Medgadget

Ultrathin Material for Surgical Patching Developed

2009-07-09T19:49:21Z

Scientists from Japan's Waseda University and the National Defense Medical College created a new material to be used as a repair patch during surgical procedures. Functionally similar to cellophane, in that it naturally sticks to surfaces, the new material can be made to be one thousand times thinner than what you wrap sandwiches in.

AFP reports:

"This is the world's thinnest adhesive plaster," said Toshinori Fujie, a researcher involved in the joint project by Tokyo's private Waseda University and the National Defense Medical College.

In an experiment repeated several times, the team placed a square piece of the new nano-sheet onto a six-millimetre-wide hole in a dog's lung.

The sheet was strong enough to withstand the pressure of the dog's breathing and helped the wounds heal within one month, leaving no visible trace, Fujie said.

Researchers hope to launch human clinical trials in three years.

PORT ACCESS System for Mitral Valve Repair Proves Its Value in Study

2009-07-09T19:13:55Z

Edwards Lifesciences is reporting the results of a study comparing traditional mitral valve repair involving a sternotomy to a minimally invasive approach via mini-thoracotomy with the company's new PORT ACCESS system, an endovascular cardiopulmonary bypass technology. The main results are that the patients are discharged earlier with fewer time spent on the ventilator and in ICU, an important benefit for both the patient's prognosis and comfort, as well as the financial advantages it brings to hospitals.

From the announcement:

The 171 patients undergoing mitral valve repair with the PORT ACCESS System had total hospital stays approximately 1.5 days less than sternotomy patients (p < 0.001). In these patients, ICU stay was reduced from 82 hours to 44 hours (p < 0.001), a 46 percent reduction.

In the same population, the number of patients requiring post-operative ventilation was reduced from 75.6 percent in the sternotomy group to 50.3 percent in the PORT ACCESS group (p < 0.001). Further, substantially fewer PORT ACCESS patients required prolonged ventilation (defined by the Society of Thoracic Surgeons, or STS, as greater than 24 hours): 5.4 percent compared to 11.8 percent with full sternotomy (p=0.039).

Trends in the mitral valve replacement data supported the findings in the repair cohort, but due to a smaller patient population size (n=42), statistical significance was not achieved for as many endpoints. One exception was the 64 percent reduction in ICU length of stay from 147 hours in the sternotomy group to 53 hours in the PORT ACCESS group (p=0.016).

Press release: Study Finds Edwards Lifesciences' Port Access System Facilitates Improved Outcomes Compared to Sternotomy...

Flashback: Edwards Announces New Cardiac Offerings...

microECoG Electrodes Create New Possibilities to Study, Intervene in Brain Function

2009-07-09T08:12:21Z

Neurosurgeons from the University of Utah have developed new tiny electrode arrays that do not penetrate the surface of the brain, potentially preventing many of the side effects common to modern high precision electrodes. Similar to electrocorticography ECoG arrays, the microECoG devices may be small enough for permanent placement under the skull.

From the University of Utah:

The researchers tested how well the microelectrodes could detect nerve signals from the brain that control arm movements. The two epilepsy patients sat up in their hospital beds and used one arm to move a wireless computer "mouse" over a high-quality electronic draftsman's tablet in front of them. The patients were told to reach their arm to one of two targets: one was forward to the left and the other was forward to the right.
The patients' arm movements were recorded on the tablet and fed into a computer, which also analyzed the signals coming from the microelectrodes placed on the area of each patient's brain controlling arm and hand movement.

The study showed that the microECoG electrodes could be used to distinguish brain signals ordering the arm to reach to the right or left, based on differences such as the power or amplitude of the brain waves.

The microelectrodes were formed in grid-like arrays embedded in rubbery clear silicone. The arrays were over parts of the brain controlling one arm and hand.

The first patient received two identical arrays, each with 16 microelectrodes arranged in a four-by-four square. Individual electrodes were spaced 1 millimeter apart (about one-25th of an inch). Patient 1 had the ECoG and microECoG implants for a few weeks. The findings indicated the electrodes were so close that neighboring microelectrodes picked up the same signals.

