Tissue monitor, tissue preservation system and corresponding method

Abstract

A body tissue preservation system for storing and preserving body tissue, the body tissue preservation system comprising: a body tissue monitor for determining a state of the body tissue, the body tissue monitor comprising: at least one sensor configured to acquire sensor data based on a plurality of measurements of the body tissue and / or an environment surrounding the body tissue; and a controller arranged to receive the sensor data from the at least one sensor, the controller being configured to: detect, for each of the one or more trigger events, one or more trigger events in the sensor data, each of the one or more trigger events including sensor data that satisfies a first threshold criterion; select, for each of the one or more trigger events, a window of sensor data associated with the trigger event; identify, for each of the one or more windows, a subset of the sensor data corresponding to the selected window; determine, for each of the one or more selected windows, whether the corresponding identified subset of sensor data satisfies a second threshold criterion; determine a state of the body tissue based on the identified subset that satisfies the second threshold criterion; and provide a state output signal based on the determined state of the body tissue.

Description

[Technical Field]

[0001] FIELD OF THE DISCLOSURE The present disclosure relates to systems and methods for monitoring body tissue, and in particular to systems and methods for storing and preserving body tissue and monitoring body tissue. [Background technology]

[0002] In some cases, one or more organs may be removed from a person after death (or voluntarily while alive) so that the organs can be used in another person. In such cases, a surgeon may remove the relevant organs from the patient. The organs are then transported so that they can be transplanted into another patient. During this process, there is a period when the organ is not connected to any patient, and the organ must be maintained in an appropriate condition so that it will remain useful after being transplanted into a patient. During this time, the organ may need to be transported from one hospital to another. A storage device designed to facilitate this organ transport is disclosed.

[0003] Aspects of the present disclosure aim to provide improved systems and methods for the storage and / or preservation of bodily tissue. Summary of the Invention [Problem to be solved by the invention]

[0004] Aspects of the disclosure are set out in independent claims, with optional features set out in dependent claims. Aspects of the disclosure may be provided in conjunction with one another, and features of one aspect may be applied to other aspects.

[0005] In one aspect, a body tissue preservation system for preserving and storing body tissue is provided. The body tissue preservation system includes a body tissue monitor that monitors the body tissue to determine a state of the body tissue. The body tissue monitor includes at least one sensor configured to acquire sensor data based on a plurality of measurements of the body tissue and / or the body tissue's surrounding environment, and a controller arranged to receive the sensor data from the at least one sensor. The controller is configured to: detect one or more trigger events in the sensor data, each of the trigger events including sensor data that meets a first threshold criterion; for each of the one or more trigger events, select a window of sensor data associated with the trigger event; for each of the one or more windows, identify a subset of sensor data corresponding to the selected window; for each of the one or more selected windows, determine whether the corresponding identified subset of sensor data meets a second threshold criterion; determine a state of the body tissue based on the identified subset that meets the second threshold criterion; and provide a state output signal based on the determined state of the body tissue.

[0006] Embodiments allow for more reliable storage and preservation of bodily tissues. This finds particular utility in the field of organ transplantation, where organs may be stored and / or transported for long periods of time. Embodiments may facilitate the identification of organs suitable or unsuitable for transplantation based on the characteristics the organs experienced during storage and / or transport. Embodiments allow for more reliable identification of organs as suitable for transplantation after storage / preservation. Examples allow for the viability of bodily tissues for transplantation to be determined and output by the system.

[0007] The system may be configured to store and preserve bodily tissue outside the body, such as bodily tissue stored and / or transported between two locations when the bodily tissue is located outside the patient's body. The system may be configured to perfuse the bodily tissue. The system may be configured to oxygenate the bodily tissue. The bodily tissue preservation system may include a bodily tissue oxygenation system. The bodily tissue may be bodily tissue for transplant. The system may be configured to monitor the bodily tissue during storage and / or transport. The status output signal may provide an indication of viability of the bodily tissue for transplant. The system may include a container unit arranged to contain the bodily tissue. Storing, preserving, perfusing, and / or oxygenating the bodily tissue may occur while the bodily tissue is contained in the container unit. The container unit may include at least one sensor. Determining the status of the bodily tissue may include determining one or more conditions (e.g., determining multiple conditions) of the bodily tissue.

[0008] The system may include at least one adjustment unit operable to adjust characteristics of the body tissue and / or the body tissue's surrounding environment. For example, the controller, the sensor, and the adjustment unit may enable automatic control of one or more operating parameters of the body tissue's storage and / or preservation. The controller may be configured to control operation of the adjustment unit to adjust characteristics of the body tissue and / or the body tissue's surrounding environment when it is determined that the identified subset of sensor data meets a second threshold criterion. The adjustment unit may be operable to adjust characteristics of oxygenation of the body tissue. The controller may be configured to control the adjustment unit to adjust at least one of (i) flow of oxygenate to the body tissue and (ii) pressure of the oxygenate flowing through the body tissue.

[0009] Selecting the window of sensor data may include selecting a time window of the sensor data. Selecting the window of sensor data may include selecting the window based on one or more other parameters, such as based on a sensor (e.g., a physical property and / or measurements from the sensor). The system may include multiple sensors, each configured to acquire sensor data based on multiple measurements related to the body tissue and / or the body tissue's surrounding environment. The controller may be configured to determine whether the identified subset of data from the first sensor meets a second threshold criterion also based on data from the second sensor. The controller may be configured to determine whether the identified subset of data from the first sensor and / or the second sensor meets multiple threshold criteria.

[0010] When the controller detects a trigger event in the sensor data from the first sensor, the controller may be configured to select a window associated with the trigger event in both the sensor data from the first sensor and the sensor data from the second sensor. The controller may be configured to detect the trigger event when both (i) the first measurement value from the first sensor satisfies a first local threshold criterion and (ii) the second measurement value from the second sensor satisfies a second local threshold criterion. For example, the local threshold criterion may allow a threshold criterion to be met only if the local threshold criterion that constitutes it is met, and a trigger event may be detected (a first threshold criterion is met) only if two separate local threshold criterion are met, e.g., when two local threshold criterion relate to data from different sensors.

[0011] The controller may be configured to detect that the sensor data meets a first threshold criterion when at least one of (i) the sensor data is outside a selected range, (ii) a change in the sensor data exceeds a threshold amount, and (iii) the sensor data reaches a time threshold. The controller may be configured to determine that the identified subset of sensor data meets a second threshold criterion when at least one of (i) the sensor data is outside a selected range for a threshold period within a selected time window, (ii) the sensor data changes by more than a threshold amount within the selected time window, and (iii) one or more selected patterns are identified in the sensor data within the selected time window. The identified subset of sensor data may include data from multiple sensors. Determining that the sensor data of the identified subset meets the second threshold criterion may include determining that (i) data from a first sensor meets the second threshold criterion, (ii) data from a second sensor meets the second threshold criterion, and (iii) cross-correlation between data from the first sensor and the second sensor meets the second threshold criterion. The controller may be configured to output an alert when the corresponding identified subset of sensor data is determined to meet a second threshold criterion.

[0012] The status output signal may include each identified subset of the sensor data that met the second threshold criterion. The status output signal may include the identified subset of the sensor data. The status output signal may include the sensor data. The status output signal may include data for each of one or more trigger events. The status output signal may provide an ordered series of notable events in the sensor data. The notable events may include at least one of (i) the trigger event, (ii) the identified subset, and (iii) the identified subset that met the second threshold criterion. The controller may be configured to provide the status output signal including a data link arranged to enable a user to select an event of interest and view sensor data associated with the notable event.

[0013] The controller may be configured to: for each of the one or more identified subsets that satisfy a second threshold criterion, select a second window of sensor data associated with the identified subset's window; for each of the one or more selected second windows, identify a subset of sensor data corresponding to each second window; for each of the one or more selected second windows, determine whether the corresponding identified subset of sensor data satisfies a third threshold criterion; and determine the state of the body tissue based on the identified subset that satisfies the third threshold criterion. The controller may be configured to determine the state of the body tissue by assigning weights to the subsets of sensor data for the body tissue. Each weight may be selected based on an associated threshold criterion satisfied by the corresponding subset of sensor data.

[0014] In one aspect, a body tissue monitor for monitoring body tissue to determine a state of the body tissue is provided. The body tissue monitor includes at least one sensor configured to acquire sensor data based on a plurality of measurements of the body tissue and / or the body tissue's surrounding environment, and a controller configured to receive the sensor data from the at least one sensor. The controller is configured to: detect one or more trigger events in the sensor data, each of the trigger events including sensor data that meets a first threshold criterion; for each of the one or more trigger events, select a time window of sensor data associated with the trigger event; for each of the one or more windows, identify a subset of sensor data corresponding to the selected window; determine, for each of the one or more selected windows, whether the corresponding identified subset of sensor data meets a second threshold criterion; determine a state of the body tissue based on the identified subset that meets the second threshold criterion; and provide a state output signal based on the determined state of the body tissue. The method may include correlating windows of events in the sensor data (e.g., where the sensor data meets the first threshold criterion), such as to identify activities (e.g., higher-level extracted patterns) that meet the selected threshold criterion. The correlation may be based on cross-correlation of data from the multiple sensors.

[0015] In one aspect, a method for archiving and storing body tissue is provided, the method including acquiring sensor data defining a stream of measurements about the body tissue and / or an environment surrounding the body tissue, detecting one or more trigger events in the sensor data, each trigger event including sensor data that meets a first threshold criterion, for each of the one or more trigger events, selecting a window of sensor data associated with the trigger event, for each of the one or more windows, identifying a subset of sensor data corresponding to the selected window, determining, for each of the one or more selected windows, whether the corresponding identified subset of sensor data meets a second threshold criterion, determining a state of the body tissue based on the identified subset that meets the second threshold criterion, and providing a state output signal based on the determined state of the body tissue.

[0016] Aspects of the present disclosure may provide systems and methods for monitoring body tissue to determine its condition. Such aspects may include any of the sensor data processing steps disclosed herein.

