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Medical “Lightsabers” Take Laser Precision to the Next Level

Medical “Lightsabers” Take Laser Precision to the Next Level

The use of medical lasers could be further expanded as their precision is improved. At present, lasers’ risk of damaging healthy tissue limits their application when used to target sensitive tissues such as those found in the brain, throat, and digestive tract.

To address this issue, a team of scientists at the University of Texas at Austin (UT Austin) has developed a flexible endoscopic device equipped with a femtosecond laser scalpel that can remove target tissue while sparing healthy surrounding cells. The technology could lead to a paradigm shift in the clinical use of lasers, says Adela Ben-Yakar, who heads the research at UT Austin. “It will enable new treatments as well as [improve] the current ones.”

The medical "light saber" emits bursts lasting only 200 quadrillionths of a second and is equipped with a mini-microscope that enables high precision for delicate procedures. The current endoscope probe package measures 23 millimeters in length with a circumference of 9.6 millimeters, enabling it to fit into large endoscopes.

The packaged endoscope overlaid with the optical system. Image courtesy of Ben-Yakar Group, University of Texas at Austin.

Ben-Yakar got involved in this research nearly a decade ago while doing postdoctoral research at Stanford University. “I was studying the laser interaction of materials and they were very precise and very clean. They could make very precise and clean cuts,” she says. “And then I started using them in cells and in biological tissues. I saw that the biggest impact really would come in biology and medicine,” she continues. “I got excited about this project and [the prospects of] bringing it to the clinic eventually.”

The initial applications that the researchers are targeting include eye surgery, repairing the vocal cords, and the removal of small tumors in the spinal cord or other tissues.

An image taken with the probe's two-photon fluorescence microscope shows cells in a 70-micrometer thick piece of vocal cord from a pig. Image courtesy of Ben-Yakar Group, University of Texas at Austin.

Ben-Yakar estimates that the device will be ready for commercialization in about five years. “We will need a couple of years of animal studies and also a couple of years of clinical studies beforehand,” she says.

One factor that may help facilitate regulatory approval is the fact that femtosecond lasers are already in use clinically. “Of course, for specific applications, we will still need to get FDA approval but that may be a Fast Track approval since the LASIK femtosecond has already been approved for eye surgery,” she says. “That hopefully should pave the way for it to be used for different applications.”

A Laser that Can ‘See’ as well as Cut

The technology could potentially be used for imaging applications as well. “It can be used to ‘see’ what is happening within the target tissue with high resolution,” Ben-Yakar says. “The doctor would have information about what is happening inside of the tissue while cutting the surface of the tissue.” This could prove to be especially useful for application such as spinal cord surgery, where a doctor must be very careful in removing unwanted tissue because of the risk of severing the nerve cord.

Ben-Yakar says that when she explains this functionality to surgeons their eyes light up and they say: “That is what we would like to have. A tool with a single laser that can see as well as cut. It may, however, be longer than five years before this imaging functionality is available commercially.

Brian Buntz is the editor-at-large at UBM Canon's medical group. Follow him on Twitter at @brian_buntz.

Minuscule Nanoparticles Could Improve Cancer Therapy

A Nanowerk article by Carl Walkey from the integrated nanotechnology and biomedical sciences laboratory at the University of Toronto reports that Chinese researchers have shown that nanoparticles smaller than 10 nm in diameter accumulate more efficiently and penetrate more deeply in tumors than larger nanoparticles.

Most nanomaterials approved for clinical use are approximately 100 nm in diameter, according to Walkey. However, this large size prevents them from diffusing effectively within the tumor. Remaining near the vessel wall, they can reach only the first few layers of tumor cells. Consequently, current nanomaterials used for medical therapeutic applications do not destroy tumor cells that lie far from blood vessels.

The Chinese team, headed by Xing-Jie Liang at the National Centre for Nanoscience and Nanotechnology (Beijing), synthesized 2-, 6-, and 15-nm gold nanoparticles stabilized with the thiolated molecule tiopronin. Introducing these nanoparticles into a 3-D breast cancer tumor model, they discovered that the 2-nm particles accumulated over 10 times more efficiently and penetrated more deeply than the 15-nm particles.

