A container for a solution used in the preparation and storage of donor blood components

Abstract

This utility model relates to transfusion medicine, and more specifically, to a container for a solution used in the preparation and storage of donor blood components. The container comprises a vessel with a wall made of an elastic polymer film material and a radiofrequency identification tag capable of recording, storing, and transmitting information about the parameters of the solution in the container. 3 fig.

Description

[0001] The utility model relates to medicine, more precisely to transfusion medicine, and more specifically to a container for a solution used in the preparation and storage of donor blood components.

[0002] In transfusion medicine, when preparing and storing donor blood components, hemopreservative solutions and glycerolization / deglycerolization solutions are used. These solutions are prepared in factories and packaged in plastic containers of varying volumes, from 250 ml to 2500 ml. These containers are primarily made of tubular polyvinyl chloride or polypropylene film. Depending on the container design and the type of solution contained within, the container may be equipped with a process port or a connector for emptying the container.

[0003] Transfusion of donor blood components is a necessary medical procedure performed for life-saving indications. Before transfusion, donor blood components must be collected from the donor. This collection is performed manually or automatically.

[0004] The manual method involves taking up to 0.5 liters of whole blood from a donor and then separating it into the necessary components.

[0005] The automated method involves the use of specialized equipment and disposable consumables, which allow the preparation of the required donor blood component directly from the donor. When preparing donor blood components using the automated method, hemopreservative solutions such as CFG (citrate-phosphate-glucose), Glugicir, CFDA-1, CFD / SAGM, and PAGGSM are used. Hemopreservative solutions vary in composition and are intended for the storage of red blood cell-containing components. Donor blood components in the presence of hemopreservatives can be stored at temperatures from +2°C to +6°C for a specific period depending on the type of hemopreservative solution used, but no more than 49 days. If longer storage is required (up to 10 years), red blood cell freezing at ultra-low temperatures (-80°C) is used.

[0006] To preserve red blood cells during long-term storage, a glycerol solution is used, which is a cryoprotectant that protects cells from excessive deformation and destruction at low temperatures.

[0007] At the final stage of storage, before transfusing the red blood cell mass to the patient, the cryoprotectant must be removed, i.e., a deglycerolization procedure must be performed, for which sodium chloride solutions in various dosages and concentrations are used.

[0008] All hemopreservative solutions used in the automated method of preparing donor blood components and solutions used for glycerolization / deglycerolization of red blood cells during long-term storage of red blood cell mass are manufactured at low temperatures in factory conditions and packaged in plastic containers of various capacities, with a volume from 250 ml to 2500 ml. These containers are disposable and are disposed of after the procedure.

[0009] Specialists in this field are well aware of these containers, as they are widely used in medical facilities. All containers of this type undergo factory heat sterilization at temperatures up to 110°C.

[0010] To reduce the risk of complications in recipients, medical personnel must have reliable information about the parameters of the hemopreservative solution or glycerolization / deglycerolization solution contained in the container at all stages, from the moment the container is filled with the solution to the moment the container is disposed of.

[0011] Currently, this parameter information is stored directly on the container in the form of a label applied directly to the outer surface of the container wall.

[0012] It should be noted that the use of container labels allows medical personnel to quickly read information about the parameters of the hemopreservative or glycerolization / deglycerolization solution contained within the container. In practice, this means that a healthcare professional, typically a nurse, must examine the label, which displays the solution parameters or other information, and identify the solution contained within the container, as well as its characteristics.

[0013] Reviewing the information on the container label only by healthcare facility personnel and then loading the container with the solution into an automated plasmapheresis machine or a glycerolization / deglycerolization machine, without the use of additional verification methods, reduces the safety of the blood component procurement procedure due to potential carelessness on the part of healthcare facility personnel. In practice, such cases have occurred, and the consequences of personnel errors related to the placement of expired solutions or the use of solutions intended for another procedure have been extremely negative.

[0014] It is also necessary to take into account that the container with the solution used in transfusion is subjected to significant heating up to 110°C during the sterilization process at the factory, and there is a risk that the label may peel off from the container, including during storage of the container, which is extremely undesirable from the point of view of compliance with safety requirements.

