TWI688366B - Method for manufacturing bone plate - Google Patents

Abstract

A method for manufacturing bone plate is provided, which includes the following steps: providing polylactic acid (PLA) and hydroxyapatite (HA); mixing the polylactic acid and hydroxyapatite, and executing a mixing process to generate a mixture; executing a base plate molding process to process the mixture go generate a base plate; executing a hole drilling process to process the base plate in order to form a plurality of holes on the base plate; and executing a surface treatment process, whereby the base plate can have hydrophilic property.

Description

Bone plate manufacturing method

The invention relates to a method for manufacturing a bone plate, in particular to a method for manufacturing a bone plate that can be absorbed, has a developing function and can help bone growth.

Bone plates, such as orbital bone plates, craniofacial facial bone plates, finger bone plates and leg bone plates, etc., are a commonly used implantable medical material, which are used as internal fixators for the treatment of fractures. For example, when a patient needs treatment for an orbital injury, it is usually necessary to implant an orbital bone plate. Bone plates can currently be divided into metal and polymer materials. Polymer bone plates can also be divided into absorbable and non-absorbable materials. However, absorbable bone plates made of polymer materials cannot have the development function; therefore, bone plates After implantation, the doctor cannot observe the patient's recovery through X-ray or CT, so there are often medical disputes.

In addition, due to the lack of hydrophilicity, the existing absorbable bone plate can only fix and connect the patient at the injured site, but cannot provide help for the patient's bone growth.

Therefore, how to propose a bone plate technology that can effectively improve various shortcomings of the conventional art has become an urgent issue.

In view of the above-mentioned problems of the conventional art, one of the objects of the present invention is to provide a method of manufacturing a bone plate to solve various problems of the conventional art.

According to one of the objects of the present invention, a method for manufacturing a bone plate is proposed, which includes the following steps: providing polylactic acid and hydroxide apatite; performing a mixing procedure to mix polylactic acid and hydroxide apatite Combine to produce a mixture; perform a green sheet forming process to process the mixture to produce a shaped green sheet; perform a hole making process to process the shaped green sheet to form a plurality of holes in the shaped green sheet; and execute a surface treatment program to make the shaped green sheet hydrophilic.

In a preferred embodiment, polylactic acid is a degradable polymer material, and the degradable polymer material is polyglycolic acid (PLGA), polycaprolactone (PCL) or polyhydroxy fatty acid ester (PHA).

In a preferred embodiment, the mixing process is a hot mixing process, and the temperature of the hot mixing process is 165°C to 185°C.

In a preferred embodiment, the mixing procedure is a room temperature kneading procedure. The room temperature kneading procedure mixes the solvent with polylactic acid in proportion and then adds hydroxyapatite for stirring.

In a preferred embodiment, the above ratio is 1:10~1:1, and the solvent is an organic solvent such as chloroform, acetone or dimethylformamide.

In a preferred embodiment, the green sheet forming process is a thermoforming process or a casting process.

In a preferred embodiment, the temperature of the thermoforming process is 165°C to 185°C.

In a preferred embodiment, the temperature of the casting process is 30°C to 45°C.

In a preferred embodiment, the hole-making procedure is a non-contact hole-making procedure. The non-contact hole-making procedure uses a laser cutting system to cut the shaped blanks to generate the holes.

In a preferred embodiment, the hole-making procedure is a contact-type hole-making procedure, and the contact-type hole-making procedure uses a machine tool to form a green sheet to generate the holes.

In a preferred embodiment, the holes include a plurality of interstitial fluid circulation holes and a plurality of screw holes.

In a preferred embodiment, the surface treatment procedure is to apply plasma surface treatment to the formed embryo.

In a preferred embodiment, the surface treatment process is to roughen the mold in the green sheet forming process.

As mentioned above, according to the manufacturing method of the bone plate of the present invention, it may have one or more of the following advantages:

(1) In one embodiment of the present invention, the bone plate manufacturing method treats polylactic acid and hydroxylapatite with a special ratio and process to enable the bone plate to have a developing function, so the doctor can observe the patient through X-ray or CT The healing situation can effectively reduce the occurrence of medical disputes.

