Plethysmograph variability processor

Information

  • Patent Grant
  • 8414499
  • Patent Number
    8,414,499
  • Date Filed
    Friday, December 7, 2007
    17 years ago
  • Date Issued
    Tuesday, April 9, 2013
    11 years ago
Abstract
A plethysmograph variability processor inputs a plethysmograph waveform having pulses corresponding to pulsatile blood flow within a tissue site. The processor derives plethysmograph values based upon selected plethysmograph features, determines variability values, and calculates a plethysmograph variability parameter. The variability values indicate the variability of the plethysmograph features. The plethysmograph variability parameter is representative of the variability values and provides a useful indication of various physiological conditions and the efficacy of treatment for those conditions.
Description
BACKGROUND OF THE INVENTION

Pulse oximetry utilizes a noninvasive sensor to measure oxygen saturation (SpO2) and pulse rate of a person. The sensor has light emitting diodes (LEDs) that transmit optical radiation of red and infrared wavelengths into a tissue site and a detector that responds to the intensity of the optical radiation after attenuation by pulsatile arterial blood flowing within the tissue site. Furthermore, the sensor may be attached to a patient's finger, foot, ear lobe, digit or other portion of the body where blood flows close to the skin. Pulse oximeters have gained rapid acceptance in a wide variety of medical applications, including surgical wards, intensive care and neonatal units, general wards, home care, physical training, and virtually all type of monitoring scenarios.


Pulse oximeters capable of reading through motion induced noise are disclosed in at least U.S. Pat. Nos. 6,770,028, 6,658,276, 6,584,336, 6,263,222, 6,157,850, 5,769,785, and 5,632,272, which are assigned to Masimo Corporation (“Masimo”) of Irvine, Calif. and are incorporated by reference herein. Low noise pulse oximetry sensors are disclosed in one or more of U.S. Pat. Nos. 7,027,849, 6,985,764, 6,934,570 6,760,607 6,377,829 6,285,896 5,782,757 5,638,818, which are also assigned to Masimo and incorporated by reference herein. Moreover, pulse oximeters capable of reading through motion induced noise and low noise optical sensors including LNOP® disposable, reusable and/or multi-site sensors and Radical®, Rad-5™, Rad-8™, Rad-9™, PPO+™ monitors are also available from Masimo.


Multiple parameter monitors and multiple wavelength sensors are described in U.S. patent application Ser. No. 11/367,033 entitled Noninvasive Multiple Parameter Patient Monitor filed Mar. 1, 2006 and U.S. patent application Ser. No. 11/367,013 entitled Multiple Wavelength Sensor Emitters filed Mar. 1, 2006, incorporated by reference herein. Moreover, multiple parameter monitors and multiple wavelength sensors including Rad-57™ and Radical-7™ monitors and Rainbow™ Rainbow™-brand adhesive and reusable sensors are available from Masimo. MS-brand processor boards incorporating SHARC® DSPs from Analog Devices, Inc. are also available from Masimo.


SUMMARY OF THE INVENTION

An aspect of a plethysmograph variability processor inputs a plethysmograph waveform, derives perfusion values, determines variability values, and calculates a plethysmograph (pleth) variability index. The plethysmograph waveform has pulses corresponding to pulsatile blood flow within a tissue site. The perfusion values correspond to the pulses. The variability values are each indicative of the variability of a series of the perfusion values. The plethysmograph variability index is representative of the variability values. The plethysmograph variability index is displayed.


In various embodiments, the perfusion values are derived by identifying peaks and valleys for the pulses, calculating AC values for the pulses from the peaks and the valleys, calculating DC values for the pulses, and normalizing the AC values with the DC values. Variability values are determined by accumulating the perfusion values in buffers and calculating one of the variability values for each of the buffers. As an example, variability values are determined by sorting the perfusion values within each of the buffers from the largest of the perfusion values to the smallest of the perfusion values and trimming at least one of the largest perfusion values and at least one of the smallest perfusion values from each of the buffers.


Plethysmograph variability indexes (PVIs) are determined from a percentage difference between a maximum perfusion value and a minimum perfusion value for each of the buffers. A median value of the PVIs is calculated. In an embodiment, physiologically acceptable pulses are identified and a minimum amount of time's worth of acceptable data for each buffer is determined. An IR channel is input for the plethysmograph waveform and a red channel is used to verify acceptable pulses.


An aspect of a plethysmograph variability processing system is an optical sensor that transmits multiple wavelengths of optical radiation into a tissue site, detects the optical radiation after attenuation by pulsatile blood flowing within the tissue site, and generates a sensor signal responsive to the detected optical radiation. A patient monitor demodulates the sensor signal so as to generate a plethysmograph channels. A digital signal processor (DSP) within the patient monitor inputs at least one of the plethysmograph channels and outputs a plethysmograph variability (PV) parameter accordingly. A PV process executes on the DSP so as to process the plethysmograph channel and derive the PV parameter. A patient monitor output is responsive to the PV parameter.


In various embodiments, the PV process has a plethysmograph input corresponding to the at least one plethysmograph channel. The pleth has pleth features. A measure pleth process extracts the pleth values from the plethysmograph according to the pleth features. A pleth value input corresponds to the pleth values. A pleth variability process generates a plurality of variability values from the pleth values. A pleth variability input corresponds to the variability values. A variability parameter process generates a pleth variability (PV) parameter from the variability values. Physiological acceptability criteria are applied to the plethysmograph input. A reduce data dispersion process trims outlying ones of the pleth values according to dispersion criteria. Post processing applies at least one of a smoothing or slew rate limit to the PV parameter. Pre-processing applies a bandpass filter to the plethysmograph input so as to remove a cyclical baseline shift or oscillation from the plethysmograph. The patient monitor output generates a graph of the PV parameter versus time so as to indicate a trend in plethysmograph variability.


