Organ container, impedance meter for organ container, and method for defining the state of organ deterioration

Abstract

The organ container (1) comprises a wall (10) surrounding an internal space (11) configured to receive an organ (13). Conductors (14) and impedance meters (16) are provided to measure a first impedance value in a first period and a second impedance value in a second period. Based on the difference between the first and second impedances, the state of deterioration of the organ present in the internal space is defined. In one embodiment, the conductor forms at least one loop around the internal space (11). In another embodiment, the conductor forms a single loop on one side of the wall of the organ container, either on the top or bottom. Multiple loops of multiple conductors may be provided, and each conductor may provide individual impedance measurements. In another embodiment, the conductors are arranged as individual impedance measuring devices that may be placed inside the organ container.

Description

Technical Field

[0001] The present disclosure relates to the physical analysis of biological materials, and more specifically, to transporting viable organs for successful transplantation into human or other mammalian recipients.

Background Art

[0002] Organ transplantation often requires transporting organs after donation since the donor and the donor hospital can be located far from the transplant hospital. The viability of the organs must be protected during transportation, and all incidents and serious adverse events that affect the quality and safety of the organs should be recorded. Many organs are classified as marginal organs after transportation and may be rejected. Therefore, the quality assessment and prediction of organ viability functions are of utmost importance. In the case of organ transplantation, transplant surgeons must determine whether the organ is acceptable for transplantation based on a limited amount of information such as donor information, transplantation diagnosis information at the time of procurement, and transportation period.

[0003] It is estimated that more than 140,000 organ transplants were performed worldwide in 2018. For example, in the United States in 2018, 3,755 kidneys were discarded, which corresponds to 17.9% of the kidneys provided. Additionally, the rejected organs included 278 pancreases, 707 livers, 3 intestines, 23 hearts, and 317 lungs. Some of these organs may have been viable but were rejected due to uncertainties during transportation. The need to provide more organs and recover as many harvested organs as possible is increasing and growing.

[0004] Organ transplant policies are well documented and maintained, for example, by the Organ Procurement and Transplantation Network (OPTN) in the United States. In Finland, a set of policies is listed in the document "National action plan for organ donation and transplantation 2023-2033." Each organ transplant must adhere to these strict policies. [Overview of the Initiative]

[0005] This summary is provided to introduce, in a simplified form, a selection of concepts that will be further described below in the detailed description. This summary is not intended to identify any significant or essential features of the claimed subject matter, nor is it intended to be used to limit the scope of the claimed subject matter. Furthermore, the claimed subject matter is not limited to any implementation that resolves any or all of the defects described in any part of this disclosure.

[0006] Organ grafts or other transportable tissues are measured repeatedly during transport. The organ container comprises a conductor configured to form a coil that generates an electric field extending to the organ graft inside the organ container. In one embodiment, the conductor forms a loop or coil around the organ container, enclosing the space for the organ transplant. In one embodiment, the conductor forms a single loop on one side of the organ container wall, either on the top or bottom. In one embodiment, the organ container wall comprises multiple loops of multiple conductors, each conductor potentially providing individual impedance measurements.

[0007] In one embodiment, the conductor is arranged as an individual impedance measuring device that can be placed inside the organ container.

[0008] The impedance measured from a conductor has one component related to the conductance of the organ graft. The conductance of an organ graft is proportional to the degradation of the organ graft. Degradation of an organ graft can result from the degradation of biological tissue at any level, including molecular, cellular, organ structure, and organ level; physical trauma such as mechanical or temperature-induced injury; lack of oxygen or other substances, viruses, other pathogens or parasites; alcohol consumption; cancer; surgical accidents; or other tissue-damaging effects, including chemical damage.

[0009] When an organ graft is placed in an organ container, the first impedance measurement of the organ graft is performed. Impedance measurements may be repeated periodically to monitor potential degradation of the organ graft. Impedance measurements may be performed across multiple frequencies. The state or rate of organ degradation may be used to assess the organ's viability.

[0010] Impedance measurements do not require direct contact with the organ graft. The conductor can be placed inside the organ container, ensuring it does not affect the organ transplant. Measurements can be autonomous, without any involvement from transport personnel. Current organ transplant policies can be applied.

[0011] In one embodiment, the organ grafts are to be placed inside three sterile bags, each of which can be considered an individual organ container. The impedance measurement coil may be mounted on the outside of the innermost sterile bag, for example, in a second sterile bag.

