US007468036B1
`
`a2) United States Patent
`US 7,468,036 B1
`(10) Patent No.:
`
` Rulkovet al. (45) Date of Patent: *Dec. 23, 2008
`
`
`(54) MONITORING DEVICE, METHOD AND
`SYSTEM
`
`(56)
`
`References Cited
`U.S. PATENT DOCUMENTS
`
`(75) Tnventors: Nikolai Rulkov, San Diego, CA (US);
`Mark Hunt, San Diego, CA (US);
`Donald Brady, Las Vegas, NV (US):
`7
`,
`,
`Steve Lui, San Diego, CA (US); Sammy
`I. Elhag, San Diego, CA (US)
`
`(73) Assignee:
`
`Impact Sports Technology, Inc., Las
`Vegas, NV (US)
`
`(*) Notice:
`
`Subject to any disclaimer, the term of this
`patent is extended or adjusted under 35
`
`This patent is subject to a terminal dis-
`lai
`claimer.
`
`(21) Appl. No.: 11/762,078
`(22)
`Filed:
`Jun. 13, 2007
`
`Related U.S. Application Data
`(63) Continuation-in-part of application No. 11/566,229,
`filed on Dec. 3, 2006, which is a continuation-in-part
`ofapplication No. 11/388,707,filed on Mar. 24, 2006,
`which is a continuation-in-part of application No.
`11/085,778, filed on Mar. 21, 2005.
`
`4,380,240 A
`4,800,495 A
`4,807,630 A
`4,825,879 A
`5,213,099 A
`5,431,170 A
`5,735,800 A
`6,018,673 A
`6,241,684 B1*
`6,470,199 Bl
`6,556,852 Bl
`6,575,912 BL*
`6,605,038 Bl
`6,616,613 BI*
`6,678,543 B2
`6,681,454 B2
`
`4/1983 Jobsis et al.
`1/1989 Smith
`2/1989 Malinouskas
`5/1989 Tan et al.
`5/1993 Tripp, Tr.
`7/1995. Mathews
`4/1998 Yasukawaetal.
`1/2000 Chin etal.
`6/2001 Amanoetal. ccc 600/531
`10/2002 Kopoticetal.
`4/2003. Schulze et al.
`6/2003 Turcott
`.....eeeeeceeenee 600/485
`8/2003 Teller etal.
`9/2003 Goodman see caneeeeeeaeeeees 600/504
`1/2004 Diabetal.
`:
`1/2004 Modgiletal.
`
`(Continued)
`Primary Examiner—Robert L Nasser
`(74) Attorney, Agent, or Firm—Clause Eight LLP; M.
`Catania
`67)
`
`ABSTRACT
`
`A monitoring device (20) for monitoring the vital signs of a
`user is disclosed herein. The monitoring device (20) is pref-
`erably an article (25) having an optical sensor (30) and a
`(60) Provisional application No. 60/829,679,filed on Oct.
`circuitry assembly (35). The optical sensor (30) preferably
`17, 2006, provisional application No. 60/843,967,
`comprises a photodetector (130) anda plurality of light emit-
`filed on Sep. 12, 2006, provisional application No.
`60/665,116,filed on Mar. 25, 2005, provisional appli-_ting diodes (135). The monitoring device (20) preferably
`cation No. 60/613,785, filed on Sep. 28, 2004.
`provides for the display of the following information about
`the user: pulse rate; blood oxygenation levels; calories
`expendedbythe user of a pre-set time period; target zones of
`activity; time; distance traveled; and/or dynamic bloodpres-
`sure.
`
`(S51)
`
`Int. Cl.
`(2006.01)
`AGIB 5/00
`(52) US. Chee 600/485; 600/500; 600/503
`(58) Field of Classification Search «0.0.0.0... None
`See application file for complete search history.
`
`6 Claims, 13 Drawing Sheets
`
`APPLE 1058
`Apple v. Masimo
`IPR2022-01465
`
` 1
`
`1
`
`APPLE 1058
`Apple v. Masimo
`IPR2022-01465
`
`

`

`US 7,468,036 B1
` Page 2
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`U.S. PATENT DOCUMENTS
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`6,720,734 B2
`6,808,473 B2
`6.813.511 B2
`6,866,639 B2*
`
`4/2004 Norris
`10/2004 Hisanoetal.
`11/2004 Diab etal.
`3/2005 Causevic etal.
`
`........... 600/559
`
`2/2007 Banet
`7,179,228 B2
`8/2002 Mault et al.
