Difference between revisions of "Milestone-Proposal:Pulse Oximeter"

From IEEE Milestones Wiki
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|a4=The major historical significance of the first 'Pulse Oximeter’ is summarized in what follows.
 
|a4=The major historical significance of the first 'Pulse Oximeter’ is summarized in what follows.
  
1.  Historical Background of Developing Pulse Oximeters   
+
1.  Historical Background of Development of Pulse Oximeters   
  
 
The supplementary oxygen is indispensable to patients with respiratory or cardiac problems, pilots in unpressurized aircrafts, mountain climbers at high altitudes, and athletes with exercise, etc. The pulse oximetry is based on a unique concept of computing a patient’s arterial oxygen saturation without need for calibration, using the pulsatile variations in optical density of tissues in the red and infrared wavelengths. Thus, pulse oximetry is particularly convenient for noninvasive continuous measurement of blood oxygen saturation [1-3].  
 
The supplementary oxygen is indispensable to patients with respiratory or cardiac problems, pilots in unpressurized aircrafts, mountain climbers at high altitudes, and athletes with exercise, etc. The pulse oximetry is based on a unique concept of computing a patient’s arterial oxygen saturation without need for calibration, using the pulsatile variations in optical density of tissues in the red and infrared wavelengths. Thus, pulse oximetry is particularly convenient for noninvasive continuous measurement of blood oxygen saturation [1-3].  
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The ‘pulse oximeter’ was invented in 1972 by Takuo Aoyagi at a Japanese medical electronic equipment manufacturer Nihon Kohen Corporation, and it has since been used as a medical device that monitors noninvasively the oxygen saturation of a patient’s blood and changes in blood volume in the skin [1-5]. At present, a typical 'pulse oximeter' uses an electronic processor and a pair of small LEDs facing a photodiode through a translucent part of the patient’s body, usually a fingertip or an earlobe, as can be seen from Fig. 1, where it should be added that one LED is red with wavelength of 660 nm, and the other is infrared with wavelength of 940 nm [5].
 
The ‘pulse oximeter’ was invented in 1972 by Takuo Aoyagi at a Japanese medical electronic equipment manufacturer Nihon Kohen Corporation, and it has since been used as a medical device that monitors noninvasively the oxygen saturation of a patient’s blood and changes in blood volume in the skin [1-5]. At present, a typical 'pulse oximeter' uses an electronic processor and a pair of small LEDs facing a photodiode through a translucent part of the patient’s body, usually a fingertip or an earlobe, as can be seen from Fig. 1, where it should be added that one LED is red with wavelength of 660 nm, and the other is infrared with wavelength of 940 nm [5].
  
2.  Development of Pulse Oximeters
+
2.  Historical Achievements of Developing Pulse Oximeters
  
 
The pulse oximetry is a noninvasive method for monitoring a person’s arterial oxygen saturation, and the development of a ‘pulse oximeter’ started in 1972. In what follows, how this device has since been commercialized is overviewed [3-5].
 
The pulse oximetry is a noninvasive method for monitoring a person’s arterial oxygen saturation, and the development of a ‘pulse oximeter’ started in 1972. In what follows, how this device has since been commercialized is overviewed [3-5].
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(5) For patients with COVID-19, the pulse oximetry helps with early detection of silent hypoxia, in which the patients still look and feel comfortable, but their SpO2 (peripheral oxygen saturation) is perilously low. This happens to patients either in the hospital or at home. Here, it should be added that low SpO2 may indicate severe COVID-19 related pneumonia, requiring a ventilator.
 
