Archive for September 29th, 2012

Page 1 of 212

Levitating Drugs May Improve Efficacy

Levitating Drugs May Improve Efficacy

Levitating Drugs May Improve Efficacy

It’s not a magic trick and it’s not sleight of hand – scientists really are using levitation to improve the drug development process, eventually yielding more effective pharmaceuticals with fewer side effects.

Scientists at the U.S. Department of Energy’s (DOE) Argonne National Laboratory have discovered a way to use sound waves to levitate individual droplets of solutions containing different pharmaceuticals. While the connection between levitation and drug development may not be immediately apparent, a special relationship emerges at the molecular level.

At the molecular level, pharmaceutical structures fall into one of two categories: amorphous or crystalline. Amorphous drugs typically are more efficiently taken up by the body than their crystalline cousins; this is because amorphous drugs are both more highly soluble and have a higher bioavailability, suggesting that a lower dose can produce the desired effect.

“One of the biggest challenges when it comes to drug development is in reducing the amount of the drug needed to attain the therapeutic benefit, whatever it is,” said Argonne X-ray physicist Chris Benmore, who led the study.

“Most drugs on the market are crystalline – they don’t get fully absorbed by the body and thus we aren’t getting the most efficient use out of them,” added Yash Vaishnav, Argonne Senior Manager for Intellectual Property Development and Commercialization.

Getting pharmaceuticals from solution into an amorphous state, however, is no easy task. If the solution evaporates while it is in contact with part of a vessel, it is far more likely to solidify in its crystalline form. “It’s almost as if these substances want to find a way to become crystalline,” Benmore said.

In order to avoid this problem, Benmore needed to find a way to evaporate a solution without it touching anything. Because liquids conform to the shape of their containers, this was a nearly impossible requirement — so difficult, in fact, that Benmore had to turn to an acoustic levitator, a piece of equipment originally developed for NASA to simulate microgravity conditions.

Levitation or “containerless processing” can form pristine samples that can be probed in situ with the high-energy X-ray beam at Argonne’s Advanced Photon Source. “This allows amorphization of the drug to be studied while it is being processed,” said Rick Weber, who works on the project team at the synchrotron.

The acoustic levitator uses two small speakers to generate sound waves at frequencies slightly above the audible range – roughly 22 kilohertz. When the top and bottom speakers are precisely aligned, they create two sets of sound waves that perfectly interfere with each other, setting up a phenomenon known as a standing wave.

At certain points along a standing wave, known as nodes, there is no net transfer of energy at all. Because the acoustic pressure from the sound waves is sufficient to cancel the effect of gravity, light objects are able to levitate when placed at the nodes.

Although only small quantities of a drug can currently be “amorphized” using this technique, it remains a powerful analytical tool for understanding the conditions that make for the best amorphous preparation, Vaishnav explained.

Argonne researchers have already investigated more than a dozen different pharmaceuticals, and the laboratory’s Technology Development & Commercialization Division is currently pursuing a patent for the method. Technology Development & Commercialization is also interested in partnering with the pharmaceutical industry to develop the technology further as well as to license it for commercial development.

After adapting the technology for drug research, the Argonne scientists teamed up with Professors Stephen Byrn and Lynne Taylor at the Department of Industrial and Physical Pharmacy at Purdue University and Jeffery Yarger of the Department of Chemistry and Biochemistry at Arizona State University. The group is now working on identifying which drugs the levitation instrumentation will impact most strongly.

Argonne National Laboratory seeks solutions to pressing national problems in science and technology. The nation’s first national laboratory, Argonne conducts leading-edge basic and applied scientific research in virtually every scientific discipline. Argonne researchers work closely with researchers from hundreds of companies, universities, and federal, state and municipal agencies to help them solve their specific problems, advance America’s scientific leadership and prepare the nation for a better future. With employees from more than 60 nations, Argonne is managed by UChicago Argonne, LLC for the U.S. Department of Energy’s Office of Science.

DOE’s Office of Science is the single largest supporter of basic research in the physical sciences in the United States, and is working to address some of the most pressing challenges of our time. For more information, please visit science.energy.gov.

It is ironic that the process used to discover pharmaceutical drug targets is the same one that decreases the actual efficacy of those drugs once ingested.crystalline vs amorphous Levitating Drugs May Improve Efficacy If you remember from basic chemistry, there are compounds that exist in highly ordered crystalline states and those that remain in amorphous form. The discovery of drug targets has often been accomplished through X-ray crystallography, which requires a sample (for example, of a defective enzyme linked to cancer or high cholesterol) to be crystallized so that the diffraction patterns can be made sense of. Scientists may spend years trying to crystallize one molecule or compound so that they can identify regions that, for example, may be blocked by pharmaceuticals.

However, when it comes to the molecular arrangement of those pharmaceuticals, crystallization actually decreases their bioavailability and solubility. Thus, it may be better for these drugs to be in amorphous form. (For a good, short summary of crystalline versus amorphous drugs, check out this slideshow). This is easier said than done because the drug preparation process is unforgiving and often leads to unintended crystallization, which is exacerbated when the solution evaporates when it is in contact with the holding vessel.

Researchers at the U.S. Department of Energy’s Argonne National Laboratory are applying a NASA technology – acoustic levitation – to this problem in an effort to improve the drug development process. Their answer: get rid of the vessel. As explained in Argonne’s press release:

The acoustic levitator uses two small speakers to generate sound waves at frequencies slightly above the audible range – roughly 22 kilohertz. When the top and bottom speakers are precisely aligned, they create two sets of sound waves that perfectly interfere with each other, setting up a phenomenon known as a standing wave.

At certain points along a standing wave, known as nodes, there is no net transfer of energy at all. Because the acoustic pressure from the sound waves is sufficient to cancel the effect of gravity, light objects are able to levitate when placed at the nodes.

Although only small quantities of a drug can currently be “amorphized” using this technique, it remains a powerful analytical tool for understanding the conditions that make for the best amorphous preparation…

The labs also released this video demonstrating their levitating droplet approach:

It will be interesting to see how Argonne, or peer groups of researchers, improve upon this process and make it scalable so that larger quantities of drugs may be produced. Currently the researchers are determining which drugs may benefit the most from this new production process, especially because amorphous compounds are generally less stable and degrade faster than their crystalline counterparts.

