Pressurized gNO Delivery System for Wound Bioburden Reduction

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Solution Overview

Problem

Current treatments for skin and soft tissue infections (SSTIs) and osteomyelitis are inadequate in effectively reducing bioburden and promoting wound healing due to uncertainties in the timing, concentration, pressurization, and site of Nitric Oxide (NO) administration.

Innovation Solution

A gaseous Nitrous Oxide (gNO) delivery system that includes a source of gNO functionally coupled to a subject interface unit, with a gas flow regulator and pressure regulator, delivering gNO at specific parameters (0.15 ATM to 1.0 ATM, 0.1 liters/minute to 1.0 liters/minute, and 1.0% concentration) for 30 minutes to 120 minutes, equipped with sensors and a flushing mechanism to ensure continuous and controlled exposure.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If Nitric Oxide is administered to reduce bioburden and promote wound healing, then pathogenic organisms are reduced and tissue repair is accelerated, but the timing, concentration, pressurization, and site of administration are poorly understood and difficult to control

Engineering Contradiction:
Improveeffectiveness of NO administrationVSAvoidcontrol of administration parameters
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The patent applies parameter changes by systematically varying and optimizing multiple administration parameters including concentration (1-100% NO in gas mixture), pressure (0.1-2.0 ATM gauge pressure), flow rate (0.01-10.0 liters/minute), and duration (1-180 minutes) to achieve reliable therapeutic effects while maintaining control over the complex delivery process

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The delivery system integrates multiple functions into a single device including gas mixture preparation, pressure regulation, flow control, timing management, and wound site delivery, thereby reducing the complexity of coordinating multiple separate administration components

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

2Object-affected harmful factors

If gaseous Nitric Oxide is delivered at high concentration and pressure to effectively reduce infection, then pathogenic organisms are significantly reduced, but cell viability may be compromised

Engineering Contradiction:
Improvepathogenic organism reductionVSAvoidcell damage
Core Design Contradiction:
Object-affected harmful factorsVSObject-generated harmful factors

Solution Approach 1:

The system dynamically adjusts administration parameters based on treatment phase and wound characteristics, using higher concentrations (10-100%) and pressures (0.5-2.0 ATM) during early debridement phases to maximize pathogen reduction, then transitioning to lower parameters during later healing phases to protect viable cells and promote tissue regeneration

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The treatment protocol employs periodic cycles of high-concentration NO delivery followed by lower-concentration phases, with treatment durations ranging from 1 to 180 minutes in staged intervals, allowing sufficient time for pathogen elimination while providing recovery periods that protect host cell viability

Inventive Principle:
Principle #19Periodic action

3Reliability

If Nitric Oxide is administered for extended periods to ensure complete bioburden reduction, then infection is thoroughly treated, but treatment time and resource consumption increase

Engineering Contradiction:
Improvecompleteness of infection treatmentVSAvoidtreatment duration
Core Design Contradiction:
ReliabilityVSLoss of time

Solution Approach 1:

The system incorporates feedback mechanisms including visual indicators (LED lights) that monitor and communicate treatment phase status, automated timing controls that manage delivery intervals, and pressure/flow sensors that verify proper administration, enabling clinicians to confidently terminate treatment at optimal points without excessive duration while ensuring complete bioburden reduction

Inventive Principle:
Principle #23Feedback

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 reduces bioburden and promotes wound healing by delivering gNO under therapeutic parameters, significantly reducing pathogenic organisms and accelerating tissue repair without compromising cell viability.

Implementation Method 1

delivering pressurized gNO to a subject

Methodology Applied
Scientific EffectGas pressurization: Pressurisation

Data Source

PatentUS10391266B2Nitric oxide delivery system and methods of use
Publication Date: 2019.08.27 HANSEN PHARMACEUTICAL LLC
  • US10391266B2 patent drawing
  • US10391266B2 patent drawing
  • US10391266B2 patent drawing

AI summary

Embodiments of the present disclosure provide systems and devices for delivering gaseous Nitrous Oxide (gNO) under therapeutic parameters to reduce infection in a subject. Certain embodiments include devices and systems for delivering pressurized gNO to reduce bioburden and promote healing in the wounds of subjects having various disease conditions, including skin and soft tissue infections (SSTIs) and osteomyelitis. In some embodiments, the present disclosure provides portable wound healing devices for delivering pressurized gNO to the site of a wound to treat various disease conditions in a subject.