KR100677871B1 - Apparatus and method for forming bone filler - Google Patents

Abstract

An apparatus and a method for forming a bone filler are provided to form bone fillers having a predetermined shape through a process of pressurizing and discharging bone fillers in a slurry state and to prevent change of property of bone filler during sintering process. The apparatus for forming bone filler includes a bone filler receiving cell(210), a pressurizing unit(220) and a hole forming body(230). In the bone filler receiving cell(210), a receiving space of bone filler is prepared and a discharge nozzle(213) through which the bone filler is discharged is prepared. The pressurizing unit(220) discharges the bone filler through the discharge nozzle(213). The hole forming body(230) is coupled with the bone filler receiving cell(210) to make a hole in the center of the bone filler. The hole forming body(230) has a hollow core(232) and a hole forming main body(234).

Description

Apparatus and method for forming bone filler

1 is a block diagram of a bone filler manufacturing system having a bone filler molding apparatus according to an embodiment of the present invention.

Figure 2 is an exploded perspective view of the bone filler forming apparatus according to an embodiment of the present invention.

3 is a cross-sectional view of the bone filling material forming apparatus of FIG.

4 illustrates a detail A of FIG. 3;

   4 (a) is an enlarged view,

   4B is a plan view.

5 is a cross-sectional view showing a state in which the piston of the bone filler forming apparatus of FIG. 2 is raised to the maximum.

6 is a cross-sectional view showing the shape when the bone filler is injected into the bone filler forming apparatus of FIG.

7 is a side view of FIG. 6.

8 is a partial cross-sectional view showing a bone filler molding process by the bone filler molding apparatus of FIG.

9 is an enlarged perspective view illustrating the bone filler formed by the bone filler forming apparatus of FIG. 2.

10 is a cross-sectional view showing an example of a grinding device provided in the bone filler material manufacturing system of FIG.

FIG. 11 is a scanning electron microscope (SEM) photograph of the bone filling material ground by the grinding apparatus of FIG. 10.

12 is a flow chart of a bone filler manufacturing method including a bone filler molding method by the bone filler molding apparatus of FIG.

FIG. 13 is a flowchart of a bone filler molding method using the bone filler molding apparatus of FIG. 2.

Explanation of symbols on the main parts of the drawings

200: forming apparatus 210: cylinder

213: discharge nozzle 230: hollow body

232: hollow core 220: piston

222: piston rod 250: elastic body

The present invention relates to a bone filler molding apparatus and a bone filler molding method, and more particularly, it is possible to eliminate the possibility of changing the physical properties of the bone filler during the sintering process, and to easily control the strength of the bone filler, The present invention relates to a bone filler molding apparatus and a bone filler molding method which can reduce unnecessary material loss of the filler and do not form a sharp surface that may damage living cells in the bone filler.

In general, when a part of bone tissue is missing or needs reinforcement at a specific part of the living body, bone is implanted at that part. As such, when bone is transplanted in vivo, the transplanted bone induces the formation of new bone at the transplantation site, and the transplanted bone itself is gradually or partially disintegrated. Is mostly filled by newly created goals.

Here, the bone transplanted into a living body is generally used by mixing a portion of bone tissue in the living body and artificial bone artificially made of a material such as ceramics. At this time, artificial bone is often referred to as bone filler or bone substitute.

These bone fillers are often manufactured using a calcium phosphate compound, which is a ceramic material, which is similar to a bone component in a living body composed mainly of phosphorus (P) and calcium (Ca). Therefore, even if the calcium phosphate-based compound is implanted in vivo, because it induces the formation of new bone without causing physiological and immune rejection. In addition to ceramic materials, calcium sulfate (CaSO ₄ ) and calcium carbonate (CaCO ₃ ) are also reported to be stable as in vivo implants.

In addition, the bone filler is prepared, including the step of slurrying the bone filler material (slurry, a mixture of solid and liquid with fluid containing insoluble solid fine particles in suspension), sintering, sieving after grinding Is made by the way. Slurrying the bone filler material is a step of slurrying by mixing and stirring the bone filler material and a pore-forming agent for forming pores in the bone filler material, and the sintering step is hard by sintering the bone filler material at a high temperature. It is a step of forming a tissue, and sieving after pulverization is a step of sintering the sintered bone filler to filter the crushed bone filler by sieving.

According to the conventional method for preparing bone filler, when the calcium phosphate-based compound is used as a raw material, the sintering temperature required to harden the calcium phosphate-based compound to an appropriate degree is very high, so the physical properties of the calcium phosphate-based compound during the sintering process, In particular, the decomposition rate in vivo is changed, there was a problem that it is difficult to control the strength of the bone filler.

In addition, according to the conventional method for preparing bone filler, since the step of sieving after crushing, the bone filler that is not crushed to the appropriate size required can not be used and must be discarded, so that loss of unnecessary material is generated, crushed bone filler There was a problem in that a sharp portion on the surface of the stimulation to damage the biological cells are formed.

