Haiyan Kangyuan Medical instrument Co., Ltd. has recently reached a milestone in the development of large-volume 3 way silicone foley catheters. Leveraging extensive real-world clinical feedback since market launch, the company identified persistent shortcomings in existing large-balloon catheters, including unstable inflation morphology, poor eccentricity control, and insufficient volume accuracy. In response to these industry-wide challenges, Kangyuan assembled a dedicated R&D task force and collaborated with overseas partners to optimise both novel silicone material formulations and precision moulding processes. Through dozens of formulation iterations, multiple production refinements, and comprehensive reliability verification, the team successfully resolved two core technical hurdles—integral moulding of large-capacity balloons and long-term inflation deformation control—completing full performance development for three benchmark sizes (16Fr/30ml, 18Fr/30ml, 18Fr/40ml) that had long been considered extremely difficult to achieve. This establishes a new performance baseline for large-volume urinary catheters in China.

Multiple pilot production runs have been conducted, with 1,000 samples per size per batch and ten full-cycle simulated mass-production tests completed. Complete in-house laboratory validation data are available, and full test reports can be provided for client verification. Batch test results show that balloon eccentricity control is significantly better than current industry standards, volume deviation is kept within a very narrow range, and retraction recovery after prolonged inflation is excellent. Key metrics such as balloon structural integrity, deformation stability, and insertion smoothness have yielded consistent, reliable data, demonstrating performance that meets or exceeds that of comparable domestic products.

Key performance improvements:

• Uniform inflation morphology: After filling, the balloon exhibits excellent sphericity consistency, with eccentricity control reaching industry-leading levels. Pressurisation results in even force distribution, improving conformability during clinical compression haemostasis.
• Stable and controllable inflation pressure: Within the rated volume range, pressure fluctuation is significantly reduced, ensuring stable morphology during and after long-term indwelling, thereby lowering the risk of catheter migration.
• Superior long-term retraction recovery: Simulated clinical indwelling tests with prolonged inflation show that the balloon deflates fully and returns to its original shape without permanent deformation, facilitating smooth removal and reducing urethral mucosal abrasion.
• Comprehensive mechanical performance upgrade: The product achieves enhanced wall compliance, structural strength, and overall insertion smoothness. The natural tube colour can be customised to meet the specific appearance requirements of hospitals and distributors.

The 3 way large-balloon silicone foley catheters from Haiyan Kangyuan are available in four tip configurations: straight tip, straight semi-tip, coude tip, and coude semi-tip. The full range offers balloon volumes up to 60 mL. Detailed specifications are as follows:

Large-volume balloon catheters are an essential consumable in urological surgery, particularly for procedures such as transurethral resection of the prostate (TURP). Postoperative bleeding from the bladder neck and prostatic fossa is a common complication. The inflated large balloon conforms precisely to these anatomical areas, providing uniform and sustained compression to effectively control oozing, while its large surface area securely anchors the catheter. This offers irreplaceable clinical advantages over conventional balloon catheters in both haemostasis and fixation.

Couvelaire tip / Dufour tip Design: The widened distal drainage lumen facilitates the passage of blood clots and tissue debris, significantly reducing the incidence of catheter obstruction and the need for irrigation.

150° Coude Tip: Designed to match the male urethra’s three narrowings and two curvatures, this tip reduces insertion resistance, minimising patient discomfort and mucosal injury during placement.

This technological breakthrough in large-volume 3 way foley catheters effectively challenges the long-standing dominance of imported products in the high-end domestic market, offering hospitals, urology departments, and interventional suites a highly stable and cost-effective domestic alternative. Driven by a commitment to addressing clinical needs, the product enables physicians to manage complex postoperative haemostasis cases with greater ease, streamlines surgical workflows, shortens postoperative nursing cycles, and tangibly improves patient comfort during indwelling catheterisation.

Looking ahead, Haiyan Kangyuan Medical will continue to pursue clinical-needs-driven, technology-led innovation, focusing on high-quality consumables for urological interventions and minimally invasive postoperative care. Through indigenous technological advancement, the company aims to contribute to the high-quality upgrading of China’s medical device industry.