Mitral Valve Delivery System with Suture Tethers
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Solution Overview
Problem
Current intravascular delivery systems face challenges in loading, delivering, and deploying replacement heart valves due to their larger size and complexity, requiring precise positioning and the ability to recapture partially deployed devices, which is difficult with existing technologies.
Innovation Solution
A delivery system comprising a handle assembly, an elongated delivery member with a steering component, a compression coil, and a suture catheter with tethers to ensure precise positioning and deployment of the heart valve, allowing for adjustment of tension and easy detachment from the delivery system.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Loss of time
If a replacement heart valve is delivered intravascularly, then the procedure time and recovery time are reduced, but the device positioning precision and control are compromised due to the complexity and size of the valve
Solution Approach 1:
The delivery system is divided into multiple functional components including an outer catheter, inner catheter, suture catheter, and delivery member, each performing specific tasks. This segmentation allows for precise control of the large heart valve device through coordinated action of smaller, more manageable components, resolving the contradiction between device size and positioning precision.
Solution Approach 2:
The patent introduces intermediate structures such as the delivery member that couples to the valve, and suture catheters with tethers that provide fine-adjustment control. These intermediaries act as mediators between the operator and the large heart valve, enabling precise positioning despite the valve's size and complexity.
2Adaptability or versatility
If the heart valve is made larger to replace malfunctioning valves, then the valve functionality is improved, but the ease of loading and delivery through vasculature deteriorates
Solution Approach 1:
The delivery system employs a nested structure where the heart valve is contained within a delivery member, which is itself contained within an inner catheter, which is contained within an outer catheter. This nesting allows the large functional valve to be compressed and delivered through small vascular access points, resolving the contradiction between valve size and ease of delivery.
Solution Approach 2:
The system transitions from a compressed, low-profile delivery state to an expanded, functional deployed state. The valve and delivery components are dynamically adjustable, allowing the large valve to be collapsed for delivery and then expanded at the target site, resolving the contradiction between valve functionality and ease of loading.
3Measurement precision
If the delivery system includes multiple control mechanisms for precise positioning, then the positioning accuracy is improved, but the device complexity increases
Solution Approach 1:
The outer catheter serves multiple functions: it provides structural support, contains the inner catheter and delivery components, and acts as a guide for navigation. This multi-functionality reduces the need for separate dedicated components, resolving the contradiction between positioning accuracy and device complexity.
Solution Approach 2:
The patent combines multiple control functions into integrated components. The suture catheter with tethers merges positioning control, tension adjustment, and valve attachment functions into a single device. The delivery member integrates coupling, positioning, and deployment functions, reducing overall system complexity while maintaining positioning accuracy.
4Loss of time
If the valve is pre-loaded into the delivery system during manufacture, then the procedure time is reduced, but the ability to adjust and recapture the valve is lost
Solution Approach 1:
The coupling between the delivery member and valve is designed to be dynamically adjustable rather than fixed. The system allows the valve to be attached, detached, repositioned, and recaptured during the procedure, providing adaptability while maintaining efficient workflow. This resolves the contradiction between procedure time and ability to adjust.
Data Source
AI summary
The present disclosure describes devices, systems, and methods for loading, delivering, positioning, and deploying an artificial heart valve device at the mitral annulus. A delivery system includes a delivery member coupled to a handle assembly and extending distally from the handle assembly. The valve device is attached at the distal end of the delivery member, and is constrained within a valve cover of an outer sheath. A delivery catheter is configured to advance the valve relative to the outer sheath, and a suture catheter includes sutures/tethers which maintain proximal tension on the valve prior to deployment.