JPH03131276A - Skin terminal device - Google Patents

Abstract

PURPOSE:To make a skin terminal device which has good adhesion and resistance to revolution of an upper adapter and is excellent in stability by sticking tightly upper and lower adapters to the flanges of skin terminal made of a sintered hydroxy-apatite body through a hole penetrating the both flanges and also through an inner cavity. CONSTITUTION:A skin terminal device is made of a sintered hydroxy-apatite body and consists of a skin terminal 1, which is equipped with a through hole 5, an upper flange 1a and a lower flange 1b, and an upper adapter 2 and a lower adapter 3, which are mainly connected to those upper flange 1a and lower flange 1b of the skin terminal 1, respectively by adhesion. Pipes 4a, 4b are buried or molded in one body in the upper and lower adapters, respectively. They are connected with each other to form an inner cavity 4 at the center of the through hole 5. As the adapters are engaged and stuck through the inner cavity of the skin terminal, an adhesion area between the flanges of skin terminal and the adhering face of the adapters becomes large, so that an adhesive force by an adhesive is made stronger.

Description

[Detailed Description of the Invention] [Industrial Application Field] The present invention relates to a skin terminal device whose main part is made of a sintered hydroxyapatite body, and has been specifically developed for long-term indwelling catheters through a skin terminal made of hydroxyapatite. This invention relates to a skin terminal device.

[Prior Art] In recent years, sintered hydroxyapatite has attracted attention as a ceramic with excellent bioactivity, and significant progress has been made in the development of applications that take advantage of its biocompatibility.

Among them, while the use of hydroxyapatite for artificial tooth roots and artificial bones has been the mainstream, for example, as disclosed in Japanese Patent Application Laid-Open No. 174148/1983,
It has been shown that hydroxyapatite not only has an affinity for living tissue, but also that it can tightly and integrally connect with skin tissue. Currently, there are devices that function as biological terminals that electrically connect the inside and outside of a living body, for example.

Currently, by utilizing the biocompatibility of hydroxyapatite as described above, in addition to the above-mentioned biological terminals or plugs, by forming conduits etc., it is possible to create GL devices such as catheters, human relay devices, etc. Progress is being made to increase the number of researchers using the facility.

In other words, in the medical field, catheters made of tubes made of rubber, plastic, metal, etc. are inserted into blood vessels, gastrointestinal tracts, respiratory tracts, urinary tracts, etc. for the purpose of diagnosis, examination, treatment, etc.
In some cases, they are left in place for long periods of time to remove contents, inject drugs into blood vessels, or reach the heart to measure pressure or install pacemaker terminals. A major research topic is how to safely use tubular bodies such as catheters in medical and engineering terms via the above-mentioned hydroxyapatite bioterminals.

Although the hydroxyapatite described above is not used, an implantable catheter device developed for the same purpose is disclosed in Japanese Patent Laid-Open No. 83-59972.

[Problems to be Solved by the Invention] In the conventional hydroxyapatite skin terminal for long-term indwelling catheters as described above, hydroxyapatite has dramatically better biocompatibility than conventional biomaterials. (Bio-Co
fflpatability), it is extremely effective for attaching a part of apatite to skin tissue. However, hydroxyapatite has low mechanical strength, is brittle, and has essentially low affinity with other materials, so it has been extremely difficult to create composites with other materials. Moreover, since the skin terminal device is placed so that part of the hydroxyapatite is on the surface of the body and the other part is on the inside of the body, it is sufficient to prevent infection from the outside and infiltration of body fluids from the inside. The development of bonding technology between hydroxyapatite, which serves as a relay part of the catheter, and the parts that connect it to the catheter has become a major technical challenge, as strong adhesive strength and sealing performance are required.

This invention was made to solve the above-mentioned problems, and it uses a skin terminal made of sintered hydroxyapatite as a base, and improves the structure and material of a liquid receiving tube (hereinafter referred to as an adapter) that is additionally formed on the skin terminal. The purpose of this improvement is to provide a highly practical skin terminal device using a configuration in which the adhesion between the skin terminal and the adapter may be insufficient even if the adhesive is insufficient for the purpose. That is.

