Biodegradable Silk Ear Tubes for Otitis Media

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Solution Overview

Problem

Previous tympanostomy tubes have been unsatisfactory due to chronic inflammation, scarring, and the need for repeated surgical interventions, posing a significant financial burden and health concern, especially in children.

Innovation Solution

Development of biodegradable silk ear tubes with customizable physical and mechanical properties, which can be designed to last for varying periods before resorption, incorporating therapeutic agents and features like pores and flanges, and formed using methods such as gel spinning or dip coating, to minimize inflammatory reactions and improve treatment outcomes for otitis media.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If traditional tympanostomy tubes are used, then the eardrum can be aerated and fluid can be prevented, but chronic inflammation and scarring occur requiring repeated surgeries

Engineering Contradiction:
Improvedurability of tube functionVSAvoidinflammation and scarring
Core Design Contradiction:
ReliabilityVSObject-generated harmful factors

Solution Approach 1:

The patent changes the material parameter from traditional non-biodegradable materials (PTFE, silicone) to biodegradable silk fibroin. This material substitution fundamentally alters the tube's interaction with tissue, allowing it to degrade naturally without causing chronic inflammation or scarring, thereby resolving the contradiction between durability and harmful effects

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The patent employs a disposable, biodegradable tube designed to fulfill its function temporarily and then degrade naturally. The silk fibroin tube provides adequate aeriation and fluid prevention during the required period, then breaks down into biocompatible byproducts that are safely absorbed by the body, eliminating the need for removal surgery and preventing long-term harmful effects

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

2Duration of action of moving object

If traditional tympanostomy tubes are used, then the eardrum remains aerated, but repeated surgical interventions are needed

Engineering Contradiction:
Improveduration of tube functionalityVSAvoidtime for repeated surgeries
Core Design Contradiction:
Duration of action of moving objectVSLoss of time

Solution Approach 1:

The patent introduces a dynamic, time-dependent material property where the tube transitions from a functional state to a degradable state. The silk fibroin tube maintains its structural integrity and aeriation function for a clinically appropriate duration, then progressively degrades and is absorbed by the body, providing a single-intervention solution that adapts to the healing process over time

Inventive Principle:
Principle #15Dynamics

3Object-generated harmful factors

If silk ear tubes are made biodegradable, then inflammation and scarring are reduced, but the tube duration must be carefully controlled

Engineering Contradiction:
Improveinflammatory reactionVSAvoidcontrol of degradation rate
Core Design Contradiction:
Object-generated harmful factorsVSDevice complexity

Solution Approach 1:

The patent applies local quality control by varying the silk fibroin composition, crystallinity, and molecular weight distribution in different regions or layers of the tube. This allows different degradation rates in different parts of the tube, enabling fine-tuned control over the overall tube lifespan while maintaining low inflammatory response throughout the material

Inventive Principle:
Principle #3Local quality

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 biodegradable silk ear tubes reduce the risk of chronic inflammation and scarring, potentially eliminating the need for repeated surgeries, providing a cost-effective and safer alternative for treating otitis media by being resorbed naturally, thus addressing the limitations of previous tympanostomy tubes.

Implementation Method 1

In some embodiments, provided silk ear tubes are formed via gel spinning or gel deposition.

Methodology Applied
Scientific EffectGel spinning:

Implementation Method 2

In some embodiments, provided silk ear tubes are formed via gel spinning or gel deposition.

Methodology Applied
Scientific EffectGel deposition:

Implementation Method 3

In some embodiments, provided silk ear tubes include multiple layers, each of which may include one or more of: pores, therapeutic agents

Methodology Applied
Scientific EffectPorosity: Porosity

Implementation Method 4

the silk ear tube is resorbable... wherein the silk ear tube is resorbed by the subject

Methodology Applied
Scientific EffectBiodegradation: Decomposition (biological)

Data Source

PatentUS11229726B2Biodegradable silk ear tubes
Publication Date: 2022.01.25 THE GENERAL HOSPITAL CORP DBA MASS GENERAL HOSPITAL
  • US11229726B2 patent drawing
  • US11229726B2 patent drawing
  • US11229726B2 patent drawing

AI summary

In some embodiments, the present invention provides methods for making resorbable ear tubes including the steps of providing a silk fibroin solution, and forming a silk ear tube from the silk fibroin solution, wherein the silk ear tube is less than 2 mm in length and has an outer diameter of less than 1.5 mm, and wherein the silk ear tube is resorbable. In some embodiments, the present invention also provides methods for treating otitis media including the step of introducing a silk ear tube into the ear canal of a subject, wherein the silk ear tube is less than 2 mm in length and has an outer diameter of less than 1.5 mm, and wherein the silk ear tube is resorbed by the subject.