Importantly, the ability of the ultrasmall nanoparticles to penetrate more deeply than larger particles enables them to penetrate to the subcellular level. In contrast to the 15-nm nanoparticles, the 2- and 6-nm nanoparticles diffused throughout the cytoplasm and even entered the cell nucleus. This is significant because stopping the growth of cancer cells often requires access to their DNA.

Walkey notes that while the ability of ultrasmall nanoparticles to diffuse deep into the tumor may foster the design of better therapeutic nanoparticles, the gold nanoparticles used in Liang's study are not suitable for clinical applications. To be effective in the battle against cancer, future nanoparticles will have to dispense with gold cores. Nevertheless, the ability of minuscule nanoparticles to penetrate deeply into tumor cells will influence the design of future cancer-fighting nanomaterials.

Will the Medical Device Tax Force You to the Unemployment Line? | Medical Device Podcast

Stryker, Hill-Rom, and Zimmer. What's the common denominator between all three of these large medical device companies? Come on, this is a total softball. For those of you that went to public school, the answer is LAYOFFS. All three device companies have attributed their recent layoffs to the impeding 2.3% medical device excise tax. But wait, there's more...

Stephen Ferguson, Chairman of the Board, The Cook Group
Both the Office of Management & Budget and the Joint Committee on Taxation estimate the device tax will raise about $20 billion from 2013 through 2020. A MassDevice.com analysis revealed that the tax is likely to bring in more than $2 billion in revenues next year from the top 50 medical device companies alone.

Want more? AdvaMed estimates the tax will kill between 39,000 and 43,000 medtech jobs. A recent KPMG survey revealed that over 60% of medical device executives believe it will increase tax compliance costs.

Okay, you get it. So let's pass the baton to Mr. Steve Ferguson, the Chairman of the Board of the Cook Group, Inc. Yes, that Cook. The parent of companies worldwide involved in the research, development, manufacture, and sale of medical devices. Before his days at Cook, Steve was a partner in the law firm of Ferguson, Ferguson & Lloyd from 1966 to 1990, and remains of-counsel with the firm Ferguson & Ferguson. He served four terms in the Indiana House of Representatives from 1967 to 1974. Ferguson received his A.B. from Wabash College in 1963 and a J.D. with distinction from Indiana University School of Law in 1966.

In this interview with Steve Ferguson, we learn all about the 2.3% medical device tax and its potential implications.

Here's What You Will Learn
  • Why has Cook taken such a vocal stance in the effort to repeal the 2.3% medical device tax?
  • Why haven't other large medical device companies followed in the footsteps of Cook? Because of fear? Because the tax will hurt smaller companies the most? Is there more to the story?
  • The medical device tax is top-line in nature. What does this mean and how will it impact the bottom line for medical device companies?
  • Why was the medical device tax even considered in the first place? Learn why it actually could have been worse than it is now!
  • But millions more people will be insured through healthcare reform. Won't medical device companies benefit from this? Steve dispels the myths to this theory.
  • Can't medical device companies just pass along the increased costs to their customers?
  • The rather obvious potential negative ramifications of the medical device tax: Outsourced manufacturing, layoffs, reduced investment in R&D, increased compliance costs. Needless to say, the list is rather long.
  • Is industry powerless to fight back? What actions can you take today to help repeal the medical device tax?

Listen to the "Will the Medical Device Tax Force You to the Unemployment Line?" podcast (right click and select "Save Link As" to download the podcast).

Download the PDF action points of the "Will the Medical Device Tax Force You to the Unemployment Line?" podcast.

Could Liquidmetal Be the Newest 'Miracle' Material for Medical?

Could Liquidmetal Be the Newest 'Miracle' Material for Medical?

Following reports that its metal alloy might be used in an upcoming iteration of the iPhone, Liquidmetal Technologies Inc. (Rancho Santa Margarita, CA) was inundated with inquiries from potential customers. Marketing manager Dennis Ogawa fielded so many calls he lost his voice.

