throbber
(12)
`
`United States Patent
`Booth et al.
`
`(10) Patent N0.:
`(45) Date of Patent:
`
`US 6,440,080 B1
`Aug. 27, 2002
`
`US006440080B1
`
`(54) AUTOMATIC OSCILLOMETRIC
`APPARATUS AND METHOD FOR
`MEASURING BLOOD PRESSURE
`
`-
`_
`_
`(75) Inventors‘ John W‘ Booth’ Bruce A‘ Fnedman’
`b th f T
`FL US
`O O ampa>
`(
`)
`.
`,
`_
`(73) Ass1gnee: GE Medical Systems 'Information
`Technologies, IIlC., Milwaukee, WI
`(Us)
`
`( * ) Notice:
`
`Subject to any disclaimer, the term of this
`patent is extended or adjusted under 35
`U-S-C- 154(1)) by 0 days-
`
`(21) Appl. No.: 09/962,380
`(22) Filed:
`Sep. 25, 2001
`
`/
`(
`)
`Int. Cl.7 ................................................ .. A61B 5 00
`51
`-
`-
`(52) US. Cl. ...................... .. 600/494, 600/495, 600/496
`(58) Field of Search ............................ .. 600/490 493—6
`’
`
`(56)
`
`References Cited
`
`U.S. PATENT DOCUMENTS
`
`9/1982 Ramsey, 111
`4,349,034 A
`4,360,029 A 11/1982 Ramsey, 111
`4,425,920 A
`1/1984 Bourland et 81.
`4,543,962 A 10/1985 Medero et al.
`4,638,810 A
`1/1987 Ramsey, III et 81.
`
`4,793,360 A * 12/1988 Miyawaki et a1. ........ .. 600/494
`4,869,261 A
`9/1989 Penal
`4,873,987 A 10/1989 Djordjevich et 211.
`4,889,133 A 12/1989 Nelson et al.
`4,949,710 A
`8/1990 Dorsett et a1.
`5 054 494 A * 10/1991 LaZZaro et a1. ........... .. 600/494
`’
`’
`5,178,154 A
`1/1993 Ackmann et a1.
`5,590,662 A
`1/1997 Hersh et al.
`5,649,543 A
`7/1997 Hosaka et a1‘
`5,785,659 A
`7/1998 Caro et aL
`5,865,755 A
`2/1999 Golub
`6,186,953 B1
`2/2001 Narimatsu
`_ d b
`_
`Cue
`y exammer
`Primary Examiner—Robert L. Nasser
`(74) Attorney, Agent, or Firm—George E. Haas; Quarles &
`Brady LLP
`(57)
`
`ABSTRACT
`
`*
`
`P
`g
`y p
`B10091 ressure of an human bein is read b a rocess that
`laces a cuff around a ortion of the human bein ’s bod .
`P
`P
`g
`y
`The Cuff is in?ated to a Prede?ned Pressure Which 0661119165
`the ?ood of blood and then the cuff is de?ated in a controlled
`manner. At a plurality of de?ation pressure levels, pressure
`pulses that occur in the cuff are integrated to produce a
`plurality of integral values. Adiastolic pressure of the human
`being is derived in response to the de?ation pressure level at
`Which occurred the integral value that is greatest in magni
`tude.
`
`20 Claims, 2 Drawing Sheets
`
`‘[16
`
`‘—__
`34
`9 V .4.
`
`‘_
`
`4
`
`207i“
`/-24
`1,
`PRESSURE
`FILTER‘
`TRANSDUCER
`25/
`
`30
`
`CONTROL
`PANEL
`AND DISPLAY
`
`CONTROLLER
`
`l
`
`E
`A
`' “29
`27
`
`l
`
`- - - K
`
`26
`
`NxSTAGE Ex 2004-1
`Nipro v NxStage
`IPR2016-00744
`
`

`
`U.S. Patent
`
`Aug. 27, 2002
`
`Sheet 1 0f 2
`
`US 6,440,080 B1
`
`‘
`16
`f
`
`34
`
`2
`3
`\ CONTROL
`PANEL
`
`"8 w?” |—
`
`22 Ami], E
`
`20: L'- 30
`/'24
`PRESSURE
`TRANSDUCER
`
`FILTER
`
`‘
`
`CONTROLLER
`
`A
`"'" \
`'
`29
`50°"
`- — - K 27
`26
`
`CUFF PRESSURE
`PULSE AMPLITUDE
`
`PULSE AREA
`
`FIG.3
`
`FIG. 4
`
`FIG. 5
`
`. ii
`
`I
`
`0
`
`.
