Cardiac Rhythm Management and Electrophysiology
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Disruptions in the electrical system of the heart can lead to serious consequences including death. To treat these conditions, minimally invasive electrophysiology procedures have been developed to restore normal cardiac rhythm. At Zeus, we have been manufacturing precision catheter componentry serving the CRM/EP market for more than 50 years.
Therapies in the science of cardiac rhythm management and electrophysiology (CRM/EP) require tight tolerance extrusions to navigate the body’s pathways. Whether the placement of pacing leads or mapping catheters, device manufacturers turn to Zeus to extrude catheter components that precisely match their design parameters. From lead delivery systems, catheter ablation, or cryotherapy catheters, Zeus extrusions are empowering lifesaving innovations to treat arrhythmias, dysrhythmias, and hypertension.
The prevalence of heart-related problems is constantly pushing the industry to develop new and better methods of treatment. Zeus products such as our ultra-thin PTFE Sub-Lite-Wall™ liners and FluoroPEELZ™ peelable fusing sleeves are allowing design engineers to push the boundaries of device innovation. Our LCP monofilament catheter braiding allows these devices to be used for MRI catheterization procedures – previously unattainable with ordinary metal braiding.
The Industry’s Thinnest Liners
Zeus’ capability to extrude PTFE in extremely thin walls (0.0015″ / 0.0381 mm) combined with the material’s superior lubricity make it an ideal selection for the lining of lead delivery systems. Our PTFE Sub-Lite-Wall™ tubing offers the thinnest extrusions with the tightest tolerances (± 0.0005″ / 0.0127 mm) in the industry. PTFE liners are chemically etched on the outside diameter (OD) to provide uniform adhesion to the outer catheter jacket. Zeus will tailor liners to your exact specifications to optimize tensile properties for your unique processing parameters while allowing maximum real estate in your working channel.
Simply PEEL It Off
Removing the FEP heat shrink from the outer shaft after reflow is a tedious task for manufacturers. Zeus has developed FluoroPEELZ™, a peelable heat shrink that is easily removed to improve efficiencies and worker safety during the catheter construction process. Large medical device manufacturers using FluoroPEELZ™ in their catheter designs have reported reduced downstream processing, increased yields, and minimal scrap – all of which provide cost savings.
Novel Materials and Treatments
Aeos™ ePTFE is an ideal material to coat left atrial appendage (LAA) occlusion devices for atrial fibrillation treatments. The porosity of this soft, flexible biocompatible product promotes cellular in-growth.
At Zeus, our reputation of quality medical device componentry together with our more than half-century of experience has made us a global leader in polymer extrusion technology. We have the expertise and capabilities to meet the continually evolving and critical demands of the medical sector.
Contact our team or call toll-free in the US 1-800-526-3842 or +1-803-268-9500 internationally for prototyping, samples, or to receive a consultation on the right solution for your design.
- APPLICATIONS
Ablation – Providing the correct balance of strength and flexibility for catheter jackets, our polymer-based catheter components have a proven track record of performance. Zeus offers a wide range of durometers and nylon grades of polymer jackets. These polymers possess excellent dielectric strength allowing secure delivery and containment of the electric currents dispersed during ablation procedures. Our products also possess broad temperature resistance and thus are able to handle both RF and cryoablation procedures.
Catheter Braiding – When metals cannot be used in certain critical procedures, Zeus offers a variety of drawn fibers including our liquid crystal polymer (LCP) monofilament as non-metallic and flexible alternatives to stainless steel braiding. These materials are MRI-compatible and available in flat and rounded profiles.
Diagnostic – When visualization is more important, such as in angiography, our catheter components are chemically inert and will not react with dyes used for contrast material. Zeus components are also amenable to a range of sterilization protocols to minimize the risk of catheter-associated infections.
Lead Delivery – Zeus products support critical functions of lead placement into target tissues. Our directional catheter components and guide sheaths can be utilized to give varying degrees of flexibility and strength for lead placement in the most challenging anatomical locations.
