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Visual Sensor Provides a Breath of Fresh Air for Medical Ventilation

Wed, 07/05/2006 - 11:00am

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The Project: Create a mechanism that dramatically improves the rate of successful intubation of patients.

The Solution: Use the existing form factor—an intubation tube—and embed a high-quality camera to assist in intubating patients and monitoring airways, while making it a disposable device.


By Ofer Fridman
In the western world, approximately 50 million intubations—the insertion of an endotrachial tube into the trachea of a patient—are performed annually. Although intubation is an extremely common practice, it is far from commonly successful. Today, however, advances in video technology and enabling CMOS sensors are allowing medical personnel in operating rooms or at the scene of an accident to successfully "see" that they are inserting and maintaining the tube properly, thus avoiding severe injury or even death.

ETView Ltd. is the company behind an innovative tracheoscopic ventilation tube (TVT). The device integrates a tiny camera capable of providing a clear view of the upper airways and trachea on a monitor or portable screen during intubation. The tube retains the same dimensions used by the medical industry for decades. The embedded 1/7 in. CMOS image sensor camera created by OmniVision is actually part of the tube's interior, yet does not impede the flow of air.

In an emergency situation, establishing a clear airway by endotracheal intubation is normally the first life-saving step performed. In emergency rooms and operating rooms worldwide, when patients are put to sleep in advance of a medical procedure, they are also intubated.

To intubate properly, a tube that is akin to a normal PVC tube, must be inserted between the vocal cords and into the trachea. Unfortunately, even with a patient's mouth held open with the aid of a laryngoscope, the vocal cords are not visible. To make the process even more complex, directly behind the trachea, which leads to the lungs, is the esophagus, which leads to the stomach. If the tube is placed by mistake in the esophagus, or if it slips from the tracheal position, the mistake can be fatal or lead to brain injuries and permanent disabilities, unless immediately corrected.
Providing Vision

Offering a high quality picture, the real-time view enables tube placement and monitoring.
The OmniVision camera is a single-chip video/imaging camera device that delivers high functionality in a single small-footprint package. The image array used in the ETView device operates at up to 30 frames per second. The underlying sensor technology is based on advanced algorithms that cancel fixed-pattern noise, eliminate smearing, and dramatically reduce blooming—issues that consistently prevent high-quality images.

When ETView began its search for existing camera technology to embed in its tracheoscopic ventilation tube, its requirements were: very small size, low-manufacturing cost, and good quality imaging. Several solutions were reviewed, but the company rapidly selected Color CMOS CameraChip by OmniVision. Since the 1/7 in. size sensor was already mass produced, it was an ideal choice for ETView. Almost immediately, ETView began development work with OmniVision.

The ability to house a camera-on-a-chip, small enough for use in an intubation tube, is a result of OmniVision's use of CMOS process technology. Complementary metal-oxide semiconductor process is not new—it has been in use for more than 30 years. The advantages of CMOS technology used in imaging include its reliability, small size, low power consumption, and low-cost features. The ability to rely on CMOS imaging is responsible for the one-chip solution as the camera takes 50% less real estate, has 50% less power consumption, and is far less complex than any competing technology.

When ETView modified the single-use intubation tube to house a camera, it expected that the picture quality would be good. Instead, the quality and clarity rivals the best medical photography in the marketplace by cameras with price tags of between $40,000 and $50,000.
A Look at the Challenge
The best environment in which to intubate a patient is an operating room. Prior to a procedure, the anesthesiologist consults with the patient and is aware of potential problems. The anesthesiologist notes that the patient looks normal, is not obese, and can easily open the mouth. Even when the situation appears completely normal, approximately 3% to 5% of all attempts end up being difficult intubations. At the very least, they don't succeed during the first attempt to insert the tube into the trachea. In the field, especially in rural areas where medics are volunteers, the first-time intubation success rate is drastically low—often less than 50%.

< The OmniVision camera is at the tip of the tracheoscopic ventilation tube.
 
