JPS61228876A - Subcataneous stay catheter - Google Patents

Abstract

(57) [Summary] This bulletin contains application data before electronic filing, so abstract data is not recorded.

Description

DETAILED DESCRIPTION OF THE INVENTION The present invention relates to a percutaneous indwelling catheter applicable to continuous mobile peritoneal dialysis and the like.

In 1976, the first clinical application was made by Bobowich et al. in the United States of America. Dialysis therapy (hereinafter referred to as CAP)
D) has rapidly become popular in Europe and the United States as a treatment for renal failure as an alternative to hemodialysis (D) and intermittent peritoneal dialysis (IPD), and is gradually increasing in Japan as well.

CARD uses hemodialysis (HD) or intermittent peritoneal dialysis (I).
Compared to PD), it has advantages such as easier reintegration into society and better clinical symptoms. However, various complications have been reported with CARD, of which the most frequent and important one is peritonitis.

In recent years, contamination during dialysis (perfusion) fluid exchange has become a problem! 1 flight a
The incidence of S-flame has been significantly reduced due to the development of a completely open chain system using soft plastic bags and the development of titanium adapters.

However, the current situation is that there are insufficient measures against the occurrence of catheter-related peritonitis.

That is, Tenkotsu (Tenc) is used as a CAPD catheter.
KhoH type, Life 0ath type, TWH type, and improved versions thereof are commercially available, but these CAPD catheters have poor compatibility with living skin tissue, and the catheter and 1! Infections are likely to occur due to poor bonding and insufficient fixation at the membrane-skin penetration site, and 11al
l! It has a high probability of inducing a flame. Recently, a catheter equipped with a cuff, seven lunges, and a collar made of porous polytetrafluoroethylene at the junction with the skin has been proposed as a CARD catheter that improves tissue compatibility with the skin.

However, since the contact surface with living body skin tissue is relatively smooth and the porosity of the catheter is small, the penetration and engraftment of living body skin tissue is poor, and furthermore, the 7-lunge has a relatively large brim shape, so it It has drawbacks such as a large incision area during insertion.

Furthermore, if a molded body with a simply increased porosity is used in the catheter, the material strength will decrease and the durability against external forces required for percutaneous implants will be impaired.

Therefore, infection due to insufficient fixation occurs during the practical stage.

At present, there is currently no CARD catheter that does not cause inconveniences such as inflammation and has excellent durability.

In view of the above-mentioned circumstances, the present inventors conducted extensive research with the aim of providing a CARD catheter with excellent compatibility with living skin and tissue, and as a result, they completed the present proposal. That is, the present invention relates to a percutaneous indwelling catheter in which a heat-resistant fiber aggregate layer is formed at the skin-penetrating site of a catheter made of biocompatible plastics. JP-A-58-48293 discloses a biocompatible plastics composite material for medical use consisting of a biocompatible fiber layer and a plastic layer, but does not disclose any specific uses thereof.

One of the features of the present invention is that a hard material such as a carbon material or a ceramic material disclosed in the above-mentioned Japanese Patent Application Laid-Open No. 58-48293 is used as a composite material Φ1 using the fiber aggregate thereof.
The reason is that it has become possible to apply it to percutaneous indwelling catheters such as CARD.

The second characteristic is that the composite material at the skin penetration site has large pores (apparent specific surface area) or many open pores, and therefore has a fiber aggregate layer that facilitates the penetration of biological tissue cells. It is composed of a dense biocompatible plastic molded body layer.

Therefore, since the percutaneous indwelling catheter of the present invention has strong bonding properties with living body skin tissue, it is particularly useful as a CARD catheter, where induction of peritonitis due to infection from the catheter and the peritoneal skin penetration portion is a problem.

The present invention will be explained in detail below.

The fiber aggregate according to the present invention is a primary processed product of fibers, for example,
Examples include braided products, woven fabrics, non-woven fabrics, felt, and threads. The form of these fiber aggregates may be appropriately selected depending on the purpose of use as a composite material, the site of use, etc.

