Expandable Braid Valvuloplasty Device for Continuous Blood Flow
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Solution Overview
Problem
Existing valvuloplasty devices face challenges such as occluding blood flow, limited patient suitability due to size constraints, and slippage during procedures, especially when used as adjuncts to percutaneous transcatheter heart valve replacement (PTVR).
Innovation Solution
An expandable braid valvuloplasty device with an optional valve for regulating blood flow and a delivery system for percutaneous deployment, expansion, and retrieval, which provides tactile feedback and minimizes occlusion, allowing for precise positioning and uniform distension of the native valve.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Force
If a balloon-based valvuloplasty device is used to generate substantial radial pressure against the native valve, then the valve can be dilated, but the device requires a relatively large cross-sectional area which increases its profile and reduces the patient population in which the device may be utilized
Solution Approach 1:
The device divides the valvuloplasty function into two separate components: a separate balloon catheter for generating radial pressure and a separate expandable braid for maintaining the dilated shape. This segmentation allows each component to be optimized independently - the balloon can be small for pressure generation while the braid provides the necessary structural support without requiring large cross-sectional area.
Solution Approach 2:
The expandable braid acts as an intermediary between the balloon catheter and the native valve. The balloon inflates to generate pressure, which is then transmitted through the braid to the valve, while the braid maintains the dilated configuration. This intermediary allows the balloon to be smaller while still achieving effective valvuloplasty.
2Force
If a balloon-based valvuloplasty device completely occludes the native valve to perform the procedure, then the valve can be dilated, but blood flow is stopped during the procedure which severely limits the amount of time over which the procedure may be practiced and brings additional risks to the patient
Solution Approach 1:
The device segments the valvuloplasty function into a balloon component for pressure generation and a braid component for maintaining patency. The balloon can be inflated to generate necessary pressure while the braid maintains an open pathway for blood flow, eliminating the need to completely occlude the valve during the procedure.
Solution Approach 2:
The expandable braid maintains continuous blood flow through the valve during the valvuloplasty procedure by providing a persistent open pathway. This continuous action allows the procedure to be performed without stopping blood flow, improving patient safety and extending the time window for procedure performance.
3Stability of the object's composition
If a valvuloplasty device incorporates a necked-in region to interface with the stenosed region of the native valve, then slippage may be reduced, but precise placement of the valvuloplasty balloon prior to inflation is required which increases the difficulty of the procedure
Solution Approach 1:
The device separates the positioning function from the valvuloplasty function. The expandable braid with its radial expansion capability provides inherent positioning stability through its interaction with the valve annulus, while the balloon catheter can be independently positioned and inflated. This segmentation reduces the precision requirements for initial placement compared to necked-in designs.
4Force
If a balloon-based valvuloplasty device is used to dilate the native valve, then the valve can be opened, but the balloon may slip out of the stenotic area during the procedure due to pressures exerted by blood ejected from the beating heart
Solution Approach 1:
The device divides the valvuloplasty function into a balloon component for pressure generation and a braid component for maintaining position. The expandable braid provides continuous radial support that anchors the device in the stenotic area, preventing slippage caused by hemodynamic forces while allowing the balloon to generate necessary pressure.
Solution Approach 2:
The expandable braid is pre-positioned in the stenotic area before balloon inflation. The braid's radial expansion capability is activated first to establish a stable platform, after which the balloon is inflated to generate additional pressure. This preliminary action ensures the device remains positioned during the procedure.
Data Source
AI summary
The present invention relates to apparatus and methods for performing valvuloplasty. In some embodiments, the apparatus includes an expandable braid valvuloplasty device. In some embodiments, the methods and apparatus may be used as an adjunct to percutaneous heart valve replacement. In some embodiments, the apparatus and methods may provide a medical practitioner with feedback, monitoring or measurement information, e.g., information relevant to percutaneous transcatheter heart valve replacement.