Medical Device Delivery System With Inner Member Centering
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Solution Overview
Problem
Existing medical device delivery systems face challenges in centering vascular valves during deployment, interfering with radiopaque marker visualization, and accommodating lyophilized tissue hydration, particularly for vascular valves requiring precise placement and hydration before deployment.
Innovation Solution
A medical device delivery system featuring a catheter with an inner member that extends beyond the catheter tip to center the valve, includes a radiolucent region for clear visualization, and a hydration lumen for hydrating lyophilized tissue, ensuring accurate positioning and hydration of the valve during deployment.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Manufacturing precision
If an inner member is extended beyond the catheter tip to center the valve during deployment, then valve centering precision is improved, but the device complexity increases
Solution Approach 1:
The inner member is nested within the catheter structure, with the distal tip portion of the inner member extending beyond the catheter distal end. This nested configuration allows the inner member to provide centering function while being contained within the overall catheter assembly during delivery, resolving the contradiction between improved centering precision and device complexity.
2Measurement precision
If a radiolucent region is incorporated into the inner member for clear visualization, then radiopaque marker visualization is improved, but the device complexity increases
Solution Approach 1:
The inner member is constructed with different radiopacity characteristics at different locations: the distal tip portion is radiolucent to allow clear visualization of radiopaque markers on the valve, while other portions may have different radiopacity properties. This local differentiation of material properties improves marker visualization without requiring complete redesign of the entire device structure.
3Adaptability or versatility
If a hydration lumen is added to hydrate lyophilized tissue, then tissue hydration capability is improved, but the device complexity increases
Solution Approach 1:
The inner member serves multiple functions: it provides structural support for valve centering, enables radiopaque marker visualization through its radiolucent properties, and facilitates tissue hydration through the hydration lumen. By integrating these multiple functions into a single component, the patent reduces overall device complexity while improving adaptability for valves containing lyophilized tissue.
4Manufacturing precision
If the inner member distal tip portion has maximum diameter approximately equal to catheter diameter, then valve centering is improved, but the device difficulty of operation increases
Solution Approach 1:
The inner member is designed with a distal tip portion that can be dynamically positioned relative to the catheter. The ability to extend the distal tip beyond the catheter end and the tapered configuration allow the operator to manipulate the device easily during delivery while maintaining precise centering capability when needed, resolving the contradiction between centering accuracy and ease of operation.
Data Source
AI summary
A delivery system (10) for implanting a medical device (30) such as a venous valve into the vasculature of a patient. The delivery system includes a delivery catheter (11) having a device-containing portion (15) adjacent to the distal end (14) thereof, and an inner member (16) extending through the catheter and beyond the distal end thereof, to an atraumatic distal tip portion (17) forward of the catheter distal end. The inner member extends through the medical device in the device-containing region, includes a proximal portion (18) with a sufficiently large diameter to prevent longitudinal movement of the device as the catheter is retracted during deployment, and centers the device upon release from the distal catheter end during deployment.