Therefore, an object of the present invention, it is possible to eliminate the possibility of changing the physical properties of the bone filler in the sintering process than before, it is easy to adjust the strength of the bone filler, reduce unnecessary material loss of the bone filler, The present invention provides a bone filler molding apparatus and a bone filler molding method that do not form a sharp surface that may damage living cells.

The above object, according to the present invention, there is provided a receiving space of the bone filling material therein bone filling material receiving cell provided with a discharge nozzle is discharged bone filling material; And a pressurizing means for discharging the bone filler through the discharge nozzle.

Here, it is preferable to further include a hollow body coupled to the bone filler material receiving cell so that the hollow is formed in the central portion of the bone filler.

The hollow body may include a hollow core spaced apart from the outlet of the discharge nozzle and positioned at the center of the outlet; And it may be installed in the bone filler material receiving cell may include a hollow body to support the hollow core.

In addition, it is preferable that the cross section of the hollow body is smaller than the cross section of the bone filler material cell so that the bone filler can pass between the bone filler material and the hollow body.

The bone filler material receiving cell may be a cylindrical cylinder provided with a discharge nozzle at one end thereof, and the pressing means may be a piston provided in a reciprocating manner in the cylinder.

Further, the discharge nozzle is preferably an inclined nozzle connected to the end of the cylinder and gradually smaller in diameter along its longitudinal direction.

And, it is preferable that a packing for sealing the inside of the cylinder is coupled to the lower end of the piston.

In addition, the piston, the piston rod is installed in the cylinder to reciprocate the inside of the cylinder, the piston rod for pressing the bone filler; And a handle provided at the piston rod, wherein the bone filler forming apparatus is coupled to an upper end of the cylinder, and a through tube through which the piston rod passes; An elastic body disposed above the through tube; And it is preferable to further include a through-tube receptor for receiving the through-tube and the elastic body, rotatably coupled to the cylinder.

The bone filler may be any one selected from calcium phosphate compounds, calcium sulfate (CaS0 ₄ ) and calcium carbonate (CaCO ₃ ); And a pore-forming agent mixed with the calcium phosphate-based compound to form pores in the bone filler during the sintering process.

The calcium phosphate compounds include calcium triphosphate (TCP, Ca ₃ (PO ₄ ) ₂ , Tricalcium Phosphate), calcium phosphate (TeCP, Ca ₄ O (PO) ₂ , Tetracalcium Phosphate), calcium diphosphate (DCPD, CaHPO). ₄ (H ₂ 0) ₂ , Dicalcium Phosphate Dihydtate) and hydroxyapatite (HA, Ca ₅ (PO ₄ ) ₃ (OH) ₂ , Hydroxyapatite) may be at least one selected from.

The pore-forming agent may be at least one selected from polymethyl methacrylate (PMMA, Poly Methyl Meta Acrylate), starch, and naphthalene (C ₁₀ H ₈ ).

In addition, the diameter of the hollow core may be in the range of 100 μm to 1000 μm.

On the other hand, the object, the step of injecting the bone filler in the inner receiving space of the bone filler material receiving cell is provided with a discharge nozzle for discharging the bone filler; Pressing the injected bone filler; And discharging the bone filler through the discharge nozzle.

Here, the step of discharging the bone filler is preferably the step of discharging the bone filler through the hollow core provided in the center of the discharge nozzle to form a hollow in the center of the bone filler.

In order to fully understand the present invention, the operational advantages of the present invention, and the objects achieved by the practice of the present invention, reference should be made to the accompanying drawings which illustrate preferred embodiments of the present invention and the contents described in the accompanying drawings.

Hereinafter, exemplary embodiments of the present invention will be described in detail with reference to the accompanying drawings.

1 is a block diagram of a bone filler manufacturing system having a bone filler molding apparatus according to an embodiment of the present invention.

As shown in the figure, the bone filler manufacturing system 1000 having a bone filler forming apparatus according to an embodiment of the present invention, a system for manufacturing a bone filler having a porous structure, the raw material and additives of bone filler A mixing device 100 for mixing and slurrying, a molding device 200 for molding the mixed bone filler in a predetermined shape, a drying device 300 for drying the molded bone filler, and dried bone A cutting device 400 for cutting the filler to a certain length, a sintering device 500 for sintering the bone filler cut to a predetermined length, and a grinding device 600 for grinding the sintered bone filler.

The mixing device 100 is a component that slurries the bone filler by uniformly mixing the raw material of the bone filler, the pore-forming agent and other additives. The mixing device 100 preferably uses a tank type mixing device such that the mixture has a uniform composition by stirring the mixture through an impeller rotationally driven by a motor, but the scope of the present invention is not limited thereto. No. Any thing can be used as long as the bone filler can be uniformly mixed and slurried.

