`a2) Patent Application Publication 10) Pub. No.: US 2008/0242958 Al
`
` ALAliet al. (43) Pub. Date: Oct. 2, 2008
`
`
`US 20080242958A1
`
`(54) MULTIPLE WAVELENGTH OPTICAL
`SENSOR
`
`filed on Apr. 14, 2007, provisional application No.
`61/033,007, filed on Mar. 2, 2008.
`
`(76)
`
`Inventors:
`
`AmmarAI-Ali, Tustin, CA (US);
`MohamedK.Diab, Ladera Ranch,
`CA (US); Arun Panch, Mission
`Viejo, CA (US); Yassir
`-
`:
`Abdul-Hafiz, Irvine, CA (US);
`eumMUS) Costa
`
`Publication Classification
`
`51)
`
`(
`Int. Cl.
`(2006.01)
`AGIB 5/00
`(52) US. C0. cieeccccsseesessesssssssseesessssssees 600/323; 600/310
`
`Correspondence Address:
`KNOBBE MARTENS OLSON & BEAR LLP
`2040 MAIN STREET, FOURTEENTH FLOOR
`IRVINE, CA 92614 (US)
`.
`Appl. No.:
`12/056,179
`Appl.
`No
`,
`Filed:
`Mar.26, 2008
`
`21)
`(21)
`(22)
`
`Related U.S. Application Data
`
`(60) Provisional application No. 60/920,474,filed on Mar.
`27, 2007, provisional application No. 60/923,630,
`
`ABSTRACT
`67)
`A multiple wavelength optical sensor has an emitter config-
`ured to radiate light having a plurality of wavelengths into a
`tissue site. The emitter comprises a plurality of LEDs config-
`ured in an array and connected within an electrical grid. A
`detector is configured to receivethe light after absorption by
`pulsatile blood flow within the tissue site. The detector gen-
`erates a sensor signal capable of being processed by a patient
`monitor so as to derive oxygen saturation, carboxyhemoglo-
`bin, methemoglobin andtotal hemoglobin.
`
` 1
`
`100 Yy
`
`110
`
`APPLE 1030
`
`1
`
`APPLE 1030
`
`
`
`Patent Application Publication
`
`Oct. 2, 2008 Sheet 1 of 32
`
`US 2008/0242958 Al
`
`2
`
`
`
`Patent Application Publication
`
`Oct. 2, 2008 Sheet 2 of 32
`
`US 2008/0242958 Al
`
`08¢
`
`LNANNYLSNILSOH
`
`NN
`
` OLGYOLINOWLNAlLWd
`YyOSssAo00dd
`
`OG¢GYVOEYOSSs00ud
`oO
`
`oll9S¢
`
`Jaauq
`
`Bidsiq
`
`olpny,
`
`C82
`
`QN3-LNOug
`
`TWWNOIS
`
`{i
`
`'
`
`oUlA
`
`SSZvse
`
`
`
`YaqvsayAXOWSA
`
`
`
`3
`
`
`
`
`
`
`
`
`Patent Application Publication
`
`Oct. 2, 2008 Sheet 3 of 32
`
`US 2008/0242958 Al
`
`t 300
`
`3710
`
`MONITOR
`
`MULTIPLE WAVELENGTH OPTICAL SENSOR
`
`320
`
`
`340
`
` EMITTER
`
`
`
` DETECTOR
`ASSEMBLY
`
`
`SENSOR
`
`
`ASSEMBLY
`
`CONTROLLER ATTACHMENT
`ASSEMBLY
`
`FIG. 3
`
`4
`
`
`
`Patent Application Publication
`
`Oct. 2, 2008 Sheet 4 of 32
`
`US 2008/0242958 Al
`
`400
` EMITTER ASSEMBLY
`
` 410
`
` BULK TEMP
`
`
`
`
`
`
`
`SUBSTRATE
`
`i
`
`EMITTER
`ARRAY
`
`EQUALIZATION
`
`
`
`DIFFUSION
`
`442
`
`MULTIPLE WAVELENGTH LIGHT
`
`FIG. 4
`
`5
`
`
`
`Patent Application Publication
`
`Oct. 2, 2008 Sheet 5 of 32
`
`US 2008/0242958 Al
`
`500
`
`DETECTOR ASSEMBLY
`
`510
`
`DETECTOR(S)
`
`SUBSTRATE
`
`|
`
`LIGHT AFTER
`TISSUE ABSORPTION
`
`FIG. 5
`
`6
`
`
`
`Patent Application Publication
`
`Oct. 2, 2008 Sheet 6 of 32
`
`US 2008/0242958 Al
`
`COLUMN
`ADDRESS
`
`690
`
`
`
`COLUMN|COLUMNDRIVERS|
`yo
`
`ARRAY
`EMITTER
`
`sy
`
`
`
`
`620
`614
`
`612
`
`|
`
`|
`
`670
`CellePtLE
`> ROWDRIVERS
`
`
`ROW
`ADDRESS
`
`ft
`
`
`FIG. 6
`
`7
`
`
`
`Patent Application Publication
`
`Oct. 2, 2008 Sheet 7 of 32
`
`US 2008/0242958 Al
`
`t700
`
`FIG.7
`
`SUBSTRATE
`
`8
`
`
`
`Patent Application Publication
`
`Oct. 2, 2008 Sheet 8 of 32
`
`YOLOaLAG
`
`008
`
`
`
`ALVYELSEANSLINDYID
`
`YALL
`
`LNNOW
`
`US 2008/0242958 Al
`
`8Oils
`
`YOLOANNOD
`
`YALLIWA
`
`028
`
`ASSV
`
`ASSV
`
`098
`
`0S8
`
`9
`
`
`
`Patent Application Publication
`
`Oct. 2, 2008 Sheet 9 of 32
`
`US 2008/0242958 Al
`
`
`
`10
`
`
`
`Patent Application Publication
`
`US 2008/0242958 Al
`
`Oct. 2, 2008 Sheet 10 of 32
`
`FIG.10
`
`11
`
`11
`
`
`
`Patent Application Publication
`
`Oct. 2, 2008 Sheet 11 of 32
`
`US 2008/0242958 Al
`
` FIG.
