阅读说明：本技术 一种富血小板纤维蛋白凝胶的分离方法 (Separation method of platelet-rich fibrin gel ) 是由 易中梅 宋娜丽 于 2021-08-20 设计创作，主要内容包括：本发明公开了医疗器械领域内的一种富血小板纤维蛋白凝胶的分离方法,用一次性无菌专用离心分装管路采集静脉全血,用离心机对采集有静脉全血的一次性无菌专用离心分装管路进行离心,用一次性无菌专用离心分装管路将离心后的红细胞和血清分离存放,血清在一次性无菌专用离心分装管路中自动凝结成富血小板纤维蛋白凝胶。本发明可解决现有技术中制备富血小板纤维蛋白凝胶的技术缺乏的问题。(The invention discloses a separation method of platelet-rich fibrin gel in the field of medical appliances, which comprises the steps of collecting venous whole blood by a disposable sterile special centrifugal subpackage pipeline, centrifuging the disposable sterile special centrifugal subpackage pipeline with the collected venous whole blood by a centrifuge, separating and storing centrifuged red blood cells and serum by the disposable sterile special centrifugal subpackage pipeline, and automatically condensing the serum into the platelet-rich fibrin gel in the disposable sterile special centrifugal subpackage pipeline. The invention can solve the problem of the lack of the technology for preparing the platelet-rich fibrin gel in the prior art.)

1. A separation method of platelet-rich fibrin gel is characterized in that: collecting the venous whole blood by using a disposable sterile special centrifugal subpackage pipeline, centrifuging the disposable sterile special centrifugal subpackage pipeline for collecting the venous whole blood by using a centrifuge, separating and storing centrifuged red blood cells and serum by using the disposable sterile special centrifugal subpackage pipeline, and automatically coagulating the serum into platelet-rich fibrin gel in the disposable sterile special centrifugal subpackage pipeline.

2. The method for separating a platelet-rich fibrin gel according to claim 1, wherein: the centrifugation process is carried out for 15min at 50g and 22 ℃ so that the blood platelets float up in the upper layer serum to form the blood platelet-rich serum.

3. The method for separating a platelet-rich fibrin gel according to claim 2, wherein: disposable aseptic special centrifugation partial shipment pipeline includes centrifugal pipeline, and centrifugal pipeline includes whole blood centrifuging tube and tail pipe, and whole blood centrifuging tube open end is connected with the end cap, and the tail pipe is connected with can dismantle the pipe of being connected with the end cap, carries out collection and the centrifugation of vein whole blood with whole blood centrifuging tube, separates the rich platelet serum preparation rich platelet fibrin gel that centrifugation came out in the splendid attire whole blood centrifuging tube with the tail pipe.

4. The method for separating a platelet-rich fibrin gel according to claim 3, wherein: separating the platelet-rich serum from the whole blood centrifugal tube to the tail tube through the conduit, thermally sealing the conduit, standing for 10-15 minutes, and automatically forming the platelet-rich fibrin gel.

5. The method for separating a platelet-rich fibrin gel according to claim 3, wherein: disposable aseptic special centrifugation partial shipment pipeline still includes the partial shipment pipeline, and the partial shipment pipeline is connected with the connecting pipe that can dismantle the connection with the end cap including the partial shipment pipe, partial shipment union coupling with the end cap of whole blood centrifuging tube to derive rich platelet serum to the partial shipment pipe in, rich platelet serum agglutinates in the partial shipment pipe and generates rich platelet fibrin gel, uses immediately on the operating table.

6. The method for separating a platelet-rich fibrin gel according to claim 5, wherein: the tail pipe and the split charging pipe are integrally formed with sawtooth tearing lines, the tail pipe or the split charging pipe is torn along the sawtooth tearing lines, and the formed platelet-rich fibrin gel is taken out and cut into a required shape for immediate use.

7. The method for separating a platelet-rich fibrin gel according to claim 6, wherein: the length of the connecting pipe is 20-30cm, the flow stopping clamp is clamped on the connecting pipe, and the flow of the platelet-rich serum is controlled by the flow stopping clamp in the process of leading the platelet-rich serum out of the whole blood centrifugal tube to the subpackaging tube.

Technical Field

The invention relates to the field of medical instruments, in particular to a separation method of platelet-rich fibrin gel.

