PRODUCT OF THE MONTH — Introducer Sheath

Freudenberg Medical, Jeffersonville, IN, has launched a new introducer sheath for medical device companies looking to accelerate time to market with a unique white label device. The FlexSeal® introducer sheath is designed for companies looking to access new design options for improving nextgeneration catheter and delivery systems or reduce time when building new feature sets into products.

The adjustable FlexSeal introducer sheath with hydrophilic coating enables support access for large bore catheter procedures. It maintains hemostasis after multiple, large catheter insertions, and it supports procedures requiring multiple devices or a wide range of device sizes. The composite shaft balances flexibility and pushability. Because of its excellent kink resistance, it inserts through challenging anatomies while maintaining lumen patency. The hydrophilic coating provides improved insertion and tracking, and the shaft and dilator profile enables smooth insertion performance.

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Microelectronics Manufacturing

NEO Tech, Chatsworth, CA, offers electronic manufacturing services for advanced implantable devices and electroceuticals, including neurostimulation devices, drug pumps, and cochlear implants. Manufacturing services include microelectronic high-density packaging technologies; interactive DFM/DFT; and electrical, mechanical, and thermal analysis; as well as development of electrical, functional, and environmental tests. Microelectronic capabilities include wafer and die processing, die attaching, automated wire bonding, and custom microelectronic packaging, including multichip packaging, multichip modules, power modules, chip-on-board, and chip-scale-modules.

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Embedded System

Corvalent, Cedar Park, TX, has announced its new CorServer 2600 server-class product family. Integrating the Intel® Xeon® E5-2600 v3/v4 processor family, CorServer enables high-performance storage and data processing at the edge, while serverclass design reduces cost by eliminating unnecessary third-party software certifications. It transmits processed, encrypted files rather than massive amounts of raw data. CorServer enables dual-processor performance for number-crunching applications such medical imaging. The CorServer 2600 family is available in 1U and 2U configurations. Server board and chassis are optimized to work together, while cabling layout enables airflow supported by low-noise internal fans.

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Probe Pin

A new stamped spring probe is available from Plastronics, Irving, TX. The H-Pin is designed to cut the cost of contact pins used in electronics reliability testing and compression-style board-to-board connectors. The H-Pin delivers the mechanical, electrical, and thermal performance of a pogo-style spring probe, but because of advances in the manufacturing process, it cuts the cost by 30–50 percent. The pin has a working range up to 1 mm with a flat spring rate and can be utilized up to 15 GHz with –1.0 dB loss. It can carry up to 4 A of current and withstand temperatures up to 200 °C. Available in various lengths and pitch sizes as low as 0.2 mm, the pins are manufactured using a high-volume BeCu stamping process and a high-speed assembly and inspection process that can produce up to 400 pins per minute.

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Laser Marking and Cutting Systems

Control Micro Systems, Orlando, FL, has developed turnkey laser marking and cutting systems for the medical sector. A high-power Ytterbium fiber laser can terminate and seal braided 304 and 316 stainless guidewire that is pulled from a reel and cut to length. The laser welds the individual strands together to prevent unraveling and creates a semispherical tip on each end. For latex catheter manufacturing, the eyelets at the catheter ends can be quickly cut with little to no debris or remelt material. The system includes the laser, optics, robots, programmable stages and other automation, and vision systems for part detection and/or process results verification.

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Solder Paste

Indium, Clinton, NY, offers a no-clean, halogenfree solder paste. The Indium8.9HF is specifically formulated to reduce voiding significantly below the industry average for improved finished goods reliability. It delivers robust reflow capabilities and a wide processing window, which accommodates various board sizes and throughput requirements, and it minimizes defects. Its unique oxidation barrier technology makes it suited for a variety of applications.

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Surface-Mount Threaded Standoffs

Keystone Electronics, Astoria, NY, has introduced a series of threaded standoffs specifically designed and packaged for use on printed circuit boards in the same manner as other surface mount components. Manufactured from steel with a tin plate, these standoffs can be added to the board using the same SMT equipment used to populate the board, reducing scrap and handling time while minimizing damage to a PCB that may occur while using traditional mounting products. The standoffs are available in 2-56, 4-40, and 6-32 threads in lengths from 1/16 up to 3/8 in. and are supplied on tape and reel with Kapton tape on the top surface for easy pickup.

