Wearable Bone Stimulator Feedback for Spinal Fusion Compliance

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Solution Overview

Problem

Current external bone stimulation devices for spinal fusion are bulky, uncomfortable, limit mobility, have unwieldy user interfaces, and lack feedback, leading to reduced patient compliance and uncertainty about therapy progress.

Innovation Solution

A wearable, non-invasive stimulator device with electrodes, a user-friendly interface, and integrated sensors to track usage and patient status, providing real-time feedback and correlation with therapy effectiveness, ensuring comfort and mobility.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If external bone stimulation devices are used to enhance bone healing, then therapeutic effect is improved, but device bulkiness and discomfort increase

Engineering Contradiction:
Improvebone healing effectivenessVSAvoiddevice comfort and mobility
Core Design Contradiction:
ReliabilityVSEase of operation

Solution Approach 1:

The device is divided into separate functional modules: a stimulator unit with electrodes for bone stimulation, a motion sensor module for activity tracking, and a separate display/feedback component. This segmentation allows each module to be optimized independently, reducing overall bulk while maintaining functionality.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The patent extracts the feedback and display functions from the main stimulator body, allowing the core stimulation device to be more compact. The motion sensor and feedback system operate independently, providing information without adding significant bulk to the therapeutic device.

Inventive Principle:
Principle #2Taking out (Extraction)

2Reliability

If traditional bone stimulation devices are used, then therapeutic function is provided, but user interface complexity increases

Engineering Contradiction:
Improvetherapy deliveryVSAvoiduser interface usability
Core Design Contradiction:
ReliabilityVSEase of operation

Solution Approach 1:

The device automatically tracks patient motion and therapy usage through integrated motion sensors, eliminating the need for manual logging or complex user input. The system self-monitors compliance and provides automatic feedback, simplifying the user interface while maintaining reliable therapy delivery.

Inventive Principle:
Principle #25Self-service

Solution Approach 2:

The patent implements automatic feedback mechanisms where the device monitors its own usage and patient response, then provides guidance without requiring complex user interaction. This reduces interface complexity while ensuring proper therapy administration.

Inventive Principle:
Principle #23Feedback

3Reliability

If external bone stimulation devices are used, then bone healing is promoted, but lack of feedback increases patient uncertainty

Engineering Contradiction:
Improvebone healing promotionVSAvoidtherapy progress information
Core Design Contradiction:
ReliabilityVSLoss of information

Solution Approach 1:

The device incorporates motion sensors that continuously monitor patient activity and therapy usage, then provide real-time feedback on compliance and progress. This feedback loop gives patients objective information about their healing process, reducing uncertainty while maintaining effective bone stimulation.

Inventive Principle:
Principle #23Feedback

Solution Approach 2:

The patent replaces subjective patient assessments with objective sensor-based measurements of motion and therapy usage. This substitution provides accurate, quantifiable feedback on healing progress without requiring complex mechanical or manual monitoring systems.

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

4Productivity

If motion tracking is implemented, then patient compliance is monitored, but device complexity increases

Engineering Contradiction:
Improvecompliance monitoringVSAvoidsensor integration
Core Design Contradiction:
ProductivityVSDevice complexity

Solution Approach 1:

The motion sensor serves multiple functions: tracking patient compliance, monitoring therapy effectiveness, and providing feedback for device adjustment. This multi-functionality justifies the added complexity by delivering multiple benefits from a single sensor integration.

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

Solution Approach 2:

The motion tracking system automatically monitors and records compliance data without requiring additional user input or complex manual tracking procedures. The device self-monitors its usage patterns and provides automatic compliance reporting, reducing the operational complexity despite enhanced monitoring capabilities.

Inventive Principle:
Principle #25Self-service

Applied Scientific Principles

This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.

Function Achieved in This Case

Enhances patient compliance and satisfaction by offering a comfortable, easy-to-use device that provides objective feedback on therapy progress, improving bone healing outcomes.

Implementation Method 1

The signal generator may be configured to generate one or more electrical impulses and to transmit the one or more electrical impulses to the electrode(s)... The one or more electrical impulses may be sufficient to enhance bone healing in the patient

Methodology Applied
Scientific EffectElectrical stimulation: Electric Field

Implementation Method 2

a motion sensor coupled to the housing and configured to sense a motion of the housing... a processor coupled to the motion sensor and including a computer-readable storage device and/or software application that stores program instructions that allow the processor to determine a magnitude of motion data obtained from the motion sensor

Methodology Applied
Scientific EffectMotion detection: Accelerometer

Data Source

PatentEP4288138B1Systems for electrical stimulation therapy
Publication Date: 2026.03.04 THERAGEN INC
  • EP4288138B1 patent drawingFigure 1
  • EP4288138B1 patent drawingFigure 2~3
  • EP4288138B1 patent drawingFigure 4

AI summary

Systems, devices and methods are provided for transcutaneously delivering energy impulses to bodily tissues for therapeutic purposes, such as for enhancing the body's bone healing process in spinal fusion patients. A therapeutic stimulator system comprises a housing for an energy source and a signal generator. The system further includes one or more electrodes coupled to the signal generator. A processor is coupled to the housing and configured to determine usage levels of the signal generator and/or motion data of the housing. The system may include a mobile device that allows the patient to input user status data, such as pain levels, and compare the user status data with the usage levels and/or the motion data, thereby improving patient compliance with a prescribed therapy regimen.