throbber
United States Patent [19J
`Athan et al.
`
`111111111111111111111111111111111111111111111111111111111111111111111111111
`US005575284A
`[111 Patent Number:
`[451 Date of Patent:
`
`5,575,284
`Nov. 19, 1996
`
`[54) PORTABLE P ULSE OXIMETER
`
`OTHER PUBLICATIONS
`
`[75)
`
`Inventors: Stephan P. Athan, Tampa; John E.
`Scha r f, Oldsmar, both of Fla.
`
`[73) Assignee: University of South Florida, Tampa,
`A a.
`
`[21) Appl. No.: 221,958
`
`(22) Filed:
`
`Apr. 1, 1994
`
`Int. Cl.6
`•••••••••••••••••••••••••••••••••••••••••.•••••.•••.•••• A61B 5/02
`[51]
`[52] U.S. Cl . ............................................... 128/633; 356/41
`[58) Field of Search ..................................... 128/633, 903;
`356/41; 2501214 A, 214 L; 607/60
`
`[56]
`
`References Cited
`
`U.S. PATENT DOCUMENTS
`
`4/1974 Tchang .
`3,802,774
`6/1974 Scheidt .................................... 128/903
`3,815,583
`9/1979 Nielsen .
`4,167,331
`5/1981 Hamaguri .
`4,266,554
`ll/1982 Loretz .
`4,357,105
`4,407,290 10/1983 Wilber .
`4,447,150
`5/1984 Heinemann.
`211985 Gloima et al ..
`4,498,020
`4,586,513
`5/1986 Hamaguri .
`911987 Hamaguri .
`4,694,833
`1/1989 Smith .
`4,800,495
`4,807,630
`211989 Malinouskas .
`4,807,631
`211989 Hersh et al ..
`4/1989 Frick et al .............................. 128/633
`4,824,242
`9/1989 Stone et al . .
`4,869,254
`4,883,353 11/1989 Hausman et al . .
`4,911,167
`3/1990 Corenman et al ..
`4,934,372 6/1990 Corenman et al ..
`5,078,136
`J/1992 Stone et al ..
`5/1992 Clark Cl al .............................. 1281633
`5,111,817
`511992 Rother .
`5,113,861
`5,149,503
`9/1992 Kohno et al ..
`5,167,230 1211992 Chance .................................... 128/633
`3/1993 Polson .
`5,190,038
`
`FOREIGN PATENT DOCUMENTS
`
`1377605
`9207505
`
`211988 U.S.S.R . ....... : .................... 2501214 L
`5/1992 WIPO .................................... 128/903
`
`"Optimization of Portable Pulse Oximetry Through Fourier
`Analysis," John E. Scharf ct al., IEEE, Jun. 1993, pp.
`233- 235, first available on Apr. 2, 1993, at the fEEE, 12th
`Southern Biomedical Conference at Tulane University, New
`Orleans, LA, held Apr. 2-4, 1993.
`"Pulse Oximetry Through Spectral Analysis," John E.
`Scharf et al., 1993 IEEE, Jun. 1993, pp. 227- 229, first
`available on Apr. 2, 1993, at the IEEE, 12th Southern
`Biomedical Conference at Thlane University, New Orleans,
`LA, held Apr. 2-4, 1993.
`.
`"Direct Digital Capture of Pulse Ox.imctry Waveforms,"
`John E. Scharf et al., 1933 IEEE, Jun. 1993, pp. 230-232,
`first available on Apr. 2, 1993, at the IEEE, 12th Southern
`Biomedical Conference at Tulane University, New Orleans,
`LA, held Apr. 2-4, 1993.
`Light- To-Frequency Convertcr-TSL220, Texas Instru(cid:173)
`ments Inc., D3619, Aug. 1990, Rev. Jun. 1991.
`Programmable Light-To-Frequency Converter-TSL230,
`Texas Instruments Inc., SOES007A, Dec. 1992, Rev. Dec.
`1993.
`CMOS-8- Bit Buffered Multiplying DAC- AD7524,
`Digital-to-Analog Converters, Rev. A, pp. 2-399, 402-403.
`Burr-Brown ACF2101 Advertisement and Product Data
`Sheet (PDS-1079, Mar. 1991).
`"Integrator IC Converts Picoamperes to Volts," Frank Good·
`enough, Electronic Design, Jun. 13, 1991, pp. 132-134.
`
`Primary Examiner- Angela D. Sykes
`Assistant Examiner-Eric F. Winak.ur
`Attorney, Agent, or Firnz-Calfee, Halter & Griswold
`
`[57)
`
`ABSTRACT
`
`A diagnostic instrument for determi ning a cardiovascular
`system parameter. In one embodiment, the instrument takes
`the form of a portable pulse ox.imeter comprising a light to
`frequency converter (LFC) as a sensor. Also provided is a
`light to frequency converter comprising a photoresistor and
`capacitor in circuit communication with an
`inverting
`Schmitt trigger and configured such that the inverter gener(cid:173)
`ates a periodic electrical signal corresponding to the amount
`of electromagnetic radiation illuminating the photoresistor.
`
`22 Claims, 6 Drawing Sh eets
`
`LFC
`
`54 :::
`
`56
`
`COUNTER
`
`JJP-SYST£M
`
`62
`
`66
`
`64
`
`~50
`
`LED
`Drivers
`
`Apple Inc.
`APL1021
`U.S. Patent No. 8,942,776
`
`001
`
`

