(12) United States Patent
`US 6,293,915 B1
`(10) Patent N0.:
`Amano et al.
`(45) Date of Patent:
`*Sep. 25, 2001
`
`USOO6293915B1
`
`(54) PULSE WAVE EXAMINATION APPARATUS,
`BLOOD PRESSURE MONITOR, PULSE
`WAVEFORM MONITOR, AND
`PHARMACOLOGICAL ACTION MONITOR
`
`(75)
`
`Inventors: Kazuhiko Amano; Kazuo Uebaba,
`both of Yokohama; Hitoshi Ishiyama,
`TOIIdC; HII‘OShI Kasahara, Kashiwa, all
`of (JP)
`
`(73) Assignee: Seiko Epson Corporation, Tokyo (JP)
`
`(*) Notice:
`
`This patent issued on a continued pros-
`ecution application filed under 37 CFR
`1.53(d), and is subject to the twenty year
`patent
`term pI‘OVlSiOIlS Of 35 U.S.C.
`154(a)(2).
`
`Subject to any disclaimer, the term of this
`patent is extended or adjusted under 35
`U.S.C. 154(b) by 0 days.
`
`.
`(21) Appl. No“
`(22) PCT Filed:
`(86) PCT NO‘:
`§ 371 Date:
`
`09/341’787
`Nov. 20, 1998
`PCT/JP98/05259
`Jul. 16, 1999
`
`(56)
`
`References Cited
`
`U.S. PATENT DOCUMENTS
`5,623,933 *
`4/1997 Amano et al.
`....................... 600/500
`5,755,229 *
`5/1998 Amano et al.
`....................... 600/500
`
`FOREIGN PATENT DOCUMENTS
`0 638 281 A1
`2/1995 (EP) .
`59—189830
`10/1984 (JP) .
`4—250132
`9/1992 (JP) .
`8—257000
`10/1996 (JP) .
`8—289876
`11/1996 (JP) .
`9—135819
`5/1997 (JP) .
`139440
`8/1990 (W)-
`W096 35368
`11/1996 (W0) ~
`OTHER PUBLICATIONS
`
`“Medical Diagnostics, vol. 1 (in Japanese)”, supervised by
`Akira Shibata, Mar.,
`10,
`1995, Nishimura Shoten,
`pp401—409.
`“Application of Wavelet Transformation to Wave Pulse of
`Living Body (in Japanese)”, Preprint of 15th Scientific
`Lectures on Biomechanism, (Japan), (1994), pp121—124.
`* cited by examiner
`Primary Examiner—Cary O’Connor
`Assistant Examiner—Navin Natnithithadha
`
`§ 102(c) Date:
`
`Jul. 16, 1999
`
`(57)
`
`ABSTRACT
`
`(87) PCT Pub. No.: WO99/26529
`
`PCT PUb- Date: Jun. 3: 1999
`.
`.
`.
`.
`.
`Forelgn Appllcatlon Pr10r1ty Data
`(30)
`Nov. 20, 1997
`(JP) ................................................... 9—320149
`
`N0V~ 21, 1997
`(JP)
`~~~~~~ 9-321768
`(JP) ................................................. 10—213494
`Jul. 12, 1998
`
`Int. Cl.7 ........................................................ A61B 5/02
`(51)
`(52) US. Cl.
`........................... 600/501; 600/500; 600/485
`(58) Field of Search ..................................... 600/500, 501,
`600/485, 486, 502
`
`the frequency
`An FFT treating section (40) carries out
`analysis of a pulse waveform MHj excluding a body move-
`ment component to yield pulse wave analysis data MKD and
`then a tidal wave-character extracting section (50) and a
`dicrotic wave-character extracting section (60) yield a tidal
`wave-character data (TWD) and a dicrotic wave-character
`data (DWD) showing the characteristics of a tidal wave and
`dicrotic wave respectively. Then, a pulse condition judging
`section (70) yields pulse condition data (ZD) on the basis of
`this data (TWD, DWD) and in succession a notifying section
`(80) advises of the pulse condition of a subject.
`
`61 Claims, 56 Drawing Sheets
`
`
`(51 0
`2 0
`PULSE WAVE
`BODV MOVEMENT
`2 2
`
`DETECTING SECTION
`DETECTING SECTION
`T
`
`
`
`
`
`21 we? 223121
`YR WAVEFEEETIEEATING
`
`E::: TA H t
`BODY MOVEMENT COMPONENT
`l
`i
`
`ELIMINATING SECTION
`
`4 0 (\
`IT\\»»M HJ
`EFT TREATING SECTION
`
`3 0 r
`
`/ M H
`
`
`
`
`
`C
`
`
`v
`v
`I
`TIDAL WAVEACHARACTER
`DICROTIC WAVE’CHARACTER
`
`EXTRACTING SECTION
`EXTRACTING SECTION
`
`
`
`L\ TWD
`
`PULSE CONDITION
`V
`I
`JUDGING SECTION
`Z D
`
`
`
`\ DWD
`
`7 0
`
`
`8 0 NOTIFYING SECTION
`
`1
`
`APPLE 1004
`
`APPLE 1004
`
`1
`
`

`

`US. Patent
`
`Sep. 25, 2001
`
`Sheet 1 0f56
`
`US 6,293,915 B1
`
`IT I C}.
`
`1
`
`1 O
`
`2 O
`
`PULSE WAVE
`DETECTING SECTION
`
`BODY MOVEMENT
`DETECTING SECTION
`
`.
`
`“A11
`
`21
`
`TH
`WAVEFORM TREATING
`SECTION
`
`2 2
`
`JUDGING
`
`smnm
`
`3 O
`
`4 O
`
`BODY MOVEMENT COMPONENT
`
`ELIMINATING SECTION
`
`NAEII
`
`FFT TREATING SECTION
`
`hAI<ID
`
`TIDAL WAVE-CHARACTER
`
`EXTRACTING SECTION
`
`DICROTIC WAVE-CHARACTER
`
`EXTRACTING SECTION
`
`
`
`
`
`
`
`-”JUDGING SECTION
`
`[)VVE)
`
`2|)
`
`8 O
`
`2
`
`

