# Medical Grade Liquid Silicone Urinary Catheter for Clinical Use
Product Overview
The Medical Grade Liquid Silicone Urinary Catheter is a high-precision disposable urinary access device engineered explicitly for short- and long-term urinary management in clinical settings. Manufactured via medical-grade liquid silicone rubber (LSR) injection molding under ISO 13485 quality management systems, this catheter addresses critical limitations of traditional latex and PVC catheters, including biocompatibility risks, tissue irritation, and extended indwelling performance degradation.
Core features include a fully smooth, burr-free surface finish (<0.8μm roughness), atraumatic rounded tip, kink-resistant shaft design, and integrated leak-proof balloon inflation channel. Unlike solvent-bonded multi-part catheters, its co-molded one-piece construction eliminates delamination risks and gaps where biofilm can form, reducing catheter-associated urinary tract infection (CAUTI) risk by up to 32% in clinical trials compared to latex alternatives. Each catheter is pre-sterilized via ethylene oxide (EO) with a 5-year shelf life, and is available in both Foley (indwelling) and intermittent (straight tip) configurations to support diverse clinical use cases.
Technical Specifications
Material Properties
All raw materials comply with USP Class VI, ISO 10993, and FDA 21 CFR Part 177.2600 biocompatibility standards, with no phthalates, latex proteins, or harmful plasticizers added:
ParameterSpecificationTest Method
Base MaterialMedical-grade high-purity addition-cure LSRISO 10993-1
Shore Hardness50 ± 5 Shore AASTM D2240
BiocompatibilityNon-cytotoxic, non-irritating, non-sensitizing, hemolysis rate < 1%ISO 10993-5, -10, -4
Extractable Heavy Metals< 10 ppm total, < 2 ppm lead, < 1 ppm cadmiumUSP <232>
Volatile Organic Compounds (VOCs)< 0.1% post-curingISO 7823-3
Physical Performance
The catheter is optimized for reliable mechanical performance across its entire service life:
ParameterSpecificationTest Method
Burst Pressure≥ 300 kPa (shaft), ≥ 200 kPa (inflated balloon)ISO 10555-1
Kink ResistanceNo lumen occlusion at 180° bend at 23°C and 37°CASTM D3176
Balloon CapacityStandard 5–30mL (±10% volume tolerance), maintains pressure for ≥ 30 days at 37°CISO 10555-3
Drainage Lumen Flow Rate≥ 200 mL/min for 12Fr, ≥ 400 mL/min for 20FrISO 10555-3
Tip AtraumaticityNo tissue abrasion observed after 100 insertion/withdrawal cycles on porcine bladder mucosaIn-house biocompatibility test
Connector LeakageNo fluid leakage at 100 kPa static pressure for 1 hourISO 80369-3
Process Parameters
All catheters are manufactured in a Class 100,000 (ISO 8) cleanroom to eliminate contamination risks:
Process StepParameter
LSR Injection Molding Temperature170–190°C
Curing Time60 ± 10 seconds
Post-Curing Treatment200°C for 4 hours to remove residual low-molecular-weight siloxanes
Sterilization MethodEthylene oxide (EO) with 7-day aeration, residual EO < 4 μg/g
PackagingIndividual blister pack with Tyvek® breathable barrier, peelable for sterile field access
Shelf Life5 years when stored at 5–35°C, relative humidity < 60%, away from direct sunlight
Product Advantages
1. Exceptional Biocompatibility for Extended Indwelling Use
The medical-grade LSR matrix is inherently inert, with no leachable plasticizers or latex proteins that trigger allergic reactions or mucosal inflammation. Unlike PVC catheters, which can stiffen at body temperature and cause urethral irritation, LSR retains its elasticity at 37°C, conforming gently to urethral anatomy to reduce patient discomfort during indwelling use of up to 90 days, per clinical guidelines.
2. Low Biofilm Adhesion Reduces CAUTI Risk
The ultra-smooth <0.8μm surface finish and hydrophobic nature of LSR reduce bacterial adhesion by 47% compared to latex catheters, according to independent in vitro testing. The one-piece co-molded construction eliminates bonded joints and gaps where biofilm typically colonizes, lowering CAUTI incidence by up to 32% in 30-day indwelling clinical trials, reducing antibiotic use and hospital readmission rates.
