Sensorized Interatrial Shunt for Automatic Atrial Pressure Control
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Solution Overview
Problem
Current treatments for cardiovascular and cardiopulmonary disorders such as heart failure and pulmonary arterial hypertension are inadequate in managing elevated cardiac filling pressures, leading to frequent hospitalizations and mortality, with existing implantable sensors facing challenges in durability, power consumption, and requiring manual adjustments that can cause over-treatment or complications.
Innovation Solution
An interatrial shunt device combined with a physiologic sensor is used to regulate blood pressure, allowing for automatic adjustment of left and right atrial pressures, minimizing delays and complications, and providing real-time monitoring and therapeutic guidance.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Loss of time
If manual adjustments are used to manage cardiac filling pressures, then treatment flexibility is maintained, but treatment delays and complications increase due to manual intervention requirements
Solution Approach 1:
The interatrial shunt device incorporates a physiologic sensor that automatically detects cardiac filling pressures and adjusts the shunt opening area without manual intervention. The device self-regulates by sensing pressure differential between atria and autonomously modifying its geometry to maintain optimal pressure balance, eliminating treatment delays associated with manual adjustments.
Solution Approach 2:
The device employs a physiologic sensor that continuously monitors cardiac filling pressures and provides real-time feedback to the control mechanism. This feedback loop enables automatic adjustment of the shunt opening area in response to pressure changes, ensuring timely therapeutic response without manual caregiver intervention.
2Reliability
If implantable sensors are used for monitoring cardiac pressures, then real-time data is obtained, but durability and power consumption issues arise
Solution Approach 1:
The patent integrates the physiologic sensor directly into the interatrial shunt device structure, merging the monitoring function with the therapeutic device. This integration eliminates the need for separate implantable sensors, reducing overall system complexity, improving durability, and minimizing power consumption by sharing the device's power source and housing.
3Adaptability or versatility
If the shunt opening area is fixed, then device simplicity is maintained, but inability to adapt to changing cardiac conditions reduces treatment effectiveness
Solution Approach 1:
The interatrial shunt device incorporates a movable element that dynamically adjusts the opening area in response to sensed pressure differential between atria. The shunt transitions from a fixed structure to a dynamic system where the opening geometry changes automatically based on real-time physiologic conditions, enabling adaptation to varying cardiac demands.
Solution Approach 2:
The device changes its geometric parameter (opening area) in response to pressure differential changes. The control mechanism modifies the shunt opening area as a variable parameter based on sensed pressure conditions, allowing the device to adapt its flow characteristics to match changing cardiac filling pressures without requiring complete redesign.
Data Source
AI summary
Interatrial shunts having incorporated physiologic sensors are provided for monitoring and treating cardiovascular syndromes, including heart failure and pulmonary hypertension, in which the one or more sensors are affixed to the shunt to measure a physiologic parameter within the interatrial shunt. The one or more sensors may be directly affixed to or within a lumenal surface of the shunt or may be disposed on a support structure in a spaced relation to the shunt lumen, the one or more sensors disposed at locations subject to little or no pannus formation or cardiac wall motion artifact.