Preformed Drug-Eluting Device for Anterior Spinal Plate

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Solution Overview

Problem

Conventional sterilization methods for orthopedic implants with drug-eluting coatings, such as steam under pressure, are ineffective for thermally sensitive drugs and costly for radiation or gas sterilization, limiting the practicality of pre-sterilized implants with drug-eluting coatings.

Innovation Solution

A preformed drug-eluting device comprising a biocompatible matrix with elutable drugs like clindamycin and rifampin, made from materials like silicone or hydrogels, which can be sterilized separately and affixed to an anterior spinal plate during surgery, allowing for flexible drug delivery and avoiding thermal decomposition.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If steam under pressure sterilization is used, then sterilization effectiveness is improved, but thermally sensitive drugs are damaged

Engineering Contradiction:

Improvesterilization effectivenessVSAvoidthermal decomposition of drugs

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The system is divided into two separate components: a sterilizable implant and a drug-eluting device. The implant can be sterilized by autoclaving, while the drug-eluting device containing thermally sensitive drugs is sterilized separately by radiation or chemical methods, then attached to the implant. This segmentation allows each component to be sterilized by the most appropriate method without compromising drug stability.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

A sterile barrier or packaging system acts as an intermediary between the implant and the drug-eluting device. This allows the implant to be pre-sterilized and packaged, then the drug-eluting device is attached in a controlled environment, maintaining sterility while avoiding thermal exposure of the drugs during the attachment process.

Inventive Principle:

Principle #24Intermediary (Mediator)

2Object-affected harmful factors

If radiation or gas sterilization is used, then drug component stability is improved, but sterilization cost increases

Engineering Contradiction:

Improvedrug component stabilityVSAvoidsterilization cost

Core Design Contradiction:

Object-affected harmful factorsVSEase of manufacture

Solution Approach 1:

The sterilization process is segmented into two stages: the implant is sterilized by cost-effective autoclaving, and only the drug-eluting device requires alternative sterilization methods. This segmentation reduces overall sterilization costs by applying the most economical method to the largest component (implant) while using necessary but more expensive methods only for the drug-containing component.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The implant is pre-sterilized and packaged before the drug-eluting device is attached. This preliminary sterilization of the implant allows the surgical site to be prepared in advance, and the drug-eluting device can be attached in a controlled surgical environment rather than requiring complex sterile packaging of the entire assembly, reducing manufacturing complexity and cost.

Inventive Principle:

Principle #10Preliminary action

3Object-affected harmful factors

If drug-containing coating is applied to pre-sterilized implant, then thermal damage to drugs is avoided, but manufacturing practicality decreases

Engineering Contradiction:

Improvethermal damage to drugsVSAvoidmanufacturing practicality

Core Design Contradiction:

Object-affected harmful factorsVSEase of manufacture

Solution Approach 1:

The system separates the implant and drug-eluting device into independent components that can be manufactured and sterilized separately. The implant is manufactured and sterilized first, then the drug-eluting device is attached during surgery. This segmentation eliminates the need for complex sterile manufacturing processes while maintaining drug stability.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The system transitions from a static pre-assembled implant-coating unit to a dynamic assembly process where components are joined in the surgical environment. This dynamic approach allows for flexibility in drug selection and implant configuration while maintaining sterility, making the system more practical for diverse surgical needs.

Inventive Principle:

Principle #15Dynamics

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 enables the use of thermally stable drugs in orthopedic implants, providing effective antimicrobial action and reducing mechanical irritation, while offering flexibility in choosing the optimal drug combination for specific patient needs, thus overcoming the limitations of traditional sterilization methods.

Implementation Method 1

at least one substance that facilitates non-irritating motion of the device across adjacent tissue

Methodology Applied

Scientific EffectFriction reduction: Lubrication

Implementation Method 2

the drug(s) present in the coating elutes therefrom over time into the region of surrounding tissue

Methodology Applied

Scientific EffectDiffusion: Diffusion

Data Source

PatentUS9078712B2Preformed drug-eluting device to be affixed to an anterior spinal plate

Publication Date: 2015.07.14 WARSAW ORTHOPEDIC INC

AI summary

A drug-eluting device comprising a drug-eluting matrix containing at least one elutable drug, a method of manufacturing a preformed drug-eluting device, and an implant kit comprising the same.