The present invention relates to a measurement device, an index calculating method, and an index calculating program. Specifically, the present invention relates to a measurement device for measuring a biological value to calculate an index value related to angiostenosis, and a method and a program for calculating the index.
Conventionally, Ankle Brachial Blood Pressure Index (ABI), which is the ratio of blood pressures in the lower and upper limbs, is used as an index of angiostenosis.
For example, as disclosed in JP 2004-261319A, the ABI has been obtained by measuring the blood pressures in the lower and upper limbs of a subject in the supine position with a blood pressure measurement device and then calculating the ratio of these pressures.
However, if the subject suffers from severe arterial calcification it may not be possible to accurately measure blood pressures due to insufficient compression of the arteries. Therefore, in this case, there is a problem that accuracy of ABI as an index of angiostenosis is decreased.
Furthermore, if the subject is afflicted with unstable pulse amplitude due to arrhythmia or small pulse amplitude due to angiostenosis, it may not be possible to accurately measure blood pressures. Therefore, in this case, there is also a problem that accuracy of ABI as an index of angiostenosis is decreased.
Moreover, there are cases where some subjects suffer from pain due to the measurement because a blood pressure measurement in the upper limbs and lower limbs is required in order to calculate ABI as described above, and therefore there is also a problem that the measurement is sometimes a great burden on the subjects. There is also a problem that measurement time for the blood pressure measurement is required.
Furthermore, as described above, a subject needs to be in the supine position in order to calculate ABI, and therefore there is also a problem that the measurement lacks simplicity as a screening test.
The present invention was made in view of these problems, and it is an object thereof to provide a measurement device for easily and accurately calculating an index value related to angiostenosis while suppressing a burden on subjects, and a method and a program for calculating the index.
In order to achieve the above-described object, in an aspect of the present invention, a measurement device is a measurement device for measuring a pulse wave and calculating an index of arteriostenosis from the pulse wave, and includes a measurement unit to be mounted on a measurement site for measuring a value corresponding to a load given to the measurement site and an arithmetic device connected to the measurement unit. The arithmetic device includes a pulse wave measurement unit for measuring a pulse wave based on a measurement value in the measurement unit, a first calculation unit for calculating a predetermined parameter value from the pulse wave, and a second calculation unit for calculating an index value corresponding to Ankle Brachial Blood Pressure Index (ABI) as the index of arteriostenosis using the parameter value.
Preferably, the measurement unit includes a cuff for being mounted on the measurement site and a sensor for detecting a pressure inside the cuff, the arithmetic device is connected to the sensor, and the pulse wave measurement unit measures a pulse wave from the sensor.
Preferably, the first calculation unit calculates, as the predetermined parameter value, from the pulse wave, at least one of a normalized pulse wave area (% MAP), which is an index indicating a sharpness of the pulse wave, an upstroke time (UT), which is an index indicating a rising feature value of an ankle pulse wave, a pulse amplitude, and an index value indicating a lower limb-upper limb pulse wave transfer function, which is a function for transfer of a pulse wave from the upper limb to the lower limb.
More preferably, the second calculation unit calculates the index value by combining two or more of % MAP, UT pulse amplitude, and the index value indicating a lower limb-upper limb pulse wave transfer function that are calculated by the first calculation unit.
More preferably, the second calculation unit calculates the index value by combining the index value indicating a lower limb-upper limb pulse wave transfer function and at least one of the % MAP, UT, and pulse amplitude that are calculated by the first calculation unit.
In another aspect of the present invention, an index calculating method is a calculating method for calculating an index value of arteriostenosis from a pulse wave, and includes the steps of obtaining the pulse wave, calculating a predetermined parameter value from the pulse wave, and calculating an index value corresponding to Ankle Brachial Blood Pressure Index (ABI) as the index of arteriostenosis using the parameter value.
In yet another aspect of the present invention, an index calculating program is a program for causing a computer to execute processing for calculating an index value of arteriostenosis from a pulse wave, and causes the computer to execute the steps of obtaining the pulse wave, calculating a predetermined parameter value from the pulse wave, and calculating an index value corresponding to Ankle Brachial Blood Pressure Index (ABI) as the index of arteriostenosis using the parameter value.
With the present invention, it is possible to calculate, from a pulse wave, an index value corresponding to ABI, which is an angiostenosis-related index value that is conventionally calculated from a blood pressure value.
Preferred embodiments of the present invention will be described hereinafter with specific reference to the attached drawings. The same numerals refer to the same components and elements throughout the description and the drawings, such that the designations and functions of these elements are also identical.