Background

To date, platelet-rich plasma (PRP) generation 1, platelet-rich fibrin gel (PRF) generation 2, and Concentrated Growth Factor (CGF) generation 3 have been the major platelet-concentrated preparations. The platelet-rich plasma preparation technology is developed earliest, and the matched equipment and the consumables are relatively more; the third generation of concentrated growth factors only requires the pro-coagulant release of growth factors on the basis of the first generation of platelet rich plasma products. Platelet rich fibrin gel (PRF): in 2001, the 2 nd generation platelet-rich concentrate proposed by Choukroun et al, mainly consisted of polymerized fibrin, leukocytes, platelets, circulating stem cells and cytokines, without anticoagulants, and the preparation procedure was simple, platelet-rich fibrin aggregation was a slow and natural polymerization process, which was similar to the natural coagulation process, and the molecular structure of the fibrin gel obtained by preparation was very similar to fibrin in natural clots. Fibrin generated by the platelet-rich fibrin is mainly in a three-dimensional net shape, belongs to a three-molecular structure, has relatively loose gel, good elasticity and large pores, and is convenient for cell proliferation and migration, so the blood product has ideal value in the aspects of promoting wound healing and tissue repair, is a blood product rich in a large amount of growth factors, platelets and leukocytes, and has very high immunological value of leukocytes contained in the blood product. Can be pressed into film, block or cut into fragments for different tissue defects, can provide a bracket and a space for cell growth and migration in the repaired tissue, reduce local inflammatory reaction and promote the regeneration and repair of soft and hard tissues.

However, in the preparation of PRF, no medicament for preventing platelet aggregation is used during blood collection, no procoagulant is added during agglutination, the preparation method is greatly different from PRP and CGF, and the preparation technology and the matched consumables are lacked.

Disclosure of Invention

The invention aims to provide a separation method of a platelet-rich fibrin gel, so as to solve the problem of the lack of a technology for preparing the platelet-rich fibrin gel in the prior art.

In order to achieve the purpose, the basic technical scheme of the invention is as follows: a separation method of platelet-rich fibrin gel comprises collecting venous whole blood by a disposable aseptic special centrifugal subpackage pipeline, centrifuging the disposable aseptic special centrifugal subpackage pipeline with the venous whole blood by a centrifuge, separating and storing centrifuged red blood cells and platelet-rich serum by the disposable aseptic special centrifugal subpackage pipeline, and automatically coagulating the platelet-rich serum into the platelet-rich fibrin gel in the disposable aseptic special centrifugal subpackage pipeline.

The principle and the advantages of the scheme are as follows: in practical application, one condition is that the gel is prepared and used in advance, venous whole blood is collected by a whole blood centrifugal tube, centrifugal treatment is carried out by a centrifugal machine, red blood cells are settled at the lower end of the whole blood centrifugal tube, platelets are suspended in upper serum and are above the red blood cells with white blood cells, the upper serum (namely, the platelet-rich serum) is guided into a connecting tube through a guide tube, the heat seal guide tube is thermally sealed, gel is automatically formed after the gel is kept still for a period of time, the preparation is completed, and the gel can be taken out and cut for use according to use requirements. The other condition is that the whole blood centrifuge tube is used in real time, after centrifugal treatment, the connecting tube is connected with the plug, the upper layer platelet rich serum is transferred to the subpackaging tube, the connecting tube and the subpackaging tube are taken down and are agglutinated and formed on an operating table in real time, and then the whole blood centrifuge tube is used for pressing the die.

Further, the centrifugation process was performed at 50g at 22 ℃ for 15 min. The centrifugation conditions are preferably selected so that the collected venous whole blood can be sufficiently and effectively centrifuged, and at least 80% of platelets in the whole blood can be floated and suspended in the supernatant serum, and red blood cells can be effectively separated from the platelet-containing serum.

