CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims priority to Argentinian Patent Application No. 20200101903, filed on July 6, 2020, which is hereby incorporated herein by reference in its entirety.

FIELD OF THE DISCLOSURE

This invention refers to a method and arrangement for the transport and monitoring, in real time and/or after the transport, of objects (blood, biological samples, medicines, food and others) with special conservation requirements such as temperature, humidity, mechanic vibrations, light intensity, pressure, etc. Mainly, it refers to a solution for the problems of conservation of the quality and integrity of the object transported, achieving also a substantial improvement in the conditions of the cold chain, monitoring and alerts in real time, assurance of the requirements of the object during transport and traceability at all points of the route.

BACKGROUND

The cold chain is a systematic, fundamental and very important process where a controlled temperature is applied to food, pharmaceutical, chemical, medical or other biological products for their conservation and safe transport, which ensures the excellent quality of a product. It is a critical factor in the success of the results, since it has an impact on the intrinsic characteristics of the product.

For example, the cold chain for human-origin biological fluids involves remaining under different conditions (freezing, cooling, protection from the light, absence of vibrations, etc.) from their obtaining until they are received and analyzed at the clinical laboratory or until processed at the blood bank; such conditions must not vary except that, due to the inherent nature of the product, it must be stored differently.

It is known as cold chain because the objects to be transported have certain requirements to enable them to maintain their original quality such as in the case of biological fluids, pharmaceutical products or food. They must be kept cold and motionless to reduce bacterial contamination, the activation of chemical and enzymatic factors, and to avoid breakdowns and alterations during transport, extending in this way the useful life for their analysis, use or consumption.

Blood must be kept and transported in equipment that complies with defined specifications and the personnel in charge must properly follow the established procedures at all times. The cold chain of blood begins at the time blood is extracted and continues until its transfusion.

The cold chain of blood is a work process that consists of a series of activities or circumstances and includes the intervention of individuals, equipment, information, steps, procedures and the environment, in many applications of these processes occurring in the health area. The cold chain is especially important in those cases of medical use since, if any link of this chain breaks, this could have extremely serious consequences on the health of patients.

The process of the cold chain of biological matter consists of three main activities: in the first place, biological samples must be kept or maintained at the correct temperature from the moment they are taken until the time of their analysis. In the second place, transport must include the equipment and materials necessary to transport the biological matter safely through the cold chain. Finally, the maintenance of the equipment, infrastructure and technical support must be appropriate to ensure a safe and reliable process.

Therefore, in this conservation and transport process it is necessary to choose and acquire equipment for the cold chain of blood such as: refrigerated containers, cold rooms and refrigerated chambers, among others. Moreover, a quality system must be established for the installation, use, vigilance, maintenance, revision, and correct repair of equipment, and a training system must be established for all the users of the equipment in such a way that we increase the quality of the products and ensure optimal results.

Furthermore, the technical personnel and users of the cold chain equipment for biological fluids is responsible for the extraction, conservation as per standard operative procedures, packing based on the distance and time of transport, storage, temperature control of the materials kept and of the delivery of the biological matter.

They shall also conduct quality control of the equipment and products of the cold chain, reception and installation of the equipment and verification of the operation of the cold chain equipment, whether new or repaired. It is crucial that all persons in charge and users of the cold chain equipment of biological fluids receive information to maintain and use such equipment correctly.

Continuing what is mentioned above, in order to protect public health it is necessary to transport biological samples in a safe, timely, efficient and legal manner from the place they are obtained to the place where they will be analyzed.

Biological samples must be packed/packaged and transported in such a way that those involved in their transport are protected from infection risks. Transport of biological matter requires good coordination and communication between the sender, the transport company and the recipient; each must assume its obligations so that the product is transported safely and reaches its destination in good conditions and at the right time.

The material should not be sent before the recipient has ensured with the competent authority that the same can be legally imported.

International regulations for the transport of infectious materials by any means of transport are based on the recommendations of the UNITED NATIONS COMMITTEE OF EXPERTS ON THE TRANSPORT OF DANGEROUS GOODS that is formed by the INTERNATIONAL CIVIL AVIATION ORGANIZATION (ICAO), INTERNATIONAL AIR TRANSPORT ASSOCIATION (IATA), DEPARTMENT OF TRANSPORTATION (DOT), UNITED STATES POSTAL SERVICE (USPS) and INTERNATIONAL MARITIME ORGANIZATION (IMO). The United Nations Committee sets forth the packing and labelling requirements and makes regular revisions of the definitions of the different types of matter. At present, the definitions include recombinant microorganisms, strains or isolates, mutant or hybrid and prions as infectious agents.

