Surgical Innovation - Zur KLS Martin Website

advertisement
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
Download