KR101817002B1 - Manufacturing method for β-tricalciumphosphate synthetic wedge using compression molding - Google Patents

Abstract

The present invention relates to a method for producing a synthetic bone wedge based on beta-tricalcium phosphate, and more particularly, to a method for producing a synthetic bone wedge, in which a bone- The present invention relates to a production method of a synthetic calcium carbonate wedge having the same size and shape because a compression molding mold is used as a mold.

Description

Technical Field [0001] The present invention relates to a method for producing a beta-tricalcium phosphate-based composite wedge using a compression molding mold,

The present invention relates to a method for producing a beta-tricalcium phosphate-based synthetic bone wedge, and more particularly, to a method for producing beta-tricalcium phosphate based synthetic wedge using a compression molding mold capable of producing a synthetic bone wedge having an adequate decomposition rate in vivo, To a method of manufacturing a composite golf wedge.

In general, orthopedic surgery is performed to treat arthritis and knee injuries. However, the artificial joint procedure is complicated, and it requires a large amount of autogenous bone to be removed during the procedure, and there is a limit to the treatment of knee injuries caused by artificial knee surgery because of the expected life cycle.

On the other hand, the high tibial osteotomy (HTO) can be used to treat arthritis and knee injuries simply by changing the supporting angle of the shin bone by changing the angle of the knee joint by a simple osteotomy.

This proximal tibial osteotomy has a wedge-shaped void formed at the site of operation, and a procedure is used in which the lower and upper portions of the void are fixed with the plate while the void is left empty.

However, this procedure requires a relatively long time to regenerate the bone by forming a relatively large empty space, which results in a burden on the patient and a long time for the patient to be cured.

In order to compensate for this, wedge-shaped synthetic bone wedges are currently used. However, synthetic wedge wedges that are currently in commercial use are mostly disused or partially porous, making it difficult for blood vessels and osteocytes to enter the interior. There is a problem that the foreign body remains, and the osseointegration is also limited, so that the share of the osteogenesis bone is not high.

In order to solve such a problem, Korean Patent No. 10-1493752 (hereinafter referred to as "cited invention") proposes a composite golf wedge having pores having a size of 200 to 450 μm and 0.5 to 2 μm and a manufacturing method thereof .

In the cited invention, the infiltration of blood vessels and the attachment of osteocytes through the pores are facilitated to improve the regenerating ability of the autogenous bone, but apatite hydroxide is used in manufacturing. Hydroxyapatite has excellent biocompatibility and bone conduction properties and is widely used as a bone graft material. However, it has a disadvantage in that the bone bound to the interface due to its slow degradation rate in vivo can not grow into the inside, and is not completely replaced with bone. In addition, there is a disadvantage that a synthetic bone wedge having a complicated shape must be mechanically processed.

The present invention has been made to solve the above-mentioned problems, and it is an object of the present invention to provide a beta-tricalcium phosphate based composite wedge using a compression molding mold capable of producing a synthetic bone wedge having a desired shape, And a manufacturing method thereof. It is an object of the present invention to provide a manufacturing method capable of mass-producing a composite golf wedge of the same size and shape because a compression molding mold is used as a frame.

It is an object of the present invention to produce a synthetic composite wedge by making the shape and size of the compression molding mold different from that of the compression molding mold and freely modifying the shape and size of the compression molding mold.

In order to accomplish the above object, the present invention provides a method for preparing a beta-tricalcium phosphate-based synthetic wedge using a compression molding mold, which comprises mixing beta-tricalcium phosphate (TCP), sodium, ; A second step of drying the mixture; A third step of putting the dried mixture into a mold and pressing it to form a synthetic bone wedge compact; And a fourth step of sintering the synthetic bone wedge formed body.

According to the present invention, a synthetic bone wedge using only beta-tricalcium phosphate is manufactured without using apatite hydroxide, and when the proximal tibial osteotomy is performed using the micro-pore formed on the surface of the synthetic bone, And the nano-pore, which acts as a micro-blood vessel, spreads the blood to the synthetic bone, which facilitates the inflow of blood vessels and promotes bone formation.

In addition, it has the effect that it is completely absorbed by the in vivo decomposition rate and does not leave any residue in the body.

In addition, since a compression molding mold is used as a mold, synthetic wedge wedges of the same size and shape can be mass-produced, and synthetic wedge wedges, can do.