`11A a
`
`wo—
`—
`
`12
`
`
`
`Patent Application Publication
`
`Oct. 2, 2008 Sheet 12 of 32
`
`US 2008/0242958 Al
`
`1120 1150
`
`FIG.11B
`
`13
`
`13
`
`
`
`Patent Application Publication
`
`Oct. 2, 2008 Sheet 13 of 32
`
`US 2008/0242958 Al
`
`CLoLCLcl
`
`rIZLVLCL
`Ocl“SlsdolOls EbcL
`
`O8Zl
`
`(wk)CP
`
`mh
`
`LLol
`
`VolOld
`
`14
`
`
`
`
`Patent Application Publication
`
`Oct. 2, 2008 Sheet 14 of 32
`
`US 2008/0242958 Al
`
`FIG.13 So
`
`*o
`
`D—
`
`t1300
`
`15
`
`
`
`Patent Application Publication
`
`Oct. 2, 2008 Sheet 15 of 32
`
`US 2008/0242958 Al
`
`FIG.14B
`
`
`
`FIG.14A
`
`1110
`
`t1400
`t1400
`
`1430
`
`1432
`
`16
`
`
`
`Patent Application Publication
`
`Oct. 2, 2008 Sheet 16 of 32
`
`US 2008/0242958 Al
`
`
`
`FIG. 14C
`
`1430
`
`1436
`
`1410
`
`
`
`1420
`
`FIG. 14D
`
`17
`
`
`
`Patent Application Publication
`
`Oct. 2, 2008 Sheet 17 of 32
`
`US 2008/0242958 Al
`
`VSlSls
`
`eLGL
`
`18
`
`18
`
`
`
`Patent Application Publication
`
`Oct. 2, 2008 Sheet 18 of 32
`
`US 2008/0242958 Al
`
`tL1500
`
`FIG.15B
`
`N_
`LO—
`
`19
`
`19
`
`
`
`Patent Application Publication
`
`Oct. 2, 2008 Sheet 19 of 32
`
`US 2008/0242958 Al
`
`LOSl
`
`H9L“DI4591‘SIs491DI4
`
`
`
`A9l“Sls
`
`8-@NOLLOAS
`
`Ni
`
`
`
`WANSwwAN
`SNS
`aNEES
`SS
`OL91
`0991
`
`NN
`“A
`RN
`
`.
`
`Z0S|Z0S1ZOSL
`
`
`00S!J00stJ00s!JO09!“Oldg9l“Ola
`
`
`
`
`
`WVNOLLOAS
`
`00s)>
`
`ga
`
`20
`
`(7A0991
`
`SESSSSS
`Ret
`. SS y
`
`NSWs
`
`OL91
`
`20
`
`
`
`
`
`
`
`
`
`
`Patent Application Publication
`
`Oct. 2, 2008 Sheet 20 of 32
`
`US 2008/0242958 Al
`
`17A
`
`FIG.
`
`21
`
`21
`
`
`
`Patent Application Publication
`
`Oct. 2, 2008 Sheet 21 of 32
`
`US 2008/0242958 Al
`
`t1700
`
`©=
`y_
`
`FIG.17B
`
`22
`
`22
`
`
`
`Patent Application Publication
`
`Oct. 2, 2008 Sheet 22 of 32
`
`US 2008/0242958 Al
`
`LOZL
`
`OLAL
`
`OOZI
`
`>LOZ)
`oss.+WyWLoLOAL
`
`OOLL
`
`LOL
`
`
`
`ag!‘Old
`
`8!“Old
`slOls
`
`4ove:Ley
`
`08
`
`@-GNOILOAS
`
`WAOZ8L
`
`
`
`H8l‘Sls
`
`VY8lSls
`
`A8l‘Sls
`
`
`
`A8l“Sis
`
`cor
`
`cOLL
`
`OLLL
`
`oor?
