Archives: 6/2006

42141123ac Dune Medical BP Probe for Breast CAGlobes [online] is reporting about Dune Medical Devices Ltd., a Caesarea, Israel start-up, raising $12.5 million in financing. The company has developed a unique hand-held surgical probe that enables detection of malignant tissue during breast surgery. The company says that its technology, that can analyze differences in electrical waveforms reflected from malignant and benign breast tissues, was successfully tested in breast, esophagus, colon, and lung cancers, and products for detection of these neoplasms are under way.
Here’s the company on its proprietary RF spectroscopy that enables intraoperative, on-contact cancer detection:
42141123aa Dune Medical BP Probe for Breast CA

The BP System is indicated for use as an intraoperative probe in breast lumpectomy procedures to aid in the selection of tissue abnormalities for excision and for intraoperative margin assessment. The clinical benefit of Dune’s device is the ability to provide the surgeon with an indication of the malignancy status of the margin of the excised tissue, in real time. Thus, surgeons can react to this information before the procedure is over and, where appropriate, remove the suspected residuals…
Dune’s real-time tissue characterization system gives the surgeon a simple, immediate, indication about the presence of cancer at the measured site. In the lumpectomy probe the measured site is a 7mm wide by 1mm deep, coin-shape, slice of tissue against which the sensor, at the tip of the probe, is pressed. If there are cancerous clusters in the “slice”, the system will flag the user by an audible and visual signal. Otherwise the system will indicate “clear”. The probe is designed for the unique demands of each procedure: In lumpectomies, it is a hand-held probe containing control buttons and audiovisual indicators, while for GI biopsy and EMR, it is designed as an endoscope insert for operation through the endoscope’s generic working channel.
Dune’s platform has two components: a disposable probe unit and an external console unit.

42141123ab Dune Medical BP Probe for Breast CA

The heart of the disposable probe unit is Dune’s proprietary miniature sensor.
This electromagnetic fringe field sensor (FFS) is capable of sensing minute differences in electromagnetic properties within its immediate vicinity. Dune’s unique design enables an accurate capture of a cell cluster’s electromagnetic signature (i.e. cancerous or healthy).

To learn more, here is the product page (don’t forget to check the animation)…
The poster presentation (.pdf)

Dear Medgadget Readers,
You may remember that a few days ago we featured a post on the emWave Personal Stress Reliever. Shortly thereafter, we received an irate response from one Miss Gabriella, Director of Public Relations for said product. We would sincerely like to offer our apologies for what she called “inaccurate and misleading statements”.
Although she never outlined the facts in error, it was nonetheless inappropriate for us to accurately and truthfully portray a product so clearly meant to relieve literally dozens of people of their hard earned $199 ($221.00 Canadian). The tactful thing to do is to take our lumps quietly, and not to mention the glaring inaccuracies rampant throughout their own website. But of all the things we’ve been called in our brief existence, tactful is not one of them. Let the witty retort commence:
In retrospect, we think it was the “pseudoscience” label that really ruffled emWave’s feathers. When a company stamps the term “scientifically validated” on their product, shouldn’t we just blindly accept that? Who would betray the sacred realm of scientific principles just to hock wares? Don’t ask questions. Don’t inquire. Blind faith got us this far, so just close your mind and enjoy the now stress-free ride. Honestly, to expect a company to back that up with even one legitimate publication is preposterous.
To clarify, they did have the integrity to cite several articles from their own company publications and two (yes, two) ‘manuscripts in progress’. Miss Gabriella was so bold as to state “a substantial body of our research has been published in respected peer-reviewed journals such as American Journal of Cardiology, Journal of the American College of Cardiology, Stress Medicine and Integrative Physiological and Behavioral Science.” Agreed. Researchers from the company including R. McCraty, R. T. Bradley, D. Tomasino, and M. Atkinson have a number of publications completely unrelated to emWave or its founding principle of “psychophysiological coherence”. And I’m sure our readers wouldn’t be interested to know that there are no peer-review published articles on “psychophysiological coherence”.
Based on the rare, but plausible, chance that I may have overlooked valid data supporting the emWave, I emailed Miss Gabriella requesting any such available literature. What I got instead was a phone call to my home from Miss Gabriella, never mind that I never gave her my home phone, nor is it listed on Medgadget.com, but I digress… No, no she didn’t try to persuade me with well-formed arguments or an armory of ‘data’ … she chose the more sly “but why don’t you like our product” approach along with the cunning “it doesn’t need evidence” angle. It wasn’t long into the conversation before Miss Gabriella complained about my argumentative tone and I quickly corrected her, stating that my tone was sarcastic, and away we were again. Finally though we were able to reach common ground: she agreed that there was no valid research supporting the emWave and I agreed that sarcasm isn’t helpful.
Sadly readers, I must confess that Gabriella had at least one valid point: there was a major inaccuracy in my pithy little review. I incorrectly refered to D. Childre as a doctor, complete with the credibility which accompanies such a title. Oh how I erred. I simply made the mistake any commoner would make when reading the emWave’s homepage by assuming ‘Doc Childre’ (the only name appearing throughout the site) was a reference to Doctor Childre. No, quite the opposite in fact. Doc Childre is simply a regular honest-joe business man who conveniently happens to have the first name of–you guessed it–Doc. When I commented to Gabriella that this was odd, she said “well Josh is an odd name too!” Alas, her years as a master debater have paid off so that I could not respond.
As this apology to you and the emWave comes to a close, I think we should recap what I learned: 1) Call the phone company and have them block my number, 2) Pseudoscience wants to be respected as the leaders in false, undocumented claims, and 3) you can call Gabriella at 831.338.8710 — we don’t expect she’ll be bothered, as she is a big fan of a scientifically-validated stress-reliever.

