Profiled Pouch and Exo Tray for Medical Device Packaging

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Solution Overview

Problem

Conventional medical device packaging systems, particularly for 3-dimensional devices, face issues with stress risers, sterile barrier breaches, and inefficient use of materials due to the rectangular shape of pouches, leading to potential damage during shipping and handling.

Innovation Solution

A profiled pouch system with shaped sheets sealed on three sides, matching the device's profile, and an Exo Tray packaging system with a rigid distal portion and flexible unloading handles, which reduces stress risers and minimizes material usage, while the Exo Tray absorbs and redirects energy to protect the sterile barrier.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If a rectangular pouch is used to accommodate 3-dimensional medical devices, then the device can be contained, but the pouch creates folds and stress risers that compromise the sterile barrier

Engineering Contradiction:

Improvesterile barrier integrityVSAvoidpouch geometry

Core Design Contradiction:

ReliabilityVSShape

Solution Approach 1:

The pouch is formed with a contoured or shaped configuration that follows the three-dimensional profile of the medical device, replacing flat rectangular surfaces with curved surfaces that adapt to the device geometry. This eliminates folds and stress risers by allowing the pouch to conform smoothly around the device contours.

Inventive Principle:

Principle #14Spheroidality (Curvature)

Solution Approach 2:

The pouch structure is customized to provide different properties in different regions - tighter conforming in areas where the device has complex geometry and more relaxed areas where the device is simpler, optimizing both protection and accommodation throughout the pouch volume.

Inventive Principle:

Principle #3Local quality

2Quantity of substance

If the pouch is sized to the largest cross section of the device, then the device fits, but the pouch requires excessive length for sealing and creates wasted material

Engineering Contradiction:

Improvepouch material usageVSAvoidsealing capability

Core Design Contradiction:

Quantity of substanceVSEase of manufacture

Solution Approach 1:

The contoured pouch design allows material to be efficiently utilized by following the device profile, eliminating the need for excessive linear dimensions that would be required with a rectangular pouch. The curved geometry provides adequate sealing surface area without requiring excessive pouch length.

Inventive Principle:

Principle #14Spheroidality (Curvature)

3Volume of stationary object

If the pouch is placed in a carton smaller than the pouch outer dimension, then shipping space is optimized, but the pouch creates folds that increase stress and potential for barrier failure

Engineering Contradiction:

Improvecarton volumeVSAvoidsterile barrier robustness

Core Design Contradiction:

Volume of stationary objectVSReliability

Solution Approach 1:

The contoured pouch conforms to the device shape, allowing it to be efficiently packed in a smaller carton without creating folds. The smooth curved surfaces eliminate stress risers that would compromise the sterile barrier during shipping and handling.

Inventive Principle:

Principle #14Spheroidality (Curvature)

4Reliability

If conventional rectangular pouches are used for terminally sterilized devices, then the sterile barrier is established, but the pouch is highly susceptible to damage from impacts and vibration during shipping

Engineering Contradiction:

Improvesterile barrier functionVSAvoidshipping damage susceptibility

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The contoured pouch design with smooth curved surfaces eliminates folds and stress risers, making the sterile barrier much more resistant to damage from impacts and vibration during shipping and distribution.

Inventive Principle:

Principle #14Spheroidality (Curvature)

Solution Approach 2:

The pouch utilizes multilayer film construction with different material properties that provide both barrier functionality and enhanced resistance to mechanical damage from shipping conditions.

Inventive Principle:

Principle #40Composite materials

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 profiled pouch system minimizes stress risers and material waste, enhancing the robustness of the sterile barrier, reducing the likelihood of contamination, and facilitating aseptic transfer, while the Exo Tray system absorbs and redirects energy to protect the pouch from damage, thereby improving the packaging efficiency and safety.

Implementation Method 1

two shaped sheets sealed on three sides by a linear seal

Methodology Applied

Scientific EffectHeat sealing:

Implementation Method 2

the Exo Tray absorbs and redirects energy to protect the pouch from damage

Methodology Applied

Scientific EffectEnergy absorption: Damping

Implementation Method 3

a flex feature allowing the unloading handles to move relative to the rigid distal portion

Methodology Applied

Scientific EffectFlexibility: Elasticity

Data Source

PatentUS11617630B2Medical device packaging systems and methods

Publication Date: 2023.04.04 MEDTRONIC VASCULAR INC

AI summary

A method includes hermetically sealing a medical device within a pouch, the pouch including peeling panels that are free from one another. The pouch is placed within a tray and the peeling panels are attached to unloading handles of the tray. The unloading handles are releasably coupled together. The method further includes simultaneously separating the unloading handles and the peeling panels to open the pouch and expose the medical device for removal thereof.