So, months later, the second patient received one array containing about 30 electrodes, each 2 millimeters apart. This patient wore the electrode for several days.

Images: Top: These two images show two kinds of microelectrode arrays, known and microECoGs, that were placed on the brains of severe epilepsy patients. The patients already had parts of their skulls removed temporarily for placement of larger ECoG electrodes, which are used to locate and treat the brain area responsible for their seizures. These larger, metallic, button-like electrodes are numbered in both images. The left image also shows two microECoG arrays, each with 16 microelectrodes connected to microwires that pass through the orange and green tubes. Because the arrays are made of fine wires embedded in clear silicone, photo-editing software was used to draw in their outlines in both images. The right image shows one microECoG array with 32 individual microelectrodes, connected with microwires entering via a clear tube from the bottom of the image. The green wires are connected to the large, conventional ECoG electrodes. Side: Microwires emerging from the green and orange tubes connect to two arrays of 16 microelectrodes. Each array is embedded in a small mat of clear, rubbery silicone. (University of Utah)

Press release: Reading the Brain without Poking It...

Full article in Neurosurgical Focus: Human neocortical electrical activity recorded on nonpenetrating microwire arrays: applicability for neuroprostheses

(hat tip: Gizmag)

Faster PCR Technology Developed

2009-07-09T08:08:56Z

Researchers from Japan's National Institute of Advanced Industrial Science and Technology are reporting on the development of a new polymerase chain reaction (PCR) technique that promises to be considerably faster than current methods. The new technology is meant to replace multiple fluorescent probes with a single multi-targeting one, resulting in improved throughput and higher precision.

From the study abstract:

In this technique, a quenching probe (QProbe) and a nonfluorescent 3′-tailed probe are used. The QProbe is a singly labeled oligonucleotide bearing a fluorescent dye that is quenched via electron transfer between the dye and a guanine base at a particular position. The nonfluorescent 3′-tailed probe consists of two parts: one is the target-specific sequence on the 5′ side, and the other is complementary to the QProbe on the 3′ side. When the QProbe/nonfluorescent 3′-tailed probe complex hybridizes with the target in PCR, the fluorescence of the dye is quenched. Fluorescence quenching efficiency is proportional to the amount of the target. We called this method the universal QProbe system. This method substantially reduces the cost of real-time PCR setup because the same QProbe can be used for different target sequences. Moreover, this method allows accurate quantification even in the presence of nonspecific PCR products because the use of nonfluorescent 3′-tailed probe significantly increases specificity. Our results demonstrate that this method can accurately and reproducibly quantify specific nucleic acid sequences in crude samples, comparable with conventional TaqMan chemistry. Furthermore, this method is also applicable to single-nucleotide polymorphism (SNP) genotyping.

Article in Analytical Chemistry: Universal Quenching Probe System: Flexible, Specific, and Cost-Effective Real-Time Polymerase Chain Reaction Method

Image: Epicatt

Smallest PFO Closure Device Gets EU OK

2009-07-09T08:06:42Z

Coherex Medical out of Salt Lake City, Utah won the CE Mark to commercialize the firm's percutaneous endovascular FlatStent EF™ in the European market. The device is designed for closing the Patent Foramen Ovales (PFO).

About the device from Coherex:

The Coherex FlatStent EF device is similar in use and function to self-expanding vascular stents that are widely used around the world by interventional cardiologists. However, the patent-pending Coherex FlatStent EF device combines a planar Nitinol™ structure with a polyurethane substrate in a unique fusion of PFO closure mechanisms designed with the intent to naturally seal PFO tunnels.
According to Coherex President and CEO, Richard J. Linder, the Coherex FlatStent EF is the first device cleared for use to close a PFO from within the PFO tunnel.

