throbber
|||||||||||||||||||||||||||||||||||||l||||||||||||||||||||||||||||||||||||||||||||||||l|||
`
`US 20090105556/X1
`
`(19) United States
`(12) Patent Application Publication (10) Pub. No.: US 2009/0105556 A1
`Fricke et al.
`(43) Pub. Date:
`Apr. 23, 2009
`
`(54)
`
`MEASUREMENT OF PHYSI0l.OGl(.‘.-\L
`SIGNALS
`
`(75)
`
`ltwcntorsz
`
`John Robert Frieke. [.exing,toI1.
`MA {US}: Matthew Corbin
`Wiggins. Concord. MA (US)
`
`Corresportdencc Address:
`()CCIIIUTI RUIILICICK & TSAO, LIP
`10 FAWCETT STREET
`(IAMBRIDGE, MA 02138 (US)
`
`(73)
`
`Assigxicez
`
`Tlax I.L(.‘.. Cantbridgc. MA (US)
`
`(21)
`
`Appl , No .:
`
`l2:’2-10,651
`
`(22)
`
`Filed:
`
`Sep. 29., 2008
`
`Related U.S.Applieatien Data
`
`(60)
`
`Provisional application No. 6t)f995_.723. filed on Sep.
`28. 2007.
`
`Publication Classification
`
`(51)
`
`Int. (:1.
`(2006.01)
`A61}? 5/00
`(2006.01)
`A613 5/I455
`(52) U.S.(Il. ....................................... .. 6lJ01'301:6()01'3l0
`
`(57)
`
`ABSTRACT
`
`A system includes an optical sensor and :1 signal processing
`module. The optical sensor is ctmligtlrt-:d to be positioned on
`an area ofskin ofa patient. The optical sensor includes a light
`source for illuminating a capillary bed in the area of skin and
`at photodetector. The pholodetector is conligtlred to receive an
`optical signal front the CElplll:1I‘_\" bed resulting from the illu-
`mination and to convert the optical signal into an electrical
`signal. the optical signal clmmctefizilig a llucluation in a level
`of blood in the capillary bed. The signal processing inodule is
`configured to process the electric signal using a nonstationary
`freque11-::y estimation ntethod to obtain a processed signal
`related to at least one ofa heart rate and at respi1'atitJ11 rate of
`the patient. Another aspect relates to obtaining a quantity
`related to the blood pressure o i‘ the patient i11 addition to or
`instead of obtaining a processed signal related to at least one
`of the heart rate and the respiration rate of the patient.
`
`100
`
`128
`
`
`
`126
`
`124
`
`001
`
`Apple Inc.
`APL1016
`
`U.S. Patent No. 8,923,941
`
`Apple Inc.
`APL1016
`U.S. Patent No. 8,923,941
`
`001
`
`

`
`PatentApplicati0n Publication
`
`Apr. 23, 2009 Sheet 1 of 20
`
`US 2009)'0105556 A1
`
`2:.
`
`mm...
`
`8.
`
`5aM
`_
`¢..i.,,
`
`
`
`m.
`
`«S
`
`33.
`
`33..
`
`mu.
`
`_.m_n_
`
`O02
`
`002
`
`
`
`
`

`
`PatentApplicati0n Publication
`
`Apr. 23, 2009 Sheet 2 of 20
`
`US 2009)'0105556 A1
`
`won
`
`N.m_n_
`
`s:,gun;£.I£'.I1gqJe
`
`O03
`
`003
`
`

`
`PatentApplicati0n Publication
`
`Apr. 23, 2009 Sheet 3 of 20
`
`US 2009)'0105556 A1
`
`‘..
`
`m_E23230
`
`cofiflwEmu
`
`mEmEmam
`
`m:omcmEmEc_
`
`
`
`.m=_n_$mn_-u=mm
`
`53:3.u_
`
`NI3-2.9
`
`
`
`m._.2wEm._am.._o=m.._amom_
`
`m__.._233:0
`
`mEm.Emmw
`
`‘.1
`
`mi25930
`
`
`
`_._oflflwo_mo
`
`mEmEmum
`
`emumum
`
`
`
`o=m._n=._E.__m_w._muuEmhmn_many...tmwi
`
`
`
`
`
`mi9=._n_5O
`
`wEmEmmm
`
`NNMmom
`
`gm259.50
`
`coEfimGEO
`
`mF_oEmmm VNM«E.
`
`mumSn
`
`2;...
`
`
`
`
`
`m:omcmEm_mE_2__u_wmmn_-u_._mm_
`
`E.
`
`>ucm:_um._u_
`
`NImama
`
`_§:maE.;£mE
`
`8»«.9...
`
`8....
`
`m.9“.
`
`004
`
`004
`
`
`
`

`
`PatentApplicati0n Publication
`
`Apr. 23, 2009 Sheet 4 of 20
`
`US 2009)'0105556 A1
`
`005
`
`005
`
`

`
`PatentApplicati0n Publication
`
`Apr. 23, 2009 Sheet 5 of 20
`
`US 2009)'0105556 A1
`
`9.5
`
`Em
`
`
`
`__._o_N__&E_m_._.._§
`
`m.m_.._
`
`006
`
`006
`
`
`

