Surgical Innovation Is Our Passion If you need a new approach, change your perspective. Sometimes it is that simple. And it explains perfectly why we have succeeded in our efforts to secure a leading position in numerous fields of medical technology. INTRO: Inspirations & Innovations 2< >3 What do you expect? Everything but the usual stuff. No lengthy presentation of the company and its product divisions. No historical outline how everything began. No data, facts, numbers. Nothing of the sort. This brochure is different. It is not about history. It is about stories. Instead of overviews, it provides in-depth views. Insights into how KLS Martin thinks. How innovations come into being. Information The KLS Martin Group has grown from a loose association of independent manufacturers into one of the leading company groups operating in the field of surgical/ medical technology – worldwide. Originally an emergency solution in response to the economic crisis of 1923, the Group is now an innovation driver in its industry. With roughly 700 employees, subsidiaries in Europe and the USA, sales agents in more than 100 countries, a product range encompassing over 13,000 instruments, plus numerous innovations. This brochure describes seven of them in depth. INTRO: Inspirations & Innovations 4< >5 Hand in Hand in the Service of Health. Or: About the readiness to reinvent oneself. Don’t worry: we are not going to play the card of the dedicated Swabian tinkerer who lives like a hermit somewhere in his Danube Valley retreat just to come out and show up at the Medica once a year with an obligatory innovation. Innovations are not products of the ivory tower. Most of the time, they are the result of an interaction of entirely different influences and suggestions. Developed hand in hand by medical specialists, research institutions und industrial partners. KLS Martin sees itself as a catalyst in this interaction, picking up the different market and medical inputs and developing, implementing and spreading them. Not without its own contributions, of course. The stories told in this brochure confirm this. The examples come from seven different product areas. Each of them witnesses KLS Martin’s readiness to reinvent itself over and over again. Consequently, each story exemplifies how innovations come into being. How lucky chances play a typical role in this process and that, sometimes, you simply can’t avoid getting on the wrong track because that is part of reaching your final goal. Therefore, the focus is on ways of thinking and acting. And on people, of course. The people working at KLS Martin, pursuing medicaltechnical solutions with passion and dedication. The people working in the operating room – the surgeons and medical staff who are the end users of our developments and therefore right in the center of all our efforts. Plus the people who are the main beneficiaries: the patients. In the final analysis, it is them for whom everything is done. In the service of health. S T O RY 1 : Vi s i o n & Re s o r p t i o n 6< >7 About Wrong Tracks and Pioneering Achievements. Or: Still a start-up company at 80. Sometimes, one needs to think in totally different dimensions: then, big things become tiny and an ultrasonic technique designed to bond layers of wood together lends itself to resorbable implant insertion in craniofacial surgery. The ultrasonic device looks like a huge impact drill. It is used for joining two layers of wood together with thermoplastic pins. These pins actually replace screws and nails. There is a lot of drilling and planing going on all over the place, chips are falling. It is hard to imagine that anything here could possibly be used for oral and maxillofacial surgery. But two men have made a long journey to see this. “This is never going to work”, says one of them, disappointedly. At such a moment, it takes an entrepreneur with vision. That’s the other one – and he responds: “O yes, it will”. Information Since 1993, KLS Martin has been searching for resorbable implant materials. In 2000, the first products were launched on the market. Since 2001, efforts have been made to develop the SonicWeld Rx® technique. In just a few years, KLS Martin turned from a medical-technical company mainly focused on metal working into an expert for injection-molding techniques used under cleanroom conditions. S T O RY 1 : Vi s i o n & Re s o r p t i o n 8< >9 Even a few years ago, only biocompatible titanium implants were used in craniofacial surgery. Operations were not only time-consuming, but usually needed a second intervention because the titanium implants had to be removed at great expense – for the patient because it meant another lengthy wound healing process; for the health insurance carriers who had to bear the cost; for the employer due to long periods of sick leave. Of course, it is theoretically possible to leave the titanium implants in place, but this would mean that the patient must be ready to live with a foreign body. The situation is entirely different for children because their skulls are still growing. In these cases, it is imperative to remove the titanium implants in order to prevent deformations that might occur during the growth phase. No wonder, therefore, that the call for resorbable implants grew ever louder. KLS Martin listened and understood. The metal-working specialist ventured to enter the chemist’s field, determined to develop, at high costs, an appropriate resorbable material in-house. The effort led nowhere, ultimately. Nonetheless, it had a good side. While others had hastily committed themselves to existing resorbable yet only partially amorphous materials, the chemical industry had made advances. In the meantime, completely amorphous materials based on lactic acid happened to become available. Following a thorough clinical evaluation, KLS Martin decided to make use of them. In hindsight, the decision was right. The KLS Martin implants made from D- and L-lactides are completely degraded within just two years. In contrast, crystalline, only partially amorphous implants can still be traced after five to six years, not to forget their tendency to cause chronic inflammations. No doubt it was the right decision at the right time. However, this was far from clear at the time when the decision was taken because the whole developmental process was still underway. The material was there, sure enough, but what about the application technique? Change of scenery: Biel, the center of the Swiss clock-making industry and also the location where a firm of consulting engineers, Woodwelding Technology AG, has its headquarters. The company had developed a novel technique for the furniture industry by which layers of wood could be joined together using thermoplastic pins. The method is also used for fixation