Universal Orthopedic Implant Packaging with Segmented Insert

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Solution Overview

Problem

Traditional packaging of femoral stem components in orthopedic hip arthroplasty is inefficient due to the need for multiple sizes of inserts and the use of friable foam, which can lead to contamination and damage during handling and exposure to bodily fluids.

Innovation Solution

A rigid synthetic polymer package with interconnected compartments and a hinge mechanism that accommodates a range of femoral stem component sizes, providing secure storage and protection until implantation, using thermoplastic aromatic polyether polyurethane for abrasion resistance and PETG for mechanical strength.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If traditional two-tray system with foam inserts is used, then sterility protection is provided, but foam abrasion creates particulate contamination

Engineering Contradiction:
Improvesterility protectionVSAvoidparticulate contamination
Core Design Contradiction:
ReliabilityVSObject-generated harmful factors

Solution Approach 1:

The patent removes the foam insert entirely from the packaging system. Instead of using foam for cushioning and stabilization, the invention employs a custom-molded plastic insert that is integral to the tray structure, eliminating the source of particulate contamination while maintaining sterility protection.

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The patent uses a composite packaging structure combining a rigid outer tray with a custom-molded plastic insert that has both rigid and flexible portions. This composite structure provides both protection and sterility maintenance without the contamination issues of traditional foam materials.

Inventive Principle:
Principle #40Composite materials

2Reliability

If inner tray is used to preserve sterility, then sterility is protected during shipping, but the tray cannot be placed on surgical tray after adhesive removal

Engineering Contradiction:
Improvesterility preservationVSAvoidsurgical tray placement
Core Design Contradiction:
ReliabilityVSEase of operation

Solution Approach 1:

The packaging tray is designed with universal functionality to serve both as a sterile shipping container and as a surgical tray component. The removable lid design allows the base tray to be placed directly on surgical trays, eliminating the need for separate inner and outer trays and enabling the same container to fulfill multiple functions throughout the surgical process.

Inventive Principle:
Principle #6Universality (Multi-functionality)

3Ease of operation

If medical device is fully removed from packaging before use, then access is provided, but device is exposed to damage and bodily fluids

Engineering Contradiction:
Improvedevice accessVSAvoidexposure to damage and bodily fluids
Core Design Contradiction:
Ease of operationVSObject-affected harmful factors

Solution Approach 1:

The packaging system is designed to be opened in a controlled manner during surgery, with the lid being partially or fully removed while the device remains protected within the tray. This preliminary action allows surgical团队成员 to access and prepare the device without complete exposure to the surgical environment, maintaining protection until the moment of implantation.

Inventive Principle:
Principle #10Preliminary action

4Adaptability or versatility

If multiple sizes of foam inserts are used, then different stem component sizes can be accommodated, but packaging complexity increases

Engineering Contradiction:
Improvesize range accommodationVSAvoidpackaging complexity
Core Design Contradiction:
Adaptability or versatilityVSDevice complexity

Solution Approach 1:

The patent employs a universal packaging tray design with a custom-molded plastic insert that can accommodate multiple sizes of stem components within a single package configuration. This eliminates the need for multiple different packaging sizes and foam insert variations, reducing complexity while maintaining adaptability to different implant sizes.

Inventive Principle:
Principle #6Universality (Multi-functionality)

Solution Approach 2:

The custom-molded plastic insert is segmented into rigid and flexible portions that can adapt to different device sizes. The flexible portion can conform to various stem component dimensions, allowing a single packaging design to serve multiple size requirements without increasing overall package complexity.

Inventive Principle:
Principle #1Segmentation

Data Source

PatentEP2841002B1Packaging for medical articles such as a size varying series of orthopedic implants
Publication Date: 2021.03.24 BEMIS HEALTHCARE PACKAGING INC
  • EP2841002B1 patent drawingFigure 1
  • EP2841002B1 patent drawingFigure 2
  • EP2841002B1 patent drawingFigure 3

AI summary

Packaging which can accommodate medical articles such as a series of orthopedic implants e.g. femoral stem components for prosthetic hip joints which have a dimension which varies minimally across the series but which vary considerably in overall size. The packaging is designed to minimize the travel of any member of the series packaged therein such that all the packaged components in the series can pass the standard handling and shipping tests typically used by the manufacturers of medical articles such as implants and preferably comprises two thermoformed tray components which each carry three types of cavities which are interconnected and designed to be assembled with their cavities facing each other to contain the lower stem, body and angled shaft of the stem component, respectively, with the cavities for the lower stem and the body cooperating to capture a minimally varying dimension of the series.