`
`.
`
`.
`
`NxSTAGE Ex 2004-2
`Nipro v NxStage
`IPR2016-00744
`
`

`
`U.S. Patent
`
`Aug. 27, 2002
`
`Sheet 2 0f 2
`
`US 6,440,080 B1
`
`FIG.‘ 2
`
`(555? K40
`[SET STEP COUNT = 0]
`
`42
`
`IINFLATE CUFF TO OCCLUDE PRESSURE]
`
`'
`
`(SET MEASUREMENT COUNT = 0|
`2
`'0
`/
`FMEAsuRE AND sToRE CUFF PRESSUREJ
`/" 48
`IINCREMENT MEASUREMENT COUNU
`
`46
`
`X
`MEASUREMENTS
`TAKEN?
`
`K- 54
`iv NO
`COMPUTE AND STORE
`OSCILLATION AMPLITUDE FOR STEP
`
`| INCREMENT STEP COUNT K’ 56
`
`IDEFLATE CUFF ONE STEP 1/’ 58
`
`64
`/
`T
`FIND STEP WITH GREATEST PEAK TO PEAK OSCILLATION]
`
`| FIND SYSTOLIC PRESSURE I/' 66
`I
`K68
`FIND STEP WITH LARGEST OSCILLATION AREA
`AND SET DIASTOLIC PRESSURE TO STEP PRESSURE
`(E
`
`NxSTAGE Ex 2004-3
`Nipro v NxStage
`IPR2016-00744
`
`

`
`US 6,440,080 B1
`
`1
`AUTOMATIC OSCILLOMETRIC
`APPARATUS AND METHOD FOR
`MEASURING BLOOD PRESSURE
`
`CROSS-REFERENCE TO RELATED
`APPLICATIONS
`
`Not applicable.
`
`STATEMENT REGARDING FEDERALLY
`SPONSORED RESEARCH OR DEVELOPMENT
`
`Not applicable.
`
`BACKGROUND OF THE INVENTION
`
`2
`cease and the pressure is again noted, Which pressure is
`referred to as diastolic pressure and is taken as an estimate
`of the true intra-arterial diastolic pressure. The difference
`betWeen the diastolic pressure and systolic pressure is
`termed pulse pressure. Previously the constriction pressure
`has been derived from an in?atable cuff connected to a
`mercury column manometer or to an aneroid type gauge
`having a dial scale calibrated in millimeters of mercury. It is
`also knoWn that the auscultatory estimate of diastolic pres
`sure can at times be inaccurate; auscultation can be very
`technique dependent and varies, for example, due to the
`hearing ability of the clinician taking the reading.
`Furthermore, auscultation can, in some cases, be quite
`confusing When determining diastolic estimates because the
`Korotkoff sounds may never disappear as the cuff pressure
`is loWered.
`A previous automatic indirect blood pressure reading
`apparatus employed the oscillometric method in Which an
`arm cuff is in?ated to a pressure at Which blood ?oW is
`occluded. The cuff then is de?ated at predetermined pressure
`increments in a step-Wise manner. At each step, the pressure
`in the cuff is measured repeatedly using a suitably short
`sampling period in order to detect pressure ?uctuations. The
`instantaneous pressure in the cuff is due to the in?ation
`pressure and the force exerted by the pressure pulsations in
`the patient’s blood vessels during each heartbeat. The beat
`ing heart causes the pressure in the cuff to oscillate at each
`step of de?ation. The apparatus continues in this fashion
`until a complete envelope of oscillation amplitude versus
`cuff pressure is obtained. The cuff pressure at Which the
`maximum amplitude oscillations are obtained is indicative
`of the mean arterial pressure. The systolic and diastolic
`pressure estimates are also determined from prede?ned
`functions of the envelope data. The oscillometrically deter
`mined systolic, MAP, and diastolic are considered estimates
`of the true intra-arterial pressure values. HoWever, it is also
`knoWn that arterial compliance plays a major role in the
`estimating functions; arterial compliance can change in
`complicated and unpredictable Ways as physiological cir
`cumstances change.
