Surgical sutures are as complex as they are multifaceted. There are countless combinations of needle and thread, each tailored to specific medical requirements. Quality always plays a crucial role. In order to guarantee safe use, a firm connection of the components is just as important as perfect needle and thread surfaces, in addition to the sterility of the product. Care must also be taken to minimize, or ideally completely avoid the memory effect of certain threads. The thread having been wound into the thread carrier results in a deformation of the material, which affects the work of the surgeon.
The steps involved in manufacturing this high-end product are equally demanding. In order to ensure the necessary tear resistance, first the needle and thread are firmly connected. This process is called crimping or swaging. For space-saving and secure storage purposes, the winding of the needle-thread combination in paper packaging – so-called paperfolds – or in plastic thread carriers (trays) have become established methods.
Even today, the suture material is often wound by hand in paperfolds. But the desire for reproducible processes and automation is increasing. Plastic trays are used as thread carriers. The crimped needle is inserted into the tray and fixed in the designated needle park, after-which the thread is quickly and precisely wound.
This is no trivial task, as Ulrich Stahl, Director New Technologies at Harro Höfliger knows. “The importance of the tray for the winding process, for example, is often underestimated, but seemingly minor details significantly influence process stability. It is essential to note that the tray and the needle-thread combination must always be compatible. In addition, we must bear in mind that there are significant documentation requirements in order to obtain market approval for a product developed in-house.”
Advantages through standardization
Based on this background, the idea for the XTray® was born – a standardized thread carrier from DS Technology. At the same time, Harro Höfliger developed a swaging and winding machine, each one optimally adapted to the thread carrier. The USM Swaging Machine and the UTW Winding Machine are available as stand-alone equipment, but can also be combined to form a Swage-Wind Combination (SWC).
First, the USM creates a reliable connection between needle and thread. Each individual needle-thread connection undergoes a so-called inline pull test in order to verify the tensile strength of the connection. The UTW winding machine then accurately places the needle in the XTray® and winds the thread in a controlled manner. An individually printable paper cover (lid), which is securely connected to the tray, ensures protection from above. The finished product is then packaged in aluminum blisters and sterilized.
Coordinating the trays with the fully automated processes pays off. Depending on the thread length, the high capacity SWC achieves an output of up to 20 units per minute. This was made possible by combining extensive device know-how and many years of process experience. “But we do not only offer the engineering,“ emphasizes Stahl. “Our team of specialists also enables us to form an extensive network capable of manufacturing this multifaceted product.”
Before entering production, customers can test the machines at Harro Höfliger with their own suture material – and of course their own trays. In addition to high output machines, appropriate equipment is also available for the production of small quantities. In keeping with the motto “From Lab to Production”, tabletop and manual machines are available – always with the option of scaling up the processes to high-performance production.
Benefits of the XTray®
- Automation capability: The XTray® is adapted to the machine winding process.
- Versatility: The XTray® can be used with most common needle-thread combinations.
- Individual design: The printed image of the lid can be customized according to customer requirements.
- Safe to use: Minimal memory effect of the thread due to oval winding.
- Time savings: Faster time to market compared to an in-house development, plus significantly lower documentation costs.
About DS Technology
DS Technology GmbH, based in Winnenden near Stuttgart, markets the XTray® and other medical and pharmaceutical products. The experts from DS Technology, with many years of experience in the pharmaceutical industry, advise and support interested parties during the entire value creation. This helps with a fast and safe product launch.
Photos: RAFF Digital, Helmar Lünig