An aspect of a plethysmograph variability method inputs plethysmograph channels, measures pleth values from the input and defines windows each encompassing a unique time interval of the plethysmograph values. Variability values are calculated, where each of the variability values are derived from the plethysmograph values encompassed in a unique one of the windows. Second windows are defined, each encompassing a unique time interval of the variability values. Parameter values are calculated, where each of the parameter values are derived from the variability values encompassed in a unique one of the second windows. Parameter values are output. In various embodiments, the plethysmograph channels each have pulses corresponding to pulsatile blood flow within a tissue site, and the plethysmograph values are based upon the pulses. The plethysmograph values are measures of blood perfusion at the tissue site. In alternative embodiments, plethysmograph values are based upon area under absorption pulses, an envelope of the pulses, a time series of normalized envelope heights or a time series of normalized envelope areas.


An aspect of a plethysmograph variability processing system has a sensor that transmits multiple wavelengths of optical radiation into a tissue site and that detects the optical radiation after attenuation by pulsatile blood flow within a tissue site so as to provide a plethysmograph input to a digital signal processor (DSP). The input is selected from channels corresponding to the multiple wavelengths. The DSP executes instructions for deriving plethysmograph variability from the plethysmograph. A measuring means generates plethysmograph values from the plethysmograph input according to predefined plethysmograph features. A calculation means derives variability values from the plethysmograph values, and a reduction means deriving a plethysmograph variability (PV) parameter from the plethysmograph values. In various embodiments, a first accumulation means applies a variability formula to a window of plethysmograph values. A dispersion reduction means trims outlying values from the first accumulation means. A second accumulation means applies data reduction criteria to a window of variability values. An acceptance means eliminates pulses from the plethysmograph input that are not physiologically acceptable. A post-processing means limits the slope of the PV parameter.





BRIEF DESCRIPTION OF THE DRAWINGS


FIG. 1 is a general block diagram of a plethysmograph variability processing system;



FIG. 2 is a graph of an exemplar plethysmograph;



FIG. 3 is a detailed flow chart of a plethysmograph variability index process; and



FIG. 4 is a general functional flow diagram of a plethysmograph variability process.





DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

PV Monitor



FIG. 1 illustrates a plethysmograph variability processing system 100 embodiment, which calculates one or more measures of plethysmograph variability (PV). The plethysmograph variability processing system 100 advantageously provides at least some of displays, alarms or controls responsive to PV so as to indicate, and affect the treatment of, a patient condition. The PV processing system 100 may further generate SpO2, pulse rate (PR), perfusion index (PI), signal quality and in multiple wavelength configurations additional blood parameter measurements such as HbCO and HbMet.


As shown in FIG. 1, the PV processing system 100 has a patient monitor 102 and a sensor 106. The sensor 106 attaches to a tissue site 1 and includes a plurality of emitters 122 capable of irradiating the tissue site 1 with at least two wavelengths of light, such as the red and infrared (IR) wavelengths utilized in pulse oximeters and in some configurations multiple wavelengths different than or in addition to those red and IR wavelengths. The sensor 106 also includes one or more detectors 124 capable of detecting the light after attenuation by the tissue 1.


Also shown in FIG. 1, the patient monitor 102 communicates with the sensor 106 to receive one or more intensity signals indicative of one or more physiological parameters and displays the parameter values. Drivers 110 convert digital control signals into analog drive signals capable of driving sensor emitters 122. A front-end 112 converts composite analog intensity signal(s) from light sensitive detector(s) 124 into digital data 142 input to the DSP 140. The input digital data 142 is referred to herein as a plethysmograph waveform, plethysmograph or pleth for short. The digital data 142 has plethysmograph channels corresponding to each emitter wavelength, such as a red channel and an IR channel. The digital data 142 is representative of a change in the absorption of particular wavelengths of light as a function of the changes in body tissue resulting from pulsing blood. The DSP 140 may comprise a wide variety of data and/or signal processors capable of executing programs for determining physiological parameters from input data. In an embodiment, the DSP executes one or more pleth variability (PV) processes 130, such as described with respect to FIGS. 3-4, below. In an embodiment, the PV processes 130 may be implemented in software, firmware or other form of code or instructions, or logic or other hardware, or a combination of the above.


Further shown in FIG. 1, the instrument manager 160 may comprise one or more microcontrollers controlling system management, such as monitoring the activity of the DSP 140. One or more output devices 180 include displays 182, alarms 184 and controls 186. Displays 182 may be numerical, such as readouts, or graphical, such as trends and bar graphs, generated by LEDs, LCDs or CRTs to name a few. Displays 182 may also be indicators, such as LEDs of various colors that signify variability magnitude. Alarms 184 may be visual or audible indications that variability is, say, above a predetermined threshold. Controls 186 may be inputs to medical equipment, such as drug administration devices, ventilators and fluid IVs, so as to control the amount of administered drugs, ventilator settings or the amount of infused fluids based up pleth variability. The instrument manager 160 also has an input/output (I/O) port 168 that provides a user and/or device interface for communicating with the monitor 102. User input devices 188 may include a keypad, touch screen, pointing device, voice recognition device, network and computer, to name a few. In an embodiment, the I/O port 168 provides initialization settings for PV processes, as described below. The monitor 102 may also be capable of storing or displaying historical or trending data related to PV and other measured parameters or combinations of measured parameters.


