throbber
US006330468B1
`(10) Patent No.:
`a2) United States Patent
`US 6,330,468 B1
`Scharf
`(45) Date of Patent:
`Dec. 11, 2001
`
`
`(54) SYSTEM USING GREEN LIGHT TO
`DETERMINE PARMETERS OF A
`CARDIOVASCULAR SYSTEM
`
`(75)
`
`Inventor:
`
`John Edward Scharf, Oldsmar, FL
`(US)
`,
`,
`(73) Assignee: University of South Florida, Tampa,
`FL (US)
`Subject to any disclaimer, the term ofthis
`patent is extended or adjusted under 35
`U.S.C. 154(b) by 0 days.
`
`(*) Notice:
`
`(21) Appl. No.: 09/185,140
`(22)
`Filed:
`Nov. 3, 1998
`
`Related U.S. Application Data
`
`OTHER PUBLICATIONS
`.
`.
`oo,
`“Optimization of Portable Pulse Oximetry Through Fourier
`Analysis” by Scharf, et al., IEEE, 6/93, pp. 233-235, first
`available on Apr. 2, 1993, at
`the IEEE, 12th Southern
`Biomedical Conference at Tulane University, New Orleans,
`LA,held 4/2-4/93.
`“Pulse Oximetry Through Spectral Analysis” by Scharf, et
`al., 1993 IEEE, 6/93, pp. 227-229,first available on Apr. 2,
`1993, at the IEEE, 12th Southern Biomedical Conferenceat
`Tulane University, New Orleans, LA, held 4/2-4/93.
`“Direct Digital Capture of Pulse Oximetry Waveforms” by
`Scharf, et al., 1993 IEEE, 6/93, pp. 230-232, first available
`on Apr. 2, 1993, at IEEE, 12th Southern Biomedical Con-
`ference at Tulane University, New Orleans, LA, 4/2-4/93.
`Light-To-Frequency Converter—TSL220, Texas Instru-
`ments, Inc., D3619, 8/90, Rev. 6/91.
`Programmable Light-To-Frequency Converter—TSL230,
`Texas Instruments, Inc., SOESOO7A, 12/92, Rev. 12/93.
`CMOS—8-Bit Buffered Mulytiplying DAC—AD7524,
`Digital—To—Analog Convertes, Rev. A, pp. 2-399, 402,403.
`(63) Continuation of application No. 08/749,898,filed on Nov.
`Burr-Brown ACF2101 Advertisement and Product Data
`18, 1996, now Pat. No. 5,830,137.
`Sheet (PDS—1079, 3/91).
`Tint. Cdn? eeeeeecceseseeeecceenneseennnsneeeeeeee A61B 6/00
`(SL)
`
`
`
`
`
`
`(52) US. CD. ee ceeeceeeceeeeeeteeceeceeeeeetenereeeeteeeeeeeeneeeeees 600/476 “In Vivo Reflectance of Blood and Tissue as a Function of
`(58) Field of Search 0.0... 600/309, 310,
`Light Wavelength” by Cui, et al., IEEE, Transactions of
`600/479, 473, 475, 476, 477; 356/41; 250/214 A,
`Biomedical Engineering, vol. 37, No. 6, Jun. 1990, pp.
`214 LA, 214 LS
`632-639.
`
`(56)
`
`References Cited
`U.S. PATENT DOCUMENTS
`
`Primary Examiner—Brian L. Casier
`(74) Attorney, Agent, or Firm—Calfee, Halter & Griswold
`TIP
`
`3,802,776
`3,815,583
`4,109,643
`4,167,331
`4,206,554
`4,267,844
`4,357,105
`
`4/1974 Tchang .
`6/1974 Scheidt .
`8/1978 Bondetal. .
`9/1979 Nielsen.
`5/1981 Hamaguri.
`5/1981 Yamanishi.
`11/1982 Loretz .
`(List continued on next page.)
`
`FOREIGN PATENT DOCUMENTS
`63-311937
`12/1988 (IP).
`1377605
`2/1986 (SU).
`WO-9011044 * 10/1990 (WO) vce eees 600/310
`92/07505
`5/1992 (WO).
`
`(57)
`
`ABSTRACT
`
`A reflectance pulse oximeter that determines oxygen satu-
`ration of hemoglobin using two sources of electromagnetic
`radiation in the green optical region, which provides the
`maximum reflectance pulsation spectrum. The use of green
`light allows placement of an oximetry probe at central body
`Sites (e.g., wrist, thigh, abdomen, forehead, scalp, and back).
`Preferably, the two green light sources alternately emit light
`at 560 nm and 577 nm,respectively, which gives the biggest
`difference in hemoglobin extinction coefficients between
`deoxyhemoglobin, RHb, and oxyhemoglobin, HbO,.
`
`5 Claims, 7 Drawing Sheets
`
`fa 50
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`ae Le J
`DRIVERS
`
`
`
`
`
`
`
`
`REMOTE
`DISPLAY
`
`NN
`
`10
`
`ID.
`
`DISPLAY
`
`LOCAL
`
`36
`
`1
`
`APPLE 1025
`
`1
`
`APPLE 1025
`
`

