Archives: 5/2009

iconsoledrive PMI Gets Approval for Powered Minimally Invasive Surgical Tools
The FDA has given 510(k) clearance to Power Medical Interventions (Langhorne, Pennsylvania) for the firm’s iDrive Intelligent Power Unit, detachable Intelligent Surgical Instruments and iConsole device. The company believes that its powered tools, that sport a high level of articulation, can make a lot of difficult laparoscopies much easier to perform.
More about the components from PMI:

A first-of-its-kind breakthrough in operating room instrumentation, the iDrive is designed to support a variety of minimally invasive procedures by offering surgeons a broad range of cutting and stapling configurations combined with increased flexibility, access and precision. The iDrive is a novel hand-held, computer-controlled power unit to which any of the company’s Intelligent Surgical Instruments can be attached. This innovation allows all of PMI’s Intelligent Surgical Instruments to be driven by a single power unit. As a result, hospitals will be able to acquire PMI’s advanced technology platform at less than half of the current cost, which may lead to significant savings for hospitals. The potential now exists for a comprehensive surgical solution that may be significantly less expensive than manual surgical stapling devices. In addition, the iDrive is reusable, easy to use, cost effective, and less wasteful, potentially leading to savings for hospitals and health networks.
The iConsole is a proprietary wireless device that communicates directly with the iDrive during surgical procedures to output specific auditory and visual reference information via its speaker and liquid crystal display. Outputs provide surgeons with important information regarding calibration, firing, and instrument and reload type, allowing surgeons to make real-time, critical decisions that may ultimately lead to an improved patient outcome.
The iDrive and iConsole combination represents a dynamic technology solution which is designed to enable the incorporation of important functional enhancements. PMI intends to aggressively pursue and implement a variety of key enhancements, which ultimately could lead to offering surgeons the world’s first wireless computer mediated platform with unprecedented capabilities such as wireless video processing, Internet access, a patient record interface and controlled tissue compression software.

Press release: Power Medical Interventions(r) Receives 510(k) Clearance to Market iDrive Intelligent Power Unit(tm) With iConsole(tm)
Link: PMI Intelligent Surgical Instrument page

trialres342 FDA OKs Boston Scis Small Coronary Drug Eluting StentBoston Scientific has received FDA approval for the smallest drug eluting stent currently available, indicated for coronary vessels ≥ 2.25mm. The company plans to launch the TAXUS® Express²® Atom™ device to the US market in June.
taxatom mg 01 us large FDA OKs Boston Scis Small Coronary Drug Eluting StentMore about the stent from Boston Sci:

Data from numerous clinical studies have shown that an estimated 10 percent of patients undergoing percutaneous coronary interventions have small vessels (<2.5 mm). Until recently, many physicians were inclined to implant bare-metal stents in these patients since they were the only approved stenting option for small vessels. Last year's launch of the TAXUS Express Atom Stent offered an alternative treatment choice for patients with small vessels who will now have the additional option of the TAXUS Liberte Atom Stent.
The TAXUS Liberte Stent features design improvements over the Company's first-generation TAXUS Express Stent, including thinner struts to allow better stent deliverability and conformability, as well as uniform stent geometry for consistent lesion coverage and drug distribution.

Press release: FDA Approves Boston Scientific’s Next-Generation TAXUS® Liberte® Atom™ Stent System
Product page: TAXUS® Express²® Atom™ Paclitaxel-eluting Coronary Stent System

tiob3423 ViRob, a Cavities Crawler
At the upcoming ILSI-Biomed Israel 2009 conference (June 15-17 in Tel Aviv), researchers from the Medical Robotics Laboratory at the Israel Institute of Technology (Technion) will be showing off a microrobot called ViRob, that has only a 1millimeter diameter and can crawl through vessels and cavities, when controlled by an external magnetic field. The big idea behind the ViRob device is that it can be used to deliver pharmaceutical payloads to precise locations or pull a microcatheter through tortuous terrain.
fdgs4534 ViRob, a Cavities CrawlerHere’s what organizers of ILSI-Biomed Israel 2009 conference tell Medgadget:

Researchers are currently examining the possibility of using ViRob as a treatment for lung cancer—the world’s deadliest cancer. ViRob could assist in targeted drug delivery to lung tumors as well as take samples from different areas within the body. In addition, a number of these micro robots could simultaneously treat a variety of metastases. Researchers also plan to install additional equipment on the robot,
including cameras, miniature tongs and other miniature equipment.
ViRob measures 1 millimeter in diameter and 14 mm in its entirety was developed in the lab of Prof. Shoham in the Medical Robotics Laboratory at the Israel Institute of Technology. The robot moves using an external electromagnetic ignition system, stimulated by an electromagnetic field with frequency and volume that do not agitate the body, enabling it to maneuver in different spaces and surfaces within diverse viscous fluids. The vibration created by the magnetic field propels the robot forward, as the tiny arms protruding from a central body grip the vessel wall. A basic prototype of the ViRob, which can move as fast as 9 mm per second, has been developed thusfar.

Link: ILSI-Biomed Israel 2009…
White paper from Technion…
A few videos below the fold demonstrating the ViRob:

(more…)

baby down Evacuate Babies Efficiently with BabyScatt
Kidnapping Evacuating babies doesn’t seem hard in theory, but imagine you are a lone nurse working in the newborn nursery when that code red goes off. Now, most likely you wouldn’t do much considering code reds go off if you so much as wink in a fire alarm’s direction. But, if you really need to get Costco amount of babies out of the building, then BabyScatt seems like a reasonable option.
From the website:

The BabyScatt is designed to Evacuate 6 babies at one time.
This cocoon like evacuation device has bumper bars on all sides to protect in case of falling debris or possible obstructions in the pathway. After reaching a place of refuge the BabyScatt continues to protect and provide a safe place for the babies to rest in the individual pockets.

Check out the product page here
(Hat Tip: Gizmodo)

56345jii Homeland Securitys Medical Tricorder for Triage, Not DiagnosisFollowing large scale disasters, paramedics can quickly get overwhelmed by the number of people injured, and have to be quick to figure out who needs to be given priority during triage. Because people don’t yell loudest in proportion to their injury, and some may have internal damage which cannot immediately be recognized, the Department of Homeland Security is sponsoring the development of the Standoff Patient Triage Tool (SPTT). Bringing together the Technical Support Working Group (TSWG), technology from Boeing and Washington University’s School of Medicine in St. Louis, the project hopes to create a device that can provide basic assessment of an injured person within thirty seconds and as far away as forty feet (12 meters).
From the DHS:

The magic behind SPTT is a technology known as Laser Doppler Vibrometry, which has been used in aircraft and automotive components, acoustic speakers, radar technology, and landmine detection. When connected to a camera, the vibrometer can measure the velocity and displacement of vibrating objects. An algorithm then converts those data points into measurements emergency medical responders can use in their rapid assessment of a patient’s critical medical conditions.
With the help of Washington University, researchers have found that best place to capture strong readings vital signs is on the carotid artery, although strong signals have been obtained from the head, chest, abdomen, even a foot. Researchers are also testing whether readings could be taken when someone is lying in an awkward position, or wearing multiple layers of clothing. So far, the results are encouraging.
Despite its promise, the SPTT is not quite as a sophisticated as StarTrek’s tricorder, which was able to comprehensively diagnose obscure diseases. The standoff patient triage tool is a quantum leap forward for medical response, but science fiction remains on the big screen for the moment. The goal is to develop a handheld unit about the size of a legal notebook and as a thick as a ream of paper. Achieving this will require hardening of the unit, and further testing of optical stabilization technology to make sure the unit can function despite a responder’s arm and hand movements. Transition and commercialization could occur sometime mid to late 2010.

