High Concentration Nitric Oxide Delivery via Mini-Cylinder

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Solution Overview

Problem

Current nitric oxide delivery systems for patients with pulmonary hypertension require large cylinders due to low concentration limits, reducing portability and suitability for home use, and are associated with toxicities at high concentrations.

Innovation Solution

A method of delivering nitric oxide at concentrations greater than 2,000 ppm in an undiluted form, using a portable device with a mini-cylinder, where the dose is administered at specific dosing rates and schedules, such as every breath or intermittently, to reduce nasal irritation and toxicity risks.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Object-affected harmful factors

If low concentration nitric oxide cylinders are used, then toxicity is reduced, but cylinder volume must be large to provide sufficient quantity

Engineering Contradiction:
Improvenitric oxide toxicityVSAvoidcylinder volume
Core Design Contradiction:
Object-affected harmful factorsVSVolume of moving object

Solution Approach 1:

The patent changes the concentration parameter of nitric oxide from traditional low concentrations (e.g., 400 ppm) to high concentrations (e.g., 2,000 ppm to 68,000 ppm). This parameter change allows smaller cylinder volumes while maintaining adequate total dosage, resolving the contradiction between toxicity reduction and sufficient quantity provision.

Inventive Principle:
Principle #35Parameter changes

2Volume of moving object

If high concentration nitric oxide cylinders are used, then cylinder volume is reduced, but toxicity increases

Engineering Contradiction:
Improvecylinder volumeVSAvoidnitric oxide toxicity
Core Design Contradiction:
Volume of moving objectVSObject-affected harmful factors

Solution Approach 1:

The patent incorporates feedback mechanisms through programmable microprocessors that monitor and control the delivery of high concentration nitric oxide. The system adjusts delivery parameters based on patient response and maintains dosing within safe limits (e.g., not exceeding 200 μg/sec), allowing high concentration delivery without excessive toxicity.

Inventive Principle:
Principle #23Feedback

Solution Approach 2:

The patent employs periodic or intermittent delivery of high concentration nitric oxide rather than continuous delivery. By delivering pulses or bursts of high concentration gas at controlled intervals, the system achieves therapeutic effect while allowing periods of lower exposure, thereby reducing cumulative toxicity.

Inventive Principle:
Principle #19Periodic action

3Quantity of substance

If large cylinders are used, then sufficient nitric oxide quantity is provided, but portability is reduced

Engineering Contradiction:
Improvenitric oxide quantityVSAvoidportability
Core Design Contradiction:
Quantity of substanceVSEase of operation

Solution Approach 1:

By changing the concentration parameter to high levels (2,000-68,000 ppm), the patent reduces the physical volume of gas cylinders needed to deliver adequate total doses. This enables portable, home-use systems while maintaining sufficient nitric oxide quantity for effective treatment.

Inventive Principle:
Principle #35Parameter changes

4Productivity

If high concentration nitric oxide is delivered, then dosing efficiency is improved, but nasal irritation increases

Engineering Contradiction:
Improvedosing efficiencyVSAvoidnasal irritation
Core Design Contradiction:
ProductivityVSObject-affected harmful factors

Solution Approach 1:

The patent uses periodic delivery patterns with intermittent high concentration pulses rather than continuous delivery. This allows the nasal passages to recover between pulses, reducing irritation while maintaining overall dosing efficiency through concentrated therapeutic bursts.

Inventive Principle:
Principle #19Periodic action

Solution Approach 2:

The system dynamically adjusts delivery parameters including concentration, flow rate, and pulse timing based on real-time patient response. This dynamic control optimizes dosing efficiency while adapting to prevent or minimize nasal irritation as it develops.

Inventive Principle:
Principle #15Dynamics

Data Source

PatentUS20230256190A1Methods Of Administering High Concentrations Of Nitric Oxide
Publication Date: 2023.08.17 MALLINCKRODT PHARMACEUTICALS IRELAND LTD
  • US20230256190A1 patent drawing

AI summary

Described are methods of administering therapeutic gases comprising high concentrations of nitric oxide, particularly concentrations above 2,000 ppm. The therapeutic gas may be administered at a certain dosing rate, such as less than 166 micrograms of nitric oxide per second. Also described are methods of administering a therapeutic gas comprising nitric oxide to a patient, wherein a dose of nitric oxide is administered from a portable device that includes a delivery system and a mini-cylinder. Methods of intermittent administration of nitric oxide pulses are also described.