Solid Wall Interatrial Shunt for Atrial Septum
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Solution Overview
Problem
Current treatments for heart failure, particularly those addressing elevated pressure in the left atrium, face challenges in effectively relieving pressure and minimizing tissue ingrowth and stroke risks.
Innovation Solution
An interatrial shunting device with a solid wall tube and anchoring assembly that secures to the atrial septum, allowing for minimal exposure in the left atrium and preventing tissue overgrowth, is designed for catheter-based delivery and deployment, featuring a self-transitioning mechanism for easy implantation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a conventional interatrial shunting device is used, then pressure relief function is provided, but tissue overgrowth occurs across the atrial septum
Solution Approach 1:
The device extracts only the necessary portion of the tube through the atrial septum, with the majority of the tube body positioned in the right atrium. This extraction principle prevents tissue overgrowth by minimizing the surface area exposed to the left atrium where tissue ingrowth would occur, while maintaining the pressure relief function through the protrusion into the left atrium.
Solution Approach 2:
Instead of positioning the main body of the device in the left atrium with minimal extension to the right atrium, the device inverts this configuration by positioning the main body in the right atrium with minimal extension to the left atrium. This inversion resolves the tissue overgrowth issue while maintaining shunt functionality.
2Reliability
If device exposure in the left atrium is increased, then pressure relief effectiveness is improved, but stroke risk increases
Solution Approach 1:
The device applies partial action by extending only a sufficient portion of the tube into the left atrium to achieve pressure relief, rather than maximizing exposure. The protrusion is calibrated to provide adequate pressure relief while minimizing stroke risk by limiting the exposed surface area that could serve as a thrombus formation site.
3Reliability
If the anchoring assembly is designed for secure engagement, then device stability is improved, but delivery complexity increases
Solution Approach 1:
The anchoring assembly employs dynamic characteristics with arms that can transition between a compressed delivery configuration and an expanded deployed configuration. During delivery, the arms are compressed to reduce profile and fit within the catheter. Upon deployment, the arms expand to engage the atrial septum and provide stable anchoring, achieving both secure engagement and simplified delivery.
Solution Approach 2:
The anchoring assembly uses a nesting principle where the arms are contained within a delivery catheter during insertion. The arms are compressed and nested within the catheter lumen, allowing percutaneous delivery through minimal access. Once positioned, the arms are released and expand outward to engage the atrial septum, providing stable anchoring without requiring complex delivery mechanisms.
Data Source
AI summary
An interatrial shunting device including a tube and an anchoring assembly. The tube defines a first end opposite a second end, and a tube wall extending to and between the first and second ends. The tube wall is a solid body and defines a lumen of the tube, with the lumen being open at the first and second ends. The anchoring assembly is carried by the tube and is configured to secure the interatrial shunting device to a native atrial septum. The solid wall tube prevents tissue overgrowth across the atrial septum, and can have minimal exposure of the device in the left atrium to minimize stroke and other risks. In some examples, the anchoring assembly is configured to be self-transitionable from a delivery state to a deployed state.