Prescribed Neuromodulation Doses With External Usage Tracking
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Solution Overview
Problem
Current spinal cord stimulation (SCS) treatment paradigms lack effective mechanisms for managing patient self-administration of therapy, leading to potential overuse and reduced effectiveness due to tolerance development and lack of scheduled follow-ups for optimization.
Innovation Solution
Implementing a system that allows clinicians to prescribe a set amount of stimulation, track usage, and provide reminders for follow-up appointments, using external controllers to manage and monitor stimulation delivery.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If patients self-administer stimulation therapy without restrictions, then ease of operation is improved, but therapy effectiveness deteriorates due to overuse and tolerance development
Solution Approach 1:
The system changes the parameter of stimulation delivery from unrestricted continuous access to controlled dosed delivery. The IPG delivers stimulation in predetermined doses with tracking of remaining doses, transforming the operational mode from free access to regulated access, thereby preventing overuse while maintaining patient autonomy
Solution Approach 2:
The system implements feedback by tracking the amount of stimulation delivered and the number of remaining doses. The IPG monitors each stimulation event and updates the remaining dose count, providing feedback to both the patient (through the external controller interface) and the clinician (through remote monitoring capabilities), enabling informed self-management without overuse
2Reliability
If clinicians monitor all patient therapy usage, then therapy optimization is improved, but device complexity increases
Solution Approach 1:
The system enables self-service by allowing patients to independently manage their own therapy dosing. The IPG automatically tracks remaining doses and prevents delivery when doses are exhausted, eliminating the need for continuous clinician intervention or complex monitoring infrastructure while maintaining optimized therapy delivery
Solution Approach 2:
The external controller serves as an intermediary between the patient and the IPG. It provides the user interface for patients to request stimulation, communicates with the IPG to authorize dose delivery, and handles the complexity of dose tracking and management, thereby simplifying the overall system architecture
Data Source
AI summary
Methods and systems for providing stimulation therapy are disclosed. Embodiments of the system include an implantable stimulator and an external controller configured to control the implantable stimulator. A clinician can prescribe a set amount of stimulation therapy to a patient. The external controller is programmed with the prescription. As the patient uses the external controller and the stimulator device the external controller tracks the amount of stimulation the patient uses. Once the patient has used all of the prescribed therapy the patient may return to the clinician for a follow-up appointment.