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WO2025059729A1 - Appareil portable pour le transport d'échantillons biologiques - Google Patents

Appareil portable pour le transport d'échantillons biologiques Download PDF

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Publication number
WO2025059729A1
WO2025059729A1 PCT/AU2024/051012 AU2024051012W WO2025059729A1 WO 2025059729 A1 WO2025059729 A1 WO 2025059729A1 AU 2024051012 W AU2024051012 W AU 2024051012W WO 2025059729 A1 WO2025059729 A1 WO 2025059729A1
Authority
WO
WIPO (PCT)
Prior art keywords
temperature
biological sample
portable device
storage chamber
cooling
Prior art date
Legal status (The legal status 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 status listed.)
Pending
Application number
PCT/AU2024/051012
Other languages
English (en)
Inventor
Michael Challenor
Akshay AKSHAY
Sheldon Savio Napoleon PINTO
Emily Yue ZHEN
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Materia Health Pty Ltd
Original Assignee
Materia Health Pty Ltd
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
Priority claimed from AU2023903028A external-priority patent/AU2023903028A0/en
Application filed by Materia Health Pty Ltd filed Critical Materia Health Pty Ltd
Publication of WO2025059729A1 publication Critical patent/WO2025059729A1/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

Links

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
    • A01N1/10—Preservation of living parts
    • A01N1/14—Mechanical aspects of preservation; Apparatus or containers therefor
    • A01N1/142—Apparatus
    • A01N1/144—Apparatus for temperature control, e.g. refrigerators or freeze-drying apparatus
    • A01N1/145—Stationary or portable vessels generating cryogenic temperatures, e.g. liquid nitrogen baths
    • 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
    • A01N1/10—Preservation of living parts
    • A01N1/12—Chemical aspects of preservation
    • A01N1/128—Chemically defined matrices for immobilising, holding or storing living parts, e.g. alginate gels; Chemically altering living parts, e.g. by cross-linking
    • 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
    • A01N1/10—Preservation of living parts
    • A01N1/14—Mechanical aspects of preservation; Apparatus or containers therefor
    • A01N1/146—Non-refrigerated containers specially adapted for transporting or storing living parts whilst preserving
    • A01N1/148—Non-refrigerated containers specially adapted for transporting or storing living parts whilst preserving with provisions specially adapted for transporting
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
    • B65D81/00—Containers, packaging elements, or packages, for contents presenting particular transport or storage problems, or adapted to be used for non-packaging purposes after removal of contents
    • B65D81/02—Containers, packaging elements, or packages, for contents presenting particular transport or storage problems, or adapted to be used for non-packaging purposes after removal of contents specially adapted to protect contents from mechanical damage
    • B65D81/05—Containers, packaging elements, or packages, for contents presenting particular transport or storage problems, or adapted to be used for non-packaging purposes after removal of contents specially adapted to protect contents from mechanical damage maintaining contents at spaced relation from package walls, or from other contents
    • B65D81/051—Containers, packaging elements, or packages, for contents presenting particular transport or storage problems, or adapted to be used for non-packaging purposes after removal of contents specially adapted to protect contents from mechanical damage maintaining contents at spaced relation from package walls, or from other contents using pillow-like elements filled with cushioning material, e.g. elastic foam, fabric
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
    • B65D81/00—Containers, packaging elements, or packages, for contents presenting particular transport or storage problems, or adapted to be used for non-packaging purposes after removal of contents
    • B65D81/18—Containers, packaging elements, or packages, for contents presenting particular transport or storage problems, or adapted to be used for non-packaging purposes after removal of contents providing specific environment for contents, e.g. temperature above or below ambient
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
    • B65D81/00—Containers, packaging elements, or packages, for contents presenting particular transport or storage problems, or adapted to be used for non-packaging purposes after removal of contents
    • B65D81/38—Containers, packaging elements, or packages, for contents presenting particular transport or storage problems, or adapted to be used for non-packaging purposes after removal of contents with thermal insulation
    • B65D81/3813—Containers, packaging elements, or packages, for contents presenting particular transport or storage problems, or adapted to be used for non-packaging purposes after removal of contents with thermal insulation rigid container being in the form of a box, tray or like container
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
    • B65D81/00—Containers, packaging elements, or packages, for contents presenting particular transport or storage problems, or adapted to be used for non-packaging purposes after removal of contents
    • B65D81/38—Containers, packaging elements, or packages, for contents presenting particular transport or storage problems, or adapted to be used for non-packaging purposes after removal of contents with thermal insulation
    • B65D81/3825—Containers, packaging elements, or packages, for contents presenting particular transport or storage problems, or adapted to be used for non-packaging purposes after removal of contents with thermal insulation rigid container being in the form of a box, tray or like container with one or more containers located inside the external container
    • F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F25—REFRIGERATION OR COOLING; COMBINED HEATING AND REFRIGERATION SYSTEMS; HEAT PUMP SYSTEMS; MANUFACTURE OR STORAGE OF ICE; LIQUEFACTION SOLIDIFICATION OF GASES
    • F25B—REFRIGERATION MACHINES, PLANTS OR SYSTEMS; COMBINED HEATING AND REFRIGERATION SYSTEMS; HEAT PUMP SYSTEMS
    • F25B29/00—Combined heating and refrigeration systems, e.g. operating alternately or simultaneously
    • F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F25—REFRIGERATION OR COOLING; COMBINED HEATING AND REFRIGERATION SYSTEMS; HEAT PUMP SYSTEMS; MANUFACTURE OR STORAGE OF ICE; LIQUEFACTION SOLIDIFICATION OF GASES
    • F25D—REFRIGERATORS; COLD ROOMS; ICE-BOXES; COOLING OR FREEZING APPARATUS NOT OTHERWISE PROVIDED FOR
    • F25D11/00—Self-contained movable devices, e.g. domestic refrigerators
    • F25D11/003—Transport containers
    • F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F25—REFRIGERATION OR COOLING; COMBINED HEATING AND REFRIGERATION SYSTEMS; HEAT PUMP SYSTEMS; MANUFACTURE OR STORAGE OF ICE; LIQUEFACTION SOLIDIFICATION OF GASES
    • F25D—REFRIGERATORS; COLD ROOMS; ICE-BOXES; COOLING OR FREEZING APPARATUS NOT OTHERWISE PROVIDED FOR
    • F25D11/00—Self-contained movable devices, e.g. domestic refrigerators
    • F25D11/006—Self-contained movable devices, e.g. domestic refrigerators with cold storage accumulators
    • F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F25—REFRIGERATION OR COOLING; COMBINED HEATING AND REFRIGERATION SYSTEMS; HEAT PUMP SYSTEMS; MANUFACTURE OR STORAGE OF ICE; LIQUEFACTION SOLIDIFICATION OF GASES
    • F25D—REFRIGERATORS; COLD ROOMS; ICE-BOXES; COOLING OR FREEZING APPARATUS NOT OTHERWISE PROVIDED FOR
    • F25D16/00—Devices using a combination of a cooling mode associated with refrigerating machinery with a cooling mode not associated with refrigerating machinery
    • F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F25—REFRIGERATION OR COOLING; COMBINED HEATING AND REFRIGERATION SYSTEMS; HEAT PUMP SYSTEMS; MANUFACTURE OR STORAGE OF ICE; LIQUEFACTION SOLIDIFICATION OF GASES
    • F25D—REFRIGERATORS; COLD ROOMS; ICE-BOXES; COOLING OR FREEZING APPARATUS NOT OTHERWISE PROVIDED FOR
    • F25D29/00—Arrangement or mounting of control or safety devices
    • F25D29/003—Arrangement or mounting of control or safety devices for movable devices
    • F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F25—REFRIGERATION OR COOLING; COMBINED HEATING AND REFRIGERATION SYSTEMS; HEAT PUMP SYSTEMS; MANUFACTURE OR STORAGE OF ICE; LIQUEFACTION SOLIDIFICATION OF GASES
    • F25D—REFRIGERATORS; COLD ROOMS; ICE-BOXES; COOLING OR FREEZING APPARATUS NOT OTHERWISE PROVIDED FOR
    • F25D3/00—Devices using other cold materials; Devices using cold-storage bodies
    • F25D3/02—Devices using other cold materials; Devices using cold-storage bodies using ice, e.g. ice-boxes
    • F25D3/06—Movable containers
