Spherically Compressed Prosthetic Heart Valve Delivery
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Solution Overview
Problem
Conventional transcatheter heart valve delivery systems face challenges in navigating tortuous paths and anatomical constraints, particularly due to the radial forces exerted by self-expanding stent frames, which require robust yet flexible delivery devices and can be difficult to deploy in limited spaces, such as the mitral valve via trans-septal approach.
Innovation Solution
The method involves crimping a stented prosthetic heart valve using spherical compression, reducing the profile length of the delivery device, allowing for a more compact and flexible deployment system that can navigate complex anatomical paths, using tools like collapsible bags or meshes with drawstrings to compress the valve into a spherical shape, enabling easier access and deployment at target sites.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Strength
If a self-expanding stent frame is used to provide fixation at the native valve site, then the valve fixation strength is improved, but the delivery device must resist significant radial forces and the profile length increases
Solution Approach 1:
The stent frame is compressed into a spherical or substantially spherical shape during delivery, rather than being constrained in an elongated configuration. This spherical compression reduces the profile length of the delivery device while maintaining the structural integrity needed for fixation upon deployment
Solution Approach 2:
The stent frame undergoes a transformation from an expanded state with high radial strength for fixation to a compressed spherical state for delivery. The material properties and geometric parameters are optimized to allow reversible transformation between these states, enabling both reduced profile length and adequate fixation strength
2Strength
If the outer sheath capsule is made robust to resist radial forces from the stent frame, then the structural strength is improved, but the flexibility to navigate tortuous paths deteriorates
Solution Approach 1:
The spherical compression of the stent frame within the capsule creates a more uniform distribution of radial forces, reducing peak stress concentrations. This allows the capsule to maintain adequate structural strength while using lighter, more flexible materials that can better navigate tortuous anatomical paths
3Ease of operation
If the stent frame is compressed to a smaller size for delivery through tight spaces, then the ease of delivery is improved, but the ability to maintain complex shape for fixation deteriorates
Solution Approach 1:
The stent frame is designed with a spherical compression geometry that preserves the essential structural features needed for fixation while minimizing the overall dimensions. The spherical shape allows uniform compression that maintains the integrity of the stent frame's complex geometry, enabling easy delivery through tight spaces while retaining fixation capability
Solution Approach 2:
The stent frame is pre-compressed into a spherical configuration before delivery, preparing it in advance for navigation through tortuous paths and tight spaces. Upon deployment, the pre-stored elastic energy and structural memory enable the frame to automatically expand into its fixation shape without requiring additional shaping operations
Data Source
AI summary
Stented prosthetic heart valve crimping tools and methods, and transcatheter delivery systems for delivering a crimped prosthetic heart valve. Methods of the present disclosure include crimping or compressing a stented prosthetic heart valve via spherical compression to a spherically compressed shape, and then delivering the so-shaped prosthesis to a target site. Delivery systems carrying a spherically-compressed prosthesis have a reduced length profile as compared to conventional, elongated configurations, providing increased maneuverability and positioning.