The Materials - ASM International

www.asminternational.org/ampJULY 2007

MPMD

TECHNICAL AND BUSINESSNEWS FOR THE MEDICALDEVICEINDUSTRY

� Company News� University

Research� Business

Briefs

INCLUDES:

TM

Materials and Processesfor Medical Devices

Materials and Processes for Medical Devices

2007 Conference Exposition

Technical Program

Highlights

Materials and Processes for Medical Devices

2007 Conference Exposition

Technical Program

Highlights

&&

A publication of ASM International 9639 Kinsman Road

Materials Park, OH 44073Tel: 440/338-5151

Fax: 440/338-4634www.asminternational.org/amp

Editorial Staff

Margaret W. Hunt, [email protected]

Donald F. Baxter Jr., Managing [email protected]

Trisha McKay, Contributing Editor

Barbara L. Brody, Art Director

Joanne Miller, Production [email protected]

Vin LeGendre, Senior [email protected]

Joseph M. Zion, [email protected]

Editorial CommitteeRoger Narayan, North Carolina State University and

the University of North Carolina, Chair

Stanley Brown, U.S. Food and Drug Administration

Howard Freese, Allegheny Technologies Inc.

David Hill, Rocket Medical

Mark Morrison, Smith & Nephew plc

William G. Ward, Wake Forest University

The MPMD Editorial Committee is strictly an advisory group, and membership on the committee in no way implies

endorsement of any of the publication's content.

Sales StaffSales Manager, East Coast/Eastern Canada:

Mike Sellaroli, Columbus, Ohio. Tel: 614/268-5260; e-mail: [email protected]

Sales Manager, Midwest/West Coast/Western Canada: Michael Balzano, Materials Park, Ohio. Tel: 216/373-6865;

e-mail: [email protected].

JULY 2007

TECHNICAL AND BUSINESSNEWS FOR THE MEDICALDEVICEINDUSTRY

FEATURES10 2007 Technical

ProgramHighlights

12 Biomedical Materials Papers from MS&T 2006

DEPARTMENTS2 Observations

4 News of the Industry

14 University Research

16 Products & Services

18 Business Briefs

ON THE COVERA stent fatigue test instrument ca-

pable of simulating the multiple axesof displacements seen in vivo has re-portedly been developed by BoseCorp. Electroforce Systems Group,Eden Prairie, Minn. This system is ca-pable of combining dynamic bending,rotation, extension/compression, andradial distention on multiple stentsunder controlled conditions. The in-strument is capable of testing for an accelerated ten-year sim-ulated life, or for fatigue to fracture studies.

The MAPS (Multi-Axis Peripheral Stent) test instrument isthe first programmable instrument for simulating the complexloading that stents see in the peripheral arteries (the renal ar-teries, the carotid arteries, and the femoral-popliteal arteries).Peripheral arteries have greater bending, twisting, andstretching motions, so stents in those arteries see greater stressesand strains.

For more information: Bose Corp. Electroforce SystemsGroup, 10250 Valley View Road, Eden Prairie, MN 55344; tel:952/278-3070; www.bose-electroforce.com.

ADVANCED MATERIALS & PROCESSES/JULY 2007 51

MPMDMaterials and Processes

for Medical Devices

TM

www.asminternational.org/amp

From September 23 to 25, ASM Inter-national is presenting its conferenceon Materials and Processes for Med-

ical Devices (MPMD) at the Desert SpringsResort and Spa in Palm Springs, Calif. Thismeeting is a unique opportunity for re-searchers from academia, industry, andgovernment to come together to explorethe latest technology related to medical de-vices and the materials from which theyare made. Today’s medical devices arehighly specialized and require highly ad-vanced biomaterials and biomaterialprocesses to be successful in their applica-tion. Whether we are discussing cardio-vascular drug-eluting stents, articulatingsurfaces for total joint replacements, orshape-memory alloys and polymers, thesuccess of medical devices in use today arecritically dependent on materials andprocesses.

This year’s conference is an outstandingcombination of Keynote addresses, oralpresentations, and posters. Our Keynotepresenters this year were selected for theirexpertise and knowledge in their respec-tive disciplines. The organizing committeechose to invite Keynote presenters fromthe clinical, academic, industrial, and na-tional laboratory settings to give a diverseperspective on current and future direc-tions for biomaterials and medical devices.These perspectives will give the attendeesan in-depth understanding of the issuesrelated to current clinical practice, whereindustry sees current medical device de-sign and development, and more far-reaching views from academia and the na-tional laboratories as to potential futureadvances.

The oral sessions are structured to give

those attending an opportunity for a fo-cused immersion in subjects related to ad-vanced materials and processing, surfaceengineering, shape memory alloys andpolymers, and fatigue, corrosion, and weardegradation. Sessions will also be dedi-cated to nano and biomaterials, elastomers,and orthopedic polymers. There is a strongemphasis on metallic biomaterials pro-cessing-structure-property-performancerelationships over a wide range of tita-nium, platinum, cobalt, nickel, iron, zirco-nium, and tantalum alloy systems. Alongwith this emphasis are sessions that coveradvances in shape memory polymers,drug delivery technology, and degradableimplant materials.

This conference is a must for those in-volved in medical device research and de-velopment of today’s medical deviceswhere real-world problems are exploredwith real-world solutions. The future ofmedical device technology depends on ex-panding our knowledge of current deviceuse and performance, and both the presentand future of biomaterials and medical de-vices will be presented at this conference.

Beyond the outstanding technical pro-gram, the venue for this year’s meeting isalso outstanding. So come and be a part ofthis rapidly growing field of biomaterialsand medical devices, and learn about thelatest in medical device technology. For com-plete details, visit www.asminternational.org/meddevices.

Jeremy L. Gilbert, Ph.D.Chair of the Organizing CommitteeProfessor and Chair, Dept. of Biomedical EngineeringSyracuse University

OBSERVATIONS

MPMD Conference 2007

52 ADVANCED MATERIALS & PROCESSES/JULY 2007

MPMDMaterials and Processes

for Medical Devices

TM

A new dental implant based on nanotechnology has been introduced by Biomet 3i, the dentalreconstructive device subsidiary of Biomet Inc., Warsaw, Ind. The NanoTite implant builds on the

benefits of Biomet 3i’s Osseotite implant by adding deposits of nanoscalecalcium phosphate crystals to approximately 50% of the surface. Accordingto pre-clinical studies, these nanoscale deposits create a complex surfaceon the implant that appears to play a key role in how the implant bondswith the bone. Human bone recognizes calcium phosphate as biologicallynatural, allowing the bone and implant to bond during healing.

For more information: Greg W. Sasso, Biomet Inc., 56 East Bell Drive,Warsaw, IN 46582; tel: 574/372-1528; www.biomet.com.

Carbon composite cervical implant stabilizes the spineAcarbon composite implant for stabilization of the cervical spine has been

developed by Icotec AG, Switzerland. It is the first bone plate system withscrews made of carbon composite. The properties of the material facilitatepost-op monitoring of the healing progress with MRI and X-ray withoutartifacts that distort the images. In addition, the composite implants pro-vide excellent fatigue resistance in dynamic applications.

With the patented Composite Flow Molding (CFM) production process,Icotec is able to produce complex shapes out of continuous-fiber-reinforcedthermoplastics. The high carbon content of continuous fibers gives the com-ponents outstanding mechanical strength similar to that of metals. TheCFM process enables the production of small details such as threading,without cutting the fibers. The composite materials are corrosion resistant,biocompatible, fatigue resistant, and very light.

