Patent Description:
In particular, the present invention relates to a device for the storage and transport of biological material, in particular organs, cells and tissues. Without any loss of generality, the following refers to a device designed for the storage and transport of a transplant organ and possibly biological samples of cells and/or tissues.

The present invention is advantageously usable for transporting biological material between various medical facilities for the purpose of performing transplants, laboratory analyses and the like.

As shown by recent data and statistics, in Piedmont about <NUM>% of transports of biological material, in particular organs, cells and tissues, take place intra-regionally. It follows that the optimal storage of biological material during its transport is a non-negligible requirement, as poor storage of biological material can compromise it, e.g. leading to loss of graft (i.e., transplant organ tissue) in the case of transplant organs or compromise of cells or tissue for laboratory analysis.

In more detail, in order to ensure proper storage of biological material during the transport thereof, it must be kept in a specific temperature range that guarantees its proper storage and preservation during transport. In particular, depending on the type of biological material, the optimal temperature range varies. For example, optimal temperature ranges for different types of biological materials are listed below:.

Some known storage and transport devices are briefly described below.

An early example of known storage and transport devices is Avionord's GISTO device, which comprises a rigid container containing a bag system; specifically, the bag system comprises a first bag, housing the organ to be transported and a transport liquid, and a second bag designed to contain the first bag. The rigid container is then contained in a polystyrene container containing ice.

A further example of a known storage and transport device involves a bag system comprising a first bag, containing the organ and the transport liquid; a second bag containing the first bag; and a third bag containing the second bag. The bag system is then contained in a polystyrene container containing ice. An example for this approach is described in <NPL>, where the first bag contains cold preservation solution, and each of the second bag and the third bag contains cold Ringer's lactate or saline.

In light of the above observations, the Applicant has noted that the known solutions could be improved, in particular to improve the storage conditions of biological material during transport thereof. In particular, considering known devices, the Applicant felt the need to improve the way in which biological material is stored, particularly in the case of organs for transplantation, even more so from the point of view of the thermo-insulation and thermo-conditioning thereof in an efficient and stable manner for the purpose of storage during transport.

The present invention therefore aims to solve the above-mentioned problems of the known art by implementing a device for the storage and transport of biological material, in particular organs, cells and tissues.

According to the present invention, a device for the storage and transport of biological material, in particular organs, cells and tissues, as claimed in the appended claims, is thus realised.

As also better described below, the present invention relates to a device for the storage and transport of biological material, in particular an organ (in particular, single or double kidney, pancreas, liver and/or heart); further biological material comprising, for example, biological samples of cells and/or tissues, which are transported in specific compartments of said device, as also better described below with reference to the Figures. Furthermore, the device can reach a total weight of, for example, around twenty-five kilos. More specifically, the device is designed to carry a weight of approximately five kilos of biological material (i.e. including the organ to be transported and the liquids for transport).

Note also that in the following, without any loss of generality, reference is made to a device designed to transport an organ, e.g. to be perfused ex vivo and transplanted, and biological samples, e.g. of cells and/or tissues.

<FIG> and <FIG> show a device <NUM> for the storage and transport of biological material, in particular an organ and possibly biological samples of cells and/or tissues. The device <NUM> comprises an isothermal container <NUM> housing in use a container <NUM> for an organ designed to contain the organ to be transported. In particular, the isothermal container <NUM> is designed to maintain a storage temperature for transporting the organ, as described in more detail below.

In particular, the <NUM> device is a static organ-preserving device, i.e., a device designed to transport marginal organs (i.e., organs requiring ex vivo perfusion) and non-marginal organs (i.e., organs not requiring ex vivo perfusion) and in which an active thermoregulation system is absent.

The container <NUM> is designed to be couplable to, for example, an electro-medical unit <NUM> of an ex vivo perfusion system <NUM>, shown schematically in <FIG>; therefore, according to an aspect of the present invention, the device <NUM> is designed to allow preservation of the transplant organ, for example for an ex vivo perfusion procedure, executable by means of the ex vivo perfusion system <NUM>, so as to preserve it, reduce the ischemia time and improve the success rate of a subsequent transplant.

The device <NUM> comprises a bag system, at least partially in contact with the organ and, in general, the biological material to be transported; in particular, the bag system is designed to preserve the organ and, in general, the biological material from the external environment and to contain a biological support liquid, also referred to hereinafter as storage liquid, during transport.

