JP4543152B2 - Transparent titanium-coated biocompatible material - Google Patents

Description

  The present invention relates to a transparent titanium-coated biocompatible material, and more specifically, imparts biocompatibility by forming a titanium film having a predetermined film thickness on the surface of a core material made of plastic or ceramics. The present invention relates to a biocompatible material for bone replacement with controlled transparency.

  In the technical field of bone substitute materials and biocompatible materials such as implants and their products, the present invention generally includes conventional bone substitute products made of difficult-to-process materials. It was developed based on the fact that it was possible to selectively control biocompatibility and surface transparency by coating a transparent titanium film on a plastic core material. The present invention provides a new type of bone substitute material capable of performing secondary processing in a medical field and material design tailored to the individual (tailor-made), and a biocompatible material and implant as its product.

The present invention is, for example, by coating a thin film of titanium or titanium alloy, biocompatible material capable of reflecting color of the core material, the pattern and / or design or the like on the surface, and, for at least visible light, transparent It is useful for providing a biocompatible material coated with titanium or a titanium alloy that can be imparted with properties.

  Furthermore, the present invention makes it possible to selectively perform the biocompatibility, control the transparency to a predetermined level, tailor-made an implant that contacts a plurality of living tissues, and post-operative follow-up measurement. The present invention has a high technical significance as providing a biocompatible material having a wide range of selectivity not found in conventional materials.

  With the aging of society, the need for bone replacement materials and biocompatible materials such as implants is increasing. In addition, bone substitute materials are required not only for elderly people but also for children and adults who have bone defects due to accidents. Therefore, the performance required for bone substitute materials is diversified, and it is desirable to design materials tailored to the individual. In some medical settings, for example, dentistry, dental technicians and dentists make tailors such as crowns, but this material can be freely colored and patterned, and its hardness can be freely controlled. It is not easy to do.

  Establishing these unprecedented technologies will facilitate and popularize tailor-made. Ceramics and titanium are mainly used as bone substitute materials. Ceramics are excellent in strength, but have brittle properties, so it is difficult to use them in stem portions and the like where a large load is applied. Titanium is not as hard as ceramics, but it is used for the stem portion because of its toughness.

  However, titanium is stronger than living bones, and when an excessive load is applied, the living bones are burdened. The strength of living bones varies from person to person. In elderly people, bone strength may be reduced, and secondary fractures are also a concern. Although it is desirable to design the material due to these individual differences, it is difficult to change the strength of titanium according to the person. Moreover, both ceramics and titanium are generally difficult-to-process materials, and in particular, the degree of freedom in shape at the medical site is low.

  There is also an implant in which ceramics and titanium are combined. For example, an implant made of calcium phosphate ceramic layer-covered Ti or Ti alloy and a method for manufacturing the same (see Patent Document 1) have been proposed. In this method, an implant used in the field of dentistry and orthopedics is made by embedding a part of a calcium phosphate ceramic coating layer in which the surface of an implant body made of Ti or Ti alloy is embedded in the surface of the body, and is resistant to peeling. It is what raises.

  The manufacturing method is as follows. In the production of an artificial hip joint, first, the wet-synthesized calcium phosphate powder is calcined at a high temperature, then pulverized with a wet ball mill, added with a binder, dispersed in a slurry, and then granulated into a powder that is spray-dried. By baking, a round tricalcium phosphate coarse powder is obtained.

  Next, this coarse powder is heated and sprinkled on the surface of the wax mold having the same shape as the artificial joint, and then the coarse powder adhered to the surface of the wax mold is pressed to form a composite wax mold in which the coarse powder is partially exposed. Make it. Then, after making a production casting mold using this composite wax mold, a Ti alloy is cast into this, and a Ti alloy artificial hip joint embedded with tricalcium phosphate coarse powder is obtained.

  Further, Tsutomu Muramatsu et al. (Non-Patent Document 1), K. De Groot et al. C. As described in a report by Wan et al. (Non-patent Document 3), a technique of combining titanium and ceramics by coating a ceramic of about several tens to several hundreds of microns using a plasma spray method around titanium. Has been proposed.

  The plasma spray method is a method in which a coating raw material powder is introduced into an arc plasma or the like, and a core material, for example, titanium, is placed at the plasma ejection destination to form a coating layer of the raw material powder on the surface of the core material. Thus, a hydroxyapatite coating layer coated around titanium is obtained. In the case of such a complex, it is possible to selectively obtain the necessary biocompatible surface.

