Viscoelastic Foam Tissue Interface for Leak-Resistant Sealing
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Solution Overview
Problem
Existing devices for applying negative pressure or fluid infusion to living tissue face challenges in achieving a comfortable and secure fit, accommodating anatomical variations, and preventing leakage due to differences in facial anatomy and movement, leading to discomfort and potential health hazards.
Innovation Solution
The use of a viscoelastic foam with specific properties, including low durometer, low density, and inherent tackiness, to create a conforming seal with living tissue, enhancing compliance and reducing leakage.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Strength
If a hard plastic frame is used for the mask, then structural support is provided, but sealing and compliance must be provided by the facial cushion which increases pressure on sensitive areas like the nasal bridge
Solution Approach 1:
The patent replaces the hard plastic frame with a flexible headgear system that distributes force across multiple points on the head and face. The headgear includes adjustable straps and cushioned contact points that conform to the patient's anatomy, providing structural support without concentrating pressure on sensitive areas like the nasal bridge. This flexible approach maintains mask positioning while reducing localized pressure points.
2Strength
If the sealing material lacks compliance, then structural integrity is maintained, but seal performance deteriorates and localized pressure points are created
Solution Approach 1:
The patent employs a composite sealing material that combines a supportive structural layer with a compliant sealing layer. The outer layer provides structural integrity and shape retention, while the inner layer conforms to the patient's facial contours and distributes pressure evenly. This multi-layer composite structure achieves both sealing effectiveness and comfort by preventing localized pressure points while maintaining seal integrity.
3Duration of action of moving object
If the device is designed for daily wear over many hours, then therapeutic benefit is achieved, but points of high contact pressure become uncomfortable for continued use
Solution Approach 1:
The patent modifies the physical parameters of the contact surfaces by incorporating soft, pressure-distributing materials with optimized durometer values. The headgear and sealing surfaces are designed with varying material hardness - softer at contact points to distribute pressure and harder at structural points to maintain shape. This parameter optimization allows the device to be worn comfortably for extended therapeutic periods without creating uncomfortable pressure points.
4Reliability
If the sealing material is heavy, then sealing effectiveness may improve, but the membrane can rupture and leak gel into the airways creating health hazards
Solution Approach 1:
The patent eliminates the use of heavy gel-based sealing materials entirely by transitioning to a disposable or easily replaceable cushioning system made from safer, lighter materials. The headgear and sealing components are designed as replaceable units that can be discarded or cleaned regularly, preventing the accumulation of degraded material that could rupture. This approach prioritizes patient safety by removing the gel leakage hazard while maintaining sealing effectiveness through alternative material systems.
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 viscoelastic foam provides a comfortable, secure seal that adapts to anatomical differences, minimizes skin abrasion, and maintains a consistent pressure differential, improving user compliance and reducing leakage.
Implementation Method 1
a tissue interface region comprising a viscoelastic foam configured to provide a contact surface of the appliance
Implementation Method 2
the viscoelastic foam comprises one or more of the following properties: a Shore A of about 0 or less, and preferably a Shore 00 durometer of about 30 or less
Data Source
AI summary
The present invention provides materials and methods for forming an interface between an appliance and living tissue using a foamed elastomeric material which contacts the tissue or similar surfaces. The elastomeric material is in the form of a durable and washable material that, when applied to or implanted in living tissue or similar surfaces, displaces and flows in to non-conforming areas creating an air and/or water tight seal that substantially returns to an original shape when removed from the contact surface. The appliance may also include structural elements designed to optimize comfort, compliance and seal achieved through minimizing the pressure variation along the contact surface of the therapy device.