In particular, with reference to <FIG>, the bag system comprises:.

The first and the second bags S1, S2 are housed in the container <NUM>.

In addition, the bag system comprises a third bag S3 designed to contain the container <NUM>, as well as the first and second bags S1, S2, to ensure the sterility thereof during transport.

In detail, the bags S1-S3 are sterile so as to maintain the sterility of the organ to be transported.

The first and second bags S1, S2 are housed in the container <NUM> and the third bag S3 is designed to envelop the container <NUM>, so as to ensure the sterility thereof during organ transport. In other words, the third bag S3, enveloping the bags S1-S2 and, thus, the organ, acts as a barrier against possible contamination.

The device <NUM> comprises a pocket <NUM> designed to house a temperature sensor <NUM> (e.g., equipped with short-range, low-power connectivity, e.g., Bluetooth), which is designed to detect indicative quantities of parameters relating to the condition of the organ in the container <NUM>, in particular the temperature of the environment surrounding the organ contained in the first bag S1 and generate corresponding data; in this way, it is possible to monitor the temperature at which the organ is placed during its transport in the device <NUM>. According to an embodiment of the present invention, shown in <FIG>, the pocket <NUM> is integrated into the first bag S1, i.e. it is formed in the first bag S1. According to an aspect of the present invention, the pocket <NUM> is hermetically sealed; furthermore, the first bag S1 is designed to be able to contain the temperature sensor <NUM> without it necessarily being sterilised before it can be inserted into the pocket <NUM>.

According to a further embodiment of the present invention, not shown herein, the temperature sensor <NUM> is arranged in a dedicated bag, not shown and separate from the bags S1 and S2, arranged in the second bag S2; in particular, the bag containing the temperature sensor <NUM> is hermetically sealed to avoid contact between the liquid inside the second bag S2 and the temperature sensor <NUM>.

According to a preferred embodiment of the present invention, the temperature sensor <NUM> is designed to detect a temperature range comprised, for example, between -<NUM> and <NUM>.

The first bag S1 is made of a biocompatible and sterile material, so that the organ to be transported is not in contact with a material that could compromise it during transport; in addition, the material of which the first bag S1 is made is resistant so that the first bag S1 itself does not break during transport. In particular, according to an aspect of the present invention, the first bag S1 is made of polyurethane or polyethylene. In addition, according to a further aspect of the present invention, the materials of the bags S2 and S3 are also resistant so that they do not break during transport. In particular, according to an aspect of the present invention, the bags S2 and S3 are made of polyurethane or polyethylene.

In addition, the storage liquid fills the first bag S1 according to a predefined volume. In particular, the total volume inside the first bag S1, i.e. including the organ to be transported and the storage liquid, is for example about <NUM> litres.

The vibration dampening liquid in the second bag S2 is, for example, a refrigerated saline solution and has a predefined volume here, e.g. about <NUM> litres, so as to effectively reduce the vibrations resulting from transporting the organ.

With reference to <FIG> and <FIG>, the container <NUM> comprises:.

In particular, in the open position, the lid <NUM> allows a user to have access to the first screen <NUM>, the organ and/or the second screen <NUM>, as shown in <FIG>. In the closed position, the lid <NUM> is arranged so as to cover the first and second screen <NUM>, <NUM> (<FIG>), so as to insulate the organ from the external environment (here contained in the bags S1, S2
with storage and vibration dampening liquids) to be transported, so as to protect it from external influences that could damage it. According to an aspect of the present invention, the lid <NUM> is made of transparent material, e.g. polyurethane, in particular ABS, so that a user can monitor the inside of the container <NUM>.

According to a further aspect of the present invention, the lid <NUM> can be coupled to the base <NUM> with a single hinge <NUM>.

