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

VSEngineering 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

Engineering Contradiction:
Improvetherapeutic effectivenessVSAvoidprotocol establishment complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

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.

Inventive Principle:
Principle #23Feedback

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.

Inventive Principle:
Principle #25Self-service

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

Engineering Contradiction:
Improvepatient assessment accuracyVSAvoidprotocol establishment time
Core Design Contradiction:
Measurement precisionVSLoss of time

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.

Inventive Principle:
Principle #23Feedback

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.

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

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

Engineering Contradiction:
Improveprotocol optimization precisionVSAvoidcommunication system complexity
Core Design Contradiction:
Measurement precisionVSDevice complexity

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.

Inventive Principle:
Principle #6Universality (Multi-functionality)

Data Source

PatentEP2529786B1Patient feedback device including a sensor and means for communicating with a programming device of an electrical stimulation system
Publication Date: 2018.11.07 NUVECTRA CORP
  • EP2529786B1 patent drawingFigure 1
  • EP2529786B1 patent drawingFigure 2
  • EP2529786B1 patent drawingFigure 3~4

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.