Arcuate Orthopedic Implant Packaging with Universal Stabilization
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Solution Overview
Problem
Traditional packaging of arcuate orthopedic implants, such as femoral components, faces issues with stabilization and sterility due to friable foam and residual adhesive, which can lead to contamination and damage during handling and implantation.
Innovation Solution
A unitary packaging system that uses a base portion with vertical projections and a second structural member to securely hold arcuate implants of varying sizes, with a clearance that captures a common thickness dimension, and is designed to accommodate different sizes of femoral components, featuring a clamshell trifold or modified inner tray configuration with venting for sterilization.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Stability of the object's composition
If traditional foam pieces are used to stabilize the femoral component within the package, then the component is secured during shipping, but the foam abrades and creates particulate contamination that compromises sterility
Solution Approach 1:
The patent replaces traditional reusable foam pieces with a disposable molded insert made from a non-friable material that is discarded after a single use. This insert is designed to be inserted into the package with the femoral component, providing stabilization during shipping without the abrasion problems of foam. The insert is then discarded before surgery, ensuring no contamination risk.
Solution Approach 2:
The patent uses a composite packaging system combining a rigid outer tray, a molded insert made from non-friable material (such as rigid plastic or metal), and a sealing film. This composite structure provides both stabilization and protection without the contamination risks of traditional foam, as each material is selected for its specific properties: rigidity for structure, non-friability for contamination prevention, and sealability for sterility maintenance.
2Reliability
If the inner tray is used to preserve sterility during shipping, then the medical device remains sterile, but the residual adhesive on the peripheral rim prevents placement on the surgical tray adjacent to the surgeon
Solution Approach 1:
The patent extracts the adhesive rim from the inner tray design, creating a clean peripheral edge without residual adhesive. This allows the inner tray to be directly placed on the surgical tray adjacent to the surgeon without contamination risk. The sterility preservation function is maintained through alternative means such as a sealed film covering the package opening or a different sealing mechanism that does not leave adhesive residues.
Solution Approach 2:
The inner tray is designed as a disposable single-use component that is discarded after the component is transferred to the surgical tray. This eliminates the need for cleaning or repositioning, and any adhesive issues are resolved by simply discarding the tray. The sterility is maintained during its single use, then it is discarded rather than reused.
3Ease of operation
If the femoral component is fully removed from protective packaging before use, then it can be accessed for implantation, but it becomes exposed to damage and bodily fluids during the waiting period
Solution Approach 1:
The package is designed with a pre-configured transfer mechanism where the inner tray with the femoral component can be directly placed onto the surgical tray before the actual surgical procedure begins. This preliminary positioning allows the component to remain protected within the inner tray during the waiting period, and only when needed is it fully accessed by removing the protective film or opening the tray, minimizing exposure time.
Solution Approach 2:
The patent uses a nested packaging structure where the femoral component is housed within the inner tray, which itself is placed within an outer tray. This nested arrangement allows for progressive access: the outer tray can be removed first, then the inner tray is positioned on the surgical tray, and only then is the component fully accessed. This maintains protection at each level while enabling easy access when needed.
4Stability of the object's composition
If different pieces of foam are used for each size of femoral component, then each component is properly stabilized, but the packaging system becomes complex and requires multiple inventory items
Solution Approach 1:
The patent designs a universal molded insert that can accommodate multiple sizes of femoral components through a single packaging platform. The insert is designed with adjustable or adaptable features such as removable dividers, adjustable positioning elements, or a generic contoured shape that fits various component sizes. This eliminates the need for different foam pieces for each size, reducing inventory complexity while maintaining proper stabilization for each component type.
Solution Approach 2:
The molded insert is designed as a segmented or modular structure with separate positioning zones or adjustable elements that can be configured for different component sizes. Rather than requiring completely different inserts for each size, the single insert can be segmented to accommodate various configurations, simplifying inventory while maintaining size-specific stabilization.
Data Source
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AI summary
The present disclosure concerns packaging adapted to accommodate a series of femoral components for artificial knee joints which vary in size but have a common thickness dimension. The packaging is designed to provide a clearance between its internal parts which approximates this common thickness dimension but is also able to accommodate variations in the other dimensions of the femoral components. In a convenient approach, a base portion is provided which has a vertical projection with a top surface adapted to support a portion of the inner surface of the major arch of the femoral components of said series. It is mated with a second structural member which has an arcurate surface whose contour approximates a portion of the outside surface of the major arch of the femoral components in this series. Means are provided for holding it in a fixed special relationship with said base portion.