done in plaster or gas concrete. Even the luminous marks used on highway roadwork sites can be fixed in place with this technique. But could it also be applied to oral and maxillofacial surgery, given the completely different dimensions? Here, a hundredth millimeter counts. An entirely new technique was therefore required. And the question was whether woodwelding could indeed be sufficiently reduced in scale, or “miniaturized”, to fit the bill. In this situation, KLS Martin once again furnished proof of its flexibility, capability and innovative vision. A company whose core competency was metal working, whose production plants were typically dominated by welding, cutting and screwing, began developing highly sophisticated injection molding techniques – under cleanroom conditions. A business with a long tradition became a start-up company again. It was hardly more than a broom chamber in which the Tuttlingen medical engineers developed an innovative, sprueless injection molding technology in an extremely short time, thereby making sure that nothing of the valuable Resomer® would be wasted. This is easy to understand if one considers that the implant material is a plastic product no less expensive than gold. Even part of the required manufacturing machinery was built in-house. By now, KLS Martin owns a state-of-the-art production plant and SonicWeld Rx® is an overwhelming market success. It is a complete system consisting of resorbable pins, meshes and plates. It is biocompatible and easy to use. It is especially beneficial for children because it spares them painful follow-up operations. SonicWeld Rx® has passed all clinical tests with flying colors and received FDA approval in record time. KLS Martin has shown that it is capable of bringing diverse influences and suggestions together and merging them with highly original ideas of its own, thus creating something totally new: a resorbable implant – an innovation that gradually dissolves. An innovation that gradually dissolves. Resorbable implants. The resorbable implant is welded in place with ultrasound. In this process, it anchors itself in the smallest bone cavities. Then it starts dissolving into nothing. Slowly, but surely – after fulfilling its function. S T O Ry 5 : D e f o r m a t i o n & D i s t r a c t i o n 10 < > 11 For Christmas, the first Schnitzel. Or: World market leadership by millimetric advances. The boy suffers from an open bite malocclusion. He is twelve years old and has never before in his whole life been able to eat solid food. Pudding, soups, yoghurt, dairy products. He must permanently breathe through his mouth. So his parents came from Italy to Switzerland with him to visit Professor Sailer, a medical specialist working at the Zurich University Hospital. He will help the boy in the months to come, with a therapy called distraction. Information KLS Martin is a world market leader in the field of distractors for oral and maxillofacial surgery. The breakthrough could be achieved in 1999 with the second product generation, developed in close collaboration with the Zurich University Hospital. The current range covers more than 80 standard distractors plus over 300 customized special designs. S T O Ry 5 : D e f o r m a t i o n & D i s t r a c t i o n 12 < > 13 Breathing, eating, being able to laugh again – distraction restores vital functions, thus bringing back the joy of living. It’s a long way to a higher quality of life. Such malpositions and deformations are often caused simply because the bone “forgets” to grow. Luckily, they can be corrected by bone distraction. The therapy works as follows: the bone is dissected in a pre-determined place and the two fragments are connected to an adjustable element on either side of the osteotomy gap. Then, the so-called distractor is adjusted continuously. By one millimeter a day. The amazing result: the distraction process stimulates the bone to grow even long after the surgical intervention took place. This is due to the bone’s callus formation, and the whole procedure is based on it. Callus is the soft, still elastic and stretchable substance formed by the osteoblasts after bone fracture, thus enabling the fragments to unite again. At this stage, the bone can therefore be formed by distraction. The technique was developed in Russia by Gavrill Ilizarov, who first used it for treating severe fractures and malformations shortly after World War II. Unfortunately, this know-how was kept in hiding behind the Iron Curtain until the late eighties. So it was not until communism collapsed that this technique became known in the West. Initially, in the early nineties, it was used only in hand and foot surgery. Starting in the mid-nineties, however, distraction was gradually introduced into oral and maxillofacial surgery as well, with KLS Martin being a main contributor to this development. Within a year, the first distractor was placed on the market. New models followed within a couple of years. Initially, only four- to twelve-year-old children were treated in this way, but soon thereafter, adults and infants were included as well. These advances were triggered by the birth of a child whose mandible was practically missing. As the poor creature was unable to breathe and its lips began to turn blue, it was immediately intubated. The operation followed within a couple of weeks. For the physician, this was not a unique case. Since then, newborns are operated even at an age of two weeks, using patient-specific distractors where necessary, manufactured at very short notice. Mostly by KLS Martin. Because smaller, more delicate, filigree distractors are required in these cases. And because KLS Martin has collaborated with world-famous surgeons and hospitals from the start. Above all with Professor Sailer, who treated the twelve-year-old Italian with the open bite malocclusion using a specially developed distractor in order to lengthen the extremely short ramus. In the course of several follow-up operations, the young boy had his mandible and maxilla distracted in such a way that he was finally able to close his mouth again. The collaboration with the Zurich University Hospital was also the basis for the second generation of distractors of the so-called Zurich design, created in 1999. These new distractors were developed as whole series and are used accordingly. For monoblock distraction, for example, a surgical marathon frequently extending over up to thirteen hours, in the course of which patients with an extremely concave face form and protruding eyeballs have their entire faces distracted forward. Not surprisingly, word of such successes has been getting around. Through congresses, for example. Or publications. And they are always enabled by KLS Martin distractors. These references document a unique