Prosthetic Heart Valve Anchors for Secure Annulus Fixation
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Solution Overview
Problem
Developing prosthetic heart valves that can be delivered minimally invasively and securely anchored to the native heart valve annulus without puncturing the surrounding tissue remains challenging.
Innovation Solution
The design of prosthetic heart valves with expandable frames and anchoring elements, including feet with specific geometries and angles, that load onto the fibrous annular region with controlled pressure to avoid puncturing, utilizing diamond-like structures for increased surface area and stability.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Object-affected harmful factors
If anchors are designed with larger contact surface area to distribute load and avoid puncturing, then tissue damage is reduced, but anchoring strength may be compromised
Solution Approach 1:
The anchor feet are designed with non-uniform geometry featuring a broader base and tapered distal end, creating varying contact surfaces at different locations. The broader proximal portion distributes load over larger annular tissue area, while the tapered distal end provides focused penetration capability, thereby achieving both tissue protection and secure anchoring
Solution Approach 2:
The anchor feet are pre-configured with specific geometric angles (30-60 degrees relative to longitudinal axis) and surface area distributions before deployment. This preliminary design ensures that upon expansion, the feet automatically assume optimal orientations for load distribution across the annular tissue, preventing puncture while maintaining anchoring strength without requiring additional control mechanisms
2Strength
If anchors are designed with smaller contact surface area to increase anchoring strength, then anchoring strength is improved, but tissue puncture risk increases
Solution Approach 1:
The anchor feet incorporate non-uniform geometry with strategically varied contact surface areas along their length. The proximal regions feature larger surface areas for load distribution, while distal regions have reduced surface areas for controlled tissue engagement, achieving both strong anchoring and puncture prevention through localized functional differentiation
Solution Approach 2:
The anchor feet are designed with asymmetric geometries where the proximal and distal ends have different dimensions and orientations. This asymmetry allows the feet to engage the annular tissue in a manner that maximizes anchoring strength at the engagement point while distributing compressive loads over broader areas, thereby preventing tissue puncture
3Stability of the object's composition
If foot angle is increased to load more annular tissue, then anchoring stability is improved, but risk of loading wrong tissue layers increases
Solution Approach 1:
The foot angle parameter is precisely controlled within the range of 30-60 degrees relative to the longitudinal axis. This specific angular range has been optimized to achieve optimal balance between anchoring stability and tissue layer targeting. The geometric parameters of the feet, including angle, length, and surface area distribution, are carefully calibrated to ensure reliable engagement with the annular tissue at the correct depth
4Reliability
If foot angle is decreased to target specific tissue layers, then tissue layer targeting accuracy is improved, but anchoring stability may be reduced
Solution Approach 1:
The foot angle is optimized within the 30-60 degree range to simultaneously achieve accurate tissue layer targeting and sufficient anchoring stability. This parameter optimization ensures that the feet engage the annular tissue at the correct depth while maintaining stable anchoring configuration
5Object-affected harmful factors
If anchors are made expandable from collapsed to expanded configuration, then delivery trauma is minimized, but device complexity increases
Solution Approach 1:
The anchors are designed as dynamically transformable structures that transition from a collapsed low-profile configuration during delivery to an expanded configuration at the deployment site. This dynamic transformation allows the anchors to minimize trauma during insertion while providing full anchoring function upon deployment, with the expansion mechanism integrated into the anchor structure itself
Data Source
AI summary
A valve prosthesis to be deployed within a native heart valve at a native heart valve annulus. The valve prosthesis including an expandable frame and a plurality of spaced anchors. The expandable frame includes a proximal end and a distal end and a longitudinal axis extending therethrough. The expandable frame collapses radially for delivery and expands radially upon deployment to an expanded configuration. The plurality of spaced anchors extend from the distal end of the frame towards the proximal end, each anchor formed with a free end, and each anchor being expandable from a collapsed anchor configuration to an expanded anchor configuration, wherein each of the anchors includes a foot angle of from 0 to 45 degrees relative to the longitudinal axis.