Vascular Access Monitoring via Pressure Differential Analysis

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Solution Overview

Problem

Existing methods for monitoring vascular access during extra-corporeal blood treatments, such as haemodialysis, are not reliable and cost-effective in detecting faulty connections or blood leaks, particularly on the venous side, due to interference in pressure signals from pumps and valves.

Innovation Solution

The method involves determining a pressure differential between venous and arterial pressures, removing interference using a test function, and analyzing this differential to detect faulty vascular access, which can be done using existing sensors with minimal additional equipment and complexity.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If pressure-based protective systems are used to monitor vascular access, then the system can detect arterial needle disconnection, but it cannot reliably detect venous needle disconnection or blood leaks in venous tubing

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

Solution Approach 1:

The monitoring function is segmented into two independent monitoring paths: one for arterial parameters and one for venous parameters. Each path uses its own pressure sensor and evaluation logic, allowing independent optimization and failure isolation. The venous monitoring path specifically evaluates venous pressure changes that indicate needle disconnection or blood leaks, while the arterial path monitors arterial pressure for its own disconnection events.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The system performs preliminary assessment of pressure values to establish baseline ranges for normal operation. By pre-defining critical pressure thresholds and ranges for both arterial and venous sides, the system can immediately detect deviations indicating faulty vascular access without requiring complex real-time analysis algorithms.

Inventive Principle:
Principle #10Preliminary action

2Measurement precision

If arterial and venous pressures are monitored separately, then the system can detect pressure changes, but it cannot distinguish between hydrostatic pressure changes and actual vascular access faults

Engineering Contradiction:
Improvepressure measurement accuracyVSAvoidpressure analysis complexity
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The system extracts and removes the hydrostatic pressure component from the total pressure measurement by using the arterial pressure as a reference. Since arterial pressure is less affected by hydrostatic changes in the venous return path, it serves as a baseline to subtract from venous pressure, isolating the true vascular access status from positional effects.

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The arterial pressure measurement acts as an intermediary reference that mediates between the venous pressure measurement and the actual vascular access status. By comparing venous pressure against arterial pressure, the system obtains a differential value that represents the true pressure gradient across the vascular access, eliminating the need for complex external references or calibration procedures.

Inventive Principle:
Principle #24Intermediary (Mediator)

3Reliability

If additional sensors and complex analysis units are added to improve detection reliability, then faulty vascular access can be detected more accurately, but the cost and complexity of the system increase

Engineering Contradiction:
Improvefault detection reliabilityVSAvoidsystem manufacturing simplicity
Core Design Contradiction:
ReliabilityVSEase of manufacture

Solution Approach 1:

The pressure sensors and evaluation unit perform multiple functions: they monitor both arterial and venous pressures, detect needle disconnections on both sides, identify blood leaks, and compensate for hydrostatic pressure changes. By making the existing components multi-functional rather than adding dedicated sensors for each function, the system achieves high detection reliability without proportionally increasing complexity or cost.

Inventive Principle:
Principle #6Universality (Multi-functionality)

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

This approach allows for reliable and safe monitoring of vascular access with reduced costs and complexity, effectively detecting changes in vascular access conditions by compensating for hydrostatic pressure changes and interference, thereby preventing blood loss during treatments.

Implementation Method 1

the pressures in both the arterial segment of the extra-corporeal blood circuit and its venous segment are monitored by means of pressure sensors

Methodology Applied
Scientific EffectPressure measurement:

Implementation Method 2

Values characteristic of the state of the vascular access are calculated from the arterial and venous pressures in a calculating unit

Methodology Applied
Scientific EffectPressure differential measurement:

Data Source

PatentUS10183110B2Method and device for monitoring a vascular access and extracorporeal blood treatment device comprising a device for monitoring vascular access
Publication Date: 2019.01.22 FRESENIUS MEDICAL CARE DEUTSCHLAND GMBH
  • US10183110B2 patent drawing
  • US10183110B2 patent drawing
  • US10183110B2 patent drawing

AI summary

The invention relates to a method and a device for monitoring a vascular access during an extracorporeal blood treatment. The method and the device according to the invention are based on the monitoring of the difference between the venous pressure measured by a venous pressure sensor and the arterial pressure measured by an arterial pressure sensor (in the extracorporeal blood circuit. According to the method and the device according to the invention, a test function describing disturbances in the extracorporeal blood circuit is determined. Said test function is used to determine a noise-free differential pressure from the measured venous and arterial pressure, said differential pressure being evaluated in an arithmetic and evaluation unit to identify a defective vascular access.