`
`oa
`co
`ce-
`cabanaSe
`+
`aed
`Lene,1
`SsKS
`TSGNetSAY
`WSs
`*.
`aS
`SSSASSNSU
`O81
`
`
`
`a-5NOILOZS
`
`COLL
`
`OOZL
`
`odZOLL
`
`OLAL
`
`23
`
`23
`
`
`
`
`
`
`
`
`
`
`Patent Application Publication
`
`Oct. 2, 2008 Sheet 23 of 32
`
`US 2008/0242958 Al
`
`OOLL
`
`ove,
`
`V6lSls
`
`
`
`d6l‘Sls
`
`24
`
`24
`
`
`
`
`
`Patent Application Publication
`
`Oct. 2, 2008 Sheet 24 of 32
`
`US 2008/0242958 Al
`
`dO0cDis
`
`VOeSis
`
`25
`
`25
`
`
`
`Patent Application Publication
`
`Oct. 2, 2008 Sheet 25 of 32
`
`US 2008/0242958 Al
`
`2101
`
`2120
`
`2120
`FIG.21B
` FIG.21A
`
`
`2130
`
`2102
`
`26
`
`26
`
`
`
`Patent Application Publication
`
`Oct. 2, 2008 Sheet 26 of 32
`
`US 2008/0242958 Al
`
`
`
`FIG, 22
`
`27
`
`27
`
`
`
`Patent Application Publication
`
`Oct. 2, 2008 Sheet 27 of 32
`
`US 2008/0242958 Al
`
`FIG.23D
`
`FIG.23C
`
`2310
`
`2200
`
`FIG.23B
`FIG.23A
`
`28
`
`
`
`Patent Application Publication
`
`Oct. 2, 2008 Sheet 28 of 32
`
`US 2008/0242958 Al
`
`doveJ00rveJ
`
`Ocre
`
`Ocr2
`
`002
`
`OLve
`
`0022
`
`Ocrv~e
`
`0022
`
`29
`
`dveSlsOveDis
`
`dveVis
`
`VveDls
`
`29
`
`
`
`
`Patent Application Publication
`
`Oct. 2, 2008 Sheet 29 of 32
`
`US 2008/0242958 Al
`
`2501
`
`2580tC2502
`
`SO2500
`
`2550
`
`30
`
`30
`
`
`
`Patent Application Publication
`
`Oct. 2, 2008 Sheet 30 of 32
`
`US 2008/0242958 Al
`
`L0Sz
`
`y08gz
`
`0952
`
`49¢Sls
`SEOvse
`
`LOSZLOS2
`Q9¢Dis09¢‘Dis
`SS"
`DIOBS_posse
`SEOFS?
`
`H9<e‘Dis
`SSOLS¢
`VDI¢Ols
`d9eSls
`
`l9¢‘Sls
`
`COGSJ
`
`COSCJ
`
`c0SZ.t+
`
`COSC
`
`VN
`
`
`
`A9¢‘Olas
`
`°o
`
`wW\™
`
`31
`
`31
`
`
`
`
`Patent Application Publication
`
`Oct. 2, 2008 Sheet 31 of 32
`
`US 2008/0242958 Al
`
`deDls QZe
`
`OLeSIs
`
`‘Sis
`
`32
`
`32
`
`
`
`
`Patent Application Publication
`
`Oct. 2, 2008 Sheet 32 of 32
`
`US 2008/0242958 Al
`
`2087Lsovasiez
`
`
`aanLNSYYNSzigzSTHLNaYNS
`
`LogeYYZz9z8182
`
`
`ZS3q0OHIV)|Peasy]LNSeand¢INNOAGOHLVYS
`
`CaCOHIVO|SUSAO[eTssr7)=XNWesovd| sova
`
`
`
`Taq0HIvo,LLasi2sovGyi0982y$s
`PACOHLVO|aab
`
`v|yoLoataszNOCONVSGONV|¥SLSIOaY9iezLOSTAS
`
`MALINTasaydal
`cy9zVis=vr
`008z£08Z
`
`
`ore?pvivdova
`
`88S
`
`ph9z
`
`oL8z
`
`wvaus|o
`
`osez
`
`ZS9Z
`
`psovd
`
`NOSGOHLVO
`
`33
`
`33
`
`
`
`
`
`US 2008/0242958 Al
`
`Oct. 2, 2008
`
`MULTIPLE WAVELENGTH OPTICAL
`SENSOR
`
`PRIORITY CLAIM TO RELATED PROVISIONAL
`APPLICATIONS
`
`[0001] The present application claims priority benefit
`under 35 U.S.C. § 119(e) to U.S. Provisional Patent Applica-
`tion Ser. No. 60/920,474, filed Mar. 27, 2007, titled Dispos-
`able Multiple Wavelength Optical Sensor, No. 60/923,630,
`filed Apr. 14, 2007, titled Disposable Multiple Wavelength
`Optical Sensor, and No. 61/033,007, filed Mar. 2, 2008, titled
`Multiple Wavelength Optical Sensor. All of the above-refer-
`enced applications are hereby incorporated by reference
`herein.
