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Medical Tubing And Extrusion Technology

Currently Medical Disposables and Low-end medical equipment in India are led by the Domestic Manufacturers. Plastic Disposables accounts for 25-30% of Medical Devices, while Implants accounts for 20-25% of Healthcare Market in India. Today, plastics are the dominant tubing materials for transferring IV Fluid, Drug and other applications for Patient Feeding in hospitals and clinics. The medical tubing segment comprises the most dynamic area in the medical device landscape. The market of plastic Tubing is expecting significant growth due to changing global demographics and the growth of medical procedures such as minimally invasive surgeries. Primary drivers of the global market for medical tubing are the increasing demand for medical devices that incorporate tubing, the growing access to health care around the globe, which carries with it a market for medical devices and the tubing associated with those devices and minimally invasive surgeries.

Critical Applications

Plastic tubing plays a pivotal role in many advanced medical procedures, such as vascular catheters, conduits for acquiring biopsy samples, and holders for stents being implanted into heart arteries. Minimally invasive techniques such as angioplasty drove the need for tubing with small diameters and thinwalls, temperature control became critical for maintaining tight dimensional tolerances. Other Examples of tubing applications include high-pressure catheter tubing, stent-delivery catheters, and balloon tubing used in medical balloons, especially stent delivery balloons. Examples of markets that rely heavily on tubing technology include the following:

• Neurovascular (e.g., treatment of stroke).
• Cardiovascular (e.g., angioplasty, stenting, cardiac ablation, and mitral valve repair).
• Peripheral interventions (e.g., stent grafts, venous therapy).
• Endoscopic and renal denervation applications
• Implants (e.g, inferior vena cava filter, and prosthetics valves).

Material & Process Requirements For High-Quality Extruded Tubing

A good understanding of polymer science and the behavior of polymer materials is extremely important for achieving high-quality extruded tubing. Polymer material suitable for medical tubing should have: Inertness to body tissues and fluids, Flexibility, Resistance to sterilization conditions, Low extraction, Clarity and Low cost for high volume applications. PVC, with the best combination of performance and cost, is the most widely used plastic medical tubing material. PVC has been the material of choice for flexible medical tubing and respiratory masks for more than 30 years because of its balance of cost and functional properties. Polyethylene is the second largest material in medical tubing based on volumes consumed. TPE, polyamide, silicone, fluoropolymer and PEEK also find specialized niches in tubing systems. PP and PC are also used as medical tubing materials.

Tubing quality is affected by a number of factors, including raw material selection, material handling, and the many parameters of the tubing extrusion process. All of these materials have their pros and cons. One drawback is that many of them contain gels, requiring that tubing manufacturers have proper understanding of the process technology and know how to either minimize or eliminate the gels in the tubing. Another drawback is residence time in the barrel. Because these materials have complex chemistries, they tend to be very sensitive to excess heat, shear, and process times. Because they degrade quickly, well-established processes, highly trained technicians, and well-maintained equipment are key to successfully extruding precision medical device tubing repeatably and reproducibly.

Advances in extrusion technology are aiding the evolution of plastic tubing with the latest developments that include special formulations offering unique combinations of desired properties such as strength, flexibility, a high gas-barrier rating and lubricity. The extrusion process is only as good as the manufacturer’s ability to control it.

A tube’s dimensions can affect the performance characteristics of extruded medical tubing. However, process parameters, equipment, and material characteristics also play an important role in determining the end properties of an extruded tube. Tubes have also shrunk dramatically in recent years, to the point where a human hair is thick compared with some tube walls. Manufacturing such products poses considerable challenges, requiring special extrusion equipment, precise process control, and painstaking inspections.

Medical Tubing Configurations

Medical Tubes are categorized mainly by following types according to Different Configurations:

  1. According to the structure : Single-Lumen, Double-Lumen, Multi-Lumen, Two-Row, Multi-Row etc.

  2. According to the performance : High-Pressure Tube, UV Protection Tube, Flame Retardant Tube Antimicrobial Tube, Gamma Ray Protection Tube.

  3. According to the usage : High-Transparent Tube, Tube With Color Line (One Or Multi-Lines), Radiopaque Tube (One Of Multi-Lines Or Whole), Micro-Flow Tube, Intravascular Tube, Balloon Tube, High-Pressure Tube.

Single and Multi-lumen tubes

No longer will a single-lumen microbore tube suffice for medical applications. What often works best is a multi-lumen tube, one with passages for several tasks. Of course, tubes need to stay the same micro-diameter but now require multiple lumens (more than one hole). Multiple lumens are designed to achieve a desired performance in the smallest space possible. Two to 12 lumens can be designed into a single tube to provide multiple activities through a single access port. ”Lumens often carry fluids, wires for steering a catheter, and devices to grasp tissue for a biopsy and doctors want to monitor their progress during a surgical procedure, so there could also be a fiber optic line in another lumen,” So the tube has become a delivery system. For example, with neurovascular devices designed to reach the brain for treatment, the catheter and delivery system require micro-diameter extrusions with precisely controlled walls. Also, Lumens are no longer expected to be round, and eccentric shapes (oblong or crescent for example) are becoming more common.

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