[0017] Aspects of the present disclosure may provide one or more computer program products that include computer program instructions configured to program a controller to perform any of the methods disclosed herein. [Brief explanation of the drawings]

[0018] Some embodiments of the present disclosure will now be described, by way of example only, with reference to the following figures. [Figure 1] 1 is a schematic diagram of an exemplary tissue preservation system. [Figure 2a] 1 is a graph of an exemplary series of pressures versus time. [Figure 2b] 1 is a graph of an exemplary series of pressures versus time. [Figure 2c] 1 is a graph of an exemplary series of pressures versus time. [Figure 2d]1 is a graph of an exemplary series of pressures versus time. [Figure 3a] 1 is an exemplary series of pressure and acceleration graphs versus time. [Figure 3b] 1 is an exemplary series of pressure and acceleration graphs versus time. [Figure 3c] 1 is an exemplary series of pressure and acceleration graphs versus time. [Figure 3d] 1 is a graph of an exemplary series of pressure and acceleration versus time.In the drawings, like numbers are used to refer to like elements. DETAILED DESCRIPTION OF THE INVENTION

[0019] The present disclosure relates to monitoring of a body tissue preservation system. The body tissue preservation system includes a body tissue monitor configured to monitor the body tissue to determine the state of the body tissue. The body tissue monitor is configured to monitor sensor data related to the body tissue (and / or its surrounding environment). The sensor data includes a plurality of measurements related to the body tissue. Monitoring the sensor data includes identifying measurements that indicate the state of the body tissue has been affected, such as measurements that are outside of an expected range. These measurements, as well as other measurements that occur nearby (e.g., in time), are then further analyzed to identify one or more patterns that may become apparent when the measurements are considered on a larger scale. The state of the body tissue may be determined based on such identified patterns.

[0020] One embodiment of a tissue preservation system and method of use thereof will now be described with reference to Figures 1-2d. It will be understood that this is one embodiment and is not intended to be limiting in light of the present disclosure. Numerous alternatives to this system will be described below to illustrate that not all of the features of Figures 1-2d are required and / or additional features may be included.

[0021] Figure 1 shows an example of a tissue preservation system 100. The tissue preservation system is composed of two parts: a container unit 10 and a base unit 60. Figure 1 shows the assembled tissue preservation system 100, with the container unit 10 housed in the base unit 60.

[0022] The container unit 10 includes a tissue receiving portion 12 and a flange 14. The container unit 10 also includes an inlet 20, an outlet 26, and one or more water conduits connected to the inlet 20 or the outlet 26. A first water conduit 22 is connected to the inlet 20 to define a flow path from the exterior of the container unit 10 into the tissue receiving portion 12. A second water conduit 24 is connected to the outlet 26 to define a flow path from the tissue receiving portion 12 to the exterior of the container unit 10. One or more walls of the container unit 10 define a recess that forms the tissue receiving portion 12. The inlet 20 and the outlet 26 each extend through a portion of the wall that defines the tissue receiving portion 12. The flange 14 extends radially outward from the container unit 10. As shown in FIG. 1 , a tissue 30 having at least one lumen 32 is stored within the container unit 10 (within the tissue receiving portion 12). The body tissue 30 is placed on the bottom surface of the body tissue receiving portion 12 of the container unit 10, and the body tissue 30 is at least partially immersed in the preservation solution .

[0023] The container unit 10 is configured as an insert for the base unit 60. The container unit 10 is sized and shaped to fit within a corresponding recess in the base unit 60. The container unit 10 is arranged to receive the body tissue 30 to be stored. This arrangement includes being configured to store the body tissue 30 within a reservoir of preservation solution 34. The container unit 10 is configured as a disposable part that is discarded after receiving the body tissue 30 for storage and preservation.

[0024] The body tissue receiving portion 12 has a size and shape that can accommodate body tissue 30 to be preserved and / or stored. The body tissue receiving portion 12 is configured to store a preservation solution 34 for preserving the body tissue 30. The body tissue receiving portion 12 is configured to store the body tissue 30 that is placed on the lower surface of the body tissue receiving portion 12. The body tissue 30 placed on the lower surface is immersed in the stored preservation solution 34 held in the body tissue receiving portion 12.

[0025] The flange 14 is configured to support the receptacle unit 10 when inserted into the base unit 60. The flange 14 is positioned to allow the receptacle unit 10 to be inserted into the base unit 60 and held in place within the base unit 60. The flange 14 provides a lip from which the receptacle unit 10 can be hung within the base unit 60.

[0026] The inlet 20 is arranged to receive a source of fluid entering from the base unit 60. The inlet 20 is configured to provide a flow path so that fluid outside the container unit 10 can be delivered to the body tissue receiving portion 12. A first aqueduct 22 is connected to the inlet 20 so as to extend a fluid flow path into the body tissue receiving portion 12. The first aqueduct 22 is arranged to be inserted into a lumen 32 of the body tissue 30 stored in the body tissue receiving portion 12 (the lumen 32 may be a vein or artery of an organ). The first aqueduct 22 is configured to connect a source of fluid outside the container unit 10 (within the base unit 60) to the body tissue 30 stored in the container unit 10. The first aqueduct 22 is arranged to deliver fluid to the body tissue 30 stored in the container unit 10.

[0027] The outlet 26 is positioned to allow fluid to exit the tissue-receiving region. The outlet 26 is positioned to allow fluid to flow from the tissue-receiving region to a corresponding region of the base unit 60. The second aqueduct 24 is connected to the inlet 20 and is positioned to be inserted into the lumen 32 of the tissue 30 stored in the tissue-receiving portion 12. The second aqueduct 24 and the outlet 26 provide a fluid flow path for fluid within the lumen 32 of the tissue 30 to be delivered out of the tissue-receiving portion 12. This fluid includes fluid delivered to the tissue 30 via the inlet 20 and the first aqueduct 22. The first and second aqueducts are positioned to allow fluid to circulate after being delivered to the tissue 30 via the inlet 20 and the first aqueduct 22, and then exit the tissue 30 via the second aqueduct 24 and the outlet 26 to leave the container unit 10.

[0028] The base unit 60 includes a container unit receiving portion 62, a connection surface 64, a controller 80, and a display screen 88. The controller 80 includes a processor 81 and a data storage portion 82. The base unit 60 also includes a first liquid storage portion 72, a liquid outlet 70, a liquid inlet 76, and a second liquid storage portion 74. The base unit 60 also includes a first sensor 84 and a second sensor 86.

[0029] The first liquid storage portion 72 is connected to the liquid outlet 70. The liquid outlet 70 provides a connection from the main body of the base unit 60 to the inside of the container unit accommodating portion 62 of the base unit 60. The second liquid storage portion 74 is connected to the liquid inlet 76. The liquid inlet 76 provides a connection from the container unit accommodating portion 62 to the inside of the main body of the base unit 60. The first sensor 84 is provided between the liquid inlet 76 and the second liquid storage portion 74. The second sensor 86 is provided on the main body of the base unit 60. The connection surface 64 is the top surface of the base unit 60. The container unit accommodating portion 62 is a recess provided on the top surface of the base unit 60. The controller 80 is connected to each of the first sensor 84, the second sensor 86, and the display screen 88.

[0030] The base unit is configured for storing and preserving the body tissue 30. The body tissue 30 in the container unit 10 may be stored and preserved within the base unit 60. The base unit 60 is configured to control conditions within the environment of the container unit 10 and to control the delivery of one or more preservation solutions to the body tissue 30 in the container unit 10. The base unit 60 is configured to be portable. A lid and handle, not shown, are provided to facilitate transportation of the base unit 60. The base unit 60 is configured to receive the container unit 10 containing the body tissue 30 to be stored and / or preserved and to allow components of the base unit 60 to be connected to the container unit 10.

[0031] The container unit receiving portion 62 is positioned to receive the container unit 10. The container unit receiving portion 62 is positioned to hold the container unit 10 therein and to allow components of the base unit 60 to be connected to the container unit 10. The container unit receiving portion 62 is configured to support the container unit 10 and allow the container unit 10 to be transported into the base unit 60 (while limiting damage to any body tissue 30 carried in the container unit 10). The container unit receiving portion 62 has a size and shape to receive the container unit 10 therein and allow for a snug fit of the container unit 10.

[0032] The top surface of the base unit 60 is positioned to support the flange 14 of the container unit 10 inserted into the base unit 60 so that the container unit 10 can be received in the container unit receiving portion 62. The top surface provides a surface against which the flange 14 of the container unit 10 can abut to secure the container unit 10 within the container unit receiving portion 62 of the base unit 60.

[0033] The first liquid reservoir 72 comprises a supply source of preservation liquid to be supplied to the body tissue 30 in the container unit 10. The first liquid reservoir 72 is a tank of the preservation liquid. The first liquid reservoir 72 is provided in the main body of the base unit 60. The liquid is stored under pressure in the liquid reservoir.

[0034] The fluid outlet 70 is arranged to be connectable to the fluid inlet 20 of the container unit 10 in the container unit housing 62. The fluid outlet 70 is arranged to deliver fluid from a fluid source in the base unit 60 to the container unit 10 (and the body tissue 30 contained in the container unit 10). The fluid outlet 70 may be connected to the fluid inlet 20 of the container unit 10 to provide a fluid flow path from the first fluid reservoir 72 of the base unit 60 to the body tissue 30 in the container unit 10.

[0035] The fluid inlet 76 is arranged to be connectable to the fluid in the container unit housing 62. The fluid inlet 76 is arranged to be connectable to the fluid outlet 26 of the container unit 10 in the container unit housing 62. The fluid inlet 76 is configured to allow fluid to pass from the container unit 10 into the base unit 60. The fluid inlet 76 is connectable to the fluid outlet 26 of the container unit 10 so that fluid can flow from the body tissue 30 in the container unit 10 into a second fluid reservoir 74 in the base unit 60. The second fluid reservoir is arranged to receive fluid from the fluid inlet 76 for storage. This arrangement allows preservation fluid from the first fluid reservoir 72 to be supplied to the body tissue 30 in the container unit 10, and used fluid that has passed through the body tissue 30 to be delivered to the second fluid reservoir.

[0036] The display screen 88 is configured to display one or more output values ​​from the system 100. The display screen 88 is configured to output sensor measurements. The display screen 88 is configured to provide output to facilitate user input, such as allowing a user to use the display screen 88 to input data controlling the storage and / or preservation of the body tissue 30 in the receptacle unit 10.

[0037] The first sensor 84 is arranged to provide an output comprising a measurement of at least one characteristic of the fluid flow. In this example, the sensor is arranged to indicate the pressure of the preservation fluid after it has been delivered to the body tissue 30 within the reservoir unit 10. In this example, the sensor is a pressure sensor configured to obtain an indication of the pressure of the fluid delivered to the reservoir unit 10.