experience in the industry. Just as does the vast number of special designs made available by KLS Martin. Day after day the little screw is turned forward by another millimeter. And each day brings the patient closer to the goal of all dreams – to breathe again, to eat in a normal way, or simply to close the eyes or the mouth. One of these special solutions benefited a man who lost half of his mandible due to a carcinoma. A tiny residual bone at the mandibular joint was additionally resected by half and then distracted over a distance of no less than 120 mm in order to close the huge gap. This is easy to write and easy to read. But the therapy as such took several months. Finally, however, the patient had regained a complete, fully functioning mandible. One that consisted of his own homogenous bone – and thus a mandible made of the single bone tissue that is hard enough to allow the insertion of titanium tooth implants. While esthetic aspects necessarily play an essential role in such cases, the primary aim is the restoration of vital functions – to allow breathing, to preserve eyesight or to enable eating. Just as in the case of the Italian boy. In the spring of 2002, he got the first distractor implanted. Then progress was made in very small steps. Millimeter by millimeter. Over months. Until finally, after the distractors had been removed, he could enjoy his first feast ever, in the truest sense of the word: a schnitzel. For Christmas. S T O RY 2 : In s p i r a t i o n & I l l u m i n a t i o n 14 < > 15 Squaring the Circle. Or: The meeting of the illuminati. The model for every operating light: daylight. But it requires a little masterpiece to create a light providing quasi-daylight quality, particularly one that lacks any ultraviolet radiation and generates only minimal heat. February 02, 2002. A Friday. In a separate room of the Gasthof Sternen, a restaurant in Kirchenhausen, eleven people are coming together early in the morning. All of them are required to maintain absolute secrecy. The date, the number of participants, the location – all these elements could well be ingredients of a modern-day mystery thriller. In fact, it is a brainstorming session of engineers, development and manufacturing specialists, marketing and sales managers. The question is: “What kind of light is needed to support the surgeon and his team in the best possible manner?” It is the moment of birth of a totally different operating light in which nothing is the way it used to be. Information KLS Martin started its operating light production as far back as in 1979. In 1990, a new series of lights was launched. In 2000, the next step was due to follow – KLS Martin presented the first operating light using a gas discharge light source, a global innovation. marLux® with centriXbeam® is the second generation of this gas discharge light, representing a complete redesign of the operating light. S T O RY 2 : In s p i r a t i o n & I l l u m i n a t i o n 16 < > 17 Of all products, operating lights are probably the most underrated ones in technological terms. In truth, however, a whole variety of engineering disciplines are involved in their production, ranging from rough-mechanical manufacturing techniques to high-precision fine mechanics, from electronics to optics. In each of these fields, it is a matter of squaring the circle, of uniting completely different things. For example, the light should be bright, similar to daylight, but not warm. On the one hand, the light head should be easy to move without any stops; on the other hand, it should remain suspended exactly in the chosen position. At the same time, forces of several hundred kilograms are acting upon the cardanic suspension. And just one more paradox: Although high-drawn housings are optimal in terms of luminous efficiency, users keep asking for increasingly flatter lights. The “illuminati” meeting at the Sternen restaurant threw everything into question. Where was KLS Martin headed? Away from the monoreflector principle, opting for the multireflector design? The technologies used by the competition were scrutinized. The big hit at the time was the LED light which, however, fails to live up to the promise when examined more closely. Many spots – a lot of spot effects, yes, but less than satisfactory results when it comes to essential requirements such as color rendition, color temperature and shadow-free illumination. Therefore, the group decided to stay with the proprietary innovation, the gas discharge light. Wild ideas were discussed. For example, light sources located outside the operating room, with the light transmitted to the surgical site via suspension arms incorporating mirror joints and ultra-thin light channels. Just as the meeting began with rigorous questioning and stocktaking, it ended with a feasibility study: now each and every feature of the light was systematically matched to the requirements of the surgeon and his team. The exercise started with an air flow-optimized design of the light and its suspension system. With its elliptical profile, it is simply perfect for the state-of-the-art vented ceilings used in operating rooms because it leaves the laminar flow practically unaffected. Thus, the cool and cleanfiltered air can reach the surgeon and the operating field almost unhindered. A real engineering feat is the central handle. While the drive motor for the operator’s control functions had previously been integrated into the handle, this motor was now assigned its place inside the light head, thus leaving just barely enough room for a specially developed camera system. However, the handle’s real highlight is its multifunctionality: it ensures that the surgeon has literally everything in his or her hand. To begin with, the handle allows the usual light head adjustment. Besides, by simply pulling or pushing it, the surgeon can adjust the illumination and – depending on the model used – increase or decrease the diameter of the light field or switch the centriXbeam® on and off. Step by step, every detail was put to the acid test during the meeting. As a result, the light source unit can now be replaced with a single movement of the hand. During endoscopic interventions, a soft, indirect background light is now automatically switched on after a certain illumination level has been reached, making it easier for the surgeon to control the surgical procedure via the monitor. The novel gas discharge light provides a light field characterized by uniform illumination. The light flows around any obstacles. By switching the innovative central reflector on and off, the surgeon can select between higher-contrast and shadowless illumination of the operating field. The 540 Facets of Light illuminate the depths of the surgical site The most innovative