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Coextrusion is on the increase in tubing for medical uses, with more layers,

more exotic materials, and much thinner walls. These require unprecedented
levels of dimensional accuracy and flaw detection.
Click Image to Enlarge

Two Ways of Making Complex Tubes Just below, Putnam Plastics wire-wraps one
tube, coats it, and then embeds it in a a tube with a second lumen. On the bottom,
Putnam coextrudes two blue stripes for position indication in a dual-lumen TPU tube.

Makers of gauging devices are scrambling to find ways to "see" some of the latest
micro tubes that have walls and coex layers only 0.0002-0.0003 in. thick. Photo: On
Line Controls

Tubing dies grow more complex: Genca recently developed a die combining three
layers, spiral mandrels, and thermal isolation to run high-heat nylon next to thermally
sensitive PVC.

Makers of puller/cutters have developed computer software to control the OD profile


of taper tubing by interpolating between specified points. (Photo: R.D.N.
Manufacturing)

Gauging suppliers have not solved all the problems of making complex tubing. Here,
a QC technician at Pexco checks a dual-lumen tube magnified 20X. On-line sensors
can only monitor OD, so lumens must be checked off-line.

David-Standard's "Corporate Extruder" is one of several newmodels with more


rugged designs for high output of thin medical tube. It runs catherers at 300 ft/min,
twice the previous rate.
Highly specialized medical tubing has always involved weird and wonderful feats of
miniaturization and complexity. But until recently, the tricks of making micro tubing
were largely a matter of artistrybased more on specialized experience and
extrusion know-how than on precisely defined die, sensor, or downstream
technology.
Indeed, tubing dies have typically been among the least sophisticated used in
extrusion. Often they are relatively basic in-line monolayer dies with spider legs
inside. Processors also frequently do without any downstream calibration: The tiny
flexible tubes of PVC or polyurethane, which remain sticky even when cool, often
dangle freely in a cooling trough supported only by internal air pressure.
Some of the tiniest and most complex tubes have been made with relatively simple
techniques. Tubes reinforced with wire or fibers and containing tiny hollow channels
or lumens blown with micro air jets, have been made for years in a series of
extrusion and coating steps that allow processors to stop and check the product after
each step.
For example, Putnam Plastics Corp. in Dayville, Conn., makes a dual-lumen tube in
which one lumen is wire-reinforced (see photo), and the other not. The sequence or
steps begins with extruding over a metal mandrel, then braiding over the tube with
flat wire. Then the tube is coated a second time, and a profile with a second lumen is
extruded over the tube (which would collapse if it weren't reinforced). The final
outside diameter is 0.079 in. 0.002 in.

Tolerances on this and other equally complex tubes have been maintained for years
by monitoring the OD and checking samples off-line after each step. Even when
processors create bump tubing and tapered tubes using computer-controlled pulling
sequences, tapers are typically checked only for OD and only at the smaller end.
"Now people are trying to get tolerances tighter," says Dave Norquist, extrusion sales
manager for the Americas at gauging supplier Beta LaserMike. "Five years ago,
tolerances were 0.003-0.004 in. Now they're 0.001 in."
Driving this change is a growing trend to coextruded tubing, which can't be monitored
from the OD alone, plus a new, more extreme level of miniaturization. Consider
Putnam's latest wire-reinforced tube, exhibited at the MD&M West show last month
in Anaheim, Calif. It has an OD of 0.022 in. and a wire spiral encapsulated in a
0.003-in. wall. It's made with tolerances of 0.0005 in.

Lots more coex to come


Both in Europe and in the U.S., makers of dies and extruders say that last year they
shipped noticeably more coextrusion equipment. "We supplied 10 three- and fivelayer dies last year," says Paul Hendess, director of technology at die maker Genca.
Competitor Guill Tool & Engineering built its first five-layer coex die for medical
tubing last year.
Hendess sees the number of coex die builds going up dramatically this year. Half the
coex dies Genca sold in 2000 were for commercial production and half for newproduct development, including replacements for monolayer flexible PVC and tubes
using exotic resins like PEEK, PTFE, and PVdF.
Coextruded tubing structures are also growing more elaborate. A seven-layer tube is
being developed for an angiographic balloon catheter by a medical-device OEM.
An increase in medical coextrusion was also the reason Milacron Inc. bought Akron
Extruders last year. The purchase adds Akron's line of small (0.75- to 2-in.),
pedestal-mounted coextruders to Milacron's single-screw line.
Sequential coextrusion of different durometers within the same layer of tubing adds
another level of complexity. Putnam first commercialized this technology over a
decade ago. Two years ago, Putnam for the first time combined dual-durometer
sequential extrusion with coextrusion of two- and three-layer catheter tubing.
Equipment maker Harrel Inc. recently patented a method of alternating polymers or
durometers using two gear pumps in tandem. One pump slows as the other speeds
up during the material switchover.
Most coextrusion of medical tubes, both for production and R&D, has been done by
medical-device OEMs. "Some OEMs have come up with multi-layer structures to
replace PVC," notes Robert Hill, sales manager at Davis-Standard Ltd. in the U.K.
"PVC replacement is happening, but not to the extent that the industry anticipated
two years ago," cautions Ray Hackney, president of Duall Plastics in Athol, Mass., a
company that was recently acquired by Bunzl Ltd. in the U.K. Charles Sparacino,
system sales engineer at Davis-Standard in the U.S., says sales of extruders for
PVC tubing have returned to normal levels after dropping sharply three years ago.
Rather than eliminating PVC outright, some new coex tubing merely reduces the
amount of PVC used by sandwiching it between other materials. This gets the

