Sealed Package Fulcrum Pivoting for Aseptic Medical Device Handling

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Solution Overview

Problem

In healthcare settings, infections are caused by microorganism contamination due to failed aseptic technique, particularly during invasive procedures with medical devices like IV lines, and there is a need for sterile packaging that prevents accidental needlestick injuries and contamination of key parts during device removal.

Innovation Solution

A sealed package design featuring a cavity with a fulcrum and a pocket that allows the medical device to pivot forward upon opening, presenting the rear end for easy access while protecting the front end, which includes a removable backing that holds the device in an unstable position until released, and features like a catch to retain the front end, ensuring no-touch handling and minimizing contamination risks.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If the device is held in a stable position within the package, then the package structure is simpler and manufacturing is easier, but the user must actively grasp and remove the device which increases the risk of touching key parts

Engineering Contradiction:
Improveease of device removalVSAvoidrisk of contaminating key parts
Core Design Contradiction:
Ease of operationVSObject-affected harmful factors

Solution Approach 1:

The device is pre-positioned in an unstable position within the cavity, with its front end extending into the front pocket. This preliminary arrangement ensures that when the package is opened, the device automatically pivots to a stable position, presenting the rear end to the user without requiring active manipulation. This eliminates the need for the user to grasp and remove the device manually, thereby preventing contamination of key parts.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The package design enables the device to self-present upon opening. The unstable initial position and the front pocket configuration work together to cause automatic pivotal movement when the package is opened, so the device itself performs the action of presenting its rear end to the user without external intervention. This self-service mechanism reduces the risk of user error and contamination.

Inventive Principle:
Principle #25Self-service

2Ease of operation

If the device is allowed to pivot freely in the cavity, then the device can present itself automatically, but the package must accommodate the pivoting movement requiring more complex cavity design

Engineering Contradiction:
Improveautomatic device presentationVSAvoidcavity structure complexity
Core Design Contradiction:
Ease of operationVSDevice complexity

Solution Approach 1:

The cavity is designed with asymmetric features: a front pocket that extends deeper than the rest of the cavity, and a fulcrum positioned at a specific location. This asymmetric configuration creates an unstable equilibrium that allows the device to pivot naturally when the package is opened, while the fulcrum provides a defined pivot point. The asymmetry enables automatic device presentation without requiring complex mechanical mechanisms.

Inventive Principle:
Principle #4Asymmetry

Solution Approach 2:

The device is allowed to pivot in a rotational dimension within the cavity, transitioning from an unstable initial orientation to a stable final orientation. The front pocket provides the necessary spatial dimension for this pivoting motion, accommodating the device's movement from one angular position to another. This dimensional freedom enables automatic presentation while maintaining a relatively simple cavity structure.

Inventive Principle:
Principle #17Another dimension (Dimensionality change)

3Stability of the object's composition

If the centre of mass is positioned far forward of the fulcrum, then the device pivots more readily into stable position, but the device may be difficult to hold in transport and the package must be larger

Engineering Contradiction:
Improvestability of pivoted positionVSAvoidpackage volume
Core Design Contradiction:
Stability of the object's compositionVSVolume of moving object

Solution Approach 1:

The cavity has different depths in different regions: a deeper front pocket to accommodate the pivoted front end of the device, and a shallower central portion for the main body. This local variation in cavity depth allows the device to pivot into a stable position with the centre of mass forward of the fulcrum, while minimizing the overall package volume by only providing extra space where needed for the pivoting motion.

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

The design facilitates safe aseptic handling by preventing contact with critical parts and reducing needlestick injuries, ensuring the sterility of medical devices until use, while also being cost-effective and adaptable for various device sizes.

Implementation Method 1

By providing the cavity with a fulcrum, and a pocket forward of and below the fulcrum, the device naturally tends to pivot (due to the position of its centre of mass forward of the fulcrum) and such pivotal movement can be accommodated by the pocket.

Methodology Applied
Scientific EffectGravitation: Gravitation

Data Source

PatentEP3291856B1Sealed packages containing a medical device
Publication Date: 2020.01.08 CONCEPTOMED AS
  • EP3291856B1 patent drawingFigure 1~2
  • EP3291856B1 patent drawingFigure 3~4
  • EP3291856B1 patent drawingFigure 5~7

AI summary

A sealed package (2) containing a medical device (4), such as a syringe, that has a predefined centre of mass. The package (2) comprises a cavity (6) containing the device (4) and a removable backing (8) that seals the device (4) inside the cavity (6). A fulcrum (32) within the cavity (6) is defined as a point of contact between the device (4) and a wall of the cavity (6), the fulcrum (32) being positioned such that the predefined centre of mass of the device (4) is forward of the fulcrum (32) so that the device (4) tends to pivot forward about the fulcrum (32) into a stable position. A front pocket (10) is formed in the cavity (6) which extends forward of and below the fulcrum (32) to receive a front end (e.g. tip 24) of the device (4) when the device (4) is free to pivot into a stable position.