`

`US. Patent
`
`Sep. 25, 2001
`
`Sheet 2 0f56
`
`US 6,293,915 B1
`
`F‘I C}. 2
`
`START
`
`s 1
`
`s 2
`
`s 3
`
`s 4
`
`DEECHONOFAPmfiE
`WAVEFORM
`
`BODY MOVEMENT
`ELIMINATING TREATMENT
`
`FFT TREATMENT
`
`
`
`YIELD OF TIDAL
`WAVE~CHARACTER DATA
`
`AND DICROTIC WAVE DATA
`
`YESSBN:@SS:SO7
`
`S 9
`
`JUDGED TO BE A XUAN
`MAI T0 YIELD ZDI
`
`JUDGED TO BE A PING
`MAI T0 YIELD 202
`
`JUDGED TO BE HUA MAI
`T0 YIELD ZD3
`
`3
`
`

`

`US. Patent
`
`Sep. 25, 2001
`
`Sheet 3 0f56
`
`US 6,293,915 B1
`
`Ir 1 C}.
`
`3
`
`1 O
`
`2 O
`
`PULSE WAVE
`DETECTING SECTION
`
`BODY MOVEMENT
`DETECTING SECTION
`
`JUDGING
`
`WAVEFORM TREATING
`SECTION
`
`SECTION
`
`C3
`
`2 1
`
`AAII
`
`30
`
`
`
`
`
`
`BODY MOVEMENT COMPONENT
`ELIMINATING SECTION
`
`41AAIIJ
`
`WAVELET TRANSFORMATION
`SECTION
`
`5 O
`
`AAI<ID
`
`6 O
`
`
`
`
`TIDAL
`
`TIDAL
`TIDAL
`WAVE—CHARACTER
`
`WAVE—CHARACTER
`WAVE/DICROTIC
`
`
`
`EXTRACTING
`WAVE DETECTING
`EXTRACTING
`
`
`
`SECTION
`SECTION
`SECTION
`
`
`
`
`
`
`PULSE CONDITION
`JUDGING SECTION
`
`ZD
`
`8 O
`
`NOTIFYING SECTION
`
`4
`
`

`

`US. Patent
`
`D...&
`
`mm.
`
`4
`
`US 6,293,915 B1
`
`”Mom¢
`
`L"\
`
`smoum><z nvo.v
`
`oz_¢<=m
`
`zo_Homw
`
`m>>Hzo_Homm”zo_H<o_4m_H4=s%oz:mm;
`Am...........................................................................................
`
`
`
`o_m<mW.v>>
`
`“mumsmzo_wmm>zooMJ<QWzo_poz=mmzo_Hommzo_pommzo_pomm02.xohwWGZ_P<Amz<mh>zosmz
`
`
`w>mosm2;->>%o2928%
`
`5
`
`
`

`

`US. Patent
`
`Sep. 25, 2001
`
`Sheet 5 0f56
`
`US 6,293,915 B1
`
`FIG.
`
`5
`
`NIH
`
`RINGING
`FILTER
`
`
`
`4 0 1
`
`
`
`400
`
`
`
`402
`I
`
`ZERO-CROSS
`DETECTING
`CIRCUIT
`
`4-0 7
`
`C38
`VOLTAGE CONTROL
`OSCILLATION
`
`COMPARING
`
`SECTION
`
`LOOP
`
`FILTER
`
`
`
`
`
`
`CIRCUIT
`
`
`6
`
`

`

`US. Patent
`
`Sep.25,2001
`
`Sheet6 0f56
`
`US 6,293,915 B1
`
`FIG.
`
`6
`
`
`
`7
`
`

`

`US. Patent
`
`Sep. 25, 2001
`
`Sheet 7 0f56
`
`US 6,293,915 B1
`
`FIG. 7
`
`FREQUENCY
`
`WAVELET ANALYSIS RESULT
`
`8
`
`

`

`US. Patent
`
`Sep. 25, 2001
`
`Sheet 8 0f56
`
`US 6,293,915 B1
`
`F I G . 8
`
`ELECTROCARDIOGRAM
`
`w(
`
`U
`
`I I
`
`II
`
`2
`
`:| |I
`
`WAVEFORM OF
`BLOOD PRESSURE
`AT PROXIMAL PORTION
`OF AORTA
`OPENING OF
`AORTIC VALVE
`
`
`
`S
`'
`'
`i
`
`‘
`
`()
`
`CLOSING OF AORTIC VALVE
`
`I
`I
`I
`
`
`/
`
`
`EFFUSION
`WA\//E
`,, ~41
`
`XTIDAL WAVE
`
`lleCROTIG WAVE
`
`_.~_..~__._—.__—_—_.—_.__—
`
`VENTRICULAR DIASTOLE
`
`I
`
`VENTRICULAR
`SYSTOLE
`
`I '
`
`,
`
`WAVEFORM OF
`BLOOD PRESSURE
`AT PERIPHERY
`
`9
`
`

`

`US. Patent
`
`Sep. 25, 2001
`
`Sheet 9 0f56
`
`US 6,293,915 B1
`
`FIG.
`
`9
`
`“ii:P2
`y2Y5Y4WEDIIIIS
`
`!!!I"
`
`P0
`
`t1
`
`P6(PO)
`
`10
`
`10
`
`

`

`US. Patent
`
`Sep. 25, 2001
`
`Sheet 10 0f 56
`
`US 6,293,915 B1
`
`FIG. 10
`
`DISTORTION
`
`RATE d
`
`
`
`'-5
`
`o
`
`5
`
`1o
`
`15
`
`20
`
`25
`
`(Y5 ’ Y4)
`
`[mmHg}
`
`11
`
`11
`
`

`

`US. Patent
`
`Sep. 25, 2001
`
`Sheet 11 0f56
`
`US 6,293,915 B1
`
`
`
`ORIGINAL
`
`WAVEFORM
`
`wn
`
`wf2
`
`W13
`
`wf4
`
`wf5
`
`“”5
`
`wf7
`
`IWTB
`
`wf9
`
`0.35
`
`m I E 5
`
`N
`
`FIG. 11
`
`f1
`
`QM
`
`3W
`
`“W
`f5‘\\/\./\/\/\/'\./\
`
`TGW
`
`fl
`
`18“
`
`f9‘\___________
`
`f10
`
`M...“
`
`HUA MAI
`
`12
`
`12
`
`