feature, however, is the central reflector. It makes the light absolutely unique. In fact, it pushes the advantages of the gas discharge technology to a still higher level. Just for comparison: A 70-watt gas discharge lamp provides a light output that is a whopping 20% higher than that of a 150-watt halogen lamp. What’s more: heat development is minimal and UV radiation extremely low as well. As the relentless stocktaking carried out during the Kirchenhausen meeting had shown beyond any doubt, the gas discharge light is superior to halogen as well as LED lights, both in terms of light output and lighting properties. The last technical challenge to be mentioned is the extremely flat light housing. Usually, such flatness leads to a reduced light output due to the extreme angle of refraction. The central reflector reliably prevents this adverse effect. Under difficult spatial conditions, this design masterpiece adds another 90 reflectors to the 450 reflectors already arranged on the inner wall of the light head. As a result, the light virtually flows around the surgeons and their assistants and is then directed into the deep cavities of the surgical site – to tissue areas that are usually beyond the reach of conventional light sources. By simply switching the central reflector on or off, the surgeon can select between shadowless or higher-contrast, “contoured” illumination of the operating field at any time during the intervention. The choice is entirely his or hers. With marLux® and centriXbeam®, the high-tech operating light with the innovative central reflector from KLS Martin, the surgeon gets what happens to be in greatest demand during an operation: “More light!” S T O RY 3 : In t u i t i o n & E l e c t r o s u r g e r y 18 < > 19 Trust Your Intuition. Or: Why our engineers think differently. The situation is exactly the same as in the operating room. There is the OR table, the operating light, the anesthesia equipment, the instruments. But one piece of equipment is new. The crucial question is: how will the surgical staff cope with it? In this case with a novel electrosurgical unit that is subjected to a usability test under simulated operating conditions. Ten test persons are asked to configure the unit for specific operations. None of them has ever seen the unit before. Simplifying complexities requires an almost child-like openmindedness to capture the essence of things – a capability that may either have been preserved or reacquired. That’s exactly where our engineers succeeded. Information KLS Martin has been working in the field of electrosurgery since the mid-sixties. The first generators were based on tube technology. In the early nineties, KLS Martin set standards with its ME 401 and ME 411 HF units. The maXium® HF unit launched in 2003 represents a milestone in terms of user-friendliness. It is the flagship of a new generation of HF surgical units. S T O RY 3 : In t u i t i o n & E l e c t r o s u r g e r y 20 < > 21 Nothing Could be More Challenging than simplifying the highly complex. Advanced high-frequency surgical units are complex technical creations that can be used across many medical fields. The hemostasis that can be achieved with them is often the difference between life or death in emergency situations. If, for example, an emergency patient is taken to hospital in the middle of the night, startling the duty staff out of their sleep, everything must proceed like clockwork, everyone must know what to do instinctively, every movement of the hand must be just right. To ensure this, it must be possible to use the highly complex technology correctly and intuitively via operator-friendly functions. This is why KLS Martin decided to set standards in this field by developing a new generation of HF units. A focal point of this endeavor – and the totally new feature in comparison with the old generation – was the user interface: in other words, operator control. Electrosurgical units can be used for cutting, coagulating, vessel sealing. Thus, you can seal off tissue or vessels by thermofusion, cut through tissue without any bleeding, devitalize tumors or resect intestinal polyps with them. In fact, the range of applications is practically unlimited. They are just as indispensable for leg amputations and heart implantations as for comparatively simple sterilization procedures. They are needed for cosmetic interventions such as the removal of spider-bursts, for tonsillectomies and in neurosurgery, say, for high-precision dissection of individual nerves. For all these different uses, a multitude of different currents are available. There are monopolar and bipolar applications. And to be sure, all these parameters vary from operation to operation. In short, once a certain level of complexity of the unit and its potential applications is reached, conventional operation – where each parameter is typically linked to a specific switch – definitely reaches its limits. This is why KLS Martin began to rely systematically on menu-controlled, display-based units. This is completely different from the conventional operating philosophy where each function is firmly assigned to a specific button, often requiring complicated multi-button operation. Instead, we began searching for new solutions. From scratch. The standard pursued was exacting: if we were going to develop a new user interface at all, it would have to be the best possible solution in functional terms: straightforward, intuitive, unambiguous, versatile, safe, and pleasing. These were the objectives. To achieve them, cooperation with an external team of specialists was sought: the Use-Lab belonging to the Münster Technical College, headed by Professor Hölscher. The main purpose of this collaboration was to avoid a mistake that happens all too often in the industry – developing a device with great capabilities but little user-friendliness: a product made by engineers for engineers. In emergency cases, blind understanding is sometimes required in the surgical team. With its maXium® unit, KLS Martin has created an intuitively comprehensible basis for HF surgery – and thus the prerequisite for a perfect interaction between the surgeon and his or her team. Instead, the user should know intuitively how to handle the unit. This requires a change of perspective for engineers. Usually, an engineer tends to use all the space available on the display to highlight the active parameter. He works with pop-ups and changing menu windows in an effort to make use of even the last square inch of space available. He routinely looks for the simplest, straight way to solve a given task. However, such simple menu-based user guidance no longer works once the user has to deal with over 40 of such highly “straight” ways. Together with Use-Lab and the product designers, the