TRUMPF Laser

Lasers for Medical Device ManufacturingQuality in Focus

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TRUMPF – Setting the Pace in Production with Lasers for Medical Device Manufacturing

With its outstanding characteristics, the laser in medical device manufacturing is the

production tool of choice. It is used for welding, cutting and marking of all convention-

al materials.

Whatever is involved – the manufacture ofendoscopes, medical instruments or implants –lasers work with speed, precision and repeata-bility. The result: highest quality.

With its innovative, reliable products and manyyears' experience, TRUMPF is one of the leadingproducers worldwide of industrial laser devicesand installations for cutting, welding and mark-ing. Since 1973, medical device manufacturershave been using TRUMPF lasers on their pro-duction lines.

To suit the large variety of applications, TRUMPFoffers laser devices and installations for auto-mated as well as manual production.

A sophisticated service concept gives userspeace of mind with regard to economically effi-cient use of the laser. This ranges from applica-tion support to individual training and service.

1973TRUMPF Laser, previously HAAS-LASER, is apioneer in industrial laser devices for spotand seam welding. Medical device manufac-turers are among the first users. The sameapplies later on when lasers are used forcutting applications.

1985TRUMPF brings the first industrial laser lightcable onto the market. It guides the laserbeam flexibly along a glass fiber, from laserdevice to processing station.The beam sepa-ration resulting from this offers manyadvantages, e.g. four longitudinal seams canbe simultaneously welded onto an endo-scope shaft, minimizing distortion.

1990TRUMPF introduces welding lasers into den-tal laboratories. Today the technology isstandard practice.

1998TRUMPF opens up entirely new possibilitieswith its diode-pumped marking lasers, intro-ducing a new quality of laser marking.

2005TRUMPF introduces new lasers for micro-processing – an area of application thatextends far into the future.

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Welding

n Small spot diameters and narrow seams

n Non-contact and no mechanical force

n Minimal heat affected zone

n Hermetic weld without porosity

n Corrosion-resistant

n As bio-compatible as the base material

n Complex contours

Cutting

n High precision

n No mechanical force

n Smallest of radii for cutting tubes

and hollow bodies

n Variable cutting angles

n Thicknesses from < 0.1 to several millimeters

n Minimal heat affected zone

n Excellent edge quality with minimal burr

Marking

n Long-term durability

n Resistant to high-temperature sterilization

n As bio-compatible as the base material

n Minimal heat input

n Flexible and fast in text/image application

n Metals and non-metals

n Resolutions to 25 μm

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Instruments for Surgery

EndoscopeSeam weldingMarking

Endoscopic forcepsSeam weldingCuttingMarking

Retrieval basket made of Nitinol Spot welding

A large number of instruments are used in surgery – and every single one is subject

to the most stringent quality requirements, from materials and processing method

upward.

The manufacture of surgical instruments requi-res large product variety and small lot sizes.Here, the high flexibility of the laser makes itideal for welding, cutting and marking applica-tions.

Surgical instruments feature many differentcutting applications. Trocars and endoscopeshafts require ultra-small radial cuts, and com-plex openings can be cut in thin-walled tubes.

Contour cuts can be found on various forcepsand scalpel points, and notches on bone rea-mers and drills. The production of linked ele-ment structures in moveable guide instrumentsis done solely via cuts in the tube.

All cuts are of high quality: they are smooth,sharp-edged, and with minimal burr. The cuttingangle is selectable. Depth of roughness andheat affected zone are just a few micrometers.

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Acetabulum reamerCuttingMarking

ForcepsCuttingWelding

Neurosurgical punchMarking

On the endoscope shaft, two tube-to-tube con-nections are welded using four weld seams,simultaneously and thus distortion-free. Theshape and cross-section of the tubes remain thesame. The simultaneous processing is madepossible by dividing up the laser beam intoseveral laser light cables.

Welding generally takes place without the useof additional material. Filler material, in theform of wire, can however be used to create aflat surface or fill a gap. The pore-free, sterilesurfaces of the laser seams have the same bio-compatibility as the base material.

