Balloon Tamponade Device with Segmented Lumens for Hemorrhage Control
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Solution Overview
Problem
Current balloon catheters for managing hemorrhage in pelvic or abdominal cavities are inadequate due to small volume, slow inflation, and inability to simultaneously control hemorrhage in both cavities, and they often mask continuing bleeding, necessitating a device that can rapidly control hemorrhage with separate lumens for fluid administration and drainage.
Innovation Solution
A balloon tamponade device with an expansible balloon and conduit system that includes separate inflation and drainage lumens, allowing for rapid inflation and deflation, and the ability to control hemorrhage in both pelvic and abdominal cavities, with optional dual balloons for simultaneous uterine and vaginal control, featuring a deforming mechanism to direct pressure effectively and prevent displacement.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If balloon catheters are used to manage hemorrhage in pelvic or abdominal cavities, then hemorrhage control is provided, but the device volume is small, inflation is slow, and the ability to simultaneously control hemorrhage in both cavities is inadequate
Solution Approach 1:
The device divides the single balloon into multiple separate balloons (first balloon for abdominal cavity, second balloon for pelvic cavity), each capable of independent inflation. This segmentation allows each balloon to be inflated rapidly to appropriate volumes for its specific cavity without the constraints of a single large-volume balloon system.
Solution Approach 2:
The device provides universal hemorrhage control capability for both abdominal and pelvic cavities through a single integrated system with multiple balloons. Each balloon can be independently inflated to manage hemorrhage in its respective cavity, making the device adaptable to different hemorrhage scenarios and locations.
2Adaptability or versatility
If single lumen catheters are used, then device simplicity is maintained, but separate fluid administration and drainage cannot be achieved
Solution Approach 1:
The catheter is divided into multiple lumens (first lumen for fluid administration, second lumen for drainage) within the balloon structure. This segmentation of functional pathways allows simultaneous fluid administration and drainage operations without cross-contamination or interference.
Solution Approach 2:
Multiple lumens are nested within the catheter structure, with each lumen serving a specific function. The nested configuration allows multiple functional channels to coexist within a single catheter assembly, providing versatile fluid management while maintaining a relatively compact device structure.
3Reliability
If balloon pressure is applied to control hemorrhage, then bleeding control is achieved, but continuing bleeding may be masked making it difficult to determine effective hemorrhage management
Solution Approach 1:
The drainage lumen provides continuous feedback about the hemorrhage status by allowing observation of drainage characteristics. Changes in drainage volume, color, or presence of blood clots provide real-time information about whether hemorrhage is actively occurring or has been controlled, enabling dynamic assessment of treatment effectiveness.
Solution Approach 2:
The drainage lumen acts as an intermediary pathway that allows indirect observation of the hemorrhage status without requiring direct visual access to the bleeding site. By monitoring what drains through this intermediary channel, clinicians can infer the state of hemorrhage control.
4Loss of time
If balloon is inflated rapidly to control hemorrhage, then hemorrhage control time is reduced, but balloon elasticity creates counter-inflation pressure that must be overcome
Solution Approach 1:
Dividing the total required volume into multiple smaller balloons allows each balloon to be inflated to a manageable pressure level. The counter-inflation pressure from each smaller balloon is less than that of a single large balloon, enabling more rapid and easier inflation without requiring excessive force.
Solution Approach 2:
By changing the physical parameters of the system (number of balloons, volume distribution, inflation pressure per balloon), the device optimizes the inflation process. Each balloon is designed with appropriate elasticity and volume characteristics that allow rapid inflation to the required pressure without excessive counter-pressure resistance.
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 effectively controls hemorrhage by applying compressive pressure to the bleeding site, allowing for rapid inflation, simultaneous management of uterine and vaginal hemorrhage, and minimizing contamination through separate lumens, thereby providing effective and efficient hemorrhage control.
Implementation Method 1
the balloon is inflated to expand the balloon to a shape within the body cavity... causes a compressive force or pressure against a wall, tissue, structure or a site that is bleeding and thereby controls hemorrhage
Implementation Method 2
a deforming means to deform the shape of the balloon so that a balloon dimension is changed in an axis or a direction. Deformation of the balloon changes the dimension of the balloon in a first direction or axis, causing expansion and compressive forces to be directed in a preferred second direction or axis
Data Source
AI summary
An implantable device for controlling hemorrhage in a body cavity comprising an expandable balloon and a conduit for supplying a physiologically compatible fluid to inflate the balloon is described. The balloon tamponade device is inserted into the body cavity and is inflated with a physiologically suitable fluid so that the balloon generally conforms to the body cavity and exerts compressive force against the walls, tissues or structures of the body cavity to control hemorrhage. The balloon may have a deforming means to limit expansion of the balloon in a direction to facilitate expansion of the balloon in another direction. The device may have additional tubes within the conduit, or a plurality of separate lumens within the conduit or tubes to allow drainage and irrigation to the body cavity. A method of controlling hemorrhage in a body cavity by using the implantable device is also contemplated.