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Articles from 2006 In January


Finding New Ways to Bond

PRODUCT UPDATE

Finding New Ways to Bond
Corinne Litchfield

When choosing an adhesive, manufacturers have many options. The chemical properties of materials to be bonded, as well as the chemical qualities of the adhesive itself, need to be considered. Surface energy, a thermodynamic effect of how a liquid will “wet out” on a surface, is one of these properties. Some plastics may be difficult to adhere to because of low surface energy. In some cases, primers may be required to help with bonding parts. However, thick, overly primed surfaces can cause adhesives to fail. Pretreating surfaces using flame or plasma treatments may improve bonding on some substrates, including polyimide and polycarbonate.

A selection of adhesive products is featured below.

Partnership Leads to Custom Adhesive for Wound Closures

Adhesives Research Inc. developed the adhesive tabs used in a wound-closure device.

An adhesives manufacturer has partnered with a developer of wound-closure products to create adhesive-coated substrate materials. Adhesives Research Inc. (Glen Rock, PA) and Clozex Medical LLC have teamed up to custom develop two adhesives for use in ClozeX wound closures, a needleless approach to the closure and healing of surgical incisions, excisions, and traumatic lacerations.

In June 2003, Clozex Medical approached Adhesives Research to discuss developing a custom bonding solution for a wound-closure device that would provide an alternative to sutures, staples, and liquid skin adhesives. The tape components in the device would require a noncytotoxic, skin-friendly adhesive. The adhesive had to securely bond to the skin, immobilize the wound-closure device during approximation of the wound margins, and keep the wound closed during the healing process.

To address these needs, Adhesives Research created two custom tape products, each coated on one side with one of the company’s proprietary ARcare adhesives. After developing several constructions and conducting trials with different raw material substrates and coat weights, the ideal coat weight was found for the first adhesive tape system to adhere to the skin for the application. The second tape system was developed with another proprietary adhesive that aggressively adheres to the top of the initial substrate in order to secure the adjustment tabs in place.

ClozeX’s patented device design uses two interlaced, multilayered, transparent films coated with Adhesives Research’s noncytotoxic, hypoallergenic, nonlatex adhesives. The adhesive tapes are designed to affix transparent pads securely to the skin adjacent to the wound and to lock the device in its final closed position. ClozeX wound closures are typically worn for 10–14 days. During wear time, the adhesive must remain in place with no peeling on the edges when rubbed against bedding and clothing.

ClozeX wound closures received the silver Medical Design Excellence Award (MDEA) at the MD&M East trade show in June 2005.

Silicone Adhesives Cure Rapidly

A manufacturer of silicone products supplies two fast-cure silicone adhesives that are suitable for use in medical devices. The MED1-4213 and MED2-4213 adhesives from NuSil Technology (Carpinteria, CA) can be used for bonding and sealing silicones together, as well as with other substrates, such as metals and plastics. The adhesives are two-part, translucent, pourable, self-leveling, high-tear-strength silicone systems. MED1-4213 cures at room temperature, and both products cure rapidly with the application of heat, whether in an oven, or by a heat gun or lamp.

“NuSil applied its expertise in silicone chemistry and adhesives technology to develop these products,” says Stephen Bruner, marketing director. “The MED1-4213 and MED2-4213 adhesives offer the medical device industry a fast-curing solution that removes the bottleneck caused by long curing times.”

Atmospheric moisture is not required for curing, and there are no curing byproducts. Product consistency allows for the adhesives to be supplied in airless, side-by-side kits that eliminate mixing and deairing difficulties. The adhesives can be used in rapid production or prototyping tasks.

Diagnostic Adhesive Turns 15

G&L Precision Die Cutting’s adhesive, GL-187, is specifically designed for use in diagnostic technologies.

Even with advances in adhesive technology, some products continue to stand the test of time. A converting company recently celebrated the 15th anniversary of its proprietary diagnostic adhesive. The GL-187 adhesive from G&L Precision Die Cutting (San Jose, CA) was specifically designed for use in medical diagnostic equipment. “We developed GL-187 for the in vitro diagnostics (IVD) industry at a time when most adhesives available were industrial adhesives. The use of industrial adhesives often caused false readings, leading to unreliable tests and a high rejection rate by IVD manufacturers,” says Jennifer Ponti, director of sales. “The sensitivity of GL-187 gave manufacturers the ability to develop more accurate and reliable tests.”