Source : http://www.anl.gov/articles/no-magic-show-real-world-levitation-inspire-better-pharmaceuticals

Full story

Medtronic Affinity Fusion Blood Oxygenation System Cleared in Europe

Medtronic Affinity Fusion Blood Oxygenation System Cleared in Europe

Medtronic Affinity Fusion Blood Oxygenation System Cleared in Europe

MINNEAPOLIS – September 24, 2012 – Medtronic, Inc. (NYSE: MDT) today announced Conformité Européenne (CE) Mark for its new Affinity Fusion® oxygenation system in Europe. This system, which is designed to serve as a patient’s lungs by oxygenating and removing carbon dioxide from blood during various open-heart surgical procedures, incorporates numerous innovations for patient safety and ease of use. Notably, system enhancements are designed to prevent and remove air bubbles that can enter the blood during the procedure, which may reduce the risk of stroke.

The Affinity Fusion oxygenation system’s new design enhancements include:

A proprietary fiber winding process with an interlaced pattern that efficiently filters the blood and removes particles and air while at the same time oxygenating the blood;

Smooth tubular pathways for blood to pass through and a first-of-its-kind curved venous inlet tube, both of which reduce blood turbulence during the surgical procedure;

Enhanced setup and customization capabilities, including a new oxygenator system holder, which gives perfusionists improved flexibility and ease of use in various operating rooms, including those with limited space.

“The new Affinity Fusion oxygenator is designed to provide perfusionists with the most innovative and enhanced product of its kind,” said cardiac surgeon Dr. John Liddicoat, senior vice president and president of Medtronic’s Structural Heart division. “With so many patients who undergo cardiac surgery each year, Affinity Fusion provides patients with a reliable oxygenation system they can count on.”

The Fusion oxygenation system is used by perfusionists during open-heart surgical procedures that require a bloodless, motionless surgical field, such as lifesaving cardiopulmonary bypass surgery. As temporary “lungs,” the system adds oxygen and removes carbon dioxide from the blood. This year, cardiopulmonary bypass will occur in roughly 1 million patients worldwide1. The development process of the Fusion oxygenator included extensive collaboration between Medtronic engineers and more than 500 perfusionists worldwide.

“During cardiopulmonary bypass, it is imperative that the equipment is designed to maximize patient safety, yet is also sophisticated, versatile and simple to use,” said Simon Phillips, chief clinical perfusionist at St George’s Hospital in London. “Being part of the collaboration process during the Affinity Fusion oxygenation system development, I am confident that this new technology will benefit patients who undergo these lifesaving procedures and the surgical teams that use it.”

The Affinity Fusion oxygenator is not available in the United States, but Medtronic plans to submit an application for U.S. clearance.

In collaboration with leading clinicians, researchers and scientists, Medtronic offers the broadest range of innovative medical technology for the interventional and surgical treatment of cardiovascular disease and cardiac arrhythmias. The company strives to offer products and services that deliver clinical and economic value to healthcare consumers and providers worldwide.

Medtronic has received the CE Mark for the Affinity Fusion, a system for oxygenating blood and removing CO2 during open heart surgeries. The company spent considerable effort designing the device to minimize the formation of air bubbles in the oxygenated blood that can lead to dangerous side effects like stroke.

Medtronic is planning on submitting papers to the FDA to seek approval for the Affinity Fusion in the U.S.

New features from the announcement:

A proprietary fiber winding process with an interlaced pattern that efficiently filters the blood and removes particles and air while at the same time oxygenating the blood;

Smooth tubular pathways for blood to pass through and a first-of-its-kind curved venous inlet tube, both of which reduce blood turbulence during the surgical procedure;

Enhanced setup and customization capabilities, including a new oxygenator system holder, which gives perfusionists improved flexibility and ease of use in various operating rooms, including those with limited space.

Source :http://wwwp.medtronic.com/Newsroom/NewsReleaseDetails.do?itemId=1348163679308&lang=en_US

Full story

New Tool for a Steadier Hand in Microsurgery (video)

New Tool for a Steadier Hand in Microsurgery (video)

New Tool for a Steadier Hand in Microsurgery (video)

WASHINGTON, Sept. 27, 2012—Even the most skilled and steady surgeons experience minute, almost imperceptible hand tremors when performing delicate tasks. Normally, these tiny motions are inconsequential, but for doctors specializing in fine-scale surgery, such as operating inside the human eye or repairing microscopic nerve fibers, freehand tremors can pose a serious risk for patients.

By harnessing a specialized optical fiber sensor, a new “smart” surgical tool can compensate for this unwanted movement by making hundreds of precise position corrections each second – fast enough to keep the surgeon’s hand on target. Researchers from the Johns Hopkins University Whiting School of Engineering and Johns Hopkins School of Medicine in Baltimore, Md., have combined the Optical Coherence Tomography (OCT) imaging technique as a distance sensor with computer-controlled piezoelectric motors to actively stabilize the tip of a surgical tool. A paper describing their new device, named SMART (Smart Micromanipulation Aided Robotic-surgical Tool), was published today in the Optical Society’s (OSA) open-access journal Optics Express.

“Microsurgery relies on excellent motor control to perform critical tasks,” said Cheol Song, a postdoctoral fellow in the Electrical and Computer Engineering Department at Johns Hopkins. “But certain fine micro-manipulations remain beyond the motor control of even the most skilled surgeon.” At its most steady, the human hand naturally trembles, moving on the order of 50-100 microns (about the thickness of a sheet of paper) several times each second.

Various optomechatronics techniques, including robotics, have been developed to help augment stability and minimize the impact of hand tremors. None so far has been able to seamlessly merge simple fiber-optic rapid and fine-grained sensing with handheld automated surgical tools. The major challenge for researchers has been finding a way to precisely measure and compensate for the relative motions of a surgical instrument in relation to the target.

The emerging imaging technique of OCT attracted the attention of the researchers because it has higher resolution (approximately 10 microns) than either MRI or ultrasound. It also uses eye-safe near infrared light to image tissues.