Press release: To Boldly Go Where No Medical Response Has Gone Before

recell DOD Helping to Get Skin Harvesting Kit to MarketAs the Obama administration continues to fight wars in Iraq and Afghanistan, the Pentagon is working on medical technology that can help soldiers recover and rehabilitate faster than ever before. Shrapnel wounds and burns caused by explosions often require grafting the damaged areas with regrown skin cells. To make this process easier and faster, Avita Medical out of Nedlands, Australia has created a kit called ReCell for harvesting autologous skin cells by clinicians even in the field. The Pentagon believes in effectiveness of this technology so much that a grant of $1.45 million has been provided to Avita by the United States Armed Forces Institute of Regenerative Medicine (AFIRM) to speed up FDA approval.

ReCell is an innovative single-use medical device for harvesting autologous skin cells. Developed as an ‘off the shelf’ kit, ReCell enables a thin split thickness biopsy, taken at the time of procedure, to be processed into an immediate cell population for delivery onto the wound surface. Once processed, the cell suspension is available for immediate use and can cover a wound up to 80 times the area of the donor biopsy.
ReCell enables the delivery of keratinocytes, melanocytes, fibroblasts and Langerhans cells harvested from the epidermal-dermal junction for application onto a wound surface in order to promote effective wound healing. Melanocyte repopulation may result in the reintroduction of pigmentation into hypopigmented areas.
ReCell has been generally used to treat smaller wounds such as small burns and scalds, donor sites, glabrous injuries, mild to moderate scars, hypopigmentation (hypopigmented scars, iatrogenic hypopigmentation and Vitiligo) and prophylactically in cosmetic rejuvenation procedures.
As the ReCell device enables cell processing at the site of treatment without the use of specialised laboratory staff, the process is both cost and time efficient.
Advantages include:

  • Improved wound healing time and scar quality.
  • Repopulation of melanocytes to reduce hypopigmentation.
  • On-site processing for immediate application.
  • Increased viability through immediate harvest and application.
  • Ability to be processed by clinician not specialised laboratory staff.
  • Info page: ReCell
    More from Sydney Morning Herald

    GI

    topues Cook Introduces High Definition Endoscopic Ultrasound Technology Needle
    Cook Medical has released a new needle for endoscopic ultrasound guided biopsies that promises to be three times brighter that other available needles. The company believes the system, designed to be used in conjunction with the EchoTip Ultra delivery device, that is compatible with most endoscopes, will deliver a better biopsy precision.
    sideues Cook Introduces High Definition Endoscopic Ultrasound Technology Needle

    During an EUS procedure, the endosonographer inserts an endoscope, which has a small ultrasound transducer at its tip, through the patient’s mouth into the esophagus, facilitating imaging from within the GI tract. EUS also enables tissue sampling through fine needle aspiration (FNA), a safer and less invasive alternative to open surgical biopsy. Under ultrasound guidance, a special needle inserted in the endoscope collects cells from targeted sites.
    Cook Medical’s EchoTip Ultra with HDFNA is a single-use, disposable needle intended for sampling of targeted submucosal GI lesions through the accessory channel of an ultrasound endoscope. The needle surface is dimpled with a high-definition pattern that greatly improves its visibility on an ultrasound monitor. This highly echogenic design provides increased assurance that the needle tip is within the target. With traditional EUS-guided FNA, multiple passes are usually necesary in order to get an accurate sample; with the enhanced visibility of EchoTip Ultra HDFNA needles, specimens can be obtained with potentially fewer needle sticks.
    EchoTip Ultra with HDFNA has all the advantages of the original EchoTip Ultra products, with an integrated sheath adjuster that makes the needles compatible with a full range of echoendoscopes and an ergonomically designed handle integrated with a nitinol stylet for precise needle control, stability and flexibility. The safety lock ring easily slides and locks at the desired needle extension and a “Zero” reference mark indicates the needle’s complete retraction within the sheath. In addition, EchoTip Ultra’s metal Luer lock provides a secure, stable platform for performing EUS procedures.