The <NUM> base here has a quadrangular shape from the top view (e.g. rectangular with rounded corners) and is e.g. made of acrylonitrile-butadiene-styrene (ABS). The base <NUM> comprises a peripheral portion <NUM>, conformed so as to be coupled to a reservoir, e.g. containing perfusion fluid for ex vivo perfusion of the organ e.g. by means of the ex vivo perfusion system <NUM> of <FIG>. Moreover, the hinges <NUM> are here arranged along one side (e.g., a long side) of the peripheral portion <NUM> of the base <NUM>; in the case of a single hinge <NUM> , the latter is, for example, arranged centrally along, e.g., the long side (extending parallel to an X axis of a Cartesian reference system XYZ) of the peripheral portion <NUM> of the base <NUM>. The base <NUM> further comprises a central portion <NUM> (shown in detail in <FIG>), which has a convex shape, in particular, along a Z axis of the Cartesian reference system XYZ, being lower than the peripheral portion <NUM>. The central portion <NUM> comprises a curved portion <NUM>, adapted to join the peripheral portion <NUM> with a base portion <NUM>, also forming part of the central portion <NUM>. The central portion <NUM> is further provided with openings <NUM>, arranged in the base portion <NUM> and designed to allow a fluidic connection between the base <NUM> and the reservoir for example of the ex vivo perfusion system <NUM> of <FIG>.

Again with reference to <FIG>, the first and second screens <NUM>, <NUM> comprise a respective peripheral portion <NUM>, <NUM>. In particular, the peripheral portion <NUM> of the first screen <NUM> is shaped to be coupled to the peripheral portion <NUM> of the base <NUM>; further, the peripheral portion <NUM> of the second screen <NUM> being designed to allow the second screen <NUM> to be positioned in contact with the peripheral portion <NUM> of the first screen <NUM> when in use.

The first and second screen <NUM>, <NUM> also comprise respective support portions <NUM>, <NUM>. In particular, the support portion <NUM> of the first screen <NUM> is designed to support the organ to be transported, is of a curved shape, in particular convex, i.e. it is, along a Z axis of a Cartesian reference system XYZ, lowered with respect to the peripheral portion <NUM>; moreover, the support portion <NUM> of the second screen <NUM> is also curved, in particular convex, i.e. it is, along a Z axis of a Cartesian reference system XYZ lowered with respect to the peripheral portion <NUM> and is designed to define, when the second screen <NUM> is placed on the first screen <NUM>, the space adapted to house the organ enveloped in the first and second bags S1, S2. In other words, the second screen <NUM> is arranged so that its concave portion faces towards the first screen <NUM>, in such a way that the respective support portions <NUM>, <NUM> face each other, in particular with their respective concavities facing each other, i.e., the second screen <NUM> is arranged so as to be overturned with respect to the first screen <NUM>. Consequently, the respective convex portions of the support portions <NUM>, <NUM> face the central portion <NUM> and the lid <NUM> of the container <NUM> respectively (see in particular <FIG>).

According to an embodiment of the present invention, the support portions <NUM>, <NUM> of the first and second screens <NUM>, <NUM> are sized according to the size of, for example, an adult kidney and an adult liver, respectively. In particular, the support portion <NUM> is sized to support organs such as an adult kidney, which has an average length comprised between <NUM> and <NUM>, a width of <NUM> and a thickness of <NUM>; therefore, the support portion <NUM> occupies only part of the first screen <NUM>, e.g. almost half of the latter and is arranged, for example, along the long as the same first screen <NUM> itself. The remaining portion of the first screen <NUM>, e.g. the remaining half, is dedicated to the peripheral portion <NUM>. Moreover, the support portion <NUM> is sized to accommodate a larger organ than an adult kidney, e.g., an adult liver, which has an average right lobe thickness comprised between <NUM> and <NUM>, a transverse diameter of about <NUM> and an antero-posterior diameter of about <NUM>; therefore the support portion <NUM> almost entirely occupies the area of the second screen <NUM>, leaving an external frame-like portion dedicated to the peripheral portion <NUM>.

It should be noted that, according to an aspect of the present invention, the support portion <NUM> of the first screen <NUM> is substantially coplanar with the peripheral portion <NUM>, i.e., the first screen <NUM>, when conformed to support an adult kidney, is substantially parallel to an XY plane of the XYZ reference system; in this case, the second screen <NUM> has a support portion <NUM> with a greater convexity than the support portion <NUM> of the first screen <NUM>, i.e., it is recessed with respect to the peripheral portion <NUM> along the Z axis of the Cartesian reference system XYZ.

According to an aspect of the present invention, the first and second screens <NUM>, <NUM> are made of soft, biocompatible and atraumatic material, in particular polyurethane ester. Furthermore, according to a further aspect of the present invention, the second screen <NUM> is designed to cover, when overturned so as to expose its convexity towards the lid <NUM> and its concavity towards the first screen <NUM> and contact its peripheral portion <NUM> with the peripheral portion <NUM> of the first screen <NUM>, the first screen <NUM> when the latter carries the organ contained in the bags S1-S2. In other words, the second screen <NUM> acts as a dome for the first screen <NUM> so as to cover the organ contained in the bags S1-S2.