`

`US. Patent
`
`Sep. 25, 2001
`
`Sheet 12 0f 56
`
`US 6,293,915 B1
`
`FIG. 12
`
`ORIGINAL
`
`WAVEFORM
`
`wf2
`
`wfi
`
`PING MAI
`
`.
`
`13
`
`13
`
`

`

`US. Patent
`
`Sep. 25, 2001
`
`Sheet 13 0f 56
`
`US 6,293,915 B1
`
`F I G.
`
`1 3
`
`ABPT
`
`A BP D
`
`ORIGINAL
`
`WAVEFORM
`
`wf1
`
`wf2
`
`wf3
`
`wf4
`
`wf5
`
`wf6
`
`wf7
`
`wf8
`
`wf9
`
`f1 JV
`f2 /\/\/\/
`
`f3 /’\/\/\/\,
`
`f4WW
`
`*5 \vavvx
`
`*6 \vvvvvvvx
`
`f7W
`
`f8W
`
`
`
`f9W
`
`XUAN MAI
`
`14
`
`14
`
`

`

`US. Patent
`
`Sep. 25, 2001
`
`Sheet 14 0f 56
`
`US 6,293,915 B1
`
`FIG. 14
`
`AMPLITUDE
`
`DICROTIC 7. 3
`
`2. 9
`
`
`
`_HUAMAI
`PINGMAI
`
`
`
`WAVE [mmHG]
`
`ANIPLITUDE OF TIDAL
`
`WAVE [mmHG]
`
`FIG. 15
`
`FUNDAMENTAL
`
`
`
`
`
`
`
`
`PINGMAI
`-HUAMAI
`
`
`
`
`W——M_
`
`
`4
`
`
`
`15
`
`15
`
`

`

`US. Patent
`
`Sep. 25, 2001
`
`Sheet 15 0f 56
`
`US 6,293,915 B1
`
`TIME1:
`
`16
`
`FIG.
`
`1.2
`
`*'
`
`‘33.
`O
`
`‘9
`O
`
`'3:
`o
`
`N
`0'
`
`o
`
`NOliV—IEIHHOOOLHV :10 iNElOHdEOO
`
`16
`
`16
`
`

`

`US. Patent
`
`Sep. 25, 2001
`
`Sheet 16 0f 56
`
`US 6,293,915 B1
`
`39
`8
`
`1..)
`
`LU
`.2.
`l—
`
`“4
`F
`
`"
`
`a?
`O
`
`*1: N
`“'2
`‘0.
`o o c Q
`O
`
`o!
`o
`
`o
`
`Nouvwaaaooomv :10 iNBlOleEIOO
`
`17
`
`[x
`H
`
`(5'
`
`H L
`
`u
`
`17
`
`

`

`US. Patent
`
`Sep. 25, 2001
`
`Sheet 17 0f 56
`
`US 6,293,915 B1
`
`TIMET
`
`18
`
`FIG.
`
`N.
`~—
`
`'—
`
`°9 QQYQN 0
`0 ©0005
`
`NOIiV'IEHHOOOinV :IO LNEHOHAEOO
`
`18
`
`18
`
`

`

`US. Patent
`
`Sep. 25, 2001
`
`Sheet 18 0f 56
`
`US 6,293,915 B1
`
`17 I (3.
`
`11 9
`
`T o
`
`PULSE NAVE DETECTING
`SECTION
`
`2 1 0 :AUTOCORRELATION
`; CALCULATING SECTION
`
`MH
`
`2 1 1
`
`NAVEFORII TREATING WE
`SECTION
`
`"Em“
`MH1 - MH 2
`
`IIULTIPLICATION
`SECTION
`
`AVERAGE VALUE
`CALCULATING SECTION
`
`NORMALIZATION
`CALCULATING SECTION
`
`2 1 2
`
`213
`
`2 1 4
`
`215
`
`"""""""""""""""""""""""""""
`
`2 2 OJPULSE CONDITION DATA
`I YIELDING SECTION
`
`IINIIUII VALUE
`DETECTING SECTION
`
`TIME MEASURING
`SECTION
`
`
`
`
`
`F I RST COMPARING
`SECTION
`
`CALCULATING SECTION
`
`224
`
`225
`
`OATA YIELDING
`SECTION
`I I I I I I I I l I I I I l l l I I I I I I I I l l I
`| I l I I I I I I I I I I I I l I I I I I I I I I I
`
`2 2 ‘5
`
`N U
`
`2 3 O
`
`DISPLAY SECTION
`
`19
`
`19
`
`

`

`US. Patent
`
`Sep. 25, 2001
`
`Sheet 19 0f 56
`
`US 6,293,915 B1
`
`FIG. 20
`
`START
`
`DETECTION OF A PULSE WAVEFORM
`
`.
`
`YIELD OF AUTOCORRELATION DATA
`
`
`
`s 1
`
`s 2
`
`8 3
`
`
`
`DETECTION OF THE MINIMUM
`VALUE OF THE AUTOCORRELATION
`
`
`
`DATA CORRESPONDING TO A PERIOD
`OF ONE BEAT
`
`IS THE MINIMUM VALUE LESS
`
`THAN 0.25?
`
`
`
`MEASUREMENT OF A TIME INTERVAL,
`IN
`WHICH THE AUTOCORRELATION DATA RD
`
`EXCEEDS 0.5,
`IN A PERIOD CORRESPONDING
`
`TO A PERIOD OF ONE BEAT
`
`s 4
`
`S 6
`
`
`
`
`
` JUDGED TO BE A HUA
`
`
`JUDGED TO BE A PING
`JUDGED TO BE A XUAN
`
`MAI TO YIELD ZD3
`MAI TO YIELD ZDZ
`MAI T0 YIELD ZDI
`
`
`
`
`
`
`
`CALCULATION OF THE RATIO OF
`THE MEASURED TIME TO THE
`PERIOD OF ONE BEAT
`
`S 7
`
`S 8
`
`DOES THE RATIO CALCULATED
`EXCEED 47%?
`
`S 1 O
`
`20
`
`20
`
`