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Wall-Mount Power Supplies

XP Power, Singapore, offers medically approved wall mount/plug-top power supplies that meet the latest Department of Energy (DoE) Level VI and EU Code of Conduct (CoC) Tier 2 standards. With single outputs of 6 and 18 W respectively, the ACM06 and ACM18 series feature a high average efficiency of up to 87.5 percent typical measured at 25, 50, 75, and 100 percent load. Both series feature a low no load input power, with all ranges consuming less than 0.075 W. The ACM06 series is available in 5, 9 and 12 VDC output models, while the ACM18 comes in 5, 9, 12, 15, 18, and 24 VDC single output models, the most common output voltages to suit most applications. Both offer a choice of detachable input plugs for either the US, UK, EU, China, or Australian use.

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Barbed Connectors

Qosina, Ronkonkoma, NY, has added barbed Kynar® connectors to its product line. Configurations include straight connectors, elbow connectors, T connectors, and reducers, which are constructed to fit a variety of both flexible and rigid tubing sizes, including 1/16, 3/32, and 1/8 in. ID. The BPA- and latex-free connectors are Reach and RoHS compliant, and are suitable for autoclave, e-beam, EtO, gamma, and steam sterilization methods. Kynar, a highly durable, premium PVDF thermoplastic material, is resistant to solvents and is designed for use in applications that require high strength and purity.

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Wireless Foot Switch

Industrial-grade wireless foot switches featuring an internal energy generator are available from Steute Industrial Controls, Ridgefield, CT. Actuation of the foot pedal generates power to send a unique, coded telegram to a compatible receiver. If, within 15 ms, the foot switch does not receive a confirmation signal from the receiver, it transmits a second telegram. The foot switch is available for operation at 915 MHz (USA/ Canada/Australia) or 868 MHz (Europe). Its maximum nominal transmission range is 50 m indoors and 700 m “free air.” It has an ingress protection rating of IP67, and its operating temperature ranges from –20 to +65 °C.

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Fluorinated Solvent

AGC Chemicals Americas, Exton, PA, has introduced a fluorinated precision cleaning solvent that provides medical device manufacturers a safer, highly effective, and environmentally friendly alternative to n-propyl bromide and trichloroethylene solvents. Amolea AT2 has no ozone depletion potential, low global warming potential, and is nonflammable, enabling manufacturers to more easily meet increasingly strict environmental regulations. The solvent is energy efficient because of its low latent heat of vaporization. It is approved for use as a precision cleaner, defluxing agent, carrier solvent for silicone and fluorinated lubricants, and moisture displacement fluid.

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MPO Interconnect Cleaning Tool

MicroCare, New Britain, CT, offers a new fiber optic cleaning tool. The new “keyless” MPO Cleanclicker® 600 cleaning tool from Sticklers® makes it easier to clean MPO connectors in high-density applications than with traditional methods. The Cleanclicker tool uses a contact spring that does not require an alignment key for controlling the flow of the cleaning ribbon on angled polished MT ferrules. Because the orientation key is eliminated from the tip, the tool can be easily inserted in either direction. The ribbon flows in an upward direction, which makes it capable of cleaning 12, 24, 48, and other fiber count MT ferrules with the standard 12-fiber arrays.

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Polycarbonate Blend

Covestro, Pittsburgh, PA, has developed a new polycarbonate blend, M4000 FR polycarbonate/polybutylene terephthalate (PC+PBT), that is appropriate for skin contact applications. Makroblend® is biocompatible according to ISO 10993-5 (cytotoxicity) and ISO 10993-10 (irritation and sensitization). In addition to its biocompatibility, the blend provides a high level of chemical resistance and flame retardancy of V-0 at 2.0 mm and 5VA at 2.3 mm. Its high toughness and high modulus makes it suitable for thin-walled designs, and its excellent flow helps molders maximize productivity. With reduced susceptibility to stress cracking, it is appropriate for molding medical device equipment housings and enclosures.

