Blood transfusion plasma bag with freeze-drying function and method for freeze-drying plasma in bag

Abstract

The invention discloses a blood transfusion plasma bag with a freeze-drying function and a method for freeze-drying plasma in the bag, and relates to the field of blood transfusion utensils, a drying opening is fixed to a freeze-drying frame, by means of the gravity effect of the plasma bag, an edge sealing notch serves as a weak point to deform, a transversely-extruded cavity structure is formed to serve as a water vapor discharging channel, and freeze-drying uniformity is ensured. A three-stage sealing design is adopted in the drying opening, when the valve element is inserted, first-stage sealing is formed through a sliding seat limiting ball, the valve element is matched with the valve seat to achieve second-stage sealing, the valve body and the valve element form three-stage external sealing, and pollution is effectively isolated. The ball can roll freely when the valve element part is pulled out, a one-way air guide structure is formed by the ball and the valve body under the vertical state by means of gravity, water vapor is allowed to be discharged, and external unclean air is prevented from being sucked in reversely. And when the bag body overturns, the balls are attached to the valve seat under the action of internal pressure, and overflow is avoided. After freeze-drying is completed, hot-pressing sealing is conducted through a reserved sealing strip, and storage can be conveniently conducted by removing a drying opening along a notch.

Description

Technical Field

[0001] The present invention relates to the field of blood transfusion apparatus, in particular to a plasma bag for blood transfusion with a freeze-drying function and a method for freeze-drying plasma in the bag. Background Art

[0002] Plasma, a vital medical resource, is widely used in the treatment of coagulation disorders, burns, immunodeficiency disorders, and emergency care for patients with massive blood loss. To extend its storage life and facilitate transportation, freeze-drying technology has been introduced into plasma preparation. Freeze-dried plasma removes water through cryogenic freezing and vacuum sublimation, allowing it to be stored at room temperature for months to years. This significantly increases its value in remote areas or disaster scenarios, allowing it to be recovered and delivered to the human body even after extended storage.

[0003] However, traditional freeze-drying methods typically rely on glass vials as storage and freeze-drying containers. While this method effectively preserves plasma activity, it has significant limitations. For example, glass vials are fragile during transportation and handling, especially in the field or in emergency medical settings, increasing the risk of breakage, leading to resource waste and pollution. Flexible plastic packaging can address this shortcoming.

[0004] Currently, there is no proven technical solution for freeze-drying 200ml of plasma directly in a bag. Existing bag designs are primarily designed for frozen or fresh storage and are not suited to the demands of freeze-drying. Therefore, developing a method and design for freeze-drying plasma directly in a bag is crucial, enabling the long-term storage and subsequent transfusion of plasma into human subjects. Summary of the Invention

[0005] The purpose of the present invention is to solve the problems of freeze-dried plasma in bags and related problems derived therefrom, and to propose a plasma bag for blood transfusion with freeze-drying function and a method for freeze-drying plasma in the bag.

[0006] To achieve the above objectives, the present invention adopts the following technical solution: a plasma bag for blood transfusion with a freeze-drying function, comprising a freeze-drying rack and a freeze-drying container suspended thereon, and a drying port reserved for freeze-drying operations on the freeze-drying container, wherein the freeze-drying container comprises a plasma bag comprising a bag body and a reserved seal integrally formed with the bag body, wherein the bag body is provided with a sealed edge with a notch provided on the sealed edge, and the drying port comprises a valve body and a ball rolling therein under gravity, and further comprises a valve seat and a valve core sliding within the valve body for on-off control;

[0007] The bag is placed on the freeze-drying rack at the drying port and suspended in the air. The weight of the bag and the supporting force of the drying port are misaligned, causing the incision to fold horizontally to form an exhaust passage. The ball in the valve body discharges the gas in the exhaust passage under the action of gravity.

[0008] As a further description of the above technical solution: the valve body includes a head and a clamping ring fixed on the top end thereof, and the head is axially penetrated with a trumpet-shaped through-hole.

[0009] As a further description of the above technical solution: the valve seat includes a seat body located in the head, the upper surface of the seat body is provided with a groove, and the lower surface of the seat body is conical and provided with a guide groove connected to the groove.

