Medical Design Briefsassets.techbriefs.com/EML/2016/mdb_digital/MDB1116.pdf · Servo-Driven Ultrasonic Welding for Medical Devices Wearables Win: See the Results of This Year’s

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Welcome to

your Digital Edition of

Medical Design Briefs

November 2016

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Intro

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From the Publishers of

www.medicaldesignbriefs.com November 2016

SPECIAL SECTION:Technology Leaders inGas/Fluid Handling/Pumps

Advances in Thermal Management Materials

Servo-Driven Ultrasonic Welding for Medical Devices

Wearables Win: See the Results of ThisYear’s ‘Create the Future’ Design Contest

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4 Medical Design Briefs, November 2016Free Info at http://info.hotims.com/61067-774

November 2016

Published by Tech Briefs Media Group, an SAE International Company

■ COLUMN

6 From the Editor

■ FEATURES

10 Advances in Thermal Management Materials andAdhesives for Medical Electronics

16 Advanced Melt Flow Controls of Servo Ultrasonic Weldingfor Medical Applications

22 2016 Contest Winner Redefines the Way We MeasureBlood Pressure

■ TECH BRIEFS

42 Complex Nanomachines Could Carry Pharmaceuticals,Detect Disease

43 Killing Cancer Cells May Be Possible with “Hairy” Nanorods

46 Edible Battery Could Power Ingestible Medical Devices

48 New Device Could Improve Diagnosis of Ear Infections

50 3D Graphene Shows Promise for Bone Implants

■ DEPARTMENTS

40 R&D Roundup

52 New Products & Services

57 Advertisers Index

■ SPECIAL SECTION

Technology Leaders in Gas/Fluid Handling/Pumps

26 Fully Calibrated MEMS-Based Single-Use Proximal Flow Sensors

29 Essential Elements in Pump Selection for Surgical AblationApplications

■ ON THE COVER

The Medical Category winner in the 14th annual“Create the Future” Design Contest is BoldDiagnostics for its entry of a ContinuousWearable Blood Pressure Monitor. High bloodpressure affects 1 billion individuals globally andmore than 80 million in the United States.There is a clinical need for a noninvasive, unob-trusive monitoring system that can acquireaccurate blood pressure measurements withgreater frequency to properly manage hyperten-sion. Bold Diagnostics has addressed thisunmet need by developing an innovative low-costdiagnostic platform that consists of a set of wearable wristbands that con-tinuously measure blood pressure and a smartphone application thatuploads a report into the patient medical record for clinician review. Formore information on this technology and the other Medical Category win-ners, please read the article on page 22.

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Real-World Evidence: NextSteps for the NESTCoordinating Center

FDA has awarded the Medical DeviceInnovation Consortium (MDIC) $3 mil-lion in seed funding to establish thecoordinating center for the medicaldevice National Evaluation System forHealth Technology (NEST). The fund-ing will also be used to set in motionthe group’s first demonstration proj-ects, piloting methods for tracking med-

ical device data and patient-reportedoutcomes through the use of real-world evidence.

NEST is designed to help improvethe quality of real-world evidence thathealthcare providers and patients canuse to make better-informed treatmentdecisions and strike the right balancebetween assuring safety and fosteringdevice innovation and patient access.

MDIC says this use of real-world evi-dence to support product approvals has

the potential to shift premarket data col-lection to the postmarket setting.

“There is great potential in using real-world data to foster innovations in medicaldevice technology that will lead to opti-mized outcomes for patients and improvedquality of life,” said MDIC Board ChairmanMike Minogue, president, CEO, and chair-man of Abiomed. “In addition, real-worldevidence will help measure the cost-effectiveness of these new technologies.”

Former FDA Commissioner MarkMcClellan, M.D., Ph.D., spoke about thenext steps for NEST at MDIC’s annualpublic forum in September. McClellan isnow director of the Robert J. MargolisCenter for Health Policy; the MargolisProfessor of Business, Medicine andHealth Policy at Duke University; and isa NEST planning board member.

“We focused on a number of issuesthat are starting to play a bigger role inreal-world evidence development,” saidMcClellan. “Critical to success is broad-based support and public confidence fornot only the mission and why we are try-ing to put data together but also how it’sbeing executed.”

McClellan says the next key step for thenew coordinating center is to establish agoverning board to oversee the nationalnetwork as it gets off the ground. Short-term projects that the group plans tofocus on include effective and efficientbalancing of pre- and postmarket deviceevidence development and improvingsafety surveillance of medical devices.

He pointed to the existing real-world evi-dence networks and individual registriesthat are all dealing with the same issuesand underlying potential sources of data,noting that these networks could be usedas a model to build a national network ofregistries. That national registry would beused to learn about how medical treat-ments could be used more effectively. Inaddition to building on existing activities,he said, it will be critical to demonstrate thevalue of the coordinating center and to setperformance metrics to track its progress.

“Within a few years, we’ll have a differ-ent view reflecting the FDA’s strategicvision for how pre- and postmarket regu-lations work, as well as a much higherexpectation about the quality of evidenceof medical devices and much higherexpectations about the efficiency and thetimeliness of the biomedical processinvolving medical devices,” he said.

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8 www.medicaldesignbriefs.com Medical Design Briefs, November 2016

Sponsored Content

KMC Systems (Merrimack, NH) has more than 30 years of experience partnering with medicaldevice and diagnostics companies to design, develop, and manufacture biomedical systems forthe in vitro diagnostic, surgical and therapeutic, life science, and laboratory automation markets.Along the way, KMC has developed sophisticated multidisciplinary product development process-es to help its customers achieve market success. To find out more about current trends affectingmedical product development, MDB recently spoke with Mike Kallelis, vice president for businessdevelopment at KMC Systems.

I N S I D E S T O RY

MDB: When KMC Systems becomesinvolved with a medical device ordiagnostic project, at what stage ofdevelopment is the product?

Mike Kallelis: KMC Systems partnerswith leading and emerging medicalproduct OEMs at various stages of aproject, based on the customers’

needs. Some partnerships begin with a fully developed proto-type that requires first-run manufacturing. Some begin when aprevious attempt at a third-party manufacturer failed, and thecustomer turns to KMC Systems for help. Some customerscome to KMC with a concept and work with our developmentengineers to design their system. Whether the customer needsa specialty engineering firm for platform development, a rep-utable contract manufacturer for production — or both —

KMC Systems can step in at any phase of the program, fromconcept through production.

MDB: What engineering specialties does KMC bring to bearon medical products? Are you finding greater emphasis insome areas, such as software engineering, than was previ-ously the case?

Kallelis: KMC is known for its specialized capabilities in labora-tory automation, with particular emphasis on platform develop-ment for in vitro diagnostics (IVDs). The company comprisesmany engineers with specialized skills in fluid handling, materi-al handling, motion controls, optics, robotics, sample manipula-tion, and traceability. KMC’s capabilities in these areas, as wellas in the traditional fields of mechanical and electrical design,are resources that we bring to bear on instrument developmentprograms. With respect to software, it’s always been a criticalarea for our customer base, especially in the development ofautomated medical devices.

MDB: How has KMC grown its capabilities in response toshifts in engineering emphasis?

Kallelis: Over the past few years, we have expanded our engi-neering capacity by nearly 100%. In turn, expansion of ourengineering team has enabled us to leverage a larger numberof qualified resources during the development phase of a pro-gram. The availability of such resources is especially importantfor maintaining the scheduling and milestone commitments wehave made to our customers. In addition, in order to betterrespond to customer needs, we’ve increased our competenciesin fluidics, optics, and software engineering.

MDB: Do new medical products often encounter difficultieswhen they are first brought to market?

Kallelis: When a new product launches, no matter how rigorousthe development process, the instrument can carry some inherentissues to market. It often takes the first 50–100 instruments toidentify issues and “work out the bugs.” These early-to-marketinstruments are often critically judged by customers, who can eas-ily be lost due to poor design or lingering production problems.

MDB: Why can’t contract manufacturing organizations reduceor eliminate such quality issues related to new products?

Kallelis: Many early, post-launch issues are very technical innature and cannot be easily resolved by a manufacturing firm.They require solid engineering for resolution. This is a conun-drum for specialty contract manufacturing organizations,because they are organized for efficiency, productivity, and highthroughput — not for solving design issues. But the design firmmay be miles away, or even on another continent, and not read-ily accessible by the tier-one manufacturer. This disconnect caninflict significant harm on the company’s market penetration,top-line growth, and customer acceptance of the new platform.

MDB: How important are quality systems for minimizing theissues that arise when bringing a new product to market?

Kallelis: Quality systems are only as good as the quality strategythat drives them. I’ve seen quality systems that are consideredcompliant and adequately address the components of a set ofregulatory guidelines, and yet are wholly inadequate for theirtrue purpose. When such systems are narrowly implemented, theQMS may pass the scrutiny of an auditor but may still not preventthe problems that can arise during the launch of a new product.

MDB: How do KMC’s quality systems coordinate with itsclients’ equivalent systems?

Kallelis: Early in the development process, a quality plan is putin place between the two parties. The plan addresses the part-ners’ roles and responsibilities, and defines how the two compa-nies will engage throughout the life of the program.Nomenclature and workflows are also discussed and agreedupon. With such a plan in place, everyone at the partneringcompanies is following the same quality roadmap.

To find out more about KMC Systems, visit the full-length version ofthis interview, available online at www.medicaldesignbrief.com/InsideStory1116.

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The demand for thermal manage-ment materials and adhesives is

driven by the unwanted and potential-ly harmful heat generated by ever-shrinking electronic components andsystems in all areas of the electronicsmarket, including medical. In recentyears, more functionality has beenincluded in a single device and the sizeof each new device has gotten smaller.Miniaturized components in tightpackages with high power output cre-ate the challenges that design engi-neers are now facing.

Thermal management needs are alsoexpanding in hot niche markets like bat-teries and LEDs, where increased com-plexity, density, and intensity are causingmanufacturers to look for new materialsand designs for better thermal conduc-tivity, dissipation, and insulation.

Factors in Thermal ManagementThere are three important basic fac-

tors that need to be considered in anyapproach to thermal management.These include:• Good heat sink or heat pipe design

and proper airflow• A high, thermally conductive interface

material that is as thin as possible• Elimination of voids along the inter-

face material so that no trapped airremains between the interface materi-al, power device surface, and heat sinksurfaceSupporting high-power integrated cir-

cuits (ICs) on today’s printed circuitboards (PCBs) requires working withinthe limitations of thermal conductivity,coefficient of thermal expansion (CTE),weight, and rigidity. Balancing these dif-ferent considerations is tricky. For exam-ple, where copper can be very useful inthermal management, it is not able tomanage a board’s CTE, and it substan-tially increases board weight.

Thermal Interface Materials As the miniaturization trend contin-

ues in medical electronics and otherindustries, the importance of good ther-mal interface design has led to develop-ment of new thermal interface materialsChoosing a thermal interface materialthat will work in an application, an engi-neer might consider power density, heatdissipation, bond line thickness, process-ing requirements, and reworkability.

Thermal interface materials can bebroadly categorized as one of the follow-ing types:• Polymer matrix composites — differ-

ent types of carbon fibers combinedwith a variety of thermosetting andthermoplastic resins, including epoxy,cyanate ester, liquid crystal, nylon,polycarbonate, acrylonitrile butadienestyrene, polybutylene terephthalate,and polyphenylene sulfide

• Metal matrix composites — silicon car-bide particle-reinforced aluminum,

beryilia particle-reinforced beryilium,carbon fiber-reinforced aluminum,copper-tungsten, copper molybdenum,aluminum silicon, and Invar silver

• Carbon/carbon composites — carbonnanofibers, vapor-grown carbon fibers, nano-graphene platelets,pyrolitic graphite, and other carbon/carbon mixesAdvanced thermal interface materials

can provide better thermal managementcharacteristics as well as improvementsin weight and strength and are beingintegrated into a range of thermal man-agement solutions, including insulating,hybrid, and nonwoven papers; insulat-ing solders; grease; phase change mate-rials; and conductive adhesives.

Insulating hybrid and nonwovenpapers. Lightweight carbon compositelaminates, aramid papers, and nonwo-vens can all be used for heat insula-tion/dissipation. Easily die-cut to com-plex shapes, they provide excellent hightemperature, abrasion, and chemicalresistance; smooth surfaces; high tor-sional rigidity and stability; and high orlow conductivity for absorbing, reflect-ing, or conducting heat.

Solder. New formulations in solderare delivering added thermal control totoday’s high-performance, high-energy,and high-heat applications. Advances insolder thermal management include:• Lead-free die attach solder alloys• Active solder — lead-free solder with

titanium or rare-earth elements added• Eutectic bonding/soldering where sili-

cone is alloyed with metals such asgold or aluminum to offer better heatdissipation/managementThermal grease. The traditional

interface material in electronics is ther-mal grease. Available in silicone or non-silicone varieties, thermal grease pro-vides thermal resistance through excel-lent gap filling and an extremely thin

Thermal interface materials eliminate voids sothat no trapped air remains between the inter-face material, power device surface, and heatsink surface.

Advances in ThermalManagement Materials and

Adhesives for Medical Electronics

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bond line. It is reworkable, and it is easyto apply, including automated dispens-ing. It provides good reliability at a lowcost. Thermal grease also can beapplied as a thermal interface pad,where the grease is impregnated in thepad. The thermal pad offers the samewetting capability as thermal grease,but can be die-cut to custom shapes fordrop-in-place assembly. Issues withgrease can include contamination (forsilicone grease), pump-out during ther-mal cycles, and imprecise or inconsis-tent application.

Phase change materials. Phasechange materials are often used to sup-plement some of the issues related togrease. These materials are solids atroom temperature but change to liquidonce the excess heat of a device pushesthe material past its melting point.Typically composed of a coating ofphase change compound on an alu-minum or polyimide substrate, newphase change materials can be coateddirectly onto a release liner withoutusing a substrate. This improves per-formance by creating a better flowwhen the phase change material is inthe liquid stage, as well as better gapand void filling. The interface is thin-ner without the substrate, resulting inmore efficient heat transfer.

The phase change material doesn’tpump out of the interface like greaseand it is more manufacturing friendly..There is no messy application orcleanup necessary, and in many cases,phase change materials provide morereliable thermal management over thelong run than grease.

Thermally conductive adhesives.Adhesives provide unique options forthermal management. They are often thebest choice where components are notconnected by mechanical attachment, orwhere the micro-movement of substrates

requires adhesion for a component tomaintain contact with the substrate. Theyare often used with semiconductor pack-ages as an interface between a chip and aheat spreader. Thermally conductiveadhesives can be configured as:• Interface pads — conformable adhe-

sive pads that are easy to handle andprovide high conductivity

• Liquids — usually epoxies, which pro-vide an ultrathin bond line and easyintegration into manufacturing dis-pensing equipment

• Tapes — high mechanical strengthplus good surface wetting and excel-lent shock absorptionIn addition to semiconductor applica-

tions, thermally conductive adhesivesare popular in medical electronics,where they are used for attachment inaddition to thermal management. It ispossible to use an adhesive that com-bines thermal and electrical conductivi-ty, for example, as an electrical groundto a board. Or conversely, to use anadhesive that is thermally conductive butelectrically insulating.

Using an adhesive for thermal manage-ment requires considering potentialtrade-offs in bond strength versus heatdissipation where thick applicationincreases the bond but decreases heat dis-sipation. It is also important to considerhow much filler is in the adhesive. A lot offiller provides high shear strength butlower flexibility. Finally, the CTE betweenthe component, substrate, and adhesive

must be calculated. All of the possibilitiesneed to be assessed in regard to suitabilityfor the manufacturing process and cost.

Working with an ExperiencedConverter/Materials Supplier

Working with an experienced thermalmanagement materials and adhesivesconverter and industrial assembly sup-plier is essential to choosing the rightthermal management materials for aparticular application.

From identification and selection ofthe appropriate materials and adhesives,to slitting, layering, laminating, preci-sion die-cutting, and packaging of thefinished product, an experienced ther-mal management materials and adhe-sives converter provides the design, pro-totyping, testing, and manufacturingknowledge required for success.

When working with customers whoare designing with thermal managementin mind, finding the right adhesives andmaterials is often a process of elimina-tion. The more knowledge of how muchheat the component generates, its placewithin the overall product, and otherthermal management details, the short-er the process of selecting and matchingappropriate adhesives and materials.

Medical electronics OEMs shouldlook for converters to provide precisiondie-cutting, multi-layer laminating, andslitting to tight tolerances; access to arange of thermal management solu-tions; and testing capabilities.

Thermal Management Materials & Adhesives

Advanced thermal interface materials can pro-vide better thermal management characteris-tics as well as improvements in weight andstrength for advanced electronics assemblies.

Thermal grease can be applied as a thermal interface pad, where the grease is impregnated in thepad. The pad can then be die-cut to a specific application shape.

