Multi-layer Wound Dressing for Thick Exudate Management

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Solution Overview

Problem

Current negative-pressure wound therapy systems face challenges in efficiently managing thick exudate and promoting wound healing, particularly in maintaining effective pressure distribution and preventing tissue ingrowth, while also requiring improvements in the integration of instillation therapy for enhanced cleansing and contamination removal.

Innovation Solution

A dressing system comprising a manifold layer with through-holes, a hydrophobic polymer film layer with pressure-responsive fluid restrictions, and an optional gel layer with apertures, designed to facilitate fluid movement and pressure gradient expansion, which works in conjunction with a negative-pressure source and instillation solution to enhance exudate removal and tissue healing.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Stress or pressure

If a traditional negative-pressure wound therapy system is used, then negative pressure can be applied to promote tissue growth, but thick exudate blocks pressure distribution and fluid flow

Engineering Contradiction:
Improvepressure distributionVSAvoidthick exudate
Core Design Contradiction:
Stress or pressureVSQuantity of substance

Solution Approach 1:

The dressing is divided into multiple functional layers: an outer layer with through-holes for pressure distribution, a middle hydrophobic polymer film layer with pressure-responsive fluid restrictions, and an inner gel layer with apertures. This segmentation allows each layer to address specific aspects of exudate management and pressure distribution independently, preventing exudate accumulation from blocking overall fluid flow and pressure transmission to the wound bed.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

Different regions of the dressing have different properties tailored to local needs. The hydrophobic polymer film has pressure-responsive fluid restrictions that selectively control fluid flow based on local pressure gradients, while the gel layer provides localized cushioning and exudate absorption. The through-holes are distributed throughout the outer layer to ensure uniform pressure distribution across the entire wound surface.

Inventive Principle:
Principle #3Local quality

2Stress or pressure

If a manifold layer with through-holes is used to distribute pressure, then pressure distribution improves, but granulation tissue can grow into the holes causing blockage

Engineering Contradiction:
Improvepressure distributionVSAvoidtissue ingrowth
Core Design Contradiction:
Stress or pressureVSObject-affected harmful factors

Solution Approach 1:

The hydrophobic polymer film layer acts as an intermediary between the outer manifold layer and the inner gel layer. Its pressure-responsive fluid restrictions control fluid flow while its hydrophobic nature prevents granulation tissue from penetrating through the through-holes into the manifold layer, thus maintaining pressure distribution pathways without blocking them with tissue ingrowth.

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The hydrophobic polymer film is a thin, flexible barrier that conforms to the wound cavity shape while maintaining its integrity. This thin film structure allows it to respond to pressure gradients (opening fluid restrictions when needed) while simultaneously serving as a physical barrier that prevents tissue ingrowth into the through-holes of the outer layer.

Inventive Principle:
Principle #30Flexible shells and thin films

3Object-affected harmful factors

If a hydrophobic polymer film with fluid restrictions is added, then tissue ingrowth is prevented and pressure distribution is maintained, but fluid flow resistance increases

Engineering Contradiction:
Improvetissue ingrowth preventionVSAvoidfluid flow resistance
Core Design Contradiction:
Object-affected harmful factorsVSLoss of energy

Solution Approach 1:

The fluid restrictions in the hydrophobic polymer film are pressure-responsive, meaning they dynamically adjust their opening based on the pressure gradient across the film. When negative pressure is applied or exudate accumulates, the restrictions open to allow fluid flow; when pressure equalizes, they close to prevent tissue ingrowth. This dynamic behavior allows the system to maintain both tissue ingrowth prevention and adequate fluid flow without constant energy loss.

Inventive Principle:
Principle #15Dynamics

4Productivity

If instillation therapy is integrated into the dressing, then wound cleansing is enhanced, but the dressing structure becomes more complex

Engineering Contradiction:
Improvewound cleansing efficiencyVSAvoiddressing structure
Core Design Contradiction:
ProductivityVSDevice complexity

Solution Approach 1:

The instillation therapy function is merged directly into the dressing structure by incorporating the gel layer with apertures as the innermost layer. This allows instillation solution to be delivered directly to the wound bed through the gel layer's apertures, combining the dressing's protective/absorptive function with the therapeutic instillation function in a single integrated device, thereby enhancing cleansing efficiency without requiring separate external instillation equipment.

Inventive Principle:
Principle #5Merging (Combining)

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 dressing system effectively manages thick exudate, reduces tissue ingrowth, and enhances wound healing by optimizing pressure distribution and fluid flow, while allowing for efficient instillation therapy to cleanse the wound site, thereby improving wound outcomes.

Implementation Method 1

a second layer adjacent to the first layer, the second layer comprising a polymer film having a plurality of fluid restrictions that are configured to expand in response to a pressure gradient across the polymer film

Methodology Applied
Scientific EffectPressure gradient expansion: Pressure Gradient

Implementation Method 2

a first layer comprising a manifold having a plurality of through-holes; The first layer may be formed from reticulated foam

Methodology Applied
Scientific EffectPorous material flow: Porosity

Data Source

PatentEP4124324A1PEEL and place dressing for thick exudate and instillation
Publication Date: 2023.02.01 SOLVENTUM INTELLECTUAL PROPERTIES CO
  • EP4124324A1 patent drawingFigure 1
  • EP4124324A1 patent drawingFigure 2~3
  • EP4124324A1 patent drawingFigure 4

AI summary

A multi-layer dressing for treating tissue with negative pressure, instillation, or both. In some embodiments a first layer may be formed from reticulated foam having a series of holes. A second layer disposed adjacent to the first layer may be formed from a perforated polymer. The dressing may optionally include a third layer formed from a soft polymer, such as a silicone gel. The third layer may also have perforations or apertures. The third layer is generally oriented to face a tissue site, and may be disposed adjacent to the first layer so that the first layer is disposed between the third layer and the first layer. The perforations or apertures in the third layer may be registered with one or more perforations in the first layer.