Pleth Waveform



FIG. 2 illustrates a plethysmograph 200 plotted on an intensity axis 201 versus a time axis 202. The plethysmograph 200 has multiple pulses 210 each with a peak 212 and a valley 214 and extending over a time period 216. A perfusion index (PI) value can be defined for each pulse 210:









PI
=

AC
DC





(
1
)








“AC” 220 designates a peak amplitude 212 minus a valley amplitude 214 for a particular pulse. “DC” 230 designates a peak amplitude 212 for a particular pulse. A plethysmograph variability measure is calculated that is responsive to the magnitude of pleth variations, such as depicted by envelope 250. One variability measure is a plethysmograph variability index (PVI), described with respect to FIG. 3, below. Other plethysmograph variability (PV) measures are described with respect to FIG. 4, below. Advantageously, PV measures may provide a numerical indication of a person's physical condition or health.


Pleth Variability Index (PVI)



FIG. 3 illustrates a PVI process 300 embodiment, which derives and displays a plethysmograph variability index (PVI). Initially, a first buffer is filled with calculated perfusion index (PI) values 310-330. In an embodiment, these values are based upon the IR channel, as described above. If a sufficient amount of physiologically acceptable data is in the first buffer 335, then a second buffer is filled with calculated plethysmograph variability index (PVI) values 340-360. The median PVI in the second buffer is calculated and displayed 370-380. If the amount of acceptable data in the first buffer is insufficient, then the display is frozen with the last calculated median PVI 390.


As shown in FIG. 3, a plethysmograph is first identified 310. In particular, only physiologically acceptable pulses are used for calculating PI. Physiological plethysmograph identification is disclosed in U.S. Pat. No. 7,044,918 entitled Plethysmograph Pulse Recognition Processor, which is assigned to Masimo and incorporated by reference herein. In an embodiment, the red channel plethysmograph is utilized to verify acceptable pulses in the IR channel. The PI of each acceptable plethysmograph is then calculated 320 according to EQ. 1 and as described with respect to FIG. 2, above. The calculated PIs are stored in a first buffer 330, and the buffer criteria are tested 335. The buffer criteria require both a minimum number of acceptable pulses and a minimum amount of time of acceptable data in the first buffer.


In an embodiment, a plethysmograph 200 (FIG. 2) has a 62.5 Hz sample rate, i.e. a sample interval of 16 msec. The first buffer holds 15 sec. of data at that sample rate. Accordingly, a sliding 15 sec. window of plethysmograph data is stored in the first buffer, and the window is moved in 1.2 sec. increments. The minimum number of acceptable pulses in the first buffer is 6, and the minimum amount of acceptable data in the first buffer is 7.5 sec. The 15 sec. window size allows one respiration cycle, assuming a worse case respiration rate of 4 breaths per min. This window size also allows 6 PIs assuming a worse case pulse rate of 25 bpm. Partial plethysmograph cycles cutoff by a particular window are ignored by that window, but are taken into account in the next window.


Also shown in FIG. 3, if the buffer criteria are met 335, then the first buffer is sorted and trimmed 340. The sort orders the PI values from the minimum PI at one end of the buffer to the maximum PI at the other end of the buffer. Then a predetermined number of PIs are dropped from each end of the buffer, i.e. both the maximum PIs and the minimum PIs are deleted. In an embodiment, 12% of the PIs are trimmed from each end of the buffer. For example, if the buffer holds 10 PIs, a 12% trim=floor(10·12/100)=floor(1.2)=1, where the floor operator truncates digits to the right of the decimal point. Hence, in this example, one max PI and one min PI are dropped from the first buffer. A plethysmograph variability index (PVI) is then calculated 350 from the trimmed first buffer. In an embodiment, PVI is calculated as:









PVI
=




PI
MAX

-

PI
MIN



PI
MAX


×
100





(
2
)








That is, PVI is the PI variation, expressed as a percentage of the maximum PI, reflected by the PI values remaining in the first buffer.


Further shown in FIG. 3, calculated PVIs are stored in a second buffer 360. In an embodiment, the second buffer holds 11 PVIs, where one PVI is derived for every 1.2 sec shift in the sliding 15 sec. window described above. Next, the median PVI is calculated from the second buffer. This median PVI value is communicated to a display 380. If the buffer criteria 335, described above, are not met, then the last calculated median PVI value is displayed 390. That is, the display is frozen with that last calculated median PVI value until the buffer criteria are satisfied.


In an embodiment, the median PVI value is displayed as a two-digit numerical value on a monitor screen along with other parameters, such as SpO2 and pulse rate. In an embodiment, the median PVI value is displayed on a monitor screen as vertical or horizontal bar graph. In an embodiment, the median PVI value is displayed on a monitor screen as trend graph versus time. In an embodiment, the median PVI value is compared to a predetermined maximum PVI threshold. If the median PVI value crosses the predetermined threshold, one or more visual or audible alarms are triggered. In an embodiment, a visual PVI alarm is one or more colored indicators, such as green, yellow and red, indicating levels of patient health or physiological condition.


Plethysmograph Variability (PV)



FIG. 4 illustrates a plethysmograph variability (PV) processor 400 embodiment having process steps 401 and initializations 402. The initializations 402 determine the specific characteristics of the process steps 401. The PV processor 400 inputs one or more plethysmograph (pleth) channels 405 and generates PV outputs 407. The pleth channels 405 each correspond to a different optical sensor wavelength, such as a red wavelength channel and an IR wavelength channel corresponding to red and IR emitters of a pulse oximeter sensor. There may be more than two channels when using a multiple wavelength sensor, such as described in U.S. patent application Ser. No. 11/367,013, cited above. For example, there may be eight channels varying in wavelength from about 630 nm to about 905 nm. In an embodiment, two or more pleth channels 405 are processed in parallel or combined as a composite pleth for increased accuracy or robustness in PV calculations. Input 410 determines which pleth channel 405 is used as the pleth input 414 for PV calculations, according to a select channel initialization 412. Input 410 may select any single channel 405 or some combination of channels 405. Pre-process 415 modifies the pleth input 414 according to a predetermined formula 417. In an embodiment, pre-process 415 filters the pleth input 414 so as to remove any slow variation or low frequency oscillation in the plethysmograph baseline or average value, such as a respiration-induced variation that shifts the entire plethysmograph up and down with inhalation and exhalation. In an embodiment, pre-process 415 is a bandpass filter having a 30 to 550 beats per minute passband. Identify acceptable pulses 420 applies pulse criteria 422 to pass only physiologically acceptable pulses 424, such as disclosed in U.S. Pat. No. 7,044,918 cited above.


