Replacement Valve Delivery With Tethered Recapture and Repositioning
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Solution Overview
Problem
Developing prostheses, particularly replacement heart valves, that can be compacted for delivery and controllably expanded for secure placement within the body while minimizing trauma, and ensuring precise deployment and securement to intralumenal tissue remains challenging.
Innovation Solution
A delivery system comprising a tether, torqueing manifold, and engagement pin mechanism that allows for controlled crimping and uncrimping of the prosthesis, enabling precise deployment and secure attachment to the native mitral valve using a transseptal or transapical approach.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If the prosthesis is compacted for delivery, then it can be delivered through minimally invasive procedures, but it becomes difficult to controllably expand for secure placement
Solution Approach 1:
The prosthesis frame is designed to dynamically change its configuration between a compressed state for delivery and an expanded state for deployment. The frame includes expandable elements such as balloons or self-expanding structures that transition from a compact form factor to a fully expanded configuration at the target location, enabling both minimally invasive delivery and reliable placement.
Solution Approach 2:
The prosthesis utilizes parameter changes in its structural configuration - specifically the transition from a compressed radial dimension during delivery to an expanded radial dimension at deployment. This parameter change is achieved through mechanisms such as inflatable balloons or shape-memory alloys that alter the prosthesis dimensions based on controlled stimuli.
2Adaptability or versatility
If the prosthesis is delivered percutaneously through tortuous vasculature, then access to heart valves is achieved, but control over deployment at the desired location becomes challenging
Solution Approach 1:
The delivery system is segmented into multiple independent components including a delivery catheter, a prosthesis frame, and a release mechanism. This segmentation allows the prosthesis to be delivered through tortuous vasculature while maintaining independent control over deployment through the release mechanism, enabling precise positioning at the target location.
Solution Approach 2:
A release mechanism acts as an intermediary between the delivery catheter and the prosthesis frame. This intermediary component controls the transition from the compressed delivered state to the expanded deployed state, providing precise control over deployment timing and location despite the complexity of percutaneous delivery through tortuous vasculature.
3Reliability
If the prosthesis is secured to intralumenal tissue, then stable placement is achieved, but trauma to the tissue occurs
Solution Approach 1:
The prosthesis incorporates self-securing features such as anchoring elements or tissue-engaging structures that automatically secure to the intralumenal tissue upon deployment without requiring external assistance. This self-service mechanism achieves stable placement while minimizing tissue trauma through controlled engagement.
Solution Approach 2:
The prosthesis utilizes parameter changes in its engagement mechanism - transitioning from a compressed state during delivery to an expanded state that gently engages with the tissue. This controlled parameter change allows secure attachment through minimal force, reducing tissue trauma while achieving stable placement.
Data Source
AI summary
Disclosed herein are embodiments of a delivery system which can be used to recapture and/or reposition a replacement valve, such as a replacement mitral valve, after initial deployment of the valve. Embodiments of the delivery system can involve a torqueing manifold that interacts with multiple tethers that are releasably coupled to eyelets of a replacement heart valve. Engagement pins may be configured to releasably retain one end of the tethers.