Balloon Catheter Blood Flow Control With Sensor Error Detection

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Solution Overview

Problem

Medical devices, particularly balloon catheters, are prone to errors due to damage during shipment, setup, or wear and tear, leading to potential life-threatening consequences during therapeutic treatments, and existing automated systems lack effective error detection and response mechanisms.

Innovation Solution

A blood flow control system with sensors and controllers that monitor physiologic conditions and pressures, comparing data to target values to identify errors and automatically transition from automatic to manual mode or inhibit functions to prevent further damage or incorrect adjustments.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Productivity

If automated blood flow control systems are used, then productivity and precision are improved, but reliability deteriorates due to undetected errors from damage or wear

Engineering Contradiction:
Improveautomation of blood flow controlVSAvoidsystem reliability
Core Design Contradiction:
ProductivityVSReliability

Solution Approach 1:

The system performs preliminary error detection by comparing current sensor data against historical data and expected physiologic responses before automated actions are executed. This advance detection of potential errors (from damage, wear, or interference) allows the system to alert operators and prevent unreliable automated control, thus resolving the contradiction between automation and reliability.

Inventive Principle:
Principle #10Preliminary action

2Ease of operation

If automated inflation and deflation is implemented, then ease of operation is improved, but harmful factors increase due to potential life-threatening errors

Engineering Contradiction:
Improveautomated balloon controlVSAvoidpatient safety risks
Core Design Contradiction:
Ease of operationVSObject-affected harmful factors

Solution Approach 1:

The system continuously monitors sensor data (pressures, flow rates, physiologic parameters) and provides feedback by comparing actual measurements against expected values. When deviations indicate potential errors or harmful conditions, the system generates alarms to alert operators, thereby maintaining ease of automated operation while mitigating patient safety risks through active monitoring and feedback.

Inventive Principle:
Principle #23Feedback

3Reliability

If manual control is used, then reliability is maintained through human judgment, but productivity decreases due to susceptibility to human error

Engineering Contradiction:
Improvecontrol accuracyVSAvoidprocedure efficiency
Core Design Contradiction:
ReliabilityVSProductivity

Solution Approach 1:

The system acts as an intermediary between manual operator control and the actual blood flow control mechanism. It provides automated monitoring, error detection, and alarm functions that support the operator's manual control decisions, thereby maintaining the reliability of human judgment while improving productivity by reducing human error and increasing procedure efficiency through automated assistance.

Inventive Principle:
Principle #24Intermediary (Mediator)

Data Source

PatentEP4121159B1Blood flow control systems and error detection thereof
Publication Date: 2025.11.05 CERTUS CRITICAL CARE INC
  • EP4121159B1 patent drawingFigure 1
  • EP4121159B1 patent drawingFigure 2
  • EP4121159B1 patent drawingFigure 3

AI summary

Systems and methods for blood flow control are described herein. In some variations, a blood flow control system may comprise a blood flow control device. The blood flow control device may be placed within a body of a patient and may comprise an expandable member and a sensor. The sensor may be configured to measure at least one of a physiologic condition of the patient and a pressure associated with the expandable member. The blood flow control system may include at least one controller communicably coupled to the sensor to: receive data indicative of at least one of the physiologic condition of the patient and the pressure associated with the expandable member from the sensor, compare the received data with target data, identify at least one error based on the comparison, and in response to identifying the error, inhibit at least one function of the blood flow control system.