Once-formed binding type urethral catheter and production method thereof

Abstract

The invention discloses a once-formed binding type urethral catheter and a production method thereof. The urethral catheter comprises an inner urethral catheter body, a balloon sleeve, a draining connector and a one-way valve, wherein the inner urethral catheter body, the balloon sleeve, the draining connector and the one-way valve are respectively processed and then assembled. A balloon water injection pipe communicated with a balloon water injection channel is arranged on the inner urethral catheter body. The inner urethral catheter body, the balloon sleeve, the draining connector, the balloon water injection pipe and the one-way valve are assembled to form a urethral-catheter internal main body. An elastic material layer is formed on the outer surface of the urethral-catheter internal main body in a dipping mode to form an integrally-connected urethral-catheter outer layer, an outlet of the draining connector and an inlet and an outlet of the one-way valve are exposed out of the urethral-catheter outer layer, and the tensile strength of the materials of the urethral-catheter outer layer is smaller than that of the materials of the inner urethral catheter body. The urethral catheter is easy to process and form; in clinical use, a balloon of the urethral catheter is not prone to being broken, a cavity channel is not prone to leakage, the balloon can be reliably contracted when the urethral catheter is pulled out, blocking is not prone to occurrence, and dredging can be easily carried out even if blocking occurs.

Description

technical field [0001] The invention relates to the improvement of the urinary catheter structure, in particular to a one-time forming bundled urinary catheter and a production method thereof, which belong to the technical field of medical devices. Background technique [0002] At present, the most commonly used latex catheter was invented by American Bard in the 1930s and introduced to China in the 1990s. During more than half a century of clinical use, its production process and technology have hardly changed substantially. It is obviously not suitable for the requirements of modern medical level, nor can it adapt to the development trend of modern industrial automation and intelligence, and the accuracy and standardization of product indicators still need to be improved. [0003] Specifically reflected in: [0004] 1. The product itself has major defects and hidden dangers in terms of safety in use. The existing production process and testing methods determine that la...

AI Technical Summary

Problems solved by technology

[0004] 1. The product itself has major defects and hidden dangers in terms of safety in use

The existing production process and testing methods determine that latex catheters will inevitably have balloon blockage, balloon rupture, cavity leakage and urinary tract allergic infection in clinical use, and will increase due to the reduction of production management level. The proportion of these cases

Among them, in terms of balloon blockage, the isolation layer or release agent in the balloon, the damage caused by the demoulding process of the balloon cavity, the residue of the balloon cavity mold and its coagulant, and the Foreign substances are the root cause of the blockage of the balloon and its cavity. In large-scale production, the existing production technology cannot completely eliminate the adverse effects of these factors; The aging of the balloon material and the degree of adhesion between the edge of the balloon and the tube body are the reasons for the rupture of the balloon. The existing products are completely made of latex material. The limitation of the outer diameter of the tube and the small tensile stiffness of the inner cavity of the ball determine the The thickness of the balloon is limited, and the realization of a stable link between the edge of the balloon and the latex molecule between the tube body is affected by many factors, and it is difficult to control. The above situation is inevitable; in terms of lumen leakage, the demoulding process is not completely dry. The damage of the latex layer, the connection mode between the one-way valve and the balloon water injection cavity are the reasons for the leakage of the cavity, which cannot be solved by the existing process; in terms of urinary tract allergic infection, it is mainly caused by the chlorination in the coagulant It is caused by calcium or calcium nitrate. The existing products are thick-walled products with one end closed. It is difficult to ensure that the leaching effect of all products meets the requirements in large-scale production. Cases of urinary tract allergies and infections are inevitable.

Moreover, in view of the above problems, there is currently no detection method that can completely monitor the technical indicators of all products

Therefore, it is inevitable that the quality defects and hidden dangers of existing urinary catheters cause a certain proportion of medical accidents.

[0005] 2. The inevitable consequence of harsh clinical conditions and backward production technology is the frequent occurrence of medical accidents

[0006] 3. The production process of latex urinary catheter is complex, with many procedures and manual operation, resulting in high cost and difficult quality control

However, the proposed method of bonding thermosetting materials and thermoplastic materials through a medium is not advisable. As we all know, whether this kind of bonding can be firm is itself a technical problem. The impact needs to be verified

Moreover, the risk of separation and falling off of the balloon sleeve and the outer layer material still exists. After the balloon is blocked, it cannot be remedied. The product cannot be formed at one time.

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