Since introducing GL-187, the company estimates it has produced components used in more than 6 billion test strips for dipstick, lateral-flow, and vertical-flow applications worldwide. From the beginning, the adhesive has been compatible with backed and unbacked nitrocellulous and most other membranes. It works with a number of substrates, including white PVC, white polystyrene, white and clear polyester, and custom materials.

The firm specializes in converting services for the IVD industry, including printing, slitting, and laminating of active membranes, absorbents, and other materials, and laminating multilayer films. Additional services include subassembly of finished devices, dry-room manufacturing, and custom making rotary test strip cutters.

Release Liner Films Are Included in DMF Filing

Several polyester-based release liners for use in medical applications are available from CPFilms Inc.

A manufacturer of precision-coated films offers polyester-based release liners suitable for medical applications. CPFilms Inc. (Fieldale, VA) has developed several liner films, including UV5A, UV10, UV12, UV30, UV50, and UV100 UV-cured. Also available is the S10 fluorosilicone release liner, which can be used with silicone-based, pressure-sensitive adhesives and other materials.

All of these liners are included in a Drug Master File (DMF) that was submitted to FDA late in 2004. “The DMF filing enables us to provide confidential information to FDA, which can then review the liner’s acceptability for use as a component in coated medical substrates,” says Doug Goldstein, new business development manager. “Once approved, FDA can report this information to prospective users of our products,” he adds. This reduces the product development cycle for potential OEMs desiring to test these release films. While awaiting review, an independent laboratory performed toxicity testing and all the liners included in the FDA submission clearly passed, according to the company. Medical applications that often require the use of release films include transdermal drug-delivery systems, disposable diagnostic-test products, wound-closure materials, adhesive bandages, and medical tapes.

Permanent Mounting Adhesive Is Also Removable

A permanent, removable mounting adhesive from Adchem Corp. can be used for mounting plastics to glass.

A manufacturer of pressure-sensitive adhesive tape systems has developed a permanent and removable mounting adhesive on double-coated polyester film. Adchem Corp. (Riverhead, NY) offers its 8311M-76G mounting adhesive for clean, permanent, and removable bonds to the medical device industry for temporarily mounting foams, polycarbonates, and plastics to glass and other hard surfaces. Even after extended exposure to direct sunlight, the adhesive delivers a strong yet removable bond, according to the company.

With a 76 gloss-gloss liner polycoated to ensure flatness and resist wrinkling, 8311M-76G is moisture resistant. The adhesive features repositioning and removability of less than 1 lb for many surfaces.

The exposed side of the 1¼2-mil polyester film is coated with 1 mil of a high-gloss, high-tack, moderate-peel, high-shear acrylic adhesive. The liner side is coated with 1 mil of a low-peel, high-shear, removable, acrylic-based adhesive. With availability up to 54 in. wide, the tape has a one-year shelf life when stored under cool, dry conditions.

Copyright ©2006 Medical Product Manufacturing News

Motor Developer Sets New Web Site into Motion

E-NEWS

Motor Developer Sets New Web Site into Motion
Shana Leonard
www.orientalmotor.com
Loaded with expanded features, an updated Web site for a motion control company features product guides that enable users to make informed purchasing decisions. An expanded application section on the Oriental Motor USA Corp. (Torrance, CA) site lists most common motion control applications. This section is equipped with a Flash demonstration of how a selected product functions, and for which application each product is best suited. In addition to the application section, the site also has in-depth product pages that include specifications, dimensions, diagrams, CAD files, and other pertinent details. One of the most user-friendly features of the site is the ability to compare up to five products at once. This option arranges selected products into a chart that allows users to easily view each product’s specifications side by side for easy comparison, and subsequently choose the most applicable motion control device for the application.
Copyright ©2006 Medical Product Manufacturing News

Consulting Firm Develops Web Site

E-NEWS

Consulting Firm Develops Web Site
Shana Leonard
www.insight-md.com
A product development firm has launched a Web site that focuses on medical device product development. Insight Product Development (Chicago, IL) realized the need for a separate Web site devoted entirely to medical project development after completing 85 medical device development projects and thousands of hours of user research in the past five years. In addition to company information, the site contains a variety of resources, including a listing of healthcare trends and several white papers. Also showcased on the site is a series of case studies that detail the company’s methodology and product development process.

