• 专利附录
  • 专利说明
  • 权利要求
  • 类似技术
  • 同族专利
  • 引用文献
  • 法律状态
  • 优先权
    • 专利摘要:
    PURPOSE: Method and apparatus for non-invasive, cuffless, continuous blood pressure determination are provided. CONSTITUTION: Arterial blood pressure of a subject is determined by detecting the EKG for the subject and selecting a fiducial point on the EKG during a pulse. Apparatus is provided for monitoring blood volume versus time at a selected location on the subject's body such as a fingertip. A time difference between the occurrence of the selected fiducial point on the EKG and a selected change in blood in volume at the selected body location is determined. This time difference depends on the arrival time of the pulse at the distal location in addition to the shape of the blood volume versus time curve. Heart rate is determined from the EKG. The arterial pressure is computed from pulse arrival time, volumetric wave shape and instantaneous heart rate for each pulse. It is preferred that the fiducial point on the EKG be an R-wave. A suitable method for determining change in blood volume utilizes photoplethysmography. Methods are disclosed for determining diastolic pressure, systolic and mean arterial pressure. In another aspect, artifact detection and rejection enabled.
    公开号:KR20000049078A
    申请号:KR1019990703153
    申请日:1997-10-14
    公开日:2000-07-25
    发明作者:하워드엘. 골럽
    申请人:디이엑스테크, 인코포레이티드；
    IPC主号:
    专利说明:

    NON-INVASIVE CUFFLESS DETERMINATION OF BLOOD PRESSURE}
    In one aspect, the method according to the invention for determining the arterial blood pressure of a human comprises searching for an EKG signal for the body. The reference point in the EKG signal is selected and the blood volume versus time wave shape is monitored at the selected location in the body. The instantaneous heart rate is determined from the EKG signal, and the arterial pressure is calculated from the instantaneous heart rate and blood volume versus time wave shape. In one embodiment, the reference point is an R-wave and the arterial pressure is calculated using the selected change in blood volume in the blood volume versus time wave shape. The change in choice in blood volume is preferably in the range of 20% to 80% in the upward slope in the wave shape. Selective changes in blood volume are more preferred in the range of 40% to 60%. The change in choice in blood volume is most preferably about 50% in the upward slope of the blood waveform. The body part selected is preferably in the distal position, such as the fingertip.
    In another aspect, the method according to the invention for determining the arterial blood pressure of a person is to search for an EKG for a person and to select a reference point in the EKG during a pulse period. And the like. Blood volume versus time is monitored at selected locations in the body. The difference between the time at which the selection reference point occurs in the EKG and the time at which the selection change in blood volume occurs at the selected body location is determined. Heart rate is determined by EKG, and arterial pressure is calculated based on time difference and heart rate. In a preferred embodiment, the reference point is an R-wave and the body part is a distal position, such as a fingertip. The preferred method of monitoring blood volume is using photoplethysmography. Arterial pressure by calculation may be diastolic pressure, systolic pressure, intermediate arterial pressure, or the like.
    In another aspect, the device according to the invention for determining the arterial blood pressure of a person comprises an EKG device for detecting the electrical activity of the heart. Devices that respond to changes in blood may include a photoplethysmograph apparatus. The output from the EKG device, the device for monitoring the blood volume, and the like goes to a signal processor or computer for calculating arterial blood pressure.
    In another feature, an apparatus for processing and calculating signals is applied to search for artifacts in blood pressure measurements, and to reject such artifacts. This technique allows for a reliable judgment that gives confidence in the blood pressure calculation for each pulse. The technique presented here provides a more reliable measure of blood pressure during the time of a good input signal and indicates that there is no measurement available to the user during the time of a wrong input signal. Inform.
    According to the present invention, there is provided an improved method and apparatus for measuring arterial blood pressure continuously, non-invasively and without the use of a blood pressure cuff. With automated artifact detection and rejection, a reliable judgment of the conviction of blood pressure calculations is made for each pulse.
