Wearable Analyte Sensing With Closed-Loop Transdermal Delivery

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Solution Overview

Problem

Existing CGM systems require multiple devices for glucose monitoring and insulin delivery, leading to user burden and potential interference between glucose concentration signals and insulin administration.

Innovation Solution

A wearable device with a sensor extending through the stratum corneum, epidermis, and dermis, incorporating control electronics and electrodes to deliver therapeutic agents via iontophoresis, electroporation, or magnetohydrodynamics, allowing closed-loop control for analyte sensing and agent delivery.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Adaptability or versatility

If multiple devices are used for glucose monitoring and insulin delivery, then functional completeness is achieved, but device complexity and user burden increase

Engineering Contradiction:

Improvefunctional completenessVSAvoidnumber of devices

Core Design Contradiction:

Adaptability or versatilityVSDevice complexity

Solution Approach 1:

The patent combines glucose sensing and insulin delivery functions into a single integrated wearable device. The sensor extends through the stratum corneum to measure interstitial glucose, while electrodes deliver insulin via iontophoresis, eliminating the need for separate CGM and insulin pump devices.

Inventive Principle:

Principle #5Merging (Combining)

Solution Approach 2:

The wearable device performs multiple functions simultaneously: it monitors glucose concentration, delivers insulin therapy, and provides closed-loop control. This multi-functional approach reduces the number of separate devices needed while maintaining complete therapeutic functionality.

Inventive Principle:

Principle #6Universality (Multi-functionality)

2Adaptability or versatility

If multiple devices are worn on the body, then comprehensive therapy is achieved, but ease of operation decreases

Engineering Contradiction:

Improvetherapy completenessVSAvoiduser burden

Core Design Contradiction:

Adaptability or versatilityVSEase of operation

Solution Approach 1:

By merging sensing and delivery functions into one device, the patent eliminates the need for users to manage multiple separate devices. The integrated system automatically performs glucose monitoring and insulin delivery without requiring separate user actions for each function.

Inventive Principle:

Principle #5Merging (Combining)

Solution Approach 2:

The device provides closed-loop control where the sensor automatically detects glucose levels and the control electronics automatically adjust insulin delivery without requiring manual user intervention. This self-regulating capability reduces user burden while maintaining comprehensive therapy.

Inventive Principle:

Principle #25Self-service

3Reliability

If separate glucose monitoring and insulin delivery devices are used, then functional independence is maintained, but signal interference occurs

Engineering Contradiction:

Improvesignal accuracyVSAvoidsignal interference

Core Design Contradiction:

ReliabilityVSObject-generated harmful factors

Solution Approach 1:

The patent integrates the glucose sensor and insulin delivery electrodes into a single wearable unit, eliminating the spatial separation that causes interference between devices. The sensor and electrodes are positioned to work together without generating interfering signals.

Inventive Principle:

Principle #5Merging (Combining)

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 device provides continuous, accurate, and user-independent analyte monitoring and therapeutic agent delivery, reducing the need for multiple devices and minimizing interference, thus improving management of health conditions.

Implementation Method 1

receive a signal from the distal end of the sensor corresponding to a concentration of one or more analytes within the subcutaneous tissue

Methodology Applied

Scientific EffectElectrical signal detection: Conduction (electrical)

Implementation Method 2

applying the electrical stimulus to the first and second electrodes to deliver the therapeutic agent across the stratum corneum via iontophoresis

Methodology Applied

Scientific EffectIontophoresis: Iontophoresis

Implementation Method 3

applying the electrical stimulus to the first and second electrodes to deliver the therapeutic agent across the stratum corneum via electroporation

Methodology Applied

Scientific EffectElectroporation:

Implementation Method 4

responsive to the electrical stimulus, an amount of the therapeutic agent is transported out of the polymer

Methodology Applied

Scientific EffectDiffusion: Diffusion

Data Source

PatentUS20250325807A1Devices and methods for sensing analytes and delivering therapeutic agents

Publication Date: 2025.10.23 DEXCOM INC

AI summary

Some examples herein provide a wearable device for sensing a concentration of an analyte and delivering a therapeutic agent. A sensor is configured to extend fully through stratum corneum, epidermis, and dermis and partially into subcutaneous tissue, and includes a distal end configured to be located within the subcutaneous tissue. A reservoir is configured to contact the stratum corneum and includes a polymer complexed with the drug. Control electronics coupled to the sensor's proximal end of the sensor include first and second electrodes, and are configured to receive a signal from the sensor's distal end corresponding to the concentration of the analyte within the subcutaneous tissue. Control electronics determine, using the signal, electrical stimulus to be applied to a first electrode and a second electrode, and apply that electrical stimulus to deliver the therapeutic agent across the stratum corneum.