Neural Stimulation Dose Up-Titration with Patient Control
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Solution Overview
Problem
Current neural stimulation therapies often result in undesirable responses, leading to patient non-compliance due to lack of control over therapy intensity, and manual titration is cumbersome, limiting adoption and efficacy.
Innovation Solution
An implantable medical device with a device-based up-titration routine that automatically increases neural stimulation dose according to a programmed schedule, allowing patient-activated back-out, using feedback from physiological sensors to adjust therapy and ensure patient tolerability and efficacy.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If manual titration is used to adjust neural stimulation dose, then therapy intensity can be optimized, but the process is cumbersome and reduces patient compliance
Solution Approach 1:
The system performs self-titration by automatically adjusting neural stimulation dose based on programmed routines and patient feedback, eliminating the need for manual intervention. The device monitors patient responses and autonomously modifies therapy parameters to optimize efficacy while maintaining compliance.
Solution Approach 2:
The system incorporates feedback mechanisms where patient responses to stimulation are monitored and used to automatically adjust therapy intensity. This closed-loop control ensures optimal dose delivery while adapting to individual patient needs, thereby improving both efficacy and compliance.
2Extent of automation
If automatic up-titration routine is implemented, then therapy intensity is optimized without manual intervention, but device complexity increases
Solution Approach 1:
The control system is segmented into distinct functional modules: dose delivery circuitry, feedback detection circuitry, up-titration control circuitry, and patient feedback interface. This modular architecture manages complexity by dividing the automatic titration function into separate, manageable components that work together systematically.
3Reliability
If higher neural stimulation dose is delivered, then therapeutic efficacy is improved, but undesirable responses increase leading to patient non-compliance
Solution Approach 1:
The system dynamically adjusts stimulation dose based on real-time patient responses and programmed routines. Rather than delivering a fixed high dose, the system adaptively titrates the dose upward only when necessary and downward when undesirable responses are detected, optimizing the balance between efficacy and tolerability.
Solution Approach 2:
The system implements periodic up-titration routines that incrementally increase dose at scheduled intervals, allowing patients to acclimate to higher levels gradually. This staged approach maintains therapeutic efficacy while minimizing abrupt increases that could cause undesirable responses and non-compliance.
Data Source
AI summary
According to an embodiment of a method performed by an implantable medical device to deliver a neural stimulation therapy to a patient, a lower dose of the neural stimulation therapy is delivered to the patient. The dose of the neural stimulation therapy is automatically increased from the lower dose to a higher dose, and the higher dose of the neural stimulation therapy is delivered to the patient. A trigger that is controlled by the patient is detected, and the dose of the neural stimulation therapy is automatically returned from the higher dose back to the lower dose in response to detecting the trigger.