For more information: Bettina Graf, Icotec AG Innovative Composite Tech-nology, Altstätten, Switzerland, tel: 41 71 757 00 20; [email protected];www.icotec.biz.

Metal-on-metal resurfacing programs formedical implants have been further expandedby Doncasters Medical Technologies, OregonCity, Oregon. Hip resurfacing is an alternativeto total hip replacement, and has been popularin Europe and other countries worldwide formany years.

The main advantage of hip resurfacing is thatit does not require the insertion of a large steminside the femur. Instead, the surface of the headof the femur and the inner surface of the acetab-ular socket are prepared and lined with metalcomponents. The procedure has been shown to

be more stable than total hip replacement.Following detailed metallurgical development

and refinement of vacuum casting processes,and collaboration with experts at SheffieldHallam University in the U.K., Doncasters Med-ical Technologies worked with pioneering sur-geon Dr. Derek McMinn to develop the special-ized metallurgy used in the Birmingham HipResurfacing (BHR) system.

For more information: Doncasters MedicalTechnologies, 13963 Fir Street, Oregon City, OR97045-0043; tel: 503/656-9653; www.doncasters.com.

Biomet Orthopedics recently received clear-ance from the U.S. Food and Drug Administra-tion to market acetabular hip liners manufac-tured from E-Poly Highly CrosslinkedPolyethylene. Vitamin E, a natural antioxidant,is expected to improve the longevity of the im-plant bearings used in total joint replacements.The E-Poly material was developed by com-bining the research of Massachusetts GeneralHospital with Biomet’s expertise in polyethylenetechnology.

In laboratory testing, E-Poly liners havedemonstrated 95 to 99% less wear than the ex-

isting low wear rates of Biomet’s clinically suc-cessful ArCom polyethylene liners. The E-Polymaterial also provides greater strength whencompared to first generation re-melted highlycrosslinked polyethylenes, while maintainingoptimal oxidation resistance. In addition, E-Polyliners offer a technologically advanced polyeth-ylene available for use with large diameterfemoral heads, designed to provide a greater de-gree of joint stability.

For more information: Biomet Inc., 56 East BellDrive, Warsaw, IN 46582; tel: 574/267-6639;800/348-9500; www.biomet.com.

Vitamin E-stabilized polyethylene improves longevity of bearings

MPM

D4


Metal injection molding

Morgan Advanced Ceramics, Fairfield, N.J.,offers metal injection molding (MIM) for med-ical components through its Alberox Prod-ucts division in New Bedford, Mass. Parts areavailable in surgical grade 17-4 PH, 316L,and 304L stainless steels; Kovar, nickel iron,tungsten, OFHC copper, and molybdenumcopper. www.morganadvancedceramics.com

Metal-on-metal resurfacing has low wear rate for implants

Dental implant technology based on nanomaterials


MPM

D5

Nitinol self-expanding stent designed for neck arteriesThe Cordis Endovascular Division of Cordis Corp. announces FDA approval to market its Pre-

cise RX Nitinol self-expanding stent and Angioguard RX emboli capture guidewire system to treatclogged neck arteries. The RX, or rapid exchange version, facilitates single op-erator use and more efficient manipulation of the catheter and guidewire duringstenting procedures.

The Cordis Angioguard Capture Guidewire is the first embolic protec-tion device shown in clinical testing to achieve a relative stroke reduction of70% during carotid stenting procedures. A polyurethane membrane with 100pores captures clinically relevant emboli. Eight Nitinol struts keep the sym-metric basket in contact with the arterial wall, and help ensure that debrisdoes not escape.

For more information: Cordis Corp., P.O. Box 025700, Miami, FL 33102-9949;tel: 800/327-7714; www.cordis.com.

Ceragenin, a new class of compounds knownas cationic steroid antimicrobials (CSAs), hasbeen designed for implantable medical devicesby Ceragenix Pharmaceuticals, Denver, Colo.The company cited a 21-day study showing thatan untreated control catheter had 30,000 bacte-rial colony forming units (CFUs) on its surface,while treated catheters had fewer than 100CFUs.

These results demonstrate the potential forCeragenins to be utilized as an antimicrobialtreatment for indwelling medical devices. The

company says the antimicrobial agent can beadded to pre-formed medical devices to preventbacterial adhesion. The coating acts as a reser-voir for the antimicrobial agent, which slowlyleaches out over time. Potential uses for CSAsinvolve devices such as endotrachael tubes,stents, central venous catheters, urinarycatheters, hemodialysis catheters, orthopedicimplants, and vascular grafts.

For more information: Ceragenix Pharmaceu-ticals, 1444 Wazee Street, Suite 210, Denver, CO80202; tel: 720/946-6440; www.ceragenix.com.

Cationic steroid antimicrobial coatings protect medical devices

Abbott’s bioabsorbable drug-eluting stent treats arteries

Dual titanium/hydroxyapatite coating is more biocompatible

Biomedical companies worldwide rely on MTS testing solutions to optimize their critical testing

processes for orthopaedic devices, biomaterials, medical devices, and medical packaging and

consumables. High-performance Bionix electromechanical and servohydraulic systems, industry-

leading MTS software, and reliable accessories provide the precision force and motion control

capabilities you need to conduct highly accurate, repeatable and meaningful biomedical testing.

DEVELOP WITH CONFIDENCE

www.mts.com© 2006 MTS Systems Corporation.MTS and Bionix are registered trademarks of MTS Systems Corporation. RTM No. 211177.

MTS BIONIX TESTING SOLUTIONS

be certain.

ACHIEVE TESTING CERTAINTY WITH MTS BIONIX® TESTING SOLUTIONS

CONTACT MTS TODAY AND LEARN MORE ABOUT THE FULL ARRAY OF BIONIX TESTING SOLUTIONS

MPM

D6


The Cormet acetabular cup has a dual coatingof plasma sprayed titanium overlaid with hydrox-yapatite, reports Corin Medical plc., England. Thetitanium coating is rougher and more biocompat-ible than the CoCr coating used in the past, andthis change appears to represent a significant im-provement. Many of Corin’s reconstructive de-vices incorporate a porous coating to enhance bonefixation for cementless applications.

The unalloyed titanium plasma spray coating

offers two main advantages over cobalt-chromium. First, titanium is more biocompat-ible than cobalt chromium; and second, it is pos-sible to create a rougher surface with titanium.Titanium typically has a 50% higher Rt valueof 139 microns, compared with 209 microns forcobalt-chromium.

For more information: Corin Medical Plc, Glou-cestershire, England; tel: 44 1285 659866; fax: 441285 658960; www.cormet.com; www.corin.co.uk.

Abbott has announced positive results fromAbsorb, the world’s first clinical trial evaluatingthe overall safety and performance of a fullybioabsorbable drug-eluting stent platform forthe treatment of coronary artery disease. Thetrial results confirm that the treatment effect ofeverolimus in the bioabsorbable stent is similarto that observed in Abbott’s studies of metallicdrug-eluting stents, with everolimus actively in-hibiting tissue growth into the artery. The rateof successful placement of the bioabsorbablestent at the site of the lesion was 93.5%.

The stent is made of polylactic acid, a provenbiocompatible material in medical implants suchas dissolvable sutures. As with a metallic stent,

the bioabsorbable stent is de-signed to restore blood flow bypropping the vessel open, pro-viding support until the bloodvessel heals. Unlike a metallicstent, a bioabsorbable stent is de-signed to be slowly metabolizedby the body and completely ab-sorbed over time.

For more information: KarinBauer Aranaz, Abbott Vascular,3200 Lakeside Drive, Santa Clara,CA 95054-2807; tel: 415/859-3414; [email protected]; www.abbottvascular.com.