3. Reliable Mechanical Performance in Clinical Environments
The kink-resistant shaft formulation maintains unobstructed urine flow even when twisted or compressed during patient movement, eliminating the need for frequent catheter repositioning. The high-strength silicone balloon maintains constant inflation pressure for 30+ days without deflation or rupture, reducing the risk of accidental catheter expulsion and associated urethral trauma.
4. Clinician-Friendly Design for Ease of Use
Color-coded Luer connectors match French (Fr) size standards for fast, error-free sizing identification, and the ergonomic inflation port is compatible with all standard syringe sizes, with a positive click feedback to confirm proper balloon inflation. The atraumatic rounded tip and lubricious surface reduce insertion force by 28% compared to PVC catheters, minimizing patient discomfort during insertion and withdrawal.
Applications
This catheter is designed for use across acute, post-acute, and long-term care settings:
- Acute Care Hospitals: Perioperative urinary management for surgical patients, critical care urinary output monitoring, and emergency department urinary retention intervention. The 12–16Fr sizes are recommended for adult general use, while 18–24Fr sizes are optimized for patients with hematuria or sediment in urine to prevent lumen clogging.
- Long-Term Care Facilities: Extended indwelling use for patients with neurogenic bladder, mobility impairment, or end-of-life care. The LSR material’s low irritation profile reduces the frequency of catheter changes, lowering care burden and patient discomfort.
- Pediatric and Obstetric Care: Latex-free formulation eliminates allergy risks for vulnerable patient populations. 6–10Fr pediatric sizes are available with smaller balloons to minimize bladder wall irritation, while 14–16Fr sizes are used for post-partum urinary management.
- Home Care Settings: Disposable intermittent catheters are designed for patient self-insertion, with a smooth, easy-to-grip shaft and pre-lubricated option for at-home urinary management for patients with chronic urinary retention.
Selection Guide
Hardness Selection
- 50 Shore A (Standard): Recommended for most adult patients, balancing flexibility for atraumatic insertion and structural rigidity to prevent kinking during indwelling use.
- 40 Shore A (Soft): Optimized for pediatric patients, geriatric patients with fragile urethral mucosa, or patients with a history of urethral stricture, to minimize irritation during extended use.
- 60 Shore A (Rigid): Designed for patients with urethral obstruction or difficult insertion cases, providing extra structural support to navigate strictures without kinking.
Size Specifications
Catheters are labeled by French (Fr) size, with 1Fr = 0.33mm outer diameter:
Fr SizeOuter DiameterRecommended Use Case
6–10Fr2.0–3.3mmPediatric patients, infants, and patients with very narrow urethras
12–16Fr4.0–5.3mmStandard adult use for general surgical, critical care, and long-term care
18–24Fr6.0–8.0mmPatients with hematuria, urinary sediment, or bladder outlet obstruction to prevent lumen clogging
All sizes are available with 5mL (standard) or 30mL (high-capacity) balloons; 30mL balloons are recommended for post-prostatectomy patients or patients with increased risk of catheter expulsion.
Material Grade
- Standard Medical Grade: Compliant with USP Class VI and ISO 10993, suitable for all general clinical use cases with indwelling time up to 30 days.
- Antimicrobial-Coated Grade: LSR surface impregnated with silver ion coating that releases slowly over 30 days, reducing bacterial adhesion by an additional 60% for high-risk patients (immunocompromised, ICU patients, history of recurrent CAUTI).
- Radiopaque Grade: LSR blended with 20% barium sulfate for full X-ray visibility, recommended for use during urological procedures where catheter positioning needs to be confirmed via imaging.
Quality Assurance
All Medical Grade Liquid Silicone Urinary Catheters are manufactured under a strict ISO 13485:2016 quality management system, with 100% in-process and final inspection to eliminate defects:
- In-Process Testing: Every production batch undergoes biocompatibility screening, dimensional accuracy inspection (±0.05mm tolerance for outer diameter and lumen size), burst pressure testing, and balloon inflation retention testing before moving to packaging.
- Final Product Validation: Each unit is individually inspected for surface defects, lumen patency, and connector integrity before sterilization. Post-sterilization testing confirms EO residual levels < 4 μg/g, well below the ISO 10993-7 limit for permanent contact devices.
- Certifications: The product carries CE marking (EU MDR 2017/745 Class IIa), FDA 510(k) clearance, and CFDA approval for global clinical use.
- Warranty: All catheters are guaranteed to be free of material and manufacturing defects for the full 5-year shelf life. In the event of a product quality issue, a full traceability system is in place to track every unit back to its raw material batch, production line, and sterilization cycle for fast root-cause analysis and corrective action.
