Smart Insulin Pen Cap with Automatic Dosing Data Capture and Feedback

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Solution Overview

Problem

Conventional diabetes treatment methods, including insulin pens and pumps, lack effective data capture and feedback mechanisms, leading to inadequate monitoring and management of insulin dosing, oral medications, blood glucose levels, and carbohydrate intake, resulting in poor adherence to therapy and glycemic control.

Innovation Solution

A smart pen cap system that provides step-by-step instructions, automatically captures and transmits data on insulin dosing, blood glucose levels, and carbohydrate intake, and includes sensors for real-time monitoring and alerts, enabling timely drug replenishment, adherence tracking, and personalized feedback to patients and healthcare providers.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Loss of information

If conventional insulin pens and pumps are used, then insulin delivery function is provided, but data capture and feedback mechanisms are insufficient

Engineering Contradiction:
Improvedata capture capabilityVSAvoidsystem complexity
Core Design Contradiction:
Loss of informationVSDevice complexity

Solution Approach 1:

The patent introduces an intermediary data capture system that includes sensors, memory, and communication interfaces to bridge the gap between simple insulin delivery devices and comprehensive diabetes management. This intermediary layer captures dosage information, blood glucose data, and carbohydrate intake without fundamentally redesigning the insulin pen itself, thus improving data capture while controlling complexity.

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The insulin delivery device is enhanced with multiple functions beyond just insulin delivery, including data capture, storage, wireless communication, and integration with mobile applications. This multi-functionality allows a single device to serve both therapeutic and monitoring purposes, addressing the information loss problem without requiring entirely separate systems.

Inventive Principle:
Principle #6Universality (Multi-functionality)

2Measurement precision

If manual data recording in logbooks is used, then data collection is possible, but errors and omissions increase

Engineering Contradiction:
Improvedata accuracyVSAvoidtime for data transposition
Core Design Contradiction:
Measurement precisionVSLoss of time

Solution Approach 1:

The system enables automatic data capture and recording without requiring patient intervention for manual entry. Sensors automatically detect insulin dosage administered, blood glucose levels measured, and carbohydrate intake recorded, eliminating the need for patients to manually transcribe data into logbooks and thereby preventing errors and omissions.

Inventive Principle:
Principle #25Self-service

Solution Approach 2:

The patent replaces the mechanical manual writing process with electronic sensors, memory storage, and digital communication systems. This substitution automates data capture from physical actions (insulin injection, blood glucose testing, carbohydrate logging) into digital formats, significantly improving accuracy and eliminating transcription errors.

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

3Reliability

If frequent doctor-patient feedback loops are implemented, then therapy optimization improves, but conventional systems lack adequate data transmission

Engineering Contradiction:
Improvetherapy effectivenessVSAvoidfeedback frequency
Core Design Contradiction:
ReliabilityVSProductivity

Solution Approach 1:

The patent implements continuous feedback mechanisms where data from sensors (insulin dosage, blood glucose, carbohydrate intake) is automatically captured, stored, and transmitted to healthcare providers via wireless communication. This creates a reliable feedback loop that enables frequent monitoring and therapy optimization without requiring manual data collection, thereby improving both reliability and productivity.

Inventive Principle:
Principle #23Feedback

Solution Approach 2:

The system introduces an intermediary digital communication layer between patient and provider, using mobile applications and wireless transmission to bridge the gap. This intermediary enables frequent, reliable data exchange without the constraints of manual logbook review, allowing therapists to optimize treatment based on continuous data streams.

Inventive Principle:
Principle #24Intermediary (Mediator)

4Reliability

If comprehensive diabetes monitoring is implemented, then glycemic control improves, but device complexity increases

Engineering Contradiction:
Improveglycemic controlVSAvoidmonitoring system complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The patent divides the comprehensive monitoring system into separate functional modules: insulin pen with dosage sensor, blood glucose meter with data capture, carbohydrate logging interface, memory storage unit, and wireless communication module. Each module performs a specific function independently, then integrates through standardized interfaces, making the overall complex system manageable and maintainable while achieving comprehensive glycemic control.

Inventive Principle:
Principle #1Segmentation

Data Source

PatentEP3209353B1Improved systems and methods for medicine delivery
Publication Date: 2020.07.15 BECTON DICKINSON & CO
  • EP3209353B1 patent drawingFigure 1A~1C
  • EP3209353B1 patent drawingFigure 2
  • EP3209353B1 patent drawingFigure 3

AI summary

Improved systems and methods for medicine delivery, and in particular, improved insulin pen needles and related devices are provided. Smart injection devices record and transfer data including medicine level, delivered dose, dose confirmation, and dose time and date. Additional data captured may include glucose concentration, insulin level, carbohydrates ingested, stress level, exercise, blood pressure, and glucose high and low excursion events. Various means of data collection and analysis are provided and systems can identify and flag patients who require intervention. Smart sleeves and add sensing capability to standard insulin pens. Pen needles are provided with sensing capability to confirm and measure doses delivered by insulin pen. A two-part pen cap include a primary sleeve that connects to the insulin pen and an end cap that provides for capturing the time of dose delivery, and monitoring the hold time for a dose delivery after plunger movement.