23123r24ss Biosignals Furanone TechnologyAustralian biotech company Biosignal and the Institute for Eye Research have received ethics approval for the human clinical trial of antibacterial coated contact lenses, The Engineer Online reports.
The company’s technology, that is designed to reduce bacteria’s ability to form biofilms on surfaces:

Biosignal’s approach to controlling bacterial contamination is a radical departure from traditional approaches. Biosignal’s anti-biofilm compounds interfere with signaling systems employed by bacteria. Bacteria depend on signaling systems to colonise surfaces, to form biofilms, and to maintain these biofilms once formed.
The Biosignal technology does not kill bacteria but “jams” signaling to stop bacterial colonisation. Thus bacterial resistance and non-target environmental impacts are avoided.
Bacteria mutate and generate resistance as a result of confronting selective pressure. This pressure is high when the survival of the organism is threatened by a biocide. The selective pressure exerted by Biosignal’s anti-biofilm compounds is low as bacteria are only prevented from settling on a particular surface. The seaweed where this mechanism was first discovered uses the naturally-occurring compounds to prevent bacterial surface colonisation. This has been effective for millions of years without causing bacterial resistance. Biosignal’s synthetic anti-biofilm compounds also appear to side-step resistance. The serious problem of increasing bacterial resistance and the fading efficacy of biocides and antibiotics suggests that Biosignal ‘s technology could have vast commercial applications.

6543456aa Biosignals Furanone TechnologyThe University of New South Wales, where most of the research on furanone antibacterial technology was done, further explains:

The core of Biosignal’s extensive IP platform is a range of novel compounds, known as furanones. These molecules act as antagonists in bacterial signalling pathways, which leads to a range of outcomes, most importantly the prevention of highly resistant biofilms forming on surfaces, including biological surfaces.
The key benefit of the technology is the prospect of effective prevention of bacterial contamination whilst avoiding the development of resistance by bacteria. Bacterial resistance is a very significant global problem, primarily caused by overuse of antibiotics and biocides. Another benefit is the fact that furanones are biodegradable.

Company website

Cochlear%20Implant Earlier Cochlear Implant Implantation Leads to Superior Speech in Deaf ChildrenWhile it should come as no huge surprise, recent work by Johanna Grant Nicholas, Ph.D., from Washington University School of Medicine in St. Louis and colleague Ann E. Geers, Ph.D., from the Southwestern Medical School at the University of Texas at Dallas, shows that the younger a deaf child receives a cochlear implant, the better their speech skills will be at age 3.5…

