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Articles from 2001 In May


Teknor Apex Launches Thermoplastics Division

Teknor Apex Launches Thermoplastics Division

Materials supplier Teknor Apex (Pawtucket, RI) has created a new division to deal exclusively with the compounding of custom and standard thermoplastic elastomers. The Thermoplastic Elastomer Div. will function independently of other Teknor Apex businesses. Company officials believe that the creation of this new unit will allow them to provide customers with total system support. As part of this support, Teknor Apex will work with customers through all stages of developing an elastomer application, including application engineering, performance testing, and process optimization. According to business manager Suresh Swaminathan, "the 'total system' embraces the entire process of developing an application and involves...working with designers, toolmakers, processors, and OEMs." An increased international presence is also cited as a benefit of the new division.

An expansion in personnel, production capacity, and research capabilities accompanies the launch. A new team of market specialists will provide information on specific end product markets. Two twin-screw compounding lines will augment manufacturing capabilities at the company's plant in Henderson, KY. Cooperative ventures with Uniroyal Chemical (Middlebury, CT) and Dupont Packaging (Markham, ON, Canada) will also help to develop new products.

Zachary Turke

In Quest to Eliminate Biofilm, Baker's Yeast Rises to the Challenge

In Quest to Eliminate Biofilm, Baker's Yeast Rises to the Challenge

The study of yeast cells may point a way toward eliminating the formation of biofilm on medical devices and implants, according to microbiologists at the Whitehead Institute for Biomedical Research in Cambridge, MA.

Fungal formations caused by Candida albicans envelop devices in a resilient biofilm coating that impairs their functionality. It also engenders infections of the skin, oral cavities, esophagus, gastrointestinal tract, and genitalia. Patients with weakened immune systems are particularly vulnerable to the organism, which causes thousands of deaths each year. Observing that yeast cells stick to the bottoms of plastic laboratory plates, microbiologist Todd Reynolds set out to find a yeast protein responsible for this adherence. "The system that initiates the formation of a biofilm in baker's yeast potentially can hold true for pathogenic Candida, as well," he says. "Once molecules involved in this process are identified, we can search for similar molecules in that fungus," says Reynolds, and ultimately find a way to neutralize them. Reynolds published his research in the February 2 issue of Science in an article coauthored by Whitehead Institute director Gerald Fink.

The researchers have identified yeast genes FLO11 and FLO8. The first encodes a cell-surface glycoprotein required for adhesion to agar, and the second gene expresses a protein that turns on FLO11 expression. Disrupting the FLO11 gene, according to the report authors, stopped the yeast cells from radiating out in their characteristic gauzy floral pattern and prevented the formation of biofilms on hard plastic surfaces. "If there's a comparable gene in Candida and a competitive inhibitor that would interfere with its ability to bind," notes Reynolds, "that could substantially inhibit the fungus from setting up a biofilm or even, perhaps, from adhering to human tissue in an infectious situation."

The fungal biofilm discoveries have been exclusively licensed to Cambridge-based Microbia Inc., a start-up biotech company cofounded by Fink. Although research is still at an early stage--the company tentatively plans to begin animal trials by the end of 2002--Microbia has discussed the technology with device OEMs, who have expressed significant interest. "Ultimately, we would want to partner with several individual device manufacturers by product area," says vice president of legal affairs Sarah Cabot.

Norbert Sparrow

Packaging Suppliers Unveil Spring Collections

Packaging Suppliers Unveil Spring Collections

Rexam Medical Packaging has optimized porosity in its foil header pouches to reduce sterilization cycle times.

A polyester/polyolefin laminate that can be processed on high-speed equipment and header bags with a range of novel properties are among recent product announcements from packaging suppliers.

The Integra Peel LCP polyester/polyolefin film laminate from Rexam Medical Packaging (Mundelein, IL) incorporates the firm's proprietary Core-Peel technology, a peelable system that is suitable for high-speed rotary and platen sealing equipment. Core-Peel products offer a wide operating range on packaging machines, and because the peel and seal functions are segregated into two layers, peel strength is independent of sealing conditions. Integra Peel LCP is designed to eliminate the curl-back effect that occurs with conventional film laminates. The films remain flat when the package is opened, thus preventing the nonsterile outer film surface from coming into contact with the product.

Combining header bag and foil lamination technology, Rexam has also developed a high-barrier peelable pouch suited for packaging moisture- and oxygen-sensitive devices that require EtO sterilization. Because it is porous, the Integra Pack Foil Header Pouch reduces EtO cycle times. After the package has been sterilized, the Tyvek header can be removed, sealing the product within the foil pouch that protects it from moisture, oxygen, and UV light.

For device-packaging applications where durability is an issue, the company has introduced a header bag based on coextruded blown films. Integra Pack Tuf 2000 combines the properties of various polymers including nylon resin technology, which provides impact strength and puncture resistance. A new coating enables a peelable Tyvek-to-film heat seal that can be processed at low temperatures and that promotes porosity and seal-transfer uniformity.

Oliver Products Co. has announced the addition of header bags to its line of medical packaging systems.

Adding to the spring bounty of packaging news, Oliver Products Co. (Grand Rapids, MI) has announced that it will begin supplying header bags to its customers. The products are manufactured using the company's proprietary DotCoat adhesive process, which enhances breathability.

"Porosity is of utmost importance in header bags," notes sales and marketing director Jeff Murak, "and by using the DotCoat process, we are able to offer our customers an uncoated Tyvek, which is almost unheard of." The product's porosity optimizes air and gas movement during sterilization and accelerates odor dissipation and degassing; consequently, the bags can be shipped shortly after treatment. They can be supplied in a range of films and gauges, and in sizes ranging from 4 to 36 in. long and 4 to 27 in. wide.

