Biodegradable Tympanic Membrane Prosthesis with Composite Layers

Solution Overview

Problem

Conventional ventilation tubes for conditions like otitis media lack control over their duration of placement, leading to premature extrusion and potential persistent perforation of the tympanic membrane, while biodegradable prostheses face challenges in maintaining lumen patency and promoting tissue healing simultaneously.

Innovation Solution

A composite tubular prosthesis with a resorbable inner layer for structural integrity and a coaxial outer layer with higher porosity and absorption rate, incorporating denatured gelatin sponge material to promote healing and closure, ensuring lumen patency and hemostatic function.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Duration of action of stationary object

If conventional non-biodegradable PE tubes are used for ventilation, then the tube maintains structural integrity and lumen patency, but the tube requires surgical removal causing patient discomfort and additional procedures

Engineering Contradiction:

Improvetube retention timeVSAvoidtube removal difficulty

Core Design Contradiction:

Duration of action of stationary objectVSEase of operation

Solution Approach 1:

The patent applies parameter changes by transitioning from non-biodegradable materials to biodegradable materials with controlled degradation rates. The tube is designed to maintain its mechanical properties and lumen patency for a specific duration (typically 6-18 months), after which it naturally degrades and is absorbed by the body, eliminating the need for surgical removal and associated patient discomfort.

Inventive Principle:

Principle #35Parameter changes

Solution Approach 2:

The patent employs a disposable biodegradable tube that is designed for temporary use only. The tube serves its ventilation function for the required treatment period and then naturally decomposes in the body, similar to a disposable product that completes its function and is discarded without recovery or removal procedures.

Inventive Principle:

Principle #27Cheap short-living objects (Disposable)

2Ease of operation

If biodegradable materials are used for the prosthesis, then surgical removal is eliminated, but maintaining lumen patency and structural integrity becomes challenging

Engineering Contradiction:

Improvetube removal easeVSAvoidlumen patency maintenance

Core Design Contradiction:

Ease of operationVSReliability

Solution Approach 1:

The patent utilizes composite materials combining biodegradable polymers with specific mechanical properties. The tube is constructed from materials like poly(L-lactide) or poly(DL-lactide) that provide sufficient structural integrity and lumen patency maintenance during the functional period, while simultaneously exhibiting controlled biodegradation characteristics that allow natural dissolution after the treatment duration.

Inventive Principle:

Principle #40Composite materials

Solution Approach 2:

The patent applies dynamics by designing a tube with time-dependent properties. The tube maintains its structural integrity and lumen patency during the initial functional period, then progressively degrades over time. This dynamic behavior allows the tube to be reliable when needed and then naturally dissolve when no longer required, eliminating removal procedures.

Inventive Principle:

Principle #15Dynamics

3Reliability

If the tube structure is designed to prevent premature extrusion, then the tube remains in place longer, but the difficulty of initial insertion and eventual removal increases

Engineering Contradiction:

Improvetube position stabilityVSAvoidinsertion and removal difficulty

Core Design Contradiction:

ReliabilityVSDevice complexity

Solution Approach 1:

The patent employs a disposable biodegradable tube that is designed for temporary use only. The tube serves its ventilation function for the required treatment period and then naturally decomposes in the body, similar to a disposable product that completes its function and is discarded without recovery or removal procedures.

Inventive Principle:

Principle #27Cheap short-living objects (Disposable)

Solution Approach 2:

The patent applies parameter changes by transitioning from non-biodegradable materials to biodegradable materials with controlled degradation rates. The tube is designed to maintain its mechanical properties and lumen patency for a specific duration (typically 6-18 months), after which it naturally degrades and is absorbed by the body, eliminating the need for surgical removal and associated patient discomfort.

Inventive Principle:

Principle #35Parameter changes

4Duration of action of moving object

If the tube extrudes prematurely, then the treatment duration is reduced, but persistent perforation of the tympanic membrane may occur

Engineering Contradiction:

Improvetube placement durationVSAvoidtympanic membrane perforation risk

Core Design Contradiction:

Duration of action of moving objectVSObject-affected harmful factors

Solution Approach 1:

The patent employs a disposable biodegradable tube that is designed for temporary use only. The tube serves its ventilation function for the required treatment period and then naturally decomposes in the body, similar to a disposable product that completes its function and is discarded without recovery or removal procedures.

Inventive Principle:

Principle #27Cheap short-living objects (Disposable)

Solution Approach 2:

The patent applies dynamics by designing a tube with time-dependent properties. The tube maintains its structural integrity and lumen patency during the initial functional period, then progressively degrades over time. This dynamic behavior allows the tube to be reliable when needed and then naturally dissolve when no longer required, eliminating removal procedures.

Inventive Principle:

Principle #15Dynamics

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 composite prosthesis maintains lumen patency and facilitates tissue healing by controlling degradation rates, reducing the need for surgical removal and promoting closure of perforations, while providing effective fluid drainage and hemostasis.

Implementation Method 1

The outer layer is composed of a material that degrades at a second degradation rate when in body tissue and exposed to body fluids, the second degradation rate being substantially higher than the first degradation rate

Methodology Applied

Scientific EffectBiodegradation: Decomposition (biological)

Implementation Method 2

incorporating denatured gelatin sponge material to promote healing and closure, ensuring lumen patency and hemostatic function

Methodology Applied

Scientific EffectAbsorption: Absorption (physical)

Data Source

PatentUS11622891B2Biodegradable prosthesis

Publication Date: 2023.04.11 SKOVLUND MEDICAL PROD

AI summary

A tympanic membrane prosthesis includes a tubular body having a lumen extending therethrough and open at each of a proximal and distal end. The tubular body forms a structurally self-supporting, body compatible, and body absorbable device. The device is formed of a composite structure that includes an inner portion having an inside surface and an outer portion having an outside surface. The inside surface forms at least a portion of the lumen extending through the tubular body. The inside surface is adapted to provide less resistance to fluid flow than the outside surface. The outside surface is adapted to produce an inflammatory reaction in adjacent tissue at a tympanic membrane. The device is adapted for insertion into an opening through the tympanic membrane for placement with the proximal end and the distal end disposed on opposite sides of the tympanic membrane.