(5) For patients with COVID-19, the pulse oximetry helps with early detection of silent hypoxia, in which the patients still look and feel comfortable, but their SpO2 (peripheral oxygen saturation) is perilously low. This happens to patients either in the hospital or at home. Here, it should be added that low SpO2 may indicate severe COVID-19 related pneumonia, requiring a ventilator.
 +
 +
(6) Thanks to Dr. Aoyagi's great accomplishments of developing the world's first 'pulse oximeter', he was honored in 2015 with 'IEEE Medal for Innovation in Healthcare Technology' for the first time in Japan.
 
|a6=The idea of pulse oximetry originated in Japan, but the device development gradually lagged in Japan due to a lack of business, clinical, and academic interest. In what follows, a number of obstacles are pointed out [4,5]:
 
|a6=The idea of pulse oximetry originated in Japan, but the device development gradually lagged in Japan due to a lack of business, clinical, and academic interest. In what follows, a number of obstacles are pointed out [4,5]:
  
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[5]  ‘Pulse oximetry’: https://en.wikipedia.org/wiki/Pulse_oximetry
 
[5]  ‘Pulse oximetry’: https://en.wikipedia.org/wiki/Pulse_oximetry
 +
 +
 +
Appendices:
 +
References [1] and [2] were written in Japanese, for which English abstracts are provided as follows.
 +
 +
① Reference [1]: This article describes the patent gazette of Japan Patent 53-26437 on the 'Pulse Oximeter' invented by Takuo Aoyagi and Michio Kishi at Nihon Kohden Corporation (Tokyo. Japan), which was applied on March 29, 1974, and obtained on October 9, 1975.
 +
This patent gazette claims the extent and distinctive features of invented technologies.
 +
 +
② Reference [2]: This article outlines Dr. Aoyagi's achievements of developing the fist pulse oximeter, featuring (i) the principle of pulse oximeter, (ii) Dr. Aoyagi's discovery of the method of developing pulse oximetry, (iii) the first product 'Ear Oximeter OLV-5100' put on sale in 1975 by Nihon Kohden Corporation, (iv)  the diffusion of pulse oximeters, (v) Dr. Aoyagi's short history, and (vi) the list of patents attained by Dr. Aoyagi.
 
|submitted=No
 
|submitted=No
 
}}
 
}}

Revision as of 05:06, 28 December 2021


To see comments, or add a comment to this discussion, click here.

Docket #:2021-21

This is a draft proposal, that has not yet been submitted. To submit this proposal, click on "Actions" in the toolbar above, then "Edit with form". At the bottom of the form, check the box that says "Submit this proposal to the IEEE History Committee for review. Only check this when the proposal is finished" and save the page.


To the proposer’s knowledge, is this achievement subject to litigation? No

Is the achievement you are proposing more than 25 years old? Yes

Is the achievement you are proposing within IEEE’s designated fields as defined by IEEE Bylaw I-104.11, namely: Engineering, Computer Sciences and Information Technology, Physical Sciences, Biological and Medical Sciences, Mathematics, Technical Communications, Education, Management, and Law and Policy. Yes

Did the achievement provide a meaningful benefit for humanity? Yes

Was it of at least regional importance? Yes

Has an IEEE Organizational Unit agreed to pay for the milestone plaque(s)? Yes

Has an IEEE Organizational Unit agreed to arrange the dedication ceremony? Yes

Has the IEEE Section in which the milestone is located agreed to take responsibility for the plaque after it is dedicated? Yes

Has the owner of the site agreed to have it designated as an IEEE Milestone? Yes


Year or range of years in which the achievement occurred:

1972

Title of the proposed milestone:

First Pulse Oximeter, 1972

Plaque citation summarizing the achievement and its significance:

The ‘pulse oximeter’ was invented in 1972 by Takuo Aoyagi at Nihon Kohden Corporation, and has since been used as a medical device that monitors patients' blood oxygen saturation. Owing to the ability to provide continuous oxygen saturation values, ‘pulse oximeters’ are of critical importance in emergency medicine as well as of great use for patients with respiratory/cardiac problems or sleep disorders such as apnea and hypopnea.

In what IEEE section(s) does it reside?

Tokyo Section

IEEE Organizational Unit(s) which have agreed to sponsor the Milestone:

IEEE Organizational Unit(s) paying for milestone plaque(s):

Unit: Tokyo Section
Senior Officer Name: Yoshiaki Nakano

Unit: {{{Unit}}}
Senior Officer Name: {{{Senior officer name}}}

IEEE Organizational Unit(s) arranging the dedication ceremony:

Unit: Tokyo Section
Senior Officer Name: Yoshiaki Nakano

IEEE section(s) monitoring the plaque(s):

IEEE Section: Tokyo Section
IEEE Section Chair name: Yoshiaki Nakano

Milestone proposer(s):

Proposer name: Hiroshi Suzuki
Proposer email: Proposer's email masked to public

Proposer name: Isao Shirakawa
Proposer email: Proposer's email masked to public

Please note: your email address and contact information will be masked on the website for privacy reasons. Only IEEE History Center Staff will be able to view the email address.

