Implantable Device Nano-Craters Thrombogenicity
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Solution Overview
Problem
Current implantable devices, such as those made from polymers, face challenges with thrombogenicity, as they tend to promote thrombus formation when in contact with bodily fluids or tissues, and existing methods to address this issue are either ineffective for long-term applications or complex and short-lived.
Innovation Solution
The implementation of nano-craters on the surface of implantable devices to enhance endothelialization and the use of degradable layers with varying degradation rates to control and remove thrombus formation, reducing the devices' thrombogenicity.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If polymer materials are used for implantable devices, then the devices can be manufactured with good biocompatibility and structural integrity, but the devices exhibit high thrombogenicity and promote thrombus formation
Solution Approach 1:
The patent applies local quality by creating nano-craters only on the blood-contacting surface of the implantable device, while the bulk material remains unchanged. This localized surface modification reduces thrombogenicity at the critical interface without compromising the overall structural integrity and biocompatibility of the polymer material throughout the device.
Solution Approach 2:
The patent changes the physical parameter of the surface by introducing nano-scale craters (50-500 nm depth) into the polymer surface. This parameter change in surface topology promotes endothelial cell attachment and reduces platelet adhesion, thereby reducing thrombogenicity while maintaining the base polymer's biocompatible properties.
2Object-affected harmful factors
If surface modifications are applied to reduce thrombogenicity, then thrombus formation is reduced, but the modifications have limited shelf-life and are only useful for short-term applications
Solution Approach 1:
The patent applies preliminary action by pre-forming stable nano-craters into the polymer surface during device manufacturing. These nano-craters provide immediate and lasting endothelial cell attachment sites that persist throughout the device's intended lifespan, unlike post-implantation coatings that degrade over time. The nano-crater structure is permanently integrated into the polymer matrix, ensuring long-term effectiveness.
Solution Approach 2:
The patent avoids using degradable coatings by instead creating permanent nano-crater structures. The nano-craters are formed by irradiating the polymer with electrons or ions, which creates stable physical structures that do not degrade. This approach eliminates the need for replacement due to coating degradation, making the solution suitable for long-term implantable devices.
3Object-affected harmful factors
If complex chemical and physical modifications are used to address thrombogenicity, then some commercial viability is achieved, but the production methods become elaborate and intricate
Solution Approach 1:
The patent replaces complex chemical modification processes with a physical irradiation process. By irradiating the polymer surface with electrons or ions, nano-craters are formed directly in the material without requiring chemical reagents, multi-step synthesis, or elaborate coating procedures. This physical approach simplifies manufacturing while achieving the same thrombogenicity reduction effect.
Solution Approach 2:
The patent changes the manufacturing approach by using controlled irradiation parameters (electron or ion beam energy, flux, and duration) to create nano-craters. This parameter-based control allows for precise adjustment of crater depth and density during a single processing step, eliminating the need for multiple sequential modification steps and reducing overall production complexity.
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 nano-craters improve endothelial cell attachment and propagation, while the degradable layers effectively manage thrombus removal, rendering the device surfaces substantially non-thrombogenic for both short-term and long-term contact with bodily fluids or tissues.
Implementation Method 1
nano-craters thereon that enhance or promote endothelialization of said at last one surface
Implementation Method 2
said first degradable layer has a first degradation rate and said second degradable layer has a second degradation rate such that said at least one first degradable layer degrades more rapidly than said at least one second degradable layer on contact with bodily fluid or tissue
Data Source
AI summary
Endothelialization of a bodily fluid or tissue-contacting, particularly blood-contacting, surface may be accomplished to render that surface substantially non-thrombogenic. Thrombosis may also be mitigated or eliminated by providing an eroding layer on the surface that results in the removal of any thrombus formation as the layer erodes. An implantable device may utilize at least one surface having a plurality of nano-craters thereon that enhance or promote endothelialization. Additionally, an implantable device may have at least one first degradable layer for contacting bodily fluid or tissue and disposed about a central core, and at least one second degradable layer between the first degradable layer and the central core. The first degradable layer has a first degradation rate and the second degradable layer has a second degradation rate which degrades more slowly than the first degradable layer on contact with bodily fluid or tissue.