Military Medicine Archive

Monday, June 29, 2009

LUCAS 2 Automatic Chest Compressor Gets US Green Light

The LUCAS™ 2 chest compression system from Jolife AB, out of Lund, Sweden, has just been approved by the FDA. The battery powered unit can be taken directly to the patient without the need for a compressed air supply, unlike the last model. The system can then pump the chest for up to 45 minutes, saving paramedics' time and much needed energy once the patient is revived and rushed to the hospital.

From the announcement by Medtronic:

LUCAS 2 builds upon the well-proven LUCAS™ 1 technology, but differs from its predecessor in that it is an electric rather than a pneumatic device. LUCAS 2 can be powered either by battery alone or using a wall or car electricity outlet. The battery is the latest in rechargeable, Lithium Ion Polymer technology and operates for up to 45 minutes (typical) on a single battery. LUCAS 2 is equipped with Smart Restart functionality. When a battery needs to be replaced, LUCAS 2 does not have to be powered down, only put into the pause mode, and when the new battery is inserted, the start position will stay the same within 60 seconds from the pause. Operation can be quickly resumed, saving time for medical personnel. LUCAS 2 offers other new features such as alerts and pauses to aid ventilation during compressions with an unsecured airway (e.g. bag-valve-mask) and quieter operation.

LUCAS 2 weighs only 17.2 lbs (7.8kg) and fits into a compact backpack measuring just 25.6h x 13w x 19.8d inches (65h x 33w x 25d centimeters).
Within the past month, LUCAS 2 has also received a CE (Conformité Européenne) Mark in Europe and marketing approval from Health Canada. Physio-Control plans to begin shipping to the U.S. markets in the fall.

Here's a video loop demonstrating the operation of LUCAS 2:

Product page: LUCAS™2 Chest Compression System...

Press release: FDA Grants LUCAS™ 2 Chest Compression System 510(k) Clearance in the United States...

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Friday, June 19, 2009

Voice Activated SonoSite Ultrasound System Keeps Hands Free to Perform Procedures

SonoSite just released their SonoRemote for controlling the company's M-Turbo and S Series ultrasounds during interventional procedures like joint injections or central line placements. In addition to traditional style buttons, the remote control features voice recognition and can be programmed to understand commands in any language. So now you can hold the probe in one hand and the syringe in the other, and not have to fiddle with reaching over to the unit to take snapshots or change parameters.

Voice or touch activated

Programmable to your voice and language

Adjust system controls from a radius of 10 meters

No need to break the sterile field

Drop-tested to 3 feet

Works with M-Turbo® and S Series™

Press release: SonoSite Begins Customer Shipments Of Ultrasound Remote Control

Product page: SonoRemote

Flashbacks: M-Turbo™: New Portable Ultrasound from SonoSite ; SonoSite S-ICU™ Ultrasound Tool; S-Nerve™ from SonoSite; The SonoSite® MicroMaxx™; Titan

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Monday, June 15, 2009

Spiderman Your Way Down During Hospital Fires

Hospital fires are not an uncommon occurrence, as one of our editors has learned having to evacuate his patients twice within just a few short months. As hospitals have become bigger and taller, the potential of dispersed people becoming trapped on different floors is only growing. Spider International, a small company out of London, UK, has developed a compact evacuation system that can rapidly bring people down to Earth on a steel cable.

The Spider Lifeline to Safety can save lives when staircases and fire exits have become impassable, or circumstances such as disability make using conventional exits impossible. It comes in to its own as a last resort and can save your life.
The ground-breaking device employs fall-arrest technology to lower people to safety down the exterior of a building using a harness and strengthened steel cable. The system allows users to descend at a regulated speed ensuring a quick exit to safety, at a pace that does not endanger the user or other people evacuating the building.
Spider Lifeline to Safety is suitable for use in all buildings providing safe exit from any height whether a two storey
house or a 50 storey office building. The device is capable of multiple evacuations, with adults able to carry their
children and a fast return of the harness to the evacuation point for immediate re-use.

The Spider Lifeline to Safety has been designed to work in all conditions and does not need any external power
source for operation. The Spider Lifeline to Safety has been rigorously tested and also includes an emergency
braking system as well as a double security mechanism for maximum safety.

