Design, Manufacturing and Physicochemical Validation of a New Biodegradable Intraurethral Device for Post-Operative...

Area of Science:

• Biomaterials Science
• Medical Device Engineering
• Urology

Background:

• Urethral stricture treatment often involves Foley catheters, leading to complications like urinary tract infections (UTIs) and requiring a second intervention for removal.
• Current catheterization methods pose risks including external contamination and patient discomfort.

Purpose of the Study:

• To develop and characterize a completely biodegradable intraurethral device (BID) as a superior alternative to traditional urinary catheterization.
• To evaluate the safety, efficacy, and degradation profile of the BID for post-operative urethral stricture management.

Main Methods:

• Synthesized a poly(d,l-lactide-co-ε-caprolactone) copolymer using a bismuth-based catalyst for the BID.
• Manufactured the BID via injection molding, adhering to ISO 13485 standards and sterilizing with e-beam irradiation (ISO 11137).
• Conducted comprehensive physico-chemical characterization (ISO 10993), degradation studies (90 days), and mechanical testing under simulated physiological conditions.

Main Results:

• The BID demonstrated a scalable synthesis with reproducible composition, high molecular weight, and safe metal content.
• Physico-chemical analysis confirmed consistent dimensions and no adverse effects post-irradiation.
• The BID showed complete hydrolytic degradation within 90 days, aligning with tissue regeneration timelines.
• Mechanical tests confirmed device stability up to 28 days and no migration at high urine flow rates (1500 mL/min).

Conclusions:

• The developed biodegradable intraurethral device (BID) presents a viable and safer alternative to Foley catheters for managing post-operative urethral stricture.
• BID effectively addresses limitations of current treatments by minimizing UTIs, preventing migration, and eliminating the need for secondary removal procedures.
• This innovation holds significant potential to improve patient outcomes and reduce healthcare burdens associated with urethral stricture management.