[Means for Solving the Problems] The skin terminal device according to the present invention has flanges on the upper and lower sides of a sintered body in which at least the portion that contacts skin tissue is made of hydroxyapatite, and has flanges along the central axis of the flanges. A through hole is provided in the pipe, and the pipe inserted into the through hole (also called the inner cavity) is connected face-to-face with the upper and lower flanges.
The extension tube, which is connected to the liquid receiving pipe on the lower flange side, is installed with the opening formed in a direction approximately perpendicular (60″ to 120°C) to the axis of the through hole. When installing the extension tube extending from the upper adapter, the opening should be formed in a direction approximately perpendicular (606 to 120°C) to the axis of the through hole, and when installing the extension tube extending from the lower adapter, the opening should be formed in approximately the same direction as the opening. Desirable.In addition, the installation connected to the upper adapter includes a partition wall made of a rubber-like elastic body whose center portion is exposed to the outside in place of the opening.Furthermore, the upper and lower adapters and the above-mentioned installations that follow are attached to the opening. is preferably made of resin or titanium.

[Function] In this invention, since the adapter to be attached to the upper and lower flanges having a through hole in the central axis is fitted and bonded through the inner cavity of the skin terminal, the flange of the skin terminal and the adhesive surface of the liquid receiving tube are bonded together. This increases the bonding area and helps strengthen the bonding force of the adhesive.

In addition, when attaching the lower socket bone that is buried in the skin and the extension tube that extends from there, the opening is formed almost at right angles to the axial direction of the skin terminal cavity, so the extension tubes are buried in a shallow area under the skin. 1. For living organisms (including patients) because it is possible. to reduce the burden.

If the extension tube is attached to the upper adapter with a mouth, the upper tube must be attached to the mouth and the bottom.

- Attaching the skin terminal (because it is set almost parallel and in the same direction as the professional one, the skin terminal can be stably attached and the angle will not be too tilted).

Furthermore, when attaching the extension tube to the upper adapter, if a partition wall made of a rubber-like elastic body is provided in place of the opening, the center portion of which is exposed to the outside, the partition wall may be used. This makes it possible to administer drugs to people who masturbate using methods other than manual therapy, such as using a syringe needle.

In addition, since the adapter and the inner cavity connecting it are made of resin or titanium, this skin terminal can be used for nuclear magnetic resonance scanning (called kiRI in the medical field), etc., which is performed while the terminal is attached to the skin. The presence of the device is not a hindrance.

[Example] Example 1; Figure 1 is a schematic sectional view showing an example of a skin terminal device according to the present invention. Further, FIG. 2A is a schematic plan view of a skin terminal made of a sintered body of hydroxyapatite constituting the embodiment of FIG. 1, and FIG. 2B is a sectional view thereof.

1-, 2A, and 2B, the skin terminal device is made of a sintered hydroxyapatite body and has a through hole 5, an upper flange lax, and a lower flange 1b.
It is mainly formed by an upper adapter 2 and a lower adapter 3 which are joined by adhesive at the respective flange surfaces of the upper flange las and lower flange 1b of this skin terminal 1.

” Lower adapter 2 and lower adapter 3 each have a vibrator 4a.
, 4b are embedded or integrally molded, and these are connected to form the inner cavity 4 which passes through the center of the through hole 5 and connects the upper and lower adapters. In this case, the upper adapter 2 is surface-jointed with the upper flange 1a using an adhesive or the like, but a bank-shaped convex portion 2a is formed around the contact surface between the upper adapter 2 and the upper flange 1a. ”
It is joined to the lower flange 2 in a way that it fits and wraps around it.

On the other hand, the surface of the lower adapter 3 is joined to the surface of the lower flange 1b by direct surface bonding to the lower flange 1b.

On the other hand, the lower adapter 2 has a hollow vibrator 7 to be connected to the vibrator 4a, and an opening 6a for attaching an extension tube (not shown) and a connecting tube is integrally molded therein. Similarly, the lower adapter 3 is also provided with an opening 6b for attaching the tube.
The lower mounting ports 6a, 6b are such that each hollow vibrator 7 communicates through the lumen 4 to form a skin terminal device.