[0038] The second sensor 86 is positioned to provide a measurement related to a different property than the first liquid. In this example, the second sensor 86 is located on the body of the base unit 60 and is configured to obtain a measurement of a property of the storage system 100. In this example, the second sensor 86 is configured to provide an indication of one or more motion properties of the system 100. The second sensor 86 in this example is an accelerometer.

[0039] Two sensors provide sensor data including a plurality of measurements. In this example, each sensor provides a time-ordered series of measurements. The measurements are taken over time to provide a data stream such as continuous measurement data (e.g., measurement data taken at least semi-regularly).

[0040] The controller 80 is configured to receive sensor data from the sensors and process the sensor data to determine the state of the body tissue 30. The data store 82 stores instructions for processing the sensor data, and the processor 81 is configured to execute the instructions to process the sensor data. The instructions include multiple processing steps for analyzing and processing the data. The instructions enable the data to be processed using the methods disclosed herein. In this example, the instructions include a series of processing steps defining one or more algorithmic approaches for processing the sensor data. The processing steps may include multiple different ways of processing the data (e.g., according to multiple different discrete or non-discrete processing steps), such that the data can be processed in multiple different ways and that this processing can be traceable and verifiable. The controller 80 is configured to process the data as described below with reference to FIGS. 2a-2d. Based on the processing of this data, the controller 80 is configured to determine the state of the body tissue 30 and provide an output based on this state of the body tissue 30. The output may be provided both during storage and / or transport and after storage and / or transport (e.g., prior to implanting the body tissue into a patient). Controller 80 is configured to control the output provided to display screen 88.

[0041] When assembled, the container unit 10 is inserted into the container unit receiving portion 62 of the base unit 60. The flange 14 of the container unit 10 rests on the connecting surface 64 of the base unit 60. The fluid outlet 70 of the base unit 60 is connected to the inlet 20 of the container unit 10, and the outlet 26 of the container unit 10 is connected to the fluid inlet 76 of the base unit 60. The first and second aqueducts of the container unit 10 are connected to the lumen 32 of the body tissue 30. A fluid flow path is defined from the first fluid reservoir 72, through the fluid outlet 70 of the base unit 60, into the inlet 20 of the container unit 10, through the first aqueduct 22, into the lumen 32 of the body tissue 30, out into the second aqueduct 24, through the outlet 26 of the container unit 10, into the fluid inlet 76 of the base unit 60, and into the second fluid reservoir 74.

[0042] The operation of body tissue preservation will now be described with reference to Figures 2a-2d. In particular, Figure 2a will be described to illustrate the processing steps performed by controller 80 to process acquired sensor data to determine the state of body tissue 30.

[0043] 2a-2d each show a graph of pressure versus time. The pressure values ​​were obtained from the first sensor 84, and the data is shown as a continuous curve. In this example, the pressure values ​​were obtained relative to the fluid pressure of the fluid supplied to the body tissue 30 while the body tissue 30 was stored outside the body.

[0044] Figure 2a shows the first graph of pressure versus time. As can be seen, there is a common baseline of pressure values ​​over time, but there are five distinct regions where the pressure values ​​deviate from this baseline. While these deviations are distinct, each deviation has its own unique or varying characteristics.

[0045] The first pressure region 201 has a short, sharp deviation, where the pressure rises steeply before returning to the baseline value. The second pressure region 202 has a shorter, sharper deviation. The second pressure region 202 records the highest pressure value, and as can be seen, the pressure in the second pressure region 202 rises and falls rapidly. The third pressure region 203 includes a more sustained pressure rise, where the pressure remains above the baseline value for a longer period of time. During this time, the pressure is not constant. There are several pressure oscillations and / or sharp increases / decreases in the pressure value at the elevated pressure value. The third pressure region 202 has multiple slope changes during the pressure rise. The fourth pressure region 204 includes a sustained pressure rise over a longer period of time. In the fourth pressure region 204, the pressure rises, remains constant, and then drops again. The pressure curve in the fourth pressure region 204 is relatively smooth. The fifth pressure region 205 includes a rise similar to that in the third pressure region 202. Although the pressure rises and falls at the beginning and end of the fifth pressure region 205 at a different rate than the rise and fall at the beginning and end of the third pressure region 202, the fifth pressure region 205 exhibits multiple gradient changes in the increased pressure.

[0046] To process this pressure data, the controller 80 is configured to identify regions of interest and examine these regions of interest. Stored instructions define how to perform this analysis. The instructions include processing the data at higher levels of granularity rather than just looking at instantaneous values. Different granularity levels may be selected based on what analysis is being performed on the data (e.g., what thresholds are met). The granularity levels may be selected depending on what threshold criteria are applied. These granularity levels may be tailored to the data being analyzed. In this example, the different granularity levels are based on time, so that processing the data at each subsequent granularity level involves processing the data over a longer period of time. The threshold criteria may be selected based on the time period over which the data is being evaluated. However, it should be understood that, within the scope of the present disclosure, granularity levels may use variables other than time (e.g., granularity over parameters other than time). Larger-scale trends are observed, which may enable better determination of the condition of the body tissue 30. Processing the data may include filtering the data to identify key points / regions of interest, as well as other appropriate processing steps, such as data aggregation and / or correlation.

[0047] As a first step, Figure 2b is an annotated version of the graph of Figure 1. To process the sensor data, one or more trigger events are identified. A trigger event is identified by detecting an indication that the sensor data meets a first threshold criterion. A trigger event includes an indication of an anomaly in the data. Anomalies include deviations from expected measurements and / or measurements that do not fall within a selected range for measurements. In this example, the first threshold criterion is determined based on a single measurement. This measurement is compared to a threshold to detect a trigger event. In this example, the threshold criterion involves evaluating whether a pressure value exceeds a pressure threshold.

[0048] Figure 2b shows the same five pressure regions as Figure 2a. For each region, there is at least one pressure measurement that exceeds the pressure threshold. Ten filled circles indicate the intersections of pressure values ​​with the pressure threshold. These filled circles form five pairs of circles, each pair defining a subset of data where the pressure exceeds the pressure threshold and the first threshold criterion is met.

[0049] Processing the sensor data includes selecting a window in the sensor data, the window of sensor data being selected to be a window that takes into account more measurements than were used to detect the initial trigger event, in this example, selecting the window of sensor data includes selecting a time window in which measurements will be used for further analysis.

[0050] In this example, five trigger events are identified. Each trigger event is when the pressure first increases above the pressure threshold. That is, the first, third, fifth, seventh, and ninth black circles in FIG. 2b represent trigger events. A window in the sensor data is selected for each trigger event. Each window is selected to encompass more data than just the pressure measurement above the pressure threshold. In this example, each window is selected to encompass all subsequent measurements until the pressure returns below the pressure threshold. That is, five windows are defined, corresponding to the five pairs of black circles shown. For each of these windows, the controller 80 is configured to acquire sensor data. That is, the controller 80 acquires a subset of the sensor data corresponding to the window. The subset of data acquired for each window includes measurements from the pressure during that time window.

[0051] The controller 80 then processes the data for each window. The window data is evaluated at a macro level, in that any decisions based on this data are made not only on instantaneous pressure values ​​but also on overall trends within the window (e.g., global pressure values ​​within the window, length of overpressure excursions, temporal height of overpressure peaks, area under the curve, overpressure, etc.). The data within each window is then processed to determine whether a second threshold criterion is met. Whether the second threshold criterion is met is evaluated based on more data than just the data corresponding to the trigger event. In this example, the evaluation is performed on the entire data within each window.

[0052] In this example, comparing the data within each window to the second threshold criterion includes evaluating whether the entire data within the window meets the second threshold criterion. In this example, satisfying the second threshold is based on the extent to which the body tissue 30 is subjected to pressure that exceeds the pressure threshold. This extent includes indicators of both (i) the absolute value of the pressure experienced by the body tissue 30 and (ii) the duration of time the body tissue 30 is exposed to high pressure. In this regard, the second threshold is evaluated based on the area under the curve within the window (e.g., the area under the curve exceeding the threshold). A determination of whether a selected window meets the second threshold criterion is evaluated based on the sum of the pressure data within the selected window and / or the integral of the pressure curve within the selected window.

[0053] In this example, if the sum of the calculated pressure exposures within the window exceeds the threshold, the window is determined to meet the second threshold criterion.

[0054] Figure 2c shows the pressure versus time graph of Figures 2a and 2b, but in Figure 2c only three windows corresponding to the third, fourth, and fifth pressure regions are shown. In this example, the other pressure regions of the graph have been effectively filtered (other pressure regions are not shown). In the context of the present disclosure, it should be understood that the other data in the graph is not discarded, but the graph is focused only on the windows corresponding to the third, fourth, and fifth pressure regions to aid in explaining the processing steps described herein.

[0055] The windows corresponding to the third, fourth, and fifth pressure regions are retained at this stage because they have areas under the curve that exceed the threshold (i.e., satisfy the second threshold criterion). As can be seen in Figures 2a-2c, these windows have larger areas under the curve. Although the second pressure region 202 has the highest pressure values, its area under the curve is not as large, so the window corresponding to the second pressure region 202 does not satisfy the second threshold criterion.

[0056] The state of the body tissue 30 is determined based on these three windows. In this example, the severity of the impact caused by the high-pressure region is determined to depend more on the overall degree of impact from the high-pressure region than on the peak pressure within the high-pressure region. The state of the body tissue 30 is determined based on the overall degree of impact from the high-pressure region rather than on the instantaneous peak pressure value. In this example, the state of the body tissue 30 is determined based on the number of windows that meet the second threshold criterion. In this example, the state of the body tissue 30 is also determined based on the total exposed pressure within the window (e.g., area under the curve). The number of windows that meet the second threshold criterion and the total exposed pressure within those windows are combined to provide a pressure score. The state of the body tissue is determined based on the pressure score.

[0057] The pressure score provides an indication of both the amount of sustained high-pressure areas and the degree of pressure within those areas. The pressure score may be a numerical value that can be used to determine the condition of the tissue (e.g., there may be a known mapping between the value of the pressure score and the condition of the tissue, such as a known amount of deterioration resulting from the tissue receiving that pressure score). The magnitude of the score provides an indication of the condition of the tissue 30. For a score indicating few (or no) high-pressure areas, the condition of the tissue 30 is good. For a score indicating many high-pressure areas, if those high-pressure areas have a high degree of pressure, the condition of the tissue 30 is poor. An indication of the viability of the tissue 30 may be provided based on the score, for example, to suggest whether the tissue 30 is likely to be viable for transplantation after being stored and preserved in the preservation system 100.

