Hydrophilic Ureteral Access Sheath for Smoother Urinary Tract

Intended Use

This sterile, single-use device is designed for urological endoscopic procedures. It establishes a stable channel over a guidewire to facilitate the insertion of a ureteral access sheath into the renal pelvis, enabling smooth and safe entry for endoscopes or other surgical instruments into the urinary tract. The sheath protects the ureter during repeated instrument exchanges and safeguards endoscopes from damage.

Product Structure

The system consists of two main components:

1. Guide Sheath
● Sheath Joint with Ergonomic Funnel Design
● Sheath Catheter with Full-length Hydrophilic Coating
● Outer Polyurethane Layer
● Embedded Stainless Steel Coil Reinforcement
● Inner PTFE Lining

2. Dilator
● Dilator Joint with Secure Locking Mechanism
● Dilator Catheter with Hydrophilic Coating
● Tapered Tip for Gradual Dilation

Key Features & Benefits

Dual Hydrophilic Coating

Both the dilator and sheath feature a proprietary hydrophilic coating, providing exceptional lubricity without fragmentation, significantly reducing friction and minimizing tissue trauma.

Spiral Steel Wire Reinforcement

Enhances kink resistance and collapse resistance while maintaining optimal flexibility.

Smooth PTFE Inner Lining

Ensures effortless passage of instruments through the sheath. The thin-wall design provides the largest possible internal lumen while minimizing outer diameter.

Soft and Flexible Tip

Reduces potential damage to urinary tract tissues.

Ergonomic Funnel Design

Acts as a handle during insertion, with a wide opening to simplify instrument introduction.

Secure Locking Mechanism

The dilator hub firmly fastens the dilator and sheath for simultaneous advancement.

Available Sizes

- Inner Diameter:10Fr, 11Fr, 12Fr, 13Fr, 14Fr

- Lengths (mm): 150, 200, 280, 350, 450, 550

Proprietary Coating Technology

● Developed through independent R&D under China’s National Key R&D Program.

● Controlled Interpenetrating Network Structure: Offers strong adhesion and durability.

● Thermal-Curing Process: Ensures uniform coating, high production consistency, and batch-to-batch stability.

● Superior Biocompatibility: Certified safe for clinical use.

● Ultra-Low Friction Coefficient (<0.05): Enables smooth and atraumatic device insertion.

Note: UV-cured coatings are not used due to limitations such as shadowing effects, batch instability, and hazardous waste issues.
Instructions for Use

● Preoperative Preparation: Activate the hydrophilic coating by hydrating the sheath and dilator.

● Insertion: Advance the guidewire to the target site. Insert the tapered tip of the dilator (pre-assembled into the sheath) over the wire. Gently advance the entire assembly into the ureter up to the renal pelvis.

● Sheath Placement: Once in position, release the lock mechanism at the dilator joint and carefully withdraw the dilator along with the guidewire.

● Instrument Access: The sheath now provides a clear working channel for endoscopes or other surgical tools to perform the procedure.

● Removal: Upon completion of the surgery, gently remove the ureteral access sheath.
Sterilization & Packaging

● Sterilized using ethylene oxide.

● Individually packaged to ensure sterility and convenience.

● For professional use only. Refer to IFU for complete instructions.

Summary

The Hydrophilic ureteral access Sheath is a modern, patient-friendly, and efficient device for urology professionals. Its hydrophilic coating, ergonomic design, and disposable nature make it ideal for minimally invasive procedures, providing comfort, safety, and operational efficiency. With versatile applications across urology interventions, it is an essential addition to any medical institution seeking high-quality, cost-effective urology consumables.