`

`U.S. Patent
`U.S. Patent
`
`Nov. 19, 1996
`Noy. 19, 1996
`
`Sheet 1 of 6
`Sheet 1 of 6
`
`5,575,284
`5,575,284
`
`~
`
`(1YVYOTd)
`
`'-4
`
`'"-
`
`--...
`--.. 1--a:::
`(.!) a:::
`~ a
`Lt... a::: a...
`
`[|“Sila
`
`~ I
`
`,,
`
`:E:
`l.&..J
`I -
`(/)
`>-
`(/)
`I
`Cl.
`::1.
`
`u a
`
`~
`
`H/SYF4ITd
`
`:I: " (/)
`a::
`l.&..J
`"""-4
`Ll..
`"""-4
`-.J
`§:
`
`~
`
`agliid
`
`a::
`l.&..J
`I -
`-J
`"""-4
`Ll..
`
`::::..
`A-I
`I
`"""-4
`
`~
`(\J
`
`-(\J
`
`-
`
`002
`
`002
`
`
`

`

`U.S. Patent
`
`Nov. 19, 1996
`
`Sheet 2 of 6
`
`5,575,284
`
`~I
`
`~ ,..--....... ---..
`w .._
`(/)
`>(cid:173)
`(/)
`I a...
`::J.L......-______ ___.
`
`a:::: w
`t--
`;:::
`::::>
`0
`(.J
`
`(\J
`'-0
`
`1..0
`1..0
`
`("')
`l()
`
`~
`
`w
`LA..
`-J D
`~~
`
`"O:::t
`lJ)
`
`(\J
`l()
`
`<l:)
`lJ)
`
`0
`1..0
`
`1..0
`
`lJ) \ '(
`
`~;
`"'0
`(lJ
`a::::
`
`~~
`a:::
`.._
`
`"' t..
`
`Cl<lJ
`l.AJ>
`-.J ·-
`t..
`C)
`
`003
`
`

`

`U.S. Patent
`
`Nov. 19, 1996
`
`Sheet 3 of 6
`
`5,575,284
`
`>..
`'Iii(
`
`~
`[1]
`0: CtJ
`~ [rJ
`0
`
`•
`
`a p
`
`\.()
`00
`
`"'':t"
`00
`
`(\J
`0'1
`
`L.
`(lJ
`
`0
`....
`L.
`c:
`0
`(.)
`0
`L.
`(.)
`
`~
`
`\.()
`\.()
`
`0')
`l.{)
`
`(\J
`l.{)
`
`LJ
`
`-.J
`
`l.... D
`~~
`
`~ I
`
`co
`(\J
`
`(.!)
`........
`lL_
`
`In
`L.
`OQJ
`UJ ::>
`-.J ·-
`L.
`0
`
`~~
`
`~~
`
`004
`
`

`

`U.S. Patent
`
`Nov. 19, 1996
`
`Sheet 4 of 6
`
`5,575,284
`
`TSL
`220
`
`52
`
`JlJlJlJUL
`53
`
`/
`72_./
`
`JOK.fl
`
`FIG. 3A
`
`84
`
`TSL
`230
`
`JUUL
`53
`
`JOK.fl
`
`FIG . 38
`
`005
`
`

`

`U.S. Patent
`
`Nov. 19, 1996
`
`Sheet 5 of 6
`
`5,575,284
`
`52
`76
`~
`
`75
`
`1/6 74HC 14
`
`74
`
`T 8200pF
`
`77
`
`JLJL
`53
`
`FIG. 4A
`
`78
`~~
`
`76
`
`FIG.
`
`48
`
`77
`
`84
`
`76
`
`Analog
`Sw; ten
`Bank
`
`77
`
`FIG.
`
`4C
`
`84
`
`III
`FIG. 40
`
`-
`-
`
`-
`-
`
`-
`-
`
`006
`
`

