Biodegradable Nasal Stent for Resorbable Ostium Patency

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Solution Overview

Problem

Existing ostial stents often cause adverse reactions due to their permanent nature and require surgical removal, which can damage surrounding tissue, and there is a need for a low-cost, efficient, and self-securing stent that resorbs in the body to maintain fluid flow in sinus cavities.

Innovation Solution

A polymeric nasal ostial stent with a cylindrical lumen, constructed from an aqueous-swellable and biodegradable polymer that retains structural integrity for up to thirty days, capable of swelling significantly to secure placement and composed of multiple biodegradable layers to control liquid transport and degradation, minimizing tissue damage upon removal.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Duration of action of stationary object

If a permanent stent is used to maintain ostial patency, then long-term fluid flow is improved, but adverse reactions and tissue damage occur due to foreign body presence

Engineering Contradiction:
Improveostial patency durationVSAvoidadverse reactions
Core Design Contradiction:
Duration of action of stationary objectVSObject-affected harmful factors

Solution Approach 1:

The patent employs a biodegradable polymer stent designed to temporary maintain ostial patency and then naturally degrade and resorb. The stent is composed of polymers such as poly(glycidyl methacrylate-co-ethylene glycol dimethacrylate) that provide sufficient structural support during the healing period (typically 30-90 days) and then progressively degrade without requiring surgical removal, thereby eliminating long-term foreign body reactions while maintaining adequate duration of action for tissue healing

Inventive Principle:
Principle #27Cheap short-living objects (Disposable)

Solution Approach 2:

The stent utilizes controlled degradation parameters of biodegradable polymers to transition from a structurally stable state during implantation to a progressively degrading state over time. The polymer composition and molecular weight are selected to provide appropriate mechanical strength initially, then gradually degrade through hydrolysis and enzymatic breakdown, allowing the stent to maintain patency during the critical healing phase and then safely resorb without causing adverse reactions

Inventive Principle:
Principle #35Parameter changes

2Duration of action of stationary object

If a permanent stent is used to maintain ostial patency, then long-term fluid flow is improved, but surgical removal is required which damages surrounding tissue

Engineering Contradiction:
Improveostial patency durationVSAvoidtissue damage during removal
Core Design Contradiction:
Duration of action of stationary objectVSObject-generated harmful factors

Solution Approach 1:

The stent is designed as a disposable, biodegradable device that eliminates the need for surgical removal. The polymer material is selected to provide adequate structural support during the healing period and then naturally degrade and resorb, avoiding the tissue damage associated with surgical extraction of permanent stents

Inventive Principle:
Principle #27Cheap short-living objects (Disposable)

Solution Approach 2:

The patent converts the potentially harmful presence of a permanent foreign body into a beneficial temporary implant that naturally degrades. The biodegradable polymer is designed to provide the necessary structural support during healing and then progressively break down through controlled degradation mechanisms, transforming the stent from a permanent foreign body into a temporary therapeutic device that eliminates the need for removal surgery

Inventive Principle:
Principle #22Blessing in disguise (Convert harm into benefit)

3Object-affected harmful factors

If a biodegradable polymer is used for the stent, then adverse reactions are reduced, but structural integrity must be maintained for limited time

Engineering Contradiction:
Improveadverse reactionsVSAvoidstructural integrity
Core Design Contradiction:
Object-affected harmful factorsVSStrength

Solution Approach 1:

The stent utilizes controlled degradation parameters of biodegradable polymers to transition from a structurally stable state during implantation to a progressively degrading state over time. The polymer composition and molecular weight are selected to provide appropriate mechanical strength initially, then gradually degrade through hydrolysis and enzymatic breakdown, allowing the stent to maintain patency during the critical healing phase and then safely resorb without causing adverse reactions

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The stent may incorporate composite polymer structures combining different biodegradable materials with complementary properties. For example, combining polymers with different degradation rates, mechanical strengths, or hydrophobicity/hydrophilicity ratios to achieve both adequate structural integrity during the healing period and controlled degradation thereafter, while maintaining biocompatibility and minimizing adverse reactions

Inventive Principle:
Principle #40Composite materials

4Reliability

If the stent swells significantly to secure placement, then retention is improved, but the stent dimensions change

Engineering Contradiction:
ImproveretentionVSAvoidstent dimensions
Core Design Contradiction:
ReliabilityVSShape

Solution Approach 1:

The stent utilizes controlled degradation parameters of biodegradable polymers to transition from a structurally stable state during implantation to a progressively degrading state over time. The polymer composition and molecular weight are selected to provide appropriate mechanical strength initially, then gradually degrade through hydrolysis and enzymatic breakdown, allowing the stent to maintain patency during the critical healing phase and then safely resorb without causing adverse reactions

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The stent employs aqueous-swellable polymer materials that undergo phase transition from a compressed or collapsed state during insertion to an expanded state upon contact with body fluids. This swelling phase transition provides secure retention of the stent within the ostium while the biodegradable nature allows the dimensional changes to be temporary and controlled, with the stent gradually returning to or maintaining its functional shape throughout the degradation period

Inventive Principle:
Principle #36Phase transitions

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 stent effectively maintains ostial patency, reduces the risk of adverse reactions, and ensures secure retention without causing long-term foreign body presence, allowing for natural degradation and minimizing tissue damage during removal.

Implementation Method 1

The polymeric tube includes a first aqueous-swellable, biocompatible and biodegradable polymer

Methodology Applied
Scientific EffectAbsorption: Absorption (physical)

Implementation Method 2

capable of swelling significantly to secure placement

Methodology Applied
Scientific EffectSwelling:

Implementation Method 3

The polymeric tube includes a first aqueous-swellable, biocompatible and biodegradable polymer

Methodology Applied
Scientific EffectHydrolysis: Hydrolysis

Data Source

PatentUS10709585B2Degradeable nasal ostial stent
Publication Date: 2020.07.14 HEMOSTASIS LLC
  • US10709585B2 patent drawing
  • US10709585B2 patent drawing
  • US10709585B2 patent drawing

AI summary

A polymeric stent having a length, an outer surface and a cross-section. A lumen passes through the entire length, the lumen having a surface forming an equivalent diameter in the polymeric stent. The polymeric stent includes a first aqueous-swellable, biocompatible and biodegradable composition (e.g., polymer) having a thickness. The aqueous-swellable and biodegradable polymer retaining structural integrity for at least 1 hours up to thirty days when swollen to between 15% and 500% of its dry diameter and kept moist by a moist aqueous environment. Barrier layers of biodegradable polymer(s) may be used to prevent migration of liquids into the lumen.