[0015] The present utility model is based on the task of creating a container for a solution used in the preparation and storage of components of donor blood, the design of which would allow medical personnel to automatically and with minimal labor costs verify or store information about the parameters of the solution at all stages of the container's use.

[0016] Another objective of this utility model is to create a container for a solution used in the preparation and storage of donor blood components, the design of which would improve the safety of its operation by reducing the likelihood of accidental errors by medical personnel.

[0017] The next objective of this utility model is to create a container for a solution used in the preparation and storage of donor blood components, which has protection from various external influences, primarily from possible mechanical impact, which would increase the safety of the container and its reliability in operation.

[0018] These and other problems are solved in a container for a solution used in the preparation and storage of components of donor blood, containing a container with a wall made of an elastic polymer film material, a radio frequency identification and information tag made with the possibility of recording, storing and transmitting information about the parameters of the solution in the container, and a protective sheet attached to the wall of the container from the side of its outer surface, wherein the radio frequency identification and information tag is placed between the protective sheet and the outer surface of the wall of the container, to which the protective sheet is attached.

[0019] It is clear that the novelty of the utility model primarily lies in the fact that the design of the container includes a radio frequency identification and information tag that is capable of recording, storing and transmitting information about the parameters of the solution in the container used in the preparation and storage of donor blood components. It should be absolutely clear to a specialist in this field of technology that when we talk about solutions used in the preparation and storage of donor blood components, we are talking specifically about solutions of hemopreservatives and solutions for glycerolization / deglycerolization.

[0020] Using a radio frequency identification tag does not cause any difficulties for medical personnel, i.e., using containers with tags is clear, convenient, and absolutely effortless for medical personnel, even with average qualifications.

[0021] Using a container equipped with an RFID tag improves the safety of the container, since, for example, compared to containers equipped with labels only, it completely eliminates the possibility of using containers with expired solutions or solutions intended for another procedure.

[0022] A significant advantage of the proposed container is that, in addition to information directly related to the solution's parameters (name, quantity, and composition), medical personnel can use a reader located on the device to automatically identify the solution and read information directly or indirectly related to the solution in the container. For example, they can read information about the solution's manufacturer, production date, and the presence of permitting documentation permitting circulation of the medical device. Thus, after medical personnel verify the information about the solution contained in the container, additional automated identification of the solution information occurs, and if this information does not match the parameters programmed into the device, the procedure is automatically prohibited.This eliminates errors made by medical personnel, and the entire process of transfusing donor blood components becomes safer.

[0023] Another significant advantage is that the radio frequency identification and information tag retains all of its characteristics and functionality during heat sterilization of the container for the solution used in the preparation and storage of donor blood components, as well as when the container is exposed to high humidity or other harsh physical conditions that the container may be exposed to during storage.

[0024] Also, the novelty of the present utility model lies in the fact that the container contains a protective sheet attached to the wall of the container from its outer surface, while the radio frequency identification and information tag is placed between the protective sheet and the outer surface of the wall of the container to which the protective sheet is attached.

[0025] The presence of a protective sheet and the placement of the identification and information label between the protective sheet and the outer surface of the container wall ensures protection of the identification and information label from various external influences, primarily from possible mechanical impact, which ultimately increases the safety of the container and its operational reliability.

[0026] The protective sheet can be made of paper with a density of at least 120 g / m 2 , or made of a polymer material, for example, polyvinyl chloride (PVC).

[0027] It is desirable that the radio frequency identification tag and paper or polymer protective sheet be made self-adhesive.

[0028] It is also possible to manufacture a container in which a radio frequency identification and information tag is implanted into the wall of the container.

[0029] The container label can be used as a protective sheet.

[0030] Such container manufacturing options increase the protection of the identification information tag from, first of all, possible mechanical impact, and thus increase the safety of the container, as well as increase the reliability of its operation.