[0010] As a further description of the above technical solution: the valve core includes a core body sealed in the head, a sealing platform for cooperating with the groove seal is fixed at the bottom of the core body, a top pin for pressing the ball after passing through the guide groove is fixed at the bottom of the sealing platform, and a plurality of side grooves are opened on the arc-shaped side wall of the core body.

[0011] As a further description of the above technical solution: two plasma conduits for entering and exiting plasma are connected and arranged on the bag body.

[0012] As a further description of the above technical solution: the freeze-drying rack includes a rack body and a limiting groove thereon for fixing a clamping ring, and the inner wall of the limiting groove is arranged in an inclined surface.

[0013] As a further description of the above technical solution: the incision has a triangular cross-section, and the incision is located above the reserved seal.

[0014] As a further description of the above technical solution: the ball is made of hollow medical-grade silicone material and slides in the guide groove and the perforation under gravity.

[0015] As a further description of the above technical solution: The plasma freeze-drying method in a bag comprises the following steps:

[0016] S1. Inject a protective agent with a concentration of 0.5-2 g / L into the freeze-dried plasma container through the plasma catheter for preparation;

[0017] S2. After preparation, the freeze-drying container is installed upright on the freeze-drying rack through the drying port and cooled in an environment of -80 degrees Celsius;

[0018] S3, after the plasma in the freeze-drying container is completely frozen, part of the core is pulled out and the container is placed in a freeze dryer for processing;

[0019] S4. After freeze-drying is completed, the core is reset and removed, and the reserved seal is permanently heat-sealed, and force is applied at the incision to separate the drying port.

[0020] As a further description of the above technical solution: in step S3, the freeze dryer process includes the following steps:

[0021] S3.1 Place the pre-frozen bag in a freeze dryer, control the vacuum degree to 5-15Pa and the temperature to -40℃ to -20℃ for 72-120 hours to complete the primary drying stage.

[0022] S3.2 When entering the secondary drying stage, control the vacuum degree to 5-15Pa, raise the temperature to 20℃, and continue until the moisture content is <2%.

[0023] In summary, due to the adoption of the above technical solution, the beneficial effects of the present invention are:

[0024] This solution places the valve body of the drying port on a freeze-drying rack and opens the drying port. Based on the gravity of the plasma in the plasma bag and the location of the drying port on one side of the plasma bag, the sealed edge of the plasma bag deforms under the action of gravity, with the incision as the weak point. The opening at the incision shrinks, and the bag body at this location is deformed by transverse compression, forming a cavity as an exhaust path for water vapor, effectively supporting uniform freeze-drying of the plasma.

[0025] The ball inside the drying port is limited by the sliding seat. When the valve core is inserted, the ball is pressed and held, so that the ball fits together to form a seal. The valve core and the valve seat form a secondary seal, and the valve core and the valve body form an external tertiary seal to ensure that the closed state will not be contaminated. At the same time, when the valve core is pulled out, the ball can roll. When it is in a vertical state, the ball cooperates with the valve body under the action of gravity to maintain a one-way water vapor outlet, avoiding the bag from inhaling air from the external non-A-level environment due to internal pressure changes. At the same time, if the bag overturns in the open state, the ball can fit on the valve seat under the internal pressure to avoid leakage of internal plasma. This method can achieve multi-stage sealing during sealing and one-way water vapor discharge during freeze-drying, and has a leak-proof effect. The overall design structure is simple, safe and efficient.

[0026] At the same time, after freeze-drying is completed, heat-press seal the reserved seal position, and remove the drying opening by tearing the incision, so that it can be easily stored. BRIEF DESCRIPTION OF THE DRAWINGS

[0027] Figure 1 A three-dimensional schematic diagram of the present invention;

[0028] Figure 2 A schematic diagram of another perspective of the present invention;

[0029] Figure 3 Schematic diagram of the explosion of the freeze-drying container of the present invention;

[0030] Figure 4 is a schematic cross-sectional view of the freeze-drying container of the present invention;

[0031] Figure 5 For the present invention Figure 4 A magnified schematic diagram of point A in the middle;

[0032] Figure 6 For the present invention Figure 5 Schematic diagram of the middle drying port in the open state;

[0033] Figure 7 Schematic diagram of the explosion of the drying port of the present invention;

[0034] Figure 8 Schematic diagram of force analysis of the freeze-drying container of the present invention on the freeze-drying rack.

