Blood component transfusion kit

Abstract

FIELD: medical equipment.SUBSTANCE: transfusion set contains a sealed transport container made of polymeric material, which contains a transfusion system, a flexible polymeric container with a lyophilized hemocomponent, which has two gateways, one of which is equipped with an additional connecting tube for connection to the transfusion system and has a built-in infusion filter and a plug, a flexible polymeric container with a sterile non-toxic apyrogenic solvent and a venous catheter. The second gateway is equipped with an additional connecting tube, which has an input with a standard needleless connector for connecting a bag with sterile non-toxic apyrogenic solvent. Both connecting pipes are equipped with additional external shut-off devices. The transport container is made of transparent polymer material.EFFECT: expanding the possibilities for providing assistance in medical institutions and uniting the healthcare and civil defense systems that work with blood and its components, and enabling use in remote areas.19 cl, 2 ex

Description

[0001] aField of technology to which the invention relates

[0002] The invention relates to the field of transfusion medicine and emergency medicine. It concerns containers specifically designed for medical and pharmaceutical purposes for collecting, storing, or administering blood, plasma, or other medical fluids, and also concerns first aid kits.

[0003] Prior Art

[0004] Massive blood loss remains the leading cause of early death among critically injured patients in both civilian and military settings. Implementation of hemostatic resuscitation strategies can reduce mortality, but such strategies may not be available on the battlefield, at the point of injury, or during extended transport, where they would be most beneficial. Because combat zones require prolonged field care, delays in access to blood products can expose wounded soldiers with severe injuries and shock to an increased risk of early death and, in survivors, to an increased risk of organ failure. Similarly, access to blood products in the prehospital setting or in rural civilian settings remains limited.

[0005] In many cases of acute blood loss, plasma infusion therapy is necessary. In cases of acute massive blood loss (more than 30% of the circulating blood volume, or more than 1500 ml for adults), accompanied by the development of acute DIC syndrome, the amount of fresh frozen plasma transfused should be at least 25-30% of the total volume of transfusion media prescribed to replace blood loss, i.e., at least 800-1000 ml. This procedure presents numerous challenges: a large supply of fresh frozen plasma is required, along with specialized storage and thawing equipment, a long thawing time, and ABO and Rh factor incompatibility between plasma components.

[0006] Special medical kits are used to provide prompt medical care in emergency situations and in the field. The inclusion of lyophilized blood components improves the ease of transportation and storage, as they do not require refrigeration equipment, refrigerated trucks, or equipment for defrosting and warming the blood component before transfusion. The use of lyophilized blood components also reduces the time it takes to provide medical care in cases of massive blood loss by performing blood transfusions.

[0007] The closest analogue of the present invention is a kit for providing emergency transfusion care, RU 2 846 790 C1, September 15, 2025. The kit comprises a container with lyophilized plasma, a flexible polymer container with a solvent, a transfusion system, a peripheral venous catheter, a napkin for treating the injection site, a patch for fixing the peripheral venous catheter, and a bandage. These elements are placed in an outer sealed flexible polymer foil bag. To improve the safety of care, the flexible polymer container with lyophilized plasma has two independent ports, one of which is connected to a fistula needle for introducing a solvent, and the other port is an infusion plug with a membrane for connection to the transfusion system. The set increases the efficiency and safety of emergency transfusion care in extreme conditions with massive blood loss and severe injuries.The combination of these products makes blood transfusions convenient, simple, and efficient in extreme conditions.

[0008] One of the prototype's shortcomings is that the kit is a standalone device and includes standard consumables that are included in field first aid kits and are standard equipment in hospitals and medical centers. This leads to redundancy and inefficient use of resources, including increased cost, weight, and volume of the kit, thereby increasing the burden on the logistics system.

[0009] The kit is additionally packaged in an outer foil pouch, but the foil packaging prevents visual inspection of the kit's contents. Therefore, damage to the kit or individual components can only be detected after opening, creating additional critical risks, especially in extreme situations and field conditions.

[0010] The overall dimensions of the kit (240 mm × 330 mm) allow it to be equipped with the minimum amount of blood component required to stop massive blood loss: two units of 250 ml each with the corresponding volume of diluent. This configuration, while increasing the kit's weight and size, does not provide the required amount of blood component for transfusion and treatment of massive blood loss (the required volume of blood component to restore blood volume can reach up to 6 units).

