Single Shot Actuator for Reliable Blood Sampling

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Solution Overview

Problem

Existing lancing devices for blood glucose monitoring are inefficient, with a low success rate for spontaneous blood droplet generation, requiring manual dexterity and multiple steps, and often result in hematoma or failed blood collection, particularly challenging for diabetic patients with retinopathies and neuropathies.

Innovation Solution

An analyte measurement device with a disposable module containing integrated sensors and penetrating members, protected by a seal, which automatically perforates the seal during loading and grips the penetrating member for reliable, painless blood sampling and integrated testing, reducing manual dexterity requirements and combining lancing with sample acquisition and testing in a single step.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If mechanical lancing devices with spring, cam and mass actuators are used, then blood can be obtained through skin piercing, but the success rate for spontaneous blood droplet generation is low (about 50%) and multiple strikes may be required

Engineering Contradiction:

Improvesuccess rate of blood sample acquisitionVSAvoidnumber of lancing strikes required

Core Design Contradiction:

ReliabilityVSLoss of time

Solution Approach 1:

The device pre-cocks the lancing mechanism and positions the lancet against the skin before activation, ensuring optimal starting conditions for blood droplet generation. The integrated test strip is also prepared in advance with receiving channels positioned to capture blood immediately upon lancing.

Inventive Principle:

Principle #10Preliminary action

Solution Approach 2:

The device incorporates sensors that detect whether a blood droplet has been successfully generated and captured. This feedback mechanism allows the system to determine if another lancing strike is needed, optimizing the number of attempts and improving overall success rate while reducing unnecessary strikes.

Inventive Principle:

Principle #23Feedback

2Ease of operation

If mechanical lancing devices are used, then skin penetration can be achieved, but manual dexterity and hand-eye coordination are required for proper operation and sample placement

Engineering Contradiction:

Improveoperation simplicityVSAvoidcoordination requirements

Core Design Contradiction:

Ease of operationVSDevice complexity

Solution Approach 1:

The device combines the lancing mechanism, blood sample collection, and test strip interface into a single integrated unit. The test strip is positioned within the device housing with receiving channels that automatically align with the lancing site, eliminating the need for separate manual sample placement operations.

Inventive Principle:

Principle #5Merging (Combining)

Solution Approach 2:

The device performs multiple functions automatically: it positions the lancet, executes the lancing action, collects the blood droplet, and interfaces with the test strip without requiring manual dexterity from the user. The system self-adjusts for proper alignment and sample capture.

Inventive Principle:

Principle #25Self-service

3Quantity of substance

If lancing devices create wounds to obtain blood, then blood can be generated, but blood may be trapped below skin surface forming hematoma or no blood flows from the wound

Engineering Contradiction:

Improveblood droplet generationVSAvoidblood flow from wound

Core Design Contradiction:

Quantity of substanceVSReliability

Solution Approach 1:

The device incorporates a vertically oriented lancet that pierces the skin at an angle optimized for blood droplet ejection. The integrated test strip receiving channels are positioned to capture blood droplets as they emerge from the lancing site, utilizing gravitational and capillary forces to ensure reliable blood collection.

Inventive Principle:

Principle #17Another dimension (Dimensionality change)

4Reliability

If integrated sensors and penetrating members are used in a disposable module, then sterility and desiccation preservation can be improved, but device complexity increases

Engineering Contradiction:

Improvesterility preservationVSAvoidmodule integration

Core Design Contradiction:

ReliabilityVSDevice complexity

Solution Approach 1:

The device is divided into a reusable housing containing the actuator and electronics, and a disposable module containing the lancet, test strip, and sensing elements. This segmentation allows the sensitive components requiring sterility to be in the disposable portion, which can be sterilized independently and then discarded after use.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The disposable module incorporates a foil seal that maintains sterility and desiccation of the test strip until use. The seal is designed to be perforated or broken during the loading sequence, providing a simple yet effective barrier that protects the integrated sensors and reagents without requiring complex sterilization systems.

Inventive Principle:

Principle #30Flexible shells and thin films

Data Source

PatentUS20140135653A9Analyte measurement device with a single shot actuator

Publication Date: 2014.05.15 AUTO INJECTION TECH LLC

AI summary

An analyte and detecting apparatus includes a housing, an access door and a front end aperture. A module is positionable in the housing. A penetrating member is positioned in the module and upon launch passes through the front end aperture. An analyte sensor is positioned in the module. A penetrating member driver is configured to be coupled to the penetrating member. A mechanism is included that moves an arm coupled to the penetrating member driver into a launch position and allows motion of the penetrating member driver.