Interatrial Shunt Sensor Placement for Real-Time Pressure Regulation

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Solution Overview

Problem

Current therapies for heart failure and pulmonary arterial hypertension, including implantable pressure sensors and interatrial shunts, face challenges such as delayed responses, potential over-treatment, and the need for caregiver intervention, while existing interatrial shunts may unmask underlying heart dysfunction.

Innovation Solution

An interatrial shunt device combined with an implantable physiologic sensor that measures physiologic parameters within the shunt, minimizing tissue overgrowth and providing real-time, automated pressure regulation without caregiver intervention.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Speed

If implantable pressure sensors are used to monitor cardiovascular parameters, then real-time pressure regulation can be achieved, but delayed responses and potential over-treatment occur

Engineering Contradiction:

Improveresponse timeVSAvoidtreatment accuracy

Core Design Contradiction:

SpeedVSReliability

Solution Approach 1:

The device incorporates a closed-loop feedback system where the physiologic sensor continuously monitors pressure parameters and automatically adjusts the shunt orifice area in real-time. This feedback mechanism eliminates delayed responses and prevents over-treatment by making adjustments only when and where physiologic conditions require them, thereby resolving the contradiction between speed and reliability.

Inventive Principle:

Principle #23Feedback

Solution Approach 2:

The interatrial shunt device performs self-regulation through automated control algorithms that process sensor data and adjust the shunt opening without external intervention. This self-service capability ensures immediate response to pressure changes while maintaining treatment accuracy through embedded decision-making logic, resolving the contradiction between rapid response and reliable treatment.

Inventive Principle:

Principle #25Self-service

2Ease of operation

If caregiver intervention is required for therapy adjustment, then treatment decisions can be made by medical professionals, but timely regulation is compromised

Engineering Contradiction:

Improvecaregiver involvementVSAvoidregulation timing

Core Design Contradiction:

Ease of operationVSSpeed

Solution Approach 1:

The device is designed to autonomously monitor physiologic parameters and adjust shunt opening without requiring caregiver intervention. The automated control system processes sensor data and implements therapy adjustments in real-time, eliminating delays associated with human response while maintaining medically sound decision-making through embedded algorithms.

Inventive Principle:

Principle #25Self-service

Solution Approach 2:

The patent replaces the mechanical system of manual caregiver adjustment with an automated electronic control system that uses sensors, processors, and actuators. This substitution enables continuous real-time regulation without human intervention, resolving the contradiction between ease of operation and regulation timing.

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

3Stress or pressure

If interatrial shunts are used to regulate blood pressure, then pressure control can be achieved, but underlying heart dysfunction may be unmasked

Engineering Contradiction:

Improveblood pressure controlVSAvoidheart function stability

Core Design Contradiction:

Stress or pressureVSReliability

Solution Approach 1:

The shunt device features a dynamic, adjustable orifice that can change its opening area in real-time based on physiologic conditions. Unlike fixed shunts that permanently alter hemodynamics, this dynamic system can modulate the shunt magnitude to maintain heart function stability while achieving blood pressure control, resolving the contradiction between pressure control and functional stability.

Inventive Principle:

Principle #15Dynamics

Solution Approach 2:

The device changes the shunt orifice area parameter dynamically in response to sensor feedback, allowing precise control of blood pressure while avoiding the fixed, potentially harmful hemodynamic alterations of traditional shunts. This parameter adjustment capability maintains heart function stability while achieving effective pressure regulation.

Inventive Principle:

Principle #35Parameter changes

4Stress or pressure

If traditional interatrial shunts are used, then blood pressure regulation can be achieved, but tissue overgrowth occurs

Engineering Contradiction:

Improvepressure regulationVSAvoidtissue response

Core Design Contradiction:

Stress or pressureVSDevice complexity

Solution Approach 1:

The shunt device incorporates a thin-film or flexible membrane structure that minimizes tissue irritation and prevents excessive tissue overgrowth. This design maintains pressure regulation functionality while reducing the mechanical stimulus for fibrous tissue proliferation, resolving the contradiction between effective pressure control and minimal tissue response.

Inventive Principle:

Principle #30Flexible shells and thin films

Data Source

PatentUS12369918B2Interatrial shunt having physiologic sensor

Publication Date: 2025.07.29 WAVE LTD V

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.