Since the mid-1960s, Bally Ribbon Mills has woven straight, tapered, flared, and bifurcated biomedical textiles, always meeting the stringent standards of regulation and market demand. All BRM woven biomedical textile structures possess the following characteristics:
• Controlled permeability/porosity
• Dimensional stability
• Low elongation (unlike knitted products)
• High tensile strength in both directions
• High burst strength
• High suture retention strength
• High abrasion and friction resistance
The FDA classifies medical devices as Class I, Class II, and Class III by the risks to the patient and / or the user and the intended use of the device. Those with high risk, classified as Class III, usually sustain or support life, are implanted, or present a potential unreasonable risk of illness or injury. Examples are implantable pace makers, stents, and vascular grafts. Many of these biomedical textile structures’ characteristics are prerequisites for use in implanted applications. Without high abrasion and friction resistance, for example, wear from internal movement could lead to malfunction and failure. Other characteristics deliver particular benefits to particular uses, such as high burst strength for vascular implants.
Of course, medical technology has evolved substantially since BRM’s first graft was woven. Today, BRM offers a range of constructions and fibers to deliver a wide range of characteristics to meet consumer demands.
Loom and Weaving Technology
BRM’s biomedical textile structures are made by weaving. Although BRM operates many different types of looms, all medical products are produced with shuttle looms. These looms use a boat-shaped device to carry filling (horizontal) yarns across the vertical yarns. This technique enables BRM to create perfect tubes, bifurcate tubes, tapered or flared tubes, and biomedical structures of special shapes.
Advancements in shuttle loom technology include the incorporation of electronic components and jacquard capabilities (a system of weaving that utilizes a highly versatile pattern mechanism to permit the production of large, intricate designs and shapes). Recently, BRM has updated its biomedical weaving capabilities with an automated shuttle loom with multiple shuttles. With this capacity BRM experts can make bifurcate grafts without any hole at the crotch and use more than one filling if needed in the same graft. BRM’s design teams have the necessary backgrounds and experience to skillfully design, engineer, and develop biomedical structures as per customer needs and performance criteria.
Yarn and Material Technologies
Absorbability is key for some biomedical structure applications, but for others non-absorbability is just as critical. Fiber material is the primary factor determining this and other capabilities.
BRM has the experience to manufacture biomedical structures with monofilament, multifilaments, hybrid fiber (that include more than one type of fiber), and metallic wire designs.
In the ‘80s and ‘90s, heavier denier polyester such as 70 denier was the industry standard. Now, many customers require the use of finer denier polyester because it is comparatively easy to deploy grafts made of fine denier fibers by catheterization. BRM has the experience, expertise, and equipment to weave the finest fibers, including 10 denier polyester.
The BRM Clean Room
All Class III medical devices must be manufactured in a tightly-controlled clean room environment due to risks associated with such devices. At BRM, all medical products are manufactured in a Class 8 certified clean room, including all aspects of weaving from making a beam and making a quill. BRM’s quality control professionals also conduct in-process and final inspections inside the clean room. With this manufacturing environment and our rigorous quality control processes, BRM is ISO 13485 certified for the design and manufacture of textile components for medical devices.
Biomedical textile use has exploded in recent years and has resulted in countless saved lives. In our previous post, “3 Ways Medical Textiles Can Save Lives,” we addressed the first important life saving method–prosthetic implants.
Prosthetic implants work in many ways to assist the body in functioning. Examples of use we mentioned in our previous post were in hard and soft tissue, dental, and vascular applications. Critical properties of an implant are porosity and fiber size. Toxicity is also important to look at, as it can mean life or death if a procedure interacts poorly with the implant material. Whether a material is stable or degradable should be determined and used according to its purpose, such as a biodegradable material for a more temporary implant.
The next two ways webbing saves lives are when it is used in aortic repair and as heart valve replacements.
An aortic abdominal aneurysm, or AAA, occurs when an artery wall weakens and can burst. It is a catastrophic, life-threatening condition that can be prevented by threading a woven AAA device into a position that will support the affected artery. This tubular prosthesis of biomedical textile becomes one with the repaired vessel through time and by inserting it via a catheter the procedure is less invasive than open heart surgery.
Repairing an artery using biomedical textiles typically involves using what the medical industry terms a “narrow fabric,” which is any non-elastic woven textile that is 12 inches or less in width and has a woven selvage on each side.