System Configuration
Referring to
The cuffs 24br, 24bl, 24ar, and 24al are worn on respective extremities of a subject 200. Specifically, they are respectively worn on the right upper arm (right upper limb), left upper arm (left upper limb), right ankle (right lower limb), and left ankle (left lower limb). As used herein, the term “extremity” refers to a site on any of the four limbs, and may be a wrist, a fingertip, or the like. Throughout the specification, the cuffs 24ar, 24al, 24br, and 24bl will be collectively referred to as “cuffs 24” unless there is a need to distinguish between individual cuffs.
The detection units 20ar, 20al, 20br, and 20bl each include hardware necessary for detecting pulse waves in an extremity of the subject 200. As all the detection units 20ar, 20al, 20br, and 20bl may have an identical configuration, they will be collectively referred to as “detection units 20” unless there is a need to distinguish between individual units.
The information processing unit 1 includes a control unit 2, an output unit 4, an operation unit 6, and a storage device 8.
The control unit 2 is a device that performs overall control of the measurement device 100 and is typically implemented by a computer that comprises a CIPU (central processing unit) 10, a ROM (read only memory) 12, and a RAM (random access memory) 14.
The CPU 10 corresponds to an arithmetic processing unit, reads a program previously stored in the ROM 12, and executes the program while using the RAM 14 as the work memory.
Additionally, the output unit 4, the operation unit 6, and the storage device 8 are connected to the control unit 2. The output unit 4 outputs measured pulse waves, the result of analysis of pulse waves, and the like. The output unit 4 may be, for example, a display device implemented by LEDs (light emitting diodes) or an LCD (liquid crystal display), or a printer (driver).
The operation unit 6 is adapted to receive instructions from a user. The storage device 8 is adapted to hold various types of data and programs. The CPU 10 of the control unit 2 reads data and programs stored in the storage device 8 as well as performing writing to the storage device 8. For example, the storage device 8 may be implemented by a hard disk drive, nonvolatile memory (e.g., a flash memory), or a removable recording medium.
The specific configuration of each of the detection units 20 is described hereinafter. The detection unit 20br detects pulse waves in the right upper arm by adjusting and detecting the internal pressure of the cuff 24br worn by the subject 200 on the right upper arm (hereinafter “cuff pressure”). The cuff 24br contains a fluid bag (not shown), such as an air bag.
The detection unit 20br includes a pressure sensor 28br, a pressure regulating valve 26br, a pressure pump 25br, an A/D (analog-to-digital) converter 29br, and a tube 27br. The cuff 24br is connected to the pressure sensor 28br and the pressure regulation valve 26br via the tube 22br.
The pressure sensor 28br is a device for detecting pressure fluctuation transmitted through the tube 22br and may be implemented, for example, on a semiconductor chip made of single crystal silicon or any other suitable material. A signal representing the pressure fluctuation detected by the pressure sensor 28br is converted to a digital signal by the A/D converter 29br and sent to the control unit 2 as a pulse wave signals pbr(t).
The pressure regulating valve 26br is interposed between the pressure pump 25br and the cuff 24br and maintains the pressure used for pressurizing the cuff 24br in a predetermined range during measurement. The pressure pump 25br operates in accordance with a detection instruction from the control unit 2 to supply air to the fluid bag (not shown) in the cuff 24br in order to pressurize the cuff 24br.
This pressurization of the fluid bag causes the cuff 24br to press against the measurement site, such that pressure variations corresponding to pulse waves in the right upper arm may be transmitted to the detection unit 20br via the tube 22br. The detection unit 20br detects the pulse waves at the right upper arm by detecting the pressure variations transmitted thereto.
Similarly, the detection unit 20bl includes a pressure sensor 28b, a pressure regulating valve 26bl, a pressure pump 25bl, an A/D converter 29b1, and a tube 27bl. The cuff 24bl is connected to the pressure sensor 28b1 and the pressure regulation valve 26bl by the tube 22b1.
Likewise, the detection unit 20ar includes a pressure sensor 28ar, a pressure regulating valve 26ar, a pressure pump 25ar, an A/D convener 29ar, and a tube 27ar. The cuff 24ar is connected to the pressure sensor 28ar and the pressure regulating valve 26ar via the tube 22ar.
Similarly, the detection unit 20al includes a pressure sensor 28al, a pressure regulating valve 26al, a pressure pump 25al, an A/D converter 29al, and a tube 27al. The cuff 24al is connected to the pressure sensor 28al and the pressure regulating valve 26al via the tube 22al.
As the functions of the components in the detection units 20bl, 20ar, and 20al are identical to those of the detection unit 20br, detailed description thereof is omitted. Likewise, reference symbols, such as “ar” and “br,” are omitted from the description of the components in the detection units 20 hereinafter unless there is a need to distinguish between them.