Laser marking fulfils the requirements for long-lasting and durable product identification. Thecolor-change thus created does not affect thesurface consistency of the material. Markedinstruments remain sterilizable at high tempera-tures. The laser masters many different markingtasks without a problem, due to its unrivaledflexibility and continuous high quality.

With its high resolution, the laser is also idealsuited to marking data-matrix codes, and thusfor the highest information density.

Like cutting, welding also benefits from highpower density of the laser. The heat affectedzone is somewhat larger than with cutting, butjust as defined and limited.

Inlets and connections to endoscopic instru-ments are welded quickly and precisely – oftenin one single set-up.

Wrist implantCuttingMarking

Larynx membraneWelding

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Passive and Active Implants

Long-life cycle and biocompatibility are of the utmost priority with medical implants.

Active implants also have to be as small and light as possible. The laser offers ideal

production methods for this.

Titanium implant systemsCutting

Where the cutting of titanium implants fororthopaedic applications is concerned, the laseris ideal not only for its cut quality but also itshigh flexibility.

Whether for implant systems for surgery to themouth, jaw, face or hand, or implants in the spi-nal region, a variety of implant shapes can becut quickly and economically without the needfor any tool changes, and via CAD/CAM.

The cutting angles can be adjusted, and thecuts have smooth surfaces and sharp edgeswith minimal burr. Finishing work is generallynot required.

With aneurysm clips for neurosurgery, the laseris used for precision welds on the clip. The weldseam is also smoothed via laser. The fine weldconnections are distortion-free. This results in optimal guidance and perfectly-shapedaneurysm clips.

The tiny but pin-sharp laser marking on the clipguarantees identification and traceability.

Hip joint prosthesisMarking

Hip shaft prosthesisMarking

Upper thigh implantsMarking

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housing are hermetically welded. Here themelt-heat spreads from pulse to pulse acrossthe housing, so that the sensitive electronicslocated inside are never heated to more than50 °C. The welding depth can be preciselyadjusted.This prevents any interior weld splatter.

Moreover, pulsed solid-state lasers are also usedfor various spot welds on internal electroniccomponents as well as in electrode production.

Laser marking of implants is highly varied andindividual. It includes the product identificationand corporate logo plus further functionalinformation. Serial numbers and data-matrixcodes ensure traceability of all patient-relateddata.

Like the weld seam, markings are also physio-logically safe.

Pulsed solid-state lasers are especially suitablefor closing the titanium housings of pacema-kers, defibrillators or implanted pumps. Overlapspot welding ensures that the two halves of the

Laser Machines for Welding and Cutting

TRUMPF laser machines are flexible in application, and suitable for every lot size. Short

set-up times and simple transmission of CAD data to the machine control enhance their

economic efficiency still further. Additional axes also ensure optimal adjustment during

3D processing.

Endoscope shaft3D cuttingSimultaneous welding

Cardiac pacemakerSpot weldingSeam welding

Endoscopic component3D welding

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Generously-sized working areas and high-precision CNC axes with travel of up to 1000 x 500 x 400 mm are among the distinc-tive features of laser machines from TRUMPF.All the machines can be combined withTRUMPF solid-state lasers of every power classvia the flexible laser light cable. This means thatboth laser and machine can be individuallyadapted to suit processing requirements.

Optically supported installation means that set-up times are drastically reduced. Movementalong contours can also be optically controlled.This enables production of a single workpiecewithout any preliminary prototype.

Repeatability of the various processing tasks isguaranteed, because the laser tool alwaysprovides constant results.

The stability of the laser and the precision ofthe machine enable processing accuracy to 20 μm during cutting and welding.

The processing data is stored in the machineand can be recalled at any time.

Additional turning and swiveling axes plus a swivelable focusing optics enable sophisti-cated 3D processing. This is useful for endo-scopic components, for instance, where severalinlets are welded in one set-up.

