Foley Catheter with Thermal Probe, 16 Fr, 3-Way, Balloon Size 5–10 ml / 30 ml

Foley Catheter with Thermal Probe, 16 Fr, 3-Way, Balloon Size 5–10 ml / 30 ml

HENAN AILE INDUSTRIAL CO., LTD with over 12 years of medical experience.
We hold certifications, including CE, ISO 13485 & USA FDA.​​​​​​​

1.Key Advantages & Product Overview

Key Advantages:

• Precision Core Body Temperature Monitoring: Detects real-time core thermal shifts with an accuracy of ±0.1°C, critical for the prevention and timely intervention of perioperative hypothermia, malignant hyperthermia, and septic fever spikes.

• Streamlined 3-Way Clinical Versatility: Eliminates secondary invasive rectal or esophageal probes. The tertiary lumen enables simultaneous or intermittent closed-loop bladder irrigation to flush out blood clots, sediment, and crystallization.

• Dual Balloon Configurations (5–10 ml / 30 ml): 5–10 ml balloon prevents catheter migration in general floor and ICU use; 30 ml high-volume balloon delivers effective mechanical compression at the prostatic fossa or bladder neck post-TURP.

• Hydrodynamic Drainage Architecture: Smoothly rounded, non-traumatic dual drainage eyes minimize insertion trauma, optimize fluid evacuation velocity, and significantly reduce catheter-associated urinary tract infections (CAUTI).

• Universal Monitor Interoperability: Compatible with standard YSI 400 series temperature monitoring cables, enabling plug-and-play connectivity with Mindray, GE, Philips, Nihon Kohden, and Dräger patient monitors.

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The Foley Catheter with Thermal Probe, 16 Fr, 3-Way, Balloon Size 5–10 ml / 30 ml is an advanced dual-purpose medical device designed for continuous core body temperature (CBT) monitoring, continuous closed urinary drainage, and therapeutic bladder irrigation. Engineered with an encapsulated high-accuracy NTC thermistor sensor at the distal tip, it provides real-time physiologic temperature feedback directly from the bladder wall and urine pool—the clinical gold standard surrogate for central venous blood temperature.

The 16 Fr outer diameter serves as the optimal clinical benchmark for adult patients, ensuring balanced flow throughput without compromising urethral safety. Its specialized 3-way lumen design isolates the drainage channel, balloon inflation lumen, and temperature sensor/irrigation port. With versatile dual-balloon configurations (5–10 ml standard retention and 30 ml hemostatic tamponade), this urinary catheter satisfies the most stringent requirements across ICUs, emergency rooms, and surgical suites.

2. Product Specifications Table

3. Material Characteristics: 100% Silicone vs. Latex-Coated

Choosing the correct catheter material directly impacts patient safety, mechanical reliability, and dwell time:

1. 100% Medical-Grade Silicone (All-Silicone):

   • Biocompatibility & Hypoallergenic Safety: Chemically inert, completely free of natural rubber proteins, eliminating the risk of Type I latex allergic reactions.

   • Superior Flow Dynamics: Thin-wall extrusion technology provides a 20%–30% larger inner lumen than equivalent latex catheters, maximizing urine evacuation and lowering encrustation risks.

   • Crystal Clarity: Fully transparent shaft allows direct visual inspection of urine clarity, hematuria color shifts, and particulate debris.

   • Extended Indwelling Time: Highly resistant to mineral deposits; approved for prolonged placement up to 28 days.

2. Silicone-Coated Medical Latex:

   • Mechanical Flexibility: Exceptional softness and tactile pliability provide smooth navigation along tortuous urethral anatomies.

   • Elastic Rebound: High-tensile balloon elasticity ensures symmetrical, firm inflation and deflation profiles.

   • Economic Efficiency: Cost-effective solution ideally suited for acute intraoperative monitoring and short-term inpatient stays (<7 days).

4. Clinical Applications & Target Patient Demographics

Target Medical Environments:

• Intensive Care Units (ICU / CCU / SICU / NICU): Precise real-time diuresis tracking and continuous core thermal regulation during severe sepsis, shock, or hemodynamic instability.

