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Articles from 2003 In January


Metal Tubing through Thick and Thin

Originally Published MDDI January 2003

From precision device components to novel microtools for surgery, a number of new uses for metal tubing are being explored.

How will future historians view the progress made in healthcare during the last half of the 20th century? Many are likely to see it as a period of progress exemplified by major advances in imaging and IVD technology. Others are likely to see it as the waning years of such barbaric practices as open heart surgery. Splitting open the patient's chest and spreading the rib cage to expose the heart is being replaced by far less invasive methods. Historians may also recognize the critical role that tubing has played in developing these less-traumatic methods, as well as the latest IVD and other medical systems. Advanced tube designs and new materials with a broader range of properties have been key factors in moving treatment closer to the patient and reducing trauma.

Available in a range of types and sizes, medical tubing essentially has become a commodity item in the healthcare industry—with applications in device, pharmaceutical, and clinical laboratory sectors. In addition to extracting samples, and delivering gases and fluids, tubing products enable physicians and surgeons to perform minimally invasive diagnostic and therapeutic procedures.

Plastics are commonly used in the manufacture of catheters, ventilator tubes, and other medical devices in which flexibility is a must. Metal is nevertheless the material of choice in products requiring precise tolerance, resistance to certain solvents or fluids, or other functional characteristics.

From Needles to Microtools

Metal tubing uses are varied—including syringe needles and other sharps, implantable device components, in vitro diagnostic probes, and marker bands for catheters and guidewires. More-sophisticated applications include heat-exchanger tubes for controlling blood temperature during surgery, microtools for surgical use, and stents.

By selecting various materials or processes, manufacturers can give metal tubing distinct characteristics. For example, tubing made from cobalt alloys can be used in the production of rigid or stiff endoscopes for use in certain diagnostic procedures. But a more elastic material, such as nitinol, can be used to produce an endoscope that offers a high degree of flexibility and kink resistance.

Tubing Selection Criteria

Metal tubing clearly has been an enabling technology for medical device innovation, and tubing selection can be critical in controlling production costs, improving quality, and enhancing product capabilities. A number of key factors should be considered when selecting tubing for use in medical equipment. Among these are:

  • The specific material properties needed.
  • The degree of precision required.
  • How the material will interact with or be enhanced by any coatings that may be applied.
  • Machining and finishing methods to be used.

Materials Characterization and Precision

Various nitinol compositions and grades of stainless steel are common materials of choice for medical tubing. Gold, titanium, platinum, and various alloy forms are also used. Each material offers strengths and weaknesses that should be assessed for the intended device application. For example, components for use in surgical procedures involving the brain will require a specialized material, such as a stainless-steel alloy that can be machined to precise tolerances yet remain free of minute metallic particles. A manufacturer of hypodermic needles may select a grade of stainless steel that can benefit from burr-free machining methods to significantly speed production times. Some stent makers, however, may take advantage of the shape-memory characteristics and biocompatibility of nitinol to increase product capabilities. Others will choose an alloy that can be coated more effectively than other metals.

The materials selected must offer precise levels of dimensional control and consistency. Such material properties as tensile strength, formability, and biocompatibility must be matched to the desired environment and function. As is the case with other materials used in medical manufacturing, metal tube fabrication requires monitoring and tight control of material characteristics.

Different applications can require different tubing fabrication methods—that is, welded or unwelded products. Unwelded seamless tubing has a number of drawbacks. Among these are higher costs, limitations in available sizes, wider tolerances, and longer delivery times. While tungsten inert gas welding is a fairly common method, some firms use proprietary methods that can enhance tubing characteristics. K-Tube (Poway, CA), for example, uses a laser welding technique that produces smaller heat-affected zones. The result, according to the firm, is that "the weld itself is practically homogenous and can withstand the same burst/pressure requirements as seamless."

Coatings

The addition of specialty coatings can enhance the functionality of metal tubing–based devices. As is done with polymer guidewires and tubing, coatings can be applied to increase lubricity, reduce the risk of infection, or add other desired characteristics. A good example is the use of coatings to increase the therapeutic value of stents—such as heparin or other drugs to combat restenosis. Material selection needs to take into account how that metal will react to intended coatings.