 
> Tucked neatly inside the tube, the camera does not represent a change to the tube's existing dimensions.
 
Not only are intubations difficult to manage logistically, undetected esophageal intubation is devastating for the patient. In this situation, the stomach can be accidentally accessed by placement of the tube in the esophagus rather than in the trachea. Since it is currently nearly impossible to see that the tube is inserted correctly, there are several traditional means used to verify placement. These involve listening for sounds over the stomach and then over each lung to hear breathing, looking for condensation in the endotracheal tube during exhalation, and observing the chest rise and fall.

There are also syringe aspiration esophageal detector devices that cost approximately $10 each that are sometimes used to confirm tube placement. They are not completely useful in that, although they can verify 100% of the time that the esophageal detector device is not in the esophagus, in 35% to 40% of the cases, they misidentify a good placement in the trachea as actually being esophageal, unnecessarily causing medical personnel to take remedial action for no reason.

One of the most common reasons for negligence claims against paramedics is unrecognized esophageal intubation. The law consistently finds that an unrecognized esophageal intubation equates to negligence. In the field, however, amid sirens and chaos, vomiting, blood, and poor lighting, current methods of intubation increase the likelihood of error.
Real-Time Monitoring
The combination of the tube and camera enable medical personnel, for the first time, to undertake the ventilation of patients with confidence. Equally important, ETView's innovation marks the first time a single-use device is used for real-time monitoring of internal organs.

The body's normal and predictable reaction to an intubation tube is to create secretions. In addition to these, there are secretions from the stomach—or aspiration. Secretions, when not handled promptly, cause pneumonia. Approximately 30% of patients artificially ventilated for more than 12 hours contract pneumonia—and 50% of these cases are fatal. By monitoring consistently, it is possible to suction the secretions before they become life threatening, no matter what their source. Even suctioning the left lung, which is difficult, given its 75° angle, can be handled with the aid of the camera.

Monitoring capabilities are capturing the imagination of doctors when they are introduced to the TVT. When doctors look at the device in operation for the first time, their tendency is to suggest new applications for it. There is virtually no training necessary to begin using the TVT. It easily and intuitively enables what should have been possible all along, and then provides the means to ensure success and ongoing assurance through monitoring.
FDA Approval
ETView had to convince the FDA that, for the patient, the TVT was based on the same tube that it had always been. ETView was able to show that the solution not only worked and was not a danger to patients, but that it actually enabled doctors to have an advantage—the rapid insertion of the tube along with availability of monitoring capabilities. ETView was able to demonstrate that its system worked under all conditions, anywhere—with 100% reliability.

ETView's solution is simple to use, even for those with less training, eliminating the need for other measures, such as X-rays to confirm correct tube position. The company's products address difficult and complicated monitoring. The products are used by hospital ERs, ORs, and ICUs, enabling continuous monitoring of the TVT position in the trachea. They are a natural addition to bedside monitors. For emergency medical services, personnel enjoy an easier insertion and higher rate of success with consistently difficult intubations. TVT provides continuous monitoring of the position of the endotracheal tube during transport to hospitals.

The Future
In the long run, the use of a disposable TVT will result in substantial savings. It is obligatory to take a mobile X-ray in the hospital for each intubation performed outside of the operating room to verify the position of the tube. The ETView TVT eliminates the necessity for the X-ray and enables difficult placement even in the field.

The company is currently selling its first-generation TVT device. Although the smallest camera available for the application is being used, it is still too large for the small tubes necessary to intubate infants and children. ETView and OmniVision are currently developing next-generation devices to address this market.
ONLINE
For additional information on the technologies and products discussed in this article, see the following websites:
Ofer Fridman is CEO of ETView Ltd., Misgav Technology Center, M.P. Misgav, Israel, 20179. Prior to joining the company, he served as COO at CardioSense, a medical device startup company in the Technion Technology Incubator. Fridman earned a BS in mechanical engineering and business administration (cum laude) with the Technion in Haifa, Israel. He can be reached at 972-4-9991996 or ofer@etview.com.
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