Bone flap cryopreservation bag and use method

Abstract

The invention discloses a bone flap cryopreservation bag and a using method, the bone flap cryopreservation bag comprises a cryopreservation bag body, a cryopreservation liquid premixing bag and an autologous plasma storage bag, one end of the cryopreservation bag body is provided with a heat sealing opening, and the cryopreservation liquid premixing bag and the autologous plasma storage bag are both arranged on the side, away from the opening end, of the cryopreservation bag body; a cryopreservation liquid pipeline is arranged between the freezing bag body and the cryopreservation liquid premixing bag, a plasma pipeline is arranged between the freezing bag body and the autologous plasma storage bag, and the plasma pipeline is arranged on one side of the cryopreservation liquid pipeline. The invention belongs to the technical field of medical instruments, and particularly provides a bone flap cryopreservation bag and a using method. According to the bone flap cryopreservation bag and the using method, a cryopreservation bag body is large in opening, bone flaps are convenient to store, the pollution probability of manual operation connection transfer is reduced, and safety and sanitation are achieved.

Description

Technical Field

[0001] The invention belongs to the technical field of medical instruments, and specifically refers to a bone flap cryopreservation bag and a use method thereof. Background Art

[0002] Cranial repair surgery is a neurosurgery that repairs skull defects caused by previous craniotomy and bone flap removal after the condition stabilizes. Different repair materials, such as autologous bone, titanium alloy, allogeneic bone, composite materials, etc., are limited for various reasons. Autologous bone reimplantation surgery has the best repair effect. Reimplantation surgery is generally performed several months later, so the skull flap needs to be stored at low temperatures.

[0003] Currently, there are no regular bone flap cryopreservation bags available in the clinic, and people often just use a sterile plastic bag instead. The cryopreservation quality is poor because the existing cryopreservation bags are filled and sucked out through tubes, and the skull bone flap is generally between 3cm*3cm and 10cm*10cm, so it cannot be crushed and can only be put in and taken out as a whole. Therefore, a new bone flap cryopreservation bag and its use method are urgently needed to solve the above problems. Summary of the invention

[0004] In order to solve the above-mentioned existing problems, the present invention provides a bone flap freezing bag and a method of use which has a large opening of the freezing bag body, is convenient for storing bone flaps, reduces the probability of contamination caused by manual operation, connection and transfer, and is safe and hygienic.

[0005] The technical solution adopted by the present invention is as follows: the bone flap freezing bag of the present invention comprises a freezing bag body, a freezing liquid premix bag and an autologous plasma storage bag, one end of the freezing bag body is provided with a heat seal, the freezing liquid premix bag and the autologous plasma storage bag are both arranged on the side of the freezing bag body away from the opening end, a freezing liquid pipeline is provided between the freezing bag body and the freezing liquid premix bag, a plasma pipeline is provided between the freezing bag body and the autologous plasma storage bag, and the plasma pipeline is provided on one side of the freezing liquid pipeline.

[0006] Furthermore, an injection Luer interface is provided on one side of the freezing bag body close to the open end, an injection pipeline is provided between the injection Luer interface and the freezing bag body, and an injection sliding clamp is sleeved on the outer side of the injection pipeline.

[0007] Furthermore, a discharge pipeline is provided on a side of the plasma pipeline away from the freezing liquid pipeline, the discharge pipeline is connected to the freezing bag body, and a discharge sliding clamp is provided on the outer sleeve of the discharge pipeline.

[0008] Furthermore, the outer side of the cryopreservation liquid pipeline is provided with a cryopreservation liquid sliding clamp, and the outer side of the plasma pipeline is provided with a plasma sliding clamp.

[0009] Furthermore, a premix Luer interface is provided on the side of the cryopreservation liquid premix bag away from the freezing bag body, and a plasma Luer interface is provided on the side of the autologous plasma storage bag away from the freezing bag body.

[0010] Furthermore, a self-sealing strip is provided at the open end of the freezing bag body.

[0011] Furthermore, the freezing bag body, the cryopreservation solution premix bag, and the autologous plasma storage bag are made of acetylene vinyl acetate and fluorinated ethylene propylene copolymer.

