WO2018054425A1 - Système et procédé de perfusion extracorporelle d'organes - Google Patents

Système et procédé de perfusion extracorporelle d'organes Download PDF

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Publication number
WO2018054425A1
WO2018054425A1 PCT/DE2017/100802 DE2017100802W WO2018054425A1 WO 2018054425 A1 WO2018054425 A1 WO 2018054425A1 DE 2017100802 W DE2017100802 W DE 2017100802W WO 2018054425 A1 WO2018054425 A1 WO 2018054425A1
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WIPO (PCT)
Prior art keywords
module
organ
base
perfusate
modules
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PCT/DE2017/100802
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German (de)
English (en)
Inventor
Susanne Kromnik
Christine Thiele
Marian GRANSOW
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Technische Universität Dresden
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Publication of WO2018054425A1 publication Critical patent/WO2018054425A1/fr

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    • 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

Definitions

  • the invention relates to a modular system and a method for extracorporeal perfusion of organs. It relates in particular to a modular system and a method which enables a functional characterization of extracorporeal perfused organs.
  • a standard transplant the following procedure is usually followed:
  • the organ intended for organ transplantation is usually transported from the donor to the recipient in a standardized "icebox.”
  • the organ is then implanted in the recipient without prior functional check or proof of function
  • a subjective assessment of organ quality based on the division of color / classification of iced areas is given (compare, for example, the "Kidney Quality Form" form in the version of 05 May 2016 provided by the German Foundation for Organ Transplantation).
  • the donor organ In the icebox, the donor organ is stored in a cold preservative solution to prevent potential damage to the organ by ischemia.
  • a cold preservative solution to prevent potential damage to the organ by ischemia.
  • the risk of such complications can be reduced if the donor organ is perfused by machine perfusion immediately after removal of the organ, or at least after the arrival of the organ containing icebox at the recipient's hospital.
  • perfusion systems For machine perfusion of organs, perfusion systems have been developed that typically have a housing that is thermally insulated from the environment.
  • the housing there is an organ holder, which receives the donor organ, and an organ cassette, in which the organ holder is inserted.
  • the perfusate is circulated through the organ by means of a pump to produce a pulsatile adjusted perfusion pressure.
  • a pressure sensor is provided seen.
  • the circulation of the perfusate is realized by means of tubes, to which the arteries and veins of the donor organ are connected via cannulas.
  • the required power supply can be maintained by means of batteries.
  • the aim of the machine perfusion is to approximate the storage conditions during the extracorporeal storage of the donor organ in the carrier as far as possible to the physiological conditions.
  • the expenditure on equipment is limited, resulting in particular from the costs for the procurement and maintenance of the carrier device.
  • the classical laboratory diagnostics which is used in the course of the transplantation of a donor organ, provides in the case of a kidney, for example, measured values for the following parameters:
  • Urine Volume The urinary volume is determined over a period of 1 to 2 hours after the kidney transplantation and ending 24 hours after transplantation. Then the urinary volume is determined once a day until the function is stable.
  • serum creatinine determination of serum creatinine content. After transplantation, serum creatinine content is determined daily for the first 7 days, then 2 to 3 times a week for the second to fourth week, once a week for the second and third months, every two weeks for the fourth to sixth month and once monthly in the 7th to 12th month.
  • the object of the invention is to eliminate the disadvantages of the prior art.
  • a system for extracorporeal perfusion of an organ is to be specified, which is suitable for different organ systems and allows a functional characterization and conditioning of the organ before the transplantation. It is also intended to provide a method which is suitable for these purposes.
  • An organ storage device for receiving the organ, - A supply device for circulating a perfusate, wherein the supply device has at least one or more guide means for guiding the perfusate, an oxygenator and a perfusate reservoir, and
  • the base system comprises base modules, a control module and an interface module, wherein the base system as base modules at least
  • a first pump module for conveying the perfusate or a part thereof
  • a perfusate pressure module with a sensor unit for determining the pressure of the perfusate
  • An organ tempering with a sensor unit for determining a temperature that is characteristic of the state of the organ, and an actuator unit for influencing this temperature, and
  • a perfusate tempering with a sensor unit for determining a temperature which is characteristic of the state of the perfusate, and an actuator unit for influencing this temperature.
  • the control module is a control module for controlling at least one base module or for controlling at least one base module and at least one additional module.
  • the interface module is an interface module for communication between the control module and at least one base module or for communication between the control module and at least one base module and between the control module and at least one additional module.
  • the organ may, for example, be an organ that belongs to the organ system kidney, liver, lung and heart.
  • the organ may be a donor organ such as a kidney, a liver, a lung or a heart.
