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What Kind of Braiding Fits Your Medical Device?

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What Kind of Braiding Fits Your Medical Device? PUBLICATION | FEBRUARY 2016 WHAT KIND OF BRAIDING FITS YOUR MEDICAL DEVICE? BRAIDING AS A PROMISING TECHNOLOGY Nowadays the medical device industry knows a broad range of different braided implants or components for cardiovascular, neurovascular or orthopedic applications such as stents, bone anchors, high-strength sutures or even parts of posterior spinal fixation systems. However, most of the medical device companies do not have their own in-house textile experts. This is where Meister & Cie AG comes into play. Not only does this publication present Meister’s commitment and services to the medical device industry but it also gives a general overview about braiding as a promising technology that can be applied in a variety of different ways in the field of clinical medicine. Meister offers the complete service portfolio throughout the entire process from your initial product idea and the development of prototypes to design freeze and in-house serial production under ISO class 8 conditions. Offering all these services under one roof, Meister is acting as an original equipment manufacturer (OEM) and is your single point of contact for the development and the serial production of your braiding. Compared to traditional stainless steel solutions, braided structures have particular advantages, for example in the case of flexibility, elasticity or the ability to be compacted so that the product fits into a cannula, expanding at the designated spot in the body later on. This latter feature offers higher levels of safety and becomes more and more important for minimally invasive procedures like arthroscopy or laparoscopy. BRAIDING The process of braiding involves three or more individual strands of material forming an interlaced pattern by being placed diagonally to the product axis (at an angle of 40 to 60°). These strands are passing alternately over and under each other and always in opposite directions, similar to the maypole dance traditionally performed in European countries. Braiding and weaving are often mixed up. In the case of weaving, two discrete sets of threads are running perpendicularly to each other (angle = 90°). The so-called wrap threads run in machine direction and the so-called fill threads run sideways – perpendicularly to the machine direction – through a shuttle system, thus creating an interlaced structure. In the medical field we can distinguish between two main families of braiding materials: metallic or non- metallic materials, either in the form of wire or as mono- or multifilament yarn. Examples of the metallic family are nitinol, cobalt-chromium, platinum etc., whereas popular examples of the non-metallic family are polyester (PET), Ultra-High-Molecular-Weight Polyethylene (UHMWPE), polyetheretherketone (PEEK) or polytetra-fluoroethylene (PTFE), to mention only a few. Synthetic members of the non-metallic family are also known as chemical fibers. Combinations between non-metallic and metallic or between different materials from one family, so-called blendings, are possible as well. This opens up an enormous number of possibilities and variations with different functions und features. DIFFERENT TYPES OF MAYPOLE BRAIDING MACHINES TURNING POINT FLAT BRAIDING MACHINE WITH 9 BOBBIN CARRIERS TUBULAR BRAIDING MACHINE WITH 18 BOBBIN CARRIERS, 9 ROTATING CLOCKWISE, 9 COUNTER-CLOCKWISE. There are two different types of maypole braiding machines: flat braiding machines producing flat tapes, and tubular braiding machines producing round structures. The two sets of bobbin carriers of the tubular braiding machine rotate on a closed circular track, one set moving clockwise, while the other one rotates counter-clockwise. The bobbin carriers of the flat braiding machine do not complete a full circle but reverse their direction at the so-called turning point, thus intersecting strands from the opposite direction on the same track. Due to the fact that equal numbers of bobbin carriers are needed for each of the two directions, tubular braiding machines always have an even number of bobbin carriers. Flat braiding machines, in contrast, generally have an odd number of bobbin carriers. BOBBIN SPINDLE EYELET BOBBIN EYELET RATCHETING COMPRESSION MECHANISM SPRING BOBBIN CARRIER The yarn can be rewound directly onto bobbins or be prepared with an additional process called twisting prior to the rewinding, depending on the condition in which the yarn is delivered. Twisting is accomplished either clockwise (S-direction) or counter-clockwise (Z-direction), by which the number of turns around the yarn’s axis is increased. The rewinding on bobbins can be performed in a simple, double, triple or x-wise manner, and even combinations of different