Prosthetic Heart Valve Sealing Member for Perivalvular Leakage
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Solution Overview
Problem
Catheter-implanted prosthetic heart valves experience perivalvular leakage due to challenges in controlling the sealing around the valve post-implantation.
Innovation Solution
The prosthetic heart valve incorporates radially collapsible and expandable sealing members that transform from an unfurled to a coiled configuration, assisted by tethers that apply axial forces, reducing leakage by engaging surrounding tissue during expansion.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If conventional prosthetic valves are implanted using catheterization, then the procedure becomes less invasive, but perivalvular leakage occurs due to difficulty in controlling sealing around the valve
Solution Approach 1:
The sealing members are designed to dynamically change configuration from unfurled to coiled based on the radial expansion state of the frame. During delivery in collapsed configuration, sealing members are unfurled and pressed against the frame outer surface. Upon balloon inflation causing frame expansion, sealing members automatically coil and engage surrounding tissue to create effective seals, thus adapting sealing mechanism to the operational state
Solution Approach 2:
The sealing members undergo parameter changes in their physical configuration (from unfurled to coiled state) in response to the radial expansion parameter of the frame. This transformation allows the sealing members to adapt to different operational conditions - compressed during delivery, expanded and sealed during operation - resolving the contradiction between minimally invasive delivery and effective sealing
2Reliability
If sealing members are designed to transform from unfurled to coiled configuration, then perivalvular leakage is reduced, but the device complexity increases due to additional tethers and transformation mechanisms
Solution Approach 1:
The sealing members are designed to self-transform from unfurled to coiled configuration automatically in response to the frame's radial expansion. The transformation is driven by the mechanical forces generated during balloon inflation, eliminating the need for external control systems, motors, or complex actuation mechanisms. This self-service approach reduces device complexity while achieving reliable sealing
Solution Approach 2:
The sealing members utilize dynamic transformation based on the operational state of the frame. The same sealing member structure serves dual purposes: unfurled state during delivery for compactness, and coiled state during operation for sealing. This dynamic adaptation eliminates the need for separate sealing mechanisms, reducing overall device complexity
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 sealing members effectively minimize perivalvular leakage by securing to the native valve, enhancing the seal and reducing leakage through controlled transformation configurations.
Implementation Method 1
The sealing members are configured to transform from an unfurled configuration extending along the outer surface of the frame when the frame is in the radially collapsed configuration to a coiled configuration when the frame is radially expanded
Implementation Method 2
the tethers are configured to apply axially directed forces to the sealing members that cause the sealing members to transform from the coiled configuration to the unfurled configuration when the frame is radially collapsed to the radially collapsed configuration
Data Source
AI summary
An implantable prosthetic valve can include a radially expandable and collapsible annular frame having an inflow end and an outflow end. A valvular structure can be positioned within the frame. A plurality of sealing members can be positioned around an outer surface of the frame, wherein the sealing members are configured to transform from an unfurled configuration extending along the outer surface of the frame when the frame is in the radially collapsed configuration to a coiled configuration when the frame is radially expanded to the radially expanded configuration.