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:
-
According to the structure :
Single-Lumen, Double-Lumen, Multi-Lumen, Two-Row,
Multi-Row etc.
-
According to the performance :
High-Pressure Tube, UV Protection Tube, Flame Retardant
Tube Antimicrobial Tube, Gamma Ray Protection Tube.
-
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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