Helical-Track Valve Delivery Tool for Atraumatic Implant Deployment
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Solution Overview
Problem
Dilation of the heart valve annulus due to ischemic heart disease prevents the valve leaflets from fully coapting, leading to regurgitation and decreased cardiac output, which can weaken the ventricle.
Innovation Solution
A delivery tool with a balloon at its distal portion facilitates movement past anatomical obstacles, and a sheath retains the implant, with a housing defining a helical track and a controller for deploying the implant using an actuator.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of manufacture
If a delivery tool is advanced through the vasculature to implant a prosthetic valve, then the valve can be replaced minimally-invasively, but the tool may interfere with or damage heart tissue and anatomical obstacles
Solution Approach 1:
A balloon is inflated at the distal end of the delivery tool to create a nosecone configuration before advancing through the vasculature. This preliminary action of inflating the balloon prepares a protective tapered surface that reduces interference with anatomical obstacles and heart tissue during the delivery process
Solution Approach 2:
The inflated balloon serves as a cushioning element that protects both the delivery tool and surrounding heart tissue during advancement. The balloon's compliance and tapered shape provide a cushioning effect that prevents damage to anatomical structures while enabling minimally-invasive delivery
2Strength
If the delivery tool is made rigid to maintain structural integrity during delivery, then the tool can withstand delivery forces, but the tool cannot navigate anatomical obstacles and curved vasculature
Solution Approach 1:
The delivery tool incorporates a dynamic balloon that can be inflated and deflated to change the tool's configuration. When inflated, the balloon provides a rigid tapered nosecone for protection; when deflated, it allows the tool to be more flexible for navigation. This dynamic transformation resolves the contradiction between structural integrity and navigability
Solution Approach 2:
The physical state of the balloon is changed from deflated to inflated, transforming the delivery tool from a flexible catheter to a rigid-protected nosecone configuration. This parameter change (inflation pressure, volume, shape) enables the tool to simultaneously achieve structural integrity for withstanding delivery forces and adaptability for navigating anatomical obstacles
3Ease of operation
If the implant is deployed by simply releasing it from the delivery tool, then the deployment process is simple, but the implant may not be positioned accurately or may deploy unevenly
Solution Approach 1:
The balloon is inflated at a specific location within the heart valve annulus before implant deployment. This preliminary positioning action ensures the implant will be accurately positioned when released, while the simple inflation/deflation mechanism maintains ease of operation
Solution Approach 2:
The system provides visual feedback through radiopaque markers on the balloon and delivery tool that allow the operator to monitor the inflation status and position of the implant in real-time. This feedback ensures accurate positioning while maintaining simple deployment procedures
Data Source
Figure 1A~1B
Figure 1C
Figure 1D
AI summary
A tool (410) for use with an implant (20) includes a housing (426) and a controller (440). The housing includes a tubular wall (428) that circumscribes a longitudinal axis; is dimensioned to house at least part of the implant; and defines a track (430) that follows a generally-helical path around the longitudinal axis. The controller includes a rod (442) that extends from a proximal part of the tool to the housing; and an actuator (444). The actuator is fixedly coupled to the rod, includes an engaging element (446) that engages the track, and is rotatable with respect to the housing. The controller and the housing mechanically cooperate such that rotation of the actuator with respect to the housing slides the housing longitudinally with respect to the actuator. Other embodiments are also described.