Mapping – For procedures where maximum flexibility is required, Zeus’ polymer linings and coatings provide optimum performance. Our drawn fiber and liquid crystal polymer (LCP) monofilament increases catheter stability and torque while enabling the capture of detailed geometries and electrical maps.
Neurostimulation – Whether for direct stimulation of nerves or to relieve chronic pain, these applications have been greatly improved through the use of catheters to place neurostimulation devices more accurately. Zeus has solutions that are optimized for such device delivery and customization is also available.
Pacemaker Insulation – Zeus heat shrinkable tubing provides insulation for implantable cardiac defibrillators (ICDs). These devices benefit from the lubricity, dielectric strength, chemical resistance, and temperature resistance of our heat shrink.
Pull Rings and Pull Wires – Deflectable catheters incorporate pull rings at the distal end attached to pull wires allowing the catheter end to be precisely manipulated to the diagnostic or treatment site. Zeus produces a range of products for wire guide coverings and sheathing for these applications.
- PRODUCTS
Catheter Liners – Typically made of PTFE that has been chemically etched to allow for bonding, these inner liners of catheters provide the utmost in lubricity, electrical performance, chemical resistance, and are UV sterilizable.
Customized Tubing – We offer a wide range of fluoropolymers and specialized plastics with a history of success in medical device applications. For your particular needs, we can provide custom etching, flaring, tipping, and prototype sampling with quick turnaround and complete technical support.
Fusing Sleeves – Heat shrinkable fluoropolymer tubing provides an excellent way to add a protective and tight jacket covering for joined catheter components or simply as an outer covering for the catheter itself. We offer heath shrink tubing in a range of polymer resins that can withstand high temperatures and contribute extremely high lubricity.
Jacketing – Catheter jackets provide additional structural support when added as layers during catheter construction and wall build-up. Removable jackets (such as Zeus FluoroPEELZ™) are also available that can be used to reflow underlying polymer coating or jacketing material over the catheter braiding.
Multi-lumen Catheter Tubing – This tubing creates multiple passages through which multiple treatments or instruments can be directed towards the treatment site. These tubings are made with tight tolerances, unsurpassed capabilities, and superior quality standards.
Non-metallic Braiding – As catheter braiding reinforcement, Zeus drawn fiber and liquid crystal polymer (LCP) monofilament provide an excellent alternative to metal wire braid for applications such as for MRI imaging where metals cannot be used.
Processing / Support Mandrels – A building block for catheter construction, this polymer core provides the central arbor around which the catheter is made and supports the desired interior diameter (ID). After construction, the mandrel is removed to produce the final ID. Our catheter fluoropolymer components are highly lubricious for easy removal and are ideal for use as build-up mandrels.
- MATERIALS
Biomaterials – The emergence of biomaterials, substances or materials that can safely interact with the body, has become a driving force in medical innovation. Bioabsorbables are especially suitable for medical applications and provide an alternative to traditional polymers and metal components. Recognizing this need, Zeus has expanded our capabilities in multiple areas to develop the most advanced biomaterials in the industry.
Absorv™ – This bioabsorbable polymer product safely exists in the body for controlled lengths of time before being absorbed without causing harm or adverse interactions. We partner with our customers to develop and deliver advanced polymers to meet their precise degradation rates and specifications. These FDA-approved products are available in multiple extrusion forms.
Aeos™ ePTFE – These advanced products from Zeus feature microscopic pores in the structure of the material by expanding PTFE under exacting conditions. The resulting porous products are imparted with unique physical properties that make them ideal for use in medical devices such as endovascular stent grafts, suture-like devices, cosmetic implants, dental and glass ionomer uses, structural heart, and tissue engineering. Aeos™ ePTFE has many of the same exceptional attributes of PTFE but differs because it provides unique properties for applications requiring porosity.