[0058] An extension of this process is described below with reference to Figure 2d. Instead of determining the state of body tissue 30 as described with reference to Figure 2c, an additional step may be implemented. Figure 2d shows the pressure versus time graph shown in Figures 2a-2c with some additional regions added that are not filtered compared to Figure 2c. Also, the removal / inclusion of different pressure regions in the graph is for illustrative purposes only, and is not intended to indicate that this data is actually discarded / used.

[0059] Compared to FIG. 2c, the process of FIG. 2d includes an additional evaluation to determine whether a window satisfies a second threshold criterion. In this example, in addition to the aforementioned evaluation, to satisfy the second threshold criterion, the window must also meet certain requirements regarding the consistency of its measurement (e.g., the shape of the curve within the window). In this example, to satisfy the second threshold criterion, the window must contain a threshold number of turning points (e.g., where the slope changes between positive and negative / contains a stationary inflection point). As can be seen, only the windows corresponding to the third and fifth pressure regions meet this requirement, and therefore only these regions satisfy the second threshold criterion.

[0060] In this example, a third threshold criterion is used to determine the state of the body tissue 30, but with an additional window generation step, which is shown in Figure 2d.

[0061] In an additional window generation step, window extensions are performed on each of the windows that met the second threshold criteria (those corresponding to the third and fifth pressure regions). The window extensions expand the windows to include more data than was used in FIG. 2c. In this example, the window extensions expand the windows to include a selected amount of data immediately preceding the window. As shown in FIG. 2d, a third window extension 213 is performed on the window corresponding to the third pressure region 202, and a fifth window extension 215 is performed on the window corresponding to the fifth pressure region 205. Each window extension includes sensor data for a selected time period prior to the corresponding window, as preselected.

[0062] It is then determined whether the data within the extended window meets a third threshold criterion. In this example, the third threshold criterion is configured to examine a relationship between the measurement data of the preselected regions and the measurement data occurring immediately before those preselected regions. In this example, determining whether the third threshold criterion is met includes determining whether a short, sharp peak occurred immediately before the preselected window. If it is determined that there was at least one peak in the window extension (e.g., where the slope increases and decreases, and this peak exceeds a selected threshold, such as 120% of the peak pressure value of the preselected pressure region), the third threshold criterion may be determined to be met if a sharp peak occurs before an extended peak with multiple slope changes. In this case, the condition of the body tissue 30 is determined (e.g., as described above) based on the extended window that meets the third threshold criterion.

[0063] With reference to the processing steps described above, it will be appreciated that the sensor data is processed to reveal additional patterns based on which the condition of the body tissue 30 may be determined. The amount of data based on which the condition of the body tissue 30 is determined may be reduced, such as to focus on certain areas of the data over other areas. The processing steps described above allow for more sophisticated and accurate data analysis to determine the condition of the body tissue 30.

[0064] Another example of monitoring sensor data of body tissue 30 and / or its surrounding environment is described below with reference to Figures 3a-3d.

[0065] Figure 3a is a graph of pressure and acceleration over time. In Figure 3a, the sensor data includes both pressure and acceleration data. The pressure data is measured by a pressure sensor, and the acceleration data is measured by an accelerometer. The pressure measurements are the same as in Figure 2a, so they will not be repeated. The acceleration data is generally at baseline values ​​over time (the acceleration data is generally within a narrow band of acceleration values). There are three regions in the acceleration data where the measurements differ significantly from the baseline values.

[0066] In the first acceleration region 301, there is an increase in acceleration. This increase occurs over a relatively short period of time, and the peak acceleration is not very high. The first acceleration region 301 occurs shortly before the second pressure region 202. There is some overlap between the two, so the second pressure region 202 begins before the first acceleration region 301 ends. In the second acceleration region 302, the acceleration increases for a longer period of time, reaching a higher acceleration peak. The second acceleration is located between the third pressure region 202 and the fourth pressure region 204. In the third acceleration region 303, there is a sustained increase in acceleration. The acceleration in this region is not particularly high, and its slope changes a lot in this region. The acceleration may oscillate somewhat and / or there may be both increases and decreases in acceleration values ​​at the increased acceleration levels.

[0067] FIG. 3b is a graph similar to FIG. 2b, but includes acceleration data and includes black circles to represent when the acceleration data exceeds a threshold. It should be understood that the threshold acceleration value is different from the threshold pressure value, but for ease of illustration, both thresholds are shown as a single line on the graph. As can be seen, there are three windows of acceleration data that exceed the threshold. These windows correspond to a first acceleration region, a second acceleration region, and a third acceleration region. The windows corresponding to the first acceleration region and the third acceleration region at least partially overlap with the windows corresponding to the second pressure region and the fifth pressure region, respectively.

[0068] In this example, as described above with respect to Figures 2a-2d, a trigger event is defined as an event in which acceleration exceeds an acceleration threshold, and the window of data analyzed is the time during which acceleration exceeds the acceleration threshold. Again, the degree of acceleration applied to the body tissue 30 is measured based on the area under the curve within the window. This process leaves pressure windows as described above, and acceleration windows corresponding to the second and third acceleration regions.

[0069] Figure 3c shows these windows and does not include the remaining areas of pressure and acceleration data. Again, it should be understood that this data is not discarded, but is simply not shown to aid in the explanation of the processing steps.

[0070] In addition to the processing steps described with reference to Figures 2a-2d, in Figures 3a-3d the processing steps include analysis of acceleration data and analysis of one data set also based on the other data set, including analysis of pressure data also based on acceleration data and / or analysis of acceleration data also based on pressure data.

[0071] 3c shows five windows that meet the second threshold criterion (sufficiently large area under the curve). These windows correspond to the third, fourth, and fifth pressure regions, and the second and third acceleration regions. When determining the state of the body tissue 30, cross-correlation of the pressure data and acceleration data for these windows is performed.

[0072] In this example, cross-correlation is performed between identified overlapping windows. In other words, cross-correlation does not need to be performed for non-overlapping windows. The windows corresponding to the third pressure region 202, the second acceleration region 302, and the fourth pressure region 204 do not overlap with other windows. That is, in those window regions, the other sensor data in those regions did not meet the first threshold criterion. However, there is overlap between the windows corresponding to the third acceleration region 303 and the fifth pressure region 205. The data for these two windows are then compared to assess whether there is a correlation between them. It should be understood that, in view of the present disclosure, multiple different trigger points and / or cross-correlations (and analysis of different combinations of data sets) may be used and should not be considered limited to those shown in this example.

[0073] Evaluating the correlation between two subsets of sensor data involves identifying whether the two windows of data have one or more characteristics in common. In this example, this evaluation is performed by comparing the gradients within the regions. The number of gradient changes (between positive and negative, or stationary inflections) is counted, along with the pattern of the changes (frequency of occurrence, characteristics of the gradient before and after the change, and percentage of the window between each change). Based on the comparison of the two characteristics, it is determined whether there is any correlation between these characteristics. In this example, this correlation may provide an indication of a selected window in the pressure data where the pressure response in that region was caused by acceleration of the system 100. In other words, where the pressure data in that region is not indicative of the characteristics of the body tissue 30 as much as it is characteristic of the transport of that body tissue 30.

[0074] In this example, pairs of windows determined to have a correlation above a threshold are identified to determine the state of the body tissue 30. When determining the state of the body tissue 30, these windows are not considered to satisfy the second threshold criterion. The state of the body tissue 30 is then determined based on the remaining windows that are considered to satisfy the second threshold criterion. In this example, the determination windows are those corresponding to the third pressure region 202, the second acceleration region 302, and the fourth pressure region 204. The determination of the state of the body tissue 30 is performed as described above with respect to FIG. 2c. Corresponding or alternative evaluations may be used to describe the acceleration data. In this example, the state of the body tissue 30 is determined based on the degree of pressure and acceleration applied to the body tissue 30 (determined based on the sum of the areas under the curve for those windows that satisfy the second threshold criterion).

[0075] A further example is described below with reference to FIG. 3d. Similar to FIG. 2d, in FIG. 3d, additional processing of the pressure data is performed to identify a pressure window containing a threshold number of turning points. No corresponding evaluation is performed for the acceleration window. As shown in FIG. 3c, the window corresponding to the fifth pressure region 205 was deemed not to meet its second threshold criterion due to its correlation with the window corresponding to the third acceleration region 303. The only windows considered in FIG. 3d are those corresponding to the third pressure region 202 and the second acceleration region 302. Similar to FIG. 2d, a new window is defined relative to the window corresponding to the third pressure region 202, and the new window includes a third window evaluation.

[0076] In this example, similar to the example of FIG. 2d, the processing step includes determining whether there is a sharp peak in the third window extension 213. Furthermore, the processing step includes cross-correlating the pressure data and acceleration data in the third window extension 213. In this example, the cross-correlation step is based on the same characteristics described above. In this example, based on the cross-correlation evaluation, it is determined that there is a correlation between the pressure data in the window extension and the acceleration data in the window extension. As can be seen, there is a sudden increase in pressure immediately after a sudden increase in acceleration. Because there is a correlation, it is determined that the presence of a sharp peak in pressure before the window corresponding to the third pressure region 202 is related to acceleration, rather than a characteristic of the body tissue 30 that responds to pressure. The third window extension 213 is then deemed to have failed the third threshold criterion of including a sharp peak before the window corresponding to the third pressure region 202. Thus, a determination of the state of the body tissue 30 is made based on the window that meets the third threshold criterion. In this case, the determination window is the window corresponding to the second acceleration region 302.

[0077] These exemplary processing steps may further facilitate processing of the sensor data to identify patterns from which the state of the body tissue 30 may be determined. These steps may also enable removal of data outliers or abnormal data values ​​that are less relevant to the state of the body tissue 30. This may reduce the likelihood of false positives and / or false negatives, where the determined state of the body tissue is incorrect (e.g., causing body tissue that is not suitable for transplantation to be used and / or causing body tissue that is suitable for transplantation not to be used). In other words, embodiments of the present disclosure may provide more reliable monitoring of the body tissue 30. Processing of the data may also provide traceability, allowing the processing steps to be updated based on observed data, for example, to account for cases where the determined state of the body tissue is deemed incorrect.

