JPH03224574A - Tube containing contrast media - Google Patents

Abstract

PURPOSE:To obtain the tube being white and having a high contrast effect and to prevent it from being discolored with the lapse of time by constituting the tube by forming the inside layer by a tubular synthetic resin in which a fluid passage is formed in the inside, forming the intermediate layer by dispersing an X-ray contrast media in the synthetic resin and giving ultraviolet ray transmission resistance to the outside layer and forming the tube consisting of three layers. CONSTITUTION:An inside layer 1 consists of a tubular synthetic resin in which a fluid passage 4 is formed in the inside, and an ethylene tetrafluoride copolymerization resin is used. An intermediate layer 2 is formed by dispersing an X-ray contrast-media consisting of white bismuth into a synthetic resin, and a white bismuth compound is a white bismuth crystal consisting of bismuth oxide, bismuth nitrate and bismuth sulfate, and that which is 83-88weight% bismuth content is used, and by dispersing and mixing it is a synthetic resin within a range of 3-25weight%, the inside layer 1 is covered. The outside of the intermediate layer 2 is covered with an outside layer 3 formed by dispersing and mixing titanium oxide of 0.05-1.0mum particle size by 0.5-2.0weight% in the synthetic resin. In such a way, the appearance shows white and at the time of using it for the human body, there is no sense of incompatibility, ultraviolet rays are prevented as to its transmission by the outside layer 3, and yellowing of white bismuth is prevented.

Description

[Detailed Description of the Invention] [Industrial Application Field] This invention relates to a contrast medium-containing tube particularly for medical use,
An X-ray contrast agent is included in the tube wall to enhance the contrast effect, and the outer layer of the contrast agent is provided with UV transmission resistance to suppress discoloration of the contrast agent.

[Conventional technology]

Tubes made of biocompatible polymer materials such as fluororesin mixed with X-ray contrast agents such as barium sulfate or bismuth oxide are used as indwelling needles that are inserted and fixed into blood vessels when administering fluids or blood transfusions, for example. There is. Even if a part of such an indwelling needle is accidentally cut off during use and enters the body's vascular system, its location can be easily detected using an X-ray photograph due to the X-ray contrast agent contained within the tube wall. It can be confirmed.

It is also used as a catheter in which the tube is inserted into the human body and its tip reaches the target site while being viewed through X-rays for purposes such as collecting blood from the heart or injecting medicine into internal organs.

Conventionally, this type of contrast medium-containing tube was manufactured by
As described in Japanese Patent Publication No. 49394, there are those in which an X-ray contrast agent is uniformly dispersed throughout the tube wall, and the
1) As described in Publication No. 9263, a resin layer containing an X-ray contrast agent is integrally provided with a resin layer not containing an X-ray contrast agent on the inner and outer surfaces, and furthermore, a resin layer containing no X-ray contrast agent is provided on the inner and outer surfaces of the resin layer containing an X-ray contrast agent.
As described in Japanese Patent Publication No. 2003-121033, there is known a device in which a part of the tube wall in the circumferential direction is provided with an X-ray contrast agent mixed portion that is continuous in the longitudinal direction.

[Problem to be solved by the invention]

By the way, barium sulfate and bismuth compounds are generally used as contrast agents in tubes containing X-ray contrast agents. In particular, since bismuth compounds have a higher contrast effect than barium sulfate, they are suitable for obtaining high contrast effects with a small amount of compounding.

However, because bismuth oxide, which has the highest bismuth content among bismuth compounds and has the highest contrast effect, is yellow in color, it is sometimes avoided by doctors and patients due to their physiological feelings compared to barium sulfate, which is white. There is a problem.

Further, even when coloring contrast medium type tubes so that they can be identified by color, there is a problem in that tubes using bismuth oxide cannot be colored in colors other than yellow to enable identification.

On the other hand, among bismuth compounds, bismuth subcarbonate and bismuth oxychloride, which are white in color, have a lower contrast effect because they have a lower bismuth content than bismuth oxide. Moreover, since these bismuths decompose at high temperatures, they cannot be mixed into fluororesins whose molding temperatures are high. Therefore, a tube containing a bismuth-based X-ray contrast agent that is white and has a high contrast effect was proposed in Japanese Patent Application No. 1-103065. However, although this tube does not decompose or foam during the manufacturing process and has a white appearance, it has the problem of yellowing over time.