Spider Lifeline product brochure...

Spider International homepage...

Flashbacks: Evacuate Babies Efficiently with BabyScatt; Evacusled for Efficient Hospital Evacuations; Emergency Evacuation Chair, Bed

Artículo Medgadget Original en Inglés

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Wednesday, June 10, 2009

aScope, a Single Use Intubating Scope from Ambu

Ambu, a Ballerup, Denmark company well known among anesthesiologists, has just released a single use intubating videoscope. The device, we think, will be particularly useful to those anesthesiologists that are on the go: performing anesthesia in ambulatory centers, private offices, GI suits, etc. The EMR personnel, with their hands always in body fluids, might also enjoy a clean scope and a nice view of the vocal cords.

Features of the aScope:

Lightweight ergonomic handle design for enhanced intubation comfort that fits small as well as large hands.

The intuitive handle design gives enhanced comfort for health care professionals.

Camera technology instead of fiberoptic bundle technology for robustness.

Endotracheal tube retention rings for a stabile and secure parking.

Anaesthetic channel with both a swivel for flexibility and a luer-lock for safe connection.

No new operation techniques to use the new Ambu® aScope™. It is easy and uncomplicated.

Packaged sterile and ready for use after connection with Ambu® aScope™ Monitor.

Significantly lower start up investment.

Single patient use only.

Press release: Ambu introduces single-use videoscope - Ambu® aScopeTM

Product page: Ambu aScope...

Ambu aScope datasheet...

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Wednesday, May 27, 2009

Homeland Security's Medical Tricorder for Triage, Not Diagnosis

Following 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

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DOD Helping to Get Skin Harvesting Kit to Market

As 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

Thursday, May 21, 2009

AV300 Portable System Helps Find Hidden Veins

AccuVein, a company out of Cold Spring Harbor, New York, is releasing to market a competitor to the popular VeinViewer from Luminetx. Both systems use infrared imaging to see hemoglobin below the skin. Designed to be portable and battery operated, the AccuVein AV300 can spot difficult to find IV sites for needle placement.

About the product from the manufacturer:

Hemoglobin in the blood absorbs infrared light. When the AccuVein AV300 is held about seven inches above the skin, veins appear noticeably different than the surrounding tissue. The vasculature shows up clearly on the skin's surface, aiding in vein location to collect a blood sample or administer IV medications.

* Easy to learn and use – No pre-use calibration or adjustments are necessary- it can be used immediately.
* Small size –The AV300 fits in your hand and weighs only 10 ounces.
* Hands-free option –Either hand-hold the AV300 or set it in a hands-free accessory.
* No patient contact –Because the AV300 has been designed to be non-contact, it may not have to be sterilized after every use.
* Works in light or dark –Use the AV300 in light or darkly lit environments.
* Rechargeable battery –The AV300 doesn't need to be plugged into an electrical outlet.
* Real world ruggedness – Designed to take the wear and tear of hospital and field applications.
* Movement tolerant –Because the AV300 shows the veins in real time, when operated properly, the device can accommodate patient movement.

Video below the fold demonstrating the AV300:

Wednesday, May 20, 2009

The Signos, Self Contained Handheld Ultrasound Gains FDA Approval

While we have reported on mobile handheld ultrasounds for phones, for those of you that have not joined the iPhone/Smartphone revolution, you are now in luck. The Food and Drug Administration (FDA) has just approved the Signos device, a handheld self-contained portable ultrasound imager with a probe. The system might come in handy as a quick initial diagnostic modality for intraabdominal processes, such as ectopics, AAAs, for carotid scans in ER in patients with ongoing TIA, as well as an assistive device for central line placements. For now, the system seems to be missing a Doppler for flow studies.

The Signos weighs half of a pound and is the size of most smartphones. It will be available with both a 3.5MHz or a 7.5MHz transducer that can be swapped. The company promotes this device for fast paced and active medical environments such as emergency departments and rural medical clinics.

Portable and Affordable: The Signos device is the size of a PDA, weighs less than one pound and features superb image resolution. The Signos is the world's smallest and most affordable ultrasound system available today.
Signos Is Ready When You Need It: With a sleep time of up to 14 days and the ability to power up in less than 1 second from sleep mode, the Signos brings ultrasound to your triage diagnostic care whenever and wherever you need it allowing you to visualize acute pathology on the spot.