developing engineers therefore designed a menucontrolled HF unit matched to the user’s perspective and perception. Each parameter was given a fixed place and size, plus clear output channel assignment. The size of the display was defined so that the parameter values are now clearly visible even from a distance of four meters – yet without enlarging the unit’s housing. User-friendliness was the norm even in designing the four patient outputs for monopolar and bipolar applications, with socket backlights facilitating the use of the system in darkened operating rooms. It is these details that ensure the unit’s superior ease of use. A final test was designed to confirm this prior to launch. The test took place in October 2003, shortly before the Medica, on Use-Lab’s premises in Steinfurt near Münster. Ten test persons, one script. Under stressful conditions, each of them was required to make the unit ready for use in a specific parameter and accessory configuration in a simulated emergency situation. None of them received any handling instructions beforehand. Each of them knew that they were being watched. Cameras recorded every motion, every hesitation, every movement of the hand. Watching behind metal-coated glass panes were the usability experts and KLS Martin’s product designers, feeling like a young father who watches his offspring playing in a soccer team for the first time. The offspring had a name: maXium® – the ingeniously simple HF unit for electrosurgery. It passed the test with flying colors. Each test person followed his/her intuition – with success. The presentation at the 2003 Medica caused quite a stir. The “knighting” was to follow soon: the internationally renowned urological department of the Ingolstadt University Hospital – an independent competence center in the field, not a KLS Martin partner hospital – tested the maXium® HF unit and decided to make the purchase. A year later, the maXium® was awarded the BadenWürttemberg 2004 International Design Prize (in gold) by Focus Dialog – for intelligent design, high operating convenience and ergonomically arranged controls. S T O RY 7 : L i g h t & L a s e r 22 < > 23 The Perfect Wave. Or: It’s so good to breathe again. “The patient has 84 metastases in the left lobe and 54 metastases in the right lobe of his lung. The diagnosis: inoperable. Not so in the department for thoracic and vascular surgery of a well-known specialized hospital. Here, a special laser with a specific wavelength is used. A wavelength customized for laser surgery on the parenchymal tissue of the lung. The laser is made by KLS Martin.” It is the wavelength that matters most. Because it is the single factor that determines the prospects – of the lung, of life. Information In laser medicine, KLS Martin considers itself as a complementary provider of special equipment for urology, vascular and parenchymal surgery. In 1993, the MY 60 Nd:YAG laser was placed on the market. In 1998, the MY 40 1.3 Nd:YAG laser followed suit. The year 2000 then saw the launch of a CO² laser that enables high-precision cutting in all microsurgical fields while keeping the thermal impact on the tissue extremely low. S T O RY 7 : L i g h t & L a s e r 24 < > 25 The Laser Removes up to 100 Metastases and preserves the lobe of the lung It was not the first time that KLS Martin had been invited by medical specialists to explore the laser. In the seventies, the laser triggered an enormous boom. Everybody was fascinated by its versatility. It can be used for industrial, manufacturing and scientific purposes – to name but a few fields of application. Every major disco has its laser show. In the mid-eighties, the first medical applications were feasible thanks to the availability of technically advanced laser units. Since then, physicians relying on the laser’s advantages have been looking for industrial partners capable of transforming their concepts into market-ripe units and instruments. One of them, one of the first pioneers, is now senior physician of the newly founded Department of Laser Medicine of the Berlin Elisabeth Hospital: Professor H.-P. Berlien. He turned to KLS Martin. In 1985, both partners became co-founders of the Laser-Medizin-Zentrum Berlin (now LMTB) headed by Professor H.-P. Berlien as medical director. The result of this collaboration was KLS Martin’s first laser: the MY 60 – one of the most compact Nd:YAG lasers, but also the one with the best beam quality, extremely efficient and easy to operate at the same time. The original idea was to use this laser in bone surgery. After all, KLS Martin is a manufacturer of forceps, scissors and scalpels and, as such, a surgical expert. After the introduction of electrosurgical units, it made indeed sense to add a laser unit such as the MY 60 to the product range as well. However, it soon became clear that the laser had its physical limitations as a bone cutter. Luckily, it is all the better suited for vascular surgery and urology. Especially hemangiomas can be treated very well with this laser. These highly proliferative, yet benign vascular anomalies are frequently found on the head and neck, for example, where they tend to look like a deformation, thus adding a psychological problem to the medical condition. For the parents of affected children like those treated by Prof. Berlien, it often was a real odyssey to find the right treatment – i.e. a therapy to remove the deformation instead of aggravating it. The MY 60 Nd:YAG laser provides help. Urology is another field where KLS Martin’s laser units are used with great success. Together with the urologist Prof. Aeikens, KLS Martin developed a laser cystoscope for treating prostatic hyperplasias on an outpatient basis. This novel technique significantly reduces the risk of intraoperative and postoperative hemorrhages and thus the need for blood transfusions. This was the situation in the mid-nineties when KLS Martin saw interesting research results showing that, in contrast to the standard wavelength of 1,064 nanometers so far used in laser surgery, the 1,318-nm wavelength is actually ideal for using the laser technique in pulmonary parenchymal surgery. Whereas the standard wavelength provides only insufficient coagulation with the result that hemorrhages frequently require conventional treatment on a clip and suture basis, the 1,318-nm wavelength eliminates this inconvenience due to its 10-fold higher absorption in water. This property makes it equally suitable for cutting as well as coagulating and sealing lung tissue because of its high water content and low density. By courtesy of Freiburg University Hospital, Dr. S. Eggeling (M. D.) Whereas the standard wavelength misses out on the real advantages of the laser technique in pulmonary parenchymal surgery, the use of the 1,318-nm wavelength