.
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`_______._..
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`
` "
`April 1999 I $1:
`.dicai device & diagnostic industry.
`' 21, no. 4 (Apt 1999)
`
`.- 2316331 Collection
`#152966:
`
`#
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`PROPERTY OF THE
` ifiig
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`NATIONAL
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`Materials Directory, p. 100
`
`001
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`N vr C
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`e E: 131%
`US. Patent No. 7,891,085
`
`
`Nevro Corp.
`Ex. 1011
`U.S. Patent No. 7,891,085
`
`001
`
`

`

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`William F. Cubert
`3 lW445-3TOI). Fax: 3 1 {M4453 1‘9")
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`DIRECTOR OF SIM-£5
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`
`
`ELI Sextun
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`GROUP SALES MANAGER
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`ACCOUNT EXECUTIVES
`Suuthwest: Carolyn Dulc-
`Nuniiwesl: Mulch Konoudi
`Midwest: Neal Hniler
`Eastern: Julie Sieinkraum
`(973:3ux-9445)
`Northeast: Keith Parry
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`CONTRIBUTING EDITORS
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`
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`Toni Medsgcr
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`SENIOR ASSOClATE ART DIRECTOR
`
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`
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` ADVERRSING TRAFFIC SJPERWSOR
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` DIGITAL PRODUCTION MANAGER
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`Mark D'Anloni
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` SENIOR PRODUCTION ARTIST
`In: If Polrnat:
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`Mam: Aguilcra
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` PROme ”NETS
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`CflTIUE- l-‘iurcs
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`.Iuan Gonzalez
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` CIRCULATION DIRECTOR
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`Willy Bniijns-Miller
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`GROUP SALES MANAGER,
`SPECIAL PROJECTS’CLASSI FIEDS
`Mandy Harrison
`SPECIAL PROJECTSICLASE FIEDG
`ACCOUNT EXECUTIVE
`Patrick Thompson
`INTERACTIVE MEDIA SALES MANAGER
`Lisa Bradley
`INTERNAWSALES
`Douglas Sellers
`Dia’t‘lar rifSrih‘I. Europe
`Tel: +49 l} 6122 95590
`Fax: +49 I] 6122 510%}
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`Hermann Jordi. Charlolle ilasler.
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`Tel: +6“ 32 665 31 86
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`n‘frVHllfI Uri-fry if: lJi'uxmiric IiufliiirJ-(ISSN DI‘J-iH-i-IX] I" mitiixltcd Inuniiily by Cumin (.‘nlurmmiclliulifi
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`llt'. I Ill-J W. (Jlg'lllpil: NHL. Sw.9fl(1.ln\' Angclcfi.Cr\‘)ll(Jh-I! IIIIIIMS-flliil: FAX II II1f-I-JT‘I-42‘I‘J. PI:-
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`rindicnis primed paint ul LIN Angela. California, and hi .Iddilinnni mailing ul'l'u-eea. SUBSCRIPTIONS—-
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`I'mc liHIuHIiI'iM NUIJMTJI’ETS :5 defined "It the sI-hwripliunwrd. il'
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`Deiim'yuulsidc United Smash} nirwrvit'e. I-'urlc1c[lfinmc Inquiries regarding submipiil NI> cull fiSlffii'ifI-
`
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`733-1. liar-1i i‘isuch: Sll] pcrwpy. prepaid. CHANGE OF ADDRIi ‘ —-\Iuiiu:s should he .xenl pmllll‘d)’
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`lo I‘D. Ila: 2165!. SI. Paul. MN 55l2l. Plan-«e provide aid nu rig luhel J'i well as new mldmas. Alluw
`1M) mum Fur change. EDi'lURTAL COM RiIiUTiUNS—Ullwlicilwl Illllllll'blilIJ'JI) h'IlllllId In: nuhmii-
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`It'd in lupin chllnll 311::qu bu illullfllllilitl by slqlnperl rulum cine-lupus. Cup)! will reteiv wer)‘ mmnii‘lld
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`Ingmph-s. nr mallumipts. NOTiCI-i
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`Imwi'lhe infiirnunim supplied Ul‘flrlilr'lfl‘lihcd ur Inr ilil)‘ npininn exprem‘d herein.
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`'1')er «\S'I'ER—Sdnl address Changes in .Ii‘rril'mi' i'Jr'i'r'r'r ii Dirlgirrli'ri'ri'mflu“
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`H): PD. ”in 2th: | ,Si. Paul. MN .‘iSl2l . (Iumulinn i‘mr Juicninliwiill I’uhIiL'alith
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`Mail I’JIJILUL'I (melinn IJI.\II ilintiun: Safes: Aim-ennui“ N0. IIfiN‘JSIT. I’Iinlcd in
`USA. DIW‘J by Cumin Cnmnlnnlcnllnm I.I.L‘. All rights rtfiI-‘fli'll- Ilk-
`pruilurliiin in ii-lmi: nr purl willmul wrillm permission is |Imlliliilul.
`
`
`
`
`
`
`Medical Device 8‘ Diagnostic Industry 0 April 1999
`
`002
`
`002
`
`

