Modular Tibial Tray With Adjustable Spline

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Solution Overview

Problem

Current orthopedic medical devices, such as tibial-tray systems, face challenges due to variations in patient anatomy, leading to excess inventory and increased costs, as they are manufactured in a wide range of sizes to accommodate different patients, with limited use of devices at extremes and inability to adjust during surgery.

Innovation Solution

A modular tibial-tray system with an adjustable spline and adapter configuration that allows for intra-operative adjustment of the spline's position and orientation using adapters with tapers and threads, enabling precise fitting without the need for multiple pre-made sizes, made from biocompatible materials like titanium alloy and polymers.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Adaptability or versatility

If orthopedic medical devices are manufactured in a wide variety of sizes to accommodate differences between patients, then patient anatomical variations are addressed, but excess inventory and costs increase

Engineering Contradiction:

Improveaccommodation of patient anatomical variationsVSAvoidexcess inventory

Core Design Contradiction:

Adaptability or versatilityVSQuantity of substance

Solution Approach 1:

The tibial-tray system is divided into modular components (tray, spline, adapter) that can be independently selected and combined. This segmentation allows the system to accommodate various patient anatomies using a limited set of modular parts rather than requiring complete device variants for each size, thereby reducing inventory while maintaining adaptability.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The adapter component serves multiple functions: it connects the tray to the spline, provides offset positioning, and enables intraoperative adjustment. This multi-functionality allows a single adapter design to address multiple anatomical variations, reducing the need for numerous specialized components and thereby decreasing inventory requirements.

Inventive Principle:

Principle #6Universality (Multi-functionality)

2Adaptability or versatility

If multiple pre-made sizes of tibial-tray systems are manufactured, then different patient sizes are accommodated, but device complexity and inventory management increase

Engineering Contradiction:

Improveaccommodation of different patient sizesVSAvoidinventory management complexity

Core Design Contradiction:

Adaptability or versatilityVSDevice complexity

Solution Approach 1:

By segmenting the system into standardized modular components with defined interfaces, the patent simplifies inventory management. Instead of tracking numerous complete device variants, the system requires inventory of individual modular parts that can be freely combined, reducing complexity while maintaining size adaptability.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The system uses adjustable parameters (adapter offset positions, spline positions) to accommodate different patient sizes rather than requiring different device geometries. This allows a single base design to be adapted to various anatomies through parameter adjustment, significantly reducing device complexity and inventory requirements.

Inventive Principle:

Principle #35Parameter changes

3Ease of manufacture

If fixed-size tibial-tray systems are used, then manufacturing and inventory are simplified, but intra-operative adjustment capability is lost

Engineering Contradiction:

Improvemanufacturing simplicityVSAvoidintra-operative adjustment capability

Core Design Contradiction:

Ease of manufactureVSEase of operation

Solution Approach 1:

The system transitions from fixed to dynamic configuration through the adapter mechanism. The adapter allows the spline position to be adjusted intraoperatively relative to the tray, providing operational flexibility while maintaining manufacturing simplicity. The modular design with standardized interfaces keeps manufacturing straightforward while enabling post-manufacturing adaptability.

Inventive Principle:

Principle #15Dynamics

Solution Approach 2:

The adapter acts as an intermediary component between the fixed tray and the adjustable spline. This intermediary provides the adjustment mechanism while allowing both the tray and spline to be manufactured as simple, fixed-geometry components. The adapter absorbs the complexity of adjustment, maintaining ease of manufacture for the primary components while enabling intra-operative flexibility.

Inventive Principle:

Principle #24Intermediary (Mediator)

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

This modular system reduces inventory and costs, allows for optimal knee joint mechanics, improves surgical outcomes by enabling real-time adjustments, and extends the life of medical components through resterilization, minimizing waste and postoperative pain.

Implementation Method 1

The adapter may include a taper—for example, a Morse taper—on the outside surface of one or both of its ends to engage the tray on its distal end

Methodology Applied

Scientific EffectFriction: Friction

Data Source

PatentUS12193941B2Tibial-tray system

Publication Date: 2025.01.14 JERRY GERALD J

AI summary

A tibial-tray system may include a tibial tray and a spline configured to extend proximally from the tibial tray and guide a femoral component of a knee system. The tibial-tray system may also include an adapter configured for attachment to the tibial tray and the spline. A distal end of the adapter may have a position relative to a position of a proximal end of the adapter such that the spline extends upward from the tibial tray at a predetermined position.