  However, including these cases, this type of implant generally has a higher strength than that of living bone because titanium is responsible for the strength of the implant, and in the examination using X-rays, There is a problem that the overlapping portion tends to be unclear and difficult to observe. The same applies to various observations and measurements using ultraviolet rays, infrared rays, visible light, and the like. Furthermore, it is difficult to change the shape of the composite without changing the characteristics.

  On the other hand, plastics are easy to change over time in the body, but a wide range of materials with various strength characteristics have been developed that are lightweight and have various properties including plastics that are compounded with fibers. In addition, plastics are promising as tailor-made materials if they can be deformed with heat and have good mechanical cutting performance, so long as changes with time are suppressed. However, the biocompatibility of plastic as a bone substitute material or the like is low.

  In addition, the demand for implants has been diversified. For example, aesthetics are also an important factor when something that is put into the oral cavity can be seen through soft tissue. In this case, for example, titanium or the like looks blackish, so it is desirable that the material is inconspicuous, such as a brighter color or transparency.

  Furthermore, with the development of medical technology and advances in research on implants and the like, more precise operation and measurement are required in medical-related experiments using medical instruments and medical measuring instruments. Therefore, it is desirable that the interface between the medical instrument, the medical measurement instrument, the implant, and the like, and the biological tissue, body fluid, and the like be in a state where it is easier to observe and measure.

  However, when observing and measuring an interface such as a titanium implant, it is not easy to process the interface containing titanium harder than bone and soft biological tissue by polishing or the like. Even in measurement using electromagnetic waves or various electromagnetic waves, the portion overlapping with titanium tends to be unclear and difficult to observe.

  Furthermore, these methods have a low degree of freedom in observation and measurement angles. In addition, in cell culture tests and calcium phosphate precipitation tests using simulated body fluids, there is a problem that the degree of freedom in observation and measurement angles is low, such that the shaded portion of titanium cannot be seen.

  In addition, medical devices that circulate body fluids, medical devices that come into contact with living bodies or living bodies and body fluids, measurement terminals, and experimental devices should be easily observed and measured while imparting or controlling biocompatibility. However, these elements are extremely important for facilitating measurement and observation.

Japanese Patent No. 2956318 Matsumoto Medical, Volume 8, 8-14 (1982) JOURNAL OF BIOMEDICALMATERIALS RESEARCH, 21, 1375 (1987) JOURNAL OF BIOMEDICALMATERIALS RESEARCH, 27, 1315-1327 (1993)

  Under such circumstances, the present inventors, in view of the above prior art, can surely solve the problems in the above prior art, new biomaterials and medical materials using titanium, and new uses thereof. As a result of intensive research with the goal of developing the form and its products, coating the appropriate core material with design and selection of shape properties, etc., with a titanium thin film showing biocompatibility with controlled transparency As a result, it was found that the intended purpose can be achieved, and the present invention has been completed.

  That is, the present invention has various colors and designs, is lightweight and easy to mold, can ensure transparency with respect to necessary observation and measurement means, and performs observation and measurement from various angles. It is an object to realize a biomaterial and a medical material having a biocompatible surface selectively on the entire surface or a part of the material. In addition, the present invention provides a new biocompatible material that can add various biocompatibility to plastics and ceramics, and can design a material suitable for each patient and intended use. It is the purpose.