[0031] Alternatively, an RFID tag can be used as an identification and information tag. RFID tags are ideal for recording, storing, and transmitting information about the parameters of the solution used in the preparation and storage of donor blood components. This information is recorded, stored, and transmitted using specialized reading and writing equipment, such as handheld RFID scanners, or RFID readers, and specialized software, such as RFID Explorer, Tag Writer, Vulcan RFID Read&Write, and RFID Scanner. RFID tags can record information, and a large amount of data can be stored on them, as the minimum memory capacity of the simplest RFID tag is 128 bits.

[0032] An alternative embodiment of the container design is to use an NFC tag as the radio-frequency identification and information tag. In this embodiment, the storage or transmission of information about the parameters of the solution used in the preparation and storage of donor blood components is accomplished using specialized reading and writing equipment, such as handheld NFC scanners, which allow both writing and reading information to the NFC tag. This writing or reading is accomplished using specialized software, such as NFC Tools GUI or Taglme Console. The amount of information that can be written to an NFC tag depends on the tag's memory capacity, but this capacity is sufficient for using NFC tags in containers designed according to this utility model.

[0033] Hereinafter, the present utility model, namely a container for a solution used in the preparation and storage of components of donor blood, will be disclosed in more detail through the following examples of the container, with reference to images, in which:

[0034] Fig. 1 schematically depicts a container for a solution used in the preparation and storage of components of donor blood, made according to the 1st example of the utility model, with a self-adhesive RFID tag and a paper protective sheet-label, front view;

[0035] Fig. 2 schematically depicts a container for a solution used in the preparation and storage of components of donor blood, made according to the 2nd example of the utility model, with an implanted NFC tag, front view.

[0036] Fig. 3 schematically depicts a container for a solution used in the preparation and storage of components of donor blood, made according to Example 3 of the utility model, with a self-adhesive RFID tag and a protective sheet made of polyvinyl chloride (PVC), front view.

[0037] Example 1

[0038] Fig. 1 shows a container 1 for a solution used in the preparation and storage of donor blood components, namely for a hemopreservative solution.

[0039] Container 1 contains a container 2 with a wall 3 made of elastic polymer film material.

[0040] Container 1 also contains a radio frequency identification and information tag 4, configured to record, store and transmit information about the parameters of the hemopreservative solution in container 1.

[0041] Radio frequency identification and information tag 4 is attached to the wall 3 of the container on its outer surface.

[0042] Radio Frequency Identification and Information Tag 4 is a Hidden H9 UHF RFID tag with the following main features:

[0043] Label type - self-adhesive;

[0044] The object to be marked is not metal;

[0045] Reading range - up to 10 m;

[0046] Frequency - UHF (860-960 MHz);

[0047] Memory block - EPC 96 bit;

[0048] TID memory block - 96 bits;

[0049] USER Memory Block - 668 bits;

[0050] Chip - Higgs 9 (Alien);

[0051] Operating temperature: -40°C to +70°C;

[0052] Label material - PET:

[0053] Size - 54×34×0.2 mm.

[0054] Container 1 also contains a protective sheet-label 5 attached to the wall 3 of the container from its outer surface, wherein the radio frequency identification and information tag 4 is placed between the protective sheet-label 5 and the outer surface of the wall 3 of the container, to which the protective sheet-label 5 is attached. The protective sheet-label 5 is made of paper with a density of 120 g / m 2 In this embodiment of the container, the RFID tag 4 and the protective sheet-label 5 are self-adhesive, i.e., when manufacturing container 1, tag 4 is glued to wall 3 of container 1, and then protective sheet-label 5 is glued to wall 3 of container 1 and to tag 4. Thus, tag 4 is located between wall 3 and protective sheet-label 5.

[0055] Example 2

[0056] Fig. 2 shows a container 6 for a solution used in the preparation and storage of donor blood components, namely a glycerolization solution.

[0057] Container 6 contains a container 7 with a wall 8 made of elastic polymer film material.

[0058] According to the utility model, container 6 contains a radio frequency identification and information tag 9, designed with the ability to record, store and transmit information about the parameters of the glycerolization solution.