Street address(es) and GPS coordinates of the intended milestone plaque site(s):

Nihon Kohden Corporation. Address: 1-31-4 Nishi-Ochiai, Shinjuku-ku, Tokyo 161-8560, Japan, GPS coordinates: N 35.71951, E 139.67898

Describe briefly the intended site(s) of the milestone plaque(s). The intended site(s) must have a direct connection with the achievement (e.g. where developed, invented, tested, demonstrated, installed, or operated, etc.). A museum where a device or example of the technology is displayed, or the university where the inventor studied, are not, in themselves, sufficient connection for a milestone plaque.

Please give the address(es) of the plaque site(s) (GPS coordinates if you have them). Also please give the details of the mounting, i.e. on the outside of the building, in the ground floor entrance hall, on a plinth on the grounds, etc. If visitors to the plaque site will need to go through security, or make an appointment, please give the contact information visitors will need. The entrance hall of Nihon Kohden Corporation.

Are the original buildings extant?

The original building is extant, and presently belongs to Nihon Kohden Corporation.

Details of the plaque mounting:

The plaque will be displayed at the entrance hall of Nihon Kohden Corporation.

How is the site protected/secured, and in what ways is it accessible to the public?

The plaque will be displayed in a showcase placed at the entrance hall of Nihon Kohden Corporation, which can be accessible to the public with permission.

Who is the present owner of the site(s)?

Mr. Hirokazu Ogino, President of Nihon Kohden Corporation.

What is the historical significance of the work (its technological, scientific, or social importance)?

The major historical significance of the first 'Pulse Oximeter’ is summarized in what follows.

1. Historical Background of Development of Pulse Oximeters

The supplementary oxygen is indispensable to patients with respiratory or cardiac problems, pilots in unpressurized aircrafts, mountain climbers at high altitudes, and athletes with exercise, etc. The pulse oximetry is based on a unique concept of computing a patient’s arterial oxygen saturation without need for calibration, using the pulsatile variations in optical density of tissues in the red and infrared wavelengths. Thus, pulse oximetry is particularly convenient for noninvasive continuous measurement of blood oxygen saturation [1-3].

The ‘pulse oximeter’ was invented in 1972 by Takuo Aoyagi at a Japanese medical electronic equipment manufacturer Nihon Kohen Corporation, and it has since been used as a medical device that monitors noninvasively the oxygen saturation of a patient’s blood and changes in blood volume in the skin [1-5]. At present, a typical 'pulse oximeter' uses an electronic processor and a pair of small LEDs facing a photodiode through a translucent part of the patient’s body, usually a fingertip or an earlobe, as can be seen from Fig. 1, where it should be added that one LED is red with wavelength of 660 nm, and the other is infrared with wavelength of 940 nm [5].

2. Historical Achievements of Developing Pulse Oximeters

The pulse oximetry is a noninvasive method for monitoring a person’s arterial oxygen saturation, and the development of a ‘pulse oximeter’ started in 1972. In what follows, how this device has since been commercialized is overviewed [3-5].

(1) The pulse oximetry is particularly convenient for noninvasive continuous measurement of arterial oxygen saturation, and also very useful in any setting where a patient’s oxygenation is unstable, including intensive care, operating, emergency and hospital ward settings, pilots in unpressurized aircrafts, assessment of patients’ oxygenation, and determining the effectiveness of or the need for supplemental oxygen. The ‘pulse oximeter’ is intended to monitor noninvasively a patient’s arterial oxygen saturation.

(2) Owing to their simplicity of usage and the ability to provide continuous and immediate oxygen saturation values, ‘pulse oximeters’ are of critical importance in emergency medicine and also of essential use for patients with respiratory or cardiac problems, especially COPD, as well as for diagnosis of sleep disorders such as apnea and hypopnea.