It should also be noted that the base <NUM> and the lid <NUM> are designed to define, when the lid <NUM> is in the closed position, a space adapted to contain both screens <NUM>, <NUM>, i.e. the container <NUM> has a volume such that it can contain the second screen <NUM> when it is overturned towards the first screen <NUM>.

It should be noted that the different sizing of the support portion <NUM> in the first and second configurations of the first screen <NUM> does not affect the total dimensions of the first screen <NUM> itself, which are therefore fixed; therefore, the dimensions of the first screen <NUM> are independent from the type of organ to be transported, as no different sizing of the entire container <NUM> is required. This feature allows for a container <NUM> with standard dimensions. Similar considerations apply to the second screen <NUM>, which has fixed total dimensions.

With reference to <FIG>, the isothermal container <NUM> comprises a main body <NUM> having a compartment <NUM> adapted to receive and contain the container <NUM> in particular when the latter is inserted into the isothermal container <NUM> for transporting the organ. In particular, the main body <NUM> is equipped with handling means, here wheels <NUM> and handles <NUM>, which allow manual handling of the isothermal container <NUM>. In this way, the device <NUM> is transportable both by land and by air.

In particular, the main body <NUM> is designed as an insulating structure that provides optimised insulation with thin layers. In particular, the insulation structure is multi-layered and comprises polyurethane foam, ABS and PMMA (polymethyl methacrylate), the latter forming the outer surface of the main body <NUM>. By way of non-limiting example, the ABS and PMMA layers have a maximum total thickness of (i.e. less than or equal to) approximately <NUM> and the polyurethane foam layer of approximately <NUM>. According to a further aspect of the present invention, the ABS and PMMA layers also cover the inner part (i.e. the part defining the compartment <NUM>) of the main body <NUM>. According to a further embodiment of the present invention, the insulation structure comprises aerogel or expanded polyethylene.

The isothermal container <NUM> comprises a lid <NUM> movably coupled to the main body <NUM>, in particular hinged to the main body <NUM> at hinges <NUM> (e.g., arranged along one long side, i.e., parallel to the X axis of the Cartesian reference system XYZ), so as to assume a respective first and second position. The isothermal container <NUM> further comprises closing elements <NUM> (e.g., snap closure devices) designed to releasably couple the lid <NUM> to the main body <NUM>, in particular by assuming a coupling position and an uncoupling position, wherein the coupling position provides that the closing elements <NUM> mechanically couple the main body <NUM> and the lid <NUM> and the uncoupling position provides that the closing elements <NUM> mechanically uncouple the lid <NUM> and the main body <NUM>. Therefore, in the first position, the lid <NUM> is designed to make the compartment <NUM> accessible from the outside; at this stage, the closing elements <NUM> are in the decoupling position. In the second position, the lid <NUM> is designed to make the compartment <NUM> not accessible from the outside, i.e. to insulate it from the external environment; at this stage, the closing elements <NUM> are in the coupling position. The second position is used, for example, when the container <NUM> is placed in the isothermal container <NUM> and, therefore, the organ contained in the container <NUM> is ready to be transported.

With reference to <FIG> and <FIG> and as explained below, the device <NUM> comprises an operator terminal <NUM>, e.g. a tablet, which can be removably coupled to the isothermal container <NUM>; in particular, the operator terminal <NUM> is designed to display a graphical interface, e.g. to allow monitoring of parameters relating to the transport of the biological material, comprising for example organ temperature, external temperature and acceleration values of the device <NUM>, in particular to detect any shocks/sudden movements. In addition, the operator terminal <NUM> is designed to support short-range connectivity, e.g. Bluetooth, to communicate with the temperature sensor <NUM>, and with a sensor system <NUM>, as further explained below.

The operator terminal <NUM> is also equipped with a GPS (Global Positioning System) tracking system to determine the position of the device <NUM> during the transport of biological material.