`

`US. Patent
`
`Sep. 25, 2001
`
`Sheet 20 0f 56
`
`US 6,293,915 B1
`
`FIG. 21
`
`RI)
`
`5; 2 2 O
`
`MINIMUM VALUE
`
`DETECTING SECTION
`
`CHANGE RATE
`
`CALCULATING SECTION
`
`2 2 7
`
`'2 2 8
`
`
`
`
`
`
`
`
`FIRST COMPARING
`
`SECTION
`
`MAXIMUM VALUE
`
`DETECTING SECTION
`
`
`
`j; 2 2 5
`
`SECOND COMPARING
`
`SECTION
`
`DATA YIELDING
`
`SECTION
`
`ZID
`
`21
`
`21
`
`

`

`US. Patent
`
`Sep. 25, 2001
`
`Sheet 21 0f 56
`
`US 6,293,915 B1
`
`_<s_02E
`
`/
`
`\
`
`
`
`7124<Dx
`
`L‘"III\
`
`mm.UHM
`
`mwd
`
`—.0
`
`mod
`
`mod.
`
`—.o-
`
`mfio-
`
`22
`
`22
`
`

`

`US. Patent
`
`Sep. 25, 2001
`
`Sheet 22 0f 56
`
`US 6,293,915 B1
`
`FIG. 23
`
`START
`
`DETECTION OF A PULSE WAVEFORM
`
`YIELD OF AUTOCORRELATION DATA
`
`
`
`S I
`
`S 2
`
`S 3
`
`
`
`DETECTION OF THE MINIMUM
`VALUE OF THE AUTOCORRELATION
`
`
`DATA CORRESPONDING TO A PERIOD
`
`
`OF ONE BEAT
`
`S 4
`
`IS THE MINIMUM VALUE LESS
`THAN 0.25?
`
`
`
`
`
`DETECTION OF THE VARIATION RATE
`OF AUTOCORRELATION DATA
`
`
`
`DETECTION OF THE MAXIMUM VALUE
`
`OF THE VARIATION RATE IN A
`
`PERIOD CORRESPONDING TO A PERIOD
`OF ONE BEAT
`
`S I
`
`1
`
`8 I 2
`
`S I 3
`
`
`
` JUDGED TO BE A HUA
`
`IS THE MAXIMUM VALUE LESS
`
`THAN 0.85?
`
`
`JUDGED TO BE A PING
`
`JUDGED TO BE A XUAN
`
`MAI TO YIELD ZDS
`MAI TO YIELD ZD2
`MAI TO YIELD ZDI
`
`
`
`S T 5
`
`23
`
`23
`
`

`

`US. Patent
`
`Sep. 25, 2001
`
`Sheet 23 0f 56
`
`US 6,293,915 B1
`
`F']:(}. 2 4
`
`1 O
`
`fl
`
`2 0
`
`PULSE WAVE
`DETECTING SECTION
`
`BODY MOVEMENT
`DETECTING SECTION
`
`2 2
`
`T'H
`
`2 1
`
`NflH
`
`JUDGING
`SECTION
`
`WAVEFORM TREATING
`SECTION
`
`30‘L\
`
`BODY MOVEMENT COMPONENT
`
`ELIMINATING SECTION
`
`
`
`C)
`
`hflij
`
`2 1 O
`
`AUTOCORRELATION
`
`CALCULATING SECTION
`
`RD
`
`220
`
`PULSE CONDITION DATA
`
`YIELDING SECTION
`
`ZID
`
`2 3 0
`
`DISPLAY SECTION
`
`24
`
`24
`
`

`

`US. Patent
`
`Sep. 25, 2001
`
`Sheet 24 0f 56
`
`US 6,293,915 B1
`
`F‘I C}. 2 5
`
`1 O
`
`2 0
`
`PULSE WAVE DETECTING
`SECTION
`
`BODY MOVEMENT
`DETECTING SECTION
`
`2 2
`
`AAII
`
`.
`
`2 1
`
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`
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`TRANSFORMATION SECTION
`
`2 4 5
`
`SECOND WAVELET
`
`M K D
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`
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`CORRECTING SECTION
`
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`
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`
`SECOND FREOUENCY
`CORRECTING SECTION
`
`
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`
`ELIMINATING SECTION
`
`MKDaj
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`
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`
`PULSE CONDITION
`YIELDING SECTION
`
`Z D
`
`2 3 O
`
`DISPLAY SECTION
`
`25
`
`

`

`US. Patent
`
`Sep. 25, 2001
`
`Sheet 25 0f 56
`
`US 6,293,915 B1
`
`FIG. 26
`
`P1
`
`P2
`
`P3
`
`.—
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`_
`
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`
`.-—"
`
`’-‘
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`4.0~3.5Hz
`
`3.5 ~3.0Hz
`
`3.0~2.5Hz
`
`2.5~2.0Hz
`
`2.0 ~1.5Hz
`
`1.5~1.0Hz
`
`1.0 ~0.5Hz
`
`0.5~0.0Hz
`
`
`MMIIIIIM
`mun-Inna
`
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`
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`
`
`mmmmmmmm
`
`
`
`
`
`
`
`26
`
`26
`
`

`

`US. Patent
`
`Sep.25,2001
`
`Sheet26 0f56
`
`US 6,293,915 B1
`
`FIG. 27
`
`
`
`27
`
`27
`
`

`

`US. Patent
`
`Sep. 25, 2001
`
`Sheet 27 0f 56
`
`US 6,293,915 B1
`
`
`
`28
`
`28
`
`

`

`US. Patent
`
`Sep. 25, 2001
`
`Sheet 28 0f 56
`
`US 6,293,915 B1
`
`
`
`29
`
`29
`
`

