Disposable Mold with Integrated Extractor for Spacer Devices
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Solution Overview
Problem
Traditional molds for producing spacer devices face issues such as difficulty in extracting the finished product, potential for cross-contamination of antibiotic substances, and deformation due to high temperatures, leading to compromised quality and safety.
Innovation Solution
A mold design featuring two half-shells with an integrated extractor component that ensures easy and quick removal of the spacer device, preventing reuse and maintaining sterility by being disposable, and avoiding additives that could contaminate the spacer material.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Quantity of substance
If traditional molds are reused after washing, then costs are reduced, but cross-contamination of antibiotic substances may occur
Solution Approach 1:
The mold is designed as a single-use disposable item. The half-shells are made of inexpensive material that can be discarded after one use, eliminating the need for washing and reuse. This prevents cross-contamination of antibiotic substances while maintaining cost-effectiveness through minimal waste of the mold itself.
Solution Approach 2:
The mold is discarded after single use to prevent contamination. The extractor component is designed to be permanently retained in the half-shell after extraction, ensuring the mold cannot be reused. This approach prioritizes patient safety by eliminating cross-contamination risks over cost recovery of the mold.
2Reliability
If the mold is subjected to high temperatures for sterilization, then sterility is achieved, but the mold material deforms
Solution Approach 1:
The mold is designed for single use only, eliminating the need for sterilization. The half-shells are made of material that would deform at sterilization temperatures (121°C), so the design accepts that the mold will be discarded after one use rather than subjected to sterilization processes.
Solution Approach 2:
The mold material is specifically selected to withstand the processing temperatures required for single-use formation (up to 100°C during polymerization) but is not designed for high-temperature sterilization. The disposable nature allows use of materials that would deform at sterilization temperatures.
3Ease of operation
If the extractor component is made movable, then extraction is facilitated, but the mold structure becomes more complex
Solution Approach 1:
The mold is divided into two separate half-shells that can be opened and closed. The extractor component is integrated into one half-shell and operates independently. This segmentation allows simple extraction mechanism without requiring complex movable structures throughout the entire mold.
Solution Approach 2:
The extractor component is designed to be manually operated by the user without requiring complex mechanisms. The simple movable structure within the half-shell allows the user to easily extract the spacer device through manual manipulation of the extractor component.
4Ease of operation
If the mold walls are made smooth, then extraction is easier, but the mold material may be absorbed by the bone cement
Solution Approach 1:
The mold walls have different surface properties in different locations. The forming surfaces are smooth to facilitate easy extraction of the spacer device. The extractor component has specific engagement features (protrusions and recesses) that provide controlled interaction points for extraction without requiring the entire mold surface to be smooth.
Solution Approach 2:
The mold is made of inert material that does not interact with the bone cement. The disposable nature ensures that any potential absorption issues are eliminated, as the mold is discarded after single use without risk of material transfer to subsequent spacer devices.
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
Facilitates easy and quick extraction of spacer devices while ensuring sterility and preventing cross-contamination, ensuring each spacer device is of high quality and safe for use, with the mold being designed for single-use only to avoid deformation and contamination risks.
Implementation Method 1
the polymerisation of the cement used for the realisation of spacer devices involves an exothermic reaction
Implementation Method 2
the polymerisation of the cement used for the realisation of spacer devices involves an exothermic reaction that brings the cement and the mold material beyond 100° C.
Data Source
AI summary
A mold for obtaining a spacer device for replacing a joint prosthesis, or a part thereof, includes a first half-shell and a second half-shell.