Sterile Gas Flow Drape for Surgical Site Infection Prevention

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Solution Overview

Problem

Hospital-acquired infections, particularly surgical site infections (SSIs), remain a significant issue due to airborne bacteria contamination in operating rooms, with existing solutions like laminar flow operating rooms being costly and ineffective in preventing bacterial invasion during surgery.

Innovation Solution

A method and apparatus creating a 'cocoon' of essentially sterile gas around the surgical site using a unidirectional coherent non-turbulent flow field of sterile gas, which is anatomically shape-conforming and positioned adjacent to the surgical incision to prevent ambient airborne particles from entering the sterile field.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Object-affected harmful factors

If laminar flow operating rooms are used to reduce airborne bacteria contamination, then the sterile environment is improved, but the cost and complexity of the system increases significantly

Engineering Contradiction:
Improveairborne bacteria contaminationVSAvoidlaminar flow system complexity
Core Design Contradiction:
Object-affected harmful factorsVSDevice complexity

Solution Approach 1:

The patent divides the operating room into distinct zones: a sterile surgical site area protected by a drape with integrated gas delivery, and the surrounding non-sterile environment. The sterile gas flow is localized only to where it is needed (through the drape at the surgical site) rather than treating the entire room, thus reducing system complexity while maintaining protection against airborne bacteria.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

Instead of providing uniform laminar flow throughout the entire operating room, the patent applies sterile gas flow locally only at the surgical site through the drape. This localized approach reduces the overall system complexity and resource requirements while effectively protecting the critical area from airborne bacteria contamination.

Inventive Principle:
Principle #3Local quality

2Device complexity

If traditional draped surgical sites are used, then the system simplicity is maintained, but airborne bacteria can penetrate through gaps and edges of the drape

Engineering Contradiction:
Improvedrape system simplicityVSAvoidbacteria penetration through drape gaps
Core Design Contradiction:
Device complexityVSObject-affected harmful factors

Solution Approach 1:

The patent integrates a pneumatic system into the drape by incorporating gas delivery channels and outlets within the drape structure. Sterile gas flows through these channels and exits at the surgical site, creating a protective gas barrier that prevents airborne bacteria from penetrating through gaps and edges, while maintaining the overall simplicity of the drape design.

Inventive Principle:
Principle #29Pneumatics and hydraulics

Solution Approach 2:

The drape is designed to serve multiple functions simultaneously: it provides the traditional physical barrier function of a surgical drape, while also incorporating gas delivery channels to create a protective sterile gas flow barrier. This multi-functionality addresses the bacteria penetration issue without requiring a completely separate complex system.

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

3Object-affected harmful factors

If high velocity gas flow is used to create sterile barrier, then the protective effect is enhanced, but turbulence increases and draws in unfiltered air

Engineering Contradiction:
Improvesterile barrier protectionVSAvoidgas flow laminarity
Core Design Contradiction:
Object-affected harmful factorsVSStability of the object's composition

Solution Approach 1:

The patent uses the drape itself as a flexible shell that contains and directs the gas flow. The drape structure guides the gas flow in a controlled manner, ensuring it remains laminar as it travels through the channels and exits at the surgical site. This prevents turbulence and avoids drawing in unfiltered air, while still providing effective sterile barrier protection.

Inventive Principle:
Principle #30Flexible shells and thin films

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

This approach effectively reduces the presence of airborne particulates and bacteria at the surgical site, minimizing the risk of surgical site infections and is cost-effective and easily implementable, making it suitable for widespread adoption across various surgical procedures.

Implementation Method 1

generates a unidirectional coherent non-turbulent flow field of sterile gas... flowing in a direction substantially level with and attached to the patient's anatomy

Methodology Applied
Scientific EffectLaminar flow: Laminar Flow

Implementation Method 2

The flow field is attached to the patient's anatomy by a boundary layer... The Coanda effect is utilized to maintain the flow field attached to the patient's anatomy

Methodology Applied
Scientific EffectCoanda effect: Coanda Effect

Data Source

PatentUS9949881B2Method for maintaining sterile surgical instruments sterile in surgery
Publication Date: 2018.04.24 MIZUHO ORTHOPEDIC SYST INC D B A MIZUHO OSI
  • US9949881B2 patent drawing
  • US9949881B2 patent drawing
  • US9949881B2 patent drawing

AI summary

A method of maintaining sterile surgical instruments sterile. The instruments are placed on a tray located on an upper surface of a sterile gas flow conditioning emitter affixed onto an anatomical surface of a patient adjacent a site of incision. The emitter has upper and lower gas vents from its interior, the upper vent facing and opening across the tray for passing sterile gas across the tray to maintain a sterile field on the tray for the instrument.