`
`BRIEF SUMMARY OF THE INVENTION
`The oscillometric blood pressure is determined indirectly
`from a cuff that is placed around a portion of the body, such
`as an upper arm, of the human being Whose blood pressure
`is desired. The cuff is in?ated to a predetermined pressure,
`preferably great enough to occlude the ?oW of blood in the
`limb of the patient. Then the cuff is de?ated in a controlled
`manner to produce a de?ation pressure in the cuff that
`decreases With time. In the preferred embodiment, the cuff
`is de?ated in regular pressure increments thereby producing
`a plurality of discrete de?ation pressure levels.
`During each of a plurality of heartbeats, the pressure
`oscillations that occur at the discrete de?ation pressure
`levels are measured and stored in the apparatus. The com
`plete data set of the amplitude of the oscillations versus the
`discrete pressure levels is knoWn as the oscillometric enve
`lope. The oscillometric estimate of the mean arterial pres
`sure is determined from this envelope data. For example, the
`estimate of the mean arterial pressure (MAP) is the de?ation
`pressure level that occurs When the oscillation measure
`ments have the greatest amplitude. Similarly, the systolic
`pressure can be estimated from the envelope data by ?nding
`the discrete pressure level Which occurred When the oscil
`lation amplitude is a predetermined fraction of the maximum
`oscillation siZe at cuff pressures above MAP. Note that
`interpolating betWeen discrete de?ation pressure levels may
`produce a more accurate estimate of systolic pressure.
`
`The invention generally relates to oscillometric blood
`pressure determining techniques, and more particularly to
`determining the diastolic pressure using that technique.
`Knowing the pressures exerted by blood on the blood
`vessel Walls of patients is of great value to those engaged in
`medical practice. In the case of humans, the pressure in the
`vascular system is measured for many reasons, including
`diagnosis, ascertainment of the progress of therapy, the
`physiological state When under anesthesia, etc. As an
`example, the determination of arterial blood pressure is an
`essential element in the diagnosis of a patient suspected of
`cardiac disease. Normal human arterial blood pressure
`ranges betWeen 80—120 millimeters of mercury, Whereas
`elevations of arterial blood pressure above that range are
`found in cases of congestive heart failure, renal artery
`disease, coarctation of the aorta, etc. Additionally, untreated
`hypertension is knoWn to be associated With an increased
`risk of stroke, coronary artery disease, and aneurysms.
`During the cycle of the heartbeat, Which normally occurs
`approximately once per second, the arterial blood pressure
`oscillates. When the heart muscle contracts, knoWn as
`systole, blood is pushed into the arteries. This increases the
`arterial pressure. When the heart muscle relaxes, knoWn as
`diastole, the arterial blood pressure falls. The maximum of
`the arterial pressure oscillation during the heartbeat is
`knoWn as systolic pressure; the minimum is knoWn as
`diastolic pressure. The arterial pressure versus time Wave
`form can also be used to calculate What is knoWn as mean
`arterial pressure. The mean arterial pressure (MAP) is cal
`culated by integrating the arterial pressure Waveform for one
`cycle and then dividing that quantity by the cycle period.
`The indirect techniques of oscillometry and auscultation are
`used in practice to estimate the systolic, mean, and diastolic
`pressures non-invasively. HoWever, it is knoWn that under
`certain rare conditions the diastolic estimate Which oscil
`lometry produces is inaccurate, yet the systolic and MAP
`estimates are good. It is the purpose of this invention to
`improve the diastolic estimate using easily obtained, but
`previously ignored oscillometric information.
