Infant Epinephrine Injector with 7-8 mm Needle

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Solution Overview

Problem

Current auto-injectors for epinephrine delivery are inadequate for infants and children weighing less than 15 kg, as they lack accuracy and may result in improper dosing or delivery location due to anatomical differences, leading to potential overdosing or intraosseous/subcutaneous delivery complications.

Innovation Solution

A medicament delivery device with a needle extending 7-8 mm from the skin surface, designed specifically for infants and children, featuring a housing with an energy storage member to expel the epinephrine dose accurately, ensuring intramuscular delivery while minimizing the risk of intraosseous or subcutaneous injection.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Adaptability or versatility

If a pediatric-use auto-injector with exposed needle length of 12.7 mm to 16 mm is used for children weighing less than 15 kg, then the device can be physically used on smaller patients, but the needle may be too long causing intraosseous delivery or too short causing subcutaneous delivery

Engineering Contradiction:
Improvedevice adaptability to smaller patientsVSAvoiddelivery location precision
Core Design Contradiction:
Adaptability or versatilityVSManufacturing precision

Solution Approach 1:

The patent applies local quality by designing a needle specifically tailored for the infant population with an exposed length of 7-8 mm, which is substantially shorter than pediatric needles (12.7-16 mm). This localized adaptation ensures the needle reaches the intramuscular space in infants with skin-to-muscle distances of 5-7 mm without penetrating into the bone, thereby achieving both adaptability to smaller patients and precision in delivery location.

Inventive Principle:
Principle #3Local quality

2Quantity of substance

If an auto-injector with volumetric tolerance of ±15 percent is used for patients weighing less than 15 kg, then the device can deliver the required dose, but the dose accuracy is insufficient for this weight range

Engineering Contradiction:
Improvedose delivery capabilityVSAvoiddose accuracy
Core Design Contradiction:
Quantity of substanceVSMeasurement precision

Solution Approach 1:

The patent applies parameter changes by reducing the volumetric tolerance from the standard ±15 percent to ±5 percent for infants weighing less than 15 kg. This parameter modification ensures that the dose delivered (0.05-0.15 mL) is sufficiently accurate for this weight range, preventing both underdosing and overdosing while maintaining the capability to deliver the required epinephrine quantity.

Inventive Principle:
Principle #35Parameter changes

3Reliability

If a needle with longer exposed length is used to ensure intramuscular delivery in larger patients, then intramuscular delivery is achieved for patients weighing more than 15 kg, but the needle extends too far for infants causing potential intraosseous delivery

Engineering Contradiction:
Improveintramuscular delivery reliabilityVSAvoidintraosseous delivery risk
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent applies segmentation by dividing the patient population into distinct weight-based categories (infants <15 kg and children ≥15 kg) and providing different needle lengths for each segment. Infants receive needles with 7-8 mm exposed length while children receive needles with 12.7-16 mm exposed length. This segmentation ensures that each group receives the appropriate needle length to achieve reliable intramuscular delivery without the harmful effect of intraosseous injection.

Inventive Principle:
Principle #1Segmentation

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 device provides precise and safe epinephrine delivery to infants and children, ensuring accurate dosing and reducing the risk of complications associated with anatomical differences, thereby effectively addressing the limitations of existing auto-injectors for this weight range.

Implementation Method 1

an energy storage member to move the needle from a first needle position to a second needle position

Methodology Applied
Scientific EffectElastic potential energy: Spring

Implementation Method 2

A portion of the force is exerted to expel the dose of epinephrine from the medicament container when the needle is in the second position

Methodology Applied
Scientific EffectElastic potential energy conversion to kinetic energy: Spring

Data Source

PatentEP3558420B1Medicament delivery device and methods for delivering drugs to infants and children
Publication Date: 2024.09.18 KALEO INC
  • EP3558420B1 patent drawingFigure 1~2
  • EP3558420B1 patent drawingFigure 3~4
  • EP3558420B1 patent drawingFigure 5~7

AI summary

A method of delivering epinephrine includes placing a distal end surface of a medical injector into contact with a target location of a patient. The medical injector includes a housing, an energy storage member, and a medicament container containing a dose of epinephrine effective for administration to the patient experiencing anaphylaxis and having a weight of less than 15 kg. The medicament container is coupled to a needle. The medical injector is actuated such that the energy storage member produces a force to move the needle from a first needle position to a second needle position. A distal tip of the needle extends from the distal end surface by a distance of between 7 millimeters and 8 millimeters when the needle is in the second needle position. A portion of the force is exerted to expel the dose of epinephrine when the needle is in the second position.