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14 Medical Design Briefs, November 2016

Thermal Management Materials & Adhesives


Fabrico, for example, selects fromservo driven rotary die-cutting, CNC die-cutting, laser die-cutting, and water jetdie-cutting to meet the complex specifi-cations of thermal management for elec-tronic components. For example, aservo-driven rotary die-cutter can main-tain tight tolerances ranging from 0.015to 0.005 in. at speeds up to 500 fpm,and is ideal for the complex, multilayerdie-cutting and lamination that a ther-mal interface pad or tape may require.

For complex foam tape die-cutting,water jet technology provides clean edgeswith no distortion. Laser die-cutting, kiss-cutting, slitting, and laminating can alsobe used in converting for medical applica-tions. If a grease or liquid thermal inter-face material is selected, the converter canprovide and plan for easy integration intothe manufacturer’s process with dispens-ing recommendations and solutions.

A converter with a fully equipped testlaboratory can ensure that customermaterials meet designed-in specifica-tions before they move to the factoryfloor, often eliminating the need to testmaterials at the customer’s facility. Acomplete test lab offers:

• Accurate and precise part dimensionmeasurement and verification

• Adhesive/release liner to determineconverting properties and high-speedapplication characteristics

• Material strength measured to ensurethat material meets applicationrequirements

• Static shear testing to measure thecohesive strength of the adhesive towithstand a fixed load over time

• Material weight measurement todetermine adhesive coating weight

• Microscopic imaging to determine dif-ferences between adhesive and materi-al over time

• Dielectric testing to determine a mate-rial’s electrical insulation properties

• Thermal testing for materials andadhesives

• Resistance and voltage testing to pro-vide a complete profile of the electri-cal properties of a material or adhesiveAnother important consideration is to

ensure that the converter has strategicrelationships with world-class materialssuppliers, such as 3M™, Loctite®, andAdhesives Research to assist its cus-tomers in selecting the best material forthe intended use and to expedite mate-rials sourcing. Whether adhesive films orliquids, all critical material propertiesmust be considered in every project,including chemical, thermal, and mois-ture resistance.

This article was written by Christian S.Yorgure, Ph.D., Manager of BusinessDevelopment at Fabrico Medical, Rochester, NY.Fabrico, Light Fabrications, and TrientTechnologies are divisions of EIS, a GenuineParts Company. For more information, visithttp://info.hotims.com/61067-162.

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Ultrasonic welding of thermoplasticshas been widely used by the medical

industry to assemble plastic parts andcomponents in just seconds withoutadditional consumables. Developmentof servo-driven ultrasonic welders intro-duces unique levels of control to theprocess. Historically, pneumatic ultra-sonic welding systems controlled ultra-sonic horn movement indirectly byrelieving pressure from air cylinder,which lacks precision, provides less con-sistent weld results, and compromisesweld strength. Today’s servo-drivenultrasonic welding systems control theprocess through a closed-loop servoposition control that dynamically seeksto meet the desired position. The abilityof servo systems to program independ-ent speeds for up to 10 different seg-ments of the weld, along with the abilityto dynamically sense when melt is beinginitiated at the beginning of the weldprocess, yields consistent and strongerweld results with less residual stress.

Weld Velocity ProfilingDuring a typical ultrasonic welding

cycle, most of the plastic melt takes placein the energy director body, and itsmolten material forms a bond.Generating maximum weld strengthwhen using pneumatic welding systemstypically requires that the weld distancebe set close to the nominal energy direc-tor height, so the energy director can becompletely melted. Failure to achievefull melt often results in lower strength,incomplete welds, and poor appearanceof welded assemblies. As the actualheight of the energy director varies(because of the variation in the moldingprocess), there is always a risk that someof the parts with a shorter energy direc-tor will have excessive flash, and if theprogrammed weld distance is reduced toavoid flash, then there is a risk of gener-ating nonhermetic welds.

Servo-driven ultrasonic welding tech-nology introduces weld velocity profil-ing, which is capable of achieving strongand reliable welds without fully collaps-ing the joint while minimizing the risk ofexcessive flash. For difficult medicalapplications, it is advantageous to profilethe speed during the weld process inorder to match the natural melt rate ofthe material. In addition, servo systemsprovide the ability to sense when theplastic resin is changing from the solidstate to the molten state at the triggerstage of the process when it senses adrop in force indicating the precisemoment to begin the weld process.

Effect of Weld VelocityExperiments were completed in

which the weld velocity was varied, andthe resulting strength and appearance

of the welds were evaluated against thestringent requirements of the medicalindustry. Analysis of welded cross sec-tions suggests that higher weld strengthwas associated with a linearly increasingweld velocity profile.

During these experiments, three dif-ferent velocity profiles were examined: 1mm per second constant profile, 0.5 mmper second constant profile, and a lin-early increasing profile from 0.25 to 0.4mm per second. Samples for each pro-file were fractured on a tensile testingmachine, and the load at break wasrecorded (see Figure 1).

The welds produced using the linearlyincreasing velocity profile were strongdespite the fact that the energy directorcollapse during weld was limited to 68–70 percent of the nominal height.Worthy of note is the fact that significant

ADVANCED MELT FLOW CONTROLS OF SERVO ULTRASONICWELDING FOR MEDICAL DEVICES

6,000

5,000

4,000

3,000

2,000

1,000

0

Load(N)

Constant1 mm/s

Constant0.5 mm/s

Profiled0.25 – 0.4 mm/s

Velocity Profile

Tensile Load Standard Deviation

2,432

153

3,207

565

5,223

305

Effect of Weld Velocity

Fig. 1 – Average failure load as a function of weld velocity; 30 welded samples evaluated at eachvelocity profile.

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numbers of these welds failed in the par-ent material, not the weld joint, and thatthe failure load of others was close toparent material strength. An example offailure through parent material is shownin Figure 2.

Parts were cross-sectioned throughthe weld area and the shape of the heat-affected zone was measured on a micro-scope using imaging software. Cross-sectional images of the weld areas result-ing from different velocity profiles showa strong correlation between the shapeof the zone and the strength. A smaller,bean-shaped weld zone, not completelycovering the full width of the contactarea between the parts, showed lessstrength. These results were consistentwith constant velocity profiles, as inFigures 3 a and b.

A larger and more uniform melt layer,proliferated into both parts, was charac-teristic of linearly profiled velocities andproduced stronger welds (see Figure 4).The depth of penetration was observedat 361 μm for the sample produced witha uniform melt velocity of 1 mm per sec-ond, while the zone for the sample pro-duced with a linearly increasing weldvelocity profile was 690 μm, or nearlytwice as deep. It appears that the precisecontrol of the melt achieved with a lin-ear profile allows greater heat propaga-tion early in the weld cycle, and resultsin a deeper, more consistent and there-fore stronger weld.

In welds performed with a linearlyincreasing velocity profile, the melt layerbuildup takes place not only in the vol-ume of the energy director, but alsowithin the mating part surfaces. Thisforms a uniform melt layer in the con-tact area of both parts and is apparent inthe melt zone shape observed under themicroscope (see Figure 4). This zoneextends into both parts of the assembly,and its size correlates strongly with highstrength welds.

Benefits of Linearly IncreasingWeld Velocity Profile in JoiningMedical Devices

Elimination of excessive weld flash.The opportunities afforded by linearlyincreasing weld velocity profile for pro-ducing strong, consistent welds, reduc-ing scrap and reject rates, and openingthe option of ultrasonic welding to pre-viously inaccessible parts are exciting.This advance control provides a pro-longed low force at the early stage of thewelding cycle, allowing increased meltpropagation in the depth of materialand melt-layer growth at the interface.In addition, welding to a distance lessthan the height of the energy directorallows for a larger weld process windowand has less propensity for generatingexcessive weld flash. Elimination ofexcessive weld flash is a key concernwhen welding medical parts. Given thevariation of size and shape of energy

directors that can occur both over mold-ing runs (typical dimensional variations)and over the life of the molding tool,any change allowing a wider process win-dow is useful.

Stronger Welds. Microscopic investi-gation of welded parts using linearlyincreasing weld velocity provides insightinto the physical characterization of theweld regions. The length and depth ofthe weld zone correlates closely with thetensile strength of the samples, with alarger zone producing higher tensilestrength values. Samples that had fullcoverage of the contact area, as well asresultant deeper penetration, showedhigh strength. These larger, more uni-form melt regions penetrated well intothe surrounding material.

Less Residual Stress. Observation ofthe samples with a polarized lightsource shows an additional im-provement in the welding process

Fig. 2 – Typical tensile failure through parentmaterial.

Fig. 3a – Constant weld velocity of 1 mm/s. Melt penetration 361 μm. Average failure load 2432 N.

Fig. 3b – Constant velocity profile of 0.5 mm/s. Melt penetration 379 μm. Average failure load 3207 N.

SERVO ULTRASONIC WELDING

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afforded by a servo-driven welder.Optimizing the weld speedthroughout the cycle allows themolecules to become less orientedand retain more of the amorphousstructure that yields higherstrengths. A reduction in numberof colors, as well as the number offringes, is evidence that these sam-ples have less residual stress result-ing from the welding process (seeFigure 5).

The lessening of residual stresslevels will be a key factor for med-ical device assemblies. High levelsof stress can accelerate failure ofplastic parts when subjected to awide variety of environmental fac-tors, such as ultraviolet exposure,chemical attack, and sterilizationprocesses, as well as normal wear.These factors all hasten the failureof a welded plastic assembly, andany process that can minimizeresidual stress levels caused duringwelding will help mitigate theirimpact. This stress reduction can beconsidered a safety improvement inmany products.

ConclusionIn summary, associating a specific

weld velocity profile with formationof a homogeneous melt layer in theinterface of the assembly offers a keyapproach to selecting optimumwelding parameters. The significant-ly enhanced capabilities of servo-driven welders in controlling materi-al flow and the rate of material dis-placement during every stage of thewelding cycle, their high repeatabili-ty and accuracy, and the optimalimplementation of these tools andfeatures enable users to develop arobust joining process with highstrength, lower occurrence of weld-ing flash, and lower residual stresses.This approach is beneficial to thewelding of small parts typical in themedical device and electronicsindustry, where strict requirementsfor strength and dimensional consis-tency are critical factors.

This article was written by JasonBarton, National Sales and MarketingManager for Dukane, St. Charles, IL.For more information, visit http://info.hotims.com/61067-164.


Fig. 5 – Melt zone image for sample welded with profiledweld velocity photographed in polarized light.

Fig. 4 – Linearly increasing velocity profile from 0.25 to 0.4mm/s. Melt penetration 690 μm. Average failure load5223 N.

SERVO ULTRASONIC WELDING

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The 14th annual “Create the Future” Design Contest for engineers, students,

and entrepreneurs worldwide, sponsored by COMSOL and Mouser

Electronics, attracted more than 1,100 innovative product ideas from engi-

neers and students in more than 71 countries. The Medical category itself received

88 outstanding entries from 32 countries. Analog Devices and Intel were support-

ing sponsors. The contest, which was established in 2002, recognizes and rewards

engineering innovations that benefit humanity, the environment, and the economy.

Winners were selected in late September from the seven categories: Medical

Products, Consumer Products, Electronics, Machinery/Automation/Robotics,

Sustainable Technologies, Automotive/Transportation, and Aerospace & Defense.

In addition to product ideas at the concept or prototype stage, contestants could

submit designs for commercial products introduced to the market within the last

12 months.

The grand prize winner receives $20,000, while the first-place winner in each

category receives a Hewlett-Packard workstation computer. The top 10 vote recip-

ients also receive prizes. The most popular vote recipient receives a GoPro® cam-

era. The others receive a Sphero® BB-8™ Droid™ or robotic gaming system.

In addition to the winner and honorable mentions listed here, there were win-

ning entries in other categories with medical applications. In the Consumer

Products category, the X-Drive Powered Wheelchair Conversion converts con-

ventional wheelchairs into powered ones. In the Machinery/Automation/Robotics

category, the 3rd Arm – A Wearable Robotic Limb for Augmenting Human

Abilities is a wearable robotic assistive device designed to be used to restore lost

functions or add functionality to amputees or to patients diagnosed with brain

stroke, multiple sclerosis, or Parkinson’s disease.

This article introduces the Medical Category winner as well as four

Medical Category Honorable Mentions. The top prize winners will be hon-

ored at an awards reception in New York City this month. Congratulations

to all who entered. All of the entries can be seen at http://contest.techbriefs.com/2016/entries/all.

High blood pressure affects 1 billion individuals globally and more than

80 million in the United States. Hypertension is the leading risk factor

for coronary artery disease, stroke, heart failure, and chronic kidney

disease. Nearly 70 percent of all healthcare expenditures ($170 billion) in the

United States are spent managing complications resulting from uncontrolled

blood pressure. Notably, high blood pressure is a modifiable risk factor that can

be managed with adequate monitoring.

Despite the overarching implications, blood pressure monitoring remains

limited by poor diagnostic solutions like the traditional blood pressure cuff that

provides inaccurate and infrequent measurements confounded by procedural

limitations. The only solution to circumventing these limitations is the ambula-

tory blood pressure monitor. Current ambulatory monitors consist of a blood

pressure cuff programmed to inflate every 15 minutes for a 24-hour period to

take repetitive discrete measurements. Despite the benefits, ambulatory mon-

itoring remains limited because of logistical constraints, expense, and poor

patient compliance as a result of discomfort.

There remains a clinical need for a noninvasive, unobtrusive monitoring sys-

tem that can acquire accurate blood pressure measurements with greater fre-

quency to properly manage hypertension.

Bold Diagnostics has addressed the unmet need by developing an innova-

tive low-cost diagnostic platform that consists of a set of wearable wristbands

that continuously measure blood pressure and a smartphone application that

uploads a report into the patient medical record for clinician review (see

Figure 1). The solution provides accurate measurements with greater frequen-

cy, which enables clinicians to positively impact clinical outcomes with proper

blood pressure management.

The wristbands calculate blood pressure based on Bold’s patent pending

Differential Pulse Arrival Time (DPAT) technology. DPAT states that the pulse

Fig. 1 – Wearable wristbands continuously measure blood pressure and asmartphone application uploads a report into the patient medical recordfor clinician review.

CONTINUOUS WEARABLE BLOOD PRESSURE MONITORSean Connell, Kyle Miller, Jay Pandit, and Jung-En Wu

Bold Diagnostics, Evanston, IL

wave generated by the heart contracting arrives at the right before the left

arm because of an inherent delay created by the anatomy of the aortic arch.

Bold has further discovered that the difference in arrival times is an indicator

of blood pressure.

Bold has developed a working prototype and conducted preliminary clinical

studies under an approved IRB protocol that demonstrate proof of concept.

The clinical study (n=15) demonstrated (i) a consistent difference in pulse

arrival times between the right and left hands and (ii) a strong correlation

between DPAT and blood pressure (±5 mmHg) in comparison to control

measurements. Study results suggest DPAT is a viable method for continuously

measuring blood pressure.

The company has developed a strategy focused on direct distribution to ter-

tiary care centers for a price between $155–$195 at cost of goods sold at

$25–$40. Following the prescribed monitoring period, the physician will review

the report and charge insurance providers for reimbursement with established

CPT codes for ambulatory monitoring. Bold anticipates a 510(k) application for

market entry by 2018.

The company aims to redefine the way blood pressure is measured with its

wearable wristbands to empower clinicians to effectively manage hypertension

and improve clinical outcomes.

For more information, visit http://contest.techbriefs.com/2016/entries/medical/6724.

Sponsored by

2016 Contest Winner Redefines the Way We Measure Blood Pressure

MEDICAL CATEGORY WINNER

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Interpower® manufactures North American and international hospital-grade power cords and cord sets. While some countries have standards in regards to overall medical equipment, a few countries/regions have standards or recommendations in regards to specific medical-related components (e.g. plugs and cords). Hospital-grade power cords and cord sets as well as plugs and sockets are subject to special requirements or recommendations in Australia, Denmark, Japan, and North America. Contact Customer Service at Interpower with questions.

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The cerVIA system, developed by Luso Labs, integrates a custom camera

scope with a unique cervical cancer lesion detection algorithm in a

point-of-care device (see Figure 3). Fitted for speculums and operated

with any Android smartphone, the cerVIA system offers automated, accurate,

and accessible cervical cancer screening for women in “low- and middle-

income” countries worldwide.

Cervical cancer continues to devastate millions of families in these coun-

tries. Of the 528,000 cases and 266,000 deaths due to cervical cancer in 2012,

90 percent occurred in low- and middle-income countries. The cancer’s preva-

lence in these countries can be partly attributed to late-stage diagnoses. Clinics

in high-income countries use cytology screening of pap smears to find abnor-

mal tissues before they progress into precancerous lesions. However, cytology

screening requires laboratories and trained scientists, neither of which is readily

found in low- and middle-income countries. As a result, a lack of appropri-

ate screening tools contributes to cervical cancer causing the projected

deaths of 447,000 women in these countries in 2030.