`The auscultatory method is commonly used by medical
`personnel to indirectly measure arterial blood pressure. In
`this technique, constrictive pressure is gradually applied
`about the limb of the patient until the ?oW of blood through
`the limb vessel has been arrested, as determined by listening
`to a stethoscope applied over the vessel at a point distal the
`point of constriction. Then upon gradual release of the
`constriction pressure, the beginning of the ?oW through the
`vessel can be heard and the constriction pressure is noted on
`a gauge reading in millimeters of mercury. This pressure is
`referred to as systolic pressure and is taken as an estimate of
`the true intra-arterial systolic pressure. The pressure then is
`gradually released further until the sounds of the ?oW again
`
`15
`
`20
`
`25
`
`30
`
`35
`
`40
`
`45
`
`55
`
`60
`
`65
`
`NxSTAGE Ex 2004-4
`Nipro v NxStage
`IPR2016-00744
`
`

`
`US 6,440,080 B1
`
`3
`Diastolic pressure can be estimated from the envelope
`data by ?nding the discrete pressure level Which occurred
`When the oscillation amplitude is a predetermined fraction of
`the maximum oscillation siZe at cuff pressures beloW MAP.
`Interpolating betWeen discrete de?ation pressure levels may
`produce a more accurate estimate of diastolic pressure. This
`method can lead to errors in the determination of diastolic
`pressure under some circumstances.
`In the preferred embodiment, the diastolic pressure is
`determined by measuring the area of the oscillation com
`plexes. The diastolic pressure is determined by ?nding the
`de?ation pressure beloW MAP that produces the largest
`oscillation area.
`If for a given measurement, the measured amplitude under
`the oscillation pulse is greatest at MAP, then the diastolic
`pressure Will be determined from the de?ation pressure
`Where the oscillation amplitude is a predetermined fraction
`of the maximum amplitude.
`In an alternative embodiment, the diastolic pressure is
`determined by ?nding a ?rst de?ation pressure at Which the
`maximum oscillation area occurs and a second de?ation
`pressure at Which the predetermined amplitude ratio occurs.
`The diastolic pressure is calculated as the average of the ?rst
`and second de?ation pressures.
`
`DESCRIPTION OF THE OF THE DRAWINGS
`
`FIG. 1 is a block diagram of an indirect noninvasive
`apparatus for measuring blood pressure;
`FIG. 2 is ?oWchart of the operation of the apparatus;
`FIG. 3 is a graph of pressure in a cuff of the apparatus;
`FIG. 4 is a graph of the amplitude of the oscillation pulses
`of the cuff pressure; and
`FIG. 5 is a graph of the area of the oscillation pulses.
`
`DETAILED DESCRIPTION OF THE
`INVENTION
`With reference to FIG. 1, an automatic blood pressure
`measuring apparatus 10 employs an in?atable cuff 12 shoWn
`Wrapped around an arm 14 of a human medical patient. The
`in?atable cuff 12 is connected to a pump 16 by a ?exible ?rst
`tube 18. The ?rst tube also connects to an electrically
`operated de?ation valve 20 and to a protective over pressure
`sWitch 34 Which responds to excessive pressure being
`applied to the cuff 12. A?exible second tube 22 couples the
`cuff 12 to a pressure transducer 24 Which produces an
`electrical signal at output that indicates the pressure Within
`the cuff.
`The output of the pressure transducer 24 is connected
`directly to one input of a multiplexer 27. The pressure
`transducer output also is coupled to a band pass ?lter 25
`Which in turn is connected to an ampli?er 26 Which has an
`output connected to another input of the multiplexer 27. The
`?lter 25 and ampli?er 26 are designed to reject the dc.
`component of pressure signal produced by the transducer 24
`and yet amplify the blood pressure oscillations, as Will be
`described. Speci?cally, the ?lter 25 passes those signals
`having frequency components in an approximate range of
`one to ten HertZ and strongly rejects other frequency com
`ponents. The ampli?er 26 magni?es loW level signals from
`the ?lter 25. The output signal from the ampli?er 26
`corresponds to the oscillations, or the ac. component, of the
`pressure in the cuff 12. These components have been used in
`previous blood pressure sensors and are Well knoWn to those
`skilled in the art. Alternatively, the un?ltered cuff pressure
`signal could be used if it has enough analog to digital
`conversion resolution.
