JPH01164373A - Skin piercing terminal - Google Patents

Abstract

PURPOSE:To prevent the deterioration of the contact capacity with the skin in spite of long time use, by a method wherein the surface layer part of the skin piercing terminal at the contact region with the skin is constituted of a material excellent in the compatibility with the skin in a specific thickness and at least the surface layer part of the region embedded in the body is constituted of a material excellent in water resistance. CONSTITUTION:A main body 1 has a cylindrical shape and the disc-shaped flange region 2 embedded in the body is provided to one end thereof and the diameter of said region 2 is usually set to about 2-30mm and the thickness thereof is set to about 2-10mm. Said main body is constituted of alumina but can be constituted of a material having excellent water resistance. Further, even when only the surface layer part of the main body 1 is constituted of said material in place of constituting the whole of the main body of the material the same effect is obtained. In this case, the thickness of the main body 1 is pref. set to 0.5mm or more. A plurality of through- holes 3 piercing through the main body 1 are provided and lead wires are inserted therein to bring the inside and outside of the body to an electrical continuity state. The diameter of each of the through-holes is about 0.1-3mm. A ring-shape member is provided to the contact region 4 with the skin of the outer peripheral surface of the main body.

Description

DETAILED DESCRIPTION OF THE INVENTION [Industrial Application Field] The present invention relates to a skin-penetrating terminal for holding a lead wire for extracting or supplying electrical signals within a living body.

[Prior Art] It is known that biological tissues, particularly nerves and muscles, are excited by electrical stimulation, resulting in generation and propagation of nerve impulses, contraction of muscles, and the like.

In recent years, functional electrical stimulation, a method that takes advantage of this phenomenon and applies electrical stimulation to the human body to restore the motor functions of limbs lost due to accidents or diseases, has been attracting attention as a treatment. .

Conventionally, in this method, one end of a lead wire for applying stimulation is implanted near the nerve, and the other end is taken out directly through the skin. For this reason, the lead wire and the skin do not come into sufficient contact with each other at the portion where the lead wire is taken out to the outside, and the interface between the lead wire and the skin is susceptible to bacterial infection and inflammation.

The skin/l-7 penetration terminal leads multiple electrical stimulation lead wires from the inside of the body to the outside of the body through the through hole of the terminal. 1, it is necessary to have excellent bio-tissue compatibility and good contact with the skin.Also, since a large number of electrode wires are required to stimulate a large number of nerves and muscles, there are many electrode wires to be passed through. It is necessary to form through-holes on the terminal at a high density, and it is desirable that the material itself has sufficient mechanical strength and fracture toughness.

Until now, skin N I' has been used as a terminal to collect various biological information such as blood pressure, blood flow rate, body temperature, and electrocardiogram signals.
Through the electrical terminal for L or a single through hole of the terminal, injection of various drug solutions, +fn during artificial kidney dialysis
Terminals for flow extraction and injection, etc., have been developed. As materials for these terminals, organic materials such as silicone rubber and fluororesin, apatite ceramics, and inorganic materials obtained by coating these on a metal-plating material have been proposed (Japanese Patent Publication No. 1982-92768).

However, when these materials are used as "-2 skin hty penetration terminals, the former organic materials have poor adhesion to the skin and are susceptible to bacterial infection and inflammation from the interface between the material and the skin tissue, and it is difficult to prevent this. Wipe the affected area frequently to prevent
J, and cannot withstand long-term use in real life.

On the other hand, abatite ceramics and materials coated with metals have excellent compatibility with skin tissues, but the former has a high strength and toughness (less than 200 MPa and ~I MPa, m'', respectively). ), it is difficult to drill a large number of through holes at a high density, and furthermore, it is difficult to use it for a long time because it is eroded deeply under the skin.

As for the latter, a coating film with a thickness of several micrometers is used because the thicker the coating film is, the easier it is to peel off, and the coating film dissolves and disappears in a short period of time, exposing the metal and deteriorating the adhesion with the skin (7). There was a problem.

[Problems to be solved by the invention] The purpose of the present invention is to solve the problems of the prior art and to provide a skin-penetrating terminal that does not deteriorate in contact with the skin even when used for a long time. shall be.

[Means for Solving the Problems] The present invention has at least one surface exposed outside the body, and a plurality of through holes penetrating the surface exposed outside the body and the surface embedded within the body, and the 11 through holes are A skin-piercing terminal for electrically communicating between the inside and outside of a living body by a lead wire inserted through the skin, the surface layer of the terminal in the area where the skin comes into contact with the skin is at least made of a material having excellent affinity for the skin, such as Ml. 0゜5
The present invention provides a skin-penetrating terminal having a thickness of 1.0 mm and at least the surface layer of the portion to be buried in the body made of a material with excellent water resistance.