[0078] It will be appreciated in view of the present disclosure that the exemplary systems and methods described above may enable improved archiving and preservation of body tissue 30, such as through improved systems and methods for monitoring body tissue 30. However, it will also be appreciated that the systems and methods described relate to specific examples. These examples are not intended to be limiting. Features described in these examples are not necessarily required, and systems and methods of the present disclosure may be provided without such features. Likewise, additional and / or alternative functionality may be provided. These additional functionality and alternative arrangements are described below.

[0079] Tissue Preservation System The tissue preservation system of the present disclosure may include a container unit 10 and a base unit 60. The container unit 10 may be configured as an insert for the base unit 60. The container unit 10 may have a standardized size and / or shape to facilitate insertion into the base unit 60. Each container unit 10 may be specific to the type of tissue with which it is intended to be used. For example, the container unit 10 may have a size selected to accommodate the intended tissue, and / or the container may have multiple inlets and outlets depending on the intended tissue (e.g., to provide preservation solution to the correct number of lumens within the tissue 30). The container unit 10 may include a restraint for securing the tissue 30 within the tissue receiving portion 12 of the container unit 10 (e.g., to restrict movement of the tissue 30 during transport).

[0080] The body tissue preservation system 100 may be for use in storing and / or transporting body tissue 30. The body tissue 30 may comprise an organ. For example, the system 100 may be arranged for storing and / or transporting organs used in organ transplantation. The system 100 may be arranged to store and preserve an organ from the time the organ is harvested until the organ is ready for transplant into a patient. The container units may be dedicated to an organ. Each container unit 10 may include one or more indicators (e.g., the indicators may be color-coded) to indicate which type of organ the container unit 10 is for.

[0081] Storing and / or preserving the bodily tissue 30 in the system 100 may include storing the bodily tissue 30 for a selected period of time (e.g., related to the amount of time between when the bodily tissue 30 is removed and when the tissue is ready to be implanted into a patient). Storing the bodily tissue 30 for the selected period of time may include controlling one or more characteristics of the bodily tissue 30 and / or its surrounding environment for preservation of the bodily tissue 30. Preserving the bodily tissue 30 may include maintaining the bodily tissue 30 in a state suitable for implantation into a patient (e.g., after a selected period of time has elapsed). For example, preserving the bodily tissue 30 may include limiting damage to the tissue after it is extracted from the patient and before it is reinserted into the patient.

[0082] The storage and / or preservation system 100 may include a bodily tissue 30 (e.g., organ) preservation system 100, such as, for example, an extracorporeal tissue storage and / or preservation system 100 (e.g., an ex vivo / ex situ system 100). The system 100 may be configured to provide one or more fluids to the bodily tissue 30 carried in the container unit 10. These fluids may constitute preservation fluids and may be passed through one or more lumens of the bodily tissue 30 to facilitate preservation of the bodily tissue 30. The system 100 may be configured for gas and / or fluid perfusion of the bodily tissue 30 within the container unit 10. For example, the system 100 may be configured for one or more of: (i) normothermic fluid perfusion; (ii) hypothermic fluid perfusion; and (iii) oxygenation of the bodily tissue 30 within the container unit 10.

[0083] The storage and / or preservation system 100 may include a tissue oxygenation system 100. The tissue oxygenation system 100 may be configured to pump one or more oxygenating fluids into the lumen of the tissue 30. The oxygenating fluid may be pumped in either a retrograde or antegrade direction. In a forward oxygenation scenario, the oxygenating fluid (e.g., oxygenating gas) is pumped into the tissue 30 via one or more arteries and removed from the tissue 30 via one or more veins (e.g., oxygenating fluid flow enters through the arteries and exits through the veins). In a retrograde oxygenation scenario, holes are drilled in the tissue 30, and the oxygenating fluid is pumped into the veins of the tissue 30 and exits through the holes. The oxygenating fluid may include any suitable oxygenating fluid configured to oxygenate the tissue 30, for example, an oxygenating gas having a sufficiently high oxygen level to sustain the tissue 30.

[0084] The container unit 10 may be disposable (e.g., to prevent contamination of subsequent body tissues by previous body tissues carried by the container unit 10). The container unit 10 may include one or more base unit coupling portions to facilitate connection of the container unit 10 to the base unit 60. For example, the container unit 10 may include one or more flanges arranged to mate with corresponding components of the base unit 60. The container unit 10 may, for example, store the preservation solution 34 within the body tissue receiving portion 12 such that the body tissue 30 stored in the container unit 10 is at least partially immersed in the preservation solution 34.

[0085] The base unit 60 may include a source of preservation solution, such as a canister of oxygen-delivering gas. The base unit 60 may be configured to be connected to the container unit 10 to supply the preservation solution to the body tissue 30 within the container unit 10, such as by providing a fluid path for the preservation solution to the arteries and / or veins of the body tissue 30. The base unit 60 may also be configured to control the supply of the preservation solution to the body tissue 30. The base unit 60 may also be configured to adjust the temperature / pressure of the environment of the body tissue 30 within the container unit 10. For example, a heater operable to increase the heat (and / or pressure) within the container unit 10 may be provided, and / or a cooling device may be provided to decrease the heat (and / or pressure) within the container unit 10.

[0086] The systems disclosed herein may include one or more sensors. The aforementioned example includes, but is not limited to, two sensors. The system 100 may have one sensor or two or more sensors. It should be understood that the location and type of sensors used are not particularly limited in light of the present disclosure. Any suitable sensor may be used, such as, for example, a temperature sensor, a pressure sensor, a vibration sensor, a humidity sensor, an oxygen concentration sensor, a flow meter, and / or a turbidity sensor. A suitable sensor may be configured to provide an indication of at least one characteristic of the storage and / or preservation of the body tissue 30. For example, the sensor may provide an indication of a characteristic that may indicate the condition of the stored and preserved body tissue 30.

[0087] The receptacle unit 10 may include one or more sensors. The sensors in the receptacle unit 10 may be connected to the controller 80 (e.g., wirelessly or via a wired connection). The sensors may be configured to enable the controller 80 to obtain an indication of one or more measurements based on which the state of the body tissue 30 can be determined. For example, the receptacle unit 10 may include at least one of: (i) a temperature sensor for the body tissue 30 and / or the surrounding environment of the body tissue 30; (ii) a pressure sensor for the body tissue 30 (e.g., one of the lumens of the body tissue 30) and / or the surrounding environment of the body tissue 30; (iii) a humidity sensor for the surrounding environment of the body tissue 30; and (iv) an oxygen sensor for the surrounding environment of the body tissue 30. The receptacle unit 10 may include a motion sensor, such as an accelerometer, configured to sense one or more characteristics of the movement of the receptacle unit 10. The receptacle unit 10 may include a sensor and be configured to transmit data from the sensor to the controller 80, which is configured to monitor the data from the sensor as described herein.

[0088] Any suitable location may be used for the one or more sensors, such as within the first fluid reservoir 72, between the first fluid reservoir 72 and the fluid outlet 70 of the base unit 60, within the inlet 20 of the container unit 10, within the first aqueduct 22, within the second aqueduct 24, within the outlet 26 of the container unit 10, within the fluid inlet 76 of the base unit 60, between the fluid inlet 76 and the second fluid reservoir 74, and / or within the second fluid reservoir 74. The sensors may be located within the container unit environment, such as on or within the tissue-receiving portion 12. The location and / or type of sensor is not particularly limited. The placement may be configured to allow one or more operating parameters of the system 100 to be monitored to allow some feedback control of the system 100.

[0089] The sensors may be configured to provide measurement data indicative of the body tissue 30 and / or the environment surrounding the body tissue 30. This measurement data may include data indicative of the movement of the body tissue 30 (within the overall system 100). This measurement data may include physical characteristics of the body tissue 30 itself. The sensors may provide measurements semi-periodically. The sensors may provide a stream of measurements. The sensors may be configured to output data that may allow the processing steps disclosed herein to be performed, e.g., data with sufficient granularity / resolution, for which a window may be defined. The sensors may be configured to provide an ordered output of measurements, such as a time-ordered output. The interval between measurements may be selected so that micro- and macro-patterns can be identified within the measurements. The sensor data may include data from one or more sensors. The sensor data may include a combination of data obtained from each of multiple sensors. Each sensor may output discrete or continuous data, such as a series of measurements. The series of measurements may be provided in a time series.

[0090] An example of the present disclosure may provide a body tissue monitor. The body tissue monitor may include one or more sensors and a controller 80 configured to perform the processing steps disclosed herein. For example, the body tissue monitor may be configured to monitor a body tissue and determine a state of the body tissue based on sensor data of the body tissue. The sensor data may include one or more measurements of characteristics of the body tissue and / or the body tissue's surrounding environment.

[0091] In the examples described herein, the controller 80 is shown within the base unit 60. However, it should be understood that this arrangement is not particularly limiting. The controller 80 may be provided by any suitable components. The controller 80 may be connectable to one or more sensors to obtain data therefrom. This connection may be wired or wireless. For example, each sensor may be connected to a communication interface configured to enable transmission of data to the controller 80. The controller 80 may be provided within the receptacle unit 10. The controller 80 may be a cloud-based service to which the sensors connect via a network and / or the controller 80 may be provided by a user device such as a mobile communication device, e.g., a smartphone.

[0092] Automatic Control The examples described herein relate to the storage and preservation of body tissue 30, where the body tissue 30 is monitored such that the state of the body tissue 30 can be determined based on sensor data acquired about the body tissue 30. The monitoring of the body tissue 30 and the determination of the state of the body tissue 30 may be used in an automated control system for the storage and / or preservation of the body tissue 30. Based on the acquired sensor data and processing of the sensor data by the controller 80, the automated control system may control one or more operational parameters of the storage and / or preservation of the body tissue 30.

[0093] The controller 80 may be configured to control one or more operating parameters of the storage and / or preservation of the body tissue 30 in the container unit 10. The system 100 may include an adjustment unit operable to adjust characteristics of the body tissue 30 and / or the environment surrounding the body tissue 30. For example, the adjustment unit may be configured to adjust a characteristic of the environment, such as temperature, and may be, for example, a heater / cooler. The adjustment unit may be configured to control characteristics of the preservation solution delivered to the body tissue 30. The adjustment unit may be configured to control the pressure and / or flow rate of the preservation solution delivered to the body tissue 30. For example, the system 100 may include one or more variable valves, such as in the base unit 60, operable to control the flow characteristics of the preservation solution to the body tissue 30. Each variable valve may be operated in a number of different states that allow different amounts of fluid to flow to the body tissue 30. The controller 80 may be configured to control the operating states of the variable valves.

