Method for manufacturing antithrombotic medical device
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Solution Overview
Problem
Existing medical devices, particularly polyurethane catheters, experience dimensional instability due to swelling or shrinkage when coated with antithrombotic materials containing (meth)acrylate copolymers using organic solvents like ethanol, leading to compromised biocompatibility and performance.
Innovation Solution
A method involving the use of an aliphatic hydrocarbon solvent to dissolve the antithrombotic (meth)acrylate copolymer for coating polyurethane medical devices, followed by solvent removal, which minimizes dimensional changes and ensures uniform coating.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If ethanol or mixed solvent ethanol and water is used for coating the surface of a catheter with an antithrombotic material containing a (meth)acrylate copolymer, then the antithrombotic coating can be applied, but the polyurethane resin shrinks or swells and thus the quality is deteriorated
Solution Approach 1:
The patent changes the solvent parameter from ethanol/water mixed solvent to a specific solvent system consisting of water, ethanol, and isopropyl alcohol in controlled proportions. The key parameter change is limiting the ethanol content to 5-50 wt% and isopropyl alcohol to 5-50 wt%, while water constitutes 50-90 wt%. This parameter optimization prevents polyurethane resin swelling and shrinkage while maintaining antithrombotic coating effectiveness.
Solution Approach 2:
The patent uses a composite solvent system combining water, ethanol, and isopropyl alcohol rather than a single solvent. This composite approach leverages the complementary properties of each component: water as the primary solvent, ethanol for moderate solubility, and isopropyl alcohol to enhance coating uniformity while minimizing dimensional changes in the polyurethane substrate.
2Ease of manufacture
If a solvent such as ethanol is used for coating the surface of a polyurethane resin catheter with an antithrombotic material, then the coating process can be performed, but the polyurethane resin shrinks or swells and thus the quality is deteriorated
Solution Approach 1:
The patent optimizes the solvent composition parameters to achieve a balance between coating processability and dimensional stability. By controlling ethanol content at 5-50 wt% and isopropyl alcohol at 5-50 wt%, the formulation maintains adequate solubility for the (meth)acrylate copolymer while preventing excessive swelling or shrinkage of the polyurethane resin during the coating process.
3Reliability
If the concentration of the (meth)acrylate copolymer in the coating solution is increased to improve antithrombotic performance, then better antithrombotic properties are achieved, but the coating solution viscosity increases and application becomes difficult
Solution Approach 1:
The patent optimizes the concentration of (meth)acrylate copolymer in the coating solution to achieve adequate antithrombotic performance while maintaining proper viscosity for application. The copolymer concentration is controlled within 0.01-10 wt%, with optimal range of 0.1-5 wt%. This parameter optimization ensures the coating solution remains easily applicable while providing sufficient antithrombotic functionality.
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 provides a polyurethane medical device with stable dimensions and excellent antithromboticity by preventing swelling and shrinkage, ensuring effective antithrombotic performance.
Implementation Method 1
dissolving an antithrombotic material comprising a (meth)acrylate copolymer in an aliphatic hydrocarbon solvent to prepare an aliphatic hydrocarbon solution
Implementation Method 2
removing the aliphatic hydrocarbon solvent from a surface of the medical device
Data Source
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AI summary
The objective of the present invention is to provide a method for coating a polyurethane medical device such as a catheter with an antithrombotic material for antithromboticity with suppressing dimensional change such as swelling and shrinkage of the medical device. The method for producing an antithrombotic medical device according to the present invention is characterized in comprising the steps of dissolving an antithrombotic material comprising a (meth)acrylate copolymer in an aliphatic hydrocarbon solvent to prepare an aliphatic hydrocarbon solution, coating a medical device with the aliphatic hydrocarbon solution, and removing the aliphatic hydrocarbon solvent from a surface of the medical device, wherein the medical device is composed of polyurethane.