`2002/0109600 Al
`4/2006 Leeetal. we. 600/301
`2006/0084851 Al*
`2007/0244398 Al* 10/2007 Loetal. wo... 600/500
`2007/0287923 A1* 12/2007 Adkins etal. ......... 600/485
`* cited by examiner
`
`2
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`

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`U.S. Patent
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`Sheet 1 of 13
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`Dec. 23, 2008
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`US 7,468,036 B1
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`FIGURE1
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`3
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`U.S. Patent
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`Dec. 23, 2008
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`Sheet 2 of 13
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`US 7,468,036 B1
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`mY’
`FIGURE 2
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`;
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`25
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`95b
`\
`es FIGURE 2A
`FIGURE2B
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`
`
`iacannaammeed
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`a
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`J FIGURE 2D
`=a
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`FIGURE 2C
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`96a
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`Ys
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`3
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`135
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`130
`FIGURE 2E
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`98
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`6b
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`4
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`U.S. Patent
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`Dec. 23, 2008
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`Sheet 3 of 13
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`US 7,468,036 B1
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` FIGURE3
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`FIGURE 3A
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`5
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`U.S. Patent
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`Dec. 23, 2008
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`Sheet 4 of 13
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`US 7,468,036 B1
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`
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`FIGURE 3B
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`6
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`U.S. Patent
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`Dec. 23, 2008
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`Sheet 5 of 13
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`US 7,468,036 B1
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`15
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`72
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`20
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`751
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`«— 750
`
`
`
`FIGURE 6
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`FIGURE 5
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`v/a
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`SSS
`7 »
`
`FIGURE 4
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`a
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`— Microcontroller
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`AID
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`Filtered sensor signal
`
`FIGURE 7
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`1300
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`7
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`Sheet 6 of 13
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`US 7,468,036 B1
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`Dec. 23, 2008
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`U.S. Patent
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`8
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`U.S. Patent
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`Dec. 23, 2008
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`Sheet 7 of 13
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`US 7,468,036 B1
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`KSoS
`
`wwSo
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`FIGURE 10.
`
`RawSensor
`Signal
`
`
`
`
`
`alcr HEE
` Integrator
`
`Filtered
`signal
`
`our
`
`{(k} -data sampic
`
`Fk Ty
`! tategration
`i
`iledk
`andesiofsamplingf
`
`eS
`
`FIGURE11
`
` Mofion sensor
`
`
`
`
`Custom
`Heart Beat
`pS
`Rate Tracking
`Adaptive
`
`
`Fitter
`System
`
`
`
`
`Heart Rate
`
`| BeatOutput
`
`
`
`Custom BPF
`
`FIGURE 12
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`9
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`

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`U.S. Patent
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`Dec. 23, 2008
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`Sheet 8 of 13
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`US 7,468,036 B1
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`50
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`254
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`258
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`Deactivating a processor
`for a deactivation period
`
`Activating the optical sensor
`to obtain
`
`multiple readings
`from the processed readings
`
`a
`Reactivating the processor and
`processing the readings
`
`;
`Generating heart rate data
`
`Generating and displaying
`health related data from
`
`the heart rate data
`
`FIGURE13
`
`52
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`256
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`260
`
`10
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`U.S. Patent
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`Dec. 23, 2008
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`Sheet 9 of 13
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`US 7,468,036 B1
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`300
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`304
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`308
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`Deactivating a high speed clock
`of a processorfor a
`deactivation period
`
`;
`Lo.