It should be noted that although a configuration for detecting pulse waves using the pressure sensors 28 is described in this embodiment, it is possible to use a configuration for detecting pulse waves using arterial volume sensors (not shown). In this case, such arterial volume sensors may include a light-emitting device for irradiating an artery and a light-receiving element for receiving the light irradiated by the light-emitting device after it is transmitted through or reflected by the artery. An alternative configuration may include a plurality of electrodes for feeding a minute constant current to the measurement site of the subject 200 so as to detect the voltage variations caused by the variations in impedance (bioelectrical impedance) that occur in accordance with the pulse wave propagation.
Overview of the Operation
In the measurement device 100 of the present embodiment, an index indicating the presence or absence of stenosis or the degree of stenosis in arteries corresponding to Ankle Brachial Blood Pressure Index (ABI), which is the ratio of the blood pressure values measured in the upper and lower limbs, is calculated from pulse waves measured in the upper and lower limbs.
Functional Configuration
The functions shown in
With reference to
The adjustment unit 30 is a functional unit for adjusting the pressure inside the cuffs 24. The functionality of the adjustment unit 30 may be implemented, for example, by the pressure pump 25 and the pressure regulating valve 26 shown in
The pulse wave measurement unit 102 is connected to the adjustment unit 30 and the A/D converter 29 for performing processing necessary to measure the pulse wave (PVR) in the extremity. The pulse wave measurement unit 102 adjusts the pressure inside the cuff 24 by providing a command signal to the adjustment unit 30 and receives cuff pressure signals Par(t), Pal(t), Pbr(t), and Pbl(t) detected in response to the command signal. Subsequently, pulse waveforms for multiple heartbeats are obtained in each extremity by recording the received cuff pressure signals Par(t), Pal(t), Pbr(t), and Pbl(t) in time series. The pulse wave measurement is performed, for example, for a predetermined duration of time (e.g., approximately 10 seconds).
The following describes an index of arteriostenosis that is calculated from the pulse waves measured in the upper and the lower limbs and corresponds to ABI.
Examples of indices of arteriostenosis using pulse waves include not only pulse amplitude but also an index indicating sharpness of a pulse wave, which is referred to as a normalized pulse wave area (% MAP). % MAP is calculated, for example, as the ratio of M to H (% MAP=M/H×100), where M is the height from the diastolic pressure when the pulse wave area is leveled and H is the peak height of the pulse wave (i.e., pulse pressure). An index value of the % MAP increases in the presence of arteriostenosis or arterial occlusion.
Moreover, another example is an index indicating a rising feature value of an ankle pulse wave, which is referred to as an upstroke time (UT). The UT is calculated as the rising period of the ankle pulse wave from the rising point to the peak. If arteriostenosis or arterial occlusion exists in the subject, the above-described period is extended, thus increasing an index value of the UIT.
The inventors of the present application examined a correlation between these indices and the ABI.
As an example, the inventors of the present application calculated a value by multiplying each of % MAP (A), UT (B), and pulse amplitude (C) by a conversion factor, as an index (the EABI), and examined the correlation between this index and the ABI. That is, the index was calculated according to the formula, EABI=aA+bB+cC+d (where a to d are coefficients), so as to compare this index with the ABI.
As indicated by P1 to P3 in
In the example of
Based on the foregoing observation, those measurement values that greatly deviate from the regression line may be attributable to inaccurate pressure measurement. For this reason, the correlation is likely to be even stronger if these cases are excluded. That is, it is proved that one or more of % MAP, UT, and pulse amplitude can be used as the index of arteriostenosis corresponding to ABI.
Another example of the index of arteriostenosis corresponding to ABI may include a function for transfer of a pulse wave from the upper limb to the lower limb (a lower limb-upper limb pulse wave transfer function). This is because, in a transfer function in which a pulse wave in the upper limb is the input to the system (the vascular paths) and a pulse wave in the lower limb is the output from the system, changes may be found in a step response if angiostenosis exists in the system. That is, it is thought that this step response can be used as the index of arteriostenosis corresponding to ABI.
To verify this, the inventors of the present application measured the pulse waves of a healthy subject and a patient with arteriosclerosis obliterans (ASO) and calculated their step responses.
That is, it can be said from this fact that less arterial occlusion exists as the correlation between the right and the left step responses is higher and arteriosclerosis is more likely to exist as the correlation is lower.
Accordingly, the inventors of the present application calculated degrees of arteriostenosis and variations in step responses using a circulatory system model. The circulatory system model employed by the inventors represents the vascular system of a body divided into multiple segments, One exemplary circulatory system model is the so-called “Avolio Model” described in Reference Literature 1. “Avolio, A. P., Multi-branched Model of Human Arterial System, 1980, Med. & Biol. Eng. & Comp., 18, 796”. The inventors used the Avolio Model as the circulatory system model for the calculations.