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Optical Sensor

TT Electronics, Woking, UK, has introduced a reflective optical sensor for medical applications. The Photologic® V OPB9000 sensor provides dependable edge and presence detection of reflective media under a wide range of ambient light conditions. The OPB9000 is a reflective, CMOS logic output sensor with programmable sensitivity, output polarity, and drain select. It offers 25+ kilolux ambient light immunity along with a wide operating temperature range. It is self-calibrating and provides temperature compensation and automatic gain control. A response time of 6 μs ensures highspeed detection for time-critical applications.

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Soft Skin Adhesive

Dow, Auburn, MI, has released a soft skin adhesive that can be used for wearable monitoring devices, wound care products, medical tape applications, and medical device attachments. Dow Corning® MG 7-1010 is a twopart, low-viscosity silicone adhesive that provides excellent adhesion to stainless steel and polycarbonate substrates. The coat weight and adhesion level can be tuned for flexibility in manufacturing. It can be direct or transfer coated. It maintains adhesive strength — even at lower coat weights. The adhesive also offers fast cure rates.

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Barbed Y Connectors

Injectech, Fort Collins, CO, has added barbed Y connectors to its line of tube-to-tube connectors. Available in a variety of stock and custom sizes, the connectors are offered in USP Class VI and bioprocess materials. Barbed connectors include Y18 for 1/8 in. (3 mm) ID tubing, Y352 for 5/32 in. (4 mm) ID tubing, and Y316 for 3/16 in. (4.75 mm) ID tubing. Standard materials include natural nylon, black nylon, animal-free polypropylene, and Kynar 1000HD. Custom materials and extended sizes are available.

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Co-extrusion Capabilities

Raumedic, Mills River, NC, has developed processing capabilities to coextrude a wide variety of metal wires and glass fibers within multilayer tubing walls. The company can co-extrude and work with copper, stainless steel, nitinol, platinum alloys, and nickel- and silver-plated wires in combination with a wide variety of polymers, including polypropylene, polyethylene, nylon, polyurethane, and silicone, as well as high-performance resins such as FEP, PEEK, PPSU, PEI, and PTFE Moldflon. The company can coextrude wires within the tubing walls, reducing fabrication costs.

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Threaded Inserts for Plastics

New aluminum versions of SI® brand threaded inserts from PennEngineering, Danboro, PA, introduce lead-free and lightweight alternatives to brass counterparts and eliminate potential environmental and recycling issues. The aluminum option — approximately 70 percent lighter than brass equivalents — can be specified for all types of SI inserts. They provide durable and reusable metal threads in plastics to accept mating hardware and subsequently allow for access to an assembly whenever required. The line includes ultrasonic/heat staking inserts for installation ultrasonically or with a thermal press, molded-in types installed during the molding process, and press-in types installed by pressing the insert into a premolded or drilled hole.

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Updated LiveLink Software

COMSOL, Burlington, MA, has announced an update to its LiveLink™ for SOLIDWORKS® product. As an add-on to the COMSOL Multiphysics® software, LiveLink for SOLIDWORKS allows a CAD model to be synchronized between the two software packages. The latest version allows easy access for launching and running simulation apps that can be used in sync with SOLIDWORKS software. Simulation specialists and analysts can now build apps with the Application Builder to let users, such as design engineers, analyze and modify a geometry from SOLIDWORKS right from the app’s interface. Users can browse and run apps from within the SOLIDWORKS interface, including those that use a geometry that is synchronized with SOLIDWORKS software.

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Fluorescence Illuminators

Excelitas Technologies, Waltham, MA, has added two new units to its X-Cite fluorescence illuminator product line. The X-Cite Vitae vIR is a customizable, multi-wavelength illumination system designed for high-precision medical illumination and diagnostic applications. The X-Cite Vitae vIR provides versatile, high-performance illumination for color-sensitive applications, including surgical endoscopy. Designed to replace traditional 180 or 300 W xenon sources, this high brightness, solid-state white light source features adjustable color temperature and repeatable output in an easily integrative turnkey system. X-Cite Vitae vIR can shape the spectrum in accordance with the camera being used to obtain the desired color temperature in an image for accurate diagnosis. It offers up to six high-power wavelengths (400–410, 450–460, 500–600, 625–640, and 780–790 nm), ranging from visible to IR, for fluorescence excitation in applications such as endoscopy and surgical visualization.

