Virtual Machine Firmware for Neuromodulation Programming
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Solution Overview
Problem
Current neuromodulation systems face complexity in programming and interpreting large numbers of modulation parameters, leading to increased firmware complexity and susceptibility to errors, as well as security risks due to frequent updates.
Innovation Solution
A system featuring an ambulatory medical device with a virtual machine that interprets programming instructions and generates modulation waveform datasets, allowing for safe and systematic management of complex stimulation waveforms, isolated from the rest of the firmware to prevent inadvertent mistakes and reduce the need for firmware revalidation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If large amounts of modulation parameters are transmitted and interpreted by firmware, then complex modulation waveforms can be achieved, but firmware complexity increases and susceptibility to errors increases
Solution Approach 1:
The patent extracts the modulation parameter interpretation function from the implantable device firmware and relocates it to an external programming device. The external device compiles modulation programs into instruction sets that are transmitted to the implantable device, which then executes these instructions. This separation removes the complex interpretation logic from the implantable firmware, reducing its complexity while maintaining the ability to handle complex modulation waveforms.
Solution Approach 2:
The patent introduces an intermediate instruction set as a mediator between the high-level modulation parameters and the implantable device execution. The external programming device translates modulation parameters into a compiled instruction set that serves as an intermediary representation, which is then transmitted to and executed by the implantable device. This intermediary layer simplifies the firmware's task to mere execution rather than interpretation.
2Adaptability or versatility
If frequent modulation parameter updates are allowed, then patient needs can be met, but security risks and susceptibility to inadvertent mistakes increase
Solution Approach 1:
The patent implements preliminary validation and compilation of modulation programs in the external programming device before transmission to the implantable device. The external device compiles the modulation parameters into instruction sets and validates them beforehand, ensuring that only safe and correct programs are transmitted. This preliminary action prevents inadvertent mistakes and security issues from reaching the implantable device.
Solution Approach 2:
The patent creates a compiled copy of the modulation program in the form of an instruction set that is transmitted to the implantable device. This compiled instruction set serves as a safe copy that can be executed without requiring the implantable firmware to interpret or validate the original modulation parameters. The copying process isolates the implantable device from direct exposure to potentially harmful parameter modifications.
3Measurement precision
If separate and independent programming of each modulation parameter is required, then precise control is achieved, but programming burden increases
Solution Approach 1:
The patent merges the separate modulation parameters into a unified modulation program that is compiled as a single instruction set. Instead of transmitting and executing individual parameter adjustments separately, the external programming device combines all modulation parameters into an integrated program structure. This merging maintains precise control over each parameter while simplifying the programming process through unified management.
Solution Approach 2:
The patent creates a universal instruction set structure that can accommodate multiple modulation parameters and configurations through a single compiled program. The instruction set format is designed to be multi-functional, capable of representing various electrode configurations, pulse parameters, and waveform characteristics in a unified manner. This universality allows precise control of individual parameters while maintaining ease of operation through a single programming interface.
Data Source
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AI summary
This document discusses, among other things, systems and methods for programming a neuromodulation therapy to treat neurological or cardiovascular diseases. A system includes an ambulatory medical device (AMD) and at least one computer-readable storage medium including instructions executable on an external system. The instructions, when executed by the external system, causes a user interface in the external system to receive a waveform function and one or more modulation parameter values. The waveform function includes one or more modulation programs characterized by one or more modulation parameters. The instructions causes a compiler to translate the waveform function into virtual machine (VM) instructions, which can be transmitted to the AMD. The AMD includes a VM that executes the VM instructions, and generates one or more modulation waveform datasets. The AMD may generate and deliver electrostimulation therapy in accordance with the one or more modulation waveform datasets.