Nordson MEDICAL has a long, successful track record of supplying high-precision, specialized extruded tubing to the medical device industry. A global partner with facilities around the world, we specialize in high-performance tubing for critical applications. We know that speed to market is key, so we offer expertise in premium, medical-grade extruded tubing with expanded capacity in our U.S. and European facilities with less than two weeks lead time on new projects specific to multi-layer PTA/PTCA applications, single-lumen, and multi-lumen tubing. We also scale to your production needs with confidence through FDA registered production sites, ISO 13485 certified facilities, and Class 8 qualified production cleanrooms.
Our single-lumen tubing includes ultrathin-wall tubing and microthin-wall tubing.
From simple to the most complex designs, our multi-lumen tubing has 2-9 lumens for simultaneous passage of guidewires, catheters, fluids, and/or gasses. The number of lumens depends on the material and cross-sectional area. Lumens can be shaped to meet user requirements and contained within a round tube or other cross section like an oval or figure-eight.
The extrusion of multiple layers of material is done simultaneously to produce multi-layer tubing. Multi-layer technology is primarily used to improve functionality; for example, to combine a weldable material with one that has other performance characteristics, like lubricity. These constructions can also increase performance and possibly reduce overall assembly and material costs, making the medical device more cost effective for the customer. Other key functionalities may include active material layers, such as hydrophilic, bioresorbable, or drug-eluting layers. The technology and materials now used to produce multi-layer products for today's medical devices have advanced greatly and provide the designer with a wealth of opportunities for optimizing size, materials, and functionality.
Co-extruded multi-layer tubing can combine materials with different but complementary properties, including durometer, color, opacity, radiopacity, or tensile strength, to provide custom catheter solutions. The most common application is medical extruded tubing with radiopaque stripes visible under x-ray. This is accomplished by encapsulating stripes containing a filler visible under x-ray within the wall of the tubing. Typical fillers include these compounds, which can be used in various concentrations to enhance radiopacity:
Advances in multi-layer medical extruded tubing have come a long way in providing increased capability to procedures that were previously difficult to execute.
|Co-Extruded Multi-Layer Component||Desired Primary Property on Inner Layer||Inner Layer Material||Desired Primary Property on Outer Layer||Outer Layer Material|
|PTA/PTCA Inner Tubing||Lubricity||HDPE||Bondable to adjacent device components||Nylon 12|
|Infusion Tubing||Chemical inertness||HDPE||Flexibility||PVC|
|Tungsten-Polymer Marker Band||Radiopacity||80% Tungsten-filled PUR||Smoothness||PUR|
|Implantable Central Venous Catheter||Flexibility||PUR||Antimicrobial||Silver ion-filled PUR|
|Coronary Implant Delivery System||Lubricity||HDPE||Bondable to adjacent device components||Pebax|
Also referred to as melt fluoropolymers as they are processed with traditional extrusion equipment, our line of fluoropolymer tubing is created through a proprietary compounding/blending process that provides custom color and radiopaque fillers while maintaining strict process control.
From pellet to product, Nordson MEDICAL processes an array of fluoropolymer materials including FEP, PFA, PCTFE, ETFE, PVDF, ECTFE, and EFEP. Nordson MEDICAL is one of the few companies in the world with expertise across all of these raw materials.
Fluoropolymers are chemically similar to polyolefins, with the exception of substituting fluorine for hydrogen. This drastically changes the properties. Fluorine's electronegativity causes the bond between carbon and fluorine to be the strongest bond in organic chemistry. This strong bond lends itself to fluoropolymers, achieving high temperature resistance, lubricity, electrical resistance, dielectric strength, and low reactivity.
