Integrated Glucose Sensor and Insulin Pump
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Solution Overview
Problem
Current diabetes management systems are cumbersome, requiring separate devices for continuous glucose monitoring and insulin delivery, necessitating fingerstick calibration and user-initiated insulin infusion, which compromises convenience and discretion.
Innovation Solution
An integrated device with a reservoir for medicament, an infusion catheter, a pump, and a continuous glucose monitor sensor assembly, where the sensor engages and advances with the introducer needle during insertion, enabling simultaneous glucose monitoring and medicament delivery based on real-time readings.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If separate devices are used for continuous glucose monitoring and insulin delivery, then each device can be optimized for its specific function, but the overall system becomes cumbersome and less convenient
Solution Approach 1:
The patent combines the continuous glucose monitoring sensor assembly and the insulin infusion pump into a single integrated device. The sensor assembly includes a glucose sensor, introducer needle, and infusion catheter that are integrated with the pump mechanism, allowing both glucose monitoring and insulin delivery functions to be performed by one device rather than requiring separate CGM and insulin pump devices.
Solution Approach 2:
The integrated device performs multiple functions: it continuously monitors glucose levels through the glucose sensor, delivers insulin through the infusion catheter, and provides real-time feedback control. The single device serves as both a diagnostic tool (glucose monitoring) and a therapeutic device (insulin delivery), eliminating the need for multiple separate devices.
2Measurement precision
If fingerstick calibration is required for glucose sensors, then measurement accuracy can be maintained, but user effort and inconvenience increase
Solution Approach 1:
The integrated pump system automatically performs calibration using its own internal sensors and algorithms. The system monitors glucose levels continuously through the subcutaneous sensor and automatically adjusts insulin delivery without requiring manual fingerstick calibrations from the user, making the calibration process self-service rather than user-managed.
Solution Approach 2:
The system uses real-time feedback from the continuous glucose sensor to automatically adjust insulin delivery. The pump receives glucose level data continuously and automatically modulates insulin infusion rate based on this feedback, eliminating the need for manual calibration interventions and providing closed-loop control that maintains accuracy without user effort.
3Ease of operation
If user-initiated insulin infusion is used, then dosing control remains with the user, but convenience and automation are reduced
Solution Approach 1:
The system implements automated feedback control where the pump continuously monitors glucose levels through the integrated sensor and automatically adjusts insulin delivery based on real-time glucose data. The system can autonomously make dosing decisions based on predefined algorithms and glucose trends, reducing the need for manual user initiation while maintaining appropriate user oversight through the interface.
Solution Approach 2:
The pump system performs self-regulation by automatically adjusting insulin delivery based on its own sensor readings and internal control algorithms. The system monitors its own performance and makes dosing adjustments without requiring constant user intervention, effectively making the insulin delivery process self-service while still allowing users to review and control the process through the user interface.
4Ease of operation
If an integrated device combines glucose monitoring and insulin delivery, then convenience is improved, but device complexity increases
Solution Approach 1:
The patent employs a nested structure where the glucose sensor assembly is integrated within the pump housing. The sensor assembly includes the glucose sensor, introducer needle, and infusion catheter that are nested within or integrated with the pump's structural components. This nesting approach allows multiple functions to be combined while minimizing the increase in overall device complexity through efficient spatial organization.
Data Source
AI summary
A device for delivering medicament to a user is disclosed. The device comprises a reservoir for storing medicament; an infusion catheter fluidly communicating with the reservoir to deliver the medicament into a subcutaneous layer of the user: a pump fluidly communicating with the reservoir and infusion catheter for pumping the medicament from the reservoir though the infusion catheter: an introducer needle movable within the infusion catheter, the introducer needle configured to facilitate (a) insertion of the infusion catheter into a subcutaneous layer of the user and (b) retraction of the introducer needle after insertion of the infusion catheter to enable delivery of medicament through the infusion catheter; and a sensor for continuously monitoring glucose level in the user, wherein the sensor is configured to (a) engage the introducer needle and/or the infusion catheter and (b) simultaneously advance along with the infusion catheter during the insertion into the subcutaneous layer of the user by the introducer needle.