Further, disposable aseptic special centrifugation partial shipment pipeline includes centrifugal pipeline, and centrifugal pipeline includes whole blood centrifuging tube and tail pipe, and whole blood centrifuging tube open end is connected with the end cap, and the tail pipe is connected with can dismantle the pipe of being connected with the end cap, carries out the collection and the centrifugation of vein whole blood with the whole blood centrifuging tube, and the rich platelet serum that centrifugation came out in the splendid attire whole blood centrifuging tube is separated with the tail pipe prepares rich platelet fibrin gel. The optimized whole blood centrifugal tube is used for collecting the whole venous blood and centrifuging, the plug is used for sealing the opening of the whole blood centrifugal tube, the guide tube is used for guiding the separated platelet-rich serum out of the guide tube, and the tail tube is used for temporarily storing the platelet-rich serum to prepare the platelet-rich fibrin gel in real time, so that the platelet-rich fibrin gel can be quickly and conveniently prepared after the whole venous blood is collected.

Further, separating the platelet-rich serum from the whole blood centrifugal tube to the tail tube through the conduit, thermally sealing the conduit, and standing for 10-15 minutes to automatically form the platelet-rich fibrin gel. The platelet-rich serum and the red blood cells are thoroughly separated preferably, the tail tube and the whole blood centrifuge tube are reliably separated by the heat seal conduit, the platelet-rich serum can be separated from the red blood cells and can be transferred on the same blood sampling structure at any time, and the platelet-rich fibrin gel is conveniently and quickly prepared by separation.

Further, disposable aseptic special centrifugation partial shipment pipeline still includes the partial shipment pipeline, and the partial shipment pipeline is including the partial shipment pipe, and the partial shipment union coupling has the connecting pipe of dismantling the connection with the end cap, is connected with the end cap of connecting pipe and whole blood centrifuging tube and derives the partial shipment pipe with rich platelet serum, and rich platelet serum gathers immediately in the partial shipment pipe and generates rich platelet fibrin gel and uses immediately on the operating table. The serum can be preferably transferred through a split charging pipeline before the platelet-rich serum is coagulated into platelet-rich fibrin gel, so that the serum can be directly used under the conditions with high cleanliness requirements such as an operating table.

Furthermore, the tail pipe and the split charging pipe are integrally formed with sawtooth tearing lines, the tail pipe or the split charging pipe is torn along the sawtooth tearing lines, and the formed platelet-rich fibrin gel is taken out and cut into a required shape for immediate use. Preferably, after the tail tube and the dispensing tube have finished preparing the platelet-rich fibrin gel, the tail tube and the dispensing tube may be torn by the zigzag tear lines to easily take out the platelet-rich fibrin gel.

Furthermore, the length of the connecting pipe is 20-30cm, a flow stopping clamp is clamped on the connecting pipe, and the flow of the platelet-rich serum is controlled by the flow stopping clamp in the process of leading the serum out of the whole blood centrifugal pipe to the subpackaging pipe. This preferably facilitates export control of platelet rich serum.

The invention has the following advantages:

1. the collection is simple and convenient, the minimally invasive operation is realized, and a disposable sterile special centrifugal split charging pipeline is adopted; the consumable cost is low, and the burden of a patient cannot be increased additionally.

2. The acquisition environment requirement is not high, and the acquisition environment is only the common II type environment.

3. The equipment requirement is flexible, and the centrifugal machine is suitable for any centrifugal machine with appropriate centrifugal force.

4. The preparation steps are simplified, and the method can be achieved by one-time centrifugation. Compared with the autologous PRP, the waiting time for the patient to use is obviously shortened, the product can be obtained within 30min, the applicable population of the patient is expanded, and the convenience is provided for the outpatient.

5. The consumptive material has the supporting negative pressure product pipe of special partial shipment, and the product directly forms on the operating table, and aseptic technique and product quality follow laminating art person's demand, use the assurance on the operating table.

6. Can be subpackaged, frozen, and used for several times.

7. The matched pipeline is also suitable for preparing PRP, and only the corresponding dose of blood preservation solution is added into the pipeline, and the preparation methods are communicated.

Drawings

FIG. 1 is a schematic view of a whole blood centrifuge tube and a tail tube connected according to an embodiment of the present invention;

fig. 2 is a schematic structural diagram of a dispensing tube in an embodiment of the present invention.

Detailed Description

The following is further detailed by way of specific embodiments:

reference numerals in the drawings of the specification include: the whole blood centrifuge tube comprises a whole blood centrifuge tube 1, a tail tube 2, a dispensing tube 3, a catheter 4, a connecting tube 5, a plug 6, a serrated tear line 7, a hard puncture head 8 and a flow stopping clamp 9.

