Mitral Valve Delivery Sheath for Staged Positioning and Recapture
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Solution Overview
Problem
Existing heart valve replacement technologies face challenges in efficient positioning, recapture, and maintenance of native valve function, particularly in mitral valve regurgitation, with bulky 2-chamber solutions causing trauma and disrupting native leaflet coaptation.
Innovation Solution
A 2-part frame prosthetic valve delivery system with staged positioning expansion, utilizing inner and outer sheaths for controlled release and expansion, and additional guidance tools like pull wires and LAA plugs for precise alignment, enabling single or 2-chamber solutions.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a self-expanding stent or wire network is used to support the replacement valve, then the valve can be positioned and held in place within the heart chamber, but the device cannot be easily recaptured or repositioned if initial positioning is incorrect
Solution Approach 1:
The stent is designed with dynamic expandability, allowing it to transition between compressed and expanded states. The stent can be expanded partially or fully, then recaptured by compressing it back into the delivery catheter for repositioning. This dynamic property enables multiple positioning attempts while maintaining reliability when properly positioned.
2Manufacturing precision
If a fully expanded device is recaptured for repositioning, then the device can be adjusted to proper position, but the recapture process is difficult because the expanded stent resists contractive forces
Solution Approach 1:
The stent's dynamic design allows it to be expanded and compressed controllably. The delivery system includes mechanisms to expand the stent to the desired degree and then recapture it by applying compressive forces through the delivery catheter, enabling repositioning without excessive complexity.
Solution Approach 2:
The stent can be expanded to a partial extent rather than full expansion, making it easier to recapture and reposition. If proper positioning is achieved with partial expansion, full expansion can occur afterward. This partial action reduces the difficulty of recapture while still achieving positioning precision.
3Reliability
If open heart surgery is performed for valve replacement, then complete valve replacement can be achieved, but the procedure is highly invasive with extended hospitalization and painful recovery
Solution Approach 1:
The patent replaces the mechanical open-heart surgical approach with a catheter-based delivery system. The prosthetic valve is delivered through a catheter and deployed within the heart chamber, eliminating the need for sternotomy and cardiopulmonary bypass. This substitution reduces patient trauma and recovery time while maintaining valve replacement effectiveness.
4Reliability
If a bulky 2-chamber solution is used for mitral valve replacement, then complete valve function can be replaced, but the device causes trauma and disrupts native leaflet coaptation
Solution Approach 1:
The delivery system and prosthetic valve design allows for localized intervention at the mitral valve site without affecting the entire 2-chamber structure. The stent is positioned to replace only the necessary valve function while preserving adjacent native structures and leaflet coaptation where possible, reducing trauma compared to bulky 2-chamber solutions.
Data Source
AI summary
Embodiments of delivery systems, devices and methods for delivering a prosthetic heart valve device to a heart chamber for expanded implementation are disclosed. More specifically, methods, systems and devices are disclosed for delivering a self-expanding prosthetic mitral valve device to the left atrium, with no engagement of the left ventricle, the native mitral valve leaflets or the annular tissue downstream of the upper annular surface during delivery, and in some embodiments with no engagement of the ventricle, mitral valve leaflets and/or annular tissue located downstream of the upper annular surface by the delivered, positioned and expanded prosthetic mitral valve device.