`
`PatentApplicati0n Publication
`
`Apr. 23, 2009 Sheet 6 of 20
`
`US 2009)'0105556 A1
`
`
`
`
`
`__“.o5_._3+u_.n.m__.mEmu:_u.._.m_..uflbutoom..._3.._fiB..ma..
`
`
`
`
`
`
`
`ea:
`
`=8awan
`
`3E:
`
`m.3
`
`007
`
`007
`
`
`

`
`PatentApplicati0n Publication
`
`Apr. 23, 2009 Sheet 7 of 20
`
`US 2009;’0105556 Al
`
`
`
`_:___..a_._9.333..._@_:mE_.u...5..2_._
`
`
`
`
`
`e8
`
`.EN-25n=.tn_._
`
`
`
`fl__.._.._»m._m:wmd.---_..........--
`
`
`
`
`
`AMI3-9.2u_I]1_iI|uV
`
`md.........0
`
`
`
`mtg:fiwmcmmam.
`
`008
`
`Nae
`
`N.3
`
`
`
`
`
`3..5.0.3.8.:._|_
`
`008
`
`
`
`
`
`

`
`PatentApplicati0n Publication
`
`Apr. 23, 2009 Sheet 8 of 20
`
`US 2009)'0105556 A1
`
`
`
`._»n.._w_.&£.u:om__._m._hfi..__E...BE_..o_N__a$m
`
`___«J.__1__
`
`__.g.____q____
`
`9%
`
`3m
`
`009
`
`m.9;
`
`009
`
`

`
`PatentApplication Publication
`
`Apr. 23, 2009 Sheet 9 of 20
`
`US 2009)'0105556 A1
`
`zuzmm._:mmwEEomm2u:_
`
`
`
`.m>:m:mEm>_mm=m>9.:mm
`
`N3.
`
`:>
`
`qsrlwmfiw
`
`
`
`
`
`Aha;wSmmm._n_o_om_o£m._E_
`
`
`
`2353:0om_Emo3:mE:_o>Em:
`
`
`
`Gm:mc__m$m
`
`
`
`Sn:2%.:$_:n_
`
`En:mam3.3.
`
`010
`
`
`
`m.9“.
`
`010
`
`

`
`Patent Application Publication
`
`Apr. 23, 2009 Sheet 10 of 20
`
`US 2009;"010S556 A1
`
`«ca»
`
`ace.
`
`M3mam"EuBum
`
`
`
`3.3$3_w.__m?_2=Egan:
`
`011
`
`E.5
`
`011
`
`
`

`
`PatentApplication Publication
`
`Apr. 23, 2009 Sheet 11 of 20
`
`US 2009;’01055S6 A1
`
`:.m_n_
`
`O12
`
`012
`
`

`
`PatentApplication Publication
`
`Apr. 23, 2009 Sheet 12 of 20
`
`US 2009)'0105556 A1
`
`N
`Q
`S‘.
`
`9
`:1
`U}
`W
`E
`:1
`[J
`
`M
`
`'1
`
`£5,
`BE
`:_Q_
`358
`c:l'_5.9
`33%
`0.2%£L""0-3
`
`c1_$E
`
`
`
`Fig.12
`
`013
`
`013
`
`

`
`Patent Application Publication
`
`Apr. 23, 2009 Sheet 13 of 20
`
`US 2009;"010S556 A1
`
`3.8.3-.H
`
`_...m..m.___.__
`
`hnwcww
`
`
`
`Omm:Em.mmumD_m=cwcoaxm
`
`
`
`_muo5_mocmfimcmm
`
`can.
`
`Emam___n_mo
`
`
`
`3got_8o_m_
`
`,w$9_u:__.s
`
`_mfio_>_
`
`
`
`Boa_m_._m._._<
`
`3mSmwm._n_
`
`014
`
`2.:
`
`3......
`
`2at
`
`014
`
`
`
`
`
`

`
`PatentApplication Publication
`
`Apr. 23, 2009 Sheet 14 of 20
`
`US 2009)'0105556 A1
`
`
`
`
`
`comcuicoou:u._._.m._:mmEn_uoaiucm.__E:£:_uuonL3:_
`
`
`
`
`
`
`
`
`
`.Em_u:.5u__sum_:n__.__.._EmaEm.E.u_ao8E
`
`
`
`
`
`
`
`
`
`_u...mEw.:._maoE..___o=..3umhu>_.._._d>..ou_..__..u....n_-Lou:_
`
`
`
`
`
`
`
`HugoEu._:mamE._=u._u£uu.7...>c_.5u:$um__.._mGn.E|
`
`
`
`
`
`
`
`
`
`a__En£mEaZ.__.u;m_o_._0250...flawE_.P:...»nmEtau;umo__oumam....._._.m...._n..E.u.Eo5mawE
`
`
`
`
`
`
`
`
`
`
`
`wmmhw.5
`
`33m
`
`8.......888.:83San
`III..E25...
`
`
`
`
`
`a.:._mma._n_Ftatw_._nu_295E2:mumEt_._£..._m_u__Sma_nJm1._N92¢Eauuoaafitauv
`
`
`
`
`
`V
`
`I‘)
`
`51uau1aJnsnauJ um pun dpuaa
`JO 31035 DJEPI.-[E13
`
`awcn_.._o..__..__
`
`_m>._ou_.=
`
`L
`
`33¢
`
`5%8!
`
`fig82
`
`
`
`E..m_“_
`
`015
`
`015
`
`
`
`

