KNOW-HOW  

XTray®: Per­fectly wound sur­gical sutures

Auto­mated man­u­fac­turing of sur­gical suture mate­rial is an extremely demanding task. With the devel­op­ment of the mul­ti­pur­pose thread car­rier XTray® and the ­cor­re­sponding machines for swaging and winding of the suture mate­rial, DS Tech­nology and Harro Höfliger pro­vide a com­pre­hen­sive solu­tion in coop­er­a­tion with var­ious spe­cial­ists.

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.

The stand-alone machines USM, for swaging, and the winding machine UTW com­bine to form a pow­erful swage-wind system.

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).

The suture mate­rial is safely and ster­ilely pack­aged in an alu­minum blister.

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.

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Photos: RAFF Dig­ital, Helmar Lünig