Oriented P4HB Implants with Antimicrobial Agents

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Solution Overview

Problem

Current medical implants made from poly-4-hydroxybutyrate (P4HB) do not contain antimicrobial agents, which are necessary to prevent colonization and reduce infections following implantation, despite their potential for prolonged strength retention and use in high-risk procedures.

Innovation Solution

Development of oriented resorbable implants and coverings made from P4HB and its copolymers that incorporate antimicrobial agents such as rifampin and minocycline, ensuring these agents are applied without losing the orientation and strength of the implants, thereby preventing colonization and infection.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If antimicrobial agents are incorporated into P4HB implants, then infection prevention capability is improved, but manufacturing complexity increases

Engineering Contradiction:
Improveinfection prevention capabilityVSAvoidmanufacturing complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The patent applies preliminary action by incorporating antimicrobial agents into the P4HB polymer matrix during the manufacturing process, specifically during extrusion or molding. This ensures the antimicrobial protection is built into the implant structure before sterilization and implantation, eliminating the need for separate post-processing steps and reducing overall manufacturing complexity.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The patent uses composite materials by combining P4HB polymer with antimicrobial agents (such as silver ions, zinc oxide, or antibiotic compounds) to create a multifunctional implant material. This composite approach integrates both structural support and infection prevention capabilities into a single material system, improving reliability without significantly increasing manufacturing complexity.

Inventive Principle:
Principle #40Composite materials

2Strength

If oriented P4HB implants are used, then mechanical strength is improved, but difficulty in incorporating antimicrobial agents increases

Engineering Contradiction:
Improvemechanical strengthVSAvoiddifficulty in incorporating antimicrobial agents
Core Design Contradiction:
StrengthVSEase of manufacture

Solution Approach 1:

The patent applies local quality by concentrating antimicrobial agents at specific locations within the oriented P4HB structure, such as at the surface or at defect sites. This localized incorporation maintains the overall orientation and mechanical strength of the implant while providing targeted infection prevention where it is most needed, avoiding the need to compromise the oriented structure throughout the entire implant.

Inventive Principle:
Principle #3Local quality

Solution Approach 2:

The patent uses parameter changes by adjusting the molecular weight, crystallinity, or orientation degree of the P4HB polymer to optimize both mechanical strength and antimicrobial agent incorporation. By carefully controlling these parameters during extrusion and annealing, the patent achieves a balance between maintaining oriented structure integrity and enabling effective antimicrobial agent distribution.

Inventive Principle:
Principle #35Parameter changes

3Duration of action of stationary object

If P4HB implants are made highly oriented, then prolonged strength retention is improved, but manufacturing precision requirements increase

Engineering Contradiction:
Improveprolonged strength retentionVSAvoidmanufacturing precision requirements
Core Design Contradiction:
Duration of action of stationary objectVSManufacturing precision

Solution Approach 1:

The patent applies periodic action through a multi-stage manufacturing process that includes sequential steps of extrusion, annealing, and cooling at controlled rates. This periodic thermal processing allows the P4HB chains to progressively orient and crystallize over time, achieving high orientation and prolonged strength retention while using standard manufacturing equipment and tolerances, thereby reducing the need for extreme manufacturing precision in any single step.

Inventive Principle:
Principle #19Periodic action

Data Source

PatentUS10874771B2Oriented P4HB implants containing antimicrobial agents
Publication Date: 2020.12.29 TEPHA INC

AI summary

Oriented resorbable implants made from poly-4-hydroxybutyrate (P4HB) and copolymers thereof, have been developed that contain one or more antimicrobial agents to prevent colonization of the implants, and reduce or prevent the occurrence of infection following implantation in a patient. These oriented implants are particularly suitable for use in procedures where prolonged strength retention is necessary and there is a risk of infection. Coverings and receptacles made from poly-4-hydroxybutyrate and copolymers thereof, containing antimicrobial agents, have also been developed for use with implantable devices to prevent colonization of these devices, and to reduce or prevent the occurrence of infection following implantation of these devices in a patient. These coverings and receptacles may be used to hold, or partially or fully cover, devices such as pacemakers and neurostimulators. Preferably, the coverings and receptacles are made from meshes, non-wovens, films, fibers, and foams, and contain rifampin and minocycline.