`
`PatentApplicati0n Publication
`
`Apr. 23, 2009 Sheet 15 of 20
`
`US 2009)'0105556 A1
`
`mam.
`
`wan.
`
`doEm_oH
`
`<91
`
`umo_E.>ouEmu.3
`
`co_..mu_c:EEooI_ommm..,..EnE
`
`
`
`momtmE_Emcmw
`
`
`
`
`
`«E3..3_co:um_ma_s3._on_
`
`many
`
`can‘
`
`mom“
`
`
`
`mmfifimEma
`
`wem3
`
`
`
`Emfimmazw.ms>on_
`
`
`
`EmEmmm:m_....._EsauucmEwumm
`
`
`
`_cb:nDEmumxw
`
`new
`
`
`
`m:_mmmoEn__m:m_m
`
`mo_m:¢
`
`-Eomcmwo._.
`
`Em:o._.
`
`«Fm.
`
`chap
`
`m.omtmE_Em:‘-ucm-EnE-
`
`mom»
`
`2.9“.
`
`016
`
`016
`
`
`
`
`
`
`

`
`Patent Application Publication
`
`Apr. 23, 2009 Sheet 16 of 20
`
`US 2009;"0105556 A1
`
`
`
`
`
`m.«mW_.._O_..~.m.__QmD~u_m_._om:mEEmc_
`
`
`
`Ew:.Gcm:_u2u_
`
`o_§_m_._<
`
`E._&m:m:.
`
`
`
`Luau.mmmorucmm
`
`E5
`
`o_§_.mc<
`
`E._£mcm_._.
`
`
`
`.2__n_mmmq-n..:mm
`
`as
`
`win.
`
`.ooos
`
`ENEtam:
`
`
`
`
`
`m_mE:mm_Ex.§m3o¢
`
`m:omcmEEmE
`
`
`
`
`
`vue.m.m__._n:mao_m>:m__mcm_w
`
`
`
`
`
`flaw.5_§_%mmm:omcm.E£m:_
`
`
`
`2.“emesmmEm:_§§__8¢
`
`9.9.
`
`E2.
`
`u_§_m_._<
`
`E.5.acm.._.
`
`NR2.
`
`
`
`_E__u_mmmn_._u:mm_
`
`E5
`
`83
`
`32
`
`.32
`
`Qmm:o_.m__%om
`
`ma£mE:mm_
`
`m:omcmEEm_.__
`
`
`
`FF:mucwz_um:u_
`
`omzmcq.
`
`::£m:m.F
`
`
`
`_mu__n_mmmaficmm
`
`m_~_._.
`
`82.
`
`fine...
`
`NN9.
`
`Ema:
`
`017
`
`mumEE=mm_
`
`em:
`
`3...:
`
`«,2:
`
`mw_.mgn_
`
`017
`
`
`
`
`
`
`

`
`Patent Application Publication
`
`Apr. 23, 2009 Sheet 17 of 20
`
`US 2009;"0105556 A1
`
`moo..Emu
`
`«:00n_n_
`
`ii!Ilxflmocm?Wm.a
`
`
`
`
`
`
`
`Bmzflmo.mmmE_§m_mn_._mmmE_m._:m_mn__mmm:.__.m.am_mD.mmmE_
`
`mam
`
`8
`
`E2:83«.2:5
`
`
`u2mE_mm_.
`tam:an...2..m>_._mmmbflam=.__:.._m_m_._<xm_aEoOn_n_mL.DgDOwXU_QEOUOF@@_.._..__I—m0
`
`
`
`
`
`
`NIN.O.Q...NI.m.N:m.o..
`
`
`
`
`Mm00QP..,.3L1...<2
`.m.mmE_3:.m:_.c_wan.
`SHEv_Jro_.xm_mn_
`
`
`
`E._Em:m._._.tmn___I
`
`co_EE_xP_an_<
`
`018
`
`9::
`
`Cat
`
`018
`
`
`
`

`
`PatentApplicati0n Publication
`
`Apr. 23, 2009 Sheet 18 of 20
`
`US 2009)'0105556 A1
`
`$2.3.2.
`
`.§mE_mm_9
`
`are.“av.an:
`
`_.
`
`mafia535.
`
`:_Baxtam:
`
`
`
`Emm:o_E.__&mm_n_n_._w_m:<xw_aEoU
`
`NImD.O:D.rNIm.OnmD.D.r
`
`EemcmfiE23
`
`:o=mE_x9_oE¢Emc_._38
`
`SOEmutmwI
`
`
`
`:287.__.Em.Bm§mn_._wm$....__§m_mn_.mmmE_m>m_mn_..mm9:_m>m_m_n_._mmmENNN:5me:
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Omen
`
`8.9“.
`
`O19
`
`019
`
`
`
`