  • the modular system according to the invention can be adapted to the respective organ system. For example, one or more additional modules can be selected for this purpose.
  • the add-on modules extend the basic system with functions that enable the perfusion of organs from different organ systems.
  • the selection of the add-on modules may be selected by a user depending on the organ system to which the organ belongs.
  • the user may select one or more additional plug-ins to augment the basic system with functions that allow for functional characterization and / or conditioning of the organ.
  • the modular system according to the invention allows thus a user-individual and / or organ-adapted perfusion of an organ.
  • the modular system according to the invention also allows automated perfusion of an organ.
  • the control module has at least one interface for communication with the interface module. Via the interface module, the control module can communicate with at least one or more, preferably all base modules. Furthermore, the control module via the interface module with one or more, preferably all additional modules communicate.
  • the base modules and the additional modules which are to communicate with the control module via the interface module, in turn have interfaces that enable communication between the respective module and the interface module.
  • Under communication is to be understood in particular a data transfer.
  • the communication between the interface module on the one hand and the interfaces of the control module, the base modules and the additional modules on the other hand can be done in each case via a cable connection or a wireless connection.
  • the control module may comprise a module bus.
  • data which is transmitted from the base modules and / or the additional modules via the interface module to the control module or which are transmitted from the control module via the interface module to the base modules and / or the additional modules can be transmitted to a data processing unit.
  • the control module has a data processing unit for evaluating process values that are detected by one or more additional modules and / or process values that are detected by one or more of the base modules.
  • the data processing unit may be a computer. It can be provided that the data processing unit processes all the process values that are supplied by the base modules and, if present, the additional module (s).
  • the control module may further comprise a user interface for monitoring the modular system according to the invention by a user of the modular system according to the invention and / or to the interaction of the user with the modular system according to the invention.
  • the user interface allows the user to access the process values received from base modules and, if present, add-on modules. It may also provide instructions via the user interface to influence the state of the organ or the modular system via one or more of the base modules and / or one or more of the add-on modules.
  • the user can for example define a desired state for the modular system, which is continuously compared in the data processing device with an actual state, or offer and / or specify specifications for one or more process parameters.
  • the term "process parameter" in the present invention refers to parameters that characterize the state of the organ and / or the state of the modular system, and parameters derived from these parameters, for example, the derived parameters include the hemodynamics of the perfused organ and the timing of all or part of the process parameters.
  • the parameters that characterize the state of the device and / or the state of the modular system include, for example, the parameters for which measurements of base modules and add-on modules are obtained Further characterizing the state of the organ and / or the state of the modular system may further include values that the user has specified via the user interface for parameters to be influenced by one or more of the base and / or add-on modules.
  • the control module can serve as a central controller for one or more, preferably all other components of the modular system according to the invention, in particular the other modules of the base system and, if present, the one or more additional modules.
  • the basic system according to the invention comprises an interface module.
  • the interface module serves for communication between the control module and at least one other, preferably all other base modules. It can simultaneously for communication between the control module and at least one, preferably serve all other additional modules, provided that the base system has at least one additional module.
  • the interface module can also be used for communication between the control module on the one hand and the organ storage device and / or the supply device on the other.
  • the interface module expediently has one or more interfaces. It may further include a power input enabling powering the interface module via the power supply unit.
  • the base system has at least one device for supplying one or more base modules with electric current.
  • This device is referred to below as a power supply unit.
  • the power supply unit can be a power supply.
  • the power supply unit can be integrated in the base system. In this case, the power supply is an internal power supply. It can be provided that the power supply unit also serves to supply the control module, the interface module or both with electric current. It may be provided that the power supply unit also serves to supply the or the additional modules with electric current. It can be provided that each of the modules, which requires a supply of electrical current, is supplied with electrical power via the power supply unit. For this purpose, these modules can each have a current input, which enables a power supply of the respective module via the power supply unit.
  • the power supply unit can thus be a central power supply for the control module, the interface module and the base and additional modules, which must be supplied with electrical power. It can be provided that the power supply via a supply bus or directly via power supply.
