Echogenic Introducer for Uterine Tamponade Balloon Catheter
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Solution Overview
Problem
Current uterine tamponade systems, such as the Bakri balloon, face challenges in efficient and accurate insertion and positioning within the uterus, particularly in managing postpartum hemorrhage, due to lack of effective accessories for maintaining balloon position and visualization during procedures.
Innovation Solution
An introducer device with a stylet and echogenic components is introduced to facilitate the insertion and positioning of the tamponade balloon catheter, providing flexibility, torsion, and column strength for navigation while enhancing visualization through ultrasound, allowing for accurate placement and maintaining the balloon in the uterus.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If a balloon tamponade catheter is inserted into the uterus to control postpartum hemorrhage, then bleeding control is achieved, but accurate positioning and visualization during insertion is difficult
Solution Approach 1:
The patent applies echogenic elements (reflective surfaces) to the catheter that change the ultrasound signal reflection, making the catheter visible on ultrasound imaging. This allows real-time visualization of catheter position and balloon placement accuracy during the procedure, directly resolving the visualization difficulty while maintaining positioning accuracy.
2Productivity
If an introducer device is used to facilitate catheter insertion, then insertion efficiency is improved, but device complexity increases
Solution Approach 1:
The introducer device is designed to perform multiple functions: it serves as both an insertion aid (providing column strength and pushability) and a positioning device (maintaining catheter position during balloon inflation). The stylet with asymmetric hub design allows the device to navigate anatomy while maintaining simplicity, achieving multi-functionality without excessive complexity.
Solution Approach 2:
The introducer device is pre-assembled with the catheter before patient insertion, with the stylet already positioned within the catheter lumen. This preliminary preparation allows rapid deployment during the procedure, improving insertion efficiency while keeping the actual procedure time short, thus balancing productivity gains against the complexity of pre-assembly.
3Stability of the object's composition
If the introducer device remains in place during use, then positioning stability is maintained, but drainage capability may be compromised
Solution Approach 1:
The introducer device is segmented into distinct functional zones: the stylet portion remains within the catheter lumen to maintain positioning stability, while the hub portion extends outward to provide drainage pathways. This segmentation allows the device to simultaneously maintain catheter position and enable fluid drainage, resolving the contradiction between stability and drainage capability.
Solution Approach 2:
The hub of the introducer device acts as an intermediary structure that mediates between the positioning function (stylet in lumen) and drainage function (external hub openings). The hub lumen provides an alternative drainage pathway that bypasses the stylet, allowing the stylet to remain in place for positioning while maintaining drainage capability through the hub structure.
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 solution enables rapid and accurate insertion, improved visualization, and effective management of uterine bleeding by maintaining the balloon's position, reducing complications and improving procedural success rates.
Implementation Method 1
echogenic component or element to assist the physician with visualization and placement of the balloon tamponade catheter within the uterus
Data Source
AI summary
A device for use with a uterine tamponade balloon catheter apparatus, such as the Bakri postpartum hemorrhage balloon, is disclosed. The device comprises a stylet comprising a hub at its proximal end and an atraumatic tip at its distal end. The device is configured to be removably coupled to the tamponade balloon catheter apparatus to aid in the insertion and positioning of the tamponade balloon catheter within the uterine cavity, allowing the balloon to function as intended for the control and management of postpartum hemorrhage and uterine bleeding. The tamponade balloon catheter includes an echogenic element to aid in visualization by ultrasound during insertion and use. Methods of use of the device are also disclosed.