TWI475984B - Method for making an infill structure - Google Patents

Description

Filling structure manufacturing method

The present invention relates to a method of making a filled structure, and more particularly to a method of making a filled structure having different densities.

In general, it is particularly important to repair and regenerate the tissue surrounding the root during the treatment after the tooth extraction operation, because if the repair is not properly performed, and the wound is naturally healed after the surgical extraction, the tooth is missing within one year. The height and width of the alveolar bone may shrink by 40%-60%. The reason for the atrophy is mainly because the regenerative repair speed of the alveolar bone located below is slower than that of the upper gingiva, which causes the upper gingiva to move along the sulcus of the missing tooth in addition to the lateral growth. Lower expansion, which in turn causes atrophy of the height and width of the alveolar bone.

In addition, because the original tooth rows are arranged very tightly, the missing tooth grooves tend to be subjected to lateral compression forces, which change the balance of the original tooth arrangement. For example, the lack of teeth in the lower jaw, so that the back side of the adjacent teeth dumped forward, resulting in the difficulty of installing dentures or artificial implants in the future. Moreover, because the height and width of the alveolar bone of the missing tooth has shrunk significantly, it may be necessary to perform surgery to remove excess gingiva before implanting to provide the height and width required for implanting.

The current repair for tooth extraction is to use artificial objects to fill the missing teeth. For example, collagen sponge is used as an artificial filler and surgically filled into the gullet of the missing tooth to reduce the atrophy of the height and width of the alveolar bone. However, the disadvantage of this method is that the height and width of the alveolar bone are still slightly shrunk. The reason is that the artificial object has no blocking effect, and it is still impossible to isolate the upper gingiva from growing downward, while maintaining a space for providing cell growth. Therefore, the height and width of the alveolar bone may still shrink.

Another way in the prior art is to place a periodontal regeneration membrane at the junction of the gums and the alveolar bone to isolate a space in the alveolar to provide periodontal tissue regeneration. However, this method takes a long time to repair because it relies entirely on the self-repair and regeneration of the alveolar bone without any other medical treatment. In addition, another artificial object 1 of the prior art is a biomedical material comprising a colloidal sponge 10. Please refer to FIG. 1 , which is a schematic diagram of a conventional artificial object. The artificial object 1 is composed of a colloidal sponge 10 and a film 11 , wherein the film 11 is bonded to the colloidal sponge by a chemical cross-linker. One end of the body 10.

However, the disadvantage of this method is that the material properties of the colloidal sponge 10 and the film 11 and the adhesive are different; the contact area of the colloidal sponge 10 and the film 11 and the flatness of the surface thereof are different, and thus the interface The bonding can cause many problems, such as the difficulty of bonding, so that the problem of loosening occurs at the adhesive interface; the chemical cross-linker applied may be too much or too little to be controlled. Causes a chemical cross-linker to be wasted or has a problem of poor adhesion.

Therefore, how to improve the current manufacturing problems of man-made objects is the goal that the relevant industry is committed to.

It is an object of the present invention to provide a method of making a filled structure, particularly a method of making a filled structure having a different density.

Another object of the present invention is to provide a method of manufacturing a filling structure that can replace existing tissue repairs.

Another object of the present invention is to provide a method of manufacturing a filling structure that solves the problem of periodontal tissue defects after occlusion.

Another object of the present invention is to provide a method of manufacturing a filling structure for use in orthopedics.

Another object of the present invention is to provide a faster and more convenient method of manufacturing a filled structure.

The method for manufacturing a filling structure provided by the present invention comprises providing a mold comprising a mother mold and a male mold; injecting a raw medical material into the female mold, so that the upper surface of the biomedical material is higher than the upper surface of the female mold; The mold and the male mold are used to squeeze the upper surface of the biomedical material so that the density of the upper part of the biomedical material is greater than the density of the lower part; the biomedical material is dried; and the biomedical material is taken out from the female mold.