[0035] Legend:

[0036] 10. Freeze-drying container; 11. Plasma bag; 111. Bag body; 112. Edge sealing; 113. Reserved seal; 114. Incision; 12. Plasma catheter;

[0037] 20. Freeze-drying rack; 21. Rack body; 22. Limiting groove;

[0038] 30. Dry port; 31. Valve body; 311. Head; 312. Perforation; 313. Snap ring; 32. Valve seat; 321. Seat body; 322. Groove; 323. Guide groove; 33. Valve core; 331. Core body; 332. Sealing platform; 333. Ejector pin; 334. Side groove; 34. Ball. DETAILED DESCRIPTION

[0039] The following will clearly and completely describe the technical solutions in the embodiments of the present invention in conjunction with the accompanying drawings. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without making creative efforts are within the scope of protection of the present invention.

[0040] like Figure 1 - Figure 8 As shown, the present invention provides: a plasma bag for blood transfusion with a freeze-drying function, comprising a freeze-drying rack 20 and a freeze-drying container 10 suspended thereon, specifically, as Figure 2 As shown, the freeze-drying rack 20 includes a rack body 21 and a limiting groove 22 thereon for fixing the clamping ring 313, and the inner wall of the limiting groove 22 is arranged in an inclined surface.

[0041] By setting up the freeze-drying rack 20, its frame 21 can be uniformly installed on a carrier for transportation, wherein the limiting groove 22 on the frame 21 can keep the clamping ring 313 pressed, overcome the torsional force of the bag body 111 on the clamping ring 313, and maintain its vertical support.

[0042] The freeze drying container 10 is provided with a drying port 30 reserved for freeze drying operation. The freeze drying container 10 includes a plasma bag 11 consisting of a bag body 111 and a reserved seal 113 integrally formed with the bag body 111. The edge of the bag body 111 is provided with a sealing edge 112, and the sealing edge 112 is provided with a notch 114. Specifically, Figure 4 As shown, the cutout 114 has a triangular cross section, and the cutout 114 is located above the reserved seal 113 .

[0043] By providing the plasma bag 11 , which includes the bag body 111 and the reserved seal 113 on the bag body 111 , secondary packaging can be performed through the reserved seal 113 when necessary, thereby ensuring the sealing performance after freeze-drying and facilitating storage.

[0044] At the same time, the two bag bodies 111 are connected to each other by hot pressing at the edge sealing 112 and keep the interior closed. The edge sealing 112 on one side has a certain incision 114, which can facilitate the deformation of the position during use and can tear the position to remove the drying opening 30.

[0045] Specifically, such as Figure 3 As shown, the bag body 111 is connected with two plasma conduits 12 for the inflow and outflow of plasma.

[0046] The plasma conduit 12 is used to control the inflow and outflow of plasma and can also facilitate the addition of protective agents.

[0047] The drying port 30 includes a valve body 31 and a ball 34 rolling under gravity therein, and also includes a valve seat 32 and a valve core 33 sliding in the valve body 31 for on-off control; specifically, Figure 6 As shown, the valve body 31 includes a sealing head 311 and a clamping ring 313 fixed at the top end thereof. The sealing head 311 is axially penetrated by a trumpet-shaped through-hole 312 .

[0048] By providing the through hole 312 , the through hole 312 of the sealing head 311 is trumpet-shaped, which can form a good fitting and sealing effect with the ball 34 , and the ball 34 will not fall off.

[0049] Specifically, such as Figure 6 As shown, the valve seat 32 includes a seat body 321 located in the head 311 , a groove 322 is provided on the upper surface of the seat body 321 , and a guide groove 323 communicating with the groove 322 is provided on the lower surface of the seat body 321 in a conical shape.

[0050] By setting the groove 322, the groove 322 can cooperate with the sealing platform 332 to achieve secondary sealing cooperation in the middle section. At the same time, the tapered guide groove 323 can guide the ball 34 to cooperate with it for sealing, and when overturned, it can cooperate with the ball 34 to seal leakage.

