Heart Valve Delivery Catheter for Commissural Rotational Alignment
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Solution Overview
Problem
Existing medical devices for delivering replacement heart valves are invasive and require significant recovery times, posing challenges in efficiently aligning the commissural posts of the replacement valve with the native heart valve during procedures like TAVI or TAVR.
Innovation Solution
A system comprising a delivery device with an inner shaft and orientation lumen, featuring an orientation mandrel and mechanism to apply compressive or tensile force, allowing precise rotation and alignment of the replacement heart valve implant within the native heart valve, utilizing a pre-formed curve to conform to the aortic arch.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If traditional invasive surgical methods are used for heart valve replacement, then reliable valve replacement is achieved, but patient recovery time increases and procedural complexity increases
Solution Approach 1:
The patent replaces traditional open-heart surgical mechanics with a catheter-based delivery system that uses endovascular access. The replacement valve is delivered through a catheter inserted via minimally invasive access points (femoral artery, subclavian artery, or jugular vein), eliminating the need for sternotomy and cardiopulmonary bypass, thereby significantly reducing recovery time while maintaining valve replacement reliability
Solution Approach 2:
The delivery catheter employs flexible shafts and sheaths that can navigate through the vascular system to reach the heart valve. The catheter's flexible construction allows it to conform to the aortic arch and deliver the valve implant precisely to the target location through minimally invasive access points, reducing procedural trauma and recovery time
2Manufacturing precision
If precise alignment of commissural posts with native heart valve is achieved, then valve function is optimized, but device complexity increases
Solution Approach 1:
The patent introduces an orientation mandrel as an intermediary component within the delivery catheter system. This mandrel provides a reference axis that facilitates alignment of the replacement valve's commissural posts with the native heart valve's commissures during deployment. The mandrel acts as a mechanical guide that simplifies the alignment process without requiring complex active control systems
Solution Approach 2:
The delivery catheter incorporates a pre-formed curve or bend that conforms to the anatomy of the aortic arch. This curved configuration positions the distal end of the catheter (where the valve is deployed) in the correct spatial orientation relative to the native valve, facilitating automatic alignment of commissural structures without requiring complex active positioning mechanisms
3Ease of operation
If the delivery device navigates through the aortic arch, then access to the heart valve is achieved, but catheter orientation control becomes difficult
Solution Approach 1:
The delivery catheter is pre-formed with a specific curve or bend that matches the anatomy of the aortic arch. This preliminary configuration allows the catheter to naturally navigate through the aortic arch and position itself correctly at the target valve site, eliminating the need for complex real-time manipulation during the procedure and reducing operator skill requirements
Data Source
AI summary
A system for delivering a replacement heart valve implant may include the implant including an expandable framework and leaflets coupled to the framework, and a delivery device including a handle and an elongate catheter extending from the handle. The catheter includes an outer sheath and an inner shaft movably disposed within the outer sheath. The implant is releasably coupled to the inner shaft. The inner shaft includes an orientation lumen extending longitudinally within the inner shaft, the orientation lumen being offset from a central guidewire lumen of the inner shaft. The delivery device includes an orientation mandrel disposed within the orientation lumen, the orientation mandrel extending distally from the handle to a distal end proximate a closed distal end of the orientation lumen. The orientation mandrel is operably coupled to an orientation mechanism of the handle configured to apply compressive force or tensile force to the orientation mandrel.