Increase Clinical Utility with Added Versatility and Applications: Increase the number of procedures and applications you can perform with either a 3.5MHz or a 7.5MHz transducer. Signostics makes switching from 3.5MHz to 7.5MHz frequencies simple with our easy to use screw on/off transducers.

See More, Do More with MotionScape and SectorView Technology: Signos uses MotionScape and SectorView technology to facilitate a wide range of high resolution clinical applications, including ultrasound guidance for needle placement, AAA exams, FAST exams, bladder volumes and more.

Image Collection: Using the included microSD card you can save up to 20,000 images on the Signos device. With the free SigViewer Software you can quickly and easily upload data and images to your computer for reports, archiving, printing or email.

Signostics Medical has not disclosed a price point or time line for for the Signos release as of yet, but their video support for the device indicates that this is something that is very close to being ready for commercialization.

Press release: Signostics Receives FDA Clearance for World's Smallest Ultrasound Product...

Product page: The Signos device...; Product brochure (.pdf)...

Signostics Medical: Signos

Flashback : Mobile Clinical Imaging On a Smart Phone

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Monday, May 11, 2009

Lab-on-a-Tube for Multimodality Neuromonitoring Post Brain Injury

Understanding the state of the intracranial environment is important in patients following traumatic brain injury. Researchers at the University of Cincinnati have created a "lab-on-a-tube" device that can drain cerebrospinal fluid (CSF) while monitoring the pressure, oxygen content, temperature, and glucose within the intracranial space. The researchers describe the new device that uses sensors wrapped into a helix in the March 20th issue of Lab on a Chip.

From the paper:

The new LOT offers numerous advantages over existing approaches: (a) only one hole is needed to place the LOT, hence it is less invasive; (b) the diameter of the LOT can be contracted or expanded to safely lie within intracranial and intravascular locations, thus minimizing the potential trauma associated with existing technologies; (c) the use of a single device is less expensive and less complicated when compared with the use of multiple individual sensors; (d) the LOT can provide both focal (brain tissue) and global (CSF/blood) information, which is an improvement over the cerebral microdialysis (MD) technique that is limited to focal neurochemical information;3,4 and (e) the buried spirally-rolled microchannels can not only deliver in vivo calibration solution for the biosensors, but also allow convection-enhanced and targeted drug delivery to be realized.

Full article in Lab on a Chip: A novel lab-on-a-tube for multimodality neuromonitoring of patients with traumatic brain injury (TBI)

Images: Side 2: Conceptual drawing of a novel lab-on-a-tube for multimodal neuromonitoring of patients with traumatic brain injury. The lab-on-a-tube can measure pressure, oxygen, temperature and glucose information as well as drain CSF simultaneously.; Side 2: Schematic drawing of LOT. PVDF-TrFE film with pressure sensor, Kapton film with glucose, oxygen and temperature sensors, and parylene microchannels were stacked, bonded and rolled spirally to form a tube. Center: Photographs of fabricated devices: LOT (ID = 1.5 mm; OD = 1.7 mm) is anchored through customized bolted ventricular and connected to LabView monitoring system and CSF drainage bag.

(hat tip: gizmag)

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Tuesday, May 5, 2009

LifeBelt CPR Device Wins in Design Contest

Pictured above is the LifeBelt® CPR, a device from Deca-Medics Inc., of Columbus, Ohio, which has recently won a $20,000 grand prize in the Create the Future Design Contest sponsored by NASA's Tech Briefs Media Group and Dassault Systèmes SolidWorks Corp.

NASA Tech Briefs explains what the device is all about:

Developed by Thomas Lach of Deca-Medics Inc., Columbus, OH, LifeBelt overcomes a critical limitation of “hands-only” CPR: the average rescuer is only capable of producing effective chest compressions for about two minutes, far shorter than the typical eight to ten minute emergency response time. With LifeBelt, half as much force is needed, resulting in less fatigue and longer-duration compressions – increasing the likelihood of a successful resuscitation.
The compact, lightweight device is designed to attach quickly, enabling a rescuer to start CPR in 15 seconds or less. An intuitive readout warns if the compression depth is too deep or shallow, giving the rescuer confidence that he or she is pushing properly.

