Hollow Guide Needle for Intradermal Sensor Placement
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Solution Overview
Problem
Existing miniaturized subcutaneous sensors and diagnostic elements face challenges with invasive implantation procedures, tissue damage, and complex handling requirements, limiting their acceptance and reliability for long-term analyte monitoring in body fluids.
Innovation Solution
A device with a hollow guide needle that partially retracts after insertion, exposing the active surface to body fluid while maintaining connection lines, eliminating the need for U-shaped guides and minimizing tissue damage, and incorporating a pre-fabricated connection system for user-friendly operation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If a U-shaped cannula-type guide is used for sensor implantation, then the guide can be removed after implantation, but the thin wall creates a cutting edge that causes substantial tissue damage
Solution Approach 1:
The guide needle is divided into two functional parts: a beveled tip for cutting through skin and tissue, and a smooth cylindrical body for minimal tissue damage during insertion and retention. This segmentation allows the cutting function to be localized to the tip only, while the majority of the guide structure remains smooth and non-traumatic to tissue.
Solution Approach 2:
Instead of designing a guide that must be removed (U-shaped with thin walls), the invention inverts the approach by creating a guide needle that remains in place permanently. The smooth cylindrical structure without a slit eliminates the cutting edge problem entirely, as there is no removal action required.
2Object-affected harmful factors
If miniaturized sensors are implanted, then invasiveness is reduced, but handling complexity increases due to the need for mounting tools and high skill levels
Solution Approach 1:
The sensor and guide needle are merged into a single integrated unit where the sensor is positioned at the tip of the guide needle. This combination eliminates the need for separate mounting tools and procedures, allowing the entire implantation to be performed through a single puncture action while maintaining miniaturization.
Solution Approach 2:
The sensor is pre-positioned and secured to the guide needle tip before implantation. This preliminary action ensures that the sensor is correctly positioned and protected during storage and handling, eliminating the need for complex mounting procedures after insertion and reducing handling complexity.
3Ease of operation
If fully implantable sensors with wireless transmitters are used, then mounting problems are avoided, but the size requires surgical implantation procedures
Solution Approach 1:
The wireless transmitter component is extracted from the implanted sensor unit and placed externally. This allows the implanted portion to be miniaturized to the point where it can be inserted through a simple needle puncture rather than requiring surgical procedures, while the external transmitter handles the wireless communication function.
4Reliability
If the guide needle is completely removed after insertion, then the sensor is exposed to body fluid, but the connection lines are interfered with and manual reconnection is required
Solution Approach 1:
Instead of completely removing the guide needle, the invention applies partial action by retracting or shortening the guide needle just enough to expose the sensor active surface to body fluid. This partial removal maintains the protective function for the connection lines while achieving the necessary sensor exposure for measurement.
Data Source
Figure 1
Figure 2
Figure 2a~2b
AI summary
An improved diagnostic analyte monitoring device has partially retractable hollow guide needles for the intradermal placement of diagnostic elements fixedly connected to measuring means within this device obviating the need to remove the guide needle and to connect the diagnostic elements to measuring means after placement into the skin. A flexible surface adhering to the skin serves for the subcutaneous implantation of the diagnostic elements within the guide needles and partial retraction of the guide needles exposes the active surface to body fluid, actuated by means designed for easy handling and safe operation. Concentration- time profiles of endogenous and exogenous analytes measured with the device are used to improve drug treatment modalities on an individualized basis.