A NEW HYBRID REJLECTANCE OPTICAL PULSE OXEMETRY SENSOR

FOR LOWER OXYGEN SATURATION MEASUREMENT

AND FOR BROADER CLINICAL APPLICATION

Masaniichi Nogawa, ChongThong Ching, Takeyuki Ida, Keiko Itakura and Setsuo Takatani

Yamagata University, Faculty of Engineering,

Biomedical Systems Engineering, Yonezawa, Yamagata, Japan, 992

ABSTRACT

A new reflectance pulse oximeter sensor for lower arterial oxygen saturation (Sa02) measurement has
been designed and evaluated in animals prior to clinical trials. The new sensor incorporates ten light emitting diode
chips for each wavelength of 730 and 880 nm mounted symmetrically and at the radial separation distance of 7
mm around a photodiode chip. The separation distance of 7 mm was chosen to maximize the ratio of the pulsatile
to the average plethysmographic signal level at each wavelength. The 730 and 880 wavelength combination was
determined to obtain a linear relationship between the reflectance ratio of the 730 and 880 nm wavelengths and
Sa02. In addition to these features of the sensor, the Fast Fourier Transform method was employed to compute the
pulsatile and average signal level at each wavelength. The performance of the new reflectance pulse oximeter
sensor was evaluated in dogs (N=5) in comparison to the 665/910 nm sensor. As predicted by the theoretical
simulation based on a 3-dimensional photon diffusion theory, the 730/880 urn sensor demonstrated an excellent
linearity over the Sa02 range from 100 to 30%. For the Sa02 range between 100 and 70%, the 665/910 and
730/880 sensors showed the standard error of around 3.5% and 2.1%, respectively, in comparison to the blood
samples. For the range between 70 and 30%, the standard error of the 730/880 nm sensor was only 2.7%, while
that of the 665/910 nm sensor was 9.5%. The 730/880 sensor showed improved accuracy for a wide range of Sa02,
particularly over the range between 70 and 30%. This new reflectance sensor can provide noninvasive
measurement of Sa02 accurately over the wide saturation range from 100 to 30%.

Keywords: Reflectance Pulse Oximetry, Transmission Pulse Oximetry, Hemoglobin Oxygen Saturation, Photon
Diffusion Theory, Hybrid Optical Sensor, Fast Fourier Transform (FF1') and Lower Oxygen Saturation.

78 SPIE Vol. 2976 0277-786X197/$1O.OO

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 INTRODUCTION

The transmission optical pulse oximeters have been widely used in the clinical environment for early
detection of hypoxia through noninvasive measurement of arterial hemoglobin oxygen saturation (Sa02) of the
blood in the peripheral tissue such as finger-tip, toe [1-3]. The optical pulse oximeters utilize the optical absorption
differences between oxy-hemoglobin and deoxy-hemoglobin (Fig. 1) in combination with the plethysmographic
principle to measure real-time Sa02 [4]. When the forward or backward scattered light from the irradiated tissue is
detected, the light signal cycles up and down with diastolic and systolic phase of each heartbeat. This phenomenon,
called photoplethysmography, assumes that pulsatile light changes in the scattered light from the tissue is due to
changes in arterial blood volume. Although the transmission pulse oximetry can offer a great accuracy for the Sa02
level above 80%, its performance becomes severely affected at lower Sa02 by the nonlinear characteristics of
optical absorption and scattering by the red blood cells and hemoglobin-free tissue. Also, the application site of the
transmission pulse oximeters is limited to finger tip, toe or ear-lobe through which the forward scattered light
signal can be detected. Alternately, with reflectance oximetry, one could measure Sa02 from various parts of body,
especially from more centrally located parts such as the forehead and cheeks. Recently, reflectance pulse oximeters
have been receiving attention in caring and monitoring the fetuses during delivery and post-delivery care [5,6].
Since the Sa02 of the fetuses will become lower than 70-80% during delivery, the reflectance pulse oximeters that
can measure low Sa02 with a greater accuracy is needed.

