Implantable Device Therapy Adjustment via Sleep Quality Metrics
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Solution Overview
Problem
Patients with chronic pain, movement disorders, and psychological disorders often experience disturbed sleep, which exacerbates their symptoms, and existing medical devices lack the ability to effectively adjust therapy based on sleep quality.
Innovation Solution
A medical device that monitors physiological parameters to determine sleep quality metrics, such as sleep efficiency and latency, and adjusts therapy delivery, like neurostimulation or drug infusion, to address disturbed sleep and worsened symptoms.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If a medical device delivers therapy to treat ailments such as chronic pain, movement disorders, or psychological disorders, then the symptoms of these ailments are addressed, but the device cannot adjust therapy based on sleep quality, leading to suboptimal treatment when sleep is disturbed
Solution Approach 1:
The medical device incorporates sleep quality monitoring capabilities that continuously track physiological parameters (such as heart rate, respiration, and brain wave patterns) and feed this information back to the therapy delivery system. This feedback loop enables the device to detect sleep disturbances and automatically adjust therapy parameters in real-time, transforming the previously static therapy delivery into a dynamic, responsive system that adapts to the patient's physiological state
Solution Approach 2:
The medical device is enhanced with multi-functionality by integrating both therapy delivery and sleep quality monitoring capabilities into a single system. The device can simultaneously perform its primary therapeutic function while also monitoring sleep parameters and adjusting therapy accordingly, eliminating the need for separate monitoring equipment and enabling comprehensive patient management
2Reliability
If a patient experiences disturbed sleep due to ailments, then symptom management deteriorates, but existing devices lack the capability to detect and respond to sleep quality changes
Solution Approach 1:
The system replaces manual sleep assessment methods with automated electronic monitoring of physiological parameters. Sensors continuously measure heart rate variability, respiration patterns, and other biomarkers that indicate sleep quality, eliminating the need for subjective patient reporting or complex polysomnography equipment while providing objective, quantifiable sleep data
Solution Approach 2:
The medical device performs self-monitoring of sleep quality parameters and automatically adjusts therapy without requiring external intervention. The system independently detects sleep disturbances through integrated sensors and autonomously modifies therapy delivery, enabling the device to serve itself in optimizing treatment based on real-time physiological feedback
3Productivity
If therapy parameters remain fixed, then device operation is simple, but treatment efficacy decreases when sleep quality varies
Solution Approach 1:
The therapy delivery system transitions from static, fixed parameters to dynamic, continuously adjustable parameters. The device automatically modifies therapy intensity, duration, and timing based on real-time sleep quality assessment, enabling the treatment regimen to adapt flexibly to the patient's physiological state and maximize therapeutic benefit throughout the sleep cycle
Data Source
AI summary
A medical device, such as an implantable medical device (IMD), determines values for one or more metrics that indicate the quality of a patient's sleep, and controls delivery of a therapy based on the sleep quality metric values. For example, the medical device may compare a sleep quality metric value with one or more threshold values, and adjust the therapy based on the comparison. In some embodiments, the medical device adjusts the intensity of therapy based on the comparison, e.g., increases the therapy intensity when the comparison indicates that the patient's sleep quality is poor. In some embodiments, the medical device automatically selects one of a plurality of therapy parameter set available for use in delivering therapy based on a comparison sleep quality metric values associated with respective therapy parameter sets within the plurality of available therapy parameter sets.