Implanted Valve Pressure Sensor for Thrombosis Detection

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Solution Overview

Problem

Current methods for monitoring heart valve function, particularly prosthetic valves, are inadequate for early detection of subclinical thrombosis due to limitations in existing imaging techniques, which can lead to valve dysfunction and increased risk of bleeding complications from anticoagulation therapies.

Innovation Solution

A monitoring apparatus with sensors to measure flow characteristics, such as blood flow or pressure, and a communication component for wireless data transmission, integrated with a self-powered energy harvesting mechanism, allowing for ongoing monitoring and providing recommendations for prevention and treatment protocols.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If routine post-procedural anticoagulation is administered to prevent thrombosis, then the risk of valve thrombosis is reduced, but the risk of bleeding complications increases

Engineering Contradiction:
Improveprevention of valve thrombosisVSAvoidbleeding complications
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The monitoring apparatus performs preliminary detection of subclinical thrombosis before it progresses to critical valve thrombosis. By measuring pressure gradients and detecting flow disturbances early, the system enables timely intervention that may reduce or eliminate the need for long-term anticoagulation, thereby preventing bleeding complications while still preventing thrombosis

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The system continuously monitors pressure gradients and flow characteristics across the prosthetic valve, providing real-time feedback on valve function. This feedback loop allows for dynamic adjustment of anticoagulation therapy based on actual valve performance and thrombosis risk, optimizing the balance between preventing thrombosis and avoiding bleeding complications

Inventive Principle:
Principle #23Feedback

2Ease of operation

If conventional imaging techniques (ultrasound or CT) are used for ongoing valve monitoring, then valve function can be assessed, but the resolution is insufficient to detect subclinical thrombus formation

Engineering Contradiction:
Improveongoing valve monitoringVSAvoiddetection of subclinical thrombus formation
Core Design Contradiction:
Ease of operationVSMeasurement precision

Solution Approach 1:

The invention replaces conventional mechanical imaging systems (ultrasound detectors, CT scanners) with a pressure-based sensing system. By measuring pressure gradients across the valve and analyzing flow-related disturbances, the system achieves superior detection capability for subclinical thrombus formation without requiring high-resolution imaging equipment

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

Solution Approach 2:

The system uses pressure gradient measurements as an intermediary parameter to indirectly detect subclinical thrombus formation. Rather than directly visualizing thrombus with imaging techniques, the pressure sensor detects hemodynamic changes caused by early thrombus formation, providing earlier and more sensitive detection

Inventive Principle:
Principle #24Intermediary (Mediator)

3Measurement precision

If high-resolution CT imaging is used to detect subclinical thrombus formation, then detection accuracy is improved, but the procedure becomes complex and expensive with additional radiation risks

Engineering Contradiction:
Improvedetection of subclinical thrombus formationVSAvoidimaging procedure complexity
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The invention replaces complex imaging systems (CT scanners, ultrasound equipment) with a simple pressure sensing device. The pressure gradient measurement system achieves equivalent or superior detection capability for subclinical thrombus without requiring expensive, complex imaging infrastructure, radiation exposure, or specialized equipment

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

Solution Approach 2:

The pressure gradient sensor is a relatively simple, low-cost device compared to CT or ultrasound imaging systems. It can be easily implanted and provides continuous monitoring without the recurring costs and complexities of expensive imaging procedures

Inventive Principle:
Principle #27Cheap short-living objects (Disposable)

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

Enables early detection of abnormal valve functioning, reducing the risk of thrombosis and bleeding complications by providing continuous, non-invasive monitoring and personalized treatment recommendations.

Implementation Method 1

measuring, by at least one implanted sensor of a monitoring apparatus, a flow characteristic at the heart valve of a patient

Methodology Applied
Scientific EffectPressure gradient measurement: Pressure Gradient

Data Source

PatentUS20220287851A1Methods of personalizing drug treatment based on real-time pressure gradient measurements
Publication Date: 2022.09.15 EDWARDS LIFESCIENCES CORP
  • US20220287851A1 patent drawing
  • US20220287851A1 patent drawing
  • US20220287851A1 patent drawing

AI summary

A valve monitoring assembly, constituted of: a prosthetic valve, constituted of a frame and leaflets positioned at least partially within the frame, that regulate blood flow through the prosthetic valve; and a monitoring apparatus constituted of: at least one sensor associated with the prosthetic valve, wherein the at least one sensor is selected from the group consisting of: flow sensor, pressure sensor, and temperature sensor; a local control circuitry; at least one communication component configured to wirelessly transmit signals; and an energy harvesting power source, configured to be secured to a patient and comprising a self-powered energy harvesting mechanism and an energy storage member, wherein the energy storage member is configured to store energy generated by the self-powered energy harvesting mechanism, and wherein the energy harvesting power source is configured to supply power to the at least one sensor, the local control circuitry and/or the at least one communication component.