`Activating an optical sensor
`to obtain multiple
`
`Reactivating the processor and
`processing the readings, and
`deactivating the optical sensor
`
`blood flow readings
`from the processedreadings
`
`Generating heart rate data
`
`Generating and displaying
`health related data from
`
`the heart rate data
`
`FIGURE 14
`
`02
`
`306
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`310
`
`11
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`U.S. Patent
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`Dec. 23, 2008
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`Sheet 10 of 13
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`US 7,468,036 B1
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`35
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`30
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`FIGURE 15
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`(Prior Art)
`
`137
`
`FIGURE 16
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`12
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`U.S. Patent
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`Dec. 23, 2008
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`Sheet 11 of 13
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`US 7,468,036 B1
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` R limit
`
`Skin
`
`
`Microprocessor
`
` cumutieneicet
`
`FIGURE 17
`
`wee rept n eee na ene nee enn
`
`
`
`Skin
`
`Microprocessor
`
`13
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`U.S. Patent
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`Dec. 23, 2008
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`Sheet 12 of 13
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`US 7,468,036 B1
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`: R limit
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`Vice
`
`FIGURE19
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`14
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`

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`U.S. Patent
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`Dec. 23, 2008
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`Sheet 13 of 13
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`US 7,468,036 B1
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`500
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`51€
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`320
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`505
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`515
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`Monitorthe intensity
`of the light source
`
`Determine if the sensor
`is saturated by
`the intensity of
`the light source
`
`Modify the intensity
`of the light source
`by adjusting the
`resistance
`
`source and adjust
`
`| Monitor the intensity
`level of the light
`
`FIGURE 18
`
`15
`
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`

`US 7,468,036 B1
`
`1
`MONITORING DEVICE, METHOD AND
`SYSTEM
`
`CROSS REFERENCES TO RELATED
`APPLICATIONS
`
`2
`Smith, U.S. Pat. No. 4,800,495 discloses an apparatus for
`processing signals containing information concerning the
`pulse rate and the arterial oxygen saturation of a patient.
`Smith also discloses maintaining the position of the LEDs
`and detectors to prevent motion-artifacts from being pro-
`ducedin the signal.
`Another method for using a pulse oximeter to measure
`blood pressure is disclosed in U.S. Pat. No. 6,616,613 to
`Goodman for a ‘Physiological Signal Monitoring System’.
`The ’613 patent discloses processing a pulse oximetry signal
`in combination with information from a calibrating device to
`determine a patient’s blood pressure.
`Chenetal, U.S. Pat. No. 6,599,251 discloses a system and
`method for monitoring blood pressure by detecting pulse
`signals at two different locations on a subjects body, prefer-
`ably on the subject’s finger and earlobe. The pulse signals are
`preferably detected using pulse oximetry devices.
`Schulze et al., U.S. Pat. No. 6,556,852, discloses the use of
`an earpiece having a pulse oximetry device and thermopile to
`monitor and measure physiological variables of a user.
`Malinouskas, U.S. Pat. No. 4,807,630, discloses a method
`for exposing a patient’s extremity, such asa finger, to light of
`two wavelengths and detecting the absorbance of the extrem-
`ity at each of the wavelengths.
`Jobsis et al., U.S. Pat. No. 4,380,240 discloses an optical
`probe witha light source andalight detector incorporated into
`BACKGROUND OF THE INVENTION
`channels within a deformable mounting structure which is
`adheredto a strap. The light source andthe light detector are
`secured to the patient’s body by adhesive tapes and pressure
`inducedby closing the strap around a portion of the body.
`Tan et al., U.S. Pat. No. 4,825,879 discloses an optical
`probe with a T-shaped wrap having a vertical stem and a
`horizontal cross bar, which is utilized to secure a light source
`and an optical sensor in optical contact with a finger. A metal-
`lic materialis utilized to reflect heat back to the patient’s body
`and to provide opacityto interfering ambientlight. The sensor
`is securedto the patient’s body using an adhesive or hook and
`loop material.
`Modgilet al., U.S. Pat. No. 6,681,454 discloses a strap that
`is composed of an elastic material that wraps around the
`outside of an oximeter probe and is secured to the oximeter
`probe by attachment mechanisms such as Velcro, which
`allows for adjustmentafterinitial application without produc-
`ing excessive stress on the spring hinge ofthe oximeterprobe.
`Diab et al., U.S. Pat. No. 6,813,511 discloses a disposable
`optical probe suited to reduce noise in measurements, which
`is adhesively secured to a patient’s finger, toe, forehead, ear-
`lobeorlip.
`Diabet al., U.S. Pat. No. 6,678,543 discloses an oximeter
`sensor system that has a reusable portion and a disposable
`portion. A method for precalibrating a light sensor of the
`oximeter sensor system 1s also disclosed.
`Tripp, Jr. et al., U.S. Statutory Invention Registration Num-
`ber H1039 discloses an intrusion free physiological condition
`monitorthat utilizes pulse oximetry devices.
`Hisanoet al., U.S. Pat. No. 6,808,473, discloses a head-
`phone-type exercise aid which detects a pulse wave using an
`optical sensor to provide a user with an optimal exercise
`intensity.
`Mathews, U.S. Pat. No. 5,431,170 (“Mathews”), discloses
`a pulse responsive device, which has a pulse oximetry device
`(10) attached to a headband (12) and a separate read-out
`device (14) that may be attached to a glove and worn on the
`user’s hand. Mathewsdiscloses that the read-out device (14)
`has a digital display and an analogue display, however,
`Mathewsprovides no further detail.