As shown in FIG. 4, measure pleth 440 extracts pleth values 444 from the remaining pulses 424 according to pleth features 442. The pleth features 434 may be a pulse peak 212 (FIG. 2) and pulse valley 214 (FIG. 2) and the pleth values 444 may relate to perfusion, such as PI described with respect to EQ. 1 above. In another embodiment, the “DC” value in EQ. 1 may be other than a pulse peak, such as a pulse valley or an average of pulse peak and pulse valley, to name a few. In other embodiments, pleth features 442 may include more that two values per pulse and pleth values 444 may be other than perfusion related. Also, measure pleth 440 may be performed over more than one pulse per pleth value 444.


As shown in FIGS. 2 and 4, in an embodiment, pleth features 442 define a pleth envelope 250 interpolated from pulse peaks 212 and pulse valleys 214. Measure pleth 440 defines a series of adjacent slices 260 of envelope height and Δ width, where Δ may vary from one pleth sample to many samples. Accordingly, pleth values 444 are the areas of each slice. In another embodiment, measure pleth 440 calculates the area under each absorption pleth pulse 270, the absorption pleth being the inverse of the intensity pleth 200. In an embodiment, the slices 260 or areas 270 are normalized with respect to a pleth value, such as a DC value or an average value, to name a few.


Also shown in FIG. 4, accumulate pleth values 445 identifies those pleth values 444 within a specified window 446. Accept window 450 determines whether there are a sufficient number of pleth values within the window 446. If not, the remaining steps 460-490 are bypassed and a default PV output 407 is generated. If so, the remaining steps 460-490 are performed. Reduce data dispersion 460 eliminates outlying data, leaving trimmed pleth values 464, according to a dispersion criteria 462. Calculate pleth variability 470 determines a variability value 474 from the trimmed pleth values 464 according to a variability formula 472. In an embodiment, the variability formula is the percentage variability in a window compared with a maximum value in the window, such as described with respect to EQ. 2, above. Accumulate variability values 475 identifies those variability values 474 within a specified window 476. Windows 446, 476 are sliding time intervals or segments having predetermined sizes according to an initialization 402. Adjacent windows may be spaced apart, abutting or overlapping in time.


Further shown in FIG. 4, calculate variability parameter 480 determines a pleth variability (PV) parameter 407 from the accumulated variability values 478 according to a reduction criteria 482. In an embodiment, PV 407 is a median of the variability values 478 in the window 476. In other embodiments, PV 407 is any of average, mode, geometric mean or weighted mean of the windowed variability values, to name a few. Post processing on the PV parameter 407 data may be performed including smoothing and a slew rate filter. In an embodiment, an exponential smoothing is used. The slew rate filter limits the positive or negative slope of the PV parameter 407 to a predetermined maximum.


PV Applications


Many clinicians currently observe a pulse oximeter plethysmograph waveform for changes in patient physiology. Unfortunately, there is no consistency among pulse oximeter manufacturers in the way a plethysmograph waveform is displayed. Further, smoothing, autoscaling and other display data processing mask changes in the raw plethysmograph waveform. Thus, some patient physiology cannot be readily predicted from mere observation of a bedside monitor plethysmograph display. Pleth variability (PV) parameters, such as PVI, advantageously quantify plethysmograph waveform variations, which are displayed in a numerical format that can also be trended as needed. Accordingly, even slight changes in physiology may be reliably observed.


PV can be advantageously used for noninvasive functional hemodynamic monitoring. A plethysmograph waveform is responsive to beat-to-beat changes in peripheral blood volume and perfusion. Thus, plethysmograph variability reflects changes in the intravascular volume status of patients. PV parameters, as described above, are clinically useful hemodynamic measurements that respond to changes in, for example, volemia, fluid responsiveness and ventricular preload. Volemia relates to the volume of blood circulating throughout the body, which is difficult to estimate in a clinical setting. Hypovolemia, for example, is an abnormally low blood volume. Fluid responsiveness is the percent increase in ventricular stroke volume after fluid volume expansion. Ventricular preload is the degree of tension in the cardiac muscle when it begins to contract.


In particularly advantageous embodiments, a PV parameter is monitored during patient treatments. As an example, a downward trend in PV monitored during the addition of fluids to a suspected hypovolemic patient indicates the efficacy of that treatment. Likewise, a downward trend in PV monitored during administration of drugs for asthma indicates the efficacy of the administered drug and the likelihood that the asthma can be controlled.


PVI or other pulse variability (PV) measure may be a significant parameter in a variety of critical conditions, for example those conditions shown in Table 1, below.









TABLE 1







Conditions Associated with Increased PV










Cardiac Causes
Non-Cardiac Causes







Cardiogenic Shock
Hypovolemia



Cardiac Tamponade
Septic Shock



Pericardial Effusion
Anaphylactic Shock



Constrictive Pericarditis
Superior Vena Cava




Obstruction



Restrictive
Asthma



Cardiomyopathy



Acute myocardial



infarction










A plethysmograph variability processor has been disclosed in detail in connection with various embodiments. These embodiments are disclosed by way of examples only and are not to limit the scope of the claims that follow. One of ordinary skill in art will appreciate many variations and modifications.