Visual inspection with acetic acid (VIA) testing has emerged as the stan-

dard for cervical cancer screening in these countries because of its acces-

sibility and affordability. Clinicians perform VIA by applying diluted vinegar

to the patient’s cervix and inspecting it for whitened precancerous lesions

after a few minutes. Unfortunately, VIA shows poor diagnostic accuracy

due to the inherent subjectivity of visualizing precancerous cervical lesions,

the inconsistent lighting conditions in clinics, and the inadequate precan-

cerous lesion detection training typically provided.

The cerVIA system solves these clinical issues in a manner that seam-

lessly integrates into standard VIA procedures. After applying vinegar to the

cervix, the clinician inserts the cerVIA device into the speculum and takes

an image through the companion Android application. The device contains

a custom lighting system that standardizes input images, consistently capturing

images with similar brightness, hue, and saturation values. These images feed

into an algorithm on an Android application that uses pixel-intensity processing

and machine-learning processes to detect precancerous lesions. The algorithm

then outputs heat maps to highlight problem areas that clinicians can examine

to make more-informed diagnoses, providing a more objective assessment

than conventional VIA.

While competitors look to supplant VIA with resource-intensive methods or

supplement VIA with expensive mobile colposcopes, the cerVIA system’s

potential lies in its simple operation that complements standard VIA testing with

objective, accurate analyses at a competitively low price of about $1.10 per

patient. In preliminary diagnostic testing, the algorithm increased testing sensi-

tivity and specificity to 91.7 percent and 88.6 percent, respectively, demonstrat-

ing an approximate 23 percent improvement over conventional VIA.

Luso Labs is planning a pilot study of the cerVIA system this winter in India

where 432 million women are at risk for cervical cancer and 80 percent of

cervical cancers are detected at stage 3. After obtaining regulatory approval

in India, the company will mass-manufacture cerVIA devices via injection

molding and bring the systems to clinics through in-country partners.


The Apnosystems Infant Care System (ICS) device is a life-saving medical

intervention that can cause a sleeping infant who has ceased breathing

to stir and resume breathing. This wearable device will change the way

we care babies, both in the hospital and at home.

Premature, low birthweight babies, postoperative babies, and those with

congenital defects are at higher risk. Such infants may suffer critical situations

during sleep resulting in temporary brain damage, permanent brain damage, or

death. The device can also help to protect babies with diagnosed unstable air-

way conditions. If an airway obstruction results in low blood oxygen saturation,

the device detects the hypoxia and provides an intervention stimulus.

Anesthesiologists agree that when a patient is in trouble, the problem must

be addressed in a matter of seconds or minutes. The ICS is a device that acts

automatically and within seconds. The ICS helps in three ways: by monitoring,

intervening, and gathering new and valuable data. This device, which is a first of

its kind, wirelessly integrates pulse oximetry with data gathering and a rescue

stimulus. The device consists of a glove that houses the sensor and the stimulus

circuitry, a pulse oximeter sensor, controlling logic, and low-energy Bluetooth

for communication with smartphones, tablets, and PCs (see Figure 2).

If a baby experiences a dangerously low heart rate or blood oxygen sat-

uration episode, and after the device’s algorithm determines the need, the

device provides a brief transcutaneous electrical nervous stimulation (TENS)

to rouse the wearer. The algorithm was based on a Collaborative Home

Infant Monitoring Evaluation

(CHIME) study to reduce false

alarms. The rescue stimulus is minimal

and cannot cause undue distress.

Caregivers can adjust the intensity of

the therapeutic stimulus to a lowest

effective dose for each individual

(high, medium, or low stimulus).

The Apnosystems ICS device may

be produced for as little as $25 per

unit. The tested technologies utilize

low-cost components. As sales vol-

umes increase, efficiencies can fur-

ther reduce unit production cost. The

ICS garment can be made of all nat-

ural fibers, making it environmentally

friendly. The ICS’s batteries are inter-

nal and rechargeable. The device can

be recharged from voltage sources that include solar arrays. The ICS can be

assembled almost anywhere in the world.

It is the only device that delivers a therapeutic, life-saving intervention using

accepted and reliable detection of health parameters. Data are gathered in real-

time on infants wearing the ICS through caregivers’ smartphones and other

devices. In emerging economies, the device is particularly useful. Premature babies

are more common and high-risk babies are more likely to be sent home without

a sufficient level of security because of lack of space in the nursing care units.


THE CERVIA SYSTEM — AUTOMATED,ACCURATE, AND ACCESSIBLE CERVICALCANCER SCREENINGRitish Patnaik, Stephanie Yang, Olachi Oleru, and Jahrane Dale

Luso Labs, Plano, TX USA

INFANT CARE SYSTEM — A THERAPEUTICWEARABLE FOR BABIESDiego Delia, Clinton Allen, and Omar Mohammed

Apnosystems, Buenos Aires, Argentina

Fig. 2 – The device wirelessly inte-grates pulse oximetry with datagathering and a rescue stimulus.The device consists of a glove thathouses the sensor and the stimu-lus circuitry, a pulse oximeter sen-sor, controlling logic, and low-ener-gy Bluetooth for communication.

Fig. 3 – The cerVIA integrates a custom camera scope with a unique cervicalcancer lesion detection algorithm in a point-of-care device.

HONORABLE MENTIONS

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Medical Design Briefs, November 2016 www.medicaldesignbriefs.com 25

Immunocept Medical Products (IMP) is an early clinical-stage healthcare

company committed to saving and dramatically improving the lives of those

with acute inflammatory-related disease by providing innovative medical

products that significantly improve organ and patient survival.

In U.S. hospitals, more than 1 million patients are admitted annually with

sepsis, making it the most expensive disease treated at $20.3 billion. Sepsis

causes nearly half of all inpatient deaths for both adults and children and more

than half of sepsis survivors are left disabled and chronically ill. These “sur-

vivors” do not improve, but they do not die. Instead, they linger on life support

in ICUs or special care units. This recently recognized problem is known as

chronic critical illness; the sepsis component is estimated to generate $17 bil-

lion in additional hospital-related costs. The total cost in the United States of

failing to control destructive inflammation exceeds $45 billion annually, includ-

ing the cost of acute care, repeat hospitalization, and chronic critical illness.

These combined costs of treating sepsis patients and survivors represents an

enormous burden on the healthcare system.

Inflammation is one of the body’s first and best defenses against injury and/or

infection. Quiescent inflammatory cells distributed throughout the body keep

quiet vigil for tissue injury or invading germs. When injury or infection occurs, local

inflammatory cells rapidly respond, secreting chemical signals (inflammatory medi-

ators) to attract more activated cells to the site; this amplifies the intensity of the

inflammatory attack to the scale of the threat. Invading germs and damaged tis-

sues are destroyed and healing is promoted. In most cases, inflammation confines

and then eliminates the threat.

However, with severe tissue injury or aggressive infection, local inflammation

can be massively amplified. Inflammatory mediators can become so abundant

that they spill out of the local site into the bloodstream and circulate throughout

the body. These circulating mediators can trigger undesired inflammation, dam-

aging vital organs, degrading their function and causing failure. There are over 100

individual molecules involved in the inflammatory cascade ranging in size from 8

to 100 kDa (kilodalton). Current treatments for sepsis focus on one or two of

the prominent molecules, which is like placing a Band-Aid on the problem, tem-

porarily alleviating symptoms, but not reversing the underlying organ damage.

Backed by 11 U.S. patents, the SeptiFlux™ hollow fiber hemofilter incor-

porates an innovative membrane filtration spectrum designed to control

destructively amplified inflammation, which is the root cause of organ failure

in both brain-dead organ donors and severe sepsis patients (see Figure 4).

The Septiflux is designed to work with all currently existing hospital

hemofiltration machines, decreasing the barriers to entry. The company’s

strategy is to leverage its unique regulatory and market relationships in the

organ donor field to launch this unique product and then use those results

to drive development of the severe sepsis market for much less money and

time than it would otherwise cost.

For both organ transplant recipients and severe sepsis patients, this means

rapid reversal of organ failure, much better survival, much less cost, and much

higher quality survivorship.


Fig. 4 – The SeptiFlux hollow fiber hemofilter incorporates an innovativemembrane filtration spectrum designed to control destructively amplifiedinflammation.

DISRUPTING SEVERE SEPSIS WITH ANINNOVATIVE FILTERChris Jaynes and Jim Matson

Immunocept Medical Products, Denver, CO

Medella Health is a wearable technology start-up based out ofWaterloo, Canada. The company is developing contact lensesthat continuously and noninvasively monitor health biomark-

ers and transmit the data to a mobile phone, so patients can bettermanage their health (see Figure 5). The company is starting with dia-betes management, but can expand this technology to many otherhealth indicators, such as heart disease and mental health.

In its two years of operation, the company has grown the team toinclude a variety of engineers, scientists, and designers, and has built amid-stage prototype that can detect glucose (and other protein bio-markers) in the eye and transmit the information to an externaldevice. By connecting this system with a mobile device, patients will getpush notifications each time their blood glucose goes into the “warningzone” (drops too low or climbs too high). In addition to this, healthcareproviders can directly receive data from their patients and with the rel-evant analytics, better understand and diagnose the condition.

Diabetes is one of the quickest growing diseases in the world,affecting 371 million patients worldwide. In North America, it costs adiabetic $1,500–$4,500 a year to monitor his or her glucose levels,leading to a staggering $25 billion in spending on diabetes monitoring.Unfortunately, the majority of diabetics struggle with managing theirconditions, partly due to the invasive and painful nature of current

blood sugar monitoring systems. This ultimately leads to their healthdeclining further and, thus, a greater drain on healthcare budgets.

The contact lenses will introduce innovative and relatively low-costtechnology to the market that allows diabetics to live their lives with-out regular interruptions. To do this, Medella plans to integrate withexisting diabetes management apps and communities (such as theBant app), develop a Medella app, and partner with doctors andoptometrists to promote the product to diabetic patients as well asgarner a base of key customers through direct sales to drive futurereferrals.


CONTACT LENS — WEARABLE HEALTHMONITOR Harry Gandhi, Huayi Gao, and Maarij Baig

Medella Health, Kitchener, ON, Canada

Fig. 5 – The contact lenses continuously and noninvasively monitor health bio-markers.

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TECHNOLOGY LEADERS Gas/Fluid Handling/Pumps

Fully Calibrated MEMS-Based Single-UseProximal Flow Sensors

In the past, the decision to opt for aparticular flow sensing technology inrespirators and ventilation deviceswas a painstaking and complex

process. More recently, however, flowsensor solutions have emerged that pro-vide a fully calibrated and temperature-compensated output signal.

Proximal flow sensors are widely usedin respiratory devices for intubatedpatients and noninvasive ventilationpatients in hospitals, home care situa-tions, and emergency rooms (see Figure1). With applications ranging fromneonatal to adult care, the associatedrequirements for proximal flow sensorsare both diverse and challenging.Sensors must be reliable and cost-effective while offering long-term stabili-ty in addition to a host of other charac-teristics. Proximal flow sensors also haveparticularly high requirements withregard to hygienic sterilization due tothe patient’s contact with air, which canpotentially be infected with pathogens.

Flow Sensing Technology Used forProximal and Expiratory Sensing

There are already a number of sensorson the market that can be sterilized withautoclaving or other methods. All ofthese sensors use one of two differentmeasurement principles: the hot-wireanemometry principle, or differentialpressure measurement via an orifice or avariable orifice to increase sensitivity atlow flow ranges. Both measurementprinciples have specific benefits.However, all sensors — regardless ofwhich principle is applied — pose diffi-culties with regard to sterilization, andgreat care is required during the clean-ing and sterilization process to preventdamage to the sensors.

One safe and cost-effective alternative(in terms of total cost of ownership) forreusing sensors might be a micro-electromechanical systems (MEMS)-based single-use proximal flow sensor.In contrast to existing technologies, thesensors are fully calibrated whereas hotwire sensors need to be calibrated

before use. A fully calibrated sensorhelps to save time for the hospital staffso that they can focus on other tasks.

Function of Proximal and Expiratory FlowBeyond pressure sensing, flow sensing

poses one of the major challenges forrespiratory devices. For the sake of sim-plicity, the following focuses on positivepressure ventilators, where the patient isconnected to the device either througha mask (noninvasive) or through intuba-tion or tracheostomy (both invasive).Modern ventilators have a wide range ofapplication modes, including pressurecontrolled, flow controlled, and manymore. For patients who cannot breathe

on their own, the trigger for the nextinhalation can be set by a timer. Butthings become more complicated if apatient is breathing spontaneously. Inthe latter case, the patient’s breathingeffort must be detected as rapidly as pos-sible to achieve good synchronizationbetween the device and patient. Thisarticle looks at the position of the sensorfor this purpose and discusses the effectof sensor position on trigger sensitivity.

In addition to the triggers to start thenext breath, the end of the inspiratoryphase also needs to be determinedbased on a value: the volume, flow, time,or pressure. This is called the limit vari-able. It is also necessary to establish the

Fig. 1 – Ventilation in emergency situation.

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flow control between the trigger and thelimit based on one of the values.

Triggers for patient-triggered ventila-tion can be set based either on the pres-sure or the flow signal. If pressure sig-nals are used as the trigger, achievingthe desired sensitivity is difficult. This ismainly due to the fact that pressure sen-sors tend to drift over time. Frequent off-set correction is therefore required toensure reliable trigger sensitivity withoutfalse triggers.

Thanks to their excellent stability, flowsensors placed in the proximal configu-ration yield a very fast response and highsensitivity. With expiratory positioningof the flow sensor, the stability and sensi-tivity are the same, but signal detectionis delayed by the travel time of the flowthrough the expiratory tube. Expiratoryflow sensing also has other advantagesover a proximal configuration such asminimizing the likelihood of contamina-tion with mucus. For its part, proximalsensing is less affected by leaks furtherdown the breathing circuit.

As noted earlier, the inspiratory phasemay be terminated based on volume,flow, pressure, or even time. The sameapplies to the flow control between thetrigger and the limit of the inspiratory

phase. For example, a ventilator settingchosen by the hospital staff might usetime-triggered inspiration as well as atime-triggered limit. In this case, theflow needs to be controlled betweenthose two points. Another setting mightuse different parameters for the trigger,limit, and control. The combination ofparameters might be chosen for medicalreasons or simply based on the prefer-ence of the staff member setting up theventilator. Monitoring the pressure,flow, and volume values over time pro-vides an opportunity to observe changesin the patient’s condition, such asreduced lung capacity.

Pressure-triggered limits can be great-ly affected by the compliance of thebreathing circuit, which can change ifthe circuit is exchanged or if the tubesand hoses are positioned differently. Amore extreme bend in the hose, forexample, can affect the circuit.

The compliance of the breathing cir-cuit has little effect on measurementand integration of the flow signal if theflow sensor is placed in the proximalconfiguration. This is not the case forexpiratory flow sensing, however. Insuch cases, having the pressure and flowsignal helps illuminate the influence of

Medical Design Briefs, November 2016 www.medicaldesignbriefs.com

Catheterablationcoolingpumps

Watson-Marlow Fluid Technology Group unveiled the new 400RXMD pumps designed to meet the demands of medical device manufacturers

repetitive pump performance

performance up to 90 psi for effective catheter ablation

eliminates the risk of human error

wmftg.com800 282 8823


Fig. 2 – Placement of expiratory and proximal flow sensors.

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compliance. Proximal flow sens-ing is less affected by leaks — dueto connecting humidifiers andnebulizers, for example — fur-ther away from the patient.

While there is undoubtedly atrend toward more intelligentand adaptive ventilation modes,the basic underlying modes willstill be based on the pressure-,flow-, volume- and time-based val-ues discussed above.

Placement of Flow Sensors:Proximal Versus ExpiratoryPlacement

It is essential to distinguishbetween dual-limb and single-limb circuits (see Figure 2). In adual-limb circuit, the inspirato-ry path and the expiratory patheach have separate tubes. Theinspiratory tube and the expira-tory tubes meet at the y-piece,and the last few centimeters tothe patient pass through a sin-gle tube. During inspiration,the air flows through the inspi-ratory tube to the y-piece andfrom there to the patient.During exhalation, the air flows to they-piece, closes a flap that prevents theair from flowing back through theinspiratory tube, and opens the expira-tory tube. In a single-limb breathingcircuit, there is only one tube from theventilator to the patient. Before thepatient, there is an expiratory valvethat lets the air from the ventilatorpass through to the patient duringinhalation. During the expirationphase, the same valve opens and allowsthe air to be released to the ambient.