`
`INCORPORATION BY REFERENCE OF
`COPENDING RELATED CASES
`
`[0002] The present disclosure is generally related to U.S.
`Provisional Application Ser. No. 60/998,659, filed Oct. 12,
`2007,
`titled Ceramic Emitter Substrate; U.S. Provisional
`Application Ser. No. 60/979,658, filed Oct. 12, 2007,titled
`Ceramic Detectors; U.S. Provisional Application Ser. No.
`60/979 ,674, filed Oct. 12, 2007, titled Connector Assembly;
`U.S. Design Patent Application Ser. No. 29/296,064, filed
`Oct. 12, 2007, titled ConnectorAssembly; U.S. Design Patent
`Application Ser. No. 29/296,067, filed Oct. 12, 2007,titled
`Connector Assembly; U.S. Provisional Application Ser. No.
`61/
`, filed Feb. 29, 2008,titled Connector Assembly;
`and U.S. Design Patent Application Ser. No. 29/
`, filed
`Feb. 29, 2008, titled Connector. All of the above-referenced
`applications are hereby incorporated by reference herein.
`
`BACKGROUND OF THE INVENTION
`
`Pulse oximetry systems for measuring constituents
`[0003]
`of circulating blood have gained rapid acceptance in a wide
`variety of medical applications including surgical wards,
`intensive care and neonatal units, general wards, homecare,
`physical training, and virtually all types of monitoring sce-
`narios. A pulse oximetry system generally includes an optical
`sensor applied to a patient, a monitor for processing sensor
`signals and displaying results anda patient cable electrically
`interconnecting the sensor and the monitor. A pulse oximetry
`sensor has light emitting diodes (LEDs), typically one emit-
`ting a red wavelength and one emitting an infrared (IR) wave-
`length, and a photodiode detector. The emitters and detector
`are attached to a patient tissue site, such as a finger. The
`patient cable transmits drive signals to these emitters from the
`monitor, and the emitters respond to the drive signals to
`transmit light into the tissue site. The detector generates a
`signal responsive to the emitted light after attenuation by
`pulsatile blood flow within the tissue site. The patient cable
`transmits the detector signal to the monitor, which processes
`the signal to provide a numerical readout of physiological
`parameters such as oxygen saturation (SpO,) and pulse rate.
`Advanced physiological monitoring systemsutilize multiple
`wavelength sensors and multiple parameter monitors to pro-
`vide enhanced measurement capabilities including,
`for
`example, the measurement of carboxyhemoglobin (HbCO),
`methemoglobin (HbMet) and total hemoglobin (Hbt).
`[0004]
`Pulse oximeters capable of reading through motion
`inducednoise are disclosed in at least U.S. Pat. Nos. 6,770,
`028, 6,658,276, 6,650,917, 6,157,850, 6,002,952, 5,769,785,
`and 5,758,644; low noise pulse oximetry sensors are dis-
`
`closedin at least U.S. Pat. Nos. 6,088,607 and 5,782,757; all
`of which are assigned to Masimo Corporation,Irvine, Calif.
`(“Masimo’”’) and are incorporated by reference herein.
`[0005]
`Physiological monitors and corresponding multiple
`wavelength optical sensors are described in at least U.S.
`patent application Ser. No. 11/367,013, filed Mar. 1, 2006 and
`titled Multiple Wavelength Sensor Emitters and U.S. patent
`application Ser. No. 11/366,208, filed Mar. 1, 2006 andtitled
`Noninvasive Multi-Parameter Patient Monitor, both assigned
`to Masimo Laboratories, Irvine, Calif. (Masimo Labs) and
`both incorporated by reference herein.
`[0006]
`Further, physiological monitoring systems that
`include low noise optical sensors and pulse oximetry moni-
`tors, such as any of LNOP® adhesive or reusable sensors,
`SofTouch™sensors, Hi-Fi Trauma™ or Blue™sensors; and
`any of Radical®, SatShare™, Rad-9™, Rad-5™, Rad-5v™
`or PPO+™ Masimo SET® pulse oximeters, are all available
`from Masimo. Physiological monitoring systems including
`multiple wavelength sensors and corresponding noninvasive
`blood parameter monitors, such as Rainbow™adhesive and
`reusable sensors and RAD-57™and Radical-7™ monitors
`
`for measuring SpO,, pulse rate, perfusion index, signal qual-
`ity, HbCO and HbMet amongother parametersare also avail-
`able from Masimo.
`
`SUMMARY OF THE INVENTION
`
`[0007] There is a need to noninvasively measure multiple
`physiological parameters, other than, or in addition to, oxy-
`gen saturation and pulse rate. For example, hemoglobin
`parameters that are also significant are total hemoglobin
`(Hbt) and the percentage of carboxyhemoglobin and meth-
`emoglobin. Other blood parameters that may be amenable to
`noninvasive optical sensor measurementare fractional oxy-
`gen saturation, bilirubin and blood glucose, to namea few.
