Solid Dose Injection Device with Retractable Blade

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Solution Overview

Problem

Existing needle-free solid drug injection systems face challenges in ensuring robust formulations can penetrate varying skin locations and types, requiring high velocity and mechanical strength, which complicates development and manufacturing, and aim to reduce pain and fear associated with needle use.

Innovation Solution

A solid dose injection device with a casing, actuation mechanism, blade, and means to push the blade and drug formulation, where a shallow cut in the skin is made to ease penetration, allowing the drug to be pushed into the body beyond the blade's depth, using a reusable actuation device and disposable cassette assembly with automatic blade retraction.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Speed

If solid drug formulations are propelled at high velocity to penetrate the skin without a needle, then skin penetration is achieved, but the formulation must be sufficiently robust which complicates development and manufacturing

Engineering Contradiction:
Improvevelocity of solid drug formulationVSAvoidformulation development and manufacturing complexity
Core Design Contradiction:
SpeedVSDevice complexity

Solution Approach 1:

The blade performs preliminary action by cutting through the stratum corneum (outer layer of skin) before the solid drug formulation is propelled into the tissue. This pre-cutting reduces the barrier the drug must overcome, allowing lower propulsion velocities and less robust formulations while still achieving effective skin penetration.

Inventive Principle:
Principle #10Preliminary action

2Force

If a blade is used to cut the skin before drug delivery, then penetration force is reduced, but the device complexity increases with additional components

Engineering Contradiction:
Improveforce required for skin penetrationVSAvoiddevice structure complexity
Core Design Contradiction:
ForceVSDevice complexity

Solution Approach 1:

The blade and solid drug formulation are combined into a single integrated propellant assembly. Both the blade and drug are propelled together through the skin in one action, eliminating the need for separate mechanisms for cutting and drug delivery, thus reducing overall device complexity while maintaining the benefit of reduced penetration force.

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The propellant mechanism serves multiple functions: it propels the blade to cut the skin, propels the solid drug formulation into the tissue, and can be designed to retract both components after delivery. This multi-functionality reduces the need for separate dedicated mechanisms for each function.

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

3Quantity of substance

If the solid drug formulation is pushed beyond the blade depth, then complete drug delivery is achieved, but the device must ensure precise depth control

Engineering Contradiction:
Improveamount of drug deliveredVSAvoidpenetration depth control precision
Core Design Contradiction:
Quantity of substanceVSManufacturing precision

Solution Approach 1:

The device incorporates a stop mechanism that creates a localized depth limit for blade insertion, while the solid drug formulation continues beyond this point. The stop provides a defined reference point that ensures consistent blade depth across different users and applications, while the drug delivery extends beyond this controlled point to ensure complete dosage delivery.

Inventive Principle:
Principle #3Local quality

Data Source

PatentEP2665431B1Drug delivery technology
Publication Date: 2023.06.07 AVAXZIPEN LTD
  • EP2665431B1 patent drawingFigure 1a~1b
  • EP2665431B1 patent drawingFigure 1c~1d
  • EP2665431B1 patent drawingFigure 2a~2b

AI summary

The present invention relates to novel drug delivery technology in the form of solid dose injection devices and methods which utilise a blade that is pushed into the skin to a predetermined depth before the before a solid drug formulation is pushed into the cut made by the blade. Thus the present invention also relates to delivering a therapeutic compound to a human or animal in the form of a solid dose injection comprising: providing an injection device comprising a casing; an actuation mechanism capable of generating a force, a blade, a solid drug formulation; and a means for pushing said solid drug formulation; wherein the blade is inserted to a predetermined depth in the skin and, following insertion of the blade, the device is actuated such that the actuation mechanism capable of generating a force acts on the means for pushing to push the solid drug formulation out of the casing and into the human or animal body.