Urinary Catheter Check-Valve Tip Design

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Solution Overview

Problem

Indwelling urinary catheters, such as Foley catheters, often cause bladder damage and infections due to poorly designed tips that allow reverse urine flow, introducing bacteria into the bladder and leading to painful urinary tract infections, with existing solutions facing manufacturing difficulties and usability challenges.

Innovation Solution

A novel double or triple lumen urinary catheter with a bladder-protecting tip and a check-valve mechanism that prevents reverse urine flow, featuring a centered drainage port, an inflatable anchor balloon, and a check-valve system with a tapered housing and arrester bar to ensure one-way fluid flow, reducing bladder trauma and infection risk.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If a conventional Foley catheter design is used, then the catheter can drain urine from the bladder, but reverse urine flow can occur introducing bacteria into the bladder causing infections

Engineering Contradiction:
Improveprevention of reverse urine flowVSAvoidbladder infection risk
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

A check valve is introduced as an intermediary component in the urine drainage path. The check valve allows unidirectional flow of urine from the bladder to the collection bag while preventing reverse flow that could introduce bacteria. This intermediary device solves the infection risk without requiring changes to the catheter's basic structure or function.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Reliability

If existing one-way flow approaches are implemented, then reverse flow prevention is achieved, but manufacturing difficulties and unusual designs arise that are difficult to adopt

Engineering Contradiction:
Improveone-way flow preventionVSAvoidmanufacturing feasibility
Core Design Contradiction:
ReliabilityVSEase of manufacture

Solution Approach 1:

The catheter is segmented into distinct functional components: the drainage lumen, the check valve module, the inflation lumen, and the collection bag interface. The check valve itself is a separate, pre-assembled unit that can be manufactured independently using standard valve manufacturing processes, then integrated into the catheter. This segmentation simplifies manufacturing compared to attempting to create a fully integrated one-way flow structure.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The check valve design uses a universal ball-valve mechanism that can be manufactured with standard materials and processes. The same basic valve design principle can be applied across different catheter sizes and specifications, reducing manufacturing complexity. The valve serves multiple functions: preventing reverse flow, allowing complete drainage, and maintaining sterility barriers.

Inventive Principle:
Principle #6Universality (Multi-functionality)

3Object-affected harmful factors

If the catheter tip design does not protect the bladder, then the catheter structure remains simple, but bladder damage such as irritation or trauma occurs

Engineering Contradiction:
Improvebladder traumaVSAvoidcatheter tip design
Core Design Contradiction:
Object-affected harmful factorsVSDevice complexity

Solution Approach 1:

The catheter tip is designed with localized protective features including a rounded, smooth tip geometry and potentially different material composition or coating at the tip region compared to the rest of the catheter. This local modification protects the bladder mucosa from trauma without requiring complex redesign of the entire catheter structure. The protective qualities are concentrated where they are most needed.

Inventive Principle:
Principle #3Local quality

4Object-affected harmful factors

If a check-valve system is added to prevent reverse flow, then infection risk is reduced, but device complexity increases

Engineering Contradiction:
Improveinfection riskVSAvoidcatheter structure
Core Design Contradiction:
Object-affected harmful factorsVSDevice complexity

Solution Approach 1:

The check valve is designed as a passive, self-regulating component that automatically responds to flow direction without requiring external control mechanisms. Urine flow in the normal direction opens the valve automatically, while any attempt at reverse flow automatically closes it. This self-service mechanism prevents infections without adding complex active control systems, sensors, or power requirements.

Inventive Principle:
Principle #25Self-service

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 effectively protects the bladder by preventing reverse urine flow and reducing the risk of infections, while being easily integrated into current medical practices, with improved manufacturing feasibility and usability compared to existing designs.

Implementation Method 1

a check-valve mechanism that prevents reverse urine flow, featuring a centered drainage port, an inflatable anchor balloon, and a check-valve system with a tapered housing and arrester bar to ensure one-way fluid flow

Methodology Applied
Scientific EffectCheck-valve mechanism: Valve

Implementation Method 2

held in place with a balloon filled with sterile water

Methodology Applied
Scientific EffectInflation: Pressure Increase

Data Source

PatentUS11938276B2Indwelling double or triple lumen urinary catheter
Publication Date: 2024.03.26 BERMEO MEDICAL LLC
  • US11938276B2 patent drawing
  • US11938276B2 patent drawing
  • US11938276B2 patent drawing

AI summary

Herein is described a double or triple lumen, indwelling, urinary catheter having a bladder-protecting tip that has a drainage port centered at the end of the tips and a fitted check-valve. The catheter is useful for catheterizing patients whose bladders are in need thereof (e.g., due to a surgical procedure or other medical problem).