`

`US. Patent
`
`Sep. 25, 2001
`
`Sheet 29 0f 56
`
`US 6,293,915 B1
`
`F‘I (3. 3 1
`
`PULSE WAVE DETECTING
`
`SECTION
`
`1 O
`
`AAII
`
`2 4-3
`
`FIRST WAVELET
`
`TRANSFORMATION SECTION
`
`AAI<I3
`
`244
`
`FIRST FREQUENCY
`
`CORRECTING SECTION
`
`2 4-0
`
`AAI<E>a
`
`BODY MOVEMENT COMPONENT
`
`ELIMINATING SECTION
`
`MKDaj
`
`2 4 7
`
`INVERSE WAVELET
`
`TRANSFORMATION SECTION
`
`MHI
`AUTOCORRELATION
`CALCULATING SECTION
`
`21o
`
`F2!)
`
`2 2 0
`
`PULSE CONDITION DATA
`
`YIELDING SECTION
`
`20
`
`230
`
`DISPLAY SECTION
`
`30
`
`30
`
`

`

`US. Patent
`
`Sep. 25, 2001
`
`Sheet 30 0f 56
`
`US 6,293,915 B1
`
`FIG. 32
`
`3 O 3
`
`
`
`
`AVERAGE VALUE
`
`
`
`
`
`
`
`
`WAVEFCRM SHAPING
`SECTION
`
`COUNTER
`
`CALCULATING
`
`CIRCUIT
`
`3 0 4
`
`SUBSTITUTION
`
`CIRCUIT
`
`
`
`
`
`AAI<ID a j
`
`AAI<ID a
`
`F‘I C}.
`
`3 3
`
`
`
`31
`
`31
`
`

`

`US. Patent
`
`Sep. 25, 2001
`
`Sheet 31 0f 56
`
`US 6,293,915 B1
`
`F‘I C}.
`
`3 4
`
`f1
`
`I O
`
`
`
`PULSE WAVE DETECTING
`
`SENSOR UNIT
`
`NIH
`
`FIRST WAVELET
`
`TRANSFORMATION SECTION
`
`NIK D f
`
`AUTOCORRELATION
`
`CALCULATING SECTION
`
`RID
`
`PULSE CONDITION DATE
`
`YIELDING SECTION
`
`ZID
`
`2 4 3
`2 1 O
`
`
`
`2 2 O
`
`2 3 O
`
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`DISPLAY SECTION
`
`
`
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`
`3 5
`
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` BASIC FUNCTION
`
`AAI<ID
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`
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`
`STORING SECTION
`
`BUFFER MEMORY
`
`TRANSLATING
`
`SECTION
`
`VV5
`
`32
`
`32
`
`

`

`US. Patent
`
`Sep. 25, 2001
`
`Sheet 32 0f 56
`
`US 6,293,915 B1
`
`II I C}.
`
`3 6
`
`1 O
`
`2 O
`
`PULSE WAVE DETECTING
`SECTION
`
`BODY MOVEMENT
`DETECTING SECTION
`
`2 2
`
`AA
`
`H
`
`2 1
`
`T'H
`
`JUDGING
`
`SECTION
`
`2 4-3
`
`WAVEFORM TREATING
`SECTION
`
`FIRST IIIAvELET
`TRANSFORMATION SECTION
`
`2 4 5
`
`SECOND WAVELET
`
`BAI<ID f
`
`TRANSFORMATION SECTION
`
`(3
`
`
` 2
`
`4 O
`
`BODY MOVEMENT
`
`ELIMINATING SECTION
`
`NAI<ID f a j
`
`AUTOCORRELATION
`CALCULATING SECTION
`
`RI)
`
`PULSE CONDITION DATA
`
`YIELDING SECTION
`
`2 I 0
`
`2 2 O
`
`2|)
`
`2 3
`
`O
`
`DISPLAY SECTION
`
`33
`
`33
`
`

`

`US. Patent
`
`Sep. 25, 2001
`
`Sheet 33 0f 56
`
`US 6,293,915 B1
`
`FIG. 37A
`
`
`
`FIG. 37C
`
`101
`
`10
`
`11
`
`
`
`34
`
`34
`
`

`

`US. Patent
`
`Sep. 25, 2001
`
`Sheet 34 0f 56
`
`US 6,293,915 B1
`
`FIG. 38
`
`10: PULSE WAVE
`
`f
`
`DETECTING SECTION
`
`
`
`35
`
`35
`
`

`

`US. Patent
`
`Sep.25,2001
`
`Sheet35 0f56
`
`US 6,293,915 B1
`
`FIG. 39A
`
`204|
`
`36
`
`36
`
`
`
`

`

`US. Patent
`
`Sep. 25, 2001
`
`Sheet 36 0f 56
`
`US 6,293,915 B1
`
`FIG.4O
`
`130
`
`“£131
`
`
`
`37
`
`37
`
`

`

`US. Patent
`
`Sep. 25, 2001
`
`Sheet 37 0f 56
`
`US 6,293,915 B1
`
`FIG. 41
`
`131
`
`130
`
`170
`
`10‘!
`
`38
`
`38
`
`

`

`US. Patent
`
`Sep. 25, 2001
`
`Sheet 38 0f 56
`
`US 6,293,915 B1
`
`
`
`39
`
`39
`
`

`

`US. Patent
`
`Sep. 25, 2001
`
`Sheet 39 0f 56
`
`US 6,293,915 B1
`
`FIG. 43
`
`131
`
`130
`
`
`
`40
`
`40
`
`

`

`US. Patent
`
`Sep. 25, 2001
`
`Sheet 40 0f 56
`
`US 6,293,915 B1
`
`F IG. 4liA
`
`110
`
`100
`
`130
`
`FjIG. 411B
`
`1
`
`1
`
`
`101
`
`41
`
`41
`
`

`

`US. Patent
`
`Sep. 25, 2001
`
`Sheet 41 0f 56
`
`US 6,293,915 B1
`
`FIG.45A
`
`PINGMAI
`
`HUAMAI
`
`XUANMAI
`
`150
`
`LL]
`0:
`
`30
`
`')
`
`11 12131415
`
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`
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`
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`
`FIG.45C
`
`TIME (s)
`
`42
`
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`
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`
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`
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`‘63:?”
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`
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`
`