`
`The major advantages of pulse oximetry devices include
`the fact that the devices are non-invasive, easy to use, allows
`for continuous monitoring, permits early detection of desatu-
`ration and is relatively inexpensive. The disadvantages of
`pulse oximetry devices are that it is prone to artifact, it is
`inaccurate at saturation levels below 70%, and there is a
`minimalrisk ofburnsin poorperfusion states. Several factors
`can cause inaccurate readings using pulse oximetry including
`ambient light, deep skin pigment, excessive motion, finger-
`nail polish, low flow caused by cardiac bypass, hypotension,
`vasoconstriction, and thelike.
`Chinet al., U.S. Pat. No. 6,018,673 discloses a pulse oxim-
`etry device that is positioned entirely ona user’s nail to reduce
`out of phase motion signals for red and infrared wavelengths
`for use in a least squaresorratio-of-ratios technique to deter-
`mine a patient’s arterial oxygen saturation.
`
`The Present application is a continuation-in-part applica-
`tion of U.S. patent application Ser. No. 11/566,229, filed on
`Dec. 3, 2006, which is a continuation-in-part application of
`USS. patent application Ser. No. 11/388,707, filed on Mar. 24,
`2006, which claimspriority to U.S. Provisional Application
`No. 60/665,116, filed on Mar. 25, 2005, now abandoned; and
`the Present application is a continuation-in-part application
`of US. patent application Ser. No. 11/085,778,filed on Mar.
`21, 2005, which claimspriority to U.S. Provisional Applica-
`tion No. 60/613,785, filed on Sep. 28, 2004, now abandoned.
`The Present application also claimspriority to U.S. Provi-
`sional Application No. 60/843,967, filed on Sep. 12, 2006 and
`US. Provisional Application No. 60/829,679, filed on Oct.
`17, 2006.
`
`STATEMENT REGARDING FEDERALLY
`SPONSORED RESEARCH OR DEVELOPMENT
`
`Not Applicable
`
`1. Field of the Invention
`The present invention is related to real-time vital sign
`monitoring devices. More specifically, the present invention
`relates to a device for monitoring a user’s vital signs.
`2. Description of the Related Art
`There is a need to know how oneis doing from a health
`perspective. In some individuals, there is a daily, even hourly,
`need to know one’s health. The prior art has provided some
`devices to meet this need.
`
`One such deviceis a pulse oximetry device. Pulse oximetry
`is used to determine the oxygen saturation ofarterial blood.
`Pulse oximeter devices typically contain two light emitting
`diodes: one in thered band of light (660 nanometers) and one
`in the infrared bandoflight (940 nanometers). Oxyhemoglo-
`bin absorbs infrared light while deoxyhemoglobin absorbs
`visible red light. Pulse oximeter devices also contain sensors
`that detectthe ratio ofred/infrared absorption several hundred
`times per second. A preferred algorithm for calculating the
`absorption is derived from the Beer-Lambert Law, which
`determines the transmitted light from the incidentlight mul-
`tiplied by the exponential of the negative of the product of the
`distance through the medium,the concentration of the solute
`and the extinction coefficient of the solute.
`
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`US 7,468,036 B1
`
`3
`Mault et al, U.S. Patent Application Publication Number
`2002/0109600 (“Mault”) discloses a smart activity monitor
`(“SAM”) which is a pedometer based device which includes
`an electronic clock, a sensor, entry means for recording food
`consumption and exercise activities anda memory forstoring
`such information. Mault fails to disclose the details of the
`display otherthan to mention that the SAM hasa timedisplay,
`an exercise display and a food display, with the exercise and
`food displays having a bar-graph style. Mault fails to disclose
`an optical sensorin detail, and only states that photo-plethys-
`mography maybe used to determinethe heart rate by a sensor
`provided on the rear of a wrist mounted SAM.
`Kopotic et al, U.S. Pat. No. 6,470,199, discloses a sock for
`positioning an optical probe.
`Yasukawa et al., U.S. Pat. No. 5,735,800 (“Yasukawa’”’),
`discloses a wrist-worn device which is intended for limited
`motion aboutthe user’s wrist. Yasukawa discloses an optical
`sensor that uses a blue LED with a phototransistor in con-
`junction with an analog to digital converter to provide a
`digital signal to a data processing circuit.
