KR101277605B1 - Plate for fixing bone and method for making the plate - Google Patents

Abstract

PURPOSE: A bone fixing board and a manufacturing method thereof are provided to enhance the intensity of a fixing board by locating thin mineral film between the thin films of a biodegradable organic polymer material. CONSTITUTION: Screw holes insert the screws. The screw is connected to a bone. A first layer(110) is composed of biodegradable organic polymer material. A strength reinforcement layer(120) is composed of a bio compatibility mineral polymer material. A second layer(130) is composed of a biodegradable organic polymer material.

Description

Bone fixation plate and manufacturing method thereof {PLATE FOR FIXING BONE AND METHOD FOR MAKING THE PLATE}

The present invention relates to a bone fixation plate, and more particularly to a bone fixation plate used to fix the bone until the fracture site is re-bonded. The present invention also relates to a method for producing the bone fixation plate.

When an accident is impacted on the human body can cause damage to the bones that make up the human body, this bone damage is called fracture. If a fracture occurs, treatment is generally performed to fix the bone until the fracture site rejoins.

Bone fixation is largely classified into in vitro fixation and in vivo fixation. Extracorporeal fixation is a method of planting metal needles outside the skin at various fractured bones and fixing the metal needles outside the skin. The internal fixation method is to expose the fracture site by cutting the skin and muscles, and then fix the bone.In this way, a long, long support is inserted into the bone, and the bone fixation plate is placed on the outer surface of the bone and the bone fixation plate is screwed to the bone. It is classified as a method of fixing. Among these treatments, bone fixation plate and screw method are the most used because they have many advantages over other methods.

At present, various forms of the fixing plate are known. For example, Korean Patent Laid-Open Publication No. 10-2011-0059299 discloses a bone fixation plate having a straight shape, and Korean Patent Publication No. 10-2006-0123370 discloses a bone fixation plate having an "X" shape. In addition, bone fixation plates such as "Y" shape and square shape are known.

As the material of the bone fixing plate as described above, metals (titanium, etc.) and biodegradable organic polymers (PLLA, PLGA, etc.) are known. However, in the case of a bone fixation plate made of metal, it is burdened by the patient or doctor because secondary surgery to remove the fixation plate after the fractured bone is cured. In the case of a biodegradable organic polymer bone fixing plate, since a certain time after the operation is decomposed in the human body does not need to be accompanied by secondary surgery, but strength is significantly weaker than metal.

Korean Laid-Open Patent Publication No. 2002-0083888 discloses a technique that can overcome the disadvantages of the bone fixing plate of biodegradable organic polymer material. This technique mixes / disperses biodegradable organic polymer monomers and biocompatible inorganic fine particles and then polymerizes to produce biodegradable organic polymer / inorganic composites and molds the biodegradable organic polymer / inorganic composites. In the composite, the inorganic particles enhance the strength. Therefore, the bone fixing plate made of the composite material has a higher strength than the bone fixing plate made of biodegradable organic polymer.

Korean Patent Publication No. 10-2011-0059299 Korean Patent Publication No. 10-2006-0123370 Korean Laid-Open Patent No. 2002-0083888

 As described above, the biodegradable organic polymer / inorganic composite of Korean Patent Laid-Open Publication No. 2002-0083888 contributes to the improvement of strength of the bone fixation plate. However, since the inorganic fine particles are dispersed in the biodegradable organic polymer monomer in the composite, even if the composite is made of material, the strength improvement of the bone fixation plate is not so great. Accordingly, the present invention is to provide a bone fixing plate having a significantly improved strength and a method of manufacturing the same.

The present invention provides a bone fixing plate having screw holes for inserting a screw to be fastened to a bone, comprising: a first layer made of a biodegradable organic polymer; A strength reinforcing layer laminated on the first layer and made of a biodegradable or biocompatible inorganic material; And a second layer laminated on the strength reinforcing layer and made of a biodegradable organic polymer.

The strength reinforcing layer has a hole in a region where the screw holes are formed, the first layer and the second layer is connected to each other through the holes of the strength reinforcing layer, the screw holes are smaller than the hole of the strength reinforcing layer It is provided in the site | part which connected the 1st layer and the 2nd layer.

Alternatively, the strength reinforcing layer may have a hole in a portion where the screw holes are formed, and the holes of the strength reinforcing layer may have the same diameter as that of the screw hole to constitute a part of the screw hole.

At least one second strength reinforcing layer made of a biodegradable or biocompatible inorganic material and at least one third layer made of a biodegradable organic polymer may be alternately stacked on the second layer.