“Although there are a handful of older, legacy devices cleared for closing PFOs, these devices are significantly larger than the Coherex FlatStent EF and they close PFOs by completely overlapping PFO openings on both sides of the septal wall,” Linder said. “Conversely, by its very design, the Coherex FlatStent EF represents the next generation approach to PFO closure. The Coherex FlatStent EF has dramatically less mass and less exposed surface area than other PFO closure systems and it is deployed almost entirely within the PFO tunnel (the only exception being two tiny anchors). As a result, the Coherex FlatStent EF uses a body’s natural defenses to enclose its polyurethane foam and Nitinol metal structure and thereby close the PFO opening from within the PFO tunnel. We believe this technology will be much safer for patients during the long term and reduce or eliminate safety concerns that are associated with older technologies."

EASE OF USE

Rapid-exchange functionality to simplify device delivery and maintain wire access throughout the procedure

Deployment similar to a self-expanding vascular stent

Single operator function

ONE DEVICE - THREE CLOSURE MECHANISMS

Lateral force to close tunnel from within

Foreign body response to stimulate endothelialization

Polymer substrate to promote cellular integration

PATIENT SAFETY

Low mass in left atrium to reduce risk of thromboembolism

Placement within tunnel to reduce risk of erosion

Device can be recovered and repositioned any time prior to detachment

Press release: Coherex Medical's Coherex FlatStent EF PFO Closure System Granted CE Mark Clearance for Closing PFOs...

Product page: COHEREX FlatStent EF™ PFO CLOSURE SYSTEM...

New Device Aims to Measure Hand Muscles Strength

2009-07-08T19:46:42Z

A team of bioengineering students from Rice University developed a device to measure the strength of intrinsic hand muscles (thenar, hypothenar, interosseus and lumbrical muscles). The Peg Restrained Intrinsic Muscle Evaluator, or PRIME, was created to replace the common test where the patient pulls and pushes at the doctor's hands and fingers. The real goal is to quantify finger/muscle strength for a more accurate diagnosis for carpal tunnel syndrome evaluation and other disorders.

Rice University reports:

The device has three elements: a pegboard restraint, a force transducer enclosure and a PDA custom-programmed to capture measurements.
In a five-minute test, a doctor uses pegs to isolate a patient's individual fingers. "You wouldn't think it works as well as it does, but once you are pegged in, you can't move anything but the finger we want you to," Miller said.

A loop is fitted around the finger, and when the patient moves it, the amount of force generated is measured. "PRIME gets the peak force," Xu said. "Then the doctor can create a patient-specific file with all your information, time-stamped, and record every single measurement." PRIME integrates with existing systems in a manner compliant with the Health Information Portability and Accountability Act, better known as HIPAA, he said.

Xu hopes it will help hospitals and rehabilitation clinics compare the effectiveness of surgical interventions and diagnose neuromuscular degenerative diseases.

Press release: Rice University team's award-winning device could benefit treatment of hand injuries...

Minimally Invasive Adiana Contraception Device Gets US Approval

2009-07-08T09:00:03Z

Hologic out of Bedford, Massachusetts won FDA approval for the Adiana® permanent contraception system. The device first delivers RF energy to provoke a minimal inflammation inside section of the fallopian tube. Next, the clinician has to place a tiny stopper to block the passage. After placement, tissue forms around the stopper and permanently prevents future pregnancies.

The Adiana permanent contraception procedure is minimally invasive, requires no incisions and can be performed in the comfort of the doctor's office using local anesthesia. Patients are normally able to return to work or resume their daily activities within one day. In contrast, traditional methods of permanent contraception, such as tubal ligation, require more invasive surgical procedures, usually are conducted in a hospital under general anesthesia and typically require four to five days of recovery. As a result, these more invasive surgical procedures can pose serious risk of complications, including anesthesia-related problems and damage to organs or blood vessels. There were approximately 70,000 female transcervical contraception procedures performed in the U.S. last year.1

The Adiana procedure is indicated for women who desire permanent birth control by occlusion of the fallopian tubes. Ideal candidates include women who do not want children in the future and would like the peace of mind and convenience of permanent birth control. The procedure may also be an ideal solution for women who desire permanent birth control but are poor candidates for surgery.