`

`U.S. Patent
`
`Nov. 19, 1996
`
`Sheet 6 of 6
`
`5,575,284
`
`100
`
`In it i a I i ze
`System
`
`102
`
`104
`
`Collect three
`quarters of
`data
`
`Collect fourth
`quar_ter of
`new data
`
`106
`
`FFT to determine:
`Red AC. Red DC.
`IR AC. and IR DC
`
`108
`
`Calculate R and
`then Sp02
`
`110
`
`Display Sp02
`or illuminate
`discrete L[Os
`
`FIG. 5
`
`112
`
`Discard oldest
`quarter of data
`
`007
`
`

`

`1
`PORTABLE PULSE OXIMETER
`
`FIELD OF THE INVENTION
`
`The present invention relates generally to medical diag(cid:173)
`nostic instruments and, more specifically, to a portable pulse
`oximeter with a remote light-to-frequency converter as a
`sensor and a telemetry system to telemeter the calculated
`saturation value to a remote display.
`
`BACKGROUND OF THE INVENTION
`
`The degree of oxygen saturation of hemoglobin, Sp02, in
`arterial blood is often a vital index of the condition of a
`patienL As blood is pulsed through the lungs by the heart
`action, a certain percentage of the deoxyhemoglobin, RHb,
`picks up oxygen so as to become oxyhemoglobin, Hb02 •
`From the lungs, the blood passes through the arterial system
`until it reaches the capillaries at which point a portion of the
`Hb02 gives up its oxygen to support the life processes in
`adjacent cells.
`By medical definition, the oxygen saturation level is the
`percentage of Hb02 over the total hemoglobin; therefore,
`Sp02=Hb0zi(RHb+Hb02) . The saturation value is a very
`important physiological value. A healthy, conscious person
`will have an oxygen saturation of approximately 96 to 98%.
`A person can lose consciousness or suffer permanent brain
`damage if that person's oxygen saturation value falls to very
`low levels for extended periods of time. Because of the
`importance of the oxygen saturation value, "Pulse oximetry
`has been recommended as a standard of care for every
`general anesthetic." Kevin K. Tremper & Steven J. Barker,
`Pulse Oximetry, Anesthesiology, January 1989, at 98.
`An oximeter determines the saturation value by analyzing
`the change in color of the blood. When radiant energy passes
`through a liquid, certain wavelengths may be selectively
`absorbed by particles which are dissolved therein. For a
`given path length that the light traverses through the liquid,
`Beer's law (the Beer-Lambert or Bouguer-Beer relation)
`indicates that the relative reduction in radiation power
`(P/Po) at a given wavelength is an inverse logarithmic
`function of the concentration of the solute in the liquid that
`absorbs that wavelength.
`For a solution of oxygenated human hemoglobin, the
`absorption maximum is at a wavelength of about 640
`nanometers (red), therefore,
`instruments that measure
`absorption at this wavelength are capable of delivering
`clinically useful information as to oxyhemoglobin levels.
`In general, methods for noninvasively measuring oxygen
`satur!ltion in arterial blood utilize the relative difference
`between the electromagnetic radiation absorption coefficient
`of deoxyhemoglobin, RHb, and that of oxyhemoglobin,
`Hb02. The electromagnetic radiation absorption coefficients
`of RHb and Hb02 are characteristically tied to the wave(cid:173)
`length of the electromagnetic radiation traveling through
`them.
`It is well known that deoxyhemoglobin molecules absorb
`more red light than oxyhemoglobin molecules, and that
`absorption of infrared electromagnetic radiation is not
`affected by the presence of oxygen in the hemoglobin
`molecules. Thus, both RHb and Hb02 absorb electromag(cid:173)
`netic radiation having a wavelength in the infrared (IR)
`region to approximately the same degree; however, in the
`visible region, the light absorption coefficient for RHb is
`quite different from the light absorption coefficient of Hb02
`
`35
`
`40
`
`45
`
`5,575,284
`
`30
`
`2