    • F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F25—REFRIGERATION OR COOLING; COMBINED HEATING AND REFRIGERATION SYSTEMS; HEAT PUMP SYSTEMS; MANUFACTURE OR STORAGE OF ICE; LIQUEFACTION SOLIDIFICATION OF GASES
    • F25D—REFRIGERATORS; COLD ROOMS; ICE-BOXES; COOLING OR FREEZING APPARATUS NOT OTHERWISE PROVIDED FOR
    • F25D31/00—Other cooling or freezing apparatus
    • F25D31/005—Combined cooling and heating devices
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/05—Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/1412—Containers with closing means, e.g. caps
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/1468—Containers characterised by specific material properties
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
    • B65D2581/00—Containers, packaging elements, or packages, for contents presenting particular transport or storage problems, or adapted to be used for non-packaging purposes after removal of contents
    • B65D2581/02—Containers, packaging elements, or packages, for contents presenting particular transport or storage problems, or adapted to be used for non-packaging purposes after removal of contents specially adapted to protect contents from mechanical damage
    • B65D2581/05—Containers, packaging elements, or packages, for contents presenting particular transport or storage problems, or adapted to be used for non-packaging purposes after removal of contents specially adapted to protect contents from mechanical damage maintaining contents at spaced relation from package walls, or from other contents
    • B65D2581/051—Details of packaging elements for maintaining contents at spaced relation from package walls, or from other contents
    • F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F25—REFRIGERATION OR COOLING; COMBINED HEATING AND REFRIGERATION SYSTEMS; HEAT PUMP SYSTEMS; MANUFACTURE OR STORAGE OF ICE; LIQUEFACTION SOLIDIFICATION OF GASES
    • F25B—REFRIGERATION MACHINES, PLANTS OR SYSTEMS; COMBINED HEATING AND REFRIGERATION SYSTEMS; HEAT PUMP SYSTEMS
    • F25B1/00—Compression machines, plants or systems with non-reversible cycle
    • F25B1/005—Compression machines, plants or systems with non-reversible cycle of the single unit type
    • F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F25—REFRIGERATION OR COOLING; COMBINED HEATING AND REFRIGERATION SYSTEMS; HEAT PUMP SYSTEMS; MANUFACTURE OR STORAGE OF ICE; LIQUEFACTION SOLIDIFICATION OF GASES
    • F25B—REFRIGERATION MACHINES, PLANTS OR SYSTEMS; COMBINED HEATING AND REFRIGERATION SYSTEMS; HEAT PUMP SYSTEMS
    • F25B21/00—Machines, plants or systems, using electric or magnetic effects
    • F25B21/02—Machines, plants or systems, using electric or magnetic effects using Peltier effect; using Nernst-Ettinghausen effect
    • F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F25—REFRIGERATION OR COOLING; COMBINED HEATING AND REFRIGERATION SYSTEMS; HEAT PUMP SYSTEMS; MANUFACTURE OR STORAGE OF ICE; LIQUEFACTION SOLIDIFICATION OF GASES
    • F25B—REFRIGERATION MACHINES, PLANTS OR SYSTEMS; COMBINED HEATING AND REFRIGERATION SYSTEMS; HEAT PUMP SYSTEMS
    • F25B21/00—Machines, plants or systems, using electric or magnetic effects
    • F25B21/02—Machines, plants or systems, using electric or magnetic effects using Peltier effect; using Nernst-Ettinghausen effect
    • F25B21/04—Machines, plants or systems, using electric or magnetic effects using Peltier effect; using Nernst-Ettinghausen effect reversible
    • F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F25—REFRIGERATION OR COOLING; COMBINED HEATING AND REFRIGERATION SYSTEMS; HEAT PUMP SYSTEMS; MANUFACTURE OR STORAGE OF ICE; LIQUEFACTION SOLIDIFICATION OF GASES
    • F25B—REFRIGERATION MACHINES, PLANTS OR SYSTEMS; COMBINED HEATING AND REFRIGERATION SYSTEMS; HEAT PUMP SYSTEMS
    • F25B2321/00—Details of machines, plants or systems, using electric or magnetic effects
    • F25B2321/02—Details of machines, plants or systems, using electric or magnetic effects using Peltier effects; using Nernst-Ettinghausen effects
    • F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F25—REFRIGERATION OR COOLING; COMBINED HEATING AND REFRIGERATION SYSTEMS; HEAT PUMP SYSTEMS; MANUFACTURE OR STORAGE OF ICE; LIQUEFACTION SOLIDIFICATION OF GASES
    • F25B—REFRIGERATION MACHINES, PLANTS OR SYSTEMS; COMBINED HEATING AND REFRIGERATION SYSTEMS; HEAT PUMP SYSTEMS
    • F25B2400/00—General features or devices for refrigeration machines, plants or systems, combined heating and refrigeration systems or heat-pump systems, i.e. not limited to a particular subgroup of F25B
    • F25B2400/24—Storage receiver heat
    • F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F25—REFRIGERATION OR COOLING; COMBINED HEATING AND REFRIGERATION SYSTEMS; HEAT PUMP SYSTEMS; MANUFACTURE OR STORAGE OF ICE; LIQUEFACTION SOLIDIFICATION OF GASES
    • F25D—REFRIGERATORS; COLD ROOMS; ICE-BOXES; COOLING OR FREEZING APPARATUS NOT OTHERWISE PROVIDED FOR
    • F25D2303/00—Details of devices using other cold materials; Details of devices using cold-storage bodies
    • F25D2303/08—Devices using cold storage material, i.e. ice or other freezable liquid
    • F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F25—REFRIGERATION OR COOLING; COMBINED HEATING AND REFRIGERATION SYSTEMS; HEAT PUMP SYSTEMS; MANUFACTURE OR STORAGE OF ICE; LIQUEFACTION SOLIDIFICATION OF GASES
    • F25D—REFRIGERATORS; COLD ROOMS; ICE-BOXES; COOLING OR FREEZING APPARATUS NOT OTHERWISE PROVIDED FOR
    • F25D2331/00—Details or arrangements of other cooling or freezing apparatus not provided for in other groups of this subclass
    • F25D2331/80—Type of cooled receptacles
    • F25D2331/801—Bags
    • F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F25—REFRIGERATION OR COOLING; COMBINED HEATING AND REFRIGERATION SYSTEMS; HEAT PUMP SYSTEMS; MANUFACTURE OR STORAGE OF ICE; LIQUEFACTION SOLIDIFICATION OF GASES
    • F25D—REFRIGERATORS; COLD ROOMS; ICE-BOXES; COOLING OR FREEZING APPARATUS NOT OTHERWISE PROVIDED FOR
    • F25D2331/00—Details or arrangements of other cooling or freezing apparatus not provided for in other groups of this subclass
    • F25D2331/80—Type of cooled receptacles
    • F25D2331/801—Bags
    • F25D2331/8014—Bags for medical use
    • F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F25—REFRIGERATION OR COOLING; COMBINED HEATING AND REFRIGERATION SYSTEMS; HEAT PUMP SYSTEMS; MANUFACTURE OR STORAGE OF ICE; LIQUEFACTION SOLIDIFICATION OF GASES
    • F25D—REFRIGERATORS; COLD ROOMS; ICE-BOXES; COOLING OR FREEZING APPARATUS NOT OTHERWISE PROVIDED FOR
    • F25D2400/00—General features of, or devices for refrigerators, cold rooms, ice-boxes, or for cooling or freezing apparatus not covered by any other subclass
    • F25D2400/12—Portable refrigerators
    • F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F25—REFRIGERATION OR COOLING; COMBINED HEATING AND REFRIGERATION SYSTEMS; HEAT PUMP SYSTEMS; MANUFACTURE OR STORAGE OF ICE; LIQUEFACTION SOLIDIFICATION OF GASES
    • F25D—REFRIGERATORS; COLD ROOMS; ICE-BOXES; COOLING OR FREEZING APPARATUS NOT OTHERWISE PROVIDED FOR
    • F25D2700/00—Means for sensing or measuring; Sensors therefor
    • F25D2700/12—Sensors measuring the inside temperature
    • F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F25—REFRIGERATION OR COOLING; COMBINED HEATING AND REFRIGERATION SYSTEMS; HEAT PUMP SYSTEMS; MANUFACTURE OR STORAGE OF ICE; LIQUEFACTION SOLIDIFICATION OF GASES
    • F25D—REFRIGERATORS; COLD ROOMS; ICE-BOXES; COOLING OR FREEZING APPARATUS NOT OTHERWISE PROVIDED FOR
    • F25D3/00—Devices using other cold materials; Devices using cold-storage bodies
    • F25D3/005—Devices using other cold materials; Devices using cold-storage bodies combined with heat exchangers

Definitions

  • the present invention relates to a portable apparatus for transport of biological samples, in particular for transport of human organs and tissues.
  • Optimal organ preservation and transportation is critical to the survival of transplant patients with a range of medical conditions including, for example, lung, heart, liver or kidney diseases.
  • a more or less comprehensive list of organs would include heart, lung, kidney, liver, pancreas and intestines.
  • Tissues - such as bone, tendon, heart valves, corneas, skin, limbs or digits - may also require transport.
  • Organ donation typically requires the transport of organs from the site of the donor to the site of the recipient. This must be done in a manner that is sterile and preserves the viability of the organ for the duration of transport, which may last a number of hours. Failure to meet these conditions is likely to lead to adverse health outcomes for the transplant recipient. While organ donation is referred to above, the same considerations apply to tissues for transplantation, and biological samples for human and animal use - for example blood products, vaccines and biologic agents.