. 0.6
0.5 Deoxy-Hb
0.4 - - - Oxy-Hb
cN)
0.3
. 0.2

0.1 __; - :.

I I I I
0 I I I I I I I

V lfl L( L( L( N O\
O N N N 00 0000
Lfl 00

Wavelength [nm]

Fig. 1. Molar extinction coefficients of oxygenated and deoxygenated hemoglobin in the red and near infrared
regions.

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 The reflectance pulse oximeter, as reported by Mendelson et al, was the first monitor to measure Sa02
from the finger-tip [7]. Although several reflectance pulse oximeters have been reported since then, they have not
acquired the clinical acceptability yet [8,9]. The effectiveness of the reflectance pulse oximeters has been hindered
by a poor signal to noise ratio and small pulsatile signals, particularly at the red wavelength. These weak signals
preclude continuous measurement at the forehead or cheek. Mendelson et al used multiple photodiodes around the
light emitting diode to increase the signal level. In 1992, Takatani et al [10] reported a multiple-light source hybrid
reflection pulse oximeter sensor that incorporated a near-infrared heater to warm the skin and to increase the
pulsatile signal level. The sensor was evaluated in animals and humans to show acceptable performance. However,
the incorporation of the heater complicated the system and possible skin burn prevented long term continuous
usage.
hi this study, improvements in sensor design and signal processing method were proposed based on the
theoretical simulation using a 3-dimensional photon diffusion theory to improve the performance of the reflectance
pulse oximeter for lower Sa02 measurement, possibly down to 40%, as well as wider clinical application without
requiring vaso-clilating method. They are:

1) To improve the overall accuracy of the reflectance pulse oximeter, a new wavelength pair of 730/880 nm will
be used, instead of the 660/910 nm pair. This combination can improve the overall linearity, with particular interest
in its application to low Sa02 measurement such as in fetal monitoring.

2) To increase the pulsatile signal level as well as to minimize tissue inhomogeneity, hence the variability among
the subjects, ten light-emitting diode (LED) chips for each wavelength will be mounted around a photodiode (PD)
chip at an equal radial distance of 7mm. The radial distance of 7 mm was decided through theoretical and
experimental studies.

3) Furthermore, to improve the signal processing method, a Fast Fourier Transform (PET) method will be used
to compute the pulsatile (AC) and average (DC) components of the reflectance optical pulse signals at each
wavelength. The DC and fundamental component of the Fourier transformed reflectance optical signal will
correspond to the DC and AC component of the conventional method.

The theoretical basis in designing this new hybrid reflectance pulse oximeter sensor and its experimental
evaluation in animals will be presented.

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 MATERIALS AND METHODS

Theoretical Basis for Designing a RefledancPu1se Oxizjiter nsor for Lrer Sg02

A solution of the 3-dimensional photon diffusion theory was used to model the reflectance pulse
oximetry (Equation 1)[see 11]. Parameters such as Sa02, hematocrit, venous saturation, arterial and venous blood
volume, and blood-free tissue optical parameters were modeled into the theory to compute the reflectance values;
particular attention was paid to obtain an optimum wavelength pair that can yield the best linear relationship
between the reflectance measurement vs. Sa02 from 100 to 30%. Also, the theory was used to study the effect of
sensor geometry, particularly the separation distance between the light source and detector, on the pulsatile signal
level.

'ref(a) =
( /1sotai
/2 a,total )A [1_(_1)n
Is,total n=1
(1)

Fig. 2a shows the ratio between the pulsatile (AC) and average (DC) signal levels of the 665 and 910 wavelengths
as a function of the separation distance between the light source and detector. With the increase in the separation
distance, the AC/DC ratio increased. Thus, better indication of the pulsatile signal is possible with a larger light
source-detector separation distance. However, since the absolute signal level decreases almost exponentially with
the separation distance, physical upper limit of the separation distance must be decided from the detectable
absolute signal level as well as the size of the application site. Fig. 2b shows the AC/DC ratio obtained from the
forehead of human subjects at 665 and 910 nm. The AC/DC ratio increased to 7 mm separation distance, but
declined at 9 mm mainly due to limitation in detection of the absolute signal level. Thus, the separation distance of
7 mm was selected for the new reflectance sensor.