`[0008] One aspect of a physiological sensor is an emitter
`that emits light having a plurality of wavelengths. A detector
`generates an output signal responsive to the emitted light after
`absorption by tissue. An attachment assembly removably
`attaches the emitter and the detector to tissue. A spacer pro-
`vides a predetermined gap between the emitter and tissue
`when the emitter is attached to tissue. A light scattering
`medium is disposed in a optical path between the emitter and
`tissue. The spacer and the light scattering medium provide at
`least a substantially uniform illumination of tissue by the
`emitted light for each of the wavelengths. In various embodi-
`ments, the light scattering medium comprises glass beads
`mixed with an encapsulant disposed proximate the spacer.
`The light scattering medium comprises microspheres mixed
`with an epoxy disposed proximate the emitter. The emitter
`comprises an array of at least eight light emitting diodes
`emitting light generally centered around eight unique wave-
`lengths. The emitter comprises an array of at least thirteen
`light emitting diodes emittinglight generally centered around
`at least twelve unique wavelengths. The detector comprises at
`least one Si photodiode andat least one InGaAs photodiode
`connected in parallel. The detector comprises two Si photo-
`diodes and four InGaAs photodiodes all connectedin parallel.
`The light emitting diodes emit light within a first range of
`about 620-905 nm and within a second range of about 1040-
`1270 nm.
`
`[0009] Another aspect of a physiological sensor compris-
`ing an emitter configuredto radiate light having a plurality of
`wavelengths into a tissue site. The emitter comprises a plu-
`rality of LEDs disposed within an emitter ceramic substrate.
`34
`
`34
`
`
`
`US 2008/0242958 Al
`
`Oct. 2, 2008
`
`A detector is configured to receive the light after absorption
`by pulsatile blood flow within the tissue site. The detector
`generates a sensor signal capable of being processed by a
`patient monitor so as to derive total hemoglobin (Hbt). The
`detector comprises a plurality ofphotodiodes disposed within
`a detector ceramic substrate. A first set of the photodiodes is
`responsive to a first set of the wavelengths and a secondset of
`the photodiodes is responsive to a second set of the wave-
`lengths. In various embodiments a diffuser scatters the radi-
`atedlight so thata tissue site is uniformly illuminated across
`all of the wavelengths. A first encapsulate containing glass
`beads is mounted in a spacer proximate the emitter ceramic
`substrate. A second encapsulate mixed with microspheresis
`disposed on the LEDs within the emitter ceramic substrate.
`The photodiodes comprise at least one Si photodiode andat
`least one InGaAs photodiode connected in parallel. The
`LEDsradiate light generally centered aroundat least twelve
`unique wavelengths. The LEDs are mountedin an array of at
`least thirteen LEDs connected within an electrical grid. The
`twelve unique wavelengths comprise eight wavelengths
`within a first range of about 620-905 nm. and four wave-
`lengths within a second range of about 1040-1270 nm.
`[0010] A further aspect ofa physiological sensor comprises
`a light source that radiates light having a plurality of wave-
`lengths, a diffuser that scatters the radiated light so that a
`tissue site is uniformly illuminated acrossall of the wave-
`lengths, and at least one detector that generatesa sensorsignal
`responsiveto the radiated lightafter tissue attenuation. In an
`embodiment, the light source comprises a ceramic substrate
`having conductors arrangedas an electrical grid anda plural-
`ity of LEDs mounted within the ceramic substrate in an array.
`In other embodiments, the diffuser comprises a first encapsu-
`lant having microspheres disposed over the LEDs; and a
`second encapsulant having glass beads disposed proximate
`the ceramic substrate. A spacer is disposed proximate the
`ceramic substrate so as to form a gap between the LEDs and
`the tissue site. A connector connects to a patient cable so as to
`communicate the sensor signal to a monitor. A flexible cou-
`pling has an optical end proximate the light source and the
`detector and a connector end proximate the connector. The
`flexible coupling has conductors that communicate the sensor
`signal from the optical end to the connector end.
