Pulsatile Nitric Oxide Delivery Synchronized With Breath Patterns

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Solution Overview

Problem

Current methods for administering nitric oxide (NO) in therapeutic settings often result in toxic byproducts like nitrogen dioxide (NO2) and fail to deliver NO in a precise, controlled manner, leading to suboptimal therapeutic effects and potential side effects.

Innovation Solution

A programmable device that detects breath patterns to deliver NO in a pulsatile manner, primarily within the first two-thirds of inspiratory time, using a breath sensitivity control and algorithms to calculate the optimal timing and volume of NO administration, minimizing NO2 formation and maximizing therapeutic efficacy.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If nitric oxide is administered continuously or in non-pulsatile manner, then therapeutic effect is maintained, but nitrogen dioxide formation increases and toxicity risk rises

Engineering Contradiction:
Improvetherapeutic effectVSAvoidnitrogen dioxide formation
Core Design Contradiction:
ReliabilityVSObject-generated harmful factors

Solution Approach 1:

The patent applies periodic action by delivering nitric oxide in pulsatile bursts synchronized with the patient's breath pattern rather than continuous administration. The device detects breaths and delivers NO pulses during inspiratory phases, creating a periodic delivery pattern that maintains therapeutic effect while reducing overall NO exposure and consequently NO2 formation.

Inventive Principle:
Principle #19Periodic action

Solution Approach 2:

The device performs preliminary action by detecting the breath pattern in advance and preparing to deliver NO pulses at the optimal timing. The breath detection algorithm identifies inspiratory events beforehand, allowing the system to synchronize NO delivery with the patient's breathing cycle and deliver pulses at the most effective moment.

Inventive Principle:
Principle #10Preliminary action

2Object-generated harmful factors

If nitric oxide delivery is precisely controlled to minimize toxicity, then nitrogen dioxide formation is reduced, but therapeutic efficacy may be compromised

Engineering Contradiction:
Improvenitrogen dioxide exposureVSAvoidtherapeutic efficacy
Core Design Contradiction:
Object-generated harmful factorsVSReliability

Solution Approach 1:

The patent applies local quality by concentrating the NO delivery into specific temporal regions (during inspiratory breaths) rather than uniform continuous delivery. This localized timing ensures that NO is delivered when it can be most effectively inhaled and distributed to target lung areas, maximizing therapeutic effect per unit of NO administered and thereby reducing total NO required and associated NO2 formation.

Inventive Principle:
Principle #3Local quality

Solution Approach 2:

The device changes parameters by adjusting the timing, duration, and frequency of NO pulses based on detected breath patterns. The system dynamically modifies delivery parameters to synchronize with patient physiology, optimizing the balance between therapeutic effect and toxicity reduction by delivering precise amounts at optimal moments.

Inventive Principle:
Principle #35Parameter changes

3Manufacturing precision

If nitric oxide is delivered in pulsatile manner synchronized with breath pattern, then precision and therapeutic efficiency are improved, but device complexity increases

Engineering Contradiction:
Improvedosing precisionVSAvoidbreath detection and control system
Core Design Contradiction:
Manufacturing precisionVSDevice complexity

Solution Approach 1:

The device applies self-service by using the patient's own breath pattern to control the timing of NO delivery. The breath detection system automatically identifies inspiratory events and triggers pulses without requiring external intervention or complex programming. The system serves itself by using physiological signals inherently present in the patient to guide therapeutic delivery.

Inventive Principle:
Principle #25Self-service

Solution Approach 2:

The patent implements feedback by continuously monitoring the patient's breath pattern and using this information to adjust NO delivery timing. The breath detection algorithm provides real-time feedback about respiratory phase, allowing the control system to synchronize pulses with inspiration and optimize therapeutic effect while maintaining simple operation.

Inventive Principle:
Principle #23Feedback

Data Source

PatentUS20210220586A1Method and apparatus for pulsatile delivery of nitric oxide
Publication Date: 2021.07.22 MALLINCKRODT PHARMACEUTICALS IRELAND LTD
  • US20210220586A1 patent drawing
  • US20210220586A1 patent drawing
  • US20210220586A1 patent drawing

AI summary

Described are methods for providing a pulsed dose of nitric oxide during at least the first two-thirds of total inspiratory time in each single breath for a therapeutically relevant period of time.