`

`This material may be protected by Copyright law (Title 17 U.S. Code)
`
`003
`
`

`

`-
`
`3W Wptifi
`_' Normtaxoic
`_Wigenic
`
`‘umr'
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`91 999 IfhllllpsCh___m|cal_ng1pany.
`a dlviglon'Bl finilflips Petigeym 90m
`'Caiculétéd iro'r'fi p'Uhllshd
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`004
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`

`

`Has one of the highest dielectric strength ratings of any thermoplastic material
`Dielectric strength: >4.000 Vimil (60 Hz)
`Dielectric constant: 3.3
`
`Dissipation factor: 0.0025
`Volume resistivity: 10IE Q-crn
`
`Shrink temperature
`
`185“ to 374°F (85° to 190°C}
`
`
`
`Wall thickness
` Tensile strength
`
`
`
`
`Electrical insulation
`
`
`
`Surface resistivity: 1014 fl/squarc
`
`
`
`
`
`
`
`
`
`Ultrathin wall thickness can be achieved (0.00015w40.004 in.)
`
`Very high tensile strength can be realized (520,000 psi).
`
`
`
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`
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`
`
`
`
`
`
`
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`
`
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`High, 455°F (235°C)
`
`5—1596 typical-—up to 70% if drawn or stretched during application
`
`
`
`
`
`
`Table II. Preperiies ofpolyester (PET) treat-shrink tubing.
`
`made as thin as with polyester tubing and still retain useful
`strength, and wall-thickness tolerances are generally quite high.
`PTFE shrink tubing is typically used as a liner inside devices and
`as a covering for metal components and devices.
`
`PET SHRINK-TUBING PROPERTIES
`
`The key properties of polyester heat-shrink tubing are listed
`in Table II. With polyester tubing, shrinkage is a function of
`temperature: the hi ghcr the temperature, the higher the shrink-
`age. PET shrink temperature ranges from approximately 185° to
`374°F {85“ to 190°C). Unrestricted, the tubing will shrink both
`radially and axially, and the best overall performance is achieved
`with minimal shrinkage (less than 15—20%). Whenev-
`er a very high radial shrinkage is required (up to 70%),
`the tubing can be drawn while it is being heated. The
`ability to draw or stretch the tubing to achieve very
`high radial shrinkage while maintaining thin walls is
`unique to polyester.
`
`Electrical Insulation. Virtually every type of heat-shrink tub-
`ing is used in electrical insulation. Materials are typically cho-
`sen based on temperature, dielectric strength, cost, and wall
`thickness. High dielectric and resistivity properties make
`polyester heat-shrink tubing an effective electrical insulation
`material that adds little dimension because of its ultrathin walls.
`
`It can be used over needles, for example, to protect the surface
`of the skin from being burned during electrical stimulation and
`has also been employed effectively to cover electrical compo-
`nents or to insulate wiring on catheters and other devices (Fig-
`ure 1}. Some manufacturers are using PET tubing over metal
`shafts for electrical insulation, replacing a coating process. Ap—
`plication of the polyester greatly reduces the likelihood of the
`
`
`
`Figure l. Black polyester shrink tubing covers a needle (right), leav-
`ing only the tip exposed. Electrical wires (left and middle) are cov-
`ered will: clear polyester inbr‘ngfor insulation.
`
`Medical Devlee It Dlagnoatie Industry - Aprll1999
`
`005
`
`SHRINK-TUBING APPLIGATIDHS
`
`Variable-Stiffness Catheters. Because of its ultra-
`
`thin walls, polyester heat-shrink tubing can be used to
`add stiffness to catheters without significantly adding to
`the size of the device. By using different thicknesses of
`tubing along the length of the catheter, varying degrees
`of flexibility can be created for improved control of the
`device. This quick and easy tubing application elimi-
`nates the need for joining dissimilar materials or adding
`braid to sections of a catheter in order to achieve mul-
`
`tiple zones of stiffness. For example, some manufac-
`turers use shrink tubing with a wall measuring l—mil
`thick at the back end of a catheter, lit‘s-mil in the middle,
`'lat-mil near the end, and no tubing at all on the tip end.
`This provides varying degrees of stiffness along the
`length and the flexibility that is required at the tip.
`56
`
`005
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`