`
`10
`
`15
`
`20
`
`25
`
`30
`
`35
`
`40
`
`45
`
`55
`
`60
`
`65
`
`4
`The multiplexer 27 selects one of the tWo pressure signals
`and couples the selected signal to an analog input 29 of a
`controller 28. The controller 28 is a computeriZed device
`Which includes a conventional microprocessor, a memory
`for storing a program that controls operation of the apparatus
`10 and data used in the execution of that program, and input
`and output circuits to interface the controller to other com
`ponents of the apparatus. For example, the output of the
`multiplexer 27 is connected to an input of an internal analog
`to digital converter of the controller 28. A control panel and
`display 32 provides a user interface to the blood pressure
`measuring apparatus. The controller 28 has an output con
`nected to control the pump 16.
`Another output of the controller 28 is coupled to a ?rst
`input of an AND gate 30. The AND gate 30 has a second
`input connected to the over pressure sWitch 34 and an output
`that connects to control the de?ation valve 20. In the event
`of an excessive pressure in the cuff 12, the over pressure
`sWitch 34 opens Which results in the output of the AND gate
`opening the de?ation valve 20 to relieve that excessive
`pressure in the cuff 12. Additional devices can be provided
`to alert the attending personnel to abnormal pressure or
`functional conditions.
`In operation, the cuff 12 is Wrapped around the arm 14 of
`a patient Whose blood pressure is to be measured. The
`attendant then activates a sWitch on the control panel 32
`Which commences the measurement operation. Speci?cally,
`the controller 28 responds to the electrical signal produced
`When that sWitch is operated by commencing execution of a
`control program Which performs a measurement cycle.
`With reference to FIG. 2, the control program commences
`at step 40 With the controller 28 initialiZing a step count to
`a value of Zero. At step 42, the controller produces output
`signals Which close the de?ation valve 20 and activatea the
`pump 16 to in?ate the cuff 12. As the cuff is being in?ated,
`the controller 28 monitors the electrical signal from the
`pressure transducer 24 Which indicates the pressure Within
`the cuff 12. The cuff is in?ated to a prede?ned pressure
`Which is knoWn to occlude the ?oW of blood Within the
`blood vessels of the arm 14. For example, if previous
`pressure measurements have been taken from this patient,
`the occlude pressure may be a prede?ned amount (eg 60
`mm of mercury) greater than the previous systolic pressure.
`Once this occlude pressure has been obtained, the controller
`28 terminates operation of the pump 16 While maintaining
`the de?ation valve 20 in a closed state.
`The controller 28 then begins a controlled de?ation of the
`cuff 12 While periodically measuring the pressure therein. In
`the preferred embodiment of the present invention, the
`controller gradually de?ates the cuff in a series of steps as
`shoWn in FIG. 3 and the nominal pressure at each step is
`referred to herein as the “de?ation pressure” or the “de?a
`tion step pressure”. For example, each step may be a
`decrease in pressure of eight millimeters of mercury. As
`noted previously the instantaneous pressure at each step is
`not alWays constant, but oscillates slightly due to the force
`exerted on the cuff 12 by the blood pulsing through the
`patient’s blood vessels. A plurality of pressure measure
`ments are taken at each step to measure those pressure
`oscillations. As Will be described, the systolic and diastolic
`pressures are derived from an analysis of the pressure
`?uctuations at the different pressure steps. Alternatively, the
`pressure Within the cuff can be de?ated in a continuous,
`preferably linear, manner While continuously measuring the
`pressure ?uctuations Within the cuff 12. As a further
`alternative, the cuff pressure measurements used to estimate
`the patient’s blood pressure can be acquired While the cuff
`is being in?ated.
`
`NxSTAGE Ex 2004-5
`Nipro v NxStage
`IPR2016-00744
`
`

`
`US 6,440,080 B1
`
`5
`The pressure measuring begins at step 44 Where the
`controller 28 sets a measurement count to Zero. The execu
`tion of the software program then enters a loop at Which a
`plurality of measurements of the pressure Within the cuff 12
`are taken. At step 46, the signal from the pressure transducer
`24 is read by the controller 28 and stored in memory. The
`signal produced by the pressure transducer 24 can be read
`directly to sense the de?ation step pressure and then the
`pressure signal processes by the band pass ?lter 25 and
`ampli?er 26 can be read to obtain a measurement of the
`amplitude of the blood pressure oscillation Waveform. Spe
`ci?cally the ?lter and ampli?er remove the baseband or do
`offset of the pressure measurement that is due to the de?a
`tion step pressure leaving only the ac. component repre
`senting the oscillation Waveform. Then, the measurement
`count is incremented at step 48 before the program advances
`to step 50 Where a determination is made Whether the
`requisite number of measurements, designated by the vari
`able X, has been taken at this pressure step. If not, the
`program execution loops back to step 46 to acquire another
`measurement.