A machine with a rotary indexing table isadvantageous in particular when loading andlaser processing take almost the sameamount of time. One example is the closure ofthe two halves of a cardiac pacemaker.

Bronchoscope3D weldingInner tube weldingCutting

Infant bronchoscope3D cuttingWelding

Laser Machines from TRUMPF

n Travel up to 1000 x 500 x 400 mm

n Precise cutting and welding

to 20 μm

n Short set-up times

n Optically supported set-up

n Appropriate for any lot size

n High repeatability

n Easy operation

n CAD/CAM interface

n Seam viewing and

control via camera

n Ideal for 3D processing

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TrocarSeam welding

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Laser Workstations for Manual Welding

Workstations from TRUMPF enable sophisticated, manually guided welds under a stereo

microscope. Machine welds are also possible via supplementary power-driven work-

piece movement.

On manual workstations the workpiece is posi-tioned by hand under the stereo microscopeand guided from weld point to weld point. Thecrosshairs on the stereo microscope show thefocal position of the welding spot. The diameterof the welding spot can be selected from 0.2 to 2 mm, with a welding depth of up to 2 mm.When the laser pulse is triggered, the smallmelt occurs in just a few milliseconds, and coolsdown again just as quickly. Overlapping spotwelds create a weld seam.

ProfiWeld and PowerWeldThe ProfiWeld is a compact, mobile workstationwith an integrated laser. A 230 V-connectionsuffices as energy supply. Ergonomics, easyaccessibility and simple handling are the dis-tinctive features of this device. This enablessophisticated manual welding of geometriesthat would normally need at least five axes ona machine.

With the PowerWeld, welding can be donemanually as well as machine-aided. The work-piece is moved in two axes on an air-cushionedplate. In addition there is a rotating axis thatcan be swiveled. Motor-driven workpiecemovement enables faster welds. Various laserdevices can be connected to the PowerWeld viaa laser light cable, depending on requirements.

Either manually or by machine: the laser andmachine data are stored and the weldingprograms can be recalled at any time.

ProfiWeldManual welding under the stereo microscope

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Surgical forcepsSpot welding

Customized Welding SolutionsThe housings of ProfiWeld and PowerWeld en-able them to be operated in any work environ-ment. Open workstations can be individuallydesigned – for long workpieces, for instance.However they have to be set up in a separateroom to ensure laser safety.

Even if the user or supplier sets up the work-station themselves, TRUMPF focusing andobservation optics can be easily integrated. Ason the PowerWeld, TRUMPF laser devices areconnected with the focusing optics at the work-station via laser light cable.

Endoscopic instrumentSeam welding

Forceps for aneurysm clipsSpot weldingSeam welding

Workstations from TRUMPF

n Manual welding of complex

geometries

n Workpiece hand-guided or via

powered axes

n Observation and monitoring via

stereo microscope or camera

n Laser welds repeatable anytime

n ProfiWeld and PowerWeld for

any working environment

n Customized solutions with open

workstations

n Laser and workstation can be set

up independently of each other

n Laser selection to suit

requirements

n One laser for several

workstations

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Marking lasers from TRUMPF provide all materials in medical device manufacturing

with clear, detailed and sharp identification. At the same time, biocompatibility is fully

maintained. Whether it is text or images – the laser marks both with high precision.

Marking Lasers for Long-Term Traceability

On metallic components marking is done withtempered colors that the focused laser beamcreates via local heating of the surface. Herethe surface remains smooth. The color is non-wearing, absolutely sterilization-resistant andjust as biocompatible as the base material.

With plastics, the marking is done via colorchanges or pigments layered inside the material.The surface also remains unchanged.

Whether it is serial numbers, text or data-matrixcodes, the individual product marking guaran-tees complete traceability of instruments andimplants.

Even the tiniest of surfaces have enough roomfor a machine-readable dot-matrix. In addition,corporate logos increase recognition consider-ably.