Liquidmetal has a number of properties, including hardness and corrosion-resistance, that might make it a good material for use in medical devices.

“It’s been overwhelming,” he says.

Some of the interest came from companies in the medical device space, which the company hopes will grow as a share of its business in the coming years.

Liquidmetal is the commercial name for a number of amorphous liquid metal alloys developed in the 1990s by researchers at the California Institute of Technology. Liquidmetal Technologies licensed the original alloy and has since been awarded or licensed more than 50 patents relating to the technology.

The material has characteristics that might make it a good fit for use in medical devices. Liquidmetal is harder than titanium and 20% lighter than stainless steel. It’s also biocompatible and wear-, water-, and corrosion-resistant, according to the company. Similar to plastics, the alloys can be injection molded.

“We can make [a part] in two to three minutes instead of two to three hours or two to three days,” says president Tom Steipp.

Tests by customers have shown that the material is nonmagnetic—making it potentially suitable for use in MRI—though the company has not verified those tests. Its hardness, strength, and durability also make Liquidmetal a good material for use in a variety of medical devices, including scalpels and implants, according to the company.

At least two medical device products featuring Liquidmetal have come to market. The ezlase Diode Dental Laser System, from Biolase Technology (Irvine, CA), uses the material for most of its housing, according to Biolase’s entry for the 2007 Medical Design Excellence Awards, put on by MD+DI. The material helped make the portable device durable and allowed it to achieve good heat dissipation, protection from impact and radiation, a compact size, and an ergonomic shape. Tooling costs were in line with those for similar plastic injection molding, according to the submission. The company produced five housing components in production quantities for under $50.

The ezlase Diode Dental Laser System, from Biolase Technology, uses Liquidmetal in its housing.

Biolase also used Liquidmetal for the housing of the iLase, a handheld pen laser for dental procedures, says Matt Duncan, president and industrial designer at Morphix Design (San Clemente, CA), which provided contract design assistance on the iLase and ezlase. He says Biolase was drawn to the material for its strength, ability to be molded to a thin wall thickeness, and ornamental finish.

Biolase used Liquidmetal mainly for aesthetics, and Duncan says he would want to conduct more testing before using it for a mechanical purpose. “That would be the case for any material,” he says.

Liquidmetal’s limitations include poor performance in temperatures sustained above 500°F, though Ogawa says that’s not typically a concern in medical devices. Its high-cycle fatigue rate—an important factor for ultrasonic applications—is undetermined.

An 18-month study to determine the biocompatibility of the material was conducted at Louisiana State University, and the company provided MD+DI with a summary matrix of the results for two of its alloys. An expert who reviewed the document for MD+DI noted apparent typos, missing information regarding test dates, and unclear or inconclusive results.

“If a toxicologist were to look at this, they would have a problem using this to really feel comfortable signing off on it to say, ‘OK, it’s safe for use,’” says Len Czuba, an MD+DI editoral advisory board member and principal at product design and development firm Czuba Enterprises (Lombard, IL).

Ogawa responded that the summary matrix was a confidential general summary for internal company communications and for nonmedical audiences. “The animal study results are not intended to convey that the material is exhaustively studied for full toxicology or readiness for application as human implants,” he says. “The company offers to share the results of the 18-month study from Louisiana State University (conducted October 15, 2002—December 1, 2003) upon execution of a mutual NDA.”

None of the current Liquidmetal alloy families contain lead or heavy metals, but Ogawa couldn't rule out the presence of tin.

"The potential presence of tin or other materials may occur as standard components, as trace elements, or natural impurities," he told MD+DI in an e-mail.

DePuy Orthopaedics researched the material for use in knee implants in 2002. Bernice Aboud, manager for metallurgy research with Depuy, said although Liquidmetal showed “promising properties,” the company chose not to bring any products using the material to market. “...[I]t didn’t meet our needs,” spokeswoman Jessica Masuga, said in a statement. “We haven’t pursued further use of this technology.”