In both cases, the flow sensor meas-uring the inspiratory flow can beplaced in the machine, where the sen-sor will not come into contact with wetor contaminated air. In the case of single-limb circuits, the expiration flowcan only be measured when a proximalflow sensor is used; otherwise only theinspiratory flow is known, and thenumber of available ventilation modesis limited. With a dual-limb circuit,either a proximal or expiratory flowsensor solution might be used.Proximal flow sensing has some advan-tages in terms of trigger sensitivity due

to the close proximity to the patient.On the other hand, that close proximi-ty also brings additional challenges,such as contamination with mucus,which might be more easily controlledwith an expiratory placement.

Most ventilator manufacturers cur-rently use the proximal configurationfor neonatal patients; where appropri-ate, special neonatal sensors are used.For adult patients, by contrast, somemanufacturers use flow sensors in proxi-mal configurations and some use expira-tory setups.

Some flow meters can be used inboth proximal and expiratory configu-rations. Proximal placement yields thehighest possible trigger sensitivity,whereas expiratory placement helpscontrol the variety of inlet conditions,in turn yielding the most accurate flow readings.

Single-Use Versus Autoclavable SensorsProximal configurations may employ

autoclavable sensors that can be reusedseveral times or a single-use option thatis disposed of after use (see Figures 3

and 4). Both options are equallyviable depending on circum-stances. Ultimately, the cost ofownership — presumably thekey factor in deciding whichoption is preferable — stronglydepends on the cost per auto-clave cycle, which consequentlydepends greatly on labor costsin the respective market.Ventilator manufacturers, there-fore, need both options to servedifferent markets.

Sensirion, for example, offerstwo options. The first option isthe reusable SFM3300-AW,which can be sterilized by differ-ent methods: autoclave steriliza-tion at 134 °C or cleaning in aCidex® activated dialdehydesolution. In the SFM3300-Dmodel, a single-use option wasadded to the SFM3300 mass flowmeter series. Both sensors workin the same flow range and ful-fill the same accuracy specifica-tions. Most importantly, the twosensors share the same pneu-matic and electrical interfaces.This enables ventilator manufac-

turers to integrate the sensors into theirdesigns and provide both solutions totheir customers without additionaldevelopment considerations.

A single-use option needs to be opti-mized for cost, whereas an auto-clavable option is optimized for stabili-ty and reliability over the lifetime ofthe sensor. To optimize costs, the single-use sensor is made from a low-cost plastic material (methyl methacry-late acrylonitrile-butadiene-styrene[M-ABS]) and is designed to workwithout additional metal meshes onthe inside. The autoclavable SFM3300-AW includes an additional EEPROM tosave hourly usage data.

The new MEMS-based, single-useproximal and expiratory sensors allowventilator manufacturers and their cus-tomers to spend less time on calibra-tion. Hospital staff can now focus moreon their patients rather than on cali-brating flow sensors.

This article was written by Daniel Träutlein,Medical Market Manager at Sensirion AG,Staefa, Switzerland. For more information,visit http://info.hotims.com/61067-165.

Fig. 3 – Single-use flow sensor.

Fig. 4 – Autoclavable flow sensor.

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Essential Elements in Pump Selection forSurgical Ablation Applications

The use of radio-frequency (RF)ablation is an important andgrowing technique at the heartof many new medical treat-

ments. This equipment uses RF energyto ablate or destroy unwanted tissues.When delivered via a catheter, it offers aminimally invasive treatment for a widevariety of conditions, including atrial fib-rillation. These systems typically includea peristaltic pump to provide cooling ortemperature control. This pump mustbe able to produce and control the highpressures (up to 130 psi) required in thisapplication.

It is critical to integrate pumps thatare designed to handle these highpressures. Some new peristaltic pumpshave been designed specifically forintegration into ablation systems.These pumps meet the demandingrequirements of these applications.

Medical Application of RF Ablation Medical devices use the RF ablation

technique to treat many types of med-ical issues, including heart issues,tumors, and back pain (see Figure 1).For example, this technique can beused in treatment systems foratrial fibrillation (AFib), a con-dition that affects 2.7 millionpeople in the United States.The condition is caused by aninterruption of the normal,steady heartbeat. The heart-beat is controlled by electricalsignals that travel through thetissues of the heart. But, whenthe heart is in AFib, these sig-nals are disrupted, causing it tobeat irregularly and often toofast. When the heart does notbeat in rhythm, it cannotpump blood properly to deliv-er the energy and oxygen thebody needs. This lack of oxy-gen-rich blood in the body andbrain are what can cause physi-cal and mental fatigue, andother symptoms of AFib. Theablation treatment is effective

when the condition is caused by tissuesof the heart wall that no longer conductthese electrical signals properly. Theablation treatment destroys the faultytissues and provides patients with a per-manent cure.

Surgical RF Ablation A typical ablation system is made up

of an RF generator, control and moni-toring equipment, an antenna, and acooling pump. The radio waves areused to create an electrical current thatdelivers heat to the targeted tissues,which creates a controlled lesion, orburn. The burned tissue is replacedwith healthy tissue through the naturalhealing process.

The business-end of the device is theantenna, which applies the energy tothe tissue being ablated. The antennaresides at the tip of a catheter or can-nula, along with electrical and temper-ature sensors that are connected to thesystem controller. The RF generatordelivers the energy through the anten-na at the specific frequencies andamplitudes, as prescribed by the treat-ment. The pump delivers cooling fluid

to maintain the correct temperature atthe treatment site and helps to protectthe surrounding healthy tissues.Catheters typically use open-loop cool-ing that delivers saline directly to thetreatment area via small holes.Cannulas typically use a closed-loopsystem in which saline is recirculatedthrough a double needle.

The pump must provide the pre-scribed flow rates to deliver the correctamount of cooling. To do so, it mustovercome the back pressure created bythe small inner diameter of the catheteror cannula tubing. These pressures canexceed 100 psi for closed-loop applica-tions. Recently, the market trend amongmedical device OEMs is to developsmaller diameter catheters for greaterprecision and reach. These microcatheters require pumps that can over-come the resulting higher back pres-sures caused by internal diameters assmall as 0.014 in. (0.36 mm).

Pump RequirementsThe pump most often chosen for the

job is a peristaltic pump, a type of pos-itive displacement pump. With a peri-

Fig. 1 – Medical devices use the RF ablation technique to treat many types of medical issues, including heart issues, tumors,and back pain.

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staltic pump, the fluid is containedwithin a flexible tube fitted inside asemicircular pump casing known as thetrack. The tube is typically built into adisposable tube set that can be discard-ed after each procedure, which mini-mizes cleaning validation. The tube ispressed against the track by a rotorwith two or more rollers attached to itsexternal circumference. As the rotorturns, the part of the tube being com-pressed is occluded (pinched closed),forcing the fluid being pumped tomove through the tube. As the tubereopens to its natural shape after thepassing of the roller, a vacuum is creat-ed, which draws fluid into the pump.The advancing roller then pushes thefluid toward the pump outlet.

A peristaltic pump is designed to giveconsistent occlusion of the tubing; toomuch or too little can cause perform-ance issues. Too little occlusion hurtsflow and pressure capability and cancause leaking through the pump. Toomuch causes the tubing to rapidly wearout, hurting flow performance and caus-ing excessive spallation.

There are two basic types of designsused in peristaltic pumps: fixed gap andspring-loaded. The fixed gap refers tothe gap between the rollers and thetrack where the tube is occluded. This isa simple, yet effective design. However, itis very much dependent on the tube wallthickness to maintain consistent occlu-sion. Tubing supplied by the pump man-ufacturer is designed with the correcttolerances to work effectively with afixed-gap pump. In many medical appli-cations, tubing is not supplied by thepump manufacturer, and it is a nonstan-dard size. For a fixed-gap design, a cus-tom roller must be specified to adapt tothe dimensions and tolerances of theselected tubing.

A spring-loaded peristaltic pump hasa spring mounted either on the trackor on the rollers. The spring provides apositive force pressing on the tube thatwill compensate for the tube’s toler-ances. The spring is selected to over-come not only the tubing’s compres-sion strength, but also to achieve thedesired pressure performance of thepumped fluid.

New Technology Used in Next-Generation Ablation Pumps

Recently, Watson-Marlow FluidTechnologies Group updated its existingsurgical ablation pump, after extensiveresearch and development in consulta-tion with market-leading medical com-panies. The new pump was built on thetechnology of its predecessor pumps inRF ablation applications.

Some of the requirements that cameout of that voice-of-customer exerciseconducted during the R&D phase are adesire for high pressure, a predictableflow-pressure profile, and the need tominimize human errors from loadingtubes. Users requested that the pumpgive positive feedback that the tube isloaded properly and ready to go. Theloading mechanism should give opera-tors confidence that the tube is properlyloaded, and that it will work every time.Figure 2 shows the resulting technology,the 400RXMD surgical ablation pump.

Where the RXMD differs from otherperistaltic pumps is the ability to pro-duce high pressures — far higher thanthe 30 psi maximum of typical peristalticpumps. Standard RXMD models arerated up to 90 psi, and custom configu-rations can achieve up to 130 psi. Athigh pressures, predictability and con-trol is essential, and the RXMD can betuned to meet a specific flow profile. Forexample, in RF ablation cooling, thepump must produce consistent flow at ahigh target pressure, but the flow mustdrop away once that target pressure ismet. Figure 3 shows this performancewith pumps set for three different targetpressures. The figure shows the pre-dictable “knee” shape of the graphs,which describes the flow profile.

What allows this extreme pressure per-formance and control is a robust trackmechanism supported by two heavy dutycoil springs. In addition, a new factoryadjustment mechanism enables the pres-sure and flow profile to be tuned.

Other enhancements include a largeropening for tube loading and a newtube holder that ensures rapid, trouble-free tube loading and minimizes the riskof human error. The sprung dual holderdesign grabs the tube firmly and effec-tively without creating flow restrictions.The tube holder’s 90 angle centers thetube in the holder for optimal perform-

Fig. 2 – Watson Marlow's 400RXMD surgical ablation pump.

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Medical Design Briefs, November 2016 31

Where on the cutting edge meets on the mend.

©2016 Colder Products Company

Medical ConnectorsLike fl uid management, health care fl ows both ways. You need a connector that’s right for every application. From luer and blood pressure connectors to single-use disposable connections, only CPC gives you cleaner, faster, safer and smarter device connections for all of your medical applications. It’s where their healthy meets your happy.

For more information, visit cpcworldwide.com/medical.


ance every time the safety coveris closed. The tube holder’s coilsprings compensate for varia-tions in tube dimensions andshore hardness within allowabletolerances.

Support beyond the ProductA purpose-designed off-the-

shelf pump is a good start, but itis not sufficient to provide aneffective solution. A companydesigning a new medical devicemust work with a supplier expe-rienced with OEM medicaldevice applications — one thatwill give access to their engineer-ing staff and take the time tounderstand the unique require-ments of the customer’s applica-tion. The customer/supplierteam will work on designing custom con-figurations, testing them, and agreeingto a written specification. The end result

of this process is an optimal pump solu-tion that meets the customer’s preciseflow and pressure requirements.

It is equally important that thesupplier has strong quality sys-tems in place, giving producttraceability and change control.The product must meet therequirements — exactly — withthe first order, and with ordersplaced years into the future.

RF ablation is an importanttechnique in medical proce-dures that helps improve thelives of patients. For systems thatrequire cooling or temperaturecontrol, the proven andenhanced RXMD peristalticpump is ideally suited to theseapplications.

This article was written by RoddTurnquist, Sales Manager OEMDivision, and Christian Skantze,Product Manager, at Watson-

Marlow Fluid Technologies Group,Wilmington, MA. For more information, visithttp://info.hotims.com/61067-166.

Fig. 3 – In RF ablation cooling, the pump must produce consistent flow at ahigh target pressure, but the flow must drop away once that target pressureis met. This graph shows this performance with pumps set for three differenttarget pressures.

Flow vs. pressure, ID 1.6 mm120%

100%

80%

60%

40%

20%

0%0 14.5 30 45 60 75 90 100 116

PSI

PressureSetting

30 PSI

60 PSI

90 PSI

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Dymax Corporation318 Industrial LaneTorrington, CT 06790 Phone: 860-482-1010Fax: 860-496-0608E-mail: [email protected]

Company Description

Dymax Corporation isa leading manufacturerof advanced light-curableadhesives, coatings, dis-pensing systems, andlight-curing equipment.Dymax products are opti-mized to work togetherto provide design engi-neers with complete sys-tem solutions to dramatically improve manufacturing efficiencyand lower costs.

The corporate headquarters are in Torrington, Connecticut,USA, with additional locations in Germany, China, Hong Kong,Korea, and Singapore.• ISO 9001 and 14001 Certified• Privately Held• 275+ Employees Worldwide• 30+ Patents• Worldwide Network of Sales Partners

Dymax MD® Medical Device Adhesives are USP Class VI andISO 10993 certified, RoHS compliant, and 100% solvent free.They are specifically designed to form high-strength bonds tothe plastic, glass, and metal substrates commonly found in dis-posable medical devices.• Fast, on-demand cures increase throughput and reduce

waste• Formulations available for bonding through UV-blocking or

practically opaque substrates• Blue and Ultra-Red® fluorescing adhesives permit in-line

visual inspection for uninterrupted processing

Target Markets

Dymax targets Design and R&D Engineers at disposable med-ical device OEMs that manufacture:• Syringes• Catheters• Respiratory Masks• Infusion Sets• Hearing Aids• Optics• Surgical Instruments• Diagnostic Equipment• Medical Device Sub-Assemblies

Products/Services Offered

At Dymax we combine our product offering with our expertknowledge of light-cure technology. Where others only supplyproducts, we are committed to developing a true collaborativepartnership, bringing our total process knowledge to our cus-tomers’ specific application challenges.

Because we understand the process as a whole, and not justindividual aspects of it, we can offer our customers a solutionwhere chemistry, material, and equipment work seamlesslytogether with maximum efficiency. Our application engineeringteams assist with product and process design, testing, evalua-tion, and pre-production trials through the life of the assemblyprocess. That’s an advantage you just can’t get anywhere else.

www.dymax.com


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MicroLumen, Inc.One MicroLumen WayOldsmar, FL 34677 USAPhone: 813-886-1200Fax: 813-886-3262E-mail: [email protected]

Company Description

MicroLumen has been a leading manufacturer of high per-formance medical products since 1987. Our shaft and tubingsystems are used in a wide range of minimally invasive, criticalOEM applications such as cardiovascular catheters, stent deliv-ery systems, urological retrieval devices, and drug delivery.

Primary materials include Polyimide, PTFE, Nylon, Pebax®,Tecoflex® (polyurethane), and various polymers specificallydesigned to provide exceptional mechanical, thermal, andchemical properties. Our proprietary process delivers signifi-cantly tighter tolerances than conventionally extruded prod-ucts.

MicroLumen offers innovative solutions and aids engineersin the design of very specialized medical devices. Our diversi-fied product line and secondary operations include: customlaser machining, etching, composite constructions, assembly,and braid/coil reinforced shafts that solve specific tasks.Contact our engineering team for possibilities.

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High Performance Medical Tubing. MicroLumen manufac-tures custom tubing for critical applications & minimally inva-sive medical devices. Polyimide is a thermoset plastic and hasexcellent mechanical, thermal, and chemical properties. Typicalapplications include cardiovascular & urological catheters,stent deployment, and drug delivery systems.

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The Lee Company2 Pettipaug Road, P.O. Box 424Westbrook, CT 06498Phone: 860-399-6281Fax: 860-399-2270E-mail: [email protected]

Company Description

Since its founding in 1948, The Lee Company has pioneeredthe development of miniature fluid control components forautomated fluid handling in medical and scientific instrumenta-tion, analytical/clinical chemistry, and medical disposable appli-cations. In response to the ever increasing demands of themedical and scientific industries, The Lee Company continuesto redefine miniature fluidics by integrating new and moreadvanced technology into smaller packages.

The Lee Company employs more than 800 people at itsTechnical Centers in Westbrook and Essex, Connecticut, whereall engineering and manufacturing is performed. Lee Companysales offices, staffed by degreed sales engineers, are locatedthroughout the United States and Europe, and the company’sdistribution network spans the entire globe.

Target Markets

In vitro diagnostics, scientific instrumentation, drug discov-ery, and medical equipment such as oxygen delivery, patientmonitoring, dialysis, and compression therapy


Lee’s unique capabilities in miniaturization and engineeringexpertise (one of every seven employees is a graduate engi-neer) keep the company at the forefront of fluid flow technolo-gy, and enable it to work effectively with customers to solve dif-ficult fluid control problems.