Spinal implantFunctional marking

BronchoscopeScaling

Surgical scissorsMarking Data-matrix code

TRUMPF offers an extensive range of diode-pumped lasers for marking applications.Different wavelengths for differing materialsensure optimal processing results.

With the TruMark Station – the enclosed laserworkstation from TRUMPF – the workpieces tobe marked are loaded by hand and removedagain after marking is completed. Differentworkpiece heights are compensated for by thez-axis. In the case of loaded pallets or largerworking areas, an x-y table with travel of up to 600 x 400 mm is available, and forcircumferential marking a rotating axis. Theworkstation and its housing can be set upwithin any work environment.

The marking laser without workstation is idealfor compact integration into customized manu-facturing solutions.

Laser marking is distinctive for precise line con-trol accompanied by high local resolution, andno additional material is required. The laserbeam is computer controlled and guided acrossthe workpiece surface at high speed. Metalsand non-metals alike are permanently marked.

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Marking lasers from TRUMPF

n Various workstations according

to CE guidelines

n Compact integration component

for customized solutions

n Wavelengths:

1064, 532, 355 nm

n Freely programmable fonts

n High resolution and

repeatability

n High information density

n For all materials

n For all workpiece geometries

Titanium screw for spinal implantMarkingLogo

Plastic cannulaMarking

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Today, ever more sophisticated processing methods are required, and medical device

manufacturing is no exception. TRUMPF has new laser devices for cutting, drilling,

ablating and structuring – applications already of great significance in the electronics,

semiconductor technology and automotive sectors.

Stainless steelStructuringWidth: 40 μm, Depth: 5 μm

Human hairThreaded through a ceramic drill hole,Ø 100 μm

CeramicMold cutoutDepth: 200 μm

Microprocessing means highly precise materialremoval with high repeatability in the micronrange. The materials machined today includesemiconductors, ceramics and all metals.

Short pulses, high peak power and extremefocusability are distinctive features of the newlaser series from TRUMPF.

Variability from pulse to pulse and the higheststability of all laser parameters such as pulseenergy, average power, beam location or beamshape make the laser an ideal tool for industri-al microprocessing.

The smallest drill holes with a diameter androundness accuracy of 1 μm are possible.Drilling diameters of 20 μm as well as aspectratios of up to 1:20 can be achieved.

New Perspectives with Laser Microprocessing

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Apart from drilling, microprocessing lasers areused in the production of ultra-fine structuresas well as for layer-by-layer removal of metalfrom molds and notches in all kinds of differentmaterials.

In medical device technology implant surfacesare already being structured for improvedosteo-integration. Further applications arebeing prepared.

TungstenDrill hole, Ø 75 μmDepth: 200 μm

TruServices – TRUMPF offers you more

ConsultingBefore the decision to buy you will receive com-prehensive consulting from our sales represen-tatives and application specialists. We alsocarry out customer-specific feasibility studiesfor you in our very well-equipped applicationlaboratories.

TrainingIn the TRUMPF training centers we provide youwith laser application training individually tai-lored to your requirements. Experienced appli-cation technicians also support you with theinstallation of your process.

ServiceLasers from TRUMPF have proven themselvesover many years in industry. Uptime is at over99 percent. In a global service network, ourlaser specialists carry out the set-up and start-upof the devices on the spot, and the mainte-nance work quickly and efficiently.

From the first contact onward, the user receives full support

from TRUMPF, and for as long as he uses the laser.

TelepresenceWith Telepresence,TRUMPF offers a service thatis unique worldwide. The operating and controldata as well as all measuring parameters canbe accessed online at any time. That way ourservice experts can quickly diagnose errors,evaluate them and often remedy them instant-ly – regardless of where in the world the laserdevice is located.

TRUMPF Laser GmbH + Co. KG

Aichhalder Straße 3978713 Schramberg

Tel.: +49 7422 515-0Fax: +49 7422 515-108E-Mail: info@de.trumpf-laser.comInternet: www.trumpf-laser.com G

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TRUMPF is certified to DIN EN ISO 9001 and VDA 6.4.