allows for the first time the tissue-sparing removal of metastases located deep inside the lung. This means that healthy neighboring tissue can be preserved to a great extent. Even the lung of the patient mentioned above, with its far more than 100 metastases, was completely free from metastases after two operations extending over several hours. KLS Martin provided the needed equipment. Thanks to the novel MY 40 1.3 Nd:YAG laser. With a weight of just 73 kg and external dimensions of 80 x 40 cm, the unit is small, handy and easy to transport. And its high power density guarantees fast vaporization with simultaneous coagulation of the lung parenchyma. But what does this mean for the patients? Breathing. Being able to breathe again, to draw a deep breath. The evaluation of more than 300 operations has shown that the conventional lobectomy rate of 25% could be significantly reduced to a mere 5%. In most cases, lung function could be completely preserved as well, thus increasing the patient’s quality of life. No wonder that, by now, almost all leading German thoracic centers are working with the MY 40 1.3 Nd:YAG laser and that many neighboring countries have already become aware of its advantages. S T O RY 4 : P r o n a t i o n & S u p i n a t i o n 26 < > 27 Lucky Luke Rides Again. Or: A call from New South Wales. They can still be found. Real cowboys. Not only in the United States, but in Australia as well. Tough fellows, high on their horses, the reins firmly in their hands. Or maybe not. The romantic image of the lonely rider begins to fade quickly when he can rotate his forearm only with pain. The cause can be plain wrist arthrosis. Or early fractures. Or a congenital malformation. Whatever it is, it’s a disaster for the cowboy because he can no longer hold the reins – the end. In truth, he is practically unfit for any kind of work that is physically demanding. Sometimes the ability to make a living depends on a little movement of the hand – and on the ulnar head that enables it. If the ulna fails, the cowboy may be unable to stay in the saddle. Information KLS Martin started the development and manufacture of the Herbert ulnar head prosthesis®, along with all the instruments associated with it, back in 1992. In Europe and Australia, KLS Martin is the market leader with its Herbert ulnar head prosthesis®. In January 2005, the product received FDA approval for the US market as well. S T O RY 4 : P r o n a t i o n & S u p i n a t i o n 28 < > 29 At this point in time, in the early nineties, KLS Martin received a call from the Department of Biomechanical Engineering of the University of New South Wales. The team around Dr. Timothy Herbert was thinking about the possibilities of a new ulnar head prosthesis® made of harder, biocompatible materials. Dr. Herbert proposed to the Tuttlingen specialists the manufacturing of a new prosthesis consisting of two components: a titanium shaft, to be used for anchoring the prosthesis to the ulna without any cement; and a head made of ceramic zirconium, to be fitted to the radius with a soft-tissue flap. Measurements were carried out and shaft lengths determined. Besides, the entire range of instruments needed for ulnar head implantation would be designed, developed, manufactured and distributed in Tuttlingen in close collaboration with the Australian team. Medically speaking, the cowboy suffers from a disorder in the distal radioulnar joint that prevents pronation and supination. The condition can be conventionally treated by ulnar head excision according to Darrach, by using the hemiresection-interposition technique according to Bowers, or by choosing the Sauve-Kapandji method. In all of these cases, the surgeon tries to alleviate the patient’s pain either by complete or partial removal of the ulnar head (or end section of the ulna), or by dissecting it from the ulna. Unfortunately, none of these surgical approaches is capable of fully restoring the hand’s function and strength. In the eighties, the cowboy would probably have been treated with a silicone implant. This was in fact a customary procedure, with initially good results. However, problems occurred after just a few months: the prostheses fractured. As became evident, the silicone material underwent abrasion as a result of the arm movements and rotations. Inflammations were a natural consequence. This was finally accomplished by 1995. The first five implantations were carried out. In the meantime, an international multi-center study group had been set up with active support from KLS Martin, bringing leading surgeons from the USA, Switzerland, Germany and Great Britain in direct contact with the Australians. In the following years, they treated 52 patients with the new ulnar head implant, among them the cowboy still threatened by job loss, just as were the other patients. The great majority of them had already undergone one or several operations before, some of them up to eight interventions. Especially for these latter patients, the Herbert ulnar head prosthesis® named after its developer and manufactured by KLS Martin was their last hope. It came true. In the summer of 2000, the surgeons of the multicenter study group got together in Barcelona for a first key user meeting aimed at discussing the results of altogether 57 cases. The evaluation showed significant improvements in the categories “pain”, “strength” and “movability”. The pain relief amounted to 48%, the load capacity was found to be improved by 25% and the movability gain was 17% for pronation and an impressing 37% for supination. These excellent results were confirmed by a second key user meeting held in Vienna in 2002. For many patients, this meant an opportunity to return to work. Presumably, one of them is high in the saddle right now, watching over a cowherd in Australia. A Great Innovation for every small movement of the hand The Herbert ulnar head prosthesis® consists of two different materials: the titanium shaft and the zirconium head. S T O RY 6 : M i c r o b e s & M i c r o S t o p ® 30 < > 31 Can Microbes Jump? Or: Why Paris is worth a trip. Whoever makes a journey has a story to tell. But as time goes by, one forgets. Being back in the workday routine means finding solutions for problems that do not appear to be that big after all. Rather small even – but the trickier for that matter. So small, actually, that they are not even visible. Nonetheless, they seem to be insuperable. All attempts at circumventing them seem to lead astray. However, the paths to real innovations are not straight but twisted and labyrinthine. Because suddenly, over a pint of beer with colleagues, it just clicks and one remembers the trip to Paris, the scientific museum, Pasteur’s swan-neck flask – and that microbes cannot jump. Microbial organisms spread