BioPuls submersible pneumatic side action grips and temperaturecontrolled bath with pneumatic lifting and lowering mechanism havebeen introduced by Instron, Norwood, Mass. The grips are to be usedalong with the standard video extensometer for testing materials thatare to be used inside the body.

It is specifically designed for the biomedical testing industry to allowfor accurate measurements of load and strain in an environment thatsimulates the human body. Configured with Instron’s 5500 Series loadframe, which includes integrated control electronics and load cells, theBioPuls submersible pneumatic grips and temperature controlled bathis an ideally suited testing solution for the research and developmentof medical devices and biomaterials,and quality control laboratories.

For more information: Instron, 825University Ave, Norwood, MA02062;tel: 800/564-8378; www.instron.com.

Micro-metal injectionmolded titanium forms ear stirrup bone

The stirrup, a small bone in thehuman ear, can be accurately repli-cated by means of micro-injectionmolding, say researchers at the Fraun-hofer Institute for ManufacturingTechnology and Applied MaterialsResearch IFAM in Bremen, Germany.With micro-metal powder injectionmolding (micro-MIM), the scientistsare able to combine and shape dif-ferent types of material. It has beenpossible for a long time to producetiny parts from stainless steel. Nowthe researchers are in a position tomake such small, delicate compo-nents out of biocompatible materialssuch as titanium and titanium alloys.

In a pilot series, the researchersmanufactured 300 miniature partswith a weight of 5.4 mg each and awall thickness of 0.3 mm. To make theparts, fine metal powder is mixedwith an organic binding agent. Themixture can then be processed on aninjection molding machine in thesame way as plastic. Following this,the binding agent is expelled from thecomponent, which is then sintered toa high density. Components could bereinforced with higher-strength ma-terial in areas subject to particularlyhigh stress, for example, or a partcould be given special magnetic prop-erties.

For more information: Philipp Im-grund, Fraunhofer Institute, Ger-many; www.fraunhofer.de.


MPM

7Submersible tensile grips replicate body environment

Tornier, a global leader in extremities ortho-pedics, has entered into a partnership withBioretec Ltd., a Finnish biomaterials company.The partnership establishes Nexa OrthopedicsInc., a wholly owned subsidiary of Tornier, asthe exclusive distributor in the United States fora line of proprietary, bioresorbable surgical de-vices to be manufactured by Bioretec.

The new product line will include pin andscrew fixation systems for use by extremityphysicians to repair and treat a wide range ofbone and joint disorders, including fractures andarthritis. Recently cleared by the U.S. FDA, theBioretec ActivaPin and ActivaScrew fixation systems feature the company’s proprietary and patent-pending Self-Locking SL and Auto-

Compression biomaterials technology. Nexa willmarket these products under its NexFix Re-sorbable Fixation System brand.

For more information: Tornier, 10750 CashRoad, Stafford, TX 77477; tel: 888/867-6437; www.tornier-us.com; www.bioretec.com; nexaortho.com.

Nanoporous ceramic filter doubles dialysis toxin removal

A ceramic filter said to be superior to the tra-ditional polymer filter for dialysis has report-edly been developed by William Van Geertruy-den, EMV Technologies LLC, Bethlehem, Pa.The new ceramic filter promises to double theamount of toxins removed during dialysis andto double the glomulellar filtration rate (GFR),or rate of toxin removal. It could reduce by 30minutes to one hour the time required for a dial-ysis treatment.

The ceramic filter nanopores correspond moreclosely to the nanosized toxins in the blood thando the larger pores of the standard dialysis filter.These polymeric pores vary in size and, whenviewed with a microscope, appear in randomarrangements of ovals, circles, slits, and othershapes.

For more information: Kurt Pfitzer, LehighUniversity, Lehigh, PA 18015; tel: 610/758-3017;[email protected]; www.lehigh.edu. EMV Tech-nologies LLC, Bethlehem, PA18015; tel: 610/419-4952; www.emvtechnologies.com.

Researchers at the National Institute of Standards andTechnology are developing state-of-the-art measuringtechniques, similar to those for making aerospace com-ponents fit together precisely, that soon could improvesuccess rates for hip replacement surgery. The NIST re-searchers are working to improve calibrations and op-erating room testing of the Computer Assisted Or-thopaedic Surgery (CAOS) tracking instruments.

The researchers have built a lightweight device calleda “phantom” that resembles the artificial socket, ball,and femur substitutes that model the joint and bone inhip operations, based on a calibrated XY coordinateframe. They drilled tiny holes at precisely measured in-tervals into the phantom and made cuts at preciselymeasured angles favored by surgeons for CAOS opera-tions. Because the precise coordinates of the mechanical(magnetic) ball and socket joint center of rotation havebeen measured, manufacturers of CAOS tracking sensors can use the phantom to test the accuracyof their measuring instruments. Surgeons also should be able to test the accuracy of their CAOSdevices, just before making their first incision, to measure ball and socket joint center of rotationcoordinates, angles for cuts into the bone, and places for the insertion of screws.

For more information: John Blair, 100 Bureau Drive, Gaithersburg, MD 20899; tel: 301/975-4261;[email protected]; www.nist.gov.


NIST measuring device aims to improve hip operation success

MPM

D8

Rapid manufacturing enablestitanium skull reconstruction

A skull reconstruction for an automobile accident victim was successfully fab-ricated of titanium via rapid manufacturing, reports Arcam AB, Sweden. The im-plant size is 180 x 130 x 5 mm, and it was designed by Instrument Development En-gineering & Evaluation at Maastricht University in the Netherlands.The implant was manufactured in the titanium alloy Ti6Al4V by FIT Fruth Innova-tive Technologien in Parsberg, Germany, by an Arcam EBM S12 machine. The im-plant was built to net shape in 12 hours and finished with moderate manual pol-ishing. The mechanical properties were excellent, with 100% density of the material.

Arcam’s EBM (electron beam manufacturing) technology manufactured the im-plant by melting thin layers of titanium powder layer by layer according to a CADprogram. The energy source is an electron beam gun, and the process takes placein a vacuum chamber.

For more information: Ulf Lindhe, Arcam AB, Sweden; tel: 46 31 7103200; fax: 4631 710 32 01; www.arcam.com.

NIST prototype hip replacement ”phantom”(left.) provides a precisely measured coordinatesystem and magnetic ball and socket joint to cali-brate and to measure the clinically relevant per-formance of Computer Assisted OrthopaedicSurgery (CAOS) tracking instruments used in del-icate operations to install artificial hip joints (right).

Tornier, Bioretec partner for bioresorbable orthopedics

Nanocomposites improve durability of tooth fillingsNanotechnology has the potential to produce tooth restorations that are both stronger than any

decay-fighting fillings available today, and more effective at preventing secondary decay, say re-searchers at the American Dental Association’s Paffenbarger Research Center, a joint research pro-gram at the National Institute of Standards and Technology. The Paffenbarger researchers have de-vised a spray-drying technique that yields particles of several such compounds. One of these isdicalcium phosphate anhydrous (DCPA) particles, which are about 50 nanometers across, 20 timessmaller than the one-micrometer particles in a conventional DCPA powder. Because these nanoscaleparticles have a much higher surface-to-volume ratio, they are much more effective at releasing ions,which means that much less of the material is required to produce the same effect. That, in turn, leavesmore room in the resin for reinforcing fibers that strengthen the final filling. To exploit that oppor-tunity, the Paffenbarger researchers also have developed nanoscale silica-fused fibers that produce acomposite resin nearly twice asstrong as the currently available com-mercial variety.