`
`PatentApplicati0n Publication
`
`Apr. 23, 2009 Sheet 19 of 20
`
`US 2009)'0105556 A1
`
`
`
`
`
`
`
` 30Dan.8mxflmnSofia.....xm_mn._wm.m_c.
`
`
`
`
`
`
`
`m___E_mn_3.3.5nzflmo252:.
`
`
`
`SO.95...83Q
`
`
`
`FcBmcm._._..._3_..:
`
`_.5—co:mE_xEnE¢.
`
`
`
`_._.__.__.....__mcm._._.52....
`
`E_:§__x2&¢
`
`MNOH
`
`35.-asI
`:.N_v_qTE.:€_mnamm_c_
`
`
`
`
`
`
`
`
`=a_.e_&umuz_a..,_aao_23_n_...._E__s_..__.._apxkaaoo~mm___Eau2.3_aEouEmueznm.Em
`
`
`
`
`
`
`EmuM:mmmaaa9.“am%a_.am2.3____._3uM:n,~-m.....
`.N:m_.o.mc...:
`
`
`
`
`
`one.‘now5moo.
`
`r...;<....\
`
`one.
`
`
`
`
`
`
`
`chain.umm_._.__QE_wn__...m2,__
`
`m___mr¢
`
`O20
`
`020
`
`
`
`

`
`AmEMP
`
`.m
`
`n.
`
`W3.2.$2.
`
`ow.«mu.mK\r\
`nu._oP:qnEN_oo_.<n_n_Man:
`
`
`
`tN3,..829maA.5H."._H_3:\.E_MFV.Jrw._._zm_on_EmmE_
`
`
`
`
`
`
`xw_n_EooWDm.umE_fim_......D2w_um_a93:39xm_n_EoO9mmE_._mm._
`
`AmzmmNImo.o-o..NI®.o;mD.o...
`co=E_ummmn_n_._m:m>:mn.m_
`9?“Em
`
`
`
`
`
`1“,co_..mE_xo._9..E.mEewcmfit.B__z
`
`002
`
`0
`
`US 2009;"0105556 A1
`
`H2...:
`
`%«:00n_n_
`
`95IiiIMSomE._am897:1mm-
`
`
`
`
`
`
`%Hmime_mamE_§m_m.o$mmE_magma_mmmE_m>m._m.o.mmmE_
`
`021
`
`om.m_n_
`
`021
`
`
`

`
`US 2009f0 105556 A1
`
`Apr. 23, 2009
`
`MEASUREMENT OF PHYSIOIJOGICAI.
`SIGNALS
`
`CROSS-Rlil"liRl-iNCl'i TO Rl-iI.A'l'l-ll.)
`APPl..lCA’l‘lONS
`
`[0001] This application claims priority to U.S. provisional
`application No. 60l995.723. filed Sep. 28. 2007'. entitled
`“Method and Devices for Measurement of Multi-rnodal
`
`Physiological Signals," which is incorporated herein by ref-
`CTCITCC.
`
`STATEMENT REGARDING FEDERALLY
`SPONSORED RESEARC H
`
`TT1e subject matter described in this application was
`[0002]
`partially funded by the Cioveminent of the United States
`under Contract No. W9]ZLK-04~P-0239 awarded by the
`U.S. Department of the Army. The government has certain
`rights in the invention.
`
`FlliI..D Ol-' Tl-IE IN]/l£N'l'I()N
`
`[0003] The invention relates to measurement ofphysiologi-
`cal signals.
`
`l3A(TKGROlJNl)
`
`Physiological signals are important for monitoring a
`[0004]
`subject‘s physical and cognitive state. Often. heart rate
`parameters are measured directly via electrocardiogram
`(ECG) measurements of a heart beat. Respiration rate data
`can be obtained from a respiration chest strap. Physiological
`signals can also be extracted from infrared (IR) photoplcthys-
`mographs (PPG). The signals of interest include heart rate,
`respiration rate, continuous blood pressure, and intrathoracic
`pressure. With respect to blood pressure. there is technology
`related to collecting data at two locations on the body and
`using pulse transit time and other parameters as the basis of
`the pressure estimate.
`
`SUMMARY
`
`In a general aspect. a system includes an optical
`[0005]
`sensor and a signal processing module. The optical sensor is
`configured to be positioned on an area ofskin ofa patient. The
`optical sensor includes a light source for illuminating a cap-
`illary bed in the area of skin and a photodetector. The photo-
`detector is configured to receive an optical signal from the
`capillary bed resulting from t.l1c illumination and to convert
`the optical signal into an electrical signal. the optical signal
`characterizing a fluctuation in a level of blood in the capillary
`bed. The signal processing module is configured to process
`the electric signal ttsinga nonstationary frequency estimation
`method to obtain a processed signal related to at least one of
`a heart rate and a respiration rate of the patient.
`[0006] Embodiments may include one or more of the fol-
`lowing. The system includes an output for providing infor-
`mation determined from the processed signal. The nonsta-
`tionary frequency estimation method includes a Hilbert
`transfonn method or an instantaneous frequency estimation
`method. The processed signal includes at least one ofinstan-
`taneous heart rate, inter—beat interval. heart rate variability.