materials, colors or titer values of yarn are possible. (Titer is the unit indicating the linear mass density of fibers, measured in tex, dtex or denier.) DIFFERENT TYPES OF TUBULAR BRAIDINGS TYPE OF BRAIDING POSSIBLE APPLICATION TUBULAR BRAIDING PART OF POSTERIOR SPINAL FIXATION DEVICE TUBULAR BRAIDING HIGH-STRENGTH SUTURE WITH YARN CORE TUBULAR BRAIDING TEXTILE CERCLAGE WITH BRAIDED CORE (DOUBLE BRAID) R&D AND QUALITY MANAGEMENT OF MEISTER & CIE AG Meister & Cie AG is a 144-year-old Switzerland-based textile processor Tubular braidings can range from a few hundredths of a mil- which has a quality management system certified to ISO 9001 and ISO limeter in diameter to a few centimeters, depending on the 13485 standards. size of machine, on the number of bobbin carriers and the titer value of yarn being used. In case some of the bobbin Based on the Medical Device Directive (Medizinprodukterichtlinie 93/42/ carriers are not loaded with the same material as the rest, EWG), Meister & Cie AG employs a complete product development pro- we talk about a blending of the final product. The stiffness cess, ranging from the proof of concept via different stages (including and specific qualities of a braiding can be influenced by the design transfer) to an initial product batch, which provides a strong basis number of stitches per centimeter, which is related directly to for MDC customers to get their CE marking and FDA approval. the braiding angle which is adjusted over the take-off mech- anism of the braiding machine. Tubular braidings can appear The risk management process of Meister & Cie AG is a constant part of in two forms: as a sort of hollow tube or in a suture-like the product development process and the following serial production. It is appearance. In the latter case, an inlay can be fed in through compliant with EN ISO 14971:2012 (Anwendung des Risikomanagements the center of a tubular braiding machine, either in the form of auf Medizinprodukte). one homogeneous core or as multiple strands of yarn. If the inlay itself is braided as well, we talk about a double braid Its long history in the production of braided textiles and a profound un- construction. The use of an inlay can have various functions: derstanding and ability of modifying machines to customer needs are two it keeps the tubular braid in a round shape thus distributing main pillars of Meister’s success in the product development process, from the load over the inlay, whereas the braiding around it works a proof of concept to a serial production. as protection, or it can be used as a functionalized core (for example for signal transmission). BENEFITS OF BRAIDED STRUCTURES There is a variety of advantages which braided structures display in the medical field. We can distinguish between the three following aspects: their mechanical and structural features, their design and – last but not least – their biological advantages. The table below gives you a structured overview about the different aspects. MECHANICAL & STRUCTURAL DESIGN BIOLOGICAL • HIGH TENSILE STRENGTH • FLEXIBILITY • CONTROLLED POROSITY • STATIC AND/OR DYNAMIC • ELASTICITY • CONTROLLED TISSUE LOAD BEARING INTEGRATION • STRUCTURE WHICH CAN BE • KINK RESISTANCE COMPACTED TO FIT WITHIN • DESIGNED POROSITY A CANNULA/CATHETER BASED • FATIGUE RESISTANCE • FLEXIBLE FOR TISSUE DELIVERY SYSTEM STIMULATION • ABRASION RESISTANCE • LOW PROFILE • ELASTICITY • SHAPE MEMORY BEHAVIOR • FLEXIBILITY FOR EXPANSION/COMPACTION • SOFTNESS • ATRAUMATIC BEHAVIOR • SECURE FIXATION • TAILORED AND TAPERED SHAPES MEISTER & CIE AG OFFERS A FULL IN-HOUSE SERVICE ACCORDING TO ISO 13485 Meister & Cie AG, a highly specialited contract manufacturer in medical braidings, offers the full range of services under one roof. We counsel and accompany our customers from the first to the last step of the development process – starting with their initial idea, continuing with different iterations of prototypes up until the in-house serial production. This allows us to keep in mind factors like necessary qualification and validation processes at an early stage and advise our customers competently so that the entire process passes as efficiently as possible, which is both time- and cost-saving. A simple and lean product lifecycle management process anchored in our quality management system is beneficial to both our internal work and our customers, medical device companies, when they have to mark their products. Apart from the development of the product, Meister offers a complete technical documentation of the entire process. In doing so, we guarantee that quality is embedded in our company culture and is part and parcel of everything we do. As shown below, our product development process demonstrates our integrated approach for the ZWICK ROELL 5 KN TENSILE TESTING MACHINE development of new braided products in
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