[0012] This invention solves the problem of evaluating the condition of harvested organs by detecting changes in their state of deterioration. The evaluation of tissue deterioration can be performed continuously during transport and in real time in the transplant operating room. This provides transplant surgeons with non-contact measurement data regarding the condition of organs / tissues during transport and potential deterioration. Transplant surgeons have new tools and further data to determine the organ condition and whether to proceed with the transplant surgery. Transplant diagnosis is a time-consuming process at the recipient hospital, and this can be mitigated with the help of data collected during transport.

[0013] Many of the associated features will become more readily apparent as they are better understood by referring to the following detailed description, which is considered in relation to the attached drawings. The embodiments described below are not limited to implementations that address any or all of the shortcomings of donor organ transport.

[0014] This specification will be better understood from the following detailed description, which can be read in reference to the attached drawings. [Brief explanation of the drawing]

[0015] [Figure 1] A schematic illustration of one exemplary embodiment of an organ container will be provided. [Figure 2] A simulated graph illustrating the relationship between measured impedance and conductance in a degraded organ is provided as a schematic example. [Figure 3] Three illustrative plots of impedance measurement are provided as examples. [Figure 4a] A schematic example of a single frequency spectrum from an organ vessel without significant organ deterioration is presented. [Figure 4b] A schematic example of a single frequency spectrum from an organ vessel exhibiting organ degradation at several frequencies is schematically illustrated. [Figure 5] A schematic illustration of one exemplary embodiment of an organ container will be provided. [Figure 6]Schematically illustrate an exemplary embodiment of an organ container having a non-rigid wall. [Figure 7a] Schematically illustrate an exemplary system for transporting an organ by an organ container. [Figure 7b] Schematically illustrate an exemplary system for transporting an organ by an organ container. [Figure 8] Illustrate a flowchart of steps of a method for defining the deterioration state of an organ. [Figure 9] Schematically illustrate an exemplary embodiment of an impedance measurement device. [Figure 10a] Schematically illustrate an exemplary embodiment of an organ container from a first viewing angle. [Figure 10b] Schematically illustrate an exemplary embodiment of an organ container from a second viewing angle. [Figure 11] Schematically illustrate an exemplary system for transporting an organ by an organ container. **DETAILED DESCRIPTION OF THE INVENTION**

[0016] Like reference numerals are used to indicate like parts in the accompanying drawings.

[0017] The detailed description provided below in connection with the accompanying drawings is intended as a description of the examples and is not intended to represent the only form in which the examples can be constructed or utilized. However, the same or equivalent functions and sequences can be achieved by different examples.

[0018] Although the examples are described and illustrated herein as being implemented within an organ container, the devices or methods described are provided as examples and not limitations. As will be understood by those skilled in the art, the examples are suitable for use in a variety of different types of tissue transport.

[0019] Figure 1 schematically illustrates an exemplary embodiment of the organ container 1. The organ container 1 includes a wall 10 surrounding an internal space 11. The internal space 11 is configured to receive an organ 13. In this embodiment, the wall 10 is rigid. The organ 13 can be placed inside an organ bag before being put inside the organ container 1. The organ container 1 can be closed by a lid. In an exemplary embodiment, after the organ container 1 receives the organ 13, it is placed inside a cooler. An example of the cooler is an ice box. In this embodiment, the organ container 1 does not provide means for cooling the organ 13 during transportation.

[0020] The organ 13 is intended for organ transplantation. The organ 13 can be received from an organ donor. In one embodiment, the organ 13 is a synthetic organ or synthetic tissue that can deteriorate during its transportation. An example of the organ 13 is a tissue fragment. The organ 13 can be from a human donor or any mammalian donor. Examples of the organ 13 are a kidney, pancreas, liver, intestine, heart, or lung.

[0021] The conductor 14 is connected to the wall 10 and provides a plurality of loops around the internal space 11. The conductor 14 is insulated from any physical contact with the organ 13. The conductor 14 is not a medical electrode directly connected to the organ 13. Typically, a medical electrode is configured to convert the energy of an ionic current inside the organ 13 into a current that can be amplified, studied, and used to aid in diagnosis. The conductor 14 is configured to form a coil or loop that generates an electric field. The organ 13 and its deterioration have a measurable effect on the electric field measured by the conductor 14.

