Non-linear Pressure Analysis for Perivascular Bleeding Detection

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Solution Overview

Problem

Current methods for detecting perivascular bleeding during extra-corporeal blood treatments, such as hemodialysis, hemofiltration, or hemodiafiltration, are inadequate as they fail to promptly identify slow pressure increases below the limiting value, leading to delayed detection and potential harm to the patient.

Innovation Solution

A method utilizing a non-linear analysis of pressure changes, where the absolute difference between measured pressure and a preset reference value is raised to a power (preferably between 2 and 4) to detect initial, subtle pressure increases indicative of perivascular bleeding, allowing for early intervention.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If conventional pressure monitoring with a preset limiting value is used, then the system is simple to operate and understand, but it fails to detect perivascular bleeding in its early stages when pressure increases are slow and below the limiting value

Engineering Contradiction:
Improvedetection reliabilityVSAvoidmonitoring system complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The patent transforms the pressure monitoring approach by changing from a single threshold parameter to multiple dynamic parameters including pressure difference, rate of pressure change, and integrated pressure values. This allows the system to detect perivascular bleeding at multiple stages of pressure increase, significantly improving detection reliability without requiring complete system redesign

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The monitoring system is segmented into multiple independent evaluation criteria: pressure difference evaluation, rate of pressure change evaluation, and integrated pressure evaluation. Each segment monitors a specific aspect of pressure behavior, and their combination provides comprehensive detection coverage while maintaining clear operational logic

Inventive Principle:
Principle #1Segmentation

2Loss of time

If a high pressure limiting value is used for detection, then false alarms are reduced, but detection is delayed until significant blood loss has occurred

Engineering Contradiction:
Improvedetection timeVSAvoiddetection accuracy
Core Design Contradiction:
Loss of timeVSReliability

Solution Approach 1:

The system performs preliminary detection actions by monitoring pressure differences and rates of change before the pressure reaches the critical limiting value. This preliminary monitoring captures early signs of perivascular bleeding, enabling intervention before significant blood loss occurs while maintaining accurate detection through multiple validation criteria

Inventive Principle:
Principle #10Preliminary action

3Reliability

If the pressure limiting value is lowered to detect early bleeding, then detection sensitivity increases, but false alarms from normal pressure fluctuations increase

Engineering Contradiction:
Improvedetection sensitivityVSAvoidfalse alarm rate
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The system uses feedback mechanisms where each evaluation criterion (pressure difference, rate of change, integrated pressure) continuously monitors and adjusts the overall detection decision. This multi-layered feedback ensures that early bleeding is detected with high sensitivity while normal pressure fluctuations are filtered out through cross-validation of multiple parameters

Inventive Principle:
Principle #23Feedback

4Measurement precision

If continuous monitoring of pressure differences is implemented, then perivascular bleeding can be detected early, but the computational requirements and system complexity increase

Engineering Contradiction:
Improvepressure change detection precisionVSAvoidcomputational complexity
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The system implements partial monitoring by focusing computational resources on the most critical evaluation criteria. Rather than analyzing all possible pressure parameters simultaneously, the system selectively monitors pressure differences, rates of change, and integrated values - providing sufficient detection precision while keeping computational complexity manageable

Inventive Principle:
Principle #16Partial or excessive action

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 quick and reliable detection of perivascular bleeding, reducing the time to intervention and minimizing blood loss into surrounding tissues, while operating in conjunction with existing pressure monitoring systems to enhance safety and reliability.

Implementation Method 1

a pressure sensor which detects a change in arterial pressure in the arterial segment and/or a change in venous pressure in the venous segment

Methodology Applied
Scientific EffectPressure measurement:

Data Source

PatentUS9295394B2Method and device for recognition of paravasal bleeding
Publication Date: 2016.03.29 FRESENIUS MEDICAL CARE DEUTSCHLAND GMBH
  • US9295394B2 patent drawing
  • US9295394B2 patent drawing
  • US9295394B2 patent drawing

AI summary

A method and a device for recognition of paravasal bleeding upon a supplying of blood to a vascular access via a line and/or upon the removal of blood from a vascular access via a line is provided. A device for extracorporeal blood treatment comprising a device for recognition of paravasal bleeding is also provided. The method and the device are based on the change of arterial pressure in the arterial branch or the venous pressure in the venous branch of the extra-corporeal circuit being registered during the extracorporeal blood treatment. One aspect of the method and the device is that pressure changes that come from a pressure level exhibiting a large difference from a reference value are more strongly considered than those that come from a pressure level that exhibits only a minor difference from the reference value.