`because Hb02 absorbs significantly more light in the visible
`spectrum than RHb.
`In practice of the pulse oximetry technique, the oxygen
`saturation of hemoglobin in intravascular blood is deter-
`s mined by (l) alternatively illuminating a volume of intra(cid:173)
`vascular blood with electromagnetic radiation of two or
`more selected wavelengths, e.g., a red wavelength and an
`infrared wavelength, (2) detecting the time-varying electro(cid:173)
`magnetic radiation intensity transmitted through or reflected
`10 back by the intravascular blood for each of the wavelengths,
`and (3) calculating oxygen saturation values for the patient's
`blood by applying the Lambert-Beer's transmittance law to
`the detected transmitted or reflected electromagnetic radia(cid:173)
`tion intensities at the selected wavelengths.
`15 Whereas apparatus is available for making accurate mea-
`surements on a sample of blood in a cuvette, it is not always
`possible or desirable to withdraw blood from a patient, and
`it obviously impracticable to do so when continuous moni(cid:173)
`toring is required, such as while the patient is in surgery.
`Therefore, much effort has been expanded in devising an
`20 instrument for making the measurement by noninvasive
`means.
`The pulse oximeters used today are desk-top models or
`handheld models that are interfaced to the patient through
`the use of a multi-wire bundle. Despite their size and level
`25 of technology, these units are still bound by several limita(cid:173)
`tions.
`A critical limitation is that of measurement accuracy. In
`pulse oximetry, signal artifact from patient-probe motion,
`ambient light, and low perfusion (low blood circulation
`through the extremities) is one of the primary causes of
`inaccurate saturation readings. ("Artifact" is any component
`of a signal that is extraneous to variable represented by the
`signal.) Inaccuracies are also caused from physiologic non(cid:173)
`Jinearitics and the heuristic methods used to arrive at the
`final saturation values.
`Another important limitation is patient confinement to the
`pulse oximeter, due to the wired probe connecting the patient
`to the unit. This limits patient mobility in every application
`. of its use, including the emergency room, operating room,
`intensive care unit, and patient ward.
`Thus, three problems plague pulse oximetry. The first
`problem relates to signal artifact management and inaccu(cid:173)
`racies of the saturation values due to the nonlinear nature of
`the sample tissue bed. The second problem relates to noise
`from signal artifact which introduces further inaccuracies.
`The third problem relates to restricted patient mobility and
`probe placement due to the wire bundle that physically
`couples the patient to the oximeter unit and the exclusive use
`50 of transmittance-type probes.
`Due to the non-linear nature of human physiology, engi(cid:173)
`neers were forced to employ techniques for calculating the
`final saturation value based not on an analytic solution, but
`rather, on a calibration curve or look-up table derived from
`ss empirical data. This is data that bas been collected over
`hundreds or possibly thousands of patients and stored as a
`look-up table in the system memory. This technique leads to
`obvious inaccuracies in the final saturation value since the
`Sp02 value in the look-up table is only as accurate as the
`60 calibration curve programmed into the system memory,
`which in tum is only as accurate as the in vitro laboratory
`oximeter used to generate iL These inaccuracies are com(cid:173)
`pounded by differences in skin characteristics between
`patients, as well as differences over the skin surface of the
`65 same patient.
`Signal artifact has three major sources: (1) ambient light
`(which causes an AC/DC masking signal), (2) low perfusion
`
`008
`
`

