Injection Needle Assembly with Optimized Projection Length

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Solution Overview

Problem

The challenge lies in accurately injecting a small amount of vaccine into the epidermal layer or dermal layer near the epidermis, as the depth of the dermal layer can vary significantly with age, gender, and medical history, leading to difficulties in determining the optimal needle length, resulting in either vaccine leakage or inadequate immunocompetence due to injection into subcutaneous tissue with fewer dendritic cells.

Innovation Solution

A needle assembly with a needle having an outer diameter of 0.15 mm to 0.20 mm, a projection length of 0.50 mm to 1.25 mm, and a cutting face length of 0.30 mm to 0.75 mm, designed to securely inject a small amount of vaccine into the dermal layer near the epidermal layer, minimizing leakage and ensuring sufficient immunocompetence, even in individuals with thin skin such as infants and steroid-dosed patients.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Strength

If a needle with larger diameter is used for injection, then the needle strength and manufacturability are improved, but the injection precision into the thin epidermal layer deteriorates

Engineering Contradiction:
Improveneedle strengthVSAvoidinjection precision into epidermal layer
Core Design Contradiction:
StrengthVSManufacturing precision

Solution Approach 1:

The needle outer diameter is changed to a specific small range (0.15-0.20mm) to enable precise injection into the epidermal layer while maintaining sufficient strength through optimized geometric parameters and material properties

Inventive Principle:
Principle #35Parameter changes

2Length of moving object

If the needle projection length is increased to reach the dermal layer, then the injection depth coverage is improved, but the risk of vaccine leakage into subcutaneous tissue increases

Engineering Contradiction:
Improveneedle projection lengthVSAvoidinjection accuracy into target layer
Core Design Contradiction:
Length of moving objectVSReliability

Solution Approach 1:

The needle projection length is optimized to a specific range (0.50-1.25mm) that ensures the needle tip reaches the dermal layer containing dendritic cells while preventing excessive penetration into subcutaneous tissue, thereby maintaining reliable injection accuracy

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The needle hub includes an adjustment portion that allows the needle projection length to be adjusted, enabling adaptation to different skin thicknesses and target layer depths while maintaining reliable injection

Inventive Principle:
Principle #15Dynamics

3Quantity of substance

If a large amount of vaccine is injected into the skin upper layer, then the vaccine diffusion toward immunocompetent cells is improved, but the pain during injection increases

Engineering Contradiction:
Improvevaccine amountVSAvoidinjection pain
Core Design Contradiction:
Quantity of substanceVSObject-affected harmful factors

Solution Approach 1:

The needle outer diameter is reduced to 0.15-0.20mm, which decreases the mechanical trauma and pain during injection while maintaining effective vaccine delivery to immunocompetent cells in the skin upper layer

Inventive Principle:
Principle #35Parameter changes

Data Source

PatentEP3248634B1Injection needle assembly and injector provided therewith for injecting drug solution into upper layer of skin
Publication Date: 2021.10.27 TERUMO KK
  • EP3248634B1 patent drawingFigure 1
  • EP3248634B1 patent drawingFigure 2A~2E
  • EP3248634B1 patent drawingFigure 3

AI summary

Provided is a needle assembly capable of injecting a chemical selectively into a skin upper layer, particularly a relatively shallow portion in a dermal layer near an epidermal layer to form a wheal without leakage of the chemical from a skin surface, and producing immunocompetence or the like even by an extremely small amount of the chemical. A needle assembly 10 includes: a needle 20 constituted by a needle tube that includes a needle hole 24 communicated from a needle tip 21 to a needle base end 23, and a cutting face 22 disposed at the needle tip 21; and a needle hub 30 that includes a tip 31c and a base end, and holds the needle 20 at the tip 31c. The needle hub 30 includes a needle tip side end face 31b from which the needle tip 21 projects. The needle 20 is configured such that an outer diameter ϕ1 is in a range from 0.15 mm (inclusive) to a length smaller than 0.20 mm, that a projection needle length L1 extending from the needle tip side end face 31b to the needle tip 21 ranges from 0.50 mm (inclusive) to 1.25 mm (inclusive), and that a needle body length L2 extending from the needle tip side end face 31b to the cutting face 22 ranges from 0.10 mm (inclusive) to 0.70 mm (inclusive).