Adjustable Interatrial Shunt with Asymmetric Flow Control
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Solution Overview
Problem
Current treatments for heart failure, particularly diastolic heart failure, are inadequate in reducing elevated left atrial pressure and preventing thrombi formation, leading to symptoms such as breathlessness and increased risk of systemic emboli.
Innovation Solution
A controlled interatrial pressure venting device with a flexible, substantially open mesh body assembly and a flow control element that allows blood to vent from the left atrium to the right atrium while minimizing flow in the opposite direction, preventing thrombi entry and reducing pressure-related tissue damage.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Stress or pressure
If a hole is created in the interatrial septum to relieve high left atrial pressure, then left atrial pressure is reduced and symptoms of heart failure are alleviated, but the risk of thrombi passage from the right atrium to the left atrium increases
Solution Approach 1:
The device incorporates a flow control element with asymmetric flow characteristics that allows preferential flow from the left atrium to the right atrium while restricting reverse flow. This local functional differentiation within the device structure enables pressure relief while preventing thrombi passage
Solution Approach 2:
The flow control element acts as an intermediary between the two atria, mediating the blood flow in a controlled manner. It permits necessary pressure equalization while blocking harmful thrombi, thus serving as a selective mediator that resolves the contradiction between pressure relief and thrombi prevention
2Stability of the object's composition
If a rigid shunt device is implanted to maintain structural integrity, then device stability is improved, but tissue damage and difficulty in navigation increase
Solution Approach 1:
The device employs a flexible structure that can dynamically adapt to the interatrial septum geometry. The flexibility allows the device to conform to tissue contours during implantation and operation, maintaining stability while minimizing tissue damage through dynamic adaptation rather than rigid imposition
Solution Approach 2:
The device utilizes flexible materials and thin-film construction to achieve both structural integrity and tissue compatibility. The flexible shell allows the device to maintain its shape and function while adapting to the soft tissue environment, reducing mechanical stress and damage to surrounding tissues
3Object-affected harmful factors
If a small opening is created in the septum, then thrombi passage is minimized, but left atrial pressure relief is insufficient
Solution Approach 1:
The device segments the flow control function into distinct structural elements that work together. The body element with its specific geometry and the flow control element with asymmetric flow characteristics create multiple flow pathways that collectively provide both pressure relief and thrombi prevention
Solution Approach 2:
The flow control element incorporates asymmetric geometry that creates different flow resistance in opposite directions. This asymmetry allows the device to permit sufficient forward flow for pressure relief while creating high resistance to reverse flow that would carry thrombi, thus resolving the contradiction between opening size and flow direction control
Data Source
AI summary
Devices and methods for treating heart disease by normalizing elevated blood pressure in the left and right atria of a heart of a mammal are disclosed. Devices may include an adjustable hydraulic diameter shunt portion which can be manually adjusted in vivo. Methods are provided for adjusting the flow rate of the devices in vivo.