benefit of PVC's low cost and high strength, but avoids the sensitive question of
direct contact by PVC with the body or fluids entering the body.
Custom processors are less involved in coextrusion than are OEMs. Most custom
extruders run some coex jobs, but rarely more than two or three layers at a time. A
five-layer tube could be a monolayer tube with two coextrusions over it. A five-layer
die is much more expensive than a series of simpler coating dies, especially as
custom processors may produce only one or two production runs of a new tube if it
doesn't make it to commercial production. And even if a new tube does take off
commercially, the OEM then may bring production in house. So either way, the
product cycle for custom processors can be short, and they have to recoup die and
tooling costs up front.

Multi-layer, multi-lumen
Multiple lumens are appearing in thin coextrusions. One of the first processors to do
this was Putnam, which builds its own dies. Five years ago, Putnam commercialized
a nylon tube with two lumens, one lined with polyethylene to reduce the coefficient of
friction without sacrificing tensile strength.
Davis-Standard in the U.K. delivered two coex lines in Europe that include individual
air control of multiple lumens. A two-layer, two-lumen TPU tubing line went to a
medical OEM in 1998 and is now in commercial production in the Far East. And a
three-layer, five-lumen line went to a medical-device OEM last year for product
development.

Die developments
With more layers, the task of maintaining concentricity grows more complicated.
Genca included a new tip-centering feature in a three-layer die built last year. The
firm is applying for a patent on the device, called a Ball Adjusting Tip (BAT). A ball
swivel is fixed in the middle of the die bushing, which is also fixed. The moving
member works like a pool cue. Adjustments are made from the back of the die to
center the tip, which is on the ball swivel near the discharge opening.
Guill also has a patent-pending "swivel-ball" die adjustment via a ball in a socket.
The die opening is inside the hollow of the ball, which is adjusted with four screws.
An unusual, patent-pending Rotary Die Head from Guill is being tested now for
medical tubing. The tip and die rotate either together or independently to provide
more even resin flow, greater wall strength, andif desiredspiral stripes. A halfdozen of these rotary dies are in use, including one making a three-layer, threelumen medical tube with 0.062-in. OD.
Guill also received a patent last year on a new "balanced-flow" spiral die for medical
tubing.
The past year or two have seen increasing use of spiral-manifold dies for both monoand multi-layer tubing. Spiral manifolds eliminate spider knit lines, which are potential
weak points in the tubing wall.
Last year, Genca built three 1-in. dies with spiral manifolds to coextrude a nylon
outer layer, flexible PVC core, and LLDPE inner surface. The layers are thermally

isolated, so the high-temperature nylon won't degrade the thermally sensitive PVC.
This die comes in three sizes from 0.5-in. to 2-in. max. die opening.
Davis-Standard says it is building more side-fed spiral dies than in the past to
accommodate air feeds for increasing numbers of lumens. Boston Scientific Corp. in
Natick, Mass., and Dunn Industries Inc. in Manchester, N.H., have made products
with up to 12 lumens. Putnam has made a 13-lumen tube for fiber optics and
probably holds the record with a 21- lumen tube made five years ago.
On the other hand, spiral-manifold dies have the disadvantage that they must be
taken apart more often for cleaning, and cleaning them is inherently more difficult.
Consequently, Genca has developed a new curved spider leg that reportedly
improves knit lines in rigid PVC. It will become commercially available later this year.
Harrel, a builder of extruders for medical tubing, aims to remedy the spider knit-line
problem with its Spirodie, developed three years ago. Harrel puts mixing spirals after
the spider in order to recombine the flow. This adds about 1.5 in. to die length.