`

`US6,330,468 B1
`Page 2
`
`U.S. PATENT DOCUMENTS
`
`4,407,290
`4,447,150
`4,498,020
`4,586,513
`4,694,833
`4,800,495
`4,807,630
`4,807,631
`4,824,242
`4,869,254
`4,883,353
`4,911,167
`4,934,372
`4,997,769
`
`10/1983
`5/1984
`2/1985
`5/1986
`9/1987
`1/1989
`2/1989
`2/1989
`4/1989
`9/1989
`11/1989
`3/1990
`6/1990
`3/1991
`
`.
`
`Wilber.
`Heinemann .
`Gloimaet al.
`Hamaguri .
`Hamaguri .
`Smith .
`Malinouskas.
`Hershetal. .
`Frick et al.
`.
`Stone et al. .
`Hausmanetal. .
`Corenmanetal. .
`Corenmanetal. .
`Lundsgaard .
`
`5,040,539
`5,047,208
`5,078,136
`5,111,817
`5,113,861
`5,149,503
`5,167,230
`5,190,038
`5,299,570
`5,308,919
`5,365,924
`5,512,940
`5,524,617
`5,575,284
`
`8/1991
`9/1991
`1/1992
`5/1992
`5/1992
`9/1992
`12/1992
`3/1993
`4/1994
`5/1994
`11/1994
`4/1996
`6/1996
`11/1996
`
`* cited by examiner
`
`.
`Schmitt et al.
`Schweitzer et al. .
`Stone et al. .
`Clark et al.
`.
`Rother.
`Kohnoet al.
`Chance .
`Polson et al.
`Hatschek .
`Minnich .
`Erdman.
`Takasugiet al.
`Mannheimer.
`Athan et al. .
`
`.
`
`.
`
`.
`
`2
`
`

`

`U.S. Patent
`
`Dec. 11, 2001
`
`Sheet 1 of 7
`
`US 6,330,468 BI
`
`JLOW3Y
`
`AV1dSI0
`
`8¢
`
`os
`oShc
`
`W307
`
`AY1dS10
`
`SYUFATYO
`
`/\iil
`
`|9T4
`
`3
`
`
`

`

`US 6,330,468 B1
`
`FIG.e
`
`=<
`
`U.S. Patent
`
`Dee. 11, 2001
`
`Sheet 2 of 7
`
`OSP
`
`ADC
`
`ox
`udm4
`wu—
`ft
`a.
`
`4
`
`

`

`hoo
`
`SDSSPIDp
`peSeay
`ZSNSSiete
`
`US 6,330,468 B1
`
`L /4
`
`U.S. Patent
`
`Dec. 11, 2001
`
`Sheet 3 of 7
`
`5
`
`

`

`U.S. Patent
`
`Sheet 4 of 7
`
`Dee. 11, 2001
`
`US 6,330,468 B1
`
`6
`
`

`

`U.S. Patent
`
`Dec. 11, 2001
`
`Sheet 5 of 7
`
`US 6,330,468 BI
`
`
`
`7
`
`

`

`U.S. Patent
`
`Dec. 11, 2001
`
`Sheet 6 of 7
`
`US 6,330,468 BI
`
`a
`
`2S].OIJ6]KF
`SST}Cen
`0x1Jowas|EbLIIId|ogy)1vaA
`axy|o-d>=!ST|tasél
`
`
`anofol]ZHNS2=vS|921age
`30AS-+-0Mddg-g.9]4\*lor
`aA140d-0si-/\WAATIO
`
`JCEZSYYyOLVNITY=SCt)ONIHOLTASryOn
`
`
`
`OE]NALNNGD119-91]Y3LNNODLIG-9)
`
`2e1a|2e
`vr]=
`|7dreConSSell
`wineS1Y0du
`
`
`“AIO“035Y4A
`be921
`
`
`81]
`
`AUBLLVE4MOTOr]LVGA
`
`1S1JSISogg1ZA
`
`8
`
`
`
`