To apply this imaging technique to their work, the research team first had to integrate an OCT-based high-speed high-precision distance sensor directly into a small, handheld surgical device. The device could then hold a variety of surgical instruments at the tip, such as a scalpel or forceps. The well-known fiber-optic based common path optical coherence tomography (CP-OCT) technique provided the essential capability. As its name suggests, the optical signal of this sensor uses the same path, or optical fiber, to both transmit and receive the near infrared light.

Because this single fiber-optic cable is so small and flexible, the researchers could easily integrate it into the front of a tool used for eye surgery. By continually sending and receiving the near infrared laser beams, the high-speed fiber-optic sensor precisely measures the motion of the probe. This information then feeds to a computer that sends signals to small piezoelectric motors integrated into the surgical device to control the position of the tool tip. This creates a series of “station keeping” maneuvers that compensate for the surgeon’s hand tremors.

Combined, the sensor and motors can operate accurately at 500 hertz (500 times each second), which is much higher than the typical tremor frequency of 0-15 hertz.

The researchers compared the effectiveness of the system by testing its ability to compensate for hand tremors during 5- and 30-second intervals. According to the researchers, these time periods were sufficient to determine the different characteristic between short- and long-term hand tremors. “A 30-second time period is enough to evaluate a surgeon’s basic physiological hand tremor characteristics,” said Song. For complete characterization, however, a record of a full surgical procedure, which typically lasts more than 3 hours, will be needed.

For their study, the tests were performed on two targets. The first was a dry “phantom,” a material that has sufficient properties to stand as a proxy for medical research. A more real-world test was also done on a viable chicken embryo, which better simulated a realistic surgical environment because of the unpredictable movements of the live embryo.

During the next few years, the researchers hope to take their instrument from the laboratory to the operating suite, and with additional refinements expand its use to other fine-scale surgeries.

“The main objective of our research has been to make an established surgical tool ‘smarter’ by incorporating fiber-optic sensors and motion control to allow surgeons to maneuver the tool tip precisely and safely,” said Jin U. Kang, another researcher with the Electrical and Computer Engineering department at Johns Hopkins. “SMART, which is capable of fine motion control and sensing, could significantly enhance the surgical performance of doctors and minimize surgical accidents.”

Abstract: Microsurgeons require dexterity to make precise and stable maneuvers to achieve surgical objectives and to minimize surgical risks during freehand procedures. This work presents a novel, common path, swept source optical coherence tomography-based “smart” micromanipulation aided robotic-surgical tool (SMART) that actively suppresses surgeon hand tremor. The tool allows enhanced tool tip stabilization, more accurate targeting and the potential to lower surgical risk. Freehand performance is compared to smart tool-assisted performance and includes assessment of the one-dimensional motion tremor in an active microsurgeon’s hand. Surgeon hand tremor—the ability to accurately locate a surgical target and maintain tool tip offset distances—were all improved by smart tool assistance.

Imagine the best and most skilled surgeons in the world performing microsurgery. And then imagine there’s a new surgical tool in town to make even the best microsurgeons even better. Especially in microsurgery a steady hand is of utmost importance. But even the best surgeons have tiny, almost unnoticeable hand tremors. That’s human after all. Now researchers from Johns Hopkins have designed and tested a new surgical tool capable of correcting for these tiny hand movements.

The new device is named SMART, which stands for Smart Micromanipulation Aided Robotic-surgical Tool. It uses optical coherence tomography (OCT) as a distance sensor with computer-controlled piezoelectric motors to actively stabilize the tip of a surgical tool. With OCT imaging techniques it is possible to acquire imaging with a high resolution of under 10 microns. And as the physiological human trembling moves on the order of 50-100 microns, a high resolution imaging technique is required if you want to correct for it.

The researchers used fiber-optic based common path, swept source OCT, which uses one single fiber-optic cable to transmit and receive the near infrared light. This small fiber-optic cable was integrated into the front of a tool used in ophthalmic surgery. The SMART can operate at 500 hertz, compared to a human tremor frequency of 0-15 hertz. The ability to compensate for the hand tremors was tested in 5- and 30-second intervals. They used a viable chicken embryo and a phantom material to test it on.

In the coming years the SMART is planned to be taken from the lab the operating room. Hopefully this tool will not only enhance the hand movements of surgeons, but also take away a little bit of the trembling fear of patients who are planning to undergo microsurgery.

Source : http://www.osa.org/en-us/about_osa/newsroom/newsreleases/2012/cyborg_surgeon_hand_and_technology_combine_in_new/

Full story

MEMS Based Rheometer May Help Study Knee Joint Fluid

MEMS Based Rheometer May Help Study Knee Joint Fluid

MEMS Based Rheometer May Help Study Knee Joint Fluid

Students painlessly measure knee joint fluids in annual Sandia contest

ALBUQUERQUE, N.M. — Texas Tech University repeated last year’s victory in the novel design category of Sandia National Laboratories’ annual competition to design new, extraordinarily tiny devices, while Carnegie Mellon University won the educational microelectromechanical (MEMS) prize for the second year in a row.

Texas Tech proposes to create a micro-rheometer to measure very thin quantities of liquid, like that found in knee joints. (Image courtesy of Texas Tech University) Click on the thumbnail for a high-resolution image.

This year’s contest attracted engineering students from nine universities, nearly double the number of competitors in 2011. The increase was due in part to participation by Mexican universities.

The student designs are blueprints to build mechanical devices in the micrometer size range, to be powered by tiny amounts of electricity.

MEMS devices are omnipresent in modern society. They help inkjet printers and laser disk players to function, probe biological cells, enable high-tech machinery, route telecommunications and much more. New uses for the devices — inexpensive to construct and to operate — continue to be discovered. Some devices are smaller than the thickness of a human hair (about 70 micrometers).

Texas Tech students, who last year won with an ingenious, dust-sized dragonfly with surveillance possibilities, this year designed a micro-rheometer device able to measure the behavior of very thin quantities of liquid, like the synovial fluid in knee joints. The method requires much smaller samples compared to macro-scale rheometers, the standard tool.