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Retractable Cord Reel

Hunter Spring, Horsham, PA, has expanded the availability of its DuraReel™ medical cord reels with its recently obtained CE mark. The medical-grade power cord reel is housed in a durable white/grey, high-impact plastic case with 10 ft of cable that retracts smoothly and safely. The easy-to-clean cord reel features a permanent antimicrobial additive that continuously protects the reel from mold, mildew, and odor. An automatic pawl and ratchet system securely locks the cord at a desired length, and a standard ball stop keeps the cord within easy reach. It has been tested specifically in environments containing E. Coli and Staphylococcus Aureus microorganisms. All contact surfaces, such as the housing, ball stop, retractable cord, and plug, have been molded with the antimicrobial additive that will not wash off or diminish over time.

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Disinfectant-Resistant Materials

Henkel, Rocky Hill, CT, is collaborating with PolyOne Corporation on the development of new materials and assembly methods that are more resistant to harsh disinfectants now in use in hospitals. The collaboration is said to provide higher-performing solutions, shorten development time, and speed up manufacturing processes. Henkel tested its Loctite® brand adhesives with PolyOne’s polymer blends to provide a complete disinfectant-resistant solution for a variety of medical devices. By evaluating and testing various Loctite adhesive and substrate combinations in its labs, Henkel helps materials suppliers provide pre-evaluated substrate and assembly method solutions to their medical device customers.

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Sensors

All Sensors, Morgan Hill, CA, has added a new sensor to BLCR series. The series is a basic low pressure, compact sensor with the company’s CoBeam2™ dual die reference technology to reduce all output offset or common mode errors. The compact size of this series is excellent for small mobile devices and battery applications. The series offers a low supply voltage (1.8–3.3 V). Features include ratiometric basic output, 0.1 percent typical linearity, improved front to back linearity, and reduced position sensitivity. It has an operating temperature range of –25 to 85 °C. Parylene coating is available upon request.

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Stepper Motor with Encoder

Lin Engineering, Morgan Hill, CA, has integrated AMT encoder technology from CUI, Tualatin, OR, into its G3718V stepper motor. The encoders are available in incremental, absolute, and commutation versions. The series comes with programmable features, including resolutions up to 4096 PPR, zero position, line drivers, and in the case of the absolute version, a 12-bit absolute output. It provides an operating temperature from –40 to +125 °C. With a step angle of 1.8°, the G3718V motor offers smooth motion and high accuracy similar to a 0.9° motor. The series also provides up to 25 oz-in (0.18 N-m) of holding torque.

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Medical Materials

Vancive Medical Technologies, Chicago, IL, has introduced three new medical materials. A breathable double-coated tape for wearable device applications is designed to serve as a construction layer connecting a device’s skin contact material to its sensor/electronics casing. The company also offers a single-coated elastic nonwoven tape with a fabric-like feel. Also breathable, this material conforms to contoured body surfaces and has applications for use in wearables, wound dressings, and other medical devices. A new microporous breathable tape can be used for surgical applications, ostomy flanges, and a variety of other end uses.

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USB Hub

ACCES I/O Products, San Diego, CA, has announced a new rugged, industrial-strength, four-port USB 3.1 hub. Designed for the harshest environments, the USB3-104-HUB features extended temperature operation (–40 to +85 °C), locking USB and power connections, and an industrial steel enclosure for shock and vibration mitigation. The OEM version (board only) is PC/104 sized and can be installed in new or existing PC/104-based systems. The hub can be bus powered or self (externally) powered. Both power jack and terminal block power inputs are available to provide a full 900 mA source at 5 V on each of the downstream ports. Additionally, a wide input power option accepts from 7 to 28 VDC. All type A and type B USB connections feature a locking, high-retention design that complies with class 1, Div II minimum withdrawal requirements.

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Medical Design Briefs Magazine

This article first appeared in the April, 2017 issue of Medical Design Briefs Magazine.

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