Finishing Methods

Metal tubing used in medical equipment applications generally has specific finishing requirements. Any process used must ensure that a smooth surface texture is provided while allowing control of the precision of both the inside and the outside diameters of the tube.

Machining Processes

Methods used to machine metal tubing for medical devices range from custom systems developed for specific fabrication needs to techniques adapted from other industries. Electrochemical machining (ECM), for example, is a noncontact method for shaping metal parts while reducing wear on both tools and machined parts. ECM has been used by jet engine manufacturers to produce complex parts, such as casings and compressor blades. The equipment is used to machine these components from the hardest alloys within tolerances of one-thousandth of an inch.

Among medical manufacturers, ECM has proven equal to a number of machining tasks—yielding high levels of quality and offering tools that can maintain high production levels. Uses range from electrochemical grinding for sharpening trocars to an electrochemical grinding wheel manufactured by Everite Machine Products Co. (Philadelphia) that can produce nearly 260 syringe needles per minute.

Lasers have been used to perform various machining operations in the manufacture of both polymer and metal microdevices for medical applications. Among these are drilling, skiving, stripping, and scribing. Resonetics Inc. (Nashua, NH), for example, uses laser micromachining to produce catheters for various medical procedures. Laser techniques have also been used to create precise microscale holes that have less than a 0.004 in. diameter. Such methods are used to manufacture catheters that incorporate electrical sensors, which can be used to monitor blood oxygenation in premature babies.

Steel and Nitinol Show Their Mettle

The metals and alloys available for use in medical tubing applications encompass commodity materials as well as those that are more innovative and specialized. Examples of the former include many of the stainless steels: nitinol typifies the latter. Each type has applications that are well suited to the materials' individual characteristics.

Stainless steel is commonly used in medical tubing applications—from stethoscopes to cannulae. But stainless steel can also be the metal of choice for manufacturing devices in which the material characteristics are critical. For instance, seamless vacuum-melted 316L-stainless-steel tubing produced by Superior Tube Co. (Collegeville, PA) has been used to produce devices used during brain surgery as well as coronary stents. The metal selected for such applications must be able to be formed and machined with high precision, and the finished part must be particle free.

Dennis Gudgel of Plymouth Tube Co. (Warrenville, IL) emphasizes the need for manufacturers to carefully consider the specifications of a given tubing application to avoid quality problems. He says bright annealed stainless steel is generally specified for medical applications. Gudgel adds, "There are additional finishing processes that can be specified, depending on application requirements. For an additional degree of cleanliness, the bright annealed tube can be thermocouple cleaned." For the highest degree of cleanliness and smoothness, Gudgel recommends electropolishing following cleaning. This process imparts a chromium-enriched interior surface that is advantageous.

No longer considered just a novel springy material, nitinol offers a number of distinct advantages for device designers and manufacturers. This unique metal has already proven useful in such medical applications as catheter guidewires, stents, and microsurgery tools. When properly treated, the material has been shown to have excellent corrosion resistance when compared with stainless steel, and to offer a high level of biocompatibility. For some applications, nitinol has been selected simply because its kink resistance enables manufacturers to tightly coil long metal tubes for efficient packaging.

Nitinol tubing also has been used as shaft material for complex microinstruments, according to T. W. Guerig of Zurich Research Laboratory (Zurich, Switzerland). Such a device, a 0.3-mm "grasper" cut from nitinol tubing, is used to percutaneously retrieve embolized occlusion coils (used to repair aneurysms) or even clots from the brain via an incision in the groin. "Micromachining capabilities continue to grow, and devices will become smaller and procedures less invasive," Guerig says. "These are trends that will continue to provide fuel for nitinol's continued development."

Conclusion

Metal tubing is a key element in the development of a range of innovative medical products. At one time, medical uses encompassed little more than syringe needles, trocars, and rigid endoscopes, but applications engineers now take advantage of the distinctive properties of such alloys as nitinol to fabricate new tools for surgeons and other caregivers. A number of critical factors, however, should be considered to ensure that materials and processes used provide adequate precision and safeguard the bottom line. Among these are material properties, the tubing's surface finish, the degree of precision needed, the coatings used, and the machining required.

Gregg Nighswonger is the senior editor of MD&DI.