Because of the filling structure manufacturing method provided by the present invention, an advantage of the present invention is that it can provide filling structures with different densities, can solve the problem of interface bonding of materials of different properties, and solve the problem of using chemical cross-linker (chemical cross-linker). And various problems derived from it, and can be manufactured in a more convenient manner.

Further, the method for producing a filling structure according to the present invention can be further understood from the following detailed description of the invention and the accompanying drawings.

Referring to FIG. 2, there is shown a method of fabricating the filling structure 2 in the first embodiment of the present invention. The manufacturing method comprises the step (S1) of providing a mold 20, wherein the mold 20 comprises a female mold 201 and a male mold 202. Next, the step (S2) is performed to inject a biomedical material 21 into the master mold 201. Further, the step (S3) is performed to press the master 201 and the male mold 202, whereby the upper surface of the biomedical material 21 is pressed so that the density of the upper portion of the biomedical material 21 is greater than the density of the lower portion. Thereafter, the step (S4) is carried out to dry the biomedical material 21. Finally, the step (S5) is carried out, and the biomedical material 21 is taken out from the master 201.

Referring to Figures 2a and 2b, the process of steps (S1) through (S2) of the present invention is shown. First, a mold 20 is provided, and then FIG. 2b shows a step (S2) of injecting the biomedical material 21 into the master mold 201, wherein the upper surface of the biomedical material 21 is higher than the upper surface of the mother mold 201, that is, the biomedical material to be added. 21 is a porous biomedical material 21 that is a little more than the original manufactured product. Further, in an embodiment, the biomedical material 21 in the female mold 201 is slightly dried first, so that the biomedical material 21 in the female mold 201 has a spongy shape, and the step (S3) is performed.

Among them, the material of the biomedical material 21 is a porous biomedical material, and the sources include collagen, gelatin, hyaluronic acid, chitosan, chitin. Polyglutamic acid (PGA), hydroxyapatite (HAP), tricalcium phosphate (TCP), bioglass. Among them, when used in the preparation of the alveolar bone filling structure, the preferred embodiment of the biomedical material 21 is collagen, gelatin, and the like. In addition, when used in the preparation of orthopedic materials, the preferred embodiment of the biomedical material 21 is hydroxyapatite (HAP), tricalcium phosphate (TCP), bioglass, hyaluronic acid. (hyaluronic acid, HA)...etc.

After the step (S2), and before the step (S3), a step of adding a chemical cross-linker to the upper surface of the biomedical material 21 (S21) may be further included, as shown in FIG. 2b. Wherein, the chemical cross-linker may be selected from the group consisting of glutaraldehyde, carbodiimide, aminosilane, genipin, hexamethylenyl diiso. Cyanate (hexamethylene diisocyanate, HMDI), formaldehyde (formaldehyde), acyl azide. Of course, it can also use other equivalent chemical cross-linkers to achieve chemical cross-linking. In a preferred embodiment, the chemical cross-linker used may be selected from glutaraldehyde, and the optimum use concentration of glutaraldehyde is from about 0.001% to 3.000%. In another preferred embodiment, the chemical cross-linker used may be selected from 1-(3-dimethylaminopropyl)-3-ethylcarbodiimide hydrochloride (1- Ethyl-3-(3-dimethylaminopropyl)-carbodiimide hydrochloride (EDC), a compound of carbodiimide, and an optimum concentration of EDC of about 1 to 300 mM.

For example, when a chemical cross-linker is used to crosslink collagen or other biomolecules, the preferred embodiment may use glutaraldehyde depending on the mechanical strength of the application range. , carbodiimide, genipin, etc. If the biomedical material to be cross-linked is hydroxyapatite (HAP), tricalcium phosphate (TCP), bioglass, or other biomedical materials, its chemical interaction Preferred examples of the chemical cross-linker are aminosilane, hexamethylene diisocyanate (HMDI), genipin, and the like.

