Infant Insulin Pump Segmented Dosing Unit

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Solution Overview

Problem

Current insulin pumps for continuous subcutaneous insulin infusion (CSII) therapy in infants face challenges due to high dosing errors, limited precision, and bulkiness, which can lead to severe medical complications, and require cumbersome dilution of insulin with saline solution.

Innovation Solution

A dosing unit with a variable pump cylinder and control valve that allows precise volumetric dosing by refilling from a separate drug container, minimizing bulkiness and reducing the risk of errors, while keeping the insulin reservoir at a cool temperature to maintain biological activity.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Duration of action of moving object

If a large volume drug container (e.g., 3 ml) is used in typical insulin pumps, then the device can supply insulin for multiple days, but the dosing precision and resolution are insufficient for infants with low total daily dose requirements

Engineering Contradiction:
Improveduration of insulin supplyVSAvoiddosing precision
Core Design Contradiction:
Duration of action of moving objectVSMeasurement precision

Solution Approach 1:

The system divides the drug container into two separate components: a large storage container (3 ml capacity) and a small dosing unit (0.3 ml capacity). The dosing unit is repeatedly refilled from the storage container, allowing multi-day supply duration while maintaining high dosing precision for infant requirements.

Inventive Principle:
Principle #1Segmentation

2Reliability

If the insulin reservoir is kept at low temperatures to maintain biological activity, then insulin stability is improved, but the device becomes bulkier and less portable

Engineering Contradiction:
Improveinsulin biological activityVSAvoiddevice volume
Core Design Contradiction:
ReliabilityVSVolume of moving object

Solution Approach 1:

The system separates the temperature-sensitive storage container from the portable dosing unit. The storage container can be kept refrigerated when not in use, while the small dosing unit (containing only 0.3 ml at a time) can be carried at body temperature, reducing the volume of the moving portable device.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The patent introduces a temperature control element that can maintain the storage container at low temperatures while allowing the dosing unit to operate at body temperature. This intermediary temperature control system enables both temperature stability for insulin activity and portability for the dosing unit.

Inventive Principle:
Principle #24Intermediary (Mediator)

3Measurement precision

If the dosing unit volume is reduced to match infant TDD requirements (e.g., 0.3 ml for 3 days), then dosing precision is improved, but the device requires frequent refilling and becomes more complex

Engineering Contradiction:
Improvedosing precisionVSAvoiddevice complexity
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The system divides the drug container into two separate components: a large storage container (3 ml capacity) and a small dosing unit (0.3 ml capacity). The dosing unit is repeatedly refilled from the storage container, allowing multi-day supply duration while maintaining high dosing precision for infant requirements.

Inventive Principle:
Principle #1Segmentation

4Object-affected harmful factors

If a small dosing unit volume (0.3 ml) is used for infants, then the risk of overdose is reduced, but the device becomes bulkier relative to the dosing requirements

Engineering Contradiction:
Improveoverdose riskVSAvoiddevice volume
Core Design Contradiction:
Object-affected harmful factorsVSVolume of moving object

Solution Approach 1:

The system divides the drug container into two separate components: a large storage container (3 ml capacity) and a small dosing unit (0.3 ml capacity). The dosing unit is repeatedly refilled from the storage container, allowing multi-day supply duration while maintaining high dosing precision for infant requirements.

Inventive Principle:
Principle #1Segmentation

Data Source

PatentEP2815778B1Portable infusion device for infants with refillable small volume dosing unit
Publication Date: 2017.08.16 F HOFFMANN LA ROCHE & CO AG
  • EP2815778B1 patent drawingFigure 1~5
  • EP2815778B1 patent drawingFigure 2
  • EP2815778B1 patent drawingFigure 3

AI summary

Disclosed is a portable infusion device comprising a dosing unit (100) and a base unit (200), the dosing unit including an inlet port (105), an outlet port (115), and a pump with a cylinder (125) and a piston (130) forming a stepwise or continuously variable dosing volume, a control valve (120) to couple the dosing volume alternatively, in a filling state (120a), to the inlet port (105) for refilling from an external liquid drug container (300) or, in a infusing state (120b), to the outlet port (115). The base unit comprises a control unit (210) and a drive unit (215). A container storage box (401) for storing the drug container (300) including a temperature control unit (410) is also disclosed.