This invention was made based on the inventors' knowledge that the cause of the yellowing of the tube is that the white bismuth compound yellows due to ultraviolet rays. The purpose of this invention is to provide a contrast agent tube that does not discolor.

[Means to solve the problem]

Therefore, in this invention, the inner layer is made of a tubular synthetic resin with a fluid passage formed therein, and the outer intermediate layer is made by dispersing an X-ray contrast agent made of a bismuth compound in the synthetic resin. Furthermore, the outer layer is made to be resistant to ultraviolet light transmission, resulting in a three-layer contrast agent type tube.

The outer layer having UV transmission resistance is preferably constructed by dispersing titanium oxide in a synthetic resin.

[Effect]

The contrast medium type tube of the present invention is used for applications such as catheters by passing fluids such as blood and drugs through the internal fluid passageway of the inner layer having a tubular shape. The intermediate layer contains X made of bismuth compound.
Since the radiographic contrast agent is dispersed, the contrast effect is high, and therefore the position of the tube within the human body can be reliably recognized by X-ray photography or XKLI vision. In addition, the outer layer has UV transmission resistance (UV shielding function), so
Since it suppresses ultraviolet rays from reaching the intermediate layer, yellowing of the bismuth compound is prevented and the tube remains white. If a white bismuth compound is used, the degree of whiteness of the contrast medium type tube can be maintained even more clearly.

Titanium oxide imparts ultraviolet transmission resistance to the outer layer,
When this is dispersed in a synthetic resin to form the outer layer, titanium oxide has high UV transmission resistance and a high melting point, so a fluororesin, which is thermoplastic and has good biocompatibility, is used as the synthetic resin. can. Therefore, the outer layer is not only easy to form and suitable for use on the human body, but also can be subjected to high temperature sterilization.

〔Example〕

Figure 1 is an enlarged cross-sectional view of a contrast agent tube. Specific examples of this tube include hard indwelling needles used for infusions and blood transfusions into the human body, and visible catheters used in the human body. be able to.

Of course, conditions such as diameter and tube wall thickness are different in these cases.

This tube consists of three layers: an inner layer 1, an intermediate layer 2 on the outside, and an outer layer 3. The inner diameter of the inner layer 1 is 0.
．． 96mm, the outer diameter of inner layer 1 and the inner diameter of middle layer 2 are 1.0
8 Tsuru, the outer diameter of the middle layer 2 and the inner diameter of the outer layer 3 are 1.20 m,
The outer diameter of the outer layer 3 is set to 1.32 mW, but these dimensions are just an example, and this type of tube should have a small outer diameter, a large inner diameter, and high mechanical strength. required. The inner layer 1 is made of a tubular synthetic resin in which a fluid passage 4 that serves as a transport path for drugs, blood, etc. is formed, and in this embodiment, a fluororesin, particularly tetrafluoroethylene copolymer resin (ETFE) is used. However, other fluororesins such as tetrafluoroethylene hexafluoropropylene copolymer resin, tetrafluoroethylene perfluoroalkyl vinyl ether copolymer resin, tetrafluoroethylene resin, vinylidene butonide resin, etc. can be used. However, depending on the purpose of the contrast medium-containing tube, synthetic resins other than fluororesin can also be used.

The intermediate layer 2 provided outside the inner layer 1 is made by dispersing an X-ray contrast agent made of white bismuth in a synthetic resin. As this synthetic resin, a tetrafluoroethylene copolymer resin is used here as in the inner layer 1, but as described above, other synthetic resins can also be used. The white bismuth compound is a white bismuth mixture consisting of bismuth oxide, bismuth nitrate, and bismuth sulfate, and has a bismuth content of 83 to 88% by weight. The mixture is dispersed and blended into the synthetic resin to cover the inner layer 1. The white bismuth compound is heat resistant and has good biocompatibility.

