Comprehensive evaluation of steerable introducer sheaths: Quality control, In-vitro performance, and safety assessment

Background: Steerable Introducer Sheaths are pivotal in minimally invasive procedures, yet existing In-vitro testing methods often fail to replicate complex human vasculature adequately, leading to insufficient evaluation of device performance under clinically relevant conditions. Current methodologies lack standardized approaches to simultaneously assess critical parameters such as kink resistance, steerability, and hydrophilic coating durability in anatomy simulation models. This limitation risks incomplete safety and efficacy assessments prior to clinical use.

Objective: The below-stated research reports the requirement for performing an In-vitro simulation test procedure to determine the performance and safety of the device before it can be used in a clinical Studies. This study addresses this gap by developing a novel In-vitro simulation test method using silicone-based anatomy simulation models that mimic human vasculature’s mechanical and geometric complexities. The proposed method aims to comprehensively evaluate device safety and performance, ensuring reliable pre-clinical validation.

Methods: The study utilized an In-vitro anatomy simulation model to assess the performance of the Steerable Introducer Sheath in navigating challenging pathways. A silicone-based anatomical model replicated human vasculature, enabling the evaluation of key parameters such as flexibility, kink resistance, pushability, and the effectiveness of the hydrophilic coating. Post-testing analysis confirmed the structural integrity and durability of the sheath after repeated use. Results demonstrated enhanced maneuverability, reduced procedural time, and improved patient safety, highlighting the sheath's efficiency in minimally invasive procedures that closely represented real anatomical structures, ensuring accurate and reliable performance assessments.

Results: The results exhibited improved maneuverability, strength of the structure, and frictional reduction, confirming the device to negotiate tortuous pathways with less resistance. Accurate fluoroscopic imaging was ensured by the radiopaque markers, and unobstructed introducer sheath passage by the PTFE inner lining. 

Conclusion: The research confirms the Steerable Introducer Sheath to be a very reliable minimally invasive device that improves procedural efficacy and patient safety. The Steerable Introducer Sheath was highly maneuverable, resistant to kinking, and procedurally efficacious during In-vitro examinations. Its hydrophilic coating reduced friction, and radiopaque markers ensured precise placement. The device is useful for minimally invasive procedures by improving catheter control, reducing complications, and optimizing patient outcomes, and it merits further clinical confirmation for broader use.