Pulse Oximetry - History

History

In 1935, Karl Matthes (German physician 1905-1962) developed the first 2-wavelength ear O₂ saturation meter with red and green filters (later switched to red and infrared filters). His meter was the first device to measure O₂ saturation.

The original oximeter was made by Glenn Allan Millikan in the 1940s. In 1949 Wood added a pressure capsule to squeeze blood out of ear to obtain zero setting in an effort to obtain absolute O₂ saturation value when blood was readmitted. The concept is similar to today's conventional pulse oximetry but was hard to implement because of unstable photocells and light sources. This method is not used clinically. In 1964 Shaw assembled the first absolute reading ear oximeter by using eight wavelengths of light. Commercialized by Hewlett-Packard, its use was limited to pulmonary functions and sleep laboratories due to cost and size.

Pulse oximetry was developed in 1972, by Takuo Aoyagi and Michio Kishi, bioengineers, at Nihon Kohden using the ratio of red to infrared light absorption of pulsating components at the measuring site. Susumu Nakajima, a surgeon, and his associates first tested the device in patients, reporting it in 1975. It was commercialized by Biox in 1981 and Nellcor in 1983. Biox was founded in 1979, and introduced the first pulse oximeter to commercial distribution in 1981. Biox initially focused on respiratory care, but when the company discovered that their pulse oximeters were being used in operating rooms to monitor oxygen levels, Biox expanded its marketing resources to focus on operating rooms in late 1982. A competitor, Nellcor (now part of Covidien, Ltd.), began to compete with Biox for the U.S. operating room market in 1983. Prior to the introduction of pulse oximetry, a patient's oxygenation could only be determined by arterial blood gas, a single-point measurement that takes several minutes for sample collection and processing by a laboratory. In the absence of oxygenation, damage to the brain starts within 5 minutes with brain death ensuing within another 10–15 minutes. The worldwide market for pulse oximetry is over a billion dollars. With the introduction of pulse oximetry, a non-invasive, continuous measure of patient's oxygenation was possible, revolutionizing the practice of anesthesia and greatly improving patient safety. Prior to its introduction, studies in anesthesia journals estimated U.S. patient mortality as a consequence of undetected hypoxemia at 2,000 to 10,000 deaths per year, with no known estimate of patient morbidity.

By 1987, the standard of care for the administration of a general anesthetic in the U.S. included pulse oximetry. From the operating room, the use of pulse oximetry rapidly spread throughout the hospital, first to the recovery room, and then into the various intensive care units. Pulse oximetry was of particular value in the neonatal unit where the patients do not thrive with inadequate oxygenation, but too much oxygen and fluctuations in oxygen concentration can lead to vision impairment or blindness from retinopathy of prematurity (ROP). Furthermore, obtaining an arterial blood gas from a neonatal patient is painful to the patient and a major cause of neonatal anemia. Motion artifact can be a significant limitation to pulse oximetry monitoring resulting in frequent false alarms and loss of data. The reason for this is that during motion and low peripheral perfusion, many pulse oximeters cannot distinguish between pulsating arterial blood and moving venous blood, leading to underestimation of oxygen saturation. Early studies of pulse oximetry performance during subject motion made clear the vulnerabilities of conventional pulse oximetry technologies to motion artifact. In 1995, Masimo introduced Signal Extraction Technology (SET) that could measure accurately during patient motion and low perfusion by separating the arterial signal from the venous and other signals. Since then, pulse oximetry manufacturers have developed new algorithms to reduce some false alarms during motion such as extending averaging times or freezing values on the screen, but they do not claim to measure changing conditions during motion and low perfusion. So, there are still important differences in performance of pulse oximeters during challenging conditions.

In 2004, a jury found that Nellcor infringed several Masimo patents related to measure-through motion and low perfusion signal processing technology. In 2005, the appellate court affirmed the infringement findings against Nellcor, and instructed the District Court to enter a permanent injunction against Nellcor’s pulse oximeters (e.g., N-395, N-595) that were found to infringe. In January 2006, Masimo and Nellcor entered into a settlement agreement, where Nellcor, among other things, agreed to discontinue shipment of the pulse oximeters that were found to infringe Masimo’s patents.

Published papers have compared signal extraction technology to other pulse oximetry technologies and have demonstrated consistent favorable results for signal extraction technology. Signal extraction technology pulse oximetry performance has also been shown to translate into helping clinicians improve patient outcomes. In one study, retinopathy of prematurity (eye damage) was reduced by 58% in very low birth weight neonates at a center using signal extraction technology, while there was no decrease in retinopathy of prematurity at another center with the same clinicians using the same protocol but with non- signal extraction technology. Other studies have shown that signal extraction technology pulse oximetry results in fewer arterial blood gas measurements, faster oxygen weaning time, lower sensor utilization, and lower length of stay. The measure-through motion and low perfusion capabilities it has also allow it to be used in previously unmonitored areas such as the general floor, where false alarms have plagued conventional pulse oximetry. As evidence of this, a landmark study was published in 2010 showing clinicians using signal extraction technology pulse oximetry on the general floor were able to decrease rapid response team activations, ICU transfers, and ICU days.

High resolution pulse oximetry (HRPO)has been developed for in-home sleep apnea screening and testing in patients for whom it is impractical to perform polysomnography . It stores and records both pulse rate and SpO2 in 1 second intervals and has been shown in one study to help to detect sleep disorderd breathing in surgical patients.

In 1995 Masimo introduced perfusion index, quantifying the amplitude of the peripheral plethysmograph waveform. Perfusion index has been shown to help clinicians predict illness severity and early adverse respiratory outcomes in neonates, predict low superior vena cava flow in very low birth weight infants, priovide an early indicator of sympathectomy after epidural anesthesia, and improve detection of critical congenital heart disease in newborns.

In 2007, Masimo introduced the first measurement of the pleth variability index (PVI), which multiple clinical studies have shown provides a new method for automatic, noninvasive assessment of a patient's ability to respond to fluid administration. Appropriate fluid levels are vital to reducing postoperative risks and improving patient outcomes: fluid volumes that are too low (under-hydration) or too high (over-hydration) have been shown to decrease wound healing and increase the risk of infection or cardiac complications. Recently, the National Health Service in the United Kingdom listed PVI monitoring as part of their suggested strategies for intra-operative fluid management.

In 2009, the world's first Bluetooth-enabled fingertip pulse oximeter was introduced by Nonin Medical, enabling clinicians to remotely monitor patients' pulses and oxygen saturation levels. It also allows patients to monitor their own health through online patient health records and home telemedicine system. In 2012, a pulse oximeter with integrated 802.11 wireless radio and a touchscreen interface was introduced by Masimo, allowing clinicians to monitor patients wherever they are at within the hospital.