Sherrie Conroy (SC): What are the key methods for developing materials that will be used to create biomedical textiles for neurotech devices?

Jeffrey Koslosky (JK): Secant Medical employs a variety of engineering approaches when engaging with device design clients to develop a biomedical textile component for a neurotech device. We believe that the key to a successful design is having a solid understanding of the performance and biological requirements of the medical device, the method of delivering the device, and the materials needed to deliver these properties. Our engineering team takes these criteria into account and begins an iterative design and development process to produce a solution for the neurotech device design. Often our textile structure may be integrated with another component within the device, or it may need to fit in a small delivery system. This iterative phase of the development process becomes the underpinning to the overall success of the project.

Another perspective for development involves a strong understanding of how various fabric architectures and constituent materials will perform and respond when used in a neurological application. We have a strong understanding of the engineering properties of these structures and how they behave in free space, knowing that the neurological environment can augment the fabric behavior in a dramatic way. Central to overcoming these challenges is the open dialogue and sharing of information and test results that occur when our textile and design engineers work closely with the engineering staff at the device developer. Since every device is unique and presents specific challenges, open communication allows for the design of the fabric to be modified to respond to these challenges and enable the technology to result in a successful development.

SC: What sorts of textile structures and fabric geometries provide the needed form and function capabilities for such devices?

JK: We have access to a wide range of textile forming techniques and offers fabric geometries that are woven, knitted, and braided. There are other fabric geometries such as nonwoven felts, but they are not very relevant for neurotech applications due to their thickness, poor mechanical properties, and ability of fibers to slough off of the structure. The selection of the fabric architectures is essential and must meet all of the performance and biological variables presented in a critical neurological application. Our engineers and designers work collaboratively with our clients to target the appropriate geometries specific to the shape and function of the fabric. The fabric can be shaped into tubular and multi-lumen structures, tether and suture geometries, or even near-net shapes that include fenestrations or branches. Our goal is to utilize our wide toolkit of forming techniques, a broad cross-section of polymeric and metallic materials, and our decades of experience in neurotech component design and production.

SC: In the early stages of development, what are the key requirements that manufacturers must know in order to identify the appropriate materials?

JK: We believe that it is critical for our team to discover as much information as possible in the early stages of development. Our medical device clients generally have a strong understanding of the performance requirements of their device, but need some assistance in understanding how to leverage a biomedical textile to meet those requirements. Our textile engineering team works as an extension of the clients’ device engineering team, to bridge the gap between the requirements of the neurology application and what’s possible with a biomedical fabric.

Initial conversations with clients typically revolve around the physical characteristics of the device, the delivery method, and the expected device performance after it is deployed. Oftentimes in neurotech applications, we are working with very small, precision devices that are delivered via micro-catheters. We are typically challenged by our clients to deliver a fabric structure that maximizes performance, but minimizes the deliverable profile.

Key to meeting these requirements is a strong understanding of the raw material options that can be utilized as constituent materials to form a textile. These can include standard polymers or bioresorbable polymers that are designed to fully resorb over a given period of time. When selecting biomaterials, the design teams must consider not just the immediate performance of the textile component, but the future biological state that can promote the growth and incorporation of the patient’s tissue into the structure.