The present invention for solving the above-described problems comprises the following technical means.
(1) A biocompatible molded article for bone replacement in which a titanium film having a predetermined film thickness is formed on part or all of the surface of a core material to impart biocompatibility, and 1) the core material is plastic or made of ceramic, 2) the titanium coating is made of pure titanium or a titanium alloy, 3) the titanium coating is transparent for at least visible light, or showed a translucent, 4) the surface of the titanium film, the cell・ Has biocompatibility,
A biocompatible molded article, wherein the titanium coating exhibits transparency or translucency, and allows a predetermined color, pattern and / or design of the core material to be reflected on the surface.
( 2 ) The biocompatible molded article according to (1), wherein a ceramic, an organic substance, or a metal coating is provided on a part of the molded article.
( 3 ) Ceramic coating, organic substance or metal coating, or a mixed layer, composition gradient layer or structural gradient layer covering a part or the whole of the core material, and further forming a titanium coating on a part or all of the core material The biocompatible molded article according to (1), wherein has a biocompatible action.
( 4 ) Any of the above (1) to ( 3 ), wherein the shape of the molded body is a crown, a dental prosthesis, or an artificial tooth root, and a portion that touches soft tissue or a living bone or a surrounding has a biocompatible action. The biocompatible molded product according to 1.
( 5 ) The biocompatible molded article according to any one of (1) to ( 4 ), wherein the titanium coating exhibits transparency and reflects the color, pattern and / or design of the core material on the surface.
( 6 ) A biocompatible metal in which at least a part of the titanium coating surface layer is Nb, Ta, W, Zr, Au, Ag, Pt, Si, Pd, Y, Hf, Ir, Mo, Fe, or Mg-based metal The biocompatible molded article according to any one of (1) to ( 5 ), comprising a film.
( 7 ) An implant comprising the biocompatible molded article according to any one of (1) to ( 6 ).

Next, the present invention will be described in more detail.
The present invention is a biocompatible molded article in which a titanium film having a predetermined thickness is formed on the surface of a core material to impart biocompatibility, and the surface transparency is controlled, and the surface layer is a titanium film. it, characterized titanium coating is transparent for at least visible light, or to exhibit a translucent, core material, be made of plastic or ceramic, the surface of the titanium film, to have a cell-biocompatible action, the It is what.

In the present invention, the titanium coating, pure titanium, or that consists of a titanium alloy. Further, at least a part of the surface layer of the titanium film is made of Nb, Ta, W, Zr, Au, Ag, Pt, Si, Pd, Y, Hf, Ir, Mo, Fe, or an Mg-based metal other than titanium. A biocompatible metal film can also be used.

  As the core material, those having a predetermined color, pattern and / or design on the surface can be used, but their specific configuration can be arbitrarily designed according to the purpose of use. . In addition, in consideration of formability, etc., it can be designed to be easy to process with metal, ceramic, or diamond cutters, microtomes, and / or abrasives, which are considered difficult with metal implants. it can.

  The biocompatible material of the present invention is preferably exemplified by artificial bone, artificial joint, artificial tooth root, artificial dental crown, dental prosthesis, denture, denture base, soft tissue implant and the like. For example, in the case of an artificial joint, the shape of the transplant site is determined by a shape measurement method such as X-ray CT, and after processing the core material into a shape that can be easily transplanted using a technique such as a rapid prototype, titanium or The titanium alloy is coated from 1 nm to 50% or less of the thickness of the core material at a film formation rate of 5 nm / min to 100 nm / min. However, it is possible to make part or all of the coating thickness less than 1 nm as long as the performance is not affected.

  In the present invention, vapor deposition such as sputtering, vapor deposition, chemical vapor deposition, and physical vapor deposition is used as a film forming method for forming the titanium film. The reason for limiting the film formation rate to 5 to 100 nm / min is that the film quality is not lowered by film formation that is more rapid than necessary. However, these film forming methods and film forming speeds are not limited to the above ranges unless the film quality and the quality of the molded body are lowered.

  In the case of an artificial tooth root, after processing the core material into a cylinder (cylinder or the like) or a screw-type shape, titanium or a titanium alloy is coated on the surface of the necessary portion at a film formation rate of 5 nm / min to 100 nm / min at 10 nm to 200 μm. . Here, as a component of the titanium alloy, for example, Ti, Nb, Ta, W, Zr, P, Au, Ca, Ag, Pt, Al, V, Si, B, N, C, Pd, Y, Hf , Ir, Mo, Fe, Mg, Na, K and the like are exemplified, but not limited thereto.

  In the present invention, if necessary, a core material having a color, a design, or the like is used in advance, or after coloring the core material, coloring or drawing is performed. If necessary, processing for shape adjustment is performed at the medical site immediately before transplantation. In addition, it is desirable to use it in a covered state where necessary measurement and observation can be performed while ensuring necessary biocompatibility. However, it is desirable to form a composite with titanium or a titanium alloy below the decomposition temperature of the core material.

  Furthermore, if necessary, in order to increase the adhesion between the core material and titanium or titanium alloy, the core material surface approaches the composition and structure of the core material, and the proportion of titanium is gradually increased. Alternatively, it is desirable to perform the gradient of the interface composition and structure, such as a technique using a titanium alloy.

