JPH0516872B2 - - Google Patents

Description

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

Continuous mobile peritoneal dialysis (hereinafter referred to as CAPD), which was first clinically applied in 1976 by Popobuitsi et al. in the United States, has become popular in Europe and the United States as a treatment for renal failure as an alternative to hemodialysis HD and intermittent peritoneal dialysis IPD. has become rapidly popular and is gradually increasing in Japan as well.

CAPD is hemodialysis HD or intermittent peritoneal dialysis
Compared to IPD, it has advantages such as easier reintegration into society and better clinical symptoms. however,
On the other hand, various complications have been reported with CAPD,
The most frequent and important of these is peritonitis.

In recent years, the incidence of peritonitis related to contamination during dialysis (perfusion) fluid exchange has been significantly reduced due to the development of completely closed systems 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.

In other words, CAPD catheters include Tenckhoff type, Life Cath type,
TWH type or improved versions thereof are commercially available, but these CAPD catheters are not compatible with living body skin tissue, and infection is likely to occur due to poor bonding and insufficient fixation between the catheter and the peritoneal skin penetration site. , which has a high probability of inducing peritonitis. Recently, CAPD to improve bio-skin tissue compatibility
As a catheter, a catheter having a cuff, flange, and collar made of porous polytetrafluoroethylene attached to the joint with the skin has been proposed.

However, since the contact surface with living body skin tissue is relatively smooth and the pore ratio is small, the above-mentioned catheter has poor penetration and engraftment of living body skin tissue, and furthermore, the flange has a relatively large brim shape, so it cannot be inserted into living body. It has disadvantages such as the incision area becomes large. Furthermore, if a molded body with a simply increased pore size is used in the catheter, the material strength will decrease and the durability against external forces required for percutaneous implants will be impaired.

Therefore, during the practical stage, infection due to insufficient fixation,
At present, there is currently no CAPD catheter that does not cause inconveniences such as inflammation and has excellent durability.

In view of the above-mentioned circumstances, the present inventors conducted intensive research aimed at providing a CAPD catheter with excellent compatibility with living skin and tissues, and as a result, completed the present invention. That is,
The present invention relates to a percutaneous indwelling catheter comprising a heat-resistant fiber aggregate layer formed on the surface of the skin-penetrating portion of the catheter made of biocompatible plastics. JP-A-59-174161 discloses a biocompatible plastic composite material for medical use consisting of a biocompatible fiber layer and a plastic layer, but does not disclose any specific uses.

One of the features of the present invention is the above-mentioned Japanese Patent Application Publication No. 59-174161
The object of the present invention is to make it possible to apply hard materials such as carbon materials or ceramic materials disclosed in 2003 to percutaneous indwelling catheters such as CAPD in the form of composite materials using these fiber aggregates.

In addition, the second feature is that the composite material at the skin penetration site is
Places that have large voids (apparent specific surface area) or many "open pores" and therefore are composed of a fiber aggregate layer and a dense biocompatible plastic molded layer that facilitate the penetration of living tissue cells. It is in.

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 CAPD catheter, where induction of peritonitis due to infection from the catheter and the peritoneal skin penetration site 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, braided products, woven fabrics, non-woven fabrics, felt, wound yarns, etc. can be exemplified. 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 fiber aggregate preferably has voids or open pores of 20 μ to 1000 μ to facilitate the invasion of tissue cells.

The fiber materials constituting the fiber aggregate include biocompatible heat-resistant fibers such as carbon fibers, graphite fibers,
Examples include inorganic fibers 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 fibers are not particularly limited, and the forms include single thread, double thread, twisted thread, etc.
Examples include spun yarn, short fibers, whiskers, etc.

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

CVD uses carbon hydrogen e.g. 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. Its temperature is 600℃~
The temperature is 3000°C, preferably 700°C to 2500°C.

FIG. 1 shows an example of an apparatus for coating fiber aggregates with carbon using the CVD method. In the figure, 14 is
This is a fiber aggregate to be subjected to CVD treatment. CVD coating uses inert gas 3 such as argon, hydrogen, nitrogen, etc. as a carrier and methane, benzene, etc. 4 at 600 to 3000℃.
Preferably, 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 700 to 2500°C, and is usually completed in 5 to 180 minutes. In the figure,
1 is a gas trap, 10 is a board made of quartz or alumina, etc., and 11 is a preheating section.

Note that, if necessary, the obtained CVD-coated fiber aggregate may be further heat-treated in an inert gas atmosphere at a temperature higher than the CVD coating temperature.