“Ninety percent of children born deaf are born to hearing parents, and these parents know very little about deafness,” Nicholas says. “They don’t know how to have a conversation in sign language or teach it to their children. Many of these parents would like their children to learn spoken language.”
The researchers tested the spoken language skills of 76 children, all 3 and a half years old, who had cochlear implants and compared those results to the length of time each child had his or her implant. They found that with increased implant time, children’s vocabulary was richer, their sentences longer and more complex and their use of irregular words more frequent. The researchers’ work was reported in the June issue of Ear and Hearing.
Nicholas notes that many of the children who received cochlear implants at the youngest ages have nearly the same spoken language skills as children with normal hearing. The researchers’ further studies — not yet published — suggest that by age 4 and a half, children who had cochlear implants very early often have normal speech and can potentially enter kindergarten with their hearing peers.
“Kids with residual hearing can get some help from hearing aids, but cochlear implants give a tremendous hearing advantage over hearing aids — the implants provide more sound information,” Nicholas says. “For example, high-frequency sounds are magnified more with cochlear implants, so kids can hear ‘s’ sounds and ‘ed’ endings better. So they tend to catch on to plurals and verb tenses faster.”
While studies like this and others favor early implantation, the decision for or against cochlear implantation is frequently put off, Nicholas indicates. Hearing parents often find they need time to learn about deafness and potential treatments. Implantation also may be delayed to make certain an infant’s deafness has not been misdiagnosed.
Even when deafness is confirmed, the idea of head surgery for their baby makes many parents hesitate. And they may be daunted by the fact that a cochlear implant is forever — the device destroys any residual hearing so that hearing aids are no longer an option.

When cochlear implants first entered the scene, most of the recipients were adults who had gone deaf later in life, frequently having never learned sign language, and as such had a huge incentive to regain functional hearing immediately. However, when it comes to younger children for whom there might someday be a biological solution to deafness, the decision can be tougher for parents to proceed to a currently acceptable solution. Hopefully this work will provide an important data set upon which to base a decision.
More from the press release or from the article in Ear and Hearing

GE Healthcare, makers of awesome imaging products, is announcing the opening of an Integrated Development Centre at the Manipal Hospital in Bangalore, India. The facility will take part in multi-center international research in an effort to bring new technologies to market sooner…

The IDC in Bangalore is expected to conduct around 1, 000 scans annually as part of the planned clinical trials and will be a part of a series of global multi-country clinical studies in the United States, the European Union and several other countries. Over time, GE Healthcare will create more IDCs in key strategic locations globally.
The research efforts of GE Healthcare’s Medical Diagnostics R&D team are currently focused on functional and molecular imaging agents that help doctors evaluate the physiology of disease and make treatment decisions earlier with confidence.
Information obtained from this site will be combined with data from other centres globally and contribute towards the development of new contrast and molecular imaging agents or new indications for existing agents.
The first studies will focus on Visipaque (iodixanol), an isosmolar contrast agent that was launched globally by GE Healthcare in 1996. Visipaque has been used in millions of x-ray and computer tomography procedures till date.
Under the terms of the collaboration, physicians at Manipal Hospital will act as study investigators and provide clinical and imaging services and administration in the hospital.

More from the Press Release (which apparently hasn’t launched on GE’s page, only through the Indian news channels)

231545113sa Bring on the Heat PacksCurious about how sodium acetate heat packs work? Sure you are! Here’s a palatable description from WeBringTheHeat.com, a manufacturer of medical heating pads :

A heat pack contains sodium acetate and water. It turns out that sodium acetate is very good at supercooling. It “freezes” at 130 degrees F (54 degrees C), but it is happy to exist as a liquid at a much lower temperature and is extremely stable. Clicking the disk, however, has the ability to force a few molecules to flip to the solid state, and the rest of the liquid then rushes to solidify as well. The temperature of the solidifying liquid jumps up to 130 degrees F in the process.
When you boil the solid, you melt it back to the liquid state. You have to completely melt every crystal, by the way, or the liquid will quickly re-solidify. You can repeat this cycle forever, theoretically, just as you can freeze and melt water as many times as you like.
All of this is mostly too technical for most of us. Let’s just say it’s magic and leave it at that.

Curious how to make your own sodium acetate? Mix 1 part baking soda, 1 part vinegar, and voila! And now that they’ve given you the secret to their heating pads, you can just make your own. But why do all that work when you can buy these heating pads, courtesy WeBringTheHeat.com!
Company says that its products are completely non-toxic, non-allergenic, FDA approved, latex free and have an unlimited shelf life and use life.

exercise%20apparatus The Not So Lazy Boy ReclinerI’ve always said that I’d exercise more if only I didn’t have to drive to the gym, and Curtis James may have found the answer. In December of 2005 he was awarded a patent for the “exercise apparatus” which is a glorified recliner, retrofitted with arm and leg exercising stations.

