Analyte Sensor Subassembly With Integrated Lead Frame And Spring Members
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Solution Overview
Problem
Existing analyte sensors face challenges in secure electrical connection and comfortable insertion through the skin due to fragility and rigidity, leading to patient discomfort and increased trauma during insertion.
Innovation Solution
An analyte sensor subassembly with an integrated lead frame and spring members for secure electrical contact, combined with a channel guide assembly and sensor insertion tool for guided insertion without a rigid introducer, ensuring stable and comfortable sensor placement.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Strength
If a rigid needle is used to provide mechanical strength for skin penetration, then insertion capability is improved, but patient discomfort and trauma increase
Solution Approach 1:
The device is divided into two separate components: a disposable sensor element and a reusable insertion device. The insertion device provides the necessary rigid needle structure for painless skin penetration, while the sensor element remains flexible and slender for patient comfort during wear. This segmentation allows each component to be optimized for its specific function without compromise.
Solution Approach 2:
The reusable insertion device acts as an intermediary that delivers the fragile sensor element through the skin without requiring the sensor itself to be rigid. The insertion device's needle provides the mechanical strength needed for penetration, while the sensor element passes through as a separate, flexible component that remains comfortable for the patient.
2Ease of operation
If a hollow tube or trocar is used to guide the sensor through the skin, then insertion capability is improved, but device complexity and trauma increase
Solution Approach 1:
The insertion function is extracted from the sensor element itself and placed into a separate reusable insertion device. This allows the sensor element to remain simple and flexible, while the complex insertion mechanism with needle and guide structures exists only in the reusable component that can be refined independently.
Solution Approach 2:
The insertion device incorporates a plunger mechanism that provides dynamic, controlled force delivery to advance the sensor element through the skin. This dynamic insertion approach allows for controlled speed and force application, improving insertion capability while keeping the sensor element itself simple and flexible.
3Object-affected harmful factors
If the sensor is made slender and flexible to increase patient comfort, then patient comfort is improved, but insertion difficulty increases
Solution Approach 1:
The system is segmented into a flexible sensor element optimized for patient comfort and a rigid insertion device optimized for easy skin penetration. The sensor element can be slender and flexible for comfort during wear, while the separate insertion device provides the mechanical strength needed for effortless insertion.
Solution Approach 2:
The insertion device performs the difficult action of skin penetration beforehand, creating a pathway through which the flexible sensor element can pass easily. The plunger mechanism applies preliminary force to pierce the skin, after which the flexible sensor element follows through the created opening without requiring itself to be rigid or sharp.
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 solution provides secure and reliable electrical connections while minimizing patient discomfort and trauma by enabling flexible sensor insertion with controlled orientation and force, maintaining sensor integrity during use.
Implementation Method 1
spring members for secure electrical contact
Data Source
AI summary
Embodiments herein provide an analyte sensor subassembly that provides an integrated structure enabling suitably secure electrical contact between an analyte sensor and the electronic components of an analyte sensor assembly. An analyte sensor subassembly assists the process of inserting the sensor into skin. An analyte sensor subassembly may operate in concert with one or more sensor insertion tools to provide insertion of an analyte sensor into the skin of a subject/patient. Associated devices, such as channel guides and sensor insertion tools, are also provided, as are methods of operation and sensor insertion.