[0022] In one embodiment, the conductor 14 forms one loop around the internal space 11. The conductor 14 is configured to measure an impedance value, and any object placed inside the loop and within the internal space 11 affects the measured impedance. When an organ 13 is placed in the internal space 11 and surrounded by the conductor 14, the organ 13 affects the measured impedance. In this embodiment, the conductor 14 has nine loops around the internal space 11, but the number of loops is not limited. The conductor 14 may form any number of loops that are practical for measuring impedance. The number of loops, as well as the direction of the loops, may be defined by the material or conductor, conductivity, shape of the wall 10, and the internal space 11. In one embodiment, the wall 10 is made of a non-conductive material such as plastic or any other material that meets the guidelines for organ transplantation. In one embodiment, the wall 10 is made of a conductive material, and the conductor 14 is mounted on the inner surface of the wall 10 while being electrically insulated from the wall 10.

[0023] In one embodiment, the conductor 14 is connected to the outside of the wall 10. In one embodiment, the conductor 14 is connected to the inside of the wall 10 while being insulated from any physical contact with the organ 13. In one embodiment, the conductor 14 is embedded in the wall 10. The conductor 14 is not in contact with the internal space 11 or the organ 13 located therein.

[0024] In one embodiment, the organ container 1 comprises a source 15 for current used to measure impedance. In one embodiment, the source 15 is a rechargeable or replaceable battery. In one embodiment, the source 15 is connectable to an external power source to provide impedance measurement. In one embodiment, the source 15 is connectable to an external power source by a wired connection. In one embodiment, the source 15 is connectable to an external power source by a wireless inductive connection. The inductive connection may be used to charge the battery of the source 15.

[0025] The impedance meter 16 is configured to measure the impedance value from the conductor 14. Impedance is measured as resistance to alternating current. In one embodiment, the impedance meter 16 measures the current, frequency, and voltage drop on the conductor 14. In one embodiment, the impedance meter 16 supplies alternating current to the conductor 14. In one embodiment, the impedance meter 16 is configured to control the source 15 to supply alternating current to the conductor 14.

[0026] The organ container 1 comprises at least one processor 17 and a memory 18 for storing instructions, which, when an instruction is executed, cause the organ container 1 to perform the functions described herein. A transceiver 19 is configured to provide a communication link from the organ container 1 to an external device such as a control computer. The control computer 120 may be at least partially located in a cloud computing environment. In one embodiment, the processor 17 and memory 18 are configured to control the functions of other electronic components of the organ container 1, such as an impedance meter 16. In one embodiment, the processor 17 and memory 18 are distributed to a system outside the organ container 1.

[0027] In one embodiment, electronic components connectable to the conductor 14 are arranged within a single module 20. Alternatively, the electronic components may be distributed at various locations on the organ container 1. In one embodiment, the electronic components are installed in a previously manufactured organ container. In one embodiment, the conductor 14 and module 20 are provided as an additional kit that can be arranged around a previously manufactured organ container. In one embodiment, the conductor 14 and module 20 are arranged within a cooler box having a predetermined location for the previously manufactured organ container, and the conductor 14 may form a loop around the predetermined location. The combination of the conductor 14, module 20, and previously manufactured organ container forms an organ container 1 according to this disclosure. The internal space 11 of the previously manufactured organ container functions as an internal space 11 surrounded by at least one loop of the conductor 14.

[0028] The processor 17 causes the organ container 1 to measure a first impedance value of the system of the conductor 14, the internal space 11, and any item positioned inside the internal space 11. The first impedance value is measured over a first period of time. In one embodiment, the first impedance value is measured at a single frequency, the frequency selected from the range of 0.1 Hz to 1 GHz. In one embodiment, the first impedance value is measured as a frequency spectrum, the frequency spectrum selected as the range of 0.1 Hz to 1 GHz, or as multiple measurement frequencies within that range.

[0029] The conductance of organ 13 has a measurable effect on the impedance of the conductor 14 when organ 13 is positioned inside the internal space 11. As organ 13 degrades, its conductance increases, which reduces the impedance of the coil, i.e., the loop of the conductor 14 near organ 13. One embodiment of the relationship between the measured impedance and conductance of a degraded organ 13 is illustrated in the exemplary graph of Figure 2. The graph is obtained with a coil excitation of 1 mA at 1 MHz. The Y-axis illustrates one embodiment of the measured impedance, and the X-axis illustrates the conductance of the organ at multiple stages of degradation. A tissue-specific simulation database can be obtained from Hasgall PA, Di Gennaro F, Baumgartner C, Neufeld E, Lloyd B, Gosselin MC, Payne D, Klingenboeck A, Kuster N, "IT'IS Database for thermal and electromagnetic parameters of biological tissues," 4.1 ver., 22 February 2022, DOI:10.13099 / VIP21000-04-1.