In the above explanation, the upper and lower adapters 2.3 are made of the same material in order to increase adhesive strength, but if sufficient adhesion with hydroxyapatite can be obtained, it is necessary to make them the same material. Alternatively, a different type of material may be used.

Furthermore, it is preferable that the vibrator 41 of the lower adapter 3 that forms the inner cavity 4 be integrally molded with the lower adapter 3. In other words, during assembly, the structure is such that the vibrator 4b and the vibrator 4a of the upper adapter 2 are bonded together. Bring the part to the surface of the body, and if there is a problem with the adhesive part, 1. Even in the event of a problem, it is convenient to be able to easily find out the fact that a problem has occurred and to make it easier to deal with it.

In the above configuration, substantially the lower half of the skin terminal 1, including the lower flange lb and the lower adapter 3, is embedded in the skin tissue for practical use. In this case, 8 shown in FIGS. 2A and 2B are a plurality of holes used for suturing to the skin during the implantation surgery, and are provided in the lower flange 3 as shown. As mentioned above, in this implanted skin terminal device, at least the part where the hydroxyapatite part contacts within the skin is closely bonded to the skin tissue due to its good biocompatibility, making it almost semi-permanent. Since it can be buried without any physical problems, it can be effectively used for experiments or treatments.

FIG. 3 is a schematic diagram illustrating each member of the embodiment shown in FIG. 1 and the method of assembling the same. FIG. 3 (1)) is an assembled sectional view, FIG. 3 (a) is a top view, (e) in Fig. 3 is a bottom view, (e) in Fig. 3 is a side view of (a), and (e) in Fig. 3 is a side view of (a).
d) is a sectional view of the upper adapter 2, and (f) of FIG. 3 is a sectional view of the lower adapter 3. Explanation of each part is shown in Figure 1 and 2A.
Since it has been explained with reference to FIG. 2B and FIG.

Here, Figure 3 (7) (b), (d), (
The assembly method will be explained using FIG. f) and FIG. 2B. first,
The upper adapter 2 shown in FIG. 3(d) is surface-bonded to the upper flange 1a using an adhesive so that the convex portion 2a fits.

Note that a screw 9a is provided at the tip of the vibrator 4a. Next, apply adhesive to the surface of the lower flange 1) formed in the same manner and the screw 9b at the tip of the vibrator 4b, insert the vibrator 4b into the through hole 5, and rotate it 1. so that the screws 9a and 9b are joined. Then, the surface of the lower flange 1b and the lower adapter 3 are joined face to face. In this way, the vibrators 4a and 4b are connected to form the inner cavity 4, and the formation of the entire skin terminal device is completed. In addition, the screws 9a, 9
I] may be integrally molded with the upper adapter 2 and the lower adapter 3, respectively.
It may also be formed from other bioinert materials. Further, the upper and lower adapters 2.3 are made of a suitable material such as resin or titanium (TI).

Hereinafter, important features of the skin terminal device according to the present invention will be supplementarily explained, including some overlaps with the above explanation.

■Adapter 2 that connects to the upper and lower flanges la and lb
．． 3 is fitted through the inner cavity 4 of the skin terminal 1. This is because adhesive is generally insufficient for adhesion between the skin terminal and the adapter, so by providing a lumen 4 in the through hole 5 to compensate for the strength, and connecting it to the upper and lower adapters, the force is directly applied to the hydroxyapatite. This is to ensure the strength of the device by preventing the adapter from getting stuck, and to ensure that the adapter is in close contact with the skin terminal. Furthermore, as mentioned above, there is not enough adhesive, so an adhesive whose volume changes less during the curing process than its adhesive strength is used for sealing.

■The lower adapter 2 has a bank-like protrusion 2a that wraps around the upper flange in order to increase the bonding area and prevent the strain in the peeling direction from directly applying to the bonding surface. Improved shape and 1° durability.

■ By the method of ■■ above, we were able to obtain high strength against the force in the tensile direction, but the inner cavity 4 of the skin terminal
As a countermeasure against shear stress in the rotational direction around the central axis of the skin terminal, the lumen and/or entrance portions 1e, 1a (
(see Figure 2B), the shape is exactly as shown in Figure 1. However, it has a polygonal or elliptical shape and an anti-rotation mechanism.

