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Researchers Show that Nanogenerator Works Inside Live Animals

A zinc oxide nanowire can be attached to a rat's heart, producing electric current as the heart bends with every beat. (Photo by Guang Zhu, Georgia Tech)

Last year, Medtech Pulse reported that Zhong Lin Wang, a professor of materials science and engineering at Georgia Tech (Atlanta), had developed minuscule piezoelectric generators that enable nanosensors to power themselves. This technology could eventually lead to medical implants and sensors powered by heartbeats, breathing, or other body movements. Now, Wang's research team has gone a step further, demonstrating that the nanogenerator works inside live animals.

As reported in MIT's Technology Review, the researchers deposited a zinc oxide nanowire on a flexible polymer substrate and encapsulated the device in a polymer casing to shield it from body fluids. The nanowire was then attached to a rat's diaphragm. Stretched by the animal's breathing, the wire generated 4 pA  of current at 2 mV. When it was attached to a rat's heart, the device provided 30 pA of current at 3 mV. These findings are reported in the journal Advanced Materials.

Zinc oxide nanogenerators would be suitable for powering nanoscale sensors that monitor such body functions as blood pressure or glucose levels. However, the femtowatt-scale power generated by Wang's current-generation devices is far too low to be practical. To overcome this limitation, the research team has built a device that integrates hundreds of nanowires in an array. While it has not been tested on live animals, this device provides an output current of about 100 nA at 1.2 V, producing 0.12 µW of power, as reported in the journal Nature Nanotechnology. The next step, Wang notes, is to connect this higher-output nanogenerator to a nanosensor inside an animal.

For more information on this piezoelectric nanowire technology, view Wang's presentation at the MPMN Webcast "Emerging Technologies Showcase."

Companies Partner to Produce Novel PEEK-Based Battery Insulators

Parts with ultrathin thermoplastic walls are suited for applications in which real estate is at a premium, such as battery insulators

Welch Fluorocarbon (Dover, NH) has developed a process for producing custom-fit battery insulators for pacemakers using Vestakeep PEEK film made by Evonik Industries (Parsippany, NJ). This technique yields thin-walled, molded liners suitable for the limited space available inside current pacemakers.

To save space and accommodate low wall-thickness tolerances, batteries are often manually encapsulated within polyimide adhesive strips or parylene conformal coatings--a task that requires considerable effort, according to the companies. And although custom-fit insulators provide an alternative option, their required thin walls, low tolerances, and long flow paths typically eliminate the possibility of injection molding as a processing method.

In an effort to solve this insulation conundrum, Welch Fluorocarbon has created a thermoforming process that enables the fabrication of these components from amorphous PEEK film. The Vestakeep film is completely melted and then molded in a vacuum, which enables the production of low-stress parts, according to the companies. Optimized for this process, the film is low stress and flows little upon melting.

Suitable for use as battery insulators in pacemakers, the film boasts good chemical resistance, including to metallic lithium. It also features tribiological and electrical properties, stability at high continuous working temperatures, and high mechanical and flame resistance.

By employing the Vestakeep PEEK film in combination with this new process, Welch Fluorocarbon reports that it can manufacture battery insulators at extremely low tolerances and with wall thicknesses measuring less than 25 µm.

Cochlear Americas Pays to Settle Kickback Charges

In a separate federal case, Cochlear Americas agreed last week to pay $950,000 to settle claims involving its sales program. Dow Jones reports that the company denied the allegations made against its sales program, but agreed to settle to avoid legal expenses.

MDEA 2010 Gold and Silver Winners Announced

2010 MDEA WINNING PRODUCTS (alphabetical by category):

CRITICAL-CARE AND EMERGENCY MEDICINE PRODUCTS

  • AccuVein AV300 portable, non-contact vein illumination device (Gold)
  • Portex UniPerc percutaneous tracheostomy kits (Gold)
  • Hamilton C2 ICU ventilator (Silver)
  • LUCAS 2 chest compression system (Silver)

DENTAL INSTRUMENTS, EQUIPMENT, AND SUPPLIES

  • PaX-Reve3D panoramic, cephalometric, and computerized tomography system (Gold)
  • Vibringe sonic irrigation system (Gold)

