limit the scope thereof in any way.

Claims

CLAIMS:
1. An apparatus for transporting and/or preserving a body part, the apparatus comprising: an inner container configured to receive a body part and a receiving fluid; an inlet configured to connect the body part to a perfusion device; and a heating device configured to heat and/or control or regulate temperature of at least a portion of the body part and/or of the receiving fluid.
2. The apparatus according to claim 1 , wherein the body part a kidney.
3. The apparatus according to claim 1 , wherein the body part a face or part thereof.
4. The apparatus according to any preceding claim, wherein the receiving fluid comprises, consists essentially of or consists of blood.
5. The apparatus according to any preceding claim, wherein the heating device is or comprises a heat pad.
6. The apparatus according to any preceding claim, wherein the inner container is configured to allow heat transfer from the heating device through the inner container.
7. The apparatus according to any preceding claim, wherein the inner container is made of a plastic film of sheet.
8. The apparatus according to any preceding claim, further comprising an outer container configured to receive at least a portion of the inner container.
9. The apparatus according to claim 8, wherein the heating device is provided on an outer surface of the outer container.
10. The apparatus according to any of claims 8 to 9, wherein the outer container comprises a pocket configured to receive the heating device.
11 . The apparatus according to any of claims 8 to 9, wherein the heating device is attached to an outer surface of the outer container.
12. The apparatus according to any of claims 8 to 11 , wherein the outer container defines an outer container receiving chamber configured to receive the inner container.
13. The apparatus according to claim 12, wherein the outer container receiving chamber comprises or is at least partially filled with an outer container liquid.
14. The apparatus according to claim 12, wherein the outer container comprises or defines an annular space or volume configured to receive or hold an outer container fluid, wherein the annular space or volume defines the outer container receiving chamber.
15. The apparatus according to claim 14, wherein the inner container is at least partially provided inwards of the outer container receiving chamber and/or is at least partially surrounded by the annular space or volume.
16. The apparatus according to any of claims 8 to 15, wherein the outer container is made of a plastic film or sheet.
17. The apparatus according to any preceding claim, wherein the inner container comprises a/the inlet configured to connect the body part to a perfusion device.
18. The apparatus according to any preceding claim, wherein the inner container comprises an outlet configured to connect the body part to a/the perfusion device.
19. The apparatus according to any preceding claim, wherein the apparatus comprises a drainage reservoir configured to collect or receive a fluid produced by the body part.
20. The apparatus according to claim 19, wherein, when the body part is a kidney, the drainage reservoir is a urine collector.
21. The apparatus according to any preceding claim, wherein the apparatus comprises or is associated with a weight measuring device.
22. The apparatus according to claim 21 , wherein the weight measuring device is configured to measure the weight of the apparatus or to measure and/or detect a change in the weight of the apparatus, in use.
23. A system for transporting and/or preserving a body part, the system comprising: an inner container configured to receive a body part and a receiving fluid; an inlet configured to connect the body part to a perfusion device, wherein the body part is cannulated to the inlet; a heating device configured to heat and/or control or regulate temperature of at least a portion of the body part and/or of the receiving fluid; and a perfusion device connected to the inlet and configured to perfuse the body part.
24. The system according to claim 23, wherein the system comprises an outlet configured to connect the body part to the perfusion device, wherein the body part is cannulated to the outlet.
25. The system according to any of claims 23 to 24, wherein the perfusion device comprises:
- a pump arranged to circulate a fluid though the perfusion device and/or to the inlet; and
- an oxygenator to oxygenate the fluid.
26. The system according to claim 24, wherein the perfusion device further comprises a fluid reservoir configured to supply fluid to the inlet and/or to the oxygenator.
27. The system according to any of claims 25 to 26, wherein the perfusion device further comprises an additional fluid reservoir configured to provide an additional fluid to the perfusion system or circuit.
28. The system according to any of claims 25 to 27, wherein the perfusion device further comprises a blood treatment unit configured to remove one or more blood components.
29. A method of transporting and/or preserving a body part, comprising: providing a body part in an inner container, the inner container containing a receiving fluid; connecting the body part to an inlet configured to be connected to a perfusion device; and controlling and/or regulating the temperature of the receiving fluid by a heating device.
30. A method according to claim 29, the method comprising connecting the body part to an outlet configured to be connected to the perfusion device.
31. A method according to claim 29 or claim 30, the method comprising perfusing the body part.
32. A method according to any one of claims 29 to 31 , the method comprising controlling and/or regulating the temperature of the body part by controlling and/or regulating the temperature of the receiving fluid.
33. A method according to any one of claims 29 to 32, the method comprising providing the inner container at least partially within an outer container containing an outer container fluid.
34. A method according to claim 33, comprising controlling and/or regulating the temperature of the body part and/or of the receiving fluid by controlling and/or regulating the temperature of the outer container fluid.
PCT/EP2021/052842 2020-02-06 2021-02-05 Organ transport apparatus WO2021156460A1 (en)