Company video presenting the Adiana system:

Press release: FDA Approves Hologic's Adiana® Permanent Contraception System...

Product page: Adiana Permanent Contraception...

Ins and Outs

2009-07-08T09:00:01Z

Why Is Wal-Mart Endorsing Employer Mandated Healthcare?... [TriplePundit]

~~Tylenol Tsar~~ FDA Panel Recommends Ban on Vicodin, Percocet... [AP]

Candidates Aplenty for Spending on Comparative Effectiveness... [WSJ]

Scientists deliver the first comprehensive estimate of the extent of dozens of endocrine disorders in the United States... [Johns Hopkins]

Schizophrenia and Bipolar Disorder Share Genetic Roots... [NIH]

What An Employer Mandate for Health Insurance Might Look Like... [WSJ]

Swine flu reaches into the lungs and gut... [Nature]

Breakthrough in combating the side effects of Quinine... [The University of Nottingham]

Nanotechnology: the things we don't know... [Nanowerk]

Nanoarches advance nanotechnology's tool box... [Nanowerk]

Glimpsing the Birth of our Earliest Reproductive Cells... [Children's Hospital Boston]

Imaging Technique Allows Researchers to Monitor Protein Changes in Mouse Tumors... [NIH]

Epigenetic mechanisms that underpin metabolic and cardiovascular diseases... [Nature Reviews Endocrinology]

Physios recommend a healthy dose of gaming... [New Scientist]

Dynasty: Influenza Virus in 1918 and Today... [NIH]

Fish on the menu of our ancestors: Already 40,000 years ago people fed themselves to a large degree on fish... [Max Planck Society for the Advancement of Science]

Are we witnessing the end of science? Does the way modern science is conducted stifles radical new ideas... [Ehsan Masood @ Guardian]

Think Your Own Music Outloud

2009-07-08T08:22:05Z

You know that tune you hum to yourself in your head? Or maybe that song that is stuck in your brain? Now, thanks to MRI researchers, you can play that for everyone around you. Dan Loyd and researchers at Trinity College have developed a media player for your brain.

Using MRI images to study active parts of the brain during various tasks or thoughts, pitches are asigned to different regions. These are then used to generate notes played at varying intensities to match the intensity of the active brain region.

While this may seem fun and whimsical, the motivation for this work is much more serious. Lloyd is comparing scans of volunteers with dementia and schizophrenia patients to gain insight into unlocking the mysteries of these conditions.

New Scientist : Eavesdropping on the music of the brain

Trinity College: Dan Lloyd

(hat tip to Gizmodo)

An Intriguing Medical Technology Story

2009-07-08T08:00:01Z

Here at Medgadget we get all sorts of news tips regarding new technologies and products coming to market from around the world. An interesting note we received two days ago was from a gentleman claiming to be from South Africa, and the note was about a recently announced investment in an Israeli company by a Taiwanese firm. We saw the press release about the investment earlier that day. Essentially, Life Keeper is a company that claims to have invented a patch-like device that can predict the onset of a heart attack. They supposedly claimed an FDA approval for their device. Two days ago Life Keeper announced that it sold a third of its equity for $370 million to a Micro-Star International, a Taiwanese firm. We tried to find more information about Life Keeper device but none was to be found, so we decided to wait and see how things develop. A few hours after the announcement is made, we receive an email from the South African. He suggested that we be skeptical of the announcement and hold off on publishing the news, and so we did.

Here's a part of what he wrote:

The reason I contacted you is to forewarn you of "a major medical breakthrough" comming from Israel where a company claiming to develop the - lifekeeper a non invasive sticky patch microchip which could read multicaridiac signs as well as blood sugar level, they claim the company that MSI of Britain (I assume subsidiary of Taiwan MSi) will pay the inventors 370 million US Dollars for 37% of the JV company to be launched with option to aquire 20% at a valuation of 5 B billion US Dollars i would like to point you to www.themarker.co.il and www.globes.co.il (English versions for more information)
Being also involved with the Israeli bio med industry as applicable to my field of interest, i would loath to see an article about "an Israeli breakthrough medical technology" resulting only in tainting of true medical innovation coming from that country and its medical practitioners.