[0012] A method for using a bone flap cryopreservation bag comprises the following steps:

[0013] S1. Place the bone flap in a freezing bag and seal the opening of the freezing bag with thermoplastic; rinse the contents of the freezing bag with saline and drain the water;

[0014] S2, placing the cryopreservation solution into a cryopreservation solution premix bag and completing the premixing; placing the cryopreservation solution in the cryopreservation solution premix bag into a sealed freezing bag body, soaking the bone flap, and exhausting air bubbles;

[0015] S3, placing the plasma into an autologous plasma storage bag and removing air bubbles;

[0016] S4, placing the entire cryopreservation bag in a program-controlled cooling device for automatic cooling or manually cooling the bag in sequence according to the program of 10 minutes at 4°C, 30 minutes at -20°C, and 16-18 hours at -80°C, and then transferring the bag to a liquid nitrogen tank for long-term storage;

[0017] S5. Resuscitation process before use: Soak the entire cryopreservation bag in a 37°C water bath. When the ice crystals melt, take it out immediately to drain the cryopreservation solution. Rinse the bone flap with saline and drain the water. Squeeze the plasma in the autologous plasma storage bag into the freezing bag, invert to mix, and refrigerate at 4°C for later use.

[0018] The beneficial effects achieved by the present invention using the above structure are as follows: the bone flap freezing bag and use method proposed in this scheme have a large opening of the freezing bag body, which is convenient for storing bone flaps. The flow direction of the freezing fluid and plasma is controlled by sliding clamps and pipelines, which reduces the probability of contamination caused by manual operation connection and transfer, and is safe and hygienic. BRIEF DESCRIPTION OF THE DRAWINGS

[0019] Figure 1 A three-dimensional diagram of the bone flap cryopreservation bag and its use method proposed in this protocol;

[0020] Figure 2 This is a front view of the bone flap freezing bag and usage method proposed in this plan.

[0021] The accompanying drawings are used to provide a further understanding of the present invention and constitute a part of the specification. Together with the embodiments of the present invention, they are used to explain the present invention and do not constitute a limitation of the present invention. In the accompanying drawings: 1. freezing bag body, 2. cryopreservation liquid premix bag, 3. autologous plasma storage bag, 4. cryopreservation liquid pipeline, 5. plasma pipeline, 6. injection Luer interface, 7. injection pipeline, 8. injection sliding clamp, 9. discharge pipeline, 10. discharge sliding clamp, 11. cryopreservation liquid sliding clamp, 12. plasma sliding clamp, 13. premix Luer interface, 14. plasma Luer interface, 15. self-sealing strip. DETAILED DESCRIPTION

[0022] The technical solutions in the embodiments of the present invention will be clearly and completely described below in conjunction with the drawings in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, rather than all the embodiments; based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without making creative work are within the scope of protection of the present invention.

[0023] like Figure 1 and Figure 2 As shown, the bone flap cryopreservation bag proposed in this scheme includes a freezing bag body 1, a freezing liquid premix bag 2 and an autologous plasma storage bag 3. A heat seal is provided at one end of the freezing bag body 1, and the freezing liquid premix bag 2 and the autologous plasma storage bag 3 are both arranged on the side of the freezing bag body 1 away from the open end. A freezing liquid pipeline 4 is provided between the freezing bag body 1 and the freezing liquid premix bag 2, and a plasma pipeline 5 is provided between the freezing bag body 1 and the autologous plasma storage bag 3, and the plasma pipeline 5 is provided on one side of the freezing liquid pipeline 4.

[0024] like Figure 1 and Figure 2 As shown, an injection Luer interface 6 is provided on one side of the freezing bag body 1 close to the open end, an injection pipeline 7 is provided between the injection Luer interface 6 and the freezing bag body 1, an injection sliding clamp 8 is provided on the outer side of the injection pipeline 7, a discharge pipeline 9 is provided on the side of the plasma pipeline 5 away from the freezing liquid pipeline 4, the discharge pipeline 9 is connected to the freezing bag body 1, and a discharge sliding clamp 10 is provided on the outer side of the discharge pipeline 9.

[0025] like Figure 1 and Figure 2 As shown, the outer side of the cryopreservation liquid pipeline 4 is provided with a cryopreservation liquid sliding clamp 11, the outer side of the plasma pipeline 5 is provided with a plasma sliding clamp 12, the side of the cryopreservation liquid premix bag 2 away from the freezing bag body 1 is provided with a premix Luer interface 13, and the side of the autologous plasma storage bag 3 away from the freezing bag body 1 is provided with a plasma Luer interface 14.

