Soluble Implant Surface Sealing for Antithrombotic Purity
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Solution Overview
Problem
Existing implant surfaces for body lumens face challenges in maintaining their pre-assigned surface characteristics, such as hydrophilicity and antithrombotic properties, due to contamination during storage, handling, and exposure to bodily fluids, which can lead to thrombosis and stenosis, and current inert storage methods complicate production, handling, and limit sterilization options.
Innovation Solution
The implant is provided with a soluble surface sealing that covers the surface portion, which dissolves upon contact with bodily fluids, preserving the target surface characteristics until implantation, allowing for dry storage and flexible handling without compromising mechanical properties.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Manufacturing precision
If implant surfaces are highly purified and treated to achieve antithrombotic properties, then surface purity and biocompatibility are improved, but the surfaces become vulnerable to recontamination during storage and handling
Solution Approach 1:
A soluble sealing layer is applied to the implant surface before storage and handling. This sealing layer is removed just before implantation through flushing with a solvent, ensuring the surface remains protected from contamination throughout storage while being ready for immediate use. This preliminary protective action resolves the contradiction by maintaining surface integrity without requiring complex packaging systems.
Solution Approach 2:
The soluble sealing layer acts as an intermediary between the highly purified implant surface and the external environment during storage. It provides a protective barrier that prevents direct contact between contaminants and the implant surface, while being removable through solvent flushing before implantation. This intermediary layer resolves the contradiction by enabling simple dry storage while maintaining surface purity.
2Reliability
If conventional packaging methods are used to protect implant surfaces, then surface protection is achieved, but sterilization options are limited and costs increase
Solution Approach 1:
The protective function is extracted from the packaging system and transferred to a soluble sealing layer applied directly to the implant surface. This eliminates the need for complex sealed packaging systems while maintaining protection during storage. The sealing layer is removed before implantation, providing surface protection without compromising sterilization options or increasing packaging complexity.
Solution Approach 2:
The sealing layer's solubility parameter is specifically designed to allow it to remain stable during storage and handling but to dissolve when exposed to solvent flushing before implantation. This parameter change enables simple dry storage packaging while maintaining surface protection, resolving the contradiction by simplifying packaging structure without sacrificing reliability.
3Reliability
If implant surfaces are protected from contamination, then antithrombotic properties are maintained, but handling and storage flexibility are reduced
Solution Approach 1:
The protective sealing layer is designed with dynamic properties - it remains intact during storage and handling to protect the surface, but can be easily removed through solvent flushing before implantation. This dynamic behavior resolves the contradiction by providing protection when needed while allowing flexibility in handling and storage operations.
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 soluble surface sealing effectively maintains the implant's surface properties, ensuring optimal interaction with bodily fluids and tissues, reducing thrombosis risk and enabling diverse sterilization methods while simplifying handling and packaging.
Implementation Method 1
a surface sealing which covers the at least a portion of the implant surface and is soluble when inserting the implant in the body lumen
Data Source
AI summary
The present invention relates to an implant for insertion in a body lumen, wherein at least a portion of the surface is arranged to contact a wall of the body lumen and/or bodily fluid flowing through the lumen when the implant is inserted in the body lumen. The abovementioned portion of surface is covered with a surface sealing which is designed to dissolve within about 30 seconds when inserting the implant in the body lumen, such that this portion of surface is exposed to the body lumen. The present invention also relates to a method of manufacturing an implant as above described, comprising the steps of obtaining an implant with a surface; providing at least a portion of such surface with target characteristics; and covering such at least a portion of surface with a surface sealing to preserve the target characteristics. The present invention also refers to an implant set comprising an implant as defined and to a use of such an implant for treating an animal or a human body, wherein the treatment procedure comprises dissolving the surface sealing covering at least a portion of a surface of the implant by flushing the surface with a dissolving solution.