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Textiles To The Rescue

Medical textiles save lives, promote healing, provide protection "It sure makes me want to come to work everyday."

  Medical textiles save lives, promote healing, provide protection "It sure makes me want to come to work every day." At a time when the U.S. textile and apparel industry is threatened by the availability of inexpensive imported products and U.S. producers are moving certain operations offshore, promising and rewarding opportunities exist in the various specialized areas of medical textiles.

Kerlix¨ A.M.D. antimicrobial wound dressing was developed by Avecia and Kendall"It is a very good field to get into," said Thomas R. Molz, executive vice president, Prodesco Corp., Perkasie, Pa. "There are quite a few jobs available in the medical sector."Kimberly Barkman, senior engineer, product development, Guidant Corp., Menlo Park, Calif., concurred. "There are many ways to make medical products better using various textile techniques," she said. New products are providing improved protection and healing properties and reducing risks to patients. "Our new endovascular AAA system has helped so many people and saved so many lives," said Barkman, referring to Guidant's ANCURE¨ System for abdominal aortic aneurysms (AAA). "It sure makes me want to come to work every day."The range of applications includes very specialized and sometimes surprising uses in devices that end up inside the body, including vascular grafts, stents, adhesion barriers, meshes, cardiac support devices and parts of artificial organs. More conventional end-uses include surgical gowns and drapes, dressings and bandages. Textiles are found, as well, in support devices such as compression stockings, braces and casts.Research and development of new products in this field often involves a multidisciplinary approach. Input from researchers in mechanical engineering, microbiology, bioengineering and molecular biology, as well as textile sciences, is necessary to address the various requirements of a particular product. Implantable TextilesDevices that are implanted inside the body must be made of nontoxic blood-compatible and biocompatible materials that are porous enough to allow tissue to grow on and enclose them. Sutures, bone-setting materials, meshes, synthetic skin or other materials must often be bioabsorbable. Whether the materials may be biodegradable or not is dictated by the intended application. Biodegradable fibers used in implants include collagen, alginate, polylactide, polyglicolide, polyamine and some polyurethanes. Non-biodegradable fibers include polytetrafluoroethylene (PTFE), polyester, polypropylene, carbon and others.
Guidant's woven polyester ANCURE System for AAA.Prodesco, a research and development firm specializing in engineered fabric and cloth structures for the medical, industrial and aerospace industries, has been a player in the medical sector since the 1960s. The company has focused increasingly on this sector over the last five years, developing and engineering medical fabrics and innovative surgical implants that require minimally invasive surgery for implantation. Such implants include vascular grafts, ligaments, heart valve components, hernia mesh, adhesion barriers and other devices. Prodesco works with a range of companies - from startups to large, established companies.Tom Molz talked to Textile Industries about working in the medical sector: "The challenge is to educate medical device manufacturers to the possibilities and potential successes of textiles for implantation. Textiles are biostable and have been approved by the Food and Drug Administration (FDA) for several decades."Prodesco is now getting into combining metal and polymers to form composite products," Molz said. These composites are assembled in a clean-room environment by mechanical means, thus removing the possibility of human error. The result is a more reproducible and cost-effective product. Guidant and W.L. GoreandAssociates Medical Products Division, Flagstaff, Ariz., both have developed vascular grafts that require minimally invasive surgery. The procedures entail shorter recovery times and far less risk to the patient than the major surgery required for traditional implantation. Guidant's ANCURE System for AAA received FDA approval in 1999. Gore's Excluder endoprostheses for the treatment of AAA and thoracic aortic aneurysms (TAA) are approved for use in Europe and are currently classified as investigational devices in the United States.The procedures entail insertion of a catheter through a small incision in the groin area or the leg into an artery to deliver the implant to the site of the aneurysm. The ANCURE System's woven polyester graft is attached to the aortic wall by small positioning hooks made from Elgiloy®, a cobalt/chromium/nickel alloy developed by American GageandMachine Co., Elgin, Ill. Gore's devices, extruded from ultra-thin expanded PTFE (ePTFE), have an outer self-expanding support structure of nitinol, a nickel/titanium alloy.
Ethicon's polypropylene mesh Prolene Hernia SystemThe Prolene Hernia System from Ethicon Inc., Somerville, N.J., a subsidiary of JohnsonandJohnson, is used for the repair of inguinal hernias. It combines three repair techniques in one system. The knitted polypropylene mesh device consists of an underlay patch that is positioned on the inside of the abdominal wall, another patch on the outside, and a connector that joins the patches and plugs the rupture in the wall.InterVascular Inc., Clearwater, Fla., manufactures knitted and woven Dacron® polyester vascular and cardiovascular grafts. Some have velour or collagen-coated external surfaces to facilitate tissue growth. Many of the knitted products are produced on warp-knitting machines using a reverse locknit stitch. Some woven devices have a leno structure, which reduces fraying and holds sutures better than other woven structures. InterVascular recently developed InterGard Silver, a graft whose surface coating of silver provides lasting antimicrobial protection. It has been approved for use in Europe and is awaiting FDA approval in the United States. Antimicrobial use in implantation applications is expected to be particularly effective because the sites are inaccessible after surgery is completed, making it difficult to impossible to use antibiotics effectively. George Du, senior principal engineer, said the graft is the first of its kind to be developed.Antimicrobial properties are added to certain of W.L. Gore's hernia meshes as well. Silver carbonate and chlorhexidine diacetate are used to control contamination during implantation of the devices.