  • this cooling mechanism relies on the rate and the uniformity of ice melting around the organ, which is unlikely to be even or precise. This leads to heterogenicity of metabolism within the organ and compromises its overall viability.
  • turbulence coupled with the weight of litres of crushed ice during transport causes pressure injury and mechanical stress.
  • rewarming injury a cascade of inflammatory events called rewarming injury, which results in further cell injury and cell death.
  • Perfusion machines such as those described in US7572622B2 and US9301519B2, provide continuous circulation of preservation fluids, blood products and dissolved oxygen to improve organ viability during transport.
  • these machines are large, complex and expensive. Their limited portability makes these machines impractical for the transport of organs between sites, particularly over long distances.
  • large randomised controlled trials have not demonstrated a significant benefit for perfusion machines over conventional practice, except in the context of extended criteria donor organs (ie. Donor organs that would traditionally not be used in transplantation).
  • a portable device for transporting a biological sample comprising:
  • thermoregulation system for adjusting the temperature of the storage chamber, said thermoregulation system comprising: a heat exchange system for transferring heat between the biological sample and the storage chamber; a temperature monitoring system for sensing the temperature of the storage chamber and the biological sample; and a controller for active control of the heat exchange system dependent on the input from the temperature monitoring system, wherein the controller operates the heat exchange system to adjust the storage chamber temperature according to a selected temperature control program.
  • This active control allows for more precise temperature management than prior technology, which is solely reliant on passive heat exchange, and allows easy adaptation for different use cases.
  • the heat exchange system includes a heating module to enable a controlled increase in temperature.
  • a heating module may enable gentle rewarming of the organ to mitigate the risk of rewarming injury and help to prevent overcooling in cold external conditions, as encountered in airplane cargos and cold climates.
  • the temperature control program is integrated with the thermoregulation system, such that temperature settings can be adapted to the requirements of the biological sample.
  • different organs have different cellular compositions and metabolic requirements, and may benefit from different temperature settings and temperature control programmes.
  • the controller may be configured with a plurality of temperature control programs allowing the portable device to be adapted to the transportation of a wide range of biological samples, including organs, tissues or other biological materials.
  • the selected temperature control program conveniently controls the heat exchange system to adjust temperature of the storage chamber and biological sample within a selected temperature range, for example 4-8°C for organs.
  • the temperature control program preferably allows a controlled rate of temperature adjustment, for example for cooling which is significantly faster than cooling using a PCM. Similar requirement for controlled temperature adjustment may apply to heating.
  • the controller may advantageously prevent overshoot of a lower temperature limit.
  • the selected programs may have upper and lower temperature limits. It engages the thermoregulation system to provide heating if the sensed temperature is below the lower temperature limit, or if the rate of cooling is too fast, and provide cooling if the sensed temperature is above the upper temperature limit.
  • the portable device further comprises a circulation module for pumping a circulation fluid through the heat exchange system for regulating the temperature of the biological sample when received in the storage chamber.
  • the circulation fluid may be used in two different contexts: non-contact with the biological sample or in direct contact with the biological sample.
  • the non-contact circulation fluid may be a heat exchange fluid such as a refrigerant or PCM that is optimised for thermal efficiency rather than biocompatibility with the biological sample.
  • examples may include organ and tissue preservation fluids such as the University of Wisconsin solution, or isotonic solutions such as a normal saline solution.
  • the integration of the circulation module with the thermoregulation system further facilitates the precision of temperature control, the efficiency of heat exchange and the speed of temperature regulation.
  • a preferred embodiment comprises at least one tissue protection module, which is designed to protect the biological sample from mechanical stress and injury.
  • the tissue protection module desirably provides a cushion that may comprise a heat conductive material in the form of a gel, a gas, a liquid, a foam or a semi-solid.
  • the tissue protection module may conveniently line the inside of the storage chamber and surround or enclose the biological sample.
  • a circulation fluid may be pumped through the tissue protection module.
  • the circulation fluid can, as described above, be circulated through as a contact circulation fluid or non-contact circulation fluid depending on the design of the tissue protection module and whether or not contact with circulation fluid is desirable for the particular biological sample, in particular organ or tissue. For example, continuous contact with circulation fluid may be desirable for a heart or a kidney, but undesirable for an amputated digit which can suffer from maceration following prolonged exposure to fluid.
  • the tissue protection module may optionally be integrated with the heating module, being provided, for example, resistive heating or Peltier heating elements.
  • the biological sample should be packaged in a sterile packaging system, typically including a plurality of bags.
  • the packaging system is desirably integrated with the temperature monitoring system to allow accurate measurement of temperature of the biological sample.
  • the packaging system may also be connected to the circulation module in a manner that allows circulation fluid to flow around the biological specimen to maximise heat transfer and temperature control.
  • the shape of the bag(s) may be tailored to the shape and sizes of different organs and tissues to reduce turbulent flow, which further enhances heat transfer.
  • the packaging system may also comprise heating element(s) to enable rewarming of a biological sample.
  • the heating element may be operable through connection, by an electrical connector, to an energy source for the portable device even when the packaging system is removed from the portable device.
  • the electrical connector may be disconnected from the energy source to enable disposal.
  • tissue protection module and the packaging system can both be removed from the external housing and folded to allow convenient transport as flat packs
  • thermoregulation systems for the portable device may comprise any practical combination of heating and cooling modules that allow active temperature control.
  • the thermoregulation system may include heat exchange systems such as an absorption refrigeration system, a PCM system, a resistive heating system and a Peltier system for both heating and cooling.
  • a PCM particularly in combination with the circulation module, may be preferred for cooling.
  • the portable device is designed to enable safe temperature management of the biological sample even in the event of a fault.
  • an electronic back up could be engaged both automatically and manually according to a fault mitigation strategy, to deliver a set safe constant temperature.
  • another fault mitigation strategy could be deployed manually. For example, an endothermic chemical reaction or a back up PCM could be activated by the user to achieve a set safe constant temperature.
  • a method for controlling temperature of a biological sample comprising:
  • thermoregulation system comprising a heat exchange system for exchanging heat between the biological sample and the storage chamber
  • the temperature control program may be selected dependent on the nature of the biological sample as described above.
  • a rewarming temperature control program allows rewarming of the biological sample to mitigate rewarming injury, for example in the context of an organ transplant.
  • the portable device for transport of biological samples may be applied to a range of biological samples, from organs to vaccines, with precise temperature control in either cooling or rewarming modes according to appropriately programmed temperature control strategies.
  • biological samples may be protected by a combination of packaging system and tissue protection module, which provides protection from mechanical stress and injury while also enhancing accurate temperature control, particularly when integrated with the circulation module and the circulation fluid in direct contact with the biological sample.
  • Figure 1 a schematic orthogonal view of the portable device for transport of biological samples according to a first embodiment.
  • Figure 2 is a schematic cross-sectional view of the portable device of Figure 1.
  • Figure 3 is a schematic cross-sectional view of a portable device for the transport of biological samples, comprising a heating and a cooling module in a second embodiment.
  • Figure 4 is a schematic cross-sectional view of a third embodiment of a portable device for transport of biological samples comprising a circulation module.
  • Figure 5 is a schematic cross-sectional view of a fourth embodiment of a portable device for transport of biological samples comprising a circulation module.
  • Figure 6 is an orthogonal exploded view of a portable device for tissue transport of a fifth embodiment comprising a tissue protection module featuring temperature sensors of a temperature monitoring system.
  • Figure 7 is an exploded view of a portable device for transport of biological samples, according to a sixth embodiment.
  • This embodiment features a circulation module which utilises peristaltic pumps to pump cooled or warmed non-contact circulation fluid or gel into a tissue protection module.
  • Figure 8 is a schematic exploded view of the portable device for transport of biological samples.
  • This embodiment features a circulation module which utilises peristaltic pumps to pump cooled or warmed contact circulation fluid into a packaging system housing an organ or tissue.
  • Figure 9 is a front view of a packaging system for an organ such as a heart according to an embodiment comprising inlet and outlet tubes which connect to a circulation module and locally heated bonded sections or “leaf-seals” of the package designed to suspend the organ in the packaging system to allow circulation fluid to flow through and evenly around, including below the organ.
  • Figure 10 is a first orthogonal view of the packaging system of Figure 9.
  • Figure 11 is an orthogonal view of an alternative packaging system, which features temperature sensors mounted on the surface, but does not feature inlet and outlet tubing.
  • Figure 12 is a schematic exploded view that shows a foldable tissue protection module for the packaging system for a heart as shown in Figure 11 .
  • Figure 13 shows an orthogonal view of the foldable tissue protection module of Figure 12 and the packaging system of Figure 11 in active use.
  • Figure 14 shows the foldable tissue protection module of Figure 13 in unfolded condition.
