January 2020
Public announcement: a key EU partnership in the field of AIMDs development.

Soft Encapsulation Enabling Next Generation of Miniaturized Implants: the SEALANT project.

While Active Implantable Medical Devices (AIMDs) enabled huge societal achievements since decades, new technologies are required to enlarge the therapeutic window. That is especially the ambition of the SELANT project, started in October 2020, enabling a next generation of medical implants

The SEALANT consortium benefits from the proven expertise and years of experience in design, development and production of components and technologies used for active medical devices:  OSYPKA AG (DE, medical devices manufacturing), Comelec SA (CH, encapsulation solutions and OEM), University of Freiburg, Department of Microsystems Engineering (IMTEK, DE, research in MEMS-based optogenetic implants) and NMI Natural and Medical Sciences Institute (DE, research institute active in miniaturized implant encapsulation and advanced testing).

The SEALANT project is supported through the Eurostars Program following promising evaluation from expert’s comity (ranked 14 out of 378 eligible projects). Independent project reviewer says: “The SEALANT application presents skillfully a project to demonstrate the usability of high technology coatings to replace traditional implantable medical encapsulations. Several attempts addressed that challenge but never achieved to date. Attaining that goal will offer this medical field with larger solutions to treat unaddressed pathologies with minimally invasive and affordable systems”.

In this project we aim at making soft encapsulation technologies safely applicable for AIMDs, to overcome the conventionally used bulky cans made of metal or glass for specific applications. The technology’s performance is investigated on different types of implants: from adapting existing products up to breakthrough micro-optical implants for optogenetics. A platform concept applicable to various AIMDs will enable design rule extraction and establish the respective encapsulation evaluation.

Starting point of the project is a recently developed multilayer coating technology with advanced barrier properties, based on Parylene-inorganic multilayer stacks (Comelec SA). While conventional Parylene is an essential process in medical device industry, the potential of these multilayer coatings has not been widely explored for its use in AIMD. With SEALANT, this brand-new coating type gives rise to new encapsulation methods that can be applied to a broader range of products. This therefore enables the development of completely new implantable products.

Dr. Thorsten Goettsche, CTO at OSYPKA AG, explains why his company is pleased to be involved in the project: “Our customers have an urgent need for faster development times and more flexible solutions for new innovative active implants, both technically and in terms of development. The market sees great potential in alternative housing or encapsulation solutions.”

“The Parylene/Inorganic multilayer coatings technology that was developed at Comelec in a unique hybrid equipment platform presents outstanding material performances. With SEALANT, we aim to demonstrate how to use it as highly reliable encapsulation material that will give rise to a completely new paradigm in the field of AIMD design”, said Dr. Florian Bourgeois, Head of Research at Comelec SA.

“The next generation of optical cochlear implants (oCI) based on the method of optogenetics faces specific challenges in view of their long-term stable encapsulation. In particular size constraints and the request for mechanical flexibility due to the oCI implantation into the spiral-shaped cochlea can only be achieved using a multilayer coating technology as targeted in this ambitious project”, explains Dr. Patrick Ruther, head of the Neural Implant Group at IMTEK.

The team is excited to pave the way for future AIMDs in a three-year cooperation.

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