JPH0622503B2 - Translucent living body terminal - Google Patents

Description

DETAILED DESCRIPTION OF THE INVENTION In the present invention, the outer peripheral portion is made of a material such as alumina or hydroxyapatite having excellent affinity with the skin, and a part or all of the center thereof is excellent in translucency and biocompatibility. And a translucent biometric terminal.

Recently, long-term implantation has been realized by forming artificial bones by using materials that are not harmful to bones and in vivo tissues, or by coating the surface of artificial organs with the above materials. , The dependence of artificial materials on the body is increasing year by year.

However, it is difficult to demonstrate that these artificial materials are not harmful to living tissues, and the course of the tissue reaction of long-term implants has not yet been elucidated. The only method for observing a long-term tissue reaction is to remove body fluid or tissue from the body or to observe it with X-rays or ultrasonic waves. Therefore, continuous observation is almost impossible, and with X-rays, ultrasonic waves, etc., it is impossible to observe a fine portion or a systematic reaction due to its resolution.

Thus, the measurement of in-vivo information cannot be continuously performed not only in the reaction between the artificial material and the biological tissue but also in the measurement of blood composition and body fluid components.

In view of the above, the inventors of the present invention have diligently studied, and not only excel in biocompatibility but also optically couple the inside and outside of the body using a calcium phosphate-based ceramics material or an alumina ceramics material having high light and light transmittance. The present inventors have arrived at the present invention by finding that in-vivo information, particularly visual observation, can be performed for a long period of time.

Hereinafter, the material composition, shape and structure of the translucent biological terminal of the present invention will be described in detail.

Material composition and manufacturing method "Calcium phosphate ceramics material" in the present invention
Is as follows.

Hydroxyapatite represented by Ca ₁₀ (PO ₄ ) ₆ (OH) ₂ . Not only the pure product represented by Ca ₁₀ (PO ₄ ) ₆ (OH) ₂ but also O
Those containing 1 to 10% of carbonate (CO ₃ ) ions, fluorine and chlorine ions instead of H ions. Ca ₁₀ (PO ₄ ) ₆ (OH) ₂ as a main component, in order to improve sinterability, strength, porosity, etc.
This _{Ca 3 (PO 4) 2,} MgO, Na 2 O, K 2 O, CaF 2, Al 2 O 3, SiO 2,
CaO, Fe ₂ O ₃ , MnO, MnO ₂ , ZnO, C, SrO, PbO, BaO, TiO
_A mixture of various well-known additives such as ₂ , ZrO ₂ . Relatively less toxic polyethylene, polypropylene, polymethylmethacrylate, polyurethane, polyester,
Compounding agent with polymer resin such as ABS, fluorine, polycarbonate, polysulfone, epoxy, silicone, diallyl phthalate, furan. Examples include tricalcium phosphate, tetracalcium phosphate having a Ca / P molar ratio of 1.0 to 2.0, bioglass, and calcium phosphate-based crystallized glass. Alumina ceramics is formed by crushing secondary particles produced by the Payer method or the like to form α-alumina crystals, press-molding with a die, and sintering at 1600 to 1700 ° C.

It should be noted that it also includes those containing the above-mentioned material composition as a main component, and mixed with well-known various additives of various polymer materials in order to improve sinterability, strength, porosity and the like.

Here, when it is used as a composite agent with a polymer, polyethylene, polypropylene, polymethyl methacrylate, polyurethane, polyester, ABS resin, fluororesin, polycarbonate, polysulfone, epoxy resin, silicone resin, diallyl phthalate resin, which is relatively less toxic ,
A resin such as furan resin can be selected.

Translucent member In the present invention, the "translucent member" means optical / mechanical connection including glass fiber, plastics fiber, etc., and further bio-glass ceramics excellent in biocompatibility, calcium phosphate-based crystal. Illustrative examples include translucent polymers such as synthetic glass, translucent apatite, single crystal alumina, silicone rubber, Teflon and polyurethane. In addition, it also includes those obtained by vitrifying the calcium phosphate ceramics material, for example, translucent apatite, hydroxyapatite powder in a space of vacuum degree 10 ^-3 -10 ^-5 torr, pressure 500 ~ 2000 kg / cm. ² is produced by a hot pressing method or the like in which sintering is performed at 500 to 1300 ° C.

Since the translucent apatite not only has transmissivity but also has biocompatibility, a product formed only from the translucent apatite is also suitable for the present invention. In addition to translucent apatite, 3CaO ・ P ₂ O ₅ -CaO ・ S
The same applies to the calcium phosphate-based crystallized glass that is crystallized after the glass having the composition in which CaF ₂ is added to the iO ₂ —CaO · MgO · 2SiO ₂ based glass is prepared.

