Peelable Advancer for Catheter Stiffness and Removal
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Solution Overview
Problem
Current delivery systems for medical devices, such as transcatheter heart valve prostheses, face challenges in navigating the vasculature due to the need for both flexibility and stiffness, particularly when advancing through introducers and navigating twists and turns within the vasculature.
Innovation Solution
A peelable advancer system is designed to be mounted on a delivery catheter, providing axial stiffness during advancement through an introducer and then removable once the distal portion of the catheter is past the introducer, featuring a shaft with split lines and a hub with parting lines to facilitate peeling off from the catheter and introducer.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Strength
If the catheter is made stiff to push through the introducer and access vessel, then the stiffness for advancing through introducer is improved, but the flexibility for navigating twists and turns of the vasculature deteriorates
Solution Approach 1:
The advancer is divided into modular components including a shaft, hub, and optional balloon, with split lines allowing the shaft to be divided into segments. This segmentation enables the advancer to provide stiffness where needed during advancement while allowing flexibility in other portions for navigating vasculature twists and turns.
Solution Approach 2:
The advancer transitions from a rigid structure during advancement to a flexible, peelable structure after delivery. The split lines enable the shaft to separate into segments that can flex and adapt to vasculature geometry, while still providing the necessary pushing force through the introducer during the advancement phase.
2Strength
If the advancer remains on the delivery catheter after advancement, then the stiffness support is maintained, but the trauma to vessel tissue and procedural complexity increases
Solution Approach 1:
The advancer is designed to be extracted or removed from the delivery catheter after it has served its purpose of providing stiffness during advancement. The split lines in the shaft and parting lines in the hub enable the advancer to be peeled off and discarded, eliminating potential trauma to vessel tissue from a foreign object remaining in place.
Solution Approach 2:
The advancer is designed as a disposable component that is discarded after use. The peelable design with split lines and parting lines facilitates easy removal and disposal of the advancer after it has completed its function of supporting the delivery catheter through the introducer and into the vasculature.
Data Source
AI summary
An advancer includes an advancer hub and an advancer shaft extending distally from the advancer hub. The advancer shaft includes a proximal end, a distal end, and a lumen extending from the proximal end to the distal end. The advancer shaft is configured to be disposed around an outer shaft of a delivery catheter, and includes a split line configured to enable splitting the shaft to enable removal of the shaft from the outer shaft. The advancer hub configured to be mounted on the outer shaft of the delivery catheter, and includes a parting line to enable splitting of the advancer hub.