virtually everywhere – unless they get lost in the windings of a labyrinth whose barriers are too much even for them. Information With its MicroStop® technology, KLS Martin offers the most innovative sterile container system currently available on the market. It facilitates the daily routine work, minimizes the contamination risks and cuts down on consumables. MicroStop® meets EN 868 and EN ISO 11607 requirements, is approved for steam sterilization procedures complying with EN 285 and has been validated according to EN 554. S T O RY 6 : M i c r o b e s & M i c r o S t o p ® 32 < > 33 A Long Search for a new form of safety What was the challenge? Sterile containers – and how they could be improved from scratch. To make them fitter for daily use – easier to control, safer, more economical. What’s the conventional practice in contrast? For each sterilization cycle, a new paper filter is required, and for each safety check, a new seal. Both require expenditures in time and money. Both require actions that could be eliminated. True, the sums involved seem to be negligible. A filter costs 10 cents at the most, and a seal is no dearer. The time needed to install them is a matter of a few seconds. So what? Why should one take the trouble to question the conventional practice with its well-organized routines? Why not just leave this situation as it is, all the more so as those consumables are a profitable business? However, this was no reason for KLS Martin not to confront the questions of how sterile containers can be generally optimized, how risks necessarily associated with the use of filters can be minimized and how the follow-up costs for hospitals and central sterile supply departments can be cut. Sure, why worry about a mere 10 cents per filter, 10 cents for a seal? But consider that large hospitals have up to 800 sets in circulation. That’s a lot of money if you put all the sterilization cycles into perspective – accumulated costs over days, weeks, months, a year. A sterile container without any follow-up costs – that, then, was the “deliverable”, the goal to pursued. The search for means and ways began. Different approaches were taken. For example, a permanent filter made of sintered metal seemed to be a promising option. However, the porous metal proved inadequate because contaminated liquids can permeate it. The use of a membrane filter was another theoretical option – again a failure, for two reasons: the high procurement costs and, more importantly, the filter’s lack of tightness. In the final instance, it failed to meet the high sterility requirements. At such stages of development, you just don’t call it a day at 5 o’clock and go home. You typically leave your office late – and together with your colleagues. And you don’t go home either because you feel a need to sit together, to talk about issues, to jot down ideas and potential solutions on a beer mat. Suddenly, one colleague talked about Paris, Pasteur and a museum in which Pasteur’s flask was on display – and probably still is. The flask with the swan-neck tube, open at its end. The flask contains a liquid that is still sterile – after decades. Pasteur proved that food goes bad faster if it is contaminated with particles and microbial organisms. But he also proved that microbes are unable to overcome the angled, swan-neck barrier – or our advanced “Pasteur flow barrier system” for that matter. Can microbes jump? It does not seem so. But KLS Martin employees can. From Paris to Tuttlingen. From Pasteur to Leibinger. From the flask to sterile containers. Thus, an idea was born. But how about its implementation? It is a long way from Pasteur’s discovery to KLS Martin’s filterless sterile barrier. The real work had still to be done. To adapt the rather high and long-drawn neck of Pasteur’s flask to the requirements of the inner surface of a container lid where space is scarce, a circular labyrinthine structure was developed jointly with the Stuttgart Fraunhofer Institute. This germ retention system does not work with an insurmountable obstacle. Rather, it redirects the particle-loaded fluid flow in such a way that the immobilized germs drop out of the flow area and the forces that carry them forward are no longer effective. To determine the separating capacity of the system, a totally new method was used, flow-dynamic investigations were carried out, and finally it became clear that the novel Pasteur flow barrier system, with a separating power of 99.9997%, is more effective than any disposable filter. When the novel sterile container was presented at the 2002 Medica trade fair, it caused quite a stir – and excitement, not least among the competition. A sterile container without any follow-up costs. With a lid made of high-performance plastic. Resistant to thermal, chemical and mechanical loads. Many times safer than containers with metal lids that are easily deformed by mechanical impact and can thus become permeable. Safer also because of its eye-catching tamper evident indicator that registers every opening, signaling like traffic lights – red or green – whether the instruments are still sterile and ready for use or not. Above all, however, the innovative sterile container caused a stir and astonishment because of its novel germ retention system that satisfies the requirements of all national and international standards relating to sterile goods packaging. MicroStop® answers the question whether microbes can jump, once and for all: Certainly not over our germ barriers. C O N TA C T: F i n a l N o t e s & A d d r e s s e s 34 < > 35 Gebrüder Martin GmbH & Co. KG A company of the KLS Martin Group Ludwigstaler Str. 132 D-78532 Tuttlingen Postfach 60 · D-78501 Tuttlingen Tel. +49 7461 706-0 · Fax +49 7461 706-193 info@klsmartin.com · www.klsmartin.com KLS Martin Subsidiaries KLS Martin France SARL 3, Rue Gambetta 68000 Colmar France Tel.+33 3 89 21 66 01 Fax+33 3 89 23 65 14 axel.siegelin@klsmartin.com Martin Nederland/Marned B.V. Vissersstraat 9a 1271 VE Huizen P.O. Box 278 1270 AG Huizen The Netherlands Tel.+31 35 523 45 38 Fax+31 35 523 53 48 info@martinnederland.nl Martin Italia S.r.l. Via Paracelso, 18 Palazzo Andromeda, Ingresso 2 20041 Agrate Brianza (Mi) Italy Tel.+39 039 605 67 31 Fax+39 039 605 67 42 info@martinitalia.it Nippon Martin K.K. 6 Fl., 4-6-16 Hiranomachi 541-0046 Chuo-ku, Osaka 541-0046 Japan Tel.+81 6 62 28 90 75 Fax+81 6 62 28 90 76 info@n-martin.com KLS Martin L.P. 11239-1 St. John`s Industrial Parkway South Jacksonville, Fl 32246 USA Office phone +1 904 641 77 46 Office fax +1 904 641 73 78 Toll free +1 800 625 15 57 sburke@klsmartin.com www.klsmartinusa.com 02.07 . 