Preparation method of PRF / biological membrane material combined integrated material

Abstract

The invention relates to a preparation method of a PRF / biological membrane material combined integrated material. The method comprises the following steps: putting a biological membrane material into a sterile container; after a non-anticoagulant blood sample is centrifuged, adding all liquid which is 0.5-1mm below the albuginea layer to the upper part of the biological membrane material, so that the biological membrane material is completely soaked in the sucked-out PRF precursor liquid; lifting the biological membrane material every 5 minutes until the biological membrane material is separated from the inner bottom of the sterile container until the liquid below the biological membrane material is in a non-flowing state, so as to obtain PRF precursor liquid and biological membrane material solidified gel; and extruding and compacting the PRF precursor liquid and the biological membrane material curing gel by adopting a sterile appliance, shaping for 10-20 minutes, and trimming according to the shape of the soft tissue defect to obtain the PRF and biological membrane material combination. According to the preparation method of the combined integrated material, the purposes of reducing the material taking operation of one donor zone, reducing the operation difficulty and relieving the economic and postoperative reaction of a patient are achieved.

Description

TECHNICAL FIELD

[0001] The application relates to a PRF / biomembrane material combined integrated material preparation method, and belongs to the technical field of soft tissue increment and post-bone grafting covering biomembrane surgical materials. BACKGROUND

[0002] Soft tissue increment surgery is a clinical treatment method for soft tissue deficiency. In clinical surgery, there are two operation areas of soft tissue donor area and recipient area. The patient's autologous soft tissue (donor area) is implanted into the soft tissue deficiency area (recipient area) to achieve the purpose of soft tissue increment. In addition, the soft and hard tissue barrier membrane is implanted in the bone grafting to avoid the large difference in growth rate between the soft and hard tissue operation areas, resulting in unsatisfactory bone tissue repair healing using the biomembrane barrier effect.

[0003] The soft tissue deficiency collects the patient's soft tissue in the donor area and implants it into the soft tissue defect in the recipient area. At the same time, the patient forms two surgical wounds. The surgical technique is difficult during the operation, and it increases the patient's fear and pain. In addition, there are two wounds that need to be anti-inflammatory and anti-edema for good healing. The operation of two operation areas increases the operation time and risk.

[0004] Recently, many reports use PRF in autologous blood to achieve the purpose of soft tissue increment. Traditional PRF preparation is to collect autologous venous whole blood in a blood collection tube to prepare a piece of PRF. The volume is limited by the diameter of the blood collection tube and the amount of PRF in autologous blood. In addition, PRF is slippery and soft, and it is difficult to achieve connection between multiple PRF implants and not to slip. It is more difficult to suture with autologous tissue.

[0005] Biomembrane material is used to isolate soft and hard tissue in bone grafting. It is mostly allogeneic material, and its comprehensive ability to improve the tissue repair efficiency and anti-inflammatory of the patient's operation area is weak. Various functional cytokines from PRF have anti-inflammatory, anti-edema and healing effects. The combination of PRF membrane and biomembrane makes up for each other's deficiencies. Various functional white blood cells in PRF can cross or stay in the biomembrane during in vitro preparation. Not only can it overcome the defect that the hard tissue cannot be tightly closed due to soft tissue deficiency in bone grafting, but also the PRF cells, i.e. cytokines, can resist local tissue inflammation, anti-edema, reduce pain, promote soft and hard tissue cell division and proliferation, and promote tissue healing.

[0006] The biomembrane and PRF membrane are implanted twice in the operation process of bone grafting. Some biomembranes become soft and deformed when they encounter blood in the operation area. In addition, some biomembranes have the defects of large hardness, supporting autologous soft tissue and being difficult to suture.

[0007] Therefore, a method for preparing PRF gel material of different sizes and volumes and a PRF / biological membrane material combined material is needed, which has small trauma, is easy to obtain, has stable structure, is easy to operate, reduces the complexity of surgical operation, can prepare PRF gel material of different sizes and volumes, and can obtain a combined material of two materials. SUMMARY

[0008] The purpose of the present application is to solve the problems of long operation time, patient physical and mental pain and fear in two operation areas, difficulty in covering PRF film and biological membrane material, and size limitation of traditional PRF gel in soft tissue augmentation surgery. Therefore, a PRF gel material of different sizes and volumes is prepared, and a PRF / biological membrane material combined material preparation method is prepared.

[0009] The purpose of the present application is achieved by the following technical scheme:

[0010] The PRF / biological membrane material combined material preparation method of the present application has the following specific preparation steps:

[0011] 1) A sterile container is prepared according to the size of the soft tissue defect, and the biological membrane material is placed in the sterile container;

[0012] 2) A non-anticoagulated blood sample is taken and centrifuged at room temperature. Before blood coagulation, all PRF precursor liquid above 0.5-1mm below the white membrane layer in the centrifuged blood is sucked and immediately added to the biological membrane material in the sterile container in step 1), so that the biological membrane material is completely soaked in the sucked PRF precursor liquid;

[0013] 3) The biological membrane material is lifted every 5 minutes to separate from the bottom of the sterile container until the liquid below the biological membrane material is in a non-flowing state, and a PRF precursor liquid and biological membrane material solidified gel is obtained;

[0014] 4) The PRF precursor liquid and biological membrane material solidified gel obtained in step 3) is extruded and compacted by a sterile instrument, and after shaping for 10-20 minutes, it is trimmed according to the shape of the soft tissue defect to obtain a PRF and biological membrane material combination.

