Atraumatic Delivery Capsule for Mitral Valve Anchoring
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Solution Overview
Problem
Current prosthetic heart valve replacement technologies face challenges in addressing the unique anatomical complexities of the mitral valve, including its non-circular shape, lack of symmetry, and radial support, which leads to issues with proper fitting and function of prosthetic devices, resulting in potential backflow and complications during deployment and anchoring.
Innovation Solution
The development of hydraulic systems for delivering prosthetic heart valve devices using a catheter-based approach with an expandable atraumatic member and a delivery capsule that can transition between containment and deployment configurations, allowing for controlled deployment and repositioning or removal of the device, and atraumatic withdrawal to prevent tissue damage.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Object-affected harmful factors
If a catheter-based approach is used to deliver prosthetic heart valve devices, then the invasiveness of the procedure is reduced, but the ability to properly fit and anchor the device in the mitral valve is compromised due to anatomical complexities
Solution Approach 1:
The delivery system employs dynamic components including an expandable frame that transitions from a compressed delivery state to an expanded deployed state, and a movable distal portion that can be repositioned along the catheter shaft. This dynamic design allows the system to adapt to the complex mitral valve anatomy while maintaining secure anchoring through the expandable structure that engages with the valve annulus.
Solution Approach 2:
The prosthetic heart valve device is segmented into multiple functional components: a delivery catheter with movable distal portion, an expandable frame with struts, a prosthetic valve assembly, and an atraumatic member. This segmentation allows each component to perform its specific function independently while working together as an integrated system, enabling both minimally invasive delivery and reliable anchoring.
2Manufacturing precision
If the mitral valve's non-circular shape and lack of symmetry are accommodated, then proper device fitting is achieved, but the device complexity increases
Solution Approach 1:
The expandable frame is designed with asymmetric characteristics to match the non-circular shape and lack of symmetry of the mitral valve annulus. The struts of the expandable frame can be configured in asymmetric patterns that conform to the specific anatomical variations of the mitral valve, allowing proper device fitting while maintaining a manageable structural design through modular strut configurations.
Solution Approach 2:
Different portions of the expandable frame and anchoring structures have locally optimized properties to address specific anatomical features of the mitral valve. The distal portion of the catheter and corresponding portions of the expandable frame are designed with specific geometries that match local anatomical variations, allowing precise fitting without requiring complete redesign of the entire device.
3Reliability
If the prosthetic valve is securely anchored in the mitral valve, then backflow is prevented, but tissue damage may occur during deployment and anchoring
Solution Approach 1:
The expandable frame design converts the potential harm of radial expansion forces into a beneficial anchoring mechanism. As the frame expands, it gently engages with the mitral valve annulus and surrounding tissue, using the natural anatomical structures to provide secure anchoring without causing significant tissue damage. The atraumatic member further protects tissue during the expansion and anchoring process.
Solution Approach 2:
The delivery system incorporates an atraumatic member that provides protective cushioning during the deployment and anchoring process. This member is positioned to protect surrounding tissues from the expandable frame and anchoring structures as they engage with the mitral valve, preventing tissue damage while ensuring secure anchoring for backflow prevention.
4Adaptability or versatility
If the delivery system allows for repositioning or removal of the device, then procedural flexibility is improved, but the device complexity and difficulty of operation increase
Solution Approach 1:
The delivery system employs dynamic components including an expandable frame that transitions from a compressed delivery state to an expanded deployed state, and a movable distal portion that can be repositioned along the catheter shaft. This dynamic design allows the system to adapt to the complex mitral valve anatomy while maintaining secure anchoring through the expandable structure that engages with the valve annulus.
Solution Approach 2:
The movable distal portion acts as an intermediary between the operator and the prosthetic valve device. It provides a controlled interface that allows repositioning and removal operations to be performed through simple proximal manipulation of the catheter, translating complex distal adjustments into simple proximal movements and reducing operational complexity.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
Enables precise and effective delivery and positioning of prosthetic heart valve devices within the mitral valve, reducing the risk of backflow and tissue damage, while allowing for repositioning or removal of the device, thus improving the success rate of mitral valve replacement procedures.
Implementation Method 1
hydraulic systems for delivering prosthetic heart valve devices
Implementation Method 2
the expandable atraumatic member is configured to expand radially outward in the deployment configuration such that at least a peripheral portion of the expandable atraumatic member extends laterally outward beyond the proximal rim of the housing
Data Source
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AI summary
Systems for delivering prosthetic heart valve devices can include, for example, an elongated catheter body, a deliver capsule carried by the catheter body, and an expandable atraumatic member. The delivery capsule includes a platform and a housing having an outer wall and a proximal rim, and the platform is configured to be releasably coupled to a prosthetic heart valve device. The housing is configured to slide along the platform from a containment configuration to a deployment configuration. The expandable atraumatic member has an an atraumatic surface and a peripheral portion. The atraumatic member has a compacted configuration and an expanded configuration in which the peripheral portion extends laterally outward over the proximal rim of the housing to protect tissue of the heart and the vasculature from potentially being damaged by the proximal rim of the housing as the delivery system is withdrawn in a proximal direction through the patient.