(3) Portable battery-operated ‘pulse oximeters’ are indispensable not only to pilots operating in unpressurized aircrafts above 10,000 feet where supplemental oxygen is required, but also to mountain climbers and athletes whose oxygen levels may decrease at high altitudes and with exercise, respectively. Some portable pulse oximeters employ software that charts a patient’s blood oxygen and pulse, serving as a reminder to check blood oxygen levels.

(4) Connectivity advancements have made it possible for patients to have their blood oxygen saturation continuously monitored without a cabled connection to a hospital monitor, not sacrificing the flow of patient data back to bedside monitors and centralized patient surveillance systems.

(5) For patients with COVID-19, the pulse oximetry helps with early detection of silent hypoxia, in which the patients still look and feel comfortable, but their SpO2 (peripheral oxygen saturation) is perilously low. This happens to patients either in the hospital or at home. Here, it should be added that low SpO2 may indicate severe COVID-19 related pneumonia, requiring a ventilator.

(6) Thanks to Dr. Aoyagi's great accomplishments of developing the world's first 'pulse oximeter', he was honored in 2015 with 'IEEE Medal for Innovation in Healthcare Technology' for the first time in Japan.

What obstacles (technical, political, geographic) needed to be overcome?

The idea of pulse oximetry originated in Japan, but the device development gradually lagged in Japan due to a lack of business, clinical, and academic interest. In what follows, a number of obstacles are pointed out [4,5]:

(1) Although the pulse oximetry solely measures hemoglobin saturation, it is neither a complete measure of respiratory sufficiency nor a substitute for blood gases checked in a laboratory, since it gives no indication of base deficit, carbon dioxide levels, blood pH, or bicarbonate concentration. The metabolism of oxygen can be readily measured by monitoring expired CO2, but saturation figures give no information about blood oxygen content. Most of the oxygen in the blood is carried by hemoglobin, while in severe anemia, the blood contains less hemoglobin, which despite being saturated cannot carry as much oxygen.

(2) Since pulse oximeter devices are treated in healthy subjects, the accuracy is poor for critically ill patients and preterm newborns. Erroneously low reading may be caused by hypoperfusion of the extremely being used for monitoring; incorrect sensor application; highly calloused skin; or movement especially during hypoperfusion. To ensure accuracy, the sensor should return a steady pulse and/or pulse waveform. Pulse oximetry technologies differ in their abilities to provide accurate data during conditions of motion and low perfusion.

(3) Obesity, hypotension, and some hemoglobin variants can reduce the accuracy of the results. Some home pulse oximeters have low sampling rates which can significantly underestimate dips in blood oxygen levels. The accuracy of pulse oximetry deteriorates considerably for reading below 80%.

(4) Since the pulse oximetry measures only the percentage of bound hemoglobin, a falsely high or falsely low reading will occur, when hemoglobin binds to something other than oxygen:

- Hemoglobin has a higher affinity to carbon monoxide than it does to oxygen, and a high reading may occur despite the patient’s actually being hypoxemic. In case of carbon monoxide poisoning, this inaccuracy may delay the recognition of hypoxia.

- Cyanide poisoning gives a high reading, because it reduces oxygen extraction from arterial blood. In this case, the reading is not false, since arterial blood oxygen is indeed high in early cyanide poisoning.

- COPD, especially chronic bronchitis, may cause false readings.

What features set this work apart from similar achievements?

Although numbers of oximeters were put on the market in the 1940s through the 1960s, any technology to realize today’s pulse oximetry had been impossible because of poor photocells and light sources. In addition, even though the first absolute reading ear oximeter was put on sale in 1964, it used eight wavelengths of light. On the other hand, a series of pulse oximeters developed since 1972 have realized the following distinctive features [3-5]:

(1) The pulse oximetry is based on a concept of computing a patient’s arterial oxygen saturation without need for calibration by using the ratio of red to infrared light absorption of pulsating components at the measuring site. This device was invented in 1972 by Takuya Aoyagi at Nihon Kohden Corporation.