Wherein, after the step (S21) is performed, and before the step (S3) is performed, the step of resting the biomedical material 21 (S22) is further included, thereby causing the biomedical material 21 to be chemically cross-linked, wherein the reaction time is 30. Minutes to 24 hours; and, preferably, the reaction time is from 30 minutes to 6 hours.

Referring to Figures 2b and 2c, the process of steps (S2) through (S3) of the present invention is shown. In an embodiment of the present invention, when the master mold 201 and the male mold 202 are pressed, thereby pressing the upper surface of the biomedical material 21 (S3), the upper portion of the biomedical material is continuously extruded. The porosity of 211 is between 0.1% and 30%, and the porosity of the lower portion 212 of the biomedical material is between 50% and 99%.

Of course, the step of pressing the master 201 and the male mold 202, thereby pressing the upper surface of the biomedical material 21 (S3), the male mold 202 can be selected as a plate, and the female mold 201 is a groove at this time. The male mold 201 and the male mold 202 are pressed to press the upper surface of the biomedical material 21 as shown in Fig. 2c. Of course, the female mold 201 and the male mold 202 may have other designs depending on the shape of the filling structure, and are not limited to the above-mentioned embodiments.

Wherein, the temperature of the male mold 202 can be controlled at 70 ° C to 150 ° C, whereby the upper surface of the extruded biomedical material 21 can be thermally crosslinked. When the temperature of the male mold 202 ranges from 70 ° C to 150 ° C, the heating time is about 30 minutes to 24 hours; wherein the preferred reaction time is 30 minutes to 6 hours.

The male mold 202 can be selected as a plate, and the plate can also have a plurality of fine void holes, each of which has a size of about 100 μm to 2 mm, so that the male mold 202 and the female mold 201 are pressed together. Medical material 21 can be dried quickly.

In addition, referring to FIG. 3, another embodiment of the present invention is shown. This embodiment is to accelerate the drying of the male mold 202 and the female mold 30 after the male mold 202 is pressed, and the special medical material 21 can be dried relatively quickly. design. Wherein, the master mold 30 is constructed in a two-layer structure, that is, the master mold 30 is composed of a mother mold inner layer 301 and a mother mold outer layer 302, and the mother mold inner layer 301 is placed in the mother mold outer layer 302, that is, It is said that the outer layer 302 of the mother mold is slightly larger in size than the inner layer 301 of the mother mold, and the inner layer 301 of the mother mold and the outer layer 302 of the mother mold can be sleeved into one, and the mother mold 30 is formed into a cylindrical shape. The inner mold layer 301 has a plurality of void holes, and the outer mold layer 302 has no holes. Each hole in the inner layer 301 of the mother mold has a size of about 100 μm to 2 mm. In this embodiment, the inner surface of the inner mold layer 301 has a plurality of holes for the purpose of reducing the time required for the drying of the biomedical material; the outer layer 302 of the mother mold is for preventing the injection of the biomedical material solution into the female mold 30 without forming a sponge. The body is lost through the inner mold layer 301.

After the biomedical material 21 extruded in the (S3) step, the density of the upper portion 211 is greater than the density of the lower portion 212, thereby obtaining biomedical materials 21 of different densities, and the biomedical material 21 is porous. Sexual biomedical material 21, as shown in Figure 2c. In one embodiment, the biomedical material 21 is a porous material, and the upper portion 211 is a dense layer, wherein each hole has a diameter of less than 30 μm, a porosity of 0.1% to 30%, and a lower portion of the biomedical material 21 212 has a plurality of holes each having a diameter greater than 50 μm, preferably between 50 and 300 μm and a porosity between 50% and 99%. In one embodiment, the step of pressing the master mold 201 and the male mold 202, thereby pressing the upper surface of the biomedical material 21 (S3), is to squeeze the biomedical material 21 to the biomedical material 21 The porosity of the side portion is between 50% and 99%, and the porosity of the upper portion of the biomedical material 21 is between 0.1% and 30%, and the step (S3) is completed.