    Several distinct arterial blood pressure parameters, such as pressure at cardiac contraction, pressure at cardiac dilatation, mean arterial pressure, pulse rate, and continuous arterial pressure, provide medically useful information. Conventional methods of measuring such pressures can be classified as follows: sphygmomanometry (cuff measurement), automated sphygmomanometry, and conversion measurement of pressure present in the artery-line arterial-line transduction, A-line).
    The importance of continuous arterial blood pressure as a medical indicator is emerging by the development of new methods to measure it. These include external pressure transduction, photoplethysmography, pulse-wave transit timing, and the like. Until now, these methods have been used mainly as experiments.
    As the most widely used conventional method, the blood pressure measurement (sphygmomanometry, cuff measurement), the pressure in the heart contraction and the pressure in the expansion of the heart and the like. Automated cuff uses a mechanically actuated pump for cuff swelling, algorithms and sensors that concentrate on the initial and unrestricted arterial flow. However, the cuff method is not suitable for continuous use by limiting the flow of blood during each measurement, and the measurement of blood pressure obtained by many automatic cuff systems Fail to meet exact standards In addition, discomfort may be caused by a cuff, which may affect the recording of blood pressure.
    A-line (measurement of the transformation of pressure present in the artery-line) used when continuous measurements are required, is free of signal artifacts and is present in line-crimping, clotting, and internal This is somewhat accurate during periods of no source such as contact between the transducer and the wall of the artery. However, the transducer needs to be inserted by surgery and can cause thrombosis and air infection. Because these methods require surgical procedures, these methods are rarely used and are not frequently recommended as use even when continuous pressure measurements are otherwise required.
    The experimental method cited above attempts to circumvent the defects of the A-line by continuously measuring external blood pressure. The direct external sensing method and the indirect calculation method have been devised at the same time.
    The direct non-invasive method uses external pressure conversion. Pressure transduction is placed against an artery that lies beneath the skin, such as a radiating artery, and mechanically detects pressure by pushing against an artery wall. However, because transducers are detection forces, they are extremely subject to mechanical noise and motion artifacts. Transducers cause problems in continuous measurements in that they interfere with the flow of blood. It also creates difficulties in keeping the transducer properly positioned in the artery. Therefore, indirect measurement method was considered.
    Pulse-wave transit-time measurement is an indirect method of estimating arterial blood pressure at the rate of pulse-waves produced in each cardiac cycle. However, although the velocity is related to blood pressure, the methods proposed so far assume that the relationship is linear, and even though this method is linear, the transit time by pulse-waves is such that the blood pressure can be accurately determined. It is possible to supply very little information about pulse waves. Another drawback of this method is that it may not apply pressure in both heart contraction and dilatation, which many practitioners find useful.
    Photoplethysmography, a technique for tracking arterial blood-volume and oxygen content in the blood, is an alternative to other indirect methods of continuously estimating blood pressure. Necessity arises. However, this method derives information from volumetric data, which can be like blood-pressure; In other words, it is assumed that the blood pressure and blood flow curves are similar, which can sometimes be true, but generally it is not. In addition, photoplethysmography measurements are made at the ends of the body, such as the earlobe and fingers, and the blood pressure observed in the periphery of the body is generally no more than the central measurement.
    The need for this method is because the insertion of the A-line is frequently judged not to be an invasive procedure undertaken to determine blood pressure, and since non-surgical methods for continuous measurements have not yet been replaced. Remains.
    1 shows an embodiment of an apparatus of the present invention; And
    2 shows a geometric representation of a graph of EKG and blood volume versus time.
    * Reference Number Description
    10: person
    12: EKG apparatus
    14: photoplethysmography apparatus
    Blood volume measuring apparatus
    18: computer or signal processor
    For the purpose of understanding the concepts that govern the invention, the physics for wave propagation in elastic tubes is important. The simplest equation for the propagation velocity of a pressure pulse in an elastic tube is first described by Moens-Kortweg. From the experimental evidence and theoretical background, the following equation was established.
    Where c is the velocity of the wave, E and h are Young's modulus and thickness with respect to the arterial wall, δ is the density of the fluid, and R is the mean radius of the tube.