The present invention, (A) applying a heat and pressure to the biodegradable organic polymer powder to form an organic thin film; (B) applying heat and pressure to the biodegradable or biocompatible inorganic powder to form an inorganic thin film; (C) forming an laminate by alternately stacking the organic thin film and the inorganic thin film so that the organic thin film is located at the outermost side, and then applying heat and pressure to the laminate; And (D) processing a plurality of threaded holes in the laminate.

The present invention, (A) applying a heat and pressure to the biodegradable organic polymer powder to form an organic thin film; (B) applying heat and pressure to the biodegradable or biocompatible inorganic powder to form an inorganic thin film; (C) forming the laminate by alternately laminating the inorganic thin film and applying and curing the biodegradable organic polymer paste on the organic thin film, and then applying heat and pressure to the laminate; And (D) processing a plurality of threaded holes in the laminate.

In the step (B), a plurality of holes are processed in the inorganic thin film, and in the step (D), the screw hole is processed where the hole is located with a smaller diameter than the hole.

According to the present invention, since the inorganic thin film of high strength is located between the thin films of biodegradable organic polymer material, the strength of the bone fixing plate is excellent.

In addition, according to the present invention, there is no problem of peeling between the thin films of different materials constituting the bone fixing plate.

In addition, according to the present invention, the bone fixing plate having the above effects can be easily produced.

1 is a perspective view showing a bone fixing plate according to the first and second embodiments of the present invention.
FIG. 2 is a cross-sectional view taken along line AA ′ of FIG. 1, illustrating a bone fixation plate according to a first embodiment of the present invention.
3 is a cross-sectional view showing an example of the use of the bone fixing plate according to the first embodiment of the present invention.
4 is a cross-sectional view showing a modification of the bone fixing plate according to the first embodiment of the present invention.
5 is a cross-sectional view taken along line AA ′ of FIG. 1, illustrating a bone fixation plate according to a second embodiment of the present invention.

Hereinafter, preferred embodiments of the bone fixing plate and its manufacturing method according to the present invention will be described in detail with reference to the drawings. It is to be understood that the terminology or words used herein are not to be construed in an ordinary sense or a dictionary, and that the inventor can properly define the concept of a term to describe its invention in the best possible way And should be construed in accordance with the meaning and concept consistent with the technical idea of the present invention.

≪ Embodiment 1 >

Hereinafter, a bone fixing plate and a manufacturing method thereof according to the first embodiment of the present invention will be described with reference to FIGS. 1 to 4.

The bone fixing plate 100 according to the first embodiment of the present invention includes a first layer 110, a strength reinforcing layer 120, and a second layer 130, as shown in FIGS. 1 and 2. .

The first layer 110 is the lowermost layer of the bone fixing plate 100, and is made of a biodegradable organic polymer. The strength reinforcing layer 120 is a layer that allows the bone fixing plate 100 to have an excellent strength, is laminated on the upper surface of the first layer 110, the biodegradable inorganic material or biocompatible inorganic material. The second layer 130 is stacked on the upper surface of the strength reinforcing layer 120, and similar to the first layer 110 is made of a biodegradable organic polymer.

The biodegradable organic polymer may include PLA (poly (lactic acid)), PLLA (poly (L-lactic acid)), PLDLA (poly (L / D-lactic acid)), PGA (poly (glycolider)) or poly (glycolic acid)), PLGA (poly (lactic-co-glycolic acid)), PLC (poly (camprolactone)) and the like can be used. The biodegradable mineral may be used beta TP (β-TCP, β-tricalcium phosphate), magnesium (Mg, magnesium), etc. As the biocompatible mineral may be used hydroxyapatite (HA, hydroxyapatite), etc. have.

The bone fixing plate 100, unlike the prior art that only mixed the inorganic fine particles with the biodegradable organic polymer monomer in order to improve the strength, it comprises an inorganic strength reinforcing layer 120 of excellent strength. Therefore, the bone fixing plate 100 has a much superior strength than the conventional.

The strength reinforcing layer 120 gives a very good strength to the bone fixing plate 100, but has a material different from the material of the first layer 110 and the second layer 130. Therefore, a peeling problem may occur between the strength reinforcing layer 120 and the other layers 110 and 130. In order to solve the peeling problem, in the bone fixing plate 100, the first layer 110 and the second layer 130 are connected to each other as shown in FIG. 2.

In order to connect the first layer 110 and the second layer 130, a plurality of holes 122 are provided in the strength reinforcing layer 120. The screw holes 140 passing through the screw 20 to be coupled to the fractured bone 10 are provided at a portion where the holes 122 are provided to have a diameter smaller than that of the holes 122. The first layer 110 and the second layer 130 are connected to each other while passing through a gap G between the circumferential surface of the hole 122 and the circumferential surface of the screw hole 140.