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`Figure 2. Clear polyester slrrink tubing (top) holds a liter-
`nracouple against a molded plastic probe and covers a coil
`spring (middle). Three tubes and two wires (the wires are not
`visible in tlre pirate) are bundled with clear polyester tubing
`(bottom).
`
`kind ot'pinhole formation that sometimes may develop in coat-
`ed surfaces.
`
`Protective Covering, Encapsulation, and Bundling.
`Polyester heat—shrink tubing is often used to cover braided
`catheter shafts. spring coils, radiopaque marker bands, and other
`parts that require a thin but tough protective covering. The tub-
`ing allows for smooth transitions over sharp edges and can be
`scaled against Fluid leakage. For instance. it has been placed
`over a rotary spring cutter to keep debris from clogging the coils
`and to act as a bearing surface inside the device. The tubing pro—
`vides a fluid seal, yet the cutter remains flexible.
`A wide range of heat-shrink tubing compositions are used in
`various strain relief applications. Many applications call for
`thick, flexible materials while others call for thinner, stil't’er
`tubes. Polyester heat-shrink tubing can be used to provide strain
`relief on catheters and other tubes to prevent kinking. A braid-
`ed catheter witi tenrl to kink at the point where the braid ends
`but-encapsulation with heat- shrinktubing providesaquick eas-
`ily applied IeinfoIccment and a smooth transition over the two
`surfaces. Repeatablc and consistent, shrink tubing is again an ef—
`ficient alternative to coatings, eliminating solvents and other
`chemicals and offering an inherently uniform surface.
`Eudoscopcs and other devices can be downsized or have more
`features added without increasing overall instrument dimen-
`sions by using shrink tubing to bundle various components (other
`tubes, wires, optical fibers. etc.) into the smallest possible space
`(Figure 2}. Connecting tubes at the ends ofa device can also be
`made of thin-wall polyester to save valuable space. Often.
`enough space can be freed up to add another working channel iu~
`side an endoscope, or to enable a designer to reduce the size ol‘
`the device by a whole french catheter size.
`’[hbe Joining. Both polyester and l‘luoropolymer heat—shrink
`tubing (typically FEP) are used in [using tubes together. Typi-
`cally, tubes of dissimilar properties—one still and one flexi-
`bleharejoined (Figure 3). An easy way to accomplish this is to
`insert a wire mandrel in the tube ends to keep them from col~
`lapsiug, butt the two ends together, attd shrink a piece of tubing
`
`Aprll1999 - Medical Device & Diagnostic Industry
`
`
`
`
` "
`proactive partlctpatmn putsusaheadt -_
`other“—customsiItEunefabricator intheifiilitstiv.
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`57
`
`006
`
`006
`
`