(2) In one embodiment of the present invention, the bone plate manufacturing method uses a hot kneading procedure and a thermoforming procedure, and the two procedures can make the polylactic acid and the hydroxyapatite mixed evenly, which can strengthen the developing function of the bone plate .

(3) In one embodiment of the present invention, the bone plate manufacturing method uses special process parameters and surface treatment procedures. The above combination can make the bone plate have excellent hydrophilicity, so it can effectively help the patient's bone growth.

(4) In one embodiment of the present invention, the manufacturing process of the bone plate is simple, so the desired effect can be achieved without greatly increasing the cost.

1: bone plate

11: Bone plate body

12: Climbing

A: Interstitial fluid circulation hole

B: screw hole

S21~S25, S31~S35, S41~S45, S51~S56: Step flow

Fig. 1 is a structural diagram of a bone plate according to a first embodiment of the invention.

Figure 2 is a flowchart of the first embodiment of the present invention.

Figure 3 is a flowchart of a second embodiment of the invention.

Figure 4 is a flowchart of a third embodiment of the invention.

Fig. 5 is a flowchart of a fourth embodiment of the invention.

The embodiments of the bone plate manufacturing method according to the present invention will be described below with reference to the related drawings. For the sake of clarity and convenience, the components in the drawings may be exaggerated or reduced in size and proportion. In the following description and/or patent application, when an element is referred to as being "connected" or "coupled" to another element, it may be directly connected or coupled to the other element or intervening elements may be present; and when the element is mentioned When "directly connected" or "directly coupled" to another element, there are no intervening elements, and other words used to describe the relationship between the elements or layers should be interpreted in the same manner. For ease of understanding, the same elements in the following embodiments are described with the same symbols.

Please refer to FIG. 1, which is a structural diagram of a bone plate according to a first embodiment of the present invention. In this embodiment, the orbital bone plate is taken as an example to illustrate its structure and manufacturing method. Of course, this manufacturing method can also be applied to other bone plates, such as craniofacial bone plates, finger bone plates and leg bone plates. As shown in the figure, bone The plate 1 includes a bone plate body 11 and a plurality of climbing plates 12.

The bone plate body 11 is connected to the brackets 12 and includes a plurality of interstitial fluid circulation holes A and screw holes B.

Each pan 12 also includes a plurality of screw holes B.

The bone plate 1 is made of polymer materials such as polylactide (PLA) and hydroxyapatite (HAP); in one embodiment, the polylactic acid may be a degradable polymer material, such as polyglycan Alkyd (PLGA), polycaprolactone (PCL) or polyhydroxy fatty acid ester (PHA). First, polylactic acid and hydroxyapatite are mixed and a mixing procedure is performed to produce a mixture. Next, a green sheet forming program is executed to process the mixture to produce shaped green sheets. Then, execute the hole-making program to process the shaped blanks In order to form a plurality of holes in the formed embryo, the holes may include the interstitial fluid circulation holes A and the screw holes B.

The surface treatment process is performed to make the shaped embryo pieces hydrophilic, that is, the manufacturing process of the bone plate 1 is completed.

As can be seen from the above, this embodiment uses a special process and a ratio to match the surface treatment process; the above process combination can make the bone plate have excellent hydrophilicity, so it can effectively help the patient's bone growth and further improve the functionality of the body 11 Promote.

Please refer to FIG. 2, which is a flowchart of the first embodiment of the present invention. As shown in the figure, the manufacturing method of the bone plate 1 of this embodiment includes the following steps:

Step S21: Provide polylactic acid and hydroxyapatite.

Step S22: Perform a mixing procedure to mix polylactic acid and hydroxyapatite to produce a mixture.

Step S23: Perform a green sheet forming program to process the mixture to produce a shaped green sheet.

Step S24: Perform a hole-making program to process the shaped blank to form a plurality of holes in the shaped blank.

Step S25: Perform a surface treatment procedure to make the shaped green sheet hydrophilic.

Please refer to FIG. 3, which is a flowchart of a second embodiment of the present invention. Different from the previous embodiment, the mixing process of this embodiment uses a hot kneading process, and the green sheet forming process uses a hot forming process.