[0094] Controlling the operating parameters may include controlling parameters related to the fluid delivered to the body tissue 30 and / or parameters related to the environment of the body tissue 30 within the container unit 10. Controlling the parameters of the environment surrounding the body tissue 30 may include controlling one or more of the temperature, pressure, oxygen concentration, and / or humidity within the environment of the body tissue 30, for example, within the body tissue receiving portion 12 of the container unit 10. Controlling the parameters related to the fluid delivered to the body tissue 30 may include controlling one or more of the pressure of the fluid delivered, the temperature of the fluid delivered, the flow rate of the fluid delivered, multiple available routes for the delivery of the fluid (e.g., multiple first conduits delivering fluid to the body tissue 30), which particular fluid is delivered, and / or through which conduit the fluid is delivered to the body tissue 30.

[0095] To achieve automatic control, the controller 80 may be configured to control one or more operational parameters of the storage and / or preservation of the body tissue 30. The controller 80 may control at least one operational parameter based on the processing steps disclosed herein. For example, if the controller 80 determines that a window of sensor data meets an associated second threshold criterion, the controller 80 may adjust at least one parameter associated with the storage and / or preservation of the body tissue 30. For example, the controller 80 may control the at least one operational parameter as a corrective measure to attempt to control the storage and preservation characteristics of the body tissue 30, e.g., as a corrective measure to attempt to correct so that the second threshold criterion is met.

[0096] The automatic control system may include detecting when a window of sensor data meets a second threshold criterion and controlling operation of a component of system 100 that may adjust a characteristic associated with that window of sensor data. For example, if the second threshold criterion is met for a window indicating that too high a value of hydraulic pressure has been experienced, the automatic control may include adjusting a component that affects pressure, such as a variable valve, to reduce the pressure. The automatic control system may provide a feedback loop to enable initiation of corrective measures based on the processing steps disclosed herein that indicate a significant event has occurred (e.g., the second threshold criterion has been met).

[0097] Each sensor may provide an indication of a characteristic of the body tissue 30 and / or the body tissue 30's surrounding environment. Each sensor may have a corresponding adjuster operable to adjust that characteristic. The automatic control may include using the adjuster corresponding to the sensor that provided data indicating that a second threshold criterion was met. The corresponding adjuster may be controlled based on the second threshold criterion, e.g., to adjust the associated characteristic accordingly. Operational data of one or more such adjusters may be used in processing the sensor data (e.g., to further facilitate cross-correlation between measurement values ​​and adjuster operation when measurement data indicates adjuster operation rather than a more significant event).

[0098] From an automated control perspective, controlling operational parameters for archiving and / or preserving body tissue 30 may include controlling output to display screen 88 and / or limiting input from a user of system 100. For example, display screen 88 may be used to display multiple operational parameters to a user. The displayed parameters may include alerts indicating that a significant impact event has occurred. A user of system 100 may input data via a screen that controls one or more operational parameters of system 100. Controller 80 may be configured to suppress input data from the user that is determined to be contrary to a significant event that has occurred. For example, if a user attempts to input a command to increase pressure but a second threshold criterion related to excessive pressure has been registered (or is currently occurring), controller 80 may issue an alert and / or prevent application of this input data.

[0099] The examples described herein relate to the supply of a preservation solution to the body tissue 30. However, it should be understood that this is not particularly limiting in view of the present disclosure. For example, the ambient conditions in the environment of the body tissue 30 may instead be controlled, such as by controlling the temperature and / or pressure. This control may be performed without the supply of a preservation solution.

[0100] It should be understood in view of the present disclosure that sensor data processing may be performed on-the-fly by the controller 80. That is, the controller 80 receives sensor data from one or more sensors (as described above) and processes the sensor data. The sensor data may be processed continuously as the controller 80 receives the sensor data. In each instance in which data is received that provides an indication of a significant event (e.g., threshold criteria are met), the controller 80 may provide an output signal, for example, to issue an alert or for automatic control. The controller 80 may also be configured to process historical data, for example, by receiving historical sensor data from at least one sensor and processing this data as described herein. For example, a combination of retrospective and on-the-fly data processing may be provided; for example, the controller 80 may store a buffer of recent sensor data and the controller 80 may periodically process the sensor data in the buffer.

[0101] output Examples of the present disclosure described herein may provide a status output signal based on the determined status of the body tissue 30. It will be understood in light of the present disclosure that the specific type of data output signal is not particularly limited. The status output signal may enable automatic control, as described above. For example, the status output signal may include a signal configured to control at least operational parameters of the storage and preservation of the body tissue 30 based on the determined status of the body tissue 30.

[0102] The status output signal may be configured to provide an indication of the determined status of the body tissue 30, such as displayed on the display screen 88. The output signal may be configured to allow the user to select the level of detail about the sensor data and / or the determined status of the body tissue 30 that the user wants to see. The output signal may include multiple links to allow the user to select what level of detail they want to use. The output signal may provide a layered output, in that the user can select the amount of data available to the user (e.g., the granularity of the data available to the user) by selecting the associated data link.

[0103] For example, the status output signal may provide an indication at the top layer whether an organ has been determined to be viable for transplant. The next layer may indicate a probabilistic value for the likelihood that the body tissue 30 is viable for transplant and / or an indication of deterioration of the body tissue 30 during storage. The next layer may provide an indication of the most severe events, such as events that meet the highest level (e.g., second or third) threshold criteria. The next layer may indicate trigger events in the sensor data. The final layer may provide the entire sensor data. As will be appreciated, more data may be provided at each subsequent layer. Links in the data may facilitate switching between different layers.

[0104] This data output arrangement allows the surgeon to receive a determined indication of the state of the body tissue 30. Using different links / levels, the surgeon can view the relevant portions of the sensor data on which the state of the body tissue 30 was determined. The links may be to different windows of data (e.g., different time windows associated with meeting respective threshold criteria). By using a particular link, the data corresponding to that link (e.g., the relevant subset of data that met the threshold criteria) may be provided to the user (e.g., the surgeon). This may allow the surgeon to confirm the determined state of the body tissue 30. In particular, this arrangement may minimize the time the surgeon spends reviewing the sensor data for delivery, as only the more significant events are displayed, reducing the amount of sensor data the surgeon needs to review. This data arrangement may also facilitate direct verifiability, auditability, and / or traceability of the determined state of the body tissue 30. For example, the reason the state of the body tissue 30 was determined may be directly identified based on the sensor data and the determined significant event. This allows for establishing what went wrong in the data processing if any problems arise with the transplanted organ, and / or allows the surgeon to ascertain why the state of the body tissue 30 was determined to be as it was. Such direct verifiability and traceability is believed to be particularly useful in organ transplantation.

[0105] Determining the condition of body tissues The examples disclosed herein are configured to determine the state of the body tissue 30 based on acquired sensor data. The sensor data may be evaluated at both a "micro" and a "macro" level. That is, instantaneous measurements may be evaluated (micro level), or multiple measurements may be evaluated together (macro level). The state of the body tissue 30 may be determined based on both these levels (micro / macro). It should be understood that the specific selection of these levels is not particularly limiting in the context of the present disclosure. In this regard, two types of regions of the sensor data may be defined. The first type of region may be referred to as an "event." An event may be considered a micro-scale occurrence in the sensor data. The second type of region may be referred to as an "activity." An activity may be considered to consist of one or more events. When more levels are used (e.g., when a third threshold criterion is applied), the third level may include one or more activities.

[0106] The controller 80 is configured to detect a trigger event. The trigger event may provide an indication of the occurrence of a significant event. It should be understood in the context of this disclosure that the exact nature of the trigger event described herein is not particularly limited. To define the trigger event, a first threshold criterion is provided that, if met, indicates that the trigger event has occurred. Any suitable first threshold criterion may be used. The first threshold criterion may be selected based on empirical or theoretical data. The first threshold criterion may be selected based on data suggesting that an event that may affect the condition of the body tissue 30 has occurred, is occurring, or is about to occur. The first threshold criterion may be selected such that, when the first threshold criterion is met, processing additional sensor data related to the trigger event allows for an improved determination of the condition of the body tissue 30.

[0107] The sensor data may include measurements from one or more sensors. The first threshold criterion may be based on an expected / target value of the parameter measured by the sensor and / or a threshold value for the parameter measured by the sensor. The first threshold criterion may be selected to be met when the measured value of the parameter is far from the expected / target value and / or exceeds a threshold value (e.g., falls outside a range between the threshold values). The first threshold criterion may provide an indication that the measurement has entered a region where review of measurements in that region may be important in determining the condition of the body tissue 30.

[0108] The first threshold criterion may not be based on the absolute value of the measurement. For example, the first threshold criterion may be based on characteristics of how the measurement changes, such as the slope, shape, and / or pattern of the measurement in the sensor data. For example, the first threshold criterion may be met if the slope of the measurement (e.g., the change between subsequent values) exceeds a threshold. The first threshold criterion may not be evaluated based on a single instantaneous measurement in the sensor data. For example, the first threshold criterion may be evaluated based on multiple measurements in the sensor data. This evaluation may be based on each measurement (e.g., a series of measurements that fit a particular pattern / measurements outside a threshold range) or on a processed form of those measurements (e.g., an average value over a selected period of time).

[0109] When a trigger event is detected, the controller 80 is configured to select a window of sensor data associated with the trigger event. The sensor data corresponding to this window may then be evaluated based on a second threshold criterion. In this regard, evaluating whether the second threshold criterion is met may include evaluating whether an activity meets the threshold criterion (while evaluating whether the first threshold criterion is met may include evaluating whether an event meets the threshold criterion). The window may be selected to encompass more sensor data than that used to evaluate whether the first threshold criterion is met.