The embodiment is basically as shown in the attached figures 1 and 2: a separation method of platelet-rich fibrin gel comprises collecting venous whole blood with a disposable sterile dedicated centrifugal subpackaging pipeline, centrifuging the disposable sterile dedicated centrifugal subpackaging pipeline with the venous whole blood with a centrifuge at 50g and 22 ℃ for 15min, separating and storing centrifuged red blood cells and platelet-rich serum with the disposable sterile dedicated centrifugal subpackaging pipeline, and automatically coagulating the platelet-rich serum into the platelet-rich fibrin gel in the disposable sterile dedicated centrifugal subpackaging pipeline.

Disposable aseptic special centrifugation partial shipment pipeline includes whole blood centrifuging tube 1, tail pipe 2 and partial shipment pipe 3, whole blood centrifuging tube 1 is the aseptic hose of negative pressure, 1 open end of whole blood centrifuging tube is pegged graft and is had end cap 6, end cap 6 is the rubber buffer, tail pipe 2 is connected with can dismantle pipe 4 of being connected with end cap 6, pipe 4 integrated into one piece is on tail pipe 2, partial shipment pipe 3 is connected with can dismantle connecting pipe 5 of being connected with end cap 6, connecting pipe 5's length is 20-30cm, connecting pipe 5 middle part centre gripping has only to flow and presss from both sides 9, connecting pipe 5 integrated into one piece is on partial shipment pipe 3, tail pipe 2, partial shipment pipe 3, pipe 4 and connecting pipe 5 are the hose. The end parts of the conduit 4 and the connecting pipe 5 are connected with a hard puncture head 8 in a soaking and pressing way, and the hard puncture head 8 can be punctured and connected with the plug 6. The tail pipe 2 and the split charging pipe 3 are both provided with opening structures which are saw-toothed tearing lines 7 integrally formed on the guide pipe 4 and the split charging pipe 3.

The preparation method comprises the following steps of preparing and using in advance, collecting venous whole blood by using a whole blood centrifugal tube 1, carrying out centrifugal treatment by using a centrifugal machine, settling red blood cells at the lower end of the whole blood centrifugal tube 1, suspending platelets in upper serum and enabling the platelets and white blood cells to be above the red blood cells, guiding the upper platelet-rich serum into a connecting tube 5 through a conduit 4, carrying out heat sealing on the conduit 4, standing for 10-15 minutes, automatically forming platelet-rich fibrin gel, completing preparation, taking out and cutting according to use requirements. The other condition is real-time preparation and use, after the whole blood centrifuge tube 1 is subjected to centrifugal treatment, the connecting tube 5 is connected with the plug 6, the flow stopping clamp 9 is taken down to transfer the upper serum layer into the subpackaging tube 3, the connecting tube 5 and the subpackaging tube 3 are formed on an operating table in a real-time agglutination mode and then are subjected to compression molding, and the whole blood centrifuge tube is suitable for being used under the conditions with high cleanliness requirements such as the operating table. Whole blood centrifuging tube 1, tail pipe 2, partial shipment pipe 3, pipe 4, connecting pipe 5 etc. all adopt disposable plastic material aseptic processing, and the consumptive material is with low costs, can not additionally increase patient's burden, and it is not high to gather the environmental requirement, ordinary II class environment can, and the equipment demand is nimble, is applicable to any centrifuge that has suitable centrifugal force. The preparation steps are simplified, one-time centrifugation is achieved, compared with self-body PRP, the device for preparing the platelet-rich fibrin gel is more efficient, the waiting time of a patient is obviously shortened, the product can be obtained within 30min, the applicable population of the patient is expanded, and particularly, convenience is provided for outpatients.

The foregoing is merely an example of the present invention and common general knowledge of known specific structures and features of the embodiments is not described herein in any greater detail. It should be noted that, for those skilled in the art, without departing from the structure of the present invention, several changes and modifications can be made, which should also be regarded as the protection scope of the present invention, and these will not affect the effect of the implementation of the present invention and the practicability of the patent. The scope of the claims of the present application shall be determined by the contents of the claims, and the description of the embodiments and the like in the specification shall be used to explain the contents of the claims.