Two-Stage Infusion Inserter with Rotatable Button and Spring Mechanism

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Solution Overview

Problem

Existing portable and wearable drug delivery devices for parenteral administration are cumbersome, prone to malfunction, and require frequent re-location, posing challenges in size, weight, cost, and skin adherence.

Innovation Solution

A two-stage infusion set inserter system with a rotatable button assembly, sliding component, and needle carrier mechanism that automatically inserts and retrieves a cannula, ensuring secure skin adherence and minimizing user interaction with the needle.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If a needle carrier mechanism with spring fingers is used to grip and manipulate the cannula, then the cannula can be securely held and positioned, but the device complexity increases due to additional mechanical components

Engineering Contradiction:
Improvecannula gripping reliabilityVSAvoidmechanical component complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The spring fingers automatically grip the cannula when the needle carrier is in the retracted position and release it when the needle carrier advances, without requiring external actuation. The spring mechanism self-regulates the gripping force based on the position of the needle carrier, eliminating the need for additional control components.

Inventive Principle:
Principle #25Self-service

Solution Approach 2:

The spring fingers are integrated into the needle carrier structure, with the fingers being part of the carrier assembly itself. This nesting reduces the number of separate components and simplifies the overall device architecture while maintaining the gripping function.

Inventive Principle:
Principle #7Nested doll (Nesting)

2Object-affected harmful factors

If a two-stage insertion mechanism is used to first insert the cannula and then retrieve the needle, then user safety is improved by minimizing needle exposure, but the insertion process time increases due to multiple stages

Engineering Contradiction:
Improveneedle exposure riskVSAvoidinsertion process time
Core Design Contradiction:
Object-affected harmful factorsVSLoss of time

Solution Approach 1:

The needle carrier is pre-loaded with the cannula in a ready-to-insert configuration. The spring fingers are pre-positioned to grip the cannula, and the entire assembly is prepared for immediate insertion. This preliminary preparation enables the two-stage process to occur rapidly without significant time loss.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The transition between the two stages is rapid and continuous. Once the cannula is inserted, the needle carrier immediately begins its retraction motion to withdraw the needle, minimizing the time the needle remains exposed. The spring mechanism provides continuous motion control to rush through the transition phase.

Inventive Principle:
Principle #21Skipping (Rushing through)

3Force

If the needle carrier is forced downward by a sliding component spring during insertion, then the insertion force is sufficient to penetrate skin, but the device complexity increases due to the sliding component mechanism

Engineering Contradiction:
Improveinsertion forceVSAvoidsliding component complexity
Core Design Contradiction:
ForceVSDevice complexity

Solution Approach 1:

The sliding component is integrated with the needle carrier assembly, combining the force application mechanism with the cannula holding and insertion function. This merging reduces the number of separate components and simplifies the overall structure while maintaining sufficient insertion force.

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The sliding component spring automatically provides the necessary insertion force when the needle carrier is actuated, without requiring additional force application mechanisms. The spring's elastic energy is converted directly into insertion force, eliminating the need for motors, actuators, or other complex force-generating components.

Inventive Principle:
Principle #25Self-service

4Ease of operation

If alignment indicia are provided on the rotatable button assembly and housing, then user operation is simplified through visual feedback, but the manufacturing cost increases due to additional marking processes

Engineering Contradiction:
Improvebutton assembly operationVSAvoidmanufacturing process complexity
Core Design Contradiction:
Ease of operationVSEase of manufacture

Solution Approach 1:

The alignment indicia utilize color contrast or visual differentiation to provide clear feedback to the user. By using distinct colors or visual patterns on the button assembly and housing, the alignment status is easily identifiable without requiring complex markings or additional manufacturing steps.

Inventive Principle:
Principle #32Color changes

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 system reduces pain during insertion, enhances user comfort, and provides a secure, easy-to-use mechanism for repeated use, while maintaining the cannula in place and safely disposing of the needle, thus addressing the limitations of existing devices.

Implementation Method 1

a sliding component spring

Methodology Applied
Scientific EffectSpring: Spring

Implementation Method 2

a needle spring, wherein the rotatable button assembly rotates from a locked to an unlocked position, wherein when force is applied onto the rotatable button assembly, the sliding component and needle carrier are forced downward by the sliding component spring, and wherein when the needle carrier reaches the injection position, the needle spring forces the needle carrier upward towards the second ending position

Methodology Applied
Scientific EffectSpring: Spring

Data Source

PatentUS20240299652A1Infusion set and inserter assembly
Publication Date: 2024.09.12 DEKA PRODUCTS LP
  • US20240299652A1 patent drawing
  • US20240299652A1 patent drawing
  • US20240299652A1 patent drawing

AI summary

A two-stage infusion set inserter system is disclosed. The inserter system includes an inserter assembly including a housing including a rotatable button assembly comprising ramps and and tab indents and a non-rotatable portion of housing, a sliding component comprising sliding component tabs, a needle carrier connected to an introduction needle, the needle carrier slidably movable from a starting position to an injection position and then to a second ending position, a sliding component spring, and a needle spring, wherein the rotatable button assembly rotates from a locked to an unlocked position, wherein when force is applied onto the rotatable button assembly, the sliding component and needle carrier are forced downward by the sliding component spring, and wherein when the needle carrier reaches the injection position, the needle spring forces the needle carrier upward towards the second ending position.