    Press release: First High-Definition Endoscopic Ultrasound (EUS) Technology Enhances Diagnostic Procedures…
    Product page: EchoTip® Ultra Endoscopic Ultrasound Needles…

    hgfd45345 Speedy Test Identifies Living Bacteria
    Identifying whether individual bacteria cells are alive or dead is important in a lot of industries from food safety to clinical diagnostics. Current methods typically involve culturing the bacteria to see if anything grows. Now a French collaboration has developed a nanotechnology technique that focuses on the physical properties of bacterial walls to differentiate between the dead from the alive.
    From Nanowerk:

    The researchers set up a fast and simple procedure – based on a conventional microcontact printing and a simple incubation technique to generate functionalized patterns so as to induce local bacteria deposition – that allowed them to produce reliable chemical patterns exhibiting different surface properties to induce selective adsorption of individual bacteria in liquid media at registered positions.
    "We have evidenced a selective adsorption of bacteria on these local chemical patterns, producing highly ordered arrays of single living bacteria with a success rate close to 100%," says Cerf.
    The team then used this controlled immobilization method to study the mechanical properties of dead or alive bacterial cell in aqueous environment. Using force spectroscopy before and after heating , they measured the Young moduli of the same cell. The cells with a damaged membrane (after heating) present a Young modulus twice as high (6.1 ± 1.5 MPa versus 3.0 ± 0.6 MPa) as that of healthy bacteria. At the same time it has been impossible to evidence a difference between the AFM images of the living and the dead cell.

    More from Michael Berger at Nanowerk
    Abstract in Langmuir:Nanomechanical Properties of Dead or Alive Single-Patterned Bacteria
    Image: Untreated bacteria deposition on a microstructured surface with APTES functionalized patterns (1100 µm x 1000 µm dark field image. Scale bar corresponds to 30 µm).

    4566hpp The Curious Case of Missing FingerprintsA 62 year old gentleman traveling from Singapore was detained for a few hours by US immigration agents when he arrived by plane because he had no fingerprints. Since all international arrivals are now required to undergo fingerprint scanning, the man was questioned and later released once things were cleared up. Turns out that an oncology drug Capecitabine the patient was taking can actually lead to deterioration of skin at the tips of fingers and toes, erasing the ability of machines to see the fingerprints.
    From a statement by the European Society for Medical Oncology:

    Capecitabine is a common anti-cancer drug used in the treatment of a number of cancers such as head and neck cancers, breast, stomach and colorectal cancers. One of its adverse side-effects can be hand-foot syndrome; this is chronic inflammation of the palms or soles of the feet and the skin can peel, bleed and develop ulcers or blisters. “This can give rise to eradication of finger prints with time,” said Dr Tan [senior consultant in the medical oncology department at the National Cancer Centre, Singapore].
    The patient, Mr S, developed a mild case of hand-foot syndrome, and because it was not affecting his daily life he was kept on a low dose of the drug.
    “In December 2008, after more than three years of capecitabine, he went to the United States to visit his relatives,” wrote Dr Tan. “He was detained at the airport customs for four hours because the immigration officers could not detect his fingerprints. He was allowed to enter after the custom officers were satisfied that he was not a security threat. He was advised to travel with a letter from his oncologist stating his condition and the treatment he was receiving to account for his lack of fingerprints to facilitate his entry in future.”
    Foreign visitors have been asked to provide fingerprints at USA airports for several years now, and the images are matched with millions of visa holders to detect whether the new visa applicant has a visa under a different name. “These fingerprints are also matched to a list of suspected criminals,” wrote Dr Tan.
    Mr S was not aware that he had lost his fingerprints before he travelled.
    Dr Tan concludes: “In summary, patients taking long-term capecitabine may have problems with regards to fingerprint identification when they enter United States’ ports or other countries that require fingerprint identification and should be warned about this. It is uncertain when the onset of fingerprint loss will take place in susceptible patients who are taking capecitabine. However, it is possible that there may be a growing number of such patients as Mr S who may benefit from maintenance capecitabine for disseminated malignancy. These patients should prepare adequately before travelling to avert the inconvenience that Mr S was put through.”

    Press release: Cancer drug causes patient to lose fingerprints and be detained by US immigration
    Image: ERIO