biomedical textiles, specializing in braided and
nonwoven components for medical devices.
Braided Structures for Cardiovascular Devices
Cutting-edge textile technology continues to enable amazing new implantable biomedical structures that were inconceivable just a few years ago. Some of the most exciting innovations to appear in the field of cardiovascular medicine are biomedical textile structures that can be incorporated into medical devices that can make major repairs to heart valves, heart muscle, or vasculature with relatively minor surgical impact to the body. This life-saving technology is made possible in part to modern engineered textiles.
Nitinol, PET and UHMWPE are primary biocompatible materials used in biomedical textiles for cardiovascular medical devices.
Cardiovascular Biocompatibility Requirements for Textile Materials
There are several key requirements for biocompatible medical textiles used in cardiovascular implants. In addition to minimally invasive heart valves, “cardiovascular implants” made with biomedical textiles also includes vascular grafts, filters, shunts, clot grabbers, and more. Every application has different requirements, but general requirements include:
- Biodegradability vs. Biostability: After implantation, “biodegradable” materials will gradually breakdown and be safely absorbed (resorbed) into the body; “biostable” materials will maintain their characteristics and dimensions for many years after implantation
- Porosity: material porosity determines the rate of tissue growth on and around the implant
- Surface: must provide suitable artificial surface for the body’s cells to attach to and grow upon
- Tensile Strength: must provide adequate tensile strength, and maintain that strength throughout the life of the implant, whether it’s biodegradable or biostable.
Nitinol (NiTi) is a biostable alloy of nickel and titanium that exhibits outstanding shape memory and superelastic properties. All nitinol devices are processed using heat. If oxygen is also present, then a non-stable thermal oxide layer can form on the nitinol surface. Electropolishing or chemical etching is usually necessary to remove the non-stable thermal oxide layer. Then the nitinol surface must be passivated, before implanting into the human body. Passivation increases the corrosion resistance of nitinol by creating a thin stable oxide layer on the material’s surface. This oxide layer protects tissue by preventing oxidation and ionization of the nickel and titanium bi-metal.
PET is an abbreviation of polyethylene-terephthalate, which is the chemical name for polyester. It is a biocompatible, biostable thermoplastic, polymeric material used in blood-contact medical devices since mid-1950. It has very good strength compared to natural fibers, and promotes rapid growth of endothelial cells in a blood environment.
UHMWPE (ultra-high molecular weight polyethylene) is a biocompatible, biostable thermoplastic material. It differs from PET in that it has higher strength and does not promote endothelial cell growth. It also provides excellent corrosion and stress wear resistance, self-lubricating qualities, and a low coefficient of friction. It has been used primarily in suture applications where strength is an important factor, such as cardiac surgery and in hip, knee, rotator cuff and spine implants/ repairs.
Biocompatible Resorbable Polymeric Yarns
Most resorbable biocompatible polymeric yarns are manufactured from poly(L-lactide) (PLLA) material or Poly(glycolic acid). PLLA yarns provide excellent radial strength in certain temporary suture applications and medical meshes used for soft tissue repair. PLLA will eventually breakdown in the body into harmless lactic acid. PGA yarns typically break-down much faster than PLLA. It is possible to “tune” the break-down speed of by using a co-polymer of PGA and PLLA – sometimes referred to as “PLGA”. The ability of this material to break down and “dissolve” on a predictable timeline makes them particularly useful for orthopedic applications where the suture provides strength and support until the body completes the healing process.
Engineering Biomedical Textile Solutions for Cardiovascular Applications
US BioDesign develops unique textile solutions to your biomedical device requirements by collaborating with your engineers to first understand the biological needs of the device component. After the anatomical requirements and limitations are defined, we often are able to suggest multiple textile solutions using our extensive medical braiding knowledge and expertise.
Whether you have an initial sketch or a completed prototype with scale drawings, we will work with you to refine your designs for optimum form, function, size, shape, manufacturability, and quality. We leverage our experience and expertise, to work as an extension of your engineering team to develop custom medical textiles that match your unique requirements for function and application.
There are never patent issues when working with US BioDesign because we do not hold any medical device patents. In fact, we are quite willing to work with your engineers to help strengthen your device patents, which may give your company an edge over the competition. We maintain strict confidentiality regarding all customer designs and product information.
Custom Braiding Technology Provides Solutions Tailored to Meet Your Needs
US BioDesign can handle all aspects of your medical device development project. Beginning at the development phase, to validation, to full production. We can help you complete your project quickly and cost-effectively. Our manufacturing processes are conducted under clean, carefully controlled environmental conditions. We are ISO 13485:2003 registered.
Innovative Solutions for Nitinol Cardiovascular Applications
US BioDesign is working with many of the leading medical device companies in the neurovascular therapy field. There are many exciting new clinical approaches to treat acute ischemic stroke patients where braiding technology is playing an important part. Our engineering expertise in braided nitinol constructs is particularly useful to some of the new technologies being developed in this field that require designing miniature nitinol devices to fit into even smaller micro-catheters.
Contact Us for Custom Biomedical Textile Solutions
US BioDesign develops and manufactures biomedical textile structures to meet the exacting design criteria of cardiovascular research physicians and biomedical device engineers. Our development process begins with a collaborative approach to discuss the goals and objectives of each new project with clients to understand the biomedical requirements of the textile structure and its role in the function of the medical device. We specialize in developing tubular braids and flat braids using implantable raw materials, especially nitinol, PET, PP and UHMWPE. We also specialize in most aspects of post-processing of braided nitinol, including: Forming, heat treating, electro-polishing, chemical etching, passivation and cut-to-size. We also have in-house test equipment to measure the precise active Af temperature of heat treated nitinol components.
Our engineering and manufacturing teams take pride in delivering ideal solutions for your cardiovascular applications. Request a quote on lifesaving biomedical textiles for cardiovascular applications, or contact US BioDesign to discuss your project’s cardiovascular biocompatibility requirements.