Norbert Sparrow

Laser Deposition Technique Creates Thin Coatings on Implants

Laser Deposition Technique Creates Thin Coatings on Implants

Laserapatite coatings can be applied in 1–3-µm layers.

In implant procedures, malfunctioning porous coatings can pose serious problems to both patients and devices. Erothitan Titanimplantate AG (Schmalkalden, Germany) has developed a technique that promotes the adhesion of extremely thin coatings of hydroxylapatite (HA) to the surfaces of implants. Laserapatite coatings—which require no implant surface preparation—can be applied in layers as thin as 1–3 µm to titanium, as well as a variety of other metals, ceramics, and polished surfaces including glass and optical devices. The technology was introduced in February at the Micro and Nano Technologies in the Life Sciences conference which was held in Zürich, Switzerland.

Erothitan's approach to implant coating differs from traditional methods in two respects. First, the company has developed a special grade of HA powder that offers superior adhesion to substrates used in orthopedic and dental implants. Second, the firm applies this powder to implants via pulsed laser deposition. Laserapatite is formed when an excimer laser strikes the powder in a vacuum chamber filled with argon gas.

"The advantage for manufacturers of medical products is that they can coat delicate components, such as spinal implants, without the burning associated with plasma spray coating," says Wolfgang Roth, president of Erothitan. Furthermore, notes Roth, Laserapatite has been shown to display better adhesion to implants and less brittleness than HA coatings applied by means of plasma spray. "With plasma spray coating, you get about 30 MPa of adhesion," says Roth, adding that many companies abandoned their use of HA because of this, opting instead for metal coatings. "But we get almost twice this adhesion with Laserapatite, and we achieve a smooth, homogeneous coating," he says.

Applications expected to benefit from the use of Laserapatite include hip implants and knee implants. The latter are being tested with a coating system that operates in air, incorporating YAG and CO 2 lasers. Stent coating and drug delivery are other possible application areas, notes Roth.

Erothitan has been working on Laserapatite since 1994. The company originally developed the technology to coat its own hip joints. Roth explains that Laserapatite was first conceived in response to Erothitan's frustrations in dealing with contract ceramic plasma spray coaters. "The [plasma spray coating] process was unreliable, and we had to make our own documentation," he says. Erothitan has performed both in vitro and in vivo tests on Laserapatite, and the coating is currently undergoing clinical trials in the United States and Europe.

The company envisions supplying medical OEMs with contract coating services incorporating Laserapatite, or licensing the technology to interested parties. Erothitan also plans to apply Laserapatite to its own line of implants, says Roth. He adds that the firm is developing a nickel-free shape-memory titanium alloy that will be easier to machine than nitinol and will alleviate concerns about allergic reactions in patients.

Benjamin Lichtman

Spaceball Brings Enhanced Motion Control to CAD/CAM Applications

Spaceball Brings Enhanced Motion Control to CAD/CAM Applications

A new tracking ball allows movement and rotation along all three axes of motion.

A manufacturer of computer peripherals has committed to several initiatives that broaden the market for its 3-D motion controllers. Fitting a range of hand sizes and designed to minimize arm and wrist stress, the Spaceball 3003 FLX and 4000 FLX controllers supplied by Labtec Inc. (Vancouver, WA) use a tracking ball that allows movement and rotation along all three axes of motion. Suited for digital content creation in a range of 3-D applications, these peripherals offer improved access for operators in CAD/CAM and other fields.

The implementation of Microsoft's DirectInput standards increases accessibility by allowing Spaceball controllers to be driven directly by a Windows operating system. Traditionally, 3-D motion controllers have been driven by the design software. Consequently, unique drivers were required for each software package and had to be individually updated when the program was revised. The Microsoft standards eliminate these concerns, allowing the controllers to work directly with the operating system regardless of the specific software or application.

A universal serial bus (USB) model broadens the controller's installation options. "With many modern computers having one or even no serial ports," says senior vice president and general manager Joyce Ouellette, "USB is emerging as the connectivity standard." The new Spaceball controller supports this standard and connects simply even to laptops. Categorized as a low-power USB device, the USB-IF certified controller will be available in June.

New users will also be attracted to Spaceball technology by the controller's compatibility with Intel's 64-bit Itanium processing platform. When it arrives on the market, this platform will offer accelerated processing times for 3-D applications. Spaceball users will be able to take advantage of this feature immediately, as the appropriate drivers will be released before the 64-bit applications arrive on store shelves.

Zachary Turke

Internet Update

Internet Update

Polymer Molding Site Launched

http://www.rimmolding.com

A new Web site offers information on polyurethane reaction injection molding (RIM). Located at http://www.rimmolding.com, the site enables product design and development personnel to learn more about RIM technology. RIM is suitable for the production of strong, lightweight parts; molding complex curves and geometries; and encapsulating metal parts. The site features resource material for both newcomers to the molding process experienced users. It also includes RIM innovations in formulas and applications and Bayer product data. A tech support page provides design engineering and materials characterization assistance. Recycling information including technical papers and lists of available technologies are also offered.