  In addition, if necessary for surface biocompatibility, interface control, transparency and reflection performance control, a ceramic, organic or metal layer is provided between titanium and the core material, or on the titanium layer. It is desirable to provide a ceramic, organic or metal layer. The reason is that if the reflection at the interface or surface is large, or if the molded product lacks stability due to peeling, etc., it is suitable for ceramics and organic substances suitable as antireflection film and buffer layer to prevent peeling at the interface. Alternatively, it is effective to provide a metal film.

  In addition, the reason is that, if there are ceramics etc. that existed in the tissue of the implantation place with implants etc., it is also effective to arrange the ceramics on the surface as necessary, etc. This is because it is also effective in controlling wettability.

  In that case, as ceramics, organic matter and metal, for example, Nb, Ta, W, Zr, P, Au, Ca, Ag, Pt, Al, V, Si, B, N, C, Pd, Y are preferable. , Hf, Ir, Mo, Fe, Mg, Na, K, Co, Cr, one or more oxides, mixtures, laminates, polylactic acid, polyvinyl alcohol, Teflon (registered trademark), silicone, porcelain, Examples include polymethyl methacrylate, polycarbonate, reethylene, polyethylene terephthalate, polytetrafluoroethylene, polyvinyl chloride, polyurethane, collagen, and nylon.

  In the present invention, a titanium coating is formed on a part or the entire surface of the core material to impart biocompatibility, and further, for example, Nb, Ta, W, Zr, P, Au, etc. , Ca, Ag, Pt, Al, V, Si, B, N, C, Pd, Y, Hf, Ir, Mo, Fe, Mg, Na, K, Co, Cr, one or more oxides, Mixtures, laminates, and ceramics such as polylactic acid, polyvinyl alcohol, Teflon (registered trademark), silicone, porcelain, polymethyl methacrylate, polycarbonate, reethylene, polyethylene terephthalate, polytetrafluoroethylene, polyvinyl chloride, polyurethane, collagen, nylon And a film of organic matter can be formed.

  Thereby, the advantage that biocompatibility, reflectivity, peeling prevention, etc. can be controlled is obtained. Further, in the present invention, biocompatibility can be imparted by forming a coating of ceramics or organic matter on a part or the entire surface of the core material and further forming a titanium coating on a part or the entire surface of the core material.

  In this case, as the ceramic or organic film, for example, Nb, Ta, W, Zr, P, Au, Ca, Ag, Pt, Al, V, Si, B, N, C, Pd are preferable. Y, Hf, Ir, Mo, Fe, Mg, Na, K, Co, Cr, one or more oxides, mixtures, laminates, polylactic acid, polyvinyl alcohol, Teflon (registered trademark), silicone, Examples include porcelain, polymethyl methacrylate, polycarbonate, reethylene, polyethylene terephthalate, polytetrafluoroethylene, polyvinyl chloride, polyurethane, collagen, and nylon.

  Examples of the method for forming the coating of ceramics or organic matter include, but are not limited to, vapor deposition such as sputtering, vapor deposition, chemical vapor deposition, and physical vapor deposition, and plating. . In the present invention, it is also possible to substitute a part of the film with another metal or organic substance as long as the adhesion and transparency of the film are not impaired.

  Specific examples thereof include Nb, Ta, W, Zr, P, Au, Ca, Ag, Pt, Al, V, Si, B, N, C, Pd, Y, Hf, Ir, Mo, Fe, Mg, Na, K, Co, Cr, one or more oxides, mixtures, laminates, polylactic acid, polyvinyl alcohol, Teflon (registered trademark), silicone, porcelain, polymethyl methacrylate, polycarbonate, reethylene, polyethylene terephthalate, Examples include polytetrafluoroethylene, polyvinyl chloride, polyurethane, collagen, nylon and the like.

  FIG. 1 shows an outline of a method for producing the biocompatible material of the present invention and an application example. In the present invention, for example, a titanium thin film exhibiting biocompatibility is coated on an appropriate core material that has been designed and selected in terms of shape, mechanical properties, color, design, etc. A biocompatible molded article having a shape and the like, with controlled biocompatibility and surface transparency, can be produced.