    For the purpose of eliminating the experimental difficulties of measuring wall thickness and Young's modulus, the Moens-Kortweg equation was modified by Bramwell and Hill (1922) so that the elastic behavior of the tube can be expressed in terms of tube pressure-volume expansion. The equation can then be reduced to
    or,
    Where V is the initial volume of the artery, ΔV represents the change in volume that results in a pressure pulse ΔP, and c represents the pulse wave velocity.
    Then, emerging as a problem involves determining the non-invasive way to measure pulse wave velocity, percent change in arterial volume, and the like. For the purpose of completing this problem, a standard EKG signal (such as photoplethysmography in preferred embodiments) and some stable measurements of blood volume versus time were chosen to be used.
    The method using the EKG signal and the blood volume versus time signal (duration of up to 50 percentage points from the slope of R-wave rising above the volume versus time in EKG) During) i ) measuring T R_50 (i) first for the i th pulse. The present period (duration) is, ascending slope upwards (T O_50 (i)) 0 % point (點) which in addition to the existing period of up to 50 percentage points (點) in the pulse 0% point (點) in (T R_0 (i) is the sum of time between arrival of R) and R-wave. T station (逆) of R_0 (i) coincides with the pulse rate, as defined in the above (or, c = 1 / T R_50 ( i)), T O_50 (i) is more relevant than as ΔV and V do. Therefore, the measurement T R_50 (i) is a measurement related to c, ΔV, V, and the like.
    Then, for the i th pulse, the combined pulse rate measurement v P (i) coincides with the inverse of T R 50 (i) , and the combined pulse rate v P (i) 2 by the square. ) Is obtained by simply squared v P (i) . In addition, the instantaneous RR interval and thereby the instantaneous cardiac velocity (i.e., RR i and IHR (i) ) for the i th pressure pulse, etc., are determined and the diastolic pressure, systolic pressure, and mean pressure for the i th pulse (P D (i) , P s (i) , and P M (i) , etc., respectively ) and the like. The theoretical background of the importance of RR interval or IHR in calculating diastolic pressure can be summarized as follows. Diastolic pressure is defined as the arterial pressure present at the end of the reduction in diastolic pressure. The diminished diastolic pressure as a function of this exponent starts at the closing of the aortic valve and ends at the opening of the aortic valve. The pressure decay rate is dependent on a variety of factors: the aortic pressure that occurs during cardiac contraction, and the dimensions of the system (associated with the rigidity of the walls of the aortic system, especially the aortic system). Depends on factors including arterial impedance and the like. Therefore, if observed for a given case, the pressure at which the reduction begins for any given heartbeat (or diastolic pressure) is related to the period of existence that continues this reduction. This duration of reduction for any given pulse is directly proportional to the instantaneous RR interval or inversely proportional to the IHR of the given pulse. Therefore, the shorter the decrease duration (higher the higher the IHR), the higher the expected diastolic pressure; The longer the decay duration (the lower the IHR), the lower the expected diastolic pressure. In summary, the equation for calculating the pressure for the i th pressure pulse is:

    In this equation, K Dv , K Dihr , and K Sconst are constants that correspond to 2.5, 0.5, 35, etc., respectively, in preferred embodiments, where K Dcal and K Scal etc. Constant. P D (i) , P s (i) , P M (i) and the like represent diastolic pressure, systolic pressure, mean arterial pressure, and the like, respectively.