“It is much easier, and usually less painful, to obtain small quantities of bodily fluids from patients,” the students wrote in their project description. The project used an advanced design process called SUMMiT V™, created and supported by Sandia, that enables the joining of five layers of silicon to form a complicated device.

Carnegie Mellon students, who last year designed a highly sensitive microvalve for more control over very small fluid flows, this year made use of the relatively large change in mass that occurs when a microdevice adsorbs even a small amount of material. The increase significantly alters any vibrational frequencies of the system. Characterizing adsorbed material this way can say a lot very quickly about what surface changes might occur in the structure under observation. For example, water vapor on MEMS devices may reduce the fatigue strength of polysilicon MEMS, while hydrocarbons adsorb onto microrelay contacts, increasing their electrical resistance.

The MEMS University Alliance, which now has more than 20 members, is part of Sandia’s outreach to universities to improve engineering education. It is open to any U.S. institution of higher learning and select Mexican universities.

The alliance provides classroom teaching materials and licenses for Sandia’s special SUMMiT V™ design tools at a reasonable cost, so universities that lack fabrication facilities can develop a curriculum in MEMS.

Carnegie Mellon students, who last year designed a highly sensitive microvalve for more control over very small fluid flows, this year made use of the relatively large change in mass that occurs when a microdevice adsorbs even a small amount of material. (Image courtesy of Carnegie Mellon University) Click on the thumbnail for a high-resolution image.

Sandia executives, led by Steve Rottler, chief technology officer and vice president of Science and Technology and Research Foundations, and Microsystems director Gil Herrera helped encourage Mexican universities’ participation in the contest, University Alliance Design Competition, by traveling to Mexico to sign memorandums of understanding to promote MEMS science and technology there.

Competing schools this year included the Air Force Institute of Technology, Arizona State University, Central New Mexico Community College, Centro de Investigación y de Estudios Avanzados del Instituto Politécnico Nacional of Mexico City, Carnegie Mellon University, Southwestern Indian Polytechnic Institute, Texas Tech University, Universidad de Autonoma de Ciudad Juarez, Universidad de Guadalajara, Universidad de Guanajuato, University of Oklahoma, University of Utah and Universidad Veracruzana.

“The Mexican universities were highly competitive with the U.S. universities,” said Keith Ortiz, Sandia manager of MEMS Technologies, who along with Gil Herrera hosted the student presentations. “We were impressed by their creativity and use of technology.”

The contest process takes nine months. It starts with students developing ideas for a device, followed by creation of an accurate computer model of a design that might work, analysis of the design and, finally, design submission. Sandia’s MEMS experts and university professors review the design and determine the winners.

Sandia’s state-of-the-art Microsystems and Engineering Sciences Applications (MESA) fabrication facility then creates parts for each of the entrants. The design competition capitalizes on Sandia’s confidence in achieving first-pass fabrication success, which restricts the entire process to a reasonable student time-frame.

Fabricated parts are shipped back to the university students for lengthy tests to determine whether the final product matches the purpose of the original computer simulation.

The University Alliance coordinates with the Sandia-led National Institute for Nano Engineering (NINE), providing additional opportunities for students to self-direct their engineering education, and the Sandia/Los Alamos Center for Integrated Nanotechnologies (CINT), a Department of Energy Office of Science center with the most up-to-date nanotechnology tools.

Travel by students and professors to the awards ceremony was made possible by grants from the International Society for Optics and Photonics. Carnegie Mellon professorial oversight was provided by Maarten de Boer. Texas Tech students were supervised by faculty adviser Tim Dallas.

For more information regarding the University Alliance and the design competition, contact Stephanie Johnson at srjohns@sandia.gov.

Sandia National Laboratories is a multi-program laboratory operated by Sandia Corporation, a wholly owned subsidiary of Lockheed Martin company, for the U.S. Department of Energy’s National Nuclear Security Administration. With main facilities in Albuquerque, N.M., and Livermore, Calif., Sandia has major R&D responsibilities in national security, energy and environmental technologies and economic competitiveness.

Sandia National Laboratories recently hosted a contest among university teams to develop new low energy microelectromechanical (MEMS) devices. The competition was as fierce as you’d expect. The winning team from Texas Tech University developed a micro rheometer, a device used to study the flow of liquids, which may end up handy for quick analysis of bodily fluids like those that build up in injured knees.

The device essentially vibrates very small drops of liquid and detects the change comapred to baseline. Because it requires tiny amounts of liquid to stick to its vibrating components, it works with extracting only small samples from patients.

Source : https://share.sandia.gov/news/resources/news_releases/students-painlessly-measure-knee-joint-fluids-in-annual-sandia-contest/

Full story

Cardiohealth Station Automates Intima-Media Thickness Detection

Cardiohealth Station Automates Intima-Media Thickness Detection

Cardiohealth Station Automates Intima-Media Thickness Detection

CardioNexus, a Houston, Texas firm that Panasonic has invested in to help the electronics giant enter the diagnostics market, has received FDA approval for its CardioHealth Station. The ultrasound system is designed to assess the state of the plaque within the carotid artery as an indicator of overall cardiovascular health. The Panasonic-branded device was unveiled last November at the American Heart Association Scientific Sessions in Chicago.

The CardioHealth® Station has a built-in portable ultrasound system optimized to perform a non-invasive examination of the carotid arteries. It provides an automated real-time measurement of the intima-media thickness (IMT) and allows the user to search for arterial plaques. Moreover, the touch-screen keyboard allows the user to input various parameters related to traditional cardiovascular risk factors. A built in calculator provides risk scores commonly used in a variety of medical environments (Framingham Risk Score, PROCAM Health Check Score, Reynolds Risk Score, Risk score based on the SCORE Project). This information is supplemented with an IMT measurement of the artery to generate a comprehensive report to aid the physician in assessing cardiovascular risk.

Our friend David E. Winchester, MD, who is the curator of EchoJournal, has filed this report from the ACC meeting in Chicago.

For physicians interested in global assessment of patients’ cardiovascular risk, Panasonic’s Cardiohealth Station compiles data from several sources to quickly summarize risk. The station is a stand-alone device which is capable of communicating with other medical devices using the Continua wireless standard. This technology allows it to incorporate body measurements, vital signs, and ECG data from other devices and combine this with demographic data either directly inputted or transmitted from a compatible EMR system.