Tightening tolerances
It's not just tubing dies that are getting more sophisticated. So are extruder drives,
calibrators, and pullers. American Kuhne last year built its first extruder with a servo
drive. It was a 1-in. model for small, very precise medical tubing. Servo drives have
been used more often for highly precise pullers and cutters than for extruders. "The
price of servo drives has come down, and this customer wanted the best," says Ed
Steward, director of process technology at American Kuhne. "If you're running a
small extruder below 10 rpm, you have more accuracy in maintaining screw speed
with a servo than with an AC drive."
As for more sophisticated downstream equipment, Conair in Pittsburgh says sales of
its vacuum sizing tanks with upgraded digital controls grew 25% last year. "A lot of
medical-extrusion people are moving away from free-extrusion tanks to vacuum
tanks," says Conair v.p. of extrusion Ernie Preiato. "They may have been struggling
to hold a tolerance of 0.002 in., but with a vacuum tank they can hold 0.0005 in."
Vacuum sizing was used recently by Pexco Inc. in Northboro, Mass., to make an
unusual three-lumen PVC tube for blood warming. The lumens aren't tiny channels,
but thin-walled compartments roughly equal in size and difficult to extrude without
deforming. In this product, Pexco maintains three different wall thicknesses: an outer
wall of 0.0036 in., an inner wall of 0.0013 in., and two 0.0017-in. supporting webs in
between.
In the past two years, both Davis-Standard's Killion Div. and R.D.N. Manufacturing
Co. developed computer software to control the OD profile on taper tubing by
interpolating between specified points. With this software, an operator can maintain
the same taper profile while changing the overall size of the tubing. The operator just
changes a single OD point, and the program calculates the new puller speed and air
pressure automatically.
Davis-Standard Killion has also sold over a dozen cutters in the past two years that
are said to be the only ones available to cut different lengths of corrugated respirator
tubing accurately. The system uses a photo-eye to spot the cutoff point at the flat cuff
on the tube where the convolutes stop. The unit cuts at 100 ft/min line speed, says

Killion downstream sales engineer Glen Beasley. "Absolutely no one else can do
this," he claims.
Medical-tubing makers are also putting more emphasis on gauging for quality
control. Medical Extrusion Technologies in Murrietta, Calif., coextruded a three-layer
tube with one lumen using ultrasonic sensors from On Line Controls in the water
bath to verify concentricity of the layers. Lumens generally interfere with ultrasonic
gauging of layer thicknesses, but the problem can be overcome in a single-lumen
tube, Medical Extrusion says.
What about sensing the position of the lumen itself? "The wall thickness from the
outer surface of the tube to the lumen can be measured under certain
circumstances, provided the signal evaluation is sophisticated," says Ernest Henzi,
senior v.p. of marketing at Zumbach Electronics. The system must be able to
distinguish the energy reflected by the outer wall of the tube from echos reflected by
the density change at the lumen. If you can isolate the second signal, you can
identify the inner wall of the lumen, he explains. "The success of this method
depends on the geometry and position stability of the lumen." If the tube twists, it
won't work.
As tubes get smaller and walls and layers get thinner, some products have dropped
below the horizon where no current sensors can pick them up. Medical Extrusion has
made a soft polyurethane tube to deliver drugs to the brain that has an 0.003-in. OD
and a wall thickness of just 0.0003 in. And Guill Tool recently ran a successful trial of
a fluoropolymer tube with 0.010-in. OD and walls only 0.0002-in. thick.
Gauging suppliers are struggling to keep up. The Ultragage 4000 ultrasonic sensor,
introduced by On Line Controls at NPE 2000 in Chicago last June, controls wallthickness down to 0.0005 in. And a new ultrasonic gauge introduced by Zumbach at
the MD&M show in Anaheim, Calif., last month measures walls down to 0.0008 in.
Thin coextruded layers may also be too fine to detect. "It has put a major burden on
makers of wall thickness monitoring devices. They're having to get their sensors
closer to the tube and to do more scans," says Davis-Standard's Sparacino.
Zumbach and Beta LaserMike both recently introduced flaw detectors for gels and
surface defects in medical tubes. Gel detection is common in wire and cable and in
film extrusion, but new for medical tubing. Previous scanners looked only for surface
imperfections.
There is now finally a way to measure diameter along the length of a taper. Beta
LaserMike launched a new Taper System at the MD&M show last month with new
programming that monitors a continuous taper. The company also has new software
that allows a high-speed scanning laser to monitor multiple strands from a single
gauge.

Going for higher output


Another change in the past two or three years is that makers of critical tubing like
catheters are raising output rates. "The standard machine for I.V. tubing had been
2.5-in. diameter, 24:1 L/D," says Davis-Standard's Sparacino. "Now the accepted
standard is 3.5-in., 24:1."

