Mechanical Spring-Loaded Pinch Roller Device for Precision Guidewire Torque Transmission in Endovascular Procedures

Abstract

Endovascular procedures require controlled guidewire manipulation, however, current torque devices are often manual, causing inconsistent rotation, slippage, and operator fatigue [1]. There exists a clinical need for improved torque precision, reduced hand fatigue, and safer wire handling, as established via surgeon surveys and stakeholder interviews. More than a million endovascular procedures are performed annually, and the demand continues to grow for minimally invasive interventions [2]. The market opportunity favors affordable, ergonomic, single-use accessories that enhance workflow reliability. The mechanical spring-loaded roller torque device is designed to meet all the criteria that stakeholders have identified. Existing torque devices rely entirely on manual twisting, which leads to inconsistent torque transfer, wire slippage, and operator fatigue, increasing complications and risk. The design integrates a pinch-roller assembly that firmly grips the guidewire, while the wind-up torsion spring mechanism delivers a precise rotation. The external housing was redesigned to have a knob that winds the torsion spring and assists with the guidewire angle. The push button releases the stored spring energy to generate consistent torque output. This system enhances control and consistency while reducing hand fatigue. Technical specifications were defined by key clinical requirements by ensuring torque transfer to be ≥2.0 N.cm and spring stiffness between 0.05 – 0.08 N · cm/degrees. Additionally, the pinch-roller friction coefficient must be ≥ 0.8, while the 9 – 11 cm casing supports one-handed ergonomic use. Design for manufacturing enables low-cost, high-volume production using injection-molded components and standardized stainless-steel springs. The estimated per-unit production cost is $4–$7, sponsoring a competitive disposable or limited-reuse product model. Medical-grade ABS plastic and silicone were selected for durability, biocompatibility, and safety, especially with autoclave sterilization. These parameters ensure reliable performance and alignment with ISO 11070, ISO 14971, and FDA 510(k) regulations compliance [3][4][5].

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