It is possible to produce a desired composite synthetic wedge by changing the shape and size of the compression molding mold and freely modify the shape and size of the frame of the compression molding mold to obtain an economical effect of mass productivity of the synthetic composite wedge .

BRIEF DESCRIPTION OF THE DRAWINGS Fig. 1 is a view showing a mold for producing a synthetic bone wedge according to an embodiment of the present invention. Fig.
2 is a photograph showing a synthetic composite golf wedge manufactured according to an embodiment of the present invention.
FIG. 3 is an X-ray diffraction pattern graph obtained by analyzing the crystal structure of a synthetic composite wedge surface produced by an embodiment of the present invention.
FIG. 4 is an X-ray diffraction pattern graph obtained by analyzing the crystal structure of a synthetic bone wedge cut face produced by an embodiment of the present invention. FIG.
5 is a nano-CT photograph of a composite golf wedge manufactured according to an embodiment of the present invention.
6A to 6C are photographs of a synthetic composite wedge manufactured by an embodiment of the present invention by scanning electron microscopy (SEM).

In the present invention, a mixture is prepared by mixing beta-tricalcium phosphate (TCP), sodium, and a binder aqueous solution so as to produce a synthetic bone wedge having a constant shape without promoting the formation of residues in the body while promoting bone formation. ; A second step of drying the mixture; A third step of putting the dried mixture into a mold and pressing it to form a synthetic bone wedge compact; And a fourth step of sintering the synthetic bone wedge formed body. The present invention also provides a method for producing a beta-tricalcium phosphate based synthetic wedge wedge using a compression molding mold.

The scope of the present invention is not limited to the embodiments described below, and various modifications may be made by those skilled in the art without departing from the technical scope of the present invention. In particular, the size and shape of the composite golf wedge are not limited to the shapes specified in the present invention.

Hereinafter, a method of producing a beta-tricalcium phosphate-based composite composite wedge using the compression-molding mold of the present invention will be described in detail with reference to FIGS. 1 to 6. FIG.

A method for producing a beta-tricalcium phosphate-based synthetic composite wedge using the compression-molding mold of the present invention is as follows.

1. Mixture production step

In order to prepare a beta-tricalcium phosphate-based composite golf wedge using the compression molding mold of the present invention, beta-tricalcium phosphate (hereinafter referred to as beta-TCP, hereinafter collectively referred to as & , A mixture of binder aqueous solutions is produced.

The β-TCP may have a spherical or rectangular structure, and the size of the particles may be several hundred nanometers to several tens of micrometers. However, since tens of micro-sized particles have a deteriorated strength property, it is preferable to use them after filtration using a 300 mesh sieve.

It is preferable that the β-TCP and sodium are mixed at a weight ratio of 5: 1, and the mixed powder in which β-TCP and sodium are mixed is mixed with the aqueous binder solution at a weight ratio of 2.5: 1 to 3.5: 1 Do. Changes in physical properties such as crystallinity and porosity according to the mixing ratio are not unusual.

At this time, PVA (polyvinyl alcohol) or a cellulose-based binder aqueous solution may be used as the binder aqueous solution, and in the present invention, it is more preferable to use an ethyl cellulose-based binder aqueous solution belonging to the cellulose system. The binder aqueous solution is used in the process of mixing the powders and does not affect the physical properties of the synthetic bone wedge.

2. Drying stage

After the mixture is formed, the mixture is dried. It is preferable to dry the mixture in a predetermined amount to facilitate drying, and it is preferable to dry the mixture for 20 to 30 hours according to the divided amount.

3. Compression molding  step

The dried mixture is placed in a mold and pressed using a hydraulic press to form a synthetic bone wedge shaped body having a predetermined shape suitable for the portion where the proximal tibial osteotomy is performed. In this case, it is preferable that the dried mixture is finely pulverized before being put into a mold, and the mold used in the compression molding is preferably a polymer based material, and a Teflon or a polyether ether ketone (PEEK ). However, in the present invention, it is more preferable to use polyether ether ketone (PEEK).

In one embodiment, FIG. 1A shows a body of a mold, FIG. 1B shows a bottom of a mold, and FIG. 1C shows a top of a mold. When the dried mixture is introduced into the mold and pressurized, a synthetic bone wedge shaped body as shown in FIG. 2 is formed.

