Expandable Patch Sealing Fetal Membrane Perforations
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Solution Overview
Problem
Current methods for sealing fetal membranes, such as those used in fetoscopy, face challenges with the delivery and application of polymeric biomimetic gluing materials, including difficulty in targeting the desired location and lack of a reproducible method for sealing perforations without causing further damage, leading to complications like preterm pre-labor rupture of fetal membranes (PPROM).
Innovation Solution
A membrane closure device and method that allows for targeted delivery and application of a patch with a separate glue, eliminating the need for mechanical fasteners, enabling one-sided sealing of fetal membranes without puncturing or damaging them, using an expandable patch and fastener delivery mechanism to secure the patch to the membrane.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Strength
If polymeric biomimetic gluing material is used for sealing fetal membranes, then adhesion strength is improved, but delivery precision and application reliability deteriorate
Solution Approach 1:
The patent introduces a delivery device as an intermediary system that bridges the gap between the gluing material and the membrane defect. This device includes a catheter for positioning, a patch for covering the defect, and a delivery mechanism that can inject glue through a needle from the proximal side, enabling precise control over where and when the adhesive is applied without direct manual manipulation.
Solution Approach 2:
The sealing system is divided into separate functional components: a patch component for mechanical coverage, a glue component for adhesion, and a delivery mechanism for precise application. This segmentation allows each component to be optimized independently - the patch for coverage area and the glue for bonding strength - while the delivery system coordinates their application with surgical precision.
2Reliability
If mechanical fasteners are used to secure the patch, then sealing reliability is improved, but membrane damage increases
Solution Approach 1:
The patent replaces mechanical fastening systems (such as staples, clips, or sutures that would penetrate or clamp the membrane) with a chemical bonding system. The glue is injected through a needle to create adhesive bonds between the patch and the membrane surface, eliminating the need for mechanical elements that would cause punctures, clamping, or tissue trauma while achieving equivalent or superior sealing reliability.
3Reliability
If a comprehensive sealing device is used, then sealing effectiveness is improved, but device complexity increases
Solution Approach 1:
The patent combines multiple sealing functions into a single integrated device assembly. The patch, glue delivery mechanism, and positioning catheter are merged into one coordinated system that can be introduced through a single access point. This integration allows the surgeon to achieve comprehensive sealing (patch coverage + glue bonding) without managing multiple separate tools or procedures, thereby reducing operational complexity despite the enhanced sealing capability.
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 solution effectively seals fetal membranes with high adhesion strength, reducing the risk of PPROM and allowing for minimally invasive procedures, as demonstrated by successful ex vivo and in-vitro applications, with the ability to withstand amniotic fluid pressure until birth.
Implementation Method 1
a fastener delivery mechanism for delivering a fastener to the perforation site for fastening the one or more expandable patches, to the membrane to seal the perforation in the membrane
Data Source
Figure 1
Figure 2A~2D
Figure 2E~2G
AI summary
Disclosed embodiments relate to a membrane closure device (100) for closing a perforation in a membrane (10), comprising: a patch guiding mechanism (110) for guiding at least one expandable patch (120) to a perforation site (12) of a membrane (10); and a fastener delivery mechanism (130, 330) for delivering a fastener (140) to the perforation site (12) and for fastening the at least one expandable patch by the fastener (140) to the membrane (10) to seal the perforation in the membrane (10) by the at least one expandable patch (120).