Biologic Macromolecule Coating with Temporary Protective Layer
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Solution Overview
Problem
Vascular stents often experience reocclusion due to injury to the endothelial cell lining, leading to thrombosis, infection, or abnormal tissue growth, as the biologic macromolecules used for promoting re-endothelialization can be deactivated during processing, storage, and sterilization due to denaturation.
Innovation Solution
A medical device with a coating of biologic macromolecules protected by a temporary water-soluble layer that dissolves within 24 hours after implantation, using low molecular weight carbohydrates to maintain the structure and function of the biologic macromolecules during processing and exposure to the physiological environment.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If biologic macromolecules are coated on the medical device surface to promote re-endothelialization, then endothelial cell adhesion and biocompatibility are improved, but the biologic macromolecules can be deactivated during processing, storage, and sterilization due to denaturation
Solution Approach 1:
A temporary protective layer is applied to the biologic macromolecules before the device undergoes processing, storage, and sterilization. This preliminary protective action prevents denaturation during these procedures, and the layer is designed to dissolve away before implantation so the macromolecules remain functional for promoting endothelialization
Solution Approach 2:
A water-soluble temporary protective layer serves as an intermediary between the biologic macromolecules and the harsh processing/sterilization environment. This intermediary layer protects the macromolecules from direct exposure to denaturing conditions while being removable before the device is used in the body
2Reliability
If a protective layer is added to preserve biologic macromolecules during processing and storage, then macromolecule functionality is maintained, but the device complexity increases
Solution Approach 1:
The temporary protective layer is designed to be discarded (dissolve away) before implantation. This allows the layer to provide protection during manufacturing and storage, then automatically disappear to reveal the functional macromolecule coating without requiring additional removal steps in the clinical setting
Solution Approach 2:
The temporary protective layer is designed as a short-living, disposable component that serves its protective function only during manufacturing and storage, then dissolves away. This allows use of simple water-soluble materials that don't need to be permanent or complex
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 temporary protective layer effectively preserves the biologic macromolecules' functionality, allowing for rapid activation and adherence of endothelial cells upon implantation, thereby enhancing the biocompatibility and reducing reocclusion risks.
Implementation Method 1
the temporary protective layer substantially dissolves within 24 hours after implantation or insertion of the medical device in a patient
Implementation Method 2
endothelial cells must migrate from adjacent areas of the artery and adhere onto the surface of the stent
Data Source
AI summary
A medical device having a coating of biologic macromolecules. The coating of biologic macromolecules is protected by a temporary protective layer disposed over the biologic macromolecules. The temporary protective layer serves to protect the structure (e.g., conformation) and/or function (e.g., target binding capacity) of the biologic macromolecules during processing, storage, handling, and/or delivery (e.g., implantation or insertion into a patient) of the medical device. Upon implantation or insertion into a patient's body, the temporary protective layer may dissolve to expose the biologic macromolecules to the physiologic environment.