Implantable Medical Device Sealing via Titanium Mediator Layer
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Solution Overview
Problem
Current sealing methodologies for implantable medical devices, such as cochlear implants, face challenges in maintaining durability and preventing delamination of protective layers, especially when exposed to harsh body fluids and electrical stimulation, leading to potential leakage and device failure over extended implantation periods.
Innovation Solution
The application of an intermediate titanium layer on the substrate region of implantable medical devices using a sputtering process enhances the adhesion of the protective silicone rubber layer, increasing its sealing characteristics by improving the bond stability and surface energy, thereby reducing the likelihood of delamination.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a protective layer is applied directly to the substrate region of the implantable medical device, then the sealing function is provided, but the adhesion strength and resistance to delamination are insufficient under harsh body fluid exposure and electrical stimulation
Solution Approach 1:
An intermediate titanium layer is deposited between the substrate region and the protective silicone rubber layer. This intermediate layer serves as a mediator that enhances the adhesion bond between the two materials, improving both the strength and reliability of the sealing interface under harsh body fluid exposure and electrical stimulation conditions.
Solution Approach 2:
The patent creates a composite structure consisting of multiple layers: the substrate region, the intermediate titanium layer, and the protective silicone rubber layer. This composite material approach combines the benefits of each layer to achieve superior adhesion and sealing integrity that cannot be obtained with a single material system.
2Ease of manufacture
If the protective layer is applied without an intermediate layer, then the manufacturing process is simpler, but the bond stability and resistance to delamination deteriorate over extended implantation periods
Solution Approach 1:
The intermediate titanium layer acts as a durable mediator that maintains stable adhesion over extended implantation periods. Although it adds a manufacturing step, the sputtering deposition process is compatible with existing implantable medical device manufacturing workflows, and the intermediate layer prevents delamination that would compromise long-term sealing durability.
3Object-affected harmful factors
If the protective layer is applied to the substrate region, then sealing protection is provided, but the peel strength and resistance to delamination are reduced under electrical stimulation and ionic solutions
Solution Approach 1:
The intermediate titanium layer serves as a protective mediator that shields the interface between the substrate and the silicone rubber from the harmful effects of electrical stimulation and ionic solutions. This mediator maintains peel strength and resistance to delamination while still providing the necessary sealing protection from body fluids.
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
This approach significantly enhances the sealing integrity of the protective layer, as demonstrated by improved peel strength and resistance to delamination under electrical stimulation and ionic solutions, ensuring the long-term reliability and protection of the implantable medical device.
Implementation Method 1
The application of an intermediate titanium layer on the substrate region of implantable medical devices using a sputtering process enhances the adhesion of the protective silicone rubber layer
Data Source
AI summary
A method of adhering a protective layer applied to a substrate region of an implantable medical device (IMD) to form a covered substrate region. The method includes obtaining the IMD, depositing an intermediate layer on a portion of the substrate region of the IMD such that the intermediate layer binds to the portion of the substrate region to create a modified substrate region, and depositing the protective layer after depositing the intermediate layer onto the intermediate layer and adhering the protective layer to the intermediate layer. In an embodiment of the present invention, this method enhances the sealing characteristics of the protective layer by, for example, reducing the likelihood of delamination of the protective layer from the IMD relative to IMDs prepared by certain other methods.