Prosthetic Valve with Shape-Memory Flanges and Balloon Frame
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Solution Overview
Problem
Dilation of the heart valve annulus due to ischemic heart disease prevents proper valve closure, leading to blood regurgitation and decreased cardiac output, as existing technologies fail to effectively deploy prosthetic valves that maintain proper function and expansion.
Innovation Solution
A prosthetic valve system featuring a self-expanding outer frame composed of shape-memory alloy flanges and an upstream support portion, coupled to a balloon-expandable tubular frame, which is delivered using a tool with a capsule and balloon to ensure precise expansion and fixation at the implantation site.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Manufacturing precision
If a balloon-expandable tubular frame is used, then the prosthetic valve can be precisely expanded at the implantation site, but the device complexity increases due to the need for a capsule and delivery tool
Solution Approach 1:
The patent employs a nested structure where the self-expanding outer frame is placed inside the balloon-expandable tubular frame, which is in turn placed inside the capsule. This nesting allows precise delivery and controlled expansion while managing device complexity through hierarchical organization of components.
Solution Approach 2:
The self-expanding outer frame is pre-formed with shape-memory properties that allow it to automatically expand to its final configuration upon release from the capsule, eliminating the need for complex expansion mechanisms for this portion and simplifying the overall delivery system.
2Ease of operation
If self-expanding flanges are used to engage the native valve, then the ease of operation is improved, but the device complexity increases due to the need for shape-memory alloy materials
Solution Approach 1:
The shape-memory alloy flanges are designed to automatically expand and engage the native valve tissue upon release from the capsule, without requiring external actuation or complex mechanisms. This self-service capability simplifies the deployment process and improves ease of operation.
Solution Approach 2:
The patent utilizes shape-memory alloy materials that change their physical parameters (shape, size) in response to temperature or stress changes during deployment, enabling automatic expansion and engagement of the flanges with the native valve tissue.
3Strength
If the outer frame is disposed radially outward from the tubular frame, then the structural integrity is improved, but the volume of the implant increases
Solution Approach 1:
The outer frame is strategically positioned radially outward from the tubular frame at specific locations to provide localized structural support and engagement with the native valve tissue, rather than uniformly increasing the volume of the entire implant.
Solution Approach 2:
The implant is divided into distinct functional segments: the tubular frame for structural support and the outer frame with flanges for engagement. This segmentation allows each component to perform its specific function efficiently without unnecessary volume increase.
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 system allows for successful deployment and expansion of the prosthetic valve, preventing regurgitation and improving cardiac output by ensuring proper valve closure and function, while maintaining structural integrity and ease of delivery.
Implementation Method 1
the outer frame being composed of a shape-memory alloy
Implementation Method 2
inflation of the balloon plastically expands the tubular frame radially
Data Source
Figure 1A
Figure 1B~1C
Figure 1D
AI summary
Apparatus for use at a native valve of a heart of a subject comprises a delivery tool 100, comprising a shaft 106, having a shaft-axis ax2; a capsule 110, disposed at a distal portion 104 of the tool, and comprising an upstream capsule-portion 112 and a downstream capsule-portion 114, the capsule being openable by moving the upstream capsule-portion and the downstream capsule-portion apart; and a balloon 120, coupled to the shaft, and disposed within the capsule; and a prosthetic valve, comprising a tubular frame that circumscribes a longitudinal axis to define a lumen along the longitudinal axis, that is compressed around the balloon, and that is disposed within the capsule; and an outer frame, the outer frame comprising one or more shape-memory flanges, constrained within the downstream capsule-portion; and a shape-memory upstream support portion, constrained within the upstream capsule-portion. The flanges are configured to automatically deflect radially outward from the tubular frame upon exposure from the downstream capsule-portion, the upstream support portion is configured to automatically deflect radially outward upon exposure from the upstream capsule-portion, the tubular frame is configured to remain compressed around the balloon upon exposure of the tubular frame from the capsule, the outer frame is disposed radially outward from the tubular frame and longitudinally overlapping the tubular frame, and while the tubular frame is exposed from the capsule the tubular frame is configured to inhibit the outer frame from radially expanding, prior to inflation of the balloon, and inflation of the balloon plastically expands the tubular frame radially.