• Complex Surgical Procedures: Cardiac bypass, neurosurgery, open abdominal interventions, and orthopedic trauma where anesthesia-induced thermal dysregulation is prevalent.

• Targeted Temperature Management (TTM): Post-cardiac arrest resuscitation protocols and therapeutic hypothermia/normothermia maintenance (32°C–36°C).

• Urologic Surgery (30 ml Balloon Model): Post-Transurethral Resection of the Prostate (TURP) and partial cystectomy, providing balloon tamponade alongside continuous bladder irrigation (CBI).

Target Patient Demographics:

• Critically ill adult patients requiring high-resolution hourly urine output and core vitals surveillance.

• Surgical candidates under prolonged general anesthesia vulnerable to unintended perioperative hypothermia.

• Urological postoperative patients requiring localized hemorrhage compression and irrigation.

5. Why Choose Our Thermal Sensing Foley Catheter?

1. Unified Clinical Workflow: Combining dual interventions into a single sterile procedure eliminates redundant catheter placements, saves nurse setup time, and minimizes urethral trauma.

2. Direct Bladder Core Thermometry: Direct mucosal contact and urine submersion reflect visceral blood flow, outperforming superficial skin stickers, peripheral axillary probes, or discontinuous tympanic readings.

3. Leak-Proof Micro-Encapsulation: Thermistor connections are sealed via ultrasonic laser welding. Even under continuous high-flow bladder irrigation, electrical isolation remains uncompromised.

4. Enhanced Patient Comfort: Optimized tip tapered geometry and smooth lateral eyes mitigate urethral friction, irritation, and stricture formation during extended dwell cycles.

6.  (FAQ)

Q1: Is a 16 Fr catheter size universally suitable for adult patients?

A1: Yes. 16 Fr is the clinical standard for adult catheterization. It provides a large enough drainage lumen to evacuate mucosal sediment and microscopic clots without placing unnecessary tensile stress on urethral tissue.

Q2: Which patient monitoring platforms are compatible with this temperature sensor?

A2: Equipped with industry-standard 400 series thermistors, the probe interfaces seamlessly with systems from Philips, Mindray, GE Healthcare, Nihon Kohden, and Dräger using standard reusable adapter cables.

Q3: When should clinicians select the 30 ml balloon over the 5–10 ml model?

A3: The 5–10 ml balloon is ideal for standard bladder drainage and anchoring. The 30 ml balloon is indicated for post-urological surgery (such as TURP), where an inflated balloon acts as a mechanical tamponade against prostatic bed bleeding.

Q4: What is the maximum recommended indwelling duration?

A4: All-silicone models are validated for extended placement up to 28 days. Silicone-coated latex variants are recommended for short-to-intermediate use not exceeding 7 to 14 days, subject to infection control protocols.

Q5: Can bacteriostatic saline be used to inflate the balloon?

A5: No. Always inflate the balloon with Sterile Water for Injection. Saline can crystallize over indwelling periods, clogging the micro-inflation channel and causing deflation failure prior to extraction.

Q6: Is this catheter with a thermal probe MRI safe?

A6: Because the catheter integrates fine conductive copper wiring for the thermistor, it is typically classified as MR Conditional. Clinicians must follow the specific safety parameters provided in the Instructions for Use (IFU) before MRI scanner entry.

Q7: How should the third irrigation lumen be handled when not actively irrigating?

A7: When continuous or intermittent bladder irrigation is suspended, the irrigation port must remain securely closed with a sterile luer-lock cap to preserve closed-system integrity and prevent retrograde microbial ingress.

Q8: Does an empty bladder skew temperature measurement accuracy?

A8: No. The distal thermistor sits in direct contact with the collapsed bladder wall. The rich microvascular network of the bladder mucosa reflects internal pelvic visceral temperature with outstanding precision even in low-output conditions.

Contact Us
Contact our export team at admin@aileindus.com for factory price quotes, technical data, or OEM product samples. We reply to all business inquiries within 12 hours.