In addition, the operator terminal <NUM> supports long-range connectivity, for example by supporting a connection by means of SIM or Wi-Fi, which allows the operator terminal <NUM> to be connectable to computer processing and storage resources (not shown) in order to communicate with them, for example to transmit parameters relating to the transport of biological material and parameters relating to the condition of the organ in the container <NUM>. According to an aspect of the present invention, the computer processing and storage resources implement the cloud computing paradigm (and therefore a cloud); further, the computer processing and storage resources are designed to communicate with external mobile and/or stationary user terminals (e.g., smartphones, tablets, desktop computers and the like), for example to transmit notifications regarding the transport of biological material. In particular, external mobile and/or stationary user terminals support long-range connectivity, e.g. by supporting a SIM or Wi-Fi connection, and are designed to connect with computer processing and storage resources.

The operator terminal <NUM> can be coupled, in particular positioned, in a releasable manner in a compartment <NUM>, e.g. it is held within the compartment <NUM> by clamp elements (not shown). In addition, the device <NUM>, in particular the lid <NUM>, comprises an electronic panel <NUM>, in particular accessible through the opening of a corresponding lid <NUM>, adapted to house the sensory system <NUM> designed to detect quantities indicative of parameters relative to the transport conditions of the biological material (in particular, external temperature and acceleration of the device <NUM>) and generate corresponding data.

The electronic panel <NUM> is also adapted to house:.

In particular, the battery <NUM> is designed to be recharged especially when the device <NUM> is not operational, i.e. when organ transport is not required.

In addition, the backup tracker device <NUM> further comprises an internal rechargeable battery (not shown) designed to power it when in use.

According to an aspect of the present invention, the battery <NUM> and the battery of the backup tracker device <NUM> are rechargeable with an external power supply (not shown), e.g. power cables.

In particular, according to an embodiment of the present invention, the temperature sensor and the stress sensor of the sensory system <NUM> are integrated into the same electronic component, i.e. the sensory system <NUM> is a single electronic component. In particular, the temperature sensor of the sensory system <NUM> makes it possible to monitor that the temperature conditions of the isothermal container <NUM> are close to room temperature (i.e., approximately <NUM>), so that the efficiency of the device <NUM> during the transport of biological material is guaranteed. Therefore, the temperature sensor <NUM> and the sensor system <NUM> monitor the internal (i.e., in the vicinity of the transported organ) and external temperature of the device <NUM> respectively.

The operator terminal <NUM> is designed to receive and process data from the stress sensor to verify that the device <NUM> is not subjected to excessive stress that could compromise organ transport. In this regard, according to an aspect of the present invention, the device <NUM> comprises a software application, installable on the operator terminal <NUM> (in particular, according to a preferred embodiment of the present invention, it is pre-installed on the operator terminal <NUM>), which is designed so that, when run on the operator terminal <NUM>, it is designed to:.

According to an aspect of the present invention, the software application is designed so that, when run on the operator terminal <NUM>, it is designed to display data from the stress sensor, for example by means of a graphical representation.

Therefore, the operator terminal <NUM> is designed to interface with the sensory system <NUM> and the temperature sensor <NUM>, which provide the operator terminal <NUM> with data on the quantities indicative of parameters relating to the transport of the biological material and relating to the condition of the organ in the container <NUM> to enable it to be monitored during the transport of the biological material. According to an aspect of the present invention, the device <NUM> comprises a software application, which is installable on the operator terminal <NUM> (in particular, according to a preferred embodiment of the present invention, it is pre-installed on the operator terminal <NUM>), which is designed so that, when run on the operator terminal <NUM>, it is designed to:.

Therefore, the operator terminal <NUM> is designed to transmit alert notifications depending on the indicative quantity data of the parameters relative to the transport of biological material.

Furthermore, according to a further aspect of the present invention, the operator terminal <NUM> is designed to receive and process the data generated by the sensory system <NUM> and the temperature sensor <NUM> for showing the trend of the parameters relative to the transport of the biological material, in particular in terms of external and internal temperature and stresses suffered, on the same operator terminal <NUM> (for example, by showing it in the form of a graph or similar graphic representation on the screen of the tablet).

The computer processing and storage resources are designed to:.

The computer processing and storage resources are further designed to:.

Therefore, the computer processing and storage resources are designed to alert users by means of alarm notifications of any extraordinary events. In order to be able to download the reports generated by the computer processing and storage resources, a software application , which can be downloaded and installed on external mobile and/or stationary user terminals or accessed via the Internet by the latter (therefore, a web software application), is designed so that, when run on the external mobile and/or stationary user terminals, the latter are designed to:.

