Therapy Parameter Evaluation Using Gait Activity Metrics

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Solution Overview

Problem

Current medical devices lack an effective method to evaluate and adjust therapy delivery based on patient activity levels, particularly for movement disorders like Parkinson's disease, where gait irregularities and freeze events are common, leading to suboptimal treatment outcomes.

Innovation Solution

A medical device system that monitors patient activity and gait using sensors like accelerometers and piezoelectric crystals, determining activity metrics for different therapy parameter sets to identify the most effective settings, allowing clinicians to evaluate and adjust therapy delivery accordingly.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If therapy parameters are adjusted to treat movement disorders, then symptom relief is improved, but objective evaluation of therapy efficacy is lacking

Engineering Contradiction:
Improvetherapy efficacy evaluationVSAvoidpatient activity data
Core Design Contradiction:
ReliabilityVSLoss of information

Solution Approach 1:

The system implements feedback by collecting patient activity data through sensors and using this information to evaluate therapy efficacy. The processor analyzes activity levels and compares them against therapy parameter sets, providing objective feedback to clinicians about which parameter sets produce the best outcomes. This closes the loop between therapy delivery and efficacy assessment.

Inventive Principle:
Principle #23Feedback

Solution Approach 2:

The patent introduces an intermediary evaluation system that mediates between therapy delivery and clinical assessment. The system includes a processor that acts as an intermediary, collecting raw sensor data, processing it into meaningful activity metrics, and presenting evaluated therapy efficacy information to clinicians. This intermediary layer transforms unstructured activity data into actionable efficacy evaluations.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Adaptability or versatility

If multiple therapy parameter sets are used to treat different symptoms, then treatment versatility is improved, but difficulty in evaluating relative efficacy increases

Engineering Contradiction:
Improvetherapy parameter setsVSAvoidevaluation process
Core Design Contradiction:
Adaptability or versatilityVSDevice complexity

Solution Approach 1:

The system segments the evaluation process by creating distinct activity metric values for each therapy parameter set. The processor separates and evaluates the efficacy of individual parameter sets independently, calculating specific activity metrics for each one. This segmentation allows clinicians to compare multiple parameter sets systematically without being overwhelmed by the complexity of evaluating them all together.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The patent applies parameter changes by varying therapy parameters across different parameter sets and measuring the corresponding changes in patient activity. The system systematically changes therapy parameters (such as stimulation amplitude, frequency, or pulse width) and uses sensor data to measure the resulting activity level changes, enabling objective comparison of different parameter configurations.

Inventive Principle:
Principle #35Parameter changes

3Measurement precision

If activity monitoring is implemented to evaluate therapy, then objective assessment is improved, but device complexity increases

Engineering Contradiction:
Improveactivity level measurementVSAvoidsensor system
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The system achieves multi-functionality by using a single sensor array to perform multiple functions: monitoring patient activity levels, detecting gait patterns, and providing data for therapy efficacy evaluation. The same sensors that track general movement also capture specific gait characteristics, eliminating the need for separate specialized sensors and reducing overall device complexity while maintaining measurement precision.

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

Solution Approach 2:

The processor performs self-service by automatically analyzing the collected sensor data and generating activity metric values without requiring external intervention. The system self-evaluates therapy efficacy by comparing activity levels against stored parameter sets, reducing the need for complex external evaluation equipment and simplifying the overall device architecture while maintaining precise measurement 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

The system provides an objective assessment of therapy efficacy by quantifying activity levels and gait regularity, enabling clinicians to select therapy parameter sets that improve patient activity and reduce gait freeze events, thereby enhancing treatment outcomes for movement disorders.

Implementation Method 1

Gait parameters may be monitored with accelerometers or other sensors capable of measuring the gait of the patient

Methodology Applied
Scientific EffectAccelerometer: Accelerometer

Implementation Method 2

A signal generated by a sensor that varies as a function of patient activity... a bonded piezoelectric crystal

Methodology Applied
Scientific EffectPiezoelectric effect: Piezoelectric Effect

Data Source

PatentUS10251595B2Collecting gait information for evaluation and control of therapy
Publication Date: 2019.04.09 MEDTRONIC INC
  • US10251595B2 patent drawing
  • US10251595B2 patent drawing
  • US10251595B2 patent drawing

AI summary

A medical device delivers a therapy to a patient. The medical device or another device may periodically determine an activity level or gait parameter of the patient, and associate each determined level or parameter with a current therapy parameter set. A value of at least one activity metric is determined for each of a plurality of therapy parameter sets based on the activity levels or parameters associated with that therapy parameter set. Whether the patient is currently experiencing or anticipated to experience gait freeze caused by their neurological disorder, such as Parkinson's disease, may also be determined. Gait freeze events may be associated with current therapy parameters and used to determine activity metric values. In some examples, the activity metric associated with certain therapy parameters may be presented to a user.