[0051] Specifically, such as Figure 6 As shown, the valve core 33 comprises a core 331 that seals within the sealing head 311. A sealing platform 332 is fixed to the bottom of the core 331, which is used to seal with the groove 322. A push pin 333 is fixed to the bottom of the sealing platform 332, which passes through the guide groove 323 and presses against the ball 34. The curved sidewalls of the core 331 are defined by a number of side grooves 334. The bag 111 is suspended in the drying port 30 on the freeze-drying rack 20. The misalignment between the weight of the bag 111 and the support force of the drying port 30 causes the cutout 114 to fold laterally, forming an exhaust passage. Under the action of gravity within the valve body 31, the ball 34 allows gas to flow out of the exhaust passage in a unidirectional manner.

[0052] By providing the ejector pin 333 , the ejector pin 333 can maintain a seal against the valve seat 32 when penetrating the valve seat 32 , and at the same time squeeze the ball 34 to restrict movement of the ball 34 , thereby achieving a stable sealing fit.

[0053] Specifically, such as Figure 5 As shown, the ball 34 is made of a hollow medical-grade silicone material and slides in the guide groove 323 and the through hole 312 under gravity.

[0054] The ball 34 is made of medical grade silicone and will not release toxic substances when in contact with plasma. At the same time, its hollow design allows it to float on the plasma. If the bag 111 is squeezed and the plasma overflows, the ball 34 can float and enter the guide groove 323 to cooperate with the seal.

[0055] When the bottle is in use, the clamping ring 313 on the sealing head 311 is inserted into the limiting groove 22 on the freeze drying rack 20, and the core 331 is pulled out by one-third. At this time, the side groove 334 on the valve core 33 is exposed, and the sealing platform 332 also has the groove 322, and the ejector pin 333 leaves the ball 34. At this time, the air in the bag body 111 can enter the perforation 312 and push the ball 34 away, and then pass through the guide groove 323 and the opposite groove 322 of the seat body 321 until it is discharged to the outside through the multiple side grooves 334. However, the outside air cannot push the ball 34 away from the bag body 111 due to the gravity of the ball 34. Therefore, after the core 331 is opened, only the internal water vapor can be discharged. If plasma enters the perforation 312, the ball 34 will float until the ball 34 enters the guide groove 323 and cooperates with the seal to prevent plasma leakage when squeezed.

[0056] Combine Figure 8It can be seen that the drying port 30 is located at the rightmost side above the plasma bag 11. Under the action of gravity F1, the double-layer thermoplastic sealing edge 112 of the plasma bag 11 has high strength, causing the sealing edge 112 to deform with the cutout 114 as a weak point. The opening of the cutout 114 changes along the force direction F2, and the bag body 111 moves downward, so that the bag body 111 at the position of the cutout 114 is deformed by transverse compression, and a cavity is formed as an exhaust path for water vapor. During freeze-drying, water vapor can gather through the cavity and enter the perforation 312 of the head 311.

[0057] When the valve core 33 is reset, the ejector pin 333 on the valve core 33 passes through the guide groove 323 to press the ball 34 into the through hole 312, preventing the ball 34 from moving and maintaining the seal. At the same time, the sealing platform 332 is inserted into the groove 322 to achieve a secondary seal. Finally, the side groove 334 of the side wall of the core body 331 is completely inserted into the head 311 to maintain a complete seal. The multi-stage sealing method can ensure that blood cannot pass through the ball 34 and external dirt cannot enter the side groove 334 after sealing. In addition, there is a sealing redundancy design of the groove 322 between the inside and the outside, which greatly avoids contamination.

[0058] In addition, when the valve core 33 is pulled out and is in a vertical state, the ball 34 cooperates with the valve body 31 under the action of gravity to maintain a one-way water vapor discharge, thereby preventing the bag body 111 from inhaling air from the external non-A-level environment due to internal pressure changes. At the same time, if the bag body 111 overturns in the open state, the ball 34 can fit on the valve seat 32 under the action of gravity and internal pressure, thereby avoiding leakage of internal plasma and maintaining an anti-leakage effect.

[0059] At the same time, after freeze-drying is completed, heat-pressing and sealing are performed at the reserved seal strip 113 position, and the drying opening 30 can be torn and removed through the incision 114, so that it can be stored conveniently.