[0015] Further, the non-anticoagulated blood sample in step 2) is preferably collected from the patient's elbow forearm vein.

[0016] Further, the parameters for centrifugal separation in step 2) are centrifugal force of 50-300g and centrifugal time of 1-15 minutes.

[0017] Further, the centrifugal separation operation in step 2) is performed using a resin material and a plastic vacuum blood collection tube without any additive, which can prolong the use time of the separation liquid to 5-15 minutes.

[0018] Further, the step 2) is centrifuged by the glass material vacuum blood collection tube without any additive, which can reduce the centrifugation time to 1-10 minutes.

[0019] Further, the step 2) is centrifuged by the glass material vacuum blood collection tube without any additive, which can reduce the centrifugation time to 1-10 minutes.

[0020] Further, the step 2) is centrifuged by the glass material vacuum blood collection tube without any additive, which can reduce the centrifugation time to 1-10 minutes.

[0021] Beneficial effects:

[0022] The combined integrated material preparation method of the application simplifies the steps of the operation, reduces one operation of taking material from the supply area, reduces the operation difficulty, uses the patient's autologous blood to separate, concentrate and enrich the plasma (PRF precursor fluid) of various growth factors, anti-inflammatory factors and induced soft tissue epithelial cell factors. The PRF precursor fluid in the plurality of blood collection tubes is taken out in vitro to synthesize PRF blocks of different sizes; PRF and biological membrane material can also be prepared in vitro to form a complete elastic membrane material that can be trimmed according to the shape of the receiving area, "biological membrane material + PRF of various growth factors and anti-inflammatory and anti-edema factors". Soft tissue augmentation surgery only needs one surgical wound, i.e. the soft tissue defect area, and directly implants the autologous extruded and compacted PRF gel material prepared according to the defect volume; in bone grafting, the isolation barrier membrane is implanted once with the material "PRF + biological membrane"; the operator does not need to lay and extend the biological membrane material; by extruding the elastic "biological membrane material + PRF of various growth factors and anti-inflammatory and anti-edema factors" after implantation, the isolation of soft and hard tissues is achieved, at the same time, the PRF in contact with the soft tissue reduces postoperative local tissue edema, reduces pain, promotes tissue healing, etc., and achieves the purpose of freeing the operator, reducing the patient's economic burden and postoperative reaction. DETAILED DESCRIPTION

[0023] The content of the application will be further described below in combination with examples.

[0024] Example 1

[0025] 1) According to the required volume of the operation area, prepare a sterile container and put Bio-Gide biological membrane in it;

[0026] 2) Prepare 2 Vacuette vacuum blood collection tubes without any additives to collect non-anticoagulated venous whole blood. Immediately after blood sample collection, centrifuge the blood sample in a centrifuge at 100g for 15 minutes. After centrifugation, collect the whole PRP precursor fluid from the blood sample above 0.5mm below the buffy coat layer and immediately add the PRP precursor fluid to the Bio-Gide biomembrane in the sterile container of step 1) and press the biomembrane material into the PRP precursor fluid using sterile tweezers;

[0027] 3) Lift the biomembrane material every 5 minutes until the liquid under the biomembrane material is in a non-flowing state to obtain a solidified gel of PRP precursor fluid and biomembrane material;

[0028] 4) Compact the solidified gel of step 3) using a sterile flat instrument to squeeze out the water from the solidified gel;

[0029] 5) Trim the preliminary hardened body of step 4) according to the shape of the soft tissue defect and remove the excess part to obtain a PRP and biomembrane material combination having a shape matching the exposed surface of the bone powder in the maxillary sinus windowing surgery area and implant the PRP and biomembrane material combination into the surgery area.

[0030] Example 2

[0031] 1) Prepare a sterile container according to the required volume of the surgery area and place Bio-Gide biomembrane into the sterile container;

[0032] 2) Prepare 4 Vacuette vacuum blood collection tubes without any additives to collect non-anticoagulated venous whole blood. Immediately after blood sample collection, centrifuge the blood sample in a centrifuge at 100g for 3 minutes. After centrifugation, collect the whole PRP precursor fluid from the blood sample above 0.5mm below the buffy coat layer and immediately add the PRP precursor fluid to the Bio-Gide biomembrane in the sterile container of step 1) and press the biomembrane material into the PRP precursor fluid using sterile tweezers;

[0033] 3) Lift the biomembrane material every 5 minutes until the liquid under the biomembrane material is in a non-flowing state to obtain a solidified gel of PRP precursor fluid and biomembrane material;

[0034] 4) Compact the solidified gel of step 3) using a sterile flat instrument to squeeze out the water from the solidified gel;

[0035] 5) Trim the preliminary hardened body of step 4) according to the shape of the soft tissue defect and remove the excess part to obtain a PRP and biomembrane material combination having a shape matching the exposed surface of the bone powder in the maxillary sinus windowing surgery area and implant the PRP and biomembrane material combination into the surgery area.