Touch Monitors Available On-Line

http://www.elotouchexpress.com

A company that designs and manufactures touch monitors recently expanded its Web site with an improved interface, simplified navigation tools, and integration of e-commerce services. The site is located at http://www.elotouchexpress.com and provides registered users with information on existing accounts and on Elo products. New users can apply for credit terms and reseller discounts by clicking through on-line forms. Interactive account services include balance, credit limit, and outstanding invoice information; order status, including shipment tracking; part number and product descriptions; and on-line forms to request a touch monitor demo program, price quote, or return authorization number. Users can select from a range of CRT and LCD touch monitors and pay for them in a familiar e-commerce fashion. By searching through product data, part numbers, and product drawings, users can choose from a variety of form factors and technologies.

Software Enables On-Line Graph Viewing

http://www.spssscience.com/viewer

Scientific graphing software enables users to publish graphs and charts as high-resolution interactive Web objects. SigmaPlot 2001 allows graphs to be posted on a Web site or Intranet page as objects instead of regular gif or jpeg files. Anyone can zoom, pan, or print the image at full resolution directly from a Web browser window. Optional security settings restrict data access to authorized users. The WebViewer, a free Internet Explorer plug-in, is automatically downloaded when the browser encounters a SigmaPlot 2001 graph. A live demonstration of the software is available at http://www.spssscience.com/viewer. Additional features include area plots that allow researchers to shade areas below or between curves, a graph style gallery that can save templates of favorite graphs for reuse, an equation solver for functions containing a single independent variable and a number of parameters, and a true-color EPS exporter.

Katherine Sweeny

In Brief

In Brief

Perlos Corp. (Nurmijärvi, Finland) has signed an agreement with Aventis (Strasbourg, France) for the production of a new type of dry-powder inhaler. According to Perlos, around 600 million inhalers were sold worldwide in 2000....Osteotech (Eatontown, NJ) recently announced that it has signed a private-label distribution agreement to market a pedical screw system and cervical plating system in the United States and Canada. The system was developed and manufactured by Alphatec Manufacturing (Palm Desert, CA), a distributor of orthopedic implant products....Regulatory affairs consulting firm CanReg Inc. (Hamilton, ON, Canada) is expanding by moving to a 12,000-sq-ft facility in Dundas, ON, Canada. The company assists pharmaceutical and medical device companies in registering their products with government agencies in the United States, Canada, Europe, Australia, and Asia....Colorado Medtech (Boulder, CO), a provider of medical technology outsourcing services and medical imaging products, has announced that it is entering a multiyear manufacturing agreement with Xanthon Inc. (Research Triangle Park, NC). Colorado Medtech will manufacture the Xpression analysis instrument, a component of Xanthon's high-throughput gene expression analyzer....Lytron Inc. (Woburn, MA) has appointed AMS Technologies, Thermotech Div. (Milan, Italy) as its support center for customer sales, technical, and applications support in Italy. AMS Technologies represents all of Lytron's product lines, including recirculating chillers, copper and stainless-steel tube fin heat exchangers, ambient cooling systems, liquid-to-liquid heat exchangers, and cold plates....Express Manufacturing Inc. (Santa Ana, CA) has moved into a new 35,588-sq-ft building that is intended for small- and mid-volume production work. Services to be housed in the building include SMT operations, prototype assembly, through-hole assembly, wave soldering, functional testing, and mechanical assembly....Bodine Assembly & Test Systems (Bridgeport, CT), a manufacturer of high-speed assembly and testing equipment, and The U.S. Baird Corp. (Stratford, CT), a manufacturer of CNC wire-bending, side-forming, and deep-drawing equipment, have formed Specialized Automation Solutions. The joint venture will provide solutions for aspects of specialized automation, material handling, testing and measurement, and technology integration....Manufacturer of arbitrary waveform and function generators Pragmatic Instruments (San Diego, CA) has announced the addition of three new domestic manufacturers representatives: Aztec Enterprises Inc. (Aurora, CO), Berndt Associates (Arlington Heights, IL), and Testech Inc. (Richardson, TX)....Shepard Caster Corp. (St. Joseph, MI) has purchased the assets of Bassick Casters from Kaspar Wire Works (Shiner, TX). Shepard Caster Corp. is a full-service caster manufacturer with a variety of in-house manufacturing capabilities including cold heating, steel stamping, die casting, painting, and assembly....PPI Modular Structures (Naples, FL) has established a new division specializing in environmental structures. Its Environmental Rooms division, based in Chicago, will expand the company's expertise in designing and building cleanrooms.

Katherine Sweeny

Copyright ©2001 Medical Product Manufacturing News

Presenting the 2001 Medical Design Excellence Awards

Originally Published MPMN May 2001

Presenting the 2001 Medical Design Excellence Awards

The Medical Design Excellence Awards (MDEA) is the only awards program devoted exclusively to recognizing contributions and advancements in the design of medical products. An impartial, multidisciplinary 10-member jury with expertise in biomedical engineering, human factors, industrial design, medicine, nursing, diagnostics, and medical packaging evaluated more than 80 products submitted to the MDEA 2001 competition. The 28 finalists representing the 10 categories are profiled here.

The MDEA program is organized by Canon Communications llc and sponsored by MPMN's sister publication, Medical Device & Diagnostic Industry magazine. Corporate sponsorship for the 2001 MDEA competition is being provided by MedSource Technologies (Minneapolis), a firm that specializes in full-service outsourcing and complete project management for medical device manufacturers; DuPont Tyvek (Wilmington, DE), a supplier of sterile packaging materials for medical products; Agion Technologies LLC (El Segundo, CA), a provider of antimicrobial surface treating services; Battelle (Columbus, OH), a company that offers R&D and project development services; Avail (Dallas), a contract manufacturer of medical disposable products; Colorado MEDtech (Boulder, CO), a full-service contract manufacturer and product developer of medical devices and equipment; and IBA Medical Sterilization & Analytical Labs (Chicago), a supplier of sterilization and laboratory services.