`The requisite number of measurements determines the
`length of time that the apparatus remains at each pressure
`step of the de?ation process. The requisite number X is large
`enough to ensure that the pressure Will be measured over at
`least one cardiac cycle. When that number of measurements
`has been taken, the program execution advances to step 52
`at Which the measurements for the current step are analyZed
`to determine Whether they contain artifacts Which Will
`interfere With accurate blood pressure determination. As is
`Well knoWn, artifacts can be produced by arm movement
`during the sensing or by an attendant bumping against the
`cuff. Various processes exist for detecting these artifacts,
`such as described in Us. Pat. No. 4,349,034, the description
`of Which is incorporated by reference. If a signi?cant artifact
`is found, the program execution returns to step 44 to acquire
`another set of measurements at the present de?ation step.
`This loop continues until satisfactory measurements are
`taken or until a determination is made by the controller 28
`that accurate measurement is not possible.
`Once a valid set of pressure measurements has been
`acquired for a given pressure step, the program execution
`advances to step 54 Where the maximum oscillation ampli
`tude for that step is computed. As the pressure Within the cuff
`is released, the force exerted on the cuff by the arterial blood
`?oW produce greater oscillations of the cuff pressure. In
`other Words, When the pressure in the cuff is relatively high,
`only the pressure peaks of each pulse of blood in the
`patient’s arm exceed the de?ation cuff pressure so as to vary
`the total cuff pressure. As the cuff 12 is de?ated further, a
`greater portion of each blood pressure pulse exceeds the
`de?ation cuff pressure, thereby producing pressure oscilla
`tions With larger amplitudes as depicted in FIG. 4. Therefore,
`at step 54, the controller 28 calculates the difference betWeen
`the greatest pressure measured during the step and the
`de?ation pressure of that step. That difference is stored in
`memory as the pulse or oscillation amplitude for the asso
`ciated de?ation pressure step.
`The operation of the measurement apparatus then pro
`ceeds to step 56 Where the de?ation step count is incre
`mented. Next at step 58, the controller opens the de?ation
`valve 20 to release a given amount of pressure Within the
`cuff 12. The controller 28 directly monitors the signal from
`the pressure transducer 24 until the pressure has decreased
`by the desired amount, for example eight millimeters of
`mercury. Then a determination is made at step 60 Whether
`the requisite number of pressure steps has been completed
`
`10
`
`15
`
`20
`
`25
`
`30
`
`35
`
`40
`
`45
`
`55
`
`60
`
`65
`
`6
`for the measurement cycle. The measurement cycle may be
`de?ned in terms of a given number of steps, or dynamically
`by observing the oscillation amplitudes measured for each
`step, the measurement cycle can terminate When those
`amplitudes are not longer changing.
`Upon completion of the measurement cycle, the controller
`28 opens the de?ation valve 20 at step 62 to release any
`remaining pressure Within the cuff 12. Then at step 64, the
`controller examines the oscillation amplitudes stored in
`memory for each of the de?ation steps. Speci?cally, the
`stored value representing the greatest oscillation amplitude
`is located, as occurred for example at time T2 in FIG. 4, and
`the de?ation step pressure at that time is identi?ed. That step
`
`pressure corresponds to the mean arterial pressure At step 66 the systolic pressure is derived by ?rst calculating
`
`a reference peak oscillation amplitude that is given fraction
`(e.g. 0.5) of the greatest oscillation amplitude. The de?ation
`step pressure at the time T1 When that reference peak
`oscillation amplitude ?rst occurred is found. The de?ation
`pressure at that step then corresponds to the systolic pres
`sure. The peak oscillation amplitude of any de?ation step
`may not correspond exactly to the calculated reference peak
`oscillation amplitude. In Which case the reference peak
`oscillation amplitude falls betWeen the peak oscillation
`amplitudes of tWo adjacent de?ation steps. When that
`occurs, the systolic pressure is derived by interpolating the
`de?ation pressures for those steps.