Duncan says medical device makers might be wary of using Liquidmetal for a couple of reasons. They might be afraid to be tied to a material with a single source or simply afraid to use something that’s fairly new and not yet widely used.

“If Apple starts using it, look out,” Duncan says. “I think that will probably legitimize it as a go-to material, at least for a while.”

Jamie Hartford is the associate editor of MD+DI. Follow her on Twitter @readMED.

Electrochemotherapy Shows Promise as Alternative Treatment for Head and Neck Cancer

OncoSec Medical Inc., whose medical electroporation technology we covered recently, has announced positive results from a Phase IV study involving 81 subjects with primary and locally recurrent squamous cell carcinoma of the head and neck. The patients were treated with the company’s OMS ElectroChemotherapy technology and showed local tumor control and quality-of-life outcomes that compare favorably to standard outcomes associated with surgery. Notably, the study demonstrated local tumor control in 94% of primary and 57% of recurrent tumors that were treated with the technology.

Applicators OncoSec 

“The ElectroChemotherapy technology is not as capital-intensive but it really puts the same sorts of ablation in the hands of surgeons.”
—Paul Goldfarb, MD

OncoSec Medical president and CEO Punit Dhillon explains that the ElectroChemotherapy technology will play an important role in the company’s overall portfolio, the main focus of which is its core immunotherapy IL-12 DNA electroporation technology. “Having done this retrospective analysis of the previously completed Phase IV study using bleomycin shows a promise in squamous cell cancer in head and neck, and the data has presented a positive outcome,” Dhillon says. “We are very interested in continuing to push the efforts to commercialize this ElectroChemotherapy technology because it is a later-stage program than our ElectroImmunotherapy pipeline.”

Punit Dhillon
OncoSec Medical president and CEO Punit Dhillon. 

Another important aspect of this treatment is its relatively low cost as opposed to standard of care. “Most of the ablative technologies used to treat cancers like these are so capital-intensive that they are really precluded from being used in many areas in the world,” says Paul Goldfarb, MD, OncoSec’s medical director with experience in surgical oncology. “The ElectroChemotherapy technology is not as capital-intensive but it really puts the same sorts of ablation in the hands of surgeons.”

The technology has the ability to ablate tumors and yet preserve the surrounding normal tissue. “That is what makes it different in many ways from many of the other technologies that ablate tumors: radiation therapy, surgery, or radiofrequency cryo,” Goldfarb says. “I think that the nice thing about the Phase IV is that it demonstrates that this is really an effective technology at treating primary cancers as well as for treating metastatic disease. I think that it offers a real potential.”

The secondary endpoints of the study were measuring the impact in terms of functional outcomes with the patients who were treated with the technology. “The functional outcome was better than with major surgical resection—certainly in recurrent cancer,” Goldfarb says.

“The Phase IV study was a single-arm study that is sort of a prelude of what to expect from our Phase III program that actually had surgery as a comparison arm,” Goldfarb continues. “That study will include survival information for the patients.” 

OncoSec

Developments regarding OncoSec's ElectroImmunotherapy Platform

OncoSec is also continuing to advance its clinical development plan for its OMS ElectroImmunotherapy platform, which is used to treat rare and deadly skin cancers. The firm has enrolled several patients in a Phase II study, called OMS-I100, which will treat metastatic melanoma. The University of California in San Francisco is leading that study with additional sites at the John Wayne Cancer Institute (Santa Monica, CA) and Lakeland Comprehensive Cancer Center (Lakeland, Florida).

In addition, the firm has enrolled several patients in a separate Phase II study known as OMS-I110 for the treatment of Merkel cell carcinoma. That study is being led by the University of Washington and the Fred Hutchinson Cancer Center in Seattle. 

Finally, the company is planning to begin enrolling patients in a Phase II study for the treatment of cutaneous T-cell lymphoma. That study, known as OMS-I120, is expected to begin by the end of 2012 and will be led by the University of California.