  • Figure 15 is an exploded view of a portable device for tissue transport according to a ninth embodiment comprising a compressor-based refrigeration .
  • Figure 16(a) shows a schematic of a cooling system for the current clinical standard of care applying to organ (heart) transplant.
  • Figure 16(b) shows a modelled temperature time profile (0 to 26 Hours) for the components of the cooling system and the organ and Figure 16(c) shows a detail from Figure 16(b) with emphasis on the first 10 hours.
  • Figure 17 shows experimental setup and results in the form of a temperature time profile for cooling a test sample with a -5°C phase change material.
  • Figure 18 shows experimental setup and results in the form of a temperature time profile for cooling a test sample contained in a sealed bag with a -25°C phase change material.
  • Figure 19 shows experimental setup and results in the form of a temperature time profile for cooling a test sample contained in a packaging module which is cooled through pumping contact circulation fluid from a cold reservoir.
  • FIG. 1 to 8 there is shown a portable device 10 for transport of a biological sample under precise temperature control according to a number of embodiments.
  • device 10 has cooling and heating functionality as described later.
  • biological sample is intended - without limitation - any tissue or organ, for example heart, lung, liver, kidney, intestine, pancreas. Also included within the definition is an amputated digit, amputated limb or cornea. Biologicals are also not limited to blood products, laboratory samples vaccines or medicaments. “Tissue” and “organ” are used interchangeably, for the purpose of example only, in the following description.
  • thermoregulation system is intended a system that actively controls temperature of a biological sample, when received within portable device 10, by controlling the operation of a heat exchange system for exchanging heat - whether for cooling or heating - for example allowing rewarming of a biological sample - between the biological sample and the storage chamber by a heat exchange system, on the basis of the temperature detected by the temperature monitoring system.
  • the heat exchange system may be of any suitable type, for example being a refrigeration system of compressor or absorption type, a Peltier cooling system or a PCM and so on.
  • a circulation module is desirably included to pump a circulation fluid, conveniently a liquid or low viscosity gel, to allow efficient heat transfer between the biological sample and heat exchange system, and precise temperature control.
  • the circulation fluid may directly contact the biological sample and comprise of, these not intended to be limiting, a preservation fluid or isotonic solution that is compatible with the biological sample.
  • the circulation fluid may be non-contact with the biological sample, in which case, the circulation fluid may be a refrigerant, antifreeze, cryopreservative or PCM, phase change material, these not intended to be limiting.
  • biological sample temperature and “storage chamber temperature” may be used interchangeably in the following description.
  • the thermoregulation system may also have back up mode(s) that allow safe operation of portable device 10 when a fault is detected.
  • tissue protection module is defined as any apparatus for mechanical protection of the biological sample. Desirably, the tissue protection module is configured to aid heat transfer and, to this end, the circulation fluid may flow through the tissue protection module as described in embodiments below.
  • Device 10 has a body 11 which forms the outer case of the device 10.
  • Body 11 is designed to contain the systems, modules and other components of the device
  • the body 11 comprises a hard outer shell to protect the internals of the portable device 10 as well as tissue stored within it.
  • body Preferably, body
  • Body 11 is of a substantially waterproof or water-resistant material.
  • a suitable material for body 11 may be selected from plastics, metals or alloys. The material may, for example, be selected from the group consisting of acrylonitrile butadiene styrene (ABS), polycarbonate and stainless steel. Other desirable properties of the material of body 11 include strength, dent/scratch resistance, corrosion resistance and light weight.
  • the material of body 11 is also desirably non-porous with ‘easy to clean’ surfaces. Cleaning of the reusable components of this invention is, in all embodiments, by wiping down with hospital grade disinfectants.
  • Body 11 may be provided with wheels 29 for mobility.
  • a small sized body 11 may have a volume of about 10 litres and be used for transport of donor tissues, eyes or amputated digits.
  • a medium sized body 11 may have a volume of about 45 litres and be used for transport of donor hearts and certain donor organs - e.g. pancreas, kidneys - as well as amputated limbs and larger volumes of tissue.
  • a large size body may have volume of about 85 litres and be used for donor lungs and livers as well as amputated limbs.
  • the portable device 10 is intended to be used as a universal container with capability to transport a range of biological samples, by nature, shape and mass, not limited to tissues and organs.
  • Device 10 includes a storage chamber 27 for accommodating the organ as described further below.
  • a thermoregulation system 30 is provided for adjusting temperature within storage chamber 27.
  • thermoregulation system 30 integrates both cooling and heating functions as will be described later.
  • the cooling function is typically required to bring the organ temperature from 37°C to a safe, hypothermic condition at 4 to 8°C range.
  • a heating function enables active warming in a controlled manner following a temperature control program as will be described later.
  • a heating function also enables precise rewarming of a biological sample, in particular, an organ for transplant or blood product for transfusion, as will also be described in detail later.
  • Temperature control of the biological sample may also involve operation of a circulation module 40 to pump a fluid around the biological sample as will also be described in detail later.
  • a circulation module 40 assists with even heat transfer between the circulation fluid and the biological sample.
  • lid 11 At the top of body 11 and closing storage chamber 27 is a lid 12. Removal or opening of lid 11 allows access to the storage chamber 27 and the heat exchange system 30. Lid 11 may be sealed tightly, preferably with a hermetic seal, to prevent leaks (of air, fluids or solids) or risk of damage to a biological sample from the exterior. Storage chamber 27 may be held at ambient pressure. There is no requirement to control pressure as well as temperature as described throughout this description.
  • the lid 12 may be sealed or closed by the use of lockable clasps 12a, which may be fabricated from a material such as stainless steel. Lockable clasps 12a may utilise hinges 12b, conveniently having a selected opening angle of 0-110 degrees. Hinges 12b are torque hinges of corrosion resistant material such as stainless steel.
  • Body 11 may comprise an insulating material layer 140 to provide insulation to slow heat transfer through the body 11 into storage chamber 27.
  • the insulating material layers may be provided in the form of insulated housings. Such insulation also allows the storage chamber 27 to be maintained at desired temperature for a longer periods. Suitable insulation may include, without limitation, extruded or expanded polystyrene, polyisocyanurate, polyurethane or other polymeric foams.
  • tissue - is contained within a packaging system 60.
  • the packaging system 60 is described in further detail below but may comprise two, three or a plurality of bags.
  • the bags may be zip lock bags.
  • Dependent on the tissue transported the packaging system 60 may comprise a bag containing preservative solution or a biocompatible isotonic solution.
  • Storage chamber 27 also contains a plurality of cushions 52 forming one embodiment of tissue protection module 50.
  • Three cushions 52 lining storage chamber 27 are shown by way of example only.
  • the cushions 52 provide physical support to the tissue and prevent mechanical stress and pressure injuries.
  • the tissue protection module 50 - particularly when integrated with a circulation module 40 as described below - may be configured to assist in heat transfer evenly across the tissue.
  • Storage chamber 27 may be provided with a temperature sensor 82 forming part of a temperature monitoring system for providing an input to control, by electronic control unit 100, of heat exchange system 30 and/or circulation module 40 of embodiments as described below.
  • Temperature sensor 82 is positioned to monitor the temperature of the storage chamber 27. Position of temperature sensor 82 is optimised to provide an accurate temperature reading for the tissue.
  • Temperature monitoring system 80 need not be limited to a single temperature or temperature sensing for the storage chamber 27.
  • Temperature monitoring system 80 may comprise a plurality of temperature sensors in the form of an array, several separate sensors or individually. An array of temperature sensors may allow an average temperature to be recorded or temperature to be recorded at different positions within the device 10, in particular, in the thermoregulation system 30 and/or circulation module 40 of embodiments described below.
  • Such temperature monitoring provides a basis for active temperature control by electronic control unit 100 with a selected temperature control program according to preferred embodiments.
  • Device 10 is provided with a battery 14 to provide power to components including electronic control unit 100. Device 10 may also be connected to an external power supply as described below.
  • Body 11 may be provided, on its base, with wheels or castors 29 to permit easy movement.
  • Heat exchange system 30 may be implemented in a number of embodiments as described below.
  • the heat exchange system 30 is implemented using a compressor-based refrigeration system as is familiar to the person skilled in the art of refrigeration.
  • a compressor-based refrigeration system takes advantage of a heat pump effect, by evaporating a refrigerant in a reduced pressure atmosphere to remove heat from an enclosure (here storage chamber 27) before condensation of the refrigerant caused by compressor. This causes excess heat to be lost to the environment before the refrigeration cycle - which at least cools an organ stored in storage chamber 27 - repeats itself.
  • Such a compressor-based refrigeration system may use any suitable refrigerant of which a wide range are available.
  • refrigerants which may be used include propane, isobutane and hydrofluorocarbons (where permitted) including chlorodifluoromethane, difluoromethane, difluoroethane, tetrafluoroethane and hydrofluoroolefins as well as hydrofluorocarbon blends.
