JP2787828B2 - Translucent biological terminal - Google Patents

Description

DETAILED DESCRIPTION OF THE INVENTION The present invention relates to a method for manufacturing a medical device, comprising a member whose outer peripheral portion is made of a material having an excellent affinity for the skin, a part or the entirety of which has an excellent translucency, and at least a contact portion with a subcutaneous tissue. TECHNICAL FIELD The present invention relates to an indwelling device for a living body, which is made of a member having excellent biocompatibility and measures optical information of a living body continuously for a long time.

In recent years, various types of implantable artificial organs have been developed, and the dependence on them is expected to increase more and more, and longer-term implantation is desired.

However, there has been almost no method of continuously measuring in vivo information such as blood composition and body fluid components for controlling these artificial organs according to the reaction of the living body.

In view of the above, the present inventors have found that when optically connecting inside and outside a living body using a material having excellent biocompatibility, it is possible to continuously obtain in vivo information, particularly spectroscopic information, in the long term. Thus, the present invention has been achieved.

Hereinafter, the present invention will be described in detail with respect to its material composition, shape and structure.

Material Composition / Production Method The “biocompatible member” in the present invention is exemplified below.

Hydroxyapatite represented by Ca ₁₀ (PO ₄ ) ₆ (OH) ₂ . Not only pure products represented by Ca ₁₀ (PO ₄ ) ₆ (OH) ₂ but also those containing 1 to 10% of carbonate ions (CO ₃ ), fluorine and chlorine ions instead of OH ions. Ca ₁₀ (P
O ₄ ) ₆ (OH) ₂ as a main component to improve sinterability, strength, porosity, etc., to improve 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 2, Z
A mixture of various known additives such as rO ₂ . Hydroxyapatite composite. Polymer resins such as polyethylene, polypropylene, polymethyl methacrylate, polyurethane, polyester, ABS, fluororesin, polycarbonate, polysulfone, epoxy, silicone, diallyl phthalate, furan, etc., and their composite materials, which have relatively low toxicity. Ceramics such as tricalcium phosphate, tetracalcium phosphate, or bioglass, calcium phosphate crystallized glass, polycrystalline alumina, single crystal alumina, zirconia, carbon, etc., and mixtures of various known additives, and composites thereof Materials, metal materials such as titanium and titanium alloys, and composite materials thereof.

Biocompatible translucent member In the present invention, “biocompatible translucent member” refers to ceramics such as single crystal germanium, single crystal calcium fluoride, single crystal silicon, and bioglass ceramics, and calcium phosphate crystallization. Examples thereof include bioceramics having excellent biocompatibility such as glass, single crystal alumina, and vitrified calcium phosphate ceramics, and translucent polymers such as silicone rubber, Teflon, polyurethane, and polyethylene. In addition, not only a simple substance of these but also a composite of them, and a fiber optically and mechanically coupled with a glass fiber, a plastic fiber or the like can be exemplified. Of these, translucent apatites obtained by vitrifying calcium phosphate-based ceramics not only have translucency but also have biocompatibility, so translucent bioterminals formed only with these are used. However, it is in accordance with the present invention.

Shape and structure The translucent biological terminal according to the present invention can be formed into a desired shape depending on the purpose of use.
The details will be described below with reference to the addition drawings.

FIG. 1 is a cross-sectional view showing an example of the translucent biological terminal of the present invention. In the figure, the translucent biological terminal is made of a hydroxyapatite sintered body centering on a translucent member 1 having good biocompatibility. The biocompatible member 01 is disposed around.

The biocompatible member 01 having the above structure is used by burying and fixing the terminal bottom 3 subcutaneously and arranging the upper end of the terminal neck 2 protruding above the skin. It is introduced, irradiates the skin tissue through the biocompatible translucent member 1, and the absorption by the substance in the living body is detected again through the translucent member 1 for the reflected light. This detection light is analyzed by an external analysis device such as an absorption spectrum measurement provided outside.

Also, depending on the type of the external light source, various in-vivo information can be obtained from the reflected light.

For example, if visible light is introduced from the outside, it is used as a so-called endoscope for observing the inside of a living body with the naked eye.

Similarly, in FIG. 2, a light-transmissive member 1 excellent in biocompatibility is used only in a portion directly in contact with a subcutaneous tissue, and an upper portion thereof is made of a member 4 excellent in light transmissivity such as general glass. The embodiment shown in FIG. 2 is suitably used when a biocompatible translucent member is used when the light attenuation rate is relatively high and its thickness cannot be increased.