[0030] Figure 3 illustrates three exemplary plots of impedance measurements at a selected frequency as a function of time. The first period is illustrated as the interval between the dashed lines 31 when the first impedance measurement is completed. The first impedance measurement is stored in memory 18. In one embodiment, the first impedance measurement is relayed via transceiver 19 to data storage outside the organ container 1. The first impedance measurement, a single measured impedance or impedance spectrum, is used to define an initial value that can be compared to subsequent measurements. In one embodiment, the first measurement sets a baseline for the organ deterioration state. The organ deterioration state may be correlated with conventional transplant diagnostic measures.

[0031] A second impedance value is measured during a second period. The second period is illustrated as the interval between the dashed lines 32. The method for measuring the second impedance is similar to that for measuring the first impedance. The difference between the first impedance value and the second impedance is calculated by comparing the two values. The deterioration state of organ 13 is defined based on this difference. The difference indicates the rate or change in the viability of organ 13, and an increase in the difference means fewer viable organs 13. The deterioration state can be used to assess the viability or organ 13. The deterioration state is relative because each new organ 13 placed in the organ container 1 may provide a different first impedance measurement. Direction, size, age, or other variables may cause a difference from the first measurement.

[0032] The three plots show different organ deterioration profiles. Plot A, illustrated by a solid line, represents exemplary organ A. Plot A shows no significant difference in measured impedance between the first and second impedance measurements. Plot B, referring to exemplary organ B, shows a small difference in measured impedance. Since a difference in measured impedance can be related to the level of deterioration in an organ, organ B may be slightly deteriorated at the time of the second measurement. Plot C, referring to exemplary organ C, shows a large difference in measured impedance when compared to A or B. It can be assumed that organ C is severely deteriorated at the time of the second measurement.

[0033] Throughout this disclosure, the number of measurements is not limited to “first” and “second” measurements, as measurements may be repeated throughout the entire transport. In one embodiment, the organ 13 is measured once when the organ container 1 receives the organ 13, and a second time immediately before the organ is removed from the organ container 1. Any number of measurements that may be performed may be performed in the sense of first and second measurements.

[0034] Referring to Figure 3, the third impedance value is measured during the third period. The third period is illustrated as the interval between the dashed lines 33, and the fourth measurement is shown between the dashed lines 34. The third measurement shows a sharp drop in the measured impedance of organ B. A sharp change in the measured impedance of organ B may indicate that something dramatic has occurred that has caused rapid deterioration of organ B.

[0035] From the fourth measurement 34, a difference d between the deterioration of organs A, B, and C can be assumed. The transplant surgeon may reject organs B and C or submit them for further examination. Organ A shows only slight signs of deterioration and is therefore considered the best specimen of the three organs A, B, and C. In one embodiment, the organ container 1 measures multiple measurements over multiple periods and detects a trend from the multiple measurements. An example of such a trend is illustrated in plots A, B, and C. The trend indicates the deterioration state of organ 13. The viability assessment of organ 13 can be defined based on the trend. In one embodiment, the organ container 1 is configured to detect the trend. In one embodiment, the organ container 1 exports the measured data to an external processor, which is configured to detect the trend.

[0036] Figures 4a and 4b schematically illustrate two embodiments of impedance frequency spectrum measurement. The frequency spectrum can be measured from multiple frequencies within the operating range of the organ container electronic equipment. In the embodiment of Figure 4a, degradation was minimal throughout all measurements. Alternatively, the embodiment of Figure 4b shows a significant dip in the frequency spectrum during transport. Degradation of organ 13 can only be detected from a limited range of frequencies. Since degradation and / or other environmental characteristics are difficult to predict, the frequencies affected by organ degradation can be shown as changes in the frequency spectrum. In one embodiment, the organ container 1 is configured to detect trends and any changes in the frequency spectrum. In one embodiment, the organ container 1 exports the measured data to an external processor, which is configured to detect the trends.

[0037] Environmental changes can affect the measured impedance. Having multiple measurements can mitigate the problem of filtering out environmental changes from organ degradation. In one embodiment, environmental changes or influences may be detected as outliers in the measured data that can be filtered out of the results. In one embodiment, the filtered data is recorded with a timestamp, allowing transport personnel to evaluate the cause of the outlier data measurement.

[0038] In one embodiment, the organ container 1 includes a display 12 configured to show the viability of the organ 13 present in the internal space 11. In one embodiment, the processor 17 defines the organ 13 as unviable if its degradation state exceeds at least one predetermined limit. In one embodiment, the display 12 is part of a user interface configured within the organ container. In one embodiment, the display 12 is a simple indicator that can illustrate the state of a measurement by a single light or color. The display 12 may indicate whether the processor 17 has detected a trend in the measurement indicating degradation of the organ 13 being transported. In one embodiment, the display 12 illustrates a graph of frequency spectral measurements, allowing the transplant surgeon to quickly assess changes that have occurred during transport.