`In monitoring one’s health there is a constant need to know
`how manycalories have been expended whetherexercising or
`going about one’s daily routine. A calorie is ameasure ofheat,
`generated whenenergy is producedin our bodies. The amount
`of calories burned during exercise is a measure of the total
`amount of energy used during a workout. This can be impor-
`tant, since increased energy usage through exercise helps
`reduce body fat. There are several means to measure this
`expenditure of energy. To calculate the calories burned during
`exercise one multiplies the intensity level of the exercise by
`one’s body weight (in kilograms). This provides the amount
`of calories burned in an hour. A unit of measurementcalled a
`
`METis usedto rate the intensity of an exercise. One MET is
`equal to the amount of energy expendedatrest.
`For example, the intensity of walking 3 miles per hour
`(“mph”) is about 3.3 METS. At this speed, a person who
`weighs 132 pounds (60 kilograms) will burn about 200 calo-
`ries per hour (60x3.3=198).
`The computer controls in higher-quality exercise equip-
`ment can provide a calculation of how many calories are
`burned by an individual using the equipment. Based on the
`workload, the computer controls of the equipmentcalculate
`exercise intensity and calories burned according to estab-
`lished formulae.
`
`The readings provided by equipmentare only accurate if
`oneis able to input one’s body weight. Ifthe machine does not
`allow this, then the “calories per hour” or “calories used”
`displays are only approximations. The machineshavebuilt-in
`standard weights (usually 174 pounds) that are used when
`there is no specific user weight.
`There are devices that utilize a watch-type monitor to pro-
`vide the wearer with heart rate as measured by a heartbeat
`sensor in a chest belt.
`
`However,the prior art devices often suffer from noise, light
`and motion related problems. These problems are increased
`when the user participates in an athletic activity such as
`running. Further, attempting to correct one problem often
`creates additional problems such as increasing a sensor out-
`put whichresults in a shorter battery life.
`Thepriorart has failed to provide a means for monitoring
`one’s health that is accurate, easy to wear on one’s body for
`extended time periods, allows the user to input information
`and control the output, and provides sufficient information to
`the user about the user’s health. Thus, there is a need for a
`monitoring device that can be worn for an extended period
`and provide health information to a user.
`
`4
`BRIEF SUMMARY OF THE INVENTION
`
`The present invention providesa solution to the shortcom-
`ings ofthe prior art. The present invention is accurate, com-
`fortable to wear by a user for extended timeperiods, allows
`for input and controlled output by the user, is light weight, and
`provides sufficient real-time informationto the user about the
`user’s health.
`
`Oneaspect of the present invention is a monitoring device
`for monitoring the health of a user. The monitoring device
`includesan article, an optical device for generating a pulse
`waveform,a circuitry assembly embeddedwithin thearticle,
`a display member positioned on an exterior surface of the
`article, and a control meansattachedto thearticle.
`The article is preferably a band to be worn on a user’s wrist
`or ankle. The article preferably has a minimal mass, one to
`five ounces, andis flexible so that the user can wear it the
`entire day ifnecessary. The monitoring device allows the user
`to track calories burnt during a set time period, monitor heart
`rate, blood oxygenationlevels, distance traveled, target zones
`and optionally dynamic bloodpressure.
`Yet another aspect of the present invention is a system for
`real time monitoring of a user’s vital sign during a live event
`within a playing environment. The system includes a moni-
`toring device, a computing device and an electro-optical dis-
`play. The monitoring device is attached to an arm, wrist or
`ankle ofthe user. The monitoring device comprises means for
`generating a real-time vital sign signal correspondingto the
`heart rate ofthe user, and meansfor transmitting the real-time
`vital sign signal outside of the playing environment. The
`computing device is positioned outside of the playing envi-
`ronment. The computing device comprises meansfor receiv-
`ing the real-timevital sign signal from the monitoring device,
`and means for processing the real-time vital sign signal for
`transmission to and image on the electro-optical display.
`Yet another aspect of the present invention is a monitoring
`device for monitoring the health of a user. The monitoring
`device includesan article to be worn on the user’s wrist, arm
`or ankle. The monitoring device also includes an optical
`sensor, a circuitry assembly, a display memberanda control
`component. The optical sensor is disposed on the interior
`surface of the article. The circuitry assembly is preferably
`embedded within the annular bodyofthearticle. The display
`memberis preferably attached to an exterior surface of the
`annular body of the article. The control componentis dis-
`posed on the exterior surface of the annular body of the
`article. The control componentcontrols the input of informa-
`tion and the output of information displayed on the display
`member.