The company has received numerous awards, including two consecutive Medical Design Excellence Awards, as well as recognition from MPMN’s sister publication, MD&DI, as an Outstanding Design Team.
Copyright ©2006 Medical Product Manufacturing News

Cryogenics Handling Firm Unveils New Site

E-NEWS

Cryogenics Handling Firm Unveils New Site
Shana Leonard
www.acmecryo.com
Redesigned for enhanced customer service and improved navigability, the new Acme Cryogenics (Allentown, PA) Web site caters to its customers. According to the manufacturer and provider of cryogenic gas and liquid handling products, the site was configured to follow an intuitive site map, enabling users to explore the site without confusion or frustration. The company cites clean product pages that group items in obvious categories and condensed display information for quick reference among the site's modifications. Other byproducts of the revamped site include simple graphics and muted colors, design decisions intended to minimize distraction and highlight important new information.
Copyright ©2006 Medical Product Manufacturing News

Tool Accessory Company Adds Features to Web Site

E-NEWS

Tool Accessory Company Adds Features to Web Site
Shana Leonard
www.lyndexnikken.com

A machine-tool accessory company has unveiled its revamped Web site. The improved Lyndex-Nikken (Mundelein, IL) site features detailed product summaries grouped by product type. Products are easily searchable on a search page, which consists of a site map and directory of contents. Access to trade show information, product news, and promotional offers is found on the news page of the site. Though users can research product and company updates through the news page, a sidebar highlighting current comp any news is present on every page of the site for quick reference. Users may opt to keep constantly informed of company news by signing up for a free e-mail newsletter, which discusses industry-related topics, as well as company and product news.

Copyright ©2006 Medical Product Manufacturing News

In Brief

INDUSTRY NEWS

In Brief

Bosch Rexroth Corp. (Hoffman Estates, IL; www.boschrexroth-us.com) has acquired the Dutch company Nyquist BV (Eindhoven, Netherlands; www.nyquist.com), a provider of industrial motion control products catering to the semiconductor and medical manufacturing industries.

Two narrow-web flexographic printers have merged. Advanced Web Technologies (Minneapolis, MN; www. awtlabel.com) and Web Label (Minneapolis, MN; www.weblabel.com) have combined their businesses with the intent of increasing sales opportunities and expanding their presence in the medical device and OEM market.

Epson Robots (Carson, CA; www.robots.epson.com) has selected AutomationSolutions LLC (Hartford, CT; www. auto-sol.com) as an authorized distributor for the New England and metropolitan New York regions. Automation Solutions specializes in motion control components.

The Society of the Plastics Industry has named Prent Corp. (Janesville, WI; www.prent.com) as the recipient of its Thermoforming Institute National Award 2005. The company won the award for its Resting Heart System, a two-piece package that holds a reduced prime cardiopulmonary bypass system used in open, arrested heart surgeries.

Nova Biomedical (Waltham, MA; www.novabio.com) has signed a three-year contract with Premier, Inc., an alliance of not-for-profit hospitals and healthcare systems. Specializing in the development of whole blood analyzers to support the care of critically ill patients, the biomedical company will supply the alliance with its blood-gas and point-of-care analyzers, as well as with additional, related products.

Brady Corp. (Milwaukee, WI; www. bradycorp.com), a provider of identification products and precision die-cut materials has acquired TruMed Technologies (Minneapolis, MN; www.trumedtech.com), a converter of disposable products and components. TruMed integrates printing, laminating, die-cutting, assembly, and in-line packaging for healthcare products such as blood-glucose test strips, electrodes, wound dressings, defibrillator pads, and other medical supplies.