The major advance with the device is the addition of an ultrasound probe for measurement of carotid intima-media thickness (CIMT). This usually requires a technologist to perform the test and a specialist to interpret the images and then additional calculation to determine if a patient’s result is abnormal and predicts a higher risk of cardiovascular disease. The Cardiohealth Station automates the detection of CIMT and uses the patient’s information to determine how abnormal the results are. The end product is a report provided for the clinician and patient which incorporates the risk factor and CIMT data to demonstrate the patient’s risk for cardiovascular disease.

Source : http://www.panasonic.com/business/medicalvideo/CardioHealth/

Full story

ThermoDock iPhone Plugin Device Measures Body Temp

ThermoDock iPhone Plugin Device Measures Body Temp

ThermoDock iPhone Plugin Device Measures Body Temp

The range of medical peripherals available for the iPhone is growing rapidly. We have IBGStar for blood glucose measurements, AliveCor for heart rhythm checks, and many more. Add to that list ThermoDock.

Many healthcare providers will be familiar with the temporal artery probe used in many hospitals, which use infrared technology to measure body temperature. These devices are especially useful for intubated patients and children; frankly, they are probably more comfortable for most patients than holding a thermometer in their mouths (let alone some of the other places temperature is measured).

ThermoDock, developed by German device maker Medisana, goes one step further (or perhaps one step back) and measures body temperature without even touching the patient. Using a small peripheral for the iPhone or iPad, ThermoDock uses similar infrared technology to the temporal artery probe to calculate body temperature.

It is part of a suite of devices made for the iPhone and iPad including blood glucose monitors, blood pressure monitors, and weight scales that can already be purchased in the United States. But there are some important factors to consider before you rush out to get one or suggest it to your patients.

According to the technical specifications supplied by Medisana, ThermoDock can measure body temperature to an accuracy of +/- 0.2-0.3 degrees celsius in about 4 seconds. They also cite that the “clinical repeatability” as 0.19 degrees celsius. To do all of this, the device is powered by the connected iPhone or iPad.

The app collects and displays data in the free VitalDoc app which can store data, display trends, and transmit information via email.

Medisana also makes several other products for iOS devices including the CardioDock, GlucoDock, and the inexplicably named Targetscale Body Analysis Scale with Target Function. Data from all of these devices is collected and displayed in the VitalDock app.

ThermoDock is available throughFirebox, where it can be purchased for $96 plus tax and shipping. Other Medisana products can be purchased here as well – the Targetscale goes for about $200 plus tax and shipping.

However, its unclear what sort of clinical testing the device has actually undergone. It has not yet received FDA approval. The device does have CE certification (CD 0483) for sale in Europe. The same appears to be true of the other devices marketed by Medisana. Its not entirely clear whether FDA clearance is something that Medisana is pursuing though other infrared thermometers have certainly sought 510(k) clearance in the past.

Nonetheless, this device certainly continues the march towards medical technology that embraces form as much as it does function.

Terumo Medical has launched its NaviCross Support Catheter line for snaking through vasculature Terumo NaviCross Unveiled: Terumos NaviCross Support Catheters for PADwhen intervening during treatment of peripheral artery disease (PAD) and Critical Limb Ischemia (CLI).

Featuring Terumo Glide Technology™ hydrophilic coating and a seamless guidewire-to-catheter transition, the NaviCross has been designed for accessing and tracking through even the most complex lesions. The shaft incorporates a stainless steel double-braided layer, combined with a 12mm tapered tip, giving it best-in-class pushability*. The catheter is compatible with .035” wire platforms and 4Fr sheaths and is available with a straight or 30 degree angled tip allowing access to vascular branches including below the knee (BTK) collaterals. It features 3 radiopaque marker bands to facilitate accurate assessment of position, while their unique spacing provides easy measurement of common balloon and stent sizes.

“The design of the NaviCross allows for true 1:1 torque with complete force transmission from my hand to the tip of the catheter without lag time or delay,” said Dr. Jihad Mustapha, Director of Endovascular Interventions and Director of Cardiovascular Research at Metro Heart & Vascular, Metro Health Hospital, Wyoming, MI. “It excels in long length lesions and is ideal for any chronic or highgrade stenoses that are located in or at an angulated vessel segment. One of the most superior support catheters for pushability, crossability, trackabilty, torquability, and (tip) visualization, there is also no buckling, which (may) lower the risk of dissection and perforations.”

Source : http://www.imedicalapps.com/2012/04/thermodock-temperature-easy-owning-smartphone/

Full story

ProUroScan System for Mechanical Imaging of Prostate

ProUroScan System for Mechanical Imaging of Prostate

ProUroScan System for Mechanical Imaging of Prostate

MINNEAPOLIS, May 1, 2012 /PRNewswire/ — ProUroCare Medical Inc. (OCTBB: PUMD), provider of proprietary medical imaging products, announced today it has received clearance from the U.S. Food & Drug Administration (FDA) for its ProUroScan™ prostate mechanical imaging (PMI) system. The approval paves the way for men and their families to receive high-resolution visual documentations as an aid in detecting prostate abnormalities that were previously detected by digital rectal examination (DRE). The ProUroScan system constructs color 2D and 3D “maps” of the prostate in real-time that, when in agreement with a DRE finding, can be permanently stored in electronic records for future analysis and comparison. ProUroCare’s patented tactile elasticity imaging technology, which uses a handheld pressure-sensing rectal probe and sophisticated image construction software to produce its prostate maps, represents a new imaging modality distinct from traditional ultrasound imaging.

The company plans to introduce the technology in 2012 to a limited number of top U.S. medical care centers in key major metropolitan markets. With assistance from Minneapolis investment firm Cherry Tree & Associates, LLC, ProUroCare has been actively seeking a strategic corporate partner with a strong sales and in-service support presence in the urologic market to fully commercialize its technology.