    Embodiments of the present invention will be described with reference to the drawings. In FIG. 1, the person 10 is monitored by an EKG lead 12. For those skilled in the art, it is understood that many leads are generally used to measure EKG. The photoplethysmography apparatus 14 monitors blood volume at the fingertip 16 of the person 10. Outputs from the EKG apparatus 12 (EKG apparatus) and the photoplethysmography apparatus 14, etc., are processed in the computer 18 or the signal processor 18, and as described above. It is generated as an output blood pressure that can represent diastolic pressure, systolic pressure, average arterial pressure, and the like, for a pulse. 2, the processor 18 detects the arrival of an R-wave. Ever, hyeolryang measuring device (14) (blood volume measuring apparatus ) are in T R_O search for the start of hyeolryang changes in (i), and hyeolryang for (對) slope rises upward with respect to time (T O_50 (i)) 50 Determine the time when the blood arrives in percentage points. As also shown in Figure 2, time at the top of the ascending slope (T O_50 (i)) 0 % point of a pulse (點) from the arrival of the (T R_O (i)) to the 50% point (點) is hyeolryang board ( Iii) It depends on the shape of the time curve. Since the present invention uses the time from the arrival of the R-wave to the 0% blood change point, the time from the 0% blood change to the 50% point, etc. Pressure determination is more accurate than in the prior art, which used pulse arrival time, otherwise wave shape, and the like, and in the present invention, the pulse arrival time and the wave shape are shape), etc.
    Another feature of the invention includes methods for automated artifact detection and automated artifact rejection that provides a reliable judgment for the confidence of each blood pressure calculation for each pulse. do. This artificial rejection method involves the calculation of two additional variables for each pulse. For the i th pulse, this method is as follows:
    qv P (i) 2 = ( i v P (3) 2 + i v P (1) 2 ) / i v P (2) 2
    Where i v P (1) 2 is five consecutive v P 2 terms {v P (i-2) 2 , v P (i-1) 2 , v P (i) 2 , v P (i + 1) 2 , v P (i + 2) 2 }, where i v P (1) 2 is the second lowest value, and i v P (2) 2 is the middle of the values I v P (3) 2 is the second highest value among the values. And
    diffv P (i) 2 = v P (i) 2 -v P (i-1) 2
    A detection algorithm for whether the i th pulse is artificial or not includes checking whether this variable is a predetermined threshold above. In a preferred embodiment, the test includes qv P (i) 2 > THRESH_qv otherwise diffv P (i) 2 > THRESH_diffv and the like. Preferred values here are THRESH_qv = 0.8 and THRESH_diffv = 0.2. In more detail, these variables are used in addition to the following others to determine the P D (i) calculation artificial. The algorithm includes qv P (i) 2 > THRESH_qv or P D (i) <PD_TOOLOW or P D (i) > PD_TOOHIGH or P D (i) > P S (i) and the like. Here, in a preferred embodiment, PD_TOOLOW = 30 and PD_TOOHIGH = 150. If any one of the above is true, it is considered that the value of the diastolic pressure P D (i) for the i th pulse cannot be found.
    In particular, in the same way, the artificial determination for the P S (i) calculation is qv P (i) 2 > THRESH_qv or diffv P (i) 2 > THRESH_diffv or P S (i) <PS_TOOLOW or P S (i) > PS_TOOHIGH or P D (i) > P S (i) and the like. Here, in a preferred embodiment, PS_TOOLOW = 50 and PS_TOOHIGH = 200. If any one of the above is true, it is considered that the value of the cardiac contraction pressure P S (i) for the i th pulse is not found.
    Finally, in particular, to determine that the calculation of P M (i) results in an artifact for the i th pulse, if the value of P D (i) cannot be found, or the value of P S (i) If not found, if either is true, then the value of the intermediate pressure for the i th pulse is not found.
    权利要求:
    Claims (35)
    [1" claim-type="Currently amended] Searching for the EKG signal for the person;
    Selecting a reference point in the EKG signal;
    Monitoring the blood volume versus time waveshape at selected locations in the human body;
    Searching for instantaneous heart rate in the EKG signal; And
    Calculating arterial pressure in an instantaneous heart rate and blood volume versus time waveshape; And arterial blood pressure, characterized in that it comprises a back and the like.
    [2" claim-type="Currently amended] 2. The method of claim 1, wherein the reference point is a point in an R-wave. 3.
    [3" claim-type="Currently amended] 3. The method of claim 2, wherein the reference point is the peak of the R-wave.
    [4" claim-type="Currently amended] The method of claim 1, wherein the calculating comprises using a selected change in blood volume in the blood volume versus time waveform. .
