The Single-Use Sphincterotome is a precision medical device designed for Endoscopic Retrograde Cholangiopancreatography (ERCP). It is used to perform sphincterotomy (incision of the bile duct or pancreatic duct sphincter) to facilitate stone removal, stent placement, or drainage therapy. Its single-use design significantly reduces cross-contamination risks while improving procedural efficiency and safety.
Primary Applications
1. Common Bile Duct (CBD) Stone Extraction: Incision of the Oddi sphincter to allow stone passage or removal.
2. Biliary/Pancreatic Duct Stricture Dilation: Assists in stent placement or balloon dilation for stricture treatment.
3. Acute Biliary Pancreatitis: Emergency sphincterotomy to relieve pancreatic duct obstruction.
4. Pancreaticobiliary Tumor Drainage: Palliative therapy to improve bile or pancreatic fluid drainage.
Usage Scenarios
- ERCP Procedures: Widely used in gastroenterology or hepatobiliary surgery for minimally invasive interventions.
- Emergency Interventions: Acute cholangitis, obstructive jaundice, or pancreatitis requiring urgent treatment.
- Outpatient/Day Surgery Centers: Ideal for short-stay or ambulatory care settings.
Product Features
1. Innovative Design
- Adjustable Cutting Wire Length: Precise control over incision depth (typically 20-30 mm), reducing perforation risks.
- Dual-Lumen Catheter: Enables simultaneous guidewire navigation and contrast injection.
- Radiopaque Markers: X-ray visible markers at the catheter tip for real-time positioning.
2. Enhanced Safety
- Single-Use: Eliminates cross-contamination risks, complying with global infection control standards (CDC, WHO).
- Sterile Packaging: Individually sterilized and ready for immediate use.
- Safety Lock Mechanism: Cutting wire activates only upon electrical current application, preventing accidental injury.
3. User-Friendly Operation
- Ergonomic Handle： Designed for comfortable grip, minimizing operator fatigue.
- Broad Compatibility: Compatible with standard duodenoscopes and working channels (≥3.2 mm).
4. Advanced Materials
- Nitinol Cutting Wire: Superelastic alloy adapts to biliary anatomical curves.
- Hydrophilic Coating: Reduces friction for smooth guidewire passage.
Key Advantages
1. Infection Risk Reduction:
- Traditional reusable sphincterotomes carry risks of incomplete sterilization. Single-use design eliminates this concern.
- Clinical data show a 40% reduction in post-procedural infections (Gut, 2022).
2. Cost Efficiency:
- No reprocessing (cleaning, disinfection, or maintenance) required. Total cost per procedure is 25-30% lower than reusable devices.
3. Operational Efficiency:
- Ready-to-use design reduces pre-procedure preparation time, critical for emergency cases.
Case Studies
Case 1: CBD Stones with Acute Cholangitis
- Patient: 65-year-old male with jaundice, fever, and a 12-mm CBD stone on CT.
- Procedure:
1. ERCP-guided insertion of the single-use sphincterotome to the distal CBD.
2. Sphincterotomy (25 mm wire length) followed by balloon-assisted stone extraction.
*Outcome: Procedure completed in 30 minutes; no post-op infection or bleeding.
Case 2: Pancreatic Cancer with Obstructive Jaundice
- Patient: 58-year-old female with pancreatic head cancer (total bilirubin: 15 mg/dL).
- Procedure:
1. Pre-cut sphincterotomy using the single-use device.
2. Metal stent placement for biliary drainage, reducing bilirubin to 3 mg/dL.
*Outcome: Avoided risks of reusable device damage; precise stent deployment.
