Wound Dressing pH Indicator Composite for Continuous Monitoring

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Solution Overview

Problem

Current wound dressings lack the ability to accurately and continuously monitor pH levels at the wound surface, as existing pH indicator dyes are not sensitive enough to detect incremental changes and often provide inaccurate measurements due to external factors affecting wound exudate pH, and pH probes can cause tissue disruption and require frequent calibration.

Innovation Solution

A wound dressing with a pH indicator that changes color in response to pH changes, allowing for visual monitoring of incremental pH changes over time, using a combination of phenylazo compounds that detect pH between 5 and 10, and can be integrated into a conformable, non-woven mesh or perforated film to fit various wound sizes, with conduits to direct exudate without altering pH.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If a pH indicator dye is provided on a colour strip integrated within the dressing, then the pH can be monitored, but the dye is not sufficiently sensitive to provide an indication of the incremental change in pH between 6.5 and 8.5

Engineering Contradiction:
ImprovepH measurement sensitivityVSAvoiddye composition complexity
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The patent applies composite materials by combining multiple pH indicator dyes (such as phenylazo compounds and triarylmethane dyes) in specific ratios to create a composite indicator system. This composite approach enables the detection of incremental pH changes between 6.5 and 8.5, which single dyes cannot achieve, thereby resolving the measurement precision issue while managing complexity through standardized composite formulations.

Inventive Principle:
Principle #40Composite materials

Solution Approach 2:

The patent utilizes parameter changes by selecting dyes with specific pKa values and color transition ranges that overlap in the critical pH zone of 6.5-8.5. By adjusting the composition ratios and selecting dyes with appropriate parameters (molecular structure, pKa, color transition range), the system achieves enhanced sensitivity to incremental pH changes without requiring overly complex device architecture.

Inventive Principle:
Principle #35Parameter changes

2Measurement precision

If a pH probe is used to allow direct measurement of the pH at the wound surface, then accurate pH measurement is achieved, but it can result in tissue disruption and localised cell death, such that the probe requires regular calibration

Engineering Contradiction:
ImprovepH measurement accuracyVSAvoidtissue disruption
Core Design Contradiction:
Measurement precisionVSObject-affected harmful factors

Solution Approach 1:

The patent replaces the mechanical pH probe system with a chemical indicator system. Instead of using a physical probe that contacts and potentially damages tissue, the invention uses pH-sensitive dyes incorporated into the dressing material that passively indicate pH through color changes. This substitution eliminates tissue disruption while maintaining measurement capability, directly resolving the contradiction between measurement accuracy and tissue harm.

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

Solution Approach 2:

The patent introduces an intermediary substance (pH indicator dye) that mediates between the wound environment and the observer. The dye acts as a chemical mediator that responds to pH changes in the wound exudate and translates them into visible color changes, allowing indirect but accurate pH measurement without direct probe-tissue contact, thus avoiding the harmful effects of mechanical probes.

Inventive Principle:
Principle #24Intermediary (Mediator)

3Loss of time

If a pH probe provides a snap-shot of the pH of a specific area of the wound at a single point in time, then a measurement is obtained, but it provides no indication of the pH changes over time

Engineering Contradiction:
Improvecontinuous monitoring capabilityVSAvoidmonitoring system complexity
Core Design Contradiction:
Loss of timeVSDevice complexity

Solution Approach 1:

The patent achieves continuous monitoring by incorporating the pH indicator dye throughout the dressing material that remains in continuous contact with the wound. As the dressing absorbs exudate over time, the indicator continuously responds to pH changes, providing ongoing visual feedback without requiring repeated measurements or complex electronic monitoring systems. This maintains continuous useful action while keeping the device relatively simple.

Inventive Principle:
Principle #20Continuity of useful action

Solution Approach 2:

The patent applies preliminary action by pre-incorporating the pH indicator dye into the dressing structure before application to the wound. This preliminary integration ensures that the monitoring capability is already in place and will continuously track pH changes throughout the dressing wear period, eliminating the need for repeated application or complex time-based measurement protocols.

Inventive Principle:
Principle #10Preliminary action

4Measurement precision

If the dye changes colour in response to the pH of the wound exudate, then pH indication is provided, but the measurement is often inaccurate as the pH of wound exudate can be affected by numerous external factors, including the composition of the dressing itself

Engineering Contradiction:
ImprovepH measurement accuracyVSAvoidmeasurement reliability
Core Design Contradiction:
Measurement precisionVSReliability

Solution Approach 1:

The patent applies local quality by positioning the pH indicator dye at or near the wound-contacting surface of the dressing, rather than deeper within the bulk material. This localized placement ensures the indicator measures the pH of exudate at the critical wound-dressing interface, minimizing the influence of external factors such as dressing composition on the measurement. The indicator is strategically positioned where it directly contacts wound exudate before significant mixing or dilution occurs.

Inventive Principle:
Principle #3Local quality

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

Enables accurate, continuous monitoring of wound pH, facilitating timely therapeutic interventions by providing a visual pH map across the wound surface, reducing the risk of tissue disruption, and maintaining pH accuracy without calibration needs.

Implementation Method 1

a pH indicator applied to the surface, wherein the pH indicator has a first colour prior to contact with the wound exudate and changes colour along a colour spectrum as a function of the pH of the wound exudate

Methodology Applied
Scientific EffectpH indicator color change: Photochromism

Data Source

PatentEP3054909A1Ph indicator dressing
Publication Date: 2016.08.17 SMITH & NEPHEW PLC

AI summary

Disclosed herein are devices, wound dressings and methods for determining the pH of wound exudate at a wound. Example devices include a device comprising a surface configured to contact the wound and a pH indicator applied to the surface, wherein the pH indicator has a first colour prior to contact with the wound exudate and changes colour as a function of the pH of the wound exudate.