`(10) Patent No.:
`a2) United States Patent
`Lamegoetal.
`(45) Date of Patent:
`Nov. 5, 2013
`
`
`US008577431B2
`
`(75)
`
`(54) NOISE SHIELDING FOR A NONINVASIVE
`DEVICE
`Inventors: Marcelo Lamego, Coto De Caza, CA
`(US); Sean Merritt, Lake Forest, CA
`(US); Cristiano Dalvi, Mission Viejo,
`CA (US); Hung Vo, Garden Grove, CA
`(US); Johannes Bruinsma, Mission
`Viejo, CA (US); Jeroen Poeze, Mission
`Viejo, CA (US); Ferdyan Lesmana,
`Irvine, CA (US); Greg Olsen, Trabuco
`Canyon, CA (US); Massi Joe E. Kiani,
`Laguna Niguel, CA (US)
`
`(73) Assignee: Cercacor Laboratories, Inc., Irvine, CA
`(US)
`
`(*) Notice:
`
`Subject to any disclaimer, the term ofthis
`patent is extended or adjusted under 35
`U.S.C. 154(b) by 918 days.
`
`EP
`WO
`WO
`
`(52) U.S.CL
`USPC we. 600/310; 600/316; 600/322; 600/323
`(58) Field of Classification Search
`USPC ccc 600/310, 316, 322, 323, 344, 473, 476,
`600/326; 356/41
`See application file for complete search history.
`
`(56)
`
`References Cited
`U.S. PATENT DOCUMENTS
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`9/1978 Shawet al.
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`(Continued)
`
`FOREIGN PATENT DOCUMENTS
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`3/1991
`419223
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`WO093/12712
`5/2000
`WO 00/25 112
`OTHER PUBLICATIONS
`
`(21) Appl. No.: 12/497,528
`
`(22)
`
`(65)
`
`Filed:
`
`Jul. 2, 2009
`
`Prior Publication Data
`
`US 2010/0004519 Al
`
`Jan. 7, 2010
`
`Related U.S. Application Data
`
`(63) Continuation-in-part of application No. 29/323,409,
`filed on Aug. 25, 2008, now Pat. No. Des. 621,516,
`which is a continuation-in-part of application No.
`29/323,408,filed on Aug. 25, 2008, now Pat. No. Des.
`606,659.
`
`(60) Provisional application No. 61/086,060,filed on Aug.
`4, 2008, provisional application No. 61/086,108, filed
`on Aug.
`4, 2008, provisional
`application No.
`61/086,063,
`filed on Aug. 4, 2008, provisional
`application No. 61/086,057, filed on Aug. 4, 2008,
`provisional application No. 61/078,228, filed on Jul. 3,
`2008, provisional application No. 61/078,207, filed on
`Jul. 3, 2008, provisional application No. 61/091,732,
`filed on Aug. 25, 2008.
`
`(51)
`
`Int. Cl.
`A6IB 5/1455
`
`(2006.01)
`
`International Search Report issued in Application No. PCT/US2009/
`052756, mailed Feb. 10, 2009 in 14 pages.
`
`(Continued)
`
`Primary Examiner — Eric Winakur
`Assistant Examiner — Chu Chuan (JJ) Liu
`(74) Attorney, Agent, or Firm — Knobbe Martens Olson &
`Bear LLP
`
`ABSTRACT
`(57)
`A noninvasive physiological sensor for measuring one or
`more physiological parameters of a medical patient can
`include a bump interposed betweena light source and a pho-
`todetector. The bump can be placed in contact with body
`tissue of a patient and thereby reduce a thickness of the body
`tissue. As a result, an optical pathlength between the light
`source and the photodetector can be reduced. In addition, the
`sensor can include a heatsink that can direct heat away from
`the light source. Moreover, the sensor can include shielding in
`the optical path between the light source and the photodetec-
`tor. The shielding can reduce noise received by the photode-
`tector.