Products include high quality 2- and 3-way miniature sole-noid valves, latching solenoid valves, high speed micro-dispense valves, nozzles, press-in check valves, calibrated flowrestrictors, fixed and variable volume pumps, custom manifoldsystems, and other inert fluid handling components.

www.theleeco.com


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INTG7 Series

Brushless DC - Magnetic Drive Centrifugal Pumps Fluid Circulation Pumps

A GORMAN-RUPP COMPANY

www.GRIpumps.com/MDB-chiller-pumps/[email protected]

• High performance - small footprint

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• Manufactured in the U.S.A. • Bellville Ohio

Markets/Applications

Medical • Food & Beverage • Alternative Energy • Electronics Cooling •

HVAC • Lasers • Chillers/Coolers • Transportation • Thermal ManagementINTG3 Series

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GRI Pumps180 Hines Ave.Bellville, OH 44813Phone: 419-886-3001Fax: 419-886-2338E-mail: [email protected]

Company Description

Gorman-Rupp Industries (GRI), a division of the U.S. ownedGorman-Rupp Company, is located in Bellville, Ohio. Since 1953

GRI has provided fluidpumps to the OriginalEquipment Man ufac tur erin a wide range of do -mestic and internation-al markets. All man -ufacturing takes placein GRI’s 98,000 squarefoot Bellville, Ohiofacility.

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Original Equipment Market, Medical, Food & Beverage,Alternative Energy, Electronics Cooling, HVAC, Lasers,Chillers/Coolers, Transportation, Thermal Management,Laboratory & Analytical Instrumentation, Printing and ImageReproduction, General Industrial, Spas, Pools, and Aquariums.


Serving the Original EquipmentManufacturer since 1953, GRI’s rep-utation and success has been builton innovative fluid pump designs,customer service, and providingproducts to meet the exact specifi-cations of our customers.

GRI’s portfolio of OEM-designed fluid pumps includesIntegrated Magnetic Drive Circulation Pumps, Magnetic DriveCentrifugal Pumps, Bellows Metering Pumps, Gear Pumps, andComplete Turnkey Pumping Systems. Whether it is replacing anexisting pump or working with OEMs on a new application,pumping water or pumping chemicals, GRI’s proven conceptsand engineered designs will provide a unique fluid pumpingsolution.

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Medical Design Briefs, November 2016 37Free Info at http://info.hotims.com/61067-797

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Halkey-Roberts Corporation2700 Halkey-Roberts Place NorthSt. Petersburg, FL 33716 Phone: 727-471-4200Fax: 727-578-0450E-mail: [email protected]

Company Description

Halkey-Roberts manu-factures plastic compo-nents and subassembliesused in disposable medicaldevices, including flowdevices, medical valves,needle-free valves, cath -eter and tracheal tubevalves, tubing clamps, clo-sures, and hand pumps.

Halkey-Roberts is ISO 9001 and ISO 13485 certified and man-ufactures to the standards of GMP.

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Halkey-Roberts supplies medical OEMs and contract manu-facturers worldwide. Our components are used in critical appli-cations such as cardiovascular, urology, oncology, anesthesia,respiratory, IV/drug delivery, and surgical devices. Our productsare also used in a number of biotech applications.


Halkey-Roberts is a global leader in the design and manufac-ture of valves for medical device companies whose productsrequire precise delivery of fluids and gases. We supply globalmedical device companies with off the shelf and custom solu-tions for their fluid and gas delivery applications. Since 1941, wehave been offering innovative solutions like our new Male LuerValves. Our vertically integrated facility in St. Petersburg,Florida, allows us to control the entire development and manu-facturing process of our products: from design, tooling, mold-ing, high speed automation, regulatory support, and productrelease. We offer extensive capabilities to customize our prod-ucts to your specific application.

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Halkey-Roberts Corporation727.471.4200

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■ Chemosensor Detects Early-Stage CancerResearchers at the University of

North Texas (UNT), Denton TX,and the Polish Academy ofSciences, Warsaw, Poland, aredesigning a chemical sensor thatidentifies cancer at an early stage.

The chemosensor, a thin poly-mer film, detects molecules ofneopterin, a chemical compoundfound in human body fluids. Anincreased presence of neopterin, produced by the immune sys-tem, often indicates poor health.

Early discovery of several types of cancer is still a challenge,as tumors develop over a period of time without noticeablesymptoms. According to the UNT team, the sensor providesdiagnostic tests that could be performed at home.

“This new approach involves developing special recognizingmaterials prepared by molecular imprinting technology,” saidFrancis D'Souza, a university distinguished research professorin UNT's Department of Chemistry.

Three-dimensional cavities, placed within the polymer, allowselective binding and subsequent detection of the target can-cer biomarker.

The University of North Texas developed the polymer. Theadditional research is being conducted in Warsaw, with thehelp of a grant from the National Science Centre.

For more information, visit www.medicaldesignbriefs.com/component/content/article/1104-mdb/features/25448.

■ Silicone Material Supports All-in-One Sample ProcessingUsing a flexible silicone material, engi-

neers from University of California—SantaCruz built an integrated optofluidic plat-form for biological sample processing andoptical analysis. The “all-in-one” system fea-tures tunable optics and novel “lightvalves.”

The device is made entirely of polydi-methylsiloxane (PDMS), a soft materialused in microfluidics and products such ascontact lenses. PDMS’ flexibility enablesnew ways to control both light and fluidson the chip.

By employing multilayer soft lithogra-phy techniques, senior graduate student Joshua Parks createdchips containing both solid-core and hollow-core waveguidesfor directing light signals. Additionally, a special “lightvalve”controls the flow of both light and fluids.

Potential applications for the technology include a range ofbiological sensors. With viral diagnostic assays, for example,fluorescently labeled antibodies can tag specific viral strains foroptical detection.


■ Laser Treatment Enables New ‘Paper Electronics’Iowa State University, Ames, IA,

has found a new way to make flexi-ble, wearable, and low-cost elec-tronics: lasers.

Inkjet-printed, multi-layer graphene electric circuits and electrodesare fabricated with a pulsed-laserprocess, improving electrical con-ductivity without damaging paper,polymers, or other fragile print-ing surfaces.

According to the researchers,Iowa State’s treatment provides away to commercialize and scale upthe manufacturing of graphene, an atom-thick carbon material.

The engineers’ computer-controlled laser technology selec-tively irradiates inkjet-printed graphene oxide. The processremoves ink binders and reduces graphene oxide to graphene— physically stitching together millions of tiny graphene flakesto improve conductivity.

“The laser works with a rapid pulse of high-energy photonsthat do not destroy the graphene or the substrate,” saidSuprem Das, an Iowa State postdoctoral research associate inmechanical engineering and an associate of the U.S.Department of Energy’s Ames Laboratory.

The fabrication method could support sensors in biologicalapplications, energy storage systems, electrical conductingcomponents, and even paper-based electronics.


■ Salt-Measuring Sensor SpotsEarly Signs of Cystic FibrosisBiomaterials scientists from Penn

State University, University Park, PA,have developed an inexpensivemethod for detecting salt in sweat orother bodily fluids. The fluorescentsensor, derived from citric acid mole-cules, is highly selective for chloride,an essential diagnostic marker in cys-tic fibrosis.

Jian Yang, professor of biomedical engineering, teamed upwith Penn State electrical engineer professor Zhiwen Liu tobuild a handheld technology that measures the salt concentra-tions. A mobile device could be especially useful in developingcountries where populations have limited access to expensiveanalytical equipment.

Yang’s material also differentiates chloride from bromide,another salt that interferes with the results of traditional clini-cal laboratory tests.

Beyond cystic fibrosis, the researchers say that the platformcan detect other diseases that display abnormal concentrations

The new device senses can-cer biomarkers. (Credit: UNT)

The optofluidic plat-form is made fromflexible polydimethyl-siloxane. (Credit: C.Lagattuta)

Naturally fluorescing poly-mer nanoparticles detecta key marker of cysticfibrosis. (Credit: YangLab/Penn State)

Suprem Das holds grapheneelectronics printed on asheet of paper. Das andJonathan Claussen, right,are using lasers to treat theprinted graphene electronics.(Credit: Christopher Gannon)

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http://data.techbriefs.com/ntbpdfclicks/l.php?201611MDBP40C



of chloride, such as metabolic alkalosis, Addison's disease, andamyotrophic lateral sclerosis.

“We are developing a platform material for sensing that islow cost, can be automated, requires no titration by trainedstaff or expensive instrumentation as in hospitals, and providesfast, almost instantaneous, results,” said Liu.


■ Miniaturized 'Lab-on-a-Stick' Measures AntibioticResistance

A portable and power-free testfrom England’s LoughboroughUniversity and the University ofReading rapidly detects bacterialresistance to antibiotics.

The new “Lab-on-a-Stick” test isan inexpensive microfluidic strip,consisting of tiny test tubes aboutthe size of a human hair. Thestrips can be used in a range ofanalyses, including bacteria iden-

tification, blood typing, and antimicrobial resistance. The dip-and-read method includes a transparent microcap-

illary film, suitable for naked-eye detection or measurementwith a smartphone camera. The film enables 10 different con-centrations of antibiotic, per sample, to be tested with a singletest strip.

The study also demonstrated a test to distinguish two veryclosely related bacteria — a harmless laboratory strain of E. colifrom a type of Salmonella that causes food poisoning.


■ Light Beams at Heart of New Arrhythmia TreatmentScientists at Johns Hopkins

University, Baltimore, MD, andGermany’s University of Bonnhave shown that light beams mayhelp patients with heart rhythmdisorders. The technique supportsnew implantable defibrillators andoffers a potential replacementover electric shock treatments.

Current heart-treatment devicesdeliver pulses of electricity that areoften painful and can damage hearttissue. Light-based methods, the researchers say, provide a gentlerremedy for patients at high risk of arrhythmia, an irregular heart-beat that can cause sudden cardiac death within minutes.

Light-sensitive proteins, embedded in living tissue, enablethe use of light sources to modify electrical activity in cells.

“We are working towards optical defibrillation of the heart,where light will be given to a patient who is experiencing car-diac arrest, and we will be able to restore the normal function-ing of the heart in a gentle and painless manner,” said NataliaTrayanova, a lead researcher and professor in JHU'sDepartment of Biomedical Engineering.

Experiments with mice and simulations of a human-heartcomputer model revealed that a light pulse to the heart couldstop the cardiac arrhythmia in a patient.


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The microfluidic strips can beused in a range of tests,including blood typing andantimicrobial resistance.(Credit: University of Reading)

A graphic shows an abnormalarrhythmia (left) and an order-ly heartbeat (right). (Credit:Patrick M. Boyle/JohnsHopkins University)

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Complex Nanomachines Could Carry Pharmaceuticals,Detect DiseaseNew insights into theproperties of matter atnanoscale may lead tonew, smaller molecularmachines.

UCLA, Los Angeles, CA

UCLA nanoscience researchers havedetermined that a fluid that behavessimilarly to water in our day-to-day livesbecomes as heavy as honey whentrapped in a nanocage of a porous solid,offering new insights into how matterbehaves in the nanoscale world.

“We are learning more and moreabout the properties of matter at thenanoscale so that we can designmachines with specific functions,” saidsenior author Miguel García-Garibay,dean of the UCLA Division of PhysicalSciences and professor of chemistry andbiochemistry. The research is publishedin the journal ACS Central Science.

A nanometer is less than 1/1,000 thesize of a red blood cell and about1/20,000 the diameter of a human hair.Despite years of research by scientistsaround the world, the extraordinarilysmall size of matter at the nanoscale hasmade it challenging to learn howmotion works at this scale.

“This exciting research, supported bythe National Science Foundation, repre-sents a seminal advance in the field ofmolecular machines,” said EugeneZubarev, a program director at the NSF.“It will certainly stimulate further work,both in basic research and real-life appli-cations of molecular electronics andminiaturized devices. Miguel Garcia-Garibay is among the pioneers of thisfield and has a very strong record ofhigh-impact work and ground-breakingdiscoveries.”

Possible uses for complex nanoma-chines that could be much smaller thana cell include placing a pharmaceuticalin a nanocage and releasing the cargoinside a cell, to kill a cancer cell, forexample; transporting molecules formedical reasons; designing molecularcomputers that potentially could beplaced inside your body to detect dis-ease before you are aware of any symp-toms; or perhaps even to design newforms of matter.

■ How it WorksTo gain this new understanding into

the behavior of matter at the nanoscale,García-Garibay’s research groupdesigned three rotating nanomaterialsknown as MOFs, or metal-organic frame-works, which they call UCLA-R1, UCLA-R2 and UCLA-R3 (the “r” stands forrotor). MOFs, sometimes described ascrystal sponges, have pores — openingsthat can store gases, or in this case, liquid.

Studying the motion of the rotorsallowed the researchers to isolate therole a fluid’s viscosity plays at thenanoscale. With UCLA-R1 and UCLA-R2, the molecular rotors occupy a verysmall space and hinder one another’smotion. But in the case of UCLA-R3,nothing slowed down the rotors insidethe nanocage except molecules of liquid.

García-Garibay’s research group meas-ured how fast molecules rotated in thecrystals. Each crystal has quadrillions ofmolecules rotating inside a nanocage,and the chemists know the position ofeach molecule. UCLA-R3 was built withlarge molecular rotors that move underthe influence of the viscous forces exert-ed by 10 molecules of liquid trapped intheir nanoscale surroundings.

“It is very common when you have agroup of rotating molecules that therotors are hindered by something withinthe structure with which they interact —but not in UCLA-R3,” said García-Garibay, a member of the CaliforniaNanoSystems Institute at UCLA. “Thedesign of UCLA-R3 was successful. Wewant to be able to control the viscosity tomake the rotors interact with one anoth-er; we want to understand the viscosityand the thermal energy to design mole-

cules that display particular actions. Wewant to control the interactions amongmolecules so they can interact with oneanother and with external electric fields.”

García-Garibay’s research team hasbeen working for 10 years on motion incrystals and designing molecular motorsin crystals. García-Garibay said under-standing this motion is importantbecause he “can get a precise picture ofthe molecules in the crystals, the precisearrangement of atoms, with no uncer-tainty. This provides a large level of con-trol, which enables us to learn the differ-ent principles governing molecularfunctions at the nanoscale.”

García-Garibay hopes to design crys-tals that take advantage of properties oflight, and whose applications couldinclude advances in communicationstechnology, optical computing, sensingand the field of photonics, which takesadvantage of the properties of light;

A fluid with a viscosity like water enters UCLA-R3, where its viscosity at the nanoscale becomes likehoney. (Credit: Xing Jiang, Miguel García-Garibay/UCLA Chemistry and Biochemistry)

UCLA-R3, a porous crystal designed by UCLAchemists. (Credit: Xing Jiang, Miguel García-Garibay/UCLA Chemistry and Biochemistry)

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light can have enough energy to breakand make bonds in molecules.

“If we are able to convert light, whichis electromagnetic energy, into motion,or convert motion into electrical energy,then we have the potential to makemolecular devices much smaller,” hesaid. “There will be many, many possibil-ities for what we can do with molecularmachines. We don’t yet fully understandwhat the potential of molecular machin-

ery is, but there are many applicationsthat can be developed once we developa deep understanding of how motiontakes place in solids.”

Co-authors are lead author Xing Jiang,a UCLA graduate student in García-Garibay’s laboratory, who this year com-pleted his Ph.D.; Hai-Bao Duan, a visitingscholar from China’s Nanjing XiaoZhuang University who spent a year con-ducting research in García-Garibay’s lab-

oratory; and Saeed Khan, a UCLA crys-tallographer in the department of chem-istry and biochemistry.

The research was funded by theNational Science Foundation (grantDMR140268).

García-Garibay will continue his researchon molecular motion in crystals and greenchemistry during his tenure as dean.

For more information, visit http://news-room.ucla.edu.

Killing Cancer Cells May Be Possible With “Hairy” NanorodsGold-iron oxide core-shellnanorods may be useful incancer therapy.

Georgia Institute ofTechnology, Atlanta, GA

Materials scientists from Georgia Techhave developed a new strategy for craft-ing one-dimensional nanorods from a

wide range of precursor materials. Basedon a cellulose backbone, the systemrelies on the growth of block copolymer“arms” that help create a compartmentto serve as a nanometer-scale chemicalreactor. The outer blocks of the armsprevent aggregation of the nanorods.

The produced structures resembletiny bottlebrushes with polymer “hairs”on the nanorod surface. The nanorodsrange in size from a few hundred

nanometers to a few micrometers inlength, and a few tens of nanometers indiameter. This new technique enablestight control over diameter, length andsurface properties of the nanorods,whose optical, electrical, magnetic, andcatalytic properties depend on the pre-cursor materials used and the dimen-sions of the nanorods.

The nanorods could have applica-tions in such areas as electronics, senso-

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ry devices, energy conversion and stor-age, drug delivery, and cancer treat-ment. Using their technique, theresearchers have so far fabricated uni-

form metallic, ferroelectric, upconver-sion, semiconducting, and thermoelec-tric nanocrystals, as well as combina-tions thereof.

Lin sees many potential applicationsfor the nanorods.

“With a broad range of physical prop-erties — optical, electrical, optoelec-tronic, catalytic, magnetic, and sensing— that are dependent sensitively ontheir size and shape as well as theirassemblies, the produced nanorods areof both fundamental and practical inter-est,” Lin said. “Potential applicationsinclude optics, electronics, photonics,magnetic technologies, sensory materi-als and devices, lightweight structuralmaterials, catalysis, drug delivery, andbio-nanotechnology.”

