Customized Airway Stents for Gradual Stenosis Dilation

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Solution Overview

Problem

Current treatments for airway stenosis often involve discretely-sized stents that poorly fit the complex anatomy, leading to complications such as granulation tissue formation, tissue necrosis, inflammation, and migration, resulting in frequent replacements and exacerbated airway problems.

Innovation Solution

A method involving the sequential implantation of customized, patient-specific airway stents with an active portion sized to gradually match the increasing diameter of the stenotic region, using internal images to determine the necessary diameter for each stent, until the stenotic region matches the healthy region, thereby minimizing pressure points and promoting airway tissue acceptance.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of manufacture

If discretely-sized stents are used to treat airway stenosis, then the treatment can be implemented with standard off-the-shelf devices, but the stents poorly fit the complex anatomy leading to complications such as granulation tissue formation, tissue necrosis, inflammation, and migration

Engineering Contradiction:
Improveavailability of standard stentsVSAvoidstent fit and stability
Core Design Contradiction:
Ease of manufactureVSReliability

Solution Approach 1:

The patent applies local quality by customizing each stent's dimensions, shape, and structural characteristics to match the specific anatomical features of the patient's airway at the stenotic site. This includes tailoring the stent's diameter, length, curvature, and radial strength to the local tissue characteristics, thereby achieving optimal fit and performance for each unique patient anatomy rather than using standardized one-size-fits-all devices

Inventive Principle:
Principle #3Local quality

Solution Approach 2:

The patent implements parameter changes by varying multiple stent parameters including diameter, length, curvature, radial strength, and material composition based on the specific anatomical measurements and clinical requirements of each patient. This allows the stent to be precisely matched to the patient's airway geometry and physiological needs, resolving the contradiction between standardization and customization

Inventive Principle:
Principle #35Parameter changes

2Loss of time

If discretely-sized stents are used, then the initial treatment can be performed quickly, but frequent replacements are required every thirty days under general anesthesia

Engineering Contradiction:
Improveinitial treatment timeVSAvoidfrequency of stent replacement
Core Design Contradiction:
Loss of timeVSProductivity

Solution Approach 1:

The patent applies preliminary action by conducting detailed pre-procedural imaging and planning to precisely measure the patient's airway anatomy and design a custom stent that optimally fits the specific stenotic geometry. This advance preparation ensures the stent is correctly sized and shaped before implantation, reducing the need for frequent replacements and follow-up interventions

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The patent implements feedback through follow-up imaging and clinical assessment to evaluate stent performance and airway remodeling over time. This feedback loop allows for monitoring of treatment effectiveness and early detection of any issues, enabling timely interventions if needed while confirming the durability of the custom-fitted stent

Inventive Principle:
Principle #23Feedback

3Length of moving object

If larger diameter stents are used to expand the stenotic region, then the airway diameter can be increased, but the stent may cause tissue damage and inflammation

Engineering Contradiction:
Improveairway lumen diameterVSAvoidtissue damage and inflammation
Core Design Contradiction:
Length of moving objectVSObject-affected harmful factors

Solution Approach 1:

The patent applies parameter changes by carefully selecting and adjusting the stent's diameter, radial strength, and expansion force parameters to achieve the target airway diameter while minimizing tissue trauma. The custom-designed stent parameters are optimized based on the specific tissue characteristics and stenosis severity, allowing effective dilation without excessive force that could cause damage

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The patent implements partial or excessive action by using a stent with slightly excessive diameter and strength parameters that provide sufficient force to dilate the stenotic region effectively, while the custom-fit design ensures the excessive parameters are distributed evenly and do not concentrate force at specific points that could cause tissue damage

Inventive Principle:
Principle #16Partial or excessive action

4Manufacturing precision

If custom patient-specific stents are manufactured, then the stent can be precisely fitted to the patient's anatomy, but the manufacturing process becomes more complex and time-consuming

Engineering Contradiction:
Improvestent fit to anatomyVSAvoidcustom stent manufacturing
Core Design Contradiction:
Manufacturing precisionVSDevice complexity

Solution Approach 1:

The patent applies local quality by customizing each stent's dimensions, shape, and structural characteristics to match the specific anatomical features of the patient's airway at the stenotic site. This includes tailoring the stent's diameter, length, curvature, and radial strength to the local tissue characteristics, thereby achieving optimal fit and performance for each unique patient anatomy

Inventive Principle:
Principle #3Local quality

Solution Approach 2:

The patent implements flexible shells and thin films by using adaptable stent construction techniques that allow the stent to conform to complex airway geometries. The stent structure incorporates flexible elements and thin-walled designs that can be precisely formed to match the patient's specific anatomical contours while maintaining structural integrity

Inventive Principle:
Principle #30Flexible shells and thin films

Data Source

PatentUS11083560B2Methods of treating airway stenosis
Publication Date: 2021.08.10 VISIONAIR SOLUTIONS LLC
  • US11083560B2 patent drawing
  • US11083560B2 patent drawing

AI summary

Methods of treating airway stenosis are provided. Methods include gradually dilating the stenotic region of a patient's airway lumen with sequentially implanted customized airway stents. The airway stents are sequentially implanted until the diameter of the stenotic region of the patient's airway has substantially the same diameter as the diameter of an adjacent healthy region of the patient's airway lumen.