`high—low heart rate ratios, respiration rate. inter-breath inter-
`val. and respiration rate variability. The lluctttation in l.l1e level
`ofblood in the capillary bed relates to a change in at least one
`
`ofvolume and pressure ofthe thoracic cavity or to a change in
`at least one of volume and pressure ofan organ in the thoracic
`cavity.
`[0007] The system includes an auxiliary sensor configured
`to detect an ambient signal. The auxiliary sensor includes at
`least one o faccelenometer. a pressure sensor. an optical detec-
`tor. a temperature sensor. and a piezoelectric device. The
`signal processing module is configured to remove an effect of
`the ambient signal from the electrical signal. The optical
`signal is a reflectance or a transmittance of the capi llary bed.
`[0008]
`ln another general aspect. a method includes ill1uni-
`nating a capillary bed in an area of skin ofa patient. receiving
`an optical signal from the capillary bed resulting from the
`illumination. converting the optical signal into an electrical
`signal. and processing the electrical signal tising a nonstation-
`ary iiequency estimation method to obtain a processed signal
`related to at least one of a heart rate and a respiration rate of
`the patient. The optical signal characterizes a fluctuation in a
`level of blood in the capillary bed.
`[0009] Embodiments may include one or more of the fol-
`lowing. The method includes outputting information deter-
`mined from the processed signal. Processing the electrical
`signal using the nonstationary frequency estimation method
`includes performing a I-lilhert trartsfornt or processing the
`electrical signal using an instantaneous frequency estimation
`method. Processing the electrical signal using the instanta-
`neotis frequency method includes band pass filtering the elec-
`trical signal. determining an instantaneous frequency of the
`electrical signal. and using the instantaneous frequency to
`obtain the processed signal.
`[0010] The method furl.hcr includes processing the electri-
`cal signal using a model to obtain a blood pressure signal
`related to a blood pressure of the patient. The optical signal
`characterizes a capillary refill time in the capillary bed. Pro-
`cessing the electrical signal includes processing the electrical
`signal in real time.
`[0011]
`In another aspect, a method for monitoring blood
`pressure includes illunlinating a capillary bed in an area of
`skin ofa patient. receiving an optical signal from the capillary
`bed resulting from the illumination. converting the optical
`signal into an electrical signal. a11d processing the electrical
`signal using a model characterizing a relationship ofthe fluc-
`tuation in the level of blood and the blood pressure of the
`patient to obtain a quantity related to the blood pressure of the
`patient. The optical signal cltaractcrizes a lltictuation in a
`level of blood in the capillary bed ofthe patient.
`[0012] Embodiments may include one or more of the fol-
`lowing. The method includes outputting information deter-
`mined based on the quantity related to the blood pressure of
`the patient. The optical signal characterizes a capillary refill
`time. The method further includes engaging a device to
`restrict circulation in the capillary bed of the patient and
`disengaging the device prior to receiving the optical signal
`from the capillary bed. The disengaging of the device occurs
`gradually. The device is an active clamping device.
`[0013] The quantity related to the blood pressure of the
`patient is a quantity related to the continuous blood pressure
`ofthe patient. Applying the model includes applying a model
`including circuit elements or properties of the capillary bed.
`The method further includes calibrating the 111odel on the
`basis of a blood pressure of the patient determined by using a
`blood pressure cuff.
`
`O22
`
`022
`
`