FIG. 3 is a cross-sectional view of a translucent biological terminal having an introduction optical path 5 and a light receiving optical path 6. When light passes through a slit 7 provided on the way, the biological fluid entering the slit 7 is shown. Alternatively, it is used to measure an absorption spectrum or the like from absorption by a substance in a living body such as a tissue.

FIG. 4 shows optical fibers 8, 9 in the introduction optical path and the receiving optical path.
FIG. 2 is a cross-sectional view of a light-transmitting biological terminal using a light-transmitting member 1 having only a portion exposed in a slit 7 and having excellent biocompatibility.
0,11 are used.

FIG. 5 is a cross-sectional view of a translucent biological terminal in which a prism 12 for total reflection measurement (ATR method) is arranged at the bottom of the terminal, and an introduction optical path 5 and a receiving optical path 6 are provided on both sides thereof. I have.

FIG. 6 is a cross-sectional view of a light-transmitting living body terminal in which the optical system can be replaced as desired. The optical system has an outer cylinder adhered and fixed to a detachable inner cylinder 15 and a biocompatible member 01. Tube part 14
The packing 13 keeps airtightness.
The portions of the bottom of the inner cylinder that are in contact with the subcutaneous tissue are provided with coating layers 10 and 11 of biocompatible members to improve biocompatibility. With such a structure, when the light-transmitting member deteriorates or the optical system breaks down, the optical system can be quickly replaced without taking out the biocompatible member 01 fixed to the living body. The invasion is reduced, and stable measurement can be performed for a longer period of time.

FIG. 7 shows a case where the light-transmitting living body terminal itself is formed only of the light-transmitting member 1 having excellent biocompatibility.

The light in the present invention means not only visible light but also ultraviolet light, infrared light, laser light and the like.

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

Example 1 A hydroxyapatite powder was prepared by gradually adding a 0.3 mol / phosphoric acid solution to 0.5 mol / calcium hydroxide at 37 ° C.
The reaction was carried out for one day to synthesize, which was obtained by filtration and drying. This synthetic powder is press-molded, processed and then heated at 1250 ° C in air for 1 hour.
After sintering for a time, a hydroxyapatite sintered body having a compressive strength of 1000 kg / cm ² and a relative density of 98% was obtained. A cylindrical body of silica glass was fitted into the central cylindrical portion, and then fixed by adhesion to obtain a light-transmitting living body terminal having the shape shown in FIG.

Here, the terminal bottom has a diameter of 24 mm, a thickness of 3 mm, and the average diameter of the terminal neck is 10 mm.

The translucent living terminal is embedded in the back skin of a mongrel dog,
As a result of observation over time, no inflammatory reaction was observed around the device and the contact surface at the bottom of the device two weeks after the operation, and optical (visible light) observation in the living body was very easily performed thereafter.

Example 2 Single crystal germanium was used as a biocompatible translucent member for the central cylindrical portion of the obtained hydroxyapatite translucent biological terminal by the method shown in Example 1 and shown in FIG. A translucent biological terminal having such a shape was obtained.

The translucent living terminal is embedded in the back skin of a mongrel dog,
When an infrared light source was connected to the introduction light path and a detector was connected to the light reception light path, a good infrared absorption spectrum was obtained.

[Brief description of the drawings]

FIGS. 1 to 7 are schematic cross-sectional views of the translucent living body terminal of the present invention. DESCRIPTION OF SYMBOLS 1 ... Biocompatible translucent member, 2 ... Terminal neck, 3 ... Terminal bottom, 4 ... Translucent member, 5 ... Introduction optical path, 6 ... Receiving optical path, 7 ... Slit, 12 ... ... ATR prism, 13 ... Packing, 14 ... Outer tube, 15 ... Inner tube, 01 ... Biocompatible member.

Claims (1)

(57) [Claims] 1. A light-transmitting biological terminal having a light-transmitting member for optically connecting the inside and the outside of a living body, wherein at least a portion in contact with skin tissue is made of a member having an affinity for the living tissue. A light-transmitting living body terminal, wherein at least two light-transmitting members are provided, and in a living body, each end of the two light-transmitting members is arranged to face each other via a slit.