[0059] The 9-band RFID tag is an M2040 / 038 NFC tag with the following main characteristics:

[0060] Label type - self-adhesive;

[0061] The object to be marked is not metal;

[0062] Reading range - up to 0.1 m;

[0063] Frequency - 13.56 MHz;

[0064] Chip - A234.2;

[0065] Operating temperature: -25°C to +70°C;

[0066] Label material - polypropylene;

[0067] Size - 20×40×0.2 mm;

[0068] Memory block - 128 bytes.

[0069] The NFC tag is implanted into the wall of the 8 container during its production.

[0070] Example 3

[0071] Fig. 3 shows a container 10 for a solution used in the preparation and storage of donor blood components, namely a deglycerolization solution.

[0072] Container 10 contains a container 11 with a wall 12 made of elastic polymer film material.

[0073] According to the utility model, the container 10 contains a radio frequency identification and information tag 13, designed with the ability to record, store and transmit information about the parameters of the deglycerolization solution.

[0074] Radio frequency identification and information tag 13 is fixed to the wall 12 of the container from its outer surface.

[0075] Radio Frequency Identification and Information Tag 13 is a transparent UHF RFID tag with the following main characteristics:

[0076] Label type - self-adhesive;

[0077] The object to be marked is not metal;

[0078] Reading range - up to 10 m;

[0079] Frequency - UHF (860-960 MHz);

[0080] EPC memory block - 96 bits;

[0081] TID memory block - 64 bit;

[0082] USER Memory Block - 512 bits;

[0083] Chip - Higgs 3 (Alien);

[0084] Operating temperature: -50°C to +85°C;

[0085] Label material - PET;

[0086] Size - 93×17×0.2 mm.

[0087] The UHF RFID tag is glued to the wall 12 of the container 10 from the side of its outer surface.

[0088] The container 10 also comprises a protective sheet 14 attached to the wall 12 of the container 10 from its outer surface, wherein the radio frequency identification and information tag 13 is located between the protective sheet 14 and the outer surface of the wall 12 of the container 10, to which the protective sheet 14 is attached. The protective sheet 14 is transparent and is made of a transparent polymer material, namely polyvinyl chloride (PVC). In this embodiment of the container, the UHF RFID tag and the protective sheet 14 made of polyvinyl chloride are self-adhesive, i.e. when manufacturing container 10, mark 13 is glued to wall 12 of container 10, and then protective sheet 14 is glued to wall 12 of container 10 and to mark 13. Thus, mark 13 is located between wall 12 of container 10 and protective sheet 14 made of polyvinyl chloride (PVC).

Claims

1. A container for a solution used in the preparation and storage of donor blood components, comprising a container with a wall made of an elastic polymer film material, characterized in that it contains a radio frequency identification and information tag made with the possibility of recording, storing and transmitting information about the parameters of the solution in the container, and a protective sheet attached to the wall of the container from the side of its outer surface, wherein the radio frequency identification and information tag is placed between the protective sheet and the outer surface of the wall of the container, to which the protective sheet is attached.

2. The container according to paragraph 1, characterized in that the radio frequency identification and information tag is self-adhesive, and the tag is glued to the wall of the container from the side of its outer surface.

3. A container according to paragraph 1, characterized in that an RFID tag is used as an identification and information tag, designed with the ability to record, store and transmit information, including the name, quantity, composition, manufacturer, production date and expiration date of the solution in the container.

4. The container according to paragraph 1, characterized in that an NFC tag is used as an identification and information tag, designed with the ability to record, store and transmit information, including the name, quantity, composition, manufacturer, production date and expiration date of the solution in the container.

5. The container according to paragraph 1, characterized in that the container label is used as the protective sheet.

6. The container according to item 1, characterized in that the protective sheet is made of paper with a density of at least 120 g / m 2 .

7. The container according to item 1, characterized in that the protective sheet is made of polyvinyl chloride (PVC).

8. The container according to paragraph 1, characterized in that the protective sheet is self-adhesive, and the protective sheet is glued to the wall of the container from the side of its outer surface.

Images