  • Puron (R 410A) is also an example of a suitable refrigerant.
  • Such a com pressor- based refrigeration system may provide cooling directly to the tissue.
  • the compressor-based refrigeration system may provide the refrigerant or heat transfer fluid to a circulation module 40 in contact with the biological sample.
  • the circulation module 40 may pump the refrigerant, or another fluid in contact with the refrigerant around the biological sample to enable more efficient cooling.
  • the compressor-based refrigeration system may provide heating, acting as a heating or ‘warming module’.
  • compressor-based refrigeration systems may be run to introduce heat from the environment into an enclosure, here storage chamber 27, by condensing the refrigerant at the enclosure boundary. This is termed 'reverse cycle’ operation.
  • the device 10, 11 of Figures 2 and 15 employ such a compressorbased refrigeration system 131 with a radiator consisting of metallic tubing 135 under the control of electronic control unit 100.
  • Operation of the compressor-based refrigeration system may be precisely controlled by the electronic control unit as described below, and according to a temperature control program specific to the biological sample.
  • circulation module 40 circulates the refrigerant, or another fluid in heat transfer contact with the refrigerant, about the biological sample to enable heating.
  • the circulation module 40 may thus facilitate either heating or cooling dependent on temperature sensed by a temperature monitoring system as described below making active temperature control of storage chamber 27 and the biological sample possible.
  • heat exchange system 30 includes a PCM to provide cooling (or heating) of storage chamber 27.
  • a PCM is a material that transitions from one form of matter to another, for example solid to liquid, by absorbing or releasing a sufficient amount of latent heat. Therefore, a PCM may be used for cooling and heating.
  • PCM The simplest PCM is water. A simple mix of water/ice will maintain a stable temperature of 0°C as long as the ice remains (assuming the temperature of the environment is above 0°C). There are many PCMs available and their properties may be tuned to allow for a variety of temperature settings to be maintained. This may be done by varying their nature or composition or by controlling the pressure above the PCM.
  • a PCM may be used to directly cool the biological sample.
  • the PCM enables cooling of a circulation fluid that is pumped around the biological sample by the circulation module 40.
  • the ECU 100 can control the circulation module 40 to vary the amount of cooled circulation fluid in contact with the biological organ to precisely delivery a desired temperature, which can be above the transition point of the PCM.
  • circulation module 40 may be operable to maintain a temperature above 0°C, such as 4°C, 8°C, 12°C, or another temperature above the transition point of the PCM.
  • a temperature above 0°C such as 4°C, 8°C, 12°C, or another temperature above the transition point of the PCM.
  • a stable temperature may be maintained for as long as the PCM has not fully transitioned to another form.
  • ice may be obtained and added to a compartment forming part of heat exchange system 30 during use. This may allow cooling to be prolonged indefinitely.
  • an alternative PCM may be used to provide a different temperature condition.
  • a gas or liquid may be compressed above atmospheric pressure and the pressure released in a controlled manner. This pressure release would cause the gas or liquid to vapourise and absorb heat.
  • This principle may be used to provide cooling in thermoregulation module 30. This principle also enables cooling of the circulation fluid.
  • the heat exchange system 30 may be implemented using absorption refrigeration.
  • absorption refrigeration the principle allows for cooling of an enclosure, here storage chamber 27, using a heat source such as electrical heating or combustion to drive the refrigeration system with a selected refrigerant.
  • Absorption refrigeration would allow the cooling system to work in a remote setting where mains electricity is not available. This principle also enables cooling of a fluid circulated by a circulation module 40 about the biological sample.
  • a Peltier based cooling system may be used for heat exchange system 30.
  • Peltier based cooling also enables cooling of a fluid circulated by a circulation module 40 about the biological sample.
  • any suitable cooling technology may be used to provide cooling to the storage chamber and biological sample.
  • Tissue Protection Module
  • tissue protection module 50 may provide a cushion for the biological sample.
  • the tissue protection module 50 may accommodate the circulation module 40 in close proximity to the biological sample, allowing a noncontact circulating fluid to be pumped into the tissue protection module 50 to evenly heat or cool the biological sample.
  • the tissue protection module 50 also advantageously provides a means for securely supporting the biological sample within it.
  • the tissue protection module 50 accommodates a packaging system 60 for the biological sample.
  • the packaging system 60 is described later.
  • a temperature monitoring system as described herein is preferably included.
  • one or both of tissue protection module 50 and packaging system 50 are provided, as required, with inlet and outlet pumps - for example peristaltic pumps - to receive or deliver circulation fluid.
  • the tissue protection module 50 comprises gel cushion(s) 52 containing a gel of low viscosity, conveniently between 1000 and 2000 centipoise, which allows the gel to be pumped in a desired embodiment as described below.
  • the gel is preferably heat conductive and preferably has a freezing point lower than water to prevent the formation of ice crystals.
  • the gel cushion 52 desirably surrounds the biological sample protecting it from mechanical stress and injury, as well as enabling even heat transfer during cooling and rewarming.
  • the gel based cushion may include a means for active circulation of the gel.
  • the gel based cushion forms part of the circulation module 40 allowing the gel cushion to be easily cooled and warmed to the desired temperature range.
  • the tissue protection module 50 here may comprise an inlet tube and an outlet tube, as shown in Figures 7 and 8.
  • the circulation fluid may be pumped into the tissue protection module 50, circulating through it, and then exiting via the outlet tube .
  • the outlet tube conveniently communicates with the heat exchange system 30 which either heats or cools the circulation fluid and pumps the fluid back through tissue protection module 52 as previously described.
  • the rate, quantity and distance of the fluid circulated between inlet tube and outlet tube and the tissue protection module 52 can be configured to minimise turbulent flow and maximise heat transfer.
  • Heating or cooling of the circulation fluid may depend on its temperature as sensed at a convenient position, for example, at the outlet tube 54.
  • the gel cushion(s) 52 may be removable from the storage chamber 27 and device 10.
  • the gel cushion(s) 52 may also include a heating module, as described below, to allow controlled warming.
  • a heating module for example comprising resistive heating element or Peltier heating element, would enable warming either within the device 10, outside the device 10 or both.
  • the gel cushion 52 may be removed from the device 10, and the heating module could be activated outside of the device 10 by the temperature control programme set to warming mode. This would allow efficient warming without the effect of a cooling element such as a PCM housed within the device 10.
  • an air-based cushioning or liquid cushioning system could be implemented.
  • An air-based cushioning system may take the form of air-pillows, bubble wrap, foam or a blend of these.
  • a liquid cushioning system could take the form of a free liquid, or a liquid contained within impermeable bags, for example of the packaging system 60 as described below. Cushioning systems may also involve semi-solids or microbeads and could be configured to enable direct contact with the tissue.
  • a liquid based cushioning embodiment similarly to the gel cushioning embodiment, may be combined with the circulation module 40 to move heat to biological sample more effectively.
  • the liquid may be heated or cooled, as required, to allow for the liquid cushion to be cooled or warmed to a desired temperature more easily.
  • liquid cushion 52 may comprise an inlet tube 53 and an outlet tube 54.
  • the circulation fluid - whether or not a refrigerant - may be pumped into the liquid cushion 52, circulating through it, and then exiting via the outlet tube 54.
  • Outlet tube 54 conveniently communicates with the heat exchange system 30 which either heats or cools the circulation fluid and pumps the fluid back through liquid cushion 52. Heating or cooling of circulation fluid may depend on its temperature as sensed at a convenient position, for example, at the outlet tube 54.
  • Air or liquid cushions could also include a heating element as described with reference to the gel cushion.
  • the tissue protection module 50 preferably comprises means for suspending the biological sample within the storage chamber 27.
  • Packaging system 60 for the biological sample is suspended by a suspending means without touching the walls of the storage chamber 27 or any other wall of the device 10. This would provide the advantage of limiting conductive heat transfer through the walls of storage chamber 27 or the device 10 generally.
  • the heat exchange system 30 may enable warming module of the biological sample, in particular an organ, to physiological temperatures in a controlled manner, that is evenly or uniformly warming the organ.
  • the warming process must be completed prior to the implantation of the tissue to maximise the chances of success in a transplant.
  • the standard of care is to simply flush the organ with a warm solution before implantation.
  • Use of a warming module, with the benefit of controlled, gradual increase in temperature, offers a superior alternative to the standard of care.
  • warming or heating functionality could be integrated with cooling within the heat exchange system 30 and, where included, the circulation module 40.
  • a cushion as described above could also be provided with a separate heating element, for example a Peltier element or a resistive heating element, for this purpose.
  • Other embodiments could include separate cooling and heating modules to form the thermoregulation module 30.
  • Heating may be provided by combustion of a fuel which may be used to provide heating to the warming module. In an embodiment, this may be combined with absorption refrigeration in the cooling module. This would allow the device to be used in an environment lacking mains electricity and be effective in remote environments.