The winning products will be displayed at the Medical Design and Manufacturing East Exposition, June 5–7, 2001, in New York City. For more information, call Canon Communications at 310/445-4200 or visit the program's Web site at http://www.mdeawards.com.


Critical Care and Emergency Products

Life Support for Trauma and Transport

Individualized, portable system provides flexible, continuous care

The Life Support for Trauma and Transport (LSTAT) system is a networked intensive-care unit and surgical table in a smart patient platform that measures only 5 in. thick. It comprises a state-of-the-art defibrillator, ventilator, suction device, three-channel fluid and drug-
infusion pump, point-of-care body chemistry analyzer, and patient monitoring subsystem. These medical subsystems are integrated onto a common information architecture that captures, stores, and transmits continuous, real-time, multidevice patient data. Integrated Medical Systems Inc., Signal Hill, CA.

Radical Signal-Extraction Technology pulse oximeter

Pulse oximeter noninvasively monitors oxygen saturation and pulse rate

The signal-extraction technology pulse oximeter was designed for continuous noninvasive monitoring of oxygen saturation of arterial hemoglobin and pulse rate for adult, pediatric, and neonatal patients in hospital and home environments. It consists of circuit boards with analog components and DSP chips with patented algorithms, an LCD, a patient cable and sensor connection, a medical-grade power supply, a serial communications port, and analog output and nurse-call interfaces. It can be used as a stand-alone pulse oximeter, a handheld oximeter for spot checking and transport monitoring, and to upgrade pulse oximetry in existing patient monitors. Masimo Corp., Irvine, CA; I.N. Inc., Los Alamitos, CA.

XCalibur Mobile Transporter

Composite ambulance cot enhances prehospital emergency care

With a 600-lb capacity, the XCalibur accommodates very heavy patients while providing ergonomic benefits to its operators. Control mechanisms are concealed inside hollow composite tubing to increase safety and reduce required maintenance. The XCalibur is made of multilayer resin and glass composites held together with epoxy adhesives. Using composite materials, the designers were able to make the cot aesthetically simple and cleanable with subassemblies that can be easily replaced using common tools. Ferno-Washington Inc., Wilmington, OH.


Dental Instruments, Equipment, and Supplies

BriteSmile 2000 tooth-whitening system

System requires less time than conventional methods

The BriteSmile 2000 incorporates fiber-optic light emitters in conjunction with a gel for a noticeable whitening effect after three applications. Fiber-optic cables are carried inside an articulating arm to bring the light from the cabinet to customized light emitters that shine in a constrained pattern. Multiple emitters illuminate only the teeth that require whitening to reduce treatment time to 11Ž2 hours. Ideo Chicago, Evanston, IL; BriteSmile Inc., Walnut Creek, CA.

WaterPik Flosser

Lightweight handheld device removes dental plaque

A single-use nylon filament enables the WaterPik to gently reach between teeth and below the gum line to remove plaque associated with gingivitis. The unit consists of a soft-grip handle that operates on one AA battery, a cartridge containing a month's supply of replaceable flossing tips, and a stand or charging base. Also available is a set of color-coded snap-on hygienic sleeves to prevent family members from accidentally sharing devices. The product is designed to be easier to use than dental floss because it comfortably reaches into areas where plaque forms and the tip does not break off between teeth. Volan Design, Boulder, CO; WaterPik Technologies, Ft. Collins, CO.


Finished Packaging

Kabiven multichamber parenteral nutrition packaging system

Package is designed to hold a total nutrient admixture in a single container

The Kabiven parenteral nutrition package holds a mixture of fat, amino acids, glucose, and electrolytes in three chambers separated by inner seals. This design simplifies preparation and allows room-temperature storage for 24 months prior to mixing. Peelable seals make it possible to mix the product without exposing the solutions to the environment. The overall packaging concept seeks to minimize environmental impact, toxic emissions or by-products, and waste volume. Fresenius Kabi, Uppsala, Sweden.

Prompt L-Pop dental adhesive system

Etching, priming, and bonding can be performed in a single step

The packaging of the Prompt L-Pop divides contents into three separate compartments. It is suitable for bonding between dentin and enamel to composite filling materials and fissure sealants, as well as for orthodontic bracket attachment. The single-patient packaging eliminates the need for bottles and evaporation while reducing cross-contamination. ESPE Dental AG, Seefeld, Germany.


General Hospital Devices and Therapeutic Products

Acapella chest physical therapy device

Device combines benefits of positive-pressure therapy and airway vibrations

Designed to mobilize pulmonary secretions, the Acapella chest physical therapy (CPT) device is intended for patients with lung disease and associated secretory problems. It is easier to tolerate and is less time-consuming than other CPT systems and facilitates the opening of airways. The vibratory positive-pressure (PEP) therapy system functions independently of gravity controls and meets the needs of patients with low-pressure and low-flow constraints. The device can be used with a standard mouthpiece, a mask, or a TheraPEP pressure port and gauge for precise measurements. It contains a one-way inspiratory valve that allows inhalation and exhalation without removing the product from the patient's mouth. Product Genesis Inc., Cambridge, MA; DHD Healthcare, Wampsville, NY.