Samples must be conditioned in such a way to ensure their transport and arrival at the laboratory in adequate conditions. Spills or container cracking with the consequent loss of material, if any, must be avoided.

Samples must be stored in a safe way, at the appropriate temperature and protected from the light in such a way as to ensure the protection of their integrity and the stability of the analytes to be tested in the case, for instance, of toxicology samples.

The transport of biological samples implies a potential source of contamination and risk for all the individuals during the process, so the company in charge of such transport of samples with biological risk makes sure to comply with the following indications:

Strict revision and confirmation that the container of the sample or culture (primary container) is properly closed and labelled with the name of the patient or the assigned code.

Each primary container must be wrapped in absorbent material and must be positioned vertically in a resistant container (secondary container) that is waterproof and with screw cap.

The secondary container must be closed and placed in a transport box (tertiary container). This container must be identified as “infectious” and indicate the sender and the addressee. When a delivery of several secondary containers is performed, the same can be packed in one same tertiary container, that can be a thermos flask, cooler, Durapax box or another that protects them from excessive heat.

Verification and control of the temperature for sending the samples in order to maintain the cold chain when required by using coolants in the cooler.

It is very important for the company to ensure the integrity of the samples in order to obtain an accurate analysis from the laboratory. Likewise, during the transport of the samples from one institution to another, regardless whether the distance is short or long, containers that prevent the possibility of spills and the triple packing must be used. For a safe transport of the samples, a relationship is established with the persons involved in the safe handling and transport of hazardous materials.

Air transport of infectious substances is governed by the international regulations published each year by the International Air Transport Association (IATA). The delivery must be made revising with the person in charge of the transport that the instructions on biosecurity are fulfilled in order to ensure the preservation of the quality of the samples and the compliance with the rules on biosecurity.

Coolants are the solution that exist at present for the refrigeration during transport (an example can be seen at www.zupeg.com.ar), but the disadvantage is that, since there is no intimate contact with the object, they have a long latency period for stabilization in which the object takes time to take the temperature of the refrigerated environment. On the other hand, there is also the problem of supercooling, which takes the object to undesired temperatures. If the object is in intimate contact with the coolants, it may freeze, which is also non-desired during transport.

As regards sensors, there are solutions that offer to place sensors in the cargo (for example, https://www.akribis.info/web/categoria-producto/logtag-recor ders/), but they are not personalized: in general, they are placed in the set of objects and not in each one of them. Besides, it is common that sensors only register temperature and, in some cases, humidity but leave aside some critical parameters that, depending on the type of product to be transported, are vital. For instance, in the case of blood, the vibrations that can cause hemolysis or, in the case of vaccines, losses due to rough handling of the cargo.

It must be mentioned that, as there is no comprehensive system that includes all solutions, there are losses that, in the case of our development, would be minimized since our solution registers the load of each device and enables its tracking thus minimizing the possibility of object loss.

The problems of the objects to be transported are evident. For example: in the case of blood and biological samples, hemolysis is produced due to vibrations or freezing and defrosting and failure of the cold chain that can lead to an alteration of the blood parameters rendering the blood useless for transfusions, or to an incorrect diagnosis in the case of lab samples. Medicines can also have economic losses due to incorrect transport, due to a failure in the cold chain and damaged goods. In turn, in the case of food, humidity, light, the cold chain and bumps can alter the quality, which leads to economic losses. SUMMARY

An arrangement for the transport of objects with special conservation characteristics during transport, being such arrangement featured by its comprising of at least four parts where the first part presents the beginning of the transport that includes a wired and/or wireless connectivity platform or mobile device (Bluetooth, NFC, or another one) that orders the start of the sensors of the DIS that will enable knowing the values of the critical parameters during the transport. The second part, where the DIS is located, comprises an isothermal sensorized receptacle for transport (RIST) of the object. A third part includes the end of the transport and is comprised by the wired and/or wireless connectivity platform or mobile device (Bluetooth, NFC, or another one), that turns off the DIS ending the sensing, and enables the automatic downloading of the data stored during the transport, and the RIST is ready to be stored and re-cooled for its next use. The fourth part comprises a control system which is defined by an online control system where the information is received from each device status (beginning- transport - end) that enables the user to revise and control the condition of the transported object in real time and to also see the progression of the service.

DESCRIPTION OF DRAWINGS

For a greater clarity and understanding of the purpose of this invention, the same has been shown in several drawings which represent the invention in one of the preferred forms of use, all by way of example, where: Figure 1 is a temperature versus time chart of the combined PCMs system of the Sensorized isothermal receptacle for transport [ Receptdculo Isotermico Sensorizado de Transporte] -hereinafter the RIST- (SI) versus the “Traditional” single PCM system (S2).