An operator is then able to download reports relating to the transport of biological material by accessing the computer processing and storage resources through the software application; for example, the operator is able to access the computer processing and storage resources through a website by means of his/her personal account.

In particular, depending on the role in the structure to which he or she belongs, the operator is authorised to view information and documents uploaded to computer processing and storage resources. In more detail, at least the following roles are envisaged:.

Therefore, depending on the role, an operator is able to have access to functions, information and documents that enable the analysis of the transport of biological material.

It should be noted that when the administrator or facility administrator generates and sends these invitations, they allow an operator to register. In particular, once the operator's personal data has been entered, the administrator or the administrator of the facility to which he/she pertains generates and sends the aforementioned invitations, so that the operator, upon receiving the invitation, can associate a password with his/her personal account and thus finalise the personal account creation procedure.

With reference to <FIG> and <FIG>, the lid <NUM> is further provided with a sample-holder compartment <NUM> provided with slots <NUM> designed to house biological samples, e.g. cells or tissues to be transported; further, according to an aspect of the present invention, the sample-holder compartment <NUM> is provided with a layer of insulating material, in particular expanded polyurethane, which allows to maintain the biological samples within the slots <NUM>, thermally insulate them and reduce the impact of any shocks on them.

The main body <NUM> also has at least one pocket (not shown) to accommodate documents to be transported with the biological material.

Referring to <FIG>, the isothermal container <NUM> comprises a thermo-conditioning panel <NUM>, e.g., a phase change panel, (PCM, Phase Changing Material) or eutectic plate, housed in a slot <NUM> formed in the main body <NUM> and adapted to receive the thermo-conditioning panel <NUM> and allow at least partial extraction thereof; in particular, the thermo-conditioning panel <NUM> is designed to allow the maintenance of the temperature for the storage of the biological material, in particular of the organ inside the container <NUM> inserted inside the isothermal container <NUM>. The thermo-conditioning panel <NUM> is made of phase change material, e.g. a panel containing a solution of salt in water operating according to the PCM PlusICE E-<NUM> model (i.e., with a triple point temperature of -<NUM>), such that when it absorbs or releases heat, it changes its state so as to bring the temperature in the compartment <NUM> within a temperature range, e.g. comprised between <NUM> and <NUM>, and maintain it there. In particular, the phase change material is able to change its state, specifically from liquid to solid and vice versa, as a result of the release and absorption of heat, respectively.

In more detail, when the thermo-conditioning panel <NUM> is taken out from the slot <NUM>, the same thermo-conditioning panel <NUM> is cooled so that the phase-change material is solid. Subsequently, the thermo-conditioning panel <NUM> is inserted into the slot <NUM> of the compartment <NUM>; in this way, the phase change material, being in an environment with a temperature higher than its own temperature, begins to absorb heat, cooling the compartment <NUM>, so that it reaches a temperature comprised between <NUM> and <NUM>. Upon reaching melting point, here the temperature of the triple point, the phase change material of the thermo-conditioning panel <NUM> begins to melt, becoming liquid at the end of the melting process; therefore, upon reaching the triple point, i.e. when the melting process begins, the phase change material continues to absorb heat, enabling the temperature inside the compartment <NUM> to be maintained almost constant, for example for at least <NUM> hours, particularly in the temperature range between <NUM> and <NUM>. It should be noted that since the thermo-conditioning panel <NUM> is no longer capable of absorbing heat when its constituent material is completely melted, the temperature inside the compartment <NUM> may gradually increase, indicatively to above <NUM>. The aforementioned maintenance of the temperature inside the compartment <NUM> is also permitted thanks to the fact that the isothermal container <NUM> is made of insulating materials, so that the temperature of the compartment <NUM> is kept constant for a longer period of time, in particular such that the biological material can be transported without significant thermal shock problems that could compromise the biological material. In other words, the presence of the thermo-conditioning panel <NUM> and the insulating materials of the isothermal container <NUM> allow the temperature in the compartment <NUM> to be kept constant for the time required to transport the biological material.

It should be noted that, according to an aspect of the present invention, the container <NUM>, the isothermal container <NUM>, the third bag S3, and the sample compartment <NUM> envisage anti-tamper labels.