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Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1996029865A1 (en) * 1995-03-27 1996-10-03 Organ, Inc. Organ evaluation and resuscitation device and method
WO1999015011A1 (en) * 1997-09-23 1999-04-01 Hassanein Waleed H Compositions, methods and devices for maintaining an organ
DE19928485C1 (en) * 1999-06-22 2000-10-19 Jostra Medizintechnik Ag Perfusion system useful for storing human or animal donor organ or body part, e.g. liver, before transplantation has inner bag with blood supply for organ and outer bag containing liquid, preferably suspended in frame
US20070015131A1 (en) * 2003-09-03 2007-01-18 Joachim Arzt Extracorporeal organ conservation
WO2012013925A2 (en) 2010-07-27 2012-02-02 University Of Strathclyde Integrated perfusion device
US20150289940A1 (en) * 2014-04-09 2015-10-15 Paul Jeffrey Campsen Suspendable organ transplant system and method of use
WO2018229080A1 (en) * 2017-06-13 2018-12-20 Universite De Technologie De Compiegne Organ perfusion device
WO2019106936A1 (en) * 2017-11-28 2019-06-06 株式会社Ｓｃｒｅｅｎホールディングス Organ container

Family Cites Families (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
SU1687262A1 (en) * 1988-08-10 1991-10-30 Киевский государственный институт усовершенствования врачей Arrangement to carry out perfusion of separate organs
SE534527C2 (en) * 2009-09-24 2011-09-20 Vivoline Medical Ab Procedure, device and fluid for treating a heart after withdrawal
US20140302480A1 (en) * 2011-11-09 2014-10-09 The General Hospital Corporation Composite tissue graft and materials and methods for its production and use
CN204763020U (en) * 2015-02-16 2015-11-18 杭州电子科技大学 External intelligent support system of subnormal temperature transplant organ
US11154049B2 (en) * 2016-01-06 2021-10-26 Washington University Systems and methods for normothermic extracorporeal organ perfusion
CN209546716U (en) * 2019-01-27 2019-10-29 宋红丽 A kind of toy organ room temperature machine perfusion system

Patent Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1996029865A1 (en) * 1995-03-27 1996-10-03 Organ, Inc. Organ evaluation and resuscitation device and method
WO1999015011A1 (en) * 1997-09-23 1999-04-01 Hassanein Waleed H Compositions, methods and devices for maintaining an organ
DE19928485C1 (en) * 1999-06-22 2000-10-19 Jostra Medizintechnik Ag Perfusion system useful for storing human or animal donor organ or body part, e.g. liver, before transplantation has inner bag with blood supply for organ and outer bag containing liquid, preferably suspended in frame
US20070015131A1 (en) * 2003-09-03 2007-01-18 Joachim Arzt Extracorporeal organ conservation
WO2012013925A2 (en) 2010-07-27 2012-02-02 University Of Strathclyde Integrated perfusion device
US20150289940A1 (en) * 2014-04-09 2015-10-15 Paul Jeffrey Campsen Suspendable organ transplant system and method of use
WO2018229080A1 (en) * 2017-06-13 2018-12-20 Universite De Technologie De Compiegne Organ perfusion device
WO2019106936A1 (en) * 2017-11-28 2019-06-06 株式会社Ｓｃｒｅｅｎホールディングス Organ container

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