Patient Feedback Device for Spinal Cord Stimulation Protocol Optimization
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Solution Overview
Problem
The increasing number of electrodes in newer medical electrical leads for spinal cord stimulation systems exponentially complicates the process of establishing optimal stimulation protocols, requiring substantial time and manual effort from healthcare professionals.
Innovation Solution
A patient feedback device with sensors and a controller that allows patients to provide real-time feedback on stimulation sensations, facilitating the development of protocols by interacting with a clinician programmer to determine effective electrode combinations and stimulation parameters.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If the number of electrodes in medical electrical leads is increased to provide more comprehensive spinal cord stimulation coverage, then the therapeutic effectiveness is improved, but the complexity of establishing optimal stimulation protocols increases exponentially
Solution Approach 1:
The patent implements a feedback mechanism where patients use a handheld device to provide real-time feedback about their stimulation sensations during programming sessions. This feedback loop allows the system to iteratively optimize electrode combinations and stimulation parameters based on actual patient response, significantly reducing the complexity of establishing optimal protocols despite having numerous electrodes available.
Solution Approach 2:
The system enables patients to actively participate in the programming process by providing their own feedback about stimulation sensations. This self-service approach allows patients to indicate which electrode combinations and parameters produce desirable paresthesia or pain relief, reducing the burden on clinicians and streamlining the protocol development process.
2Measurement precision
If manual programming approaches are used to establish stimulation protocols with increased electrode combinations, then comprehensive patient assessment is possible, but the time required for protocol establishment increases substantially
Solution Approach 1:
The handheld feedback device enables real-time communication of patient sensations to the programming device, creating an efficient feedback loop that maintains assessment accuracy while dramatically reducing the time required to evaluate different electrode combinations and parameters compared to traditional manual methods.
Solution Approach 2:
The patent replaces the manual, time-consuming process of patient feedback with an automated electronic system. The handheld device with sensors and communication capabilities substitutes for traditional manual assessment methods, allowing rapid transmission of patient responses to the programming device for immediate processing and protocol optimization.
3Measurement precision
If real-time patient feedback is collected during programming sessions, then the precision of protocol optimization is improved, but the complexity of the communication system between patient device and programming device increases
Solution Approach 1:
The handheld feedback device is designed as a multi-functional unit that combines sensors for detecting patient responses, processing circuits for signal conditioning, and communication interfaces for data transmission. This universal design consolidates multiple functions into a single device, achieving precise real-time feedback collection while managing communication system complexity through integration.
Data Source
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AI summary
A patient feedback device (145) for communicating with a programming device (130) of an electrical stimulation system (100). The device includes a housing, a sensor (165), a controller and a communication port (175). The sensor is supported by the housing and generates a sensor signal in response to an action from the patient (105). The controller is supported by the housing and is in operative communication with the sensor. The controller receives the sensor signal and sends information to the communication port based on the sensor signal. The communication port is connected to the housing and is in operative communication with the controller. The communication port receives information from the controller and wirelessly transmits a communication signal to the programming device of the electrical stimulation system.