Copyright ©2003 Medical Device & Diagnostic Industry

Making the Most of Composite Tubing

Originally Published MDDI January 2003

Some medical procedures require the use of composite tubing to provide characteristics that metal cannot. While some composite tubes are used to increase the range of capabilities offered by a device, others are used to make the product safer for both patient and practitioner.

Risk reduction and increased capabilities are key goals of composite tubing products developed by Polygon Co. (Walkerton, IN). The company's composite tubes, with diameters as small as 3 mm, are designed to have high dielectric strength and high stiffness characteristics. They are also radiolucent and resistant to chemicals. Because the composites are nonmagnetic and nonconductive, surgical tools made from the materials are well suited for use during procedures using open MRI systems. They also produce minimal distortion when used under imaging machines. Additional applications include respirators, ventilators, and other air circulation equipment.

Combining attributes of PTFE and silicone, Sil-Kore tubing manufactured by W. L. Gore & Associates Inc. (Newark, DE) is characterized by high lubricity, light weight, high tensile strength, and multimodal sterilization capability. The tubing is 30–50% lighter than comparable silicone tubing and has less than half the surface area, according to the company. The tubing is intended primarily as an endoscope component and for fiber-optic buffering uses.

Applying the theory that the sum of a tube's properties can be greater than its parts, Teel Plastics Inc. (Baraboo, WI) manufactures multilayer tubing for medical applications. Layers of different materials (such as polypropylene, polyethylene, polystyrene, nylon, and butyrate) are combined to create barrier properties that a single layer could not, according to the company. By using this layering technique, tubing can be fabricated that offers increased puncture and wear resistance; barrier protection to blood, human tissues, and gases; and a translucent barrier to moisture, oxygen, or solvents. Materials can also be combined to create specified physical properties. Among the medical products that use multilayered tubing are plastic swab sticks, pipettes, and pinch-sealed tubing.

Copyright ©2003 Medical Device & Diagnostic Industry

Computer Simulations Speed Up Development of Drug-Delivery Systems

Originally Published MPMN January/February 2003

HOTLINE

Computer Simulations Speed Up Development of Drug-Delivery Systems

Nonlinear computer simulations can reduce production costs and time to market

Simulation results 
can be used to support regulatory filings.

Advanced material properties research has been successfully coupled with a nonlinear finite element analysis (FEA) solver to create computer simulations of drug-delivery system components. According to the product's developer, Innova Engineering Inc. (Irvine, CA), the results of these studies can be used for regulatory filings and to support design and development activities. 

Capabilities of the product involve empirically developing material properties data from lab instrumentation and directly importing the nonlinear data into the solver for reliable and accurate analysis. "For example, the results of stress and strain curves of an injection-molded dogbone measured in the 'as-molded' condition would be used for extremely accurate FEA," says John Cogger, Innova's president. "Advanced adaptive meshing functionality can be deployed when displacing soft, molded materials."

The computer simulations evaluate the effects of manufacturing processes on device performance. Other applications include long-term time-dependent product shelf life studies, pre-and post-sterilization analyses, and bracketing studies at extreme tolerance ranges involving coupled components.

According to the company, of particular interest is the optimization of elastomeric components as well as conventional thermoplastics requiring specialized analysis techniques for accurate design and modeling.

Susan Wallace
   

Innova Engineering Inc., 5 Park Plz., Ste. 150 Irvine, CA 92614; phone: +1 949 975 9965; fax +1 949 975 9969; e-mail: jcogger@innovaengineering.com

Copyright ©2003 Medical Product Manufacturing News

Device Automates Marker Band Swaging

Originally Published MPMN January/February 2003

HOTLINE

Device Automates Marker Band Swaging

Band-to-band position accuracy of ±0.01 mm is achieved

Automated process equipment from MSI uses a proprietary segmental compression system to position and swage marker bands to balloon catheters.

A developer of catheter-processing equipment has developed a marker band-swaging device that automates a meticulous manual process. Marker bands are compressed and secured to the inner member of a balloon catheter to facilitate visualization of the balloon and stent during clinical use. During the swaging process, an operator typically positions the tiny band by hand under a microscope or magnifying lens and attaches it by means of thermal bonding, adhesive bonding, or industrial roll swaging. These processes require the operator to precrimp the band using tweezers to prevent movement during attachment. 