`

`US. Patent
`
`Sep. 25, 2001
`
`Sheet 42 0f 56
`
`US 6,293,915 B1
`
`FIG. 46
`
`DISTORTIONRATE
`
`o'
`
`HUA MAI
`
`PING MAI
`
`XUAN MAI
`
`43
`
`43
`
`

`

`US. Patent
`
`Sep. 25, 2001
`
`Sheet 43 0f 56
`
`US 6,293,915 B1
`
`FICL 47
`
`588
`
`
`
`6
`
`llilll
`
`CBM-ZOOO
`
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`
`58
`
`44
`
`44
`
`

`

`US. Patent
`
`Sep. 25, 2001
`
`Sheet 44 0f 56
`
`US 6,293,915 B1
`
`EFFUSION WAVE
`/
`
`SYSTOLIC
`BLOOD PRESSURE BPsys
`
`TIDAL WAVE
`/
`
`ABPp
`
`ASP
`
`BP
`TD
`
`/DICROTIC NOTCI—I
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`ABPD
`
`MEAN
`BLOOD PRESSURE BPmean
`
`
`
`BPDP DIASTOLIC
`BLOOD PRESSURE
`
`BF,
`dir
`
`TIME [s]
`
`45
`
`FIG. 48
`
`O
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`E
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`5::
`%
`g 3
`35 H
`Q
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`
`45
`
`

`

`US. Patent
`
`Sep. 25, 2001
`
`Sheet 45 0f 56
`
`US 6,293,915 B1
`
`FIG.149
`
`[mmHg]
`
`BPmean
`
`FICL 50
`
`60708090100110
`
`60708090100110
`
`46
`
`46
`
`

`

`US. Patent
`
`Sep. 25, 2001
`
`Sheet 46 0f 56
`
`US 6,293,915 B1
`
`FIG. 51
`
`[mmHg]
`
`3040506070
`ABP
`
`90
`
`100
`
`110
`
`120
`
`130
`
`140
`
`150
`
`47
`
`47
`
`

`

`US. Patent
`
`Sep.25,2001
`
`Sheet47 0f56
`
`US 6,293,915 B1
`
`
`
`OZHUQDHmEDm
`
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`
`48
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`

`

`US. Patent
`
`Sep. 25, 2001
`
`Sheet 48 0f 56
`
`US 6,293,915 B1
`
`L
`
`L
`
`E
`
`HUA MAI PING MAI XUAN MAI
`
`49
`
`FIG. 53
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`
`49
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`

`

`US. Patent
`
`Sep.25,2001
`
`Sheet49 0f56
`
`US 6,293,915 B1
`
`naqéfm
`
`ABPD
`
`[mmHg]
`
`9.0mdv.0mdmd70o
`
`
`50
`
`50
`
`
`

`

`US. Patent
`
`00259
`
`m
`
`6
`
`US 6,293,915 B1
`
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`51
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`
`

`

`US. Patent
`
`25,2neS
`
`S
`
`65f0
`
`US 6,293,915 B1
`
`mNm
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`

`

`US. Patent
`
`Sep.25,2001
`
`Sheet52 0f56
`
`US 6,293,915 B1
`
`II
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`

`

`US. Patent
`
`Sep.25,2001
`
`Sheet53 0f56
`
`US 6,293,915 B1
`
`mm
`
`ON
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`
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`
`54
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`
`
`54
`
`

`

`US. Patent
`
`Sep. 25, 2001
`
`Sheet 54 0f 56
`
`US 6,293,915 B1
`
`FIG. 60
`
`
`
`
`
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`
`
`
`
`g.
`
`
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`
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`
`55
`
`55
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`

`

`US. Patent
`
`Sep. 25, 2001
`
`Sheet 55 0f 56
`
`US 6,293,915 B1
`
`FIG. 61
`
`
`
`56
`
`56
`
`

`

`US. Patent
`
`Sep. 25, 2001
`
`Sheet 56 0f 56
`
`US 6,293,915 B1
`
`
`
`-60
`
`7—40
`
`—20
`
`0
`TIME [min]
`
`20
`
`4o
`
`60
`
`FIG.63
`
`'%
`
`E0
`
`5 D 9
`
`:
`[1-]
`Di
`0-.
`
`FIG.64
`
`150
`
`Control
`
`Nf (15 min)
`
`[mmHg] 0
`BLOODPRESSURE
`
`
`100
`
`50
`
`ABPP
`
`ABPD
`
`ABPP
`
`ABPD
`
`57
`
`57
`
`

