Catalyst-Enhanced Blood Sampling via Needle Obstruction
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Solution Overview
Problem
Conventional body fluid sampling devices for diabetes management are cumbersome, require significant user intervention, and often fail to consistently express sufficient blood volume, especially at alternate sites, leading to pain and potential delayed or improper treatment.
Innovation Solution
The development of an integrated device that uses a skin-penetration member with a catalyst to obstruct the wound opening, enhancing perfusion and allowing for automatic or semi-automatic body fluid sampling and transport, reducing the need for user intervention and improving sample reliability.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If conventional separate-component systems are used for body fluid sampling, then the system can perform lancing, transport, and quantification functions, but the device becomes bulky and complicated for the user
Solution Approach 1:
The patent combines lancing, transport, and quantification functions into a single integrated device. The device includes a lancing mechanism with a skin-penetration member, a transport mechanism with a capillary tube, and a quantification system with optical components, all integrated into one handheld unit that users can operate simply by placing their finger on the device.
Solution Approach 2:
The integrated device performs multiple functions: it lances the finger to obtain blood, transports the blood sample through capillary action, and quantifies glucose levels using optical detection. This multi-functional design eliminates the need for separate lancing devices, transport mechanisms, and glucose meters.
2Quantity of substance
If finger lancing is used to obtain sufficient blood volume, then adequate sample can be obtained, but the user experiences significant pain
Solution Approach 1:
The device applies a catalyst to the sampling site before lancing to enhance perfusion and facilitate blood expression. This preliminary action prepares the tissue to provide adequate blood sample with less mechanical force required, thereby reducing pain.
Solution Approach 2:
The device changes the physical parameters of the sampling process by using a hollow needle design that allows blood to be drawn through the needle during retraction, and by controlling the penetration depth and speed to minimize pain while obtaining sufficient blood volume.
3Object-affected harmful factors
If alternate site testing is used to reduce pain, then lancing pain is reduced, but sufficient blood volume is difficult to express
Solution Approach 1:
The device applies a catalyst to the alternate site before lancing to enhance local perfusion. This preliminary action ensures that adequate blood flow is present at the sampling site, making it easier to obtain sufficient blood volume from less sensitive areas like the palm or forearm.
Solution Approach 2:
The device uses capillary action through a hollow needle to transport blood from the alternate site. The capillary forces draw blood through the needle during retraction, enabling sufficient sample collection from sites with lower blood flow without requiring excessive manual manipulation.
4Ease of operation
If manual user intervention is required for blood expression, then the user can control the sampling process, but the device requires significant user intervention and is cumbersome
Solution Approach 1:
The device enables self-service operation where the user simply places their finger or alternate site on the device, and the system automatically performs lancing, blood expression, and glucose measurement. The catalyst application and blood transport mechanisms operate automatically without requiring the user to manually milk or squeeze the site.
Solution Approach 2:
The device uses capillary action through the hollow needle to automatically transport blood from the sampling site to the analysis chamber. This passive fluid transport mechanism eliminates the need for active pumping or manual manipulation to obtain sufficient blood volume.
5Quantity of substance
If the skin-penetration member is retracted immediately after lancing, then the wound opening remains open for blood expression, but insufficient blood volume is obtained
Solution Approach 1:
The hollow needle acts as an intermediary that remains in place after lancing to facilitate blood collection. The needle serves as both the lancing instrument and the collection conduit, allowing blood to be drawn through it during retraction without requiring complex wound obstruction mechanisms.
Solution Approach 2:
The device uses capillary action through the hollow needle to automatically draw blood during the retraction phase. The capillary forces within the needle create negative pressure that pulls blood through the needle as it is withdrawn, ensuring sufficient sample collection without requiring the needle to remain inserted or complex obstruction mechanisms.
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 effectively and reliably expresses sufficient body fluid for analysis, reducing pain and user burden, while ensuring accurate glucose monitoring without the need for complex mechanical arrangements, thus improving diabetes management.
Implementation Method 1
at least one catalyst device configured to enhance perfusion of body fluid at the sampling site
Implementation Method 2
an inner lumen in communication with the first end; wherein the at least one actuator is configured to locate the at least one skin-penetration member so as to obstruct the wound opening while transporting body fluid through the inner lumen
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 at least one skin-penetration member having a first end configured to pierce the surface of the skin, and a inner lumen in communication with the first end; at least one actuator operatively associated with the at least one skin-penetration member; and at least one catalyst device configured to cause perfusion of body fluid at the sampling site; wherein the at least one actuator is configured to locate the at least one skin-penetration member so as to obstruct the wound opening while transporting body fluid through the inner lumen. Associated methods are also described.