Implantable Pump Conductivity Sensor for Pocket Fill Detection

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Solution Overview

Problem

Implantable medical pumps and ports face a significant risk of inadvertently injecting infusate into the tissue pocket surrounding the device during refill procedures, which can lead to fatal overdoses.

Innovation Solution

The implementation of a conductivity sensor arrangement with electrodes on the exterior of the implantable pump or port to detect the introduction of infusate into surrounding tissue, combined with positioning markers, needle detection sensors, and reservoir volume sensing technology, to enhance safety during refills.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If refill procedures are performed without conductivity monitoring, then the refill process is simple and quick, but the risk of inadvertent pocket fill and fatal overdose increases

Engineering Contradiction:

Improvesafety during refillVSAvoiddevice structure

Core Design Contradiction:

ReliabilityVSDevice complexity

Solution Approach 1:

The conductivity sensor is pre-positioned on the external surface of the implantable medical device housing, ready to detect fluid presence before inadvertent injection occurs. The sensor activates automatically during refill procedures to provide real-time monitoring, preventing pocket fill before it can cause harm.

Inventive Principle:

Principle #10Preliminary action

Solution Approach 2:

The conductivity sensor acts as an intermediary detection mechanism between the refilling apparatus and the tissue pocket. It provides an intermediate warning signal when fluid is detected in the pocket area, allowing intervention before fatal overdose occurs.

Inventive Principle:

Principle #24Intermediary (Mediator)

2Reliability

If conductivity sensors are added to detect pocket fill, then safety during refill is improved, but the device complexity and manufacturing difficulty increase

Engineering Contradiction:

Improvedetection accuracyVSAvoidmanufacturing process

Core Design Contradiction:

ReliabilityVSEase of manufacture

Solution Approach 1:

The conductivity sensor uses simple electrode structures that can be easily manufactured and integrated into the device housing. The sensor components are designed to be cost-effective and straightforward to produce, minimizing manufacturing complexity while maintaining detection functionality.

Inventive Principle:

Principle #27Cheap short-living objects (Disposable)

3Reliability

If real-time conductivity monitoring is implemented, then the risk of pocket fill is reduced, but the refill procedure time increases

Engineering Contradiction:

Improvesafety monitoringVSAvoidrefill procedure duration

Core Design Contradiction:

ReliabilityVSLoss of time

Solution Approach 1:

The conductivity sensor provides continuous monitoring throughout the entire refill procedure, from needle insertion to fluid administration. This continuous detection ensures that any inadvertent pocket fill is immediately detected, allowing for rapid response while maintaining uninterrupted safety surveillance.

Inventive Principle:

Principle #20Continuity of useful 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 significantly reduces the risk of pocket fill during refills by providing real-time monitoring and alerts, thereby ensuring safer targeted drug delivery systems.

Implementation Method 1

a conductivity sensor configured to monitor fluid in proximity to the conductivity sensor for an inadvertent injection of infusate into a pocket of tissue surrounding the implantable medical device

Methodology Applied

Scientific EffectElectrical conductivity: Conduction (electrical)

Data Source

PatentUS20250152811A1Implantable medical devices that detect inadvertent delivery of drug to a subcutaneous pocket

Publication Date: 2025.05.15 MEDTRONIC INC

AI summary

An implantable medical device configured to monitor fluid in proximity to an implantable medical device for an inadvertent introduction of infusate into a pocket of tissue surrounding the implantable medical device during a refill procedure, the implantable medical device including one or more sensors configured to monitor fluid in proximity to an exterior of the implantable medical device during a procedure to refill the device with infusate, and a processor configured to monitor the one or more sensors during an infusate refill procedure and to activate one or more notification, alert or alarm features to notify a user that a pocket fill may be occurring.