The larger machine roughly doubles line speed from 100-150 ft/min of tubing to 200300 ft/min. "That's about the maximum for catheter production now, and there aren't
many people going that fast," notes Holton Harris, president of Harrel.
Raising outputs requires more rugged extruders. Merritt Davis Corp. in Hamden,
Conn., just introduced the new Millenium Series 1.5-in. extruder for medical tubing,
which offers an optional rigid H-frame on the portable coextrusion models. And
Davis-Standard's Corporate Extruder series, introduced last year, also has a heavier
base and more rigid frame.
Davis-Standard's Killion Div. last year developed a "hands-free" feeding technique
that captures soft, ultra-thin silicone tubing as small as 0.0032-in. OD and feeds it
automatically into the puller/cutter on start-up. The die bushing has a trumpetshaped inlet that delivers tubing to the pinch point of the puller. Otherwise, manually
feeding such soft, droopy tubi
Change one tubing lumen into two, or two lumens into three, or even split one tube
into two in a Y shape: These are some of the dramatic alterations that can be made
on the fly with a novel articulated die concept available for license from Specialty
Silicone Fabricators, a medical tubing maker in Paso Robles, Calif.
Click Image to Enlarge

Moving die parts can reshape the internal and external geometry of silicone medical
tubing on the fly. The system has yet to be tried with thermoplastics.

Three or more pairs of moving elements create a continuous Y-shaped tube that
splits from one tube into two (or even three).

Multiple moving die parts shape this profile from a round tube to a flat oval with ribs
inside. Its used for surgical drains.

Specialty Silicones latest die technology creates spiral lumen paths that prevent
kinking.
Change one tubing lumen into two, or two lumens into three, or even split one tube
into two in a Y shape: These are some of the dramatic alterations that can be made
on the fly with a novel articulated die concept available for license from Specialty
Silicone Fabricators, a medical tubing maker in Paso Robles, Calif. It builds dies with
moving components capable of extruding profiles that transform continuously from
one shape to another.
Specialty Silicones shape-shifting Geotrans (geometric transition) die technology
has been used so far only for the companys silicone rubber tubing, but it can be
licensed for non-medical thermoplastic applications.

Moving die parts


Specialty Silicone has patented a number of dies with moving parts:

Continuous Y-shaped lumen has one lumen that splits into two or three inside a
continuous tube.
Lumens can start and stop, previously accomplished only by welding plugs in a
secondary operation. This tooling (U.S. Patent 6,394,141, May 02) raises and lowers
tines in the die mandrel.
Three moving die sections make a one-piece, Y-shaped tube (U.S. Patent
5,945,052, Aug. 99) with one inlet tube that transforms seamlessly into two. Previously
such tubes could be made only by welding individual tubes onto a molded Y connector,
with the inherent risk that the welds could come apart. Specialty Silicone has even built
dies to transform one tube into three.
A one-piece surgical drain changes shape from a small round tube with 3/16-in. OD
into a wide, flat hollow profile 10 x 4 mm and then back again (U.S. Patent 5,549. 579,
Aug. 96). The single lumen transforms from round to a flat oval with ribs on one side that
keep the flat lumen from collapsing. The mandrel is round in front, sloping smoothly into a
flat oval with lengthwise ridges on one side. As the mandrel oscillates back and forth in
the die, it changes the lumen from round to ribbed oval. At the same time, die plates
outside of the profile move in and out to reshape the outside from round to flat and back,
keeping nearly constant wall thickness.
Specialty Silicones latest tooling (patent pending) creates spirals inside a profile. For
example, multiple lumens can loop or twist around each other inside a solid tube to

prevent kinking. Spirals are made with a linear sequence of two or more tortuous
conduits, threaded to give different cross-sections.

A solid panel can also be molded in the die wall in the form of a spiral baffle to
provide static mixing or turbulent flow. The lumen spins, stops, then spins in the
other direction. The spirals go one inch in one direction, then reverse and spiral one
inch in the other direction, explains v.p. of R&D Charles Schryver, co-inventor of the
dies. Then the wall between the two lumens stops, and the two lumens flow
together.

Specialty Silicones first patent simply creates tubing with a constant ID and variable
OD (Patent 5,511,965 April 96). This can produce catheter tubes with stiff, thick sections
and thin, flexible sections. Variable OD is made by moving a ring forward and back
against the die plate to alter the gap between the die opening and mandrel.

Good for thermoplastics?


An unanswered question is whether Specialty Silicones moving-die technologies will
work with thermoplastics. Commercial designers and makers of profile dies for both
silicones and thermoplastics give a qualified yes. Shear and viscosity requirements
are similar, they say, except that thermoplastic extrusion provides continuous flow,
while silicone extrusion can start and stop. Silicone dies need cooling channels, and
thermoplastic dies need heating channels. Neither can be used in moving die parts.
My gut feeling is that it could be done, says James Rathert, general manager at die
maker Genca. But it would be complex. He notes that moving parts could create
pockets where thermoplastics could burn, while silicone doesnt degrade in the die.