  • the control module can be designed such that it can influence the energy supply to the other base modules and / or the additional modules.
  • the modular system comprises an organ storage device for receiving the organ.
  • the organ storage device can have an organ perfusion chamber in which the organ can be stored.
  • the organ storage Direction may have a thermal insulation against the environment.
  • the organ storage device may be a module of the modular system according to the invention. However, other organ storage devices can be used together with the base system according to the invention.
  • the modular system according to the invention further comprises a supply device.
  • the supply device allows the circulation of the perfusate.
  • the supply device has guide means for guiding the perfusate.
  • the guide means may be tubes.
  • the perfusate can be led to the organ storage device and led away from the organ storage device.
  • the inputs and outputs of the organ located in the organ storage device may be connected to the tubes.
  • the inlets and outlets of the organ may be all functional inlets and outlets of the organ, in particular arteries and veins of the organ.
  • the supply device also has an oxygenator and a perfusate reservoir.
  • the oxygenator for example, the perfusate can be enriched with oxygen and carbon dioxide can be removed from the perfusate.
  • the oxygenator is traversed by a process gas which may contain nitrogen, oxygen and carbon dioxide.
  • the supply device may be a module of the modular system according to the invention. However, other utilities may be used in conjunction with the base system of the present invention.
  • the supply device is intended for single use. It can also be provided that the Organlagerungseinrich- tion is intended for single use. If both the supply device and the organ storage device are intended for single use, they can together form a set that is intended for single use and is therefore referred to below as a disposable set.
  • the base system may have a docking point for the organ storage device and / or the supply device.
  • the docking station can provide a supply of Provide organ storage device and / or the supply device with electric power via the power supply unit. It can also have an interface for communication with the control module via the interface module. In this way, a data connection of the base system to the organ storage device and / or a data connection of the base system to the supply device can be realized.
  • the base system according to the invention has several base modules.
  • a basic module can have a sensor unit for determining a process parameter, that is to say a parameter which characterizes the state of the modular system and / or of the organ.
  • a base module may alternatively or additionally comprise an actuator unit for influencing a process parameter.
  • the modular system according to the invention can have at least one base module which has a sensor unit and an actuator unit.
  • the base system comprises a first pump module for conveying the perfusate or a part thereof.
  • the first pump module causes the circulation of the perfusate. It can be provided that perfusate, which emerges from the organ located in the organ storage device, first passed to the reservoir and collected there perfusate. Subsequently, the perfusate or a part thereof can be led to the oxygenator. Perfusate, which passes through the oxygenator, is oxygenated there. The oxygenated perfusate can then be returned to the organ. If only part of the perfusate is oxygenated, the oxygenated substream can be combined with non-oxygenated perfusate.
  • the perfusate circuit can have multiple partial circuits.
  • the first pump module may be suitable for generating a pulsatile perfusion pressure.
  • the first pump module may have an interface for communication with the control module via the interface module. It can also have a current input, which allows a power supply of the first pump module via the power supply unit.
  • the perfusate may be, for example, a fluid such as blood, a fluid obtained from blood, or a blood substitute.
  • the base system comprises a perfusate pressure module.
  • the perfusate pressure module has a sensor unit for determining the pressure of the perfusate.
  • the perfusate pressure module may have an interface for communication with the control module via the interface module. It may further include a power input enabling power to be supplied to the perfusate pressure module via the power supply unit.
  • the basic system according to the invention comprises an organ temperature control module.
  • the organ tempering module has a sensor unit for determining a temperature that is characteristic of the state of the organ.
  • the organ tempering module also has an actuator unit for influencing this temperature.
  • the organ tempering module can enable the determination and adjustment of the temperature of the organ in the organ storage device.
  • the sensor unit may be a temperature sensor, and the actuator unit may be a heating and / or cooling element.
  • the organ tempering module may have an interface for communication with the control module via the interface module. It may further comprise a current input, which allows a power supply of the organ temperature control module via the power supply unit.
  • the basic system according to the invention comprises a perfusate temperature control module.
  • the perfusate tempering module has a sensor unit for determining a temperature that is characteristic of the state of the perfusate.
  • the perfusate temperature control module also has an actuator unit for influencing this temperature.
  • the perfusate tempering module may allow the determination and adjustment of the temperature of the recirculated perfusate.
  • the sensor unit may be a temperature sensor.
  • the actuator unit may be a heat exchanger. to act.