Goldenberg Snarecoil needle

Disposable needle reduces patient anxiety and pain

The Goldenberg Snarecoil needle is a sterile, single-use device that is designed for obtaining bone-marrow specimens in an outpatient setting under local anesthesia. It consists of two sections: a handle constructed of injection-molded polycarbonate plastic components, and a needle made of stainless-steel tubing and a sharpened wire. An inner snare mechanism allows the physician to capture the specimen after insertion with a simple movement of the device's lever. The needle is then removed with a minimal amount of force and without causing specimen distortion. Ranfac Corp., Avon, MA; Alec S. Goldenberg, MD, Bellevue Hospital Center, New York City.

Grab n Go III portable medical oxygen system

Device combines an oxygen cylinder, regulator, and content gauge

The Grab n Go III was designed to simplify the administration of portable medical oxygen while improving safety through the elimination of exposure
to high-pressure gas connections. The precision-machined unit has fewer parts than a conventional portable oxygen system. Components are integrated to provide value through ease of use and safety, while reducing overall cost to end-users. Praxair Inc., Danbury, CT; Western Medica, Westlake, OH; Lewellen Design Inc., Wooster, OH.

Protectiv Acuvance IV safety catheter

Safety feature provides needlestick injury protection

Designed for the administration of medically prescribed fluids, the Protectiv Acuvance IV safety catheter is a sterile, nonpyrogenic, nontoxic, single-use IV device. The catheter features a unique needle-holder design to facilitate handling of the device during insertion and threading into the vein. Almost the same size as conventional IVs, the Protectiv Acuvance does not require changes in insertion technique and can be redirected to enter the vein, if needed. Ethicon Endo-Surgery Vascular Access, Cincinnati, OH; BioPlexus, Tolland, CT.


Implant and Tissue-Replacement Products

Ancure endograft system

Abdominal aortic aneurysm treatment is less traumatic

The Ancure surgical procedure uses a catheter to insert a sheath through the femoral artery in the leg, a less-invasive procedure that causes fewer traumas than traditional surgical techniques. The device's graft implant passes through a 5-mm aperture and is then positioned, deployed, and fastened remotely. The delivery technique involves removing the implant jacket, exposing the ipsilateral attachment system, using pull rings to release the implant, controlling its movement, and sealing it. Numbered safety tabs prevent out-of-sequence deployment. Stirling Design, Aptos, CA; Guidant Corp., Indianapolis.

Helex septal occluder

Prosthesis minimizes invasive closure of atrial septal defects

A permanently implanted prosthesis is composed of an implantable occluder that is premounted on a 9-F delivery system and a preshaped delivery catheter for access to atrial septal defects that eliminates the need for a long intruder sheath. Within the 9-F delivery catheter is a control catheter, which pushes the device during delivery, and an integral retrieval cord that allows device withdrawal during loading and retrieval. Both catheters are supplied with radiopaque markers at their distal tips for fluoroscopic visualization during device deployment. A cardiologist can reposition or remove a malfunctioning device without compromising patient safety. W. L. Gore and Associates, Flagstaff, AZ.

Nucleus 24 Contour cochlear implant

Implant benefits those with severe to profound hearing loss

The Nucleus 24 Contour is an implant with a permidiolar electrode array that safely places stimulating electrodes adjacent to the modiolar wall of the cochlear without the use of invasive bands or positioners. The implant operates by receiving sound through a speech processor, then transforming it into electrical impulses that are transferred through the electrode array to stimulate the ganglion nerve cells in the modiolus. To achieve optimal access to the auditory nerve, a conical cavity is drilled in the temporal bone with a tiny entrance that can accommodate insertion of the implant. Cochlear Ltd., Sydney, Australia.


In Vitro Diagnostics

Benchmark automated histology staining system

Automated system stains tissue samples on glass microscope slides

The Benchmark automates the labor-intensive steps required in baking, dewaxing, cell conditioning, and staining tissue for cancer and infectious disease diagnosis. The slides are processed with various reagents that remove embedded paraffin, pretreat tissue to expose targets, and bind and detect specific antigens or DNA and RNA sequences with localized color change or fluorescence. The system can control slide temperature and evaporation, minimize solvent exposure, control multiple instruments through a single user interface, and read patient sample and reagent bar codes. Ventana Medical Systems Inc., Tucson, AZ.

EScreen drugs-of-abuse testing system

A networked point-of-care system designed for drug testing

The eScreen includes eCup, a specimen cup with a smart lid, and an optical Internet appliance that scans, reads, and writes drugs-of-abuse test assay results and sends the results confidentially via a secure Internet connection. The fluid sample is transferred from the cup to the test chambers by means of a plunger that acts directly on a portion of the urine sample to force it between a double-walled stem to the lid and then distribute it into three test chambers. eScreen Inc., Los Angeles.


Over-the-Counter/Self-Care Products

TravelMate female urinary device

A noninvasive female urinary device reduces need to self-catheterize prior to travel

TravelMate is an alternative to female urinals and traditional urinary catheters that is noninvasive and reduces the risk of urinary tract infection. It consists of a piece of polyethylene that conforms to shape variations in the area surrounding the urethral orifice. It creates a comfortable leak-free seal between the device and the body but is small enough to be easily positioned even while sitting in a wheelchair or standing. Caring Hands Inc., Hayden, ID; JB Engineering Inc., Pomona, CA.


Radiological and Electromechanical Devices

Beta-Cath interventional cardiology device

Prevents or treats restenosis following balloon angioplasty

To prevent vessel closure, the Beta-Cath delivers a prescribed dose of beta radiation to the coronary artery vessel wall from inside the coronary artery via a catheter-delivery system. The transfer device stores, shields, and delivers beta radiation through individual sealed sources that travel to the artery, then return to the device via a fluid-hydraulic delivery method. A small multilumen single-use delivery catheter allows radiation to reach the treatment site while preventing it from touching body tissues. Novoste Corp., Norcross, GA; Innovation Factory, Norcross, GA.

