Active Agent Delivery Device for Mucosal Penetration

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Solution Overview

Problem

Current needle-free active agent delivery systems face challenges in overcoming the mucus barrier for transmucosal delivery, leading to low bioavailability and therapeutic efficacy due to poor absorption of large molecules like proteins and peptides.

Innovation Solution

The development of active agent delivery devices that utilize a high-pressure jet of active agent formulation to penetrate mucosal membranes, facilitated by a power reservoir and a movable separator, which propels the active agent at high velocity through the mucosal layer, enhancing absorption and bioavailability.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If conventional needle-free delivery systems are used, then the delivery method is non-invasive and simple, but the active agent absorption is poor due to the mucus barrier

Engineering Contradiction:
Improvenon-invasive deliveryVSAvoidactive agent absorption
Core Design Contradiction:
Ease of operationVSReliability

Solution Approach 1:

The patent changes the physical parameters of active agent delivery by transitioning from passive diffusion to active high-pressure jet injection. The pressure parameter is increased significantly to penetrate the mucus barrier, and the velocity parameter is enhanced to achieve transmucosal delivery, thereby resolving the contradiction between non-invasive operation and reliable absorption.

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The patent replaces the conventional passive mechanical diffusion system with an active mechanical jet injection system. By using a high-pressure jet mechanism, the system overcomes the mucus barrier that prevents effective absorption in conventional systems, while maintaining the non-invasive characteristic of needle-free delivery.

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

2Reliability

If high pressure is applied to penetrate the mucus barrier, then active agent absorption is improved, but the device complexity increases due to power reservoir and separator mechanisms

Engineering Contradiction:
Improveactive agent absorptionVSAvoiddevice structure
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The patent segments the device into distinct functional components: a power reservoir for generating pressure, a movable separator for controlling the jet release, and a delivery mechanism. This segmentation allows each component to be optimized independently while working together to achieve reliable transmucosal delivery, managing the complexity through functional modularity.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The power reservoir is pre-charged with pressurized gas or stored energy before use, and the movable separator is pre-positioned to contain the active agent. This preliminary preparation allows the device to deliver a high-pressure jet on demand without requiring complex real-time pressure generation systems, thereby reducing operational complexity while maintaining reliable absorption.

Inventive Principle:
Principle #10Preliminary action

3Speed

If the active agent is delivered at high velocity, then penetration of the mucosal layer is enhanced, but the diffusion control becomes more difficult

Engineering Contradiction:
Improveactive agent velocityVSAvoiddiffusion control
Core Design Contradiction:
SpeedVSEase of operation

Solution Approach 1:

The patent applies local quality by creating a focused high-velocity jet at the specific delivery point that penetrates the mucus barrier, while the surrounding area maintains normal diffusion conditions. The high velocity is localized to the jet core where penetration is needed, while the periphery allows for controlled diffusion into the mucosal tissue, thus managing diffusion control despite high velocity.

Inventive Principle:
Principle #3Local quality

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 devices achieve increased diffusion and absorption of active agents across the mucosal barrier, potentially delivering them systemically or to specific immune sites, improving bioavailability and therapeutic efficacy.

Implementation Method 1

a power reservoir and an active agent reservoir, separated by a movable separator. In certain embodiments, the device utilizes vaporization energy to apply a force to the movable separator, which propels the active agent formulation at a high velocity

Methodology Applied
Scientific EffectPressure gradient: Pressure Gradient

Implementation Method 2

The high-pressure delivery of the active agent formulation can provide for an increased diffusion rate across the mucosal barrier, which can maximize active agent absorption into the cells in the mucosal layer

Methodology Applied
Scientific EffectDiffusion: Diffusion

Implementation Method 3

the device utilizes vaporization energy to apply a force to the movable separator, which propels the active agent formulation at a high velocity

Methodology Applied
Scientific EffectVaporization: Evaporation

Data Source

PatentUS11865286B2Active agent delivery devices and methods of using the same
Publication Date: 2024.01.09 RGT UNIV OF CALIFORNIA
  • US11865286B2 patent drawing
  • US11865286B2 patent drawing
  • US11865286B2 patent drawing

AI summary

Provided are active agent delivery devices configured to deliver an active agent formulation into or through a mucosal layer in a subject. The active agent delivery devices include a power reservoir configured to eject the active agent formulation at a pressure sufficient to deliver the active agent formulation into or through a mucosal layer in a subject. Methods of using the subject active agent delivery devices are also provided.