Orthopedic Implant Sustained Drug Release Paste

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Solution Overview

Problem

Implantable orthopedic devices face challenges in sustained elution of therapeutic agents, as existing methods often result in rapid release due to the use of liquid formulations, which do not provide a prolonged therapeutic effect.

Innovation Solution

A method involving the formation of a paste comprising a therapeutic agent, a biodegradable solid delivery medium, and water is injected into a reservoir within an orthopedic implant body, where it solidifies, allowing for gradual elution through channels and pores, extending the release period.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If liquid formulations are used for therapeutic agent delivery, then the device can be easily filled and administered, but the therapeutic agent releases rapidly instead of providing sustained elution

Engineering Contradiction:
Improveease of fillingVSAvoidduration of therapeutic release
Core Design Contradiction:
Ease of operationVSDuration of action of moving object

Solution Approach 1:

The patent changes the physical state parameter of the therapeutic formulation from liquid to paste form. The paste has higher viscosity and contains a solid binder (such as calcium sulfate or other biodegradable materials) that controls the release rate. This parameter change allows the formulation to be injected through standard catheters while providing sustained release over weeks or months rather than rapid clearance.

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The therapeutic agent is combined with a solid binder material to form a composite paste formulation. The binder (e.g., calcium sulfate, biodegradable polymers) provides structural integrity and controls degradation rate, while the therapeutic agent provides the active pharmacological effect. This composite approach enables both injectability and sustained release properties.

Inventive Principle:
Principle #40Composite materials

2Duration of action of moving object

If a solid delivery medium is used to achieve sustained release, then the therapeutic effect is prolonged, but the device becomes more complex to manufacture and fill

Engineering Contradiction:
Improveduration of therapeutic releaseVSAvoidease of device filling
Core Design Contradiction:
Duration of action of moving objectVSEase of manufacture

Solution Approach 1:

The paste formulation has optimized rheological parameters (viscosity, flow properties) that allow it to be injected through standard medical catheters and delivery devices. The consistency is controlled to be pumpable and injectable while maintaining the solid binder content necessary for sustained release. This parameter optimization bridges the gap between solid-state sustained release and liquid-state ease of administration.

Inventive Principle:
Principle #35Parameter changes

3Reliability

If the therapeutic agent is released quickly, then the initial therapeutic effect is strong, but the duration of action is insufficient for long-term implant benefit

Engineering Contradiction:
Improvetherapeutic efficacyVSAvoidduration of elution
Core Design Contradiction:
ReliabilityVSDuration of action of stationary object

Solution Approach 1:

The paste formulation is designed to provide an initial burst release component followed by sustained release. The formulation may include components that release quickly initially and then transition to slower release as the solid binder degrades. This preliminary action ensures adequate initial therapeutic levels while establishing long-term sustained release capability.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The solid binder material is designed to degrade continuously over time, providing a continuous source of therapeutic agent release. As the binder degrades, it maintains a consistent release rate over extended periods (weeks to months), ensuring continuous therapeutic action without interruption or need for re-dosing.

Inventive Principle:
Principle #20Continuity of useful action

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 approach enables a sustained release of therapeutic agents over an extended period, ensuring prolonged therapeutic efficacy by using a biodegradable solid binder and strategic reservoir and channel design for sequential elution.

Implementation Method 1

a solid delivery medium that is biodegradable under the influence of synovial fluid

Methodology Applied
Scientific EffectBiodegradation: Decomposition (biological)

Implementation Method 2

The mixture is injected into a reservoir within an orthopedic implant body, and is stored in the reservoir

Methodology Applied
Scientific EffectPhase change (solidification): Phase Change

Data Source

PatentUS10624996B2Orthopedic implant for sustained drug release
Publication Date: 2020.04.21 DUKE UNIV
  • US10624996B2 patent drawing
  • US10624996B2 patent drawing
  • US10624996B2 patent drawing

AI summary

A method includes forming a mixture including a therapeutic agent and a solid delivery medium, injecting the mixture into a reservoir within an orthopedic implant body, and storing the injected mixture in the reservoir.