Adjustable Transapical Heart Valve Implant for Post-Deployment Positioning
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Solution Overview
Problem
Existing methods for delivering prosthetic heart valves are invasive and do not adequately mimic the functionality of natural heart valves, often leading to complications such as tissue damage and paravalvular leaking, and lack effective post-deployment adjustment mechanisms.
Innovation Solution
A method and system for delivering an adjustable heart valve implant through the heart's apex, using an introducer assembly to deploy a prosthetic valve portion that can be suspended within the mitral valve and affixed to the heart's apex with an anchor portion, allowing for adjustable distance and rotation, and featuring deployable wings for secure attachment.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If open heart surgery is performed to replace a heart valve, then the heart valve can be replaced with a prosthetic valve, but the procedure has significant risks and can lead to many complications
Solution Approach 1:
The patent uses an introducer assembly as an intermediary device to deliver the prosthetic valve through a minimally invasive transapical approach. The introducer assembly includes an outer shaft that guides the collapsed prosthetic valve through the apex of the heart into the left ventricle, avoiding the need for open heart surgery while still achieving effective valve replacement
Solution Approach 2:
The prosthetic valve is nested within the outer shaft of the introducer assembly in a collapsed state during delivery. The valve is then expanded in situ within the heart, transforming from a compact deliverable form to a functional expanded state, similar to nested dolls
2Object-affected harmful factors
If a prosthetic valve is delivered using a catheter to avoid invasive surgery, then the procedure is less invasive, but the existing approaches do not adequately mimic the functionality of the natural mitral valve and may cause tissue damage
Solution Approach 1:
The prosthetic valve is designed with dynamic characteristics that mimic the natural mitral valve. The positioning members can be adjusted to accommodate the dynamic motion of the heart, and the valve structure allows for natural cardiac remodeling while maintaining proper valve function throughout the cardiac cycle
Solution Approach 2:
The patent employs adjustable positioning members that can be repositioned after initial deployment to optimize valve function. The distance between the positioning members can be modified to account for cardiac remodeling and to prevent paravalvular leaks, allowing parameter adjustment based on patient-specific responses
3Productivity
If a heart valve implant is deployed, then the valve replacement is completed, but there are no adequate ways for replacing or adjusting the implant after deployment
Solution Approach 1:
The positioning members are designed to be adjustable after deployment. The outer shaft can be retracted to expose the positioning members, allowing them to be repositioned along the inner shaft to adjust the valve's position and orientation. This dynamic adjustability enables post-deployment repairs and optimizations
Solution Approach 2:
The same introducer assembly and inner shaft mechanism used for initial valve deployment can be reused for post-deployment adjustments and potential valve replacements. The system is designed to accommodate multiple interventions at the same access site, eliminating the need for separate procedures for adjustments
Data Source
AI summary
Systems and methods are provided for repairing a heart valve, such as a mitral, tricuspid or aortic valve, using an adjustable and removable implant that can be delivered to the heart through the apex in a simplified and non-invasive manner. The implant can include a prosthetic valve portion coupled to a proximal end of a shaft, and an anchor portion coupled to a distal end of the shaft. The prosthetic valve can be suspended within an opening of the heart valve while the anchor portion is affixed to the apex of the heart. When the implant is deployed, a distance between the prosthetic valve portion and the anchor portion can be adjusted, and/or the implant or a portion thereof can be rotated to thereby change the position of the prosthetic valve within the heart valve. This can allow correcting for post-implantation movements of the implant to mitigate potential complications.