Medical Device Link.

Industry News

Hüls Med-Tech Division Develops Innovative Surface Treatment Technologies

When Hüls AG (Marl, Germany), a global supplier of chemicals and polymers, established a division devoted to new developments and medical technology a little more than three years ago, the potential synergy was too good to pass up, according to R&D managers Roland Kunz and Peter Ottersbach. "We have substantial know-how in polymers," says Ottersbach,"so it made a lot of sense for the company to get involved in the medical device market, where polymers are a basic material." The division, which is now part of Creavis, a wholly owned subsidiary of Hüls, has parlayed this expertise into the development of innovative technologies for the surface treatment of medical devices.

One of the more recent breakthroughs involves a bacteria-repellent coating that reduces bacteria and fungus adhesion to catheters and related devices by more than 90% compared to untreated surfaces. "The process involves covalently bonding a hydrophilic coating to the polymeric surface," says Kunz. "Because the coating is extremely thin—on the order of 10 µm—it will not affect the final size of the product." Nor will it affect the material's mechanical properties, says Ottersbach, who notes that catheter manufacturers were among the first to take advantage of this technology. "But in fact a broad range of devices can benefit from the application," he adds. While the surface treatment is compatible with numerous materials, thus far it has been used primarily with polyurethane, polyamide, polyolefin, and, in the near future, silicone, according to Ottersbach.

The control of cell proliferation is another area of expertise. "On some devices, you want to promote cell adhesion," says Kunz, citing synthetic implants to which the host's cells are attached in order to camouflage the artificial presence. If the patient's immune system fails to recognize that a foreign object has been introduced, the body's defense mechanism will not react. In other instances, the goal is to prevent cell proliferation: cell colonization on intraocular lenses, for example, can have an adverse effect on their transparency.

"We work closely with manufacturers and determine precisely what it is they want to achieve," explains Ottersbach. "Then we see if it is possible to treat the product efficiently."

The company also is able to enhance lubricity in devices by treating them with a hydrogel-based coating. Hydrogels of varying chemical compositions and physical characteristics are used according to the specific materials and applications.

"We have numerous surface-treatment methods at our disposal," says Ottersbach, citing dip coating, plasma deposition, UV processes, and grafting as examples. "We have a system that can suit almost any application."

Creavis Medical Technology is also able to modify materials to improve their haemocompatibility and can conduct numerous biological tests to characterize surface biocompatibility.

For more information about the company and the services it provides, contact Creavis Medical Technology, Paul-Baumann-Str. 1, D-45764 Marl, Germany; phone: +49 2365 494058; fax: +49 2365 495119.

While there is little debate regarding the superior microbial barrier properties of single-use operating room gowns made of nonwoven material compared to reusable cotton gowns, operating room staff tend to consider the latter to be more comfortable. To debunk what they term a misconception, DuPont Nonwovens (Le Grand-Sacconex, Switzerland), which produces the nonwoven material, and SCA Mölnlycke Clinical Products AB (Mölnlycke, Sweden), which uses the spun-laced nonwoven fabric to make its Klinidrape gowns, commissioned a wear trial. In the trial, conducted by the North Carolina State College of Textiles (Raleigh, NC, USA), gowns made of DuPont's Sontara material and the cotton garments received identical scores in the overall comfort category.

Thirty-nine evaluators wore the gowns under controlled conditions, at rest, and while engaged in various activities during five assessment periods. When the average of these periods was taken, the Sontara gowns were rated equal to their cotton counterparts in three characteristics—one of which was the overall comfort category—and outscored them in six other characteristics. Cotton prevailed in five categories.

"The nonwoven Klinidrape of Sontara is generally equivalent to the cotton gown in all specific comfort descriptors except weight and stiffness," assessors wrote in the executive summary of the report. "At the same time, because of its greater moisture-absorption capacity, the cotton gown has an advantage in the perception of comfort sensations associated with feelings of skin or clothing wetness."

The Sontara material is formed by entangling a randomly oriented batting of short staple fibres into a sheet of nonwoven fabric. Because no binders, chemicals, or adhesives are required to hold the fibres together, the fabrics achieve a high level of purity. This technology can be used to make spun-laced fabrics from almost any type of fibre including nylon, wood pulp, cotton, and polyester. The fabric used for the operating room gowns is a blend of wood pulp and polyester that is treated with bacteria and liquid repellents.

