Company insight Material matters
The manufacture of medical devices demands a lot from materials and components, which must meet very specific requirements for use in the human body, and that need to be versatile, robust and easy to work with. Nate Doyle, a VP at Compounding Solutions, tells us how the company’s ReZalloy products bring a new era of flexibility and reliability to medical tubing.
mainstay of the medical device industry. Its softness and pliability make it a key ingredient in many devices and components. And its capabilities are consistently being expanded, thanks to innovative manufacturers like Compounding Solutions. A global leader in the manufacture of thermoplastic medical compounds, the company focuses on producing speciality plastics compounds and concentrates that meet the strict requirements of the medical device industry. Its medical TPU and polyether block amide (PEBA) alloys, which are grouped under the ReZalloy name, consist of a series of polyether or polyester- based materials made specifically to meet the strict needs of medical applications. Extremely soft and pliable, ReZalloy materials are found in wound care systems, cardiovascular catheters, speciality films, distal tips, neurovascular catheters, semi- compliant balloons used in stent implantation and more. It is in its use as intravascular tubing, however, that the extreme flexibility and reliable strength of ReZalloy Rx materials comes to the fore, as they allow for confident navigation through tortuous anatomical systems.
W
hen it comes to versatile materials, thermoplastic polyurethane (TPU) is a
“Our clients will find a base resin that is off the shelf, and that may get them close to what they need for a device, but can alter it with fillers, additives, colours, stabilisers and other factors to bring it to the specification required for their medical device,” says Nate Doyle of Compounding Solutions. “We are mostly a service company, making custom products to our customers’ specification, but we also develop our own resin technologies, and ReZalloy 1200 is the latest.”
On the Shore A scale, which measures the hardness of softer materials such as rubber, the lower the number the softer the material, and ReZalloy 1100 is a low- modulus TPU alloy with a hardness range of 35shA to 60shA. The ReZalloy 1200 series, also a low-modulus PEBA alloy, has a range of 45shA to 90shA. “TPU’s lower limit is around 70shA, so we wanted to give engineers more design space for their tubes, as they can minimise the walls in their tubing to achieve higher elongation balloons,” says Doyle. “With PEBA, the concept is the same – to increase flexibility and, therefore, the ability to navigate tinier spaces in the human body, opening up more neurological and vascular applications.
“The goal is to enable more minimally
invasive procedures,” he adds. “The 1200 series is still very new, and its properties are extremely novel. The 1100 has some direct competitors, but the 1200 series is unique, and could open up many new neurovascular applications.”
Intent on innovation
The low modulus of the ReZalloy series is ideally suited to bonding to typical catheter materials and other substrates when overmoulding. Superior softness and flexibility are coupled with exceptional softness, translucency, excellent elasticity, and abrasion and tear resistance. “The 1200 has similar applications in the body to 1100, but in the catheter market space, cardiovascular applications often use PEBA, so now we can offer similar chemistry along the entire catheter tube,” Doyle explains.
“Based on customer feedback, we are also seeing fewer issues with processability, including extrusion die drool, charring and degradation,” he adds. “These are issues with other materials, but less so with the 1200. Also, handling is better. As materials get softer, they often become more tacky, so sub-100shA the tubes and parts may stick together and need deforming to separate them, but the 1200 has very low tackiness.” Compounding Solutions is able to address such specific issues in materials design because it works hand-in-hand with its customers to understand the specific needs of the medical device sector, and its dedication to R&D is unparalleled. Indeed, the company is currently investing in a new expedite line, intended to allow its customers to rapidly produce new products as part of their innovation process. The expedite line will come online in July of 2025. “R&D is a big part of what we do,” says Doyle. “We are an extension of our customers’ materials teams, so we are there to help get new ideas to market faster.” ●
Compounding Solutions is there to help get new ideas to market faster. Medical Device Developments /
www.medicaldevice-developments.com
https://compoundingsolutions.net 79
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