`

`5,575,284
`
`10
`
`3
`(in which the intensity of the desired AC/DC signal is very
`low thereby allowing other artifact sources to mask the
`desired signal more easily), and (3) patient or sensor motion
`(which generates a largeAC/DC artifact masking the desired
`signal). When the oximetry signal is amplified, the noise
`components arc amplified along with the desired signal. This
`noise acts to corrupt the primary signal, during both pre(cid:173)
`processing as well as post-processing, thereby reducing the
`accuracy of the pulse oximeter reading. Signal artifact is
`prevalent with both reflectance- and transmittance-type
`probes.
`Restricted patient mobility is due to the hard wired
`interface that links the patient probe to the large, bulky
`oximeter unit This link is a multi-wire bundle that is used
`to provide an electrical path for the LED drivers and the 15
`photodiode located at the end of the wire bundle in the
`probe. Probes employing transmittance-type method arc
`restricted to the ears, fingers, or toes and, thus, require
`physical access to these areas exclusively.
`Oximeters are large because of the circuitry heretofore
`believed necessary to capture the signals and because such
`higher-powered circuitry shortens battery life. Typical digi-
`tal oximeters use a silicon photodiode, a current-to-voltage
`convener (a transirnpedance amplifier), a preamplifier, filter
`stage, a sample and hold, and an analog-to-digital (AID)
`convener to capture the oximetry signal. These components
`make the creation of truly portable oximeters difficult
`because of the large footprint and high power requirements
`of each device. The AID convener, in particular, is typically
`large and power-hungry.
`SUMMARY OF THE INVENTION
`
`4
`tively illuminate an intravascular blood sample with two
`wavelengths of electromagnetic radiation. The electromag(cid:173)
`netic radiation interacts with the blood and a residual optical
`signal is both reflected and transmitted by the blood. A
`5 photodiode in the light-to-frequency converter (LFC) col(cid:173)
`lects oximetry data from the intravascular blood sample
`iJluminated by the two LEDs. The LFC produces a periodic
`electrical signal in the form of a pulse train having a
`frequency, the logarithm of which is in linear relationship to
`the logarithm of the intensity of the optical signal received
`by the LFC. The data becomes an input to a high-speed
`digital counter, which converts the pulsatile signal into a
`form suitable to be entered into a central processing unit
`(CPU) of a computer system.
`In the alternative, a CPU with an internal counter can be
`used, thereby eliminating the nee(! for an external counter
`and further reducing the system size.
`Once inside the CPU, the time-domain data is converted
`into the frequency domain by, for example, performing the
`20 well-known Fast Fourier Transform (FFT) on the time(cid:173)
`domain data. The frequency domain data is then processed
`to determine the saturation value.
`It is therefore an advantage of the present invention to
`25 provide a portable, low-power oximeter.
`It is a further object of this invention to provide· an ·
`improved sensor in the form of a light-to-frequency con(cid:173)
`verter to r~uce the parts count of prior art systems.
`These and other advantages of the present invention shall
`30 become more apparent from a detailed description of the
`invention.
`
`According to the present inventipn, an oximeter is pro(cid:173)
`vided with a light-to-frequency converter as a sensor and a
`telemetry system to telemeter the calculated saturation value 35
`to a remote station. The light-to-frequency convener elimi(cid:173)
`nates the need for a separate photodiode, a current-to(cid:173)
`voltage converter, a preamplifier, a filter, a sample and hold,
`and an analog-to-digital (AID) converter found in typical
`digital oximeters, thereby significantly reducing the circuit 40
`footprint and power consumption. In short, the light-to(cid:173)
`frequency convener can be directly connected to an input of
`a microcontroller or other CPU. The use of telemetry allows
`accurate hemoglobin saturation level determination to be
`made without the patient being tethered by a wire bundle to 45
`a remote display. Powerful portable systems can be realized
`using very large-scale integrated circuit (VLSI) multichip
`module (MCM) technology.
`An oximeter made under the present invention is a truly 50
`portable unit, capable of capturing and processing oximetry
`data in a very small package and transmitting calculated
`saturation values to a remote receiver. The type of receiver
`that is particularly useful in the context of the present
`invention is a caregiver's wrist receiver or other type of
`receiver that communicates to a primary caregiver. In addi(cid:173)
`tion, this invention can conununicate with other types of
`receivers, such as a nurses' station receiver or some other
`personal data receiver. Spread spectrum communication
`techniques allow highly secure and noise-immune telemetry 60
`of saturation values in noisy clinical and healthcare envi(cid:173)
`ronments.
`The oximeter of the present invention uses a pair of light
`emitting diodes, a light-to-frequency converter, a high-speed
`counter, a computer system, and an display or other output. 65
`According to the present invention, two light emitting
`diodes (LEOs), a red LED and an infrared LED, altema-
`
`55
`
`BRIEF DESCRIPTION OF THE DRAWINGS
`In the accompanying drawings, which are incorporated in
`and constitute a part of this specification, embodiments of
`the invention are illustrated, which, together with a general
`description of the invention given above, and the detailed
`description given below serve to example the principles of
`this invention.
`FIG. 1 is an electrical schematic representation of a
`generic prior art pulse oximeter;
`FIG. 2A is an electrical schematic representation of one
`embodiment of a pulse oximeter of the present invention;
`FIG. 2B is an electrical schematic representation of
`another embodiment of a pulse oximeter of the present
`invention;
`FIG. 3A is an electrical schematic representation of the
`implementation of the TSL220 light-to-frequency convener
`in the oximeter of the present invention;
`FIG. 3B is an electrical schematic representation of the
`implementation of the TSL230 light-to-frequency converter
`in the oximeter of the present invention;
`FIG. 4A is an electrical schematic representation of an
`implementation of a light-to-frequency converter of the
`present invention;
`FIG. 4B is another embodiment of the LFC shown in FIG.
`4A;
`FIG. 4C is yet another embodiment of the LFC shown in
`FIG. 4A; and
`FIG. 4D is still another embodiment of the LFC shown in
`FIG. 4A; and
`FIG. 5 is a flow chart showing the major process steps
`taken by the computer system in calculating the saruration
`value.
`
`009
`
`