`The present inventor has found that the diastolic pressure
`occurs at the highest de?ation pressure at Which the oscil
`lations have the greatest area. In other Words, the diastolic
`pressure of the patient can be derived by integrating pressure
`measurements for each de?ation step and ?nding de?ation
`cuff pressure of the de?ation step at Which the greatest
`integral occurred. This is accomplished at step 68 by sum
`ming the pressure measurements during each de?ation step
`and identifying the ?rst de?ation step to occur that is
`associated With the largest sum. The de?ation pressure for
`that step corresponds to the diastolic pressure.
`Therefore, the present apparatus determines the systolic
`pressure based on a fraction of the mean pressure during the
`measurement cycle, and determines the diastolic pressure
`based on an integral of the pressure oscillations Which occur
`during each step; and speci?cally, based on the de?ation
`pressure Which occurs at a step that has the greatest integral.
`As a variation of the method by Which the diastolic
`pressure value is determined, the integration procedure
`described above is used to produce a ?rst estimate of the
`diastolic pressure. Then a second estimate of the diastolic
`pressure is derived by ?rst calculating a reference value that
`is given fraction of the greatest oscillation amplitude. The
`de?ation step that occurred after the occurrence of the
`greatest oscillation amplitude are inspected to ?nd the step
`having a peak oscillation amplitude that is closest arithmeti
`cally to the reference value. The de?ation pressure at that
`step then is de?ned as the second estimate of the diastolic
`pressure. That second estimate also can be derived by
`interpolating the de?ation pressures for adjacent de?ation
`steps betWeen Which the reference value is located. The a
`diastolic pressure value then is determined by averaging the
`?rst and second estimates of the diastolic pressure, although
`other arithmetic functions can be employed to derive the
`diastolic pressure value from those estimates.
`The foregoing description Was primarily directed to a
`preferred embodiment of the invention. Although some
`attention Was given to various alternatives Within the scope
`of the invention, it is anticipated that one skilled in the art
`
`NxSTAGE Ex 2004-6
`Nipro v NxStage
`IPR2016-00744
`
`

`
`US 6,440,080 B1
`
`7
`Will likely realize additional alternatives that are noW appar
`ent from disclosure of embodiments of the invention.
`Accordingly, the scope of the invention should be deter
`mined from the following claims and not limited by the
`above disclosure.
`What is claimed is:
`1. A method for indirectly measuring blood pressure
`comprising:
`placing a cuff around a portion of a human being;
`varying pressure Within the cuff to produce a plurality of
`cuff pressure levels;
`While at a given cuff pressure level, measuring and storing
`the given cuff pressure level and a plurality of pressure
`oscillation amplitude values to produce a pressure
`oscillation Waveform, thereby producing a plurality of
`measurements;
`integrating a plurality of pressure oscillations of the
`pressure oscillation Waveform to produce a plurality of
`integral values; and
`deriving a ?rst estimate of diastolic pressure for the
`human being in response to the cuff pressure level
`Which occurred coincident With the pressure oscillation
`Which produced the integral value that is greatest in
`magnitude.
`2. The method as recited in claim 1 Wherein the integrat
`ing comprises individually summing pressure oscillation
`amplitude values Which correspond to each of the plurality
`of pressure oscillations.
`3. The method as recited in claim 1 Wherein varying
`pressure Within the cuff comprises in?ating the cuff.
`4. The method as recited in claim 1 Wherein varying
`pressure Within the cuff comprises in?ating the cuff to a
`predetermined pressure, and thereafter de?ating the cuff to
`produce the plurality of pressure levels Which decrease With
`time.
`5. The method as recited in claim 1 further comprising:
`determining a peak value for each pressure oscillation;
`identifying a peak value of greatest magnitude;
`deriving a second estimate of diastolic pressure Which
`corresponds to the cuff pressure level Which occurred
`coincident With the pressure oscillation that has the
`peak value of greatest magnitude; and
`calculating a diastolic, pressure value as a function of the
`?rst estimate of diastolic pressure and the second
`estimate of diastolic pressure.