  • the heat exchange system 30 may be integrated with a circulation module 40 configured with a system of pumps and tubing that pumps the circulation fluid around a biological sample to efficiently control its temperature.
  • the circulating fluid could be the refrigerant or biocompatible solution such as a preservation solution.
  • a range of liquids may be used as the circulating fluid depending on the context: a non-contact or a contact circulation fluid in relation to the biological sample.
  • the non-contact circulation fluids may be a heat exchange fluid, such as a refrigerant, cryopreservative or PCM.
  • the choice of non-contact circulation liquids depends on its heat transfer capacity and ability to remain in the liquid form at 0°C or below with biocompatibility a lesser consideration.
  • a circulation fluid in direct contact with the biological sample may include organ and tissue preservation fluids such as the University of Wisconsin solution, or isotonic solutions such as a normal saline solution.
  • the choice of contact circulation liquids are based on its compatibility with the biological sample being transported.
  • the circulation module 40 may be integrated with the packaging system 60 as described below.
  • the sterile circulation fluid in direct contact with the biological sample within the packaging system may be used to facilitate heat exchange.
  • a convenient circulating fluid in direct contact with organs and tissues may include as the University of Wisconsin and normal saline solutions.
  • the circulation module 40 may include disposable tubing. As the circulation module 40 includes a pump, cushion, cushion connections (e.g. inlet tube and outlet tube as described above) and any other tubing forming portion of the circulation module 40 and heat exchange system 30, the pump may be disconnected from the tubing. This would allow the tubing of device 10 to be disposed, enabling sterility of the system to be maintained after each use.
  • the flow of circulating fluid through the circulation module 40 may be controlled by pumps and valve(s).
  • a range of pump types may be suitable, including peristaltic pumps, syringe pumps, diaphragm pumps, gear pumps, centrifugal pumps, micropumps, rotary vane pumps, piston pumps, membrane pumps, needle pumps, infusion pumps, vacuum pumps, insulin pumps, elastomeric pumps, osmotic pumps, implantable pumps, positive displacement pumps, axial flow pumps, impeller pumps and rotary lobe pumps.
  • a pump may be selected with to reduce turbulent flow.
  • Peristaltic pumps may be preferred in some embodiments.
  • the pump is electrically operated under the control of an electronic control unit (ECU) 100 for portable device 10.
  • ECU electronice control unit
  • the ECU is described below.
  • the pump and circulation module 40 is operated in either cooling or warming mode, depending on whether the temperature detected is above or below the desired settings.
  • the circulation module 40 when combined or co-operating with the heat exchange system 30 and the ECU, form the thermoregulation system, which can deliver a range of temperature control programmes that may be specific to different type of biological samples.
  • Preferred embodiments of the device 10 include a temperature monitoring system for sensing temperature of storage chamber 27 and the biological sample. Temperature monitoring may involve any suitable temperature sensor 82, for example a thermocouple, an infrared imaging system or a plurality of temperature sensing devices. A plurality of temperature sensors may be included.
  • the temperature monitoring system 80 provides temperature signals which are inputs for the control of the thermoregulation module 30 and circulation module 40, where included, to control temperature of the biological sample.
  • an array of thermocouple sensors is implemented throughout device 10.
  • thermocouple sensors are integrated with the thermoregulation module 30 and circulation module 40.
  • Thermocouple sensors may also be integrated with packaging system 60.
  • An array of thermocouple sensors, or any desired temperature sensor, would allow temperature to be recorded at a variety of positions within device 10 to gain a better understanding of the internal temperatures of the device 10 and the temperature of the biological sample, thereby optimising temperature. Positions that may be preferred for temperature sensors to be placed include the storage chamber 27, the packaging system 60, the heat exchange system 30 and the circulation module 40, where used.
  • thermocouple sensor or thermocouple sensor array may be provided by temporary connection.
  • temporary connection may take the form of 'press stud' or any other suitable system. This allows packaging system 60 to be disposed of along with the temperature sensor tip of the thermocouples without interfering with the architecture and operability of device 10.
  • an infrared imaging or IR sensor system is used to implement the temperature monitoring system. This system would provide the advantage that the temperature monitoring system need not be combined with the packaging system 60, which would allow it to be reused.
  • an array may be used. This may take the form of numerous IR detectors which allow the temperature of the tissue to be analysed at various points in time during transportation. Jn this embodiment, an IR array may be used to create an image or heat map to be displayed to the user, which would allow the system to detect areas of uneven temperature distribution on the tissue.
  • ECU 100 is included within device 10 for automatic temperature control of the heat exchange system 30 as well as automatic control over the circulation module 40 where this is included to allow circulation of warm/cold fluid from the circulation module to warm/cool the biological sample.
  • ECU 100 may actively control temperature, in one embodiment using feedback control, the operation of heat exchange system 30 being controlled as a function of temperature sensed by the temperature monitoring system 80. For example, if storage chamber 27 temperature is above setpoint, thermoregulation module 30 is operated to provide cooling. Where thermoregulation module 30 has heating functionality, and sensed temperature is below setpoint, thermoregulation module 30 is operated to provide heating.
  • ECU 100 may implement a range of temperature control programs, for example including the following:
  • Each of these temperature control strategies may be adapted to different types of tissue, for example organs such as kidneys, hearts, lungs or livers.
  • ECU 100 may include different temperature control logic for each type of tissue.
  • the above temperature control strategies may be implemented by ECU 100 control over any or all of the following, dependent on the variance of sensed temperature from desired temperature: heat exchange system 30, circulation module 40, heating or cooling element integrated with tissue protection module 50, heating element integrated with packaging system 60 (the latter being described below).
  • heat exchange system 30 heat exchange system 30, circulation module 40, heating or cooling element integrated with tissue protection module 50, heating element integrated with packaging system 60 (the latter being described below).
  • Such temperature control using the ECU 100 is precise and may be accurate to ⁇ 0.5°C.
  • ECU 100 may also enable wireless or wired communication of the device 10 with other computer systems in hospital systems or in transport vehicles. For example, a Bluetooth or other Wifi wireless communication system may be adopted.
  • ECU 100 may include inputs from sensors such as positioning sensors, orientation sensors and so on.
  • HMI 124 may provide prompts for a user to perform a necessary operation.
  • Device 10 also preferably includes a display to show operating parameters, in particular biological sample temperature (or a suitable proxy temperature, e.g. storage chamber temperature), average biological sample temperature during transport and time since biological sample stored in the device and state of battery charge.
  • a display to show operating parameters, in particular biological sample temperature (or a suitable proxy temperature, e.g. storage chamber temperature), average biological sample temperature during transport and time since biological sample stored in the device and state of battery charge.
  • Such display is conveniently coupled to ECU 100.
  • An alarm may be provided to indicate any fault with the device 10 or the transport process.
  • a control strategy for ECU 100 and device 10 may be implemented by command entered through the HMI 124.
  • the biological sample is packaged within a packaging system 60 to be disposed in storage chamber 27 of device 10.
  • Packaging system 60 protects the biological sample whilst also providing a sterile environment. A two, three or plurality of bags may be adopted to ensure sterility in handling.
  • a three-layer bag system may be used as packaging system 60.
  • An inner bag contains, for example, an organ which is sterile and surrounded by preservation solution. This bag is sealed in a sterile condition before being placed within another sterile bag before being sealed. This is followed by a third bag, which protects the inner bags from contact with an unsterile environment.
  • packaging system 60 may comprise two bags.
  • the tissue is contained within an inner sterile bag with preservation solution, and may besealed by zip lock mechanism.
  • the top of the packaging system 60 may be ripped by the user along a pre-weakened strip to facilitate sterile handling.
  • the bags may be configured to stand flat on a flat surface like a table to facilitate easy handling.
  • the bags may also feature a double zip lock system to help prevent leaks.
  • an outer bag is used to enclose and maintain the sterility of the inner bag(s).
  • the inside of this outer bag is sterile, while the outside is not when in use.
  • the outer bag is configured to allow the outer edge of the bag to be rolled down to expose the inner bag, allowing easy handling and maintenance of sterile conditions of the inner bag(s).
  • the packaging system 60 is disposable in order to maintain sterility and prevent cross-contamination between use.
  • the packaging system 60 may also comprise of other embodiments, including a rigid internal case, particularly for the storage of tissue samples such as cornea, skin and blood vessels.
  • a rigid internal case particularly for the storage of tissue samples such as cornea, skin and blood vessels.
  • An outer bag as described above, may be used to accommodate the rigid case to maintain sterility.
  • the packaging system 60 is combined with the circulation module 40. This would allow the circulation fluid to be circulated through the packaging system 60. This would allow the temperature of the packaging system to be precisely controlled and may be implemented by having an inlet port and outlet port to the packaging system. This would allow a biocompatible solution to be circulated through the system.
