Cardiac Valve Introducer Sheath With Embolic Filter Stabilization
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Solution Overview
Problem
Current catheter-based cardiac valve procedures face challenges in maintaining precise positioning and stabilization due to cardiac movement, leading to potential damage to adjacent structures and increased risk of emboli, while existing stabilization methods like balloons restrict blood flow and increase pressure.
Innovation Solution
An introducer sheath with an embolic protection unit and a locking system that stabilizes the catheter at the cardiac valve, using an expandable filter to cover side branch vessels and minimize interference with blood flow, while allowing precise delivery of medical devices.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Stability of the object's composition
If balloons are inflated to stabilize the catheter position, then catheter stability is improved, but blood flow is restricted and pressure increases upstream
Solution Approach 1:
The patent removes the balloon stabilization mechanism from the system and replaces it with an embolic protection filter that provides stabilization without restricting blood flow. The filter is deployed from the catheter to engage with the aortic wall, providing anchoring force without occluding the vessel lumen.
Solution Approach 2:
The embolic protection filter serves as an intermediary element between the catheter and the aortic wall. Instead of using balloons that directly occlude the vessel, the filter engages with the aortic wall to provide stabilization while maintaining blood flow through the vessel lumen.
2Manufacturing precision
If the catheter is positioned precisely adjacent to the heart valve, then delivery accuracy is improved, but the risk of damaging adjacent cardiac structures increases due to cardiac movement
Solution Approach 1:
The patent deploys the embolic protection filter before delivering the medical device to the cardiac valve. The filter is positioned and stabilized first, creating a secure platform that prevents catheter movement during subsequent device delivery, thereby protecting adjacent structures from damage.
Solution Approach 2:
The embolic protection filter acts as a cushioning element that prevents direct contact between the catheter and adjacent cardiac structures. By engaging with the aortic wall beforehand, it creates a buffer zone that protects vulnerable structures during catheter manipulation and device delivery.
3Stability of the object's composition
If balloons are inflated throughout the procedure to maintain position, then catheter stabilization is improved, but the procedure time increases and patient exposure to restricted blood flow increases
Solution Approach 1:
The embolic protection filter is designed as a single-use, disposable component that is deployed briefly during the procedure to provide stabilization, then removed. This eliminates the need for prolonged balloon inflation and associated risks, as the filter provides sufficient stabilization only for the critical device delivery phase.
Solution Approach 2:
The embolic protection filter is deployed periodically only when needed for stabilization during device delivery, rather than being continuously inflated throughout the entire procedure. This periodic deployment reduces procedure time and patient exposure to stabilization mechanisms while maintaining catheter stability when required.
Data Source
AI summary
A catheter device for transvascular delivery of a medical device to a cardiac valve region of a patient comprises an elongate sheath with a first lumen, a distal end for positioning at a heart valve, a second lumen that extends parallel to or in the sheath, and an expandable embolic protection filter. The filter is arranged to extend from an orifice of the second lumen and, in the expanded, covers ostia of the side branch vessels in the aortic arch.