Sinus-engaging Valve Fixation Member for Minimally Invasive Implantation
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Solution Overview
Problem
Current valve prostheses for treating native stenosed valves often require high radial forces for fixation, which can lead to damage to native leaflets, embolism of calcific or thrombotic material, and leakage around the prosthetic valve, and may not be suitable for minimally invasive procedures.
Innovation Solution
A valve prosthesis with a collapsible design that applies axial forces to sandwich the native valve complex from both the aortic and left-ventricular sides, using a distal and proximal fixation member to couple the prosthesis to the native valve without fully opening the native leaflets, thereby reducing the risk of embolism and leakage, and allowing for minimally invasive implantation without the need for suturing.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Strength
If high radial forces are applied for fixation, then the prosthesis is securely anchored, but damage to native leaflets, embolism of calcific or thrombotic material, and leakage around the prosthetic valve occur
Solution Approach 1:
The fixation member is divided into multiple engagement arms (typically three) that independently engage with the aortic sinus. Each arm applies localized axial force rather than concentrated radial force, distributing the anchoring load to reduce damage to native leaflets and surrounding tissue while maintaining secure fixation.
Solution Approach 2:
Instead of applying radial forces outward from the center of the prosthesis (conventional approach), the engagement arms apply axial forces along the longitudinal axis, pointing toward the aortic sinus. This inverted force application method achieves secure anchoring without the harmful radial compression that damages native leaflets and creates embolism risk.
2Strength
If radial forces are applied for fixation, then the prosthesis is securely anchored, but leakage around the prosthetic valve increases
Solution Approach 1:
The engagement arms apply axial forces directed toward the aortic sinus rather than radial forces outward. This inverted force direction allows the prosthesis to be securely anchored while the native valve leaflets remain in their natural position against the aortic wall, maintaining the sealing interface and preventing paravalvular leakage.
Solution Approach 2:
Each engagement arm applies force locally at its engagement point with the aortic sinus, creating localized anchoring without global radial compression. This localized force application preserves the natural apposition of native leaflets to the aortic wall at the sealing interface, preventing leakage while achieving secure fixation.
3Ease of operation
If the native leaflets are fully opened for implantation, then the prosthesis can be inserted, but embolism of calcific or thrombotic material occurs
Solution Approach 1:
The engagement arms are oriented to apply axial forces toward the aortic sinus rather than requiring the native leaflets to be fully opened. This inverted configuration allows the prosthesis to be implanted while the native leaflets remain partially closed, preventing dislodgement of calcific or thrombotic material that would otherwise occur during full leaflet opening.
Solution Approach 2:
The engagement arms are pre-positioned to engage with the aortic sinus before the native leaflets are fully opened. This preliminary engagement provides stable anchoring early in the implantation process, allowing subsequent steps to proceed without requiring complete leaflet opening, thereby reducing embolism risk.
4Strength
If conventional fixation methods are used, then anchoring is achieved, but suturing is required which increases procedural complexity
Solution Approach 1:
The engagement arms are designed to self-anchor into the aortic sinus through their axial force application, creating stable fixation without requiring external suturing. The mechanical engagement of the arms with the sinus structure provides inherent anchoring strength, eliminating the need for additional suturing steps and reducing procedural complexity.
Solution Approach 2:
The suturing function is extracted from the implantation procedure entirely. The engagement arms provide all necessary anchoring through their axial force application and mechanical engagement with the aortic sinus, removing the need for sutures and associated procedural complexity while maintaining strong anchoring.
Data Source
AI summary
A prosthesis is provided for implantation at a native semilunar valve of a native valve complex, the native valve complex having three semilunar sinuses and three native commissures. The prosthesis includes a valve prosthesis support, which comprises a support structure comprising exactly three engagement arms that meet one another at three respective junctures. The engagement arms are shaped so as define three peak complexes at the three respective junctures, and three trough complexes, each of which is between two of the peak complexes. Upon implantation of the prosthesis, each of the engagement arms is at least partially disposed within a respective one of the semilunar sinuses, such that each of the peak complexes is disposed distal to and in rotational alignment with a respective one of the native commissures, and each of the trough complexes is disposed at least partially within the respective one of the semilunar sinuses.