`
`21 Claims, 43 Drawing Sheets
`
`71450
`
`APPLE 1038
`
`1
`
`APPLE 1038
`
`
`
`US 8,577,431 B2
`
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`US 8,577,431 B2
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`
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`
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`
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`
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`B2
`B2
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`7,530,955
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`7,606,606
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`7,729,733
`7,734,320
`7,761,127
`7,761,128
`7,764,982
`D621,516
`7,791,155
`7,801,581
`7,822,452
`RE41,912
`7,844,313
`7,844,314
`7,844,315
`7,865,222
`7,873,497
`7,880,606
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`7,891,355
`7,894,868
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`7,904,132
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`8,036,728
`8,046,040
`8,046,041
`8,046,042
`8,048,040
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`8,118,620
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`8,130,105
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`8,150,487
`8,175,672
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`
`4
`
`
`
`US 8,577,431 B2
`Page 5
`
`(56)
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`
` Per-
`
`* cited by examiner
`
`5
`
`
`
`U.S. Patent
`
`Nov.5, 2013
`
`Sheet 1 of 43
`
`US 8,577,431 B2
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`Nov. 5, 2013
`
`Sheet 2 of 43
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`US 8,577,431 B2
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`SENSOR 201a
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`FIG. 2A
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`7
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`
`U.S. Patent
`
`Nov.5, 2013
`
`Sheet 3 of 43
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`US 8,577,431 B2
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`Nov. 5, 2013
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`Sheet 4 of 43
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`US 8,577,431 B2
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`200C
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`FIG. 2C
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`9
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`
`U.S. Patent
`
`Nov. 5, 2013
`
`Sheet 5 of 43
`
`US 8,577,431 B2
`
`\
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`
`210d
`
`ETHERNET PORT
`(OPTIONAL)
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`
`U.S. Patent
`
`Nov.5, 2013
`
`Sheet 6 of 43
`
`US 8,577,431 B2
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`13
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`U.S. Patent
`
`Nov. 5, 2013
`
`Sheet 9 of 43
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`US 8,577,431 B2
`
`
`
`FIG. 3D
`
`14
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`
`
`U.S. Patent
`
`Nov.5, 2013
`
`Sheet 10 of 43
`
`US 8,577,431 B2
`
`DETECTOR
`SHELL
`306b
`
`FIG. 3E
`
`15
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`
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`
`U.S. Patent
`
`Nov. 5, 2013
`
`Sheet 11 of 43
`
`US 8,577,431 B2
`
` 306f
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`FIG.3F
`
`16
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`
`U.S. Patent
`
`Nov. 5, 2013
`
`Sheet 12 of 43
`
`US 8,577,431 B2
`
`
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`
`420
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`17
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`U.S. Patent
`
`Nov. 5, 2013
`
`Sheet 13 of 43
`
`US 8,577,431 B2
`
`CO—
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` 900nm
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`
`FIG.5
`
`WAVELENGTH
`
`18
`
`
`
`U.S. Patent
`
`Nov. 5, 2013
`
`Sheet 14 of 43
`
`US 8,577,431 B2
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`605
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`
`U.S. Patent
`
`Nov. 5, 2013
`
`Sheet 15 of 43
`
`US 8,577,431 B2
`
`
`
`FIG.6E
`
`20
`
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`
`U.S. Patent
`
`Nov. 5, 2013
`
`Sheet 16 of 43
`
`US 8,577,431 B2
`
`701A
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`107
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`FIG. 7A
`
`21
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`
`U.S. Patent
`
`Nov. 5, 2013
`
`Sheet 17 of 43
`
`US 8,577,431 B2
`
`7018
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`FIG. 7B
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`22
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`U.S. Patent
`
`Nov. 5, 2013
`
`Sheet 18 of 43
`
`US 8,577,431 B2
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`Nov.5, 2013
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`Sheet 19 of 43