For more information: Michael E.Newman, National Institute of Stan-dards and Technology, 100 BureauDrive, Gaithersburg, MD 20899;[email protected]; tel: 301/975-3025.

Silica gel fibers made into bioresorbable wound dressing

Bioresorbable wound dressingsbased on silica gel fibers are underdevelopment by Bayer InnovationGmbH, Leverkusen, Germany. Thesilica gel forms a scaffold aroundwhich skin cells can grow and is ab-sorbed by the body during thewound-healing process. On behalfof Bayer Innovation, Bayer Tech-nology Services developed the man-ufacturing process, set up the pilotplant, and will run it in compliancewith the guidelines for Good Manu-facturing Practice (GMP) at the Lev-erkusen site.

The bioresorbable wound dressingwill be tested in the treatment ofchronic wounds in a number ofstudies. Once the clinical phase of de-velopment has been completed suc-cessfully, regulatory approval in thefirst market is expected in 2010. Theportfolio will be expanded in the fu-ture by integrating active substancesthat promote wound healing into thefibers. These substances include anti-inflammatory drugs, analgesic in thefuture drugs, and growth factors.

For more information: Bayer Inno-vation GmbH, Leverkusen, Ger-many; www.bayer-innovation.com;http://www.bayer.com/en/Research-and-Innovation.aspx.


MPM

9

MPM

D10


MPMD 2007 begins withkeynote presentations by fourdistinguished speakers.�Dr. Tejal Desai is currently Pro-

fessor of Physiology and Bioengi-neering at the University of California,San Francisco. Her research combinesmethods and materials originally usedfor micro-electro-mechanical systemsto create implantable biohybrid de-vices for cell encapsulation, targeteddrug delivery, and templates for celland tissue regeneration.

� Amr Salahieh is President & CEO

Sadra Medical, Campbell, Calif. An ex-perienced medical device entrepreneurwith over 17 years of experience, Amrfounded Sadra Medical with the visionto significantly improve valve replace-ment therapy by facil itating a mini-mally invasive, elegant procedure.

� Duncan Maitland is currently

Medical Technology Program Leader inthe Applied Physics and Biophysics Di-vision at Lawrence Livermore NationalLaboratory. He currently leads a largemulti-institutional, multidisciplinaryteam developing therapeutic interven-tional devices based on thermallyacti vated shape-memory polymers.

�Stuart B. Goodman is the Robert

L. and Mary Ellenburg Professor ofSurgery, and Professor with Tenurein the Department of OrthopaedicSurgery at Stanford University. Hisbasic science interests center on thebiological response of implant ma-terials and biocompatibil ity, usingtissue retrieval, in vivo and in vitromodels.

The technical sessions cover the following topics:

Bioactive/Biomimetic Surfaces and Drug Delivery SystemsBiological remodeling and repair can be augmented by engineering

approaches aimed at accelerating a beneficial biological response.Such technologies are being developed today in cardiovascular andorthopedic, as well as stem cell tissue engineering environments. Thissession provides an overview of technologies that are projected tohave significant impact on future clinical environments.

Regulatory issuesThese presentations will relate to the role that national and inter-

national standards, specifications, guidelines, and test methods playin the production and marketing of medical devices. The repeatabilityand reliability of test results from methods shown in these documentswill be discussed. Also, a perspective on the task of many ISO Tech-nical committees to progress from material-based standards to per-formance-based standards is an issue for presentation, as is the im-portance that many regulatory agencies are placing on more “clinicallyrelevant” test methods

Corrosion – Two SessionsTissues in the human body contain water, dissolved oxygen, pro-

teins, and various ions such as chloride and hydroxide, and theypresent an aggressive environment for implant materials. Every basemetal or alloy implanted in the body will corrode – the only questionis to what extent? Corrosion releases active ions into the physical en-vironment, in addition to deterioration of dimensional parameters ofthe corroding body. Thus, corrosion and biocompatibility of a med-ical device are key aspects of its safety and long-term efficacy. Thescope and limitations of corrosion test techniques and examples ofhow these techniques have been used to assess corrosion behaviorwill be presented in these sessions.

Surface Engineering – Four sessionsThe surface engineering sessions will address development and

use of both novel and established surfaced treatment technologiesfor medical devices. Coatings discussed include carbon, aluminumoxide, titanium boride, and other ceramics. Other topics include sur-face modifications such as texturing and grit blasting.

Advanced Materials and Emerging TechnologiesThe papers presented in this session will discuss new materials that

enhance the function of implantable devices. These include shapememory materials for devices that are more easily implanted, ac-tive materials that fill aneurysms or close holes in the heart, biodegrad-able materials that dissipate harmlessly, and bioabsorbable materialsthat speed recovery. Actuators that rely on active materials (shapememory polymers, shape memory metal alloys, and electroactivepolymers) are reviewed. Presenters will discuss how these materialsare leading to the development of lighter weight, silent, more power-efficient and less intrusive implantable devices. MPMD

This ASM conference and expo will be held in Palm Desert,

California, Sept. 23-25.Visit www.asminternational.org/

meddevices for complete details .

2007Conference & ExpositionConference & Exposition

MPM

D12


The Promise of Aerosol Printed 3D Nanostructured Ceramic/Polymer Composites as Next Generation Orthopedic Tissue Engineering ScaffoldsHuinan Liu and Thomas J. WebsterDivision of EngineeringBrown University, Providence, Rhode Island

Previous studies have demonstrated that well-dispersed nanophase titania particles in PLGA (poly-lactide- co-glycolide) composites promoted bone celladhesion and calcium deposition. However, relativelyfew advantages of nanocomposites have been incor-porated into the orthopedic clinics due to challengesinvolved with integrating nanoscale structures or com-ponents into macro architectures while preserving theirnano-features. With traditional 3D fabrication methods,it is difficult to precisely control the 3D internal and ex-ternal nano-architecture of scaffolds, especially whena second phase (ceramic nanoparticles) is involved.

Therefore, a novel aerosol-based 3D printing tech-nique (M3D system) developed by Optomec of Albu-querque, N.M., was chosen to fabricate nanocom-posite scaffolds for bone tissue engineeringapplications. The M3D system was selected because3D macro hierarchical structures in natural bone arealso built from constituent nano-components.

The objective of this study was to test the effective-ness of this 3D printing technique for nanocompositefabrication as well as promoting osteoblast (bone-forming cells) adhesion and infiltration.

The pore size, shape, and distribution can be pre-cisely controlled by the pre-designed CAD model bythis 3D printing technique. Moreover, the surfaces ofsuch nanocomposite scaffolds demonstrated uniformdispersion of titania nanoparticles after 3D printing

The results provide a promising means of fabri-cating a macro structure from nanocomposites formore effective orthopedic applications. In this manner,it is envisioned that an orthopedic surgeon could usescans of fractured bone to develop a CAD modeledbone nanocomposite.

For more information: Huinan Liu, Brown Univer-sity, Providence, RI 02912; [email protected].

Injection Molding of Micro Medical ComponentsUtilizing MEMS Technologies for ToolingDonald F. HeaneyPennsylvania State University.

Discrete micro-components fabricated via MEMStooling and injection molding techniques can be ofany chemistry, ranging from pure polymer to metaland ceramic. This paper describes the basic processfor tool design and fabrication, processing method,and dimensional capabilities of the final product.

In the powder injection molding (PIM) process, poly-mers serve as a carrier for metallic or ceramic powders.The polymer/powder mixture is injection molded intoan oversized mold. Subsequent thermal processing re-

moves the polymer and sinter-densifies the powder toa net shape metallic or ceramic component.