[0026] The freezing bag body 1, the cryopreservation solution premix bag 2 and the autologous plasma storage bag 3 are made of acetylene vinyl acetate and fluorinated ethylene propylene copolymer.

[0027] A method for using a bone flap cryopreservation bag comprises the following steps:

[0028] S1, storing the bone flap in the freezing bag body 1, and sealing the opening end of the freezing bag body 1 with thermoplastic; flushing the contents of the freezing bag body 1 with physiological saline and then controlling the moisture;

[0029] S2, placing the cryopreservation solution into the cryopreservation solution premix bag 2, and completing the premixing; placing the cryopreservation solution in the cryopreservation solution premix bag 2 into the sealed freezing bag body 1, soaking the bone flap, and exhausting air bubbles;

[0030] S3, placing the plasma into the autologous plasma storage bag 3, and exhausting the air bubbles;

[0031] S4, placing the entire cryopreservation bag in a program-controlled cooling device for automatic cooling or manually cooling the bag in sequence according to the program of 10 minutes at 4°C, 30 minutes at -20°C, and 16-18 hours at -80°C, and then transferring the bag to a liquid nitrogen tank for long-term storage;

[0032] S5. Resuscitation process before use: immerse the entire cryopreservation bag in a 37°C water bath, take it out immediately to drain the cryopreservation solution when the ice crystals melt, rinse the bone flap with saline, control the water, squeeze the plasma in the autologous plasma storage bag 3 into the freezing bag body 1, invert to mix, and refrigerate at 4°C for later use.

[0033] During specific use, the self-sealing strip 15 is opened to place the bone flap into the freezing bag body 1, and then thermoplastic sealing is performed. At this time, the injection sliding clamp 8 and the discharge sliding clamp 10 are opened, and physiological saline is injected from the injection Luer interface 6. The physiological saline enters the freezing bag body 1 along the injection pipeline 7, and then the physiological saline in the freezing bag body 1 is discharged from the discharge pipeline 9. The bone flap in the freezing bag body 1 is rinsed with physiological saline. After the rinsing is completed, the freezing bag body 1 and the bone flap are drained, and then the injection sliding clamp 8 is used to close the injection pipeline 7, and the discharge sliding clamp 10 is used to close the discharge pipeline 9.

[0034] Cryopreservation liquid is injected into the cryopreservation liquid premix bag 2 from the premix Luer interface, and premixing is completed in the cryopreservation liquid premix bag 2. Then, the cryopreservation liquid sliding clamp 11 is opened, and the cryopreservation liquid in the cryopreservation liquid premix bag 2 is placed in the sealed freezing bag body 1 to soak the bone flap and exhaust the air bubbles. The plasma is placed in the autologous plasma storage bag 3 through the plasma Luer interface 14 to exhaust the air bubbles. The entire cryopreservation bag is placed in a programmable cooling instrument for automatic cooling or manually cooled according to the program of 10 minutes at 4°C, 30 minutes at -20°C, and 16-18 hours at -80°C, and then transferred to a liquid nitrogen tank for long-term storage.

[0035] Resuscitation process before use: immerse the entire cryopreservation bag in a 37°C water bath, take it out immediately when the ice crystals are observed to melt, open the discharge sliding clamp 10 to empty the cryopreservation liquid in the freezing bag body 1, and then inject normal saline from the Luer interface 6, use normal saline to rinse the bone flap and control the moisture, squeeze the plasma in the autologous plasma storage bag 3 into the freezing bag body 1, invert to mix, and refrigerate at 4°C for later use.

[0036] The cryobag is provided with a corresponding outer packaging bag. Each cryobag is sterile and independently packaged to prevent contamination during the freezing process. In order to ensure the use of extra-long pipelines, quality control is carried out through pipeline heat sealing. Each freezing bag body 1 contains a label bag for convenient insertion of written sample information to ensure the integrity of the label during the freezing and thawing process. The freezing bag body 1 has different capacity sizes of 50-1000mL, and the recommended freezing volume is 20-270mL.