`

`U.S. Patent
`
`Dec. 11, 2001
`
`Sheet 7 of 7
`
`US 6,330,468 Bl
`
` INITIALIZE
`
`
`
`SYSTEM
`
`00
`
`COLLECT THREE
`QUARTERS OF
`DATA
`
`c0e
`
`204
`
` COLLECT FOURTH
`
`QUARTER OF
`
`
`
`NEW DATA
`
` PLACE TIME-DOMAIN
`
`DATA INTO THE
`
`FREQUENCY DOMAIN:
`DETERMINE PSD)|
`AND PSB 5
`
`
`
`
`
`
` CALCULATE R AND
`Sp05
`
`210
`
`DISCRETE LEDs
`
`DISCARD OLDEST
`QUARTER OF DATA
`
`
`DISPLAY Sp0-
`OR ILLUMINATE
`
`
`
`
`TRANSMIT DATA TO
`REMOTE DISPLAY
`
`
`
`
`FIG.9
`
`9
`
`

`

`US 6,330,468 B1
`
`1
`SYSTEM USING GREEN LIGHT TO
`DETERMINE PARMETERS OF A
`CARDIOVASCULAR SYSTEM
`
`Thisis a continuation of U.S. patent application Ser. No.
`08/749,898, filed Nov. 18, 1996, entitled GREEN LIGHT
`PULSE OXIMETER, now USS. Pat. No. 5,830,137.
`
`FIELD OF THE INVENTION
`
`The present invention relates generally to medical diag-
`nostic instruments and, more specifically, to a pulse oxime-
`ter using two green light sources to detect
`the oxygen
`saturation of hemoglobin in a volumeof intravascular blood.
`BACKGROUND OF THE INVENTION
`
`The degree of oxygen saturation of hemoglobin, SpO.,,in
`arterial blood is often a vital index of the condition of a
`
`patient. 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, HbO,.
`From the lungs, the blood passes through the arterial system
`until it reaches the capillaries at which point a portion of the
`HbO, gives up its oxygen to support the life processes in
`adjacent cells.
`By medical definition, the oxygen saturation level is the
`percentage of HbO, divided by the total hemoglobin;
`therefore, SpO,=HbO.,/(RHb+HbO,). 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 consciousnessor 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 oxim-
`etry has been recommendedasa 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
`interacts with a liquid, certain wavelengths may be selec-
`tively absorbed by particles which are dissolved therein. For
`a given path length that the light traverses throughthe 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.
`the
`For a solution of oxygenated human hemoglobin,
`extinction coefficient maximumis at a wavelength of about
`577 nm (green) O. W. Van Assendelft, Spectrophotometry of
`Haemoglobin Derivatives, Charles C. Thomas, Publisher,
`1970, Royal Vangorcum LTD., Publisher, Assen, The Neth-
`erlands.
`Instruments that measure this wavelength are
`capable of delivering clinically useful information as to
`oxyhemoglobinlevels. In addition, the reflectance pulsation
`spectrum showsa peak at 577 nm as well. Weijia Cui, Lee
`L. Ostrander, Bok Y. Lee, “In Vivo Reflectance of Blood and
`Tissue as a Function of Light Wavelength”, IEEE Trans.
`Biom. Eng. 37:6:1990, 632-639.
`In general, methods for noninvasively measuring oxygen
`saturation in arterial blood utilize the relative difference
`
`between the electromagnetic radiation absorption coefficient
`of deoxyhemoglobin, RHb, and that of oxyhemoglobin,
`HboO,,.The electromagnetic radiation absorption coefficients
`ot RHb and HbO, are characteristically tied to the wave-
`length of the electromagnetic radiation traveling through
`them.
`
`10
`
`15
`
`30
`
`35
`
`40
`
`45
`
`50
`
`55
`
`60
`
`65
`
`2
`In practice of the transmittance pulse oximetry technique,
`the oxygen saturation of hemoglobin in intravascular blood
`is determined by (1) alternatively illuminating a volume of