`

`5
`DETAILED DESCRIPTION OF THE
`PREFERRED EMBODIMENT
`
`5,575,284
`
`6
`ment, the data is converted into the frequency domain by, for
`example, performing the well-known Fast Fourier Trans(cid:173)
`form (FFT) on the data. It is also believed that other common
`techniques of converting time-domain data to the frequency
`5 domain will suffice; e.g., discrete cosine transform, wavelet
`transform, discrete Hartley transform, and Gabor transform.
`The frequency domain data is then analyzed to determine the
`saturation value by code executing on the computer system
`64, as will be more fully explained in the text accompanying
`FIG. 4. Once calculated, the saturation value is displayed on
`10 a display 68.
`In addition to performing saturations calculations, the
`computer system 64 controls LED drivers 66, which control
`the LEDs 58, 60.
`FIG. 2B shows another embodiment of the pulse oximeter
`of the present invention. The embodiment of FIG. 28 diliers
`from the embodiment in FIG. 2A in two respects. First, the
`computer system 64 and counter 62 are implemented by a
`microcontroller 84 having an internal high-speed counter 82
`associated therewith. Second, the microcontroller 84 and the
`20 display 68 are placed in circuit communication using a
`transmitter 86 and receiver 88. The transmitter 86 transmits
`a signal 90 through an antenna 92. The receiver 88 receives
`the signal 90 through a second antenna 94 and passes the
`information to the display circuit 68. The LFC 52, the
`25 counter 62, the computer system 64, the display 68, the LED
`drivers 66, the LEOs 58, 60, and the other components are
`connected in electrical circuit communication as shown in
`.FIGS. 2A and 2B. One suitable LFC 52 is the TSL220,
`manufactured and sold by Texas Instruments, P.O. Box
`30 655303, Dallas, Tex. 75265. FIG. 3A is an electrical sche(cid:173)
`matic representation showing the use of the TSL220 in. the
`oximeter of the present invention. The capacitor 70 and
`resistor 72 are in circuit communication and have the values
`as shown in that figure. Another suitable LFC 52 is the
`TSL230, shown in FIG. 3B, is manufactured by Texas
`Instruments. Unlike the TSL220, the TSL230 requires no
`external capacitor and provides microprocessor compatible
`control lines; therefore, the TSL230 is a one-chip sensor.
`Yet another suitable LFC 52 is a novel LFC circuit, which
`40 was invented by Stephan Peter Athan, one of the coinvcntors
`of this invention, and is shown in FIG. 4A. In that circuit, a
`pbotoresistor 73 having a variable resistance is placed in
`circuit communication with a pulse generating circuit that is
`configured to generate a periodic electrical signal corre-
`45 sponding to the value of the variable resistance of the
`pbotoresistor. In one embodiment, a photorcsistor 73, a
`capacitor 74, and an inverter 75 are placed in circuit com(cid:173)
`munication and have the values shown in that figure. The
`photoresistor 73 is placed across the input node 76 and the
`50 output node 77 of the inverter 73. The capacitor 74 is placed
`between the input node 76 and ground. The inverter 75 is
`ideally an inverting Schmitt trigger with hysteresis at its
`input; however, other inverters are also believed to be
`suitable.
`The photoresistor73 can be a standard cadmium sulfide or
`cadmium selenide photoresistor, which are both widely
`available from many sources. Other types of photoresistors
`are also available. As is known in the art, the photoresistor
`73 has a variable resistance that depends on the amount of
`e lectromagnetic radiation 78 being emitted onto the photo(cid:173)
`resistor. The photoresistor 73, capacitor 74, and inverter 75
`are configured such that the period of time in which the
`capacitor74 charges and discharges corresponds to the value
`of the variable resistance of the photoresistor 73. Thus, the
