Preparation method of bone meal particle / biological membrane material combined integrated material

Abstract

The invention relates to a preparation method of a bone powder particle / biological membrane material combined integrated material. The method comprises the following steps: covering a bone powder particle material with a biological membrane material; 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 as to obtain a primary hardened body; the primary hardened body is added into a pressing mold with a cavity matched with the bone defect in shape, and the biological membrane material is made to be matched with the exposed surface position of the bone defect part in the inner cavity position of the pressing mold; and the primary hardened body in the pressing mold is extruded and compacted and then shaped, and a target product is obtained. According to the preparation method of the combined integrated material, the purposes of reducing the operation difficulty, increasing the bone grafting number and relieving economic and postoperative reactions of patients are achieved.

Description

Technical Field

[0001] The invention relates to a method for preparing a bone powder particle / biomembrane material combined integrated material, belonging to the technical field of materials for bone grafting surgery. Background Art

[0002] Bone grafting is a common treatment method for bone defects in clinical practice. It requires the use of bone powder particles instead of bone graft materials and membrane barrier isolation materials. In clinical application, bone powder particles are repeatedly weighed and implanted into the bone defect site, and the bone powder particles are piled up as much as possible to shape into an anatomical shape. Then the biomembrane material is flattened and covered on the bone powder particle material. Finally, the patient's tissue is repaired and healed to form the state before the bone defect.

[0003] For bone defects that are container-shaped without enclosures, or container-shaped with low edges and defects, in clinical surgical applications, since bone powder is in granular form, the bone powder particles will slip off when adjusting the biomembrane material, increasing the difficulty of bone grafting surgery; the biomembrane material needs to be opened again and the shaped bone powder particles need to be re-stacked, resulting in a long surgical operation and repeated and cumbersome operations. In addition, after surgery, as the patient's body position and movement gravity change, the bone powder particles may slip or deform, causing the bone grafting surgery to fail to achieve the expected bone defect repair effect.

[0004] Therefore, there is a need for a combination material that is structurally stable, easy to shape, reduces the complexity of surgical operations, and can implant two materials at one time. Summary of the invention

[0005] The purpose of the present invention is to solve the problems of bone powder granular materials and biofilm materials used in existing bone grafting operations, such as difficulty in shaping granular materials and difficulty in covering biofilm materials. To this end, a method for preparing a bone powder granular / biofilm material combined integrated material is provided.

[0006] The objective of the present invention is achieved through the following technical solutions:

[0007] The present invention provides a method for preparing a bone powder particle / biofilm material combined integrated material, wherein the specific preparation steps of the method are as follows:

[0008] 1) piling bone meal particles in a sterile container and covering the bone meal particles with biofilm material;

[0009] 2) taking a non-anticoagulated blood sample and centrifuging it in a centrifuge at room temperature, completing the centrifugation before the blood coagulates, and immediately adding all the liquid above 0.5-1 mm below the buffy coat layer in the centrifuged blood onto the biofilm material in the sterile container of step 1) to combine the biofilm and the bone powder particles with the biofilm to form a gel mass;

[0010] 3) lifting the gel mass to be away from the bottom of the sterile container every 5 minutes until no bone powder particles fall off the gel mass after lifting it, thereby obtaining a preliminary hardened body;

[0011] 4) adding the preliminary hardened body obtained in step 3) into a pressing mold having a cavity matching the shape of the bone defect, so that the position of the biomembrane material in the cavity of the pressing mold matches the exposed surface position of the bone defect;

[0012] 5) The preliminary hardened body in the pressing mold is squeezed and compacted, and the excess part is removed and fixed for 10 to 20 minutes to obtain a combination of bone powder material and biofilm material whose shape matches the shape of the bone defect part.

[0013] Furthermore, in step 2), the non-anticoagulated blood sample is preferably whole blood collected from the patient's cubital forearm vein.

[0014] Furthermore, the parameters of the centrifugal separation in step 2) are a centrifugal force of 50-300 g and a centrifugal time of 1-15 minutes.