“Most cardiac arrests don’t occur in a hospital or controlled environment,” said Mr. Lach. “They happen at home or at work. This is an easy-to-use product for all of us.”

Product page: LifeBelt...

Full story@NASA Tech Briefs: Life-Saving CPR Device Wins Create The Future Design Contest...

Press release: Deca-Medics Wins NASA Tech Briefs 'Create the Future' Competition With CPR Aid Designed In SolidWorks 3D CAD Software...

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Wednesday, April 22, 2009

Next Generation of Ossur Power Knee in Action

Ossur, a developer of prosthetic implants, announced that last week its second generation Power Knee bionic prosthesis was implanted in a patient at Walter Reed Army Medical Center.

The Power Knee uses sensor and actuators, coupled with artificial intelligence to better mimic natural walking with less effort by the patient.

In 2006, working in partnership with Victhom Human Bionics, Ossur introduced the POWER KNEE, representing the most advanced technology of its kind with the ability to replace lost muscle function and provide increased safety. Used mostly within the Department of Defense and the Veterans Healthcare Administration, the POWER KNEE marked a new milestone in amputee mobility, safety and advancing natural motion through a powered gait process.
Just three years later, working closely with Walter Reed Army Medical Center and in collaboration with partner Victhom Human Bionics, the next generation of the POWER KNEE has been developed. "The second generation is smaller, sleeker, quieter, lighter and is expected to become widely used by both unilateral and dual amputees," stated Lt. Col. (Dr.) Paul F. Pasquina, chief, Integrated Department of Orthopaedics and Rehabilitation at Walter Reed and the National Naval Medical Center, according to Inside Nova.

Lieutenant Colonel Greg Gadson is the first in the world to receive the commercially-ready prosthetic knees and will soon be followed by other patients at WRAMC. LTC Gadson was serving in Baghdad in May of 2007 when the truck he was riding was struck by a bomb, leaving him on the side of the road bleeding and in and out of consciousness. Ten days later, he was at Walter Reed Army Medical Center with first his left leg amputated, then his right. His undoubting spirit and triumph over tragedy has made him a role model and leader among champions. Notwithstanding the 2008 Super Bowl Champions, the New York Giants, who credit Gadson with giving them the motivation they needed in what became a legendary season. "LTC Gadson was a leader on the football field at West Point. He was a leader to his battalion in combat. And he's been a leader in our rehabilitation environment," added Pasquina.

"It's sort of like driving a school bus and then someone puts you in a sports car," Gadson explained. "You still know how to drive, but it’s quite a different feeling. I just hope this is a path for people to really expand their lives," Gadson said.

According to Ossur, a full commercial release of the Power Knee is expected by 2010.

Press Release : Next Generation of the POWER KNEE(TM) in Early Release at Walter Reed Army Medical Center...

Product page: Ossur Power Knee...

Flashback : The Power Knee

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Monday, April 20, 2009

Mobile Clinical Imaging On a Smart Phone

Engineers at Washington University in St. Louis adapted a small ultrasound prove to interface with a Microsoft Windows mobile smartphone. Although the screen may be too small to diagnose anything properly, it is thought the concept will be used to scan a patient away from the clinic, with the data wirelessly sent to physicians with large screen computers for evaluation.

In order to make commercial USB ultrasound probes work with smartphones, the researchers had to optimize every aspect of probe design and operation, from power consumption and data transfer rate to image formation algorithms. As a result, it is now possible to build smartphone-compatible USB ultrasound probes for imaging the kidney, liver, bladder and eyes, endocavity probes for prostate and uterine screenings and biopsies, and vascular probes for imaging veins and arteries for starting IVs and central lines.

"You can carry around a probe and cell phone and image on the fly now," said Richard [William D. Richard, Ph.D., WUSTL associate professor of computer science and engineering]. "Imagine having these smartphones in ambulances and emergency rooms. On a larger scale, this kind of cell phone is a complete computer that runs Windows. It could become the essential computer of the Developing World, where trained medical personnel are scarce, but most of the population, as much as 90 percent, have access to a cell phone tower."

