Cold Plasma Surface Treatment for Biocompatible Subcutaneous Devices
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Solution Overview
Problem
Existing inserter devices for medical devices like infusion sets and sensors cause physiological and psychological distress due to needle insertion, risk contamination, and can lead to foreign body response, reducing drug absorption and increasing infection risk.
Innovation Solution
A method involving cold plasma treatment of medical device surfaces with polymers like zwitterionic or phosphorylcholine species to reduce foreign body response and enhance biocompatibility, using atmospheric pressure plasma to create a linking layer for biomolecule immobilization.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a needle or cannula is inserted into the subcutaneous layer for medical treatment, then the medical device can deliver medication or monitor physiological parameters, but the patient experiences physiological and psychological distress and discomfort
Solution Approach 1:
The patent applies plasma treatment to modify the surface properties of the cannula, changing parameters such as surface energy, roughness, and chemical composition. This creates a biocompatible surface that reduces foreign body response and patient discomfort while maintaining the cannula's functional integrity for medication delivery
Solution Approach 2:
The patent creates a composite surface structure by depositing polymer coatings (such as polyethylene glycol or phosphorylcholine) onto the cannula surface through plasma treatment. This composite structure combines the mechanical strength of the original cannula material with the biocompatibility of the polymer coating, reducing foreign body response while maintaining structural integrity
2Duration of action of stationary object
If the cannula remains in place in the subcutaneous layer for extended periods (more than three days), then continuous medication delivery is achieved, but the body identifies the cannula as a foreign body and rejects it, reducing drug absorption
Solution Approach 1:
The plasma treatment process modifies surface parameters including wettability, surface energy, and chemical composition to create a biocompatible interface. This reduces the foreign body response and allows the cannula to remain in place for extended periods without triggering rejection, thereby maintaining continuous drug absorption
Solution Approach 2:
The patent introduces polymer coatings (such as PEG or phosphorylcholine) as intermediary layers between the cannula and the body tissue. These intermediary materials act as biocompatible barriers that prevent the immune system from recognizing the cannula as a foreign body, thereby extending retention time while maintaining drug absorption efficiency
3Ease of operation
If the insertion needle is exposed for longer periods during the insertion process, then proper positioning and insertion can be achieved, but the risk of contamination from touching, airborne particles, or unclean surfaces increases
Solution Approach 1:
The patent applies plasma treatment and polymer coating to the cannula surface before insertion as a preliminary protective action. This pre-treatment creates a contamination-resistant surface that prevents adsorption of proteins, bacteria, and other contaminants, allowing the needle to remain exposed during insertion without increasing contamination risk
Solution Approach 2:
The polymer coating serves as an intermediary protective layer between the insertion needle and the environment. This coating barrier prevents direct contact between the needle surface and contaminants (skin oils, airborne particles, unclean surfaces) while allowing the insertion procedure to proceed with proper positioning and accuracy
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 method reduces patient discomfort, minimizes contamination risk, and extends device tolerance in the subcutaneous layer by reducing foreign body response and enhancing biocompatibility.
Implementation Method 1
treating a portion of the medical device with cold plasma
Implementation Method 2
functionalizing the plasma-treated portion with a polymer
Data Source
AI summary
Methods of modifying a medical device and manufacturing a medical device are disclosed. One embodiment of a method of modifying a medical device includes treating a portion of the medical device with cold plasma and functionalizing the plasma-treated portion with a polymer. One embodiment of a method of manufacturing a medical device includes providing a subcutaneous part configured to be positioned subcutaneously in a user and performing a surface treatment on a portion of the subcutaneous part.