Angled Needle Infusion Set for Intradermal Delivery

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Solution Overview

Problem

Current insulin infusion sets face challenges in delivering insulin to the upper 3 mm of the skin surface, the intradermal space, due to difficulties in maintaining needle insertion depth and stability, and are prone to user error and skin tenting, which affects drug absorption and comfort.

Innovation Solution

An infusion set with an adhesive secured main hub, slidable top cover, and angled needle that mimics the Mantoux technique, using flexible arms to secure and stretch the skin, and a tortuous path adhesive segment to isolate the needle from external forces, allowing precise intradermal needle insertion and maintaining the needle in place.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If a needle is inserted into the upper 3 mm of skin surface (intradermal space), then drug absorption is improved, but needle insertion depth control and stability deteriorate

Engineering Contradiction:
Improvedrug absorptionVSAvoidneedle insertion depth control
Core Design Contradiction:
ReliabilityVSManufacturing precision

Solution Approach 1:

The skin is stretched and secured to the hub before needle insertion, preparing the insertion site in advance to ensure precise depth control and prevent needle displacement during infusion

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

A needle hub is introduced as an intermediary component between the needle and the skin, providing a stable base that facilitates precise intradermal needle placement and maintains needle position during the infusion process

Inventive Principle:
Principle #24Intermediary (Mediator)

2Manufacturing precision

If the Mantoux technique is used for intradermal injection, then needle insertion angle is improved, but user variability and error increase

Engineering Contradiction:
Improveneedle insertion angleVSAvoiduser variability
Core Design Contradiction:
Manufacturing precisionVSReliability

Solution Approach 1:

The device performs the needle insertion function automatically through a spring-loaded mechanism, eliminating the need for manual needle insertion by the user and thereby reducing user variability and error

Inventive Principle:
Principle #25Self-service

Solution Approach 2:

The manual mechanical action of needle insertion by the user is replaced with an automatic spring-loaded mechanism that propels the needle into the skin at the correct angle, ensuring consistent and reliable insertion

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

3Reliability

If needle insertion depth is reduced to target intradermal space, then drug absorption is improved, but susceptibility to shock and external forces increases

Engineering Contradiction:
Improvedrug absorptionVSAvoidsusceptibility to shock
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The needle is pre-secured within the needle hub structure before insertion, providing protective support that cushions the shallow intradermal needle against shock and external forces during the infusion process

Inventive Principle:
Principle #11Beforehand cushioning (Prior cushioning)

4Manufacturing precision

If skin is stretched for needle insertion, then needle insertion precision is improved, but skin surface tenting occurs

Engineering Contradiction:
Improveneedle insertion precisionVSAvoidskin surface tenting
Core Design Contradiction:
Manufacturing precisionVSShape

Solution Approach 1:

The skin is stretched and secured to the hub in advance of needle insertion, preparing the insertion site to ensure precision while the pre-secured state prevents skin relaxation and tenting during the actual needle insertion

Inventive Principle:
Principle #10Preliminary action

Data Source

PatentEP3459574B1Slide-activated angled inserter for intradermal drug infusion
Publication Date: 2024.08.07 BECTON DICKINSON & CO
  • EP3459574B1 patent drawingFigure 1
  • EP3459574B1 patent drawingFigure 2
  • EP3459574B1 patent drawingFigure 3

AI summary

An infusion set has an adhesively secured main hub, and a slidable top cover, needle hub and angled or cantilevered needle that can be used for performing an intradermal needle insertion precisely targeting the upper 3 mm of skin surface, for example, one that substantially duplicates the Mantoux insertion technique, for injecting into the intradermal layers of skin, while maintaining a degree of comfort to the user. By sliding the top cover, the cantilevered needle is loaded and released or the angled needle is slid into an insertion site, while flexible arms and adhesive are used to stretch and/or flatten a skin surface, or otherwise create skin tension, at the insertion site.