`intravascular blood with electromagnetic radiation of two or
`more selected wavelengths, e.g., a red (600-700 nm) wave-
`length and an infrared (800-940 nm) wavelength, (2) detect-
`ing the time-varying clectromagnetic radiation intensity
`transmitted through by the intravascular blood for each of
`the wavelengths, and (3) calculating oxygen saturation val-
`ues for the patient’s blood by applying the Lambert-Beer’s
`transmittance law to the transmitted electromagnetic radia-
`tion intensities at the selected wavelengths.
`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-
`toring is required, such as while the patient is in surgery.
`Therefore, much effort has been expanded in devising an
`instrument for making the measurement by noninvasive
`means.
`
`A critical limitation in prior art noninvasive pulse oxime-
`ters is the few number of acceptable sites where a pulse
`oximeter probe may be placed. Transmittance probes must
`be placed in an area of the body thin enough to pass the
`red/infrared frequencies of light from one side of the body
`part to the other, e.g., ear lobe, finger nail bed, and toe nail
`bed. Although red/infrared reflectance oximetry probes are
`knownto those skilled in the art, they do not function well
`because red and infrared wavelengths transmit through the
`tissue rather than reflect back to the sensor. Therefore,
`red/infrared reflectance sensor probesare not typically used
`for many potentially important clinical applications includ-
`ing: use at central body sites (e.g., thigh, abdomen, and
`back), enhancing poor signals during hypoperfusion,
`decreasing motion artifact, etc.
`
`SUMMARYOF THE INVENTION
`
`According to the present invention, a reflectance oximeter
`is provided using two green light sources to detect the
`oxygen saturation of hemoglobin in a volume of intravas-
`cular blood. Preferably the two light sources emit green light
`centered at 560 nm and 577 nm,respectively, which gives
`the biggest difference in absorption between
`deoxyhemoglobin, RHb, and oxyhemoglobin, Hbo,. The
`green reflectance oximeter is a significant
`improvement
`compared to the red/infrared state of the art because the
`reflectance pulsation spectrum peaks at 577 nm.Practically,
`several combinations of two green light sources can be used.
`Ideally, these light sources comprise very narrow band(e.g.,
`1.0 nm wide) sources such as laser diodes at the desired
`frequencies. However, the benefits of the present invention
`can be realized using other green light sources, such as
`narrow band(e.g., 10 nm wide) light emitting diodes (LEDs)
`at two green frequencies (e.g., 562 nm and 574 nm) with
`optional ultra-narrowband (e.g., 0.5—4.0 nm wide) filters at
`two green frequencies (¢.g., 560 nm and 577 nm).
`In one embodimentof the present invention, two filtered
`green LEDsalternatively illuminate an intravascular blood
`sample with two green wavelengths of electromagnetic
`radiauion. The electromagnetic radiation interacts with the
`blood and a residual optical signalis reflected by the blood.
`Preferably a photodiode in a light-to-frequency converter
`(LFC) detects the oximetry optical signals from the intra-
`vascular blood sample illuminated by the two LEDs. The
`LEC produces a periodic electrical signal in the form of a
`pulse train having a frequency proportional to the light
`
`10
`
`10
`
`