    [5" claim-type="Currently amended] The method of claim 4, wherein the change in selection in blood volume is in the range of 20% to 80% at an upward slope in the wave shape.
    [6" claim-type="Currently amended] 5. The method of claim 4, wherein the change in selection in blood volume is in the range of 40% to 60% at an upward slope in the wave shape.
    [7" claim-type="Currently amended] 5. The method of claim 4, wherein the change in selection in blood volume is about 50% in the upward slope of the wave shape.
    [8" claim-type="Currently amended] The method of claim 1, wherein the selected body part is a distal position.
    [9" claim-type="Currently amended] 10. The method of claim 8, wherein the distal position is the tip of the finger.
    [10" claim-type="Currently amended] The method of claim 1, wherein monitoring the blood volume versus time waveform comprises using photoplethysmography. .
    [11" claim-type="Currently amended] Searching for an EKG for a person;
    Selecting a reference point in the EKG during the pulse;
    Monitoring the blood volume versus time waveform at selected locations in the human body;
    Determining a difference between the time at which the selection reference point occurs and the time at which the selection change occurs in blood volume at a selected location in the body;
    Determining heart rate in the EKG; And
    Calculating arterial pressure and heart rate based on time differences; And arterial blood pressure, characterized in that it comprises a back and the like.
    [12" claim-type="Currently amended] 12. The method of claim 11, wherein the reference point is a point of R-wave.
    [13" claim-type="Currently amended] 13. The method of claim 12, wherein the reference point is the peak of the R-wave.
    [14" claim-type="Currently amended] The method of claim 11, wherein the selection change in blood volume is in the range of 20% to 80%.
    [15" claim-type="Currently amended] The method of claim 11, wherein the selection change in blood volume is in the range of 40% to 60%.
    [16" claim-type="Currently amended] The method of claim 11, wherein the selection change in blood volume is about 50%.
    [17" claim-type="Currently amended] 12. The method of claim 11, wherein the selected body part is a distal position.
    [18" claim-type="Currently amended] 18. The method of claim 17, wherein the distal position is a fingertip.
    [19" claim-type="Currently amended] 12. The method of claim 11, wherein monitoring the blood volume versus time waveform comprises using photoplethysmography. .
    [20" claim-type="Currently amended] 12. The method of claim 11, wherein the arterial pressure is diastolic pressure.
    [21" claim-type="Currently amended] 12. The method of claim 11, wherein the arterial pressure is systolic pressure.
    [22" claim-type="Currently amended] 12. The method of claim 11, wherein the arterial pressure is meas arterial pressure.
    [23" claim-type="Currently amended] 21. The method of claim 20, wherein the following equation is calculated to determine the diastolic pressure, P D (i) :


    Where T R_50 (i) represents the difference between the time at which the selection reference point occurs and the time at which the change in blood volume occurs at the selection body position; K Dv and K Dihr are constants, and K Dcal is a constant for measurement of scale; And IHR (i) is the instantaneous heart rate.
    [24" claim-type="Currently amended] 24. The method of claim 23, wherein K Dv is about 2.5 and K Dihr is about 0.5.
    [25" claim-type="Currently amended] The method of claim 21, wherein the following equation is calculated to determine the heart contraction pressure, P s (i) :

    Here, K Sconst is a constant, K Scal is a method for determining the arterial blood pressure (human arterial blood pressure), characterized in that the constant for measurement.
    [26" claim-type="Currently amended] 27. The method of claim 25, wherein K Sconst is about 35.
    [27" claim-type="Currently amended] 23. The method of claim 22, wherein the following equation is calculated to determine the median arterial pressure, P M (i) :

    A method for determining arterial blood pressure of a person, characterized in that.
    [28" claim-type="Currently amended] Searching for an EKG for a person;
    Selecting a reference point in the EKG during the pulse;
    Monitoring the blood volume versus time waveform at selected locations in the human body; And
    Determining a difference between the time at which the selection reference point occurs and the time by the sum of the time at which the blood volume change starts and the time from the blood volume as a function of the blood flow waveform to the selection change or the like; And arterial blood pressure, characterized in that it comprises a back and the like.
