Body-Fluid Analyte Sensor With Sealed Sensor Compartment
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Solution Overview
Problem
Existing continuous analyte monitoring systems face challenges such as complex manufacturing processes, high costs, and difficulty in protecting electrical contacts due to voluminous components and intricate encapsulation, which complicates handling and increases sensor volume.
Innovation Solution
A medical device with a sealed compartment housing an analyte sensor and electronics unit, featuring a detachable cap design for easy assembly and integration, using a retraction mechanism for the insertion cannula, and a septum for environmental protection, allowing for simple and cost-effective manufacturing and use.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Object-affected harmful factors
If traditional encapsulation methods are used to protect electrical contacts, then environmental protection is improved, but device complexity and manufacturing cost increase
Solution Approach 1:
The device is divided into two separate compartments: a sterile sensor compartment that remains sealed and a non-sterile electronics compartment. This segmentation allows the electrical contacts to be protected from environmental factors without requiring complex encapsulation of the entire device, as only the sensor compartment needs to maintain sterility.
Solution Approach 2:
The electrical contacts and electronics are extracted from the sterile field and placed in a separate non-sterile electronics compartment. This extraction eliminates the need for complex sterile encapsulation of electrical components, as they are intentionally designed to remain outside the sterile boundary.
2Reliability
If complex encapsulation is used to protect electrical contacts, then reliability is improved, but ease of manufacture deteriorates
Solution Approach 1:
By segmenting the device into sterile and non-sterile compartments, the manufacturing process is simplified. The sensor compartment can be sterilized independently using standard autoclaving procedures, while the electronics compartment is assembled separately without requiring sterile conditions, reducing overall manufacturing complexity.
Solution Approach 2:
The sensor compartment is designed as a disposable sterile component that can be manufactured using cost-effective materials and sterilization methods. This approach eliminates the need for expensive, complex encapsulation materials and allows for simple autoclaving sterilization, improving ease of manufacture while maintaining reliability.
3Object-affected harmful factors
If voluminous components are used for electrical contact protection, then environmental protection is improved, but sensor volume increases
Solution Approach 1:
The electrical contacts are extracted from the sensor compartment and placed in the external electronics compartment. This eliminates the need for voluminous protective encapsulation within the sensor, allowing the sensor to maintain a compact size while electrical contacts are protected in their separate location.
Solution Approach 2:
The sterile barrier between compartments uses thin film structures rather than voluminous protective housings. This allows environmental protection to be achieved with minimal volume addition, keeping the sensor compact while maintaining the integrity of the sterile boundary.
Data Source
AI summary
A medical device for detecting at least one analyte in a body fluid, a method for assembling the medical device and a method of using the medical device are disclosed. The medical device comprises:an analyte sensor having an insertable portion;an insertion cannula receiving the insertable portion of the analyte sensor;an electronics unit connected with the analyte sensor; anda housing comprising an electronics compartment receiving the electronics unit and—a sensor compartment receiving the analyte sensor,the sensor compartment forming a sealed compartment receiving the insertable portion of the analyte sensor,the sealed compartment comprising detachable upper and lower caps,the lower cap configured for detachment before insertion,the insertion cannula being attached to the upper cap, wherein detaching the upper cap after insertion removes the insertion cannula,wherein the electronics compartment at least partially surrounds the sensor compartment.