Claims
  • 1. A plethysmograph variability method comprising: inputting a plethysmograph waveform having pulses corresponding to pulsatile blood flow within a tissue site;deriving a plurality of perfusion values corresponding to the pulses, wherein deriving the plurality of perfusion values comprises: identifying of the pulses and valleys of the pulses,calculating differential values for the pulses from the peaks of the pulses and the valleys of the pulses,determining reference values for the pulses, andnormalizing the differential values with the reference values;determining a plurality of variability values indicative of the variability of a plurality of series of perfusion values, wherein each variability value is determined by calculating a difference between a first perfusion value of a series of perfusion values and a second perfusion value of the series of perfusion values and normalizing the difference with the first perfusion value;calculating a plethysmograph variability parameter representative of the plurality of variability values; anddisplaying the plethysmograph variability parameter.
  • 2. The plethysmograph variability method according to claim 1, wherein determining variability values comprises: accumulating the plurality of perfusion values in a plurality of buffers; andcalculating at least one of the plurality of variability values for each of the buffers.
  • 3. The plethysmograph variability method according to claim 2, wherein determining the plurality of variability values further comprises: sorting the plurality of perfusion values within each of the buffers from a largest perfusion value to a smallest perfusion value; andtrimming at least one perfusion value from a set of largest perfusion values and at least one perfusion value from a set of smallest perfusion values from each of the buffers.
  • 4. The plethysmograph variability method according to claim 3, wherein determining variability values further comprises calculating a plurality of plethysmograph variability indexes (PVIs) from a percentage difference between a maximum perfusion value and a minimum perfusion value for each of the buffers.
  • 5. The plethysmograph variability method according to claim 4, wherein calculating a plethysmograph variability parameter comprises calculating a median value of the PVIs.
  • 6. The plethysmograph variability method according to claim 5, further comprising: identifying the pulses, wherein the pulses comprise physiologically acceptable pulses identified from a group comprising the physiologically acceptable pulses and physiologically unacceptable pulses; anddetermining a minimum amount of time of acceptable data in each of the buffers.
  • 7. The plethysmograph variability method according to claim 6, further comprising: verifying the physiologically acceptable pulses using a red channel,wherein inputting the plethysmograph waveform comprises using an IR channel for the plethysmograph waveform.
  • 8. The plethysmograph variability method according to claim 1, wherein the first perfusion value is a largest perfusion value of the series of perfusion values and the second perfusion value is a smallest perfusion value of the series of perfusion values.
  • 9. The plethysmograph variability method according to claim 1, wherein the first perfusion value is a maximum perfusion value of the plurality of perfusion values and the second perfusion value is a minimum perfusion value of the plurality of perfusion values.
  • 10. The plethysmograph variability method according to claim 1, wherein the reference values comprise the peaks of the pulses.
  • 11. The plethysmograph variability method according to claim 1, wherein the reference values comprise the valleys of the pulses.
  • 12. The plethysmograph variability method according to claim 1, wherein the reference values comprise averages of the peaks of the pulses and the valleys of the pulses.
  • 13. A plethysmograph variability processing system comprising: an optical sensor that transmits multiple wavelengths of optical radiation into a tissue site, detects the optical radiation after attenuation by pulsatile blood flowing within the tissue site, and generates a sensor signal responsive to the detected optical radiation;a patient monitor that demodulates the sensor signal so as to generate a plurality of plethysmograph channels; anda digital signal processor (DSP) within the patient monitor configured to: receive at least one plethysmograph channel of the plurality of plethysmograph channels,determine a plurality of plethysmograph values from the at least one plethysmograph channel, wherein the plethysmograph values comprise perfusion values that are calculated by normalizing differences between peaks of the at least one plethysmograph channel and valleys of the at least one plethysmograph channel with reference values,calculate a plurality of variability values based on the plurality of plethysmograph values, wherein each variability value is calculated by normalizing a difference between a first perfusion value and a second perfusion value with the first perfusion value,calculate a plethysmograph variability (PV) parameter based on the plurality of variability values,generate a patient monitor output that is responsive to the PV parameter.
  • 14. The plethysmograph variability processing system according to claim 13, wherein the DSP is further configured to apply physiological acceptability criteria to the plethysmograph values.
  • 15. The plethysmograph variability processing system according to claim 14, wherein the DSP is further configured to remove plethysmograph values according to dispersion criteria.
  • 16. The plethysmograph variability processing system according to claim 15, wherein the DSP is further configured to apply at least one of a smoothing or slew rate limit to the PV parameter.
  • 17. The plethysmograph variability processing system according to claim 16, wherein the DSP is further configured to apply a bandpass filter to the at least one plethysmograph channel to remove a cyclical baseline shift.
  • 18. The plethysmograph variability processing system according to claim 17, wherein the patient monitor output generates a graph of the PV parameter versus time so as to indicate a trend in plethysmograph variability.
  • 19. The plethysmograph variability processing system according to claim 13, wherein the optical sensor is associated with one of a foot, an ear, and a digit.
  • 20. The plethysmograph variability processing system according to claim 13, wherein the optical sensor is associated with a body portion wherein blood flows close to the skin.
  • 21. A plethysmograph variability method comprising: inputting at least one plethysmograph channel of a plurality of plethysmograph channels;calculating a plurality of plethysmograph values from the at least one plethysmograph channel by normalizing differences between peaks of the at least one plethysmograph channel and valleys of the at least one plethysmograph channel with reference values;defining a plurality of windows each encompassing a unique time interval of the plethysmograph values;calculating a plurality of variability values, each of the variability values derived by normalizing a difference between a first plethysmograph value in a first window and a second plethysmograph value in the first window with the first plethysmograph value;defining a second plurality of windows each encompassing a unique time interval of the variability values;calculating a plurality of parameter values, each of the parameter values derived from the variability values encompassed in a unique one of the second windows; andoutputting the parameter values.
  • 22. The plethysmograph variability method according to claim 21, wherein: the plethysmograph channels each have a plurality of pulses corresponding to pulsatile blood flow within a tissue site; andthe plethysmograph values are based upon the pulses.
  • 23. A plethysmograph variability processing system having a sensor that transmits multiple wavelengths of optical radiation into a tissue site and that detects the optical radiation after attenuation by pulsatile blood flow within a tissue site so as to provide a plethysmograph input to a digital signal processor (DSP), the input selected from a plurality of channels corresponding to the multiple wavelengths, the DSP executes instructions for deriving plethysmograph variability from the plethysmograph, comprising: a plethysmograph input;means for generating plethysmograph values from the plethysmograph input by normalizing differences between peaks of the plethysmograph input and valleys of the plethysmograph input with reference values;means for deriving variability values from the plethysmograph values, wherein each variability value is determined by calculating a difference between a first plethysmograph value and a second plethysmograph value and normalizing the difference with the first plethysmograph value; andmeans for deriving a plethysmograph variability (PV) parameter from the plethysmograph values.
  • 24. The plethysmograph variability processing system according to claim 23, further comprising means for removing outlying plethysmograph values.
  • 25. The plethysmograph variability processing system according to claim 24, further comprising means for applying data reduction criteria to a window of variability values.
  • 26. The plethysmograph variability processing system according to claim 25, further comprising means for eliminating pulses from the plethysmograph input that are not physiologically acceptable.
  • 27. The plethysmograph variability processing system according to claim 26, further comprising means for limiting the slope of the PV parameter.
  • 28. The plethysmograph variability processing system according to claim 23, wherein the tissue site is at least a portion of one of a foot, an ear, and a digit.
  • 29. The plethysmograph variability processing system according to claim 23, wherein the tissue site located at or near a body portion where blood flows close to the skin.
PRIORITY APPLICATIONS