DirectView CR800 system

System facilitates wide electronic x-ray distribution

A radiographic digital image capture and processing system utilizes exam-room exposure sources and cassette-based techniques to create electronic records of patients' images for future reference. Typical imaging applications include chest x-rays, bone x-rays, and soft tissue images. The DirectView CR800 has a remote operations panel that allows multiple units to be placed throughout the imaging environment to improve workflow and patient care. Eastman Kodak Co., Rochester, NY.

Echo-Coat ultrasound needles

Needle shafts are visible under ultrasound imaging

Ultrasound needles are coated to render the shaft visible with ultrasound imaging, enabling the devices to be used under ultrasound guidance during aspirations, biopsies, localizations, and amniocentesis procedures. Echo-Coat ultrasound coating is a layered polyurethane system when applied to 304-stainless-steel needles, the porous microstructure entraps tiny bubbles of air to enhance the echogenicity regardless of the needle angle relative to the ultrasound beam. STS Biopolymers Inc., Henrietta, NY.


Rehabilitation and Assistive-Technology Products

Claro and WatchPilot digital hearing instruments

Digital hearing aid system is remote controlled

Claro uses two microphones to create digital response and digital perception processing to emulate normal human hearing. An AudioZoom function
creates a directional response, allowing the user to increase sound levels of speech while decreasing background noise. The digital perception processing uses 20 overlapping and interdependent channels to process sound like the normal ear. A fine-scale noise canceller scans channel signals and identifies and increases speech signals and reduces other noises. Phonak, Warrenville, IL.

Helios personal oxygen system

High-efficiency liquid oxygen system designed for ambulatory use

A portable oxygen system consists of a 46-L reservoir and a pneumatic 4:1 conserver device, which allow for a good combination of duration and small size. The unit weighs 3.4 lb when full. The double-walled oxygen bottles have multilayered, glass paper and aluminum foil insulation contained in a vacuum to reduce heat transfer and cryogenic evaporative losses. The volume of oxygen supplied to the user is delivered in a pulse at the beginning of patient inspiration to maximize efficacy. Tyco Healthcare Puritan-Bennett, Indianapolis; Omnica Corp., Irvine, CA.

Pathfinder prosthetic foot

Provides a wide range of motion and optimizes the wearer's gait

Intended for lower-extremity amputees who have moderate to high activity levels, the Pathfinder prosthetic foot combines shock absorption and energy storage capabilities. To provide an optimal gait, the device incorporates a triangular design, a closed shape, and three main sides that act together synergistically. The sides—a pneumatic heel spring, composite toe springs, and a composite foot plate—are connected at three main joints: toe connectors, the heel connector, and the proximal connector. Ohio Willow Wood Co., Mt. Sterling, OH.


Surgical Equipment, Instruments, and Supplies

Aortic connector system

Implant allows minimally invasive bypass surgery method

The Aortic connector system creates the proximal anastomosis of an aortic autologus vein graft and eliminates the need for hand suturing. The system comprises a nitinol implant, injection-molded ABS delivery device, and stainless-steel release tubes. The aortic delivery device has a pipette configuration to allow greater accuracy and reduced hand movement. Redgroup, Minneapolis; St. Jude Medical, St. Paul, MN.

InsideView video projection method

Surgeons can view the internal operative site and their hands simultaneously

An advanced video projection method displays high-resolution images on a sterile disposable screen positioned within the surgical field. The system's 3.15 million-pixel Sony monitor is equipped with a zoom lens that is held securely within an optical-fixture mechanism. The disposable EtO-sterilized screen kits are made of high-grade, lightweight optical plastics. Applications include endoscopy, radiological procedures, and urologic, gynecologic, and cardiac interventions. LSI Solutions, Rochester, NY.

Mammotome handheld breast biopsy system

Multiple biopsy samples are collected with a single needle insertion

The Mammotone system is a minimally invasive, highly accurate mobile instrument for helping doctors diagnose breast cancer at the earliest stages. The probe is inserted once into the patient's breast via a small incision. Once inserted and positioned via ultrasonic imaging, it uses vacuum aspiration and an internal rotating cutter to collect multiple samples up to eight times the weight of those obtained using traditional spring-loaded biopsy equipment. A metal tissue marker can be deployed through the probe into the sampled biopsy making it easier to locate the lesion site for postprocedure mammographic diagnosis. Plexus Corp., Neenah, WI; Herbst Lazar Bell, Chicago; Dow Plastics, Midland, MI; Ethicon Endo-Surgery Inc., Cincinnati.

Neptune waste-management system

Evacuates, collects, and disposes of hazardous fluids and gases

The Neptune waste-management system is designed to dispose of hazardous surgical fluid waste and smoke from electrocautery or laser devices. The system consists of a rover that can collect up to 20 L of fluid at one time and a docking station that sterilizes collected fluid prior to disposal. The system also includes a traditional suction canister-tree combined with a smoke evacuator, an optional power IV pole to aid in the delivery of irrigation fluid waste, and a digital display that monitors fluid absorption. American Immuno Tech Inc., Costa Mesa, CA; Bio-Medical Devices Inc., Costa Mesa, CA; Stryker Instruments Div. of Stryker Corp., Kalamazoo, MI.