[0039] In one embodiment, the display 12 displays raw impedance measurements received from the impedance meter 16. The display 12 may show values ​​at a selected time, values ​​from a selected period, or values ​​as the difference between different measurements.

[0040] Figure 5 illustrates an exemplary embodiment of an organ container 1 having rigid walls 10. This embodiment includes a single loop of conductor 14 surrounding an internal space 11. The impedance measuring device may comprise various components known to those skilled in the art.

[0041] Figure 6 illustrates an exemplary embodiment of an organ container 1 having a non-rigid wall 10 in which the conductor 14 is a flexible conductor. In one embodiment, the organ container 1 is a bag in which a module 20 having electronic components is positioned to reduce the movement of a normal organ bag. The conductor 14 is flexible and conforms to the shape of the bag.

[0042] Organ container 1 can be used as a standard organ container, allowing personnel participating in the transport of organ 13 to follow any existing policies. A standard organ container model may have either rigid or flexible walls.

[0043] Figure 7a illustrates one exemplary embodiment of a system in which the organ container 1 is part of an organ container system. The organ container 1 provides one of at least two sterile barriers 71, 72 configured to surround an organ 13. In one embodiment, the organ container 1 is a second organ bag 72 configured to surround an organ 13 positioned in a first organ bag 71. In one embodiment, the impedance measurement function is distributed across multiple components within the organ transport. In one embodiment, the organ container 1 forms a system configured to transport the organ 13.

[0044] Figure 7b illustrates an exemplary embodiment in which organ container 1 provides one of at least three sterile barriers 71, 72, and 73 configured to surround an organ 13 as required by several organ transport policies. Organ container 1 is located within an organ container system. In this embodiment, the three sterile barriers 71, 72, and 73 are configured to surround each other. Organ container 1 can be selected to be any one of the three sterile barriers 71, 72, and 73.

[0045] Figure 8 illustrates a flowchart of the steps of a method using the organ container 1 disclosed herein. Step 80 includes measuring an impedance value from the conductor 14 using an impedance meter 16. Step 81 includes measuring a first impedance value in a first period. Step 82 includes storing the first impedance measurement in memory 18. Step 83 includes measuring a second impedance value in a second period. Step 84 includes comparing the difference between the first impedance and the second impedance. Step 85 includes defining the state of deterioration of the organ 13 present in the internal space 11 based on the difference.

[0046] Figure 9 schematically illustrates one exemplary embodiment of an impedance measuring device 90 for an organ container. In this embodiment, the impedance measuring device comprises a module 20 and a conductor 14. In one embodiment, the conductor 14 forms a loop around the module 20. In one embodiment, the module 20 is outside the loop formed by the conductor 14. The impedance measuring device 90 may be designed to generate an electric field toward the internal space 11. In one embodiment, the impedance measuring device comprises a shielded housing configured to restrict the direction of the electric field beyond the internal space 11. The shape, size, and selection of the material may be used to provide direction measurement. In one embodiment, the impedance measuring device 90 comprises multiple loops of the conductor 14.

[0047] In one embodiment, the conductor 14 is configured to measure an impedance value, and any object placed in its vicinity affects the measured impedance. When an organ 13 is placed in the internal space 11 near the conductor 14, the organ 13 affects the measured impedance.

[0048] Figures 10a and 10b schematically illustrate one exemplary embodiment of the organ container 1 from two different angles. Multiple impedance measuring devices 90 are mounted on the walls 10 and bottom of the organ container 1. In one embodiment, the organ container 1 has only one impedance measuring device 90 at the bottom of the organ container 1. In one embodiment, multiple impedance measuring devices 90 provide individual measurements that can be used to calculate the degradation of the organ 13. In one embodiment, multiple impedance measuring devices 90 can be used to detect and cancel measurement errors. In one embodiment, the arrangement of multiple impedance measuring devices is used to cancel out movement artifacts caused by the organ 13 moving within the organ container 1 during transport. When the impedance measuring devices 90 are positioned on the walls 10 or bottom of the organ container 1, the conductor 14 forms at least one loop on the wall 10 or bottom, from which the electric field caused by the impedance measurement extends into the internal space 11. In one embodiment, the multiple impedance measuring devices 90 are synchronized to provide measurements at different times, with only one impedance measuring device 90 measuring the internal space 11 at a time.