`

`US 6,330,468 B1
`
`3
`iotensity. The data becomes an input to a high-speed digital
`counter, either discrete or internal to a processor(e.g., digital
`signal processor, microprocessor, or microcontroller), which
`converts the pulsatile signal into a digital word suitable to be
`analyzed by the processor. In the alternative, a separate
`silicon photodiode, a current-to-voltage converter (a tran-
`simpedance amplificr), a preamplificr, a filter, a sample and
`hold, and an analog-to-digital (A/D) converter can be used
`to capture the oximetry signal.
`Once inside the processor, the time-domain data is con-
`verted into the frequency domain by, for example, perform-
`ing the well-known Fast Fourier Transform (FFT). The
`frequency domain data is then processed to determine the
`oxygen saturation value using any of a number of methods
`knownto those skilled in the art.
`
`It is therefore an advantage of the present invention to
`provide a green-light
`reflectance-type pulse oximeter
`capable of measuring oxygen saturation at central body
`surfaces.
`
`10
`
`15
`
`is a further object of this invention to provide a
`It
`reflectance-type pulse oximeter using only green wave-
`lengths of light to measure oxygen saturation.
`These and other advantages of the present invention shall
`become more apparent from a detailed description of the 5
`invention.
`
`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 belowserve to example the principles of
`this invention.
`
`FIG. 1 is a block diagram of a pulse oximeter of the
`present invention;
`FIG. 2 is a block diagram of an alternative circuit of a
`pulse oximeter of the present invention;
`FIG. 3 is a bottom plan view of an oximeter probe
`according to the present invention;
`FIG. 4 is a sectional view taken substantially along the
`plane designated by the line 4—4of FIG. 3;
`FIG. 5 is a bottom plan view of a face 88 of the oximeter
`probe of FIGS. 3 and 4;
`FIG. 6 is an exploded view of the oximeter probe of FIGS.
`3 and 4;
`FIG. 7 is an enlarged partially exploded view showing the
`housing and housing spacer of the oximeter probe of FIGS.
`3 and 4;
`FIG. 8 is a schemato-block diagram showing the interface
`between the processor, the LED drivers, and the light-to-
`frequency converter of the pulse oximeter of present inven-
`tion.
`
`FIG. 9 is a flow chart showing the major process steps
`taken by the processor in calculating the saturation value.
`DETAILED DESCRIPTION OF THE
`PREFERRED EMBODIMENT
`
`While the present invention will be described more fully
`hereinafter with reference to the accompanying drawings, in
`which a preferred embodiment of the present invention is
`shown,it is to be understood at the outset of the description
`which follows that persons of skill in the appropriate arts
`may modify the invention here described while still achiev-
`ing the favorable results of this invention. Accordingly, the
`
`30
`
`35
`
`40
`
`45
`
`50
`
`55
`
`60
`
`65
`
`4
`description which follows is to be understood as being a
`broad, teaching disclosure directed to personsof skill in the
`appropriate arts, and notas limiting upon the present inven-
`tion.
`
`two green light
`invention,
`According to the present
`sources alternatively illuminate a patient’s skin 2 and an
`associated intravascular blood sample 4 with two different
`green wavelengths of electromagnetic radiation. The elec-
`tromagnetic radiation interacts with the blood 4 and a
`residual optical signalis reflected by the blood 4 to the LFC.
`A processor analyzes this optical signal, determines the
`oxygen saturation from the signal, and displays a number
`corresponding to the determined saturation value.
`Referring now more particularly to the accompanying
`drawings, FIG. 1 showsa pulse oximeter 10 accordingto the
`present invention. ‘he oximeter 10 of the present invention
`comprises two emitters of green light 12, 14 that illuminate
`a volumeof intravascular blood 4, The green light sources
`12, 14 are shown schematically as including light emitting
`diodes (IEDs) 13, 15 in FIG. 1; however, other greenlight
`sources can be uscd, suchas laser diodes,filtered white light
`sources, filtered broad-band LEDs,etc. Suitable LEDs 13,
`15 include part. nos. TLGA-183P (peak wavelength 574 nm)
`and TLPGA-183P (peak wavelength 562 nm) from Toshiba
`Ltd.
`through various sources, such as Marktech
`International, 5 Hemlock Street, Latham, N.Y., 12110, (518)
`786-6591. The wavelengths of light that can be used range
`from about 500 nm to about 600 nm.
`
`Depending onthe particular green light sources chosen,
`green optical filters 16, 18 might be needed. For example,if
`the Toshiba Ltd. part nos. TLGA183P and TLPGA-183P are
`used as green LEDs 13, 15 then narrow-band optical filters
`16, 18 need to be used. Suitable optical filters include
`custom-made molded acrylic aspheric lens/filters having
`peak wavelengths of 560 nm and 580 nm, respectively, and
`which have bandwidths of less than 5 nm, which are
`available from Innovations In Optics, Inc., address 38
`Montvale Avenue, Suite 215, Storeham, Mass. 02180, (716)
`279-0806. Also, depending on the particular green light
`sources used, more than one emitter of green light might be
`needed. For example,
`if green LEDs TLGA183P and
`TLPGA-183Pare used, then one to four LEDsof each green
`frequency are needed.
`Whichever particular green light sources are used, the
`greenlight 20 emitted fromthe first emitter of green light 12
`must have a peak wavelength that is different than the peak
`wavelength of the green light 22 emitted by the second
`emitter of green light 14. Also, the wavelength bands of the
`green light emitted by the green light sources 12, 14 must be
`narrow enoughthat usably different signals are generated by
`the interaction between the light 20, 22 and the volume of
`intravascular blood 4, For example, either of two sets of
`wavelengths is equally functional: 542 and 560 nm or 560
`and 577 nm. 560 and 577 nm are preferred duc to current
`commercial availability.
`Whichever peak wavelengths and wavelength bands are
`used, what is importantis that electromagnetic radiation 20
`from the first source 12 must have an absorption coefficient
`with respect to oxyhemoglobin that is substantially different
`(i.c., measurably different) than the absorption coefficient
`with respect to oxyhemoglobin of electromagnetic radiation
`22 emitted by the second source 14. Likewise, if some other
`substance other than oxygen (e.g., carbon monoxide
`(HbCO)) is to be detected, what is important is that elec-
`tromagnetic radiation 20 from the first source 12 must have
`an absorption coefficient with respect to the substance to be
`
`11
`
`11
`
`

