Valve Prosthesis Axial Fixation Minimizes Leaflet Damage
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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, and leakage, 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 fixation member in the ascending aorta and a proximal fixation member in the left ventricular outflow tract, minimizing radial force and avoiding full opening of native leaflets.
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, and leakage occur
Solution Approach 1:
The fixation system is divided into two separate fixation members (proximal and distal) that apply axial forces independently, rather than relying on a single mechanism applying high radial force. This segmentation allows distributed loading that secures anchoring while minimizing localized damage to native structures.
Solution Approach 2:
Instead of applying radial force outward from the center to achieve fixation, the invention applies axial forces from both ends (proximal and distal fixation members) to sandwich the native valve complex. This inverted approach achieves secure anchoring through compression along the axis rather than radial expansion, thereby avoiding damage to native leaflets.
2Reliability
If traditional valve prosthesis implantation is performed, then valve replacement is achieved, but suturing and invasive procedures are required
Solution Approach 1:
The two fixation members are designed to be deliverable and deployable through minimally invasive catheter-based techniques without requiring external suturing or complex surgical intervention. The device performs its own fixation function through the interaction of the proximal and distal fixation members applying axial forces, eliminating the need for traditional suturing procedures.
Solution Approach 2:
The collapsible valve structure allows the prosthesis to be nested within a delivery catheter in a compressed state for minimally invasive insertion, then expanded in situ to its functional configuration. This nesting principle enables simple catheter-based delivery while achieving reliable valve replacement functionality.
3Ease of operation
If native leaflets are fully opened for access, then implantation is facilitated, but embolism and damage to native leaflets increase
Solution Approach 1:
Instead of opening the native leaflets widely to access the implantation site, the invention approaches from both ends (proximal and distal) and applies axial compressive forces to sandwich the native valve complex in its closed or partially open state. This inverted approach maintains leaflet closure while achieving secure fixation, thereby eliminating embolism risk associated with full leaflet opening.
Data Source
AI summary
A prosthesis for implantation at a native semilunar valve includes a prosthetic distal valve, which includes a pliant material configured to collapse inwardly towards a longitudinal axis of the prosthesis during diastole, and to open outwardly during systole, and a distal fixation member configured to be positioned in a downstream artery of the subject. The apparatus also includes a proximal fixation member coupled to the distal fixation member, and configured to be positioned at least partially on a ventricular side of the native semilunar valve. The proximal fixation member is shaped so as to define a lattice that is shaped so as to define an intermediary portion that is coupled to the pliant material of the valve and diverges outwardly from the longitudinal axis, and a distal portion that is distal to the intermediary portion and diverges outwardly from the intermediary portion of the lattice. Other embodiments are also described.