Protein Detection Kit for Infusion Pump Refilling Safety

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Solution Overview

Problem

Implantable infusion pumps face safety concerns during refilling due to human error, where healthcare professionals may inject medication into surrounding tissues instead of the reservoir, leading to potential overdose, underdose, or adverse events, as it is challenging to determine if the correct reservoir has been accessed during the refilling process.

Innovation Solution

A kit and method using a color-changing composition, such as biuret, to detect proteins in withdrawn fluid, ensuring that the correct reservoir is accessed before refilling by indicating a color change upon contact with proteins, thereby preventing pocket fills and ensuring safe refilling of the infusion pump.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If a needle is inserted into the pump reservoir for refilling, then the medication can be delivered to the patient, but there is a risk that the needle may incorrectly access surrounding tissues instead of the reservoir

Engineering Contradiction:
Improvecorrect reservoir accessVSAvoidpocket fill error
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent applies preliminary action by testing the fluid withdrawn from the reservoir before refilling with new medication. The system withdraws a sample fluid through the needle, tests it for protein content using a reagent, and only proceeds with refilling if the test confirms correct reservoir access. This preliminary testing step prevents the harmful effect of pocket fill errors by ensuring the needle is properly positioned in the reservoir before medication is administered.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The patent implements feedback by using a color-changing reagent that provides immediate visual confirmation of correct reservoir access. When fluid containing protein (indicating correct reservoir access) is withdrawn, the reagent changes color to signal successful access. This feedback mechanism allows healthcare professionals to verify proper needle placement before proceeding with refilling, thereby preventing pocket fill errors.

Inventive Principle:
Principle #23Feedback

2Reliability

If the pump system is designed to prevent exposure to foreign materials, then pump malfunction and infection are prevented, but it becomes difficult to detect whether the correct reservoir has been accessed during refilling

Engineering Contradiction:
Improvepump safetyVSAvoidreservoir access verification
Core Design Contradiction:
ReliabilityVSDifficulty of detecting and measuring

Solution Approach 1:

The patent applies color changes by using a reagent that changes color when it contacts fluid containing protein. This color change provides a simple, visual method to detect whether the correct reservoir has been accessed during refilling. The reagent is introduced into the withdrawn fluid, and if the fluid contains protein (indicating correct reservoir access), the reagent changes color to provide clear verification. This solves the detection difficulty while maintaining pump safety standards.

Inventive Principle:
Principle #32Color changes

Solution Approach 2:

The patent uses an intermediary substance (the protein-detecting reagent) to verify reservoir access. The reagent acts as a mediator between the withdrawn fluid and the verification process, providing indirect but reliable evidence of correct needle placement. This intermediary approach allows detection of reservoir access without compromising the pump's protection against foreign materials, as the reagent is introduced only in the external testing container, not into the pump reservoir itself.

Inventive Principle:
Principle #24Intermediary (Mediator)

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

The solution effectively reduces the risk of errors by providing a visual indication of correct reservoir access, preventing medication from being injected into surrounding tissues and ensuring accurate refilling of the infusion pump, thus enhancing patient safety.

Implementation Method 1

A kit and method using a color-changing composition, such as biuret, to detect proteins in withdrawn fluid, ensuring that the correct reservoir is accessed before refilling by indicating a color change upon contact with proteins

Methodology Applied
Scientific EffectProtein detection via color change:

Data Source

PatentUS10434248B1Kit and method of reducing human error during implanted infusion pump refilling
Publication Date: 2019.10.08 AMNEAL PHARMACEUTICALS LLC
  • US10434248B1 patent drawing
  • US10434248B1 patent drawing
  • US10434248B1 patent drawing

AI summary

Protein detection kit usable with implanted infusion pumps. The kit includes at least one container containing a protein-detecting composition and having an interface for allowing fluid to be introduced and a visual indicating mechanism for providing a visual indicator indicative of protein detection.