[0110] Selecting a window of data may include selecting data for measurement before and / or after a trigger event. The window may be selected to encompass sensor data that contributes to the trigger event. The selected window may encompass more data from which a larger-scale pattern may be determined (e.g., at a larger scale than the pattern determined in detecting the trigger event). The window of data may be selected to encompass all data that meets a selected condition, e.g., all data proximate to the data that contributes to the trigger event that meets the selected condition (e.g., associated threshold criteria). The selected window may also include data from other sensors. For example, the selected window may include data from all sensors, or from only one or a selected number of sensors. For example, sensors may be selected based on relationships between parameters the sensors measure (e.g., to encompass potentially relevant data but avoid unnecessary data). Selecting a window may include selecting multiple windows (e.g., one for each sensor data), and selecting the windows may be based on cross-correlation of sensor data for evaluation of threshold criteria fulfillment. For example, the windows may be selected to enable application of the cross-correlation systems and methods disclosed herein.

[0111] It should be understood that, in view of the present disclosure, the window need not be a time window. For example, selecting a window may include selecting multiple measurements on either side of a trigger event. The number of measurements may be independent of time (e.g., the sensor may provide measurements randomly). For example, selecting a window may include selecting based on characteristics of the system 100, such as a position within a periodic motion. The window may be selected to allow larger scale patterns in the sensor data to be identified. The selected window may provide more sensor data to evaluate (relative to the second threshold criterion).

[0112] Based on the selected window, a relevant subset of sensor data is identified for that window. The subset of data may include all data within that window (e.g., across multiple sensors). The subset of data may include a portion of the data within that window (e.g., measurements from some but not all of the sensors). The identified data may be selected based on a second threshold criterion.

[0113] The second threshold criterion may be evaluated in a manner similar to the evaluation of the first threshold criterion. However, the evaluation of the second threshold criterion may be based on data within a selected window, which may encompass more data than the data on which the first threshold criterion was evaluated. The evaluation of the second threshold criterion may include any suitable evaluation. The second threshold criterion may be different from the first threshold criterion. Satisfying the second threshold criterion may include an indication that a larger-scale trend or characteristic is evident in the sensor data.

[0114] The second threshold criteria may be selected to provide a more significant indication of the state of the body tissue 30. For example, fulfillment of the second threshold criteria may provide a more statistically significant indication of the state of the body tissue 30 than fulfillment of the first threshold criteria. This indication may be either positive or negative regarding the state of the body tissue 30, e.g., whether the body tissue 30 is healthy or unhealthy, such as whether minimal deterioration has occurred or whether significant deterioration has occurred. If at least one second threshold criterion is fulfilled, the determined state of the body tissue 30 may be considered more reliable than if the second threshold criterion is not fulfilled. The second threshold criterion may be associated with a response of the sensor data known to correspond to a particular indicator of the state of the body tissue 30. For example, the second threshold criterion may be selected as an indicator that the sensor data corresponds to a known state of the body tissue 30 and that is more closely related to the state of the body tissue than the first threshold criterion.

[0115] The state of the body tissue 30 may be determined based on one or more subsets of the sensor data that meet the second threshold criteria. It will be understood in view of the present disclosure that the state of the body tissue 30 may be determined based on the sensor data and which threshold criteria are met within the sensor data. For example, if meeting the second threshold criteria provides a statistically significant indication of the state of the body tissue 30, the state of the body tissue 30 may be determined based on the number of instances within the sensor data in which the second threshold criteria are met. For example, the controller 80 may determine a score based on the sensor data, and the state of the body tissue 30 is based on the determined score. The score may be based on the number of second threshold criteria that are met. The score may also be based on the extent to which each second threshold criterion is met, for example, whether the subset clearly or only slightly meets the second threshold criterion.

[0116] The controller 80 may be configured to determine the state of the body tissue 30 based on a weighted combination of sensors. Regions of the sensor data deemed most indicative of the state of the body tissue 30 may be assigned a greater weighting (e.g., these regions may be windows that meet the second threshold criterion). Regions in the sensor data deemed at least partially indicative of the state of the body tissue 30 may be assigned a medium weighting (e.g., these regions may be regions in the sensor data where the first threshold criterion is met but the second threshold criterion for the corresponding window is not met). Regions in the sensor data that are less indicative of the state of the body tissue 30 may be assigned no weighting or a lower weighting (e.g., these regions may be regions where the first threshold criterion is not met). Any suitable combination of sensors and / or processing may be provided that allows an indicator of the state of the body tissue 30 to be determined. This processing of the sensor data may be based on historical data for body tissue monitoring where the state of the monitored body tissue is known.

[0117] Determining the state of the body tissue may include following an algorithmic approach. A series of operators may be defined to process the sensor data. For example, for each trigger event, the corresponding identified subset of data may be processed according to one or more operators. Each operator may include a function that processes the data to provide an output that may enable the state of the body tissue 30 to be determined. Each subset of data that meets the second threshold criterion may be processed according to one or more operators. Output from these operators may provide the state of the body tissue 30; for example, if the output from an operator indicates the state of the body tissue 30 exceeds a threshold range of significance, the state of the body tissue may be determined based on the operator.

[0118] The sensor data may include data from one or more sensors. Determining the state of the body tissue 30 may be based on data from multiple sensors. Data from each sensor may be processed to determine an indicator of the state of the body tissue 30, for example, as described above. The state of the body tissue 30 may be determined based on data from multiple sensors, for example, rather than based on data from only one sensor. The state of the body tissue 30 may be determined by simultaneously considering data from multiple sensors. Data from different sensors may be, for example, correlated with each other so that both sets of data and / or relationships between the data sets are taken into account when determining the state of the body tissue 30.

[0119] It should be understood in view of the present disclosure that any suitable process for cross-correlation of data may be used. Two data sets may be compared to identify correlations between them. For example, a score may be determined for the correlation of any events / activities in the two data sets, and if the score exceeds a threshold, the two events / activities may be determined to be related to each other. The cross-correlation may be performed based on any relevant regions of each data set. For example, a window of a first data set may be compared to a corresponding window of a second data set. As another example, a window of a first data set may be compared to a second data set only if it also has a defined window therein (e.g., one that meets a second threshold criterion). Whether sensor data meets the first and / or second threshold criterion may be based on multiple data sets and their correlations. For example, threshold criteria may be applied to multiple data sources such that the criterion can be met based on both data sets even if either data set alone does not meet the criterion. Similarly, even if these data sets alone meet the threshold criterion, the criterion may only be met if both data sets meet the criterion (and / or their combination / correlation).

[0120] It should be understood in view of the present disclosure that the examples described herein relate to a body tissue preservation system 100, such as an oxygen delivery system, but are not limited thereto. Aspects of the present disclosure may relate to a body tissue monitor for monitoring a body tissue to determine the state of the body tissue. For example, any suitable body tissue may be monitored. This monitoring may be provided with any suitable sensors to enable processing of sensor data as described herein. For example, a body tissue, such as an organ (e.g., heart / lungs), and its function may be monitored, such as using an echocardiogram or other suitable arrangement, to monitor the state of the patient and one or more of the body tissues, such as the organ. It will be understood in view of the present disclosure that any relevant body tissue from which suitable sensor data can be obtained may be monitored using the processes described herein for monitoring body tissue.

[0121] In the examples described herein, events that meet threshold criteria may be considered to be events affecting the body tissue, such that, for example, the state of the body tissue may be determined based on those events. It should be understood in view of the present disclosure that such events may typically indicate harm to the body tissue (as opposed to, for example, the body tissue being healthy). For example, a large and sustained pressure eruption may indicate that the body tissue is highly unlikely to be suitable for transplantation. However, it will be understood that this is not particularly limiting. For example, the absence of abnormalities (e.g., no areas meeting threshold criteria) may be considered to indicate that the body tissue is healthy. The absence of abnormalities may also indicate that one or more sensors are not functioning properly. The controller 80 may be configured to determine sensor malfunction based on cross-correlation between sensors and / or by detecting insufficient variability in the sensor data (e.g., when different threshold criteria are met). In other examples, patterns and / or values ​​indicative of healthy tissue may be identified.

[0122] Alternatives, Variations, and / or Additional Features In the examples described herein, a fluid flow path between the base unit 60 and the container unit 10 is described. It should be understood that, in view of the present disclosure, the described flow paths are merely exemplary. For example, the base unit 60 may include a source of preservation solution, and one or more flow paths may be defined to allow the supply of the preservation solution to the body tissue. The flow path may be via the inlet 20 in the container unit 10, or a tube may be provided that may pass through the side of the container unit 10 and enter the body tissue receiving portion 12. Multiple fluid flow paths may be provided to allow the supply of preservation solution to the body tissue within the container unit 10. For example, the container unit 10 may be configured so that multiple first water conduits can be connected to the body tissue for supplying the preservation solution. Additionally, the container unit 10 may not have an outlet 26. For example, when gas is delivered to the body tissue, the gas may exit the body tissue to the surrounding environment, for example, through a vent / filter into the atmosphere.

[0123] The container unit 10 may include one or more fluid treatment elements. The fluid treatment elements may include passages sized and / or shaped to treat the fluid therein, such as reducing bubble size, humidifying, and / or cooling the fluid therein. These fluid treatment elements may be used to treat the input preservation fluid being delivered to the body tissue. For example, the input preservation fluid may be an oxygen-delivering gas, and the fluid treatment elements may treat the input preservation fluid as it is received at the inlet 20 of the container unit 10 and passes through the first conduit 22 into the body tissue.

[0124] Although the embodiment includes the flange 14, the flange 14 need not be included. For example, the base unit 60 may include an attachment to hold the receptacle unit 10 within the receptacle unit receiving portion 62 of the base unit 60, such as a strap, hook, or other mounting means to secure the receptacle unit 10 in place. The receptacle unit 10 may include a suitable attachment to ensure that it is securely held to the base unit 60. The receptacle unit 10 may also be provided without the flange 14 or attachment.

[0125] The examples described herein include a first liquid reservoir and a second liquid reservoir. However, it should be understood that one or both of these liquid reservoirs may not be included. For example, the base unit 60 may be configured to generate preservation liquid on-site. The first liquid reservoir 72 may be a gas canister that stores an oxygenated liquid. The second liquid reservoir 74 may not be included, for example, if the preservation liquid may be vented from the container unit 10 to the atmosphere or if the liquid inlet 76 of the base unit 60 is connected to an outlet that drains / pours out used preservation liquid. The preservation liquid may be recycled within the base unit 60 (e.g., cleaned and treated to ensure oxygen levels are within a threshold) so that the preservation liquid can be resupplied to body tissues, for example.