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`US 8,577,431 B2
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`Nov.5, 2013
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`Sheet 21 of 43
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`US 8,577,431 B2
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`
`Nov. 5, 2013
`
`Sheet 22 of 43
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`US 8,577,431 B2
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`EMITTER 1104
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`27
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`U.S. Patent
`
`Nov. 5, 2013
`
`Sheet 23 of 43
`
`US 8,577,431 B2
`
`DETECTOR;
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`
`28
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`
`U.S. Patent
`
`Nov. 5, 2013
`
`Sheet 24 of 43
`
`US 8,577,431 B2
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`EMITTER (POINT SOURCE)
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`29
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`
`U.S. Patent
`
`Nov. 5, 2013
`
`Sheet 25 of 43
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`US 8,577,431 B2
`
`
`
`FIG. 14A
`
`30
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`
`U.S. Patent
`
`Nov. 5, 2013
`
`Sheet 26 of 43
`
`US 8,577,431 B2
`
`FROM EMITTERS
`
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`
`31
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`
`U.S. Patent
`
`Nov. 5, 2013
`
`Sheet 27 of 43
`
`US 8,577,431 B2
`
`1410¢
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`FIG. 14C
`
`32
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`
`U.S. Patent
`
`Nov.5, 2013
`
`Sheet 28 of 43
`
`US 8,577,431 B2
`
`605b
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`33
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`US 8,577,431 B2
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`1
`NOISE SHIELDING FOR A NONINVASIVE
`DEVICE
`
`RELATED APPLICATIONS
`
`This application claims the benefit of priority under 35
`US.C. §119(e) of the following U.S. Provisional Patent
`Applications:
`
`2
`light detector. For example, noninvasive sensors often include
`a clothespin-shaped housing that includes a contoured bed
`conforming generally to the shape of a finger. The contoured
`bed positions the finger for measurement and attempts to
`stabilize it.
`
`Unfortunately, this type of contour cannotbe ideal, espe-
`cially for measuring blood constituents like glucose.
`
`Multi-Stream Data Collection System For
`Non-Invasive Measurement of Glucose
`and Other Analytes
`Multi-Stream Sensor Front Ends for
`Noninvasive Measurement of Glucose
`and Other Analytes
`Multi-Stream Detector For Noninvasive
`Measurement Of Glucose And Other
`Analytes
`Multi-Stream Emitter For Noninvasive
`Measurement Of Glucose And Other
`Analytes
`Noise Shielding For A Non-Invasive
`Device
`Contoured Protrusion for Improving
`Pp
`UM.007
`
`61/078,207—Jul. 3, 2008 Spectroscopic Measurement of Blood
`Constituents
`UM.O011
`Sensor For Improving Measurement Of
`Blood Constituents
`
`Attorney Docket
`Pp
`UM.002PR
`
`M
`
`
`
`
`
`UM.003
`
`UM.004.
`
`UM.005
`
`UM.006
`
`
`
`Pp
`
`Pp
`
`Pp
`
`Pp
`
`Pp
`
`
`
`App. No.
`
`Filing
`Date
`
`Title
`
`
`
`61/086,060
`
`61/086,108
`
`61/086,063
`
`61/086,057
`
`61/078,228
`
`61/091,732
`
`Aug. 4, 2008
`
`Aug. 4, 2008
`
`Aug. 4, 2008
`
`Aug. 4, 2008
`
`Jul. 3, 2008
`
`Aug. 25,2008
`
`This application also claimsthe benefit ofpriority under 35
`USS.C. §120 as a continuation-in-part of the following U.S.
`Design Patent Applications:
`
`App. No.
`
`Filing
`Date
`
`Title
`
`Attorney Docket
`
`29/323 409
`
`Aug. 25,2008
`
`29/323 ,408
`
`Aug. 25,2008
`
`Patient Monitoring MLHUM.009DA
`Sensor
`Patient Monitor
`
`MLHUM.010DA
`
`30
`
`35
`
`40
`
`The foregoing applications are hereby incorporatedbyref-
`erence in their entirety.
`
`45
`
`BACKGROUND
`
`50
`
`SUMMARY
`
`This disclosure describes embodiments of noninvasive
`
`methods, devices, and systems for measuring a blood analyte,
`such as oxygen, carbon monoxide, methemoglobin,
`total
`hemoglobin, glucose, proteins, glucose, lipids, a percentage
`thereof(e.g., saturation) or for measuring many other physi-
`ologically relevant patient characteristics. These characteris-
`tics can relate, for example, to pulse rate, hydration, trending
`information and analysis, and the like. In certain embodi-
`ments, a noninvasive sensor interfaces with tissue at a mea-
`surementsite and deformsthe tissue in a way that increases
`signal gain in certain desired wavelengths. In an embodiment,
`a protrusion can be provided in a finger bed of a noninvasive
`sensorfor a patient’s finger. The protrusion can reducetissue
`thickness, thereby sometimes increasing signal gain by tens
`of times or even more. This protrusion can include different
`sizes and shapes depending onthe tissue site and the desired
`blood analyte to be measured.
