Single-Use Bone Plate System with Aperture Clusters
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Solution Overview
Problem
The current bone plate systems for internal fixation of fractured bones require a large inventory of components, repeated sterilization, and often necessitate the presence of manufacturer representatives, leading to increased costs and logistical challenges for surgical facilities, especially in trauma settings where resources may be limited.
Innovation Solution
A single-use bone plate system with a containerized kit containing a reduced variety of bone plate fasteners and instruments, designed for specific surgical indications, which includes threaded and non-threaded aperture clusters for polyaxial and fixed-angle locking constructs, reducing the need for extensive inventory and sterilization processes.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If a complete tray with many bone plate fasteners and instruments is provided for every surgical procedure, then the surgeon has access to all necessary components for any surgical indication, but the inventory cost, sterilization cost, and device complexity increase significantly
Solution Approach 1:
The system divides the complete bone plate system into multiple standardized trays, each containing a specific subset of components appropriate for particular surgical indications. This segmentation allows facilities to stock multiple specialized trays rather than one complete tray, reducing overall inventory complexity while maintaining versatility through selective tray assembly.
Solution Approach 2:
The bone plate fasteners and instruments are designed with universal features that allow them to function across multiple surgical indications. Standardized aperture designs, fastener types, and instrumentation enable a reduced set of components to address diverse fracture patterns, reducing the number of specialized components needed in each tray.
2Adaptability or versatility
If many bone plate fasteners of numerous sizes and types are provided in sterile condition, then the surgeon can treat various fracture patterns, but the sterilization cost and loss of time for tray preparation increase
Solution Approach 1:
Trays are pre-assembled with the appropriate number and type of bone plate fasteners and instruments needed for specific surgical indications. This preliminary preparation eliminates the need for time-consuming tray assembly and sterilization in the operating room, as trays can be sterilized in advance and stored ready for use.
Solution Approach 2:
The system employs single-use, disposable bone plate fasteners and instruments that are provided in pre-sterilized trays. These components are designed for one-time use and then discarded, eliminating the need for repeated sterilization cycles and reducing time losses associated with sterilization validation and reprocessing.
3Adaptability or versatility
If a large inventory of bone plate components is maintained, then all surgical indications can be covered, but the overall cost including inventory, sterilization, and instrumentation increases
Solution Approach 1:
The inventory is segmented into multiple specialized trays rather than one complete tray. Each tray contains a curated subset of components for specific fracture types, allowing the facility to maintain smaller, more manageable inventories while still covering all surgical indications through selective tray combination.
Solution Approach 2:
The system standardizes key parameters such as fastener dimensions, aperture configurations, and instrument specifications across different trays. This parameter standardization allows components to be interchanged between trays, reducing the total quantity of unique components needed while maintaining versatility across surgical indications.
4Adaptability or versatility
If threaded and non-threaded apertures are provided in clusters, then both fixed-angle locking and polyaxial compressive constructs can be achieved, but the bone plate design complexity increases
Solution Approach 1:
The bone plate features asymmetric aperture clusters with threaded and non-threaded apertures positioned at specific locations and angles. This asymmetric design allows the plate to provide both fixed-angle locking (via threaded apertures) and polyaxial compression (via non-threaded apertures) capabilities while maintaining a relatively simple overall plate geometry.
Solution Approach 2:
The system merges threaded and non-threaded aperture types into integrated clusters on the bone plate. This combination allows both locking and compression functions to be achieved with a single plate design, reducing the need for multiple specialized plates and simplifying the overall system while providing construct flexibility.
Data Source
AI summary
A bone plate system and method for implanting the bone plate. The bone plate may include a head portion and a shaft portion, the shaft portion having a longitudinal axis and comprising a plurality of discrete aperture clusters. Each aperture cluster may include a non-threaded, non-locking bone fastener aperture configured to provide a polyaxial compressive construct and at least one threaded, locking bone fastener aperture. Once aligned with the bone, a first bone fastener is inserted into the bone through at least one of the non-threaded apertures in a direction normal to the longitudinal axis, compressing the bone along the longitudinal axis of the shaft portion of the bone plate. A second bone fastener is inserted into the bone through at least one of the threaded, locking bone fastener apertures in a direction oblique to the longitudinal axis and securing the bone plate to the bone.