EEEEt.
0.2
665nm
______
I 9lOnm
0 I

3 5 7 9
Separation Distance [mm]

Fig. 2a. Theoretical relationship between the AC/DC ratio and light source-detector separation distance at the
Sa02 95%.

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 0.12
0.1
0.08
0.06
0.04
0.02
0
3 5 7 9
Separation Distance [mm]

Fig. 2b. Experimental results of the relationship between the AC/DC ratio and light source-detector separation
distance.

Now we focus upon selection of the wavelength pair that can yield a linear relationship between the
reflectance ratio vs. Sa02. The Sa02 is usually derived using a linear regression equation

Sa02 = AxR + B (2)

where A and B are the constants that are related to physiological and sensor parameters, and R is given as:

R = (AC/DC)X1 /( AC/DC) (3).

Thus, here AC and DC values were computed using Equation 1 for the radial separation distance of 7
mm for various wavelength pairs. Fig. 3a and 3b show the values of R vs. Sa02 for various wavelength pairs. As
shown in Fig. 3a, when the red wavelength of 665 nm was used in combination with the near infrared wavelengths
of 880, 910, 940 urn, the R values and Sa02 showed a nonlinear relationship. The linear regression line estimate
can give an accurate Sa02 for the range of 100-70%, but below 70% errors can increase. Fig. 3b shows the results
when 665 nm was replaced with 730 nm. A linear relationship exists between the R values and Sa02 for the range
of 100-30%. From this result, the wavelength pair of 730 and 880 nm was selected to derive Sa02.

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 ('.1
0 0
C.J

Cl) U)

0.8 0.9
R R

(a) (b)
Fig. 3. R values between 665 nm and near infrared wavelengths of 880, 910 and 940 nm vs. Sa02 (a) and R values
between 730 nm and near infrared wavelengths of 880, 910 and 940 urn vs. Sa02 (b). In the figure, broken lines are
the theoretical simulation and solid lines are the linear regression equations.

The Hybrid Reflectance Optical Pulse Oximeter Sensor

The schematic diagram of the hybrid reflectance pulse oximeter sensor is shown in Fig. 4. A photodiode
(PD) chip is located at the center and is surrounded by an optical barrier that blocks direct coupling between the
light emitting diode (LED) and PD. Ten LED chips for each wavelength of 730 and 880 nm are placed
symmetrically and at an equal radial distance of 7 mm around the PD to enhance pulsatile signal level and
minimize the tissue inhomogeneity, hence the variability among the subjects. The diameter of the sensor is 23.0
mm with the thickness being 6.7 mm. Its weight is 7.2 gm. A four layered ceramic circuitry design allowed to
accommodate twenty LED chips and a PD chip on a single substrate, resulting as a compact hybrid sensor design.
After layout of LED and PD chips and wire bonding, the hybrid circuit was placed in a header and its surface was
covered with an optical clear epoxy. After the epoxy cured, its surface was polished.

SIDE VIEW ________

TOP VIEW
Fig. 4. A schematic drawing of the newly developed reflectance pulse oximeter sensor.

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 Signal Processing

To compute the pulsatile signal amplitude at each wavelength for each beat, the conventional beat-to-beat
detection method invites errors due to low pulsatile signal level as well as due to a respiratory effect. To circumvent
this problem, a Fast Fourier Transform (FFT) method was used to compute the DC and fundamental spectral density
of the Blackman windowed 10 second reflectance pulse data at each wavelength. From these values, R values were
derived using Equation 3.