(2) Because of their simplicity of usage and the ability to provide continuous and immediate oxygen saturation values, pulse oximeters are of critical importance in emergency medicine and also of great necessity for patients with respiratory or cardiac problems as well as for diagnosis of sleep disorders such as apnea and hypopnea.

(3) Portable battery-operated pulse oximeters are useful not only for pilots operating in unpressurized aircrafts above 10,000 feet where supplemental oxygen is required, but also for mountain climbers and athletes whose oxygen levels decrease at high altitudes and with exercises, respectively. Some portable pulse oximeters employ software that charts a patient’s blood oxygen and pulse, serving as a reminder to check blood oxygen levels.

(4) Connectivity advancements have made it possible for patients to have their blood oxygen saturation continuously monitored without a cabled connection to a hospital monitor, not sacrificing the flow of patient data back to bedside monitors and centralized patient surveillance systems

(5) A typical pulse oximeter uses an electronic processor and a pair of small LEDs facing a photodiode through a translucent part of the patient’s body, usually a fingertip or an earlobe, as can be seen from Fig. 1, where one LED is red with wavelength of 660 nm, and the other is infrared with wavelength of 940 nm.

Supporting texts and citations to establish the dates, location, and importance of the achievement: Minimum of five (5), but as many as needed to support the milestone, such as patents, contemporary newspaper articles, journal articles, or chapters in scholarly books. 'Scholarly' is defined as peer-reviewed, with references, and published. You must supply the texts or excerpts themselves, not just the references. At least one of the references must be from a scholarly book or journal article. All supporting materials must be in English, or accompanied by an English translation.

[1] T. Aoyagi and M. Kishi, “Optical device for measuring arterial oxygen saturation”, Japan Patent, 53-26437, 1978 (in Japanese).

[2] ‘Mr. Takuo Aoyagi and the pulse oximeter’: https://www.nihonkohden.co.jp/information/aoyagi/ (in Japanese)

[3] J.W. Severinghaus and Y. Honda, “History of blood gas analysis. VII. Pulse oximetry”, J. Clinical Monitoring, vol. 3, pp. 135-138, 1987.

[4] K. Miyasaka, et al., “Tribute to Dr. Takuo Aoyagi, inventor of pulse oximetry”, J. Anesthesia, vol. 35, pp. 671-709, 2021

[5] ‘Pulse oximetry’: https://en.wikipedia.org/wiki/Pulse_oximetry


Appendices: References [1] and [2] were written in Japanese, for which English abstracts are provided as follows.

① Reference [1]: This article describes the patent gazette of Japan Patent 53-26437 on the 'Pulse Oximeter' invented by Takuo Aoyagi and Michio Kishi at Nihon Kohden Corporation (Tokyo. Japan), which was applied on March 29, 1974, and obtained on October 9, 1975. This patent gazette claims the extent and distinctive features of invented technologies.

② Reference [2]: This article outlines Dr. Aoyagi's achievements of developing the fist pulse oximeter, featuring (i) the principle of pulse oximeter, (ii) Dr. Aoyagi's discovery of the method of developing pulse oximetry, (iii) the first product 'Ear Oximeter OLV-5100' put on sale in 1975 by Nihon Kohden Corporation, (iv) the diffusion of pulse oximeters, (v) Dr. Aoyagi's short history, and (vi) the list of patents attained by Dr. Aoyagi.

Supporting materials (supported formats: GIF, JPEG, PNG, PDF, DOC): All supporting materials must be in English, or if not in English, accompanied by an English translation. You must supply the texts or excerpts themselves, not just the references. For documents that are copyright-encumbered, or which you do not have rights to post, email the documents themselves to ieee-history@ieee.org. Please see the Milestone Program Guidelines for more information.


Please email a jpeg or PDF a letter in English, or with English translation, from the site owner(s) giving permission to place IEEE milestone plaque on the property, and a letter (or forwarded email) from the appropriate Section Chair supporting the Milestone application to ieee-history@ieee.org with the subject line "Attention: Milestone Administrator." Note that there are multiple texts of the letter depending on whether an IEEE organizational unit other than the section will be paying for the plaque(s).