Expandable Heart Valve Commissure Support for Secure Anchoring
Find Innovative SolutionsGenerate Solutions
Solution Overview
Problem
Existing medical devices for replacing heart valves are often invasive and lack efficient mechanisms for secure anchoring and sealing, leading to challenges in treating defects such as regurgitation and stenosis.
Innovation Solution
A replacement heart valve implant with an expandable anchor member and circumferential support member, featuring a plurality of crowns and valve leaflets, which shifts between delivery and deployed configurations for secure anchoring and sealing within the native heart valve, allowing for minimally invasive percutaneous delivery.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If traditional surgical methods are used for heart valve replacement, then secure anchoring and sealing can be achieved, but the procedure becomes highly invasive requiring open surgery
Solution Approach 1:
The anchor member transitions from a compressed delivery configuration to an expanded deployed configuration, enabling dynamic adaptation to the native valve anatomy. This dynamic expansion allows the device to achieve secure anchoring without requiring open surgical incisions, as the expandable structure can be delivered through a catheter and then expanded in situ to engage with the native valve tissue
Solution Approach 2:
The replaceable valve is nested within the expandable anchor member, which itself is delivered through a delivery catheter. This nested configuration allows the entire valve replacement system to be delivered percutaneously through a minimally invasive access point, while the anchor member provides the secure anchoring function traditionally requiring open surgery
2Reliability
If an expandable anchor member with multiple components is used, then secure anchoring is achieved, but the device complexity increases
Solution Approach 1:
The anchor member and valve are combined into a single integrated replaceable valve assembly, where the valve is secured to the anchor member. This merging of components simplifies the overall device structure compared to separate anchoring and valve components, while still achieving secure anchoring through the integrated design
Solution Approach 2:
The anchor member is segmented into multiple crowns or lobes that can independently engage with the native valve anatomy. This segmentation allows each segment to contribute to the anchoring function, distributing the mechanical load and improving reliability while maintaining a relatively simple overall structure
3Reliability
If valve leaflets are movable within the anchor member lumen, then proper valve function is achieved, but the manufacturing precision requirements increase
Solution Approach 1:
The valve leaflets are designed to be movable within the anchor member lumen, transitioning from a closed compressed state during delivery to an open expanded state during deployment. This dynamic design allows the leaflets to achieve proper valve function with natural movement rather than requiring precise pre-positioning, reducing manufacturing precision requirements
Solution Approach 2:
The valve leaflets utilize the expansion force of the anchor member to automatically open and assume their functional position. This self-service mechanism eliminates the need for complex positioning mechanisms or high-precision pre-positioning during manufacturing, as the leaflets naturally find their correct orientation through the expansion process
Data Source
Figure 1
Figure 2
Figure 3
AI summary
A replacement heart valve implant defining a central longitudinal axis extending from an upstream end to a downstream end may include an expandable anchor member configured to shift between a delivery configuration and a deployed configuration, a circumferential support member distinct from and attached to the expandable anchor member, at least a portion of the circumferential support member extending downstream of the expandable anchor member, and a plurality of valve leaflets secured to the expandable anchor member. The plurality of valve leaflets may include a valve leaflet commissure movable from a first longitudinal position relative to the downstream end in the delivery configuration to a second longitudinal position relative to the downstream end in the deployed configuration.