Zar [David Zar, research associate in computer science and engineering] said the vision of the new system is to train people in remote areas of the developing world on the basics of gathering data with the phones and sending it to a centralized unit many miles, or half a world away where specialists can analyze the image and make a diagnosis. Zar wrote the phone software and firmware for the probes; Richard came up with the low-power probe electronics design. He began working on ultrasound system designs 25 years ago, and in that span he has shrunk the electronics from cabinet-sized to a tiny circuit board one inch by three inches. A typical, portable ultrasound device may cost as much as $30,000. Some of these USB-based probes sell for less than $2,000 with the goal of a price tag as low as $500.

Another promising application is for caregivers of patients with Duchene's Muscular Dystrophy. A degenerative disease that often strikes young boys and robs them of their lives by their late 20s, DMD is a degenerative disease for which there is no cure. The leading treatment to slow its progression is a daily dose of steroids. Patients often experience some side effects from steroids, which are dose related. These side effects include behavioral problems and weight gain. Researchers now know that physical changes in muscle tissue can indicate the efficacy of the steroids. Measuring these changes in muscle can be accomplished with ultrasound and may allow researchers to optimize steroid dosing to maximize efficacy while minimizing side effects.

"The idea is that caregivers, who otherwise have to transport a young person, often wheelchair bound, to a hospital or clinic on a regular basis for examination, can be trained to do ultrasound to track muscle condition," Zar said. "This could lower the dosage to the least effective amount to further increase quality of life of the patient and the caregiver and hopefully extend life. We're really excited about this application. The caregiver would only have to do a one-minute scan, transfer the data captured to the clinic, and the results would come back to the caregiver. A group at the WUSTL Medical School studying Duchene's Muscular Dystrophy is very interested in our devices and hopes they can incorporate them into their research plans."

Full story: Ultrasound imaging now possible with a smartphone ...

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Tuesday, April 14, 2009

Latest Update on DoD, DARPA, and Dean Kamen's Prostheses

We have followed the Defense Department's investment in developing advanced prosthesis spurred by noted medical technology developer Dean Kamen. Over the weekend, CBS 60 Minutes, took us on a behind the scenes tour of Dean Kamen's company, DEKA, and the most recent advancements in prosthesis development.

Ling [Dr. Geoffrey Ling, an Army colonel and neurologist who's leading the Revolutionizing Prosthetics program] told Pelley [60 Minutes correspondent] it's a very large scale project. "It is very much like a Manhattan Project at that scope. It is over $100 million investment now. It involves well over 300 scientists, that is engineers, neuroscientists, psychologists.

The technology development is fascinating and ever improving, but clearly there is a ways to go to make this prosthetic cost effective and more functional for widespread implementation.

60 Minutes: The Pentagon Bionic Arm...

NOTE: Please join us in welcoming a new addition to Medgadget editorial board. Martin Neumann is a a post-doc in Nuclear, Plasma and Radiological Engineering at University of Illinois. In addition to holding a PhD in Nuclear Engineering, he is also a medical student, now finishing his second year. In between exams, upcoming USMLE, post-doc work, ets, he will be blogging to educate all of us. This is his first post.

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Monday, March 30, 2009

US Paramedics Get New Monitoring Gadget

Medtronic's Physio-Control, Inc. received FDA approval to market the new LIFEPAK 15 portable monitor/defibrillator. The system is equipped with the latest gadgetry like a metronome to aid with compressions during CPR, a high contrast screen for easier outdoor operation, and Masimo's pulse oximetry.

Here is a more complete list of features:

Noninvasive and continuous detection of carbon monoxide (SpCO), oxygen saturation (SpO2), and methemoglobin (SpMET) through integrated Masimo Rainbow technology.

The CPR Metronome with audible prompts has been proven to aid users in performing compressions and ventilations within the recommended range of AHA Guidelines.

Energy dosing to 360J for difficult-to-defibrillate patients.

Easy to acquire pre-medication 12-lead ECG and reliable, continuous monitoring of all 12 leads in the background to alert you to changes via our ST Trending feature.

Large, high quality dual-mode color LCD screen with one touch switching to high-contrast SunVue™ mode for use in bright sunlight

Advanced Lithium-ion battery technology to give you up to six hours of operating time-enough juice to run a shift

A platform with a new state-of-the-art processor and more memory so the 15 can grow and adapt as your needs change

Company video introducing the device:

Press release: Physio-Control Receives FDA 510(K) Clearance For LIFEPAK® 15 Monitor/Defibrillator...