This application claims priority to prior U.S. Provisional Patent Application No. 60/873,663 filed Dec. 9, 2006 titled Plethysmograph Variability Index and U.S. Provisional Patent Application No. 60/998,782 filed Oct. 12, 2007 titled Plethysmograph Variability Index. All of the above-referenced applications incorporated by reference herein.

US Referenced Citations (209)
Number Name Date Kind
4432374 Osanai Feb 1984 A
4867165 Noller et al. Sep 1989 A
4960128 Gordon et al. Oct 1990 A
4964408 Hink et al. Oct 1990 A
5041187 Hink et al. Aug 1991 A
5069213 Polczynski Dec 1991 A
5163438 Gordon et al. Nov 1992 A
5337744 Branigan Aug 1994 A
5341805 Stavridi et al. Aug 1994 A
D353195 Savage et al. Dec 1994 S
D353196 Savage et al. Dec 1994 S
5377676 Vari et al. Jan 1995 A
D359546 Savage et al. Jun 1995 S
5431170 Mathews Jul 1995 A
D361840 Savage et al. Aug 1995 S
D362063 Savage et al. Sep 1995 S
5452717 Branigan et al. Sep 1995 A
D363120 Savage et al. Oct 1995 S
5456252 Vari et al. Oct 1995 A
5482036 Diab et al. Jan 1996 A
5490505 Diab et al. Feb 1996 A
5494043 O'Sullivan et al. Feb 1996 A
5533511 Kaspari et al. Jul 1996 A
5561275 Savage et al. Oct 1996 A
5562002 Lalin Oct 1996 A
5590649 Caro et al. Jan 1997 A
5602924 Durand et al. Feb 1997 A
5632272 Diab et al. May 1997 A
5638816 Kiani-Azarbayjany et al. Jun 1997 A
5638818 Diab et al. Jun 1997 A
5645440 Tobler et al. Jul 1997 A
5685299 Diab et al. Nov 1997 A
D393830 Tobler et al. Apr 1998 S
5743262 Lepper, Jr. et al. Apr 1998 A
5758644 Diab et al. Jun 1998 A
5760910 Lepper, Jr. et al. Jun 1998 A
5769785 Diab et al. Jun 1998 A
5782757 Diab et al. Jul 1998 A
5785659 Caro et al. Jul 1998 A
5791347 Flaherty et al. Aug 1998 A
5810734 Caro et al. Sep 1998 A
5823950 Diab et al. Oct 1998 A
5830131 Caro et al. Nov 1998 A
5833618 Caro et al. Nov 1998 A
5860919 Kiani-Azarbayjany et al. Jan 1999 A
5890929 Mills et al. Apr 1999 A
5904654 Wohltmann et al. May 1999 A
5919134 Diab Jul 1999 A
5934925 Tobler et al. Aug 1999 A
5940182 Lepper, Jr. et al. Aug 1999 A
5995855 Kiani et al. Nov 1999 A
5997343 Mills et al. Dec 1999 A
6002952 Diab et al. Dec 1999 A
6011986 Diab et al. Jan 2000 A
6027452 Flaherty et al. Feb 2000 A
6036642 Diab et al. Mar 2000 A
6045509 Caro et al. Apr 2000 A
6067462 Diab et al. May 2000 A
6081735 Diab et al. Jun 2000 A
6088607 Diab et al. Jul 2000 A
6110522 Lepper, Jr. et al. Aug 2000 A
6124597 Shehada Sep 2000 A
6129675 Jay Oct 2000 A
6144868 Parker Nov 2000 A
6151516 Kiani-Azarbayjany et al. Nov 2000 A
6152754 Gerhardt et al. Nov 2000 A
6157850 Diab et al. Dec 2000 A
6165005 Mills et al. Dec 2000 A
6184521 Coffin, IV et al. Feb 2001 B1
6206830 Diab et al. Mar 2001 B1
6229856 Diab et al. May 2001 B1
6232609 Snyder et al. May 2001 B1
6236872 Diab et al. May 2001 B1
6241683 Macklem et al. Jun 2001 B1
6256523 Diab et al. Jul 2001 B1
6263222 Diab et al. Jul 2001 B1
6278522 Lepper, Jr. et al. Aug 2001 B1
6280213 Tobler et al. Aug 2001 B1
6285896 Tobler et al. Sep 2001 B1
6321100 Parker Nov 2001 B1
6325761 Jay Dec 2001 B1
6334065 Al-Ali et al. Dec 2001 B1
6343224 Parker Jan 2002 B1
6349228 Kiani et al. Feb 2002 B1
6360114 Diab et al. Mar 2002 B1
6368283 Xu et al. Apr 2002 B1
6371921 Caro et al. Apr 2002 B1
6377829 Al-Ali Apr 2002 B1
6385471 Mortz May 2002 B1
6388240 Schulz et al. May 2002 B2
6397091 Diab et al. May 2002 B2
6430525 Weber et al. Aug 2002 B1
6463311 Diab Oct 2002 B1
6470199 Kopotic et al. Oct 2002 B1
6501975 Diab et al. Dec 2002 B2
6505059 Kollias et al. Jan 2003 B1
