TWI708621B - Bone implant material - Google Patents

Abstract

A bone implant material comprising calcium sulfate powder and adhesive powder, and the adhesive powder is selected from pregelatinized starch, maltodextrin, gum arabic, gelatin, shellac, Guanhua bean gum, and Sanxian gum , Methyl cellulose, sodium hydroxymethyl cellulose, ethyl cellulose, hydroxyethyl cellulose, hydroxypropyl cellulose or any combination of the above. The bone implant material of the present invention is suitable for use in 3D printing technology to make bone implants, and the bone implant made by using the bone implant material of the present invention in subsequent applications has good compressive strength and degradation time.

Description

Bone implant material

The present invention relates to a bone implant material, in particular to a bone implant material suitable for the production of bone implants by 3D printing technology.

Human bones are highly vascularized bone tissues (osseous tissue) that provide structural support for the body, bear various physiological stresses in daily life, and maintain normal body activities. However, due to factors such as trauma, developmental defects, tumor resection, aging, osteoporosis, infections, etc., the problems of bone defects and sports injuries are increasing. It is estimated that about 2 million patients worldwide need bone implant surgery each year. It is estimated that the number of bone implant operations will increase by another 50% by 2030.

Hard bone tissue defects caused by trauma, aging, disease or surgery are often slower than other tissues in the body, and it is often necessary to rely on biomedical materials to transplant or fill in order to repair the lost bone tissue. Bone regeneration is mainly through the absorption and accumulation of calcium. Osteocytes and various other cells can reshape or heal bone defects as needed. In order to reduce the possible rejection risk of bone implants, if the patient’s condition permits bone defects, most clinically tend to choose to implant metabolizable bone implants. In the process of metabolism, bone cell growth elements are released to induce and assist the growth of autologous new bone, and finally achieve the purpose of bone healing, and then restore the original function and appearance of the bone.

Currently, bone defect treatment often has many different conditions due to size, location, and injury. Therefore, a bone implant that can adjust the shape as needed is an important key. 3D printing technology can produce fully customized bone implants based on medical tomographic data. The American Society for Testing and Materials (ASTM) divides 3D printing technology into seven types. Among them, "Binder Jetting" is based on the concept of inkjet printers, and 3D printing software is used to confirm every printed product. The relative position of the layer, the printing nozzle of the 3D printing machine is used to spray the adhesive powder layer by layer on the printing powder bed to fix the powder. After the layer-by-layer processing procedure, the appearance of the printed product is achieved shape.

"Adhesive spray molding technology" uses a wide range of materials, such as ceramics, polymers, metals, cast sand or various composite materials, among which the most widely used mineral ceramic powder materials are calcium sulfate and calcium sulfate It is also an orthopedic biomedical ceramic material that can be absorbed by the human body. However, calcium sulfate suitable for 3D printing needs to have the characteristics of uniform average particle size, good fluidity, resistance to moisture and agglomeration, so the price is higher. In addition, the hardness of the 3D printed molded products made by using calcium sulfate in the prior art is low, which is still only suitable for consumer cultural and creative goods (such as dolls) or public art models, and cannot be applied to bone implants. Due to the above-mentioned reasons, the current bone implants made with 3D printing technology are not popular enough. Therefore, there is still a need to develop novel technologies that allow 3D printed products to be applied to bone implants.

Therefore, the purpose of the present invention is to provide a bone implant material suitable for 3D printing technology to make bone implants.

Therefore, the bone implant material of the present invention includes calcium sulfate powder; and adhesive powder, selected from pregelatinized starch, maltodextrin, gum arabic, gelatin, shellac, Guanhua bean gum, and Sanxian gum , Methyl cellulose, sodium hydroxymethyl cellulose, ethyl cellulose, hydroxyethyl cellulose, hydroxypropyl cellulose or any combination of the above.

The effect of the present invention is that the bone implant material of the present invention is matched with the calcium sulfate powder through a specific type of adhesive powder, so that it is suitable for use in the production of bone implants by 3D printing technology. And in subsequent applications, the bone implant made by using the bone implant material of the present invention has good compressive strength and degradation time.

The other features and effects of the present invention will be clearly presented in the embodiments with reference to the drawings, in which: Fig. 1 is a perspective view of an application example 1 of the bone implant material of the present invention for a molded product for bone implants; 2 is an application example of the bone implant material of the present invention; 2 is a perspective view of a molded product for bone implants; Figure 3 is an application example of the bone implant material of the present invention 3 a molded product for bone implants Top view; and Figure 4 is a side view of a molded product for bone implants of Application Example 3 of the bone implant material of the present invention.