As a raw material of the bone filler, any one selected from calcium phosphate compounds, calcium sulfate (CaS0 ₄ ) and calcium carbonate (CaCO ₃ ) may be used, but the scope of the present invention is not limited thereto. In addition, hereinafter, a case where a calcium phosphate-based compound is applied as a raw material of bone filler will be described, and this description is similarly applied even when calcium sulfate (CaS0 ₄ ) or calcium carbonate (CaCO ₃ ) is used as a raw material of bone filler. Can be.

Calcium phosphate compounds as raw materials for bone fillers include calcium triphosphate (TCP, Ca ₃ (PO ₄ ) ₂ , Tricalcium Phosphate), calcium phosphate (TeCP, Ca ₄ O (PO) ₂ , Tetracalcium Phosphate), calcium diphosphate ( Although at least one of DCPD, CaHPO ₄ (H ₂ 0) ₂ , Dicalcium Phosphate Dihydtate, and hydroxyapatite (HA, Ca ₅ (PO ₄ ) ₃ (OH) ₂ , Hydroxyapatite) is preferably selected and used, The scope of the invention is not limited thereto.

The pore-forming agent is mixed with the calcium phosphate-based compound and volatilized in the process of sintering the bone filler by the sintering apparatus 500 described later to form pores in the bone filler (Micro-pore). The bone filler may be a porous structure by the formation of pores, and thus, when implanted in a living body, blood easily penetrates into the pores to effectively support bone formation. As the pore-forming agent, it is preferable to select and use at least one of polymethyl methacrylate (PMMA, Poly Methyl Meta Acrylate), starch, and naphthalene (C ₁₀ H ₈ ), but the scope of the present invention Is not limited thereto.

Other additives include solutions for slurrying the raw material of the bone filler, sintering additives to improve the sintering power of the bone filler, foaming agents to assist in the formation of pores, and the like. Cast oil (Cast-Oil) is used as a solution for slurrying raw materials of bone filler, polyethylene glycol (PEG, Poly Ethylene Glycol) is used as a sintering additive, and hydrogen peroxide (H ₂ O) is used as a blowing agent. ₂ ) is preferably used, but the scope of the present invention is not limited thereto.

Hereinafter, the bone filler forming apparatus 200 will be described with reference to FIGS. 2 to 9.

Figure 2 is an exploded perspective view of the bone filler molding apparatus according to an embodiment of the present invention, Figure 3 is a cross-sectional view of the bone filler molding apparatus of Figure 2, Figure 4 is a detailed view of the portion A of FIG. 4 (a) is an enlarged view, Figure 4 (b) is a plan view, Figure 5 is a cross-sectional view showing a state in which the piston of the bone filling material forming apparatus of Figure 2 is raised to the maximum, Figure 6 is Fig. 7 is a sectional view showing the shape when the bone filler is injected into the bone filler forming apparatus, Fig. 7 is a side view of Fig. 6, and Fig. 8 is a partial sectional view showing the bone filler molding process by the bone filler molding apparatus of Fig. 2. 9 is an enlarged perspective view illustrating the bone filler formed by the bone filler molding apparatus of FIG. 2.

The bone filler forming apparatus 200 is a device for molding the bone filler slurried by the mixing device 100 into a predetermined shape, and the bone filler containing cell 210 in which the bone filler is accommodated, that is, the cylinder 210 of the present embodiment. And, the piston 220 to pressurize and discharge the bone filler, the hollow body 230 to form a hollow in the discharged bone filler, and the through tube coupled to the upper end of the cylinder 210 to support the piston 220 ( 240, an elastic body 250 that provides elastic force to the through tube 240, and a through tube receiver 260 that accommodates the through tube 240 and the elastic body 250.

The cylinder 210 is a component in which the bone filler mixed in the slurry state is accommodated by the above-described mixing device 100, the cylinder body 211 in which the bone filler is accommodated, and the discharge nozzle 213 in which the bone filler is discharged. It is provided.

The cylinder body 211 provides a space in which the bone filler is accommodated. For this purpose, the bone filler material receiving space 215 is provided therein. In addition, the outer surface of the lower portion of the cylinder body 211 is preferably formed with a plurality of protrusions and protrusions 217 to easily grip the cylinder 210.

The discharge nozzle 213 is a component that allows the bone filler contained in the cylinder body 211 to be discharged. To this end, a discharge port 213a through which the bone filler is discharged is provided at the lower end of the discharge nozzle 213, and according to the shape and size of the discharge hole 213a, the shape of the outer surface of the bone filler discharged through the discharge nozzle 213 and The size is determined.

In the present embodiment, the discharge port 213a is in the shape of a circle and its diameter is substantially 1 mm, but is not limited thereto, and may be any closed curve such as a polygon and the size thereof may also be changed as necessary. have. In addition, in this embodiment, the outlet 213a is provided as one, but the scope of the present invention is not limited thereto, and a plurality of bone fillers are provided at one bone filler molding apparatus 200 at the same time. It may also be ejected molded.

