Infusion Set Inserter Assembly With Spring-Driven Cannula Placement

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Solution Overview

Problem

Existing wearable drug delivery devices for parenteral administration face challenges such as malfunction, size, weight, and cost, and often require frequent relocation due to skin adherence issues.

Innovation Solution

An inserter assembly with a casing, sharp holder, bias member, and trigger mechanism that propels an insertion sharp through the skin, coupled with an infusion set base and adhesive, allows for controlled and automatic drug delivery by actuating the trigger upon skin adhesion and displacement.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Extent of automation

If wearable devices are designed for controlled release of therapeutics, then automatic drug delivery is achieved, but device size, weight, and cost increase

Engineering Contradiction:

Improveautomatic drug deliveryVSAvoiddevice weight

Core Design Contradiction:

Extent of automationVSWeight of moving object

Solution Approach 1:

The device is divided into separate components: a reusable inserter assembly that performs the insertion function and a disposable infusion set that contains the medication reservoir and delivery mechanism. This segmentation allows the heavy electronic control components to be minimized in the reusable portion while the disposable portion can be lightweight and simple.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The infusion set is designed as a disposable component that is discarded after use, eliminating the need for expensive, heavy materials and complex cleaning/maintenance systems. The reservoir, tubing, and insertion components are made as a single-use unit that reduces overall device weight and cost.

Inventive Principle:

Principle #27Cheap short-living objects (Disposable)

2Duration of action of stationary object

If adhesive is used to attach the infusion set base to the skin, then frequent relocation is reduced, but skin adherence issues occur

Engineering Contradiction:

Improveattachment durationVSAvoidskin adherence issues

Core Design Contradiction:

Duration of action of stationary objectVSObject-affected harmful factors

Solution Approach 1:

An adhesive layer is introduced as an intermediary between the infusion set base and the skin. This adhesive mediator provides secure attachment without requiring direct bonding between the device and skin, reducing irritation and adherence issues while maintaining long-term attachment durability.

Inventive Principle:

Principle #24Intermediary (Mediator)

3Productivity

If a needle or stylet is used for parenteral delivery, then effective drug delivery is achieved, but malfunction rate increases

Engineering Contradiction:

Improvedrug delivery effectivenessVSAvoidmalfunction rate

Core Design Contradiction:

ProductivityVSReliability

Solution Approach 1:

A bias member (spring) is pre-loaded in the inserter assembly to provide cushioning and controlled force during the insertion process. This pre-loaded mechanical system ensures reliable needle delivery through the skin without requiring complex electronic actuators, reducing malfunction risk while maintaining effective drug delivery.

Inventive Principle:

Principle #11Beforehand cushioning (Prior cushioning)

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 reliable, compact, and cost-effective automatic drug delivery systems that minimize skin adherence issues and enhance user convenience by reducing manual intervention.

Implementation Method 1

a bias member within the cavity. The bias member may be positioned between the sharp holder and a wall of the cavity. The inserter assembly may further comprise a trigger having a first state in which the bias member is maintained in an energy storing state and a second state in which the bias member is released from the energy storing state. The bias member may be configured to propel the sharp holder to displace the insertion sharp out of the casing when released from the energy storing state

Methodology Applied

Scientific EffectElastic potential energy storage and release: Spring

Implementation Method 2

The inserter assembly may further comprise an infusion set base in retaining engagement with the body. The infusion set base may have an adhesive included on a bottom face thereof

Methodology Applied

Scientific EffectAdhesion: Adhesive

Data Source

PatentUS20250325746A1Infusion Set and Inserter Assembly Systems and Methods

Publication Date: 2025.10.23 DEKA PRODUCTS LP

AI summary

An inserter assembly comprising a first unit including a skin contacting face which surrounds an opening and a second unit housed within the first unit. The second unit comprises an infusion set base disposed within the opening and having a bottom face which is substantially level with the skin contacting face and covered at least partially with adhesive and further comprising a spring biased insertion assembly. The second unit further comprising a cannula sub assembly carried by an insertion sharp of the insertion assembly. The spring biased insertion assembly and a cannula of the cannula sub assembly are driven into skin and the cannula sub assembly is coupled into the infusion set base by an insertion spring which is released from an energy storing state after the skin has been tugged upward beyond a certain distance by the adhesive as the inserter assembly is withdrawn from the body.