Expandable Access Catheter for Transseptal Alignment
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Solution Overview
Problem
Current catheters struggle to provide safe and efficient access across the atrial septum for large profile, stiff devices like TMVR devices, as they lack proper alignment with the mitral annulus and sufficient support from surrounding tissues, especially when accessed from above via the superior vena cava.
Innovation Solution
An access catheter with two movable coaxial tubes and a braided expansion structure that expands to a larger diameter, allowing for precise alignment and support across the atrial septum, enabling the use of high profile devices with improved alignment and stability, particularly when accessed from above via the superior vena cava.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If access is made from below via the inferior vena cava using traditional catheters, then smaller profile catheters can be delivered, but alignment with the mitral annulus axis cannot be easily accomplished for large profile devices
Solution Approach 1:
The patent inverts the traditional access approach by providing access from above via the superior vena cava instead of from below via the inferior vena cava. This inversion allows the catheter to approach the mitral annulus from a direction that naturally aligns with its axis, solving the alignment problem for large profile devices.
Solution Approach 2:
The patent changes the dimensional approach by accessing the atrial septum from a superior direction rather than an inferior direction. This dimensional change in access trajectory enables proper alignment with the mitral annulus axis while accommodating large profile devices that cannot be delivered from below.
2Ease of operation
If access is made from above via the superior vena cava, then improved alignment with the mitral annulus is achieved, but the limbus does not provide stabilizing benefit
Solution Approach 1:
The patent introduces an intermediary stabilizing structure that mimics the function of the limbus. This structure provides the necessary stabilizing support and tissue engagement from the superior access direction, compensating for the absence of the natural limbus stabilizing benefit.
Solution Approach 2:
The patent changes the parameters of the access system by modifying the catheter structure to include features that provide stability from the superior approach. This includes design elements that engage with surrounding tissues to create reliable support, transforming the unstable superior access into a stable delivery path.
3Productivity
If traditional catheters are used for transseptal puncture from below, then the procedure is adequate for smaller catheters, but large profile stiff catheters undergo large curves within the left atrium
Solution Approach 1:
The patent inverts the access direction to eliminate the need for large curves within the left atrium. By approaching from above via the superior vena cava, the catheter can travel in a more direct path to the mitral annulus, improving delivery efficiency for large profile devices.
Solution Approach 2:
The patent performs preliminary alignment and positioning actions during the access phase. The catheter is pre-aligned with the mitral annulus axis during the transseptal puncture from above, eliminating the need for subsequent large curves and repositioning maneuvers within the left atrium.
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 access catheter facilitates safer and more efficient delivery of large profile devices across the atrial septum by providing enhanced alignment with the mitral annulus and support, improving the trajectory and placement of TMVR devices compared to traditional methods.
Implementation Method 1
When the inner tube is placed into tension the braided tube assumes a large diameter expanded configuration
Data Source
AI summary
An access catheter provides access for a large bore stiff therapeutic catheter across the atrial septum from above via the superior vena cava. The access catheter has an expandable member that direct a delivery tube outwards in a radial direction to place a delivery tube opening into direct contact with the fossa ovalis. The braided expandable member allows blood flow to pass when it is expanded; the expandable member provides support against the opposite wall of the right atrium. A hollow dilator tube enters the delivery tube to form a tenting shape to the fossa and a guidewire is passed across the fossa ovalis. Standard procedure allows delivery of the therapeutic catheter over the guidewire.