In addition, the discharge nozzle 213 is provided as an inclined nozzle in which the diameter gradually decreases along the longitudinal direction of the cylinder body 211, thereby allowing the bone filler to receive a stronger compressive force in the process of being pressurized and discharged. The hollow body 230 to be described later may be easily installed inside the cylinder 210.

The piston 220 is a component for pressurizing and discharging the bone filler contained in the cylinder 210, the piston rod 222 for reciprocating the inside of the cylinder 210 and pressurizing the bone filler, and the upper end of the piston rod 222 And a piston handle 224 provided to allow the user to easily grip the piston 220, and a packing 226 provided at the lower end of the piston rod 222 to seal the inside of the cylinder 210.

The piston rod 222 is a component that reciprocates inside the cylinder 210 and pressurizes the bone filler contained in the cylinder 210, one end of which is connected to the piston handle 224 and the other end of which is connected to the packing 226. And pressurizes the bone filler by transferring the pressure applied to the piston handle 224 to the packing 226.

The piston handle 224 is a component that allows a user to easily grip the piston 220 and to effectively transmit force to the piston rod 222. To this end, the piston handle 224 is provided in a shape close to the bar (bar) as a whole is provided to be substantially perpendicular to the piston rod 222.

The packing 226 is a component that allows the piston rod 222 to pressurize while being in close contact with the inner wall of the cylinder 210. Therefore, the packing 226 uses a high elastic rubber material to improve adhesion with the cylinder 210, but the scope of the present invention is not limited thereto, and other materials having elasticity may be used. And, the packing 226 is provided in a cylindrical shape having a packing groove 226a formed in the upper portion, the lower end of the piston rod 222 is inserted into the packing groove 226a to receive the pressing force from the piston rod 222 It delivers to the bone filler contained in the cylinder (210).

As such, in the present embodiment, but selected as a means for pressing the bone filler contained in the cylinder 210 by using the piston 220, the scope of the present invention is not limited to this, the cylinder 210, such as a shared pressure method Any configuration may be adopted as long as the bone filler can be discharged by pressurizing it.

The hollow body 230 is a component for forming a hollow (macro-pore) in the bone filler discharged from the cylinder 210, the hollow core 232 for forming a hollow in the bone filler, and the hollow core ( A hollow body 234 supporting 232.

The hollow core 232 is a component for forming a hollow inside the bone filler discharged through the discharge port 213a of the discharge nozzle 213. Here, the hollow is like the pores formed by the pore-forming agent, when the bone filler is implanted in vivo, the body fluid including blood penetrates into the hollow so that bone is effectively generated, and the generated bone cells are adsorbed (site) ) To prevent the escape of generated bone cells. As such, the hollows may be regarded as a kind of pores because the pores and the forming method perform substantially the same role as the pores, and in this respect, the hollows may be referred to as macro-pores. In order to form such a hollow in the bone filler, the hollow core 232 is provided in the shape of a cylinder and one end is provided so as to be located in the center of the outlet 213a. In this embodiment, the hollow core 232 has a circular cross section and a diameter of 100 μm to 1000 μm, but the scope of the present invention is not limited thereto.

The hollow body 234 is a component that supports the hollow core 232 protruding from the bottom of the hollow body 234 so as to be installed in the cylinder 210. To this end, the hollow body 234 is provided in a rectangular parallelepiped shape is installed on the inner upper end of the discharge nozzle 213, the installation is simply by the geometry of the hollow body body 234 and the discharge nozzle (213) Is done. That is, when the hollow body 234 is located at the inner upper end of the discharge nozzle 213, each corner formed at four sides of the hollow body 234 is in contact with the inner wall of the discharge nozzle 213. In the state, since the discharge nozzle 213 is an inclined nozzle whose diameter decreases downward, the hollow-form body 234 can no longer move downward. Therefore, since the hollow body 234 is not fixed inside the cylinder 10 by a coupling method such as fastening, the hollow body 230 may be separated from the cylinder 210 if necessary.

In addition, as shown in (b) of FIG. 4, since the free space 215a is formed between the hollow body body 234 installed inside the cylinder 210 and the inner wall of the cylinder 210, the bone filler is In the process of being discharged through the discharge nozzle 213, the bone filler may be discharged without being disturbed by the hollow body 234.

As such, the bone filler forming apparatus 200 according to an embodiment of the present invention, by providing one hollow core 232 for one outlet 213, one hollow is formed in the bone filler, The scope of the present invention is not limited thereto, and a plurality of hollow cores 232 may be provided to allow a plurality of hollows to be formed in the bone filler.

The through pipe 240 is a component that supports the piston rod 222 so that the reciprocating motion of the piston rod 222 is smoothly performed. Thus, the through tube 240 is provided in a structure that can be inserted through the piston rod 222. In addition, the upper through-pipe 242 having a diameter larger than the inner diameter of the cylinder 210 and the lower through-pipe 244 having a diameter smaller than the inner diameter of the cylinder 210, the lower through-pipe 244 is a cylinder 210 By inserting into the upper end of the) it can stably support the piston rod 222 that moves up and down through the through-tube 240.