[0060] In conventional freeze-drying operations, the opening and closing of the bag body 111 need to be performed in a Class A environment to avoid contamination. After freeze-drying is completed, it needs to be sealed under a vacuum or nitrogen atmosphere, which makes the traditional operation method have high environmental requirements. The bag body 111 of this solution adopts a low-temperature-resistant and vacuum-resistant multi-layer composite film (such as PVDF / PE composite material) with a thickness of 0.2-0.5mm to ensure that it will not break in liquid nitrogen rapid freezing (-196°C) and freeze-drying vacuum environment (0.005mbar). At the same time, it has moisture-proof and anti-oxidation properties, which is safer than using traditional glass containers. At the same time, combined with the design of the drying port 30, it has lower environmental requirements and is more adaptable to use in areas with poor medical conditions as a whole.

[0061] The method for direct plasma freeze-drying using the plasma bag 11 proposed above comprises the following steps:

[0062] Step 1: Separate 200 ml of plasma from fresh whole blood, add a protective agent (such as 5% trehalose, 2% mannitol), and let it stand at 4°C for 2 hours to stabilize plasma proteins and coagulation factors.

[0063] Step 2: The pretreated plasma is placed in a plasma bag 11. The bag body 111 is made of a multi-layer composite film that is resistant to low temperatures and vacuum, and the capacity is designed to be 200-250 ml to accommodate freeze-drying expansion.

[0064] Step 3: Pre-freeze the filled bag 111 at -80°C for 6 hours, followed by primary drying (-40°C, 5Pa, 96 hours) and secondary drying (20°C, 5Pa, 72 hours) to ensure that the moisture removal rate is >98% and the residual water content is controlled below 2%.

[0065] Step 4: Sealing and Storage: After freeze-drying, the package is temporarily sealed by pressing the valve core 33. After removal from the freeze dryer, it is permanently sealed at the reserved seal 113 using heat sealing technology. The packaged freeze-dried plasma is then torn or cut at the incision 114 to obtain the packaged freeze-dried plasma. Store at ambient temperature (20-25°C) for at least 12 months.

[0066] With respect to the above steps, the following more specific implementation methods are proposed:

[0067] S1. Injecting vitamin C at a concentration of 0.5-2 g / L into the freeze-drying container 10 containing plasma through the plasma conduit 12 for preparation (to regulate plasma pH and protect protein stability);

[0068] S2. After preparation, the freeze-drying container 10 is suspended and mounted on the freeze-drying rack 20 through the drying port 30 and cooled in an environment of -80 degrees Celsius at a cooling rate of not less than 2°C / min.

[0069] S3, when the plasma in the freeze-drying container 10 is completely frozen, remove at least one-third of the core 331 and place it in a freeze dryer for processing;

[0070] S3.1, place the pre-frozen bag 111 on the inner shelf of the freeze dryer which has been pre-cooled to -40°C,

[0071] S3.2. Control the vacuum degree at 5-15 Pa and the temperature at -40°C to -20°C in the freeze dryer for 72-120 hours to complete the primary drying stage.

[0072] S3.3, when entering the secondary drying stage, control the vacuum degree to 5-15Pa, raise the temperature to 20℃, and continue until the moisture content is <2%

[0073] S4. After freeze-drying is completed, the core 331 is reset and removed, and the reserved seal 113 is permanently heat-sealed. Force is applied to the incision 114 to remove the drying opening 30.

[0074] In summary, the valve body 31 of the drying port 30 is placed on the freeze-drying rack 20, and the gravity of the blood is used to deform the plasma bag 11 to form a water vapor exhaust path, thereby avoiding air outlet blockage of soft materials compared to glass; combined with the three-level sealing of the valve of the drying port 30, it is protected from contamination, can unidirectionally guide water vapor, and prevent the bag body 111 from inhaling external air and internal plasma leakage, thereby greatly avoiding pollution and reducing environmental requirements; and after freeze-drying, the bag is hot-pressed and sealed, and the drying port 30 is removed through the incision 114 for easy storage, which can effectively support uniform freeze-drying of plasma, and has a simple structure, is safe and efficient, and is convenient for storage, and is more suitable for application in areas with underdeveloped medical conditions.

[0075] The above description is only a preferred specific embodiment of the present invention, but the scope of protection of the present invention is not limited thereto. Any technician familiar with the technical field, within the technical scope disclosed by the present invention, who makes equivalent replacements or changes based on the technical solution and inventive concept of the present invention, should be covered by the scope of protection of the present invention.

