Customizable Intraoperative Mold for Uniform Antibiotic Coating
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Solution Overview
Problem
Existing processes for coating intramedullary nails with antibiotic cement are inconsistent, prone to debris generation, and require extensive operating room time, involving multiple personnel and materials waste, while being limited to specific implant designs and not adaptable to different manufacturers.
Innovation Solution
A customizable intraoperative mold system with standoff tabs and flexible molds that prevent coating material from entering internal openings and allow for uniform antibiotic coating, reducing operating time and personnel needs, and accommodating various implant designs and materials.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Manufacturing precision
If traditional coating processes are used, then antibiotic cement can be applied to the nail surface, but the coating distribution becomes inconsistent and varies in thickness
Solution Approach 1:
The nail is inserted into a mold with precisely defined geometric constraints before coating. The mold includes internal openings that are pre-positioned to correspond with the nail's threading openings, establishing the coating geometry in advance before the coating process begins.
Solution Approach 2:
A mold acts as an intermediary tool between the nail and the coating material. The mold provides a controlled environment with defined internal openings that guide the coating material flow, ensuring uniform distribution and consistent thickness around the nail surface.
2Reliability
If coating material is applied to ensure adequate antibiotic coverage, then infection treatment is improved, but coating debris is generated and difficult to remove
Solution Approach 1:
The internal openings of the nail are filled with plugs before coating. These plugs prevent coating material from entering the openings, thereby extracting or removing the source of potential debris generation in those areas while maintaining adequate external coating for infection treatment.
Solution Approach 2:
Plugs are inserted into the nail's internal openings before the coating process. This preliminary action prevents coating material from entering the openings during application, eliminating the creation of hard-to-remove debris in those specific areas while maintaining sufficient external coating.
3Adaptability or versatility
If pre-engineered features like threaded openings are provided in the nail, then locking functionality is enabled, but these openings are partially or wholly filled with compound during coating
Solution Approach 1:
Plugs are inserted into the threaded openings to remove or block the path for coating material. This extracts the coating material from the openings, preserving the opening clearance and preventing the compound from filling the threaded features while maintaining the nail's locking functionality.
Solution Approach 2:
The coating process is segmented into controlled zones. The plugs create distinct boundaries that separate the coating application area from the internal openings. This segmentation allows coating material to be applied uniformly to the external surface while preventing intrusion into the threaded openings.
4Reliability
If existing coating processes are used, then antibiotic cement can be applied to the nail, but extensive operating room time and multiple personnel are required
Solution Approach 1:
The coating process is merged with a single-step insertion of a pre-assembled tooling assembly containing the mold and plugs. This combined approach eliminates multiple separate operations and personnel requirements, reducing operating room time while maintaining reliable antibiotic coating application.
Solution Approach 2:
The mold and plug assembly is designed as a self-contained tooling system that can be inserted and removed as a single unit. This self-service design eliminates the need for multiple personnel to perform separate coating operations, reducing operating time while ensuring reliable coating application.
5Reliability
If traditional coating methods are used, then antibiotic cement can be applied, but the process is not adaptable to different manufacturers' implant designs
Solution Approach 1:
The mold and plug assembly is designed as a universal tooling system that can accommodate different implant designs and manufacturers. The modular and adjustable nature of the tooling allows it to adapt to various nail geometries, threading patterns, and lengths while maintaining reliable antibiotic coating application.
Solution Approach 2:
The tooling system incorporates dynamic or adjustable features that allow it to adapt to different implant designs. The mold and plug components can be configured or selected to match specific implant geometries, providing versatility across different manufacturers while ensuring consistent coating 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 solution achieves consistent and controlled antibiotic distribution, reduces operating room occupancy and patient anesthesia time, and allows for the use of thermally unstable materials, while being adaptable to different implant designs and environmentally friendly.
Implementation Method 1
The nails are made by injecting antibiotic-impregnated polymethylmethacrylate or 'cement' around a metal core using a silicone tube as a mold
Implementation Method 2
A mixture of orthopedic cement, such as polymethyl methacrylate (PMMA), similar to what is used to hold a knee replacement in place, is prepared. This viscous, play-dough like substance is placed onto the surface of the nail, and allowed to cure. Once hardened
Data Source
AI summary
A preconfigured, customizable intraoperative mold for the assembly of implants having uniform coating(s). One or more plugs are adapted to prevent incursion of coating material into engineered or other openings in the implant. The dimensions of these plugs, or other standoffs, is chosen to control spacing of the implant away from the interior surfaces of the mold. The plugs and/or standoffs thus further control a thickness, profile, distribution, types, or other configuration of the coating materials.