    [29" claim-type="Currently amended] 29. The method of claim 28, wherein the selective change in blood volume is about 50%.
    [30" claim-type="Currently amended] 30. The method of claim 29, wherein the selection reference point is an R-wave and the selection position of the human body is the fingertip.
    [31" claim-type="Currently amended] 29. The method of claim 28, wherein monitoring the blood volume versus time waveform uses photoplethysmography.
    [32" claim-type="Currently amended] Calculating a blood pressure for a series of pulses in the time window;
    Determining a distribution of blood pressure for a series of pulses; And
    Searching for artifacts in the distribution; An artifact detection method, characterized in that it comprises a back and the like.
    [33" claim-type="Currently amended] Computing qv P (i) 2 = ( i v P (3) 2 + i v P (1) 2 ) / i v P (2) 2 , where i v P (1) 2 is five consecutive v P 2 terms {v P (i-2) 2 , v P (i-1) 2 , v P (i) 2 , v P (i + 1) 2 , v P (i + 2) 2 } I v P (1) 2 is the second lowest value, i v P (2) 2 is the middle of the values, and i v P (3) 2 is the middle of the values ) Is the second highest value in-);
    Determining the diastolic pressure, P D (i) ;
    Determining the cardiac contraction pressure, P S (i) ; And
    qv If P (i) 2 > THRESH_qv, or if P D (i) <PD_TOOLOW, or if P D (i) > PD_TOOHIGH, or if P D (i) > P S (i) , P for the i th pulse Determining whether D (i) is an artifact; And diastolic pressure artifact, characterized in that it comprises.
    [34" claim-type="Currently amended] calculating qv P (i) 2 ;
    diffvP (i) 2= vP (i) 2-vP (i-1) 2Calculating; And
    qv if P (i) 2 > THRESH_qv, or diffv P (i) 2 > THRESH_diffv, or if P S (i) <PD_TOOLOW, or P S (i) > PD_TOOHIGH, or P D (i) > P S (i) , when the systolic pressure calculation is artificial, determining systolic pressure, diastolic pressure, and the like; A method for determining an artifact of cardiac contraction pressure, and the like.
    [35" claim-type="Currently amended] If either P D (i) , P S (i), etc., is artificial, then P D (i) is artificial, or P S (i) when the median arterial pressure is artificial A method for searching for an artifact in a median arterial pressure, P M (i), calculation, comprising determining whether is an artifact.
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    同族专利:
    公开号 | 公开日
    US5857975A|1999-01-12|
    AU740573B2|2001-11-08|
    CN1263421C|2006-07-12|
    DE69734288T2|2006-07-06|
    JP3671059B2|2005-07-13|
    EP0944352B1|2005-09-28|
    CN1237885A|1999-12-08|
    AT305265T|2005-10-15|
    AU4755697A|1998-07-03|
    EP0944352A1|1999-09-29|
    CA2268073A1|1998-06-18|
    WO1998025516A1|1998-06-18|
    US5865755A|1999-02-02|
    JP2001504362A|2001-04-03|
    DE69734288D1|2005-11-03|
    KR100609927B1|2006-08-04|
    CA2268073C|2005-08-23|
    引用文献:
    公开号 | 申请日 | 公开日 | 申请人 | 专利标题
    法律状态:
    1996-10-11|Priority to US08/729,445
    1996-10-11|Priority to US08/729,445
    1996-10-11|Priority to US8/729,445
    1997-10-14|Application filed by 디이엑스테크, 인코포레이티드
    2000-07-25|Publication of KR20000049078A
    2006-08-04|Application granted
    2006-08-04|Publication of KR100609927B1
    优先权:
    申请号 | 申请日 | 专利标题
    US08/729,445|1996-10-11|
    US08/729,445|US5865755A|1996-10-11|1996-10-11|Method and apparatus for non-invasive, cuffless, continuous blood pressure determination|
    US8/729,445|1996-10-11|
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