Fistula-Isolating Device for Wound Bed Segmentation
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Solution Overview
Problem
Applying reduced pressure to wounds with a fistula can lead to slower healing due to effluent being drawn onto other tissue areas, especially with intestinal fistulas, where the effluent can be corrosive.
Innovation Solution
A fistula-isolating device with an adjustable passageway member and perimeter member that contracts under reduced pressure, isolating the fistula and accommodating different wound bed heights, combined with a distribution manifold and ostomy appliance to manage effluent, creating a sealed space for effective reduced-pressure treatment.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Quantity of substance
If reduced pressure is applied to the whole tissue site including the fistula, then fluid drainage from the wound bed is improved, but effluent from the fistula is drawn onto other portions of the tissue site causing slower healing
Solution Approach 1:
The treatment area is divided into two separate zones: a first region over the wound bed and a second region over the fistula. The isolation device creates a physical barrier that segments the effluent collection pathways, allowing wound effluent to be drawn into the manifold while preventing fistula effluent from contaminating the wound bed. This segmentation resolves the contradiction by enabling fluid drainage from the wound while isolating the harmful fistula effluent.
Solution Approach 2:
The fistula is effectively extracted or removed from the reduced-pressure treatment zone by placing an isolation device over it. This allows the fistula to be excluded from the therapeutic environment, preventing its effluent from affecting the wound bed while maintaining reduced pressure over the wound area for optimal healing.
2Reliability
If reduced pressure is applied to the whole tissue site including the fistula, then wound bed treatment is provided, but corrosive effluent from intestinal fistula interferes with healing
Solution Approach 1:
An isolation device acts as an intermediary barrier between the fistula and the wound bed. This intermediary structure allows the reduced-pressure system to function effectively over the wound while blocking the harmful corrosive effluent from reaching and damaging the wound bed tissues. The intermediary protects the vulnerable wound area from chemical injury.
3Device complexity
If a fixed-length passageway member is used in the isolation device, then device structure is simplified, but it cannot accommodate wound beds of different heights
Solution Approach 1:
The passageway member is designed with adjustable or variable length capabilities, transforming it from a static fixed-component to a dynamic adaptable structure. This allows the isolation device to be configured for different wound bed depths and patient anatomies, enhancing versatility without requiring multiple different devices. The adjustable design maintains reasonable structural complexity while achieving adaptability.
4Strength
If the perimeter member does not contract under reduced pressure, then device structural integrity is maintained, but it cannot automatically accommodate different wound bed heights
Solution Approach 1:
The perimeter member is constructed from flexible, compliant material that can contract and deform under reduced pressure while maintaining structural integrity. This flexible design allows the isolation device to adapt automatically to different wound bed heights and contours, conforming to the patient's anatomy without requiring rigid adjustable mechanisms. The flexibility enables automatic accommodation while preserving sufficient strength to maintain the sealed environment.
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 solution effectively isolates the fistula from the rest of the wound bed, preventing corrosive effluent from interfering with healing and allowing for efficient reduced-pressure treatment, promoting faster healing and tissue growth.
Implementation Method 1
a perimeter member that contracts under reduced pressure and that automatically accommodates wound beds of different heights
Data Source
AI summary
Systems, methods, and devices are disclosed that involve a fistula-isolating device for use when reduced pressure is applied to a wound bed having a fistula. In one instance, the fistula-isolating device includes an adjustable passageway member and a perimeter member that contracts under reduced pressure and that automatically accommodates wound beds of different heights. In another instance, the fistula-isolating device involves a body shaped as a frustro-conical body that is readily sized for different depth wound beds. Other systems, methods, and devices are presented.