Tissuebond applicator and Tissuemed 180 light source system

A light activates applied tissue sealant

The Tissuebond applicator contains a solution composed of porcine albumin glycerol, water for injection, and methylene blue that allows the surgeon to see where the sealant has been applied and stimulates the bonding process when the light is applied to it. The applicator is a disposable, finger-controlled penlike delivery system that dispenses an accurate bead of adhesive onto the desired tissue area. The light source is controlled by a foot switch and delivers a cold-filtered light beam through a handheld wand. DCA Design Consultants, Warwick, UK; Tissuemed Ltd., Leeds, UK.

Copyright ©2001 Medical Product Manufacturing News

Electric or Hydraulic?

Originally Published in MPMN May 2001

PRODUCT UPDATE

Electric or Hydraulic?

A comparison of injection molding machines

Electric injection molding machines, like this one from Milacron, are accurate and energy efficient.

When electric injection molding machines were introduced in 1985, they gained immediate popularity because of their low energy consumption and high accuracy. However, these benefits came at a cost: the sticker price of an electric machine was far greater than that of a conventional hydraulic molder. More than 15 years later, the debate on the cost-benefit ratio continues. This article compiles some of the claims made by manufacturers on both sides of the divide. It is based primarily on information provided by Boy Machines (Exton, PA), a supplier of hydraulic equipment, and Milacron Inc. (Batavia, OH), which produces electric injection molding machines.

Price is one of the first things that companies consider when investing in capital equipment. While there are exceptions to every rule, the base price of a hydraulic machine is generally less than that of an electric counterpart. How much less varies, but Boy Machines national sales manager George Dallas says that "in a 14.2–88-tn range of clamping forces, hydraulic machines often offer a 50% saving." Advocates of electric molders are quick to point out, however, that the actual cost of a machine involves more than its purchase price; operational costs must also be taken into account.

Power consumption is one of the major factors in how expensive a molder is to operate. An increasingly salient issue as the price of electricity rises across the country, energy efficiency is often what allows electric injection molders to justify their higher purchase price. In some comparisons performed by Milacron, electric machines consumed up to 90% less power than hydraulic molders. Manufacturers say these savings can be achieved because electric machines do not constantly circulate hydraulic fluid, consuming energy only when motion is required. With generally lower operating temperatures, electric machines also require less power for cooling. According to Milacron general manager Barr Klaus, these factors make it possible to "run two or three all-electric machines on the same amount of electricity as one conventional [hydraulic] unit." He goes on to say that "the larger the [electric] machine and the higher the throughput, the greater the savings." Those in the hydraulic machine camp respond that these figures compare new electric machines to dated hydraulic ones, and that recent technological advances have reduced this deficit. For example, Dallas says that Boy's new hydraulic machines "employ an electronically controlled variable-flow pump that makes their energy consumption only slightly higher than comparable electric machines."

Cleanroom use

This hydraulic molder by Boy Machines and other similar units have low purchase prices and other benefits.

Since many medical parts must be produced under sterile conditions, suitability for cleanroom use is an important consideration for manufacturers, and both machines have their advantages. Electric models don't contain fluids that can leak and taint parts. Hydraulic molders eliminate the belt drives and other power-transmission elements that can abrade and cause particulate contamination. Both sides also have a ready response to these concerns. Boy's new machines localize the use of hydraulic fluids, minimizing the damage caused should a leak develop. Klaus says that Milacron's electric molders do not produce particulates "when the belts are set up correctly and operating at the recommended tension."

When it comes to accuracy and repeatability, electric machine makers claim superiority because electric units are digitally controlled like precision machine tools. According to Klaus, Milacron's "electric machines consistently hold tolerances one-half those of even a Hunkar Class 1 hydraulic machine." The lack of hydraulic fluid and tubes that can expand and valves that can stick contributes to this effectiveness. Because they use less material, electric molding machines also offer the benefits of producing less waste and reducing manufacturing costs. Hydraulic machine manufacturers point out that accuracy is not just a function of the control system. Instead, the ability to accurately produce parts is determined by the control system in conjunction with the entire mechanical system. New hydraulic units, say supporters, have been designed with innovative features and accurate mechanical systems that allow them to achieve similarly accurate outcomes. The variable-flow pump that limits drift on the Boy machines is an example of such technology.

Productivity factors

Precision means little, however, if a molder doesn't also offer good rates of production. While throughput depends upon the complexity of the part, both types of injection molding machines have features that enhance productivity. Both electric and hydraulic machines can be used during unmanned shifts.

Similarly, both units can run instantaneously upon start-up. Waiting for oil to preheat, a concern for hydraulic systems in the past, is no longer an issue, according to Dallas. Boy's machines, he says, are "ready to operate from the moment they are switched on." One advantage of hydraulic machines is the ability to perform certain hydraulic functions, such as core pulls, within the mold. (Integrating a hydraulic unit to an electric molder to perform such tasks can negate some of the benefits cited by manufacturers.)

Hydraulic and electric injection molding machines offer other benefits that don't fall neatly into any of the above categories. For instance, both sides maintain that their units have fewer parts, and thus require less maintenance. It is possible that both assertions are correct, if the comparison is limited to a type of part. Hydraulic machines don't have as many motors, joints, gear mechanisms, and subsystems. Electric models eliminate the hoses, filters, tubes, and valves of a hydraulic system. Manufacturers of electric machines say that their equipment offers a number of other cost-related benefits. Higher accuracy means electric units use less total material and produce less waste, reducing manufacturing costs. The costs associated with storing and disposing of used hydraulic fluid are completely avoided. Lower power requirements can also allow electric molders to lower construction costs for new plants as they can function with smaller electrical hardware, bus bars, and air-conditioning units. Another advantage of electric machines is generally quieter operation. Klaus says that Milacron's electric machines run at "about 70 dB, the same noise level as an office copier." This low noise level allows them to be used where sound is a concern.

