Deflectable Medical Device Shaft Coextrusion and Position Sensing
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Solution Overview
Problem
Current medical devices, such as steerable sheaths and catheter-introducers, face challenges in manufacturability due to manual processing requirements and lack of visualization capabilities, which increase production time and complexity, and hinder precise positioning during medical procedures.
Innovation Solution
The development of a medical device with a shaft comprising an inner liner, a spiral patterned polymeric material, and an outer layer, which includes electrodes for improved visualization and reduced manual processing, allowing for automated guidance systems to determine the device's position and monitor electrophysiological data.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If manual bonding of spaghetti tubes to inner liner is used, then deflectability is achieved, but manufacturing time and expense increase
Solution Approach 1:
The patent combines the deflectable element and the inner liner into a single coextruded component, eliminating the separate manual bonding step. The inner liner is coextruded with an integrated deflectable element (spaghetti tube) already incorporated, creating one unified piece that is then heat-set to achieve the desired deflection characteristics. This merging of components directly resolves the contradiction by maintaining deflectability while eliminating manual assembly time.
Solution Approach 2:
The deflectable element is pre-formed and integrated into the inner liner during the coextrusion process before the heat-setting step. The spaghetti tube is already in place within the inner liner structure before any deflection operations, allowing subsequent heat-setting to achieve the desired deflection without requiring manual positioning or bonding steps during assembly.
2Strength
If braided wire assembly is used, then torque transmission is improved, but manual processing requirements increase
Solution Approach 1:
The patent integrates the torque transmission function directly into the coextruded inner liner structure itself, rather than requiring a separate braided wire assembly. The inner liner is formed with embedded reinforcing elements or structural features during coextrusion that provide torque transmission capability, eliminating the need for manual assembly of braided wire components.
3Difficulty of detecting and measuring
If fluoroscopy is used for visualization, then position detection is achieved, but ionizing radiation exposure increases
Solution Approach 1:
The patent incorporates radiopaque materials or markers into the deflectable element or inner liner structure that can be visualized through non-ionizing imaging modalities. These embedded features change or reflect electromagnetic properties that allow detection by automated guidance systems using non-ionizing radiation, thereby maintaining position detection capability while eliminating harmful ionizing radiation exposure.
Data Source
AI summary
Medical devices, methods of manufacturing medical devices, and systems comprising medical devices are provided. The medical device comprises a shaft having a proximal end, a distal end, and a major lumen disposed therein extending between the proximal end and the distal end. The major lumen is configured to receive a second medical device therein. The shaft comprises an inner liner, a generally planar element wrapped in a spiral pattern about the outer surface of the inner liner, and an outer layer. The generally planar element has a longitudinal axis and a plurality of longitudinally extending ribs and comprises a polymeric material.