Sterile Orthopedic Fixation Kit with Pre-Assembled Implant

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Solution Overview

Problem

Current orthopedic fixation systems often require hospitals to sterilize non-sterile implants and instruments, leading to potential hospital-acquired infections due to improper cleaning and sterilization processes.

Innovation Solution

A sterile packaged implant kit mounted on an insertion device and a complementary sterile packaged instrument kit, including a drill guide, drill bit, locating pins, instrument handle, and implant tamp, which are packaged and sterilized together to maintain sterility throughout the surgical process.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of manufacture

If implants and instruments are delivered in non-sterile form and sterilized at the hospital, then manufacturing complexity is reduced, but the risk of hospital-acquired infections increases due to improper cleaning and sterilization

Engineering Contradiction:

Improvemanufacturing complexityVSAvoidrisk of hospital-acquired infections

Core Design Contradiction:

Ease of manufactureVSObject-affected harmful factors

Solution Approach 1:

The implant and instruments are sterilized in advance during manufacturing and packaged in sterile containers before delivery to the hospital. This preliminary sterilization action eliminates the need for hospital sterilization processes, reducing the risk of hospital-acquired infections while maintaining manufacturing efficiency.

Inventive Principle:

Principle #10Preliminary action

Solution Approach 2:

The system employs disposable sterile packaging and single-use instruments that are pre-sterilized and discarded after one use. This approach ensures sterility without requiring complex hospital sterilization infrastructure, thereby reducing infection risk while keeping manufacturing relatively simple.

Inventive Principle:

Principle #27Cheap short-living objects (Disposable)

2Object-affected harmful factors

If implants are delivered in sterile packaged form, then the risk of hospital-acquired infections is reduced, but manufacturing complexity and cost increase

Engineering Contradiction:

Improverisk of hospital-acquired infectionsVSAvoidmanufacturing complexity

Core Design Contradiction:

Object-affected harmful factorsVSEase of manufacture

Solution Approach 1:

The implant is pre-assembled on the insertion device and packaged together as a single sterile unit. This merging of components into one integrated sterile package reduces the number of separate sterilization processes needed, thereby lowering manufacturing complexity while maintaining sterility and reducing infection risk.

Inventive Principle:

Principle #5Merging (Combining)

Solution Approach 2:

The insertion device serves multiple functions: it holds the implant during transport, provides a guide for insertion, and acts as part of the sterile packaging system. This multi-functionality reduces the number of separate components that need to be sterilized and packaged individually, simplifying manufacturing while ensuring sterility.

Inventive Principle:

Principle #6Universality (Multi-functionality)

3Device complexity

If instruments are provided as part of an instrument tray requiring cleaning and sterilization, then device complexity is reduced, but the time and resources required for sterilization increase

Engineering Contradiction:

Improvedevice complexityVSAvoidtime required for sterilization

Core Design Contradiction:

Device complexityVSLoss of time

Solution Approach 1:

The instruments are packaged in disposable sterile containers that are discarded after single use. This eliminates the need for repeated cleaning and sterilization cycles, saving significant time and resources while maintaining simple device design. The disposable nature ensures sterility without requiring complex reprocessing procedures.

Inventive Principle:

Principle #27Cheap short-living objects (Disposable)

4Ease of operation

If the implant is pre-mounted on the insertion device in a sterile package, then the surgical process is simplified and readiness is improved, but packaging complexity increases

Engineering Contradiction:

Improvesurgical process simplicityVSAvoidpackaging complexity

Core Design Contradiction:

Ease of operationVSDevice complexity

Solution Approach 1:

The implant and insertion device are permanently assembled as one integrated unit during manufacturing and packaged together in a single sterile container. This merging eliminates the need for separate packaging of each component and simplifies the surgical process by providing a ready-to-use assembled system, while the packaging complexity is managed through efficient single-unit design.

Inventive Principle:

Principle #5Merging (Combining)

Data Source

PatentUS11090095B2Method and apparatus for an orthopedic fixation system

Publication Date: 2021.08.17 BIOMEDICAL ENTERPRISES INC

AI summary

An orthopedic fixation system includes a sterile packaged implant kit and a sterile packaged instrument kit. The sterile packaged implant kit includes at least one surgical implant, an insertion device, and an implant package adapted to receive the at least one surgical implant and the insertion device therein. The implant package maintains the at least one surgical implant and the insertion device sterile after sterilization of the sterile packaged implant kit. The sterile packaged instrument kit includes one or more instruments necessary to use the sterile packaged implant kit and an instrument package adapted to receive the one or more instruments therein. The instrument package maintains the one or more instruments sterile after sterilization of the sterile packaged instrument kit.