The next day newspapers in Israel published stories that claim that Micro-Star International representatives never even heard of Life Keeper and denied any deals between the two companies. Moreover, it turns out that the third highest ranking Mossad officer, and the one negotiating the release of an Israeli soldier kidnapped by Hamas, was involved in the formation of Life Keeper. Now there's a bizarre medical device story. To learn more about this developing scandal, follow these links:

Jerusalem Post: Intrigue surrounds biotech 'mega-sale'...

Globes: Supposed Life Keeper buyer: We never heard of them...

Haaretz: Was new Shalit negotiator victim of financial sting?

TED Talk: "3 Ways The Brain Creates Meaning"

2009-07-07T21:17:35Z

Tom Wujec, though not a neuroscientist, but an information expert at Autodesk, gave a quick TED talk about how the brain creates meaning out of the environment it is perceiving. By better understanding these principles, he believes that we can improve our ability to use our brains for complicated problem solving and ideas creation.

Apple iPhone to Replace Your Hearing Aids?

2009-07-07T20:32:28Z

A new application for the Apple iPhone has been designed to aid people with poor hearing, featuring abilities that not even a hearing aid can boast of. Essentially a volume booster, the app amplifies everything that is being heard by the microphone and allows the user to set which frequencies to boost and which to filter. Additionally, the application continuously keeps a recorded buffer of what it hears, allowing you to quickly replay the last five to thirty seconds of a misheard conversation.

Link @ iTunes: SoundAMP

NanoMaxx Tiny 6 Lb. Ultrasound System Unveiled

2009-07-07T18:37:30Z

SonoSite announced this morning the release of a new portable ultrasound NanoMaxx system that weighs only 6 pounds. The company claims that this point-of-care ultrasound produces imagery similar in quality to the firm's flagship M-Turbo model. Designed for mobile applications (such as private offices, emergency rooms or EMRs, central line accesses on the floor, etc.), the system sports battery with two hour life. For this model the company offers a comprehensive line of transducers that deliver "high resolution diagnostic imaging across a range of clinical applications to support clinical diagnosis and to guide interventional procedures." Ready to be distributed internationally, the device still needs final approval from the FDA to be marketed in the US.

Features from the announcement:

One Button Technology Optimizes Workflow
Based on SonoSite’s 4th generation Turbo technology platform, the NanoMaxx system incorporates proprietary, advanced imaging algorithm technologies, including ColorHD™ to deliver exceptional image quality in a lightweight, rugged form factor.

With a touch screen that responds easily to the tap of a finger, and one button optimization, clinicians can readily acquire high resolution images to increase clinical productivity at the point-of-care. A system boot-up time of less than 20 seconds and long battery life further enhance workflow when using the NanoMaxx system.

Designed to Help Hospitals Meet New Standards of Care
Clinical studies have proven that bedside ultrasound increases the accuracy of interventional procedures and it is now recommended by two government-based agencies1 and three US medical societies.2 At introduction, the NanoMaxx tool is available with a complement of five transducers to support a wide range of examinations and procedures including thoracic assessment for hemothorax, hydrothorax and pneumothorax, vascular access, needle aspirations and injections, as well as abdominal, cardiac, nerve, OB/Gyn, musculoskeletal, small parts and vascular scanning.

The clinical capabilities of the NanoMaxx will help eliminate the risk and cost of transporting patients to the imaging lab for many examinations and procedures.

Mount it. Carry it. Or Use it on a Stand
The small footprint of the NanoMaxx system, along with its space-saving solutions, enables seamless integration with a variety of exam-room configurations. It can be wall mounted, placed on an exam table, or used from a highly maneuverable stand. Physicians can easily carry the NanoMaxx tool from room-to-room, to a satellite office, the operating room or to a field site for immediate use.