[0126] Some examples described herein include a variable valve, which may be used to control at least one operational parameter of the storage and / or preservation of the body tissue within the container unit 10. However, it should be understood in view of the present disclosure that any suitable component may be provided to facilitate control of at least one operational parameter of the storage and / or preservation of the body tissue. For example, a heater / cooler may be included to regulate the temperature of the preservation solution and / or to regulate the ambient temperature of the body tissue's environment. Other adjustments may include an oxygen source to regulate the oxygen concentration of the preservation solution, a selection valve to control the flow of fluid from multiple fluid sources (e.g., to select which fluid source to use), etc.

[0127] From the foregoing description, it will be understood that the illustrated examples are merely illustrative and include features that may be generalized, omitted, or substituted as described herein and in the claims. Referring generally to the drawings, it will be understood that schematic functional block diagrams are used to illustrate the functionality of the systems and devices described herein. Furthermore, processing functions may be provided by devices supported by electronic devices. However, it will be understood that functionality need not be so divided, and no particular structure of hardware other than that described and claimed below is implied. The functionality of one or more illustrated elements may be further subdivided and / or distributed throughout the devices of the present disclosure. In some examples, the functionality of one or more illustrated elements may be integrated into a single functional unit.

[0128] As will be understood by those skilled in the art in view of this disclosure, each example described herein can be implemented in a variety of different ways. Features of any aspect of the present disclosure may be combined with features of any other aspect of the present disclosure. For example, method aspects may be combined with apparatus aspects, and functionality described with reference to the operation of particular pieces of apparatus may be provided in a manner that does not use those particular types of apparatus. Furthermore, each feature of each example is intended to be separable from the features with which it is described in combination, unless some other feature is explicitly stated as essential to its operation. Each of these separable features may, of course, be combined with any other feature of the described example, or with any other feature or combination of features of any other example described herein. Furthermore, equivalents and modifications not described above may also be employed without departing from the present invention.

[0129] Certain functions of methods described herein may be implemented in hardware, and one or more functions of an apparatus may be implemented in method steps. It is also understood that, in view of the present disclosure, the methods described herein need not be performed in the order described, nor necessarily in the order illustrated. Thus, aspects of the present disclosure described with reference to a product or apparatus are also intended to be implemented as a method, and vice versa. The methods described herein may be executed by a controller, for example, in a computer program, in hardware, or any combination thereof. Examples of computer programs include software, middleware, firmware, and any combination thereof. Such programs may be provided as signals or network messages, or recorded on a computer-readable medium, such as a tangible computer-readable medium that stores a computer program in a non-transitory form. Examples of hardware include computers, mobile devices, programmable processors, general-purpose processors, application-specific integrated circuits (ASICs), field-programmable gate arrays (FPGAs), and arrays of logic gates.

[0130] In some examples, one or more memory elements may store data and / or program instructions used to perform the operations described herein. Embodiments of the present disclosure provide a tangible, non-transitory storage medium including program instructions operable to program a processor to perform any one or more of the methods described and / or claimed herein and / or to provide a data processing apparatus as described and / or claimed herein.

[0131] Other examples and modifications of the present disclosure will be apparent to those skilled in the art in view of the present disclosure.

Claims

1. 1. A tissue preservation system for storing and preserving tissue, comprising: a body tissue monitor for monitoring the body tissue to determine a state of the body tissue; and The body tissue monitor includes: at least one sensor configured to acquire sensor data based on a plurality of measurements of the body tissue and / or an environment surrounding the body tissue; a controller arranged to receive the sensor data from at least one of the sensors; Equipped with The controller detecting one or more trigger events in the sensor data, each trigger event comprising the sensor data meeting a first threshold criterion; for each of one or more of the trigger events, selecting a window of the sensor data associated with the trigger event; for each of one or more of the windows, identifying a subset of the sensor data corresponding to the selected window; For each of the one or more selected windows, determining whether the corresponding identified subset of the sensor data satisfies a second threshold criterion; determining the state of the body tissue based on the identified subset that meets the second threshold criterion; providing a status output signal based on the determined status of the body tissue. It is configured as follows: A body tissue preservation system.

2. configured to store and preserve said body tissue outside the body; 10. The tissue preservation system of claim 1.

3. configured to supply oxygen to the body tissue within the container unit; 3. The body tissue preservation system according to claim 1 or 2.

4. the body tissue is a body tissue for transplantation, the body tissue preservation system is configured to monitor the body tissue during storage and / or transport; the status output signal is indicative of the viability of the implant tissue.

4. A body tissue preservation system according to any one of claims 1 to 3.

5. The tissue preservation system comprises: the container unit arranged to contain the body tissue; and The container unit comprises: At least one of said sensors, Equipped with 4. The tissue preservation system of claim 3.

6. The tissue preservation system comprises: at least one adjustment unit operable to adjust the properties of said body tissue and / or the environment surrounding said body tissue; Including, 6. A body tissue preservation system according to any one of claims 1 to 5.

7. the controller is configured to control operation of the adjustment unit to adjust the characteristic of the body tissue and / or the body tissue's surrounding environment when the identified subset of sensor data is determined to satisfy the second threshold criterion.

7. The tissue preservation system of claim 6.

8. the controller is configured to control the regulator to regulate at least one of: (i) the flow of oxygenate to the body tissue; and (ii) the pressure of the oxygenate flowing through the body tissue.

8. The body tissue preservation system according to claim 6 or 7, dependent on claim 3.

9. selecting the window of sensor data includes selecting a time window of the sensor data.

9. A tissue preservation system according to any one of claims 1 to 8.

10. The tissue preservation system comprises: Multiple sensors, and each of the plurality of sensors is configured to acquire the sensor data based on the plurality of measurements related to the body tissue and / or an environment surrounding the body tissue; 10. A body tissue preservation system according to any one of claims 1 to 9.

11. the controller is configured to determine whether the identified subset of sensor data from a first sensor meets the second threshold criterion also based on sensor data from a second sensor.

11. The tissue preservation system of claim 10.

12. if the controller detects the trigger event in the sensor data from the first sensor, the controller is configured to select the window associated with the trigger event in both the sensor data from the first sensor and the sensor data from the second sensor, and the controller is configured to determine that one or more threshold criteria are met based on a cross-correlation of data from the first sensor and the second sensor.

12. The tissue preservation system of claim 11.

13. the controller is configured to detect that the sensor data meets the first threshold criterion when at least one of: (i) the sensor data is outside a selected range; (ii) a change in the sensor data exceeds a threshold; and (iii) the sensor data reaches a time threshold.

13. A tissue preservation system according to any one of claims 1 to 12.

14. the controller is configured to determine that the identified subset of sensor data meets the second threshold criterion if at least one of: (i) the sensor data is outside a selected range for a threshold period within the selected time window; (ii) the sensor data changes by more than a threshold amount within the selected time window; and (iii) one or more selected patterns are identified in the sensor data within the selected time window.

14. A tissue preservation system according to any one of claims 1 to 13.

15. the controller is configured to output an alert when the corresponding identified subset of the sensor data is determined to satisfy the second threshold criterion.

15. A tissue preservation system according to any one of claims 1 to 14.

16. The status output signal is each of the identified subsets of the sensor data that meet the second threshold criterion; Including, 16. A tissue preservation system according to any one of claims 1 to 15.

17. The status output signal is the identified subset of the sensor data; Including, For example, the status output signal may be: the sensor data; Including, 17. The tissue preservation system of claim 16.

18. The status output signal is data for each of said one or more trigger events; Including, 18. A tissue preservation system according to any one of claims 1 to 17.

19. the state output signal provides an ordered series of notable events in the sensor data; The notable events are: (i) the trigger event; and (ii) the identified subset; and (iii) the identified subset that meets the second threshold criterion; and at least one of:

19. A tissue preservation system according to any one of claims 1 to 18.

20. the controller is configured to provide the status output signal including a data link arranged to allow a user to select the event of interest and view the sensor data associated with the event of interest.

20. The tissue preservation system of claim 19.

21. The controller for each of one or more identified subsets that meet the second threshold criterion, selecting a second window of the sensor data that is associated with the window of the identified subset; for each of the one or more selected second windows, identifying the subset of the sensor data corresponding to each of the second windows; For each of the one or more selected second windows, determining whether the corresponding identified subset of the sensor data satisfies a third threshold criterion; determining the state of the body tissue based on the identified subset that meets the third threshold criterion. It is configured as follows:

21. A tissue preservation system according to any one of claims 1 to 20.

22. the controller is configured to determine the state of the body tissue by assigning weights to the subset of the sensor data of the body tissue; each of the weightings is selected based on an associated threshold criterion satisfied by the corresponding subset of the sensor data; 22. A tissue preservation system according to any one of claims 1 to 21.

23. 1. A body tissue monitor for monitoring a body tissue to determine a state of the body tissue, comprising: The body tissue monitor includes: at least one sensor configured to acquire sensor data based on a plurality of measurements of the body tissue and / or an environment surrounding the body tissue; a controller arranged to receive the sensor data from the at least one sensor; and The controller detecting one or more trigger events in the sensor data, each trigger event comprising the sensor data meeting a first threshold criterion; For each of one or more of the trigger events, selecting a time window of the sensor data associated with the trigger event; for each of one or more of the time windows, identifying a subset of the sensor data corresponding to the selected time window; For each of the one or more selected time windows, determining whether the corresponding identified subset of the sensor data satisfies a second threshold criterion; determining the state of the body tissue based on the identified subset that meets the second threshold criterion; providing a status output signal based on the determined status of the body tissue. It is configured as follows: A body tissue monitor characterized by:

24. 1. A method for storing and preserving body tissue, comprising: acquiring sensor data defining a stream of measurements about the body tissue and / or an environment surrounding the body tissue; detecting one or more trigger events in the sensor data, each trigger event involving the sensor data meeting a first threshold criterion; for each of one or more of the trigger events, selecting a window of the sensor data associated with the trigger event; for each of one or more of the windows, identifying a subset of the sensor data corresponding to the selected window; For each of the one or more selected windows, determining whether the corresponding identified subset of the sensor data satisfies a second threshold criterion; determining a state of the body tissue based on the identified subset that meets the second threshold criterion; providing a status output signal based on the determined status of the body tissue; Including, A method characterized by:

25. 1. A computer program product comprising:

25. Computer program instructions configured to program a controller to perform the method of claim 24. Including, 1. A computer program product comprising:

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