Balloon Catheter Sampling for Reliable Respiratory Virus Collection

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Solution Overview

Problem

Existing biological sample collection methods, particularly for respiratory tracts, are prone to errors leading to false-negative results due to inadequate virus collection, especially during initial stages of infection or low viral loads, posing a risk of untreated infections and community spread.

Innovation Solution

A device comprising distal and proximal balloon assemblies with a double lumen catheter and agitator for inflating and aspirating collection liquid, agitating the liquid, and transferring it to a vial for testing, ensuring thorough virus collection from upper and lower respiratory tracts.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If a swab is used to collect samples from the respiratory tract, then the collection process is simple and quick, but the sample collection is inadequate leading to false-negative results

Engineering Contradiction:
Improvesample collection reliabilityVSAvoidcollection device complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The device is divided into multiple functional segments: a catheter for insertion, a balloon assembly for isolation, an agitator for mixing, and a collection chamber for sample accumulation. This segmentation allows each component to perform its specific function effectively, ensuring reliable sample collection while maintaining reasonable device complexity through modular design.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

Collection liquid is introduced as an intermediary substance to facilitate virus collection. The liquid medium allows for effective contact between the swab and viral particles, enabling thorough sample collection. The agitator then mixes the collection liquid to ensure complete viral particle recovery before aspiration.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Measurement precision

If PCR amplification is performed to detect viral content, then detection sensitivity is improved, but the process becomes laborious and time-consuming

Engineering Contradiction:
Improveviral detection precisionVSAvoiddetection process time
Core Design Contradiction:
Measurement precisionVSLoss of time

Solution Approach 1:

The device performs preliminary action by ensuring complete and adequate sample collection during the initial sampling phase. The balloon isolation and agitation process maximizes viral particle recovery in the collection liquid, providing a sufficient viral load that reduces or eliminates the need for time-consuming PCR amplification steps, thereby shortening the overall detection time while maintaining precision.

Inventive Principle:
Principle #10Preliminary action

3Reliability

If sample collection is performed during initial stages of infection or low viral loads, then early detection is achieved, but false-negative results increase due to inadequate virus collection

Engineering Contradiction:
Improveearly detection reliabilityVSAvoidviral load in sample
Core Design Contradiction:
ReliabilityVSQuantity of substance

Solution Approach 1:

The balloon is inflated before sample collection to pre-isolate the respiratory tract segment, preventing viral particle loss. This preliminary isolation ensures that even when viral loads are low during early infection stages, all available viral particles are captured in the collection liquid, maintaining reliable detection without requiring high viral quantities.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The agitation process continuously mixes the collection liquid to ensure complete contact between the swab and all viral particles present. This continuous mixing action maximizes viral particle recovery efficiency, ensuring that even trace amounts of virus during early infection are thoroughly collected and detected, preventing false-negative results.

Inventive Principle:
Principle #20Continuity of useful action

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 provides fast, reliable, and error-free sample collection, reducing false-negative results and viral load, thereby preventing disease spread and alleviating healthcare system burden.

Implementation Method 1

distal and proximal balloon assemblies with a double lumen catheter and agitator for inflating and aspirating collection liquid

Methodology Applied
Scientific EffectPressure: Pressure Increase

Implementation Method 2

agitator for inflating and aspirating collection liquid, agitating the liquid

Methodology Applied
Scientific EffectMechanical agitation: Stirring

Implementation Method 3

double lumen catheter and agitator for inflating and aspirating collection liquid

Methodology Applied
Scientific EffectSuction: Suction

Data Source

PatentEP4277539B1A device for collection and scavenging of biological samples, and drug delivery for hollow organs
Publication Date: 2025.12.24 THEKKEDATH RAMACHANDRAN
  • EP4277539B1 patent drawingFigure 1
  • EP4277539B1 patent drawingFigure 1A
  • EP4277539B1 patent drawingFigure 2

AI summary

The present invention discloses a device for the collection and scavenging of biological samples, and drug delivery for upper and lower respiratory tracts and hollow organs. The device comprises a distal balloon assembly (101) comprising distal carrier disc (101a) and a distal balloon (102), a proximal balloon catheter assembly (103) comprising proximal carrier disc (103a) and a proximal balloon (104), an inflation tube (108), a double lumen catheter (105) with an outer tube (105a) and an inner tube (105b), an agitator (106) working by methods such as ultrasonication, vibration, rotation, to-and-fro movements, pulsations etc, a flexible rod (107) to mount the agitator (106). Thus, the invention provides the device or a catheter with balloons to isolate pathogens or viruses from nasal cavity, nasopharynx, or relevant segment of hollow organs, with or without the use of water or similar liquids.