Surgical hosiery from Sigvaris provides compression support to the leg.All Wrapped UpDressings and bandages must protect wounds from infection as well as from further injury. Among new products in this category is Kerlix® A.M.D, an antimicrobial wound dressing developed by United Kingdom-based Avecia and Tyco Healthcare's Kendall Division, Mansfield, Mass. The 100-percent cotton dressing contains Cosmocil CQ polyhexamethylene biguandine (PHMB).In the future, "living" bandages may be available to fight infection or deliver medicines or drugs. A research team led by Alex Fowler, associate professor of mechanical engineering, University of Massachusetts (UMass), Dartmouth, is working to develop biologically active fabrics that have potential medical and apparel applications. The interdisciplinary team includes researchers from UMass Dartmouth and Harvard Medical School in the fields of mechanical engineering, textile sciences, microbiology, bioengineering and molecular biology. The goal is to incorporate viable microenvironments containing genetically engineered bacteria or mammalian cells into hollow fiber-based fabrics and poly-laminate fabrics in order to provide sustained bio-active properties to the fabrics.Support SystemsSupport devices help to hold blood vessels or bones in place during healing and help restore normal function by providing pressure and/or a rigid framework around the affected area. Surgical support hosiery provides compression support to the leg in cases of thrombosis, varicosity, lymphoedema and similar conditions. Pressure is greatest at the ankle and decreases up the leg, reducing the diameter and supporting the walls of the veins, and counteracting the pressure of the blood on the walls and increasing blood flow. Sigvaris, Switzerland, manufactures a range of knitted nylon/elastane stockings and pantyhose that provide from light to extra-strong compression.The Militex Division of New York City-based Gehring Textiles has developed several new fabrics in its line of D3 spacer fabrics that are suitable for sports-medicine applications. (See "Quality Fabric Of The Month," TI, April 2001). The fabric structure allows greater control over such properties as elasticity, according to Gehring. The fabrics are warp-knitted on Karl Mayer machinery.Protective CoverSurgical apparel and accessories, breathable membranes, and barrier products such as surgical drapes must be fluid-proof to protect against possible contamination by fluid-borne viruses and bacteria. Apparel must be comfortable and provide freedom of movement. Typically, the fabrics are knitted, woven or nonwoven cotton, polyester, polypropylene, polyethylene, viscose or glass fiber. Barrier protection may be provided by means of coating, lamination or encapsulation. Products may be reusable or disposable. It is estimated that the annual U.S. surgical pack and gown market is $1 billion. According to the Association of the Nonwoven Fabrics Industry (INDA), Cary, N.C., nonwoven disposable medical/surgical products sales generated $462 million in 1999.
Standard Textile's ComPel surgical gowns are made from microdenier polyester fabric. Cost-effective, eco-friendly waste management of disposable medical products is a concern in the nonwovens sector. OREX Technologies International (OTI), an operating unit of Isolyser Co. Inc., Norcross, Ga., has developed OREX®, a dissolution technology that reduces such waste, and EnviroGuard, a hot-water-soluble polyvinyl alcohol (PVA), hydroentangled spunlaced nonwoven used in such products as Allegiance Healthcare's Resolve surgical gowns and drapes. EnviroGuard fabric biodegrades into carbon dioxide and waste. It may be dissolved in water heated to 205°F in an OREX processor and released into a wastewater treatment system. Reusable products comprise approximately 50 percent of the total product in this category, up from 10 to 20 percent in the late 1980s to early 1990s. The increase is due primarily to technological advances for reusable products, said Richard Stewart, vice president, product development, Cincinnati-based Standard Textile, a manufacturer of reusable surgical, incontinence-care and other health-care-related products. "The advances have made reusables more viable from a clinical perspective," he said. "As well, they cost much less per use than disposables, as laundering costs are less than costs of acquiring comparable disposables."The woven solution-dyed microdenier polyester fabric used in the company's ComPel surgical gowns is specifically designed and engineered for use in the surgical environment. The fineness of the filament, rather than an applied coating, gives the fabric its fluid resistance, which is enhanced by fluorocarbons.Fabric woven from microdenier yarn requires different weaving machinery than more conventional fabrics. ComPel fabrics are woven by Precision Fabrics Group, Greensboro, N.C., on water-jet looms.Staying DryStandard Textile's ComPly and Integrity reusable incontinence products are twice as durable as similar products using traditional constructions, according to Stewart.ComPly fabric's tricomponent knitted loop construction combines polyester, to wick liquids away from the body, and cotton, to provide an absorbent padding. A vinyl or polyurethane barrier on the under side protects bedding.Integrity fabric is a stitch-bonded polyester/rayon nonwoven. The stitching forms the top face, while the nonwoven web absorbs liquids.

December 2001