The content of the present invention will be described in detail below:

Herein, the specific aspect of the “bone implant” is, for example, but not limited to, joint implants, spinal implants, cranio-maxillofacial implants, ankle implants or trauma implants (Bone plate, bone nail) etc.

The bone implant material of the present invention includes calcium sulfate powder and adhesive powder. Preferably, in some embodiments of the present invention, the bone implant material further comprises dispersant powder. The components of the bone implant material and subsequent applications of the bone implant material are described in detail below.

In some embodiments of the present invention, the calcium sulfate powder is, for example, calcium sulfate hemihydrate, calcium sulfate anhydrous, calcium sulfate dihydrate, or any combination of the foregoing. Preferably, the particle size range of the calcium sulfate powder is 150 μm or less.

The adhesive powder helps to make molded products made by 3D printing have a good appearance and shape. The adhesive powder is selected from pregelatinized starch, maltodextrin, acacia, gelatin, shellac, Guanhua bean gum, sanxian gum, methylcellulose, sodium hydroxymethylcellulose , Ethyl cellulose, hydroxyethyl cellulose, hydroxypropyl cellulose or any combination of the above. The above adhesive powder It is a water-based solid powder, which facilitates 3D printing. Moreover, the aforementioned adhesive powder is organic and can be removed by sintering during subsequent applications, so that the prepared bone implant meets the requirements of biocompatibility and non-toxicity. Preferably, the particle size range of the adhesive powder is 150 μm or less. In some embodiments of the present invention, the total amount of the calcium sulfate powder is 100 parts by weight, and the content of the adhesive powder ranges from 0.1 to 50 parts by weight, so that the bone implants prepared by subsequent applications have Better physical structure and better mechanical properties.

The dispersant powder can further prevent the "powder agglomeration" phenomenon of the bone implant material. Preferably, the dispersant powder is selected from silicon dioxide, magnesium aluminum silicate, or any combination of the above. Preferably, the particle size range of the dispersant powder is 150 μm or less. In some embodiments of the present invention, the total amount of the calcium sulfate powder is 100 parts by weight, and the content of the dispersant powder is in the range of 0.1 to 30 parts by weight, so that the bone implants prepared by subsequent applications have Better mechanical properties.

The bone implant material of the present invention is suitable for use in 3D printing technology to make bone implants, wherein the specific type of 3D printing is, for example, but not limited to, Binder Jetting. In some embodiments of subsequent applications of the bone implant material of the present invention, the following steps are included: using the bone implant material to produce a molded product for bone implants using 3D printing technology.

In other embodiments of the subsequent application of the bone implant material of the present invention, the following steps are included: using 3D printing technology to make the bone implant material into bone The molded product for implants is heated to obtain a semi-finished product. Then the semi-finished product is sintered to obtain a sintered product, and finally a protective layer formed by a pharmaceutical-grade excipient (such as sodium alginate) is placed on the sintered product to obtain a bone implant. Wherein, the function of the heating is to further remove the moisture in the molded product for bone implants and to improve the degree of solidification of the molded product for bone implants. The temperature and time of the heating are not particularly limited, and can be based on the bone implant The amount of material and the volume and weight of the molded product for bone implant can be adjusted freely. The function of the sintering is to destroy and dissipate the organic matter in the semi-finished product, and to transform the calcium sulfate powder in the semi-finished product into the form of anhydrous calcium sulfate as much as possible. The sintering method is not particularly limited, and can be based on the bone graft. The amount of input material, the volume and weight of the molded product for the bone implant, and the specific application of the bone implant can be adjusted freely.

The present invention will be further described in the following examples, but it should be understood that the examples are only for illustrative purposes and should not be construed as limiting the implementation of the present invention.

[Example 1]

Calcium sulfate, adhesive (specific type is gum arabic) and dispersant (specific type is silica) are crushed, ground and sieved in sequence, and then powders with a particle size of 150 μm or less are screened out. Next, 100 parts by weight of the calcium sulfate powder, 6 parts by weight of the adhesive powder, and 1 part by weight of the dispersant powder were taken and mixed with an electric mixer for 30 minutes to obtain a bone implant material.