All of these properties lend to fluoropolymers being extremely biocompatible, and thus ideal, for medical applications. Their drawback is in long-term-use applications under load, as fluoropolymers are notorious for cold-flow, or material creep.Fluoropolymer Properties Chart
Fluoropolymers are known for their combination of superior properties, whether chemical, electrical, or physical. Chances are that when you choose to use a fluoropolymer, it will have to be bonded with another part, whether metal, plastic, ceramic or composite, in order to perform its intended function. This can be a problem, since fluoropolymers are notorious for their lack of bondability. This lack of bondability is caused by the very stable, covalent carbon-fluorine bonds that make up your fluoropolymer. These bonds are so stable that the polymer has difficulty bonding to anything else, even temporarily. To improve bondability, one must remove some of these carbon-fluorine bonds. This process is called fluoropolymer etching, and is a solution that Nordson MEDICAL offers to combat the bondability problem.
Etching is a chemical process that removes the fluorine atoms from the surface layer of the fluoropolymer. This surface layer is so thin; it is most conveniently measured in Angstroms. Once the fluorine atoms are removed, the carbon atoms left behind in the etched polymer quickly form temporary bonds with atoms from the air, such as oxygen, nitrogen, and sometimes even hydrogen. Since these bonds are much weaker, the carbon atoms are still reactive, reducing the surface lubricity and allowing for a more bondable product. Because of the loss of carbon-fluorine bonds, once the surface of your fluoropolymer is etched, the properties of the etched area are changed. One will no longer have the lubricous and low energy surface that is expected from a fluoropolymer. Instead, one will have a wettable, bondable, frictional surface upon which to glue, mold, or print onto your product.
While there are a variety of methods available for fluoropolymer etching, Nordson MEDICAL exclusively uses a solution of Sodium Naphthalene for our in house etching processes. We offer alternate etching chemistries through subcontracts currently in place with outside etching companies.
Etching will only affect the chemistry of the surface with which it comes in contact. The properties of your fluoropolymer are kept intact not only underneath the etched surface, but on the entire remaining unetched surface as well, meaning that the etched product's bulk properties are unaffected by this process.
The results of the etching are not permanent, however. If left unused for long periods of time or stored incorrectly, the etched part regains its initial low bondability.
Nordson MEDICAL offers a variety of etching configurations:
At Nordson MEDICAL, all of our fluoropolymer products are custom manufactured to meet our customers' needs. We can assist whether you have a current design or require our engineering support to design an etching solution for your application.
PEEK is becoming an increasingly popular choice for catheter-based devices. With excellent strength and heat endurance, PEEK is one of the few polymers that can replace metal, even in high-temperature sterilization applications. This versatile material allows designers to heat form, tip, taper, flare, or flange complex catheter designs. Visit our Online Store for PEEK extrusions.
Tapered tubing has a transition in outer and inner diameter in a section of the extruded tube. More complex than typical extrusion operations, tapered tubing production requires sophisticated control on the tube pulling/cutting station combined with other process equipment to achieve precise tapered tubing dimensions.
Bump tubing is similar to tapered tubing but has a bump (area of increased outer diameter) along the length of the tube.
The dimensions that can be achieved using this technology depend on the material used. Advantages of this type of specialized extruded tubing include eliminating labor-intensive assembly steps such as welding and stretching.
We can extrude complex shapes and geometries to give you a custom profile.
Nordson MEDICAL brings state-of-the-art extrusion equipment together with materials and engineering expertise to develop specialized extruded tubing for the most demanding interventional and surgical applications. We offer:
Medical device designers of catheter-based devices use lubricious materials to ease insertion into the body or into another device, boost pushability, and increase sensitivity of movement. These lubricious materials are used as a tubing liner, as an alternative to hydrophilic coatings, or as a way to improve bonding to other components. We have multiple configurations of lubricious, single-lumen extruded tubing available in our Online Store with the following market-leading lubricious additives: EverGlide®, PEBASlide, ProPell S™, and Mobilize. Contact us to discuss custom medical extruded tubing with lubricious materials and additives.
Sometimes process parameters and extrusion equipment are more important than the actual dimensions of the tube.
Technical information on single- and multi-lumen tubing, multi-layer tubing, and more