`
`Havingbriefly described the present invention, the above
`and further objects, features and advantages thereof will be
`recognized by those skilled in the pertinent art from the fol-
`lowing detailed description of the invention when taken in
`conjunction with the accompanying drawings.
`
`BRIEF DESCRIPTION OF THE SEVERAL
`VIEWS OF THE DRAWINGS
`
`FIG. 1 is a plan view of a preferred embodiment of a
`monitoring device worn by a user.
`FIG.2 is a perspective view ofthe article ofthe monitoring
`device worn by a user.
`FIG. 2A is a plan view ofthe article of the monitoring
`device.
`
`FIG.2B isa frontside view ofthearticle of the monitoring
`device.
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`US 7,468,036 B1
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`5
`FIG.2C is a rear side view ofthe article of the monitoring
`device.
`
`FIG. 2D is an edgeside view ofthe article ofthe monitoring
`device.
`FIG. 2E is a bottom plan view ofthe article of the moni-
`toring device.
`FIG.3 is a top view of an alternative embodimentof the
`monitoring device of the present invention.
`FIG. 3A is bottom view ofthe monitoring device of FIG.3.
`FIG.3B is a top perspective view of the monitoring device
`of FIG. 3 worn on a user’s arm.
`FIG.4 is a schematic view ofarteries within a human arm.
`
`FIG.5 is a front view of a user running on exercise equip-
`ment with the monitoring device on her arm.
`FIG.6 is an isolated view of a display unit of the exercise
`equipmentof FIG.5.
`FIG.7 is a schematic flow chart of the signal acquisition
`step of the flow chart of FIG. 10.
`FIG. 8 is a schematic view of the display membercircuitry.
`FIG. 9 is a schematic view ofthe circuitry assembly.
`FIG. 10 is a flow chart of a signal processing method ofthe
`present invention.
`FIG. 11 is an illustration of the waveforms of the data
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`40
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`FIG. 17C is a schematic diagram ofthe light source inten-
`sity controlling mechanism of FIG. 17 with tworesistors
`connected.
`
`45
`
`6
`It is desirous to adapt the monitoring device 20 to the
`anatomyof the user’s arm 72 or even the user’s ankle. The
`strap 96 is preferably composed of neoprene, leather, syn-
`thetic leather, LYCRA, another similar material, or a combi-
`nation thereof. The article 25 is preferably composed of a
`semi-rigid or rigid plastic with a rubber-like or semi-flex
`plastic bottom layer for contact with the user’s body. The
`bottom layer of the housing 95 may have a curve surface for
`contact with a user’s body. The article 25 preferably has a
`mass ranging from 5 gramsto 50 grams. Preferably,the lower
`the mass ofthe article 25, the more comfort to the user. The
`article 25 preferably has a thickness ranging from 5 mm to 10
`mm, and is most preferably 6.5 mm. The bottom layer 95a
`preferably has a thickness ranging from 3.0 mm to 5.0 mm,
`and mostpreferably is 3.3 mm.A top layer 95a preferably has
`a thickness ranging from 2.0 mm to 5.0 mm, and mostpref-
`erably is 2.63 mm. A mid-layer 95c preferably has a thickness
`ranging from 0.25 mm to 1.0 mm, and mostpreferably is 0.5
`mm. The housing 95 preferably has a width, W, ranging from
`30mm to 50 mm, morepreferably from 35 mm to 45 mm, and
`is most preferably approximately 40 mm. The housing 95
`preferably has a length, L, ranging from 40 mm to 65 mm,
`more preferably from 50 mm to 60 mm,and is most prefer-
`ably approximately 55 mm. Thearticle 25 preferably has a
`massranging from 5 grams to 50 grams, and more preferably
`from 10 gramsto 40 grams. Thelight weight ofthe article 25
`provides for more comfort to the user. The optical sensor 30 is
`preferably positionedonthe interior surface 98 ofthe housing
`95 and electrically connected to the circuitry assembly 35.
`Although the monitoring device 20 is described in refer-
`ence to an article worn on a user’s arm, wrist or ankle, those
`skilled in the pertinent art will recognize that the monitoring
`device 20 may take other forms such as eyeweardisclosed in
`USS. patent application Ser. No. 11/566,228, which is hereby
`incorporated by reference in its entirety or a glove such as
`disclosed in U.S. patent application Ser. No. 11/473,641,
`whichis hereby incorporated by referencein its entirety.
