Catheter Deflection via Compressive Sheath Tip Interaction
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Solution Overview
Problem
Existing delivery catheters for prosthetic heart valves face challenges in navigating tortuous anatomy and accurately steering through the vasculature, particularly due to the complexity and additional components required for deflection mechanisms.
Innovation Solution
The use of a compressive force mechanism within the catheter design, where a sheath component advances distally against a tip with a proximally-extending projection, or an inner component with a prosthesis retainer, to achieve deflection without additional pull wires or components.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If pull wire mechanisms are used for catheter deflection, then the catheter can be steered through tortuous anatomy, but the device complexity and catheter profile increase
Solution Approach 1:
The patent removes the pull wire mechanism entirely from the catheter structure. Instead of adding complex deflection components, the invention uses the natural flexibility and memory properties of the catheter material itself to achieve steering through tortuous anatomy, thereby maintaining operational capability while eliminating the complexity and profile increase associated with pull wires
Solution Approach 2:
The patent changes the physical parameters of the catheter by using shape memory materials that can alter their stiffness and flexibility characteristics. The catheter transitions between a flexible state for navigation and a stiffer state for prosthesis delivery, eliminating the need for additional mechanical deflection components while maintaining steering capability
2Ease of operation
If pull wire mechanisms are used for catheter deflection, then the catheter can be steered through tortuous anatomy, but the catheter profile increases
Solution Approach 1:
By completely removing the pull wire deflection mechanism, the patent eliminates the additional components that would increase the catheter's external profile. The steering function is achieved through the intrinsic properties of the catheter construction rather than added mechanical elements, thereby maintaining a compact delivery system
3Reliability
If traditional open-heart surgery is used for valve replacement, then the prosthetic valve can be reliably implanted, but patient trauma and surgical risks increase
Solution Approach 1:
The patent replaces the mechanical open-heart surgical system with a percutaneous transcatheter delivery system. The prosthetic valve is compressed into a catheter and delivered through the femoral artery to the aortic position, eliminating the need for sternotomy, cardiopulmonary bypass, and heart cessation while maintaining reliable valve implantation through controlled expansion at the target site
4Object-affected harmful factors
If percutaneous transcatheter techniques are used for valve delivery, then patient trauma is reduced, but navigation through tortuous anatomy becomes more difficult
Solution Approach 1:
The patent employs shape memory materials that can change their mechanical properties in response to temperature or other stimuli. The catheter and prosthetic valve assembly transitions from a flexible, compressible state during navigation to a rigid, expanded state at the implantation site, enabling easy passage through tortuous vasculature while maintaining structural integrity for reliable valve deployment
Data Source
AI summary
Distal tips for use with delivery catheters are disclosed that are configured to facilitate deflection of the catheters as they are advanced through the vasculature to a desired treatment site. Distal tips so configured realize one or more of the objectives of safer, more accurate steering of the catheter through the vasculature.