Amniotic Membrane Tympanic Construct for Perforation Repair
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Solution Overview
Problem
Current materials and techniques for repairing tympanic membrane defects often lead to complications such as ear infections, hearing loss, tinnitus, facial paralysis, or hematoma, indicating a need for safer and more effective methods and materials.
Innovation Solution
A tympanic construct is created using treated amniotic or chorionic membranes, processed with an alcohol composition and terminally sterilized, which are then used to repair defects in the tympanic membrane, reducing the risk of complications and enhancing healing.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If typical graft materials (temporalis fascia, skin, periosteum, fat, vein tissue, homologous dura, silastic, paper, teflon) are used to repair tympanic membrane perforations, then the perforation can be repaired, but complications such as ear infection, hearing loss, tinnitus, facial paralysis, or hematoma occur
Solution Approach 1:
The patent extracts and utilizes only the amniotic membrane portion of the placenta, separating it from other potentially harmful components. This selective extraction provides a sterile, biocompatible graft material that avoids the complications associated with traditional graft materials while maintaining repair effectiveness.
Solution Approach 2:
The amniotic membrane undergoes specific processing parameters including alcohol treatment (90-100% ethanol for 24-384 hours), terminal sterilization (gamma irradiation or electron beam), and drying to achieve optimal properties for tympanic membrane repair. These parameter changes transform the raw tissue into a safe, effective graft material.
2Object-affected harmful factors
If amniotic membrane is used as a graft material, then complications are reduced, but the membrane requires extensive processing including alcohol treatment and terminal sterilization
Solution Approach 1:
The amniotic membrane is processed and sterilized in advance before surgical use. The alcohol treatment and terminal sterilization steps are performed beforehand to ensure the membrane is ready for immediate implantation, reducing intraoperative complexity and ensuring safety.
Solution Approach 2:
Alcohol (90-100% ethanol) serves as an intermediary agent in the processing sequence, providing both fixation and preliminary sterilization before the final terminal sterilization step. This intermediary treatment simplifies the overall process by combining multiple functions in one step.
3Reliability
If the amniotic membrane is treated with alcohol composition and terminally sterilized, then safety is improved, but the handling characteristics and adhesion properties must be optimized
Solution Approach 1:
The alcohol treatment duration (24-384 hours) and concentration (90-100% ethanol) are optimized to achieve the right balance between sterilization and preservation of handling characteristics. Terminal sterilization parameters are also optimized to maintain tissue integrity and adhesion properties while ensuring safety.
Solution Approach 2:
The patent applies alcohol treatment for an extended period (24-384 hours) which may seem excessive, but this partial excessive action ensures complete sterilization and optimal tissue preparation without compromising handling characteristics. The extended treatment time ensures thorough processing while maintaining tissue viability.
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 use of treated amniotic or chorionic membranes as a tympanic construct provides a safe and effective means to repair membrane defects, reducing post-operative complications and promoting healing by improving handling characteristics and adhesion to surrounding tissue without the need for additional support materials.
Implementation Method 1
The membrane(s) is/are treated with at least one alcohol composition followed by terminal sterilization to form a tympanic construct
Implementation Method 2
the terminal sterilization is gamma irradiation or electron beam irradiation
Implementation Method 3
the terminal sterilization is gamma irradiation or electron beam irradiation
Data Source
AI summary
A tympanic construct fabricated from at least one amniotic membrane, at least one chorionic membrane, or at least one amniotic membrane and at least one chorionic membrane obtained from human birth tissue is provided. Methods of preparing a tympanic construct, methods of repairing tympanic membrane defects and surgical sites, as well as kits for the same are also provided.