Thereafter, in the step (S4) of drying the biomedical material 21, the biomedical material 21 is dried by freeze drying, vacuum drying, and hot air drying. In a preferred embodiment, the drying method used is the use of freeze drying. Wherein, in an embodiment, in the step (S4) drying the biomedical material 21, the porosity of the dry biomedical material 21 to the lower part of the biomedical material 21 is between 50% and 99%, and the biomedical material The porosity of the upper portion of 21 is between 0.1% and 30%, and the step (S4) is completed.

Subsequently, the step of taking the biomedical material 21 from the master mold 201 in the step (S5) is until the lower portion of the biomedical material 21 has a plurality of holes each having a diameter of 50 to 300 μm, and the upper side of the biomedical material 21 The portion has a plurality of holes, each having a diameter of less than 30 μm, and the biomedical material 21 is taken out from the 201 female mold. As shown in Fig. 2d, it is shown that the finally removed filling structure 2 has a different density, wherein the density of the upper portion 211 is greater than the density of the lower portion 212.

In addition, the master mold 30 is constructed in a two-layer structure, and the filling structure 2 has a more detailed manufacturing method, including first injecting the biomedical material 21 solution into the master mold 30, and drying it for several hours to several days. The sponge-like structure of the medical material 21 has a prototype shape. Next, the previously proposed male mold 202 and the female mold 30 are pressed together to produce a uniform dense layer on the upper surface of the biomedical material. After the pressing is completed, before the step of drying the biomedical material, the male mold 202 and the female mold 30 are placed upside down, and the outer mold 302 of the mother mold is taken out, and the inner mold layer 301 is retained, by the plural of the inner mold layer 301. The holes are used to accelerate the material drying process; wherein the step of placing the male mold 202 and the female mold 30 upside down is not necessary, that is, the male mold 202 and the female mold 30 do not necessarily need to be placed upside down. This embodiment can effectively reduce the time required for the biomedical material 21 to perform the drying step. Of course, the method described above is only one example of drying the biomedical material 21, and the method of drying the biomedical material 21 is not limited thereto.

In summary, the manufacturing method of the present invention may include steps (S1), (S2), (S3), (S4), (S5); in addition, the following steps may also be performed, including steps (S1), (S2) ), (S21), (S22), (S3), (S4), (S5).

Further, in the above two manufacturing methods, for the step (S3), there are two different process selections for controlling the temperature of the male mold 202. That is to say, the temperature control of the male mold 202 can be room temperature or between 70 ° C and 150 ° C, wherein the biomedical material 21 can thermally crosslink when the temperature is controlled between 70 ° C and 150 ° C. Further, the filling structure 2 may be produced by using the master mold 201 or the master mold 30 which is formed by a two-layer structure.

In summary, the more specific manufacturing process of the present invention can be mainly divided into:

(1) Simple extrusion, the steps of which are (S1), (S2), (S3), (S4), (S5), wherein (S3) the temperature of the male mold 202 is room temperature.

(2) The chemical crosslinking method is combined with extrusion, and the steps are (S1), (S2), (S21), (S22), (S3), (S4), (S5), wherein (S3) male mold The temperature of 202 is room temperature.

(3) The thermal crosslinking method is combined with extrusion, and the steps are (S1), (S2), (S3), (S4), (S5), wherein the temperature of the (S3) male mold 202 is controlled at 70 ° C to 150 °C.

(4) The chemical crosslinking method is combined with the thermal crosslinking method and the extrusion, and the steps are (S1), (S2), (S21), (S22), (S3), (S4), (S5), wherein (S3) The temperature of the male mold 202 is controlled at 70 ° C to 150 ° C.

Of course, the above four manufacturing methods can be selected to use the master mold 201 or the master mold 30 formed by the two-layer structure to fabricate the filling structure 2.

With the filling structure manufactured by the present invention, a filling structure manufacturing method having different densities is provided. The filling structure can replace the existing problems for tissue repair, solving the problem of missing teeth or orthopedic patches. That is to say, the use and preparation of the filling structure is not limited to the dental department, but can also be applied to other departments, such as orthopedics. In the case of orthopedics, the bone can be further divided into an external cortical bone and an internal sponge bone, which can be filled with auxiliary treatment according to the required filling structure.