Heart Valve Repair
A heart valve textile is a medical fabric supported by a polymer frame structure that is threaded into position using a catheter. The procedure is called trans aortic valve replacement or TAVR for short. To gather separated material from the diseased vessel during surgery, a tubular tapered narrow fabric is also used. It is threaded just outside the replacement valve, protecting downstream vessels from displaced debris during the procedure. Upon completing the valve replacement, the device collecting debris is compressed and withdrawn.
As you can see, using biomedical textiles have greatly impacted medicine for the better by providing meticulously made fabrics and structures that support bodily function and life. Prosthetic implants, aortic repair and valve replacement are only a few examples of their impact on human life and wellness.
Bally Ribbon Mills proudly produces prototypes and full-scale production lines of woven tapes, webbing, prosthetics and dental biotextiles. Our medical textile engineers, and weavers work in confidence to protect your intellectual property and help create life-changing and life-saving biomedical textiles. You can also trust us to manufacture your devices in a certified clean room while following rigorous quality standards such as ISO 13485.
Contact us today for more information on our medical textiles.
These days, medical devices look more like a futuristic movie prop than reality. Made of various metals, plastics and biomedical textiles, improved devices include prosthetics, aortic repair woven tubular and fine flat woven scrims. These textiles are softer, more flexible, stronger, and more versatile than previous available options, which makes them more sustainable in crucial cardiovascular and orthopedic applications.
Rigid materials and methods are seeing improvements thanks to biomedical textiles. Not only is the physical outcome a benefit of these innovations, but so are the cost efficiency and healthcare outcomes. Bally Ribbon Mills developed a timely, broad product line of biomedical textiles for medical use, contributing to the field’s innovations.
Within the product line, you can find woven tapes and webbing in either flat fabrics or straight or bifurcated tubular structures, dental, orthopedic and prosthetic biotextiles. Webbing, in particular, offers many life-saving advances in medicine. The first of three ways webbing can save lives is with prosthetic devices.
A prosthetic is any foreign or synthetic material or part that’s purpose is to replace a body part. One type of prosthetic devices is an implant. Permanent or temporary in nature, the implant’s material and characteristics depend on its purpose and environment in which it will be used. These small to large prosthetics can replace body parts, monitor bodily functions, deliver medication or support tissues and organs. Common examples are hip implants, which are permanent, and chemotherapy ports, which are removed after medication is no longer needed.
Medical devices of biomedical textiles are a fairly new technique used for prosthetic implants, and require high standards. These requirements are:
Porosity— A measure of the density of a woven fabric
Fiber Size — Determines porosity and implant size
Toxicity– A measure of when a fiber polymer or fabrication technique needs to be free of contaminants and completely non-toxic, including the fibers
Bio-Friendliness – A measure of how adaptable the fiber is within the human body. For example, use of biodegradable and bio-stable elements will allow body cells to properly adhere to and subsequently grow on the device.
Though there is a wide variety of uses for biomedical textiles in prosthetics, below are a few of the most common uses in medicine today.
Soft Tissue Implants— Artificial tendons and skin patches are examples of these. Chemical structure, hydrophilicity, surface roughness, flexibility, electric charge, hydrophobicity and micro heterogeneity are all important characteristics of soft tissue implants that affect tissue growth and cell attachment.
Hard Tissue Implants — Artificial joints and bones are examples of hard tissue implants. Crucial properties include chemical stability, biocompatibility, strength, and processability. This type of implant is used to stabilize a hard tissue and promote tissue growth around the implant itself.
Dental Prosthesis — A trip to the dentist for dental prosthetics can relieve pain, enhance speech, improve appearance and prevent disease. Ideally, a biocompatible, bondable material will be used to match the patient’s natural appearance.
Vascular Devices — Used to replace weakened or blocked cardiovascular system components, vascular implants are used for a variety of reasons. A graft or stent allows for bypass of a blockage to restore circulation. Weaving technology creates anatomically correct straight or branched structures for these procedures. Tightly woven grafts are used to prevent a hemorrhage directly following implantation. Blood compatibility, porosity, re-absorbability, easy tissue growth and defect free weaving to resist clotting are all important factors in this type of procedure.
As you can see, biomedical textiles play a major role in saving and improving lives on a daily basis within complex and simple medical procedures and treatments. There are two more fascinating ways webbing saves lives that we’d like to share with you, and Bally Ribbon Mills is proud to design and produce these necessary textiles.
Check back in two weeks to find out the other two ways these materials can save lives.