Photolithography is a technology in which radia-tion-sensitive polymeric materials called resists arecoated onto substrates. The resist film is subsequentlyexposed in an image-wise fashion through a mask.The exposed resist film is then developed, typicallyby immersion in a developer solvent, to generatethree-dimensional relief and to expose the feature de-tail on the metal substrate. The exposed substrate actsas a cathode for plating. Hard nickel is the preferredmaterial for microtooling fabrication, since it is oneof the hardest materials that can be plated in highthicknesses.

For more information: Donald F. Heaney, Pennsyl-vania State University, University Park, PA 16802;[email protected].

Fatigue and Wear Evaluation of Ti-15Al-33Nb and Ti-21Al-29Nb Alloys for Biomedical ApplicationsCarl J. Boehlert,

Michigan State UniversityToshikazu Akahori and Mitsuo NiinomiTohoku University.

In this work, the fatigue and wear behavior of Ti-15Al-33Nb and Ti-21Al-29Nb was evaluated and com-pared to that for other titanium-based biomedical im-plant alloys, in particular Ti-6Al-4V. Fatigue stressversus life curves were generated for tests at roomtemperature in air at a stress ratio of R=0.1 for max-imum stresses between 75% and 90% of the ultimatetensile strength.

Results indicated that the fatigue strength and fa-tigue life of the Ti-Al-Nb alloys are comparable tothose of Ti-6Al-4V. Wear resistance of the Ti-Al-Nballoys was significantly greater than that of Ti-6Al-4V. Based on these results, it is proposed that tita-nium-aluminum-niobium alloys will be of consider-able future interest for biomedical applications.

The good fatigue strength of the investigated mi-crostructures is considered to be due to the balance ofstrength and ductility brought by the omega and BCCphases, which leads to increased resistance to fatiguecrack initiation and small fatigue crack propagation.

The wear resistance of the Ti-Al-Nb alloys was morethan three times greater than that for Ti-6Al-4V. Basedon the data for the fatigue and wear behavior, the as-processed Ti-15Al-33Nb and Ti-21Al-29Nb alloysmerit further evaluation for biomaterial applications.

For more information: Carl J. Boehlert, MichiganState University, East Lansing, MI 48824; [email protected].

Oleylamine Modified Magnetic NanoparticlesOtto C.Wilson Jr., Lema Ricks, Gloryvee Rivera, Erin Blair,Stephanie Kennedy, Patrick MehlCatholic University of America, Washington, D.C.

The surface chemistry of magnetic nanoparticles(MNP) plays a crucial role in enhancing colloid sta-bility and subsequent interactions between MNPs andcells. Oleylamine (OLA) is a lipid-like molecule thathas been used to improve the colloid stability of anumber of metal and metal oxide based nanoparticles.Due to its hydrophobic tendencies, OLA is typically

Biomaterials at Materials This article contains brief summaries of some of the papers on biomaterials presented during the Biomaterials Symposium at MS&T’06 in Cincinnati.

MPM

D13


Science & Technology 2006utilized in nonaqueous based synthesis reactions.

The presence of OLA during the nucleation andgrowth of MNPs from aqueous ferric and ferrous chlo-ride solutions (0.1-1 M) resulted in the formation ofhighly dispersed MNPs. The purpose of this studywas to investigate the influence of OLA on the colloidstability, particle size, and bioactivity of MNPs usingfibroblast cells.

One of the most surprising results was that the syn-thesis of MNPs under acidic conditions greatly im-proved the colloid stability of unmodified nanopar-ticles. In each synthesis case, the resulting MNPparticle suspension had a pH between 2 and 3, due toan excess of hydrochloric acid as a product of the re-action. Typical MNP synthesis reactions add excessbase to maintain alkaline pH conditions.

OLA influenced the colloidal stability, size, andbioactivity of MNPs. Oleylamine improved the col-loidal stability of MNPs on a level comparable toMNPs synthesized under acidic conditions. Thermalgravimetric analysis indicated that approximately 10wt% OLA adsorbs on the surface of MNPs during thesynthesis reaction.

For more information: Otto Carl Wilson Jr., CatholicUniversity of America, Washington, DC 20064;[email protected].

In-Situ X-Ray Analysis of Mechanism of Non-Linear Super Elastic Behavior of Ti-Nb-Ta-Zr System Beta Type Titanium Alloy forBiomedical ApplicationsMitsuo Niinomi, Toshikazu Akahori and Masakai Nakai,Tohoku University, Japan.

Ti-Nb-Ta-Zr system alloys such as Ti-29Nb-13Ta-4.6Zr and Ti-35Nb-7Zr-5Ta exhibit excellent biocom-patibility and very low Young’s moduli. The authorsinvestigated the effects of alloying elements on me-chanical properties and tensile deformation behav-iors of Ti-XNb-10Ta-5Zr, Ti-30Nb-XTa-5Zr, and Ti-30Nb-10Ta-XZr. The X represents the alloying elementthat was systematically changed during the study.

The study showed that the elastic deformation be-havior of Ti-30Nb-10Ta-4.6Zr does not obey Hooke’slaw. However, the detailed mechanisms of the elasticdeformation behavior of Ti-30Nb-10Ta-5Zr are notyet clearly understood.

As part of the study, Ti-30Nb-10Ta-5Zr, and Ti-25Nb-10Ta-5Zr, and Ti-35Nb-10Ta-5Zr were fabri-cated by powder metallurgy and forging processes.Then the changes in the phase constituents and X-raydiffraction profiles of these alloys were investigatedby X-ray diffraction analysis under tensile loadingand unloading conditions. Finally, the mechanismsof the elastic behaviors of these alloys were evaluated.

For more information: Mitsuo Niinomi TohokuUniversity, Japan. [email protected].

Adsorption of Gum Arabic on Bioceramic NanoparticlesOtto Carl Wilson Jr.Catholic University of America; Washington, D.C.Ana Cecilia Roqu,e Universidade Nova de Lisboa, Portugal.

Surface modification agents tailor the surface chem-

istry and biological activity of bioceramic nanoparti-cles in very intriguing ways. However, the specificmodes of interaction between macromolecules andnanoparticles can be difficult to characterize. The aimof this study was to investigate the adsorption of gumArabic on hydroxyapatite (HAp) and magneticnanoparticles (MNP) using the bicinchoninic acid(BCA) test. Gum Arabic (GA) is a natural gum emul-sifying agent, and it shows promise for dispersingnanoparticles in aqueous solutions.

Competitive adsorption studies showed thestrength of the interaction between GA molecules andthe MNP and HAp particle surface in the presence ofphosphate ions. Experimental results revealed thatup to 50% of the GA can be displaced from the MNPand HAp particle surface in the presence of phos-phate, due to the strong affinity of phosphate for eachbioceramic surface.

The maximum amount of GA adsorbed on HApand MNP was 0.2 g GA/g HAp and 0.6 g GA/gMNP. Both bioceramic surfaces adsorbed equiva-lent amounts of GA when expressed in terms of ad-sorbate mass/area of adsorbent (0.004 g GA/m2

nanoparticles). GA molecules were displaced fromthe surface of HAp and MNPs when in the presenceof phosphate ions.

For more information: Otto Carl Wilson Jr., CatholicUniversity of America, Washington, DC 20064;[email protected].

Research center unites biomedical competitors

The University of Cincinnati has received $1 millionto establish a research center that will allow competingbiomedical companies to pool their funding to developnew medical technologies for minimally invasive sur-gical procedures. Known as the Minimally InvasiveMedical Technologies Center (MIMTeC), initial fundingcomes from a five-year grant from the National ScienceFoundation’s Industry/University Cooperative Re-search Center program and membership fees from aconsortium of national biomedical device companies.

