Think pocket ultrasounds are just novelties? Advances in technology are seeing the miniaturization of devices that can not only triage patients, but also help minimize costs.
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| The ACUSON P10 from Siemens weighs just 1.6 pounds and is ideal for trauma patient assessment and care. |
Like all electronic devices, ultrasound technology is becoming smaller, lighter, and more portable. Yet, even hand-carried ultrasound (HCU) products on the market today are not exactly like carrying an iPhone in your pocket. Despite ultrasound’s versatility as a quick method to confirm heartbeat and visualize internal fluids or trauma, the HCU size—and price—makes it impractical for every paramedic or physician in the emergency department to carry one in the field or to every waiting patient. Recently, a new class of “pocket ultrasounds” has been developed to fill the more portable needs of clinicians.
As their name implies, pocket ultrasound devices are small, lightweight, and able to fit into one’s pocket or perhaps even around a clinician’s neck like a stethoscope. At under $10,000, they’re also significantly less expensive than HCUs, and one young Cornell University inventor is developing a therapeutic pocket ultrasound for vein ablation that may cost as little as $100. Pocket ultrasounds are not likely to replace full-featured HCUs or their larger cousins any time soon, but they do have the potential to change the way clinicians treat and triage patients in certain clinical settings.
Two FDA-Approved Models
There are currently only two FDA-approved pocket ultrasound products on the market.
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| With a foldout screen and keyboard, the ACUSON P10 is easy to use. |
Mountain View, Calif-based Siemens Medical Solutions USA has the ACUSON P10™, which has been on the market for more than a year. The ACUSON P10 was designed to be a handheld diagnostic and screening tool for emergency medical technicians and other clinicians, such as OB/GYNs, who require an imaging device for faster, accurate, point of care situations, such as confirming a trauma patient’s blood flow and heartbeat, or an abnormal buildup of abdominal fluid.
The ACUSON P10 features a dedicated 2 to 4 MHz phased array transducer for BD-mode imaging in both fundamental and harmonic imaging modes, weighs 1.6 pounds, and has a small foldout screen and keyboard, similar to an extralarge flip phone with a transducer. Its footprint—or handprint—is a bit larger than a Blackberry, but certainly able to be held in one’s palm.
According to Scott Ashworth, vice president of worldwide sales and service, ultrasound, Siemens Medical Solutions USA, the ACUSON P10’s rechargeable battery gives users a continual run time of an hour. Assuming an average ultrasound study to be between 2 and 3 minutes long, a clinician may be able to get 20 to 30 applications out of a single charge. The ACUSON P10 also comes with a memory card slot for storage of both still frame and CINE image data.
The other FDA-approved pocket ultrasound that is just being released in the United States is the Signos Personal Ultrasound from Palo Alto, Calif-based Signostics Inc. Like the P10, the Signos was developed as a point of care ultrasound, designed to enable clinicians to more accurately examine and triage patients. Exact specifications were not available beyond the press releases and the company’s Web site (www.signosticsmedical.com)
However, according to these marketing sources, the Signos weighs in at “approximately half a pound.” Online videos and brochures show a handheld device that resembles a thick PDA with a similar-sized screen and a transducer attachment.
In terms of therapeutic ultrasound, George K. Lewis, Presidential and National Science Foundation Fellow at Cornell Biomedical Engineering, Ithaca, NY, has developed a revolutionary pocket ultrasound device that will initially be designed for vein ablation in plastic surgery applications. It has yet to receive 510(k) FDA approval, but if all goes well, the device may be available in the next 5 years at an extremely low cost. (See sidebar.)
Not an HCU Replacement
Neither the P10 nor the Signos device was intended to become a replacement for HCUs, but rather an extension of them.
Ashworth said, “The P10 provides access to more patient information at initial point of care, for example, in the ED or the ambulance, or really any triage environment, increasing the quality of patient care, which ultimately delivers an overall reduction in health care costs.”
Similarly, Signostics marketing materials do not tout it as an HCU replacement, but said that their Signos will appeal not only to ED clinicians and OB/GYNs, but also primary care, remote health care, critical care, pediatrics, and sports medicine, to make quick clinical assessments.
