Cervical Ripening Device with Finger-Guided Balloon
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Solution Overview
Problem
Current cervical ripening systems, such as the Foley catheter, often cause discomfort, are cumbersome to place, and can apply unwanted pressure to the fetus, necessitating a more efficient and comfortable method to facilitate cervical dilation during childbirth.
Innovation Solution
A cervical ripening device with a flexible, biocompatible elongated body and an expandable balloon that can be easily positioned using a physician's finger, minimizing discomfort and avoiding direct contact with the fetus, featuring a small diameter and adjustable length for optimal placement and pressure application.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a Foley catheter is used for cervical ripening, then cervical dilation can be achieved, but the catheter tip and balloon may deeply protrude into the uterus and apply unwanted elevated pressure to the fetus
Solution Approach 1:
The patent introduces a stylet as an intermediary component that guides the catheter through the cervix without allowing the balloon to protrude into the uterus. The stylet acts as a mediator between the operator and the catheter placement, ensuring controlled insertion and preventing the balloon from contacting the fetus while still achieving effective cervical dilation through the internal os.
Solution Approach 2:
The patent applies local quality by creating a localized stopping mechanism at the internal os using the stylet. The stylet's presence creates a defined boundary that allows the balloon to exert pressure precisely at the internal os without extending further into the uterine cavity, thus concentrating the dilating effect where needed while avoiding fetal contact.
2Adaptability or versatility
If a Foley catheter with a large drainage channel is used, then urinary drainage function is provided, but the greater circumference causes further discomfort to the patient upon insertion into the cervix
Solution Approach 1:
The patent segments the catheter's functions by separating the urinary drainage capability from the cervical dilation function. The catheter is designed with a smaller circumference suitable for cervical insertion, while the urinary drainage function is made optional through an removable or collapsible drainage channel, allowing the device to be optimized for comfort during insertion while retaining adaptability for drainage if needed.
Solution Approach 2:
The patent applies dynamics by making the drainage channel configurable - it can be present for urinary drainage needs but can be collapsed or removed to reduce circumference for cervical insertion comfort. This dynamic configuration allows the same device to adapt to different functional requirements without compromising patient comfort during the critical insertion phase.
3Reliability
If a Foley catheter is used for cervical ripening, then cervical dilation can be achieved, but the use of a multi-component system with stylet is cumbersome
Solution Approach 1:
The patent merges the stylet and catheter into a single integrated unit where the stylet is incorporated as an integral component of the catheter assembly. This merging eliminates the need for separate stylet insertion and removal steps, simplifying the overall procedure while maintaining the guiding function that prevents balloon protrusion into the uterus. The combined design reduces device complexity without sacrificing the controlled placement 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 device allows for effective cervical ripening with reduced patient discomfort and easier placement, minimizing the risk of fetal distress and systemic side effects, while avoiding the complications associated with traditional Foley catheter use.
Implementation Method 1
The resulting inflated balloon is often 5 cm to 6 cm in diameter, and the area in contact with the internal os is roughly 30 to 45 cm2. It has been found that the resultant pressure of the inflated balloon at the distal end of the Foley catheter in contact with the internal os may promote the ripening process.
Implementation Method 2
an expandable member positioned adjacent to the balloon that, when expanded, may accommodate a physician's finger, thereby allowing tactile manipulation of the distal end of the device to facilitate the proper placement of the device through the cervical canal
Data Source
AI summary
The invention includes systems and methods using certain embodiments of a medical device to facilitate child birth through cervical ripening. Certain embodiments of the invention may include an elongated body having a proximal end and a distal end where the distal end terminates in a tip. The tip may be covered by a balloon disposed adjacent to the tip, and an expandable member may be positioned adjacent to the balloon such that when expanded, the expandable member may at least partially cover the balloon, and accommodate the user's finger to guide and place the device through the cervix and into the internal os, where, upon expansion of the balloon, pressure is applied to the internal os to facilitate cervical ripening and child birth.