[0049] Figure 11 illustrates one exemplary embodiment of an impedance measuring device 90, the device being positioned inside an organ container. In the embodiment of Figure 11, the impedance measuring device 90 is positioned inside a second organ bag 72. In one embodiment, the impedance measuring device 90 is positioned inside an organ container having rigid walls 10. The impedance measuring device comprises 10 conductors 14 forming at least one loop configured to fit into an internal space 11.

[0050] An organ container is disclosed herein. The organ container comprises a wall surrounding an internal space, the internal space being configured to receive an organ, a conductor connected to the wall and forming at least one loop, and a source for current. The conductor is configured to measure impedance from the internal space. An impedance meter is configured to measure impedance values ​​from the conductor. At least one processor and memory for storing instructions, the instructions, when executed, cause the organ container to measure a first impedance value in a first period, store the first impedance measurement in the memory, measure a second impedance value in a second period, compare the difference between the first impedance and the second impedance, and define the state of deterioration of the organ present in the internal space based on the difference. In one embodiment, the conductor forms at least one loop around the internal space. In one embodiment, the conductor forms at least one loop on the wall, and the electric field generated by the impedance measurement extends into the internal space. In one embodiment, the organ container comprises a plurality of loops formed by conductors facing the internal space from different positions on the wall. In one embodiment, a memory storing at least one processor and instruction, wherein when the instruction is executed, the memory causes the organ container to measure impedance at a single frequency, the frequency of which is selected between 0.1 Hz and 1 GHz. In one embodiment, a memory storing at least one processor and instruction, wherein when the instruction is executed, the memory causes the organ container to measure impedance at multiple frequencies to provide a frequency spectrum, the frequency spectrum of which is selected between 0.1 Hz and 1 GHz. In one embodiment, a memory storing at least one processor and instruction, wherein when the instruction is executed, the memory causes the organ container to measure multiple measurements over multiple periods, detect a trend from the multiple measurements, and define the viability of the organ based on the trend.In one embodiment, the organ container includes a display indicating the viability of the organ present in the internal space. In one embodiment, the wall is a rigid wall. In one embodiment, the wall is a non-rigid wall and the conductor is a flexible conductor. In one embodiment, the organ container is part of an organ container system and provides one of at least two sterile barriers configured to surround the organ. In one embodiment, the organ container is a second organ bag configured to surround an organ positioned in a first organ bag.

[0051] Alternatively, or additionally, organ container systems comprising organ containers are disclosed herein.

[0052] Alternatively, or additionally, methods for defining the state of deterioration of organs residing in an organ container are disclosed herein. The organ container comprises a wall surrounding an internal space, the internal space comprising a wall configured to receive an organ, a conductor connected to the wall and providing at least one loop, and a source for electric current. The method is to measure an impedance value from the conductor by an impedance meter, the impedance measurement comprising the steps of extending an electric field from the conductor into the internal space and measuring the impedance from an organ residing in the internal space, measuring a first impedance value in a first period, storing the first impedance measurement in memory, measuring a second impedance value in a second period, comparing the difference between the first impedance and the second impedance, and defining the viability of the organ based on the difference. In one embodiment, the method comprises measuring the impedance at a single frequency or as a frequency spectrum. In one embodiment, the method comprises measuring a plurality of measurements over a plurality of periods, detecting a trend from the plurality of measurements, and defining the viability of the organ based on the trend. In one embodiment, the method includes measuring impedance at a single frequency, the frequency being selected between 0.1 Hz and 1 GHz. In another embodiment, the method includes measuring impedance at multiple frequencies to provide a frequency spectrum, the frequency spectrum being selected as being in the range of 0.1 Hz to 1 GHz.

[0053] Alternatively, or additionally, an impedance measuring device for an organ container is disclosed, the organ container comprising a wall surrounding an internal space configured to contain an organ. The impedance meter comprises a conductor forming at least one loop configured to fit within the internal space; a source for current, the conductor configured to measure an impedance value from the internal space; and at least one processor and memory storing instructions, the instructions, when executed, cause the impedance meter to measure a first impedance value in a first period, store the first impedance measurement in the memory, measure a second impedance value in a second period, compare the difference between the first impedance and the second impedance, and, based on the difference, define the state of deterioration of the organ present in the internal space.