Barry Goldberg, MD, director of ultrasound, Department of Radiology at Thomas Jefferson University Hospital, Philadelphia, said that physicians at his hospital have used their pocket ultrasounds mainly in the emergency department and intensive care units. Goldberg likes to say that they can be utilized as an “imaging stethoscope.”
“You want to use this somewhere where you want to get a quick bit of information,” Goldberg said, “where it might not be totally diagnostic, but will provide some important information.”
Even if vendors improve the image resolution of pocket ultrasounds to be as detailed as that of the HCU units, Goldberg doubts that they will ever be able to replace HCUs because of their screen size.
Goldberg said, “If there’s a moderate to large amount of fluid, or if there is an enlarged mass or organ, you can make it out with a pocket ultrasound screen, but you’d want to see more detail.”
Ashworth adds that even the most portable HCUs are not practical in the field compared to a pocket ultrasound. “An HCU doesn’t fit in a lab coat pocket or a jacket. It’s much larger, it’s more user dependant, and its boot-up time is much longer. For all of these reasons, it’s really not considered a triage type point of care ultrasound device.”
A Variety of Applications
So what can these little pocket ultrasounds do? There are many clinical applications in various fields.
Goldberg said, “When you’re examining a patient and you believe you feel a large liver, if you have one of these machines, you can actually then image the place where your hand is feeling something big and see whether in fact the liver is enlarged. Or if you’re palpating the abdomen and you think there’s free fluid—ascites, sometimes that isn’t the case, but you can easily use this machine to see whether the fluid is there.”
Similarly, in an emergency trauma situation where the clinician might feel for a pulse, a pocket ultrasound can quickly visualize whether the heart is beating, or if there’s significant bleeding in the abdomen or pleural or pericardial effusion.
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The other major area where pocket ultrasound may add to the point of care is in OB/GYN applications. The pocket ultrasound can assist in guiding a needle for amniocentesis, give a snapshot of the fetus’s position, or detect the heartbeat.
In fact, fluid removal in many clinical settings may benefit from being able to more accurately guide the needle into the fluid with potentially less risk of injury to other tissues. Nevertheless, it should be noted that studies are just beginning to evaluate if these devices will provide better outcomes.
The Cost Factor
While the cost of a pocket ultrasound is far less than that of an HCU, it is still not an insignificant amount. The list price for the Siemens ACUSON P10 is $9,499, according to Ashworth. The Signos model’s price has not been disclosed, but marketing materials say it will be “affordable.”
The size and price tag of these existing pocket ultrasounds may make hospital administrators nervous about handing one to every physician in lieu of a stethoscope. Dropping or accidentally losing one during hectic emergency situations would certainly be more costly than the loss of a stethoscope.
Further innovations and increased competition will inevitably bring the cost down, and there is at least one young inventor who may have a solution for dramatically lowering costs. (See below)
Tor Valenza is a staff writer for Axis Imaging News.
The $150 Therapeutic Pocket Ultrasound
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A year and half ago, George K. Lewis, Presidential and National Science Foundation Fellow at Cornell Biomedical Engineering, Ithaca, NY, was researching methods to use ultrasound for enhancing the penetration of drugs to malignant brain cells after tumor resection. Having limited funding to purchase a high-power $30,000 ultrasound device for his research, Lewis used his engineering background to build his own device.
What developed from that process is a new way to build a therapeutic ultrasound, which not only is superefficient and small, but also costs only $150 in spare parts.
Lewis said his device will potentially have multiple applications when used with various transducers and power levels. At low powers, the unit can be utilized for improved drug delivery and DNA delivery. At higher powers, focal therapy using focused transducers can cauterize a tumor instead of surgery.
Lewis said, “What existed before this technology was 30-pound boxes with another box, which was called an impedance matching box, and then your transducer. That was 50% efficient at delivering energy. Now we have a 1.5- x 2-inch device that delivers the same voltage 99% effectively or efficiently.”
Thus far, the technology has been tested only in industrial and experimental therapeutic applications. Lewis’s new company, Zetroz Inc, Ithaca, is in the process of commercializing its proprietary “0z circuit” for plastic surgery ablations. In the future, Lewis also may develop a system for imaging ultrasounds that will make them more powerful, smaller—and less expensive.
—T. Valenza