[0011] Disclosure of the essence of the invention

[0012] The objective of the present invention is to create a specialized module that can be easily integrated into first aid kits, including pre-hospital care within a brigade's medical company, separate medical battalion, or medical detachment. A further objective of the present invention is to optimize the kit for use in regulated clinical protocols.

[0013] The technical result of the present invention consists of increasing the flexibility and functionality of the device by creating a module for integration into pre-hospital first aid kits or clinical protocols, and including a minimum number of necessary components in the kit, allowing for its adaptation to various application conditions. The invention also improves the efficiency and safety of transportation and transfusion through the use of a lyophilized blood component and high reliability and effectiveness of quality control during production, use, and transportation thanks to packaging that allows for the completeness of the kit, as well as the integrity and safety of components, to be assessed during production, transportation, and prior to use, prior to opening.

[0014] The technical result provides a transfusion kit containing a transport container including a flexible polymer container with a lyophilized hemocomponent, having two gateways with a connecting tube each, wherein one of the tubes has a built-in infusion filter and a plug, a flexible polymer container with a sterile non-toxic apyrogenic solvent, a transfusion system, a venous catheter, wherein the transport container is sealed and made of a transparent polymer material.

[0015] A transfusion set using water for injection as a non-toxic, apyrogenic solvent.

[0016] A transfusion set that uses 0.9% sodium chloride solution as a non-toxic, apyrogenic solvent.

[0017] A transfusion set that uses plasma as the blood component.

[0018] A transfusion set that uses cryoprecipitate as a blood component.

[0019] A transfusion set that uses red blood cells as the blood component.

[0020] A transfusion set that uses platelet concentrate as a blood component.

[0021] A transfusion kit in which the lyophilized blood component is obtained by pooling at least 3, preferably 4 doses, preferably 5, preferably 6, preferably 7, preferably 8, preferably 9, preferably 10, preferably 11, preferably 12 doses of plasma.

[0022] A transfusion set in which the lyophilized blood component is pathogen-reduced.

[0023] A transfusion set in which the lyophilized blood component has a standardized composition.

[0024] A transfusion set in which the lyophilized plasma is group AB lyophilized plasma or autologous lyophilized plasma.

[0025] A transfusion set in which the lyophilized cryoprecipitate is group AB lyophilized cryoprecipitate or autologous lyophilized cryoprecipitate.

[0026] Transfusion set which contains instructions for use.

[0027] A transfusion set in which the instructions are in the form of pictograms or step-by-step visual instructions printed on the transport container.

[0028] The transfusion set additionally includes a napkin impregnated with an antiseptic selected from alcohol, chlorhexidine, or a combination of both.

[0029] The transfusion set additionally includes a venous tourniquet.

[0030] The transfusion set additionally includes a bandage.

[0031] A transfusion set in which the transport container is made of transparent soft or rigid polymer material.

[0032] A transfusion set in which the transport container is divided into sections.

[0033] The lyophilized hemocomponent is selected from plasma, red blood cells, platelet concentrate, or cryoprecipitate. The hemocomponent may be obtained from donor blood or directly from the donor by apheresis; for example, plasma may be obtained by plasmapheresis. Furthermore, the lyophilized hemocomponent may be selected to be different from plasma.

[0034] The use of a quarantined or pathogen-reduced (inactivated) blood component allows transfusions to be performed on patients without the risk of infection, since inactivation allows the destruction of pathogens (viruses, bacteria, protozoa), which further increases the safety of transfusion care.

[0035] In a preferred embodiment, the lyophilized hemocomponent is an inactivated hemocomponent, preferably cryoprecipitate, more preferably universal inactivated lyophilized cryoprecipitate, more preferably universal inactivated pooled lyophilized cryoprecipitate.

[0036] Plasma from at least three donors with blood type 4 (AB) was used to obtain universal inactivated lyophilized pooled cryoprecipitate. The use of a blood component that is universal in blood type eliminates the need for donor-recipient matching without increasing the risk of post-transfusion complications. The use of an autologous lyophilized blood component is suitable for transfusion support for armed forces, internal troops, and rescue teams in the field, improving the safety and effectiveness of blood transfusions in extreme situations.