FINISHED PACKAGING

  • Cimzia Packaging (Gold)
  • Orthopaedic Implant Skinpack Package for Femoral Hips (Silver)

GENERAL HOSPITAL DEVICES AND THERAPEUTIC PRODUCTS

  • Alice PDx recording device (Gold)
  • HyGreen intelligent hand hygiene system (Gold)
  • Littmann electronic stethoscope Model 3200 with Zargis Cardioscan heart sound analysis software (Gold)
  • DivibaX mixing transfer device (Silver)
  • FreeVac needlestick prevention syringe (Silver)
  • Zio Patch continuous cardiac ECG (electrocardiogram) data recorder (Silver)

IMPLANT AND TISSUE-REPLACEMENT PRODUCTS

  • Morphix suture anchor (Gold)
  • AngelMed Guardian implantable cardiac monitoring and alerting system (Silver)
  • Orbital tissue expander (OTE) (Silver)

IN VITRO DIAGNOSTICS

  • PREVI Isola high-throughput specimen and agar plate management system (Gold)
  • ABL90 FLEX blood analyzer (Silver)
  • Contour USB blood glucose monitor (Silver)
  • Oragene•DNA self collection kit (OG-500) (Silver)

OVER-THE-COUNTER AND SELF-CARE PRODUCTS

  • Vitala Continence Control Device (CCD) (Gold)
  • GlowCap internet-connected pill bottle cap (Silver)
  • Oralflo pill swallowing cup (Silver)

RADIOLOGICAL AND ELECTROMECHANICAL DEVICES

  • DynaTRIM trans-rectal interventional MRI with DynaCAD digital imaging workstation for prostate (Gold)
  • Vanguard breast imaging and interventional coil for Siemens MAGNETOM ESSENZA MRI scanner (Gold)
  • SAVI breast brachytherapy applicator (Silver)
  • TNT 12000 x-ray test device (Silver)

REHABILITATION AND ASSISTIVE-TECHNOLOGY PRODUCTS

  • M320 AlterG anti-gravity treadmill (Gold)
  • Computerized Prosthesis Alignment System (Compas) (Silver)
  • Intel Reader digital reading device (Silver)
  • Tibion Bionic Leg wearable rehabilitation device (Silver)

SURGICAL EQUIPMENT, INSTRUMENTS, AND SUPPLIES

  • Ajust adjustable single-incision sling (Gold)
  • RIO robotic arm interactive orthopedic system (Gold)
  • SERENGETI Minimally Invasive Retractor System (Gold)
  • Duet TRS Reload Tissue Reinforcement System (Silver)
  • FinESS Sinus Treatment (Silver)
  • Hydrodebrider endoscopic suction irrigator system (Silver)
  • Quill SRS knotless surgical wound closure device (Silver)

Read more about this year's competiton here.

MDEA Gold and Silver Awards Handed Out at MD&M East Ceremony

Gold and silver Medical Design Excellence Awards (MDEA) were handed out at a ceremony on Wednesday at the MD&M East trade show in New York City.

Charlie McCurdy, CEO of Canon Communications, which coordinates the MDEA competition, opened the ceremony with a few words acknowledging innovation in the medical device industry. Along with the announcement of this year's pioneering products by Sherrie Conroy, director of content, medical brands for Canon, the ceremony also featured the presentation of the Biomedical Engineering IDEA award to the next generation of innovators and potential future MDEA winners. Presented by the National Collegiate Inventors and Innovators Alliance, BME IDEA honor is bestowed upon a group of young innovators that develop a product that uniquely addresses a current problem in the medical device market and has potential for commercialization. A group from Johns Hopkins University took home this year's grand prize for its rapid hypothermia induction device. Supported by corporate sponsors The Medtech Group, Nordson EFD, and Vante and selected by an impartial panel of jurors, the MDEA program recognized 39 products in 10 categories.

Gold and silver distinctions are listed below. For a detailed overview of this year's winners, read our previous blog post or check out the April cover story in MPMN's sister publication, MD+DI.

2010 MDEA Gold Winners (Winning product names are followed by the category in which they won)

Suppliers to MDEA-winning products gather on stage at the MDEA ceremony at MD&M East.