The bone fixing plate 100 has a three-layer structure of the first layer 110, the strength reinforcing layer 120 and the second layer 130. However, the number of layers of the bone fixing plate 100 may be made larger than this. For example, the same layer as the strength reinforcing layer 120 (hereinafter, referred to as a “second strength reinforcing layer”) in the second layer 130 and the same layer as the first layer 110 or the second layer 130 (hereinafter referred to as “the second strength reinforcing layer”). May be further alternately stacked. 4 illustrates a seven-layer bone fixing plate in which two second strength reinforcement layers 140 and two third layers 150 are alternately stacked.

Hereinafter, a method of manufacturing the bone fixing plate 100 will be described.

The method for manufacturing the bone fixing plate 100 includes a first step to a fourth step.

In the first step, heat and pressure are applied to the biodegradable organic polymer powder to form an organic thin film. This organic thin film is used as the first layer 110 and the second layer 130.

In the second step, heat and pressure are applied to the biodegradable or biocompatible inorganic powder to form an inorganic thin film. In the second step, a plurality of holes 122 are processed in the inorganic thin film. The inorganic thin film is used as the strength reinforcing layer 120.

In the third step, the inorganic thin film is laminated on the organic thin film on which the first layer 110 is to be formed, and the organic thin film on which the second layer 130 is formed is laminated on the inorganic thin film to form a laminate. Thereafter, in the third step, heat and pressure are applied to the laminate. The heat is similar to the molding temperature of the organic thin film and lower than the molding temperature of the inorganic thin film. Therefore, the organic thin film for forming the first layer 110 and the organic thin film for forming the second layer 130 are connected to each other while passing through the holes 122 processed in the inorganic thin film.

When the bone fixing plate is to be formed in a seven-layer structure as shown in FIG. 4, in the third step, two inorganic reinforcing layers 140 are formed on the organic thin film to form the second layer 130. The thin film and two organic thin films to form the third layer 150 are alternately stacked to form a laminate, and then heat and pressure are applied to the laminate.

In the fourth step, a plurality of screw holes 140 are processed in the laminate formed as above. At this time, the screw holes 140 are processed where the holes 122 on the organic thin film are located. Therefore, the screw holes 140 are provided at a portion where the organic thin film to form the first layer 110 and the organic thin film to form the second layer 130 are connected. In addition, the screw holes 140 are processed to a diameter smaller than the diameter of the holes 122. Therefore, the connection state between the organic thin film to form the first layer 110 and the organic thin film to form the second layer 130 is maintained even if the screw holes 140 are processed.

On the other hand, as described above, in the third step, an inorganic thin film for forming the strength reinforcement layer 130 is laminated on the organic thin film to form the first layer 110, and heat on the biodegradable organic polymer powder on the inorganic thin film. After applying and curing the paste prepared by adding to form a laminate, heat and pressure may be applied to the laminate. In this case, the organic thin film formed in the first step is used only as the first layer 110.

The bone fixing plate 100 as described above is initially manufactured in a square shape, as shown in FIG. Therefore, the operator cuts the bone fixation plate 100 of the square shape into the shape desired by him (date form, "Y" form, "X" form, etc.), and then cut the bone fixing plate as shown in Figure 3 It may be fixed to the bone 10 having the fracture site 12 with a screw 20.

≪ Embodiment 2 >

Hereinafter, the bone fixing plate 200 and the manufacturing method thereof according to the second embodiment of the present invention will be described with reference to FIGS. 1 and 5.

The bone fixing plate 200 according to the second embodiment of the present invention includes a first layer 210, a strength reinforcing layer 220, and a second layer 230 as shown in FIGS. 1 and 5. The first layer 210 and the second layer 230 are the same as the first layer 110 and the second layer 130 of the first embodiment, and description thereof will be omitted.

The strength reinforcing layer 220 is a layer that allows the bone fixing plate 200 to have an excellent strength, as in the first embodiment, the biodegradable inorganic material or biocompatible inorganic material on the upper surface of the first layer 210 It is stacked.

The strength reinforcing layer 220 has a plurality of holes 222. However, these holes 222, unlike the holes 122 in the first embodiment, is provided with the same diameter as the diameter of the screw holes 240, a part of the screw holes 240 as shown in FIG. To achieve. Therefore, in this embodiment, the gap G in the first embodiment is not provided.

In the first embodiment, the first layer 110 and the second layer 130 are connected to each other while passing through the gap G to solve the peeling problem. However, in the present embodiment, the first layer 210 and the second layer 230 are connected to each other while passing through the gap between the particles forming the strength reinforcing layer 220, thereby solving the peeling problem.

