Adjustable Interatrial Shunt Flow Control for Changing Atrial Pressure
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Solution Overview
Problem
Existing interatrial shunts have fixed diameters that fail to account for a patient's changing physiology, leading to diminishing clinical effectiveness over time, and lack the ability to adjust sizing based on individual patient needs.
Innovation Solution
The development of adjustable interatrial shunting systems with expandable flow control elements that can be adjusted perioperatively or post-implantation to match the patient's changing conditions, using mechanisms such as shape memory actuators, electromagnetic motors, and sensors to control blood flow between the left and right atria.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of manufacture
If a fixed diameter shunt is used, then the device structure is simple and easy to manufacture, but the clinical effectiveness diminishes over time as patient physiology changes
Solution Approach 1:
The shunt device incorporates an expandable flow control element that can dynamically adjust its diameter from a compressed delivery state to an expanded deployed state. This dynamic capability allows the shunt to adapt to changing patient physiology over time, maintaining clinical effectiveness while resolving the contradiction between structural simplicity and reliable performance.
Solution Approach 2:
The flow control element changes its physical parameter (diameter) from a small compressed configuration during delivery to a larger expanded configuration during deployment. This parameter change enables the shunt to provide appropriate flow resistance as patient conditions evolve, addressing the reliability issue without significantly complicating the manufacturing process.
2Device complexity
If a single size shunt is used, then the device design is simplified, but it cannot accommodate individual patient needs and changing conditions
Solution Approach 1:
The shunt system incorporates an adjustable flow control element that can be modified after implantation to accommodate different patient needs. This dynamic adjustability provides versatility for individual patient care while maintaining a relatively simple base device design that can be tuned post-deployment.
Solution Approach 2:
The system includes sensors that monitor physiological parameters and provide feedback to a controller, which then adjusts the flow control element accordingly. This feedback mechanism enables the shunt to adapt to individual patient conditions and changing physiology, enhancing versatility without requiring multiple different device designs.
3Reliability
If the shunt diameter is increased to provide more flow, then left atrial pressure is reduced more effectively, but the risk of excessive shunting and right heart volume overload increases
Solution Approach 1:
The flow control element provides dynamic control of shunt diameter, allowing the system to optimize blood flow between the left and right atria. This dynamic adjustment capability enables effective left atrial pressure reduction while preventing excessive shunting that could cause right heart volume overload, as the flow can be tuned to appropriate levels.
Solution Approach 2:
Sensors monitor physiological parameters including atrial pressures and flow rates, providing feedback to a controller that adjusts the flow control element to maintain optimal shunting. This feedback control prevents both insufficient pressure reduction and excessive shunting, avoiding right heart volume overload while achieving effective treatment.
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
These systems provide dynamic control of blood flow, improving clinical outcomes by adapting to the patient's evolving health status, enhancing treatment efficacy for heart failure patients with elevated left atrial pressure.
Implementation Method 1
In some embodiments, the actuation mechanism includes one or more shape memory elements
Implementation Method 2
electromagnetic motors, and sensors to control blood flow between the left and right atria
Data Source
AI summary
The present technology is generally directed to interatrial shunting systems and associated devices and methods. For example, a system configured in accordance with embodiments of the present technology can include a shunting element implantable into a patient at or adjacent a septal wall. The shunting element can have a lumen that fluidly connects a left atrium and a right atrium of the patient to facilitate blood flow therebetween when the shunting element is implanted. In some embodiments, the system further includes a flow control element to selectively control blood flow between the left atrium and the right atrium.