  • the heat exchanger is preferably arranged in the oxygenator. By means of the heat exchanger, the temperature of the perfusate can be selected from hypothermic to normothermic.
  • the heat exchanger may communicate with a heating and / or cooling unit or be part of a heating and / or cooling unit.
  • the perfusate tempering module may have an interface for communication with the control module via the interface module. It can also have a current input, which enables a power supply of the perfusate temperature control module via the power supply unit.
  • the base system has at least one fastening device for an additional module.
  • fastening devices may be formed on a housing of the base system.
  • the module or modules can be positioned at a predetermined location in the modular system according to the invention.
  • the housing of the base system can accommodate one or more, preferably all base modules. It can also accommodate one or more add-on modules.
  • the modular system according to the invention has, in its simplest embodiment, the base system without additional modules.
  • the basic system may be extended by one or more additional modules depending on the organ system to which the organ to be perfused belongs and on the wishes of the user.
  • An additional module can have a sensor unit for determining a process parameter, that is to say a parameter which characterizes the state of the modular system and / or the organ.
  • An additional module may alternatively or additionally comprise an actuator unit for influencing a process parameter.
  • the modular system according to the invention can have at least one additional module which has a sensor unit and an actuator unit.
  • additional modules without sensor or actuator unit may also be provided, for example a heating module, a cooling module or both.
  • the actuator unit of one of the basic and additional modules can be used to change or maintain the process parameter.
  • the modular system according to the invention can have, for example, one or more of the following additional modules, the list not being conclusive:
  • An optical measuring module with a sensor unit for the optical determination of at least one parameter that characterizes the state of the organ;
  • a blood gas measuring module having a sensor unit for determining at least one blood gas parameter in the perfusate
  • a gas actuator module with an actuator for influencing the content of nitrogen, oxygen and / or carbon dioxide in the perfusate; a second pump module for conveying the perfusate or a part thereof, the pump module having a sensor unit for determining the pressure and an actuator unit for conveying the perfusate;
  • a perfusate measuring module having a sensor unit for determining the volume flow of the perfusate and / or a sensor unit for determining the pressure of the perfusate; a heating module; and a cooling module.
  • the modular system according to the invention may have one or more other additional modules instead of these additional modules or in addition to these additional modules.
  • Each additional module should have an interface for communication with the control module of the base system. The communication can take place via the interface module.
  • Data can be transmitted from the additional module to the control module via the interface module.
  • data, in particular instructions can be transmitted from the control module to the additional module via the interface module.
  • An add-on module may further include a power input enabling powering the add-on module via the power supply unit.
  • the optical measuring module can enable an optical evaluation of the organ. It can, for example, have a sensor unit which operates in the infrared and / or visual spectral range. By using the optical measuring module, for example, one or more tissue properties of the organ can be determined.
  • the optical measuring module can be for example a camera.
  • the optical measuring module may require a geometric adaptation to the organ storage device.
  • the blood gas measurement module may allow the determination of one or more blood gas parameters in the perfusate.
  • the blood gas parameters include, in particular, the partial pressure of oxygen, the partial pressure of carbon dioxide and the pH in the perfusate. In addition, other blood gas parameters can be determined.
  • the blood gas parameters can be determined in the arterial and / or venous perfusion branch of the perfusion circulation. From blood gas parameters, for example, process parameters such as oxygen consumption and / or carbon dioxide production can be derived.
  • the blood gas measuring module has a sensor unit for determining at least one blood gas parameter in the perfusate.
  • the gas actuator module can enable the influence of the content of at least one gas in a process gas.
  • the process gas is the process gas that flows through the oxygenator.
  • the content of nitrogen, oxygen and / or carbon dioxide in the process gas can be influenced, the enumeration being not exhaustive.
  • the gas adjusting module can have an actuator unit for influencing the content of nitrogen, oxygen and / or carbon dioxide in the process gas. It can be provided that the actuator unit of the gas adjusting module influences the content of nitrogen, oxygen and / or carbon dioxide in a gas distributor supplying the process gas.
  • the term "influencing" means in particular the adjustment of the content of at least one gas in the process gas.
  • the second pump module can facilitate the circulation of the perfusate or a part thereof. This may be particularly useful when an organ system requires perfusate delivery through multiple inputs and outputs.
  • a second pump module is particularly advantageous for the perfusion of a liver. For the perfusion of a kidney, however, the second pump module is not mandatory.
  • the second pump module may be suitable for generating a pulsatile perfusion pressure.
  • the Peifusat measurement module may allow for the determination of the volume flow of circulated perfusate, the determination of the pressure of the recirculated perfusate, or both.
