Inflatable Cervical Cuff Compression to Delay Preterm Labor
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Solution Overview
Problem
Existing interventions for cervical insufficiency, such as cervical cerclage and vaginal progesterone application, are limited in efficacy and invasive, and there is a lack of effective methods to prevent preterm labor and pelvic organ prolapse in multiple gestations.
Innovation Solution
Cervical control devices and systems that include an inner cuff and positioning balloon, which are inserted into the vagina to compress and support the cervix, providing adjustable compression and support to prevent preterm labor and pelvic organ prolapse, using inflation media to control cervical length, dilation, and orientation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If cervical cerclage (suture) is placed in the cervix to delay birth, then preterm labor is prevented, but the procedure is invasive and has limited efficacy in multiple gestations
Solution Approach 1:
The patent replaces the mechanical suture (cervical cerclage) with an inflatable device that uses gas or liquid under pressure to achieve cervical compression. The inflatable member expands within the cervix to apply continuous compressive force, eliminating the need for invasive sutures while maintaining effectiveness in both singleton and multiple gestations.
Solution Approach 2:
The device transitions from a static suture to a dynamic inflatable system that can adjust its compression force by controlling the inflation/deflation of the inflatable member. This allows the device to adapt to different cervical states and gestational conditions, providing adjustable support without invasive procedures.
2Reliability
If vaginal progesterone is applied to the cervix to maintain its length and structure, then cervical insufficiency is treated, but the medication is flushed out by vaginal discharge over time and requires invasive transvaginal access
Solution Approach 1:
The patent replaces the chemical mechanism of vaginal progesterone with a mechanical inflatable device that physically compresses the cervix to maintain its length and structure. This mechanical approach eliminates the problem of medication being flushed out by vaginal discharge, as the compression force is directly applied through the inflatable member without requiring continuous medication application.
Solution Approach 2:
The inflatable member acts as an intermediary that delivers cervical compression without requiring direct contact with vaginal discharge. The device creates a sealed compression zone that maintains its effect regardless of vaginal discharge flow, eliminating the need for repeated medication application.
3Reliability
If cervical compression is applied to delay labor and allow mucus plug regeneration, then preterm birth is prevented, but the device must be inserted into the vagina which may be considered invasive
Solution Approach 1:
The patent employs a flexible inflatable member that can be inserted into the vagina in a deflated state and then inflated to provide cervical compression. The flexible nature of the inflatable member allows it to conform to the vaginal anatomy while providing targeted compression, making the insertion process more tolerable compared to rigid devices.
Solution Approach 2:
The device uses dynamic inflation/deflation to achieve cervical compression only when needed, rather than requiring continuous insertion. The inflatable member can be inflated to provide compression for labor delay and deflated for removal, reducing the duration of vaginal insertion and associated discomfort.
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 devices effectively delay preterm labor, prevent preterm birth, and support pelvic organs, reducing the risk of infection and promoting amniotic fluid retention, while being non-invasive and customizable to individual patient needs.
Implementation Method 1
an inflatable member configured to expand when inflation media is supplied to compress the cervix
Implementation Method 2
expand when inflation media is supplied to compress the cervix, which may, or may not, be partially dilated
Implementation Method 3
compression of the cervix via use of the systems, devices, and methods disclosed herein may act to hold the cervix closed so that the leaking of amniotic fluid from the membrane may be slowed or stopped
Implementation Method 4
a flexible membrane configured to expand when inflation media is added to the inner chamber to contact and/or compress the cervix
Data Source
AI summary
Systems, devices, and methods are provided that control, support, and/or elongate a cervix to treat pregnancy complications and/or delay an onset of labor so that a gestational period for a fetus may be extended, thereby preventing preterm labor and delivery of the fetus. The cervical control systems may include a main body configured for placement in a vagina. The main body has in internal passageway configured for acceptance of a cervix therein and an inflatable and/or expandable inner cuff extends from portion of the internal passageway. The inner cuff may be expandable inward toward the cervix, or downward away from the uterus, or both inward and downward so that the inner cuff may engage, or grip, the cervix thereby holding the cervical control system in place while compressing the cervix closed, elongating the cervix, and/or adjusting an angle of orientation of the cervix.