6515273 Al-Ali Feb 2003 B2
6519487 Parker Feb 2003 B1
6525386 Mills et al. Feb 2003 B1
6526300 Kiani et al. Feb 2003 B1
6541756 Schulz et al. Apr 2003 B2
6542764 Al-Ali et al. Apr 2003 B1
6580086 Schulz et al. Jun 2003 B1
6584336 Ali et al. Jun 2003 B1
6595316 Cybulski et al. Jul 2003 B2
6597932 Tian et al. Jul 2003 B2
6597933 Kiani et al. Jul 2003 B2
6606511 Ali et al. Aug 2003 B1
6632181 Flaherty et al. Oct 2003 B2
6639668 Trepagnier Oct 2003 B1
6640116 Diab Oct 2003 B2
6643530 Diab et al. Nov 2003 B2
6650917 Diab et al. Nov 2003 B2
6654624 Diab et al. Nov 2003 B2
6658276 Kianl et al. Dec 2003 B2
6661161 Lanzo et al. Dec 2003 B1
6671531 Al-Ali et al. Dec 2003 B2
6678543 Diab et al. Jan 2004 B2
6684090 Ali et al. Jan 2004 B2
6684091 Parker Jan 2004 B2
6697656 Al-Ali Feb 2004 B1
6697657 Shehada et al. Feb 2004 B1
6697658 Al-Ali Feb 2004 B2
RE38476 Diab et al. Mar 2004 E
6699194 Diab et al. Mar 2004 B1
6714804 Al-Ali et al. Mar 2004 B2
RE38492 Diab et al. Apr 2004 E
6721582 Trepagnier et al. Apr 2004 B2
6721585 Parker Apr 2004 B1
6725075 Al-Ali Apr 2004 B2
6728560 Kollias et al. Apr 2004 B2
6735459 Parker May 2004 B2
6745060 Diab et al. Jun 2004 B2
6760607 Al-Ali Jul 2004 B2
6770028 Ali et al. Aug 2004 B1
6771994 Kiani et al. Aug 2004 B2
6792300 Diab et al. Sep 2004 B1
6813511 Diab et al. Nov 2004 B2
6816741 Diab Nov 2004 B2
6822564 Al-Ali Nov 2004 B2
6826419 Diab et al. Nov 2004 B2
6830711 Mills et al. Dec 2004 B2
6850787 Weber et al. Feb 2005 B2
6850788 Al-Ali Feb 2005 B2
6852083 Caro et al. Feb 2005 B2
6861639 Al-Ali Mar 2005 B2
6869402 Arnold Mar 2005 B2
6898452 Al-Ali et al. May 2005 B2
6920345 Al-Ali et al. Jul 2005 B2
6931268 Kiani-Azarbayjany et al. Aug 2005 B1
6934570 Kiani et al. Aug 2005 B2
6939305 Flaherty et al. Sep 2005 B2
6942622 Turcott Sep 2005 B1
6943348 Coffin, IV Sep 2005 B1
6950687 Al-Ali Sep 2005 B2
6961598 Diab Nov 2005 B2
6970792 Diab Nov 2005 B1
6979812 Al-Ali Dec 2005 B2
6985764 Mason et al. Jan 2006 B2
6993371 Kiani et al. Jan 2006 B2
6996427 Ali et al. Feb 2006 B2
6999904 Weber et al. Feb 2006 B2
7003338 Weber et al. Feb 2006 B2
7003339 Diab et al. Feb 2006 B2
7015451 Dalke et al. Mar 2006 B2
7024233 Ali et al. Apr 2006 B2
7027849 Al-Ali Apr 2006 B2
7030749 Al-Ali Apr 2006 B2
7039449 Al-Ali May 2006 B2
7041060 Flaherty et al. May 2006 B2
7044917 Arnold May 2006 B2
7044918 Diab May 2006 B2
7067893 Mills et al. Jun 2006 B2
7096052 Mason et al. Aug 2006 B2
7096054 Abdul-Hafiz et al. Aug 2006 B2
7132641 Schulz et al. Nov 2006 B2
7142901 Kiani et al. Nov 2006 B2
7149561 Diab Dec 2006 B2
7186966 Al-Ali Mar 2007 B2
7190261 Al-Ali Mar 2007 B2
7215984 Diab May 2007 B2
7215986 Diab May 2007 B2
7221971 Diab May 2007 B2
7225006 Al-Ali et al. May 2007 B2
7225007 Al-Ali May 2007 B2
RE39672 Shehada et al. Jun 2007 E
7239905 Kiani-Azarbayjany et al. Jul 2007 B2
7245953 Parker Jul 2007 B1
7254431 Al-Ali Aug 2007 B2
7254433 Diab et al. Aug 2007 B2
7254434 Schulz et al. Aug 2007 B2
7272425 Al-Ali Sep 2007 B2
7274955 Kiani et al. Sep 2007 B2
D554263 Al-Ali Oct 2007 S
7280858 Al-Ali et al. Oct 2007 B2
7289835 Mansfield et al. Oct 2007 B2
7292883 De Felice et al. Nov 2007 B2
7295866 Al-Ali Nov 2007 B2
7328053 Diab et al. Feb 2008 B1
7332784 Mills et al. Feb 2008 B2
7340287 Mason et al. Mar 2008 B2
7341559 Schulz et al. Mar 2008 B2
7343186 Lamego et al. Mar 2008 B2
D566282 Al-Ali et al. Apr 2008 S
7355512 Al-Ali Apr 2008 B1
20050085702 Diab Apr 2005 A1
20060058691 Kiani Mar 2006 A1
20080064965 Jay et al. Mar 2008 A1
