Flexible Cervical Dilator Balloon Inflation Trauma Reduction
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Solution Overview
Problem
Existing cervical dilation methods using rigid metallic rods are lengthy, prone to operator error, and can cause damage or infection due to multiple insertions and potential trauma to the vagina, cervix, uterus, and surrounding organs.
Innovation Solution
A cervical dilator with a flexible shaft and inflatable balloon that provides tactile feedback and allows for controlled inflation to dilate the cervix quickly and safely, requiring only one or two insertions and minimizing trauma.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If rigid metallic rods are used for cervical dilation, then the cervix can be dilated, but the procedure is lengthy and causes trauma to the vagina, cervix, uterus, and surrounding organs
Solution Approach 1:
The patent replaces rigid metallic rods with a flexible shaft that has a rounded tip, eliminating the need for multiple rigid insertions. The flexible material allows atraumatic navigation through the cervix and uterus, preventing damage to surrounding organs while maintaining procedural effectiveness.
Solution Approach 2:
The dilation process is segmented into controlled phases using a flexible shaft with incremental dilation capabilities. The flexible design allows gradual, controlled expansion rather than forcing through rigid rods, reducing trauma while achieving the same dilation goal.
2Adaptability or versatility
If multiple rigid rods are inserted sequentially, then the cervix can be dilated to required size, but the risk of infection and injury increases with each insertion
Solution Approach 1:
The patent combines multiple rod functions into a single flexible shaft with integrated balloon dilation capability. This eliminates the need for sequential insertion of multiple rigid rods, reducing the number of insertion/removal cycles from twelve to one, thereby minimizing infection risk while maintaining full dilation capability.
Solution Approach 2:
The patent uses pneumatic balloon inflation to achieve cervical dilation instead of mechanical rod insertion. The balloon can be inflated to controlled sizes within the cervix, providing adaptive dilation without requiring multiple external insertions, thus reducing infection exposure.
3Measurement precision
If rigid rods are used for uterine sounding, then uterine depth can be measured, but the endometrial canal and uterine fundus are at risk for puncture and injury
Solution Approach 1:
The flexible shaft with rounded tip provides atraumatic uterine sounding by conforming to the uterine cavity shape rather than forcing through it. The flexibility allows the shaft to follow the natural contours of the endometrial canal, eliminating puncture risk while maintaining measurement accuracy through tactile feedback and visual markers.
4Productivity
If twelve separate rod insertions are performed, then complete cervical dilation is achieved, but the procedure is time-consuming and exposes the patient to repeated trauma
Solution Approach 1:
The patent merges the functions of twelve separate rigid rods into a single flexible shaft with integrated balloon dilation. This consolidation reduces the procedure to one insertion with controlled balloon inflation, dramatically increasing speed while reducing the skill requirement for precise sequential rod insertion.
Solution Approach 2:
The patent uses dynamic balloon inflation to adapt the dilation process to patient anatomy in real-time. The balloon can be inflated to different sizes and pressures as needed, providing dynamic adjustment without requiring the operator to select from multiple rigid rod sizes, thereby simplifying operation 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 cervical dilator facilitates faster and safer uterine sounding and cervical dilation, reducing the risk of injury and infection by using a flexible design and controlled balloon inflation, thus improving the efficiency and safety of the procedure.
Implementation Method 1
The balloon is configured to be inflated using fluid pressure to dilate the cervix
Implementation Method 2
A flexible dilator with tactile feedback
Data Source
AI summary
A cervical dilator and methods of using the cervical dilator include guiding a shaft and a balloon of the cervical dilator through a cervix to seat the balloon in an uninflated state within a cervix. Seating the balloon includes locating proximal and distal ends of the balloon near proximal and distal ends of the cervix such that the balloon fills a canal of the cervix. After seating the balloon within the canal of the cervix, the method includes introducing a predetermined amount of fluid into the balloon cavity to fill the balloon to an inflated state. While the balloon is in the inflated state, the method includes waiting a predetermined time period to allow cervical dilation. After waiting the predetermined time period, the method includes applying light tension to the exterior surface of the shaft to remove the shaft and the balloon in the inflated state from the cervix.