[0054] Alternatively, or additionally, the control functions described herein can be implemented, at least in part, by one or more hardware components or hardware logic components. Embodiments of the devices described herein are compute-based devices comprising one or more processors, which may be microprocessors, controllers, or any other preferred type of processor, for processing computer-executable instructions to control the operation of the device in order to control one or more sensors, receive sensor data, and use the sensor data. Computer-executable instructions may be provided using any computer-readable medium accessible by the compute-based device. Computer-readable mediums may include, for example, computer storage media such as memory and communication media. Computer storage media such as memory include volatile and non-volatile, removable and non-removable media implemented in any way or technique for storing information such as computer-readable instructions, data structures, program modules, or other data. Computer storage media include, but are not limited to, RAM, ROM, EPROM, EEPROM, flash memory or other memory technologies, CD-ROM, digital versatile disk (DVD) or other optical storage, magnetic cassette, magnetic tape, magnetic disk storage or other magnetic storage devices, or any other non-transmission media that can be used to store information for access by computing devices. In contrast, communication media may embody computer-readable instructions, data structures, program modules, or other data in modulated data signals such as carrier waves, or other transport mechanisms. As defined herein, computer storage media do not include communication media. Therefore, computer storage media should not be construed as the propagated signal itself. A propagated signal may reside within the computer storage media, but the propagated signal itself is not an embodiment of the computer storage media.While computer storage media are described as being located within a computing-based device, it should be understood that storage can be distributed or located remotely and may be accessed via a network or other communication link, for example, by using a communication interface.

[0055] The apparatus or device may include an input / output controller arranged to output display information to a display device which may be separate from or integrated with the apparatus or device. The input / output controller may also be arranged to receive and process input from one or more devices, such as user input devices (e.g., a mouse, keyboard, camera, microphone, or other sensors).

[0056] The methods described herein may be executed by machine-readable software on a tangible storage medium, for example, in the form of a computer program, which includes computer program code means adapted to perform all steps of any of the methods described herein when the program is executed on a computer, and the computer program may be embodied on the computer-readable medium. Embodiments of the tangible storage medium include computer storage devices, which include computer-readable media such as disks, thumb drives, and memory, and do not include only propagated signals. Propagated signals may reside in the tangible storage medium, but propagated signals themselves are not embodiments of the tangible storage medium. The software may be preferred to run on parallel or serial processors so that the method steps can be executed in any preferred order or simultaneously.

[0057] Any range or device value shown herein may be extended or modified without loss of the desired effect.

[0058] While at least a portion of the subject matter has been described using language specific to structural features and / or behaviors, it should be understood that the subject matter as defined in the attached claims is not necessarily limited to the specific features or behaviors described above. Rather, the specific features and behaviors described above are disclosed as embodiments implementing the claims, and other equivalent features and behaviors are intended to be within the scope of the claims.

[0059] It will be understood that the benefits and advantages described above may relate to one embodiment or to several embodiments. Embodiments are not limited to those that solve any or all of the problems described, or that have any or all of the benefits and advantages described. It will be further understood that references to "some" items refer to one or more of those items.

[0060] The steps of the methods described herein may be performed in any preferred order, or, where appropriate, simultaneously. Additionally, individual blocks may be removed from any of the methods without departing from the spirit and scope of the subject matter described herein. Any aspect of the embodiments described above may be combined with any aspect of any of the other embodiments described to form further embodiments without losing the desired effect.

[0061] The term “equipped with” is used herein to mean including an identified method block or element, but such block or element does not include an exclusive list, and the method or device may include additional blocks or elements.

[0062] The above description is given only as an example, and it will be understood that various modifications can be made by those skilled in the art. The above specification, examples, and data provide a complete description of the structure and use of exemplary embodiments. Although various embodiments have been described above with some degree of specificity or by reference to one or more individual embodiments, those skilled in the art can make numerous modifications to the disclosed embodiments without departing from the spirit or scope of this specification.

Claims

1. Organ container (1), A wall (10) surrounding an internal space (11), wherein the internal space (11) is configured to receive an organ (13), and the wall (10) A conductor (14) connected to the wall (10) and forming at least one loop, A source (15) for electric current is provided, The conductor (14) is configured to measure the impedance from the internal space (11), The impedance meter (16) is configured to measure the impedance value from the conductor (14), At least one processor (17) and a memory (18) for storing instructions, wherein when an instruction is executed, the organ container (1) During the first period, measure the first impedance value. The memory (18) is used to store the first impedance measurement value. During the second period, measure the second impedance value. The difference between the first impedance and the second impedance is compared. An organ container (1) is characterized by at least one processor and memory for storing instructions that define the state of deterioration of the organ (13) present in the internal space (11) based on the aforementioned difference.

2. The organ container (1) according to claim 1, characterized in that the conductor (14) forms at least one loop around the internal space (11).

