Continuous Analyte Sensor With Dissolvable Tip for Low-Trauma Insertion
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Solution Overview
Problem
Existing continuous analyte sensors cause trauma to surrounding tissue due to a sharpened tip left implanted for an extended period, leading to scarring and inhibition of wound healing, and require complex insertion processes involving needles that add complexity and need for electrical connection post-insertion.
Innovation Solution
A sensor device with a blunt tip and a piercing element that dissolves upon insertion, supported by a mounting unit, and a membrane with a hardening agent for increased column strength, allowing direct insertion without buckling, and a stimulus-responsive material for implantation without an inserter.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Duration of action of stationary object
If a sharpened tip sensor is implanted in tissue throughout the usable life of the sensor, then the sensor can provide continuous monitoring, but it causes trauma to surrounding tissue leading to scarring and inhibition of wound healing
Solution Approach 1:
The sensor device is divided into two separate components: a dissolvable piercing element and a sensor body. The piercing element performs the insertion function and then dissolves, while the sensor body remains for continuous monitoring. This segmentation allows the piercing function to be temporary while the monitoring function is long-term, resolving the contradiction between implantation duration and tissue trauma.
Solution Approach 2:
The piercing function is extracted from the permanent sensor structure and implemented as a separate dissolvable piercing element. This element is used only during insertion and then disappears through dissolution, leaving only the sensor body in place. This extraction eliminates the ongoing tissue trauma associated with a permanent sharp tip while maintaining the ability to perform continuous monitoring.
2Object-affected harmful factors
If a dissolvable piercing element is used for skin insertion, then tissue trauma is minimized, but the piercing element must rapidly biodegrade which may compromise structural integrity during insertion
Solution Approach 1:
The material properties of the piercing element are specifically selected to change over time. The element has high strength and rigidity initially to enable effective skin penetration, then progressively degrades through biodegradation. This time-dependent parameter change allows the element to provide sufficient strength during insertion while ultimately minimizing long-term tissue trauma through dissolution.
Solution Approach 2:
The piercing element is made from biodegradable materials that combine the necessary mechanical properties for skin penetration with the ability to degrade safely in tissue. These composite or specially formulated materials provide the dual functionality of being strong enough for insertion while being designed to break down into harmless byproducts, resolving the contradiction between initial strength requirements and eventual tissue compatibility.
3Object-affected harmful factors
If the sensor body has a blunt tip, then tissue trauma is reduced, but the sensor may buckle during insertion without sufficient column strength
Solution Approach 1:
The insertion function and the sensor body function are separated into different components with different tip characteristics. The dissolvable piercing element has a sharp tip for effective penetration, while the sensor body has a blunt tip for minimal tissue trauma. During insertion, the sharp piercing element provides the necessary mechanical advantage, while the blunt-tipped sensor body follows without needing to perform the piercing action, thus avoiding buckling while minimizing trauma.
4Ease of operation
If the membrane is made flexible for comfort, then ease of operation is improved, but the membrane may peel during insertion without sufficient rigidity
Solution Approach 1:
The membrane is pre-coated with a hardening agent before insertion. This preliminary action creates a temporary protective layer that reinforces the membrane during the insertion process, preventing peeling and damage. After insertion is complete, the hardening agent dissipates or is removed, restoring the membrane's flexibility for comfortable operation. This preliminary reinforcement resolves the contradiction between needing flexibility for comfort and rigidity during insertion.
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
Reduces tissue trauma by minimizing wound scarring and simplifies the insertion process, ensuring effective and comfortable analyte monitoring without the need for additional insertion tools.
Implementation Method 1
a piercing element comprising a material that rapidly dissolves upon insertion into the host
Implementation Method 2
a hardening agent to enhance column strength and prevent membrane peeling
Data Source
AI summary
Sensor devices including dissolvable tissue-piercing tips are provided. The sensor devices can be used in conjunction with dissolvable needles configured for inserting the sensor devices into a host. Hardening agents for strengthening membranes on sensor devices are also provided. Methods of using and fabricating sensor devices are also provided.