Crescent-Shaped Retention Balloon Catheter for Hypospadias

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Solution Overview

Problem

Traditional catheters used for hypospadias surgery are prone to dislodgement, cause discomfort and bladder spasms, are difficult to connect with urine collection systems, and lead to a high incidence of urinary tract infections due to their design and material properties.

Innovation Solution

A dual-lumen catheter with a crescent-shaped retention balloon that inflates and deflates within the catheter, coated with a hydrophilic material, featuring an angulation joint for easy insertion and removal, and a one-way valve to prevent backflow, reducing contact with the bladder and incorporating an external self-flushing system.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If a retention balloon is used to prevent catheter dislodgement, then catheter security is improved, but discomfort and bladder spasms increase due to large surface area contact with the bladder lining

Engineering Contradiction:

Improvecatheter securityVSAvoiddiscomfort and bladder spasms

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent applies asymmetry by changing the retention balloon shape from a traditional spherical form to a crescent shape. This asymmetric design allows the balloon to contact only specific portions of the bladder lining rather than distributing contact over a large surface area, thereby maintaining catheter security while reducing discomfort and bladder spasms

Inventive Principle:

Principle #4Asymmetry

Solution Approach 2:

The crescent-shaped retention balloon implements local quality by concentrating the retention function in a specific localized area of the bladder rather than distributing it broadly. The balloon is positioned to contact only the lateral wall of the bladder, providing secure anchoring while leaving other areas of the bladder lining untouched, thus minimizing irritation and spasms

Inventive Principle:

Principle #3Local quality

2Reliability

If a retention balloon is used to secure the catheter, then dislodgement is prevented, but the balloon contacts the bladder lining over a large surface area causing discomfort

Engineering Contradiction:

Improvecatheter securityVSAvoidballoon contact area with bladder

Core Design Contradiction:

ReliabilityVSArea of stationary object

Solution Approach 1:

Inventive Principle:

Principle #4Asymmetry

Solution Approach 2:

The crescent-shaped balloon design effectively extracts or removes the unnecessary portions of the balloon that would contact the bladder lining. By taking out only the essential retention function and eliminating excess material, the design achieves secure catheter anchoring with minimal contact area, reducing the harmful effect of large surface area contact

Inventive Principle:

Principle #2Taking out (Extraction)

3Device complexity

If traditional catheters are used, then they are simple in design, but they are difficult to insert in severe hypospadias cases with hypertrophied utricle

Engineering Contradiction:

Improvecatheter design simplicityVSAvoidinsertion difficulty

Core Design Contradiction:

Device complexityVSEase of operation

Solution Approach 1:

The patent applies dynamics by incorporating a flexible section with an angulation joint into the catheter design. This dynamic feature allows the catheter to change its configuration from a straight rigid tube to a flexible angled structure, enabling it to navigate through the hypertrophied utricle and severe anatomical variations during insertion while maintaining relative design simplicity

Inventive Principle:

Principle #15Dynamics

Solution Approach 2:

The catheter is segmented into distinct functional sections: a flexible section with an angulation joint that allows bending, and a rigid section that provides structural support. This segmentation enables the catheter to combine ease of insertion through flexible navigation with maintaining structural integrity and simplicity in its overall design

Inventive Principle:

Principle #1Segmentation

4Device complexity

If traditional catheters are used, then they have a simple structure, but they are easily kinkable and can obstruct urine flow

Engineering Contradiction:

Improvecatheter structure simplicityVSAvoidurine flow patency

Core Design Contradiction:

Device complexityVSReliability

Solution Approach 1:

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The patent incorporates curvature principles through the angulation joint design, which allows controlled bending at specific angles rather than random kinking. This curved geometry guidance prevents the catheter from forming sharp kinks that would obstruct urine flow, while still allowing the necessary flexibility for insertion into severe hypospadias cases

Inventive Principle:

Principle #14Spheroidality (Curvature)

5Reliability

If suturing the catheter to the glans penis is used to prevent dislodgement, then catheter security is improved, but it causes pain during removal and long-term visible deep tracts

Engineering Contradiction:

Improvecatheter securityVSAvoidpain and tissue damage

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent extracts the retention function from the distal end of the catheter (where suturing would occur at the glans) and relocates it to the proximal end within the bladder. By taking out the suturing requirement entirely and replacing it with an intravesical retention mechanism, the design achieves catheter security without causing pain or tissue damage during removal

Inventive Principle:

Principle #2Taking out (Extraction)

Solution Approach 2:

The crescent-shaped retention balloon acts as an intermediary mechanism that provides catheter security without direct tissue attachment. Instead of suturing the catheter to the glans penis (which causes damage), the balloon mediates retention by anchoring to the bladder lining, eliminating the need for invasive suturing and subsequent tissue trauma

Inventive Principle:

Principle #24Intermediary (Mediator)

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 catheter provides secure and comfortable placement, reduces bladder spasms and infection risk, facilitates easy urine collection, and minimizes damage to the urethra during removal, while maintaining patency and preventing kinking.

Implementation Method 1

coated with a hydrophilic material

Methodology Applied

Scientific EffectHydrophilic coating: Hydrophile

Implementation Method 2

The presently described catheter is secured within a patient's bladder by a retention balloon

Methodology Applied

Scientific EffectFriction: Friction

Data Source

PatentUS11872352B2Multi-function hypospadias catheter

Publication Date: 2024.01.16 HAMAD MEDICAL CORP

AI summary

The presently described catheter is an improved multi-function hypospadias catheter adapted to be urethrally inserted and secured within a patient's bladder using an attached internal crescent shaped retention balloon. The inverted crescent configuration of the balloon reduces the contact surface area between the balloon and a patient's bladder wall to reduce bladder spasms. The catheter is removed from the patient (when needed) via deflation of the crescent shaped balloon, which deflates completely so as to not contact a patient's urethra during insertion and removal of the catheter. The catheter includes a double lumen with a one-way flow valve. One lumen provides a passageway to drain urine from a patient's bladder. The second lumen provides a passageway to inflate and deflate the crescent shaped retention balloon.