Nasal Lumen Expandable Structure for Sinusitis Patency
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Solution Overview
Problem
Current surgical treatments for chronic sinusitis, such as FESS, often result in postoperative issues like recurrent inflammation, polyposis, adhesion, and stenosis of sinus ostia, which can lead to suboptimal outcomes, and existing devices for preventing scarring and synechiae formation are not entirely effective.
Innovation Solution
A method involving the delivery and expansion of an expandable structure within the nasal lumen, which is stable in a range of diameters and can be deployed to match the geometry of the nasal lumen, using a shape memory and polymer combination that resists crushing and collapse, and can be removed by temperature change, allowing for minimal pressure application and gradual medication release.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If FESS surgery is performed to establish drainage pathways, then sinus patency is improved, but postoperative scarring and synechiae formation occur leading to recurrent inflammation and stenosis
Solution Approach 1:
The expandable structure is deployed preemptively during surgery to maintain sinus ostia patency before scarring can occur. The structure proactively prevents synechiae formation by keeping the drainage pathways open during the critical healing period, rather than waiting for stenosis to develop and then treating it.
Solution Approach 2:
The structure serves as a protective barrier that cushions the sinus ostia against the harmful effects of postoperative scarring and adhesion formation. By being in place before fibrosis can close the ostia, it prevents the harmful effect of stenosis rather than trying to reverse it later.
2Reliability
If stents or packing devices are used to prevent scarring and synechiae formation, then adhesion prevention is improved, but device complexity and potential for complications increase
Solution Approach 1:
The structure utilizes temperature-responsive shape memory properties to change its physical state from compressed (for delivery) to expanded (for function). This parameter change allows a simple material to perform complex functions of preventing adhesion while maintaining ease of delivery and removal without complex mechanisms.
Solution Approach 2:
The shape memory material automatically returns to its predetermined expanded shape when exposed to body temperature, eliminating the need for complex deployment mechanisms. The structure self-activates upon reaching the target site, and can be removed by reversing the temperature stimulus, reducing operational complexity.
3Productivity
If expandable structures are deployed to maintain lumen patency, then sinus drainage is improved, but the structure may apply excessive pressure to surrounding tissue causing inflammation
Solution Approach 1:
The structure's mechanical properties change with temperature - at delivery temperature it is compliant and flexible, minimizing pressure on tissue. At body temperature, it transitions to a more rigid expanded state that maintains patency. This parameter change allows the structure to provide support when needed while minimizing harmful pressure effects during delivery and in normal operation.
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 expandable structure effectively maintains the patency of the nasal lumen, reduces tissue inflammation, and facilitates healing by minimizing scarring and synechiae formation, while allowing for local medication delivery, thereby improving long-term surgical outcomes.
Implementation Method 1
The structure includes a shape memory portion and a polymer portion. The shape memory portion may be made of a shape memory material such as a shape memory alloy (SMA) or a shape memory polymer (SMP).
Implementation Method 2
The polymer portion may resist expansion of the SM portion. The polymer portion may include an elastic body that has high recoil and low creep.
Data Source
AI summary
A method of treatment of nasal conditions comprising: delivering an expandable structure in a crimped configuration to a nasal lumen; expanding the expandable structure within the nasal lumen to a stable expanded configuration; removing the structure from the nasal lumen, after a time period, where removing comprises causing the structure to self-crimp. The expandable structure optionally comprises: a first shape memory (SM) portion which is in a strain-induced state; and a second portion which resists expansion of said structure due to said first portion, over a plurality of different expansion states of said first portion. Optionally, the properties of the second portion vary over its cross section. For example an outer surface and/or peripheral layer may have desirable environmental resistance properties and/or a frame may have desirable mechanical properties, for example a high creep resistance.