  • the perfusate measuring module can thus permit a pressure determination in addition to the determination of the pressure by means of the perfusate pressure module already present as the base module.
  • a heating module, a cooling module or both can be provided as additional modules, in particular if the user does not want to use his own thermostat.
  • the heating module, the cooling module or both can be in communication with the actuator unit of the organ tempering module and / or the perfusate tempering module. They can serve as heat or cold source for the actuator unit of the organ tempering module and / or the perfusate tempering module.
  • a base system for monitoring, controlling and / or regulating a device for extracorporeal perfusion of an organ is also provided.
  • the basic system can be extended by one or more additional modules and has base modules, a control module and an interface module.
  • the base system has at least as basic modules
  • a first pump module for conveying a perfusate or a part thereof
  • a perfusate pressure module with a sensor unit for determining the pressure of the perfusate
  • an organ temperature control module having a sensor unit for determining a temperature that is characteristic of the state of the organ, and an actuator unit for influencing this temperature
  • the control module is a control module for controlling at least one base module or for controlling at least one base module and at least one additional module.
  • the interface module is an interface module for communication between the control module and at least one base module or for communication between the control module and at least one base module and between the control module and at least one additional module.
  • the device for extracorporeal perfusion of an organ may be an organ storage device for receiving the organ, in particular the organ storage device described above in connection with the modular system.
  • the device for extracorporeal perfusion of an organ may have, in addition to the organ storage device, a supply device for circulating the perfusate. These may be the utility described above in connection with the modular system.
  • the device for extracorporeal perfusion of an organ may be a disposition Have sable set consisting of the organ storage device and the supply device.
  • the basic system according to the invention can have one or more of the following additional modules: an optical measuring module with a sensor unit for the optical determination of at least one parameter which characterizes the state of the organ; a blood gas measuring module having a sensor unit for determining at least one blood gas parameter in the perfusate; a gas actuator module with an actuator unit for influencing the content of nitrogen, oxygen and / or carbon dioxide in a process gas; a second pump module for conveying the perfusate or a part thereof, the pump module having a sensor unit for determining the pressure and an actuator unit for conveying the perfusate; a perfusate measuring module with a sensor unit for determining the volume flow of the perfusate and / or a sensor unit for determining the pressure of the perfusate; a heating module and a cooling module.
  • an optical measuring module with a sensor unit for the optical determination of at least one parameter which characterizes the state of the organ
  • a blood gas measuring module having a sensor unit for determining at least one blood gas parameter
  • the basic system corresponds to the modular system described above, except that it has no organ storage device and no supply device and that the term "process parameter" in this embodiment refers to parameters relating to the state of the organ and / or the state of the device for extracorporeal perfusion of an organ
  • the base system together with an organ storage device and a supply device, can form inventive modular system. Further details of the basic system can therefore be found in the description of the modular system.
  • a method for extracorporeal perfusion of an organ is further provided by means of the modular system according to the invention.
  • the method comprises the determination of at least one parameter which characterizes the state of the organ, by means of at least one basic module of the basic system or by means of the basic system extended by at least one additional module. It may be provided that the method comprises the influencing of at least one parameter which characterizes the state of the organ by means of at least one base module of the base system or by means of the basic system extended by at least one additional module. It may be provided that the parameter characterizing the state of the organ is determined by the sensor unit of a base and / or additional module and is influenced by the actuator unit of this module.
  • the respective base module or additional module can transmit at least one measured value for the parameter to the control module via the interface module, the control module process the measured value and generate instructions for the respective base module or additional module which can be sent to the base module or additional module via the interface module be transferred, and the base or additional module based on the instructions influence the parameter by means of its actuator.
  • one or more base modules and / or one or more additional modules transmit measured values for parameters that are characteristic of the state of the organ and / or the state of the modular system via the interface module to the control module;
  • the control module processes the measured values of the base modules and the additional modules while obtaining a result describing the actual state of the organ and / or the modular system, comparing the actual state with a desired state, one or more modules from the basic and / or or add-on modules of the modular system that are capable of the state of the organ and / or the modular system from the current state to the target state towards generate instructions to the selected module (s) to affect the state of the device and / or the modular system and transmit the instructions to the selected module (s) via the interface module; the selected module (s), according to the instructions, affect the state of the organ and / or the modular system to reach the target state.
