Wearable Hypoglycemia Injection Device with Sensor-Triggered Glucagon Delivery

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Solution Overview

Problem

Diabetic patients experiencing hypoglycemia while asleep are unable to self-administer treatment, posing a significant risk due to their inability to recognize symptoms or seek help, highlighting the need for an automated system to administer glucose-regulating agents like glucagon.

Innovation Solution

An emergency injection device worn on the body, equipped with a glucose sensor, acoustical alarm, and automatic injector, which detects low blood glucose levels, alerts the patient, and automatically administers a dose of glucagon after a predetermined time if the patient does not manually abort the injection, ensuring timely treatment during unconscious hypoglycemic events.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If an automated injection system is implemented to treat hypoglycemia when the patient is unconscious, then the reliability of treatment administration is improved, but the device complexity increases

Engineering Contradiction:
Improvetreatment administration reliabilityVSAvoiddevice complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The device is divided into distinct functional modules: a sensor module for detecting glucose levels, a control module for processing sensor data and determining injection timing, an alarm module for alerting the patient, and an injection module for administering glucagon. This segmentation allows each module to be optimized independently while working together to solve the reliability-complexity contradiction.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The device performs preliminary monitoring of blood glucose levels continuously and maintains readiness to administer treatment before hypoglycemic symptoms become severe. The system proactively detects low glucose levels and prepares for automatic injection, ensuring treatment is administered before the patient becomes fully unconscious and unable to self-treat.

Inventive Principle:
Principle #10Preliminary action

2Ease of operation

If automatic injection is delayed by a predetermined period after alarm activation, then the patient has opportunity to abort unnecessary injection, but the response time to treat severe hypoglycemia increases

Engineering Contradiction:
Improvepatient control capabilityVSAvoidtreatment delay
Core Design Contradiction:
Ease of operationVSLoss of time

Solution Approach 1:

The system implements a partial delay mechanism where the alarm is activated immediately upon detecting hypoglycemia, giving the patient a head start to respond. The predetermined period before automatic injection is set to a minimum necessary duration that allows conscious patients to abort unnecessary injections while being short enough to ensure timely treatment of severe hypoglycemia. This balances patient control with rapid response by using just enough delay to prevent false treatment without excessive waiting.

Inventive Principle:
Principle #16Partial or excessive action

3Reliability

If the needle remains in the septum during storage, then the sterile integrity is maintained, but the injection cannot be administered until the needle pierces the septum

Engineering Contradiction:
Improvesterile integrityVSAvoidinjection activation time
Core Design Contradiction:
ReliabilityVSLoss of time

Solution Approach 1:

The needle is pre-positioned within the septum in a ready-to-pierce configuration during device assembly and storage, maintaining sterile integrity while being prepared for rapid deployment. The mechanical coupling between the needle and injector is pre-established, so that when the controller activates the injector, the needle immediately pierces the septum and enters the patient's body without requiring additional setup or positioning actions.

Inventive Principle:
Principle #10Preliminary action

Data Source

PatentEP3220978B1Apparatus and methods for administering a pharmaceutical agent
Publication Date: 2021.08.11 ZEALAND PHARMA AS
  • EP3220978B1 patent drawingFigure 1A~1B
  • EP3220978B1 patent drawingFigure 1C
  • EP3220978B1 patent drawingFigure 1D

AI summary

An injection device adapted to be worn on the body of a patient. The device includes an injector containing an agent for treating hypoglycaemia. A control assembly including a signal receiver is configured to receive signals from a glucose sensor, the control assembly being electrically coupled to an alarm and configured to activate the alarm upon a signal received in the signal receiver being indicative of hypoglycaemia, the control assembly being configured to cause the injector to administer through a needle a dose of the agent to the patient after a predetermined period of time of the signal receiver receiving the signal indicative of hypoglycaemia, the control assembly having a manually activated switch that when activated prior to the expiration of the predetermined period of time causes the control assembly to abort the injection of the agent.