Removable Water-Soluble Coating for Implantable Frame Projections
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Solution Overview
Problem
Existing implantable medical devices with sharp projections can inadvertently damage other parts of the device or the body vessel during deployment, due to their sharp edges, and there is a need for a protective covering that is removable and biocompatible to prevent such damage.
Innovation Solution
A biocompatible, water-soluble removable material is applied to the sharp edges of the device's projections to form a protective coating that dissolves rapidly upon implantation, providing durability during delivery and rapid exposure of the edges for secure engagement with the body vessel.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If sharp projections are used on the implantable frame, then engagement with the body vessel is improved, but damage to the device or body vessel during deployment occurs
Solution Approach 1:
A protective coating is applied to the sharp projections before implantation to prevent damage during deployment. The coating is subsequently removed at the implantation site, allowing the sharp edges to engage the body vessel securely without causing damage during the delivery process.
Solution Approach 2:
A protective coating material serves as an intermediary between the sharp projections and the surrounding environment during delivery. This coating prevents harmful interactions while allowing the sharp edges to perform their function after the coating is removed at the implantation site.
2Object-affected harmful factors
If a protective covering is applied to the projections, then damage prevention is improved, but the sharpness required for engagement is reduced
Solution Approach 1:
The protective coating is applied in advance to prevent damage during delivery, then removed at the implantation site to restore the sharpness of the projections. This temporal separation allows the coating to provide protection when needed while not interfering with the sharp edges when engagement is required.
Solution Approach 2:
The protective coating is discarded after serving its protective function during delivery, and the sharp edges are recovered by removing the coating at the implantation site. This allows the projections to transition from a protected state during delivery to a sharp state for engagement.
3Ease of operation
If a removable material is used for protection, then ease of operation is improved, but the complexity of the device increases
Solution Approach 1:
The protective coating is designed to be self-removing through dissolution in the body's aqueous environment. This eliminates the need for manual removal mechanisms, reducing device complexity while maintaining ease of operation during the implantation process.
Solution Approach 2:
The coating material's solubility parameter is utilized to enable automatic removal. By selecting a material that dissolves in the body's aqueous environment, the device simplifies the removal process without requiring additional mechanical or operational 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 solution effectively protects the device and the body vessel from damage during deployment, ensuring secure implantation while maintaining the necessary sharpness for engagement with the vessel's interior.
Implementation Method 1
The removable material preferably has a sufficient solubility within a body vessel for the removable material to dissolve rapidly enough during a transcatheter delivery procedure to expose the sharp edge during deployment of the implantable frame
Data Source
AI summary
Medical devices for implantation in a body vessel, and methods of using and making the same, are provided. A medical device can include a frame with one or more projections, each of which can be covered with a biocompatible, water-soluble removable material. The projections can be barbs positioned to engage the interior wall of a body vessel or to attach a material, such as a valve leaflet or graft, to the frame. The removable material can be dissolved within a body vessel upon implantation to expose the covered projection. Methods of making an implantable medical device and methods of treating a subject are also disclosed.