<FIG> and <FIG> show a further embodiment of device <NUM> according to the present invention. In particular, in <FIG>, parts that are common to those shown with reference to <FIG>, <FIG> and <FIG> are indicated in <FIG> and <FIG> with the same reference numbers and will not be described further hereinafter.

In particular, the device <NUM> of <FIG> and <FIG> comprises a conveyor trolley <NUM> including an upright <NUM> designed to connect the isothermal container <NUM> with the user terminal <NUM>, as well as to carry the same user terminal <NUM> at a corresponding support portion <NUM>; as also shown in <FIG> and <FIG>, the user terminal <NUM> can be coupled, in particular positioned, in a releasable manner in the compartment <NUM>, here formed in the support portion <NUM>, even more specifically maintained inside the compartment <NUM> by means of clamp elements (not shown). The conveyor trolley <NUM> further comprises a pair of handles <NUM>, conveniently placed to the side of the user terminal <NUM>, to allow transport of the isothermal container <NUM>. In addition, the transport trolley <NUM> comprises a document holder <NUM>, in particular a compartment <NUM> accessible by means of a cover <NUM>, arranged on the upright <NUM> to allow the transport and accessibility of documents useful for the transported organ.

It is further noted that, in the embodiment of <FIG> and <FIG>, the lid <NUM> of the isothermal container <NUM> is coupled to the main body <NUM> by means of connecting means (not shown), such as, for example, magnets or the like; in this way, the lid <NUM> and the main body <NUM> are without hinges but nevertheless appropriately connected to each other when in use.

In particular, the <NUM> device provides a single system for transporting organs, biological samples and accompanying documentation in dedicated compartments.

In addition, the device <NUM> allows the organ to be physically separated from its thermo-conditioning and thermo-insulation system. In particular, the thermo-conditioning panel <NUM> enables thermo-conditioning, i.e. maintaining the ideal transport temperature to keep the organ as intact as possible during transport. On the other hand, thermo-insulation is achieved through the use of thermo-insulating materials, in particular ABS, PMMA, expanded polyethylene, aerogel of the isothermal container <NUM>.

In addition, the use of bags S1-S3, as well as the container <NUM>, makes it possible to have an organ containment system that is independent of the type of organ; furthermore, the insertion of a temperature sensor between the bags S1 and S2 makes it possible to check the temperature of the organ during transport. Moreover, the container <NUM> is such that it can then be used in ex situ perfusion systems, in pre-transplantation, thus avoiding the need to further transfer the organ from one container to another, an operation that could compromise possible organ operations.

In addition, the device <NUM> monitors data relating to organ temperature, external ambient temperature, possible stresses and the position of the device <NUM> during transport; in this way, it is possible to have good control of the transport conditions of the biological material (in particular in terms of monitoring the temperature relative to the organ, monitoring the external temperature, monitoring possible shocks suffered by the system by means of a stress sensor), as well as the position of the latter, so as to be able to generate reports relating to the transport of the biological material and possible alarm notifications in order to warn an operator of critical conditions.

In addition, the present device <NUM> makes it possible to standardize hospital protocols, as the monitoring of these data makes it possible to guide the workflow (in particular, standardizing the latter, as explained below) and reduce the possibility of errors in the transport of biological material.

Claim 1:
A device (<NUM>) for the storage and transport of biological material including at least one organ, the device (<NUM>) comprising:
a container (<NUM>) designed to contain the organ;
an isothermal container (<NUM>) configured to house in use the container (<NUM>) designed to contain the organ; and
a bag system comprising:
- a first bag (S1) designed to contain the organ to be housed in the container (<NUM>) and a storage liquid for storing the organ; and
- a second bag (S2) designed to contain the first bag (S1), containing the at least one organ and the storage liquid, and a vibration dampening liquid to reduce the transmission of the vibrations on the organ during transport of the organ,
wherein the first and the second bags (S1, S2) are housed in the container (<NUM>),
wherein the bag system further comprises a third bag (S3) designed to contain the container (<NUM>) to ensure the sterility thereof during transport,
and wherein the device (<NUM>) further comprises a pocket (<NUM>) designed to house a temperature sensor (<NUM>) designed to detect indicative quantities of parameters relating to the condition of the organ in the container (<NUM>), the pocket (<NUM>) being inside the or integrated into the first bag (S1) or being inside the second bag (S2).