  • the packaging system 60 may be combined with the heat exchange system 30, to provide warming as described above. This may be done by providing Peltier heating elements or resistive heating elements within the packaging system 60.
  • the packaging system 60 may include electrical connectors that would enable it to be electrically connected to the body 11 of the device 10. This would allow electrical power from the device 10 to power the resistive heating elements in the packaging system 60 when the warming module is initiated, for example.
  • a local leaf seal may be used to ensure the tissue remains suspended in the packaging system 60. This may be achieved by bonding small areas of both sides of a bag of the packaging system together, while leaving the majority unbonded. This would allow the biocompatible solution to flow freely within the bag and around the biological sample, preferably with minimal turbulent flow to maximise efficiency of heat transfer.
  • a sealing clip is used to close the packaging system 60.
  • This sealing clip 66 may use a long lateral closing arm that is sealed across the top of the bag. This would create a water-tight seal at the top of the bag while being readily openable.
  • Device 10 conveniently comprises an energy source to enable operation of the various components including ECU 100, heat exchange system 30, circulation module 40 and accessory components, for example being included in the packaging system 60 as described above. It will be understood that not all components are included in all embodiments as described above.
  • the energy source is external to portable device 10, for example comprising a wired connection to an external energy source, such as mains electricity or an external computing device.
  • the energy source is provided by an on-board source such as a battery or photovoltaic cell.
  • the battery 14 may be provided as a single unit or separated into a plurality of batteries.
  • the battery uses lithium-ion technology and is rechargeable.
  • Battery 14 may be recharged by mains power or another source, for example a 12 V supply available on a transport vehicle carrying the device 10.
  • device 10 is powered by mains supply or 12V battery (e.g. located on a vehicle transporting device 10) whilst the battery 14 is recharging.
  • the energy source may be provided using a combination of mains power, battery power or other power source.
  • the energy source may be selected to conserve on-board energy where provided.
  • mains power is desirably used when available with battery capability to allow for remote use.
  • PCM based cooling in combination with circulation module 40 also reduces energy usage as a pre-primed PCM would not require a source of energy to achieve cooling.
  • less power is used than for a compressor-based refrigeration system and extends the time the device 10 may be used away from mains electricity.
  • device 10 comprises a heat exchange system 30 comprising separate cooling module 16 and heating module 17 allowing direct cooling and heating as required of tissue stored in storage chamber 27.
  • Cooling module 16 in this embodiment, comprises a chamber or container containing a PCM.
  • the PCM changes state from solid to liquid or from liquid to gas, absorbing heat from the environment. In this way, cooling is achieved, which transferred into the biological sample via cooling of the storage chamber 27.
  • an ice/water mixture could be employed, if desired, with an additive such as a salt or compound to lower its freezing point.
  • Cooling module 16 is conveniently configured to allow refilling whilst the device 10 is in use, for example by adding more ice.
  • Cooling module 16 may comprise a series of containers, for example as packages or blocks which contain the PCM. These blocks may be disposed about the storage chamber 27 surrounding the tissue and its packaging system 60 and enabling even cooling of the tissue. As the PCM is unpowered, this provides great flexibility as to the exact placement of the blocks since it is not necessary for the blocks to align with electrical plugs or sockets.
  • cooling module 16 may comprise both a PCM and Peltier cooler. Cooling module 16 may be arranged to allow for the majority of cooling to occur using a PCM, conserving power, with backup cooling being provided by the Peltier cooler. This embodiment allows the Peltier cooler to extend the lifetime of the PCM.
  • the separate heating module 17 of the embodiments described with reference to Figure 3 may provide heat by a variety of mechanisms, for example Peltier heating, resistive heating method or other method suitable for portable device 10.
  • the heating module 17 On command entered to HMI 124 and ECU 100, the heating module 17 begins a heating cycle. At this point, the heating module 17 may initiate a heating cycle to warm the biological sample. An automatic heating cycle is conveniently programmed into ECU 100 for this purpose.
  • the heating module 17 could be removable from the body 11 of device 10, separating it from the cooling module 16. Conveniently, heating module 17 - while containing the tissue - could operate through resistive heating with electrical connection to device 10. A wire extending between device 10 and heating module 17 would provide power to resistive heating element(s) allowing heating away from device 10, for example on a separate bench or table. Battery 14 or mains power could be used as energy source as with other embodiments.
  • cooling module 116 may comprise a compartment or container for a PCM. This PCM - conveniently an ice/water mixture - may be refilled, as described with reference to Figure 3. The change of state of the PCM cools the circulating fluid and in combination with the circulation module, cools the biological sample.
  • the packaging system 60 is suspended in the tissue protection module 50 with a heat conductive and flexible gel cushion 52.
  • a thermocouple 82 located on the packaging system 60 provides temperature data to the ECU 100 and HMI 124.
  • Thermocouple 82 could be substituted by an I R temperature sensor or other temperature sensor, an array of IR temperature sensors being shown in Figure 8.
  • cooling module 116 could include a block of frozen biocompatible solution or mixture (for example a eutectic mixture) which is used for heat exchange with the biological sample.
  • Circulation module 40 is placed in heat transfer contact with cooling module 116 by tubes 18 including valves 15.
  • the tubes 18 are arranged in a serpentine configuration. This configuration allows circulation of fluid, driven by peristaltic pump 44, adjacent to the cooling module 116 as well as proximate to tissue in gel cushion 52.
  • the pump 44, tubes 18 and valves 15 are located on a top panel 46 with inlet and outlet spigots 47 and 48 connectable to inlet tube 53 and outlet tube 54 of gel cushion 52. Further detail of this configuration is described herein.
  • Valves 15 are operated by ECU 100 to allow only respectively cooled or heated fluid to reach the storage chamber and preferably tissue protection module 50 - comprising cushions 52 - which is also preferably connected to the circulation module 40.
  • device 10 is in ‘cooling’ mode whereby cooled circulation fluid is driven, by the pump 44, from the cooling module 16 through tubes 18 before passing into the cushions 52 of the tissue protection module 50 as described in detail above.
  • Cushions 52 are connected together to allow a flow of circulation fluid between cushions 52 allowing heat to evenly transfer from, i.e. cool, the tissue into the cushions 52.
  • the flow of circulation fluid may be controlled by controlling pump 44 speed based on the temperature sensed by thermocouple 82.
  • heating module 117 would allow warming of tissue surrounded by the tissue protection module 50.
  • Heating module 117 may provide heat to the circulation fluid by a variety of mechanisms, for example Peltier heating, resistive heating method or other method suitable for portable device 10.
  • the heating module 117 On command entered to HMI 124 and ECU 100, for example when a transplant operation is imminent, the heating module 117 begins a heating cycle.
  • the heating cycle causes the valves 15 to change position (compared to the cooling cycle) and, with pump 44 operating, driving a flow of circulation fluid in heat transfer contact with the heating module 117.
  • the heated circulation fluid evenly loses heat to the biological sample via the cushions 52 of the tissue protection module 50.
  • the circulating fluid used for heat transfer in cooling or heating the tissue via the circulation module 40 and tissue protection module 50 must be heat conductive but otherwise may take a variety of forms. Desirably, the circulating fluid would be a liquid with a freezing point below 0°C and a boiling temperature above 40°C. A range of liquids, such as ethylene glycol or polypropylene glycol, may be suitable.
  • cooling module 116 and heating module 117 are combined into a single unit.
  • Such embodiment most conveniently includes a reverse cycle compressor-based refrigeration system or Peltier heater/cooler system. This embodiment would allow heat transfer via the circulation module 40 without need for use of valves 15 as the single unit heater/cooler allows active and precise control over temperature under control of the ECU 100.
  • device 10 has similarities with that of Figure 4, though also including circulation of fluid by circulation module 40 through the packaging system 60 as well as through cooling and heating modules 16, 17, tubing 18, valves 15 and pump 44.
  • circulation through a tissue protection module 50 is omitted in favour of circulation through the packaging system 60.
  • the packaging system 60 is still accommodated by the tissue protection module 50, cushions 52 supporting the packaging system 60 and the tissue within to reduce pressure injuries and facilitate even heat transfer.
  • the circulating fluid directly contacts the tissue.
  • the circulating fluid is a preservative or isotonic solution suitable for preserving the tissue within packaging system 60.
  • the preservative solution may be any suitable solution depending on the nature of the biological sample, for example Collins solution (e.g where tissue is a kidney), EuroCollins solution, phosphate buffered sucrose (PBS), University of Wisconsin solution and so on.
  • Temperature sensor(s) 82 may be positioned within the packaging system 60, the storage chamber 27 and/or tissue protection module 50 to allow accurate temperature readings to be obtained.
  • ECU 100 receives temperature signals from temperature sensor(s) 82 as an input allowing control over heating or cooling in dependence on monitored temperature.
  • ECU 100 may control heating or cooling in a range of ways including adjusting the flow rate of the pump 44, changing the position of the valves 15 and controlling the heating or cooling by adjusting power input to heating or cooling elements (where the output is electronically controllable). ECU 100 thus allows precise and even control over heating or cooling.