LIFEPAK 15 product page...

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Wednesday, March 25, 2009

Easy Hemoglobin Monitoring Without Butterflies, Needles or Catheters

Masimo Corporation, a company that has declared a war on CVP catheters everywhere, is now opening a new front in this battle, by expanding the testing parameters of its pulse oximeters to include continuous non-invasive hemoglobin monitoring. The function allows clinicians to continuously monitor patients at risk for bleeding, whether in OR, ER or in ICU, set proper transfusion targets, and generally provide a more watchful eye on patients.

From a statement by the company:

The availability of noninvasive, continuous, and immediate hemoglobin measurements is expected to have wide ranging clinical impact, from surgery and intensive care to less acute care settings, including the emergency department, physician office, ambulatory surgery center, and long-term care facility by facilitating prompt detection of internal bleeding and more appropriate administration of blood transfusions. Early benefits and impact of Masimo SpHb were evident in feedback received from clinicians at hospitals around the world who participated in the limited market release.
SpHb is part of the Masimo Rainbow SET Pulse CO-Oximetry patient monitoring platform—the first-and-only upgradable technology platform capable of continuously and noninvasively measuring multiple blood constituents and helping to predict fluid responsiveness in patients previously requiring invasive procedures. Masimo Rainbow SET noninvasive measurements—including: total hemoglobin (SpHb™), oxygen content (SpOC™), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), PVI™, oxyhemoglobin (SpO2), pulse rate (PR), and perfusion index (PI)—have the potential to facilitate faster, easier and safer health decisions.

Currently available in bedside Masimo Radical-7® and Rad-87® Pulse CO-Oximeter patient monitors, SpHb will also be offered in handheld monitors and select multiparameter patient monitoring brands through Masimo Rainbow SET Pulse CO-Oximetry technology license agreements.

Press release: Masimo Initiates Full Market Release of First-Ever Noninvasive Continuous Hemoglobin Monitor

Product page: Masimio Rainbow SET® Hemoglobin

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Thursday, January 29, 2009

Appropriate Attire for a Walk Through the Park After a Nuclear Meltdown

Radiation Shield Technologies, a Coral Gables, Florida firm, just announced that it received a US patent for the firm's Demron™ safety fabric. The company claims that the material makes better NBC (Nuclear Biological Chemical) suits, since the metallic fabric is more flexible and lighter than lead.

From the announcement:

Demron is a lead-free, toxin-free, and PVC-free material that allows heat dissipation and resists chemical penetration and cracks. Made of liquid metal, Demron nuclear protection fabrics feel cool and, unlike traditional nuclear suits, they're lightweight, flexible and foldable. Demron has proved to block gamma rays, X-rays and other nuclear emissions, by the Lawrence Livermore National Laboratory, part of the National Nuclear Security Administration within the U.S. Department of Energy, the Georgia Institute of Technology, and the Columbia University College of Physicians and Surgeons. Demron is currently deployed worldwide by NATO, NASA, the National Guard, US Navy, UAE and the governments of South Korea, China, Saudi Arabia and Australia, among others. Scientists have selected it for thermo-mechanical suits for future space travel.

Press release: Radiation Shield Technologies Granted Key U.S. Nanotechnology Patent for World's First and Only Nuclear Radiation-Blocking, Anti-Chemical, Biological-Protection Fabric

Link to patent at USPTO.gov

Radiation Shield Technologies company page...

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New Bone Cement to Prevent Dangerous Battle Injury Infections

Osteomyelitis (OM) is a dangerous bacterial bone infection that often occurs in patients with open fractures. So it is not surprising that injured American soldiers serving in Afghanistan and Iraq have been getting OM, with an end result sometimes being a limb amputation. Now researchers from the Center for Musculoskeletal Research in Rochester with help from the Department of Orthopedics at Aarhus University Hospital in Denmark, Infectious Disease Service at Brooke Army Medical Center in San Antonio, and Heraeus Medical GmbH, created a new colistin-infused bone cement that is showing itself to be effective against the variety of bacterial pathogens that cause OM. Interestingly, Stryker already has a bone cement that features colistin, a product called Simplex P with Erythromycin & Colistin.