Remmele Engineering (St. Paul, MN; www.remmeleautomation.com) has acquired the May Coating Technologies division of Acumeter Laboratories (St. Paul, MN; www.acumeter.com). Remmele plans to integrate the division’s web handling and coating equipment into its own automation division.

Wise-Hamlin Plastics (St. Charles, IL; www.wiseplastics.com) has renamed itself Wise Plastics Technologies Inc. and relocated its two plants, now combined under one roof that houses a 110,000-sq ft manufacturing facility.

Copyright ©2006 Medical Product Manufacturing News

Microactuators Feature New Precision Bonding Process

INDUSTRY NEWS

Microactuators Feature New Precision Bonding Process

Corinne Litchfield

A new precision bonding process developed by university researchers has been used in the design and fabrication of piezoelectric microactuators. With the largest unit only a hair’s breadth wide, the microactuators, built by researchers at Pennsylvania State University (University Park, PA; www.psu.edu), are based on pairing commercially available materials with existing micromachining technology.

The microactuators provide controlled force, high resolution, and large displacements. Potential medical product applications include microfluidic pumps and valves, such as those found in insulin pumps, diagnostic equipment, and portable oxygen generators.

“These new piezoelectric microactuators are the first to use microfabrication methods, which are used to make computer chips and micromachines from silicon-based materials,” says Srinivas A. Tadigadapa, associate professor of electrical engineering and developer of the bonding process and microactuators. “Our new low-temperature wafer-bonding techniques, which make the actuators possible, can also be used for precision integration of dissimilar materials in other microelectromechanical systems.”

The microactuators are made from flat strips of bulk PZT, a commercially available piezoelectric material that shrinks slightly when voltage is applied. A micromachined silicon beam is bonded at both ends to a relatively thick PZT substrate using solder bonding techniques. When the PZT substrate is actuated by applying an electric field across it, the resulting compressive stress on the silicon beam causes it to buckle and results in a convex deflection.

For the bonding process utilized in making the microactuators, the researchers used photolithography and low-temperature solders to produce the required bridge shape. “The PZT loses polarity if you heat it too high, so the temperature is crucial,” says Tadigadapa. As a result, the researchers used a low-temperature solder bonding process at 200° C.

Using the new bonding process, the researchers have built actuators with dimensions ranging from 350 to 600 µm long, 50 to 100 µm wide, and 5 to 6 µm thick. The bandwidth of an actuator was measured at 265 KHz. In tests, the actuators showed good repeatability with a large amplitude stroke of about 8 µm when actuated using –100 to 100 V.

The actuators and bonding process are described in a paper, “Fabrication and Performance of a Flextensional Microactuator,” which appears in the October issue of Journal of Micromechanics and Microengineering. The paper was written by Tadigadapa, Jongpil Cheong, Abhijat Goyal, and Christopher D. Rahn.

Copyright ©2006 Medical Product Manufacturing News

Manufacturer Acquires Heparin Supplier

INDUSTRY NEWS

Manufacturer Acquires Heparin Supplier

Corinne Litchfield

A manufacturer of medical implants and other devices has acquired a European supplier of heparin technologies. Gore (Flagstaff, AZ; www.gore.com) has purchased Carmeda AB, a Swedish manufacturer of a clinically proven, hemocompatible surface coating for medical devices. Carmeda has supplied Gore with heparin and heparin-related technologies for nearly 10 years. The firm’s leadership team and workforce will continue to be based at its existing facility in Upplands Väsby, Sweden.

The Carmeda BioActive Surface (CBAS) coating mimics the anticlotting properties of the lining of blood vessels. It uses a patented end-point attachment chemical bonding of heparin to the device. The heparin molecules on the CBAS-coated surface sway in the bloodstream, similar to seaweed in water. The swaying motion enables the heparin’s active sequence to interact with substances in the flowing blood. As a result, CBAS displays stable anticlotting activity.

Gore uses the CBAS coating in its Gore-Tex Propaten vascular graft, which is made of expanded PTFE (ePTFE). The CBAS coating provides hemocompatibility by minimizing clot formation on the inside surface of the graft. Such clots can result in blockages that can reduce blood flow through the graft that may require clinical intervention. Commercially available to physicians in Europe and elsewhere outside the United States, the Propaten graft is an investigational device in the United States. A U.S. clinical study under an FDA IDE is ongoing.

