Sensor Inserter Assembly for Continuous Glucose Monitoring

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Solution Overview

Problem

Conventional methods for monitoring glucose levels in diabetics are invasive, bulky, and inconvenient, often requiring manual and periodic testing, which can lead to inconsistent monitoring and increased risk of hyperglycemic or hypoglycemic episodes due to their inflexibility and discomfort.

Innovation Solution

A subcutaneously implantable electrochemical sensor system with a small, comfortable design that allows continuous monitoring of glucose levels, featuring a sensor control unit with conductive contacts, a transmitter, and optional components like an adhesive, mounting unit, and alarm system, along with an insertion kit for easy sensor placement, enabling automatic and continuous glucose level monitoring.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Extent of automation

If electrochemical sensors are directly implanted into blood vessels or subcutaneous tissue for continuous monitoring, then continuous glucose monitoring capability is achieved, but device size becomes large and bulky

Engineering Contradiction:
Improvecontinuous monitoring capabilityVSAvoiddevice size
Core Design Contradiction:
Extent of automationVSVolume of moving object

Solution Approach 1:

The device is divided into two separate components: a small implantable sensor that is inserted subcutaneously for continuous monitoring, and a separate external receiver unit that processes and displays the data. This segmentation allows the implantable portion to be miniaturized while maintaining continuous monitoring functionality.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The system transitions from a single bulky implantable device to a distributed architecture where the sensor is implanted in the third dimension (subcutaneous space) while the processing and display functions are moved to an external device, effectively utilizing spatial separation to reduce implantable volume.

Inventive Principle:
Principle #17Another dimension (Dimensionality change)

2Reliability

If sensor guides are used to hold the sensor in place on or near the skin, then sensor positioning is achieved, but the device becomes bulky and restricts patient movement

Engineering Contradiction:
Improvesensor positioning stabilityVSAvoidpatient freedom of movement
Core Design Contradiction:
ReliabilityVSEase of operation

Solution Approach 1:

The sensor guide function is extracted from the implantable sensor itself and implemented as a separate adhesive mounting device applied to the skin surface. This allows the sensor to be securely positioned without requiring the sensor structure itself to include bulky guiding or anchoring mechanisms.

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

An adhesive mounting device serves as an intermediary between the patient's skin and the sensor, providing secure attachment and positioning while allowing the sensor to remain small and flexible. The adhesive layer acts as a mediator that transfers the positioning function without adding bulk to the sensor.

Inventive Principle:
Principle #24Intermediary (Mediator)

3Loss of information

If cables or wires are included to connect the sensor to analysis equipment, then signal transmission is achieved, but the device complexity and bulk increase

Engineering Contradiction:
Improvesignal transmission capabilityVSAvoiddevice structure
Core Design Contradiction:
Loss of informationVSDevice complexity

Solution Approach 1:

The mechanical connection system (cables and wires) is replaced with a wireless communication system. The implantable sensor contains a transmitter that wirelessly transmits glucose data to the external receiver, eliminating the need for physical connections and reducing device complexity.

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

Solution Approach 2:

The sensor utilizes flexible printed circuit boards and thin-film technology to create flexible, thin connections between sensor components, replacing rigid cables and wires with flexible, integrated circuit traces that maintain signal transmission while minimizing bulk.

Inventive Principle:
Principle #30Flexible shells and thin films

4Measurement precision

If periodic manual blood testing is performed, then glucose level determination is achieved, but monitoring consistency varies and hyperglycemic or hypoglycemic episodes may occur

Engineering Contradiction:
Improveglucose level determinationVSAvoidmonitoring consistency
Core Design Contradiction:
Measurement precisionVSReliability

Solution Approach 1:

The system provides continuous real-time monitoring of glucose levels through the implantable sensor, replacing periodic manual testing with uninterrupted measurement. This continuous action ensures consistent monitoring and immediate detection of glucose level changes, preventing hyperglycemic or hypoglycemic episodes.

Inventive Principle:
Principle #20Continuity of useful action

Solution Approach 2:

The system implements continuous feedback by constantly monitoring glucose levels and immediately transmitting data to the receiver, allowing patients to receive real-time information about their glucose status and take appropriate actions before critical episodes occur.

Inventive Principle:
Principle #23Feedback

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 system provides continuous, automatic glucose monitoring, allowing patients to engage in normal activities while receiving timely alerts for threshold glucose levels, thereby reducing the risk of severe glycemic events and improving management of diabetes.

Implementation Method 1

A number of these devices use electrochemical sensors which are directly implanted into a blood vessel or in the subcutaneous tissue of a patient

Methodology Applied
Scientific EffectElectrochemical detection:

Implementation Method 2

The mounting unit may include an adhesive that adheres to the skin of the patient

Methodology Applied
Scientific EffectAdhesion: Adhesive

Data Source

PatentUS9980670B2Sensor inserter assembly
Publication Date: 2018.05.29 ABBOTT DIABETES CARE INC
  • US9980670B2 patent drawing
  • US9980670B2 patent drawing
  • US9980670B2 patent drawing

AI summary

An analyte monitor includes a sensor, a sensor control unit, and a display unit. The sensor control unit typically has a housing adapted for placement on skin and is adapted to receive a portion of an electrochemical sensor. The sensor control unit also includes two or more conductive contacts disposed on the housing and configured for coupling to two or more contact pads on the sensor. A transmitter is disposed in the housing and coupled to the plurality of conductive contacts for transmitting data obtained using the sensor. The display unit has a receiver for receiving data transmitted by the transmitter of the sensor control unit and a display coupled to the receiver for displaying an indication of a level of an analyte, such as blood glucose. An inserter having a retractable introducer is provided for subcutaneously implanting the sensor in a predictable and reliable fashion.