`65 output of the inverter 75 is a periodic signal, the period of
`which depends on the amount of electromagnetic radiation
`being emitted onto the photoresistor 73.
`
`15
`
`Before describing the details of the present invention, a
`description of a generic prior art pulse oximeter may be
`helpful in understanding the advantages of the pulse oxime(cid:173)
`ter of the present invention. Reference is had, therefore, to
`FIG. 1, which shows a generic prior art pulse oximeter 10.
`A typical prior art oximeter 10 has a photodiode 12 for
`detecting an optical signal 14 reflected from or transmitted
`through a volume of intravascular blood (not shown) illu(cid:173)
`minated by one or more light emitting diodes (LEOs, not
`shown). The LEDs emit electromagnetic radiation at a
`constant intensity; however, an optical signal 14 with a
`time-varying intensity is transmitted through or reflected
`back from the intravascular blood for each of the wave(cid:173)
`lengths. The photodiode 12 generates a low-level current
`proportional to the intensity of the electromagnetic radiation
`received by the photodiode 12. The current is converted to
`a voltage by a current to voltage converter 16, which may be
`an operational amplifier in a current to voltage (transimped(cid:173)
`ance) configuration.
`The signal is then filtered with a filter stage 18 to remove
`unwanted frequency components, such as any 60 Hz noise
`generated by fluorescent lighting. The filtered signal is then
`amplified with an awplifier 20 and the amplified signal is
`sampled and held by a sample and hold 21 while the signal
`is digitized with a high-resolution (12-bit or higher) analog
`to digital converter (ADC) 22.
`The digitized signal is then latched by the CPU (not
`shown) of the computer system 24 from the ADC 22. The
`computer system 24 then calculates a coefficient for the
`oxygen saturation value from the digitized signal and deter(cid:173)
`mines the final saturation value by reading the saturation
`value for the calculated coefficient from a look-up table
`stored in memory. The final saturation value is displayed on
`a display 26.
`Thus, the generic prior art pulse oximeter 10 requires
`numerous devices to determine the oxygen saturation value
`from the optical signal. Moreover, these devices, particularly
`the ADC 22, require a relatively large amount of space and
`electrical power, thereby rendering a portable unit imprac(cid:173)
`tical.
`Under the present invention, the prior art oximeter 10 is
`modified so that the photodiode 12, current to voltage
`converter 16, filter 18, amplifier 20, sample and hold 21, and
`analog-to-voltage converter 22 are replaced wilh a light-to(cid:173)
`frequency converter and a high speed counter.
`FIG. 2A shows one embodiment of a pulse oximeter 50 of
`the present invention. The oximeter 50 of the present inven(cid:173)
`tion comprises a light-to-frequency converter (LFC) 52 for
`detecting an optical signal 54 from a volume of intravascular
`volume of blood 56 illuminated by one or more light
`emitting diodes (LEOs) 58, 60. The LEOs 58, 60 emit
`electromagnetic radiation at a constant intensity; however,
`an optical signal 54 with a time-varying intensity is trans- 55
`mitted through or reflected back by the intravascular blood
`for each of the wavelengths. In the preferred embodiment,
`the reflected optical signal 54 is analyzed to determine the
`saturation value. The LFC 52 produces a periodic electrical
`signal in the form of a pulse train having a frequency 60
`corresponding to the intensity of the broadband optical
`signal received by the LFC 52. The periodic data then
`becomes an input to a high-speed digital counter 62, which
`converts the periodic signal into a form suitable to be entered
`into a computer system 64.
`Once inside the computer system 64, the LFC signal is
`analyzed to determine the saturation value. In one cmbodi-
`
`35
`
`010
`
`