Animal Study

The mongrel dogs with body weight of 15-20 Kg were anesthetized with intra-venous injection of
pentobarbital sodium. The animal was intubated and the respiration was controlled with the ventilator. A 100 liter
plastic bag was auached to the inlet port of the ventilator to regulate the respirated gas content. The left femoral
artery was cannulated to monitor arterial pressure as well as to obtain arterial blood samples. The blood gases were
analyzed using a Chiba-Coming blood gas analyzer model 188. The reflectance pulse oximeter sensor was attached
to the inner lining of the mouth to obtain plethysmographic signals. The oxygen content of the gases inside the bag
was reduced by a step-wise manner to obtain a decremental change in Sa02 of approximately 10% . When the Sa02
became stabilized, the reflectance signals were recorded in a PCM data recorder (RD-lilT, TEAC). The study was
canied out initially with the 730/880 urn sensor, followed with the 665/910 urn sensor. The recorded data were later
re-sampled at 500 Hz and analyzed using a IBM PC/AT compatible personal computer (486DX4, Gateway2000).
The performance of two sensors was comparatively analyzed.

RESULTS

Fig. 5a and 5b show the R values vs. Sa02 of the 665/910 nm and 730/880 urn sensor as obtained in the
dog study. As predicted by the theoretical study, the relationship between the R values and Sa02 of the 665/910 nm
sensor was quite non-linear; a linear regression equation can be applied to the Sa02 values above 70%. On the
contrary, the 730/880 nm sensor revealed a linear relationship between the R values and Sa02 over 100-30% range.
When we examine the accuracy of the two sensors for the high Sa02 region, 100<Sa02<z70%, 730/880 nm sensor
showed slight improvement of the stanthrd error from 3.50 to 2.11%. In the lower saturation region, 70<Sa02<z30%,
the improvement was significant with the stanthrd error of the 730/880 sensor being 2.69% as compared with that of
the 665/910 sensor being 9.49%.

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 1uI .
0
90 0 90

80 80

'70 0 70
(
C/) C,) 60
00
0
0
50 50
0
40 0 40
0 0
30 p 3C
0.4 0.6 0.8 1 1.2 1.4 0.5 0.6 0.7 0.8 0.9 1 1.1
R R

Sa02 = -31.OxR + 107.4 Sa02 = -136.2xR+177.5

(100<Sa02<70% ) (100<Sa02<30%)
(a) (b)
Fig. 5. Sa02 vs. R values of the 665/910 nm sensor (a) and 730/880 nm sensor (b). The Sa02 values were derived
from blood gases measurement using Chiba Coming Blood Gas Analyzer 188.

Table 1. Statistical analysis of the accuracy of the 665/910 nm and 730/880 nm sensors.

1949
665/9lOnm 730/880nm

70-100 0.66(3.48) 3.50

c2
70-100
)%StandardE1TOr
-1.85(2.07) 2.11
30-70 2.07(3.62) 2.69

DISCUSSION

In this study, a new hybrid reflectance pulse oximeter sensor has been evaluated in animals. The new
sensor demonstrated significantly improved accuracy over a wide range of Sa02, particularly at lower Sa02
between 70 and 30%. The contributing factors for this improved performance are 1) sensor geometry, 2)
wavelength selection, and 3) signal processing method [12].
Concerning the sensor geometry, the separation distance between the light source and detector was
optimized to yield the largest AC/DC ratio. Although the theoretical study revealed that the AC/DC ratio increases
with the radial separation distance, the reduction in the absolute signal level led us to choose the separation
distance of 7 mm. For this separation distance, in order to enhance the signal level and average out the
inhomogeneous effect of tissue, ten LED chips for each wavelength were placed symmetrically and at the equal
radial distance around a photodiode chip. The changes in the reflectance signal that is specific to inhomogeneous
effect and movement artifacts can be minimized to reduce abrupt changes in the signal level. This sensor geometry
helped to minimize differences among individuals. To incorporate this layout into a final sensor design, a special