An exercise apparatus is provided which includes a chair, an arm-exercising station, and a leg-exercising station. The arm-exercising station is mounted in the armrests of the chair and includes a support frame attached to the base portion of the chair, a pair of elongated left and right exercise bars disposed within the left and right armrest portions of the chair operable for selective pivotal movement within the armrest portions, and a resistance device attached to the bars for resisting the pivotal movement of the bars. The leg-exercising station is associated with the underside of the footrest portion of the chair and includes a pedal assembly configured for rotational movement. The pedal assembly is automatically raised and positioned for use when the footrest is pivoted forwardly. The leg-exercising station is concealed within the chair when not in use.

I forsee a Budweiser tribute in the near future but until then we here at Medgadget salute you Mr. Exercise Lazy-Boy inventor guy.
Full patent. . .
(hat tip: Patently Silly)

1325423exx AS Port® Proximal Anastomosis SystemToday, it seems, we have cardiac surgery day at Medgadget. Cardica Inc., a Redwood City, CA company, has announced initiation of clinical trials in the US and Europe of its device for coronary bypass procedures. AS-Port® Proximal Anastomosis System is designed to let cardiac surgeons attach a coronary bypass graft to the aorta without a tedious stitching around the graft.
Company explains:

Our PAS-Port system is a fully automated device used to perform an end-to-side proximal anastomosis between a saphenous vein and the aorta. To complete a proximal anastomosis, the cardiac surgeon simply loads the bypass graft vessel into the PAS-Port system, places the end of the delivery device against the aorta and turns the knob on the opposite end of the delivery tool…
The device first creates an opening in the aorta and subsequently securely attaches the bypass graft to the aortic wall, using a medical grade stainless steel implant that is formed into its final shape by the delivery tool. The innovative design of the PAS-Port system allows the surgeon to load the bypass graft and rapidly complete the anastomosis, typically in approximately three minutes, with little or no injury to the bypass graft vessel or the aorta.
An important advantage of our PAS-Port system is that, in contrast to conventional hand-sewn proximal anastomoses, the vascular connections created can be performed without clamping the aorta, potentially avoiding the associated risks such as neurological complications. Surgeons use our PAS-Port system in conventional CABG procedures and in OPCAB. We will be working on adaptations to the PAS-Port system for use in endoscopic applications.

32644213sas AS Port® Proximal Anastomosis System
The product page and video
AS-Port® Proximal Anastomosis System FDA SSED sheetMore

octopus evolution2 The New Octopus® for Beating Heart Surgery
Medtronic Inc. came out with its latest version of the Octopus®, a popular device designed to stabilise coronary artery during the distal anastomosis in the off-pump coronary artery bypass procedures.

The Octopus Evolution tissue stabilizer is used in beating-heart surgery, with suction pods holding the surface tissue of the heart stable while the surgeon attaches a transplanted vessel around blockages in the coronary arteries. This latest stabilizer provides a new range of options to help the surgeon easily position the device on any target area of the heart surface, stabilize the suture site to a degree unattainable before, and then work with unimpeded view as the bypass is sutured in place…
The Octopus Evolution provides a key technology to allow “off-pump” or “OPCAB” surgery on the beating heart. Off-pump surgery has become an attractive alternative to the traditional heart-lung machine, which is used to pump and oxygenate the patient’s blood if the heart must be stopped for repairs.

octopus evo 4positions2 The New Octopus® for Beating Heart Surgery

The Octopus Evolution device represents a decade of Medtronic product innovation, achieving new levels of flexibility, stability and ease of use with several key product enhancements including:
The arm supporting the suction pods provides a greater degree of stability, flexibility, range of motion for ease of positioning, and longer effective reach to targeted vessels.
Combining the articulating head link that provides a new range of motion unseen in past devices with the patented Octopus suction pods, which allows the head to be positioned with the pods pointing up, down, or to the side.
The device’s head link designed with a lower profile and surgeon-controlled pod spread, which aids in providing the appropriate visualization of the target area.
An enhanced device clamp and turret assembly that have made the device much easier to set up on any location on the sternal retractor.

Medtronic press release
Product page