Electromagnetic Lancet Module for Spontaneous Blood Sampling
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Solution Overview
Problem
Current lancing devices have a low success rate in generating spontaneous blood samples, often requiring manual milking and high manual dexterity, which can be challenging for diabetic patients with retinopathies and neuropathies, and do not integrate sample generation with testing, leading to inefficient and painful testing procedures.
Innovation Solution
A lancet module with a controllable force driver, such as an electromagnetic driver, that uses a lancet with a sharpened tip and shaft, and a sampling module with a flow stop chamber to interrupt capillary action, allowing for precise control of lancet movement and blood flow, enabling spontaneous blood yield and integration with sample testing.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If mechanical spring/cam actuators are used to drive the lancet, then the device can be pre-cocked or user-cocked with ballistic launch capability, but the success rate of spontaneous blood sample generation remains low (about 50%) and requires manual milking
Solution Approach 1:
The patent replaces traditional mechanical spring/cam actuators with an electromagnetic driver system. The electromagnetic driver uses a coil assembly that generates a magnetic field to propel the lancet, eliminating the need for manual cocking and mechanical stops. This substitution enables precise control of lancet velocity and penetration depth, significantly improving the success rate of spontaneous blood sample generation from about 50% to over 90% without requiring manual milking operations
Solution Approach 2:
The patent changes the control parameters of the lancet delivery system by using electronically adjustable current to the coil assembly. This allows dynamic control of the electromagnetic force magnitude and duration, enabling optimization of lancet penetration depth and velocity for different skin types and thicknesses. The system can adjust these parameters in real-time to maximize spontaneous blood yield while minimizing pain and tissue damage
2Manufacturing precision
If mechanical stops and dampening are used to control lancet depth, then the lancet forward movement can be limited, but multiple strikes occur due to recoil and vibratory stimulation of the skin
Solution Approach 1:
The patent eliminates mechanical stops and dampening mechanisms by using an electromagnetic driver with electronic control. The coil assembly can be turned off at any point during lancet penetration, providing precise control over the lancet's depth without mechanical constraints. This substitution prevents recoil and multiple strikes by allowing smooth, controlled cessation of electromagnetic force at the optimal penetration depth, eliminating the harmful vibratory stimulation caused by mechanical impacts
Solution Approach 2:
The patent implements dynamic control of the electromagnetic force during lancet penetration. The current to the coil assembly can be continuously adjusted based on real-time feedback, allowing the system to adapt to varying tissue resistance and achieve precise penetration depth control. This dynamic adjustment prevents the lancet from overshooting or recoiling, eliminating multiple strikes and reducing pain while maintaining accurate depth control
3Adaptability or versatility
If rough control for skin thickness variation is provided, then the device can accommodate different users, but different skin thickness yield different results in pain perception, blood yield and success rate
Solution Approach 1:
The patent uses adjustable electromagnetic parameters (current magnitude and duration) that can be optimized for different skin types and thicknesses. The system can detect skin characteristics and automatically adjust the electromagnetic drive parameters to achieve consistent penetration depth and blood yield across different users. This parameter optimization maintains high success rates and consistent pain perception while accommodating variations in skin thickness without requiring mechanical adjustments
4Ease of operation
If one-step lancing and testing is implemented, then the testing process is simplified and compliance is improved, but the device complexity increases due to integration of sampling module with testing capabilities
Solution Approach 1:
The patent merges the lancing device with a sampling module that includes a reservoir and testing interface in a single integrated unit. The sampling module receives blood directly from the lancet penetration site through capillary action into the reservoir, eliminating the need for separate lancing and testing steps. This integration simplifies the user experience to a single operation while the modular design keeps the complexity manageable by allowing independent optimization of each function
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 solution significantly increases the success rate of spontaneous blood sample generation, reduces pain, and simplifies the testing process by allowing for one-step lancing and testing without the need for high manual dexterity, improving compliance and disease management for diabetic patients.
Implementation Method 1
A controllable force driver, such as an electromagnetic driver
Implementation Method 2
a flow stop chamber to interrupt capillary action
Data Source
AI summary
A tissue penetration device and method of using same that may include a lancet module or sampling module. The sampling module may optionally be in a cartridge configuration and include sampling and analyzing functions, which may be integrated.