Folded Membrane Hemostatic Device for Uterine Adaptation
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Solution Overview
Problem
Existing hemostatic devices for treating postpartum hemorrhage face challenges in easily inserting into and conforming to the shape of the uterus, while efficiently stimulating uterine muscle contraction and blood vessel constriction without hindering further uterine contraction.
Innovation Solution
A hemostatic device comprising a membrane with a plurality of folds and holes, configured to be fluidically connected to a vacuum source, allowing the device to expand and fit the uterus while inducing negative pressure to attract uterine walls and promote hemostasis.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a flat flexible plate is used to apply negative pressure to the uterus, then the uterus can be mechanically shrunk and blood vessels constricted to stop bleeding, but the device cannot easily be introduced into a little uterus like a partially retracted uterus and may hinder further contraction of the uterus
Solution Approach 1:
The hemostatic device incorporates a flexible membrane with folds that can dynamically change its configuration. The membrane transitions from a compressed state for insertion to an expanded state for hemostasis, allowing adaptation to varying uterine sizes and shapes while maintaining effective contact with the uterine wall throughout the procedure
Solution Approach 2:
The device utilizes changes in the physical state of the membrane through compression and expansion. When compressed, the membrane fits into a compact form for easy insertion; when expanded under negative pressure, it provides sufficient surface area for effective hemostasis. This parameter change allows a single device to serve multiple sizes of uterus
2Reliability
If a flexible portion is inserted into the uterus with holes to create negative pressure, then the uterine wall can be stimulated to contract and vessels constricted, but the area of the uterine wall in contact with the device is limited and the space between the device and uterine wall allows vacuum to escape
Solution Approach 1:
The membrane is designed with folds that extend in multiple directions, creating a three-dimensional structure that increases the contact surface area with the uterine wall. The folds form peaks and valleys that project toward the uterine wall, ensuring comprehensive coverage and preventing vacuum escape through gaps
Solution Approach 2:
The membrane incorporates curved folds and rounded features that conform to the natural curvature of the uterine wall. This curved design enhances the contact area and distribution of negative pressure across the uterine surface, improving hemostatic effectiveness while maintaining a compact profile for insertion
3Area of stationary object
If an inflatable balloon is added to reduce depression between the device and uterine wall, then the contact area can be increased, but the device becomes more complicated to use
Solution Approach 1:
The hemostatic function and the contact enhancement function are merged into a single integrated membrane structure. The folds and peaks of the membrane simultaneously provide contact with the uterine wall and distribute negative pressure, eliminating the need for separate inflatable balloons or additional components
Solution Approach 2:
The membrane serves multiple functions: it acts as a barrier to prevent vacuum escape, provides contact surfaces for hemostasis, distributes negative pressure evenly, and maintains a compact profile for insertion. This multi-functionality eliminates the need for additional components like inflatable balloons, reducing device complexity while maintaining effectiveness
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 device effectively stops bleeding by attracting uterine walls and promoting muscle contraction, while its retractive design allows it to adapt to varying uterine sizes and prevent flattening, maintaining efficient hemostasis.
Implementation Method 1
when a negative pressure is created in the internal volume by the pump, the walls of the uterus are attracted by the respective face of the plate and held together
Implementation Method 2
the pump creates a negative pressure within the uterus via the holes in the flexible portion
Data Source
AI summary
The disclosure relates to a hemostatic device (1) comprising at least one chamber (2) delimited by a membrane (4), each chamber (2) being configured to be fluidically connected to a vacuum source, the membrane (4) being configured to be placed so as to face, at least partially, a bleeding area of a body cavity, the membrane (4) comprising a plurality of holes (6) leading into the chamber (2) and configured to induce a negative pressure in the body cavity when a negative pressure is applied in the chamber (2) by the vacuum source, the induced negative pressure being configured so that the walls of the cavity are attracted to the membrane (4), wherein the membrane (4) has at least two opposite faces (4a, 4b), each face comprising a plurality of folds (8) extending in at least one first direction.