Brian Buntz is the editor-at-large at UBM Canon's medical group. Follow him on Twitter at @brian_buntz. 

Congress to Take Up Medical Device Tax Repeal After Memorial Day Weekend

House Republicans are set to vote on Erik Paulsen's (R-Minn.) bill to repeal the tax on medical devices following Memorial Day weekend. Paulsen has become one of the medical device industry's strongest proponents in Congress. GOP leaders have decided to move forward with the bill following the holiday weekend, Paulsen told Minnesota Public Radio Tuesday night.

The bill, titled the Protect Medical Innovation Act, was first introduced in April 2010 and had 236 cosponsors from both parties in the House as of last week Friday, more than enough for passage. Medical device makers will be required to pay a 2.3 percent tax on revenue in 2013 contained in President Barack Obama's Patient Protection & Affordable Care Act.

As reported by PostStar.com on May 20, US Rep. Bill Owens (D-Plattsburgh) also agreed to cosponsor legislation to repeal a tax on the medical device industry that is set to take effect next year.

Medical device manufacturers and industry associations are afraid that the medical device tax will cause companies to cut back on research and development and make US plants less competitive with those in other countries, forcing US jobs overseas.

––Yvonne Klöpping

This Week In Devices - [5/25/12]: Are Medical Devices a Ticking Time Bomb?

This Week in Devices [ 5/25/12] : Are Medical Devices a Ticking Time Bomb?

 

Medical Devices – A Ticking Time Bomb?

  • The Economist examines the potential dangers as medical devices become more digitized and networked

    Source: The Econonmist


     

Medical Device Manufacturers get a Little Help from NASA

  • Since they aren't launching space shuttles anymore NASA engineers are reaching out to other industries to provide assistance and expertise – including companies in the medical device sector.

    Source: Cleveland.com
 

A Better, Faster Wheelchair

  • New Zealand-based design student Oscar Fernandez has created a model for a wheelchair that quickly and easily converts into a motorized scooter for more speed and power. 

    Source: Wired
 

A DIY X-Ray Machine?

  • A high school student builds his own x-ray machine for $700.
    Source: Popular Science
 

Weekly Vitals: Senate OKs MDUFA, Medtech Jobs in Jeopardy, and More

It was an action-packed week for the medical device industry. As expected, the Senate passed the MDUFA reauthorization bill. Plus, Medtronic announced layoffs, prompting us to take a look back at some of the most hard-hitting layoffs experienced by the medical device industry in the past 18 months. And last but certainly not least, winners of the 2012 Medical Design Excellence Awards were announced this week in conjunction with the MD&M East trade show. Read about these and more stories in our weekly roundup below.

2012 MDEA Winners

MD+DI is proud to present the WINNERS of the 2012 MDEA competition!

Sponsored by MD+DI and organized by UBM Canon, the Medical Design Excellence Awards (MDEA) competition is the premier awards program for the medical technology community, recognizing the achievements of medical product manufacturers and the many people behind the scenes—engineers, scientists, designers, and clinicians—who are responsible for the groundbreaking innovations that are changing the face of healthcare

 
 
Winning products were announced at the MDEA Presentation Ceremony held on Wednesday, May 23, 2012 at 4:30 pm during a cocktail reception inside the Philadelphia Marriott Downtown hotel. The ceremony was held in conjunction with the MD&M East Event at the adjacent Pennsylvania Convention Center, May 22-24.
 

Critical-Care and Emergency Medicine Products

Dental Instruments, Equipment, and Supplies

Finished Packaging

General Hospital Devices and Therapeutic Products

Implant and Tissue-Replacement Products

In Vitro Diagnostics

Over-the-counter and Self-care products

Radiological and Electro-mechanical Devices

Rehabilitation and Assistive-Technology Products

Surgical Equipment, Instruments, and Supplies

For more information about the Medical Design Excellence Awards—including additional details about the manufacturers and suppliers that created the 2012 MDEA-finalist products—visit the MDEA website at www.MDEAwards.com or e-mail:[email protected].

