Purpose:
The purpose of this announcement is to provide information regarding Confluent Medical’s new REACH Compliant TPU offering using our filmcast technology.

Filmcast Overview and Roles of Thin TPU strike layers:
Confluent’s filmcasting technology applies ultra-thin microlayers of polymer continuously onto a wire. This technique is particularly suited for creating composite structures where tight tolerances are required.  The inner liner options include PTFE for instances where lubricity is paramount, or polyimide for applications requiring dielectric properties or increased strength.

Many shaft constructions feature braiding or coiling, along with thermoplastic outer jackets carefully tailored to emphasize specific performance attributes such as flexibility or kink resistance. In numerous catheter or shaft designs, thermoplastic outer jackets are utilized to facilitate bonding to luers, hubs, strain reliefs, or other external components. To optimize adhesion for subsequent lamination processes, customers often prefer incorporating thin “strike layers” of thermoplastic materials over the liner and/or braid matrix. These strike layers are typically extremely thin, with wall thicknesses ranging from 0.0001″ to 0.00025″, and are directly applied over the liner material.

One popular choice for strike layers is the family of thermoplastic polyurethanes, commonly known as TPUs. Confluent presently offers several durometers in this family including Tecoflex 60D, 80A, and 93A. 

Benefits of REACH Compliant TPU’s:
To filmcast the specific TPU grades mentioned above, the industry standard method utilizes a solvent that is REACH restricted. In a recent finding that could have ramifications in the industry, the EPA has found that the particular solvent, as a whole chemical substance, presents “an unreasonable risk of injury to human health when evaluated under its conditions of use.”  This finding determined that the solvent posed an unreasonable risk to health in 29 of 37 use cases, which include domestic manufacturing, import, processing in plastics manufacturing, various other industrial uses, as well as disposal.  The EPA is expected to propose a set of risk management actions, which will then be followed by a public comment period.  There is still substantial uncertainty as to the final restrictions, which puts the established filmcast TPU supply chain in question

In the current state, European (EU) MDR regulations have strict limitations on the amount of restricted substances that can be contained in devices sold in the EU.  Ensuring compliance of components utilizing filmcasted TPU strike layers may require extensive testing by the tubing manufacturer and the end customer to ensure compliance to the MDR guidelines.

Benefit of Confluent Medical’s REACH Compliant TPU’s:
To mitigate this risk mentioned above, Confluent has developed a REACH Compliant TPU offering that drastically simplifies the overall compliance process.  These materials can be applied utilizing no restricted substances.  This is a huge benefit to customers as there are no restricted solvents to remove or extensive and expensive testing to conduct.  The resulting product looks and performs like the products our customers are accustomed to working without the current hurdles of ensuring compliance.

Timeline:
April 1, 2024 Confluent Medical will began offering our REACH Compliant TPU’s with No REACH Restricted Materials to the market.  Estimated lead times are expected to be consistent with our current best in class turn around.  If you would like to discuss further and learn more about Confluent Medical’s REACH Compliant TPU offerings, our experts are ready to help you at https://confluentmedical.com/.