`

`5,575,284
`
`7
`As shown in FIG. 4B, a resistor 79 with a substantially
`fixed resistance can be placed in series with the photoresistor
`78 and placed across the input 76 and output 77 of the
`inverter 75. In addition, as shown in FIG. 4C, a multiplying
`digital to analog converter (MDAC) 80 can be placed in
`series with the photoresistor 73 and placed across the input
`76 and the output 77 of the inverter 75. As shown in that
`figure, the MDAC 80 is interfaced to the rnicrocontroller 84,
`which can then control the parameters, and therefore the
`sensitivity (i.e., shifting the frequency associated with a
`given amount of illumination to accommodate a broader
`range of light frequencies), of the circuit by selectively
`asserting more or les~ resistance in series with the photore(cid:173)
`sistor 73. One suitable MDAC is the AD7524 available from
`Analog Devices, which is essentially a computer controlled
`R2R network, which is known in the art.
`As shown in FIG. 4D, a bank of capacitors with varying
`capacitance values can be connected in the circuit of FIG.
`4A. The capacitors are interfaced to the circuit via a com(cid:173)
`puter controlled bank of analog switches, as shown in that 20
`figure. The microcontroller 84 can control the parameters of
`the circuit, and therefore the sensitivity (i.e., shifting the
`frequency associated with a given amount of illumination to
`accommodate a broader range of light frequencies), by
`selectively connecting one or more of the capacitors to line 25
`76.
`While the LFC of FIGS. 4A-4D is believed to be par(cid:173)
`ticularly useful in connection with the portable pulse oxime-
`ter of the present invention, it is also believed to have utility
`beyond that of oximetry or other cardiovascular measure- 30
`ment.
`Referring back to FIGS. 2A and 2B, the Red LED 58 is
`a red LED, emitting light having a wavelength of approxi·
`mately 660 nm. One suitable LED is the P417-ND, which is
`available from by Digikey, 701 Brooks Avenue South, Thief 35
`River Falls, Minn. 5670I.lt is believed that an LED emitting
`any wavelength of light in the visible spectrum is suitable;
`however, because a solution of human hemoglobin has an
`absorption maximum at a wavelength of about 640 nanom(cid:173)
`eters (red), the closer to that wavelength, the more accurate 40
`the results (otherwise, calibration curves are required, as is
`known in the art).
`The IR LED 60 is an infrared LED, emitting electromag(cid:173)
`netic radiation having a wavelength of approximately 940 45
`nm. One suitable LED is the F5FIQT-ND, which is also
`available from Digikey. It is believed that to be suitable, the
`IR LED 60 must emit electromagnetic radiation at a wave(cid:173)
`length such that the absorption of the emitted electromag(cid:173)
`netic radiation by the blood 56 is unaffected by the presence
`or absence of oxygen bound to the hemoglobin molecules.
`The counter 62 may be any high speed counter capable of
`being interfaced to a computer system. One suitable counter
`is the 4020 CMOS counter, which is manufactured by
`numerous manufacturers, e.g., Texas Instruments, P.O. Box 55
`655303, Dallas, Tex. 75265, as is well known in the art.
`Interfacing the counter 62 to the computer system 64 may
`be done in several ways. The counter 62 and computer
`system 64 may be configured to either (1) count the pulses
`generated by the LFC 52 during a given time period or (2) 60
`count the number of pulses of a free-running clock (corre(cid:173)
`sponding to the amount of time) between the individual
`pulses of the LFC 52. Either method will provide satisfac(cid:173)
`tory data. The latter method can be implemented in several
`ways. For example, the counter can be reset at each period 65
`of the LFC signal. In the alternative, at each edge of LFC
`pulse train, the value in the counter can be saved to a register
`
`8
`and subtracted from the value stored at the previous edge.
`Either way, the result is a counter value corresponding to the
`time difference between the two pulse edges. Many con(cid:173)
`figurations are possible. The counter 62 can either count
`5 pulses or elapsed time between edges and the computer
`system 64 either reads the value in the counter periodically
`by polling the counter, or the computer system 64 reads the
`value whenever the counter 62 generates an interrupt. Again,
`many configurations are possible.
`The computer system 64 can be any computer system
`capable of performing oximetry calculations to the desired
`accuracy in the desired period of time (calculations may be
`done either in real time or after collection of desired data)
`and capable of interfacing with a counter 62, a display 68,
`and LED drivers 66. The computer system 64 may include
`15 a CPU, random access memory (RAM), read-only memory
`(ROM), and associated control circuitry, such as decoders
`and multi-phase clocks,

This document is available on Docket Alarm but you must sign up to view it.


Or .

Accessing this document will incur an additional charge of $.

After purchase, you can access this document again without charge.

Accept $ Charge
throbber

Still Working On It

This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.

Give it another minute or two to complete, and then try the refresh button.

throbber

A few More Minutes ... Still Working

It can take up to 5 minutes for us to download a document if the court servers are running slowly.

Thank you for your continued patience.

This document could not be displayed.

We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.

Your account does not support viewing this document.

You need a Paid Account to view this document. Click here to change your account type.

Your account does not support viewing this document.

Set your membership status to view this document.

With a Docket Alarm membership, you'll get a whole lot more, including:

  • Up-to-date information for this case.
  • Email alerts whenever there is an update.
  • Full text search for other cases.
  • Get email alerts whenever a new case matches your search.

Become a Member

One Moment Please

The filing “” is large (MB) and is being downloaded.

Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.

Your document is on its way!

If you do not receive the document in five minutes, contact support at support@docketalarm.com.

Sealed Document

We are unable to display this document, it may be under a court ordered seal.

If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.


Access Government Site

We are redirecting you
to a mobile optimized page.





Document Unreadable or Corrupt

Refresh this Document
Go to the Docket

We are unable to display this document.

Refresh this Document
Go to the Docket