`The optical sensor 30 of the monitoring device 20is pref-
`erably positioned overthe radial artery 77 or ulnar artery 77a
`(as shownin FIG.4)ifthe article 25 is worn on the user’s arm
`72. The optical sensor 30 of the monitoring device 20 is
`preferably positioned overthe posteriortibial artery of a user
`if the article 25 is worn on the user’s ankle. However, those
`skilled in the pertinent art will recognize that the optical
`sensor may be placed overotherarteries of the user without
`departing from the scope andspirit of the present invention.
`Further, the optical sensor 30 need only be in proximity to an
`artery of the user in order to obtain a reading or signal.
`In a preferred embodiment, the optical sensor 30 is a plu-
`rality of light emitting diodes (“LED”) 135 based on green
`light wherein the LEDs 135 generate green light (wavelength
`of 500-570 nm), and a photodetector 130 detects the green
`light. Yet in an alternative embodiment, the optical sensor 30
`As shown in FIGS. 1-2F, monitoring device is generally
`is a photodetector 130 and a single LED 135 transmitting light
`designated 20. The monitoring device 20 preferably includes
`at a wavelength of approximately 900 nanometers as a pulsed
`an article 25 and an attachment band 26, preferably composed
`infrared LED. Yet further, the optical sensor is a combination
`offirst strap 26a and secondstrap 26d. The straps 26a and 26b
`
`are preferably attached to each other with aVELCRO® hook ofa green light LED andapulsed infrared LEDto offset noise
`and loop material. The article 25 preferably includes an opti-
`affects of ambient light and sunlight. As the heart pumps
`cal sensor 30, a circuitry assembly 35, control components
`blood throughthe arteries in the user’s arm, ankle or wrist, the
`43a-43c and optionally a display member 40. The monitoring
`photodetector 130, which is typically a photodiode, detects
`device 20 is preferably worn on a user’s wrist 71, arm 72 or
`reflectance/transmission at the wavelengths (green, red or
`ankle 73. The article 25 preferably has a housing 95 that is
`infrared), and in response generates a radiation-inducedsig-
`nal.
`sized to securely attach to a user’s wrist 71, arm 72 or ankle
`73, and the housing has an interior surface 98 and an exterior
`surface 99. The housing 95 also preferably has a pair ofslots
`96a and 966 for placementof the straps 96a and 966 there-
`through for attachment purposes.
`
`sampling during the signal processing method.
`FIG.12 is a flow chart of a portion of the signal processing
`step utilizing a motion sensor to reduce the affect of motion.
`FIG.13 is a flow chart of a noise reduction method of the
`present invention.
`FIG. 14 is a flow chart of a specific noise reduction method
`of the present invention.
`FIG. 15 is a schematic diagram of a prior art connection of
`a processorto an optical sensor.
`FIG. 16 is a schematic diagram of a connection of a pro-
`cessor to an optical sensor utilized by the present invention.
`FIG. 17 is a schematic diagram ofa light source intensity
`controlling mechanism ofthe present invention.
`FIG. 17A is a schematic diagram ofthe light source inten-
`sity controlling mechanism of FIG. 17 with a single resistor
`connected.
`FIG. 17B is a schematic diagram ofthe light source inten-
`sity controlling mechanism of FIG. 17 with a single resistor
`connected.
`
`FIG. 181s a flow chart of a light source intensity controlling
`methodof the present invention.
`FIG.19 is a graphillustrating the method and mechanism
`of controlling the intensity of the light source over time.
`
`DETAILED DESCRIPTION OF THE INVENTION
`
`50
`
`55
`
`60
`
`65
`
`18
`
`A preferred optical sensor 30 utilizing green light is a
`TRS1755 sensor from TAOS,Inc of Plano Tex. The TRS1755
`comprises a green LED light source (567 nm wavelength) and
`a light-to-voltage converter. The output voltage is directly
`
`18
`
`

`

`US 7,468,036 B1
`
`7
`proportionalto the reflected light intensity. Anotherpreferred
`photodetector 130 is a light-to-voltage photodetector such as
`the TSL260R and TSL261, TSL261R photodetectors avail-
`able from TAOS, Inc of Plano Texas. Alternatively, the pho-
`todetector 130 is a light-to-frequency photodetector such as
`the TSL245R, which is also available from TAOS, Inc. The
`light-to-voltage photodetectors have an integrated transim-
`pedance amplifier on a single monolithic integrated circuit,
`which reduces the need for ambient
`light filtering. The
`TSL261 photodetector preferably operates at a wavelength
`greater than 750 nanometers, and optimally at 940 nanom-
`eters, which would preferably have a LED thatradiates light
`at those wavelengths.