`

`US 6,293,915 B1
`
`1
`
`PULSE WAVE EXAMINATION APPARATUS,
`BLOOD PRESSURE MONITOR, PULSE
`WAVEFORM MONITOR, AND
`PHARMACOLOGICAL ACTION MONITOR
`
`TECHNICAL FIELD
`
`The present invention relates to a pulse wave examination
`apparatus suitable for specifying the type of human pulse
`wave, a blood pressure monitor using the mean blood
`pressure and pulse pressure as its parameters and a pulse
`waveform monitor and a pharmacological action monitor
`which use a parameter related to a dicrotic notch part of an
`arterial pressure waveform.
`
`BACKGROUND ART
`
`The pulse wave is usually defined as a wave of blood
`which is output from the heart and propagates through a
`blood vessel. For this reason, it is known that various types
`of medical information can be obtained by the detection of
`pulse wave and analysis of the detected pulse wave. with the
`progress of studies on the pulse wave, it has become clear
`that various types of information, not obtainable only from
`the blood pressure and the pulse rate, can be obtained by
`analyzing the pulse wave, collected from the human body,
`by various techniques, making a diagnosis possible on the
`basis of these types of information.
`The inventors of the present
`invention remarked the
`relation between the pulse waveform and its distortion rate
`in PCT/JP96/01254 (Title of the Invention: DIAGNOSTIC
`APPARATUS FOR DETECTING CONDITION OF LIV-
`
`ING BODYAND CONTROLLER) and made it possible to
`diagnose the living condition of a subject by detecting and
`treating the pulse waveform of the subject, calculating the
`distortion rate of the waveform and specifying the waveform
`from the distortion rate.
`
`Here, the relationship between a pulse waveform and a
`distortion rate which are mentioned in the above application
`will be described briefly.
`First, there are various types of pulse waveforms and the
`forms are diversified. Here, typical forms of pulse wave-
`forms by the classification of Chinese medicine which is one
`of a traditional oriental medicine will be described. FIGS.
`
`45A to 45C are the charts showing representative pulse
`waveforms by this classification.
`The pulse waveform shown in FIG. 45A is called a “Ping
`mai” which is the pulse condition of a normal man in good
`health. This “Ping mai” is characterized in that, as shown in
`the figure,
`the pulse is relaxed, and exhibits a constant
`rhythm without disruption.
`Secondly,
`the pulse waveform shown in FIG. 45B is
`called a “Hua mai” which is the pulse condition of a man
`who shows an abnormality in his blood stream condition.
`The waveform of a Hua mai exhibits a sharp, rapid rise, and
`then falls off immediately, the aortic dicrotic notch is deep
`and at the same time the subsequent peak is considerably
`higher than that of a Ping mai. It is considered that diseases
`such as a mammary tumor, liver or kidney ailment, respi-
`ratory ailment, stomach or
`intestinal ailment or
`inflammation, or some other illness cause the movement of
`the blood to be very fluent and smooth, which causes this
`“Hua mai”.
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`the pulse waveform shown in FIG. 45C is
`Moreover,
`called a “Xuan mai” which is the pulse condition of a man
`whose blood vessel wall tension has increased. The Xuan
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`mai is characterized in that its waveform rises steeply and
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`2
`remains at a high pressure state for a fixed period of time
`without an immediate drop. This “Xuan mai” is seen in
`diseases such as liver and gall ailments, dermatological
`ailments, high blood pressure, and pain ailments.
`It
`is
`believed that tension in the automatic nervous system causes
`the walls of the blood vessels to constrict, decreasing
`elasticity, so that the effect of the blood pulsation of the
`pumped blood is not readily expressed, causing this phe-
`nomenon.
`
`The ordinate and the abscissa in the graphs of FIGS. 45A
`to 45C show blood pressure (mmHg) and time (second)
`respectively.
`The relationship between the pulse condition of the pulse
`waveform and its distortion rated is shown in FIG. 46. Here,
`the distortion rate d of the pulse waveform is determined by
`the following equation (1):
`
`d
`
`\/A§+A§+---+Afi
`A1
`
`(1)
`
`wherein A1 is the amplitude of a basic wave component in
`the pulse wave and A2, A3, .
`.
`.
`, An are the amplitudes of the
`second, third,
`.
`.
`. and nth harmonic components respec-
`tively.
`It is therefore possible to specify the pulse condition of the
`pulse waveform quantitatively from the correlation shown in
`FIG. 46 if the pulse waveform of a subject is detected and
`the detected waveform is subjected to FFT (Fourier
`transformation) treatment to find the amplitudes A1 to An
`from which the distortion rate d is calculated.
`
`As shown in FIG. 46, when the pulse condition of the
`subject is judged to be a Hua mai, the distortion rate d is in
`a range between 0.98 and 1.22. When the pulse condition is
`judged to be a Ping mai, the distortion rate d is in a range
`between 0.92 and 1.10. When the pulse condition is judged
`to be a Xuan mai, the distortion rate d is in a range between
`0.73 and 0.94.
`
`In this case, the pulse condition can be judged to be a Hua
`mai or a Ping mai when the distortion rate d of the pulse
`waveform is in a range between 0.98 and 1.10. Also, the
`pulse condition can be judged to be a Ping mai or a Xuan mai
`when the distortion rate d of the pulse waveform is in a range
`between 0.92 and 0.94. It is therefore difficult to judge the
`pulse condition precisely by a conventional pulse wave
`examination apparatus.
`In the meantime, a blood pressure gauge measuring a
`maximum blood pressure and a minimum blood pressure
`and displaying these pressures is used in noninvasive detec-
`tion of blood pressure.
`Although the maximum blood pressures or minimum
`pressures of subjects are alike, there are various types of
`waveforms for blood pressure. Hence the characteristics of
`the blood pressure of an individual expressed only by a
`maximum blood pressure and a minimum blood pressure are
`insufficient.
`
`The mean blood pressure is an important parameter for
`knowing the condition of the blood pressure of an indi-
`vidual. The mean blood pressure cannot be obtained only by
`measurements of a maximum blood pressure and minimum
`blood pressure.
`In sphygmic detection adopted in Chinese medicine or in
`Indian traditional medicine, a medical examination is carried
`out by examining the pulse waveform detected by the fingers
`when a medical examiner presses with an optimum pressing
`force against a distal position of the forearm from the arteria
`radialis,
`that
`is, a medical examination is conducted by
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`US 6,293,915 B1
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`3
`detection of a variation with the pressing force, which
`variation is felt by the fingers of the medical examiner
`corresponding to a variation in blood pressure.
`In Chinese medicine, for instance, the pulse waveform felt
`when a proper pressing force is applied to the arteria radialis
`is roughly divided into three categories, which are desig-
`nated as a “Ping mai”, “Hua mai” and “Xuan mai” respec-
`tively as aforementioned. The Ping mai is deliberate and
`mild and its rhythm is stable and reduced in turbulence. This
`Ping mai is a pulse image for a man in good health. The Hua
`mai is the type in which the flow of the pulse is felt to be very
`fluent and smooth, showing abnormality in the blood stream
`condition. The Xuan mai is felt to be a straight, tense and
`long pulse and is regarded to be due to tension or aging of