The advantages of the filling structure manufacturing method provided by the invention include that the filling structure with different hole sizes can be manufactured in a relatively simple manner, and the filling structure with different density can be provided; the problem of interface bonding of different material properties can be solved: solving the use The problem of chemical cross-linker and the single source of material, the process is relatively simple, so it is faster and more convenient to make the filling structure.

The present invention has been described above by way of a preferred embodiment, and is not intended to limit the spirit of the invention. Modifications made without departing from the spirit and scope of the invention are intended to be included within the scope of the appended claims.

1. . . Artificial object

10. . . Glial sponge

11. . . film

20. . . Mold

201. . . Master model

202. . . Public model

twenty one. . . Biomedical materials

211. . . Upper part

212. . . Lower part

30. . . Master model

301. . . Inner layer

302. . . Master outer layer

The first figure is a schematic diagram of a conventional filling structure;

The second figure is a flow chart of a manufacturing method of the filling structure of the present invention;

The third figure is a schematic view of an embodiment of the invention.

20. . . Mold

201. . . Master model

202. . . Public model

twenty one. . . Biomedical materials

211. . . Upper part

212. . . Lower part

Claims (11)

A method for manufacturing a filling structure, comprising the steps of: providing a mold comprising a master mold and a male mold; and injecting a raw medical material into the master mold such that an upper surface of the biomedical material is higher than the master mold Surface; pressing the master mold and the male mold, thereby pressing the upper surface of the biomedical material such that the density of the upper portion of the biomedical material is greater than the density of the lower portion; drying the biomedical material; And the biomedical material is taken out from the master mold. The manufacturing method according to claim 1, wherein after the step of injecting the biomedical material into the master mold, the method further comprises adding a chemical cross-linker to the surface of the biomedical material. A step of. The manufacturing method according to claim 2, wherein the step of adding the chemical cross-linker further comprises the step of allowing the biomedical material to stand to chemically crosslink, chemically The crosslinking reaction time is 30 minutes to 6 hours. The manufacturing method of claim 1, wherein the male mold is a plate, and the plate further has a plurality of void holes, wherein the public template is used in the step of drying the biomedical material. The plurality of void holes of the block accelerate the drying process. The manufacturing method according to claim 1, wherein the temperature of the male mold ranges from 70 to 150 ° C to cause thermal crosslinking of the biomedical material. The manufacturing method according to claim 5, wherein when the temperature of the male mold is in the range of 70 to 150 ° C, the heating time is 30 minutes to 6 hours. The manufacturing method according to claim 1, wherein the master mold comprises an outer layer of a master mold and an inner layer of a master mold; and before the step of drying the biomedical material, the step of removing the outer layer of the master mold is included . The manufacturing method of claim 7, wherein the inner layer of the master mold has a plurality of void holes, and the plurality of holes are formed by the inner layer of the master mold during the step of drying the biomedical material To speed up the drying process. The manufacturing method according to claim 1, wherein the step of pressing the master mold and the male mold, thereby pressing the upper surface of the biomedical material, is to squeeze the biomedical material to The porosity of the lower part of the biomedical material is between 50% and 99%, and the porosity of the upper part of the biomedical material is between 0.1% and 30%. The manufacturing method according to claim 1, wherein the step of drying the biomedical material is to dry the biomedical material to a porosity of 50% to 99% of a lower portion of the biomedical material, and The porosity of the upper part of the biomedical material is between 0.1% and 30%. The manufacturing method of claim 1, wherein the step of taking the biomedical material from the master mold is until the lower portion of the biomedical material has a plurality of holes each having a diameter of 50 ~300 μm, and the upper part of the biomedical material has a plurality of holes, each of which has a diameter of less than 30 μm before the biomedical material is taken out from the master mold.