Inverted Prosthetic Heart Valve Delivery via Nested Frames
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Solution Overview
Problem
Current methods for delivering and deploying prosthetic mitral valves are complex and often require large delivery catheters, posing challenges for minimally invasive procedures and are poorly tolerated by elderly patients, with a need for devices and methods that can deliver a prosthetic heart valve with a small profile for insertion and expand within the heart.
Innovation Solution
A prosthetic heart valve design featuring an inner and outer frame coupled at multiple joints, allowing the outer frame to be inverted and moved between configurations, enabling the valve to be compressed for delivery through a small sheath and expanded within the heart, utilizing shape-memory materials and actuation wires for deployment.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Length of moving object
If a prosthetic valve is delivered through a large delivery catheter, then the valve can be delivered to the heart, but the procedure becomes more invasive and difficult for elderly patients to tolerate
Solution Approach 1:
The prosthetic valve is nested within a delivery catheter in a compressed configuration, allowing the valve to be delivered through a smaller catheter than would be required if the valve maintained its expanded dimensions throughout delivery. The valve is then deployed from the catheter at the target site.
Solution Approach 2:
The prosthetic valve transitions from a static compressed configuration during delivery to a dynamic expanded configuration at the implantation site. This dynamic transformation allows the valve to fit through a small catheter and then expand to its functional size within the heart.
2Area of moving object
If a prosthetic valve is compressed for delivery through a small sheath, then the profile is reduced for minimally invasive delivery, but the valve must be expanded within the heart to perform its function
Solution Approach 1:
The prosthetic valve is segmented into multiple components including an inner frame, an outer frame, and leaflets. These segments can be compressed together for delivery and then separated or expanded at the implantation site to achieve the functional configuration.
Solution Approach 2:
The outer frame is inverted relative to the inner frame during delivery to reduce the overall profile. After delivery, the outer frame is repositioned to its normal orientation, allowing the valve to expand to its functional size. This inversion technique allows the valve to pass through a smaller catheter while maintaining the ability to expand to full size.
3Length of moving object
If the outer frame is inverted for delivery, then the valve can be delivered through a smaller catheter, but the coupling joints must allow movement between inverted and non-inverted positions
Solution Approach 1:
The outer frame is designed to be invertible relative to the inner frame through coupling joints that allow movement between inverted and non-inverted positions. This inversion reduces the valve's profile during delivery, allowing it to pass through a smaller catheter.
Solution Approach 2:
The coupling joints between the inner and outer frames are designed to be movable, allowing the outer frame to transition between inverted and non-inverted configurations. This dynamic joint design enables the valve to change its shape during delivery and deployment without requiring a completely rigid structure.
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 the delivery of a prosthetic heart valve with a small profile through a smaller catheter, reducing the complexity and invasiveness of the procedure, and allows for effective expansion within the heart, potentially reducing morbidity and costs associated with valve replacement therapies.
Implementation Method 1
The outer frame is formed with a shape-memory material and has a biased, expanded configuration. The actuation wires can be used to assist in the reversion of the outer frame from the inverted configuration to the expanded configuration.
Data Source
Figure 1A~1B
Figure 1C~1D
Figure 2A~2B
AI summary
Apparatus and methods are described herein for use in the transvascular delivery and deployment of a prosthetic heart valve. In some embodiments, an apparatus includes an outer sheath, a tube member movably disposed within the outer sheath, a retention device coupled to the tube member, and a valve holder. A prosthetic heart valve is disposed within the outer sheath and includes an outer frame and an inner frame that is removably coupled to the valve holder. The outer frame is disposed in an inverted configuration relative to the inner frame. A first actuation wire is releasably coupled to a first portion of the outer frame and releasably coupled to the retention device at a first location on the retention device. A second actuation wire is releasably coupled to a second portion of the outer frame and releasably coupled to the retention device at a second location on the retention device.