In the hot mixing process, single-screw or twin-screw mixers and granulators can be used to pour polylactic acid and hydroxide apatite in proportion, after mixing through the above machines, and enter the granulator shape In one embodiment, the temperature of the hot mixing process may be 165°C~185°C; in another embodiment, the temperature of the hot mixing process may be 165°C~175°C.

In the thermoforming process, an injection molding machine or a hot press forming machine and a forming die can be used; in one embodiment, the temperature of the thermoforming process can be 165°C to 185°C; in another embodiment, the temperature of the thermoforming process The temperature can be 165℃~175℃.

In addition, the hole-making procedure may be a non-contact hole-making procedure, that is, the shaped blanks are cut by a laser cutting system to generate the holes; in one embodiment, the laser cutting system may be a CO2 laser or a nanosecond laser , Picosecond laser, femtosecond laser with cutting head, scanning head and cutting jig etc. In addition, the hole-making procedure may be a contact-type hole-making procedure, that is, machining the shaped blanks with a machine tool to generate the holes; in one embodiment, the machine tool may be a drilling machine or a five-axis machining machine.

In addition, the surface treatment procedure of this embodiment adopts plasma surface treatment. After the above-mentioned hole-making procedure is completed, plasma surface treatment is performed on the shaped embryo pieces to make the shaped embryo pieces hydrophilic.

It can be seen from the above that the bone plate manufacturing method uses a hot kneading procedure and a thermoforming procedure to make the polylactic acid and the hydroxyapatite uniformly mixed. The above can strengthen the development function of the bone plate 1 and improve the plasma surface treatment procedure Effect.

Similarly, the manufacturing method of this embodiment can also be applied to various bone plates, such as orbital bone plates, craniofacial bone plates, finger bone plates and leg bone plates.

As shown in the figure, the manufacturing method of the bone plate 1 of this embodiment includes the following steps:

Step S31: Provide polylactic acid and hydroxyapatite.

Step S32: Perform a hot mixing process to mix the polylactic acid and the hydroxyapatite at a temperature of 165°C to 185°C to produce a mixture.

Step S33: Perform a thermoforming process to process the mixture at a temperature of 165°C to 185°C to produce shaped blanks.

Step S34: Perform a hole-making program to process the shaped blank to form a plurality of holes in the shaped blank.

Step S35: Perform a plasma surface treatment procedure to make the formed embryos hydrophilic.

It is worth mentioning that the absorbable bone plate made of existing polymer materials cannot have the development function; therefore, after the bone plate is implanted, the doctor cannot observe the patient's recovery through X-ray or CT, so there are often medical disputes The situation arises. On the contrary, according to the embodiment of the present invention, the bone plate manufacturing method treats polylactic acid and hydroxyapatite with a special ratio and process, so that the bone plate can have a developing function, so the doctor can observe the patient's recovery through X-ray or CT Circumstances, it can effectively reduce the occurrence of medical disputes.

In addition, according to an embodiment of the present invention, the bone plate manufacturing method uses a hot kneading procedure and a hot forming procedure, and the two procedures can make the polylactic acid and the hydroxyapatite uniformly mixed, which can enhance the developing function of the bone plate.

In addition, due to the lack of hydrophilicity, the existing absorbable bone plate can only fix and connect the patient at the injured site, but cannot help the patient's bone growth. On the contrary, according to the embodiment of the present invention, the bone plate manufacturing method uses special process parameters and surface treatment procedures. The above combination can make the bone plate have excellent hydrophilicity, so it can effectively help the patient's bone growth.

Furthermore, according to the embodiment of the present invention, the manufacturing process of the bone plate manufacturing method is simple, so the desired effect can be achieved without significantly increasing the cost. As can be seen from the above, the method of manufacturing a bone plate of the present invention can indeed provide excellent technical effects.

Please refer to FIG. 4, which is a flowchart of a third embodiment of the present invention. The difference from the foregoing embodiment is that the mixing procedure of this embodiment adopts a room temperature mixing procedure, the green sheet forming procedure uses a casting forming procedure, and the surface treatment procedure uses a surface roughening treatment procedure.

