Catheter Malfunction Detection via Physiologic Pressure Modulation

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Solution Overview

Problem

Infusion catheters in implanted systems can malfunction due to improper placement, migration, blockages, or leaks, leading to ineffective delivery of therapeutic substances to the intended internal delivery site, which can result in incomplete or dispersed medication and additional complications.

Innovation Solution

The method involves analyzing pressure modulation profiles within the catheter to determine if the catheter is properly located, functioning correctly, and not obstructed or leaking by comparing measured fluid pressure to expected physiologic pressure changes at the internal delivery site, using a pressure sensor and control electronics to develop and compare pressure modulation profiles.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If catheter pressure monitoring is implemented to detect malfunctions, then reliability of therapeutic substance delivery is improved, but device complexity increases due to additional pressure sensors and control electronics

Engineering Contradiction:
Improvecatheter placement accuracyVSAvoidsystem complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The catheter system performs self-diagnosis by monitoring its own pressure characteristics to detect malfunctions such as improper placement, migration, blockages, or leaks. The pressure sensor and control electronics automatically analyze pressure modulation profiles and generate malfunctions determinations without requiring external intervention, enabling the system to service itself and maintain reliable operation.

Inventive Principle:
Principle #25Self-service

2Reliability

If continuous pressure monitoring is performed to detect catheter malfunctions, then reliability of delivery is improved, but use of energy increases due to continuous operation of pressure sensor and signal processing

Engineering Contradiction:
Improvedelivery effectivenessVSAvoidenergy consumption
Core Design Contradiction:
ReliabilityVSUse of energy by moving object

Solution Approach 1:

The system employs periodic pressure monitoring rather than continuous monitoring, analyzing pressure modulation profiles at predetermined time intervals. The control electronics are configured to evaluate pressure characteristics periodically to detect malfunctions, which reduces energy consumption while maintaining adequate monitoring capability for catheter placement verification and malfunction detection.

Inventive Principle:
Principle #19Periodic 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

This approach allows for the accurate identification of catheter malfunctions, ensuring proper placement and operation, thereby ensuring effective delivery of therapeutic substances and minimizing complications by terminating fluid delivery when a malfunction is detected.

Implementation Method 1

measuring pressure of a fluid within a lumen in a catheter

Methodology Applied
Scientific EffectPressure sensing:

Data Source

PatentUS8323244B2Catheter malfunction determinations using physiologic pressure
Publication Date: 2012.12.04 MEDTRONIC INC
  • US8323244B2 patent drawing
  • US8323244B2 patent drawing
  • US8323244B2 patent drawing

AI summary

Methods and systems for determining whether an implanted catheter used to deliver fluids to a selected internal delivery site is malfunctioning. The malfunctions may include that the infusion section of the catheter is not located at or has migrated away from the selected internal delivery site, is leaking, is blocked, etc. The determination is made by analyzing the pressure modulation of fluid within the catheter and determining whether the pressure of the fluid in the catheter is modulated by physiologic pressure changes experienced at the selected internal delivery site. The physiologic pressure modulations at the selected internal delivery site may be caused by, e.g., cardiac activity, respiration, changes in patient's posture, etc.