In the present invention, the surface layer of the terminal in the area that comes into contact with the skin is made of a material that has excellent affinity with the skin and is coated with at least 0.
The reason why the thickness is 5 mm or more is that even if such a material is gradually dissolved, there is sufficient remaining thickness and a good adhesion state with the skin hq can be maintained for a long period of time.

Such materials include crystallized glass in which apatite crystals or letrochite crystals are formed.

Examples include calcium triphosphate and apatite.

On the other hand, the reason why at least the surface layer of the terminal in the part buried in the body is made of a material with excellent water resistance is that this part does not require adhesiveness to the body and is to prevent it from dissolving and disappearing due to body fluids. be. Examples of such materials include the following as long as they have excellent water resistance and do not adversely affect the body when dissolved in minute amounts. That is, examples of metals include copper, cobalt-chromium alloys, titanium alloys, and precious metals; examples of plastics include fluororesin, polysulfone resin, polyester resin, polyethylene resin, and polymethyl methacrylate resin; examples of ceramics include glass, glass ceramics, alumina sintered bodies,
A zirconia sintered body is exemplified.

This will be explained below based on the drawings. FIG. 1 is a plan view of a terminal according to the present invention, and FIG. 2 is a sectional view ΔΔ of FIG. 1.

In the figure, 4 is a part that comes into contact with the skin scraper, 2 is a part that is implanted into the body, and 3 is a through hole.

The main body as shown! The body has a cylindrical shape, and one end thereof is provided with a disk-shaped flange-shaped portion 2 to be buried inside the body. The diameter of this part 2 is usually about 2 to 30 mm, and the thickness is about 2 to 10 mm. This main body is made of alumina, but instead of this, it can be made of the material with excellent water resistance as described in 1. Moreover, the same effect can be obtained by forming only the surface layer of the main body with the material instead of forming the entire body with the material. In that case, the thickness of the surface layer is 0
．． It is preferable to set it to 5 mm or more.

Reference numeral 3 indicates a plurality of through holes passing through the main body, and lead wires are inserted through the through holes to establish electrical continuity between the inside and outside of the body. The diameter of this through hole is in the range of about 0.1 to 3 mm.

A ring-shaped member is provided on the outer peripheral surface of the main body at a portion 4 that comes into contact with the skin. This member is made of the material described above that has excellent affinity with the skin, and its thickness d is 2 mm or more so that it can be used stably for a long period of time.

This member is fixed to the main body by mechanically fixing the adhesive 9.

When using such a terminal, the lead wire is inserted through the through-hole, and part 2 of the main body is buried in the body, and part i is fixed so as to be in contact with the skin. Then, the skin gradually integrates and adheres to the site 4. Note that the gap between the lead wire and the through hole is sealed with bone cement.

[Example] Using the materials shown in Table 1, skin-penetrating terminals as shown in FIGS. 1 and 2 were produced.

The external shape was processed by lathe processing, and the through-hole drilling was performed by ultrasonic processing. The diameter of the through hole is 0.7mmφ
So, the large number is 24. In addition, the thickness d of the surface layer of the part that contacts the skin hq was set to 5 mm. When these terminals were buried in the skin of rabbits or dogs for one month, no inflammation or other tissue reactions were observed, and the terminals adhered firmly to the skin.

[Effects of the Invention] The terminal according to the present invention is extremely useful in practice since good adhesion to the skin is stably maintained over a long period of time.

Table=1

[Brief explanation of the drawing]

FIG. 1 is a plan view of a terminal according to the invention. FIG. 2 is a ΔA cross-sectional view of FIG. 1. 3...Through hole 4... Parts that come into contact with the skin

Claims (3)

[Claims] (1) At least one surface is exposed outside the body, and has a plurality of through holes that penetrate the surface exposed outside the body and the surface implanted inside the body, and a lead wire inserted through the through holes is used to electrically connect the inside and outside of the body. A skin-penetrating terminal for communicating with the skin, the surface layer of the terminal in the area that comes into contact with the skin is made of a material with a thickness of at least 0.5 mm that has excellent affinity with the skin, and is buried in the body. A skin-penetrating terminal in which at least the surface layer of the part is made of a material with excellent water resistance. (2) The terminal according to claim 1, wherein the material having excellent affinity with the skin is crystallized glass, apatite sintered body, or calcium triphosphate. (3) The materials with excellent water resistance include copper, cobalt-chromium alloy, titanium alloy, precious metal, fluororesin, polyester resin, polyethylene resin, polymethyl methacrylate resin, polysulfone resin plastic, glass, glass ceramics, and alumina. The terminal according to claim 1, which is one selected from ceramics such as a sintered body and a zirconia sintered body.