AccuVein AV300 portable, non-contact vein illumination device, Critical-Care and Emergency Products (See MPMN's case study on the development of this product)

Ajust adjustable single-incision sling, Surgical Equipment, Instruments, and Supplies

Alice PDx recording device, General Hospital Devices and Therapeutic Products

HyGreen intelligent hand hygiene system, General Hospital Devices and Therapeutic Products

Cimzia Packaging, Finished Packaging

DynaTRIM trans-rectal interventional MRI with DynaCAD digital imaging workstation for prostate, Radiological and Electromechanical Devices

Littmann electronic stethoscope Model 3200 with Zargis Cardioscan heart sound analysis software, General Hospital Devices and Therapeutic Products (See MPMN's case study on the development of this product)

Morphix suture anchor, Implant and Tissue-Replacement Products

M320 AlterG anti-gravity treadmill, Rehabilitation and Assistive Technology Products

PaX-Reve3D panoramic, cephalometric, and computerized tomography system, Dental Instruments, Equipment, and Supplies

Portex UniPerc percutaneous tracheostomy kits, Critical-Care and Emergency Products

PREVI Isola high-throughput specimen and agar plate management system, In Vitro Diagnostics

RIO robotic arm interactive orthopedic system, Surgical Equipment, Instruments, and Supplies

SERENGETI Minimally Invasive Retractor System, Surgical Equipment, Instruments, and Supplies (See MPMN's case study on the development of this product)

Vanguard breast imaging and interventional coil for Siemens MAGNETOM ESSENZA MRI scanner, Radiological and Electromechanical Devices

Vibringe sonic irrigation system, Dental Instruments, Equipment, and Supplies

Vitala Continence Control Device (CCD), Over-the-Counter and Self-Care Products

 

2010 MDEA Silver Winners

ABL90 FLEX blood analyzer, In Vitro Diagnostics

AngelMed Guardian implantable cardiac monitoring and alerting system, Implant and Tissue-Replacement Products

Computerized Prosthesis Alignment System (Compas), Rehabilitation and Assistive Technology Products

Contour USB blood glucose monitor, In Vitro Diagnostics

Duet TRS Reload Tissue Reinforcement System, Surgical Equipment, Instruments, and Supplies

DivibaX mixing transfer device, General Hospital Devices and Therapeutic Products

FinESS Sinus Treatment, Surgical Equipment, Instruments, and Supplies (See MPMN's case study on the development of this product)

FreeVac needlestick prevention syringe, General Hospital Devices and Therapeutic Products

GlowCap internet-connected pill bottle cap, Over-the-Counter and Self-Care Products

Hamilton C2 ICU ventilator, Critical-Care and Emergency Products

Hydrodebrider endoscopic suction irrigator system, Surgical Equipment, Instruments, and Supplies

Intel Reader digital reading device, Rehabilitation and Assistive Technology Products

LUCAS 2 chest compression system, Critical-Care and Emergency Products

Oralflo pill swallowing cup, Over-the-Counter and Self-Care Products

Orbital tissue expander (OTE), Implant and Tissue-Replacement Products

Orthopaedic Implant Skinpack Package for Femoral Hips, Finished Packaging

Quill SRS knotless surgical wound closure device, Surgical Equipment, Instruments, and Supplies

SAVI breast brachytherapy applicator, Radiological and Electromechanical Devices

Tibion Bionic Leg wearable rehabilitation device, Rehabilitation and Assistive Technology Products

TNT 12000 x-ray test device,Radiological and Electromechanical Device
Zio Patch continuous cardiac ECG (electrocardiogram) data recorderGeneral Hospital Devices and Therapeutic Products

Weakened Euro Tempers Growth Expectations

In addition, Germany and the United Kingdom have already announced plans to cut spending in the next few years, and Haresco believes that device firms will be under increased pricing pressure, especially those in the spinal and orthopedic care markets.

"In some countries like the U.K., we expect to see those pressures in the fourth quarter of 2010 as the fiscal 2011 budget kicks in," he said.

Companies that earn the bulk of their revenue in the United States, such as NuVasive Inc., for which the United States accounts for about 90% of its sales, are unlikely to be affected by pricing pressures in the European Union.

First Ready-to-Use Silicone Lubricant for the Medical Device Industry Introduced at MD&M East

Duraglide lubricants are offered by MicroCare Medical.