  • the inventive method can be realized using software.
  • the software can be executed in the control module.
  • the inventive method enables a functional characterization of an organ based on process parameters that are detected by base and / or additional modules.
  • the invention makes it possible to perfuse and condition organs extracorporeally before a potential implantation.
  • process parameters in particular derived process parameters, enable a functional characterization of the organ.
  • additional modules having sensor and / or actuator units and the process values which can be obtained by means of the sensor units enable the creation of a genetic product family for perfusion of organs of various organ systems on the hardware side and a genetic algorithm for organ system over the software gripping function characterization.
  • the invention provides a device topology that allows for the perfusion of organs of different organ systems with a family of devices using different additional modules in organ-individual compilation partly the same modules.
  • the resulting generic perfusion system family enables the ex-vivo perfusion, conditioning and functional characterization of the respective perfused organs in the case of individual assemblies of modules.
  • the sensor and actuator units enable a generic function characterization on the basis of the individually connected modules and the process parameters they record.
  • the use of the modular system according to the invention for functional characterization and / or conditioning of an extracorporeally perfused organ is thus provided.
  • FIG. 1 shows a schematic representation of an embodiment of the inventive modular system.
  • the first embodiment of the modular system 1 according to the invention shown in FIG. 1 comprises a base system 2, an organ storage module 3 and a supply module 4.
  • the organ storage module 3 and the supply module 4 together form a disposable set 5.
  • the basic system 2 has a control module 6 , an interface module 7 and base modules 8.
  • the base system 2 can be extended by one or more additional modules 9.
  • the basic system 2 has the following basic modules 8:
  • a first pump module 11 for conveying the perfusate or a part thereof
  • a perfusate pressure module 12 with a sensor unit for determining the pressure of the perfusate
  • the base system 2 can be extended, for example, by one or more of the following additional modules 9, whereby the extended basic system 2A is obtained: an optical measuring module 21 with a sensor unit for optically determining at least one parameter which characterizes the state of the organ;
  • a blood gas measuring module 22 having a sensor unit for determining at least one blood gas parameter in the perfusate
  • a gas actuator module 23 having an actuator unit for influencing the content of nitrogen, oxygen and / or carbon dioxide in a process gas
  • a second pump module 24 for conveying the perfusate or a part thereof, the pump module having a sensor unit for determining the pressure and an actuator unit for conveying the perfusate;
  • a perfusate measuring module 25 with a sensor unit for determining the volume flow of the perfusate and / or a sensor unit for determining the pressure of the perfusate;
  • the optical measuring module 21 can be adapted to the organ storage module 3 by means of a geometric adaptation 211.
  • the control module 6 can communicate with the base modules 8 and, if present, the additional modules 9 via the interface module 7.
  • the interface module 7, the control module 6, the base modules 8 and the accessories Set modules 9 each have a corresponding interface (not shown).
  • the interface module 7 on the one hand and the control module 6, the base modules 8 and the additional modules or 9 on the other hand there are data links 41. There may be more data connections from the interface module 7 with the organ storage module 3, the supply module 4 or both (not shown), if these modules 3, 4 have corresponding interfaces.
  • the base system 2 has at least one power supply device 42 for supplying the control module 6, the interface module 7, the base modules 8 and, if present, the one or more additional modules 9 with electric current.
  • the power supply device 42 can also supply the organic storage module 3, the supply module 4 or both with electric current.
  • the control of the power supply device 42 can be carried out by the control module 6 via the interface module 7. For this purpose, a further data connection 41 between the interface module 7 and the power supply device 42 may be provided.
  • the control module 6 has a data processing unit 43.
  • data received via the interface module 7 from the control module 6 can be processed using software, for example to calculate derived process parameters.
  • instructions for base modules 8 and / or the additional module or modules 9 can be generated and transmitted to the respective base module or additional module 8, 9 via the interface module 7 and the associated data connections 41.
  • the data processing unit 43 can use all currently available process parameter values which are transmitted by the sensor units and actuator units of the base modules 8 and, if present, the additional modules 9.
  • the control module 6 further comprises a user interface 44 via which interactions 32 of a user 31 with the control module 6 are possible.
  • the user 31 also has the option for interactions 33 with the disposable set 5.
  • the base system 2, which has no additional modules 9, is the non-expanded base system 2. It has the control module 6, the interface module 7, the base modules 8 and the power supply device 42.
  • a base system additionally having one or more add-on modules 9 is the extended base system 2A.

