Flexible Implantable Composites for Controlled Bioactive Release

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Solution Overview

Problem

Medical implants often face issues such as impaired healing due to bacterial infection and immune system reactions, and existing technologies lack efficient methods for delivering bioactive agents directly to the implant site.

Innovation Solution

Development of implantable composites comprising a biocompatible polymer and a releasable bioactive agent, which can be applied to medical devices close to the time of use, allowing for controlled release of the agent near the implant site, thereby enhancing implant functionality and reducing infection risks.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If a medical implant is used to replace or augment biological tissue, then the implant provides structural support and functional enhancement, but the implant surface can recruit cellular debris and biological material that become infected with bacteria and fungi, leading to periprosthetic infections

Engineering Contradiction:
Improveimplant functionalityVSAvoidbacterial infection
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent applies preliminary action by pre-coating the implant surface with a bioactive agent (such as antibiotics, antifungals, or other therapeutic substances) before implantation. This preliminary treatment ensures that the implant surface is already protected against bacterial and fungal infections from the moment of implantation, preventing the recruitment and infection of cellular debris without compromising the implant's structural integrity and functionality.

Inventive Principle:
Principle #10Preliminary action

2Reliability

If the immune system recognizes the implant as a foreign body and attempts to fight it using natural defenses, then the implant triggers an immune response, but this lowers the strength of the subject's immune system and can lead to further serious problems

Engineering Contradiction:
Improveimplant acceptanceVSAvoidimmune system suppression
Core Design Contradiction:
ReliabilityVSObject-generated harmful factors

Solution Approach 1:

The patent converts the harmful immune response into a beneficial effect by using the immune system's natural mechanisms against the implant in a controlled manner. The bioactive agent coating is designed to modulate the immune response, transforming the harmful foreign body reaction into a controlled, beneficial healing response that promotes tissue integration while maintaining immune system strength. This approach turns the immune system's natural defense mechanism into an ally rather than an adversary.

Inventive Principle:
Principle #22Blessing in disguise (Convert harm into benefit)

3Reliability

If a bioactive agent is delivered at or near the tissue adjacent the implant site to prevent infections and enhance implant function, then the bioactive agent provides localized therapeutic effects, but configuring each implant to deliver a bioactive agent is not always possible or practical due to differing manufacturing regulations

Engineering Contradiction:
Improveinfection preventionVSAvoidmanufacturing complexity
Core Design Contradiction:
ReliabilityVSEase of manufacture

Solution Approach 1:

The patent applies segmentation by separating the implant device from the bioactive agent delivery system. The implant itself remains a simple medical device subject to medical device regulations, while the bioactive agent is applied separately as a coating or attached component. This segmentation allows the implant and bioactive agent to be manufactured under different regulatory frameworks, simplifying the overall manufacturing process while still achieving localized therapeutic effects at the implant site.

Inventive Principle:
Principle #1Segmentation

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 implantable composites provide a controlled release of bioactive agents, reducing infection risks and enhancing the functionality of medical implants by applying them directly to the implant site, improving healing and reducing foreign body reactions.

Implementation Method 1

a releasable bioactive agent

Methodology Applied
Scientific EffectControlled release:

Data Source

PatentUS8951546B2Flexible implantable composites and implants comprising same
Publication Date: 2015.02.10 SURMODICS MD LLC
  • US8951546B2 patent drawing
  • US8951546B2 patent drawing

AI summary

Described herein are implantable composites, kits comprising the composites, implant devices comprising the composites, and methods of making and using same, including point of use methods.