(2) Attachment of an extension tube (not shown) extending from the lower adapter 3 The opening 6b is approximately perpendicular to the axis of the inner cavity 4 (tolerable range of 60 to 120 degrees). This is to reduce the burden on the patient and to allow the extension tube to be buried in a shallow position under the skin.

■ Stabilize the skin terminal device by making the extension tube extending from the lower adapter 2 almost perpendicular (60 to 120 degrees) to the axis of the lumen 4 and extending in the same direction as the extension tube extending from the lower adapter. It is possible to ensure sex. This prevents 17 the angle of the skin terminal after fixation to the skin tissue from tilting and causing severe strain on the skin or the patient when the terminal is oriented at a different angle or the direction is changed (for example, in the opposite direction). This is to do so.

■The upper and lower adapters 2 and 3 and the mounting that connects to them are port 6a.
, 6b is made of resin or titanium, so the skin terminal device can be worn 1. It is possible to conduct tests such as nuclear magnetic resonance scanning (MHI) without any problem even if the device is left as it is.

Incidentally, the dimensions of the large hole of the skin terminal device according to the present invention are such that the height between the outer edges of the upper and lower adapters 2.3 is approximately 15
The height of the skin terminal 1 is approximately 5.5mm, the diameter of the lower flange 1a is approximately 8.5mmφ, and the diameter of the lower flange 1b is approximately 1mm.
5 mmφ, the diameter of the through hole 5 is 2.5 mmφ, the diameter of the inner cavity 4 is 2
．． It is 3mmφ. Note that this numerical value is not limited.

Example 2; FIG. 4 is a schematic explanatory diagram showing another example of the present invention. FIG. 4(a) shows a sectional view, and FIG. 4(1)) shows a side view. In the drawings, 1 to 8 are the same as or equivalent to those in the embodiment shown in FIG. The explanation will be omitted.

In (a) and (b) of Fig. 4, "-adapter 2
is provided with a cylinder whose outer side meets the through hole 5, and an inner cavity 4 is formed within this cylinder. The lower surface of the second part of the upper adapter 2 is in contact with the surface of the upper flange 1a,
The lower part of the cylinder having the inner cavity 4 is formed so as to extend beyond the lower flange 1b into the inside of the lower adapter 3. On the other hand, the lower adapter 3 is provided with a hollow vibe 7a that matches the hollow vibe 7 (the opening 61), and the cylindrical shape of the upper adapter 2 has the inner cavity 4 formed on two sides of the hollow vibe 7a. The bottom portions are connected so that the inner cavity 4 and the hollow vibe 7a are spatially connected. Torii” 1
Fluoro b is connected to the lower adapter 3 at the screw portion 10, and the lower adapter 3 and the socket f=j are connected so that the hollow tapes 7 and 7a are spatially electrically connected.

On the upper surface of the upper swallowtail piglet 2, four thin cylindrical parts are provided at the center, into which a septum (partition wall) 11 made of an airtight elastic material such as rubber is fitted. upper lid 12 having a septum in the center 1 and a hole 13 having an area smaller than 11;
1. Press the septum 11 from above to 70% of the thickness in the thickness direction using the threaded portion 14 to form a septum portion. ing. As in the embodiment, the lower half of the skin terminal 1° on the lower adapter 3 side is buried in the skin tissue.

This embodiment device is constructed as described above, and the part exposed to the two parts of the skin forms the septum part. In this configuration, via the septum 11
It can be effectively used as a skin terminal device that enables drug administration using a needle or the like. When the injection needle is pulled out, the septum 11 remains airtight again (7) It can be used many times without causing pain to the patient.
This has the advantage that the rubber of the septum j1 can be easily replaced (exchanged, etc.).

