Obstetrical Catheter Flat Balloon Design
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Solution Overview
Problem
Conventional Foley catheters cause obstruction of the fetal head and increased risk of maternal urethral and bladder injury during labor due to their large, spherical balloon volume, leading to obstructed labor and potential surgical complications.
Innovation Solution
A low-profile urinary catheter with a thin, flat, flexible pancake-like balloon placed proximal to the traditional balloon, reducing obstruction volume and presence in the bladder, allowing for urine removal without obstructing the fetal vertex.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a conventional Foley catheter with a spherical balloon is used to retain the catheter in the bladder, then the catheter is securely retained and urine can be removed, but the large spherical volume of the balloon causes obstruction of the fetal head and may lead to obstructed labor and maternal tissue injury
Solution Approach 1:
The patent transitions from a three-dimensional spherical balloon to a two-dimensional flat disc-shaped balloon. This dimensional reduction dramatically decreases the volume occupied in the bladder while maintaining the retention function. The flat disc configuration allows the balloon to conform to the bladder floor without projecting upward to obstruct the fetal head, thus resolving the contradiction between secure retention and fetal obstruction.
Solution Approach 2:
The patent changes key geometric parameters of the retention balloon: replacing a spherical shape with a flat disc shape, reducing the overall volume, and decreasing the height projection into the bladder lumen. These parameter changes maintain the anchoring function while eliminating the obstructive effect on the fetal vertex.
2Reliability
If a large volume spherical balloon is inflated in the bladder, then the catheter is securely anchored, but the large obstructive volume increases the occurrence of direct obstruction of the descending fetal head and arrest of labor
Solution Approach 1:
By flattening the balloon into a disc shape, the patent reduces the vertical dimension that would otherwise obstruct labor progression. The flat configuration allows the balloon to sit against the bladder floor without projecting into the pelvic inlet, thereby maintaining anchoring reliability while preserving labor productivity.
Solution Approach 2:
The patent applies the balloon retention function locally at the bladder floor rather than distributing volume throughout the bladder lumen. This localized anchoring approach provides secure catheter fixation while minimizing interference with the global process of labor and fetal descent.
3Ease of operation
If a conventional Foley balloon is used, then urine can be drained from the bladder, but the spherical configuration consumes relatively large volume within the patient's bladder and increases the rate of cesarean section
Solution Approach 1:
The flat disc-shaped balloon maintains the urine drainage function while occupying minimal volume within the bladder. The two-dimensional configuration allows the balloon to lie flat against the bladder floor, providing adequate drainage capability without the three-dimensional bulk that would interfere with fetal descent or necessitate cesarean section.
Data Source
AI summary
The invention provides an improved indwelling urinary catheter of the inflatable type having a unique, low profile device by which to retain the catheter within the bladder, so that urine can be removed therefrom while avoiding obstruction to the descending fetal vertex during the process of labor and delivery, Thus, making it better suited for obstetrical applications. The retaining device consumes less obstructing volume in the bladder than that which would ordinarily be consumed by a conventional Foley-style balloon, whereby both the frequency and severity of fetal vertex obstruction and its resulting increased time of labor, operative delivery and injury to maternal urologic tissue can be reduced. The obstetrical Foley retains the tradition Foley-style balloon distal to the improved low-profile laboring balloon for insufflation in the event a surgical delivery by cesarean section is indicated. The traditional balloon with its larger volume allows easy identification of the bladder during surgical delivery. This unique design allows the added advantage of multiple options and uses in a single Foley catheter without the need of changing catheters.