Implantable Device Parameter Segmentation for Patient Safety
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Solution Overview
Problem
Current implantable heart stimulators, such as pacemakers, require frequent physician intervention to adjust parameters that impact a patient's lifestyle, leading to insufficient granularity in adapting to daily changes and potential suboptimal hemodynamic support.
Innovation Solution
An implantable medical device with a telemetry unit and user interface allowing patients to modify selected parameters wirelessly, such as transition times between nighttime and daytime stimulation rates, while restricting access to parameters requiring medical expertise, like atrioventricular delay intervals, to improve lifestyle adaptation and quality of life.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If patients can access and modify all device parameters, then adaptability to lifestyle changes improves, but safety risks increase due to potential incorrect adjustments of complex parameters
Solution Approach 1:
The patent segments device parameters into two distinct categories: patient-modifiable parameters (e.g., transition times between nighttime and daytime rates) and physician-only parameters (e.g., atrioventricular delay intervals). This segmentation allows patients to adapt lifestyle-relevant settings while preventing them from modifying complex parameters that require medical expertise, thus resolving the contradiction between adaptability and safety.
2Ease of operation
If physician follow-up frequency is reduced, then patient convenience improves, but ability to monitor and adjust parameters timely deteriorates
Solution Approach 1:
The patent enables patients to perform self-service by allowing them to directly modify selected device parameters related to their lifestyle needs, such as transition times between nighttime and daytime stimulation rates. This eliminates the need for frequent physician follow-ups while ensuring timely adaptation of parameters, as patients can make adjustments immediately when needed.
3Adaptability or versatility
If more parameters are made accessible to patients, then lifestyle adaptation granularity improves, but device complexity increases
Solution Approach 1:
The patent implements a segmented parameter access structure where the control unit maintains distinct access rights for different parameter groups. Patients can access and modify a specific subset of parameters (e.g., transition times) while other parameters remain restricted to physician control. This segmentation provides lifestyle adaptation granularity without overwhelming patients with excessive complexity.
Solution Approach 2:
The control unit acts as an intermediary that manages parameter access based on user identity (patient vs. physician). When a patient attempts to modify a parameter, the control unit checks whether that parameter is within the allowed subset. This intermediary mechanism enables fine-grained adaptability while abstracting away the complexity of access control from the user interface.
Data Source
AI summary
An implantable medical device (IMD) that can be wirelessly connected to user interface by which a patient can enter values of selected control parameters for controlling the IMD whereas other control parameters are not accessible via said user interface and can only be modified by a physician or other authorized personnel.