3. The organ container (1) according to claim 1, characterized in that the conductor (14) forms at least one loop on the wall, and the electric field generated by the impedance measurement extends into the internal space (11).

4. The organ container (1) according to claim 3, characterized by comprising a plurality of loops formed by the conductor (14) facing the internal space (11) from different positions on the wall (10).

5. The organ container (1) according to any one of claims 1 to 4, comprising the at least one processor (17) and the memory (18) for storing instructions, wherein when the instructions are executed, the at least one processor (17) and the memory (18) for storing instructions cause the organ container (1) to measure the impedance at a single frequency, the frequency being selected from 0.1 Hz to 1 GHz.

6. The organ container (1) according to any one of claims 1 to 4, comprising the at least one processor (17) and the memory (18) for storing instructions, wherein, when the instructions are executed, the instructions cause the organ container (1) to measure the impedance at a plurality of frequencies in order to provide a frequency spectrum, the frequency spectrum being selected as being in the range of 0.1 Hz to 1 GHz.

7. The organ container (1) according to any one of claims 1 to 6, comprising the at least one processor (17) and the memory (18) for storing instructions, wherein the instructions, when executed, cause the organ container (1) to measure a plurality of measurements over a plurality of periods, to detect a trend from the plurality of measurements, and to define the viability of the organ (13) based on the trend.

8. The organ container (1) according to any one of claims 1 to 7, characterized by comprising a display (12) that indicates the viability of the organ (13) located within the internal space (11).

9. The organ container (1) according to claim 8, characterized in that the display (12) displays raw impedance measurements.

10. The organ container (1) according to any one of claims 1 to 9, characterized in that the wall (10) is a rigid wall.

11. The organ container (1) according to any one of claims 1 to 9, characterized in that the wall (10) is a non-rigid wall and the conductor (14) is a flexible conductor.

12. The organ container (1) according to any one of claims 1 to 11, wherein the organ container (1) is part of an organ container system, and the organ container (1) provides one of at least two sterile barriers (71, 72, 73) configured to surround the organ (13).

13. The organ container (1) according to claim 12, characterized in that the organ container (1) is a second organ bag (72) configured to surround the organ (13) positioned within the first organ bag (71).

14. The organ container (1) system according to claim 12 or 13.

15. A method for defining the state of deterioration of an organ (13) located within an organ container (1), wherein the organ container (1) is A wall (10) surrounding an internal space (11), wherein the internal space (11) is configured to receive the organ (13), A conductor (14) connected to the wall (10) and providing at least one loop, A source (15) for electric current is provided, The aforementioned method, A step of measuring the impedance value from the conductor (14) using an impedance meter (16), wherein the impedance measurement involves extending the electric field from the conductor (14) into the internal space (11) and measuring the impedance from the organ (13) present in the internal space (11), A step of measuring a first impedance value during the first period, A step of storing the first impedance measurement value in memory (18), The second step involves measuring the second impedance value during the second period, A step of comparing the difference between the first impedance and the second impedance, A method characterized by comprising the step of defining the state of deterioration of the organ (13) based on the difference.

16. The method according to claim 15, characterized in that the impedance is measured at a single frequency or as a frequency spectrum.

17. The method according to claim 15 or 16, characterized by measuring multiple measurements over multiple periods, detecting a trend from the multiple measurements, and defining the viability of the organ (13) based on the trend.

18. The method according to any one of claims 15 to 17, characterized in that the impedance is measured at a single frequency, the frequency being selected from 0.1 Hz to 1 GHz.

19. The method according to any one of claims 15 to 17, characterized in that the impedance is measured at multiple frequencies in order to provide a frequency spectrum, wherein the frequency spectrum is selected to be in the range of 0.1 Hz to 1 GHz.

20. An impedance measuring device (90) for an organ container (1), wherein the organ container comprises a wall (10) surrounding an internal space (11) configured to contain an organ (13), An impedance meter is, A conductor (14) that forms at least one loop configured to fit within the internal space (11), A source (15) for electric current is provided, The conductor (14) is configured to measure the impedance value from the internal space (11), At least one processor (17) and a memory (18) for storing instructions, wherein when an instruction is executed, the impedance meter is used to store the instructions. During the first period, measure the first impedance value. The memory (18) is used to store the first impedance measurement value. During the second period, measure the second impedance value. The difference between the first impedance and the second impedance is compared. An impedance measuring device (90) comprising at least one processor (17) and a memory (18) for storing instructions, which causes the device to define the state of deterioration of the organ (13) located within the internal space (11) based on the aforementioned difference.

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