! Generally, the IIIt aggregate preferably has voids or open pores of 20 μ to 1000 μ to facilitate the invasion of tissue cells.

The fiber material constituting the fiber aggregate includes biocompatible heat-resistant fibers such as carbon fibers and graphite fibers.

Examples include RmtaM made of silica, alumina, zirconia, apatite, etc., and metal fibers made of stainless steel, titanium, boron, etc. The above fibers may be used alone or in combination.

In addition, the form and thickness of the il miscellaneous yarn are not particularly limited, and the forms include single yarn, double yarn, and twisted yarn.

Examples include spun yarn, staple fibers, and whiskers.

The fiber material can be used as it is or CVD (Chcmica
It is used after being coated with carbon by a method such as lV apor deposition. In particular, the inorganic fibers or metal fibers are preferably coated with carbon from the viewpoint of further improving biocompatibility.

CVD uses hydrocarbons such as methane, ethylene.

Gas such as propane, butane, benzene, toluene, etc. is decomposed at a temperature higher than the decomposition temperature of the gas, and the fibers are coated with carbon. The temperature is 600°C to 3000°C, preferably 700°C to 2500°C.

FIG. 1 is an example of placement when carbon is coated onto a fiber aggregate by the CVD method. In the figure, 14 is a fiber aggregate to be subjected to CvD treatment. CVD coating is carried out using an inert gas such as argon, hydrogen, or nitrogen as a carrier and methane, benzene, etc. at 600 to 3000°C, preferably 100 to 2500°C.
It is carried out by introducing it into a tube 9 made of quartz, alumina, etc., of an electric furnace 8 maintained at a temperature of .degree. C., and is usually completed in 5 to 180 minutes. In the figure, 1 is a gas trap, 1G is a board made of quartz or alumina, etc., and 11 is a preheating section.

In addition, the obtained CVD cover was 111m! If necessary, the coalescence may be further heat treated under an inert gas atmosphere at a temperature higher than the CvD coating temperature.

CvD treatment may be performed in the IIH state, but
It is preferable to carry out the process after processing into a single object, nonwoven fabric, felt, etc.

The biocompatible plastic deck referred to in the present invention includes elastomers, and may be any general commercially available biocompatible plastic.

For example, fluorine-based materials such as polytetrafluoroethylene.

Silicone resin such as silicone rubber, vinyl chloride resin, vinylidene chloride resin, fluorinated silicone rubber.

polyethylene, polypropylene, polyester.

Plastics such as polyhydroxyethyl methacrylate, polyacrylamide, polysulfone, poly N-vinyl bi-Olidone, segmented polyurethane may be exemplified. In addition, these plastics are etched to improve adhesion as described below.

It is also preferable to perform surface treatment by glow discharge treatment or coating with a surface treatment agent.

The catheter of the present invention made of the above-mentioned plastic material is of the tenkotsu type, the life scrap type, and the TWH1'! Alternatively, the catheter may be an improved product thereof, and the type and shape thereof is not particularly limited as long as it is a catheter used for CAPD.

The connection between the fiber-N aggregate layer and the catheter is performed using IIM! Any method can be used as long as the porosity and flexibility of the single combined layer are not compromised.

Most commonly, a thin layer of adhesive is applied to the catheter surface and the 511°C aggregate layer is crimped thereto. Instead of using an adhesive, the surface of the catheter may be melted and the fiber aggregate may be fused thereto. Alternatively, it is also possible to apply an adhesive, knit or wrap IS, * directly on the surface of a partially melted catheter, or to implant hair.

Adhesives that can be used for the bonding include silicone adhesives and polyethine-vinyl acetate copolymers.

Polyester, nylon, urethane elastomer or
Examples include vinyl acetate and acrylic resin.

The non-adhered portions between the fibers m are necessary to show the flexibility of the entire layer and also to allow the living body mna to penetrate and be immobilized.