The swaging machine developed by Machine Solutions Inc. (MSI; Flagstaff, AZ) automates much of this operation. The operator simply places the band on the shaft and then inserts the shaft into the machine. The device automatically positions and swages the marker band based on parameters that were input into the system's PLC.

The machine's technology is based on the company's proprietary segmental compression mechanism, a series of segments operating together to provide uniform radial compression. The segments are machined as a single die, which grips, positions, and swages the bands. Precise positioning is achieved by means of a laser through-beam sensor system. 
Specially designed rollers move the catheter shaft through the machine, while the band is held in the swaging head. 

According to marketing director James Kasprzyk, the swaging device achieves a band-to-band position accuracy of ±0.01 mm. The mechanism "is delicate enough to attach the marker band without completely compressing the balloon catheter," he says.

"Our one-piece die closes to form a very accurate opening at very small sizes with no setup or shimming required," says Kasprzyk. "The machine combines the positioning process with the swaging, which reduces the overall manufacturing cycle time," he adds. In addition to short cycle times and accurate band positioning, machine features include minimal wear of die parts and clean operation.

Kelly Donoghue

Machine Solutions Inc., 1186 W. University Ave., Ste. D, Flagstaff, AZ 86001; phone:  +1 928 556 3109; fax: +1 928 556 3084; e-mail: jamesk@machinesolutions.org; http://www.machinesolutions.org 

Copyright ©2003 Medical Product Manufacturing News

Plated Radiopaque Wires Increase Functionality

Originally Published MPMN January/February 2003

HOTLINE

Plated Radiopaque Wires Increase Functionality

Compared with welded units, the components offer greater flexibility and decreased profiles 

This cross section of an LCX wire from Scilogy Corp. shows the benefits of plating nitinol and stainless-steel wires.

Replacing welded units, plated radiopaque wires from Scilogy Corp. (Miami) can increase functionality in a variety 
of medical applications. "Traditionally, radiopaque wire devices have been constructed by soldering a radiopaque and a nonradiopaque wire segment together end to end, but this results in a stiff joint that lacks flexibility and that can bend during use," explains president Frank Vellined. "Our LCX wires eliminate these problems because they consist of a nitinol or stainless-steel coil that is plated with, rather than welded to, gold or platinum for radiopacity," he says. 

According to Vellined, this plated design also translates into cost savings for device manufacturers, as it requires less of the expensive radiopaque materials than welded models. "The LCX wires offer the same level of radiopacity as precious-metal wires, but at half the cost," he says. Other product benefits are said to include higher conductivity, greater flex life, and decreased device profiles.

LCX wires are supplied in diameters ranging from 0.001 to 0.062 in. and in lengths up to 80 in. Shipped in coils, the wires can be customized to produce different levels of stiffness and radiopacity. Multifilar, tapered, close-wound, and variable-pitch configurations are available. Product applications span guidewires, high-conductivity leads, stents, aneurysm coils, springs, catheter wires, and flexible endoscope shafts.

Zachary Turke

Scilogy Corp., 4608 SW 74 Ave., Miami, FL 33155; phone: +1 305 269 0500; fax: +1 305 269 0501

Copyright ©2003 Medical Product Manufacturing News

Multicomponent System Balances Cure Speed and Shelf Life

Originally Published MPMN January/February 2003

INDUSTRY NEWS

Multicomponent System Balances Cure Speed and Shelf Life

Elaine Paoloni

A multicomponent cure system for GE Silicones' Tufel II line of elastomers optimizes the extrusion of thick-wall tubing.

A two-part cure system for the Tufel II line of translucent, addition-cure elastomers from GE Silicones (Waterford, NY; www.healthcare-silicones.com) provides customers with a high degree of flexibility. The system, which consists of the new IN-7 inhibitor and CA-7 platinum catalyst master batches, allows users to balance product cure speed and shelf life.

"Fabricators can vary the ratio of CA-7 catalyst to IN-7 inhibitor, within recommended limits, to optimize their cure speed," says Eric Bishop, GE Silicones healthcare industry manager. "Adding more CA-7 will accelerate the cure and allow for increased extrusion line speed. Adding more IN-7 will slow the cure and extend the mixed shelf life of the blended compound. As a result, fabricators have more flexibility than with our CA-6 one-component cure system," he adds. With such latitude, customers can meet specific equipment requirements and produce particular extrusion-profile configurations.

