Integrated Analyte Measurement System with Electromechanical Lancing
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Solution Overview
Problem
Current lancing devices for blood glucose monitoring are inefficient, with a 50% success rate for spontaneous blood droplet generation, requiring manual dexterity and multiple steps for testing, and causing pain and discomfort, especially for diabetic patients with retinopathies and neuropathies.
Innovation Solution
An integrated analyte measurement system with an electromechanical driver and microfluidic structures that automatically generate and capture blood samples using penetrating members and analyte sensors, reducing pain and manual dexterity requirements through electronic control of penetrating member position and velocity, and integrating sample generation with testing.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If mechanical lancing devices with spring, cam and mass actuators are used, then lancing function is achieved, but spontaneous blood droplet generation success rate is only 50% and multiple strikes may occur
Solution Approach 1:
The patent replaces the complex mechanical spring-cam-mass actuator system with an electronic control system that uses a motor-driven mechanism to advance and retract the penetrating member. This electronic control system provides more precise control over the lancing process, enabling consistent single-strike performance and achieving spontaneous blood droplet generation in substantially all strikes rather than only 50% of mechanical launcher strikes.
2Ease of operation
If mechanical lancing devices are used, then skin piercing is achieved, but control for skin thickness variation is rough and pain perception varies
Solution Approach 1:
The patent implements a dynamic control system that can adjust the penetration depth and velocity of the penetrating member based on detected skin thickness variations. The electronic control system modifies operational parameters in real-time, allowing the device to adapt to different skin thicknesses across various users and body locations, thereby reducing pain perception and improving ease of operation compared to fixed mechanical stop systems.
3Productivity
If integrated sample generation and testing is implemented, then testing steps are reduced, but device complexity increases
Solution Approach 1:
The patent combines the lancing device with the analyte testing device into a single integrated system. The penetrating member is positioned within the analyte sensor, and the electronic control system coordinates both the lancing and testing functions. This merging eliminates the need for separate manual steps of blood collection and test strip application, achieving spontaneous blood droplet generation directly onto the sensor and reducing overall testing steps despite increased integration complexity.
4Ease of operation
If manual dexterity operations are required for sample placement, then testing can be performed, but operation difficulty increases for patients with retinopathies and neuropathies
Solution Approach 1:
The integrated device performs sample placement automatically without requiring manual dexterity from the user. The electronic control system advances the penetrating member to create a wound, captures the spontaneously generated blood droplet, and delivers it to the analyte sensor automatically. This self-service mechanism eliminates the need for users to manually guide blood droplets onto test strips, making the device accessible to patients with retinopathies and neuropathies who lack fine motor control.
Data Source
AI summary
An integrated analyte measurement system includes a housing and a disposable configured to be positioned in the housing. A plurality of penetrating members are positioned in the disposable. A penetrating member driver is configured to be coupled to each of a penetrating member. A plurality of analyte sensors are positioned in the disposable. The disposable houses both used and unused penetrating members and analyte sensors.