For example, plain gold nanorods ofdifferent lengths may allow effectiveplasmonic absorption in the near-infrared range. The upconversionnanorods can used for biological label-ing because of their low toxicity, chemi-cal stability, and intense luminescencewhen excited by near-IR radiation,which can penetrate tissue much betterthan higher energy radiation such asultraviolet, as is often required withquantum dot labels. The gold-iron oxidecore-shell nanorods may be useful incancer therapy, with MRI imaging

Georgia Tech researchers (left to right) Yanjie He, Zhiqun Lin, and Jaehan Jung demonstrate howmagnetic nanorods in the vial are attracted to a magnet held near the vial. The researchers havedeveloped a new strategy for crafting one-dimensional nanorods based on cellulose using a widerange of precursor materials. (Credit: Rob Felt, Georgia Tech)

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enabled by the iron oxide shell, andlocal heating created by the photother-mal effect on the gold nanorod corekilling cancer cells.

“We have developed a very generaland robust strategy to craft a rich varietyof nanorods with precisely controlleddimensions, compositions, architectures,and surface chemistries,” said ZhiqunLin, a professor in the School ofMaterials Science and Engineering at theGeorgia Institute of Technology. “To cre-ate these structures, we used nonlinearbottlebrush-like block copolymers as tinyreactors to template the growth of anexciting variety of inorganic nanorods.”

Nanorod structures aren’t new, butthe technique used by Lin’s lab pro-duces nanorods of uniform sizes — suchas barium titanate and iron oxide, whichhave not yet been demonstrated via wet-chemistry approaches in the literature— and highly uniform core-shellnanorods made by combining two dis-similar materials. Lin and former post-doctoral research associate XinchangPang say the precursor materials appli-cable to the technique are virtuallylimitless.

“There are many precursors of differ-ent materials available that can be usedwith this robust system,” Lin said. “Bychoosing a different outer block in thebottlebrush-like block copolymers, ournanorods can be dissolved and uniform-ly dispersed in organic solvents such astoluene or chloroform, or in water.”

■ How it WorksFabrication of the nanorods begins

with the functionalization of individuallengths of cellulose, an inexpensivelong-chain biopolymer harvested fromtrees. Each unit of cellulose has threehydroxyl groups, which are chemicallymodified with a bromine atom. Thebrominated cellulose then serves asmacroinitiator for the growth of the blockcopolymer arms with well-controlledlengths using the atom transfer radicalpolymerization (ATRP) process, with,for example, poly(acrylic acid)-block-polystyrene (PAA-b-PS) yielding cellu-lose densely grafted with PAA-b-PS (i.e.,cellulose-g-[PAA-b-PS]) that give the bot-tlebrush appearance.

The next step involves the preferen-tial partitioning of precursors in theinner PAA compartment that serves as ananoreactor to initiate the nucleationand growth of nanorods. The denselygrafted block copolymer arms, togetherwith the rigid cellulose backbone, giveresearchers the ability to not only pre-vent aggregation of the resultingnanorods, but also to keep them frombending.

A vial containing water-soluble gold nanorods.(Credit: Rob Felt, Georgia Tech)

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“The polymers are like long spaghettiand they want to coil up,” Lin explained.“But they cannot do this in the complexmacromolecules we make because withso many block copolymer arms formed,there is no space. This leads to thestretching of the arms, forming a veryrigid structure.”

By varying the chemistry and the num-ber of blocks in the arms of the bottle-brush-like block copolymers, Lin andcoworkers produced an array of oil-soluble

and water-soluble plain nanorods, core-shell nanorods, and hollow nanorods(nanotubes) of different dimensionsand compositions.

For example, by using bottlebrush-liketriblock copolymers containing denselygrafted amphiphilic triblock copolymerarms, the core-shell nanorods can beformed from two different materials. Inmost cases, a large lattice mismatchbetween core and shell materials wouldprevent the formation of high-quality

core-shell structures, but the techniqueovercomes that limitation.

“By using this approach, we can growthe core and shell materials independ-ently in their respective nanoreactors,”Lin said. “This allows us to bypass therequirement for matching the crystal lat-tices and permits fabrication of a largevariety of core-shell structures with dif-ferent combinations that would other-wise be very challenging to obtain.”

In addition to the researchers alreadymentioned, co-authors included gradu-ate research assistant Yanjie He and post-doctoral researcher Jaehan Jung inGeorgia Tech’s School of MaterialsScience and Engineering.

The research was supported by the AirForce Office of Scientific Researchunder grant FA9550-16-1-0187 and wasreported in the journal Science.

For more information, visit http://www.news.gatech.edu/


Edible BatteryCould PowerIngestibleMedical DevicesBatteries made withmelanin pigments couldpower devices fordiagnosing and treatingdisease.Carnegie Mellon University,Pittsburgh, PA

Nontoxic, edible batteries could oneday power ingestible devices for diagnos-ing and treating disease. One team reportsnew progress toward that goal with theirbatteries made with melanin pigments,naturally found in the skin, hair, and eyes.

“For decades, people have been envi-sioning that one day, we would have edi-ble electronic devices to diagnose or treatdisease,” says Christopher Bettinger,Ph.D. “But if you want to take a deviceevery day, you have to think about toxicityissues. That’s when we have to thinkabout biologically derived materials thatcould replace some of these things youmight find in a RadioShack.”

About 20 years ago, scientists diddevelop a battery-operated ingestible

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camera as a complementary tool to endoscopies. It can imageplaces in the digestive system that are inaccessible to the tradi-tional endoscope. But it is designed to pass through the bodyand be excreted. For a single use, the risk that the camera witha conventional battery will get stuck in the gastrointestinal tractis small. But the chances of something going wrong wouldincrease unacceptably if doctors wanted to use it more fre-quently on a single patient.

The camera and some implantable devices such as pacemakersrun on batteries containing toxic components that aresequestered away from contact with the body. But for low-power,repeat applications such as drug-delivery devices that are meant tobe swallowed, nontoxic and degradable batteries would be ideal.

“The beauty is that by definition an ingestible, degradabledevice is in the body for no longer than 20 hours or so,”Bettinger says. “Even if you have marginal performance, whichwe do, that’s all you need.”

While he doesn’t have to worry about longevity, toxicity is anissue. To minimize the potential harm of future ingestibledevices, Bettinger’s team at Carnegie Mellon University(CMU) decided to turn to melanins and other naturally occur-ring compounds. In our skin, hair, and eyes, melanins absorbultraviolet light to quench free radicals and protect us fromdamage. They also happen to bind and unbind metallic ions.“We thought, this is basically a battery,” Bettinger says.

Building on this idea, the researchers experimented with bat-tery designs that use melanin pigments at either the positive ornegative terminals; various electrode materials such as man-ganese oxide and sodium titanium phosphate; and cations suchas copper and iron that the body uses for normal functioning.

“We found basically that they work,” says Hang-Ah Park,Ph.D., a post-doctoral researcher at CMU. “The exact numbersdepend on the configuration, but as an example, we can powera 5 mW device for up to 18 hours using 600 mg of activemelanin material as a cathode.”

Christopher Bettinger, Ph.D., is developing an edible battery made withmelanin and dissolvable materials. [Credit: Bettinger lab]

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Although the capacity of a melanin bat-tery is low relative to lithium-ion, it wouldbe high enough to power an ingestibledrug-delivery or sensing device. For exam-ple, Bettinger envisions using his group’sbattery for sensing gut microbiomechanges and responding with a release ofmedicine, or for delivering bursts of a vac-cine over several hours before degrading.

In parallel with the melanin batteries,the team is also making edible batterieswith other biomaterials such as pectin, anatural compound from plants used as agelling agent in jams and jellies. Next,they plan on developing packaging mate-rials that will safely deliver the battery tothe stomach.

When these batteries will be incorporat-ed into biomedical devices is uncertain,but Bettinger has already found anotherapplication for them. His lab uses the bat-teries to probe the structure and chem-istry of the melanin pigments themselvesto better understand how they work.

The researchers presented theirwork today at the 252nd NationalMeeting & Exposition of the AmericanChemical Society (ACS) in August2016. Bettinger acknowledges fundingfrom the National Science Foundationand the Shurl and Kay CurciFoundation.

For more information, visit https://www.acs.org.

New Device Could Improve Diagnosisof Ear InfectionsA shortwave infraredinstrument could seedeeper, help improvediagnosis of earinfections.Massachusetts Institute ofTechnology, Cambridge, MA

A new device developed by re -searchers at MIT and a physician atConnecticut Children’s Medical Centercould greatly improve doctors’ ability toaccurately diagnose ear infections. Thatcould drastically reduce the estimated 2million cases per year in the UnitedStates where such infections are incor-

rectly diagnosed and unnecessary antibi-otics are prescribed. Such overprescrip-tions are considered a major cause ofantibiotic resistance.

The new device, whose design is stillbeing refined by the team, is expectedultimately to look and function verymuch like existing otoscopes, thedevices most doctors currently use topeer inside the ear to look for signs ofinfection. But unlike these conventionaldevices, which use visible light and canonly see a few millimeters into the tis-sues of the ear, the new device insteaduses shortwave infrared light, which canpenetrate much deeper.

The findings have been reported inthe journal PNAS, in a paper by Moungi

Researchers have developed a new way of imaging the middle ear using infrared light, which theysay could provide much more accurate diagnosis of ear infections. (Credit: David L. Chandler/PNAS)

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Bawendi, the Lester Wolfe Professor ofChemistry at MIT; Jessica Carr, an MITdoctoral student; Oliver Bruns, an MITresearch scientist; and Tulio Valdez, apediatric otolaryngologist at ConnecticutChildren’s Medical Center and associateprofessor of otolaryngology at theUniversity of Connecticut.

The one clear diagnostic sign of aninfection in the ear is a buildup of fluidbehind the eardrum, Carr explains. Butthe view through a conventional otoscopecan’t penetrate deeply enough into the tis-sues to reveal such buildups. More expen-sive specialized equipment can offer moreinformation needed for a firm diagnosis,but these tools are usually only available inthe offices of specialists, who are not con-sulted in the vast majority of cases.

“A lot of times, it’s a 50-50 guess as towhether there is fluid there,” Carr says.“If there’s no fluid, there’s no chance ofan infection. One of the limitations ofthe existing technology is that you can’tsee through the eardrum, so you can’teasily see the fluid. But the eardrumbasically becomes transparent to ourdevice.” Fluid within the ear, by contrast,“becomes very dark and very apparent.”

While there are more advanced sys-tems under development that do providedata on these deeper parts of the ear,Carr says, those “haven’t been widelyadopted. They’re not familiar to thephysicians, who have to use a whole rangeof technologies in their work. These aresomething new and unfamiliar, and some

of these devices require a trained audiol-ogist to run them.” So the MIT teamworked to make the new device as famil-iar as possible, closely resembling the oto-scopes that doctors already use.

“We developed something easy to use,and that wouldn’t require much train-ing,” she says.

This diagram shows the structures of the middle ear, along with examples of the kinds of imagesprovided by today’s conventional visible-light otoscopes (top) and by the newly developed short-waveinfrared (SWIR) otoscope. The new otoscope can probe deeper to provide clearer indications of thepresence of fluid, which can indicate an infection. (Credit: David L. Chandler/PNAS)

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50 Medical Design Briefs, November 2016



Exceptional Temperature and Chemical Resistance

Epoxy Adhesive EP62-1Med

peace of mind Studies have shown that about 8 million children each yearin the United States are diagnosed with otitis media, the med-ical term for middle-ear infections, Carr says. These are espe-cially prevalent among young children: About 80 percent ofthem will have at least one such diagnosis by the age of three.But the studies show that such diagnoses are correct only 51percent of the time — “essentially a coin toss,” Carr says.

The roughly 4 million incorrect diagnoses are about evenlysplit between false positives and false negatives, indicating thatabout 2 million children every year are incorrectly thought tohave such infections, and are prescribed unnecessary antibi-otics. Once the presence of an infection is determined, doctorsmust then try to distinguish between viral and bacterial causes,something this device cannot determine, although it can pro-vide some clues.

After initial successful tests on 10 adult subjects, the team isnow in the process of carrying out tests on pediatric patientsto confirm the accuracy of the diagnostic results. Assumingthe tests go well, the team hopes to commercialize the device.The ultimate cost, Carr says, will depend on the cost of theinfrared imaging system — which is finding a variety of appli-cations, including in the self-driving cars being developed byGoogle and other companies, because of its ability to seethrough fog and during night time. The cost of those devices,originally developed for military uses, has already fallen dras-tically over the last couple of years, she says, and widespreadproduction could drop those costs rapidly.

“The potential impact of this work is huge,” says KarinaCañadas, an assistant professor of pediatric otolaryngology atBaylor College of Medicine in Texas, who was not involved inthis work. “Ear infections are one of the most common reasonsfor visits to the pediatrician, but sometimes the view of the mid-dle ear in a wiggly irritated child is not easy, making a good examnot always possible. With this technology even a brief examwould be able to detect middle ear fluid more confidently.”

The research was supported by the Laser BiomedicalResearch Center at MIT funded by the National Institutes ofHealth, MIT’s Institute for Soldier Nanotechnologies, and theAir Force Office of Scientific Research.

For more information, visit http://news.mit.edu.

3D Graphene ShowsPromise for Bone ImplantsWelded nanoscale sheets form tough,porous material.

Rice University, Houston, TX

Flakes of graphene welded together into solid materials maybe suitable for bone implants, according to a study led by RiceUniversity scientists. The Rice lab of materials scientist PulickelAjayan and colleagues in Texas, Brazil, and India used spark plas-ma sintering to weld flakes of graphene oxide into porous solidsthat compare favorably with the mechanical properties and bio-compatibility of titanium, a standard bone-replacement material.The discovery is the subject of a paper in Advanced Materials.

The researchers believe their technique will give them theability to create highly complex shapes out of graphene in min-

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utes using graphite molds, which theybelieve would be easier to process thanspecialty metals.

“We started thinking about this forbone implants because graphene is

one of the most intriguing materialswith many possibilities and it’s general-ly biocompatible,” said Rice postdoc-toral research associate ChandraSekhar Tiwary, co-lead author of the

paper with Dibyendu Chakravarty ofthe Inter national Advanced ResearchCenter for Powder Metallurgy and NewMaterials in Hyderabad, India. “Fourthings are important: its mechanicalproperties, density, porosity, and bio-compatibility.”

Tiwary said spark plasma sintering isbeing used in industry to make complexparts, generally with ceramics. “Thetechnique uses a high pulse current thatwelds the flakes together instantly. Youonly need high voltage, not high pres-sure or temperatures,” he said. Thematerial they made is nearly 50 percentporous, with a density half that ofgraphite and a quarter of titaniummetal. But it has enough compressivestrength — 40 MPa — to qualify it forbone implants, he said. The strength ofthe bonds between sheets keeps it fromdisintegrating in water.

To see how graphene oxide layersstack when welded by spark plasma sin-tering, watch a molecular dynamics sim-ulation at https://www.youtube.com/watch?v=9itxVFu_p5U.

For more information, visit http://news.rice.edu.

A focused ion beam microscope image shows 3D graphene layers welded together in a block. Thematerial is biocompatible and its material properties meet the standards necessary for considera-tion as a bone implant, according to researchers at Rice University. (Credit: Ajayan Group)

EVERY PART IS IMPORTANTHigh Quality Parts For High Quality Life

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Medical Design Briefs, November 2016

What’s On

Featured Sponsor Video:Amputee Grasps Objectswith LifeHandGrasping with suitable pressure, withoutdamaging or dropping objects — healthypeople do this all the time without havingto consider it. Researchers have nowmastered artificially reproducing thissequence for the first time with theLifeHand 2 — supported by micromotorsfrom FAULHABER.techbriefs.com/tv/LifeHand_2

World's First Nanofish forTargeted Drug DeliveryUniversity of California San Diegoengineers have created a magneticallypropelled, fish-like nano-swimmer thatcould be used to carry drugs to specificsites of the body. The artificial fish are 100times smaller than grains of sand, and aremade from gold and nickel segmentslinked by silver hinges.techbriefs.com/tv/Nanofish

Gentle Light Beams to TameLethal Heart DisordersUsing human heart models andexperiments with mice, Johns HopkinsUniversity scientists have shown thatbeams of light could replace electricshocks in patients suffering from a deadlyheart rhythm disorder. Their findingscould pave the way for a new type ofimplantable, optical defibrillator.techbriefs.com/tv/optical-defibrillator

Vulcan: Robo-WheelchairNavigates AutonomouslyBetween 2 and 5 million people in theUnited States would benefit from anintelligent robotic wheelchair. Universityof Michigan engineers have built awheelchair called Vulcan that can explorean environment and build its owncognitive map of that environment.techbriefs.com/tv/Vulcan-wheelchair

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PRODUCT OF THE MONTH■ LCP Monofilament

Zeus Industrial Products, Orangeburg,SC, has launched an MRI-compatibleliquid crystal polymer (LCP) monofil-ament. This technology overcomes asignificant limitation of other vascularvisualization procedures and removesradiation exposure as a consequence.According to the company, the LCPmonofilament has exceptional tensile strength and provides asafe braiding option for the development of MRI-compatibleintravascular catheters. The LCP monofilament has a suitableheat tolerance for autoclaving. It is said to provide excellenttorque response, pushability, and kink resistance, and it is chem-ically inert. The fiber displays less fraying (“bird nesting”) thancomparable monofilament and multifilament fibers during thebraiding process and can be wound onto Steeger and Wardwellbobbins and DIN 160 spools. The Class VI-approved monofila-ment can be supplied with tight tolerances in customizable sizesand profiles.