90-685-02-04 . Printed in Germany · Copyright by Gebrüder Martin GmbH & Co. KG · Alle Rechte vorbehalten · Technische Änderungen vorbehalten · We reserve the right to make alterations · Cambios técnicos reservados · Sous réserve de modifications techniques · Ci riserviamo il diritto di modifiche tecniche And what objectives would you like to achieve with us? Group & Companies • • • • • • • • • • • • D ata & Fac ts >1 People & Trade Fairs Know-how & Core Competency Gebrüder Martin Rudolf Buck Karl Leibinger KLS Martin USA KLS Martin Germany Stuckenbrock Orthosurgical Implant Inc. (OII) USA • • • • • Surgical instruments Operating lights Electrosurgical units Medical lasers Implant systems D ata & Fac ts >2 Over 700 employees worldwide 40 experts for research & development 180 sales representatives 30 trainees Over 200 trade fairs, training courses and events annually D ata & Fac ts >3 The Companies The Products The Employees The Group and its claim The Group and its products The Group and its employees KLS Martin is a medium-sized group of companies with a readiness to innovate and invest, based on a clear growth strategy. We offer more than marketable products. We develop comprehensive medical-technical problem solutions with a high practical relevance because they have been implemented in close collaboration with the users. The result are products and systems that impress with a high innovation level and differentiate themselves from the competition by significant USPs (unique selling propositions). They benefit the surgeon, the medical staff and the patients alike because they serve health and its restoration. With its comprehensive, user-oriented product portfolio, KLS Martin sees itself as partner of all the people working in the operating room and the central sterile supply department. Our product range comprises more than 13,000 instruments and units, plus surgical and comprehensive services. The name of KLS Martin stands for top-quality and innovative medical technology. Our special strengths include maxillary, hand and HF surgery and operating lights. Many of our innovative developments give us a leading position in a number of market segments. The secret behind this success are top achievements at any level, from our own research and development (R&D) through production based on highly advanced manufacturing techniques, thus guaranteeing maximum quality and functionality, to the internationally operating sales organization. Above all, however, the success of our products is due to the fact that they are “made in Germany”. KLS Martin employs over 700 people worldwide, 180 of them in its sales organization and more than 40 in R&D. Some of them are highly qualified specialists, depending on the field of activity. All of them are ready to give their best, actively supported by their employer, in order to live up to the high demands. Just as international as the Group are its multicultural employees, used to communicating with each other in German, English, Spanish, French and Italian as the main languages. The Group and its foundation Back in 1923, the Gebrüder Martin sales company was founded under the pressure of the global economic crisis. Germany was in the grip of inflation and money that did not lose its value could only be earned abroad. As a certain business size was necessary to operate successfully abroad, seven Tuttlingen competitors decided to join forces. The Group and its specialized sales partners KLS Martin earns about 75 percent of its proceeds in foreign markets, roughly two thirds of this share in Europe. The Group is represented in the USA, Japan, Italy, France and the Netherlands, either by its own subsidiaries or by partner companies. The Tuttlingen Logistics Center serves specialized dealers in over 100 countries of the world. The Center boasts 50,000 storage locations. More than 2,000 order items are processed day after day at a service level of 95 percent. The Group and its quality management At KLS Martin, a comprehensive quality system regulates and controls all processes, from product development to customer complaints. The system fully complies with the DIN EN ISO 13485 and DIN EN ISO 9001 international standards and the European medical device legislation. National regulations – such as those of the American Food and Drug Administration (FDA) or the Canadian legislation – have been fully integrated as well. Besides, KLS Martin has been operating its own high-tech lab for years, which provides check analyses and performs and documents investigations. Where needed, we do not hesitate to cooperate with well-known institutes as partners. In this way, all materials and products are put to the acid test prior to placing them on the market. Either through our in-house lab capable of simulating even the most extreme processing conditions. Or through our application engineers, who carry out qualified on-site investigations on the customer’s premises. The Group and its training opportunities KLS Martin offers qualified occupational training and interesting prospects to active young people who are eager to learn and determined to pursue a professional career, either in a technical or commercial field. Our apprentices and trainees are valued highly because we know that their knowledge, skills and qualifications are indispensable for us to secure our competitiveness on the international markets of the future. Therefore, we are glad to take on the task of offering people opportunities for responsible work and safe jobs. The Group and its events Every year, KLS Martin participates in over 200 trade fairs and events all around the world, many of them even organized by us. A list of the most important events is regularly published on our website at: www.klsmartin.com. C O N TA C T D ATA Surgical Innovation Is Our Passion Gebrüder Martin GmbH & Co. KG A company of the KLS Martin Group Ludwigstaler Str. 132 D-78532 Tuttlingen Postfach 60 · D-78501 Tuttlingen Tel. +49 7461 706-0 · Fax +49 7461 706-193 info@klsmartin.com · www.klsmartin.com KLS Martin – in a nutshell KLS Martin Subsidiaries Our claim Surgical innovation is our passion. KLS Martin France SARL 3, Rue Gambetta 68000 Colmar France Tel.+33 3 89 21 66 01 Fax+33 3 89 23 65 14 axel.siegelin@klsmartin.com Martin Nederland/Marned B.V. Vissersstraat 9a 1271 VE Huizen P.O. Box 278 1270 AG Huizen The Netherlands Tel.+31 35 523 45 38 Fax+31 35 523 53 48 info@martinnederland.nl Martin Italia S.r.l. Via Paracelso, 18 Palazzo Andromeda, Ingresso 2 20041 Agrate Brianza (Mi) Italy Tel.+39 039 605 67 31 Fax+39 039 605 67 42 info@martinitalia.it Nippon Martin K.K. 6 Fl., 4-6-16 Hiranomachi 541-0046 Chuo-ku, Osaka 541-0046 Japan Tel.+81 6 62 28 90 75 Fax+81 6 62 28 90 76 info@n-martin.com KLS Martin L.P. 11239-1 St. John`s Industrial Parkway South Jacksonville, Fl 32246 USA Office phone +1 904 641 77 46 Office fax +1 904 641 73 78 Toll free +1 800 625 15 57 sburke@klsmartin.com www.klsmartinusa.com