Downloadable Stimulation Pattern Framework for Adaptive Therapy Regimens
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Solution Overview
Problem
Existing medical devices for electrical stimulation therapy are limited by rigid firmware-defined therapy patterns, requiring extensive validation and verification for each new pattern, leading to costly and time-consuming regulatory processes.
Innovation Solution
A system that allows for flexible stimulation pattern definition and delivery through downloadable software, enabling clinicians to create tailored therapy regimens using a stimulation pattern construct collection, with firmware acting as a 'player' to execute these patterns, reducing the need for full system validation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If firmware is used to define therapy patterns in medical devices, then the device can deliver electrical stimulation therapy, but the device becomes rigid and requires extensive validation for each new pattern
Solution Approach 1:
The patent transforms the static firmware-based therapy pattern definition into a dynamic software-based system. The firmware acts as a flexible platform that can execute various software applications, each defining different stimulation patterns. This allows the device to adapt to new therapy patterns without requiring firmware changes, thereby maintaining reliability while improving adaptability.
Solution Approach 2:
The patent segments the therapy pattern definition functionality from the core device firmware. Instead of embedding all therapy patterns directly in firmware, the system separates the pattern definition into independent software applications that can be loaded, updated, or removed without affecting the core device functionality. This segmentation enables extensive validation of individual pattern software components while maintaining overall system reliability.
2Device complexity
If predefined stimulation patterns are used in firmware, then the device structure remains simple, but the therapy customization capability is limited
Solution Approach 1:
The patent implements a universal firmware platform that can execute multiple different software applications for defining various stimulation patterns. The firmware provides a common execution environment that supports diverse therapy regimens, allowing a single device structure to serve multiple therapy customization needs without increasing overall complexity.
Solution Approach 2:
The patent introduces software as an intermediary layer between the simple firmware structure and the complex therapy customization requirements. The firmware remains relatively simple and generic, while the software applications provide the complex pattern definitions. This intermediary software layer enables extensive therapy customization without requiring complex changes to the underlying device structure.
3Adaptability or versatility
If new stimulation patterns are implemented through firmware updates, then the device can support new therapies, but the regulatory validation process becomes time-consuming and costly
Solution Approach 1:
The patent uses software copying instead of firmware rewriting to implement new therapy patterns. Each new stimulation pattern is encapsulated as a separate software application that can be copied, loaded, and executed by the existing firmware. This approach allows rapid deployment of new patterns without the time-consuming regulatory validation required for firmware updates, as the core device hardware and firmware remain unchanged.
Solution Approach 2:
The patent enables preliminary validation and testing of new stimulation pattern software applications before they are deployed to patients. The software can be developed, tested, and validated in isolation before being loaded onto the device. This preliminary action separates the validation process from the device certification process, reducing the time and cost associated with regulatory validation for each new pattern.
Data Source
AI summary
A system to provide flexible stimulation pattern definition, delivery, and control to dynamically adjust a therapy regimen for electrical stimulation therapy based on patient needs. Firmware in an electrical stimulation delivery device that executes the therapy regimen may be implemented as a “player” of a series of instructions for the received stimulation patterns. The system may include a wearable device or an implantable device. An external computing device configured to program the electrical stimulation delivery device may include a stimulation pattern construct collection from which a clinician can select, assemble, and modify waveforms, bursts, pattern, sensing or other event triggers etc. to create a therapy regimen. The external computing device may transmit software that defines the selected regimen to the electrical stimulation delivery device memory, where the device “plays” the instructions to deliver electrical stimulation according to the therapy regimen.