[0036] Example 3

[0037] 1) Prepare a sterile container according to the required volume of the surgical area, and place the Lando biomembrane in the sterile container;

[0038] 2) Prepare 4 BD glass vacuum blood collection tubes without any additives to collect non-anticoagulated venous whole blood. Immediately after blood sampling, centrifuge the blood samples in a centrifuge at 150g for 3 minutes. After centrifugation, remove all the liquid above 1 mm below the white membrane layer in the blood, and immediately add it to the biomembrane in the sterile container of step 1), and use sterile forceps to completely press the biomembrane material into the blood to extract the PRF precursor liquid;

[0039] 3) Lift the biomembrane material every 5 minutes until the liquid below the biomembrane material is in a non-flowing state, and obtain a PRF precursor liquid and biomembrane material solidified gel;

[0040] 4) Firm the solidified gel formed in step 3) with a sterile flat instrument, and squeeze out the water therein;

[0041] 5) Trim the preliminary hardened body obtained in step 4) according to the shape of the gum recession, and remove the excess part, and implant the PRF biomembrane gel into the defect site of the gum papilla to make the receded gum papilla full and plump.

[0042] Example 4

[0043] 1) Prepare a sterile container according to the required volume of the surgical area, and place the Lando biomembrane in the sterile container;

[0044] 2) Prepare 4 BD glass vacuum blood collection tubes without any additives to collect non-anticoagulated venous whole blood. Immediately after blood sampling, centrifuge the blood samples in a centrifuge at 120g for 3 minutes. After centrifugation, remove all the liquid above 1 mm below the white membrane layer in the blood, and immediately add it to the biomembrane in the sterile container of step 1), and use sterile forceps to completely press the biomembrane material into the blood to extract the PRF precursor liquid;

[0045] 3) Lift the biomembrane material every 5 minutes until the liquid below the biomembrane material is in a non-flowing state, and obtain a PRF precursor liquid and biomembrane material solidified gel;

[0046] 4) Firm the solidified gel formed in step 3) with a sterile flat instrument, and squeeze out the water therein;

[0047] 5) Trim the preliminary PRF+biomembrane hardened body obtained in step 4) according to the shape of the thin gum and the shape of the gum recession caused by the thin gum, and remove the excess part, and implant the PRF gel under the thin gum to completely cover the originally exposed white bone, increase the gum thickness, and reduce the risk of continued gum recession.

Claims

1. A method for preparing an integrated PRF / biofilm material combination, characterized in that, The specific preparation steps of this method are as follows: 1) Prepare a sterile container according to the size of the soft tissue defect, and put the biofilm material into the sterile container; 2) Take a non-anticoagulated blood sample and centrifuge it at room temperature. Before blood agglutination, aspirate all the PRF precursor fluid above 0.5-1 mm below the white membrane layer in the centrifuged blood and immediately add it to the biofilm material in the sterile container in step 1), so that the biofilm material is completely immersed in the aspirated PRF precursor fluid. 3) Every 5 minutes, lift the biofilm material until it is detached from the bottom of the sterile container until the liquid below the biofilm material is no longer flowing, thus obtaining the PRF precursor liquid and the solidified gel of the biofilm material. 4) Using sterile instruments, the PRF precursor solution and biofilm material solidified gel obtained in step 3) are squeezed together and shaped for 10-20 minutes. Then, the mixture is trimmed according to the shape of the soft tissue defect to obtain the PRF and biofilm material combination.

2. The method for preparing a PRF / biofilm material integrated composite material as described in claim 1, characterized in that, In step 2), non-anticoagulated blood samples are collected from the patient's elbow and forearm veins to obtain whole blood.

3. The method for preparing a PRF / biofilm material integrated composite material as described in claim 1, characterized in that, The parameters for centrifugation in step 2) are centrifugal force 50-300g and centrifugation time 1-15 minutes.

4. The method for preparing a PRF / biofilm material integrated composite material as described in claim 1, characterized in that, In step 2), vacuum blood collection tubes made of resin or plastic material without any additives are used for centrifugal separation.

5. The method for preparing a PRF / biofilm material integrated composite material as described in claim 1, characterized in that, In step 2), a vacuum blood collection tube made of glass material without any additives is used for centrifugal separation.

6. The method for preparing a PRF / biofilm material integrated composite material as described in claim 1, characterized in that, Step 4) The prepared PRF and biomembrane material combination is soaked in serum before implantation into the surgical area for a period of no more than 4 hours at room temperature.