[0037] At least 3 units of fresh frozen plasma (FFP) of 200-300 ml were used, from which at least 3 units of cryoprecipitate of 40-60 ml were obtained. The cryoprecipitate doses were pooled to obtain 1 unit of pooled cryoprecipitate of 200 to 250 ml, depending on the initial amount of plasma.

[0038] The preferred embodiment of a pooled blood component allows the kit to be equipped with a sufficient amount of blood component to stop massive blood loss—5 units of 200 ml each with the corresponding volume of diluent—without exceeding the overall dimensions of the prototype. Therefore, if an emergency transfusion is indicated, only two kits need to be quickly prepared, increasing the efficiency and safety of transfusion care. The use of universal inactivated cryoprecipitate of standard composition in the kit also further enhances the efficiency and safety of transfusion.

[0039] All items included in this kit are placed in a common shipping container. This container is made of transparent polymeric material, ensuring its tightness and protection from environmental influences, including UV radiation, as well as allowing visual inspection of the integrity of the kit and its individual components. The outer packaging may be flexible, and notches at the top of the package may be provided for quick opening without the use of additional tools. In another embodiment of the present invention, the shipping container may be rigid, such as a blister pack. Rigid packaging improves the reliability of transporting the kit and prevents damage to the flexible containers containing the blood component and solvent. For ease of removal of the kit components, the shipping container may be divided into sections designed to accommodate these components.The container can be additionally equipped with a temperature indicator and / or a sterility indicator to increase the safety of transfusion and the reliability of quality control.

[0040] The container with the lyophilized blood component is made entirely of air- and moisture-impermeable material and includes a label that meets the requirements for labeling donor blood and its components. In the preferred embodiment, the container for storing, transporting, and rehydrating the lyophilized blood component is made of a double-sided, vapor-impermeable, transparent, flexible material with a tensile strength of 1000 N / cm. 2 and a relative elongation of 450%. The container for storage, transportation and rehydration of lyophilized blood plasma has the following dimensions: width 120 mm and length 160 mm on the inside, width 130 mm and length 170 mm on the outside.

[0041] The container design features two independent ports with connecting tubing, each. One of the tubes has a built-in infusion filter designed to retain undissolved solid particles of the lyophilisate and a Luer Lock plug to maintain sterility and allow for quick connection to a blood transfusion system. The other tube has an inlet with a standard needleless connector for attaching a bag of sterile, non-toxic, apyrogenic diluent, preferably saline or, preferably, water for injection. Both tubes are equipped with additional external shutoff devices for added safety. The shutoff device can be used to shut off the line, preventing backflow of the diluent after its transfer. One tube is designed to connect to the saline delivery system.The other is for connecting a blood transfusion system and its components using standard fittings, such as Luer Lock components. This allows for rapid rehydration and transfusion of blood components under extreme conditions.

[0042] Separating the sluice gates eliminates the risk of solvent residues entering the recipient's bloodstream after rehydration of the lyophilized component, improving transfusion safety, particularly when using water for injection as a solvent. To further enhance transfusion safety, the sluice gates can be color-coded or have different textures, allowing the transfusion system to be connected to the correct sluice gate, free of solvent residues, when using water for injection.

[0043] A break-away cannula with first-opening detection maintains the seal inside the container containing the lyophilized component and allows for monitoring for signs of leakage. For hanging the blood component container, 22 mm long slots are provided along its perimeter, and a special flexible polymer mount (for example, 20 mm wide and 150 mm long) is provided. This mount size allows the container to be secured in an upright position on readily available field plasma gravity transfusion devices.

[0044] To ensure long-term infusion, the kit includes a venous catheter. When performing long-term transfusions, secure fixation of the needle in the vein with a catheter is essential, especially when treating unconscious patients or those who have difficulty maintaining a steady position of the elbow or other venipuncture site.

[0045] To ensure aseptic technique during venipuncture, an antiseptic-impregnated napkin may be included in the kit. The antiseptic for treating the injection site may be alcohol-based, chlorhexidine-based, or a combination of both.

[0046] The kit can optionally include a venous tourniquet. Using a tourniquet improves vein visualization, which is especially important for effective and safe transfusions when providing emergency care in extreme conditions.