Current members of MIMTeC include Ethicon-EndoSurgery, Procter and Gamble, Boston Scientific,Medtronic, Cordis Corp., the U.S. Army, and Great-batch Inc.

For more information: Balakrishna Haridas, Univer-sity of Cincinnati, Cincinnati, OH 45221; tel: 513/556-3745 ; [email protected] ; www.uc.edu.

Anodic plasma treatment makesmicro-textured implant surfaces

Anodic microplasma-chemical treatment of implantsurfaces is a cost-effective way to modify surface to-pography and chemistry of titanium implant surfaces,report researchers from the University of Rostock, Ger-many. The goal was to texture the implant surface atthe nanoscale without applying a coating.

The technology is based on a pulsed DC voltage thatgenerates a microplasma discharge in the thin steamfilm between the immersed specimen and electrolyte.A thick oxide layer is produced, with properties thatdepend on the electrical parameters. After removal ofthe thick oxide layer, a fine, microscale and nanoscalesurface structure remains.

For more information: Ulrich Beck, University of Ro-stock, IIEF, Institute GS, 18051 Rostock, Germany;www.uni-rostock.de. [email protected].

Nanotube oxide coatings on implants can deliver drugs

Researchers at the University of California, San Fran-cisco report that they have grown metal oxide nano-tubes that can hold therapeutic proteins or drugs anddeliver these agents in a highly controlled manner. Bychanging the length and diameter of nanotubes, theyprecisely control the dosage and deliver drugs at phys-iological rates for a specified duration of time. In thecase of orthopedic implants with nanotubes on the im-plant surfaces, drugs such as antibiotics can be loadedin the tubes and released at the site of implantation.

For more information: Ketul Popat, University ofCalifornia at San Francisco, San Francisco, CA 94143;tel: 415/476-2414; [email protected]; www.ucsf.edu.

Injected microgel particles could replace spinal fusion

Scientists at the University of Manchester believe in-jections of tiny sponge-like particles could provide analternative to major surgery in the treatment of chroniclower back pain. Dr. Brian Saunders and Prof. TonyFreemont have developed tiny gel particles that swelland stiffen when injected into a damaged area.

The material is a fluid at a low pH and can be injectedthrough a syringe. However, it changes to a stiff gelat physiological pH values due to absorption of waterby the particles. Investigations have revealed that de-generated animal intervertebral disks containing theinjected microgels regain their mechanical properties.

For more information: Brian Saunders, University ofManchester, England; [email protected]; www.manchester.ac.uk.

NSF funds new Rutgers plant biomaterials initiative

Hybrid materials made by combining naturally oc-curring plant substances, such as starch from corn orpotatoes, with synthetic degradable polymer biomate-rials are to be developed by Rutgers University, NewBrunswick, N.J., in a program funded by the NationalScience Foundation. This initiative can yield cost-effec-tive, bio-based materials to replace petroleum-derivedplastics while creating new economic opportunities forAmerican farmers now threatened by low commodityprices.

Materials scientists, polymer chemists, and biomed-ical engineers will bring their expertise in syntheticpolymers and biomedical technology to the project.Agriculture and food scientists and engineers will addtheir knowledge and skills in plant materials, biopoly-mers and food industry technology.

For more information: Joseph Blumberg, Rutgers

UNIVERSITY RESEARCH


MPM

D14

The First Aid Splint developed at Sheffield Hallam University ap-plies rigidness and heat quickly to the limb by means of a special gelcreated by a chemically reactive metal strip and saturated sodiumacetate solution. Paul Chamberlain, [email protected];http://www.shu.ac.uk .

The Mann Foundation for Biomedical Engineering has announceda $100 million gift to enable the commercialization of innovative bio-medical technologies at Purdue University, West Lafayette, Ind. Theinstitute will help identify approximately two new biomedical proj-ects per year out of the hundreds with commercialization potential,growing to as many as six ongoing projects when in full operation.https://engineering.purdue.edu/BME/.

A motion-sensing system for an inner ear implant based on ac-celerometers instead of gyroscopes is under development at the Uni-versity of California, San Francisco. A 9-volt battery powers the de-vice for 24 hours, compared with cochlear implants that needrecharging after 12 hours. In addition, a computer model shows howthe current from the electrodes flows over the vestibular nerve indifferent situations. Charles Della Santina, [email protected]; www.jhu.edu.

University, New Brunswick, NJ 08901; tel: 732/932-7084x652; [email protected]; www.rutgers.edu.

Ortho surgery team designs scaffold ligament tissue

A research team led by Cato T. Laurencin, M.D., Ph.D.,at the University of Virginia Health System has createda synthetic matrix on which the anterior cruciate liga-ment can be regenerated effectively for treatment oftears. “This is the first tissue-engineered matrix for ACLto demonstrate such substantial neo-ligament forma-tion, in terms of both vascularity and collagen forma-tion,” says Dr. Laurencin. “We tested one synthetic ma-trix with actual ACL cells from our animal model andone without these cells. While both systems encour-aged the ingrowth of neo-ligament tissue, matrices withseeded cells performed particularly well in this study.”

For more information: Dr. Cato Laurencin, Univer-sity of Virginia Health System, PO Box 800795, Char-lottesville, VA 22908-0795; [email protected]; tel:434/243-0250; www.healthsystem.virginia.edu/toplevel/home/home.cfm.

Nanoscale polymer films deliver drugs to organs

Nanoscale films composed of DNA and water-sol-uble polymers that allow controlled release of DNAfrom surfaces have reportedly been developed at theUniversity of Wisconsin, Madison. When coating im-plantable medical devices, the films offer a novel wayto route useful genes to exactly where they could do themost good. Dr. David Lynn and colleagues have coatedintravascular stents with these nanoscale films, whichcould deliver genes that prevent the growth of smoothmuscle tissue into stents, or treat the underlying causesof cardiovascular disease.

For more information: David Lynn, University of Wis-consin, Madison, WI 53706-1691; tel: 608/262-1086 ; fax:608/262-5434; [email protected]; www.wisc.edu.

Nanoparticles improve delivery of medicines and diagnostics

Nanoparticles that can deliver medicine deep intothe lungs or infiltrate cancer cells while leaving normalcells alone have reportedly been developed atPrinceton University, Princeton, N.J. Only 100 to 300nanometers wide, the particles can be loaded with med-icines or imaging agents, such as gold and magnetite,that will enhance the detection capabilities of CT scansand MRIs.

The Flash NanoPrecipitation technology allows theresearchers to mix drugs and materials that encapsu-late them. The Princeton-led team is the first to applythe technology to the production of nanoparticles, whichare too large to pass through the membrane of normalcells, but will pass through larger defects in the capil-laries in rapidly growing solid tumors.

For more information: Prof. Robert Prud’homme,

Princeton University, Princeton, NJ 08544; tel: 609/258-4577; [email protected]; www.princeton.edu.

Prosthetic arm providessensory feedback for control

An international team led by the Johns Hopkins Uni-versity Applied Physics Laboratory in Laurel, Md., hasdeveloped a prototype of the first fully integrated pros-thetic arm that can be controlled naturally, provide sen-sory feedback, and allow eight degrees of freedom.Proto 1, developed for the DARPA RevolutionizingProsthetics Program, is a complete limb system that alsoincludes a virtual environment for patient training, clin-ical configuration, and recording limb movements andcontrol signals during clinical investigations.

For more information: Stuart Harshbarger, The JohnsHopkins University, Applied Physics Laboratory, 11100Johns Hopkins Rd., Laurel MD 20723-6099; tel: 240/228-5000; [email protected]; www.jhuapl.edu.

