Infusion Set Data Storage for Automated Priming

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Solution Overview

Problem

Current infusion sets for continuous medical substance administration in diabetic patients face challenges such as unauthorized or used sets being used, manual priming processes that are visually demanding, and potential safety-critical situations due to lack of automated compliance monitoring.

Innovation Solution

An infusion set with a processor-controlled dosing device and integrated data memory that uses RFID or optical identification systems to ensure only authorized sets are used, automatically monitors priming and operating states, and enables automated priming processes, preventing misuse and ensuring therapy compliance.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If manual priming monitoring is required, then the patient can control the priming process, but the patient's eyesight demands are high and diabetes symptoms make this difficult

Engineering Contradiction:
Improvepriming process monitoringVSAvoidpatient eyesight requirements
Core Design Contradiction:
Ease of operationVSObject-affected harmful factors

Solution Approach 1:

The infusion device automatically performs the priming process without requiring patient monitoring. The device self-regulates the filling of the catheter tubing with medication, eliminating the need for the patient to visually monitor droplet emergence from the cannula tip.

Inventive Principle:
Principle #25Self-service

Solution Approach 2:

The manual visual monitoring process is replaced by an automated electronic control system. Sensors and processors detect when priming is complete based on fluid flow parameters, substituting the mechanical/visual monitoring task with an electronic detection and control system.

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

2Adaptability or versatility

If infusion sets with standard Luer-lock connectors are used, then compatibility between different infusion sets and pumps is achieved, but unauthorized or used sets may be connected

Engineering Contradiction:
Improveconnector compatibilityVSAvoidinfusion set authorization
Core Design Contradiction:
Adaptability or versatilityVSReliability

Solution Approach 1:

An RFID data storage device acts as an intermediary between the infusion set and the delivery device. This intermediate component carries authorization information that the delivery device reads to verify whether the infusion set is authorized for use, bridging the gap between physical compatibility and logical authorization.

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The authorization information is copied onto an RFID tag or data storage device attached to the infusion set. This digital copy of authorization data can be read and verified by the delivery device without affecting the physical connector design, allowing verification of authenticity while maintaining compatibility.

Inventive Principle:
Principle #26Copying

3Reliability

If data storage devices are integrated into infusion sets, then authorization and usage tracking are enabled, but the device complexity increases

Engineering Contradiction:
Improveinfusion set authorization verificationVSAvoidinfusion set structure
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The data storage functionality is extracted as a separate, removable component (RFID tag or data cartridge) that can be attached to or removed from the infusion set. This allows the authorization verification function to be added without permanently complicating the infusion set structure, and the data component can be replaced independently.

Inventive Principle:
Principle #2Taking out (Extraction)

4Reliability

If automated priming is implemented, then patient safety is improved by preventing overpriming, but the system complexity increases

Engineering Contradiction:
Improvepriming accuracyVSAvoidpriming control system
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The automated priming system uses feedback from sensors that detect when the catheter tubing is properly filled. The system continuously monitors priming progress and automatically stops when the correct amount of medication has been delivered, preventing overpriming while managing complexity through intelligent control algorithms.

Inventive Principle:
Principle #23Feedback

Data Source

PatentEP2015804B1Infusion apparatus with a data storage device
Publication Date: 2019.02.13 ROCHE DIABETES CARE GMBH
  • EP2015804B1 patent drawingFigure 1
  • EP2015804B1 patent drawingFigure 2
  • EP2015804B1 patent drawingFigure 3

AI summary

An infusion apparatus (1a, 1b, 1c) for administering a medical liquid includes: a data storage unit (2) for the exchange of data over a data exchange device (4) with an administering device (3) characterized by the transmission of information on a data storage unit (2) using a bi-directional data exchange device (4) of the administering device to determine deviations from the therapy conformal operating state in such a way that an operating state can be established either automatically or by using a pump. The “auto-priming process” corresponds to the setup of a specific therapy conformal operating state. If information that defines and determines a specific priming volume is in the data memory (2) of the infusion apparatus, the external administering device can trigger an automatic or semiautomatic priming process.