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

VSEngineering 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

Engineering Contradiction:
Improveaccess to all necessary componentsVSAvoidinventory management complexity
Core Design Contradiction:
Adaptability or versatilityVSDevice complexity

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.

Inventive Principle:
Principle #1Segmentation

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.

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

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

Engineering Contradiction:
Improveability to treat various fracture patternsVSAvoidtray preparation and sterilization time
Core Design Contradiction:
Adaptability or versatilityVSLoss of time

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.

Inventive Principle:
Principle #10Preliminary action

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.

Inventive Principle:
Principle #27Cheap short-living objects (Disposable)

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

Engineering Contradiction:
Improvecoverage of surgical indicationsVSAvoidinventory quantity
Core Design Contradiction:
Adaptability or versatilityVSQuantity of substance

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.

Inventive Principle:
Principle #1Segmentation

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.

Inventive Principle:
Principle #35Parameter changes

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

Engineering Contradiction:
Improveconstruct type flexibilityVSAvoidbone plate aperture configuration
Core Design Contradiction:
Adaptability or versatilityVSShape

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.

Inventive Principle:
Principle #4Asymmetry

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.

Inventive Principle:
Principle #5Merging (Combining)

Data Source

PatentUS11045234B2Bone plate system and method
Publication Date: 2021.06.29 BIOMET CV
  • US11045234B2 patent drawing
  • US11045234B2 patent drawing
  • US11045234B2 patent drawing

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.