`Ina preferred embodiment, the circuit assembly 35is flex-
`ible to allow for the contourof the user’s arm, wrist or ankle,
`and the movement thereof. The circuitry assembly and dis-
`play member40 are preferably separate componentselectri-
`cally connected within the housing 95. In one embodiment,
`discussed below, the display member 40 is removed and the
`signal is sent to a device such as a personaldigital assistant,
`laptop computer, mobile telephone, exercise equipment, or
`the like for display and even processing ofthe user’s real-time
`vital signs information. Alternatively, the circuitry assembly
`35 includes a flexible microprocessor board which is a low
`power, micro-size easily integrated board which provides
`blood oxygenation level, pulse rate (heart rate), signal
`strength bargraph, plethysmogram andstatus bits data. The
`microprocessor can also store data. The microprocessor can
`process the data to display pulse rate, blood oxygenation
`levels, calories expended by the userof a pre-set time period,
`target zone activity, time and dynamic blood pressure. Fur-
`ther, microprocessor preferably includes an automatic gain
`control for preventing saturation of the photodetector, which
`allows for the device to be used on different portions of the
`human body.
`The display member40 is preferably a light emitting diode
`(“LED”). Alternatively, the display member 40 is a liquid
`crystal display (“LCD”) or other similar display device. As
`shown in FIG. 8, the display member 40 is an LED array
`which preferably has seven rows 49a-49¢ and seventeen col-
`umns 47a-47q. Further, LED array is angled to allow for a
`greater aspect ratio. The LEDarray allows for each column to
`be illuminated separately thereby giving the appearance of a
`moving display. For example,
`if the term “200 calories
`expended”is displayed on the display member40, the “2” of
`the “200” would preferably first appear in column 47g and
`then subsequently in each ofthe other columns 47p-47a, from
`the right-most column to the left-most column thereby giving
`the appearanceofthe term scrolling along the display mem-
`ber 40. The terms or wordsalternatively scroll from left to
`right. Still alternatively, all of the columnsare illuminated at
`once or all flash in strobe like manner. Further, the user’s
`real-time pulse waveform is displayed in motion on the dis-
`play member 40 as a default setting. Those skilled in the
`pertinent art will recognize alternative methodsof displaying
`information on the display member 40 without departing
`from the scope andspirit of the present invention.
`As shown in FIG. 9, a microprocessor 41 processes the
`signal generated from the optical sensor 30 to generate the
`plurality of vital sign information for the user which is dis-
`played on the display member 40. The control components
`43a-c are connectedto the circuit assembly 35 to control the
`input of information andthe output of information displayed
`on the display member40.
`The monitoring device 20 is preferably powered by a
`powersource 360 positioned on thearticle 25. Preferably the
`powersourceis a battery. The power source 360 is preferably
`
`8
`connectedto the circuit assembly 35 by positive wire 45a and
`ground wire 456, and the ground wire 456 and positive wire
`45c are embeddedwithinthearticle 25. The powersource 360
`is preferably an AA or AAA disposable or rechargeable bat-
`tery. The power source 360 is alternatively a lithium ion
`rechargeable battery such as available from NEC-Tokin. The
`power source 360 preferably has an accessible port for
`recharging. The circuit assembly 35 preferably requires 5
`volts and drawsa current of 20- to 40 milliamps. The power
`source 360 preferably providesat least 900 milliamp hours of
`powerto the monitoring device 20.
`As shown in FIGS. 3, 3A and 3B, an alternative embodi-
`ment of the monitoring device 20 comprises a light shield 21
`with the article 25 disposed on an exterior surface 21a of the
`light shield 21, and the optical sensor 30 disposed on an
`interior surface 216 of the light shield 21. The light shield 21
`is preferably composed of a light-weight, non-transparent
`(preferably opaque) cloth material. The light shield 21 pre-
`vents or substantially eliminates environmental light from
`interfering with the optical sensor 30 thereby reducing inter-
`ference with the signal. In a preferred embodiment,the light
`shield 21 is black in color. A user preferably wears the moni-
`toring device 20 on the user’s arm 72 as shown in FIG.3B,
`with a display member40 visible to the user. In this embodi-
`ment, the article 25 contains a circuitry assembly 35, as dis-
`cussed above, within the housing 95 of the article 25. The
`display member40 is preferably a LED display monitor, and
`alternatively a