`

`
`
`be left on or peeled off to leave an ultrasmooth surface finish;
`nicking the shrink tubing at an end before shrinking facilitates
`removal. Because the tubing is clear. the operator can see when
`the tubes are fused. This ability to ntonitor the process is very
`useful during product development attd production to avoid ap-
`plying too mtteh or too little heat.
`Tillie Marking and Printing. Nearly all types ofheat-shrink
`tubing can be used in tube marking and printing with the ex-
`ception of PTFE (because it
`is extremely difficult to get any
`type of ink to bond to P’TFE). Depth marks and printing can eas-
`ily be added to catheters and metal shafts with heat-shrink tub-
`ing (Figure 4). Typically. thin bands of colored shrink tubing can
`be accurately positioned and used for marking. Labeling infor-
`mation can be added by preprinting on the shrink tubing, then ap—
`plying it to the product, avoiding the need to send the devices
`themselves to a printer for labeling or to bring printing inks and
`solvents into the manufacturing facility for in-housc printing.
`Some products, such as catheters made from high-density
`polyethylene, cannot be readily printed without surface treat-
`ment. adding more complexity. Manufacturers who do print on
`their products can position clear heat-shrink tubing on top of the
`printed surface for protection without adding substantially to
`over them. Since poiyestcr tubing has a low shrink temperature,
`the diameter of the product.
`the parts do not distort during this initial application when the
`CallieterTip Forming. The low shrink temperature and high
`shrinking process squeezes the tubes and holds them together
`melt temperature of polyester heat-shrink tubing enables it to be
`tightly during fusing. And given polyestcr’s high melt tempera-
`used effectively to form smoothly tapered tips on the ends of
`ture, the high heat applied to fuse the tube ends does not melt the
`catheters (Figure 5). In the initial operation. a section of heat-
`shrink tithing. After the tubes are joined, the shrink tubing can
`
`
`Figure 3. In tribe joining, itertt-sitrt'nk tithing is used to hold
`it iow-rinrotneter eiear tube and o itigit-rlnronrerer white tnbe
`rightly rogetiterforfnst'ng. The sin-ink tribe is shown partintiy
`(middle) and contpfeteiy removed (bottom) from the joint.
`
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`Circle Reader Service #83
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`PROPORTIONAL
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`IPERfOkMANCE
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`Figure 4. A clear tube (top) is marked with bands of shrink
`tubing. Prepriuted shrink tubing (middle two images) is
`strewn before and after shrinkage in a iabeliug application.
`At bottom, alternating white and biack bands of tubing are
`shrunk onto a clear catheter tube.
`
`
`
`
`
`Figure 5. In catheter tipforming, clear polyester shrink tub-
`ing iSfirst attached to the end efa catheter tube. Heat is ap-
`Ph'ed with a hot-air torch (extendingfrom background) white
`a hemestat is used to put! and draw the shrink tube, forming
`H smooth, tapered tip. A wire is used to prevent the tip H)
`from collapsing during the process.
`
`shrink tubing is slid onto the end ofa catheter tube, leaving a tail
`off the end. A rod is then inserted in the catheter to maintain the
`UP inner diameter, and heat is applied to shrink the tubing to the
`substrate. Once the tubing is attached, the heat is increased to
`cause the substrate to melt and flow. Pulling on the shrink tube
`draw. the catheter tube to a very thin, smooth tip. Once again,
`because the shrink tubing is clear, an operator can easily moni-
`lor the process. Finally, the shrink tubing is peeled off to com—
`plete thejoh.
`Micro Hose Clamps. Bands of polyester heat-shrink tubing
`can function as micro hose clamps on balloon catheters to rein
`force bonds and help prevent failure under pressu re (Figure 6}.
`A narrow band oftubing is applied over the end of the balloon.
`With its high hoop strength. the polyester grips the part much like
`
`
`
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`I High Cycle Life
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`April 1999 - Medical Device a Diagnoetle Industry
`
`Circle Reader Service #90
`
`5 9
`
`008
`
`008
`
`