Figure 2 shows some of the possible sizes and conformation of the RIST.

Figure 3 shows a possible location of the integrated sensorization device [Dispositive Integrado de Sensorization ] -hereinafter DIS- placed in the center of the RIST, simulating an object to be transported (A and B).

DETAILED DESCRIPTION OF THE EXAMPLE

The referred drawings show the object of this invention and a detail of its parts. It must be mentioned that the system is formed by four principal elements:

The first element includes a wired and/or wireless (Bluetooth, NFC, or another one) connectivity platform or device that starts the collection of data by the DIS added to the RIST in order to know the state of integrity of the sample during transportation. In turn, this platform or device has a bar code and/or QR and/or OCR reader and/or a similar system that enables the identification of the samples and their transmission to the DIS for the later storing.

The second element is the above-mentioned RIST that inside has one or more Phase Change Materials (PCM), which enables the fast cooling and isothermal maintenance of the system for a long period of time (Fig. 1). Depending on the temperature requirements of the samples to be transported (freezing, cooling and room temperature), the combination of phase change materials to be used in each RIST is defined. The aim of the correct design and combination of added PCM is to avoid supercooling (Fig. 1), undesired effect in conservation systems. The RIST also has the DIS, that is formed by a set of one or more sensors that are defined based on the characteristics of the object to be transported and that enables the continuous collection or at intervals defined by the user of the state of the object transported with respect to different parameters such as temperature, vibration, light intensity, etc. This information is stored in the DIS and also transmitted to a server, thus giving the possibility of receiving alerts in real time with respect to any problem during transport such as vibration excess or change of temperature, among others. Before the beginning of the transport, the RIST enables control by the user since it has a visual indication system that informs if the device reached the optimal temperature and is ready for transport.

The RIST is designed as required by the object to be transported as shown in Figure 2 (model with 24 spaces for tubes) and is built from a combination of materials that on the external side minimize the transfer of heat with the environment while, inside, favor the thermal transfer in contact with the samples.

- External side: Double wall with insulation inside that reduces thermal transfer with the exterior.

- Internal side (in contact with the object): simple wall that favors thermal transfer from the PCMs.

- Inside: receptacle that consists of a space to install the DIS (Fig. 3) and a double chamber: external maintenance chamber (A) and internal cooling chamber (B) that holds the PCMs (Fig. 3-B). The external chamber has a bigger receptacle for the PCM chosen as preservative. The internal chamber has a smaller receptacle for the PCM chosen for the cooling and fast stabilization of the system.

- DIS (integrated sensorization device) [Dispositive Integrado de Sensorizacion ]: set of sensors such as those of vibration, acceleration, gyroscope, GPS, temperature and others and electronic board formed by one wired and/or wireless microprocessor and/or microcontroller. It has an internal memory to store information, backup battery and capacity to transmit data in real time through communications.

The third element is a wired and/or wireless connectivity platform or device (Bluetooth, NFC, or another one) identical to that mentioned above but that, in this case, orders the end of the collection of data to the DIS and starts the automatic local downloading of the information collected during transport.

The fourth and last element is the control system which is defined by an online control system where the information is received from the RIST and/or the platform or mobile device, enabling the user to revise and control the condition of the transported object in real time and to also see the progression of the service. The control system has configurable alerts to determine maximum times of transport and necessary controls depending on the profile. It includes a system to store the information and algorithms to analyze data for the search of parameters and the prevention of possible failures. Furthermore, it has artificial intelligence in charge of recognizing patterns in the cargoes and their measurements in order to determine transport problems and also sensor deviations. The complete operation of the system is detailed below:

The system starts when the user controls the visual indicator and withdraws from the freezer or refrigerator (depending on the desired temperature) one or more components of the RIST, makes a connection with the DIS through a platform or mobile device and executes the order to start operating the sensors. The user scans the object or objects to be transported in the platform or with the mobile device, the apparatus takes such information and transmits it to the DIS for its storing. Once the loading of the RIST ends, it remains in sensing status and ready for transport. During transport the DIS located inside the RIST stores and /or transmits the values of the referred sensors continuously or at pre-established intervals. When the transport ends, the RIST connects with the platform or mobile device, starts a communication with the DIS and downloads the entire information stored (sensor values, sample information, etc.) to be transmitted to the control system. When the downloading of information ends, the DIS enters a low-power mode and the RIST is ready to be stored and cooled again for its next use.

During this entire operation, the control system can monitor in real time the state of the RIST in transport, set alerts and warnings on unwanted states, and notify them.

After specially describing and determining the nature of this invention and how it is to be implemented, the following is hereby claimed as property and exclusive right.

What is claimed is: