Ballistic Microneedle Infusion Set with Shock-Isolating Hub

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Solution Overview

Problem

Current insulin infusion sets face challenges in delivering medication to the upper 3 mm of skin surface, the intradermal space, due to difficulties in needle insertion and maintenance, skin tenting, and lack of shock isolation, which affects drug absorption and user comfort.

Innovation Solution

An infusion set with a disposable ballistic inserter that inserts a needle at a controlled high speed, secured by a skin-securing adhesive layer, and an inner and outer hub that isolates the needle from external forces, allowing precise delivery to the intradermal space while minimizing skin tenting and maintaining needle position.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If a needle is inserted to deliver insulin to the upper 3 mm of skin surface (intradermal space), then drug absorption is improved, but needle insertion difficulty and maintenance difficulty increase

Engineering Contradiction:
Improvedrug absorptionVSAvoidneedle insertion and maintenance
Core Design Contradiction:
ReliabilityVSEase of operation

Solution Approach 1:

The adhesive layer is applied to the skin surface before needle insertion to pre-secure the insertion site. This preliminary action prevents skin movement during and after insertion, making it easier to maintain the needle at the precise intradermal depth of 1-3 mm without requiring complex insertion techniques or follow-up adjustments.

Inventive Principle:
Principle #10Preliminary action

2Manufacturing precision

If a needle is inserted at high speed to reduce skin tenting, then insertion precision is improved, but device complexity increases

Engineering Contradiction:
Improveinsertion precisionVSAvoidinserter mechanism
Core Design Contradiction:
Manufacturing precisionVSDevice complexity

Solution Approach 1:

A disposable ballistic inserter is used to achieve high-speed needle insertion without requiring complex reusable mechanisms. The inserter is a simple, single-use device that propels the needle at high speed to minimize skin tenting, then is discarded. This approach achieves precise insertion without the complexity of adjustable, reusable insertion devices.

Inventive Principle:
Principle #27Cheap short-living objects (Disposable)

3Stability of the object's composition

If the needle is isolated from external forces through hub structure, then needle position stability is improved, but device complexity increases

Engineering Contradiction:
Improveneedle position stabilityVSAvoidhub structure
Core Design Contradiction:
Stability of the object's compositionVSDevice complexity

Solution Approach 1:

The hub is divided into an inner hub and an outer hub, creating a nested structure that isolates the needle. The inner hub holds the needle while the outer hub provides protection and shock isolation. This segmented design stabilizes the needle position against external forces while maintaining a relatively simple overall structure through the natural nesting of components.

Inventive Principle:
Principle #1Segmentation

4Stability of the object's composition

If adhesive is used to secure the infusion set to skin, then infusion set stability is improved, but skin irritation risk increases

Engineering Contradiction:
Improveinfusion set stabilityVSAvoidskin irritation
Core Design Contradiction:
Stability of the object's compositionVSObject-affected harmful factors

Solution Approach 1:

The adhesive is applied only to the outer hub of the infusion set, which contacts the skin surface, while the inner hub and needle remain adhesive-free. This localized application of adhesive provides stable attachment to the skin without exposing the needle or internal components to adhesive materials, reducing the risk of skin irritation while maintaining infusion set stability.

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

Enables effective delivery of insulin to the intradermal space, reducing skin tenting and maintaining needle position, thereby enhancing drug absorption and user comfort by ensuring precise and stable needle insertion and isolation from external forces.

Implementation Method 1

The outer hub may have a surrounding member that may have an outer skin adhesive, and the inner hub may have an inner skin adhesive.

Methodology Applied
Scientific EffectAdhesive: Adhesive

Implementation Method 2

a disposable ballistic inserter that inserts a needle at a controlled high rate of speed to substantially reduce tenting of the skin surface and insert the needle at a depth to deliver insulin or other medicament to the upper 3 mm of skin surface

Methodology Applied
Scientific EffectBallistic motion:

Implementation Method 3

The infusion set is still further provided with an inner and outer hub that may isolate an inserted needle from external forces such that the needle may be maintained at a depth to deliver content to the upper 3 mm of skin surface, the intradermal space, during normal use.

Methodology Applied
Scientific EffectShock isolation:

Data Source

PatentEP3391921B1Ballistic microneedle infusion device
Publication Date: 2024.08.21 BECTON DICKINSON & CO
  • EP3391921B1 patent drawingFigure 1
  • EP3391921B1 patent drawingFigure 2
  • EP3391921B1 patent drawingFigure 3A

AI summary

An infusion set has a disposable inserter that can insert a needle at a controlled rate of speed to a depth to deliver insulin or other medicament to the upper 3 mm of skin surface, and a skin securing, adhesive layer to secure the skin surface at the insertion site such that the inserter that can insert a needle without a risk of tenting of the skin surface. Position of the inserted needle can be maintained by providing a separated inner and outer hub of the infusion set that can isolate the inserted needle from external forces such that the needle can be maintained at a depth to deliver insulin or other medicament to the upper 3 mm of skin surface during normal use.