Built to Last
The NanoMaxx system’s highly integrated architecture and ruggedized design, including the industry’s first elastomeric bumper for extra durability, allows it to be used in the most austere and demanding environments. A magnesium shell that is significantly stronger and lighter than plastic helps to protect the system against accidental droppage. As with all SonoSite systems, the NanoMaxx ultrasound tool and its transducers are built to withstand a one meter drop test.

Product page: SonoSite NanoMaxx...

Press release: SonoSite Introduces The 6 Lb. NanoMaxx - A Breakthrough Ultrasound Tool Aimed At Reducing Patient Safety Risks And Healthcare Delivery Costs...

Coming Soon: Online Treatment for Insomnia

2009-07-07T08:00:03Z

Researchers from the University of Virginia Health System conducted a study of an internet based intervention program designed to help people suffering from insomnia. The cleverly named SHUTi (Sleep Healthy Using the Internet) online app offers clinical outcomes that seem to be as good or even better than those achieved with personalized treatments offered by therapists. Here's one of the lead members of the research team speaking about the study:

JAMA/Archives Media Relations Dept weights in:: Internet-Based Intervention May Improve Insomnia...

Abstract in Archives of General Psychiatry: Efficacy of an Internet-Based Behavioral Intervention for Adults With Insomnia Arch Gen Psychiatry. 2009;66(7):692-698.

S H U T i...

Filligent's BioMask Made Available Over The Counter in Hong Kong

2009-07-07T08:00:02Z

A new microbe killing mask previously available only to medical professionals is now being released over the counter in Hong Kong. The mask, BioMask™, is part of a series of products by Filligent Inc. called BioFriend, that use a material shown to kill H1N1, MRSA, SARS, and Bird Flu, among other pathogens, on the spot. The BioFriend™ technology, a coating that can be applied to various substrates, works by mimicking oligosaccharide sites on human cells through which viruses and bacteria might normally attach. More specifically, the device mimes the terminal sialic acid residue on the surface oligosaccharide of a cell membrane. Once bound, the pathogen is then destroyed by embedded copper and zinc ions which impair their cell walls and disturb their normal metabolism. The benefit to this approach is that since the microbes are being killed rather than simply filtered, a perfectly airtight seal is not as necessary as with current masks such as the N95, and there is little risk of mask to hand to body transmission, thus making the mask a good candidate for unsupervised public use. The mask stays effective for 8 hours of active wear.

From the press release:

The revolutionary mask, which traps and kills germs like H1N1 upon contact, was launched at Asia's leading drugstore chain, Watsons, today. In addition, Hong Kong's biggest travel agency, Hong Thai, will be providing the BioMask(TM), on a complimentary basis, to all air travelers through the end of August...The launch and availability of the BioMask(TM) in consumer retailers and service providers is significant because, as CEO Melissa Mowbray-d'Arbela says, "The BioMask(TM) is the first 'intelligent' face mask. You don't have to be a health care worker or medical professional to use it correctly. Instead, the mask is very easy to put on, wear and dispose of properly. Thus, it's one of the best forms of protection for ordinary people and their children during this year's swine flu crisis."
Whereas ordinary surgical masks fit poorly with lots of leakage from the sides and become easily contaminated with live germs, the BioMask(TM) is easy to put on, fits securely and kills germs continuously. Unlike an ordinary mask, it is not covered with live germs when you take it off.

The BioMask(TM) is the first product in Filligent's revolutionary anti- microbial BioFriend(TM) personal care range to be launched at Watsons. Other BioFriend(TM) products, including a dry-sanitizing handkerchief (QuickCloth), adhesive dry-sanitizing stickers (QuickPatch), odour-control insole (BioSole), cosmetic puffs (BioPuff) and self-sanitizing cosmetic sponge (BioSponge), will be launched later this year. The innovative personal care line will also soon be available at Park 'n' Shops throughout Hong Kong.

Press release: High-Tech 'Smart' Face Mask Helps Hong Kong Families Combat Swine Flu...

Product page: Filligent BioMask...