Claims

1. A plasma bag for blood transfusion with a freeze-drying function, comprising a freeze-drying rack (20) and a freeze-drying container (10) suspended thereon, and a drying port (30) reserved for freeze-drying operation on the freeze-drying container (10), characterized in that: The freeze-drying container (10) includes a plasma bag (11) consisting of a bag body (111) and a reserved seal (113) integrally formed with the bag body (111); a sealing edge (112) is provided at the edge of the bag body (111), and a notch (114) is provided on the sealing edge (112); the drying port (30) includes a valve body (31) and a ball (34) rolling therein under gravity, and also includes a valve seat (32) and a valve core (33) sliding in the valve body (31) for on-off control; The bag body (111) is placed on the freeze-drying rack (20) at the drying port (30) and is suspended in the air. The gravity of the bag body (111) and the supporting force of the drying port (30) are misaligned, causing the position of the incision (114) to be folded horizontally to form an exhaust passage. The ball (34) in the valve body (31) flows out of the gas in the exhaust passage in a unidirectional manner under the action of gravity.

2. The plasma bag for blood transfusion with freeze-drying function according to claim 1, characterized in that: The valve body (31) comprises a sealing head (311) and a clamping ring (313) fixed at the top end thereof, and the sealing head (311) is axially penetrated by a trumpet-shaped through-hole (312).

3. The plasma bag for blood transfusion with freeze-drying function according to claim 2, characterized in that: The valve seat (32) includes a seat body (321) located in the sealing head (311), a groove (322) is provided on the upper surface of the seat body (321), and a guide groove (323) is provided on the bottom of the seat body (321).

4. The plasma bag for blood transfusion with freeze-drying function according to claim 3, characterized in that: The valve core (33) includes a core body (331) sealed in the head (311), a sealing platform (332) for cooperating with the groove (322) for sealing is fixed at the bottom of the core body (331), a top pin (333) is fixed at the bottom of the sealing platform (332) for passing through the guide groove (323) and pressing the ball (34), and a plurality of side grooves (334) are formed on the arc-shaped side wall of the core body (331).

5. The plasma bag for blood transfusion with freeze-drying function according to claim 4, characterized in that: The bag body (111) is connected to and provided with two plasma conduits (12) for the inflow and outflow of plasma.

6. The plasma bag for blood transfusion with freeze-drying function according to claim 5, characterized in that: The freeze-drying rack (20) comprises a rack body (21) and a limiting groove (22) thereon for fixing a snap ring (313), wherein the inner wall of the limiting groove (22) is arranged in an inclined surface.

7. The plasma bag for blood transfusion with freeze-drying function according to claim 1, characterized in that: The cutout (114) has a triangular cross section, and the cutout (114) is located above the reserved seal (113).

8. The plasma bag for blood transfusion with freeze-drying function according to claim 6, characterized in that: The ball (34) is made of a hollow medical-grade silicone material and slides in the guide groove (323) and the through hole (312) under gravity.

9. A method for freeze-drying plasma in a bag, using the plasma bag for blood transfusion with freeze-drying function according to claim 8, characterized in that: The following steps are involved: S1. Injecting a protective agent having a concentration of 0.5-2 g / L into a freeze-drying container (10) containing plasma through a plasma conduit (12) for preparation; S2, after preparation, the freeze-drying container (10) is suspended and installed upright on the freeze-drying rack (20) through the drying port (30) and cooled in an environment of -80 degrees Celsius; S3, the plasma in the freeze-drying container (10) is completely frozen, a portion of the core (331) is pulled out, and the core is placed in a freeze dryer for processing; S4. After freeze-drying is completed, the core (331) is reset and removed, and the reserved seal (113) is permanently heat-sealed, and force is applied at the incision (114) to separate the drying port (30).

10. The plasma freeze-drying method in a bag according to claim 9, characterized in that: In step S3, the freeze dryer process includes the following steps: The pre-frozen bag (111) is placed in a freeze dryer, and the vacuum degree is controlled to be 5-15 Pa and the temperature is -40°C to -20°C for 72-120 hours to complete the primary drying stage; When entering the secondary drying stage, the vacuum degree is controlled at 5-15Pa, the temperature is raised to 20℃, and continued until the moisture content is <2%.

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