Packaged Antimicrobial Suture with Transfer Mechanism
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Solution Overview
Problem
Surgical site infections (SSIs) occur frequently due to bacterial colonization on implantable medical devices, which can spread bacteria from the surgical site to surrounding tissue, increasing treatment costs and patient trauma.
Innovation Solution
A packaged antimicrobial suture is developed with an inner package containing antimicrobial agent reservoirs and an outer package that subjects the suture and inner package to specific time, temperature, and pressure conditions to transfer an effective amount of antimicrobial agent, inhibiting bacterial colonization.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If antimicrobial agents are applied to implantable medical devices, then bacterial colonization is inhibited, but the shelf life is limited due to agent degradation or loss
Solution Approach 1:
The patent applies antimicrobial agents to packaging components (packaging film, desiccant, indicator strip) before the package is sealed and sterilized. This preliminary application ensures that antimicrobial protection is already in place on all surfaces that will contact the medical device when the package is opened, extending the effective shelf life without requiring the agent to persist throughout the entire storage period.
Solution Approach 2:
The patent uses packaging components as intermediaries to deliver antimicrobial protection. Instead of relying solely on the medical device itself to provide long-term antimicrobial activity, the packaging system acts as a mediator that releases or transfers antimicrobial agents to the device and surrounding environment, thereby extending protection beyond the device's own coating lifespan.
2Reliability
If antimicrobial agents are transferred during sterilization, then bacterial colonization is prevented, but the sterilization process complexity increases
Solution Approach 1:
The patent combines the sterilization process with the antimicrobial agent transfer process into a single integrated cycle. The packaging system is designed so that the same time, temperature, and pressure conditions used for sterilization also facilitate the transfer of antimicrobial agents from the packaging components to the medical device and packaging surfaces, eliminating the need for separate processing steps.
Solution Approach 2:
The packaging components are designed to serve multiple functions: they provide structural containment, enable sterilization, facilitate antimicrobial agent transfer, and may include indicators for sterilization verification. This multi-functionality reduces overall system complexity by consolidating multiple requirements into unified packaging and processing solutions.
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 effectively prevents bacterial colonization on the suture and inner package, reducing the risk of SSIs and extending the shelf life of antimicrobial medical devices by using adsorbent materials to moderate the antimicrobial agent's rate of increase.
Implementation Method 1
using adsorbent materials to moderate the antimicrobial agent's rate of increase
Data Source
AI summary
A packaged antimicrobial suture. The packaged antimicrobial suture includes an inner package having a source of antimicrobial agent, the source of antimicrobial agent comprising a plurality of patches, each patch having a pair of antimicrobial material reservoirs; at least one suture positioned within the inner package, the at least one suture comprising one or more surfaces; and an outer package having an inner surface, the outer package having the inner package positioned within; wherein the at least one suture, the inner package and the inner surface of the outer package are subjected to time, temperature and pressure conditions sufficient to transfer an effective amount of the antimicrobial agent from the antimicrobial agent source to the at least one suture and the inner package, thereby substantially inhibiting bacterial colonization on the at least one suture and the inner package. A method of making a packaged antimicrobial suture having is also provided.