Microneedle Enclosure and Applicator for Low-Latency Glucose Monitoring
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Solution Overview
Problem
Conventional continuous glucose monitoring (CGM) devices suffer from tissue trauma during insertion and signal latency due to the time required for glucose analyte to diffuse from capillary sources to the sensor, leading to inaccurate glucose measurements, particularly during rapid blood glucose level changes.
Innovation Solution
A microneedle enclosure and applicator device for a CGM device that includes a housing, a cuff, a shuttle, and a locking mechanism to safely contain and apply a microneedle array, allowing for shallow skin penetration into the upper dermal region, reducing insertion pain and latency.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional CGM devices use deep subcutaneous insertion, then the sensor can access interstitial fluid, but tissue trauma and insertion pain increase
Solution Approach 1:
The patent changes the insertion depth parameter from deep subcutaneous (conventional CGM) to shallow dermal (microneedle array). This parameter change allows the sensor to access the dermal papilla layer where capillaries are present, providing sufficient interstitial fluid access while significantly reducing tissue trauma and pain compared to deep subcutaneous insertion.
Solution Approach 2:
The patent uses a microneedle array that creates multiple shallow punctures as a copy/alternative to the single deep insertion method. The array of microneedles (e.g., 9-25 needles) collectively provide the same sensor functionality through shallower penetration, distributing the mechanical stress and reducing individual needle trauma.
2Measurement precision
If conventional CGM devices use deep subcutaneous insertion, then the sensor can measure glucose levels, but signal latency increases due to diffusional lag
Solution Approach 1:
The patent changes the spatial parameter of sensor location from deep subcutaneous tissue to shallow dermal papilla layer. This parameter change reduces the diffusion distance for glucose molecules to reach the sensor, thereby reducing signal latency while maintaining accurate glucose measurement capability through access to capillary-rich areas.
3Object-affected harmful factors
If a microneedle array is used for shallow penetration, then insertion pain and latency are reduced, but device complexity increases
Solution Approach 1:
The patent employs a nested structure where the microneedle array is housed within an enclosure that is itself contained within the applicator device. The applicator includes nested components such as the cuff receiving the microneedle enclosure, the shuttle mechanism within the cuff, and the biasing elements integrated within these structures. This nesting allows the complex microneedle array system to be compact and manageable.
Solution Approach 2:
The patent incorporates biasing elements (springs) that provide automatic return force to the microneedle array after insertion. This self-service mechanism automatically retracts the microneedles post-deployment without requiring manual intervention, simplifying the overall operation despite the complex initial deployment mechanism. The biasing elements also assist in maintaining contact force during insertion.
4Reliability
If the microneedle array is contained in an enclosure with complex deployment mechanism, then safe application is achieved, but ease of operation decreases
Solution Approach 1:
The patent pre-configures the microneedle array within the enclosed applicator mechanism before use. The biasing elements are pre-loaded, the cuff is pre-positioned, and the microneedles are pre-loaded in the array structure. This preliminary preparation ensures that during actual operation, the user only needs to trigger the deployment sequence, simplifying the user action while maintaining the complex safety features.
Solution Approach 2:
The patent divides the applicator into separable components: the reusable applicator body containing the complex mechanism, and the disposable microneedle array cartridge or enclosure. This segmentation allows the complex deployment mechanism to be manufactured and tested separately, while the user interacts with simpler components. The modular design improves ease of operation by allowing users to handle only the lighter, simpler cartridge portion.
Data Source
Figure 1~2A
Figure 2B
Figure 3A~3D
AI summary
An applicator for an analyte monitoring device may include an actuatable housing having a body defining a cavity therein and having a distal opening and a side opening. A cuff and a shuttle are received within the cavity and are separately translatable relative to the housing body. A base may removable engage the housing body at the distal opening. The housing body, the cuff, the shuttle, and/or the base may be engaged with one another with one or more releasable coupling features. The base may be removed from an engagement with the housing body, causing the cuff and the shuttle to be aligned and positioned in a configuration in which the analyte monitoring device, held by the shuttle, is ready for insertion into the skin.