Medical Device Therapy Parameter Configuration and Testing
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Solution Overview
Problem
Current medical device systems for treating nervous system disorders lack a method to safely and effectively configure and test therapy parameters before applying treatment, potentially leading to intolerance or adverse reactions in patients.
Innovation Solution
A medical device system that allows users to configure and test therapy parameters in a manual treatment mode, evaluating system configuration information, determining patient tolerance, and preventing treatment delivery beyond safe limits, while enabling different therapeutic approaches such as electrical stimulation, drug infusion, or their combination.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If therapy parameters are configured and tested before treatment delivery, then patient safety and tolerability are improved, but device complexity and operational time are increased
Solution Approach 1:
The system performs preliminary configuration and testing of therapy parameters in a manual mode before transitioning to automated treatment delivery. Users can configure parameters and test them on themselves to ensure tolerability and effectiveness before the system autonomously delivers treatment, thereby preventing adverse reactions while maintaining a relatively simple device architecture
Solution Approach 2:
The system enables users to self-configure and self-test therapy parameters through an intuitive interface. Users can adjust parameters, test them on themselves, and receive feedback about tolerability without requiring complex external testing equipment or professional intervention, thus improving safety without significantly increasing device complexity
2Reliability
If therapy parameters are tested on patients before treatment, then treatment efficacy and tolerability are improved, but time for treatment delivery is increased
Solution Approach 1:
Patients can perform parameter testing and configuration in advance during manual mode, allowing them to identify effective and tolerable parameters before actual treatment begins. This preliminary action eliminates the need for time-consuming trial-and-error testing during treatment delivery, as parameters are pre-validated and stored for immediate use
Solution Approach 2:
The system creates and stores a copy of the tested and validated parameter set for use during automated treatment delivery. Once parameters are tested and confirmed effective in manual mode, the system preserves this parameter configuration and applies it during run mode without repeating the testing process, thus maintaining efficacy while reducing treatment time
3Ease of operation
If manual mode configuration is allowed, then ease of operation is improved, but risk of incorrect parameter delivery is increased
Solution Approach 1:
The system incorporates feedback mechanisms that monitor patient responses during manual parameter testing and provide real-time guidance. Users receive feedback about parameter tolerability and effectiveness, allowing them to adjust parameters safely while the system tracks which parameters result in positive outcomes, thereby reducing the risk of incorrect parameter delivery
Solution Approach 2:
The system includes safety features and validation checks that are activated before automated treatment delivery begins. These pre-configured safety mechanisms review and verify the parameters selected during manual mode, cushioning against potential errors by ensuring only safe and validated parameters are deployed to automated treatment delivery
Data Source
AI summary
Apparatus and method support the configuration and testing of therapy parameters for a medical device system in the treatment of nervous system disorders. With the embodiment, the medical device system operates in a manual treatment therapy mode, in which the medical device system evaluates a set of information that is indicative of a system configuration. The medical device system determines if the set of information is acceptable. During the manual treatment therapy mode, the medical device system applies therapeutic treatment to a patient in accordance with the set of information. If the patient cannot tolerate the therapeutic treatment, the user indicates so through a user interface. The medical device system may associate the patient's intolerance to therapeutic treatments that equal or exceed the patient's level of tolerance. Moreover, the medical device system may use this information to prevent a delivery of therapeutic treatment that exceeds the patient's level of tolerance during a run mode.