MicroCare Medical (New Britain, CT), a supplier of cleaners, additives, coatings, and lubricants, and silicone specialist Dow Corning Corp. (Midland, MI) have announced a partnership that has yielded what they claim is the first ready-to-use silicone lubricant developed specifically for the medical device industry. Developed to ensure patient comfort by minimizing friction, the PDMS-based Duraglide Siloxane lubricants are custom-formulated to suit customers' application-specific requirements.

"A lot of sharps in the medical industry, such as syringe needles and knives, are coated with a silicone-type of treatment to make it so that they are more comfortable when piercing skin," explains Jay Tourigny, vice president of operations for MicroCare Medical. "Until today really, [OEMs] would have to buy a concentrate and then mix it down to the actual formula that they would use."

Although adept at engineering and manufacturing, many companies lack the skills to adequately mix solvents or chemicals and achieve coating consistency, Tourigny notes. As a result, parts may be produced that are underlubricated, which can cause patient trauma, or overlubricated. "On a syringe needle, for example, if you overlubricate it, the silicone can stay wet indefinitely and you can actually dilute whatever it is you are trying to inject into the patient in terms of the medicine," Tourigny says.

By partnering with Dow Corning, however, MicroCare Medical can supply companies with a premixed, calibrated formula so that they can avoid the in-house mixing of solvents or chemicals altogether. In addition to simplifying the coating process, this offering also saves companies time and effort because they only have to qualify one process.

In addition to speaking about the Duraglide Siloxane lubricants while at MD&M East, MicroCare Medical is also promoting its general DuraGlide family of dry film lubricants. The line is designed to help engineers and manufacturers address challenges of stacked tolerances, which are found in a variety of devices, including single-use products. To do so, the lubricant film helps to reduce forces required to actuate the device by 25 to 30%, according to the company. 

Voodoo or Viable Treatment?

Powered by a battery pack that is slightly smaller than a laptop, the device is connected to patients for 20 hours a day. Healthy brain cells aren't affected because they don't divide, according to NovoCure's Eilon Kirson, who heads R&D. Although already approved for use in Europe, the product still has its skeptics.

"I think the technology is interesting, but I think it's totally unproven," said Henry Friedman, a professor of neuro-oncology at Duke University.

Roger Stupp, a researcher involved with the current clinical studies for the device, says that patients using the Novo TTF had much fewer side effects than chemotherapy patients. He also said that when the company first approached him about the device, he thought the idea was "completely voodoo, goofy, nuts."

NovoCure plans to meet soon with FDA to discuss the filing of an application for approval.

Steve Wilcox Speaks about FDA Infusion Pump Workshop

This Week In Brief: June 8, 2010

Contract manufacturer Melitron (Guelph, Ontario, Canada) has announced the launch of a new Web site designed to aid OEMs in evaluating outsourcing capabilities. The site provides information on the company's manufacturing capabilities and product expertise. It also highlights the technology markets that the company serves. A full-service contract manufacturer of precision metal components, electronic chassis, industrial enclosures, and frames and racks, the firm provides manufacturing technologies and automated systems for medical device OEMs. Its services include design and prototyping, fabrication, finishing, and assembly operations.

Carnegie Mellon University (Pittsburgh) will be holding the Fourth Annual Materials Science and Engineering Graduate Symposium in the spring of 2011. Started three years ago as a half-day event to showcase graduate-student research, the symposium has expanded into a full-day symposium. This spring, the event featured 14 oral presentations, 19 poster presentations, and corporate sponsorship in the form of a grant from Goodfellow Corp. (Oakdale, PA), a supplier of metals and materials for research and industry.

Okuma America Corp. (Charlotte, NC), a provider of CNC and machining technology, has announced that WTO (Charlotte, NC), a manufacturer of precision tool holders, has joined Partners in THINC (Charlotte, NC), a facility and concept offering integrated solutions and a one-stop shop designed to streamline manufacturing processes, improve capabilities, and explore advanced manufacturing options. As a member of Partners in THINC, WTO will work closely with Okuma Engineering to ensure that the latest technology is available to maximize machine utilization.

Avery Dennison Corp. (Pasadena, CA) is marking its 75th anniversary. Founded in June 1935 by R. Stanton Avery, who is said to have developed the world's first self-adhesive label and label-making machinery, the company offers pressure-sensitive technology and materials.