Miniature robot navigatessurface of beating heart

A miniature mobile robot that facilitates minimallyinvasive beating-heart intrapericardial therapies isunder development at Carnegie Mellon University,Pittsburgh, Pa. The HeartLander enters the chestthrough an incision below the sternum, and adheres tothe epicardial surface of the heart. It navigates to anylocation on the epicardium, and administers therapyunder control of the physician.

In the current HeartLander prototype, suction main-tains prehension of the epicardial surface, and wire ac-tuation from offboard motors enables locomotion. Mag-netic tracking and fluoroscopy provide feedback to thephysician, who controls the device through a joystickinterface.

For more information: Cameron Riviere, CarnegieMellon University, Pittsburgh, PA 15213-3890; tel:412/268-3083; [email protected]; www.cmu.edu.

MPM

D15


Hybrid biomaterials madeof polymer hydrogels

Hybrid polymer hydrogel materials that can re-spond rapidly and reversibly to mechanical forcesfor long periods are being researched at the Uni-versity of Delaware, Newark. Tissue scaffolds aremade from hydrogel biomaterials consisting of syn-thetic polymers and peptides. Spring-like, coiledpolymers are being combined via noncovalent in-teractions. They can be disrupted temporarily byforce, yet have the ability to re-form after the forceis removed. Once the design of these novel poly-mers is perfected, they can serve as building blocksfor artificial tissue.

For more information: Xinqiao Jia, University ofDelaware, Newark, DE 19716; tel: 302/831-6553;[email protected] ; www.udel.edu.

Micro-engineered devicesAdmedes Schuessler, Germany, produces micro-

machined medical device components at the highestlevel of accuracy and precision. Complex shapes andpatterns in any length can be cut from tubing in therange of 0.4 to 12 mm diameter as well as in sheet ma-terial. www.admedes.com

Device coatingsArmoloy of Connecticut offers BIO-TDC coatings

that are biologically compatible to ISO 10993 and USP24,2000, reduce friction and eliminate galling, resist cor-rosion, and increase wear life. www.armoloy.com

High-purity metal powdersAdvanced Specialty Metals Inc., Nashua, N.H. pro-

vides PREP ultra-clean, high-purity metal powders andleak-tight, bimetallic transition joints, key ingredientsfor performance-enhancing components. Serving as anactive partner, we work together with our customersfrom the product concept stage through full-scale pro-duction. www.asmpowders.com

Bioactive coatingsAPS Materials, Dayton, Ohio, produces both porous

and bioactive coatings for the orthopaedic marketplace.The coatings consist of Commercial Pure (CP) Titaniumand its alloys, specifically Ti-6Al-4V, as well as Hydroxy-apatite, a calcium phosphate material that is used as asynthetic bone substitute. www.apsmaterials.com

Stent test instrumentsBose Corporation Electroforce Systems Group, has

developed a multi-axis peripheral stent (MAPS) test in-strument for stent applications in peripheral arteries.It is capable of combining dynamic bending, rotation,extension/compression, and radial distention on mul-tiple stents under controlled conditions. It can test anaccelerated 10 year simulated life, or perform fatigueto fracture studies. www.bose.com

Bioceramic materialsCeradyne Inc. is developing bioceramic materials for

orthopedics applications such as hip, knee, and spinereplacement. Ceramics offer the combined attributesof biocompatibility, wear resistance, hardness, strength,rigidity and inertness. www.ceradyne.com

Catheter devicesDymax Inc. offers bonding options for various com-

binations of dissimilar substrates such as polycarbonate,Nylon, PET, acrylic, PEBAX and stainless steel. DYMAXMD 209-CTH light curing adhesive provides a singlesolution for all these combinations. www.dymax.com

Stainless steel tubeEagle Stainless Tube & Fabrication Inc. offers an en-

tire range of miniature to large precision-machined partswith intricate geometrics such as threads, slots,external/internal hexes, of materials such as stainlesssteel, aluminum, titanium, Monel, Inconel, and brass.www.eagletube.com.

Medical wireFort Wayne Metals, Fort Wayne, Ind., produces round

wire or flat wire of any shape, strands or composites.Wire is also available in titanium alloys or Nitinol. Production facilities are geared specifically for pro-ducing medical grade wire in special shapes. www.fortwaynemetals.com

Medical device productionKammann Machines Inc. announces that it has

successfully transferred its precision-based screen print and conversion technology to the inline pro-duction of disposable medical devices. www.kammannmachines.com

Laser technologiesLaserage Technology Corp. offers laser machining of

stents; laser welding of most metals; and laser ma-chining, cutting, and drilling of metals, plastics, com-posites and ceramics. www.laserage.com

Micro molderMakuta Technics Inc. is an ISO 9000: 2001 certified

micro molder that produces minimally invasive de-vices, catheters, catheter tips, surgical devices and manyother micro molded devices and components.www.makuta.com

Tubes for surgical implantsMinitubes, France, fabricates tubes in a wide range

of alloys for stents and orthopedics. Products includehigh precision, very concentric seamless tubes. Alloysinclude stainless steel, cobalt alloys, titanium alloys,tantalum alloys, and precious metal alloys, all with op-timized surface finish. www.minitubes.com

Electronic medical devicesMinnetronix specializes in the design and manufac-

ture of electronics-based medical devices, such as car-diovascular systems, point-of-care diagnostic instru-ments, therapeutic devices, implantable devices, andmonitoring equipment. www.minnetronix.com

Laser micromachiningNorman Noble, Cleveland, Ohio, has the largest laser

micromachining facility in the world, as well as a fullydedicated laser research and development departmentin house. The R&D team of experts is prepared to assistin manufacturing the most complicated and intricatemedical devices. www.nnoble.com

Plasma treatment systemPlasmaTech has designed the AL140 Gas Plasma/

PECVD system for production coating and surface treat-ment of medical device components and disposables.It has a 850mm X 450mm X 350mm aluminum chamber,is clean-room compatible, and can be supplied with aspecial process gas introduction system for thin film(PECVD) coatings. www.plasmatech.com

Powder metalsPowder Allloy Corp., Leis Partners, Winona Lake,

Ind., manufactures and distributes a wide variety ofpowder metals such as titanium and spherical cobaltpowders designed for the porous coatings of implantsand for the injection molding of implants. www.leispartners.com

PRODUCTS&SERVICESM

PMD16


�

�

�

�

�

�

Medical thermoplasticsRTP Co., Winona, Minn., offers a brochure called “Se-

lection of Thermoplastic Materials for Medical Appli-cations,” which covers application requirements andmaterial properties. www.rtpcompany.com

Design servicesSynovis Interventional Solutions Inc., offers wire

coiling, straightening, forming and grinding; laser pro-cessing; swiss machining, CNC milling and turning,and EDM; plastic injection molding; joining, assembly,and packaging. www.synovis.com

MicromachiningMicrolution Inc. presents the Microlution 310-S, a

three-axis mill that provides ultra-high accuracy to sup-port micromachining needs across industries. With apositioning accuracy of 2 microns and a cost of less than$90,000, the 310-S is ideal for low-volume production.www.microlution.com

Miniature stepper motorMicroMo Electronics announces the ADM 1220 minia-

ture stepper motor, with an external motor-diameter ofonly 12 mm and a length of 17.2 mm. The ADM1220 hasa holding torque without current of 2.4 mNm and can

achieve a high boost torque of 4.1 mNm. www.micromo.com

Implant partsTornos S.A., Switzerland, has prepared a 14-page

brochure describing its capabilities in manufacturingdental implants, nails, transfixing pins, hip screws, andother parts. www.tornos.ch

Engineered wireUlbrich Stainless Steels & Special Metals Inc., North

Haven, Conn., announces the acquisition of Delta Precision Alloys of Montgomeryville, Pa. Delta Ulbrich Precision Metals will become part of the Ulbrich Specialty Wire Group. The Wire Group specializes in shaping, drawing, rolling and platingcustom engineered wire based products in a widerange of specialty metals and alloys. www.ulbrich.com

Photochemical etchingVacco Industries, South El Monte, Calif., provides

precision photochemical etching that offers many ad-vantages to multiple applications looking for specificbenefits in the design and production of thin metal com-ponents. www.vacco-etch.com

MPM

D17


�

�

� Exhibitor at MPMD 2007

BUSINESS BRIEFSAbbott Laboratories expects to file for FDA approvalof its Xience V drug-eluting stent system in the secondquarter of 2007. The company anticipates a launch inthe first half of 2008.