On the outside of the intermediate layer 2, 0.5 to 2.0 μm of titanium oxide with a particle size of 0.05 to 1.0 μm is contained in the same synthetic resin as above.
It is coated with an outer layer 3 which is dispersed in weight percent.

Needless to say, the above-mentioned compounding into the intermediate layer 2 and the outer layer 3 is carried out by a known method for dispersing and blending the compound into a thermoplastic synthetic resin.

Such a contrast agent-containing tube has a white appearance because an X-ray contrast agent made of a white bismuth compound is dispersed in the intermediate layer 2, and can be used without discomfort when used in the human body as a catheter or the like. Furthermore, although it is a white bismuth compound that is easily yellowed by ultraviolet rays, the ultraviolet rays that cause yellowing are prevented from passing through by the titanium oxide in the outer layer 3, and therefore do not reach the white bismuth. Yellowing is prevented and the white color of the contrast agent tube is maintained for a long period of time.

When the blending ratio of the white bismuth compound in the intermediate layer 2 is less than 3% by weight, the contrast function and the degree of whiteness decrease, while when it exceeds 3% by weight, the contrast function and coloring function are satisfactory, but 25% by weight. If it exceeds %, the cost will increase. In addition, the outer layer 3 contains titanium oxide from 0.5 to
2.0% by weight is dispersed, but this is 0.5% by weight.
When the content is less than 2.0% by weight, the ultraviolet transmission resistance decreases, causing yellowing of the intermediate layer 2, and when it exceeds 2.0% by weight, the cost increases.

The inventors used a tetrafluoroethylene copolymer resin for the inner layer 1, and added 85% by weight of the tetrafluoroethylene copolymer resin to
The white bismuth mixed crystal having a bismuth content of 85% by weight is dispersed in an amount of 15% by weight to constitute the intermediate layer 2, and
Contrast agent Tinib, which was used as the outer layer 3, was prepared by dispersing 1.0% by weight of titanium oxide in a tetrafluoroethylene copolymer resin. When we tested the appearance of this tube, especially changes in whiteness, we found that this tube did not change color even after one month of outdoor exposure test, and the surface remained smooth, whereas the outer layer 3 was not present. The double contrast medium-containing tube containing only the inner layer 1 and intermediate layer 2 turned yellow within one day.

In addition, as the material for each layer 1.2.3, in place of the above-mentioned tetrafluoroethylene copolymer resin, tetrafluoroethylene-hexapropylene copolymer resin, tetrafluoroethylene perfluoroalkyl vinyl ether copolymer resin, tetrafluoroethylene perfluoroalkyl vinyl ether copolymer resin, Good results similar to those described above were obtained using ethylene fluoride resin, vinylidene fluoride resin, and other fluororesins.

〔Effect of the invention〕

As explained above, in this invention, an X-ray contrast agent made of a bismuth compound is dispersed in the intermediate layer, so the contrast effect is high, and since the outer layer has UV transmission resistance, Since it suppresses the arrival of ultraviolet rays, the bismuth compound is prevented from yellowing and the tube remains white.

Titanium oxide imparts ultraviolet transmission resistance to the outer layer,
When dispersed in a synthetic resin to form the outer layer, titanium oxide has high ultraviolet transmission resistance, and like the bismuth compound described above, it also has a high melting point, so the synthetic resin forming the intermediate and outer layers As a material, a fluororesin which is thermoplastic and has good biocompatibility can be used. For this reason, each layer is not only easy to form and suitable for use on the human body, but also
It can be made into a contrast tube that can also be subjected to high temperature sterilization.

[Brief explanation of drawings]

FIG. 1 is an enlarged cross-sectional view showing an embodiment of the contrast tube. ■...Inner layer, 2...Middle layer, 3...Outer layer, 4
...Fluid passage.

Claims (2)

[Claims] (1) An intermediate layer made of an X-ray contrast agent made of a bismuth compound dispersed in the synthetic resin is provided on the outer periphery of the inner layer made of a tubular synthetic resin in which a fluid passage is formed, and an A contrast agent-containing tube characterized by forming an outer layer having penetration resistance. (2) The contrast agent-containing tube according to claim 1, wherein the outer layer having ultraviolet transmission resistance is made of a synthetic resin in which titanium oxide is dispersed.