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2016 Product of the YearFinalist

■ Fast-Curing SiliconeA high-temperature-resistant, flexible one-

part silicone from Master Bond, Hackensack,NJ, is a one-part acetoxy type silicone systemthat meets USP Class VI specifications for bio-compatibility and ISO 10993-5 testing for cyto-toxicity. MasterSil 910Med is a translucentpaste that also withstands many sterilization

methods, including liquid sterilants, gamma radiation, and EtO. As asilicone, it delivers high flexibility and has an elongation of 400–600percent, which imparts reliable thermal cycling and mechanical shockresistance. It offers excellent bond strength to metals, composites,glass ceramics, rubbers, plastics, and other silicone substrates and isserviceable over a temperature range of –75 to +400 °F. It is also a com-petent electrical insulator with a volume resistivity of >1015 -cm.


■ Fluorinated SolventsAGC Chemicals Americas, Exton, PA, offers a

series of fluorinated solvents that provide medicaldevice manufacturers with a safer, highly effectiveand environmentally friendly alternative to halo-genated solvents. The AsahiKlin™ AE-3000 Series ofsolvents are approved for use as precision cleaningsolvents, defluxing agents for electronic circuitry, car-rier solvents for silicone and fluorinated lubricants,and moisture displacement fluids. The products haveno flash point, no ozone depletion potential, and lowglobal warming potential, enabling manufacturers to more easily meetincreasingly strict environmental regulations. The products also have lowsurface tensions, low viscosities, and high liquid densities. Benefitsinclude chemical and thermal stability, recyclability, and rapid dry time.


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■ External Power SupplySager Power Systems, Middleborough, MA, offers the ME60 Series of

the SL Power family of medical-grade external power supplies. The 60-

W ME Series meets IEC 60601-1-2, fourth edition, electromagnetic com-

patibility (EMC) requirements and are approved to AAMI ES/CSA

C22.2/EN/IEC60601-1, third edition,

with 2× Means of Patient Protection

(MOPP). The power supplies also

adhere to the U.S. Department of

Energy’s Level VI efficiency require-

ments. The new models are specifical-

ly designed for next-generation home

healthcare medical devices such as surgical, patient monitoring equip-

ment, and therapeutic electromedical devices that require a high level

of EMC, electromagnetic interference protection, and ac input per-

formance. The power supplies use high-quality electrolytic capacitors,

ensuring a seven-year-plus product life. Low common mode noise, high

levels of ESD (IEC61000-4-2, level 4 standard: 8kV/15kV) and surge

protection (IEC61000-4-5, level 4 standard: 2kV/4kV) help to ensure

the highest overall performance.


■ Spot-Curing SystemDymax, Torrington, CT, has introduced a new smaller LED spot-curing

system with unique curing flexibility. The BlueWave® MX-150™ system

can be used as a benchtop

unit or integrated into an

automated system, and its

LED emitters are available

in 365, 385, or 405 nm

wavelengths. The system is

designed to offer higher,

more consistent curing intensities than traditional spot-curing systems.

Located at the point of cure, this system’s curing energy is created

using an LED chip in the emitter to provide more consistent curing by

eliminating the potential loss of intensity caused by long or bent light-

guides. The system is comprised of two main parts: a controller with a

touchscreen interface and a high-intensity LED emitter. An optional

lightguide can be connected without experiencing any intensity loss.

The unit can be activated by a foot pedal, its LCD touch screen, or

through a PLC interface.


■ 3D Textile EngineeringSecant Medical, Telford, PA,

has developed 3D textile engi-

neering technology by integrating

traditional textile engineering

with advanced biomaterials. By

combining the spatial resolution

capability with advanced biore-

sorbable polymers, the company

uses its proprietary bioelastomer Regenerez® to assist in enhancing the

biomechanical properties of these 3D structures. This technology

transforms a simple, synthetic textile into an elastomeric scaffold,

which provides for a broad range of bioresorbable polymers for the

structural design. The company has begun development of an anatom-

ical scaffold prototype based on the trachea. The 3D textile engi-

neered trachea scaffold demonstrates the precision of creating 20 C-

shaped rings stacked along the length of the prototype with narrow,

flexible regions spaced in between to mimic the natural bioarchitec-

ture of the trachea.


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When power is critical to your equipment as well as your patients, you can rely on MEGA Electronics to deliver.

Power supplies and cords to UL60601-1 and international approvals. Power supplies meet Energy Level VI, 4th edition and 2x MOPP.

Upon your next requirement, please keep MEGA in mind.

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■ Rotary Indexing RingWeiss North America, Willoughby, OH, offers

indexing rings, which feature a flat design and aresuitable for ring-style chassis systems that canaccommodate as many as 24 stations for assemblyprocesses. The TR1100 indexing rings can have acentral opening as large as 1750 mm. The dial ringhas a minimum outside diameter of 1100 mm and a maximum insidediameter of 800 mm with a ring thickness of 25 mm. For an assemblystation, the ring-shaped design allows for extra free design space, andthe rotating aluminum ring can be adjusted to customer specificationsin terms of diameter and thickness. The ring’s indexing precision indegree seconds is ±18 in. and the indexing precision in radian meas-urement is ±0.048 mm (at Ø 11 mm).


■ PTFE C-Ring SealBal Seal Engineering, Foothill Ranch, CA, has

expanded its line of sealing products to includethe spring-energized PTFE “C-ring” seal. This seal,which can be retrofit into grooves originallydesigned for elastomeric O-rings, offers improvedperformance and service life in hardware with

large tolerance variations. The C-ring seal combines the low friction prop-erties of PTFE and simple, streamlined jacket geometry to achieve bettersealing for more cycles. The seal is available in a range of materials, includ-ing virgin PTFE and filled PTFE. It is ideal for use in low-pressure (<500psi), low-speed (<100 ft/min) applications that require frictional control,and its polymer jacket expands under thermal cycling conditions to main-tain contact pressure. Cross sections range from 1/16 to ½ in., with radialtolerances of 0.010 to 0.075 in. Tolerance ranges are dependent on ambi-ent pressure, media type, and surface finish conditions.


■ Rapid OvermoldingProto Labs, Maple Plain, MN, has expanded the company’s rapid

injection molding offerings with an overmolding service. The new capa-bility can produce from 25 to 10,000+ custom overmolded parts in 15days or less. The company says the introduction of rapid overmoldinggives designers and developers another option for making high-qualityprototype or low-volume production parts as quickly as possible.

Overmolding, which is a multistep process, is used to improve gripand durability, dampen vibration, and to add two-color aesthetics toparts. The overmolding process can also reduce manufacturing costsby simplifying multipart assemblies. The process uses engineering-grade thermoplastics and liquid silicone rubber materials to createovermolded prototypes and end-use production parts.


■ High-Performance MaterialsEpoxySet, Lincoln, RI, has released the

the SetWORX™ line of high-performancematerials, which were developed to benonhazardous for shipping, thus reducingcosts associated with hazardous materials.Most of the materials in the SetWORX line contain no BPA, tin, or phtha-lates. Examples included the SetWORX USEAL U47MP and SetWORX60. The USEAL U47MP is a durable, abrasion-resistant urethane adhesiveand sealant for environmental protection that yields strong bonds to mostsubstrates. The SetWORX 60 is a toughened epoxy that exhibits highbond and peel strength to metals, ceramics, and many hard-to-bond plas-tics such as PVC, Lexan, and Ultem, even at higher temperatures. It alsohas excellent electrical insulating and dielectric properties.


STATEMENT OF OWNERSHIP

U.S. Postal Service Statement of Ownership (Required by 39 U.S.C. 3685) 1.Publication Title: Medical Design Briefs 2. Publication Number: 004-865 3. Filing Date:10/20/16 4. Issue Frequency: Monthly 5. No. of Issues Published Annually: 12 6.Annual Subscription Price: $75.00 7. Complete Mailing Address of Known Office ofPublication (Street, City, County, State, and Zip+4) (Not printer): ABP International(d/b/a Tech Briefs Media Group), an SAE International Company, 261 Fifth Avenue,Suite 1901, New York, NY 10016 8. Complete Mailing Address of Headquarters orGeneral Business Office of Publisher (Not printer): SAE International, 400Commonwealth Drive, Warrendale, PA 15096-0001 9. Full Names and CompleteMailing Addresses of Publisher, Editor, and Managing Editor. Publisher (Name andComplete Mailing Address): Joseph T. Pramberger, 261 Fifth Avenue, Suite 1901, NewYork, NY 10016; Editor (Name and Complete Mailing Address): Sherrie Trigg, 261 FifthAvenue, Suite 1901, New York, NY 10016; Managing Editor: None 10. Owner (If thepublication is owned by a corporation, give the name and address of the corporationimmediately followed by the names and addresses of all stockholders owning or hold-ing 1 percent or more of the total amount of stock. If not owned by a corporation, givethe names and addresses of the individual owners. If owned by a partnership or otherunincorporated firm, give its name and address as well as those of each individualowner. If the publication is published by a nonprofit organization, give its name andaddress). Full Name and Complete Mailing Address: SAE International, 400Commonwealth Drive, Warrendale, PA 15096-0001 11. Known Bondholders,Mortgagees, and Other Security Holders Owning or Holding 1 Percent or More ofTotal Amount of Bonds, Mortgages, or Other Securities. Full Name and CompleteMailing Address: None 12. For Completion of Nonprofit Organizations Authorized toMail at Nonprofit Rates. The purpose, function, and nonprofit status of this organiza-tion and the exempt status for federal income tax purposes: Not applicable 13.Publication Name: Medical Design Briefs 14. Issue Date for Circulation Data Below:November 2016 15. Extent and Nature of Circulation (Average No. Copies Each IssueDuring Preceding 12 Months/Actual No. Copies of Single Issue Published Nearest toFiling Date): a. Total No. Copies (Net Press Run): 29,571/29,197 b. Paid and/orRequested Circulation: (1) Paid or Requested Mail Subscriptions (Include Advertisers’Proof Copies/Exchange Copies): 26,202/26,609 (3) Sales Through Dealers andCarriers, Street Vendors, and Counter Sales (Not Mailed): 599/0 c. Total Paid and/orRequested Circulation (Sum of 15b(1), 15b(2), and 15b(3): 26,802/26,609 d. FreeDistribution by Mail (Samples, Complimentary, and Other Free): (1) NonrequestedCopies Stated on PS Form 3541: 1,982/1,900 (3) Nonrequested Copies DistributedThrough the USPS by Other Classes of Mail: None/None (4) Nonrequested CopiesDistributed Outside the Mail: 424/300 e. Total Nonrequested Distribution (Sum of 15d(1), (2), and (3)): 2,405/2,200 f. Total Distribution (Sum of 15c and 15e):29,207/28,809 g. Copies Not Distributed: 364/388 h. TOTAL (Sum of 15f and 15g):29,571/29,197 i. Percent Paid and/or Requested Circulation (15c ÷ f times 100):90.6%/91.1% 16. This Statement of Ownership will be printed in the November 2015issue of this publication. 17. I certify that all information furnished on this form is trueand complete. I understand that anyone who furnishes false or misleading informationon this form or who omits material or information requested on the form may be sub-ject to criminal sanctions (including fines and imprisonment) and/or civil sanctions(including civil penalties): Joseph T. Pramberger, Publisher.

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UNBEATABLE QUALITY, SPEED AND PRECISION.

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Magnetic Component Engineering, Inc.Tel 310.784.3100www.mceproducts.com [email protected] AS9100C | ISO 9001:2008

Speakers:Andrew Fisk, PhD.Director of Technology andInnovation, Pulse Technologies

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Upcoming...

Webinars

This 30-minute Webinar includes:• Live Q&A session • Application Demo • Access to archived event on demand

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Advanced Technology in Medical Device Manufacturing Thursday, November 3, 2016 at 2:00 pm U.S. EDT

The development and use of new and novel materials and processes hasallowed quantifiable increases in product performance and patient safety. In this Webinar, you will learn about custom developed materials,superfinished and engineered surfaces, and additive manufacturing formedical device implants.

■ VOC-Free SolventsA line of solvent blends from Kyzen,

Nashville, TN, is designed to replace AK225,nPB, TCE, and other undesirable solvents.The “clean and green” chemistries includeMetalnox M6920, Metalnox M6922, andMetalnox M6900. Classified as a non-VOCchemistry, Metalnox M6920 is nonflamma-ble and has a global warming potential of 1.The chemistry is compatible with stainlesssteel, copper, iron, and aluminum with orwithout excess water, and has excellentdegreasing qualities for most lubes/oils.With PEL limits of 800 ppm, M6920 is suit-able for metals, plastics, and elastomers.VOC-compliantMetalnox M6922effectively solubi-lizes ionic con-taminants in hy -dro carbon-basedoils, water solu-ble soils, and electronic fluxes. With ultralowglobal warming potential of 1 and low sur-face tension rating of 12.7 dyne/cm (wetta-bility), M6922 is suitable for replacing harshchemistries. Metalnox M6900 is a nonflam-mable chemistry used in immersion process-es or vapor-only processes.

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■ Fanless Embedded SystemAmerican Portwell Technology, Fremont,

CA, has released the RICH-33B0-8171, afanless embedded system. The rugged andcompact design of the embedded systemoffers low power consumption, making itideal for medical applications. The RICH-33B0-8171 is equipped with the PortwellWADE-8171 Mini-ITX board. Based on theIntel® Pentium® and Celeron® processorN3000 product families with a 6 W thermaldesign power, the board features Intel® HDGraphics architecture, which supports upto three displays with a maximum resolu-tion of 4K. It also features DDR3L SO-DIMM up to 8 GB supporting 1333/1600MT/s, one HDMI on the rear I/O with res-

olution up to3840 2160,and one lega-cy VGA inter-face support.Designed forIoT applica-tions, the 200

200 45 mm box integrates the MiniPCIe interface to provide wireless connec-tivity options, such as Wi-Fi, Bluetooth,3G/4G/GPS, and NFC functionalities. Thesystem supports temperatures ranging from0 to 60 °C.


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MULTIPHYSICS MODELING, SIMULATION, APP DESIGN ANDDEPLOYMENT SOFTWARE

COMSOL Multiphysics® is an integrated software envi-ronment for creating physics-based models and simula-tion apps. Add-on products allow the simulation of elec-trical, mechanical, acoustic, fluid flow, thermal, andchemical applications. Interfacing tools enable its inte-gration with all major technical computing and CADtools. Simulation experts rely on COMSOL Serverproduct to deploy apps to their colleagues and cus-tomers worldwide. https://www.comsol.com/products

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3M™ MINI DELTARIBBON (MDR)HIGH-SPEED TRANSMISSIONSYSTEMPerformance and Reliabilityin Miniature

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SILICONEPASSES USPCLASS VITESTING Master Bond MasterSil912Med is a single-

component silicone with a paste viscosity for bonding,sealing, and coating medical devices. This noncorro-sive, neutral cure compound complies with USP ClassVI and ISO 10993-5 specifications. It resists manykinds of sterilization including gamma and other typesof radiation, EtO, and some types of liquid sterilants.http://www.masterbond.com/tds/mastersil-912med

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PRODUCT SPOTLIGHT


■ Noncontact Magnetic Sensors

Steute Wireless, Ridgefield, CT, offers wire-

less, noncontact magnetic sensors. In the

presence of their actuating magnet, the sen-

sors send a unique, coded telegram to one or

more compatible, easily-programmable

receivers that accept up to 10 discrete

telegrams per channel. The sensors are pow-

ered by a long-life, field-replaceable lithium

battery. They are available for operation at

915 MHz (USA/Canada/Australia) or 868

MHz (Europe). The sensors have a maximum

nominal transmission range of 40 m indoors

(450 m free air) and a sensing range of up to

30 mm. They feature bidirectional communi-

cations with the receiver confirming receipt

of telegram. A limit switch signal is config-

urable at the receiver (e.g., NO, NC, other).

