Bioimpedance Cervical Tissue Measurement Device

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Solution Overview

Problem

Current methods for detecting pre-term labor are inadequate, leading to misdiagnosis and delayed intervention, as they rely on qualitative examinations and lack sensitivity and specificity, resulting in high rates of neonatal morbidity and mortality, and increased medical costs.

Innovation Solution

A bioimpedance measuring device with a tip member equipped with multiple electrodes is used to non-invasively measure the electrical impedance of cervical tissue, providing diagnostic information that can detect early onset of labor and assess tissue abnormalities, allowing for earlier and more accurate prediction of pre-term labor.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If conventional qualitative examination methods are used to detect pre-term labor, then the examination process is simple and easy to perform, but the diagnostic accuracy and sensitivity are insufficient leading to misdiagnosis

Engineering Contradiction:
Improvediagnostic accuracyVSAvoidexamination method complexity
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The patent replaces conventional mechanical qualitative examination methods with electrical impedance measurement technology. The bioimpedance measuring device uses electrical signals to detect changes in cervical tissue properties, transforming a mechanical examination into an electrical measurement system that provides quantitative diagnostic data with higher precision.

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

Solution Approach 2:

The invention measures changes in electrical impedance parameters of cervical tissue to detect pre-term labor. By monitoring variations in resistivity and reactance of the cervix over time, the device provides objective quantitative parameters that improve diagnostic accuracy compared to subjective qualitative assessments.

Inventive Principle:
Principle #35Parameter changes

2Loss of time

If conventional examination methods are used, then the equipment required is simple, but the detection timing is delayed resulting in reduced effectiveness of intervention

Engineering Contradiction:
Improvedetection timingVSAvoidearly detection capability
Core Design Contradiction:
Loss of timeVSMeasurement precision

Solution Approach 1:

The bioimpedance device detects cervical tissue changes before clinical symptoms of pre-term labor appear. By measuring electrical impedance changes in the cervix, the system identifies early remodeling processes that precede visible cervical softening or dilation, enabling preliminary detection and earlier intervention.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The device provides continuous or repeated impedance measurements that give feedback on cervical tissue status over time. This temporal feedback allows clinicians to monitor changes dynamically and detect the transition from normal to pre-term labor conditions at an earlier stage than conventional single-point examinations.

Inventive Principle:
Principle #23Feedback

3Reliability

If qualitative cervical examination is performed, then the procedure is non-invasive and simple, but the sensitivity and specificity for predicting pre-term labor are low

Engineering Contradiction:
Improveprediction reliabilityVSAvoidmeasurement system complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The patent replaces subjective mechanical cervical examination with objective electrical impedance measurement. The bioimpedance device provides quantifiable data on cervical tissue properties, replacing the clinician's tactile assessment with measurable electrical parameters that have higher reliability for predicting pre-term labor.

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

Solution Approach 2:

The invention utilizes changes in electrical impedance parameters (resistivity, reactance, phase angle) as objective indicators of cervical remodeling. These measurable parameter changes provide more reliable and consistent data for prediction compared to subjective qualitative descriptors used in conventional examinations.

Inventive Principle:
Principle #35Parameter changes

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 bioimpedance measuring device enables earlier detection of pre-term labor, reducing neonatal mortality, minimizing unnecessary medical treatments, and improving maternal safety by providing more accurate diagnostic information compared to conventional techniques.

Implementation Method 1

A bioimpedance measuring device with a tip member equipped with multiple electrodes is used to non-invasively measure the electrical impedance of cervical tissue

Methodology Applied
Scientific EffectElectrical Impedance: Electrical Resistance

Data Source

PatentUS8060195B2Devices, systems and methods for bioimpedance measurement of cervical tissue and methods for diagnosis and treatment of human cervix
Publication Date: 2011.11.15 JOHNS HOPKINS UNIVERSITY
  • US8060195B2 patent drawing
  • US8060195B2 patent drawing
  • US8060195B2 patent drawing

AI summary

Featured are apparatuses for measuring bioimpendence of tissues of the cervix, more specifically the mammalian cervix. Also featured are methods for examining the tissues of the cervix for clinical or diagnostic purposes such as during routine gynecological examinations to determine early onset of labor in pregnant patients or to assess such tissues for the presence of abnormalities such as cancerous lesions in both pregnant and non-pregnant women. Also featured are methods for treating onset of early or pre-term labor that embody such devices, apparatuses and methods of the present invention. Also featured are systems embodying such devices, apparatuses and/or methods, where such systems preferably are configured to provide diagnostic and/or clinical information to further assist the diagnostician or clinician in diagnosing and/or examining pregnant or non-pregnant patients.