`
`US 2009f0l05556 A1
`
`Apr. 23, 2009
`
`Fmbodiments may include one or more of the fol-
`[0014]
`lowing advantages.
`[0015] A system or method as described above can be used
`for both military and civilian applications. Combat casualty
`care requires close tnonitoring ofvital signs from tl1e moment
`that a ntedic first attends to a wounded soldier in the battle-
`
`lield and thence through the many transfer stages to the point
`of full hospital care. generally removed lrom the combat
`scene. Similar needs are evident in the civilian community
`where critical care is administered by first responders at the
`scene ofaccidents, by emergency room staff, and by intensive
`care unit staff. It is often desirable to obtain ntaxitnttnt infor-
`mation using as little equipment as possible. The system and
`method described herein support this need. They reduce the
`burden of equipment logistics. the burden of extra wires and
`sensors on and around the patient, and the complexity and
`cost of ttsing multiple devices.
`[0016]
`For both military and civil ian applications. a dispos-
`able. wearable device in keeping with the system and t11et.l1od
`described herein can be adapted to stay with a patient and to
`report vital signs througltout the care and transport processes.
`Further. the system can be configured to provide medical
`personnel with real-tirne visibility of vital signs as well as
`recording. ofthis information for playback by attending inedi-
`cal stat ff at a later time. The disposability of the device allows
`it to be fabricated with low cost parts and clinlinatcs the need
`for sanitizatiorr and asset tracking logistics in large scale
`clinical or military uses.
`[0017]
`Such system and methods additionally support
`applications in fitness monitoring. where their ease ofuse and
`robustness make them a compelling alternative to chest strap
`monitors for the rnonitorillg ofcardiac and respiratory param-
`eters during exercise. An car-worn device can also integrate a
`speaker unit for mobile electronic devices sucl1 as mobile
`phones or music players.
`[0018] An advantage of applying a nonstationary fre-
`quency estimation method [e.g.. analysis involving monitor-
`ing the frequency changes of the signal over titne_. such as
`monitoring changes in the instantaneous principal frequency
`over time) is that it is possible to avoid a tradcoff inherent i11
`many stationary estimation methods between frequency reso-
`lution and duration of data signals being analyzed. For
`example. iftlte signal is assumed to be stationary within each
`of a series of data windows. the frequency resolution is gen-
`erally inversely proportional to the duration of the window.
`As the window duration increases. the assumption of a sta-
`tionary signal is increasingly violated andfor nonstationary
`events (e.g.. transients) are more difficult to detect. At least
`sotne nonstationary frequency analysis methods. which may
`be based. without limitation. on a Hilbert transform approach.
`tracking of a rtonstationary model. nonstationary principal
`frequency analysis. or other tirne-freqttency tnethods. miti-
`gate the effects of such a time-freqttency tradeoll‘. Further-
`more. use o fsuch nonstationary teeltniques. as opposed to use
`of time domain peak picking andfor threshold based tech-
`niques. can provide robustness ofalgorithm against artifacts.
`and provide sensitivity to periodicity without being burdened
`by a window that can reduce the time resolution.
`[0019] Other features and advantages are apparent from the
`following description and frotn the appended claims.
`
`l3Rllil*' l)lESCRIP'l‘l()N O1’ DRAWINGS
`
`1’ IG. 1 is a schematic diagram ofa pl1otoplel.l1ys111o-
`[0020]
`graph (Pl’G} sensor system.
`
`FIG. 2 is a graph ofa PPG detector signal taken over
`[0021]
`a 25 second period by an earlobe PPG device.
`[0022]
`FIG. 3 is a flow diagram of signal processing of a
`detector signal from a PPG device to obtain heart rate and
`respiration rate parameters.
`[0023]
`FIG. 4 is a graph ofa result ofband—pass filtering the
`data shown in FIG. 2 between 0.5 Hz and 5.5 I-12 to extract a
`
`cardiac signal.
`[0024]
`FIG. Sis a graph ofa result ofband-pass filtering the
`data shown in FIG. 2 between 0.17 Hz and 0.5 Hz to extract a
`
`respiration signal.
`[0025]
`FIG. 6 is a graph ofan inter-beat interval obtained by
`applying an instantaneous frequency method to the cardiac
`signal shown in FIG. 4.
`[0026]
`FIG. 7 is a graph of a spectral analysis of the inter-
`beat interval data shown in FIG. 6.
`
`FIG. 8 is a graph of the respiration rate obtained by
`[0027]
`applying an instantaneous frequency method to the respira-
`tion signal shown itt FIG. 5.
`[0028]
`FIG. 9 is a diagram ofl’l-‘G measurentents related to
`physiological states used to determine intrathoracic pressure.
`[0029]
`FIG. Ill is a graph of the output ofa matched filter-
`ing process using the PPG detector signal shown in FIG. 2 and
`a pulse pilot signal.
`[0030]
`FIG. ll is a block diagram of a least mean squares
`(LMS) adaptive filter.
`[0031]
`FIG. 12 is a sclrematic diagram of an active clamp-
`ing mechanism ttsed to stimulate capillary refill.
`[0032]
`FIG. 13 is a diagram ofa system model relating a
`PPG signal to blood pressure.
`[0033]
`FIG. 14 is a graph of trends in various physiological
`parameters before and during a stress event.
`[0034]
`1" IG. 15 is a block diagram ofa portable electronics
`unit.
`
`FIG. 16 is a flow diagram of methods to estimate a
`[0035]
`heart rate and a respiration rate.
`[0036]
`FIG. 17 is a flow diagram ofa processing delay in
`the estimation ofa heart rate.
`
`FIG. 18 is a [low diagram of a processing delay in a
`[0037]
`first method for the estimation of a respiration rate.
`[0038]
`l--‘IG. 19 is allow diagram ofa processing delay in a
`second method for the estimation ofa respiration rate.
`[0039]
`FIG. 20 is a flow diagram ofa processing delay in a
`third method for the estirnation of a respiration rate.
`
`l)l'i'l"Al I .1"-D DI ESCRIPTION
`
`[0040] Referring to FIG. 1. examples of an infrared pho-
`topletltysinograph (PPG) device 100 are used to obtain physi-
`ological signals related to one or more of heart rate. respira-
`tion rate. blood pressure. and intrathoracic pressure. Such
`signals may be relevant
`for monitoring a person's state.
`including one or more of the pcrson’s physical state, long-
`ternt health. psychological state. andfor cognitive state. More
`generally. the physiological signals may provide information
`about the activity of the person's sympathetic and parasym-
`pathetic nervous system. The PPG device 100 illustrated in
`FIG. I is attached to an earlobe 102 of a person. for example.
`using a clamping or adhesive approach. However. in other
`embodiments. PPG device 100 is used on other areas of the
`skin ofa person. including but not limited to a portion of a
`forehead. a neck. an arm. a foreamt. a finger. a leg. a back, an
`abdomen. or a stomach. In general. a requirement for the
`positioning of PPG device 100 is that the Pl-‘G sensor be
`located such that it can obtain a measurement via the skin that
`
`023
`
`023
`
`