The elastic body 250 is a component that provides elastic force to the through tube 240 in the process of injecting the bone filler into the cylinder 210 (to be described later), and the tube for injecting the bone filler into the cylinder 210. When the clearance tube 240 moves upward, the elastic body 250 provided to contact the upper surface of the through tube 240 is in a compressed state to provide an elastic force to the upper surface of the through tube 240.

The through tube container 260 is a component that accommodates the through tube 240 and the elastic body 250 therein. To this end, the through-tube receiving groove 264 is formed in the interior of the through-tube receptor 260 concave. In addition, a through tube receptor handle 262 is provided at an upper portion of the through tube receptor 260 to easily grip the through tube receptor 260.

Hereinafter, a process in which the bone filler is injected and molded into the bone filler forming apparatus 200 having such a configuration will be described. First, the injection process will be described.

As shown in FIG. 5, when the finger is hooked to the piston handle 224 and the piston rod 222 is sufficiently raised in the (+ X) direction, the packing 226 coupled to the lower end of the piston rod 222 is lowered. When the piston rod 222 is further raised in the (+ X) direction, the lower through pipe 244 coupled with the cylinder 210 is separated from the cylinder 210. At this time, the elastic body 250 is in a compressed state to provide an elastic force to the upper through-pipe 242 in the (-X) direction.

In this state, when the cylinder 210 is rotated 90 degrees about the Y axis, as shown in FIGS. 6 and 7, the longitudinal direction of the piston rod 222 and the longitudinal direction of the cylinder 210 are perpendicular to each other. . Therefore, even if the external force that raises the piston rod 222 in the (+ X) direction is removed, the through tube 240 is subjected to the force in the (-X) direction by the elastic body 250 in the compressed state. 220 and the cylinder 210 may maintain a state in contact with each other at a right angle.

As such, when the piston 220 and the cylinder 210 are maintained at right angles by the elastic force of the elastic body 250, the user holds the bone filler material space 215 inside the cylinder 210 while holding only the cylinder 210. Inject bone filler into the

When the injection of the bone filler is completed, after raising the piston rod 222 again in the (+ X) direction, the cylinder 210 is rotated 90 degrees about the Y axis to parallel the piston rod 222 and the cylinder 210. Position and lower the piston rod 222 in the (-X) direction so that the lower through pipe 244 is coupled to the cylinder 210 and the lower portion of the piston rod 222 is positioned inside the cylinder 210 , The bone filler forming apparatus 200 is returned to the state as shown in FIG. 3.

As such, according to the bone filler material forming apparatus 200 according to an embodiment of the present invention, the user can easily inject the bone filler material by simply rotating the cylinder 210 by 90 degrees while pulling the piston 220. After the bone filler is injected into the cylinder 210, the cylinder 210 may be rotated 90 degrees again to return to its original state, and then the bone filler molding process may be performed. Therefore, the time required to manufacture the bone filler is saved, and the user's convenience can be increased.

Next, a process in which the bone filler is molded by the bone filler molding apparatus 200 will be described.

As illustrated in FIG. 8, when the bone filler (B ₁ , shown in FIG. 8) received inside the cylinder 210 through the piston rod 222 is pressed downward, the bone filler contained in the cylinder 210 ( B ₁ ) proceeds downward by the pressing force of the cylinder 210, the bone filler (B ₂ , shown in FIGS. 8 and 9) is discharge-molded through the discharge port 213a. At this time, one end of the hollow core 232 is located in the center of the discharge port 213a, so that the hollow (P) in the same shape as the cross-sectional shape of the hollow core 232 inside the bone filler (B ₂ ) to be ejected Is molded. Accordingly, the outer diameter D ₄ of the molded bone filler B ₂ is equal to the diameter D ₂ of the discharge nozzle 213, and the diameter D ₃ of the hollow P is the diameter of the hollow core 232 ( Is equal to D ₁ ).

As such, when the bone filler is molded using the bone filler forming apparatus 200 according to an embodiment of the present invention, the bone filler is in the sintering process of the bone filler to be described later, when the bone filler is not compressed and molded Compared to 100 ℃ to 200 ℃ can be sintered at a lower temperature. The reason is that the sintering process heats the particles to supply the binding energy between the particles. Therefore, compressing the bone filler prior to sintering the bone filler closes the gap between the particles constituting the bone filler, which is necessary for the bonding between the particles. Is reduced.

As such, when the bone filler is sintered at a low sintering temperature, the possibility that the physical properties of the calcium phosphate compound, which is a raw material of the bone filler, changes significantly during the sintering process. If the physical properties of the bone filler, in particular, the rate of degradation in the living body changes, when the bone filler is implanted in the living body, the bone filler may not be degraded at an appropriate rate while new bone is produced, so that new bone cannot be effectively formed. do. In contrast, in one embodiment of the present invention, by lowering the sintering temperature of the bone filler, it is possible to effectively induce the formation of new bone tissue.

