Biomarker-BODE Index Integration for COPD Prognosis

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Solution Overview

Problem

Current methods for assessing COPD severity and predicting clinical outcomes in patients with chronic obstructive pulmonary disease (COPD) are cumbersome, unreliable, and do not provide adequate risk stratification, especially for ambulatory patients, with limited ability to replace the BODE index effectively.

Innovation Solution

A method that combines the determination of specific biomarkers (pro-adrenomedullin, pro-natriuretic peptide, pro-Vasopressin, and Procalcitonin) with selected BODE-index parameters (body-mass index, degree of airflow obstruction, dyspnea, and exercise capacity) for prognosis and risk assessment, allowing for a more reliable and convenient monitoring of COPD management.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If traditional BODE index assessment is used alone, then the method is simple to operate, but the prediction reliability of mortality and exacerbation risk is insufficient

Engineering Contradiction:
Improveprediction reliabilityVSAvoidassessment complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The patent combines the BODE index assessment with four specific biomarkers (pro-adrenomedullin, pro-natriuretic peptide, pro-vasopressin, and procalcitonin) to create a composite assessment system. This merging of clinical parameters and biochemical markers resolves the contradiction by maintaining the simplicity of the BODE index while adding reliable predictive power through biomarker integration, achieving both operational ease and prediction reliability.

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The patent creates a multi-functional assessment tool that simultaneously evaluates airflow obstruction, exercise capacity, dyspnea, body mass index, and biomarker levels. This universal system serves multiple purposes: it predicts mortality risk, exacerbation risk, and overall disease prognosis, thereby resolving the contradiction by making a single comprehensive tool that is both simple to use and highly reliable across multiple prediction dimensions.

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

2Measurement precision

If comprehensive biomarker panels are used, then the prediction accuracy improves, but the ease of operation and patient burden increases

Engineering Contradiction:
Improveprediction accuracyVSAvoidpatient burden
Core Design Contradiction:
Measurement precisionVSEase of operation

Solution Approach 1:

The patent uses blood-based biomarker measurements as a proxy or copy of the complex physiological state assessment. Instead of requiring extensive functional testing and patient effort, simple blood draws provide precise predictive information through the four biomarkers, thereby resolving the contradiction between measurement precision and ease of operation by replacing complex assessments with accessible biochemical copies.

Inventive Principle:
Principle #26Copying

Solution Approach 2:

The patent shifts from measuring complex functional parameters (exercise capacity, airflow limitation) to measuring biochemical parameters (biomarker concentrations). This parameter change allows for high prediction accuracy through sensitive laboratory assays while significantly reducing patient burden, as blood draws are far less intrusive than comprehensive pulmonary function testing and exercise challenges.

Inventive Principle:
Principle #35Parameter changes

3Reliability

If more biomarkers are added to the assessment, then the risk stratification ability improves, but the device complexity and cost increase

Engineering Contradiction:
Improverisk stratification abilityVSAvoidassessme nt complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The patent selects exactly four specific biomarkers (pro-adrenomedullin, pro-natriuretic peptide, pro-vasopressin, and procalcitonin) rather than using exhaustive panels. This partial action approach provides sufficient risk stratification ability by focusing on the most predictive markers, thereby resolving the contradiction by achieving adequate reliability without the complexity and cost of comprehensive biomarker profiling.

Inventive Principle:
Principle #16Partial or excessive action

Data Source

PatentEP3232201A1Prediction of outcome in patients with chronic obstructive pulmonary disease
Publication Date: 2017.10.18 BRAHMS GMBH
  • EP3232201A1 patent drawing
  • EP3232201A1 patent drawing
  • EP3232201A1 patent drawing

AI summary

The present invention relates to a method for the prognosis and/or risk assessment and/or monitoring of therapy and/or management of patients with COPD the method comprising the steps of: i) providing a sample of a bodily fluid from said patient, ii) determining in said sample the level of at least one biomarker, selected from the group consisting of pro-adrenomedullin (proADM), pronatriuretic peptide, pro-Vasopressin (proAVP) and Pro-calcitonin (PCT) or fragments thereof of at least 12 amino acids in length, iii) determining one, two or three of the BODE-index parameters body-mass index (BMI, parameter B), degree of airflow obstruction (FEV1, parameter O), dyspnea (parameter D) and exercise capacity (parameter E), iv) correlating said level of said at least one biomarker determined in step ii), in combination with said one, two or three BODE-index parameters determined in step iii) to the prognosis and/or risk assessment and/or monitoring of therapy and/or management of patients with COPD.