[0047] The kit may also include a bandage for applying an aseptic pressure dressing after the transfusion to prevent bleeding from the injection site. Using the bandage further enhances the safety of transfusion care.

[0048] The outer package contains a label containing information about the product name, batch number, expiration date, and manufacturer. The kit may also include instructions for use, preferably in the form of pictograms or step-by-step visual instructions that can be understood without language knowledge or prior training. Having instructions for use further enhances the effectiveness and safety of transfusion care in emergency situations and reduces the risk of medical error by providing a clear sequence of actions. Preferably, the images are applied directly to the packaging, such as the outer sealed bag.

[0049] The lyophilized form can be reconstituted with water for injection or saline. To reconstitute the lyophilized form, add 200 ml of water for injection to the resulting lyophilized blood component. The resulting reconstituted solution is visually inspected for clarity and the absence of foreign matter. The resulting product is transfused directly to the recipient if transfusion is indicated.

[0050] The invention is illustrated by the following specific examples, but is not limited thereto.

[0051] Example 1

[0052] To provide emergency transfusion care in extreme conditions, the outer package of the kit is opened. The flexible polymer container with the lyophilized blood component is removed and attached to the container with the solvent. To do this, the needle-free connector is connected to a bag with a non-toxic, apyrogenic solvent, the clamp is opened, and the solution is transferred by gravity into the container with the lyophilisate, rocking it to ensure uniform rehydration. The locking device is closed, and the connector is removed from the port of the container with the solvent. After the lyophilized blood component is completely dissolved (after 2-3 minutes), the container is suspended in an upright position, threading the fastening device through the slot and securing it in the form of a loop at the top of the container. The fistula needle of the transfusion system is inserted into the sluice. The transfusion system is primed. A venous catheter is inserted.The transfusion system's injection needle is inserted into the injection port of the venous catheter, allowing the blood to flow by gravity into the vein. The required number of blood component transfusions are administered, after which the venous catheter is removed from the vein.

[0053] Example 2

[0054] The kit for providing emergency transfusion care in extreme conditions for acute massive blood loss is used similarly to Example 1. The kit contains a lyophilized blood component, which is a pathogen-reduced, pooled cryoprecipitate consisting of 5 doses. For easy removal, the outer packaging has internal dividers that create sections for placing the items and facilitating their removal from the main packaging. The kit also includes instructions for use on paper, in the form of pictograms, or step-by-step visual instructions printed on the outer packaging.

[0055] It is known (see Galstyan G.M., Gaponova T.V., Zhiburt E.B. et al. CLINICAL USE OF CRYOPRECIPITAL / / HEMATOLOGY AND TRANSFUSIONOLOGY. - 2020. - No. 65. - P. 87-114.) that cryoprecipitate transfusions made it possible to increase the plasma fibrinogen concentration in patients who survived the first 12 hours after admission; the risk of death was reduced for each gram of fibrinogen administered within the first 12 hours. The time of initiation of cryoprecipitate replacement therapy is important. Among patients with multiple trauma, who received cryoprecipitate transfusions within the first 90 minutes as one of the initial components of massive transfusion therapy, there was a reduced requirement for blood components (red blood cell-containing components, platelet concentrates, and FFP). In 2007, the first version of the European Guidelines for the Management of Bleeding in Trauma recommended cryoprecipitate transfusions for massive bleeding accompanied by a fibrinogen concentration of less than 1 g / L.However, when these guidelines were updated in 2010 and 2013, it was recommended to initiate cryoprecipitate transfusions when plasma fibrinogen concentrations were less than 1.5-2.0 g / L or when functional fibrinogen, as determined by viscoelastic testing, decreased. In trauma, transfusions of an average of 8.7 units of cryoprecipitate increased plasma fibrinogen concentrations by 0.55 g / L, or 0.06 g / L per unit of cryoprecipitate. According to European guidelines for the treatment of trauma, it is recommended to transfuse 15-20 units of cryoprecipitate per 70 kg of patient body weight. Early use of cryoprecipitate is an effective means of endothelial protection, complementing physiological VWF and ADAMTS13 and preventing the development of thrombotic complications. Therefore, transfusions of lyophilized cryoprecipitate are becoming relevant for victims with massive blood loss.