In addition, since the sintering temperature of the bone filler can be lowered as described above, the width of the sintering temperature can be selected in the sintering process of the bone filler, thereby making it easy to control the strength of the bone filler determined according to the sintering temperature.

In addition, the hollow (P) formed inside the bone filler (B ₂ ) formed by the bone filler material forming apparatus 200 according to an embodiment of the present invention is a bone filler material is similar to the pores formed by the pore-forming agent When implanted in the blood, it acts as a blood supply and bone conduction pathway to promote the production of new bone, and provides a site for the generated bone to adsorb to prevent the escape of the generated bone. And, the shape and size of the hollow (P) can be accurately adjusted according to the user's intention by adjusting the shape and size of the hollow core (232).

In addition, according to the bone filler material forming apparatus 200 according to an embodiment of the present invention, since the bone filler is molded to have a certain size, bone filler having a size suitable for implantation into a living body by sieving after crushing the bone filler The screening process becomes unnecessary. Therefore, in the method of manufacturing a bone filler, which is accompanied by a conventional grinding and sieving process, it is possible to reduce unnecessary material loss caused by discarding a portion of the bone filler is not crushed to a suitable size.

Drying device 300 is a component that creates a drying a bone filling material (B ₂₎ formed by the above-described bone filler forming apparatus 200, the lower the viscosity of the bone filling material (B _2), the cutting state . Drying apparatus 300, the bone filler in the temperature range of 100 ℃ to 200 ℃ by a heating means such as a hot air dryer or a vacuum dryer for 1 hour to 2 hours.

The cutting device 400 is a component that cuts the dried bone filler into a length of approximately 0.5 mm to 1.5 mm. As such, the cutting of the bone filler to a relatively small length is to allow the bone filler to be adaptively implanted into the graft site regardless of the narrow area where the bone graft material is to be implanted in the living body. Therefore, in order to cut the bone filler in the range of such a small length, the cutting device 400 is preferably used that can be precisely cut, such as a laser (laser) cutter, water jet (zet) cutter, but of the present invention The scope of the right is not limited thereto.

 The sintering apparatus 500 sinters the cut bone filler at a high temperature so that the bone filler has a certain hardness, and volatilizes pores in the bone filler by volatilizing a pore former uniformly mixed with the calcium phosphate compound during the sintering process. It is a component to form. At this time, the sintering temperature may be selected in the range of 1000 ° C to 1200 ° C, and sintering may be performed for 1 to 2 hours.

 Hereinafter, the grinding device 600 will be described with reference to FIGS. 10 and 11. FIG. 10 illustrates an example of the grinding device 600, and FIG. 11 is a scanning electron microscope (SEM) image of the bone filler material ground by the grinding device 600 of FIG. 10.

The grinding device 600 is a component for grinding the outer shape of the cylindrical bone filler having pores formed through a sintering process, and seals the container body 610 and the container body 610 in which the bone filler to be ground is accommodated. The cover 620, the grinding plate 620 for grinding the corner portion of the bone filler by friction, and the strong impact is generated between the bone filler in the process of being received inside the container body 610, the bone filler is ground. The organic solvent 630 which prevents it from being provided is provided.

Container body 610 is to be accommodated because the bone filling material to be ground is provided there is a space to accommodate the bone filling material therein. In addition, the container body 610 may be rotated about one axis by a driving means such as a motor.

 The grinding plate 620 is a component for grinding the corner portion of the bone filler when the container body 610 is rotated in a state in which the bone filler to be ground is accommodated in the container body 610. To this end, the grinding plate 620 includes a metal plate, such as stainless steel, and diamond particles evenly distributed on the surface of the metal plate. Such a grinding plate 620 is attached along the inner wall of the container body 610 to grind the corner portion of the bone filler in which the bone filler is accommodated in the container body 610.

The organic solvent 630 serves as a cushion to prevent the bone fillers accommodated in the container body 610 from being impacted by the impact of each other, and makes frequent contact with the outer surface of the bone filler to soften the outer surface of the bone filler. . At this time, the organic solvent 630 does not dissolve the bone filler, and a solution having a specific gravity greater than that of water (H ₂ 0) so that the grinding process may proceed in a state where the bone filler is three-dimensionally distributed in the organic solvent 630. It is desirable to choose. Therefore, although methanol (CH ₃ OH) may be selected as the organic solvent 630, the scope of the present invention is not limited thereto.