CVD treatment may be performed in the fiber state, but
It is preferable to carry out the process after processing into braid, woven fabric, non-woven fabric, felt, etc.

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

For example, fluorine resins such as polytetrafluoroethylene, silicone resins such as silicone rubber, vinyl chloride resin, vinylidene chloride resin, fluorinated silicone rubber, polyethylene, polypropylene, polyester, polyhydroxyethyl methacrylate,
Polyacrylamide, polysulfone, poly-N
- Plastics such as vinylpyrrolidone, segmented polyurethane, etc. may be exemplified. It is also preferable that these plastics be surface-treated by etching, glow discharge treatment, or coating with a surface-treating agent to improve adhesion as described below.

The catheter of the present invention made of the above-mentioned plastic material may be a Tenkov type, a Lifecass type, a TWH type, or an improved product thereof, and its shape is not particularly limited as long as it is a catheter used for CAPD.

Any method can be used to join the fiber aggregate layer and the catheter as long as the porosity and flexibility of the fiber aggregate layer are not impaired.

Most commonly, a thin layer of adhesive is applied to the surface of the catheter and the fiber 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. or,
It is also possible to apply an adhesive, directly knit or wrap fibers on the partially melted surface of the catheter, or to implant fibers.

Adhesives that can be used for the bonding include silicone adhesives, polyethine-vinyl acetate copolymers,
Examples include polyester, nylon, urethane elastomer, vinyl acetate, and acrylic resin.

The non-adhered portions between the fibers are necessary for the flexibility of the entire layer and for the penetration and immobilization of biological cells.

If sufficient strength can be obtained, mechanical force may be used, such as by winding the fibers around the catheter or forming the fibers into a bag-knitted structure and fixing the fibers over a plastic material.

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

FIG. 2 illustrates a continuous mobility peritoneal dialysis CAPD catheter utilizing the composite of the present invention. In the figure, 15 is a catheter made of silicone, 16 is a dialysate container, 17 is a transfer tube, and 18 is a joint made of ceramics, titanium, etc., which connects the dialysis container 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 a bag-knitted CVD-coated silica fiber bonded 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 structure 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.

Although Figure 2 shows an example in which the composite material of the present invention is attached to a Tenckhoff-type catheter, it may also be used with catheters used for continuous mobile peritoneal dialysis, such as Life Cath and THW-type catheters. The composite material of the present invention may be applied to any skin-penetrating part, regardless of its type or 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 Manufacturing Example of a Heat-Resistant Fiber Aggregate of the Present Invention Using an apparatus as shown in FIG. 1, a 0.5 mm thick plain woven fabric made of silica fibers 14 was placed on a quartz board 10.

Argon gas 3 flows at 100c.c./min and methane gas 4 flows at 1c.c./min to form a mixed gas at 1000℃.
It was introduced into a quartz tube 9 in an electric furnace 8 held at The inner diameter of the quartz tube 9 preheated (500° C.) from the trap 1 by the ribbon heater 11 of the electric furnace is 55 mmφ, and the length of the soaking zone is 30 cm. At first, only argon gas 3 was flowed to raise the temperature of the electric furnace to 1000°C, and then methane gas was added to the argon gas and flowed. The mixture was allowed to flow for about 1 hour, and then cooled in an argon atmosphere. Take out this cooled CVD coated silica fiber cloth,
Further, heat treatment was performed 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 the drawing]

FIG. 1 is an explanatory diagram of a CVD treatment apparatus used in the present invention, 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...CVD gas, 5,6,
7...Flowmeter, 8...Electric furnace, 9...Quartz tube, 1
0...Quartz board, 11...Ribbon heater, 1
2... thermocouple, 13... pit, 14... fiber aggregate, 15... catheter, 16... dialysate container, 17... transfer tube, 18... joint, 19... composite material of the present invention, 20...cuff, 21...dialysate flow valve.

Claims (1)

[Scope of Claims] 1. Carbon fibers with or without carbon coating, which have voids or open pores that facilitate the penetration of biological tissue cells on the surface of the skin-penetrating part of a catheter made of biocompatible plastic; A percutaneous indwelling catheter for CAPD comprising a biocompatible heat-resistant fiber aggregate layer made of a single or composite biocompatible heat-resistant fiber selected from graphite fibers, inorganic fibers, or metal fibers. 2. The catheter according to claim 1, wherein the void or open pore has a size of 20μ to 1000μ.