In the normal temperature mixing process, the solvent can be mixed with polylactic acid in a specific ratio and then added with apatite hydroxide for stirring; in one embodiment, the above ratio is 1:10~1:1, and the solvent It is other organic solvents such as chloroform, acetone or dimethylformamide; in another embodiment, the above ratio is 3:7~1:10; in yet another embodiment, the above ratio is 1:10.

As mentioned above, the surface treatment program of this embodiment adopts a surface roughening process; before performing the casting process, the surface roughening process is executed to process the mold, thereby roughening the surface of the mold, and then performing the casting process.

In the casting process, the mixed solution of polylactic acid and hydroxyapatite is poured into the mold after surface roughening by casting, and dried by vacuum drying method, and finally the embryo is formed; in one embodiment The temperature of the vacuum drying method is less than 55°C; in another embodiment, the temperature of the vacuum drying method is 35°C to 45°C. The above process and parameters can also achieve excellent results.

Similarly, the manufacturing method of this embodiment can also be applied to various bone plates, such as orbital bone plates, craniofacial bone plates, finger bone plates and leg bone plates.

As shown in the figure, the manufacturing method of the bone plate 1 of this embodiment includes the following steps:

Step S41: Provide polylactic acid and hydroxyapatite.

Step S42: Perform a normal temperature mixing procedure to mix the polylactic acid with the solvent at a specific ratio, and then add hydroxyapatite to stir to produce a mixture.

Step S43: Process the mold with the surface roughening process.

Step S44: Perform a casting forming process to process the mixture with the above-mentioned module and a temperature of less than 55° C. to produce shaped blanks.

Step S45: Perform a hole-making program to process the shaped blank to form a plurality of holes in the formed blank.

Please refer to FIG. 5, which is a flowchart of a fourth embodiment of the present invention. Different from the previous embodiment, the mixing procedure in this embodiment uses a hot mixing procedure, and the blank forming procedure uses a thermoforming procedure, and the surface treatment procedure uses a surface roughening treatment procedure or uses both a surface roughening treatment procedure and a plasma Surface treatment procedures.

First, a hot mixing process is performed to mix polylactic acid and hydroxyapatite to produce a mixture, and the parameters and equipment used are the same as those in the second embodiment, so they will not be repeated here.

The surface treatment program of this embodiment adopts a surface roughening process; before executing the thermoforming program program, a surface roughening process program is executed to process the mold, thereby roughening the surface of the mold, and then performing the thermoforming process.

In the thermoforming process, the above mixture can be processed by an injection molding machine or a hot press forming machine and a forming die after surface roughening to produce a shaped green sheet.

Next, a hole-making procedure can be executed to complete the manufacturing procedure of the bone plate 1. The hole-making procedure is the same as that in the previous embodiment, so it will not be repeated here.

In addition, the plasma surface treatment procedure can be used more selectively; after the above-mentioned hole-making procedure is completed, the plasma surface treatment can be performed on the formed embryos to further enhance the hydrophilicity of the formed embryos.

Therefore, the bone plate manufacturing method adopts a hot mixing procedure and a hot forming procedure to make the polylactic acid and the hydroxyapatite uniformly mixed, and the surface roughening treatment procedure or the surface roughening treatment procedure and the plasma surface can be used at the same time Processing procedures; the above method can further strengthen the development function of the bone plate 1.

As can be seen from the above, the surface treatment procedure of the manufacturing method of the bone plate 1 can selectively adopt the surface roughening treatment procedure, the plasma surface treatment procedure or both the surface roughening treatment procedure and the plasma surface treatment procedure, making it more capable Meet the actual needs.

Similarly, the manufacturing method of this embodiment can also be applied to various bone plates, such as orbital bone plates, craniofacial bone plates, finger bone plates and leg bone plates.

As shown in the figure, the manufacturing method of the bone plate 1 of this embodiment includes the following steps:

Step S51: providing polylactic acid and hydroxyapatite.

Step S52: Perform a hot mixing process to mix the polylactic acid and the hydroxyapatite at a temperature of 165°C to 185°C to produce a mixture.

