Neurostimulator Reader Provisioning for Dose-Based Mode Switching
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Solution Overview
Problem
There is a lack of technology for the initial provisioning and refilling of non-invasive neurostimulators, which are medical devices used to prevent, diagnose, monitor, or treat various medical conditions.
Innovation Solution
A system comprising a processor, memory, and a medical device with a reader configured to switch modes based on content read from a storage medium, enabling initial provisioning and refilling through a point-of-sale terminal and a database.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If a medical device is designed to be non-invasive and portable, then ease of operation and patient comfort are improved, but the capability for initial provisioning and refilling becomes limited
Solution Approach 1:
The patent introduces a reader device as an intermediary between the portable medical device and a storage medium (such as a card or external memory). The reader enables the portable device to read configuration data and therapy parameters from the storage medium, providing provisioning and refilling capabilities without requiring complex built-in storage or connectivity in the portable device itself.
Solution Approach 2:
The patent extracts the storage function from the portable medical device and places it in an external storage medium. This allows the medical device to remain simple and portable while still accessing therapy programs and configuration data when needed, resolving the contradiction between portability and provisioning capability.
2Adaptability or versatility
If a medical device stores all therapy data internally, then adaptability is improved, but device complexity and cost increase
Solution Approach 1:
The patent extracts the bulk storage function from the medical device to an external storage medium, keeping only essential operational data in the device's internal memory. This reduces device complexity and cost while maintaining adaptability through the external storage interface.
Solution Approach 2:
The reader device serves multiple functions: it reads configuration data during initial provisioning, loads therapy parameters during refilling, and enables mode switching. This multi-functional approach provides comprehensive data storage capability without adding corresponding complexity to the medical device itself.
3Device complexity
If a medical device has no usage tracking capability, then device complexity is reduced, but reliability of treatment monitoring decreases
Solution Approach 1:
The reader device acts as an intermediary for usage tracking by reading usage data from the medical device and comparing it against the therapy parameters loaded from the storage medium. This enables reliable treatment monitoring without requiring complex built-in tracking and analysis capabilities in the medical device itself.
Data Source
AI summary
A medical device, such as a neurostimulator, is provided that includes a housing, a power supply, a signal generator and one or more electrodes coupled to the housing. The signal generator is configured to apply one or more electrical impulses to the one or more electrodes for a period of time, the period of time being defined as a single dose. The device is configured to switch from an activated mode and a deactivated mode after specific number of single doses have been emitted by the signal generator.