`In disclosed embodiments, the protrusion is employed in
`noninvasive sensorsto assist in measuring and detecting vari-
`ous analytes. The disclosed noninvasive sensor can also
`include, among other things, emitters and detectors posi-
`tioned to produce multi-stream sensor information. The non-
`invasive sensor can have different architectures and can
`
`The standard of care in caregiver environments includes
`patient monitoring through spectroscopic analysis using, for
`example, a pulse oximeter. Devices capable of spectroscopic
`analysis generally include a light source(s) transmitting opti-
`cal radiation intoor reflecting offa measurementsite, such as,
`body tissue carrying pulsing blood. After attenuation bytis-
`sue and fluids of the measurement site, a photodetection
`include or be coupled to other components, such as a display
`device(s) detects the attenuated light and outputs a detector
`device, a network interface, and the like. The protrusion can
`signal(s) responsive to the detected attenuatedlight. A signal
`be employedin any type of noninvasive sensor.
`processing device(s) process the detector(s) signal (s) and out-
`In certain embodiments, a noninvasive physiological sen-
`puts a measurementindicative of a blood constituentof inter-
`sor for measuring one or more physiological parameters of a
`est, such as glucose, oxygen, met hemoglobin, total hemo-
`medical patient can include a bump interposed between a
`globin, other physiological parameters, or other data or
`light source and a photodetector. The bump can be placed in
`combinationsof data useful in determiningastate or trend of
`contact with body tissue of a patient and thereby reduce a
`65
`wellness of a patient.
`thickness ofthe bodytissue. As a result, an optical pathlength
`In noninvasive devices and methods, a sensor is often
`between the light source and the photodetector can be
`reduced. In addition, the sensor can include a heat sink that
`adapted to position a finger proximate the light source and
`
`49
`
`49
`
`
`
`US 8,577,431 B2
`
`4
`FIG.11 illustrates a block diagram of some of the compo-
`nents that may include an embodimentof a sensor, according
`to an embodimentof the disclosure;
`FIG. 12 illustrates an example detector portion that may be
`employed in an embodiment of a sensor, according to an
`embodimentofthe disclosure;
`FIG. 13 illustrates an example multi-stream operation of
`the system of FIG. 1, according to an embodiment of the
`disclosure;
`FIG. 14A illustrates another example detector portion hav-
`ing a partially cylindrical protrusion that can be employedin
`an embodimentof a sensor, according to an embodiment of
`the disclosure;
`FIG. 14B depicts a front elevation view of the partially
`cylindrical protrusion of FIG. 14A;
`FIGS. 14C through 14E illustrate embodiments of a detec-
`tor submount;
`FIGS. 14F through 14Hillustrate embodimentof portions
`of a detector shell;
`FIG.14] illustrates a cutaway view of an embodimentof a
`sensor;
`FIGS. 15A through 15F illustrate embodiments of sensors
`that include heat sink features;
`FIGS. 15G and 15Hillustrate embodiments of connector
`
`features that can be used with any of the sensors described
`herein;
`FIGS. 16A and 16B illustrate embodiments of disposable
`optical sensors; and
`FIG. 17 illustrates an exploded view of certain components
`of an example sensor.
`
`DETAILED DESCRIPTION
`
`The present disclosure generally relates to non-invasive
`medical devices. In an embodiment, a physiological sensor
`includesa detector housing that can be coupled to a measure-
`mentsite, such as a patient’s finger. The sensor housing can
`include a curved bed that can generally conform to the shape
`of the measurementsite. In addition, the curved bed can
`include a protrusion shaped to increase an amount oflight
`radiation from the measurementsite. In an embodiment, the
`protrusion is