Manufacturing Systems Today: Stent & Catheter Manufacturing

Catheter tube-bonding system
Beahm DesignsThe Split Die Thermal Bonder 620B catheter manufacturing system from Beahm Designs Inc. combines two processing steps in one machine to shorten cycle times and reduce the likelihood of error. The machine offers users the ability to preshrink and bond, or fuse, two components of different diameters by applying heat and radial compression. Two heating-cooling process cycles, combined with the system's dual-die head bores, allow preshrinking and welding to be performed within a single process cycle. Bond widths can vary, and very narrow weld profiles are possible. Bonding in demanding applications, such as those calling for short balloon bonds and ultrasmooth lap and butt welds, can be executed with high precision, according to the manufacturer. The system is designed to provide high repeatability as well.
Beahm Designs Inc.
LOS GATOS, CA

Blockwise EngineeringStent-crimping machine
The J-Crimp Model RJG stent-crimping machine is a full-featured radial-compression machine suitable for performing the stent attachment step in the assembly of balloon-expandable stent-delivery catheters, as well as other medical device manufacturing functions. Available from Blockwise Engineering LLC, the unit is centered on a radial-compression station with hardened-stainless-steel dies that form a cylindrical opening whose diameter can range up to 16 mm. It is suited for volume production because process parameters are stored in the memory of a programmable logic controller (PLC), and it promotes process flexibility by allowing a sequence of diameter- or force-controlled steps. A stepper motor provides power to open and close the compression station, an integrated encoder measures the diameter of the opening, and a force transducer measures the actuating force, which is proportional to the radial compression force. The system's PLC controls the compression force and may also control pressurization and evacuation of the balloon and the temperature of the compression dies.
Blockwise Engineering LLC
TEMPE, AZ

Catheter-tipping machine
Cath-TipA precision system for tipping medical catheters can form tips on and weld catheter components made from almost all thermoplastic materials, in addition to handling challenging tipping and bonding applications. Powered by a 1.0-kW, 450-kHz, radio-frequency generator and using high-density-carbide tipping dies, this semiautomatic machine is designed and built by Cath-Tip Inc. for rigorous industrial use. It has a keypad-entry programmable controller for heat control, part feed, part clamping, and air cooling. Two-stage heating optimizes heat control and cycle times. A stepper motor and leadscrew drive are programmed for precision part feeding and placement. In addition, quick-change tooling makes product changeovers and cleaning simple, and programmable air cooling accelerates the lowering of die temperatures to keep the tipping cycle short.
Cath-Tip Inc.
SANDY, UT

Tube- and stent-cutting system
Precision Automated Laser Systems Inc. offers the easy-to-operate PTCS-10F precision tube-cutting system for wet or dry cutting of tubular metal components ranging in diameter from 0.010 to more than 1 in. Featuring fiber laser sources and automated material indexing, the system can cut stents and catheters. It is suited for cutting nitinol stents, allowing the use of oxygen or argon assist gases when cutting wet or dry. The compact unit has application in both large production facilities and small R&D labs and can be used to advantage by job shops and providers of part-processing services.
Precision Automated Laser Systems Inc.
SAN CLEMENTE, CA

Balloon catheter inspection system
Interface CatheterThe Auto-i 360 balloon inspection system is intended to enhance catheter quality control by making it easier to find, identify, and classify such defects as gel spots, "fish eyes," and foreign particles. Manufactured by Interface Catheter Solutions, the system performs both visual inspection and dimensional measurement of medical balloons in a single operation, classifying and sizing defects and issuing a pass-fail determination with detailed analysis and data reporting. It uses a high-speed camera and telecentric measuring lens to measure all dimensional aspects of the balloon and detect even very small flaws. Its pressure capability to 13 atm makes it compatible with compressed air or nitrogen. Gauge R&R analyses have found the system to be an accurate, consistent, and reliable tool for balloon inspection that can significantly reduce inspector-to-inspector variability.
Interface Catheter Solutions
LAGUNA NIGUEL, CA