Polyolefin Airway Exoskeleton for Adhesive-Free Cuff Assembly
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Solution Overview
Problem
Existing laryngeal devices, such as supraglottic airway devices with gastric drainage, face issues with material visco-elastic characteristics affecting their ability to deliver advantages like ease of insertion, reduced morbidity, and gastric drainage, while also causing potential occlusion and co-morbidity due to the use of materials like PVC and LSR that require adhesives and solvents for bonding.
Innovation Solution
An airway management device with a polyolefin-based exoskeleton structure and a thermoplastic elastomer inflatable cuff, utilizing self-adhesive properties to eliminate the need for adhesives, providing a high degree of stiffness and flexibility, allowing for simultaneous gastric access and endoscopic evaluation, and preventing occlusion of the gastric drain tube.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If PVC and LSR materials are used for construction of SADs, then the device can provide anatomical seal and respiratory mechanics, but adhesives and solvents are required for bonding components during manufacture
Solution Approach 1:
The patent changes the material parameters from PVC/LSR to polyolefin and TPE, which fundamentally alters the bonding requirements. The polyolefin airway and TPE cuff combination eliminates the need for adhesives and solvents while maintaining the anatomical seal function, as the TPE material provides self-adhesive properties and elastic sealing without chemical bonding agents.
Solution Approach 2:
The patent employs a composite material system consisting of polyolefin for the airway structure and TPE for the inflatable cuff. This composite approach combines the rigidity and chemical stability of polyolefin with the elasticity and self-adhesive properties of TPE, achieving both structural integrity and ease of manufacture without requiring external adhesives or solvents.
2Shape
If inflatable cuff is deflated immediately prior to deployment, then a flat profile of the distal tip is achieved, but the distal tip becomes bulbous when the inflatable cuff is inflated in situ
Solution Approach 1:
The patent changes the material parameter from inflatable cuff to non-inflatable cuff, eliminating the volume change that causes the bulbous distortion. The TPE material maintains a consistent, flat distal tip profile in both deflated and inflated states, as it does not undergo the same volumetric expansion as traditional inflatable cuffs, thereby maintaining a flat profile throughout deployment.
3Device complexity
If pre-formed non-inflatable cuff is used, then the device structure is simplified, but the distal tip configuration becomes bulbous and occlusion of drain tube is prevented
Solution Approach 1:
The patent changes the material parameter from conventional non-inflatable cuff to TPE material with specific visco-elastic properties. This material change allows the cuff to maintain a flat distal tip profile while still providing the necessary sealing and drainage functions, eliminating the bulbous shape issue inherent in traditional non-inflatable cuffs.
4Ease of manufacture
If thermoplastic elastomers are used for SADs, then no adhesives are required for assembly, but the material visco-elastic characteristics affect the ability to deliver advantages
Solution Approach 1:
The patent optimizes the TPE material parameters including durometer hardness (30-70 Shore A), glass transition temperature (-50°C to 0°C), and molecular weight to achieve the desired balance between ease of assembly and reliable performance. These parameter adjustments ensure the TPE provides sufficient elasticity for self-adhesive assembly while maintaining the necessary mechanical properties for reliable airway sealing and gastric drainage.
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 device ensures quick and trauma-free intubation with minimal loss of oxygen supply, maintaining airway access and gastric drainage, while avoiding the disadvantages of prior art materials by using polyolefin and TPE compounds for enhanced visco-elastic response and assembly without solvents.
Implementation Method 1
The visco-elastic characteristics of the materials used for construction of the various SAD's exert significant influence over the ability of the device to deliver the above stated advantages
Implementation Method 2
by providing a first bore of sufficient size to receive the oxygen supply tube, the body will include a moment of inertia for the cross-sectional shape to provide a high degree of stiffness
Implementation Method 3
SAD's using TPE do not require adhesives as they are essentially a one piece more rigid airway tube covered with TPE material to form the required shape without an inflatable cuff
Data Source
AI summary
An airway management device comprising a body having a proximal end for receiving an oxygen supply tube and an distal end for insertion into a trachea of a patient; said body including a linear portion adjacent to the proximal end and a curved portion adjacent to the distal end; said body including an external shell and having a first bore through said shell for receiving the oxygen supply tube; wherein flexural strength for said airway management device is provided by said shell.