Angiotech Pharmaceuticals Inc., a global specialtypharmaceutical and medical device company, an-nounced the initiation of its United States pivotalstudy examining the Vascular Wrap Paclitaxel-ElutingMesh (“Vascular Wrap”).

Berlin Heart GmbH announces that its EXCOR Pe-diatric ventricular assist device has received condi-tional approval for IDE purposes in the United States.The U.S. FDFA has granted conditional approval forthe prospective IDE study to begin initially at ten cen-ters with ten patients.

Boston Scientific’s Vitality DR implantable car-dioverter defibrillator (ICD) has been approved byJapan. The device is the smallest dual-chamber ICDcurrently offered in Japan.

Cardica Inc. has received $1.25 million in paymentsfrom Cook Medical for development and highvolume production tooling for the Cook Vascular Ac-cess Closure Device, an innovative automated systemdesigned to close access openings in femoral arteriesafter interventional vascular procedures.

CardioTech International Inc. has launched a new

web site that provides easy access to its broad arrayof polymer technology, products, and medical devicecontract development and manufacturing services.www.cardiotech-inc.com

Carestream Health Inc. announces that EastmanKodak Company’s former Non-Destructive Testing(NDT) group will become part of Carestream Health.The company’s NDT group designs and producesunique film and digital imaging solutions globallyfor the industrial radiography market.

The Cordis Endovascular Division of Cordis Corp.announces FDA approval to market its PRECISE RXNitinol Self-Expanding Stent and Angioguard RX Em-boli Capture Guidewire System to treat clogged neckarteries.

EaglePicher Medical Power has released the world’ssmallest implantable-grade medical battery. The MicroBattery, which is at least 50% smaller and lighter thanknown commercially available products, can theo-retically power the device for more than 15 years.

Researchers in the European Union are developinga dental prosthesis that releases the correct dosage ofa required medicine on a continuous basis. This willhelp to avoid the peak concentrations that occur ontaking pills, aggravating side effects.

Exactech Inc. has received clearance from the U.S.

MPM

D18


The Abacus utilizes Windows™ or Palm™-basedhandheld computers and desktops to pack functionalityinto a convenient, lightweight instrument. The Abacussoftware provides all display and control functions. A unique, ergonomically designed, makes it easy tohold for extended periods of time. The tension-mounteddetector head has a wide range of motion that can beeasily adjusted for use in many working environment.

S.E. International, IncP.O. Box 39Summertown, TN 38483-0039 USA

Tel: 931-964-3561 Email: [email protected]

The first major changein a GM pancake-basedinstrument in decades.

See our website at www.seintl.com

Operating Range:R/h - 0 to 2,000,000 R/hr

mR/h - 0 to 2,000 mR/hSv/h - 0 to 20,000 Sv/h

cpm - 0 to 750,000 cpmcps - 0 to 12,500 cpsTotal counts - >99,999,999,999

THE METAL PROCESSING ADVANTAGE

Vacuum Heat Treating &Brazing for Medical Devices•Twenty years experience

processing medical devices

•Flux-less brazing

•Responsive service for quotes, turnaround and order tracking

•Full lot integrity and traceability

•White glove handling of critical parts

•Processing and metallurgical consultation

800.347.3236 • www.solaratm.com

MPM

D20


BUSINESS BRIEFSFood and Drug Administration to market theEquinoxe Reverse Shoulder, designed for patientswho have an irreparable rotator cuff and os-teoarthritis. It is compatible with the Equinoxe pri-mary stem, allowing surgeons to change from a pri-mary to a reverse without removing the humeralstem.

Greatbatch Inc., a manufacturer of batteries and othercomponents for implantable medical devices, an-nounced a definitive agreement with Biomec Inc.,pursuant to which Greatbatch would purchase sub-stantially all of the assets of Biomec.

Researchers from Iowa State University report a newvaccine delivery system using microspheres of abiodegradable polymer. The microspheres may notonly reduce the need for booster shots in some cases,but also appear to stimulate an immune response thattraditional vaccines do not.

Invibio announces that a spinal implant made of thecompany’s carbon fiber-reinforced PEEK-Optimapolymer has received regulatory approval from theJapanese Ministry of Health, Labour and Welfare.

Irvine Scientific, has launched the SIS/AI dual-pur-pose catheter for Saline Infusion Sonohysterography.

Medtronic Inc. has submitted the final module of its

pre-market approval application to the U.S. FDA forapproval to commercially market and sell the TalentThoracic stent graft system, which provides a mini-mally invasive treatment alternative to open heartsurgery .

MIV Therapeutics Inc., a developer of next-gener-ation biocompatible coatings for cardiovascular stents,has completed the acquisition of Biosync Scientific,an India-based designer and developer of innovativeinterventional cardiology products, including cardio-vascular stents.

Smith & Nephew PLC announces that its AdvancedWound Management business has agreed to purchaseBlueSky Medical Group Inc., a privately held com-pany headquartered in Carlsbad, California, from itsfounders for an initial payment of $15 million.

SurModics Inc. has entered into an expanded corpo-rate technology agreement with St. Jude Medical,Inc., in which SurModics licensed multiple technolo-gies for products being developed in St. Jude Med-ical’s Cardiovascular and Cardiac Rhythm Manage-ment divisions.

Tornier, a developer of prosthetic devices, has an-nounced an agreement to acquire of Nexa Orthope-dics Inc., a California-based manufacturer of ortho-pedic medical devices.

Continued

ASM has assembled some of the world’s foremost materials experts to provide a practical understanding of the properties, processes and applications of the materials that are shaping, and will continue to shape, the medical device industry.

2007 Seminars

Who Should Attend:

• Product Designers

• Mechanical Engineers

• Quality Engineers

• Materials Engineers

• Research and Development

• Sales and Marketing

2007 Seminar Schedule

Minneapolis, MN July 9-13, 2007

Boston, MA July 30-August 3, 2007

Plymouth, IN August 20-24, 2007

Palm Desert, CA September 26-27, 2007

Miami Beach, FL November 5-9, 2007

Seminar Week-at-a-GlanceMonday

Basic Metallurgy for the Medical Device Engineer

OR

Introduction to Polymers for Medical Devices

Tuesday

Failure Analysis of Medical Devices (Metals and Ceramics)

OR

Failure Analysis of Polymers for Medical Devices

Wednesday

Fracture, Fatigue and Corrosion for Medical Device Validation

Thursday

Nitinol for Medical Devices

Friday

Metallographic Interpretation for Medical Devices

For more details, contact ASM Customer Service, 800-336-5152 or 440-338-5151, ext. 0. Visit us at www.asminternational.org/medcourses.htm.

The Materials - ASM International

Documents

Transcript of The Materials - ASM International