Trans-Septal Delivery Catheter for Staged Mitral Valve Deployment
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Solution Overview
Problem
Existing catheter-based delivery systems face challenges in effectively deploying heart valve prostheses to the mitral valve via a trans-septal approach due to limited space within the left ventricle, making successful deployment difficult.
Innovation Solution
A delivery system comprising a heart valve prosthesis with an anchoring member and inner valve support, and a delivery catheter with multiple shafts that allow for sequential expansion and deployment of the prosthesis in a radially compressed configuration, using a combination of outer, intermediate, and inner shafts to facilitate positioning and expansion within the native mitral valve.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of manufacture
If a trans-septal approach is used to deliver the heart valve prosthesis to the mitral valve, then the minimally invasive benefit is achieved, but the limited space within the left ventricle makes deployment difficult
Solution Approach 1:
The delivery catheter is divided into multiple shafts (outer shaft, intermediate shaft, inner shaft) that can be independently manipulated. This segmentation allows the operator to control prosthesis deployment in stages, first expanding the anchoring member to secure position, then expanding the inner valve support, making the constrained deployment process manageable despite limited left ventricle space
Solution Approach 2:
The delivery catheter employs a nested structure where the intermediate shaft is disposed within the outer shaft, and the inner shaft is disposed within the intermediate shaft. This nested configuration allows multiple functional components to be delivered through a single trans-septal puncture while maintaining the ability to independently deploy each component in sequence within the constrained left ventricle space
2Length of moving object
If the heart valve prosthesis is delivered in a radially compressed configuration, then it can be advanced through vasculature, but it requires complex multi-shaft delivery catheter for controlled expansion
Solution Approach 1:
The delivery catheter uses a nested multi-shaft structure where the intermediate shaft is disposed within the outer shaft, and the inner shaft is disposed within the intermediate shaft. This nested configuration allows all components to be delivered through a single trans-septal puncture site while maintaining the ability to independently deploy each component in sequence
Solution Approach 2:
The delivery catheter employs dynamic, multi-stage deployment where shafts are retracted in sequence to expand the prosthesis components. The outer shaft is retracted first to expand the anchoring member, then the intermediate shaft is retracted to expand the inner valve support, providing controlled expansion adaptability within the constrained left ventricle space
Data Source
Figure 1
Figure 2A~2B
Figure 3A
AI summary
A delivery system for delivering a heart valve prosthesis includes a heart valve prosthesis and a delivery catheter. The heart valve prosthesis includes an anchoring member and an inner valve support, and further includes a radially collapsed configuration and a radially expanded configuration. The delivery catheter includes a handle, an outer shaft, an intermediate shaft, an inner shaft, and a distal tip component. The delivery catheter further includes a delivery configuration. In the delivery configuration, the outer shaft of the delivery catheter is configured to retain a first portion of the anchoring member, the intermediate shaft is configured to retain a first portion of the inner valve support, and the distal tip component is configured to retain a second end of the anchoring member and a second end of the inner valve support each in a radially compressed state.