Hydraulic machines have their advantages as well, however. Manufacturers say that one of these benefits is the elimination of toggle clamps, parts that build tonnage through mechanical leverage and thus are subject to wear. Hydraulic machines also don't use recirculating ball screws, components that are repeatedly subject to wear at the same point in the cycle. In keeping with their lower purchase price, hydraulic machines "can sometimes offer less-expensive replacement parts and servicing," Dallas says.

There are no clear-cut answers for manufacturers weighing the pros and cons of electric and hydraulic injection molding machines. There are advantages and disadvantages to each option: ultimately the machine that is right for your company must be determined based on the specific application.

Zachary Turke

Copyright ©2001 Medical Product Manufacturing News

Carbon Fiber Reinforced Polymer Specified for Prosthetic Device

Originally Published MPMN May 2001

Profile

Carbon Fiber–Reinforced Polymer Specified for Prosthetic Device

Other materials could not support weight loads.

The Total Concept prosthetic ankle uses materials that can withstand more than 3 million cycles.

In developing the Total Concept adjustable-heel-height articulated ankle, Century XXII Innovations Inc. (Jackson, MI), a manufacturer of prosthetic limbs, experienced difficulties in complying with ISO requirements. The ankle-case housings had to endure at least 2 million cycles of released 80-kg weight loads—equivalent to a person walking 2 million steps. "Over a six-month period, we molded the part using a half-dozen different materials including Kevlar and PEEK," recalls director of engineering Grant Wild. "But these materials just couldn't handle the required 80-kg weight loads."

The company's prototype housings were giving out after just 50,000 cycles. "The parts cracked at the knit lines due to the molding materials' inability to take the required weight loads," explains Wild. Kevlar and PEEK are used in many medical devices, but they did not fit this particular application. "All the materials that we tested had good tensile strength, but they were too brittle for cycling loads." The materials had only –1% elongation, which is insufficient for repetitive impact absorption. Realizing that its project was in jeopardy, the company asked its molder, Hilco Technologies (Grand Rapids, MI), for a material with a better combination of tensile strength and elongation properties.

The search led to Latamid 66 H2 K/40 Natural, a nylon 6,6 reinforced with carbon fiber and developed by LATI USA (Mount Pleasant, SC). Like Kevlar and PEEK, nylon 6,6 has good tensile strength and toughness for handling repetitive impact loads. However, because it is reinforced with 40% glass fibers, it also achieves a high notched Izod strength for added toughness, as well as +2% elongation at break.

Before trial testing, LATI engineers performed mold-flow analysis to optimize gate locations and to verify that knit lines were not in a critical, highly stressed area of the part. After molding one of the ankle-case housings using Latamid, Hilco tested it to see if it could pass the ISO weight-load requirements. The Latamid part withstood more than 3 million cycles. In less than 60 days, the part passed all the ISO testing requirements.

After successful trial testing, Century XXII engineers standardized the material for all its ankle housings. In addition to providing a solution to the material-durability problem, Latamid reduced material costs by 66%, according to the company.

The ankle prosthetic is available in narrow foot and unisex foot models. The device can be easily adjusted to any fixed angle, from neutral up to 10° dorsiflexion (toe up) or 25° plantar flexion (toe down). Adjustments can be done without any tools and without removing the foot: a simple push-button valve mechanism releases the ankle, allowing the amputee to make the desired adjustment.


Wire-Harness Software Speeds Design of Vision-Correction System

Program simplifies layout of harness and cable paths.

EMbassy Works allows users to map out how wires will interact with connectors.

In the process of designing and building its Pulse FS Laser for the vision-correction surgery market, Intralase (Irvine, CA) experienced an unforeseen challenge. The wiring harness design for the system would take months if created conventionally by using tape measures and string. EMbassy Wire Harness software from Linius Technologies (Westborough, MA) enabled the company to finish the project in a week, substantially accelerating ramp up, according to Intralase engineering manager Bob Ozarski.

EMbassy Works offers a wire list import function that automatically creates wires by means of a configurable ASCII from/to list or by manual input. The autorouting function automatically routes the wires and cables into a network of predetermined paths. Design Rule Checks enables verification of design integrity and determines whether the design meets both engineer specifications and corporate standards. Changes in components and cable-routing alterations because of bundle size and data line or power line location are easily and quickly implemented. Design Rule Checks can be modified and an upgraded cable assembly manufactured.

Linius' wire harness software can plan out and display harnesses inside chassiss.

Intralase purchased a floating seat of EMbassy Works, a version that operates within the SolidWorks CAD software environment. It allows engineers to build prototypes in parallel while producing virtual cable assemblies. "The physical prototype was being built simultaneously and entered testing almost immediately following the EMbassy Works layout," Ozarski says. Automatic calculations provided wire length and bundle diameter data in a format that was immediately accessible and continually updatable whenever the design changed, he added.

Since Intralase expected to produce approximately140 units during the first run, the company used EM~Nailboard and EM~Report, EMbassy Works' manufacturing and backend functions that streamline the creation of manufacturing documentation. EM~Nailboard automatically creates accurate manufacturing drawings in life-size and not-to-scale versions. EM~Report extracts design data to produce material and labor cost estimates, a bill of materials, and wire run lists.

With the help of EMbassy Works, Intralase engineers were able to define 135 cable routes in 7 days.

Copyright ©2001 Medical Product Manufacturing News