From a press statement by the University of Rochester Medical Center:

Not common in the United States and not potentially fatal, A. baumannii OM had been largely ignored until recently by physicians and the pharmaceutical industry, which focuses on life-threatening infections that affect millions, not hundreds. Then military outbreaks of the infection started among American soldiers returning from Iraq in 2003, with the number of A. baumannii OM infections seen in field hospitals, and in stateside facilities receiving injured soldiers, growing. At the same time, data began to emerge from hospitals treating soldiers suggesting that easily contracted A. baumannii may be arriving first at the fracture site and "priming" it so that it becomes more vulnerable to methicillin-resistant Staphylococcus aureus (MRSA), which recently surpassed HIV as the most deadly pathogen in the United States despite nearly universal use of the best available antibiotics.
"If you apply the findings from two small studies to the entire U.S. military, which is a leap, perhaps 2,000 soldiers come into field hospitals with compound fractures each year that become infected with A. baumannii," said Edward Schwarz, Ph.D., professor of Orthopaedics within the Center for Musculoskeletal Research at the University of Rochester Medical Center. "About a third of them go on to get a staph infection after they reach the hospital, with about a third of those, perhaps 200 soldiers, suffering infectious complications that could cost them a limb. Studies already underway in our lab seek to clarify how the initial infections could gradually be replaced by catastrophic MRSA, and to prove that we can save limbs by putting an established antibiotic into bone cement for the first time."

Approaches commonly used to overcome MDR [multi-drug resistant] infections after orthopaedic injuries include applying a large dose of antibiotic locally to the site of infection via bone cement. Bone cements composed of Plexiglas (polymethyl methacrylate or PMMA) have been used for decades for plastic surgery, to anchor in bone prostheses and to fill in holes in bone caused by trauma. Such materials became even more useful when researchers realized decades ago that they could load them with antibiotics to deliver large doses of drug directly to the injury site without subjecting the whole body to toxic levels of antibiotic. While bone cements laced antibiotics against staph and strep infections are common (e.g. vancomycin), no group had ever developed a bone cement treatment using colistin against A. baumannii.

Schwarz and colleagues developed a group of mice infected with drug resistant A. baumannii strains isolated directly from soldiers wounded in Iran and Afghanistan. The mice were then treated with either colistin by injection, local colistin via PMMA bead bone cement or a bone cement control with no drug.

Researchers measured the amount of bacteria in the mice as they responded to treatment with a new test of parC gene activity, a gene known to be present only in A. baumannii. Experiments confirmed that all study mice were infected with the bacteria, and that 75 percent of the strains were resistant to multiple antibiotics. Importantly, the bone cement containing colistin significantly reduced the infection rate such that only 29.2 percent of mice had detectable levels of parC after 19 days (p<0.05 vs. i.m. colistin and placebo). Colistin via injection failed to control the infection and was no better than placebo.

Press release: New Bone Cement May Prevent Amputations

Flashback: Rapid-Sequencing the Superbug

Image: Acinetobacter baumannii

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Tuesday, December 16, 2008

New Treatment Tested for Post Combat Tinnitus

Last March we wrote about an innovative audio device that promises to treat tinnitus, or ringing in the ears, that people often contract after experiencing very loud sounds like explosions or techno concerts. Now the U.S. Army is sponsoring a trial to test the Oasis™ from Neuromonics out of Bethlehem, Pennsylvania on soldiers returning from some loud combat actions in Afghanistan and Iraq.

From a Neuromonics press release:

The tinnitus study will evaluate the Neuromonics Tinnitus Treatment and counseling for active-duty military servicemembers. Trial sites are expected to include large troop-based military installations. Further study is expected to include technological changes to the tinnitus treatment device, as well as evaluating treatment for specific sub-groups of servicemembers, such as those with post-traumatic stress disorder (PTSD) or traumatic brain injury (TBI).
The Neuromonics Tinnitus Treatment is currently in use in 30 Veterans Affairs and six Department of Defense medical centers throughout the country. It is a compact, non-invasive medical device that delivers a prescribed acoustic neural stimulus, customized for each patient’s individual audiological profile, and incorporates specially processed, relaxing music. After clinical customization, the patient listens to the device daily for six-plus months.