Example 3; FIG. 5 is a schematic explanatory diagram showing the case where the device of the example shown in FIG. 1 is applied to an indwelling catheter. In the figure, A
- The area below the A line is skin tissue and the subcutaneous area below ■
This is the part that is buried in the fabric. The lower tube 15 has an outer diameter of 3
~・5φ, inner diameter 1~2■φ, length 100~500m
n+, which is attached to the opening 6b with a fixing thread 16 or the like. The tip of the lower tube 15 has a length of approximately 12 mm, which is prepared according to the thickness of the indwelling catheter 18.
It is connected to the indwelling catheter 18 via the m+a connector 17. The indwelling catheter 18 is connected to a predetermined blood vessel or the like (not shown). -Cannier adapter 2 side installation is port 6b
has a lower tube 15 and an upper tube 1 of similar size.
9 is attached and extended via a fixture 20, and an intermittent infusion plug 21 is attached via a Luer adapter 21 at 1. A required liquid such as blood or a drug solution is connected to the Luer adapter 22,
Low doses are given to the body as needed. The system also allows blood and other samples to be taken if required.

FIG. 6 shows the application of the device shown in FIG. 4 to an indwelling catheter. , is a schematic explanatory diagram showing two cases. Similar to the embodiment shown in FIG. 5, the portion below the line B-B is buried in the skin tissue and the subcutaneous tissue below it. The lower tube 15 and the indwelling catheter 18 are connected in the same way as in FIG. 5, but a detailed explanation will be omitted.

[Effects of the Invention] As described in Section 2 below, according to the present invention, the skin terminal, which is partially embedded in the skin tissue, is made of a sintered body of hydroxyapatite17, and the two upper and lower flanges of this skin terminal are A UFO-type hydroxyapatite skin terminal device was formed in which the upper and lower adapters are brought into close contact with the flange through the inner cavity connecting the upper and lower adapters through the through hole 12, so that the upper adapter has good adhesion and anti-rotation properties. A skin terminal device with excellent skin terminal stability can be provided. Therefore, by putting this skin terminal device into practical use, a long-term indwelling catheter with excellent stability and long life can be obtained.

Further, this device can be used for tests such as nuclear magnetic resonance scanning without any problem while being worn.

[Brief explanation of the drawing]

Figure 1 is a cross-sectional view showing one embodiment of the present invention, Figure 2A is a plan view of a skin terminal made of a sintered body of hydroxyapatite, Figure 2B is a cross-sectional view thereof, and Figure 3 is a cross-sectional view of the skin terminal made of a sintered body of hydroxyapatite. FIG. 4 is a schematic illustration showing another embodiment of the present invention, and FIG. 5 is an application of the device of the embodiment shown in FIG. 1 to an indwelling catheter. FIG. 6 is an explanatory diagram showing a case where the embodiment device of FIG. 4 is applied to an indwelling catheter. In the figure, 1 is the skin terminal, ]a is the upper flange, 1b is the lower flange, 2 is the upper adapter, 3 is the lower adapter, 4 is the inner cavity, 4a, 4b are the vibrators, 5 is the receiving hole, 6a, 6b are the 1 mounting port, 7° 7a is a hollow pipe, 8 is a hole, 9.11 is a septum, and 12 is an upper lid.

Claims (4)

[Claims] (1) A sintered body having flanges on the top and bottom, a through hole along the central axis of the flange, at least the part that contacts skin tissue is made of hydroxyapatite, and a tube inserted into the through hole. and two upper and lower receiving tubes connected to each other, the attachment port of an extension tube connected to the lower flange on the side to be buried in the skin and extending from the lower receiving tube is substantially perpendicular to the axis of the through hole. A skin terminal device characterized in that it is shaped in a direction. (2) The installation port of the extension tube extending from the upper receiving pipe is
2. The skin terminal device according to claim 1, wherein the skin terminal device is formed in a direction substantially perpendicular to the axis of the through-hole and in substantially the same direction as an attachment port connected to the lower receiving pipe. (3) A claim characterized in that, in place of the attachment port of the extension tube formed in the upper receiving pipe, a partition made of a rubber-like elastic body is attached so that the center portion thereof is exposed to the outside. 1. The skin terminal device according to 1. (4) The skin terminal device according to any one of claims 1 to 3, wherein the upper and lower receiving tubes and the extension tube attachment ports connected thereto are made of resin or titanium.