Step S53: Process the mold with the surface roughening process.

Step S54: Perform a thermoforming process to process the mixture with the above-mentioned mold and a temperature of 165°C to 185°C to produce a shaped blank.

Step S55: Perform a hole-making program to process the shaped blank to form a plurality of holes in the shaped blank.

Step S56: Perform a plasma surface treatment procedure to make the formed embryonic sheet hydrophilic.

In summary, according to the embodiment of the present invention, the bone plate manufacturing method treats polylactic acid and hydroxyapatite with a special ratio and process, so that the bone plate can have a developing function, so the doctor can observe through X-ray or CT The situation of the patient's recovery can effectively reduce the occurrence of medical disputes.

In addition, according to an embodiment of the present invention, the bone plate manufacturing method uses a hot kneading procedure and a thermoforming procedure, and the two procedures can make the polylactic acid and the hydroxyapatite uniformly mixed, which can enhance the developing function of the bone plate.

In addition, according to the embodiment of the present invention, the bone plate manufacturing method uses special process parameters and surface treatment procedures. The above combination can make the bone plate have excellent hydrophilicity, so it can effectively help the patient's bone growth.

Furthermore, according to the embodiment of the present invention, the manufacturing process of the bone plate manufacturing method is simple, so the desired effect can be achieved without significantly increasing the cost.

It can be seen that the present invention has achieved the desired enhancement effect by breaking through the previous technology, and it is not easy to think about by those who are familiar with the art. Its progress and practicality have obviously met the patent application requirements. I filed a patent application in accordance with the law, and urge your office to approve this application for a patent for invention, in order to encourage creativity and to feel virtuous.

The above is only exemplary, and not restrictive. Any other equivalent modifications or changes made without departing from the spirit and scope of the present invention should be included in the scope of the attached patent application.

S21~S25: Step flow

Claims (9)

A method for manufacturing a bone plate, comprising: providing a polylactic acid and a hydroxylapatite; mixing the polylactic acid and the hydroxylapatite and performing a mixing procedure to produce a mixture; wherein the mixing procedure is a Hot mixing process, and the temperature of the hot mixing process is 165 ℃ ~ 185 ℃, or the mixing process is a room temperature mixing process, the room temperature mixing process will a solvent in a ratio of 1:10 ~ 1:1 After the polylactic acid is mixed, the hydroxyl apatite is added for stirring, and the solvent is an organic solvent, and the organic solvent is chloroform, acetone, or dimethylformamide; a green sheet forming process is performed to process the mixture to Generating a shaped green sheet; performing a hole-making process to process the shaped green sheet to form a plurality of holes in the shaped green sheet; and performing a surface treatment program to make the shaped green sheet hydrophilic. The method for manufacturing a bone plate as described in item 1 of the patent scope, wherein the polylactic acid is a degradable polymer material, and the degradable polymer material is polyglycolic acid (PLGA), polycaprolactone (PCL) or Polyhydroxy fatty acid ester (PHA). The method for manufacturing a bone plate as described in item 1 of the patent application scope, wherein the green sheet forming process is a thermoforming process or a casting forming process. The method for manufacturing a bone plate as described in item 1 of the patent application scope, wherein the temperature of the thermoforming process is 165°C to 185°C. The method for manufacturing a bone plate as described in item 1 of the patent application scope, wherein the temperature of the casting process is 30°C to 45°C. The method for manufacturing a bone plate as described in item 1 of the patent application scope, wherein the hole-making procedure is a non-contact hole-making procedure, and the non-contact hole-making procedure uses a laser cutting system to cut the shaped embryo to produce the pieces Holes. The method for manufacturing a bone plate as described in item 1 of the patent application scope, wherein the hole-making procedure is a contact-type hole-making procedure, and the contact-type hole-making procedure uses a tool to machine the shaped blank to generate the holes. The method for manufacturing a bone plate as described in item 1 of the patent application scope, wherein the surface treatment procedure is to apply plasma surface treatment to the shaped embryo. The method for manufacturing a bone plate as described in item 1 of the patent application scope, wherein the surface treatment process is to roughen the mold in the embryo forming process.

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