`
`BRIEF DESCRIPTION OF THE DRAWINGS
`
`FIG. 11s a perspective view of a physiological mea-
`[0011]
`surement system,
`[0012] FIG.2 isa general block diagram of a physiological
`measurement system;
`[0013] FIG.3 are block diagrams ofa multiple wavelength
`optical sensor and a monitor;
`[0014]
`FIG. 4 is a general block diagram of an emitter
`assembly;
`[0015]
`FIG. 5 is a general block diagram of a detector
`assembly;
`[0016]
`FIG. 6 is a general block diagram of an emitter
`array;
`FIG. 7 is a block diagram of an emitter component;
`[0017]
`FIG. 8 is a block diagram ofa circuit substrate;
`[0018]
`FIGS. 9A-B are perspective views ofmultiple wave-
`[0019]
`length optical sensor embodiments;
`[0020]
`FIG. 10 is a perspective view of a patient cable and
`corresponding sensor connector;
`[0021]
`FIGS. 11A-B are exploded perspective views of
`multiple wavelength optical sensor embodiments;
`
`FIGS. 12A-C are exploded perspective views of an
`[0022]
`optical assembly;
`[0023]
`FIG. 13 is an exploded perspective view of a contact
`assembly;
`[0024]
`FIGS. 14A4-D are exploded perspective views, and
`perspective and side views, respectively, of a connector
`assembly;
`[0025]
`FIGS. 15A-B are perspective views of emitters;
`[0026]
`FIGS. 16A-H aretop, cross-sectional, side and bot-
`tom views, respectively, of emitter embodiments;
`[0027]
`FIGS. 17A-B are perspective views of a detector
`components;
`[0028]
`FIGS. 18A-H aretop, cross-sectional, side and bot-
`tom views, respectively, of detector components;
`[0029]
`FIGS. 19A-Bare perspective and top views, respec-
`tively, of a detector;
`[0030]
`FIGS. 20A-B are top views of detector component
`embodiments;
`[0031]
`FIGS. 21A-B are perspective views of multiple
`wavelength optical sensor embodiments;
`[0032]
`FIG. 22 is a perspective view of an emitter assem-
`bly;
`FIGS. 23A-Dare bottom,side, top and perspective
`[0033]
`views of an emitter assembly;
`[0034]
`FIGS. 24A-D are views of an encapsulated emitter
`assembly;
`[0035]
`FIG. 25 is an exploded, perspective view of an opti-
`cal assembly;
`[0036]
`FIGS. 26A-I are assembly views for an optical
`assembly;
`[0037]
`FIGS. 27A-E are views of a cable connection
`assembly; and
`[0038]
`FIG. 28 is a general block diagram of an emitter
`driver.
`
`DETAILED DESCRIPTION OF THE PREFERRED
`EMBODIMENTS
`
`FIG. 1 illustrates a physiological measurementsys-
`[0039]
`tem 100 having a monitor 110 and a multiple wavelength
`optical sensor 120 with enhanced measurement capabilities
`as compared with conventional pulse oximetry. In particular,
`the multiple wavelength optical sensor 120 allows the mea-
`surement of various blood constituents and related param-
`eters in addition to oxygen saturation and pulse rate. Alterna-
`tively, the multiple wavelength optical sensor 120 allows the
`measurement of oxygen saturation and pulse rate with
`increased accuracy or robustness as compared with conven-
`tional pulse oximetry.
`[0040]
`In one embodiment, the optical sensor 120 is con-
`figured to plug into a monitor sensor port 112 via a patient
`cable 130. Monitor keys 114 provide control over operating
`modes and alarms, to name a few. A display 116 provides
`readouts of measured parameters, such as oxygen saturation,
`pulse rate, HbCO, HbMet and Hbtto namea few. Other blood
`parameters that may be measured to provide importantclini-
`cal information are fractional oxygen saturation, bilirubin
`and blood glucose, to name a few.
`[0041]
`In this application, reference is made to many blood
`parameters. Some references that have common shorthand
`designations are referenced through such shorthand designa-
`tions. For example, as used herein, HbCO designates car-
`boxyhemoglobin, HbMet designates methemoglobin, and
`Hbt designates total hemoglobin. Other shorthand designa-
`tions such as COHb, MetHb, and tHb are also commonin the
`
`35
`
`35
`
`
`
`US 2008/0242958 Al
`
`Oct. 2, 2008
`
`art for these same constituents. These constituents are gener-
`ally reported in terms of a percentage, often referred to as
`saturation, relative concentration or fractional saturation.
`Total hemoglobin is generally reported as a concentration in
`g/dL. The use of the particular shorthand designators pre-
`sented in this application does notrestrict the term to any
`particular manner in which the designated constituent is
`reported.
`FIG.2 illustrates a block diagram a physiological
`[0042]
`measurement system 200. This measurement system includes
`a monitor 210 and an optical sensor 220 communicating via a
`patient cable 230. The monitor 210 has one or more processor
`boards 250 communicating with a host instrument 280. Gen-
`erally, the processor board 250 communicates with the sensor
`220 so as to control the emission of light into a tissue site 10.
`Also the processor board 250 receives and processesa corre-
`sponding sensor signal responsive to the emitted light after
`scattering and absorption by tissue site constituents. Accord-
`ingly, the processor board 250 derives physiological param-
`eters relating to pulsatile blood flow within the tissue site and
`communicates values for those parametersto the host instru-
`ment 280. Generally, the host instrument 280 provides user
`I/O and communications with external devicesso as to define
`
`operating conditions and communicate those conditions to
`the processor board 250. The host instrument 280 also trans-
`fers parameter values from the processor board for display
`and for triggering alarms.