For more information about the study or the material, contact DuPont Nonwovens, P.O. Box 50, CH-1218 Le Grand Saconnex, Switzerland; phone: +41 22 7175896; fax: +41 22 7176112; e-mail: geoffrey.katz@che.dupont.com.

Seventeen Belarussian manufacturers and suppliers of medical equipment have formed BELMEDPROIMPEX, an independent association established to promote medical technology and assist member companies in the global marketplace. A brochure provides information on the medical equipment produced by the member companies and their manufacturing capabilities.

Companies profiled in the 22-page brochure include Optical Machine Tool Building and Vacuum Plants, which manufactures equipment for the processing of optical components and pharmaceutical granulators; Altimed, a developer and manufacturer of endoprosthetic joints; Belreas Ltd., which supplies rehabilitation equipment; and Express Service, which manufactures injection and infusion pumps.

In addition to its other activities, BELMEDPROIMPEX organizes inward and outward trade missions and healthcare-related exhibitions and conferences. For more information about the association or to request a brochure, contact BELMEDPROIMPEX, Fabritsius St. 28, Office 302, 220001 Minsk, Republic of Belarus; phone: +375 17 2262146; fax: +375 17 2262149; e-mail: root@yupocom.belpak.minsk.by.

AlphaGary Corp. (Leominster, PA, USA) is beginning the new year with expanded and refurbished R&D and quality assurance laboratories. A total of about 8000 sq ft of space was reengineered, according to managing director Robert N. Gingue, at a cost of more than US$700,000. Both the quality assurance and R&D labs have more than doubled in size, a reflection of the company's commitment to the development of new technology, says Gingue.

"AlphaGary is a pioneer in the introduction of specialty compounds for a wide variety of applications," says Gingue. "The expansion of the R&D lab will provide us with the facilities we need to continue and even improve on our history of technological leadership. The improved quality assurance lab will help to ensure that we do so without compromising the quality of our products," he adds.

AlphaGary supplies vinyl and thermoplastic compounds, alloys containing nitrile rubber, urethane, polyolefin, and ethylene vinyl acetates to the medical and other industries. The company is certified to ISO 9001 and QS 9000.

A needleless valve system that affords healthcare personnel easy access to IV lines by means of a standard luer fitting is now available to other device manufacturers. According to Alaris Medical Systems Inc. (Basingstoke, Hants, UK), a small number of contracts have already been signed and as many as 30 other medical device companies have inquired about the SmartSite needleless valve.

SmartSite consists of a proprietary valve design that allows for flow and reseal without a needle, cannula, or cap. The user swabs the valve port, attaches the standard male luer to the port, delivers the medication, and detaches the luer when complete. The device contains no latex and can withstand EtO and gamma sterilization.

"The prevalence and associated costs of treating needle sticks make a product like the SmartSite valve highly desirable to many device manufacturers," says marketing director Bob White.

By making the technology available to other device manufacturers, Alaris Medical, which has incorporated the SmartSite system into all of its major disposables, hopes to make it the standard of care in needleless systems across the industry. For more information, contact Alaris Medical Systems Inc., Unit 12/13, Intec 2, Wade Rd., Basingstoke, Hants RG24 8NE, UK; phone: +44 1256 474455; fax: +44 1256 330860.

Braun Formenbau GmbH (Bahlingen, Germany), a specialist in the design and production of two- and multiple-component precision injection moulds and injection-moulded parts, has recently begun placing greater emphasis on the manufacture of medical components. Last year, general manager Eric Braun together with two partners founded E. Braun GmbH, a company dedicated to this endeavour. "We have gained valuable experience in the medical field over the past 20 years," says Verena Bohnhorst of Braun's marketing department. "We have some loyal customers in the medical arena, and we are in the process of building more of these relationships. Among the intentions of E. Braun GmbH is the production of sophisticated medical products using Braun Formenbau's injection moulds."

Working together, the two suppliers offer their customers complete solutions. While Braun Formenbau develops custom injection moulds in close cooperation with clients, E. Braun will produce the medical parts on a just-in-time basis. The E. Braun facility is expected to be in operation by May. Maintenance and repair of the injection moulds is handled by Braun Formenbau. For more information, contact Braun Formenbau GmbH, Unter Gereuth 14, Bahlingen D-79353, Germany; phone: +49 7663 93200; fax: +49 7663 3727.