Catheter and Process for Producing the Catheter

Abstract

A catheter having a catheter layer composed of a composition containing ETFE and PTFE in a weight ratio of 99:1 to 45:55, wherein there is got a luminal internal surface consisting of a material that exhibits lubricity substantially identical with that of PTFE and has a resistance to radioactive rays not had by PTFE.

Description

TECHNICAL FIELD[0001]The present invention relates to a catheter for medical use to be used for diagnosis or therapy by being inserted into a blood vessel or other body lumen, and to a process for producing the catheter.BACKGROUND ART[0002]In recent years, catheters have been being used in an increasing number of diagnostic and / or therapeutic methods for alleviating the physical and time-basis burdens on patients. Generally, for insertion of a catheter into a living body-through a blood vessel, ureter, trachea, esophagus or the like and bringing the catheter accurately to a predetermined site in the living body without damaging the blood vessel wall, organs or the like, the catheter must meet the structural requirements for high operationality and safety when serving as a medical device and, simultaneously, the luminal internal surface of its tube (referred to also as “catheter body”) must exhibit lubricity.[0003]The lubricity is necessary for externally injecting a liquid medicine ...

AI Technical Summary

Benefits of technology

[0030]The luminal internal surface of the catheter according to the present invention has a lubrication characteristic substantially identical with that of PTFE. Therefore, the use of the catheter according to the present invention makes it possible to easily carry out injection externally a liquid medicine or the like to a predetermined site in a patient's body through the lumen of the catheter body, drainage of a body fluid or the like present in the living body, and passage of other therapeutic devices therethrough. In addition, the luminal internal surface of the catheter according to the present invention is composed of a material having a resistance to radioactive rays not had by PTFE. Therefore, a sterilizing method using radioactive rays, which obviates toxicity and ensures that the treatment time required for sterilization is short, can be applied to the catheter according to the present invention.

Problems solved by technology

These methods, however, have problems as to the toxicity of the gas, the long treatment time required for sterilization, etc.

According to this method, toxicity is obviated and the treatment time required for sterilization is short.

However, the sterilization method using radioactive rays cannot be applied to the above-mentioned catheters using PTFE.

This is because PTFE is deteriorated when irradiated with ionizing radiations of not less than 1 kGy, and is extremely deteriorated in mechanical properties at an absorbed dose of around 25 kGy, which is a sterilizing dose generally used in the cases of sterilization with γ-rays, electron beams and the like.

For example, when the radioactive-ray sterilization is applied to the catheter described in Patent Document 1 in which PTFE is used to form the inner layer, PTFE is conspicuously lowered in breaking elongation and, therefore, mere bending of the catheter body would result in exfoliation or cracking of the inner layer.

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