  • automatic control mode may be preferred, manual control by a user via manual inputs to HMI 124 is also an option. As examples, a user may prefer manual control over initiating a heating cycle or changing a temperature control programme based on tissue type.
  • Packaging system 60 for transporting a donor heart for transplant.
  • Packaging system 60 includes a bag 61 which has a pocket formed by sealing of two walls of the pockets at different places 28 as shown in Figures 8 to 10. This ensures that the heart, or other organs and tissues, can be suspended in the bag 61 whilst the circulation fluid passes around the organ or tissue freely through the bag 61 . It also isolates the organ or tissue from potential injury through impact with the circulation module 40 or its tubing 18.
  • Packaging system 60 may use a plurality of leaf seals 28, each leaf seal being disposed around the bottom half of the bag. Such arrangement prevents the tissue within the packaging system 60 from slipping into the bottom of the bag 61 while still allowing a fluid, for example preservation fluid, to flow freely around the tissue, preferably in laminar flow.
  • a fluid for example preservation fluid
  • Device 10 of Figure 6 may include a heating module 17 removable from the body 11 of device 10, separating it from the cooling module 16. Conveniently, heating module 17 - while containing the tissue - could operate through resistive heating with electrical connection via heating connector 17a to device 10. Peltier heating could be used as an alternative.
  • a wire extending between device 10 and heating module 17 would provide power to resistive heating element(s) disposed around the heating module 17 to enable even heating of tissue.
  • the use of heating connector 17a allows separate removal of heating module 17 and tissue allowing heating away from device 10, for example on a bench or table. Battery 14 or mains power could be used as energy source as with other embodiments. In some embodiments, where a passive cooling module, such as a PCM is used, this would allow a heating cycle to bypass the cooling action of the PCM and therefore achieve faster warming and consume less energy.
  • the tissue protection module 50 may be foldable allowing it to be flat packed for ease of manufacture and assembly.
  • the device 10 is provided with a heat exchange system 30 in the form of a temperature controlled refrigeration system 130 designed to maintain the biological at a desired temperature, i.e. 4-8°C, by use of a refrigeration cycle.
  • a refrigerant fluid circulates within a closed loop to absorb and dissipate heat.
  • the refrigeration system 130 has five main components: compressor 131 , condenser 132, expansion valve 133, metallic tubing 135 and evaporator 137. Refrigerant flows between the various components through metallic tubing 135.
  • expansion valve 133 high pressure liquid refrigerant pressure drops causing the refrigerant to cool significantly and partially evaporate.
  • evaporator 137 cold refrigerant enters the evaporator coils where it absorbs heat from the biological and the storage chamber 27 causing the refrigerant to evaporate completely and return to compressor 131 as a low pressure gas.
  • refrigeration system 130 is run in ‘reverse cycle’ it allows controlled warming.
  • This feature may be advantageous in the context of organs and tissues for transplantation and blood products for transfusion. This is a feature absent in existing transportation technologies.
  • FIG 16 showing a schematic diagram of the conventional practice in organ preservation
  • the diagram (a) shows a triple-bag system, where the organ is contained with the innermost bag suspended in preservation solution at 4°C, surrounded by a second bag containing crushed saline solution kept at -20°C, and contained within an outer bag that provides for sterility.
  • the triple-bag system is contained within an insulated container filled with ice cubes.
  • graphs (b) and (c) showing the expected temperature conditions of the organ based on conventional practice based on mathematical modelling. The graphs show that the temperature of the organ falls to -3°C after around 30 minutes and remains below 0°C for 8 hours, which is well below the desired temperature range for organ preservation at 4-8°C. This highlights that the conventional practice likely subjects organs and tissues to hypothermic injury.
  • a sample of chicken breast of similar mass to a human heart (480 g) was selected to simulate an organ. Starting conditions are shown in Figure 17(b). Specifically, the chicken breast was at a starting temperature of 36°C at To and placed in a litre of saline solution at 4°C. To this mixture, a PCM was added (2520 g) at a temperature of -5.3°C.
  • a temperature sensor was placed inside the centre of the chicken breast. This whole assembly was placed an insulated box and the lid closed. This experiment showed that the chicken breast slowly reached 5.5°C after 2-3 hours, and was maintained at the target temperature of 4-8°C for 6.5 hours as shown in Figures 17(c) and (d). This shows that while a PCM-only system can deliver the safe temperature conditions, time to target temperature (8°C) was very long (1 hour 30 minutes), especially given that the limit for warm ischaemia of a donor heart is 3-4 hours. In addition, the PCM was only able to maintain the target temperature for a limited time before being exhausted and needing to be replaced.
  • FIG. 18(a)-(f) shows the results of a bench top experiment (with cooler set up as shown in Figures 18(a) and (b), (b) showing the temperature sensors) whereby a piece of chicken breast was cooled from body temperature to 4-8°C using passive cooling with a commercial PCM with a melting point of -25°C.
  • starting conditions are shown in Figure 18(c). Specifically, a sample of chicken breast (480 g) at a starting temperature of 36.5°C at To was placed in a litre of saline solution at a starting temperature of 4°C. To this mixture, a PCM was added (2406 g) at a temperature of -5.3°C. A temperature sensor was placed inside the centre of the chicken breast. This whole assembly was placed in an insulated box (as shown in Figures 18(a) and (b)) and the lid closed.
  • FIG. 19(a)-(f) this shows the experimental data obtained from a simulation of a portable device as described with reference to Figure 4 of this specification and schematically shown in Figures 19(a) and (e).
  • a reservoir (centre block) of PCM (1980 g) and water (1800 mL) was created with starting conditions tabulated in Figure 19(b).
  • This fluid was pumped into a bag containing the chicken breast (420 g) at 36°C and water at 4°C (1480 mL).
  • a temperature sensor was placed inside the centre of the chicken breast. This whole assembly was placed an insulated box and the lid closed. The temperature was monitored for 24 hours.
  • the invention described herein may include one or more range of values (eg. volume, temperature etc).
  • a range of values will be understood to include all values within the range, including the values defining the range, and values adjacent to the range which lead to the same or substantially the same outcome as the values immediately adjacent to that value which defines the boundary to the range.
  • the numerical parameters set forth in the specification and claims are approximations that may vary depending upon the desired properties sought to be obtained by the present invention. Hence “about 80%’’ means “about 80%” and also “80%”. At the very least, each numerical parameter should be construed in light of the number of significant digits and ordinary rounding approaches.

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Abstract

Un dispositif portable (10) destiné à transporter un échantillon biologique comprend : (a) un boîtier (11) recevant une chambre de stockage (27) destinée à recevoir l'échantillon biologique ; (b) un système de thermorégulation destiné à ajuster la température de la chambre de stockage (27) comprenant : un système d'échange de chaleur (30) destiné à transférer la chaleur entre l'échantillon biologique et la chambre de stockage ; un système de surveillance de température (82) destiné à détecter la température de la chambre de stockage (27) et de l'échantillon biologique ; et un dispositif de commande (100) destiné à commander activement le fonctionnement du système d'échange de chaleur (30) et la température de la chambre de stockage (27) en fonction de la température détectée par le système de surveillance de température (82). Le dispositif de commande (100) actionne le système d'échange de chaleur (30) pour réguler la température de la chambre de stockage (27) selon un programme de régulation de température sélectionné tel que commandé par le dispositif de commande (100). Le programme de régulation de température sélectionné peut être sélectionné par un utilisateur en fonction de la nature de l'échantillon biologique, le dispositif portable (10) étant conçu pour transporter une plage d'échantillons biologiques, qu'il s'agisse d'organes, de tissus ou de vaccins par exemple tout en permettant une régulation précise de la température.
PCT/AU2024/051012 2023-09-20 2024-09-20 Appareil portable pour le transport d'échantillons biologiques Pending WO2025059729A1 (fr)

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AU2023903028A AU2023903028A0 (en) 2023-09-20 A portable apparatus for transport of biological samples
AU2023903028 2023-09-20

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Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20080145919A1 (en) * 2006-12-18 2008-06-19 Franklin Thomas D Portable organ and tissue preservation apparatus, kit and methods
US20130008182A1 (en) * 2009-12-16 2013-01-10 Brian Hrudka Self-contained temperature controlled apparatus
US20210063062A1 (en) * 2019-06-25 2021-03-04 Ember Technologies, Inc. Portable cooler

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20080145919A1 (en) * 2006-12-18 2008-06-19 Franklin Thomas D Portable organ and tissue preservation apparatus, kit and methods
US20130008182A1 (en) * 2009-12-16 2013-01-10 Brian Hrudka Self-contained temperature controlled apparatus
US20210063062A1 (en) * 2019-06-25 2021-03-04 Ember Technologies, Inc. Portable cooler

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