1 and 5, the bone fixing plate 200 of the three-layer structure is shown. However, the bone fixing plate 200 may be provided with a larger number of layers than three layers as described in the first embodiment.

Hereinafter, a method of manufacturing the bone fixing plate 200 will be described.

The method for manufacturing the bone fixing plate 200 includes a first step to a fourth step.

In the first step, heat and pressure are applied to the biodegradable organic polymer powder to form an organic thin film. This organic thin film is used as the first layer 210 and the second layer 230.

In the second step, the inorganic thin film is formed by applying heat and pressure to the biodegradable or biocompatible inorganic powder, wherein the inorganic thin film is formed to form a gap between the inorganic powder particles. The volume occupied by the gap in the inorganic thin film can be adjusted by appropriately selecting the size of the inorganic powder particles, the temperature of the heat applied to the inorganic powder and the size of the pressure. The inorganic thin film formed in the second step is used as the strength reinforcing layer 220.

In the third step, the inorganic thin film is laminated on the organic thin film on which the first layer 210 is to be formed, and the organic thin film on which the second layer 230 is formed is laminated on the inorganic thin film to form a laminate. Thereafter, in the third step, heat and pressure are applied to the laminate. The heat is similar to the molding temperature of the organic thin film and lower than the molding temperature of the inorganic thin film. Therefore, a part of the organic thin film constituting the first layer 210 and a part of the organic thin film constituting the second layer 230 are connected to each other while passing through gaps in the inorganic thin film.

In the fourth step, a plurality of screw holes 240 are processed in the laminate formed as above. The screw holes 240 are inserted into the screw to be fastened to the fractured bone.

On the other hand, in the third step, in the third step, the inorganic thin film to form the strength reinforcement layer 230 is laminated on the organic thin film to form the first layer 210, and heat on the biodegradable organic polymer powder on the inorganic thin film. After applying and curing the paste prepared by adding to form a laminate, heat and pressure may be applied to the laminate. In this case, the organic thin film formed in the first step is used only as the first layer 210.

While the present invention has been particularly shown and described with reference to exemplary embodiments thereof, it is to be understood that the invention is not limited to the disclosed exemplary embodiments. It is to be understood that various changes and modifications may be made without departing from the scope of the appended claims.

100, 200: bone fixing plate 110, 210: the first layer
120, 220: strength reinforcement layer 122, 222: hole
130, 230: second layer 140: second strength reinforcement layer
150: third layer

Claims (7)

In a bone fixing plate having screw holes for inserting a screw to be fastened to the bone,
A first layer made of a biodegradable organic polymer;
A strength reinforcing layer laminated on the first layer and made of a biodegradable or biocompatible inorganic material; And
And a second layer laminated on the strength reinforcing layer and made of a biodegradable organic polymer. The method of claim 1,
The strength reinforcing layer has a hole in a region where the screw holes are formed, the first layer and the second layer is connected to each other through the holes of the strength reinforcing layer, the screw holes are smaller than the hole of the strength reinforcing layer Bone fixation plate provided at the site where the first layer and the second layer are connected. The method of claim 1,
The strength reinforcing layer has a hole in a region where the screw holes are formed, the hole of the strength reinforcing layer is provided with the same diameter as the screw hole bone fixing plate constituting a part of the screw hole. The method of claim 1,
At least one second strength reinforcing layer made of a biodegradable or biocompatible inorganic material and at least one third layer made of a biodegradable organic polymer are alternately stacked on the second layer. (A) applying heat and pressure to the biodegradable organic polymer powder to form an organic thin film;
(B) applying heat and pressure to the biodegradable or biocompatible inorganic powder to form an inorganic thin film;
(C) forming an laminate by alternately stacking the organic thin film and the inorganic thin film so that the organic thin film is located at the outermost side, and then applying heat and pressure to the laminate; And
(D) processing a plurality of screw holes in the laminate; bone fixing plate manufacturing method comprising a. (A) applying heat and pressure to the biodegradable organic polymer powder to form an organic thin film;
(B) applying heat and pressure to the biodegradable or biocompatible inorganic powder to form an inorganic thin film;
(C) forming the laminate by alternately laminating the inorganic thin film and applying and curing the biodegradable organic polymer paste on the organic thin film, and then applying heat and pressure to the laminate; And
(D) processing a plurality of screw holes in the laminate; bone fixing plate manufacturing method comprising a. The method according to claim 5 or 6,
In step (B), a plurality of holes are processed in the inorganic thin film, and in step (D), the screw hole is processed to a location where the hole is located with a smaller diameter than the hole.

Images