`

`US 6,330,468 B1
`
`5
`(i-e., measurably
`is substantially different
`detected that
`different) than the absorption coefficient with respect to the
`substance to be detected of electromagnetic radiation 22
`emitted by the second source 14. If levels of oxygen and
`carbon monoxide saturation are to be detected, a third green
`wavelength is added to determine RHb, HbO,, and HbCO
`components. These three components are then used to
`determine levels of oxygen and carbon monoxidesaturation.
`Saturation of HbCO and other blood components is deter-
`mined in a mannerlike HbO.,as disclosed herein.In short,
`the two green light sources alternatively illuminate the blood
`and the resulting signals are placed in the frequency domain
`and used to determine a ratio (R) value. From the R value,
`the saturation value is determined using a look-up table.
`The green light 20, 22 alternately illuminating the volume
`of intravascular blood 4 results in an optical signal 24 with
`a time-varying intensity reflected back from the intravascu-
`lar blood 4 for each of the wavelengths. The resulting signal
`24 comprises the data needed to determine the saturation of
`oxygen in the hemoglobin. The signal 24 is detected by an
`optical detector 26 such as a photodiode 26 of a light-to-
`frequency converter (LFC) 28, which is interfaced to a
`processor 30 via an LFC signal line 32. The LFC signalis
`input into a counter 34, which is in circuit communication
`with the processor 30.
`The LFC 28 produces a periodic electrical signal in the
`form of a pulse train having a frequency corresponding to
`the intensity of the broadband optical signal received by the
`LEC 28. One suitable LFC 52 is the 'I'SL235, manufactured
`and sold by Texas Instruments, P.O. Box 655303, Dallas,
`Tex. 75265. Other LFCs in Texas Instruments’ TSL2XX
`
`series may also be used. Using an LFC eliminates the need
`for a separate silicon photodiode, a current-to-voltage con-
`verter (a transimpedance amplifier), a preamplifier, filter
`stage, a sample and hold, and an analog-to-digital (A/D)
`converter to capture the oximetry signal. As shownin FIG.
`2, and described below in the text accompanying FIG. 2,
`these components can be used in the alternative.
`Referring back to FIG. 1,
`the counter 34 may be an
`external counter or a counter internal to the processor 30, as
`shownin FIG. 1. If the counter 34is an external counter, any
`high speed counter capable of being interfaced to a proces-
`sor may be used. One suitable counter is the 4020 CMOS
`counter, which is manufactured by numerous manufacturers,
`e.g., Texas Instruments, P.O. Box 655303, Dallas, Tex.
`75265, as is well knownin the art.
`The processor 30 may be any processor that can process
`oximetry data in real time and interface and control the
`various devices shown in FIG. 1. One suitable processor is
`a PIC17C43 8-bit CMOS EPROMmicrocontroller, which is
`available from Microchip Technology Inc., address 2355
`West Chandler Blvd., Chandler, Ariz. 85224-6199, (602)
`786-7668. Another suitable processor is the TMS 320C32
`digital signal processor, also manufactured by Texas Instru-
`ments. Another suitable processor is a Zilog 893XX. These
`processors have internal counters 34. Many other CISC and
`RISC microprocessors, microcontrollers, and digital signal
`processors can be used. Some might require random access
`memory (RAM), read-only memory (ROM), andassociated
`control circuitry, such as decoders and multi-phase clocks,
`floating point coprocessors,etc. (all not shown) all in circuit
`communication, as is well known in the art. To be suitable,
`the processor 30 must be capable of being a signal analyzer.
`That
`is,
`the processor 30 must have the computational
`capacity to determine the saturation value from the collected
`data (LFC periodic pulses or ADC data, etc.).
`Interfacing the counter 34 and the processor 30 may be