When the bone filling material is inserted into the grinding device 600 having such a configuration and the grinding device 600 is rotated at a constant angular speed, the edge portion of the bone filling material begins to be worn by friction between the bone filling material and the diamond particles. As time goes by, the bone filler having a cylindrical shape, as shown in FIG. 11, is provided with a hollow P, a pore Q is formed three-dimensionally, and the bone filler is generally close to a spherical shape. (B ₃ ). As such, when the bone filler is provided in a spherical shape, a sharp portion is removed from the bone filler, and thus, when the bone filler is implanted in vivo, the bone filler is implanted by the sharp portion of the surface of the bone filler in the process of generating and fixing new bone. The living cells in contact with the bone filler are stimulated and not damaged. In addition, there is an edge portion of the bone filler there is an advantage that the bone filler is not easily broken.

Hereinafter, referring to FIGS. 12 and 13, a bone filler manufacturing method including a bone filler molding method according to an embodiment of the present invention will be described.

FIG. 12 is a flowchart of a bone filler manufacturing method including a bone filler molding method by the bone filler molding apparatus 200 of FIG. 2, and FIG. 13 is a flowchart of a bone filler molding method by the bone filler molding apparatus 200 of FIG. 2. to be.

First, the bone filler is slurryed by uniformly mixing the calcium phosphate compound, the pore-forming agent and other additives with the mixing device 100 (S210). At this time, by adjusting the amount of the pore-former to be mixed, it is possible to control the amount of pores formed in the bone filler in the sintering process to be described later, thereby adjusting the overall porosity of the bone filler.

Next, by using the above-described bone filler material forming apparatus 200 by pressing the injection of the bone filler in the slurry state (syringe) to form a bone filler having a hollow formed therein (S220). This will be described in detail with reference to FIG. 13 as follows.

First, the bone filler mixed in the slurry state is injected into the bone filler material receiving space 215 of the cylinder 210 of the bone filler material molding apparatus 200 (S212). Then, the bone filling material is pressed to the discharge nozzle 213 side of the cylinder 210 by the piston 220 provided in the bone filling material forming apparatus 200 (S214). The bone filler is pressurized by the piston 220 is discharged through the discharge port 213a provided at the lower end of the discharge nozzle 213, the hollow core 232 provided in the center of the discharge port 213a is hollow inside the bone filler It is molded in the provided state (S216).

At this time, the shape and size of the bone filler is approximately determined according to the shape and size of the outlet 213a, and the shape and size of the hollow is determined by the shape and size of the hollow core 232. Since the shape and size of the outlet 213a and the hollow core 232 can be changed in various ways, the bone filler can be adjusted to various shapes and sizes in the process of forming the bone filler, thereby controlling the overall porosity of the bone filler This has a possible advantage.

Next, the molded bone filler is dried for 1 hour to 2 hours in the range of 100 ℃ to 200 ℃ using the drying apparatus 300 (S230). Then, the bone filler is weakened by the drying process is in a state capable of cutting.

Next, the dried bone filler is cut to a predetermined length (S240), and the cut bone filler is sintered (S250). At this time, sintering is performed in the range of 1000 degreeC-1200 degreeC for 1 hour-2 hours. In general, in order to sinter the calcium phosphate-based compound, a temperature of 1200 ° C. or more is required, but when the bone filler is molded by pressing the bone filler by the bone filler molding method using the bone filler molding apparatus 200 according to an embodiment of the present invention, The bone filler is sinterable in a temperature range of 1000 ° C to 1200 ° C, lower than 1200 ° C. This is because, as described above, the sintering temperature of the bone filler is affected by the degree of compression of the bone filler, the sintering temperature is lowered by pressing the bone filler with a piston in the bone filler molding process.

In general, the calcium phosphate-based compound may have a change in physical properties at a temperature of 1200 ° C. or higher, and when the bone filler is manufactured using the bone filler forming apparatus 200 according to an embodiment of the present invention, bone at a temperature lower than 1200 ° C. By being able to sinter the filler, it is possible to significantly reduce the possibility that the physical properties of the bone filler during the sintering process, particularly the rate of degradation in vivo, will change. In addition, when the sintering temperature of 1200 ℃ or more is required in the sintering process of the bone filler, it is difficult to control the strength of the bone filler determined according to the sintering temperature because the range of the sintering temperature that can be selected is narrow, When the bone filler is molded and sintered, the strength of the bone filler can be easily adjusted as the width of the sintering temperature that can be selected in the sintering process of the bone filler becomes wider.

In the sintering process, the bone filler loses its viscosity and becomes a solid state to have the hardness necessary for implantation into a living body. In addition, when the pore-forming agent evenly distributed in the bone filler is volatilized, pores are formed three-dimensionally throughout the bone filler.

Finally, the bone filler (B ₃ , shown in FIG. 11) having a final shape is obtained by grinding the corner portion of the sintered bone filler (S260).

As such, when the bone filler is manufactured using the bone filler molding apparatus 200 according to an embodiment of the present invention, the bone filler is pressurized at the same time as the molding step before the sintering process, so that the sintering temperature is compared with the prior art. Even if low, it is possible to obtain a bone filler having sufficient strength to be implanted and used in vivo. Therefore, since the bone filler is sintered at a lower temperature than before, the possibility of changing the physical properties of the bone filler during the sintering process of the bone filler in which the calcium phosphate-based compound is used is significantly reduced, and the strength of the bone filler can be easily adjusted. Will be.

