Heart Valve Delivery System With Nested Shafts and Tether Release
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Solution Overview
Problem
Challenges exist in developing prostheses, particularly replacement heart valves, that can be compacted for delivery and controllably expanded for secure placement within the body, with difficulties in accessing and deploying the prosthesis to a desired location, especially through tortuous vasculature, and securing it to intralumenal tissue in an atraumatic manner.
Innovation Solution
A delivery system comprising an inner shaft with a manifold and an outer shaft member, utilizing attachment tethers to releasably connect to a replacement heart valve, allowing controlled deployment and release through axial translation of the shafts, enabling precise placement and secure attachment to the native heart valve.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If a prosthesis is compacted for delivery through tortuous vasculature, then it can be delivered percutaneously to the desired location, but it becomes difficult to control deployment and secure attachment at the target site
Solution Approach 1:
The delivery system employs nested shaft structures where an inner shaft with manifold is contained within an outer shaft member. This nested configuration allows the complex deployment mechanism to be compacted within a small delivery profile while maintaining full functionality at the target site, resolving the contradiction between compact delivery and complex deployment control.
Solution Approach 2:
The prosthesis attachment mechanism is segmented into multiple tethers that can be independently controlled through the manifold. This segmentation allows precise control over deployment timing and sequence, enabling complex deployment patterns while maintaining a compact delivery configuration through the tortuous vasculature.
2Reliability
If attachment tethers are used to releasably connect to the replacement heart valve, then controlled deployment is achieved, but the device complexity increases
Solution Approach 1:
The outer shaft member serves multiple functions: it protects the tethers during delivery, guides their deployment through aligned apertures, and controls their release through axial translation. This multi-functionality reduces the need for separate dedicated components, thereby limiting the increase in device complexity while achieving reliable controlled deployment.
Solution Approach 2:
The manifold acts as an intermediary structure that receives and organizes multiple tethers, providing a centralized control point for the release mechanism. This intermediary simplifies the overall system architecture by consolidating tether management functions, reducing complexity while maintaining reliable controlled deployment capability.
3Reliability
If the outer shaft member covers the manifold apertures to prevent premature release, then prosthesis security is improved, but the release mechanism becomes more complex
Solution Approach 1:
The release mechanism transitions from a static covered state to a dynamic released state through simple axial translation of the outer shaft member. This dynamic transformation allows the system to maintain security during delivery (covered state) while enabling controlled release at the target site through a simple linear motion, avoiding complex multi-step release mechanisms.
Solution Approach 2:
The apertures in both the manifold and outer shaft member are configured to align along the axial direction, creating a linear pathway for tether release. This aligned aperture geometry simplifies the release mechanism to a straightforward axial translation motion, preventing premature release while avoiding complex release mechanisms.
4Object-affected harmful factors
If minimally invasive procedures are used for valve replacement, then patient trauma is reduced, but access to the heart and control of prosthesis placement becomes more difficult
Solution Approach 1:
The delivery system replaces complex mechanical manipulation required in open surgery with a streamlined catheter-based mechanical system that can be delivered percutaneously. The inner shaft manifold with its aperture array provides precise mechanical control over tether release and prosthesis deployment, achieving accurate placement control through minimally invasive access by substituting the open surgical mechanical system with a specialized catheter system.
Solution Approach 2:
The delivery system acts as an intermediary tool that bridges the gap between percutaneous access and precise intracardiac prosthesis placement. It provides the necessary mechanical interface and control mechanisms within the constrained percutaneous access environment, enabling accurate placement control that would otherwise require open surgical exposure while maintaining minimally invasive benefits.
Data Source
Figure 1
Figure 2A~2B
Figure 2C
AI summary
Disclosed are embodiments of delivery systems for delivery of replacement heart valves. This can include mitral, aortic, tricuspid, and pulmonary valves. The delivery systems can include one or more different components and configurations that advantageously improve placement of the replacement heart valves during the operation of the delivery system.