[0056] In addition, in accordance with the Decree of the Government of the Russian Federation dated 14.05.2025 N 641, during the transfusion of cryoprecipitate, the compatibility of the donor and adult recipient in terms of Rh factor and erythrocyte antigens C, c, E, e, K is not taken into account and a biological test is not carried out, which allows for the provision of ultra-fast resuscitation care in cases of massive blood loss.

[0057] The present invention comprises the necessary components for transfusion care, including emergency and field treatments. It enables the safe and effective preparation of a transfusion solution, including a universal solution with a standardized composition, by pooling blood components from several different donors. Pooling blood components and using multiple doses further enhances the effectiveness of care for victims with massive blood loss and severe injuries in hard-to-reach areas and locations. Furthermore, eliminating the need for preliminary defrosting and the use of additional specialized equipment reduces the preparation time for transfusion to 10 minutes, ensuring rapid care. The lyophilized form is convenient for transportation and storage without refrigeration.The above-mentioned advantages of the invention, as well as its long shelf life (up to 5 years), allow for its application in various areas of military and civilian medicine and the use of the present invention in hard-to-reach areas and locations, including for providing assistance in cases of acute massive blood loss. The proposed solution can be implemented using materials and components from various manufacturers. The invention expands the potential for the use of lyophilized blood components and the provision of assistance in medical institutions and healthcare and civil defense units that handle blood and its components, enabling the use of the kits both on the battlefield and in rural clinics and other remote areas.

Claims

1. A transfusion kit comprising a sealed transport container made of a polymeric material, including a transfusion system placed therein, a flexible polymeric container with a lyophilized hemocomponent, having two gateways, one of which is equipped with an additional connecting tube for connection to the transfusion system and has a built-in infusion filter and a plug, a flexible polymeric container with a sterile non-toxic apyrogenic solvent and a venous catheter, characterized in that the second gateway is equipped with an additional connecting tube, which has an entrance with a needle-free connector for connecting a bag with a sterile non-toxic apyrogenic solvent, and both connecting tubes are equipped with additional external locking devices, wherein the transport container is made of a transparent polymeric material.

2. The kit according to item 1, characterized in that the non-toxic apyrogenic solvent is water for injection.

3. The kit according to item 1, characterized in that the non-toxic apyrogenic solvent is a 0.9% sodium chloride solution.

4. A kit according to any one of paragraphs 1-3, characterized in that the blood component is plasma.

5. A kit according to any one of paragraphs 1-3, characterized in that the blood component is cryoprecipitate.

6. A kit according to any one of paragraphs 1-3, characterized in that the blood component is erythrocytes.

7. A kit according to any one of paragraphs 1-3, characterized in that the blood component is a platelet concentrate.

8. A kit according to any one of claims 1 to 7, characterized in that the lyophilized hemocomponent is obtained by pooling at least 3, preferably 4 doses, preferably 5, preferably 6, preferably 7, preferably 8, preferably 9, preferably 10, preferably 11, preferably 12 doses of plasma.

9. A kit according to any of paragraphs 1-8, characterized in that the lyophilized blood component is pathogen-reduced.

10. The kit according to claim 4, characterized in that the lyophilized plasma is lyophilized plasma of group AB or autologous lyophilized plasma.

11. The kit according to claim 5, characterized in that the lyophilized cryoprecipitate is a lyophilized cryoprecipitate of group AB or an autologous lyophilized cryoprecipitate.

12. A set according to any of paragraphs 1-11, characterized in that it contains instructions for use.

13. The set according to item 12, characterized in that the instructions are made in the form of pictograms or step-by-step visual instructions applied to the transport container.

14. A set according to any one of paragraphs 1-13, characterized in that it additionally includes a napkin impregnated with an antiseptic selected from an alcohol-based antiseptic, an antiseptic containing chlorhexidine, or a combination thereof.

15. A kit according to any one of paragraphs 1-14, characterized in that it additionally includes a venous tourniquet.

16. A set according to any of paragraphs 1-15, characterized in that it additionally includes a bandage.

17. A set according to any of paragraphs 1-16, characterized in that the transport container is made of a soft or hard polymer material.

18. A set according to any of paragraphs 1-17, characterized in that the transport container is divided into sections.

19. A kit according to any one of paragraphs 1-18, characterized in that the transport container is equipped with a temperature indicator and / or a sterility indicator.