“This is a major milestone for the company, for physicians looking for more assurance and documentation in their evaluations and for men eager for more information to assess and make decisions about their prostate health,” said Rick Carlson, CEO of ProUroCare Medical. “A color image can go a long way in documenting a person’s prostate condition, and this development puts us one step closer to supplementing other screening measures with a helpful, high quality visual aid that can be referred and compared to over time.”

As a standard of care, the American Urological Association (AUA) currently recommends that beginning at age 40, men receive a DRE and a prostate specific antigen (PSA) blood test in their yearly physical, yet data from community-based studies suggest the positive predictive values of DRE and PSA combined achieve only a 56 percent predictive value. Furthermore, neither test creates a physical or visual record of the prostate. The ProUroScan system is being introduced as an adjunctive technology to a DRE for physicians to use to further clarify and document abnormalities associated with the prostate gland.

“Having a visual aid of irregularities can be so helpful to physicians and patients, particularly in the area of prostate care where decision-making is often difficult,” said Dr. Robert Weiss, a urologic oncologist with the Cancer Institute of New Jersey and a faculty member at Robert Wood Johnson Medical School who used the ProUroScan technology as part of its clinical trial process. “The quality and resolution of the images are excellent, providing an immensely valuable supplement to the DRE, where physicians must rely on a gloved finger to feel for changes in the size and shape of the gland.”

The prostate imaging system’s FDA 510(k) was first submitted by ProUroCare’s development partner Artann Laboratories, Inc. and later processed in accordance with the de novo provisions accounted for in Section 513(f)(2) of the Federal Food, Drug and Cosmetic Act. The FDA filings were supported by data from a 2009 National Institute of Health and National Cancer Institute-supported clinical study of patients evaluated at five leading U.S. medical centers, as well as an earlier study conducted specifically at the Robert Wood Johnson Medical Center in New Brunswick, N.J.

About ProUroCare Medical Inc.

ProUroCare Medical Inc. is a publicly traded company engaged in the business of creating innovative medical imaging products. Based in Minneapolis, Minn., the company’s stock trades on the OTCBB market.

This news release contains certain “forward-looking” statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements are typically preceded by words such as “believes,” “expects,” “anticipates,” “intends,” “will,” “may,” “should,” or similar expressions. These forward-looking statements are not guarantees of ProUroCare’s future performance and involve a number of risks and uncertainties that may cause actual results to differ materially from the results discussed in these statements. Factors that might cause ProUroCare’s results to differ materially from those expressed or implied by such forward looking statements include, but are not limited to, the ability of ProUroCare to find adequate financing to complete the development of its products; the high level of secured and unsecured debt incurred by ProUroCare; the impact and timing of actions taken by the FDA and other regulatory agencies with respect to ProUroCare’s products and business; the dependence by ProUroCare on third parties for the development and manufacture of its products; and other risks and uncertainties detailed from time to time in ProUroCare’s filings with the Securities and Exchange Commission including its most recently filed Form 10-K and Form 10-Q. ProUroCare undertakes no duty to update any of these forward-looking statements.

ProUroCare Medical out of Eden Prairie, MN has been cleared in the US to sell its ProUroScan tactile elasticity imager for visualizing the prostate.

The probe employs mechanical sensors that detect the stiffness of the prostate while it’s palpated, and the data is processed and the prostate displayed on the laptop for the physician to assess.

From the product page:

The system provides an image or record of the pressures that are generated from palpation of the posterior surface of the prostate using a rectal probe. The system’s operation is based on measurement of the stress pattern created when the probe is pressed against the prostate through the rectal wall. Temporal and spatial changes in the stress pattern provide information on the elastic structure of the gland and allow two-dimensional reconstruction of prostate anatomy and visualization of prostate mechanical properties. The prostate image is displayed on a screen that allows physicians to visualize tissue abnormalities in the prostate gland. In addition to the real time visual image, the results are stored electronically as a digital record.

New ProUroScan probe ProUroScan System for Mechanical Imaging of ProstateThe ProUroScan System probe is specially designed for the rectal anatomy to minimize patient discomfort. It is ergonomic for the clinician and similar to a traditional DRE for the patient. The probe utilizes highly sensitive pressure sensors located on the face of the probe head to palpate the prostate. The probe’s positioning system ensures that the person administering the scan examines the entire surface of the prostate, and assists prostate image construction.

Source : http://www.prnewswire.com/news-releases/prourocare-medical-receives-fda-clearance-for-prouroscan-elasticity-imaging-system-149636535.html

Full story

Nevro Senza High Frequency Neurostimulator Going on Trial

Nevro Senza High Frequency Neurostimulator Going on Trial

Nevro Senza High Frequency Neurostimulator Going on Trial

MENLO PARK, Calif. – May 23, 2012 – Nevro Corp., a medical device company focused on achieving improved pain relief for patients suffering from debilitating chronic pain, today announced that the U.S. Food and Drug Administration (FDA) has granted approval for initiation of its SENZA-RCT study, a U.S. prospective, randomized, controlled pivotal clinical trial evaluating the safety and efficacy of Nevro’s high-frequency spinal cord stimulation system for the treatment of chronic pain.

Spinal cord stimulation is an established pain treatment that delivers electrical pulses to the spinal cord to mask the transmission of pain signals to the brain. The electrical pulses are delivered by small electrodes that are placed near the spinal cord and are connected to a compact battery powered generator implanted under the skin. While these electrical pulses can reduce pain, they are often associated with unpleasant tingling and buzzing sensations known as paresthesia.

Nevro’s Senza™ High-Frequency Spinal Cord Stimulation (HF-SCS) System delivers similar electrical pulses but at a higher rate than currently available devices. Data from previous European clinical studies suggest that Nevro’s proprietary high-frequency waveform may be effective in treating low back pain and other challenging types of chronic pain that often do not respond to conventional spinal cord stimulation. Data also show that Nevro’s technology can deliver pain relief without paresthesia, which has allowed many patients in countries where the system is available to experience, for the first time, true relief from chronic pain without unpleasant side effects.