The ingress protection rating is IP67, and

mechanical life expectancy is >1 million actu-

ations. The operating temperature range is

–20 to +65 C. Options include stainless-steel

or glass-fiber-reinforced plastic housing and

transmission range extenders.


■ Sigma-Delta A/D ConvertersAnalog Devices, Norwood, MA, has intro-

duced a series of 24-bit simultaneous sam-

pling sigma-delta A/D converters for wide-

bandwidth, high-density healthcare equip-

ment. The AD7768 series includes a power

scalable mod-

ulator and dig-

ital filter on

each channel

to enable the

synchronized,

precise meas-

urement of both ac and dc signals in instru-

mentation applications, including modular

data acquisition, audio test, and asset condi-

tion monitoring. The high throughput, fast

settling response and simultaneous sampling

enables faster test times, which reduces test-

ing costs and allows more efficient instrumen-

tation design. The AD7768 series’ high chan-

nel count provides healthcare devices, such as

clinical vital signs monitoring equipment,

with the means to significantly expand chan-

nel density while maintaining low power and

high input bandwidth. The new converters

also deliver improved power quality monitor-

ing by detecting harmonic distortion over a

wider bandwidth for detection and diagnosis

of grid imbalance.


CLAD METAL MEDICAL WIREAnomet Products manufacturesclad metal medical wire com-bining high-strength, highlyconductive, biocompatible, andradiopaque alloys into one

material “system” with a complete metallurgical bondbetween layers. Typical wire combinations include316LVM, Gold, MP35N, Nitinol, Palladium, Platinum,Silver, Tantalum, Titanium, and others. Customized com-posite wire solutions to meet your unique wire challenges. www.anometproducts.com/content/medical-materials.

Anomet Products

USED LABORATORYEQUIPMENTPhotoMachining, Inc. isa contract laser manufac-turer and custom systemsbuilder. We specialize inlaser micromachining

using lasers from the far IR through the UV. Inaddition, we sell used, refurbished, and “like new”laboratory equipment including lasers, optics, opti-cal hardware, electronics, microscopes, etc. [email protected], or phone 603-882-9944.www.photomachining.com

PhotoMachining, Inc.

CLEAN ROOMMOLDING, ASSEMBLY, ANDPACKAGING

Medbio is an ISO 13485:2003 certified full-servicecontract manufacturer, specializing in precisioninjection molding, assembly, packaging, design sup-port, and project management. All manufacturing isdone in our certified ISO Class 7 and 8 clean rooms.From components to full assemblies, Medbio has theexperience to solve your most difficult manufactur-ing challenges. www.medbioinc.com

Medbio, Inc.

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ADVERTISERS INDEX

3D Systems ..........................................................771 ..........................1

ACCES I/O Products ..............................................805 ........................46

Anomet Products...................................................817 ........................56

Braxton Manufacturing Co., Inc. .............................814 ........................53

COMSOL, Inc. ..............................................775, 818 ....................5, 56

CPC - Colder Products Company ..............................789 ........................31

Dymax Corporation ........................................779, 790 ..................11, 32

Fluid Metering, Inc. ...............................................813 ........................53

Fluortek................................................................809 ........................49

GRI Pumps ...................................................794, 795 ........................36

Halkey-Roberts Corporation .............................796, 797 ........................37

Heilind Electronics..................................................819 ........................56

Hunter Products, Inc. ............................................816 ........................50

Indium Corporation ................................................780 ........................13

Interpower Corporation...........................................787 ........................23

INTROTEK International...................................798, 799 ........................38

Iwaki America........................................................806 ........................47

KMC Systems, Inc. ...............................................778........................8-9

Magnetic Component Engineering, Inc. ....................812 ........................55

Master Bond Inc. .........................................810, 820 ..................50, 56

mdi Consultants, Inc. ............................................807 ........................47

Medbio, Inc. ........................................................821 ........................56

MEGA Electronics Inc. ...........................................815 ........................54

MicroLumen Inc. ..........................................791, 804..............33, 44-45

Microspec Corporation ...........................................802 ........................41

Nason ..................................................................803 ........................43

New England Wire Technologies ..............................784 ........................19

NewAge® Industries Inc. ........................................822 ........................56

NORDSON Medical Value Plastics Fluid Mgmt. ....800, 801..........................39

Okay Industries ......................................................825....................COV III

Pexco...................................................................774 ..........................4

PhotoMachining, Inc. .............................................823 ........................56

Proto Labs, Inc. ...................................................777 ..........................7

Qosina .........................................................769, 792...COV IA-COV IB, 34

Rofin-Baasel, Inc. ..................................................770 ....................COV II

Smalley ................................................................776 ..........................6

Steute Meditech, Inc. ............................................826 ...................COV IV

Superior Tube Co. .................................................772 ..........................2

Swiss Automation, Inc. ..........................................811 ........................51

Tech Briefs TV......................................................................................52

Teleflex Medical OEM..............................................773 ..........................3

The Lee Company ..........................................786, 793 ..................21, 35

Thermacore, Inc. ..................................................781 ........................14

TRUMPF Inc. ................................................783, 824 ..................17, 56

Ulbrich Stainless Steels & Special Metals, Inc. ..........785 ........................20

Unimed S.A. ........................................................808 ........................48

Watson-Marlow Fluid Technology Group ....................788 ........................27

Zeus, Inc. ............................................................782 ........................15

For free product literature, enter advertisers’ readerservice numbers at www.techbriefs.com/rs, or visit theWeb site beneath their ad in this issue.

Reader ServiceCompany Number Page

Publisher ....................................................................Joseph T. PrambergerAssociate Publisher ....................................................................Helene Beck

(908) 300-2538Sales Director........................................................................Desiree Stygar

(908) 300-2539Editorial Director ........................................................................Linda L. BellEditor & Director of Medical Content ..........................................Sherrie Trigg Managing Editor, Tech Briefs TV.................................................Kendra SmithProduction Manager .............................................................Adam SantiagoAssistant Production Manager.................................................Kevin ColtrinariCreative Director ......................................................................Lois ErlacherSenior Designer ...................................................................Ayinde FrederickMarketing Director ...............................................................Debora RothwellMarketing Communications Manager ...........................................Monica BondDigital Marketing Coordinator .................................................Kaitlyn SommerAudience Development/Circulation Director .........................Marilyn SamuelsenAudience Development Coordinator............................................Stacey NelsonSubscription Changes/Cancellations [email protected]

TECH BRIEFS MEDIA GROUP, AN SAE INTERNATIONAL COMPANY261 Fifth Avenue, Suite 1901, New York, NY 10016(212) 490-3999 FAX (646) 829-0800Chief Executive Officer ..................................................Domenic A. MucchettiExecutive Vice-President .........................................................Luke SchnirringTechnology Director ................................................................Oliver RockwellSystems Administrator ..............................................................Vlad GladounWeb Developer........................................................................Karina CarterDigital Media Manager ............................................................................Peter BonavitaDigital Media Assistant Manager ............................................................Anel GuerreroDigital Media Assistants ...............Peter Weiland, Howard Ng, Md JaliluzzamanDigital Media Audience Coordinator.............................................Jamil BarrettCredit/Collection ......................................................................Felecia LaheyAccounting/Human Resources Manager ......................................Sylvia BonillaOffice Manager.....................................................................Alfredo VasquezReceptionist ..............................................................Elizabeth Brache-Torres

MEDICAL DESIGN BRIEFS ADVERTISING ACCOUNT EXECUTIVES MA, NH, ME, VT, RI, Eastern Canada.............................................Ed Marecki.........................................................................................Tatiana Marshall

(401) 351-0274

CT .......................................................................................Stan Greenfield(203) 938-2418

MI, IN, WI..............................................................................Chris Kennedy(847) 498-4520 ext. 3008

NJ, PA, DE...............................................................................John Murray(973) 409-4685

Southeast, TX ...........................................................................Ray Tompkins(281) 313-1004

NY, OH..................................................................................Ryan Beckman(973) 409-4687

MN, ND, SD, IL, KY, MO, KS, IA, NE, Central Canada .......................Bob Casey(847) 223-5225

Northwest, N. Calif., Western Canada.........................................Craig Pitcher(408) 778-0300

CO, UT, MT, WY, ID, NM .............................................................Tim Powers(973) 409-4762

S. Calif., AZ, NV ............................................................................Tom Boris(949) 715-7779

Europe — Central & Eastern.......................................................Joseph Heeg49-621-841-5702

Sven Anacker 49-202-27169-11

Europe — Western......................................................................Chris Shaw44-1270-522130

Integrated Media Specialists.....................................................Patrick Harvey(973) 409-4686

Angelo Danza(973) 874-0271

Scott Williams(973) 545-2464

Rick Rosenberg(973) 545-2565

Todd Holtz(973) 545-2566

Reprints ................................................................................Rhonda Brown(866) 879-9144, ext. 194

Medical Design Briefs, ISSN# 2158-561X, USPS 4865, copyright ©2016 in U.S., is publishedmonthly by Tech Briefs Media Group, an SAE International Company, 261 Fifth Avenue, Ste.1901, New York, NY 10016. The copyright information does not include the (U.S. rights to)individual tech briefs that are supplied by NASA. Editorial, sales, production, and circulationoffices are located at 261 Fifth Avenue, Suite 1901, New York, NY 10016. Subscriptions fornon-qualified subscribers in the U.S. and Puerto Rico, $75.00 for 1 year. Single copies $8.50each. Foreign Subscriptions 1 year U.S. funds $195.00. Single copies $21.75 each. Digitalcopies: $24.00. Remit by check, draft, postal, express orders or VISA, MasterCard orAmerican Express. Other remittances at sender’s risk. Address all communications for sub-scriptions or circulation to Medical Design Briefs, 261 Fifth Avenue, Suite 1901, New York, NY10016. Periodicals postage paid at New York, NY and additional mailing offices.POSTMASTER: Send address changes and cancellations to Medical Design Briefs, P.O. Box 47857, Plymouth, MN 55447.November 2016, Volume 6, Number 11.

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mailto:[email protected]














































Nanoscale Sculpturing of Metals Can Improve Biocompatibility forImplants Kiel UniversityKiel, Germanywww.uni-kiel.de/pressemeldungen


GLOBALL INNOVATIONSIGLOBALL INNOVATIONSI

How metals can be used dependsparticularly on the characteristicsof their surfaces. A research team

at Kiel University has discovered how tochange the surface properties withoutaffecting the mechanical stability of met-als or changing the metal characteristicsthemselves. This fundamentally newmethod is based on using an electro-chemical etching process, in which theuppermost layer of a metal is roughenedon a micrometer scale in a tightly con-trolled manner. Through this new“nanoscale-sculpturing” process, metalssuch as aluminum, titanium, or zinc canpermanently be joined with nearly allother materials. The process can enablethe metals to become water repellent. Itcan also improve their biocompatibility,which can make medical implants safer.

“We have now applied a technology tometals that was previously only knownfrom semiconductors. To use thisprocess in such a way is completely new,”said Dr. Jürgen Carstensen, co-author ofthe publication. In the process, the sur-face of a metal is converted into a semi-conductor, which can be chemicallyetched and thereby specifically modifiedas desired. “As such, we have developeda process which — unlike other etchingprocesses — does not damage the metalsand does not affect their stability,” saidRainer Adelung, head of the FunctionalNanomaterials team at the Institute forMaterials Science.

■ How it WorksThe surfaces of metals consist of many

different crystals and grains, some ofwhich are less chemically stable than oth-ers. These unstable particles can bespecifically removed from the surface ofa metal by a targeted etching. The topsurface layer is roughened by the etchingprocess, creating a three-dimensionalsurface structure. This changes the

properties of the surface, but not of themetal as a whole. This is because theetching is only 10–20 μm deep, a layer asthin as a quarter of the diameter ofhuman hair.

The change due to etching is visible tothe naked eye: the treated surfacebecomes matte. “If, for example, wetreat a metal with sandpaper, we alsoachieve a noticeable change in appear-ance, but this is only two-dimensional,and does not change the characteristicsof the surface,” explained Dr. Mark-Daniel Gerngross.

Through the etching process, a 3Dstructure with tiny hooks is created. If abonding polymer is then appliedbetween two treated metals, the surfacesinterlock with each other in all direc-tions like a three-dimensional puzzle.“These 3D puzzle connections are prac-tically unbreakable. In our experiments,it was usually the metal or polymer thatbroke, but not the connection itself,”said Melike Baytekin-Gerngross, leadauthor of the publication.

Even a thin layer of fat — such as thatleft by a fingerprint on a surface — doesnot affect the connection. “In our tests,we even smeared gearbox oil on metalsurfaces. The connection still held,”explained Baytekin-Gerngross. In addi-tion, exposing the puzzle connections toextreme heat and moisture to simulateweather conditions did not affect theirstability. Carstensen noted, “Our connec-tions are extremely robust and weatherresistant.” A beneficial side-effect of theprocess is that the etching makes the sur-faces of metal water repellent. The result-ing hook structure functions like a closelyinterlocked 3D labyrinth, without holesthat can be penetrated by water. The met-als therefore possess a kind of built-in cor-rosion protection. “We actually don'tknow this kind of behavior from metalslike aluminum. A lotus effect with pure

metals — i.e., without applying a water-repellent coating — that is new,” saidAdelung.

“Because the nanoscale-sculpturingprocess creates a 3D surface structure,which can be purely physically bondedwithout chemicals, the targeted etchingcan also remove harmful particles fromthe surface, which is of particularly greatinterest in medical technology,” saidGerngross.

Titanium is often used for medicalimplants. To mechanically fix the titani-um in place, small quantities of alu-minum are added. However, the alu-minum can trigger undesirable sideeffects in the body. “With our process,we can remove aluminum particles fromthe surface layer, and thereby obtain asignificantly purer surface, which ismuch more tolerable for the humanbody. Because we only etch the upper-most layer on a micrometer scale, thestability of the whole implant remainsunaffected,” explained Carstensen.

The team’s results have been pub-lished in the journal Nanoscale Horizonsof the Royal Society of Chemistry. Theresearchers have so far applied for fourpatents for the process.

GLOBALL INNOVATIONSI

A strip of aluminum – the surface of which hasbeen treated with an electrochemical etchingprocess – is permanently bonded with thermo-plastic by heating. [Credit: Julia Siekmann / KielUniversity]

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Accu-LaserSwiss gives you manufacturing capabilities never before available. This new technology fully integrates a six-axis precision automatic lathe with a fully enabled laser cutting module. It cuts costs, dramatically reduces cycle time and lets you create features that would be impossible on a conventional Swissturn – like slots as narrow as .0015" and small holes with no “tool wear.” As co-developer of this innovative laser machining process, Okay is the only manufacturer offering it today. Give us a call or drop us an email and see how you can start doing more for less tomorrow.

Accu-LaserSwissTM redefines manufacturing capabilities, speed, precision and cost-savings for ultra-complex metal tubes.

Okay Headquarters | 200 Ellis Street | New Britain, CT 06051Tel (860) 225-8700 | [email protected] | okayind.com

Manufacturing. Rely. Ability.

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Swiss-Type Turning • Laser Cut Tubes • CNC Machining • Automated Assembly • Laser Welding & Marking • Precision Metal Stamping Accu-Blade® Scissors & Blades • Production Proven Prototyping® • Award-Winning Product Development

Other locations: Medical Products Manufacturing: Berlin, CT USA • Medical Precision Components Manufacturing: Alajuela, Costa Rica


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12 Reasons Why Leading OEMs Choose Steute Medical-Grade Foot Switches

1 Powder-coated and molded-in colors…

no paint to crack or chip.

2 Up to IP X8 ingress Protection…

to meet application needs.

3 Choice of “actuator forces”…

to best meet user needs.

4 Choice of actuator styles…

to best meet ergonomic needs.

5 Choice of output signals…

analog, digital, USB, RS232, other.

6 Choice of signal sources… micro switches,

potentiometers, Hall-effect sensors, other.

Mammotome® is a registered trademark of Devicor Medical Products, Inc.

7 Contoured surfaces… for ease of cleaning.

8 Choice of colors and graphics… for ease-of-use and aesthetic-compatibility.

9 Optional carrying handles/foot rests… for ease-of-use/navigation.

10 Ergonomically optimized… for weight , mobility, and user-comfort.

11 Choice of operation… wireless, cabled or hybrid.

12 Compliant to latest Medical Standards… IEC, CSA, UL, FCC, other.

Examination Chair

Control

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Our design team would be pleased to configure a foot switch that is easy-to-use and complements the

cosmetics of your medical device… with no NRE or tooling costs.

Contact us for a no-obligation design consultation, or to discuss receiving a complimentary sample

for evaluation.

www.steutemeditech.com [email protected](203) 244-6302

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Documents

Medical Design Briefsassets.techbriefs.com/EML/2016/mdb_digital/MDB1116.pdf · Servo-Driven Ultrasonic Welding for Medical Devices Wearables Win: See the Results of This Year’s