[Application Examples 1 to 3]

According to the model drawings of different bone implants, using the bone implant material of Example 1, put the bone implant material of Example 1 into a 3D printing machine (the manufacturer is Yanneng Technology Co., Ltd., In the model M10), the adhesive spray molding method is used for 3D printing, and the molded products for bone implants of application examples 1 to 3 are produced. Among them, the molded product for bone implants in Application Example 1 is shown in FIG. 1, the molded product for bone implants in Application Example 2 is shown in FIG. 2, and the molded product for bone implants in Application Example 3 is As shown in Figure 3 and Figure 4.

[Application example 4]

Put the bone implant material of Example 1 into a 3D printing machine (manufacturer is Yanneng Technology Co., Ltd., model M10), and use the adhesive spray molding method according to the bone implant model. 3D printing, get a molded product for bone implant. Next, the molded product for bone implants is heated (temperature of 50±3°C, time of 30 to 60 minutes) to obtain a semi-finished product (a solid cylinder with a diameter of 1.5 cm and a height of 3 cm). Then, the semi-finished product is sintered (the initial temperature is 25°C, the heating rate is 1°C/min, and the temperature is raised to 100°C for 30 minutes during the heating process, and the final temperature is 1100°C and the temperature is maintained for 60 minutes), Get a sintered product. Finally, a layer of excipient (specific type is sodium alginate) is coated on the surface of the sintered product and left to stand to dry to form a protective layer to prepare a bone implant.

[Property Evaluation]

1. Compressive strength: use a universal tester (manufacturer is Guoke Enterprise Co., Ltd., model MTS810) and in accordance with ASTM D695 standard method, measure application 4 The compressive strength of the bone implant (unit: Mpa). For the purpose of providing the compressive strength required by the bone implant during the operation of bone implantation, preferably, the compressive strength of the bone implant is at least 10Mpa.

2. Degradation time: According to ISO 10993-14 and ASTM F1635 standard methods, measure the degradation time of the bone implant in Application Example 4 (unit: day). For the purpose of remodeling or healing the bone defect site, preferably, the degradation time of the bone implant is at least 14 days.

It can be seen from Figures 1 to 4 that through 3D printing technology, especially adhesive spray molding technology, the application examples 1 to 3 molded products for bone implants made by using the bone implant material of Example 1 have a good appearance . It is shown that the bone implant material of Example 1 can be applied to 3D printing technology, and can be made into bone implants with various shapes and good appearance.

It can be seen from Table 1 that the bone implant of Application Example 4 prepared by using the bone implant material of Example 1 has good compressive strength and degradation time. In addition, the obtained application example 4 bone implant has high compressive strength, which is sufficient to provide the compressive strength required during the operation of the bone implantation; and the degradation time is long, which is beneficial to remodeling or healing the bone defect.

In summary, the bone implant material of the present invention contains specific types of adhesion Powder, and preferably also contains a specific type of dispersant powder, matched with the calcium sulfate powder, so as to be suitable for use in 3D printing technology to make bone implants, and in subsequent applications, use the bone implant of the present invention The bone implant made of the material has good compressive strength and degradation time, so it can indeed achieve the purpose of the invention.

However, the above are only examples of the present invention. When the scope of implementation of the present invention cannot be limited by this, all simple equivalent changes and modifications made in accordance with the scope of the patent application of the present invention and the content of the patent specification still belong to Within the scope of the patent for the present invention.

Claims (7)

A bone implant material, comprising: calcium sulfate powder; and adhesive powder, selected from pregelatinized starch, maltodextrin, gum arabic, gelatin, shellac, Guanhua bean gum, sanxian gum, and methyl Cellulose, sodium hydroxymethyl cellulose, ethyl cellulose, hydroxyethyl cellulose, hydroxypropyl cellulose or any combination of the above; the particle size range of the adhesive powder is 150 μm or less. The bone implant material according to claim 1, wherein the total amount of the calcium sulfate powder is 100 parts by weight, and the content of the adhesive powder ranges from 0.1 to 50 parts by weight. The bone implant material according to claim 1, wherein the bone implant material further comprises a dispersant powder selected from silicon dioxide, magnesium aluminum silicate, or any combination of the foregoing. The bone implant material according to claim 3, wherein the total amount of the calcium sulfate powder is 100 parts by weight, and the content of the dispersant powder is in the range of 0.1 to 30 parts by weight. The bone implant material of claim 1, wherein the calcium sulfate powder is selected from calcium sulfate hemihydrate, calcium sulfate anhydrous, calcium sulfate dihydrate, or any combination of the foregoing. The bone implant material according to claim 1, wherein the calcium sulfate powder has a particle size range of 150 μm or less. The bone implant material according to claim 3, wherein the particle size range of the dispersant powder is 150 μm or less.

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