Here, to control the transparency of the surface is simply is to control the thickness of the titanium coating layer, the thickness and structure of the whole surface layer, by controlling the physical properties, against at least visible light transmittance It means controlling sex. In the present invention, the entire biocompatible material can be made transparent, translucent or opaque as required. In the present invention, at least the transparency to visible light means that, in addition to visible light, as shown in the examples measured in the examples described later, if necessary, the transparency to X-rays is used as appropriate. Can be controlled.

  For example, when transparent with visible light, an effect of making the biocompatible material inconspicuous and an effect of facilitating optical observation from the back side or inside the material can be obtained. In that case, naturally, it is also possible to perform various surface modification techniques on the metal coating and observe the effects and the like from the back side or inside the material. In addition, for example, when transparent to X-rays, it is possible to observe even a portion that is behind the biocompatible material. Even in the case of X-ray CT, the biocompatible material has a low X-ray absorption rate, so that measurement of surrounding substances is not hindered. It is also possible to make a part of the biocompatible material transparent and selectively give the above-mentioned effects.

  In the present invention, a part of the biocompatible material can be made translucent and opaque as necessary. For example, when it is made translucent and opaque with visible light, the surface state of the biocompatible material can be confirmed with the naked eye. In addition, for example, when translucent and opaque with respect to X-rays, the surface of the biocompatible material can be easily specified even when a core material with good permeability is used. Even in the case of X-ray CT, the shape of the biocompatible material can be measured. In addition, the entire biocompatible material can be made translucent and opaque to give the above-mentioned effects.

  In the present invention, the core material can be a biocompatible material even in plastics and ceramics having low biocompatibility. Therefore, the mechanical properties of the entire biocompatible material can be designed in various ways. For example, when a relatively soft material such as plastic or resin is used for the core material, it is easy to cut, for example, about 200 ° C. Can provide a material that can be easily thermally deformed. Further, for example, there is an advantage that it is easy to produce a slice specimen after being experimentally embedded in the bone of an animal.

  In the present invention, biocompatible materials having various colors and designs can be provided. As described above, this can be realized by reflecting the color, pattern or design of the material of the molded body core on the surface. For example, the biocompatible material can be made inconspicuous by adjusting the color to the color of the patient's biological tissue. Further, for example, it is possible to provide fashionability by appropriately setting the design and color according to the patient's request. By applying these techniques to biocompatible materials, it is possible to supply biocompatible materials tailored to individual patients and intended uses, and biocompatible materials can be applied to a wide range of uses and tailor-made.

  According to the present invention, (1) to provide a biocompatible material for bone replacement in which a titanium coating is formed on the surface of a plastic or ceramic core material to impart biocompatibility and the surface transparency is controlled. (2) Biocompatibility can be produced by giving biocompatibility to a necessary part of the core material or a part of the entire surface, and it is possible to produce biocompatible materials having various colors and designs. It is possible to provide a material that can secure the material. (3) It can be selectively combined even in a single implant, such as a metallic luster only on one side or patterning the coating layer. (4) This makes it possible to add various biocompatibility to plastics and ceramics, meet various demands, and ensure transparency. Various observations such as observation of the material and surroundings are also facilitated. (5) Furthermore, materials that can be easily processed at medical sites and surgical sites, for example, those that can be processed with instruments held by dental technicians or dentists It is possible to provide a biocompatible material tailored to individual patients and intended use, and it is possible to provide a wide range of uses and tailor-made, so that a special effect is achieved. .

  EXAMPLES Next, although this invention is demonstrated concretely based on an Example, this invention is not limited at all by the following Examples.

(1) Production of transparent, translucent and metallic luster titanium-coated biocompatible material Using a transparent plastic rod and glass rod with a diameter of 1 mm to 3 mm and a length of 3 mm to 20 mm as a core material, part or all of its surface Then, a titanium thin film having a thickness of about 1 nm to 1 μm was formed at a film forming rate of 50 nm / min to produce a biocompatible molded body. The specific method is as follows. A core material is fixed to a substrate holder of a sputtering apparatus for sputtering up, DC plasma of 50 W to 1 KW is generated at a vacuum degree of 0.01 to 1 Pa, and a titanium target (JIS type 2 or more, 99.9% or higher, high purity Co., Ltd.) After performing pre-sputtering for 5 min or more at Chemical Research Laboratory), 50 nm
A biocompatible molded body was formed by forming a film for 1 s or more at / min.

