Frozen Stem Cell Aerosol Delivery for Lung Viability

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Solution Overview

Problem

Current methods for delivering stem cells to the lungs face challenges such as invasive surgery, limited delivery to deep lung regions, and high cell viability loss due to physical stresses and hypoxia, with existing inhalation methods not effectively preserving stem cell viability during delivery.

Innovation Solution

The development of frozen stem cell compositions that undergo a phase change from liquid to solid, allowing for targeted delivery to the lungs while maintaining viability, using low-energy micronization to achieve optimal particle size for deep lung deposition and protection from premature thawing.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Adaptability or versatility

If stem cells are delivered via intravenous route, then systemic distribution is achieved, but cell viability is reduced due to pulmonary emboli and physical stresses

Engineering Contradiction:

Improvedelivery route flexibilityVSAvoidcell viability

Core Design Contradiction:

Adaptability or versatilityVSReliability

Solution Approach 1:

The patent introduces a specialized aerosol delivery system that acts as an intermediary between the stem cells and the patient's respiratory system. This system includes a nebulizer device that generates controlled aerosol clouds containing the stem cells, allowing them to be transported through the airway without direct contact with harsh environments that cause cell death in intravenous delivery.

Inventive Principle:

Principle #24Intermediary (Mediator)

Solution Approach 2:

The patent utilizes phase transition by delivering stem cells in aerosol form (liquid/gas phase) rather than in suspension. The aerosolized stem cells can be inhaled and deposited directly into lung tissue, bypassing the circulatory system's harmful effects while maintaining cell viability through the gentle phase transition from liquid suspension to aerosol droplets.

Inventive Principle:

Principle #36Phase transitions

2Ease of manufacture

If stem cells are delivered via direct instillation into trachea, then local delivery is achieved, but delivery to deep lung regions is limited

Engineering Contradiction:

Improvedelivery simplicityVSAvoiddelivery coverage area

Core Design Contradiction:

Ease of manufactureVSArea of stationary object

Solution Approach 1:

The patent employs pneumatic principles by using a nebulizer device that generates aerosol clouds through pressurized gas flow. This aerosolized form allows the stem cells to be carried by respiratory currents deep into the lung parenchyma, reaching alveolar regions that are inaccessible through direct tracheal instillation, thereby expanding delivery coverage while maintaining procedural simplicity.

Inventive Principle:

Principle #29Pneumatics and hydraulics

3Productivity

If stem cells are exposed to physical stresses and hypoxia, then in vivo distribution occurs, but cell viability is reduced by approximately 90%

Engineering Contradiction:

Improvecell distribution efficiencyVSAvoidcell viability

Core Design Contradiction:

ProductivityVSReliability

Solution Approach 1:

The patent applies preliminary action by preparing stem cells in a cryopreserved state before delivery. The cells are frozen and stored under controlled conditions, then thawed and aerosolized immediately before administration. This preliminary cryopreservation protects cells from the harsh in vivo environment during storage and transport, ensuring high viability upon delivery to the target site.

Inventive Principle:

Principle #10Preliminary action

Solution Approach 2:

The patent creates an inert protective environment by suspending stem cells in a specialized aerosol matrix that shields them from physical stresses and hypoxia during delivery. The aerosol droplets provide a protected microenvironment that maintains cell viability while allowing efficient distribution to lung tissue, dramatically reducing cell death compared to direct intravenous injection.

Inventive Principle:

Principle #39Inert atmosphere (Inert environment)

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 enhances stem cell viability and targeted delivery, maximizing therapeutic potential by protecting cells until they reach their intended target, improving treatment effectiveness for lung conditions like acute lung injury and COPD.

Implementation Method 1

frozen stem cell compositions that undergo a phase change from liquid to solid

Methodology Applied

Scientific EffectPhase change: Phase Change

Implementation Method 2

using low-energy micronization to achieve optimal particle size for deep lung deposition

Methodology Applied

Scientific EffectMicronization: Abrasion

Data Source

PatentUS11389400B2Aerosilization of stem cells or stem cell derivatives for pulmonary delivery

Publication Date: 2022.07.19 UNITED STATES OF AMERICA THE AS REPRESENTED BY THE SEC OF THE ARMY

AI summary

A treatment system delivers a breathing gas and frozen stem cells or other biologic particles (FBP) to a bronchus of a lung of a patient in order to treat lung and other conditions. The breathing gas and the FBP are usually delivered through separate lumens. The FBP may be delivered concurrently with other frozen particles, such as frozen saline particles (FSP). The FBP/FSP will remain frozen at all times from preparation to delivery, and will thaw only after they are released into the lung.