`[0043]
`In an embodiment, the optical sensor 220 includes
`an emitter array 222, at least one detector 224, a temperature
`sensor 226 and a memory 228. The emitter array 222 irradi-
`ates a tissue site 10 with multiple wavelength light. One or
`more detectors 224 detect the light after attenuation by the
`tissue site 10. The temperature sensor 226 is located so as to
`detect the bulk temperature of the emitters within the emitter
`array, so as to accurately determine emitter wavelengths, as
`described below. The memory 228 can include any of a wide
`variety of memory devices known to an artisan from the
`disclosure herein, including an EPROM, an EEPROM,a flash
`memory, a ROM, a non-volatile RAM and a two-terminal
`serial memory device, to name a few, and combinationsofthe
`same. The memory 228 can advantageously store a wide
`variety of sensor-related information, including sensor type,
`manufacturer information, sensor characteristics including
`wavelengths emitted, wavelength correction data, emitter
`drive requirements, demodulation data, calculation mode
`data, calibration data and sensorlife data to name a few. The
`memory can also store software such as scripts and execut-
`able code, encryption information, monitor and algorithm
`upgrade instructions and enabled parameters.
`[0044] Although described herein with respect to various
`disposable sensor embodiments, a sensor may be reusable,
`resposable (partially reusable/partially disposable), adhesive
`or non-adhesive, or a transmittance, reflectance or transflec-
`tance sensor. Further, a sensor may be configured fora variety
`of tissue sites such as a finger, hand, foot, forehead or ear or
`for attachment to multiple tissue sites, including multiple-
`head sensors capable of simultaneous multi-site measure-
`ments.
`
`the processor board 250
`[0045] As shown in FIG. 2,
`includes a front end signal conditioner 252, an analog-to-
`digital (A/D) converter 253, a digital signal processor (DSP)
`258, a memory reader 256, emitter drivers 254 anddigital-to-
`analog (D/A) converters 255. In general, the drivers 254 con-
`vert digital control signals into analog drive signals capable of
`
`activating the emitter array 222. The front-end 252 and A/D
`converter 253 transform composite analog intensity signal(s)
`from light sensitive detector(s) 224 into digital data input to
`the DSP 258. In an embodiment, the DSP 258 is adapted to
`communicate via a reader 256 with one or more information
`elements such as the memory 228.
`[0046] According to an embodiment, the DSP 258 com-
`prises a processing device based on the Super Harvard
`ARChitecture (“SHARC”), such as those commercially
`available from Analog Devices. However, the DSP 258 can
`comprise a wide variety of data and/or signal processors
`capable of executing programsfor determining physiological
`parameters from input data. According to an embodiment, the
`processor board 250 may comprise one or more microcon-
`trollers (not shown) for board management, including, for
`example, communications of calculated parameter data and
`the like to the host instrument 280.
`
`[0047] Also shownin FIG.2, the host instrument 280 com-
`municates with the processor board 250 to receive signals
`indicative of the physiological parameter information calcu-
`lated by the DSP 258. The host instrument 280 preferably
`includes one or more display devices, alarms, user I/O and
`communication ports 284. The alarms may be audible or
`visual indicators or both. The user I/O maybe, as examples,
`keypads, touch screens, pointing devices or voice recognition
`devices. The displays may be indicators, numericsor graphics
`for displaying one or more ofa pulse rate, plethysmograph
`data, signal quality, perfusion index and blood constituents
`values, such as SpO,, carboxyhemoglobin (HbCO), meth-
`emoglobin (HbMet) andtotal hemoglobin (Hbt), or the like.
`The host instrument 280 may also be capable of storing or
`displaying historical or trending data related to one or more of
`the measured values or combinationsof the measured values.
`
`A patient monitor is disclosed in U.S. App. No. 11,367,033,
`filed on Mar. 1, 2006, titled Noninvasive Multi-Parameter
`Patient Monitor, which is assigned to Masimoand incorpo-
`rated by reference herein.
`[0048]
`FIG. 3 illustrates a physiological measurementsys-
`tem 300 having a monitor 310 and a multiple wavelength
`sensor 320. The sensor 320 has an emitter assembly 340, a
`detector assembly 350, an interconnect assembly 360, an
`attachment assembly 370 and a connector assembly 380. The
`monitor 310 has a sensor controller 312 that communicates
`
`with the sensor 320 via a cable 330. As but one example, the
`sensor controller 312 may include emitter drivers, detector
`signal conditioning circuitry, A/D and D/A connectors, and a
`DSPincorporated onto a processor board, such as described
`with respect to FIG. 2, above.
`the emitter assembly 340
`[0049] As shown in FIG. 3,
`respondsto drive signals received from the sensor controller
`312 so as to emit light having a plurality of wavelengths. The
`detector assembly 350 provides a sensor signal to the sensor
`controller 312 in responseto the emitted light after absorption
`by a tissue site. The interconnect assembly 360 mechanically
`mounts the emitter assembly 340 and the detector assembly
`350 and provideselectrical communication between the cable
`330 and these assemblies 340, 350. The attachment assembly
`370 attaches the emitter assembly 340 and detector assembly
`350 to a tissue site. The connector assembly 380 provides a
`mechanical and electrical interface to the connector at one
`
`end of the cable 330. A tape assembly example of an attach-
`ment assembly is described with respect to FIGS. 11A-B,
`below. A contact assembly example of a connector assembly
`is described with respect to FIGS. 13-14, below.