[0015] Furthermore, in step 2), the centrifugal separation operation is performed using a resin or plastic vacuum blood collection tube without any additives, which can extend the use time of the separation solution to 5-15 minutes.

[0016] Furthermore, in step 2), the centrifugation time can be reduced to 1-10 minutes by using a glass vacuum blood collection tube without any additives for centrifugation.

[0017] Furthermore, the bone powder material and biofilm material assembly prepared in step 5) is soaked in serum before being implanted into the surgical area for standby use, and the standby time is no more than 4 hours at room temperature.

[0018] Beneficial effects:

[0019] The combined integrated material preparation method of the present invention simplifies the steps of bone grafting surgery, reduces the difficulty of operation, increases the number of bone grafts, maintains the anatomical structure of the bone graft, and uses the patient's own blood to separate and concentrate the plasma (PRF precursor fluid) enriched with multiple growth factors, anti-inflammatory factors, bone induction and bone growth promoting factors, and prepares the bone powder granular material and biomembrane material in vitro to form a complete elastic whole material that can be plastic with the bone defect area, "bone powder granules + membrane material + multiple growth factors and anti-inflammatory and anti-edema factor PRF". The bone grafting surgery only requires implanting one material, namely "bone powder granules + membrane"; the surgeon does not need to pile up granular materials for shaping, and does not need to flatten and extend biomembrane materials; the three materials are implanted at the same time in an instant, and the elastic "bone powder granules + biomembrane material + multiple growth factors and anti-inflammatory and anti-edema factors (PRF)" material is squeezed after implantation to achieve the desired bone increment and anatomical shape, thereby liberating the surgeon and reducing the patient's economic and postoperative reactions. DETAILED DESCRIPTION

[0020] The present invention will be further described below with reference to the embodiments.

[0021] Example 1

[0022] 1) Pile 500 mg of Bio-Oss bone powder particles with a diameter of 0.25 mm in a sterile container and cover it with Bio-Gidee biofilm;

[0023] 2) Collecting non-anticoagulated venous whole blood using a Vacuette blood collection tube without any additives, and immediately placing the blood sample in a centrifuge after removal from the body, adjusting the centrifugal force to 100 g, and centrifuging for 15 minutes; after aspirating all the liquid above 0.5 mm below the buffy coat layer in the centrifuged blood, immediately and slowly adding it to the biofilm in the sterile container of step 1), and completely immersing the bone powder particle material in the blood extract, and observing the formation of gel agglomerates;

[0024] 3) Every 5 minutes, the gel mass is lifted up with sterile tweezers to be away from the bottom of the sterile container until no bone powder particles are scattered on the bottom of the container after lifting, thereby obtaining a preliminary hardened body;

[0025] 4) adding the bone powder gel mass formed in 3) above into a pressing mold with a cavity matching the shape of the bone defect, so that the biomembrane material is located on the exposed surface of the bone defect;

[0026] 5) The preliminary hardened body obtained in step 4) is added into a pressing mold and squeezed to be compacted, and the excess part is removed and fixed for 10 minutes to obtain a three-in-one combination of bone powder material and biofilm material whose shape matches the shape of the bone defect part.

[0027] Example 2

[0028] 1) 250 mg of bone powder particles with a diameter of 0.25 mm were piled into a sterile container, and Bio-Gide biofilm was covered on the bone powder particles;

[0029] 2) Collecting non-anticoagulated venous whole blood with a Vacuette blood collection tube without any additives, and immediately placing the blood sample in a centrifuge after ex vivo operation, adjusting the centrifugal force to 100 g, and centrifuging for 3 minutes; aspirating all the liquid above 0.5 mm below the buffy coat layer in the centrifuged blood, and immediately and slowly adding it to the biofilm in the sterile container of step 1), and completely immersing the bone powder particle material in the blood extract, and observing the formation of gel agglomerates;

[0030] 3) Every 5 minutes, the gel mass is lifted up with sterile tweezers to be away from the bottom of the sterile container until no bone powder particles are scattered on the bottom of the container after lifting, thereby obtaining a preliminary hardened body;

[0031] 4) Add the preliminary hardened body obtained in step 3) into a cavity pressing mold that fits the extraction socket, and squeeze it until it is compacted, so that the biofilm material is on the crown side of the extraction socket.