Examples of the surface observed with an electron microscope are shown in FIGS. As shown in these figures, the titanium film was uniformly formed. An example of the appearance photograph is shown in FIG. Naked eye, i.e. in the visible light, compact of titanium film thickness 1 [mu] m has low transparency, the film thickness transparency becomes high due to the reduced appearance of substantially transparent although the film thickness of the titanium little color in 30nm is It was.

  The right sample in FIG. 4 is an example in which the transparency is low, and the right sample is in a state of high transparency. The molded product with low transparency can be clearly confirmed with the naked eye, but in observation with X-ray CT, it was transparent and easy to measure. The molded body of the acrylic core became soft at temperatures up to 300 ° C., easily deformed, and could be processed such as cutting at room temperature. When this sample was embedded in a living bone of a mouse or dog, it adhered to the bone within a period of several days to several months and showed high biocompatibility. These specimens could be easily processed with a metal cutter, a microtome, and an abrasive.

A 10 mm square plastic plate, a glass plate and an aluminum oxide plate are used as core materials, and a part of the surface thereof has a film formation rate of 5 nm / min to 100 nm / min and a thickness of about 1 nm to 200 μm in the same manner as in Example 1. A titanium thin film was formed to produce a biocompatible molded body. Naked eye, i.e. in the visible light, the titanium film thickness 1 [mu] m or more shaped bodies has low transparency, the film thickness transparency becomes high due to the decrease, the titanium film thickness is substantially transparent although there is little in the 30nm color It was an appearance. The molded product with low transparency can be clearly confirmed with the naked eye, but in observation with X-ray CT, it was transparent and easy to measure.

  A cylindrical plastic or screw-shaped colored plastic rod and metal rod having a diameter of 1 mm to 3 mm and a length of 3 mm to 20 mm are used as a core material, and a film is formed on a part or the entire surface in the same manner as in Example 1. A titanium thin film having a thickness of about 1 nm to 1 μm was molded at a speed of 50 nm / min to produce a biocompatible molded body. The titanium coating was uniformly formed, and the shape of the core material was reflected on the surface for all materials.

Naked eye, i.e. in the visible light, the titanium film thickness 1 [mu] m or more shaped bodies has low transparency, the film thickness transparency becomes high due to the decrease, the titanium film thickness is substantially transparent although there is little in the 30nm color It was an appearance, and the color and design of the core material were reflected on the surface. The molded product with low transparency can be clearly confirmed with the naked eye, but in observation with X-ray CT, it was transparent and easy to measure. The molded body of the plastic core became soft at temperatures up to 300 ° C., easily deformed, and could be processed such as cutting at room temperature.

A plastic petri dish having a diameter of about 50 mm to 60 mm is used as a core material, and a titanium thin film of about 1 nm to 200 μm is formed on the surface at a film forming speed of 5 nm / min to 100 nm / min in the same manner as in Example 1. A biocompatible molded body was produced. Naked eye, i.e. in the visible light, the titanium film thickness 1 [mu] m or more shaped bodies has low transparency, the film thickness transparency becomes high due to the decrease, the titanium film thickness is substantially transparent although there is little in the 30nm color It was an appearance. The molded product with low transparency can be clearly confirmed with the naked eye, but in observation with X-ray CT, it was transparent and easy to measure. The surfaces of these molded bodies were less fogged than the untreated surfaces. Moreover, when cell culture was performed with a sample transparent to the naked eye, it was possible to observe from the lower surface.

An acrylic pin of φ1.6 × 5 mm , which was biocompatible by the same method as in Example 1, was implanted in the rat femur. After 4 weeks, the acrylic pin was collected with the femur. There were no findings suggesting infection or lesion at or near the site where the acrylic pin was implanted, and the acrylic pin was firmly fixed to the femur. A micro X-ray CT tomographic image of an acrylic pin and surrounding tissue and a 3D computer model of the tomographic image are shown in FIGS. 5 and 6, respectively. The tomographic image was not affected by the Ti coating due to the biocompatibility treatment.

  In addition, the outline of the acrylic pin was clearly reproduced in the 3D computer model. That is, the acrylic pin subjected to the biocompatibility treatment was bonded to the bone like a general titanium implant, and the embedded state could be observed non-destructively by X-ray CT. As a limitation of CT imaging technology, it is difficult to obtain a correct image when a metal, such as a titanium alloy implant, having a significantly different X-ray absorption characteristic from that of bone is imaged simultaneously with the bone.