`6. The method as recited in claim 5 Wherein calculating a
`diastolic pressure value averages the ?rst estimate of dias
`tolic pressure and the second estimate of diastolic pressure.
`7. The method as recited in claim 1 further comprising
`determining an estimated mean arterial pressure for the
`human being from the plurality of measurements.
`8. The method as recited in claim 1 further comprising
`determining an estimated systolic pressure for the human
`being from the plurality of measurements.
`9. A method for indirectly measuring blood pressure
`comprising the steps of:
`(a) placing a cuff around a portion of a human being’s
`body;
`(b) in?ating the cuff to a predetermined pressure;
`(c) periodically measuring pressure in the cuff thereby
`producing an oscillation pressure Waveform;
`(d) de?ating the cuff by a predetermined increment of
`pressure, Which results in a de?ation pressure in the
`cuff;
`(e) repeating the steps (c) and (d) for a plurality of times
`thereby producing a plurality of oscillation pressure
`Waveforms;
`
`10
`
`15
`
`20
`
`25
`
`30
`
`35
`
`40
`
`55
`
`60
`
`65
`
`8
`(f) utiliZing an oscillometric technique to estimate a
`systolic pressure and a mean arterial pressure for the
`human being from a plurality of oscillation amplitudes
`derived from the oscillation pressure Waveforms;
`(g) integrating the plurality of measurements taken during
`each different de?ation pressure to derive an integral
`value for each different de?ation pressure; and
`(h) deriving a ?rst estimate of diastolic pressure of the
`human being from the de?ation pressure associated
`With the greatest integral value.
`10. The method as recited in claim 9 further comprising:
`identifying a separate peak value for each of the plurality
`of oscillation pressure Waveforms;
`identifying a peak value of greatest magnitude;
`deriving a second estimate of diastolic pressure Which
`corresponds to the de?ation pressure Which occurred
`coincident With the oscillation pressure Waveform that
`has the peak value of greatest magnitude; and
`calculating a diastolic pressure value as a function of the
`?rst estimate of diastolic pressure and the second
`estimate of diastolic pressure.
`11. The method as recited in claim 10 Wherein calculating
`a diastolic pressure value averages the ?rst estimate of
`diastolic pressure and the second estimate of diastolic pres
`sure.
`12. The method as recited in claim 9 Wherein the step of
`integrating the plurality of measurements comprising sepa
`rately summing a plurality of measurements.
`13. The method as recited in claim 9 Wherein the step of
`in?ating the cuff to a predetermined pressure comprising
`activating an electrically operated pump.
`14. The method as recited in claim 9 Wherein the step of
`de?ating the cuff comprises opening an electrically con
`trolled valve for a period of time.
`15. The method as recited in claim 9 Wherein de?ating the
`cuff comprises opening an electrically controlled valve,
`measuring pressure in the cuff, and closing the electrically
`controlled valve When the pressure in the cuff has decreased
`by the predetermined increment.
`16. An apparatus for producing information indicative of
`blood pressure of an human being through indirect mea
`surement comprising:
`an in?atable cuff;
`a pump connected to the cuff, for in?ating the cuff to a
`pressure above systolic pressure of the human being;
`a de?ating valve connected to the cuff to release ?uid
`from Within the cuff thereby varying pressure Within
`the cuff;
`a transducer that measures pressure oscillations in the cuff
`caused by heartbeats of the human being; and
`a controller responsive to the transducer for initially
`energiZing the pump to in?ate the cuff and subse
`quently energiZing the de?ating valve incrementally to
`de?ate the cuff at predetermined pressure increments,
`Wherein the controller integrates the pressure oscilla
`tions occasioned by successive heartbeats to produce a
`plurality of integral values and identi?es as a diastolic
`pressure, the pressure Which occurs in the cuff When the
`pressure oscillations have an integral value of greatest
`magnitude.
`17. The apparatus as recited in claim 16 Wherein the
`controller integrates the pressure oscillations by summing a
`plurality of measurements of pressure in the cuff acquired
`from the transd

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