In addition, when the bone filling material is manufactured using the bone filling material forming apparatus 200 according to the embodiment of the present invention, since the process of sintering the bone filling material and then pulverizing the bone filling material is not necessary, material loss can be significantly reduced. The sharp portion of the bone filler surface, which may irritate and damage living cells, is not formed.

In addition, when the bone filler is manufactured using the bone filler forming apparatus 200 according to an embodiment of the present invention, it is easy to control the size and the amount of pores, so that the overall porosity of the bone filler can be effectively controlled. do.

In the above described exemplary embodiments of the present invention by way of example, the scope of the present invention is not limited to the specific embodiments as described above, the patent of the present invention by those skilled in the art to which the present invention belongs Changes may be made as appropriate within the scope of the claims.

As described above, according to the present invention, by molding the bone filler in a predetermined shape through the process of pressurizing and discharging the bone filler in the slurry state, it is possible to eliminate the possibility of changing the physical properties of the bone filler in the sintering process than before, It is easy to adjust the strength of the bone filler, bone filler filling apparatus and bone filler molding method that can reduce the unnecessary material loss of the bone filler, and does not form a sharp portion that may damage the living cells on the surface of the bone filler Can provide.

Claims (14)

A bone filling material accommodating cell provided with an accommodating space therein and having a discharge nozzle through which the bone filling material is discharged; And And a bone filling material for discharging the bone filler through the discharge nozzle. The method of claim 1, The bone filler material forming apparatus further comprises a hollow forming body coupled to the bone filler material receiving cell so that the hollow is formed in the central portion of the bone filler. The method of claim 2, The hollow body is, A hollow core spaced apart from an outlet of the discharge nozzle and positioned at the center of the outlet; And The bone filler material molding apparatus is installed in the bone filler material receiving cell comprising a hollow body for supporting the hollow core. The method of claim 3, The bone filler material forming apparatus, characterized in that the cross-section of the hollow body is smaller than the cross-section of the bone filler material receiving cell so that the bone filler can pass between the bone filler material receiving cell and the hollow body. The method of claim 1, The bone filler material cell, It is a cylindrical cylinder provided with the discharge nozzle at one end, The pressing means, Bone filling material forming apparatus, characterized in that the piston is inscribed in the cylinder so as to reciprocate. The method of claim 5, The discharge nozzle is bone filling material forming apparatus, characterized in that the inclined nozzle connected to the end of the cylinder gradually decreases in diameter along its longitudinal direction. The method of claim 5, Bone filler material forming apparatus characterized in that the lower end of the piston is combined with a packing for sealing the inside of the cylinder. The method of claim 5, The piston is Installed in the cylinder to reciprocate the inside of the cylinder, A piston rod for pressurizing the bone filler; And A handle provided on the piston rod, The bone filler forming apparatus is coupled to the upper end of the cylinder, A through tube through which the piston rod passes; An elastic body disposed above the through tube; And The bone filler material forming apparatus further comprises a through-tube receptor for receiving the through-tube and the elastic body rotatably coupled to the cylinder. The method of claim 1, The bone filler is, Any one selected from a calcium phosphate compound, calcium sulfate (CaS0 ₄ ) and calcium carbonate (CaCO ₃ ); And And a pore forming agent mixed with the calcium phosphate-based compound to form pores in the bone filler during sintering. The method of claim 9, The calcium phosphate compound, Calcium Phosphate (TCP, Ca ₃ (PO ₄ ) ₂ , Tricalcium Phosphate), Calcium Phosphate (TeCP, Ca ₄ O (PO) ₂ , Tetracalcium Phosphate), Calcium Diphosphate (DCPD, CaHPO ₄ (H ₂ 0) ₂ , Dicalcium Phosphate Dihydtate) and hydroxyapatite (HA, Ca ₅ (PO ₄ ) ₃ (OH) ₂ , Hydroxyapatite) is a bone filler molding apparatus, characterized in that at least one selected. The method of claim 9, Pore formers, Bone filler molding apparatus, characterized in that at least one selected from polymethyl methacrylate (PMMA, Poly Methyl Meta Acrylate), starch and naphthalene (Naphthalene, C ₁₀ H ₈ ). The method of claim 3, The diameter of the hollow core, the bone filler material forming apparatus, characterized in that the range of 100㎛ to 1000㎛. Injecting the bone filler into an inner receiving space of the bone filler material containing the discharge nozzle for discharging the bone filler; Pressing the injected bone filler; And And a step of discharging the bone filler through the discharge nozzle. The method of claim 13, Discharging the bone filler, bone filler material forming method characterized in that for discharging through the hollow core provided in the central portion of the discharge nozzle to form a hollow in the central portion of the bone filler.

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