Bioweb™ Electrospun Nonwovens – Zeus Bioweb™ is a technology produced through electrospinning PTFE into polymeric fibers with extremely small thicknesses ranging from nano- to micro-scale. Together, these electrospun fibers form microporous materials with a broad range of properties. Similar to expanded PTFE, Bioweb™ has a lower basis weight than our Aeos™ ePTFE but has comparable chemical and temperature resistance. Bioweb™ is used in medical and industrial applications for biological interactions or as a specialty filtration device. Our process allows us to create encapsulation technology, spin membrane/sheet, and develop 3‑D structures for coating substrates of varying shapes and sizes with this material.
FEP – Fluorinated ethylene propylene (FEP) is a melt-processable fluoropolymer that allows for long, continuous lengths and has several distinct advantages over PTFE. Applications where FEP tubing is usually chosen require more optical clarity and flexibility. In heat shrinkable form, FEP has a lower recovery temperature than PTFE and can be used to reflow softer underlying materials such as Pebax® catheter jackets. This fluoropolymer can be made into heat shrink and convoluted products. This chemically inert material has low gas permeability, possesses an excellent UV transmission rating and dielectric strength; and is gamma, ETO, e-beam, and autoclave sterilizable. FEP can operate in sustained temperatures from -328 °F (-200 °C) to 399 °F (204°C).
LCP – Liquid crystal polymer, or LCP, is a thermoplastic resins which exhibits unique properties. These materials have a host of desirable traits including exceptional mechanical strength, heat tolerance for autoclaving, and chemical inertness. Through Zeus’ innovative proprietary processing, we have developed an LCP monofilament fiber for use as catheter braiding. This material possesses excellent tensile strength and surpasses many similar monofilaments such as nylon, polyethylene naphthalate (PEN), and even polyether ether ketone (PEEK) in terms of stiffness. Most importantly, however, LCP monofilament used as catheter braiding results in a device that is fully compatible with magnetic resonance imaging (MRI) procedures.Pebax® – This material (also known as PEBA, or polyether block amide) is used as a jacketing material in catheters which provides structural support and strength while retaining flexibility. Pebax® is a versatile polymer whose properties can be easily altered by varying its monomeric ratios and block types thus imparting a wide range of mechanical properties such as flexibility. Pebax® is available in Shore D hardness ranges from 35 to 72.PEEK – Polyether ether ketone (PEEK) is a high performance fluoropolymer that has excellent heat endurance and one of the highest strength-to-weight ratios of any thermoplastic. PEEK products are used in a variety of medical applications due to its columnar stiffness and torsional strength in very thin walls. PEEK can be sourced with ID’s as small as 0.002″ (0.051 mm) and walls as thin as 0.0015″ (0.0381 mm) nominal. PEEK Drawn Fiber is an alternative option for braiding in catheters where metal may not be preferable. PEEK fiber can also be used in place of other materials such as glass. PEEK tubing is lightweight and able to withstand operating temperatures of 500 ºF (260 ºC). PEEK tolerates high burst pressures and possesses exceptional torsion stability. PEEK is also thermoformable and resistant to gamma radiation, wear, and impact.PTFE – Polytetrafluoroethylene, or PTFE, is highly lubricious and is the preferred material in many applications in the medical field. This material has the lowest coefficient of friction of any polymer and easily tolerates ETO and autoclave sterilizations. Our PTFE Sub-Lite-Wall™ is used for the lining of catheter inside diameters (IDs) and allows easier access to difficult-to-reach body spaces. This material may be supplied etched on the OD in order to allow better bondability with other materials. PTFE Sub-Lite-Wall™ Heat Shrink improves the lubricity of wire guides over long lengths for use in endoscopy applications. PTFE’s working temperature range is -328 °F (-200 °C) to 500 °F (260 °C) and can be extruded in precision tolerances. This diverse polymer is available in a variety of forms including special profiles, monofilament, and multi-lumen for passing of wire guides, irrigation, steering cables, and more.