The greatest benefits of the multicomponent cure system, according to Bishop, are realized in silicone tubing applications--especially those that require thick-wall tubing, such as the high-pressure transfer of materials via pumps and in ophthalmic usages. "In addition to the cost savings generated by the potential productivity gains, many customers have reported an improvement in the porosity of thick-wall tubing," says Bishop.

Both IN-7 inhibitor and CA-7 catalyst master batches are supplied in 7-lb quantities, sufficient to mix with 1000 lb of Tufel II base silicone elastomer. Specific formulations are provided in a product data sheet available online at the company's Web site. Combining IN-7 and CA-7 with any of the five Tufel II bases maintains the original USP Class VI compliance status of the elastomer bases, if used in accordance with information on the product data sheet.

Copyright ©2003 Medical Product Manufacturing News

DeRoyal Acquires Waterstone Medical

Originally Published MPMN January/February 2003

INDUSTRY NEWS

DeRoyal Acquires Waterstone Medical

Zachary Turke

This 16-L Omni-Jug canister will now be offered by DeRoyal following its acquisition of Waterstone Medical Inc.

In a bid to increase its portfolio of waste fluid-management solutions, DeRoyal (Knoxville, TN; www.deroyal.com) has acquired the assets of Waterstone Medical Inc. (Falls Church, VA; www.waterstonemedical.com). Taking effect in the fourth quarter of 2002, this acquisition allows DeRoyal to better serve its customers' needs by offering large-volume canisters. "With increased efforts by the EPA to reduce medical waste and OSHA's requirements on fluid-waste management, people are in need of quick, flexible, and simple solutions," explains DeRoyal president Steve Ward. "With the addition of Waterstone's product line, DeRoyal is now in a position to help our customers meet all of these challenges through a single vendor," he says.

As part of the acquisition, DeRoyal will now offer the 16-L disposable Omni-Jug suction canister. Designed to fit into standard ring stands, this product reduces the number of canister changes required during operations involving heavy fluid irrigation. The company will also now supply the 15-L gravity-fed Drain-Jug drain receptacle. Used primarily during cystoscopies and arthroscopies, this product replaces open-topped buckets that can be knocked over during surgery or cleanup.

In addition to these canisters, DeRoyal will distribute the Aqua-Box siphoning unit and the Puddle Guppy aspirator. The Aqua-Box is a wall-mounted device that can be used to discard fluid from a standard suction canister in 12 seconds. It measures 14 x 16 in. and runs independently of a facility's vacuum system. Featuring a detachable handle, the Puddle Guppy device eliminates the need for towels and mats on the floor during surgery. 

DeRoyal will supply these acquisitions through its acute-, patient-, and wound-care divisions. The company also features an OEM division that services the medical device industry from 25 manufacturing facilities in America and abroad. 


Copyright ©2003 Medical Product Manufacturing News

Flexible Molded Foam Has Good Memory

Originally Published MPMN January/February 2003

INDUSTRY NEWS

Flexible Molded Foam Has Good Memory

Elaine Paoloni

The Bayfit 582 viscoelastic molded-polyurethane foam system from Bayer Corp. allows manufacturers to customize the slowness of recovery in products such as cushions and padding.

A state-of-the-art memory-foam material recovers its shape much more slowly than ordinary foams. The Bayfit 582 polyurethane system from Bayer Corp. (Pittsburgh, PA; www.bayer.com/polymers-usa) can be used to produce flexible, molded-foam medical products with viscoelastic properties that can be tailored to a manufacturer's requirements.


"Currently, there are very few molded-polyurethane foam systems that offer a viscoelastic formulation as an option," says Rick McHale of the polymers and chemicals communications department at Bayer Corp. "The viscoelastic performance--the length of time it takes the foam to return to its molded shape--can be adjusted to meet a manufacturer's needs." 


Tailored to manufacturers that have experience with diphenylmethane diisocyanate (MDI)-based polyurethane formulations, Bayfit 582 is supplied ready for processing. It is a full polyurethane system, consisting of an MDI-based isocyanate component and a polyether polyol component. The viscoelastic properties of the system can be customized to attain a manufacturer's desired rate of recovery. Additionally, the indentation force deflection of the system can be adjusted to achieve a consistency ranging from very soft to very firm.


