Wellness Factor Algorithm for Implantable Pulse Generator Therapy Optimization

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Solution Overview

Problem

Current methods for evaluating the effectiveness of implantable neurostimulator therapies, such as Spinal Cord Stimulation (SCS) and Deep Brain Stimulation (DBS), rely heavily on subjective qualitative measurements and lack widespread use of quantitative measurements, making it difficult to universally assess therapy effectiveness for all patients.

Innovation Solution

A system that employs a wellness modelling algorithm to correlate qualitative and quantitative patient measurements, allowing for the determination of a wellness factor that can adjust the stimulation program to improve therapy efficacy, using a combination of qualitative patient feedback and objective quantitative data from sensors.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If subjective qualitative measurements are used to evaluate therapy effectiveness, then patient feedback can be obtained, but the assessment lacks objectivity and reliability

Engineering Contradiction:
Improvepatient feedback collectionVSAvoidtherapy effectiveness assessment
Core Design Contradiction:
Ease of operationVSReliability

Solution Approach 1:

The patent introduces an intermediary algorithm that processes both qualitative patient feedback and quantitative sensor measurements to generate a wellness factor. This intermediary computation layer transforms subjective inputs into an objective assessment metric, resolving the contradiction between ease of feedback collection and reliability of assessment.

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The system implements a feedback mechanism where quantitative measurements from sensors continuously monitor patient status and are combined with qualitative feedback. This closed-loop feedback system enhances assessment reliability by objectively verifying and adjusting therapy effectiveness based on multiple data sources.

Inventive Principle:
Principle #23Feedback

2Device complexity

If only qualitative measurements are used, then implementation is simple, but measurement precision is insufficient

Engineering Contradiction:
Improvemeasurement systemVSAvoidtherapy effectiveness measurement
Core Design Contradiction:
Device complexityVSMeasurement precision

Solution Approach 1:

The patent merges qualitative patient feedback with quantitative sensor measurements into a unified wellness factor assessment. By combining these complementary measurement types through an integrated algorithm, the system achieves high measurement precision without requiring complex separate systems for each measurement type.

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The wellness factor algorithm serves multiple functions: it processes qualitative feedback, integrates quantitative measurements, generates objective assessments, and guides therapy adjustments. This multi-functional approach achieves high measurement precision while maintaining relatively simple system architecture.

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

3Reliability

If quantitative measurements are incorporated into the assessment system, then objectivity and reliability improve, but device complexity increases

Engineering Contradiction:
Improvetherapy effectiveness assessmentVSAvoidmeasurement and processing system
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The system employs self-service principles by using the implantable device's existing sensors to automatically collect quantitative measurements and integrate them with patient feedback. The algorithm autonomously processes data and generates wellness factors without requiring external complex processing equipment, thus improving reliability while limiting complexity increase.

Inventive Principle:
Principle #25Self-service

4Productivity

If a comprehensive algorithm using both qualitative and quantitative data is implemented, then therapy optimization improves, but computational requirements and processing time increase

Engineering Contradiction:
Improvetherapy optimization efficiencyVSAvoiddata processing time
Core Design Contradiction:
ProductivityVSLoss of time

Solution Approach 1:

The system performs preliminary action by continuously collecting and pre-processing quantitative measurements in the background while the patient provides qualitative feedback. The algorithm has pre-established correlation models that enable rapid integration of new data, reducing real-time processing requirements and allowing comprehensive therapy optimization without significant time loss.

Inventive Principle:
Principle #10Preliminary action

Data Source

PatentUS20240390680A1Determination and Use of a Wellness Factor in an Implantable Medical Device System Using Qualitative and Quantitative Measurements
Publication Date: 2024.11.28 BOSTON SCI NEUROMODULATION CORP
  • US20240390680A1 patent drawing
  • US20240390680A1 patent drawing
  • US20240390680A1 patent drawing

AI summary

A system is disclosed in one example which allows for modelling the wellness of a given Implantable Pulse Generator (IPG) patient. The modelling, embodied in an algorithm, uses one or more qualitative measurements and one or more quantitative measurements taken from the patient. The algorithm correlates the qualitative measurements to the various quantitative measurements to eventually, over time, learn which quantitative measurements best correlate to the qualitative measurements provided by the patient. The algorithm can then using current quantitative measurements predict a wellness factor or score for the patient, which is preferably weighted to favor the quantitative measurements that best correlate to that patient's qualitative assessment of therapy effectiveness. Additionally, the wellness factor may be used to adjust the stimulation program that the IPG device provides to the patient.