Steerable Valve Delivery Shaft With Runner-Wire Bending Control
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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, especially when accessing tortuous vasculature or anatomical locations, and securing them atraumatically to intralumenal tissue.
Innovation Solution
A delivery system comprising an outer sheath assembly and inner assembly with steerable components, including a steerable rail and pull wires, allows for bending and controlled deployment of expandable implants, such as replacement heart valves, to desired locations within the body, facilitating secure attachment and expansion.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If a prosthesis is compacted for delivery through tortuous vasculature, then accessibility to remote anatomical locations is improved, but the ability to controllably expand and securely place the prosthesis at the target site deteriorates
Solution Approach 1:
The delivery system is divided into multiple functional segments including an outer sheath assembly, inner assembly, steerable rail, and pull wires. Each segment can be independently controlled to navigate tortuous vasculature while maintaining the ability to deploy the prosthesis at the target site. The segmented structure allows the system to bend and steer through complex anatomical paths while preserving deployment capability.
Solution Approach 2:
The delivery system incorporates dynamic steering capabilities through pull wires that can be tensioned to bend the steerable rail at controlled locations. This dynamic control allows the system to adapt its shape to navigate tortuous vasculature while maintaining the ability to precisely position and deploy the prosthesis at the target anatomical location.
2Object-affected harmful factors
If a prosthesis is delivered percutaneously through tortuous vasculature, then minimally invasive access is achieved, but the ability to securely attach the prosthesis to intralumenal tissue deteriorates
Solution Approach 1:
The prosthesis incorporates self-expanding features that allow it to automatically expand and attach to the intralumenal tissue at the target site after delivery through tortuous vasculature. The self-service mechanism ensures reliable attachment without requiring additional complex deployment mechanisms, maintaining security of attachment despite the minimally invasive delivery approach.
3Adaptability or versatility
If the delivery system is made flexible to navigate tortuous vasculature, then deliverability to remote locations is improved, but the precision of prosthesis placement at the target site deteriorates
Solution Approach 1:
The delivery system incorporates feedback mechanisms that allow the operator to control the bending and steering of the flexible rail in real-time. By monitoring the position and applying corrective steering inputs through the pull wires, the system can navigate tortuous vasculature while maintaining precise control over the final placement location of the prosthesis at the target site.
Data Source
AI summary
Devices, systems and methods are described herein to provide improved steerability for delivering a prosthesis to a body location, for example, for delivering a replacement valve to a native valve location in a heart. Disclosed are a number of features that can improve steerability or release of the prosthesis into the body location. In one preferred delivery system, a proximal handle can be manipulated to apply tension to a pair of diametrically opposed axial runner wires extending through lumens in a wall of a flexible tubular shaft. By applying tension to a pair of axial runner wires, the tubular shaft can be stiffened along a plane extending substantially through the pair of axial runner wires, while the shaft is permitted to freely bend in a perpendicular plane. This feature advantageously provides the ability to adjust the steerability and flexibility of a tubular shaft to meet the requirements of a particular procedure.