Multipart Retention Bumpers for Stable Transcatheter Valve Delivery
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Solution Overview
Problem
Prosthetic heart valves experience migration during delivery due to size mismatch and varying contact material and shape between the crimped valve and the folded balloon, leading to inaccurate deployment and complications.
Innovation Solution
The use of balloon catheters with multipart retention bumpers, including a proximal and distal multipart retention bumper configured in an interlocked state, to maintain the axial position of the prosthetic heart valve and reduce migration during delivery and deployment.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If the prosthetic heart valve is crimped onto the folded balloon, then the valve can be delivered through the vasculature, but the size mismatch between the crimped valve and folded balloon reduces friction forces and mechanical lock, leading to valve migration
Solution Approach 1:
The patent introduces a retention bumper as an intermediary component between the prosthetic heart valve and the balloon catheter. This bumper provides enhanced friction and mechanical interlocking to prevent valve migration during delivery, while not interfering with the deployment process. The bumper acts as a mediator that improves retention without compromising the primary delivery function.
Solution Approach 2:
The patent modifies the physical parameters of the balloon catheter system by adding a retention bumper with specific dimensional characteristics. The bumper's diameter is designed to be larger than both the crimped valve and folded balloon, creating overlapping contact zones that increase friction forces and mechanical lock. This parameter change directly addresses the retention issue while maintaining delivery capability.
2Manufacturing precision
If the crimped prosthetic heart valve is the component with the largest diameter, then it can be properly formed, but it is subject to the largest forces during delivery through the introducer, causing migration
Solution Approach 1:
The retention bumper is installed on the balloon catheter before the prosthetic heart valve is crimped onto the balloon. This preliminary action ensures that the bumper is already in position to provide protection and reduce forces on the valve during the delivery process, preventing migration before it can occur.
Solution Approach 2:
The retention bumper serves as an intermediary that absorbs and distributes the forces exerted on the prosthetic heart valve during delivery through the introducer. By positioning the bumper between the valve and the external environment, it reduces the direct forces on the valve, preventing migration while allowing proper valve formation.
3Length of moving object
If the balloon is pleated and folded to reduce its diameter for delivery, then it can be navigated through the vasculature, but the contact material and shape between the crimped valve and folded balloon vary, reducing retention
Solution Approach 1:
The patent changes the dimensional parameters of the retention bumper to account for the pleated and folded state of the balloon. The bumper's diameter is designed to be larger than both the crimped valve and the folded balloon, ensuring consistent contact and retention forces despite the balloon's reduced and varied shape during delivery.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
The multipart retention bumpers effectively prevent or reduce prosthetic heart valve migration by maintaining axial position and reducing forces on the valve, ensuring accurate deployment and reducing complications.
Implementation Method 1
the balloon is inflated to expand the prosthetic heart valve into a deployed configuration
Data Source
Figure 1
Figure 2A~2B
Figure 3
AI summary
Balloon catheters for delivery of prosthetic hear valves are configured to deploy a prosthetic heart valve through inflation. The balloon catheters are further configured with one or more retention bumpers to reduce or prevent migration of the prosthetic heart valve during delivery. Balloon catheters described herein may include expandable multipart retention bumpers.