“There is a real, unmet need for additional treatment options for chronic pain patients,” said Leonardo Kapural, M.D., Ph.D, medical director of Wake Forest University Health Sciences, Chronic Pain Center in Winston-Salem, N.C., who serves as the principal investigator for the SENZA-RCT trial. “Early studies suggest that high-frequency spinal cord stimulation may expand the group of patients treatable with spinal cord stimulation therapy while eliminating paresthesia, a highly unpleasant side effect of current systems. If these benefits are confirmed in the SENZA-RCT study, Nevro’s high-frequency spinal cord stimulation system could represent an important breakthrough in the management of chronic pain.”

The SENZA-RCT study is a prospective, randomized, controlled pivotal trial that will enroll approximately 300 patients across up to 15 U.S. centers. The study is the first to include active spinal cord stimulation systems in both arms of the trial. Patients will be randomized to receive either Nevro’s high-frequency or conventional low-frequency spinal cord stimulation.

Early Studies Show Promising Results

Clinical research from an earlier, prospective, European study found that high-frequency spinal cord stimulation offered significant and sustained pain reduction in patients with chronic back and leg pain.[1] Of the 83 patients enrolled in the study, 87 percent presented with predominant back pain and 81 percent had failed prior back surgery. Patients reported pain using the Visual Analog Scale (VAS), a widely accepted pain measurement scale. Results of the study showed that following treatment with Nevro’s Senza System, average back pain scores dropped from 8.4 at baseline to 2.7 at six-month follow-up, with a median reduction in pain score of 78%. Average leg pain scores were reduced from 5.4 at baseline to 1.4 at six months, with a median reduction of 83%. Pain reduction was sustained out to one year. These results were achieved without patients experiencing paresthesia.

“Results from this initial clinical study suggest high-frequency spinal cord stimulation may be effective in patients who have debilitating back pain, a group that is typically very difficult to treat,” said Jean-Pierre Van Buyten, M.D., chairman of the Multidisciplinary Pain Center AZ Nikolaas Sint-Niklaas, Belgium. “Nevro’s treatment has allowed many of my patients to go from bed rest to a more active life.”

Nevro’s Senza High-Frequency Spinal Cord Stimulation System is authorized for sale in Europe and Australia. In the United States, the product is limited by federal law to investigational use only and is not available for commercial use.

About Chronic Pain

Chronic pain is a widespread and often severely debilitating condition that is estimated to affect more than 100 million adults in the U.S. and to cost the nation up to $635 billion each year in medical treatment and lost productivity.[2] Chronic pain is often the result of injury, as with most back pain, or a side effect of disease, as is common among cancer patients. In some cases, patients suffer chronic pain in the absence of trauma. Those suffering from chronic pain often report that pain interferes with every aspect of their lives including work, marriage, parenting, and overall emotional well-being and frequently leads to depression or anxiety. There is no cure for chronic pain and treatment usually requires more than one therapy. In addition to spinal cord stimulation, current therapies to relieve chronic pain include surgery, pharmacology, acupuncture and behavior modification.

About Nevro Corp.

Privately held Nevro Corp., headquartered in Menlo Park, Calif., is the leader in high-frequency spinal cord stimulation for chronic pain. The company’s proprietary high-frequency waveform technology appears to be unique in its potential to effectively treat challenging conditions such as low-back pain while avoiding the unpleasant tingling, buzzing and shocking that can occur with currently available systems. Nevro’s investors include Johnson & Johnson Development Corp, Bay City Capital, Three Arch Partners, Aberdare Ventures, and Accuitive Medical Ventures. For more information visit www.nevro.com.

The novel Nevro system is composed of the following familiar components.

8 contact leads

External trial stimulator, which mimics the output of the implantable pulse generator (IPG)

IPG

Patient remote control

Clinician programmer

Portable recharging system

Various accessories such as lead extensions

The components are designed to offer other notable benefits, including:

Patient ease-of-use: extended telemetry range for the remote control and simple interface for the remote control

Physician ease-of-use: lead placement at anatomic midline rather than physiologic midline and surgical procedure without the need for OR paresthesia mapping

Source : http://nevro.com/corporate/nevro-receives-fda-approval-to-initiate-landmark-u.s.-randomized-pivotal-trial-of-innovative-chronic-pain-treatment

Full story

Twente Photoacoustic Mammoscope May Lead to Radiation-Free Breast Cancer Screening

Twente Photoacoustic Mammoscope May Lead to Radiation-Free Breast Cancer Screening

Twente Photoacoustic Mammoscope May Lead to Radiation-Free Breast Cancer Screening

ScienceDaily (May 7, 2012) — X-ray mammography is an important diagnostic tool in the fight against breast cancer, but it has certain drawbacks that limit its effectiveness. For example, it can give in false positive and negative results; it also exposes women to low doses of ionizing radiation, which — while accepted as safe — still carry some risk.

In the first phase of clinical testing of a new imaging device, researchers from Netherlands’ University of Twente and Medisch Spectrum Twente Hospital in Oldenzaal used photoacoustics — light-induced sound — rather than ionizing radiation to detect and visualize breast tumors. The team’s preliminary results, which were conducted on 12 patients with diagnosed malignancies and reported today in the Optical Society’s (OSA (http://www.osa.org)) open-access journal Optics Express (http://www.opticsinfobase.org/oe), provide proof-of-concept support that the technology can distinguish malignant tissue by providing high-contrast images of tumors.

“While we’re very early in the development of this new technology, it is promising. Our hope is that these early results will one day lead to the development of a safe, comfortable, and accurate alternative or adjunct to conventional techniques for detecting breast tumors,” explained researcher Michelle Heijblom, a Ph.D. student at the University of Twente.

Photoacoustics, a hybrid optical and acoustical imaging technique, builds on the established technology of using red and infrared light to image tissue and detect tumors. This technology, called optical mammography, reveals malignancies because blood hemoglobin readily absorbs the longer, redder wavelengths of light, which reveals a clear contrast between blood-vessel dense tumor areas and normal vessel environments. However, it is difficult to target the specific area to be imaged with this approach.

As a means of improving this, the researchers combined the light-based system’s ability to distinguish between benign and malignant tissue with ultrasound to achieve superior targeting ability. The result of their refinements is a specialized instrument, the Twente Photoacoustic Mammoscope (PAM), which was first tested in 2007.