`
`36
`
`36
`
`
`
`US 2008/0242958 Al
`
`Oct. 2, 2008
`
`whereT, is the temperature of a particularlight emitter, I,,,,..
`is the drive currentfor that light emitter and £1,,,,,. is the total
`drive current forall light emitters.
`[0055]
`In yet another embodiment, an operating wave-
`length for each LED is determined by measuring the junction
`voltage for each LED 710. In a further embodiment, the
`temperature of each LED 710 is controlled, such as by one or
`morePeltier cells coupled to each LED 710, and an operating
`wavelength for each LED 710 is determinedas a function of
`the resulting controlled temperature or temperatures. In other
`embodiments, the operating wavelength for each LED 710 is
`determined directly,
`for example by attaching a charge
`coupled device (CCD)to each light emitter or by attaching a
`fiberoptic to each light emitter and couplingthe fiberoptics to
`a wavelength measuring device, to name a few.
`[0056]
`FIG.8 illustrates an interconnect assembly 800 hav-
`ing a circuit substrate 810, an emitter mount 830, a detector
`mount 820 and a connector mount 840. The emitter mount
`830 mounts andelectrically connects to an emitter assembly
`860 having multiple light emitters. The detector mount 820
`mounts andelectrically connects to a detector assembly 850
`having a detector. The connector mount 840 attaches a con-
`nector 870 having conductors that mate with a patient cable
`connector 890. A first plurality of conductors disposed on the
`circuit substrate 810 electrically interconnect the emitter
`mount 830 and the connector 870. A second plurality of
`conductors disposed onthe circuit substrate 810 electrically
`interconnect the detector mount 820 and the connector 870.
`
`FIG.4 illustrates an emitter assembly 400 having a
`[0050]
`substrate 410, an emitter array 420, an equalization 430 anda
`diffusion 440. The emitter array 420 has multiple light emit-
`ting sources, each activated by drive signals 422. The light
`emitting sources are capable of generating light 442 having
`multiple wavelengths. The equalization 430 accounts for dif-
`ferences in emitter intensity and tissue absorptionofthelight
`across the multiple wavelengths so as to at least partially
`equalize wavelength-dependentvariations in intensity at the
`detector. The substrate 410 provides a physical mount for the
`emitter array and emitter-related equalization and an electri-
`cal connection between the emitter array and an interconnect
`assembly, such as described above. Advantageously, the sub-
`strate 410 also maintains a uniform bulk temperature mea-
`surementso as to calculate the operating wavelengths for the
`light emitting sources. One example of an emitter array
`embodiment420 is described with respect to FIG. 6, below.
`One example of equalization 430 is described with respect to
`encapsulants, below. Examples of substrates 410 are
`described with respect to ceramic and board substrates,
`below.
`
`FIG.5 illustrates a detector assembly 500 including
`[0051]
`a substrate 510, detector(s) 520 and an EMIshield 530. The
`substrate 510 acts as a mechanical support for, and provides
`electrical contacts to, the detector(s) 520. In an embodiment,
`the substrate 510 acts as an electrical insulator allowing the
`detector(s) 520 to be electrically isolated from EMIshielding
`530 applied to a detector component. In an embodiment, the
`substrate 510 is a ceramic material.
`
`FIG.6 illustrates an emitter array 600 having mul-
`[0052]
`tiple light emitters (LE) 610 capable of emitting light having
`multiple wavelengths. Row drivers 670 and column drivers
`690 are electrically connected to the light emitters 610 and
`activate one or more light emitters 610 by addressing atleast
`one row 620 andat least one column 640 of anelectrical grid.
`In one embodiment,the light emitters 610 each includea first
`contact 612 and a second contact 614. Thefirst contact 612 of
`a first subset 630 of light emitters is in communication with a
`first conductor 620 of the electrical grid. The second contact
`614 of a second subset 650 of light emitters is in communi-
`cation with a second conductor 640.
`
`FIGS. 9A-Billustrate embodiments of a multiple
`[0057]
`wavelength optical sensor. In particular, illustrated are a dis-
`posable sensor 900 including an adult/pediatric sensor 901
`configured forfinger placement and an infant/neonate sensor
`902 configured for toe, foot or hand placement. Each sensor
`900 has a tape end 910 and an opposite connector end 920
`electrically and mechanically interconnected via a flexible
`coupling 930. The tape end 910 attaches an emitter and detec-
`tor to a tissuesite, as described below. The emitter illuminates
`the tissue site and the detector generates a sensor signal
`responsiveto the light after tissue absorption, such as absorp-
`tion by pulsatle arterial blood flow within thetissue site. The
`sensor signal is communicatedvia the flexible coupling 930
`to the connector end 920. The connector mates with a cable
`FIG.7 illustrates an example of an emitter assembly
`[0053]
`(not shown) that communicates the sensor signal to a monitor
`700 having light emitting diodes 710, a temperature sensor
`(not shown). The monitor calculates a variety of physiologi-
`720 and a substrate 730. The substrate 730 provides a thermal
`cal parameters