The Bayfit 582 system produces low-resilience, cold-cure molded-polyurethane foams with low to medium load-bearing properties and excellent elongation, the company reports. It processes with standard mold releases and tooling similar to that used with conventional high-resilience polyurethane foam systems. It is suitable for molding both small and large parts. In addition, the foam can be pigmented in a variety of colors.


While its strength does not equal that of metal or rigid thermoplastics such as polycarbonate or ABS, Bayfit 582 could serve as an alternative to some other shape-memory materials, says McHale. "It depends on the physical-property requirements of the application." 


The Bayfit 582 system brings slow shape-recovery performance to a variety of products, including medical devices. "Devices that involve frequent or long-term human contact, such as armrests for wheelchairs and physical therapy equipment, ergonomic padding, patient-positioning aids, and other similar products, could benefit from padding molded with this viscoelastic material," says McHale. 

Copyright ©2003 Medical Product Manufacturing News

Firm Constructs Class 100,000 Cleanroom for Blister Film Pro

Originally Published MPMN January/February 2003

INDUSTRY NEWS

Firm Constructs Class 100,000 Cleanroom for Blister Film Production

Zachary Turke

Tekni Films' cleanroom initiative facilitates adherence to CFR 21, FDA GMPs, and ISO 9001 standards.

Continuing an initiative it began in 2001, Tekni Films (Somerville, NJ; www.tekni-films.com) has become the first company to offer a Class 100,000 cleanroom for blister film lamination and conversion in North America. "The new cleanroom at our Somerville headquarters represents a major industry improvement in the levels of quality and control that can be achieved during the production of pharmaceutical blister films," says vice president Michael Franklin. "Now, pharmaceuticals can be packaged with the same level of cleanliness with which they're produced, making it easier for companies to meet CFR 21, FDA GMPs, and ISO 9001 manufacturing protocols," he says.


As part of the upgrade, the 54,000-sq-ft facility now offers temperature- and humidity-controlled air in the areas used for lamination, slitting, and rewinding. Stability and in-bound and in-process quality assurance testing have also been converted to areas that meet cleanroom standards. Other factory features include a computerized batch recordkeeping system, a just-in-time raw-material storage area for rush orders, and a secure final packaging and shipping area. 


The Somerville cleanroom facility was constructed as a duplicate of one that has been in operation at the company's European headquarters in Erembodegem, Belgium since 2001. According to Franklin, this cleanroom film production facility was the first of its kind in the world and is being used to service pharmaceutical companies located in Europe, the Middle East, and Canada. The firm's Canadian and South American facilities are scheduled to complete cleanroom facilities in the first quarter of 2003.


In operation since 1971, Tekni Films supplies blister packaging films that provide a barrier to moisture vapor transmission and meet specific barrier and processing needs. The firm's product offerings include monolayer PVC, Aclar, VapoShield, and Novinex films. 
 

Copyright ©2003 Medical Product Manufacturing News

Product Genesis Expands Mid-Atlantic Presence with Company Acquisition

Originally Published MPMN January/February 2003

INDUSTRY NEWS

Product Genesis Expands Mid-Atlantic Presence with Company Acquisition

Zachary Turke

Handheld devices will be a new specialty
for Product Genesis.

Device design and development firm Product Genesis (Cambridge, MA; www.productgenesis.com) has acquired the RefacDesign product development group from Refac International Ltd. (Edgewater, NJ; www.refac.com). According to Product Genesis company sources, this acquisition was engineered to expand the firm's presence in the mid-Atlantic region and complement its design capabilities by offering new medical device and instrumentation expertise. 

"We have experience with complex technical devices, and Refac's focus is on handheld products," explains Product Genesis sales and marketing vice president Peter Flentov. "The synergy of the two firms working together will allow us to offer a superior line of design services to take our customers' products from minds to market," he says.

In the past, Product Genesis has worked successfully with neurological devices, blood-perfusion monitors, medical imaging products, disposables, microscissors, and cancer-detection kits. RefacDesign's past work includes needle-free injectors, fluid-control syringes, bone-growth stimulators, gas chromatographs, and mass spectrometers. The acquisition was scheduled to take effect in the fourth quarter of 2002, after which all services will be offered under the Product Genesis banner. 

Copyright ©2003 Medical Product Manufacturing News