`done in several ways. The counter 34 and processor 30 may
`
`10
`
`15
`
`30
`
`35
`
`40
`
`45
`
`50
`
`55
`
`60
`
`65
`
`6
`be configured to either (1) count the pulses generated by the
`LFC 28 during a given time period or (2) count the number
`of pulses of a free-running clock (corresponding to the
`amount of time) between the individual pulses of the LFC
`28. Either method will provide satisfactory data. The latter
`method can be implemented in several ways. For example,
`the counter can be reset at each period 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 and subtracted fromthe
`value stored at the previous edge. Either way, the result is a
`counter value corresponding to the time difference between
`the two pulse edges. Manyother configurations are possible.
`‘The counter 34 can either count pulses or elapsed time
`between edges and the processor 30 either reads the value in
`the counter periodically by polling the counter, or the
`processor 30 reads the value whenever the counter 34
`generates an interrupt. Again, many other configurations are
`possible.
`Green light sources 12, 14 are driven along green light
`source power driver lines 35 by drivers 36. Although four
`green light source power driver lines 35 are shown for
`clarity, in the alternative there need be only two suchlines
`and they and the sources 12, 14 are electrically connected
`such that only one source emits green light if one of the two
`driver lines is grounded andthe other is at, e.g., +5 VDC
`(current limited), and vice versa. For example, if the sources
`12, 14 are diodes 13, 15, then the cathode of diode 13 is
`connected to the anode of diode 15, the anode of diode 13
`is connected to the cathode of diode 15, and the two nodes
`are connected via green light source powerdriverlines 35 to
`current-limited drivers 36.
`
`The drivers 36 drive the sources 12, 14 at the required
`voltage and current in an alternating manner, as known to
`those skilled in the art. If sources 12, 14 include LEDs13,
`15, then several suitable driver configurations, known to
`those skilled in the art, are available to drive the LEDs 13,
`15 at the required voltage and current. For example, a 74,
`74H,or 74S family buffer or inverter, such as a 7400 can be
`used to directly drive LEDs with suitable current limiting
`resistors (all not shown). As another example, it is common
`to drive LEDs from CMOS, NMOS, 74LS, or 74HC family
`devices with an NPN or PNPtransistor such as a 2N2222
`with suitable currentlimiting resistors (all not shown). Both
`drivers are widely known to those in the art. Additionally,
`constant current drivers 36 for LEDs 13, 15 will tend to
`produce a constant brightness from the LEDs 13, 15. The
`exact parameters of the driver will depend on the particular
`sources 12, 14 selected and are available from common
`sources.
`
`Whatiscritical about the drivers 24 is that they properly
`drive the sources 12, 14 and that they be interfaced with the
`processor 30 in such a way thal oximetry data is gathered.
`For example, the processor 30 might actually control the
`alternate Ulumination of the green sources 12, 14 by actively
`controlling the drivers 36. As another example, the drivers
`36 might have a local oscillator (not shown) that causes the
`sources 12 14to alternatively illuminate the patient’s skin 2
`and the processor would then receive a timing signalrelating
`to which source is currently illuminating.
`Some drivers 36 might need a normalizing function that
`increasesor decreases the intensily of electromagnetic radia-
`tion generated by the light sources 12, 14 in the system. For
`example,
`it might be desirable to be able use a single
`oximeter configuration to measure the oxygen saturation of
`an infant and later to use the same oximeter configuration to
`measure oxygen saturation levels of an adult. Since the
`nature of skin 2 and hair of an infant are different from that
`
`12
`
`12
`
`