The device is built into a hospital bed, where the patient lies prone and positions her breast for imaging. Laser light at a wavelength of 1,064 nanometers scans the breast. Because there is increased absorption of the light in malignant tissue the temperature slightly increases. With the rise in temperature, thermal expansion creates a pressure wave, which is detected by an ultrasound detector placed on one side of the breast. The resulting photoacoustic signals are then processed by the PAM system and reconstructed into images. These images reveal abnormal areas of high intensity (tumor tissue) as compared to areas of low intensity (benign tissue). This is one of the first times that the technique has been tested on breast cancer patients.

By comparing the photoacoustic data with conventional diagnostic X-rays, ultrasound imaging, MRI, and tissue exams, the researchers showed that malignancies produced a distinct photoacoustic signal that is potentially clinically useful for making a diagnosis of breast cancer. The team also observed that the photoacoustic contrast of the malignant tissue is higher than the contrast provided by the conventional X-ray mammographies.

In looking to the future, notes Heijblom, “PAM needs some technical improvements before it is a really valuable clinical tool for diagnosis or treatment of breast cancer. Our next step is to make those improvements and then evaluate less obvious potential tumors, benign lesions, and normal breasts with it.”

We acquired images of breast malignancies using the Twente photoacoustic mammoscope (PAM), to obtain more information about the clinical feasibility and limitations of photoacoustic mammography. Results were compared with conventional imaging and histopathology. Ten technically acceptable measurements on patients with malignancies and two measurements on patients with cysts were performed. In the reconstructed volumes of all ten malignant lesions, a confined region with high contrast with respect to the background could be seen. In all malignant cases, the PA contrast of the abnormality was higher than the contrast on x-ray mammography. The PA contrast appeared to be independent of the mammographically estimated breast density and was absent in the case of cysts. Technological improvements to the instrument and further studies on less suspicious lesions are planned to further investigate the potential of PAM.

Dutch researchers from the University of Twente and Medisch Spectrum Twente Hospital in Oldenzaa have been investigating photoacoustic technology as a new imaging modality in detecting breast cancer tumors. The Twente Photoacoustic Mammoscope (PAM), a device that uses lasers to generate sound waves within the breast, has shown the ability to identify malignant tumors. According to the study abstract, “In all malignant cases, the PA contrast of the abnormality was higher than the contrast on x-ray mammography.”

lasers for breast cancer Twente Photoacoustic Mammoscope May Lead to Radiation Free Breast Cancer Screening

The PAM device projects a laser beam into a breast, heating up areas having more hemoglobin faster than the rest of the tissue. The temperature gradient in turn creates a physical expansion of the region, which propagates in the form of a sound wave through the breast. An ultrasound detector is then used to spot the source of these waves, pinpointing the location of a malignant tumor.

From an announcement by the Optical Society of America:

By comparing the photoacoustic data with conventional diagnostic X-rays, ultrasound imaging, MRI, and tissue exams, the researchers showed that malignancies produced a distinct photoacoustic signal that is potentially clinically useful for making a diagnosis of breast cancer. The team also observed that the photoacoustic contrast of the malignant tissue is higher than the contrast provided by the conventional X-ray mammographies.

In looking to the future, notes Heijblom, “PAM needs some technical improvements before it is a really valuable clinical tool for diagnosis or treatment of breast cancer. Our next step is to make those improvements and then evaluate less obvious potential tumors, benign lesions, and normal breasts with it.”

Source : http://www.sciencedaily.com/releases/2012/05/120507141351.htm

Full story

MD Hearing Aid line offers reasonable low-cost solution for persons with hearing loss

MD Hearing Aid line offers reasonable low-cost solution for persons with hearing loss

A study presented at the American Academy of Otolaryngology – Head & Neck Surgery Foundation Annual Meeting in Washington, D.C. shows that the MD Hearing Aid line offers a reasonable low-cost solution to those who are not using hearing aids or other amplification devices because of cost concerns.

In the study, researchers at the Michigan Ear Institute sought to evaluate a novel, inexpensive (under $200.) over- the-counter hearing aid regarding to its acoustic properties and also to test the hearing aid on patients with varying levels of hearing loss to evaluate their perceived benefit by using validated questionnaires.

Hearing loss affects approximately 34 million people in the United States, but hearing aid usage rates have historically remained at just 24%. One major reason for this low rate of use is that hearing aids are typically very expensive, with the average cost of a single hearing aid approximately $1,900. Medicare and most insurance companies do not cover this cost. Many medical studies have linked untreated hearing loss in the elderly with a higher risk of social isolation, depression, anxiety, and symptoms consistent with Alzheimer’s dementia.

The MDHearingAid was evaluated using a Fonix 6500c Hearing Aid Analyzer, measured according to accepted standards. The measurements included saturated sound pressure level curve, high-frequency average full-on gain, frequency response, total harmonic distortion, equivalent input noise level, and input-output curve. Then the device was tested on a group of participants with mild to moderately-severe hearing loss who were unwilling or unable to purchase a custom hearing aid due to cost considerations. The participants were asked to wear the device for a minimum of 30 days and complete these self-reported surveys: “International Outcome Inventory – Hearing Aids” and “Satisfaction with Amplification in Daily Living”.

Researcher Seilesh Babu, M.D. found that the MDHearingAid met the acoustic targets. All participants demonstrated user satisfaction scores that were within the standard range for patients with mild to moderately-severe hearing loss. The study found that the low-cost MDHearingAid is electroacoustically adequate and a reasonable low-cost solution to meet the needs of those value- and cost-conscious patients who were not using amplification via a custom hearing device.

Dr. Babu stated that further development and investigation of these instruments is warranted, to provide a potential opportunity for greater numbers of persons with hearing loss to have access to hearing aids and reap the medical, social, and emotional benefits from improved communicative abilities.

Source : http://www.news-medical.net/news/20120928/MD-Hearing-Aid-line-offers-reasonable-low-cost-solution-for-persons-with-hearing-loss.aspx

Related Posts Plugin for WordPress, Blogger...

Full story

Page 1 of 212
Copyright © 2017 Medical Technology & Gadgets Blog MedicalBuy.net. All rights reserved.
Proudly powered by WordPress. Developed by Deluxe Themes