To prepare a titanium film of about 1 [mu] m from the deposition rate of 5 nm / min at 100 nm / min on the glass plate of the alumina plate and 26 × 76 mm in 50mm square. A photograph of the sample is shown in FIG. The thin film was fixed stably without any peeled part. During the film formation, the alumina plate was not damaged and no alteration was observed. The film surface was in a state imitating the shape of the underlying surface.

Acrylic pins 1.6 dia. × 7 mm, and, 26 × 76 mm glass plates from the film formation rate 5n m / min to about 1nm in 100n m / min 100 nm of Nb, to produce a thin film of Ta or the like. A photograph of the sample is shown in FIG. The thin film was fixed stably without any peeled part. During the film formation, the glass plate was not damaged and no alteration was observed. The film surface was in a state imitating the shape of the underlying surface.

  As described above in detail, the present invention relates to a transparent titanium-coated biocompatible material, and according to the present invention, biocompatibility is imparted to a necessary part of the core material or a part of the entire core material, and various colors, The biocompatible material which has a design can be produced, and the material which can ensure transparency with respect to a required measurement means can be provided. Further, it can be selectively combined in a single implant or the like such that only one surface has a metallic luster or a coating layer is patterned.

  This makes it possible to add various biocompatibility to plastics and ceramics, to meet various demands, and to ensure transparency. Various observations are also facilitated. Furthermore, materials that can be easily processed at medical sites and surgical sites, for example, materials that can be processed with instruments held by dental technicians and dentists can be provided. The present invention makes it possible to supply biocompatible materials tailored to individual patients and applications, and to create new technologies and new industries in the art as enabling a wide range of applications and tailor-made. It contributes.

It is a conceptual diagram which shows the outline of the manufacturing method of the biocompatible material of this invention, and an application example. It is an outline photograph of the biocompatible molded object material of this invention. It is an electron micrograph of the surface of the biocompatible molded object material of this invention. Exterior biocompatible of molding material of the present invention (Left: 30 nm film thickness sample, right: 1 [mu] m film thickness sample) is. It is a cross-sectional image by X-ray CT of the material by the manufacturing method (Example 5) which concerns on this invention. It is a X-ray CT image of material by the manufacturing method (Example 5) which concerns on this invention. It is the external appearance photograph (left: glass plate, right: alumina plate) of the material by the manufacturing method (Example 6) which concerns on this invention. It is an appearance photograph (upper left: glass plate Ta coating, upper right: acrylic pin Ta coating, upper left: glass plate Nb coating, upper right: acrylic pin Nb coating) of the material by the manufacturing method (Example 7) based on this invention.

Claims (7)

A biocompatible molded article for bone replacement in which a titanium film having a predetermined thickness is formed on a part or all of the surface of a core material to impart biocompatibility, and (1) the core material is made of plastic or ceramics. becomes, (2) the titanium coating is made of pure titanium or a titanium alloy, (3) the titanium film, transparent for at least visible light, or shows a semi-transparent, the surface of (4) titanium film, Has cell / biocompatibility action,
A biocompatible molded article, wherein the titanium coating exhibits transparency or translucency, and allows a predetermined color, pattern and / or design of the core material to be reflected on the surface.   The biocompatible molded article according to claim 1, wherein a ceramic, organic matter, or metal coating is provided on a part of the molded article.   Ceramics, organic matter or metal coating, or mixed layer, composition gradient layer or structure gradient layer covers part or the whole of the core material, and titanium coating formed on part or all of the core material is biocompatible. The biocompatible molded article according to claim 1, which has a sexual effect. The biocompatible composition according to any one of claims 1 to 3 , wherein the shape of the molded body is a crown, a dental prosthesis, or an artificial root, and a soft tissue or a portion in contact with a living bone or a surrounding has a biocompatible action. Form. The biocompatible molded article according to any one of claims 1 to 4 , wherein the titanium coating exhibits transparency and reflects the color, pattern and / or design of the core material on the surface. At least a part of the titanium coating surface layer is composed of a biocompatible metal film of Nb, Ta, W, Zr, Au, Ag, Pt, Si, Pd, Y, Hf, Ir, Mo, Fe, or Mg-based metal The biocompatible molded article according to any one of claims 1 to 5 . An implant comprising the biocompatible molded article according to any one of claims 1 to 6 .