Cardiac Valve Delivery Sheath With Embolic Filter Stabilization
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Solution Overview
Problem
Current catheter-based cardiac valve procedures face challenges with precise positioning, stabilization, and embolic protection, leading to potential damage to adjacent structures and increased risk of complications such as stroke due to blood clotting and turbulence.
Innovation Solution
A medical device comprising an introducer sheath with an embolic protection unit and a locking system that stabilizes the catheter at the cardiac valve, using an expandable embolic protection filter to cover side branch vessels and minimize interference with blood flow.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Stability of the object's composition
If balloons are fully inflated throughout the procedure to stabilize the TAV position, then positioning stability is improved, but blood flow restriction increases and blood pressure rises upstream
Solution Approach 1:
The catheter system employs dynamic positioning elements that can be adjusted between inflated and deflated states. The balloons are inflated only when positioning is required, then deflated during the procedure to allow normal blood flow, and re-inflated only if repositioning is needed. This dynamic approach resolves the contradiction by providing stability only when necessary while minimizing blood flow restriction during the procedure.
Solution Approach 2:
The positioning balloons are inflated in periodic intervals rather than continuously - inflated for positioning, deflated for procedure execution, and re-inflated only if adjustment is needed. This periodic action reduces the cumulative time of blood flow restriction while maintaining positioning stability when required, directly addressing the harmful effects of continuous inflation.
2Measurement precision
If the catheter is advanced to achieve precise positioning at the cardiac valve, then positioning precision is improved, but the risk of misalignment and damage to adjacent structures increases
Solution Approach 1:
The system performs preliminary positioning actions using inflated balloons to establish the correct catheter position before advancing the medical device. The balloons are inflated at the target location to secure positioning, then the device is delivered, and finally the balloons are deflated and removed. This preliminary stabilization reduces the risk of misalignment damage during the procedure.
Solution Approach 2:
The positioning balloons serve as an intermediary element between the catheter and the cardiac valve. Instead of directly advancing the catheter tip to the valve (which risks misalignment), the balloons are inflated as a mediating structure to provide stable positioning, allowing precise device delivery without direct catheter-valve contact risks.
3Manufacturing precision
If the procedure duration is extended to ensure proper device delivery and positioning, then delivery accuracy is improved, but the risk of clotting and emboli formation increases
Solution Approach 1:
The system dynamically adjusts the procedural timeline by using quick-inflate/deflate balloon positioning that achieves stable catheter placement rapidly. This reduces the overall procedure duration compared to traditional methods, thereby minimizing the time window for clot formation and emboli risk while maintaining delivery accuracy through effective dynamic positioning.
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.