Variable Tension Cervical Ripening Balloon Catheter
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Solution Overview
Problem
Existing cervical ripening devices, such as balloon catheters, often fail to provide sufficient traction force for timely cervix dilation during labor induction, and may have contraindications or complications like increased risk of spontaneous rupture of fetal membranes or prolonged labor.
Innovation Solution
A cervical ripening device featuring a balloon catheter with a variable tensioning system, including a fastener and pad, allows for provider-controlled, measurable advancement of traction force to apply dilatative pressure, reducing the need for large saline volumes and enhancing visibility and rigidity.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Force
If a balloon catheter is used for mechanical ripening with adhesive tape on the leg, then the device can be secured in place, but the traction force is insufficient to achieve timely cervix dilation
Solution Approach 1:
The patent applies a variable tensioning system that allows dynamic adjustment of traction force on the balloon catheter. The fastening mechanism can be repositioned along the catheter tube to increase or decrease tension, enabling the system to adapt to different stages of cervical dilation and maintain optimal force application throughout the ripening process.
Solution Approach 2:
The patent incorporates a force gauge that provides real-time feedback on the traction force applied to the balloon catheter. This allows the healthcare provider to monitor the actual force being applied and adjust the fastening position accordingly, ensuring sufficient traction force is maintained to achieve timely cervix dilation while avoiding excessive force that could cause complications.
2Stability of the object's composition
If adhesive tape is used to secure the catheter to the leg, then the device can be maintained in position, but the traction force becomes ineffective when cervix dilation progresses
Solution Approach 1:
The variable tensioning system allows the catheter to maintain stable positioning while enabling dynamic adjustment of traction force. As cervix dilation progresses, the fastening can be repositioned to maintain optimal tension, ensuring the traction force remains effective throughout the entire ripening process rather than becoming ineffective at later stages.
3Force
If large amounts of saline are used to inflate the balloon, then the balloon can apply sufficient pressure to the cervix, but labor duration is delayed
Solution Approach 1:
The patent optimizes the volume of saline used to inflate the balloon, using a moderate amount (e.g., 30-50 mL) rather than large volumes (80 cc or more). This parameter optimization achieves sufficient dilatative pressure for effective cervical ripening while avoiding the delayed labor process that has been associated with excessive saline volumes in previous studies.
4Stability of the object's composition
If a Foley device is used for cervical ripening, then the catheter can be secured, but the risk of spontaneous rupture of fetal membranes increases
Solution Approach 1:
The patent removes the urinary collection component from the catheter design, using a simpler balloon catheter configuration without the extended tubular portion that extends beyond the balloon. This extraction of the problematic element eliminates the risk of spontaneous rupture of fetal membranes associated with Foley devices while maintaining the necessary security and traction capabilities for cervical ripening.
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
This solution enables more effective and controlled cervix dilation, potentially reducing labor duration, medication use, cesarean section rates, and medical costs, while being suitable for various pregnancy conditions.
Implementation Method 1
The balloon is inserted above the cervix of the pregnant woman and inflated with a sterile solution, such as saline, in order to apply force to the cervix
Implementation Method 2
The fastener is connected to the second end of the catheter tube. The fastener couples to the pad in a plurality of positions to selectively vary a traction force of the balloon
Data Source
AI summary
A cervical ripening device includes a balloon catheter and a variable tensioning system. The balloon catheter includes a balloon insertable above the cervix of a pregnant woman and a catheter tube having a first end connected to the balloon, a second end, and a passageway extending from the first end to the second end. The passageway is connected to the balloon and the balloon is inflatable with a fluid to apply dilatative pressure against the cervix. The variable tensioning system includes a fastener and a pad. The pad is temporarily affixed to a leg of the pregnant woman. The fastener is connected to the second end of the catheter tube. The fastener couples to the pad in a plurality of positions to selectively vary a traction force of the balloon to apply dilatative pressure against the cervix.