[0032] 5) The product obtained in step 4) is cured for 15 minutes to obtain a target product of a bone powder particle gel assembly having a biofilm and a tooth root shape.

[0033] Example 3

[0034] 1) Pile 100 mg of Bio-Oss bone powder particles with a diameter of 0.25 mm into a mass in a sterile container;

[0035] 2) Collecting non-anticoagulated venous whole blood with a glass vacuum blood collection tube without any additives, and immediately placing the blood sample in a centrifuge after ex vivo operation, adjusting the centrifugal force to 100 g, and centrifuging for 5 minutes; after aspirating all the liquid above 1 mm below the buffy coat layer in the centrifuged blood, immediately and slowly adding the liquid above the biofilm in the sterile container of step 1), and completely immersing the bone powder particle material in the blood extract, and observing the formation of gel agglomerates;

[0036] Soaking the bone powder particles in a blood extract to form a gel mass;

[0037] 3) Every 5 minutes, the gel mass is lifted up with sterile tweezers to be away from the bottom of the sterile container until no bone powder particles are scattered after lifting, thereby obtaining a preliminary hardened body;

[0038] 4) Add the preliminary hardened body obtained in step 3) into a horizontal pressing mold and squeeze it until it is compacted.

[0039] 5) The step 4) is cured for 10 to 15 minutes to obtain a target product of a bone powder particle gel assembly having a biofilm covering the bone defect and matching the shape of the adjacent black triangle area.

Claims

1. A method for preparing a bone powder particle / biofilm material combined integrated material, characterized in that: The specific preparation steps of this method are: 1) piling bone meal particles in a sterile container and covering the bone meal particles with biofilm material; 2) taking a non-anticoagulated blood sample and centrifuging it in a centrifuge at room temperature, completing the centrifugation before the blood coagulates, and immediately adding all the liquid above 0.5-1 mm below the buffy coat layer in the centrifuged blood onto the biofilm material in the sterile container of step 1) to combine the biofilm and the bone powder particles with the biofilm to form a gel mass; 3) lifting the gel mass to be away from the bottom of the sterile container every 5 minutes until no bone powder particles fall off the gel mass after lifting it, thereby obtaining a preliminary hardened body; 4) adding the preliminary hardened body obtained in step 3) into a pressing mold having a cavity matching the shape of the bone defect, so that the position of the biomembrane material in the cavity of the pressing mold matches the exposed surface position of the bone defect; 5) The preliminary hardened body in the pressing mold is squeezed and compacted, and the excess part is removed and fixed for 10 to 20 minutes to obtain a combination of bone powder material and biofilm material whose shape matches the shape of the bone defect part.

2. The method for preparing a bone powder particle / biofilm material combined integrated material as claimed in claim 1, characterized in that: In the step 2), the non-anticoagulated blood sample is collected from the patient's cubital venous whole blood.

3. The method for preparing a bone powder particle / biofilm material combined integrated material as claimed in claim 1, characterized in that: The parameters of the centrifugal separation in step 2) are a centrifugal force of 50-300 g and a centrifugal time of 1-15 minutes.

4. The method for preparing a bone powder particle / biofilm material combined integrated material according to claim 1, characterized in that: In the step 2), a vacuum blood collection tube made of resin or plastic material without any additives is used for centrifugal separation.

5. The method for preparing a bone powder particle / biofilm material combined integrated material according to claim 1, characterized in that: In the step 2), a glass vacuum blood collection tube without any additives is used for centrifugal separation.

6. The method for preparing a bone powder particle / biofilm material combined integrated material according to claim 1, characterized in that: Step 5) The prepared bone powder material and biofilm material assembly is soaked in serum before implantation into the surgical area for standby use at room temperature for no more than 4 hours.