In addition, if sufficient strength can be obtained, am
Mechanical force may be used, such as by winding the sN or forming the sN into a bag-knitted shape and fixing it by covering the plastic material.

One embodiment of the percutaneous indwelling catheter of the present invention will be shown below.

FIG. 2 illustrates a continuous agility peritoneal dialysis (CARD) catheter utilizing the composite material of the present invention.

In the figure, 15 is a silicone catheter, 16 is a dialysate container, 11 is a transfer tube, and 18 is a joint made of ceramics, titanium, etc., which connects the dialysis chamber 16 and the transfer tube, and the transfer tube 17 and the catheter 15.

Reference numeral 19 is a composite material of the present invention, which is made by bonding bag-knitted CvD-coated silica fibers to the surface of the silicone tube catheter 15 with a silicone adhesive, and is located at the skin penetration site.

Reference numeral 20 denotes a cuff made of Dacron (polyester) felt or the like, which is normally used for the purpose of fixing the catheter 15 inside a living body. 21 is a dialysate flow valve.

When the composite material of the present invention is applied, the cuff 20 may be left in place, but since the bond between the composite material 19 of the present invention and the skin tissue is strong, the cuff 20 is not necessarily required. In this case, the construction of the catheter becomes simple and the surgical procedure can be significantly simplified.

The catheter shown in FIG. 2 was applied clinically and was found to have excellent bonding properties with living tissue and to be fully usable for practical use.

Note that FIG. 2 shows an example in which the composite material of the present invention is attached to a Tenckhoff-type catheter.
The composite material of the present invention may be applied to the skin-penetrating part of any catheter used for continuous mobile peritoneal dialysis, such as Life Cath or THW type catheter, regardless of the type.

Furthermore, it has been confirmed that carbon fibers, CVD-treated carbon fibers, metal fibers, inorganic fibers, etc. can be used in place of the above-mentioned CvD-coated silica fibers as fiber aggregates, and have good bonding properties with living skin tissues and can be put to practical use. It was done.

Reference Example 1 Example of manufacturing a heat-resistant 1111 combination of the present invention A silica fiber 14 with a thickness of 0.5
The plain woven fabric No. 8 was placed on a quartz board No. 10.

100 cc/stn of argon gas 3 and 100 cc/stn of methane gas 4 were flowed as a mixed gas.
It was introduced into a quartz tube 9 in an electric furnace 8 maintained at .degree. Preheating from the trap 1 with the ribbon heater 11 of the electric furnace (50
The inner diameter of the quartz tube 9 heated to 0°C is 55 mm, and the soaking zone length is 30
It is α. At first, only argon gas was flowed and the electric furnace was turned on for 10 minutes.
The temperature was raised to 00° C., and then methane gas was added to the argon gas to flow. The mixture was allowed to flow for about 1 hour, and then cooled in an argon atmosphere. The cooled CVD-coated silica fiber cloth was taken out and further heat-treated at a temperature of 2000° C. for 30 minutes in an argon atmosphere. A silica fiber cloth subjected to CVD treatment was obtained by lowering the temperature.

[Brief explanation of drawings]

FIG. 1 shows the C V D 511 I! used in the present invention.
I! FIG. 2 is an explanatory diagram of indwelling, and FIG. 2 is a diagram showing one embodiment of the percutaneous indwelling catheter of the present invention. 1...Trap, 2...Mantle heater, 3...Inert gas, 4...CV
D gas, 5.6.7...Flowmeter, 8...
...Electric furnace, 9...Quartz tube, 10...
Quartz board, 11... Ribbon heater, 12.
...Thermocouple, 13...Bit, 14...
... Fiber aggregate, 15 ... Catheter, 1
6... Dialysate container, 17... Transfer tube, 18... Joint, 19...
...Composite material of the present invention, 20...Cuff, old...
...Dialysate flow valve.

Claims (1)

[Claims] (1) A percutaneous indwelling catheter comprising a heat-resistant fiber aggregate layer formed on the surface of the skin-penetrating portion of a catheter made of biocompatible plastic.