`
`US 2009f0 105556 A1
`
`Apr. 23, 2009
`
`is related to blood [low or pressure. for example to measure a
`level of blood in a capillary bed 104, for example. a blood
`volume. a rate of blood flow. or a rate of change of blood
`volume. Note also that the approach is not limited to use of a
`single PPG device on an individual. In some embodiments.
`multiple PPG devices are used. for example. on the torso
`andfor at dilferent extremities. and signals obtained at the
`different PPG devices are processed independently or in com-
`bination to determine underlying characteristics of the indi-
`vidual ‘s state.
`
`In some embodiments. such as that shown in FIG. 1.
`[0041]
`an infrared light source 106 illuminates the earlobe 102. The
`blood level in capillary bed 104 affects the amount of light
`108 that is backscattered or reflected by earlobe 102. Light
`108 backscattered by earlobe 102 is received by an optical
`transducer such as a photodetector 110 and converted into a
`detector signal 112. Since the blood How in capillary bed 104
`is controlled by the heart beat ofthe person and thus the blood
`level in the capillary bed varies with time. the backscattercd
`light 108 and hence the detector signal 112 are also tittie-
`varying. In another embodiment. the PPG sensor operates in
`transmission mode and the light transmitted through the cap-
`illary bed is received by the photodetector.
`[0042] The detector signal 112 is sent to a signal processing
`unit 114 which processes the detector signal. which contains
`information about the person’s pulse. to extract desired physi-
`ological data. in various embodiments including one or more
`ofinstantaneous hean rate. inter-beat interval. heart rate vari-
`ability. high-low heart rate ratio. respiration rate. inter-breath
`interval. respiration rate variability. blood pressure, and
`intrathoracic pressure. A single PPG device 100. referred to
`below as an integrated Mnlti—Modal Physiological Sensor
`(IMMPS). is capable of producing multiple (or all) of such
`types of physiological data.
`[0043]
`In some embodiments. the PPG device 100 provides
`real-time visibility of physiological paratneters and vital
`signs. which can be transmitted to other equipment for real-
`time processing or for playback or off-line processing at a
`later time. in some embodiments. the PPG device includes
`user output devices. such as a set of light emitting diodes
`(I..l7.Ds} {e.g.. a red LEI) ] 16. a yellow LED 118. and a green
`LED 120} or an audio device for producing alert sounds.
`which provide on-device status on PPG device 100. As an
`example for use of such output devices. when a selected
`physiological parameter is in a normal range. green LED 120
`is turned on: when the physiological parameter is in a slightly
`abnormal range, yellow LED 118 is turned on; when the
`physiological parameter is in a dangerous range. red LEI") 1 16
`is turned on. In some embodiments. the audio output device is
`used to provide other audio output. such as the output for an
`electronic device such as a mobile phone or a music player. In
`some embodiments. a wireless link 122 to an external moni-
`toring system l24. such as a bedside system or a wearable
`system. provides sensor data to the external system enabling
`a numeric readout 126 of various physiological parameters.
`In some embodiments, the PPG device. or at least some
`wearable portion ofthe device. is disposable. In such dispos-
`able embodimenls, the bedside system can be designed to be
`sterilized and reused: in another etnbodiment. the bedside
`system itself is also disposable. in some embodiments. the
`bedside system includes or comntunicates with a centralized
`monitoring system that monitors PPG devices of multiple
`patients.
`
`the photodetector based
`In some embodiments.
`[0044]
`detector signal is augmented with other signals. for example.
`accelerometer or pressure sensor signals. For example. aux-
`iliary sensors 130 are Oonllected to signal processing Ltnit 114
`via a wired connection 132. In other embodiments. auxiliary
`sensors 130 are connected to signal processing unit 114 via a
`wireless connection. Auxiliary sensors 130, such as te111pera-
`ture sensors. accelerometers. pressure transducers. optical
`detectors. or piezoelectric films or matrices can provide aux-
`iliary signals 132 related to ambient sources ofnoise to signal
`processing unit 114. Signal processing unit 114 incorporates
`auxiliary signals 132 into the signal processing, liir example.
`to increase the signal-to-noise ratio ofthe desired physiologi-
`cal data.
`
`Heart and Respiration Rate Signals
`
`[0045] Referring to FIG. 2, in an embodiment ol‘ the I-‘PU
`device that uses a photodetector signal obtained from at an
`earlobe location. a detector signal 200 obtained from the PPG
`device 100 has a high-frequency pulse signal 202 whose local
`peaks in the time domain have a one-to-one correspondence
`with cardiac beats. Significant low-frequency amplitude vari-
`ability in the detector signal is due in large part a respiration
`signal 204. which modulates the baseline of the pulse signal.
`[0046] The time varying heart and respiration components
`in detector signal 200 can be modeled as
`s(r}=;I_.,t.r]eos [(1)_.,{'r}.r+1pH( T)]+_-I Rf.t]co.-s [m,,t_r+¢R( ?}]+
`NE! D.
`
`i 1 l
`
`where A,,(t} is the amplitude modulation ofpulse signal 202.
`[1],,(t) is the frequency modulation ofpulse signal 202. I]!3(1) is
`the phase modulation of pulse signal 202. . 3(1) is the ampli-
`tude modulation of respiration signal 204. 0;-R[t) is the fre-
`quency modulation of respiration signal 204. $30) is the
`phase modulation of respiration signal 204. and MI) is the
`time varying noise. which includes baseline drift and broad-
`band noise in the overall signal band.
`[0047] Given the measured detector signal 200 (s{l)). signal
`processing is performed to estimate Lhe slowly varying corn-
`ponents of the heart rate U.tH(t) and the respiration rate uJ,.(t).
`It is known that uJ,,(t)-=(um-=1 beat per second 1 Hz for heart
`rate and Lt}R{i)='-°tJ);,U~l 2 breaths per minute»-t).2 Hz for respi-
`ration rate.
`
`[0048] Amplitude, phase. and frequency modulation cause
`spectral spread that broadens the pure tones implied by these
`frequencies. Amplitude and phase modulation and rapid fluc-
`tuations of the frequency modulation are confounding com-
`ponents of detector signal 200. The slowly varying compo-
`nents of mm are the desired components for obtaining heart
`and respiration rate information.
`is com-
`[0049]
`For both heart and respiration rate. w[t).
`posed of three pans: constant frequency too, which is the
`nominal heart or respiration rate: a zero-meat . slowly varying
`lreqttericy component S2, having a time scale ofminutcs; and
`a zero-mean. rapidly varying frequency component Qrhaving
`a time scale ofseconds. In this case. the composite heart rate
`or respiration rate is written as
`
`(o{.'}--(o,+Q,{i‘}+§2,( I}.
`
`ill
`
`The signal ofinterest is the combination of the constant and
`the slowly varying cornponent (for both heart rate and respi-
`ration rate) and is written as
`
`ti)! u‘}=t:J°+fl_{r].
`
`{3}
`
`024
`
`024
`
`