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Abstract

La présente invention concerne un système modulaire de perfusion extracorporelle d'un organe, lequel comporte un dispositif de stockage d'organe (3), un dispositif d'alimentation (4), destiné à la circulation d'un liquide de perfusion et un système de base (2) extensible à un ou plusieurs modules complémentaires (9). Le système de base (2) comprend des modules de base (8), un module de commande (6) et un module d'interface (7). Le système de base comprend, en tant que modules de base, au moins un premier module de pompe (11), un module de pression de produit de perfusion (12), un module d'équilibrage de température de l'organe (13) et un module d'équilibrage de température du produit de perfusion (14). Le système de base peut être extensible par un ou plusieurs des modules complémentaires suivants : un module de mesure optique (21), un module de mesure de gaz sanguin (22), un module de commande de gaz (23), un deuxième module de pompe (24), un module de mesure de produit de perfusion (25), un module de chauffage (26) et un module de refroidissement (27) Selon l'invention, l'utilisation des différents modules complémentaires lors de l'assemblage spécifique à l'organe des modules partiellement identiques, permet une perfusion d'organes de différents systèmes d'organes au moyen d'une famille d'appareils. Les paramètres du procédé permettent une caractérisation fonctionnelle de l'organe.
PCT/DE2017/100802 2016-09-22 2017-09-21 Système et procédé de perfusion extracorporelle d'organes WO2018054425A1 (fr)

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DE102016117901.9A DE102016117901A1 (de) 2016-09-22 2016-09-22 System und Verfahren zur extrakorporalen Perfusion von Organen

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ES2921361B2 (es) * 2021-02-16 2023-05-08 Ebers Medical Tech S L Dispositivo de perfusion modular y versatil para preservar un organo en condiciones de operacion regulables
CN115843786B (zh) * 2023-03-01 2023-07-14 基点生物科技(成都)有限公司 生物样本低温存储设备

Citations (4)

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US20050255442A1 (en) * 2004-05-14 2005-11-17 Organ Recovery Systems Apparatus and method for perfusion and determining the viability of an organ
DE10340487B4 (de) 2003-09-03 2007-07-12 Technische Universität Dresden Perfusionskreislauf
WO2015143552A1 (fr) * 2014-03-26 2015-10-01 University Of Manitoba Appareil pour conservation de cœurs prélevés pour la transplantation
WO2016090498A1 (fr) * 2014-12-12 2016-06-16 Freed Darren Appareil et procédé de perfusion d'organe

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IL273422B (en) 2004-10-07 2022-07-01 Transmedics Inc Methods and systems for extracorporeal organ treatment
US9113624B2 (en) 2008-10-15 2015-08-25 Covidien Lp System and method for perfusing biological organs
US10602740B2 (en) 2012-07-10 2020-03-31 Lifeline Scientific, Inc. Organ perfusion apparatus with downstream flow control

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DE10340487B4 (de) 2003-09-03 2007-07-12 Technische Universität Dresden Perfusionskreislauf
US20050255442A1 (en) * 2004-05-14 2005-11-17 Organ Recovery Systems Apparatus and method for perfusion and determining the viability of an organ
WO2015143552A1 (fr) * 2014-03-26 2015-10-01 University Of Manitoba Appareil pour conservation de cœurs prélevés pour la transplantation
WO2016090498A1 (fr) * 2014-12-12 2016-06-16 Freed Darren Appareil et procédé de perfusion d'organe

Non-Patent Citations (2)

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HUGO SACHS ELEKTRONIK (HARVARD APPARATUS): "Tissue Bath & Perfusion Systems Selection Guide Precision Systems for Physiology Research", 21 October 2013 (2013-10-21), XP055437218, Retrieved from the Internet <URL:https://www.harvardapparatus.com/media/harvard/pdf/Perfusion+Systems+Selection+Guide.pdf> [retrieved on 20171221] *
HUGO SACHS ELEKTRONIK: "Universal Perfusion System UP 100 in-vivo liver, kidney perfusion: Core items", 21 October 2013 (2013-10-21), XP055437216, Retrieved from the Internet <URL:https://web.archive.org/web/20131021105741/http://www.hugo-sachs.de:80/index.php/perfusion-systems-organ-baths/organ-perfusion/other-organ-perfusion-systems/liver-kidney/core-items.html> [retrieved on 20171221] *

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