The stimulus is designed to provide relief and relaxation in the initial phase of treatment, and then progressively over a period of several months, to facilitate desensitization to the tinnitus. In this way, the therapy can help the brain filter out the tinnitus perception, so that it no longer intrudes on the patient’s conscious attention, and no longer has a disturbing impact on quality of life. By targeting the condition’s underlying neurological basis, Neuromonics may offer enhanced effectiveness for patients compared to alternatives.

Press release: Neuromonics Awarded $1 Million to Conduct Army Tinnitus Study

Product page: Oasis™ Device

Flashback: Digital Audio Used for Treatment of Tinnitus

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Thursday, December 11, 2008

US Navy to Trial Hemopure Stabilized Hemoglobin

U.S. Naval Medical Research Center (NMRC) has submitted to the FDA a revised investigational new drug application to begin a clinical trial of Hemopure® [hemoglobin glutamer - 250 (bovine)], a stabilized hemoglobin, for pre-hospital battlefield treatment of trauma patients. The study is entitled "Operation Restore Effective Survival in Shock" (Op RESUS).

The drug, a product of Biopure Corp, a Cambridge, Mass company, has been under development for many years now. At present, Hemopure® has been approved for marketing in South Africa, where it is "indicated for the treatment of adult surgical patients who are acutely anaemic. Hemopure is indicated for the purpose of eliminating, delaying, or reducing the need for allogenic red blood cells." The company says Hemopure provides "an oxygen treatment bridge" in surgical patients by buying time for patients to build up their own reserves of red blood cells following surgery, hence eliminating the need for red blood cell transfusions in the immediate post operative period.

From the press release:

In June 2008, the NMRC submitted and subsequently withdrew an Op RESUS protocol for a Phase 2 clinical trial of Hemopure for resuscitation of operations casualties with severe traumatic hemorrhagic shock, when blood transfusion is not available. The proposed trial hypothesis is that for such casualties Hemopure will improve survival and other clinical parameters, and will be relatively safe and well tolerated, in comparison with "standard fluid." If the trial is permitted to proceed, subjects will sign an informed consent prospectively. The revised Op RESUS protocol addresses some of the issues raised by the FDA on the initial filing.
Under a research agreement with Biopure, the NMRC assumed primary responsibility, subject to funding, for designing, seeking FDA acceptance of and directing a trial for Hemopure's prehospital use in trauma patients with hemorrhagic shock. The NMRC has developed protocols for trials in civilian casualties in the United States and abroad (RESUS) as well as Op RESUS. To date, Congress has appropriated funds for the development of Hemopure for potential use in military and civilian trauma indications and to cover military administrative costs. This funding is being used for trial preparation and for preclinical studies of Hemopure in animal models, including those that mimic military trauma scenarios. RESUS remains on clinical hold, and the Company anticipates that NMRC will also submit an amended version of that protocol.

Biopure Corporation develops, manufactures and markets pharmaceuticals, called oxygen therapeutics that are intravenously administered to deliver oxygen to the body's tissues. Hemopure(R) [hemoglobin glutamer - 250 (bovine)], or HBOC-201, is approved for sale in South Africa for the treatment of surgical patients who are acutely anemic. On November 21, 2008, the Company announced that it had terminated most of its work force for financial reasons. Using its limited resources, the Company is developing Hemopure for other indications and is supporting the U.S. Navy's government-funded efforts to develop a potential out-of-hospital trauma indication. Biopure's veterinary product Oxyglobin(R) [hemoglobin glutamer - 200 (bovine)], or HBOC-301, the only oxygen therapeutic approved for marketing by both the U.S. Food and Drug Administration and the European Commission, is indicated for the treatment of anemia in dogs. Biopure has sold approximately 200,000 units of Oxyglobin since its launch.

Of note, there is a substantial amount of controversy revolving around Hemopure. Biopure, the manufacturer, has filed a lawsuit against Charles Natanson, et al of the NIH regarding a critical article he and colleagues wrote in the May 21st issue of JAMA.

Biopure press release: U.S. Naval Medical Research Center Resubmits...

Slide presentation (.pdf) about Hemopure for clinicians in South Africa...

Hemopure South Africa...

Biopure's Oxygenation Technology...

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