`

`
`
`The number of people
`OVGI“ 65 will double to about 70 million
`by 20301 -— a potential boon to health care,
`biotechnology, and medical services.
`
`[ Ever think what that could mean for you?]
`
`FIDELITY SELECT HEALTH CARE PORTFOLIOS
`ONEYEAR
`FIVE YEAR
`TEN YEAR
`
`
`
`
`
`
`Biotechnology
`13.31% 21 .44%
`25.75%6
`Health Care
`36.97% 29.74% 26.04%
`
`
`
`Medical Delivery
`—- 9.05% 1 3.96% 19.12%
`
`
`
`Medical Equipment
`N/A
`MIA
`
`
`
`and Systems
`
`RETURNS AS OF 12331.93. PAST PERFORMANCE IS NO GUARANTEE OF FUTURE RESULTS.2
`
`
`
`If you follow developments in health care and understand
`
`the industry fundamentals — which is more than just
`
`watching stock prices — you may want
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`
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` a hose clamp, reinforcing the bond and
`
`keeping it from lifting off. It also provides
`a smooth transition without adding sig-
`nificantly to the bond diameter. The tub-
`ing can also be used to terminate braiding.
`spring coils, and other parts to provide a
`smooth transition.
`
`Masking Procedures. A simple but
`very effective application of polyester
`heatvshrink tubing involves masking
`areas during coating operations. For ex—
`ample, one manufacturer might require a
`white coating over a clear balloon. btlt
`the neck must remain uneoated so that a
`UV~eurabIe adhesive can be used to bond
`
`-
`.-i-'
`tile" KW...-
`amen-w?»
`
`it to the catheter. A piece of heat-shrink
`tubing is applied to the neck. and the bal-
`loon is then dipped in the coating. After it
`dries. the tubing is peeled away. leaving
`the neck uneoated [Figure 7}. The key to
`this application is the thinness of the
`polyester tubing; a thicker shrink tubing
`would leave a prominent ridge of coat-
`ing material on the balloon.
`In another recent application. a manu-
`facturer needed to apply a slippery coat-
`ing to a length of wire that has a line
`
`
`figure 6. Clear, l-nnn bands of polyester shrink tithing are shrunk over boll:
`ends of a latex balloon (shown nnntflaterl andparrt'ally inflated). Tlre shrink trib-
`lng acts like hose clamps to reinforce the bonds and prevent the lighted balloon
`from peeling away from the catheter lobe and looking.
`
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`Call for new FostalenIMFostathaneTMand
`Fostelink'”information and samples.
`
`Foster Corporation
`PO. Box 997
`
`Dayville, CT 06241
`Tel:
`(860) 774-3964
`Fax: (860) 779-0805
`lSO 9001 Registered
`
`Foster West Corporation
`4336 Loses Ftoad. Suite 3
`North Las Vegas. NV 89030
`Tel: (702) 6444880
`Fax: [702) 544-5819
`SO 9002 Registered
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`With years of experience and expertise in providing
`innovative solutions in meeting the Medical
`Products Industry‘s needs for radiopaque poly~
`mers, specialty compounds, custom thermoplas-
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`it’s no wonder more
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`22 03
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`
`
`Figure 7. Clear angioplasty balloons are shown rrfter o 1le lie
`coating has been applied to one end. Polyester shrink tubing
`was nsertl to mask the small-diameter ends to prevent tltetn
`from being coated. This enables the manufacturer to use a
`UV-eurrtble adhesive. The shrink tubing has been removed
`front the end of the top balloon and partially reutovedfroin
`the bottom balloon.
`
`spring coil at the end. Polyester heat-shrink tubing was used to
`mask the spring to keep it from being coated during the dipping
`process. The low shrink temperature permitted the masking op-
`eration to be carried out without heat distortion to the coil, and
`the tight shrink tit prevented the coating from flowing into the
`spring. At the end of the process. the polyester tubing was sim-
`ply peeled away.
`
`CONCLUSION
`
`While some of the applications and many of the specific uses
`discussed in this article are only possible with polyester heat—
`shrink tubing, other heat-shrink tubing materials are available in—
`cluding polyolefin, fluoropolymers. and PVC. All of these ma—
`lerials are used in medical device [manufacturing PET
`heat-shrink tubing is particularly useful because olits ability to
`be produced with ultrathin walls. Other tubes are often too thick:
`designers do not have enough space to incorporate shrink tubing
`with walls thicker than 0.00] in. The ultrathin walls and other
`
`properties of PET tubing make it an extremely valuable tool for
`designers attempting to rethink the way that they build medical
`devices.
`
`ACKNOWLEDGMENT
`
`The author would like to thank Mike Barbcre and Ilidia
`
`Porto. both of Advanced Polymers Inc. for their assistance.
`
`
`Mark Saab is president of Advanced Polymers lire.
`NH). l
`
`
`fStllL’tit,
`
`A hypertext version of this article will be available on Medical Device
`Link. http:ttwwwdeviceiinkcomtmddi. by May 1.
`
`
`
`
`
`Medical Device & Diagnostic Industry - Aprll1999
`
`Web Site: uwwtostereompcom
`
`62
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