“We are very excited at the prospects for the winning combination of two premier biomedical technologies, bioactive heparin and ePTFE, for improving medical device performance and positively impacting patients’ lives,” says Paul Begovac, technology leader at Gore.

Copyright ©2006 Medical Product Manufacturing News

Joint Venture to Serve as Asian Supply Source

INDUSTRY NEWS

Joint Venture to Serve as Asian Supply Source
Shana Leonard
Rollprint and Acme Packaging codeveloped ClearForm thermoformable web.
Alliantz Flexible Packaging Pte. Ltd., Singapore, derives from a joint venture between Rollprint Packaging Products Inc. (Addison, IL; www.rollprint.com) and Acme Packaging Company (Pte.) Ltd. (Singapore; www.acmepack.com). The new company will serve both local and multinational firms requiring an Asian flexible packaging supply source. Its primary focus is on sterile medical disposable and industrial applications.

Company headquarters for Alliantz are located in Singapore and are slated to have Class 100,000 cleanroom manufacturing areas, ISO 9000 certification, and a three-layer, blown-film extrusion line. Dhuanne Dodrill, president of Rollprint, will serve on Alliantz’s board as chairman. Two former Acme executives and Rollprint’s vice president of business development will join her as members of the board. “The Alliantz joint venture will enable Rollprint to take its global supply abilities to the next level,” says Dodrill. “It allows us to manufacture our technologically advanced flexible packaging structures locally for companies with facilities in Southeast Asia.”

As a result of the endeavor, executives plan on expanding joint-development projects between Alliantz and Rollprint. Acme and Rollprint formerly collaborated on developing ClearForm, a thermoformable bottom web. Acme Packaging is a supplier of sterile medical devices; Rollprint offers packaging materials and caters to the needs of many peelable, chemical-resistant, formable, and barrier applications.

Copyright ©2006 Medical Product Manufacturing News

Combating Antimicrobial Resistance: The War against Bacterial Infection

INDUSTRY NEWS

Combating Antimicrobial Resistance: The War against Bacterial Infection
Shana Leonard
A silver-based surface modification for devices prevents the creation of biofilms.
Modern medicine has equipped developed nations with the ammo to quickly disarm many diseases that used to decimate populations. However, irresponsible use and unnecessary prescription of antibiotics has led to the rise of a stronger bacterial army. This misuse of antibiotics could be responsible for an evolutionary mutation in bacteria, resulting in their immunity to certain antimicrobial treatments.

Though the increase of antimicrobial-resistant bacteria may pose an imminent threat, it is too soon to raise the white flag of surrender. Several developments in curbing infections contracted while in the hospital have been announced. They are in the form of a coating and a surface treatment. And they may just prove to be worthy foes.

Antimicrobial resistance is an alarming problem in hospitals, since patients tend to be vulnerable and thus more susceptible to infection. According to the Centers for Disease Control and Prevention (CDC), close to 2 million patients each year in the United States acquire an infection while in the hospital. Seventy percent of the bacteria that cause these infections are resistant to at least one of the drugs most commonly used to treat them. The most prevalent antimicrobial-resistant strains of bacteria are vancomycin-resistant Enterococcus and methicillin-resistant Staphylococcus aureus.

Many hospital-acquired, or nosocomial, antimicrobial-resistant infections can be attributed to the formation of biofilms on implanted medical devices. Biofilms occur when organisms secrete a sticky substance that enables the organism to adhere to a surface. The biofilms then synthesize a polysaccharide that envelops the organism, protecting it from the body’s defense system. AcryMed Inc. (Portland, OR; www.acrymed.com) has introduced a surface treatment that blocks this bacterial formation.

A microbiocidal coating for gauze kills bacteria and prevents it from recolonizing at wound sites.

