Blood Sampling Device with Vacuum Skin Interface
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Solution Overview
Problem
Conventional blood sampling devices rely heavily on user intervention, such as 'milking,' to obtain sufficient blood for glucose monitoring, resulting in inconsistent and painful experiences for diabetic patients.
Innovation Solution
The development of a device with a skin interface member and skin-penetration mechanism that includes features like adjustable penetration depth, tactile feedback, and catalysts like heat and vacuum to enhance blood expression, reducing pain and improving sample consistency.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If conventional lancing devices are used, then the device structure is simple, but the user must manually milk the finger to obtain sufficient blood, resulting in inconsistent sampling and increased pain
Solution Approach 1:
The device automatically expresses blood from the lancing site using a vacuum mechanism without requiring the user to manually milk the finger. The system self-regulates blood collection through controlled vacuum application, eliminating the need for user intervention in the blood expression process.
Solution Approach 2:
A vacuum pump or pressure differential mechanism is employed to create negative pressure that draws blood from the lancing site through a capillary or conduit directly to the test strip. This pneumatic system replaces manual milking with automated pressure-driven fluid transport.
2Reliability
If manual milking is required to obtain sufficient blood, then the device structure remains simple, but the sampling consistency and reliability deteriorate
Solution Approach 1:
The device automatically expresses blood from the lancing site using a vacuum mechanism without requiring the user to manually milk the finger. The system self-regulates blood collection through controlled vacuum application, eliminating the need for user intervention in the blood expression process.
Solution Approach 2:
The device incorporates sensors to detect blood flow and volume, providing real-time feedback to adjust the vacuum pressure and duration. This feedback mechanism ensures consistent blood sample acquisition by automatically adapting to variations in user physiology and lancing depth.
3Quantity of substance
If deeper lancing is performed to increase blood flow, then the blood production increases, but the pain level increases due to nerve stimulation
Solution Approach 1:
A vacuum pump or pressure differential mechanism is employed to create negative pressure that draws blood from the lancing site through a capillary or conduit directly to the test strip. This pneumatic system replaces manual milking with automated pressure-driven fluid transport.
Solution Approach 2:
The device applies vacuum pressure immediately after lancing to facilitate spontaneous blood flow before the user can react or experience maximum pain. This preliminary action captures blood at the optimal moment, reducing the need for deeper lancing and subsequent pain.
4Reliability
If multiple separate components are used for lancing, transport, and quantification, then each component can be optimized, but the overall system becomes bulky and complicated for users
Solution Approach 1:
The device integrates the lancing mechanism, vacuum blood collection system, test strip holder, and result display into a single handheld unit. This consolidation maintains the functional advantages of separate optimized components while eliminating the bulk and complexity of multiple separate devices that users must coordinate.
Data Source
AI summary
An arrangement for producing a sample of body fluid from a wound opening created in a skin surface at a sampling site includes: a housing, the housing comprising a first opening; a skin interface member disposed in the first opening, the skin interface member comprising an inner member having a second opening, and an outer member at least partially surrounding the inner member and attached to the first opening; and at least one skin-penetration member configured and arranged to project within the second opening. Arrangements having alternatively constructed skin interface members are also described.