Balloon-Tipped Catheter Sealing for NOTES Sterility

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Solution Overview

Problem

Current Natural Orifice Transluminal Endoscopy Surgery (NOTES) procedures face challenges in maintaining sterility during the delivery of materials and obtaining tissue samples within the peritoneum, as well as preventing bodily fluid spillage and infection.

Innovation Solution

A multi-luminal system comprising an outer catheter with a balloon-tipped catheter that expands to seal the opening, preventing bodily fluids from entering and ensuring sterility, along with a deployable device for delivering therapeutic agents or collecting tissue samples.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Object-affected harmful factors

If a catheter assembly is used to access body cavities through natural orifices, then the procedure becomes minimally invasive, but maintaining sterility and preventing bodily fluid spillage becomes challenging

Engineering Contradiction:
Improveinfection riskVSAvoidsterile delivery difficulty
Core Design Contradiction:
Object-affected harmful factorsVSEase of operation

Solution Approach 1:

The patent employs a nested catheter structure with multiple concentric catheters (outer catheter, inner catheter, balloon-tipped catheter) where each catheter is inserted within the previous one. This nesting allows the system to maintain sterility while navigating through natural orifices, as the outer catheters protect the inner sterile components until deployment.

Inventive Principle:
Principle #7Nested doll (Nesting)

Solution Approach 2:

The balloon-tipped catheter acts as an intermediary seal between the non-sterile external environment and the sterile internal cavity. When inflated, the balloon creates a barrier that prevents bodily fluids from contaminating the sterile deployable device, enabling safe delivery through natural orifices.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Reliability

If the balloon tip is expanded to seal the opening and prevent fluid entry, then sterility is maintained, but the complexity of the device increases

Engineering Contradiction:
Improvesterility maintenanceVSAvoidmulti-luminal system complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The balloon-tipped catheter serves multiple functions: it seals the opening to maintain sterility, protects the deployable device during advancement, and can be deflated and retracted into the inner catheter for compact storage. This multi-functionality justifies the added complexity by eliminating the need for separate components.

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

Solution Approach 2:

The balloon tip is designed to be dynamically adjustable - inflated when needed to create a seal and protect the device, then deflated and retracted into the inner catheter when no longer needed. This dynamic behavior allows the system to transition between different functional states, reducing complexity during storage and transport.

Inventive Principle:
Principle #15Dynamics

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 system effectively minimizes the risk of contamination and infection by maintaining a sterile environment during procedures, allowing for safe delivery of devices and collection of tissue samples within the body cavities.

Implementation Method 1

the distal end of the balloon-tipped catheter comprises a balloon tip that can be expanded to contact the wall of the outer catheter to provide a seal

Methodology Applied
Scientific EffectElastic expansion: Elasticity

Data Source

PatentEP2382001B1Balloon-tipped endoscopic system
Publication Date: 2019.03.06 COOK MEDICAL TECHNOLOGIES LLC
  • EP2382001B1 patent drawingFigure 1a~1c
  • EP2382001B1 patent drawingFigure 2
  • EP2382001B1 patent drawingFigure 3

AI summary

Multi-luminal endoscopic systems (10) for sterilely delivering deployable devices (30) or obtaining bodily tissues. The system comprise an outer catheter (24) comprising a wall that encloses an outer lumen (5); an inner catheter (20) movably disposed within the outer lumen and having an inner lumen (7); a balloon-tipped catheter (26) movably disposed within the inner lumen and having a distal end and a proximal end, wherein the distal end of the balloon- tipped catheter comprises a balloon tip (15) that can be expanded to contact the wall of the outer catheter to provide a seal to prevent bodily fluids from entering the outer lumen; and a push catheter having a lumen and is located within the outer lumen. The delivery systems can comprise concentric catheters. Systems used for tissue collecting can comprise catheters with different common center.