4. Sintering step

The synthetic bone wedge formed body formed by compression molding is sintered. At this time, the sintering temperature, that is, the sintering temperature is gradually raised and sintered, and each sintering temperature is maintained for a predetermined time. The reason for this stepwise heat treatment is to form a synthetic bone wedge consisting purely of β-TCP only.

The sintering temperature is preferably in the range of 1000 to 1200 占 폚. If the sintering temperature exceeds the above-mentioned range in the process of obtaining only β-TCP, the phase transition can be made to α-TCP, which is a high temperature type, which is lower in mechanical strength and chemical stability than β-TCP.

Therefore, it is more preferable that the composite wedge-shaped body is fired at 1180 캜 for 12 hours. The most stable β-TCP can be produced at sintering at 1180 ° C.

In addition, in the process of sintering the composite wedge formed body, the composite wedge formed body can be double shielded by using a high purity alumina ceramic. This prevents the gas penetration into the sintering furnace and maintains the partial pressure and the content of oxygen constant Thereby preventing the deterioration of the strength of the synthetic bone wedge and preventing the residual sodium that has not been volatilized during sintering from adhering to the surface of the synthetic bone wedge.

5. Sterilization step

Since the synthetic bone wedge manufactured is inserted into the human body, the sintered composite wedge shaped body can be sterilized by gamma sterilization to improve stability.

Example  - Synthetic bone  Manufacture of wedges

To a mixed powder obtained by mixing 60 g of? -TCP powder and 12 g of sodium, 23 ml of an aqueous solution of ethylcellulose binder was added and mixed for 5 minutes to prepare a mixture. The mixture is divided into about 16 g and dried in an oven at 25 ° C for 24 hours. The dried mixture is finely pulverized, placed in a mold, and press-molded at a pressure of about 2800 kg / cm 2 using a hydraulic press for 3 minutes to form a composite composite wedge compact.

Thereafter, the composite composite wedge compact is sintered at 1180 캜 for 12 hours. In the sintering process, double shielding is performed using alumina ceramics, and gamma sterilization of the sintered synthetic wedge shaped body is performed.

2, and the crystal structure of the surface is analyzed by using an X-ray diffraction pattern graph. As shown in FIG. 4, when the crystal structure of the cut surface is analyzed, As shown in FIG. This is similar to the X-ray diffraction pattern graph of pure β-TCP. When the proximal tibial osteotomy using the synthetic bone wedge produced by the present invention is performed, it is completely absorbed by the in vivo dissolution rate and remains in the body There is an effect that does not.

The synthetic bone wedge thus manufactured is photographed by nano-CT, as shown in FIG. 5, and is observed by a scanning electron microscope (SEM) as shown in FIGS. 6A to 6C. 5 and 6, micro-pores and nano-pores can be identified. Micro-pores formed on the surface of the synthetic bone allow blood to be rapidly absorbed and synthesized through a nano-pore Because the blood spreads to every corner of the bone, blood flow is facilitated and bone formation is promoted.

Claims (8)

A first step of mixing a beta-tricalcium phosphate (TCP), sodium, aqueous binder solution to form a mixture;
A second step of drying the mixture;
A third step of putting the dried mixture into a mold and pressing it to form a synthetic bone wedge compact; And
A fourth step of sintering the composite wedge formed body;
Wherein the step of forming the composite wedge comprises the steps of: The method according to claim 1,
Wherein the fourth step is to maintain the sintering temperature for a predetermined period of time and to sinter the synthetic composite wedge formed body. 3. The method of claim 2,
Wherein the fourth step has a sintering temperature of 1180 ° C. The method according to claim 1,
Wherein the fourth step further comprises a double shielding treatment of the synthetic bone wedge formed body using high purity alumina ceramics. ≪ RTI ID = 0.0 > 8. < / RTI > The method according to claim 1,
In the first step, mixed powder of β-tricalcium phosphate (TCP) and sodium is mixed at a weight ratio of 5: 1, and the mixed powder and the binder aqueous solution are mixed at a weight ratio of 2.5: 1 to 3.5: To produce a mixture. ≪ RTI ID = 0.0 > 8. < / RTI > The method according to claim 1,
Wherein the sintered synthetic bone wedge formed body is subjected to a gamma sterilization treatment after the fourth step, and then the beta-tricalcium phosphate based composite wedge is produced. delete delete

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