`a blood vessel wall.
`
`Such a medical examination method, however, is depen-
`dent upon the pulse waveform classified by the sense of the
`medical examiner posing problems with regard to its objec-
`tivity and reproducibility.
`The present invention has been conducted in the above
`situation and has an object of providing a pulse wave
`examination apparatus which can judge the pulse condition
`objectively and accurately.
`Another object of the present invention is to provide a
`blood pressure monitor which can indicate blood conditions
`in more detail than the information of a maximum and
`
`minimum blood pressure and can monitor the monitor
`parameters signifying blood pressure noninvasively.
`A further object of the present invention is to provide a
`pulse waveform monitor which can carry out an examination
`by the pulse waveform objectively and reproducibly.
`DISCLOSURE OF THE INVENTION
`
`(1) Apulse wave examination apparatus according to the
`present invention comprises:
`a pulse wave detecting means for detecting a pulse
`waveform from a living body;
`a tidal wave-character extracting means for extracting the
`characteristics of a tidal wave from the pulse waveform
`to yield tidal wave-character information;
`a dicrotic wave-character extracting means for extracting
`the characteristics of a dicrotic wave from the pulse
`waveform to yield dicrotic wave-character information;
`and
`
`a pulse condition judging means for judging the pulse
`condition of the living body on the basis of the tidal
`wave-character information and the dicrotic wave-
`character information.
`
`(2) In the pulse wave examination apparatus according to
`(1), preferably the tidal wave-character extracting means
`yields the tidal wave-character information on the basis of a
`variation in the amplitude in the time-domain of the tidal
`wave, and the dicrotic wave-character extracting means
`yields the dicrotic wave-character information on the basis
`of a variation in the amplitude in the time-domain of the
`dicrotic wave.
`
`(3) In the pulse wave examination apparatus according to
`(2), preferably the variations in the amplitude in the time-
`domain of the tidal wave and the dicrotic wave are calcu-
`
`lated from the primary or secondary time derivative of the
`pulse waveform.
`(4) Apulse wave examination apparatus according to the
`present invention comprises:
`a pulse wave detecting means for detecting a pulse
`waveform from a living body;
`a frequency analyzing means for performing a frequency
`analysis of the pulse waveform;
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`a tidal wave-character extracting means for extracting the
`characteristics of a tidal wave from the result of the
`
`analysis of the frequency analyzing means to yield tidal
`wave-character information;
`a dicrotic wave-character extracting means for extracting
`the characteristics of a dicrotic wave from the result of
`
`the analysis of the frequency analyzing means to yield
`dicrotic wave-character information; and
`a pulse condition judging means for judging the pulse
`condition of the living body on the basis of the tidal
`wave-character information and the dicrotic wave-
`character information.
`
`(5) In the pulse wave examination apparatus according to
`(4), preferably the tidal wave-character information extract-
`ing means specifies a period of the tidal wave in the pulse
`waveform and extracts the characteristics of the tidal wave
`from the tidal waveform on the basis of the result of the
`
`analysis of the frequency analyzing means in the period of
`the tidal wave to yield tidal wave-character information, and
`the dicrotic wave-character information extracting means
`specifies a period of the dicrotic wave in the pulse waveform
`and extracts the characteristics of the dicrotic wave from the
`
`tidal waveform on the basis of the result of the analysis of
`the frequency analyzing means in the period of the dicrotic
`wave to yield dicrotic wave-character information.
`(6) In the pulse wave examination apparatus according to
`(4) or (5), preferably the frequency analyzing means per-
`forms FFT treatment of the pulse waveform.
`(7) In the pulse wave examination apparatus according to
`(4) or (5), preferably the frequency analyzing means per-
`forms wavelet transformation treatment of the pulse wave-
`form.
`
`(8) The pulse wave examination apparatus according to
`any one of (1) to (7), preferably further comprises a notifi-
`cation means for communicating the pulse condition judged
`by the pulse condition judging means.
`(9) Apulse wave examination apparatus according to the
`present invention comprises:
`a pulse wave detecting means for detecting a pulse
`waveform from the detecting position of a living body;
`a auto-correlation calculating means for calculating auto-
`correlation data giving the auto-correlation of the pulse
`waveform detected by the pulse wave detecting means;
`and
`
`a pulse condition-data yielding means for yielding pulse
`condition data giving the type of pulse waveform based
`on the auto-correlation data.
`
`(10) In the pulse wave examination apparatus according
`to (9), preferably the pulse condition-data yielding means
`produces the pulse condition data by comparing the auto-
`correlation data with a prescribed threshold value.
`(11) In the pulse wave examination apparatus according to
`(10), preferably the pulse condition-data yielding means
`comprises a minimum value detecting section for detecting
`the minimum value of the auto-correlation data during a
`period of one heart beat, and a comparing section for
`comparing the minimum value, detected by the minimum
`value detecting section, with the threshold value to yield the
`pulse condition data.
`(12) In the pulse wave examination apparatus according
`to (10), preferably the pulse condition-data yielding means
`comprises a minimum value detecting section for detecting
`an average minimum value by averaging each minimum
`value of the auto-correlation data detected in each of plural
`heart beat periods, and a comparing section for comparing
`the average minimum value, detected by the minimum value
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`5
`detecting section, with the threshold value to yield the pulse
`condition data.
`
`(13) In the pulse wave examination apparatus according
`to (9), preferably the pulse condition-data yielding means
`comprises: a time measuring section for comparing the
`auto-correlation data with a prescribed threshold value to
`measure a time interval in which the auto-correlation data
`exceeds or is less than the threshold value; a calculating
`section for calculating the ratio of the time interval, mea-
`sured by the time measuring section, to a period of one heart
`beat; and a comparing section for comparing the result,
`calculated by the calculating section, with a prescribed
`threshold value to yield the pulse condition data.
`(14) In the pulse wave examination apparatus according
`to (13), preferably the calculating section calculates the ratio
`of the time interval, measured by the time measuring
`section,
`to a period of one heart beat and calculates the
`average of the calculated results.
`(15) In the pulse wave examination apparatus according
`to (9), preferably the pulse condition-data yielding means
`comprises a change rate calculating section for detecting the
`change rate of the auto-correlation data on the basis of the
`auto-correlation data, and a change rate comparing section
`for comparing the change rate, detected by the change rate
`calculating section, with a prescribed threshold value to
`yield the pulse condition data.
`(16) In the pulse wave examination apparatus according
`to (15), pr