With reference to
In the Avolio Model of
Therefore, as shown in
It was proved from
As an example, the inventors of the present application calculated, as an index, a value (EABI) by multiplying each of % MAP (A). UT (B), pulse amplitude (C), and the index calculated from the step response (D) (e.g., the upper area) by a conversion factor, and examined the correlation between this index and the ABI. That is, the index was calculated according to the formula, EABI=aA+bB+cC+dD+e (where a to e are coefficients), so as to compare this index with the ABL.
It was proved from
As in the cases discussed in relation to
Operational Flow
With reference to
The CPU 10 outputs the index EABI of arteriostenosis calculated from the pulse waves in Step S121. This output may be displayed on a screen or transmitted to a separate device, such as a PC or an external recording medium.
It should be noted that examples of the calculating method in the Step S113 include various calculating methods. This is because, as described above, any one or a combination of two or more of % MAP, UT, pulse amplitude, and lower and a lower limb-upper limb pulse wave transfer function (e.g., the upper area) can be used as the index EABI.
For example,
With reference to
Subsequently, in Step S209, the CPU 10 calculates the index EABI=aA+bB+cC+dD+e (where a to e are coefficients) using a conversion factor defined in advance.
By performing the above operation, an index indicating the presence or absence of stenosis or the degree of stenosis in arteries corresponding to ABI can be calculated from the pulse waves.
As mentioned above, it is known that blood pressure values are susceptible to calcification of the arteries. Also, the subject may have unstable pulse amplitude due to arrhythmia or small pulse amplitude due to angiostenosis and it is also known that blood pressure values are susceptible to these conditions.
In contrast, since the wave pulses are calculated based on waveforms for several heartbeats, it is less susceptible to the aforementioned conditions. Therefore, the case where the index is calculated from a pulse wave is harder to be affected by arrhythmia or calcification than the conventional case where the index is calculated from a blood pressure value, so that the index is accurately calculated in the former case.
Although it is possible to use any one of the indices (% MAP, UT, pulse amplitude, and the lower limb-upper limb pulse wave transfer function (e.g. the upper area)) obtained from the pulse waves as an index indicating the presence or absence of stenosis or the degree of stenosis in arteries, the more accurate index can be obtained by combining these indices. Furthermore, the inventors of the present application proved that it is possible to obtain a particularly accurate index by using or combining the lower limb-upper limb pulse wave transfer function (e.g., the upper area) in particular.
Moreover, since there is no need to measure a blood pressure, it is possible to perform a measurement concerning a subject not in a supine position but in a sitting position, and to remarkably enhance simplicity as a screening test.
Furthermore, a program for causing the measurement device 100 or an arithmetic device such as a personal computer (upon obtaining values/data from the measurement device 100) to calculate the above index indicating the presence or absence of stenosis or the degree of stenosis in arteries from the pulse waves may also be provided. Such a program may be provided as a program product by storing the program on a computer-readable recording medium, such as a flexible disk, a CD-ROM (compact disk-read only memory), a ROM (read only memory), a RAM (random access memory), and a memory card associated with a computer. Also, such a program can be recorded on a computer-readable recording medium included in a computer, such as a hard disk, and provided as a program product. Moreover, the program may be provided by allowing it to be downloaded via a network.
It should be noted that the program according to the present invention may invoke necessary modules, among program modules provided as part of a computer operating system (OS), in a predetermined sequence at predetermined timings, and cause such modules to perform processing. In this case, processing is executed in cooperation with the OS, without the above modules being included in the program itself. Such a program that does not include such modules can also be the program according to the present invention.
Also, the program according to the present invention may be provided incorporated in part of another program. In this case as well, processing is executed in cooperation with the other program, with the modules of the other program not included in the program itself. Such a program incorporated in another program can also be the program according to the present invention.
The program product that is provided is executed after being installed in a program storage unit such as a hard disk. Note that the program product includes the program itself and the recording medium on which the program is stored.
The embodiments of the present invention described above are to be considered in all respects only to be illustrative and not restrictive. The scope of the invention is indicated by the appended claims rather than the above description, and all changes which come within the meaning and range of equivalency of the claims are to be encompassed within the scope of the invention.
Number | Date | Country | Kind |
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2011-237574 | Oct 2011 | JP | national |
Filing Document | Filing Date | Country | Kind | 371c Date |
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PCT/JP2012/076111 | 10/9/2012 | WO | 00 | 3/28/2014 |