For details, refer to the method for producing a calcium phosphate-based crystallized glass described in JP-B-55-11625.

Shape or Structure The bio-terminal configuration of the present invention may be desired according to the purpose of use, but a typical example thereof will be described in detail with reference to the accompanying drawings.

That is, FIG. 1 is a cross-sectional view showing an example of the biomedical terminal of the present invention, in which the biomedical terminal is made of a hydroxyapatite sintered body, and its central portion is excellent in transparency from the outside. The translucent apatite 1 is embedded.

The biological terminal of the above structure is used by embedding and fixing the bottom of the terminal under the skin and projecting the upper end of the terminal head 2 onto the skin. Used.

Similarly, FIG. 2 has the same structure as the above example except that the translucent apatite is embedded only in the bottom of the terminal.

Further, in FIG. 3, the entire biometric terminal is formed of translucent apatite.

FIG. 4 shows that the main part of the biomedical terminal shown in FIG. 3 is formed of a hydroxyapatite sintered coating material (see Japanese Unexamined Patent Publication Nos. 52-82893, 53-75209, 53-118411, etc.). Show.

FIG. 5 shows a surface of a transparent member such as an optical fiber for optical communication or an optical fiber for transmitting laser light, which is coated with a calcium phosphate ceramics material. FIG. 6 shows a case where a calcium phosphate ceramics material is coated or provided on a translucent member such as a surface of the optical fiber for optical communication which is primarily coated with silicone resin or the like.

FIG. 5 to FIG. 6 enable direct observation of a deep part of a living body by optically connecting an imaging device and a storage device or the like with an optical fiber.

Hereinafter, the present invention will be described in detail with reference to experimental examples.

Experimental Example 1 1. Manufacture of translucent bio-terminals Hydroxyapatite powder is 0.5 mol / causium hydroxide and 0.3 mol / phosphoric acid solution slowly dropped,
The reaction was carried out at 0 ° C for 1 day to synthesize, and this was obtained by filtration and drying.
30 g of this synthetic powder was filled in a mold with an inner diameter of 30 mm, and this was sintered for 1 hour at 1100 ° C. in a closed space with a vacuum degree of 10 ^-4 torr and a pressure of 900 kg / cm ² , and a compression strength of 1000 kg / cm ² A hydroxyapatite sintered body having a relative density of 99% and a light-transmitting property was obtained. An ultrasonic processing machine and a dental diamond bar were used to obtain a biometric terminal having the shape shown in FIG.

Here, the terminal bottom has a diameter of 24 mm, a thickness of 3 mm, and the terminal head neck has an average diameter of 6 mm.

2. Animal experiment The above-mentioned living body terminal was embedded in the flank skin of a mongrel dog and observed over time. As a result, the terminal was strongly bonded and adhered to the skin tissue at the bottom and neck 2 weeks after the operation, and could not be removed even if pulled. After a lapse of one year, no abnormal findings such as inflammatory reaction were visually observed.

In addition, no inflammatory cells were found in the usual histological examination.

Experimental Example 2 Powder finely pulverized with an alumina (Al ₂ O ₃ ) pulverizer (particle size 5 μ
m) was plasma-sprayed on the surface of a silica optical fiber wire (diameter 1 mm) for optical communication using a plasma gun (9 MB manufactured by Meteco Co., Ltd.) to obtain a terminal having the shape shown in the attached FIG. The length of the sprayed portion of this terminal was 10 mm, and the maximum diameter was 1 mm.

Next, a predetermined number of these were pierced and embedded in the chest of an adult dog so that the tips thereof were located subcutaneously, and after about 3 weeks, they were completely bonded and fixed to the skin tissue.

Therefore, as a result of connecting and measuring the terminal gold wire to an electrocardiograph, an extremely clear electrocardiogram was obtained in which the effects of skin impedance and artifacts were completely eliminated.

[Brief description of drawings]

FIGS. 1 to 6 attached herewith are schematic cross-sectional views of the biological terminal of the present invention. 1 ... Translucent member, 2 ... Terminal head, 3 ... Terminal bottom, 4 ... Optical fiber, 5 ... Hydroxyapatite, 6 ... Alumina, 7 ... Primary coating layer.

Claims (2)

[Claims] 1. A translucent biomedical terminal, characterized in that at least a portion in contact with skin tissue is made of a calcium phosphate ceramics member, and has a translucent member for optically connecting the inside and outside of the living body. 2. A translucent biomedical terminal, characterized in that at least a contact portion with the skin tissue is made of an alumina ceramics member and has a translucent member for optically connecting the inside and outside of the living body.