SilvaGard is a silver nanoparticle technology that can be applied to devices without changing their composition. Though silver is recognized as an effective antimicrobial, it formerly was underused in the prevention of biofilms because of limited application methods, according to the company. Silver application as a form of surface modification has had drawbacks in the past. Conventional methods of application, such as sputter coating, can be expensive and coatings apply in a directional fashion from the source of the silver, reports Bruce Gibbins, PhD, founder and chief technology officer of AcryMed. Unlike other methods of silver application, SilvaGard is applied via a fluid-phase method. This procedure entails forming the silver in water so that the silver follows the water throughout all the crevice of a device that is suspended in the fluid bath. This treatment results in the thorough application of the coating in nooks and crannies that may be missed using other methods.

A number of tests conducted by AcryMed on the efficacy of silver concluded that the majority of devices treated with SilvaGard demonstrated a 99% reduction in bacterial growth, as compared with untreated devices. The company touts additional test results revealing that the product exhibited a complete resistance to biofilm formation. “We think that there’s a high degree of interest in making medical devices less susceptible to nosocomial infections,” says Gibbins. “Making medical devices more resistant to infection is important. I think that SilvaGard is a technology that will play a part in that.”

Materials successfully treated with the product include stainless steel, PEEK, polyurethane, silicone, and Teflon. It is suited for use on devices such as catheters, bone pins, and pacemakers. Catheters and other invasive devices are the leading cause of exogenous nosocomial infections because of their support of the development of biofilms. AcryMed also produces a line of ionic silver–based antimicrobial dressings and gel for wound care.

Whereas AcryMed has developed a surface solution that prevents the formation of biofilms, the University of Florida (Gainesville, FL; www.ufl.edu) and Quickmed Technologies Inc. (Gainesville, FL; www.quickmedtech.com) have announced a microbiocidal coating for wound dressings that kills the two most common antibiotic-resistant bacteria. The coating acts as a barrier, impeding bacteria from reaching the wound and recolonizing.

The distinguishable trait of this coating lies in the method of bacterial attack. Commonly used metals such as silver, iodine, and copper attack bacteria by traveling into the cell and reacting with essential proteins. Conversely, the coating developed by the University of Florida uses polyquats that interact with the negatively charged surface of bacteria, thus creating regions of membrane instability. The polymer essentially punches holes in the bacterial membrane, causing materials such as potassium, proteins, and DNA to leach out. The interaction of the polymer with the bacterial membrane is similar to sticking a pin in a balloon, according to Gregory Schultz, PhD, director of the University of Florida’s Institute for Wound Research and codeveloper of the coating.

According to the researchers, the coating will prove more effective than other antimicrobial methods, including silver-based dressings. Schultz predicts that since silver kills bacteria in the same manner as antimicrobials such as penicillin, bacteria will eventually develop resistance to silver as well. Because of the polymer’s method of killing bacteria by puncturing its membrane, it is virtually impossible for bacteria to develop a resistance to it, according to Schultz.

As a preventative measure to stave off infection, the coating can be chemically bonded to gauze bandages. Though the developers plan to expand the use of coating on wound dressings, they are currently collaborating with companies to apply the coating to cotton-based products such as ready-to-wear hospital clothing and bed sheets. The coating-protected clothing and sheets could prove to be invaluable in hospitals, since the transfer of bacteria from doctors to patients is among the leading causes of nosocomial infections. “The coating has the potential to significantly reduce the risk of transference of resistant bacteria within healthcare facilities,” says Schultz. A modified version of the polymer coating as a hand disinfectant for hospital use is also currently in development.

Though these advancements have been made in the fight against antimicrobial-resistant infection, a significant threat to patients remains. As Bruce Gibbins of AcryMed notes, “There’s pretty significant costs in both lives and in healthcare when overcoming infections.” An estimated 90,000 people die each year from nosocomial infections, according to the CDC. In addition to the increased patient risk, these infections also incur large price tags for hospitals. Substantial costs for treatment of hospital-acquired infections are a byproduct of prolonged patient stays and added drug treatments. In 2000, the World Health Organization estimated U.S. costs for treating nosocomial infections at a hefty $10 billion each year. Innovative biocidal products such as AcryMed’s SilvaGard and the University of Florida’s coating may significantly impact the medical community; however, many experts feel that maybe the war has only just begun.

Copyright ©2006 Medical Product Manufacturing News