`
`US 2009f0 105556 A1
`
`Apr. 23, 2009
`
`The phase tnodulation noted is Eq. ( l ), 12(1). is assumed to be
`small. since large phase modulation can be represented as
`frequency modulation and this is already captured in S2, or $2,.
`[0050] Applying [Eq. (3) to ta]. (1), a new equation for llifl‘
`measured raw signal 200 is obtained:
`
`.rt.'}"‘-.-igttlcos [(i1,,r(t)t+qt,:,,-{t}]+.-Iyqtrtcos [
`uJRtt}t+1p__‘R{I}]+l\-"III.
`
`M}
`
`where for both heart and respiration rate, small components
`them are defined as
`-pan ,'
`.,,’QJ('rlrt‘1:+¢{f}
`
`(5)
`
`and by construction |¢E(t]|<<l and ¢E(t) is zero mean.
`[005]] Using the Law of Cosines and the fact that lt]iE(l.]
`l-(<1. the following equation for raw signal 200 is obtained:
`
`.rtr}=.-[t_;,ttt1{ cos [tirqttltjn-¢m{t}sin [tit_q{rlr}'}+.‘l'Rl!l{
`cos [(o,,{r]r]—q1<Rttisiu [to,,tr,1r,1'}+.«\r't ti.
`
`{6}
`
`[0052] The formulation in Eq. (6) of PPG detector signal
`200 suggests a number of methods to estimate the desired
`slowly varying heart and respiration rate signals riiH(t) and
`liJR[l).. respectively. Such estimation techniques can include
`instantaneous frequency determittation via analytic signals.
`tnoving averages. band pass filtering. synchronous detection.
`correlation detection, narrowband processes (e.g._. demodu-
`lation). matched filtering, wavelet filtering. short—time fre-
`quency analysis (e.g., short-time fast Fourier transform.
`Wigner-Ville transform). state estimation (e.g.. Kalntan fil-
`tering. unscented filtering). Doppler processing, or a combi-
`nation of the above methods. A number of these techniques
`can be implemented to account for the no nstationary nature of
`the detector signal, which relates to the time variation of the
`frequency modttlation signals. tu(t).
`[0053] Referring to FIG. 3, one example of a procedure for
`obtaining heart rate parameters andfor respiration rate param-
`eters involves receiving the detector signal 200. such as that
`shown in FIG. 2. from a PPG photodetector [IR Plethyst11o-
`graph 300). To emphasize the pulse signal in order to extract
`cardiac parameters from the detector signal. the respiratory
`modulation is removed by band-pass filtering (302) the detec-
`tor signal between approximately 0.5 Hz and approxitnately
`5.5 I12. I3and-pass filtering of the detector signal shown in
`FIG. 2 results in a cardiac signal shown in FIG. 4. which has
`significantly less amplitude variability due to respiratory con-
`tamination. The band-pass filtered signal pulse signal can be
`expressed as
`
`§I’fJ=-fnt!J{ we tniriitrirr-mnsin ts-‘wtr;}+fi't:i.
`
`{Tl
`
`where fi£(t) is the content of the noise. N(t). within the heart
`rate bandwidth. Likewise, referring again to FIG. 3. to extract
`parameters related to respiration from a PPG detector signal.
`the pulse signal is retnoved by band-pass filtering (304) the
`detector signal between approximately 0.1 7 Hz (equivalent to
`10 breaths per minute) and 0.5 Hz (30 breaths per minute].
`Band—pass filtering the detector signal of FIG. 2 produces a
`respiration signal shown in l"'IG. 5. which retains primarily
`low frequency respiration components of the original signal.
`[0054]
`Focusing now on the cardiac signal. one approach to
`detecting heart beats in the cardiac sigial is by threshold-
`based peak picking. which can be used to determine the time
`of specific events such as heart beats. In some implement‘ -
`tions. peak picking can be sensitive to the threshold selected.
`For example. if the threshold is set too low. then false beats
`can be counted. and the inter-beat interval (I131) is determined
`to be shorter than it really is. If the threshold is set too high.
`
`then true beat peaks may be tnissed. For general processing it
`is convenient to select a single threshold. but if the data are
`suificiently variable then selecting a single threshold is not
`possible.
`[0055] Other appro

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