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 hybrid circuit consisting of four layers of ceramic substrates were designed and fabricated. A total of twenty LED
chips, one PD chip and an optical barrier were all together mounted on this header with its top covered with a clear
epoxy, allowing a compact hybrid optical reflectance sensor.
As for wavelength selection, the 730/880 nm pair was used instead of the conventional 6651910
combination. The relationship between the R values computed using Equation (3) and Sa02 was linear over a wide
range of Sa02; theoretical prediction based on the photon diffusion theory agreed well with the experimental
results. Since the optical absorption due to deoxygenated hemoglobin at 730 nm is less than a half of that at 665 nm
(Fig. 1), nonlinear relationship between the optical reflectance and the Sa02 value was minimized at a wide range
saturation. Moreover, since the optical penetration depth into tissue at 730 nm is deeper than that at 665 nm, and
closer to that at 880 nm, measured reflectance signals at 730 and 880 nm wavelengths contain information come
from similar depth inside the tissue.
In addition to the sensor geometry and wavelength selection, the new signal processing method utilizes
the Fast Fourier Transformation of the reflectance pulse signal to derive AC and DC components. Approximately
10 second data was analyzed to compute the DC and fundamental spectral density from which the R value was
derived. This method resulted in minimization of the errors involved with the detection of each pulse amplitude.
In conclusion, the new reflectance pulse oximeter sensor in combination with the new signal processing
method demonstrated improved performance in noninvasive measurement of Sa02 over its wide range. The new
reflectance pulse oximeter sensor can broaden the clinical application of the reflectance pulse oximetry in caring
patients in the operating room, ICU and fetuses during delivery. Currently, clinical evaluation of the sensor is under
progress.

ACKNOWLEDGMENT

This research was partially supported by a grant-in-aid from the Japanese Ministry of Education
(Principal Investigator: Setsuo Takatani, grant # 08408038). The authors also acknowledge Nihon Cohn, Komaki,
Japan for their kind support in fabrication of the sensor.

REFERENCES

1. Yelderman M., New W. Jr.: Evaluation of pulse oximetry; Anesthesiology 59:349-352, 1987.

2. Severinghaus J.W., Naife K.H.: Accuracy of response of six pulse oximeters to profound hypoxia;
Anesthesiology 67:551-558, 1987.

3. Pologe J.A.: Pulse oximetry; technical aspects of machine design; mt. Anesthesiol. Clin. 25:137-153, 1987.

4. Van Assendelft OF: Spectrophotometry of hemoglobin derivatives.; Assen, The Netherlands: Royal

86

Downloaded From: http://proceedings.spiedigitallibrary.org/ on 04/28/2014 Terms of Use: http://spiedl.org/terms

 Vangorcum Ltd., 1970.

5. Dildy P., van den Berg, M. Katz, S. Clark, H. Jongsma, J. Nijhuis, C. Louks: Intrapartum fetal pulse oximetry:
Fetal oxygens saturation trends during labor and relation to delivery outcome; Am. J. Obstet. Gynecolo.
171:679-84, 1994.

6. T. Eskes, H. Jongsma, P. Houx: Percentiles for gas values in human umbilical cord blood; Europ. J. Obstet.
Reprod. Biol. 14:341-346, 1983.

7. Mendelson Y., Cheung P.W., Neuman M.R., et al: Spectrophotometric investigation of pulsatile blood flow
for transcutaneous evaluation of a new reflectance pulse oximetry; Adv. Exp. Med. Biol. 159:93-102, 1983.

8. Mendelson Y., Kent J.C., Yocum B.L. et a!: Design and evaluation of a new reflectance pulse oximeter
sensor; Med. Instrumentation 22:167-173, 1988.

9. Shimada Y., Nakashima K., Fujiwara Y., et al: Evaluation of new reflectance pulse oximeter for clinical
applicability; Med. Biol. Eng. Comput. 29:557-561, 1991.

10. Takatani S., Davies C., Sakakibara N., Zuriuck A., et a!. : Experimental and clinical evaluation of a
noninvasive reflectance pulse oximeter sensor; J. Clin. Monit. 8:257-266, 1992.

11. Takatani S., Noda H., Takano H., Akutsu T.: A miniature hybrid reflection type optical sensor for
measurement of hemoglobin content and oxygen saturation of whole blood; IEEE Trans. Biomed. Engr.
35(3):187-198, 1988.

12. Nogawa M.: Development of a reflectance optical pulse oximeter sensor for lower arterial oxygen saturation
measurement and broader clinical application; M.S. Thesis, Electrical and Information Engineering
Department, Yamagata Univ., Yonezawa, Yamagata, Japan, 1997.

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