`

`US 6,330,468 B1
`
`10
`
`15
`
`30
`
`35
`
`45
`
`50
`
`7
`of an adult, it is generally accepted that an LED intensity
`calibrated to measure the oxygensaturation level of an adult
`will be too bright to measure the oxygen saturation level of
`an infant (the optical signal 24 is so bright that the photo-
`diode 26 saturates). Likewise, it is generally accepted that a
`light intensity calibrated to measure saturation of an infant
`will be too dim to provide adequate data to measure the
`oxygen saturation of an adult or a person with heavily
`pigmented skin 2. The normalizing function adjusts the
`intensities of the sources 12, 14 to provide a useful signal
`under most circumstances.
`
`8
`desirable in clinical and health care environments. A suitable
`902-908 MHz or 2.4 GHz spread spectrum transmitter/
`receiver pair is available from common sources, such as
`Digital Wireless Corp., One Meczway, Norgrass, Ga., 30093
`(transmitter) and Telxon Pen-Based Computer, 3330 W.
`Market Street, PO. Box 5582, Akron, Ohio 44334-0582
`(receiver).
`Preferably, the transmitter 42 transmits the determined
`parameters, such as oxygen saturation, other gas saturation,
`pulse rate, respiration rate, etc.
`to the receiver 44, which
`requires a high level of digital signal processing capability
`In the oximeter 10 of the present invention, the normal-
`at the sensor location. However, in the alternative, different
`izing function might be not needed if an LFC is used. The
`data can be transmitted such as that has not been completely
`TSL235 has a dynamic range of approximately 118 dB.
`processed, e.g., the raw square-wave output 32 from the
`Moreover,
`the TSL230 is an LFC with a computer-
`LEC 28 or digital words from the high speed counter. This
`interfacable gain control for amplification or attenuation of
`alternative embodiment requires significantly less process-
`the opticalsignal, thereby providing an even higher dynamic
`ing powerat the sensor location.
`range. These very wide dynamic ranges allow the use of
`Referring now to FIG. 2, an alternative oximeter 60
`drivers 36 to be configured such that the intensities of the
`according to the present invention is shown. The use of
`light sources 12, 14 are set at fixed, predetermined values.
`green sources 12, 14 and drivers 36 are the same as FIG. 1.
`Said another way, these LFCs are so sensitive that an light
`The optical signal 24 with the time-varying intensity is
`intensity suitable for an infant mightstill generate a reflected
`detected by a photodiode 62. The photodiode 62 generates a
`optical signal 24 in an adult strong enough to determine the
`low-level current proportional to the intensity of the elec-
`saturation value of that adult. Thus, the drivers 36 might not
`tromagnetic radiation received by the photodiode 62. The
`need to have the ability to normalize the intensities of the ,
`current is converted to a voltage by a current to voltage
`sources 12, 14.
`converter 64, which may be an operational amplifier in a
`Preferably, the processor 30 is in circuit communication
`current to voltage (transimpedance) configuration.
`with a local display 38 to display a visual image correspond-
`The resulting signal 65 is then filtered with a filter stage
`ing to the oximetry data. The local display 38 can be any
`66 to remove unwanted frequency components, such as any
`display capable of displaying a visual image corresponding
`60 Hz noise generated by fluorescent lighting. The filtered
`to one or more oxygen saturation values at
`the desired
`signal 67 is then amplified with an amplifier 68 and the
`resolution. The local display 38 can display any numberof
`amplified signal 69 is sampled and held by a sample and
`different visual images; corresponding to the oximetry data.
`hold 70 while the sampled and held signal 71 is digitized
`For example, a simple numeric liquid crystal display (LCD)
`with a high-resolution (e.g., 12-bit or D higher) analog to
`can be used to numerically display the saturation value. In
`digital converter (ADC) 72. The digitized signal 73 is then
`the alternative, or in addition, a graphical LCD can be used
`read from the processor 30.
`to display the saturation value and display the pulse plethys-
`mograph waveform.In addition, discrete display LEDs (not
`Referring now to FIGS. 3-7, one embodiment of a probe
`shown) maybe used if the designer desires to display merely
`80 according to the present invention is shown. Surface
`mount LEDs 13¢-13d and 15a—15d and the LFC 28 are
`40
`a binary oxygen saturation level. For example, green,
`mounted onaprinted circuit board (PCB) 81. Surface mount
`yellow,and red discrete LEDs can be configured to represent
`LEDs 13a@-13d can be part no. SML-O1LOMTT86 (563 nm),
`safe, critical, and emergency conditions corresponding to
`saturation values of greater than 90 percent, 70 to 90 percent,
`from ROHM Corp., 3034 Owen Drive, Antioch, Tenn.
`37013, which are available from Bell Industries, Altamente
`arid less than 70 percent, respectively.
`Springs, Fla. Surface mount LEDs 15a—15d can be part no.
`Preferably, the processor 30 is also in circuit communi-
`SSL-LXISYYC-RP-TR from Lumex Optocomponents,Inc.
`cation with a remote display 40 to display a second visual
`(585 nm), which are available from Digikey Corp., 701
`image corresponding to the oximetry data. Like the local
`Brooks Avenue South, Thief River Falls, Minn. 56701-0677.
`display,
`the remote display 40 can have any number of
`The LEDs 13a—-13d and 13d and 15a—15d are surface
`configurations. In addition to the displa

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