Autonomous Neurostimulator Programming via Patient Feedback
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Solution Overview
Problem
The programming of implantable medical devices, such as neurostimulators, is time-consuming, prone to human error, and stressful for both clinicians and patients, and requires frequent adjustments due to changing patient conditions and electrode positions, with existing automated systems being complex and intimidating for elderly or mentally unfit patients.
Innovation Solution
A medical device system comprising a programmable implantable device, a patient device, and a clinician device, where the patient device automatically poses questions to the patient, decides on actions based on feedback, and submits adjusted parameters, while allowing patients to selectively communicate with clinicians for support, using a computer program product and computer-readable medium.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If automated programming system is implemented, then productivity is improved, but device complexity increases
Solution Approach 1:
The system is divided into three distinct components: the implantable medical device, the patient device for autonomous interaction, and the clinician device for remote monitoring and intervention. This segmentation allows the complex automation functionality to be distributed across multiple devices, reducing the complexity burden on any single component while maintaining high productivity.
Solution Approach 2:
The patient device serves as an intermediary between the implantable medical device and the clinician device. It autonomously interacts with the implantable device to adjust parameters based on patient feedback, while also serving as a communication bridge to the clinician when needed. This intermediary role enables automated programming without requiring direct complex interactions between the implantable device and external systems.
2Loss of time
If automated programming is implemented, then loss of time is reduced, but reliability may worsen due to potential errors
Solution Approach 1:
The patient device continuously gathers feedback from the patient about stimulation sensations and uses this feedback to automatically adjust programming parameters. The system also incorporates feedback loops where the clinician can review adjustments and intervene if necessary. This multi-layered feedback mechanism ensures that automated programming remains accurate and reliable while being time-efficient.
Solution Approach 2:
The system is designed with safety mechanisms that cushion against potential errors: the clinician device can pre-approve parameter adjustment ranges, the patient device includes validation checks before applying changes, and the system allows easy reversal of adjustments. These beforehand cushioning measures protect against programming errors while maintaining automation benefits.
3Ease of operation
If patient自主 programming is enabled, then ease of operation is improved, but object-generated harmful factors increase due to potential misuse
Solution Approach 1:
The patient device enables patients to autonomously adjust their own programming parameters based on their real-time sensations and needs. The system provides user-friendly interfaces and automated decision-making algorithms that guide patients through programming adjustments without requiring medical expertise, thereby improving ease of operation while maintaining safety through built-in validation and clinician oversight capabilities.
Data Source
AI summary
A medical device system (1) and a method for operating a medical device system are de-scribed. The medical device system, comprises: a programmable implantable medical device (3), configured for providing stimulations to a patient (11) in accordance with programmed stimulation parameters; a patient device (5), comprising a first interface (19) configured for communication and interaction with the patient and a second interface (23) configured for submitting data for programming the implantable medical device, and a clinician device (7), comprising a third interface (27) configured for communication and interaction with a clinician (29) and a fourth interface (33) configured for data communication with the patient device, wherein, for programming the implantable medical device, the patient device is configured to automatically pose at least one question to the patient via the first interface, and to automatically decide upon an action according to at least one feedback from the patient entered via the first interface and to submit the adjusted stimulation parameter to the implantable medical device, and wherein the patient device and the clinician device are further configured to provide an option to the patient to selectively establish a communication between the patient and the clinician.