Dermal Sensor Placement Using Trocar Cannula and Antifibrotic Coating
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Solution Overview
Problem
Current glucose monitoring devices, particularly continuous glucose monitors (CGMs), face challenges due to imprecise placement of sensors in the dermal lymphatic sinus, leading to inconsistent signal integrity and skin irritations, which affects the reliability and longevity of glucose monitoring in diabetic patients.
Innovation Solution
A method for precisely placing a sensor within the dermal lymphatic sinus or reticular dermis using a trocar and cannula system, ensuring maximal exposure to lymph, and connecting it to an external or internal device for data transmission, with options for wireless communication and coatings that reduce fibrotic and inflammatory responses.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If sensors are inserted into the skin for glucose monitoring, then glucose levels can be detected continuously, but signal integrity deteriorates over time and skin irritations occur
Solution Approach 1:
The patent applies preliminary action by pre-coating the sensor device with biologic or synthetic molecules (such as chitosan, hyaluronic acid, Teflon, glycosaminoglycans like Heparin and Heparin sulfate) before insertion. This pre-applied coating creates an antifibrotic and anti-inflammatory barrier that prevents tissue reactions in advance, thereby maintaining signal integrity and reducing skin irritations throughout the device's operational life, resolving the contradiction between reliability and duration.
2Measurement precision
If sensors are placed in the dermal lymphatic sinus, then maximal exposure to lymph is achieved, but precise placement is difficult leading to inconsistent signaling
Solution Approach 1:
The patent employs an intermediary approach by using a trocar and cannula system as a delivery mechanism. The trocar is inserted at a shallow angle into the dermal lymphatic sinus, the obturator is removed, and the sensor device is slipped through the hollow cannula. Lymph draining from the cannula confirms correct placement. This intermediary system enables precise placement in the difficult-to-access dermal lymphatic sinus, achieving maximal lymph exposure and consistent signaling while making the procedure easier to perform with accurate positioning.
3Quantity of substance
If sensors invade deeper tissues for monitoring, then lymph exposure is increased, but tissue reactions and skin irritations worsen
Solution Approach 1:
The patent applies preliminary anti-action by pre-coating the sensor device with biologic or synthetic molecules (including chitosan, hyaluronic acid, Teflon, and glycosaminoglycans such as Heparin and Heparin sulfate) that possess antifibrotic and anti-inflammatory properties. This pre-applied protective coating counteracts the harmful tissue reactions that would otherwise occur when the sensor invades deeper tissues to access lymph, thereby enabling increased lymph exposure while reducing skin irritations and tissue reactions.
Data Source
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AI summary
The present invention provides for a method and apparatus for inserting and using dermal interstitial sensors in, for example, an analyte monitoring system. The present invention permits the proper positioning of a cannula tip and/or sensor(s) within the reticular dermis.