Actuatable Arm Prosthetic Valve for Aortic Leaflet Grasping
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Solution Overview
Problem
Current prosthetic heart valves face challenges such as perivalvular leaks, device migration, restricted blood flow, and the need for ongoing blood thinner use due to their design, which lacks natural hemodynamics and is prone to complications like tissue trauma and arrhythmias during transcatheter procedures.
Innovation Solution
The development of prosthetic heart valves with actuatable arms that can securely grasp native leaflets, modular replaceable leaflets, and minimal exposed metal surfaces, allowing for smaller device sizes, improved blood flow, and reduced trauma during implantation, along with optical visualization and adjustable annular repair mechanisms.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If prosthetic valves are made highly rigid and larger in size to prevent migration, then device stability is improved, but tissue trauma and restricted blood flow increase
Solution Approach 1:
The device is divided into separate functional components: a delivery catheter with cutting elements for removing failed valve leaflets, and a replacement valve assembly with grasping arms. This segmentation allows the rigid valve body to be delivered through a flexible catheter and deployed without causing tissue trauma, as the cutting and grasping functions are separated from the valve structure itself.
Solution Approach 2:
The delivery catheter acts as an intermediary tool that enables the rigid valve to be inserted and positioned without direct contact with the aortic wall. The catheter performs the traumatic cutting and grasping functions, while the valve itself remains rigid only for structural support, avoiding direct trauma to surrounding tissues.
2Reliability
If prosthetic valves are made larger in size to prevent migration, then device stability is improved, but restricted blood flow and ischemia increase
Solution Approach 1:
The failed valve leaflets are cut and removed before the replacement valve is deployed. This preliminary action creates space and eliminates obstruction to blood flow, allowing the new valve to be smaller while still maintaining stability through the grasping arm mechanism.
Solution Approach 2:
The failed valve leaflets are extracted and removed from the aortic valve structure. This extraction eliminates the source of restricted blood flow and allows the replacement valve to function without causing ischemia, while still providing stability through the grasping arms that secure the valve to the annulus.
3Measurement precision
If manual manipulation of prosthetic valve is required to engage leaflets, then positioning accuracy is improved, but procedure complexity and time increase
Solution Approach 1:
The grasping arms are designed to automatically engage with and secure the valve leaflets upon deployment. The arms are actuated by the delivery system itself, eliminating the need for manual manipulation by the operator. This self-service mechanism maintains positioning accuracy while significantly reducing procedure complexity.
Solution Approach 2:
Manual mechanical manipulation by the operator is replaced with an automated mechanical actuation system integrated into the delivery catheter. The grasping arms are actuated by wires or mechanisms within the catheter, transforming the positioning process from manual to automated, thereby reducing procedure complexity while maintaining precision.
4Strength
If exposed metal surfaces are present in mechanical valves, then structural strength is improved, but need for ongoing blood thinner use increases
Solution Approach 1:
The valve structure uses composite materials combining metal framework for structural strength with polymer or tissue-coated surfaces. The metal provides the necessary mechanical strength, while the polymer or tissue coatings eliminate exposed metal surfaces that would otherwise promote thrombus formation, thereby eliminating the need for ongoing blood thinner use.
Solution Approach 2:
The valve incorporates a biodegradable or resorbable coating that temporarily protects the metal surface during the healing period. This coating degrades over time as the tissue integrates with the valve, providing the necessary strength while preventing thrombus formation during the critical period, and eliminating the need for long-term blood thinner therapy.
Data Source
AI summary
The present disclosure relates generally to the systems, devices and methods for devices, and systems to treat aortic heart valve. The patent describes prosthetic valve embodiments with actuatable arms, which grasp onto leaflets and significantly reduce risk of device migration and device size. The patent describes methods and embodiment to cut the diseased leaflets prior to prosthetic valve implantation, optionally under optical visualization. The patent describes prosthetic valve devices with reduced bare metal, valve housing units, and replaceable prosthetic leaflets. The patent describes atraumatic annular repair method and embodiments.