Expandable Prosthetic Heart Valve Support Structure
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Solution Overview
Problem
Current prosthetic heart valves are not configured to easily accommodate a replacement expandable prosthetic heart valve within a previously-implanted valve, leading to challenges in maintaining flow capacity and secure seating during valve-in-valve procedures.
Innovation Solution
A prosthetic heart valve with a support structure that is initially resistant to radial compression but can be radially expanded to receive a percutaneously-delivered prosthetic heart valve, utilizing a dilation force to transform into an expanded configuration, allowing for the deployment of a new valve within the existing one without excising the previous valve.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Strength
If a traditional rigid support structure is used in a prosthetic heart valve, then structural strength and stability are improved, but the ability to receive a replacement valve is worsened
Solution Approach 1:
The support structure is divided into multiple expandable segments that can be collapsed for delivery and then expanded to create space for a replacement valve. Each segment includes expansion portions that allow radial expansion while maintaining structural integrity during normal function.
Solution Approach 2:
The support structure transitions from a static rigid configuration to a dynamic structure that can expand and contract. The expansion-resistant configuration provides structural strength during normal use, while the expandable configuration allows reception of replacement valves through controlled radial expansion.
2Productivity
If the support structure is made expansion-resistant to maintain valve size, then flow capacity is improved, but the ability to deploy a new valve within is worsened
Solution Approach 1:
The radial expansion parameter of the support structure is changed from fixed to variable. The structure maintains a first radial expansion resistance during normal function to preserve flow capacity, then allows controlled radial expansion to a larger diameter to accommodate replacement valve deployment.
Solution Approach 2:
The support structure is pre-configured with expansion portions and weakened sections that enable future expansion. The structure is delivered in a collapsed state, then expanded to its operational size, and finally expanded again to receive the replacement valve, with each expansion phase prepared in advance.
3Ease of manufacture
If a non-expandable support structure is used, then manufacturing simplicity is improved, but the ability to perform valve-in-valve procedures is worsened
Solution Approach 1:
The support structure incorporates multiple segments with expansion portions that can be manufactured using standard techniques. The segmented design allows for controlled expansion while maintaining manufacturing feasibility, balancing simplicity with future expandability.
Solution Approach 2:
The support structure is designed to be delivered in a collapsed configuration, then expanded to its operational size. The same structure can be expanded again to receive a replacement valve, with the expansion portions and weakened sections allowing controlled deformation without complete structural failure.
4Adaptability or versatility
If the support structure allows radial expansion, then the ability to receive a replacement valve is improved, but structural stability during normal function is worsened
Solution Approach 1:
The radial expansion parameter is changed from fixed to variable based on operational needs. During normal function, the structure maintains a first radial expansion resistance for stability. When valve replacement is needed, controlled radial expansion occurs to a larger diameter, and the structure stabilizes at this new size through the expansion portions and weakened sections.
Solution Approach 2:
The support structure transitions between different stable states: a first stable configuration during normal function and a second stable configuration after expansion to receive a replacement valve. The dynamic structure maintains stability in each state while allowing transition between states when needed.
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
Enables secure seating and maintains flow capacity by allowing for the deployment of a new prosthetic heart valve within the existing one, facilitating valve-in-valve procedures without the need for excising the previous valve, thus providing a solution for repeated valve replacements.
Implementation Method 1
a support structure which is substantially resistant to radial compression when deployed in a patient's native heart valve annulus
Implementation Method 2
The transformation from expansion-resistant to expanded/expandable can be achieved by subjecting the expansion-resistant support structure to an outward force, such as a dilation force, which may be provided by a dilation balloon
Data Source
AI summary
A prosthetic heart valve configured to replace a native heart valve and having a support frame configured to be reshaped into an expanded form in order to receive and/or support an expandable prosthetic heart valve therein is disclosed, together with methods of using same. The prosthetic heart valve may be configured to have a generally rigid and/or expansion-resistant configuration when initially implanted to replace a native valve (or other prosthetic heart valve), but to assume a generally expanded form when subjected to an outward force such as that provided by a dilation balloon or other mechanical expander.