[0037] Cryobags are used for extremely low temperature freezing, as low as -196°C, and then thawed at 37°C. Therefore, cryobags and corresponding outer packaging bags are made of acetylene vinyl acetate and fluorinated ethylene propylene copolymer, which are suitable for liquid nitrogen freezing.

[0038] It should be noted that, in this article, relational terms such as first and second, etc. are only used to distinguish one entity or operation from another entity or operation, and do not necessarily require or imply any such actual relationship or order between these entities or operations. Moreover, the terms "include", "comprise" or any other variants thereof are intended to cover non-exclusive inclusion, so that a process, method, article or device including a series of elements includes not only those elements, but also other elements not explicitly listed, or also includes elements inherent to such process, method, article or device.

[0039] Although embodiments of the present invention have been shown and described, it will be appreciated by those skilled in the art that various changes, modifications, substitutions and variations may be made to the embodiments without departing from the principles and spirit of the present invention, and that the scope of the present invention is defined by the appended claims and their equivalents.

Claims

1. A bone flap cryopreservation bag, characterized in that: The invention comprises a freezing bag body, a cryopreservation liquid premix bag and an autologous plasma storage bag. A heat seal is arranged at one end of the freezing bag body. The freezing liquid premix bag and the autologous plasma storage bag are arranged on a side of the freezing bag body away from the opening end. A freezing liquid pipeline is arranged between the freezing bag body and the cryopreservation liquid premix bag. A plasma pipeline is arranged between the freezing bag body and the autologous plasma storage bag. The plasma pipeline is arranged on one side of the freezing liquid pipeline.

2. A bone flap cryopreservation bag according to claim 1, characterized in that: An injection Luer interface is arranged on one side of the freezing bag body close to the opening end, an injection pipeline is arranged between the injection Luer interface and the freezing bag body, and an injection sliding clamp is sleeved on the outer side of the injection pipeline.

3. A bone flap freezing bag according to claim 2, characterized in that: A discharge pipeline is provided on the side of the plasma pipeline away from the freezing liquid pipeline. The discharge pipeline is connected to the freezing bag body, and a discharge sliding clamp is provided on the outer sleeve of the discharge pipeline.

4. A bone flap freezing bag according to claim 3, characterized in that: The outer side of the cryopreservation liquid pipeline is sheathed with a cryopreservation liquid sliding clamp, and the outer side of the plasma pipeline is sheathed with a plasma sliding clamp.

5. A bone flap cryopreservation bag according to claim 4, characterized in that: A premix Luer interface is provided on the side of the cryopreservation liquid premix bag away from the freezing bag body, and a plasma Luer interface is provided on the side of the autologous plasma storage bag away from the freezing bag body.

6. A bone flap cryopreservation bag according to claim 5, characterized in that: The open end of the freezing bag body is provided with a self-sealing strip.

7. A bone flap cryopreservation bag according to claim 6, characterized in that: The freezing bag body, the cryopreservation liquid premix bag and the autologous plasma storage bag are made of acetylene vinyl acetate and fluorinated ethylene propylene copolymer.

8. A bone flap cryopreservation bag and a method of use according to claim 7, characterized in that: The following steps are involved: S1. Place the bone flap in a freezing bag and seal the opening of the freezing bag with thermoplastic; rinse the contents of the freezing bag with saline and drain the water; S2, placing the cryopreservation solution into a cryopreservation solution premix bag and completing the premixing; placing the cryopreservation solution in the cryopreservation solution premix bag into a sealed freezing bag body, soaking the bone flap, and exhausting air bubbles; S3, placing the plasma into an autologous plasma storage bag and removing air bubbles; S4, placing the entire cryopreservation bag in a program-controlled cooling device for automatic cooling or manually cooling the bag in sequence according to the program of 10 minutes at 4°C, 30 minutes at -20°C, and 16-18 hours at -80°C, and then transferring the bag to a liquid nitrogen tank for long-term storage; S5. Resuscitation process before use: Soak the entire cryopreservation bag in a 37°C water bath. When the ice crystals melt, take it out immediately to drain the cryopreservation solution. Rinse the bone flap with saline and drain the water. Squeeze the plasma in the autologous plasma storage bag into the freezing bag, invert to mix, and refrigerate at 4°C for later use.

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