20080079299 Jackson Apr 2008 A1
Foreign Referenced Citations (8)
Number Date Country
2001-321347 Nov 2001 JP
2002-028138 Jan 2002 JP
2006-516000 Jun 2006 JP
WO 2004034898 Apr 2004 WO
WO 2004080300 Sep 2004 WO
WO 2005096922 Oct 2005 WO
WO 2005096922 Oct 2005 WO
WO 2006097866 Sep 2006 WO
Non-Patent Literature Citations (44)
Entry
Cannesson et al., Relation between Respiratory Variations in Pulse Oximetry Plethysmographic Waveform Amplitude and Arterial Pulse Pressure in Ventilated Patients: Critical Care, Aug. 23, 2005; 9(5): 562-568.
Szecsei, Homework Helpers Basic Math and Pre-Algebra, 2006, The Career Press, p. 133.
Steele DW et al, Continuous Noninvasive Measurement of Pulsus, Academy Emergency Medicine: Official Journal of the Society for Academic emergency Medicine, 1995 , 894-900, 2(10), Hanley & Belfus, Philadelphia, PA.
Dr. James Rayner et al, Continuous Noninvasive Measurement of Pulsus Paradoxus Complements Medical Decision Making in Assessment of Acute Asthma Severity, 2006; 130:754-765.
Gregory D. Jay et al, Analysis of Physician Ability in the Measurement of Pulsus Paradoxus by Sphygmomanometry, 2000; 228;348-352.
Robert F. Tamburro et al, Detection of Pulsus Paradoxus Associated with Large Pericardial Effusions in Pediatric Patients by Analysis of the Pulse-Oximetry Waveform, 2002;109;673-677.
Jeff A. Clark et al, Comparison of Traditional and Plethysmographic Methods for Measuring Pulsus Paradoxus, Jan. 2004; 158:48-51.
Dale W. Steele et al, Pulsus Paradoxus an Objective measure of Severity in Croup, 1998;157:331-334.
Frey B et al, Pulse Oximetry for Assessment of Pulsus Paradoxus: A Clinical Study in Children, Mar. 1999;25(3):333-4.
Steele DW et al, Pulsus Paradoxus: An Objective Measure of Severity in Croup, Nov. 1997;52(11):1115.
Dell R et al, Direct Measurement of Pulsus Paradoxus in Acute Severe Asthma, Sep. 1996;150(9):914-8.
Wright RO et al, Continuous, Noninvasive Measurement of Pulsus Paradoxus in Patients With Acute Asthma, Oct. 1995;2(10):894-900.
Steele DW et al, Continuous Noninvasive Determination of Pulsus Paradoxus: A Pilot Study, Oct. 1995;8(10):1669-74.
Pitson DJ et al, Use of Pulse Transit Time as a Measure of Inspiratory Effort in Patients With Obstructive Sleep Apnoea.
Awad et al., Different Responses of Ear and Finger Pulse Oximeter Wave Form to Cold Pressor Test, Anesth Analg 2001, vol. 92, pp. 1483-1486.
Kirk Shelley M.D., Ph.D., Using the Pulse Oximeter to determine Intravascular Volume Status Non-Invasively, Yale University, School of Medicine, undated PowerPoint presentation, 17 slides.
Shelley et al., What Is the Best Site for Measuring the Effect of Ventilation on the Pulse Oximeter Waveform?, Anesth Analg, Aug. 2006, vol. 103 No. 2, pp. 372-377.
Shelley et al, The Use of Joint Time Frequency Analysis to Quantify the Effect of Ventilation on the Pulse Oximeter Waveform, Journal of Clinical Monitoring and Computing (2006) 20: 81-87.
Cannesson et al., Relation between respiratory variations in pulse oximetry plethysmographic waveform amplitude and arterial pulse pressure in ventilated patients, Critical Care 2005, 9:R562-R568.
Feissel et al., Plethysmographic dynamic indices predict fluid responsiveness in septic ventilated patients, Intensive Care Med (2007) 33, pp. 993-999.
Golparvar et al., Evaluating the Relationship Between Arterial Blood Pressure Changes and Indices of Pulse Oximetric Plethysmography, Anesth Analg 2002 vol. 95, pp. 1686-1690.
Cannesson et al., Respiratory Variations in Pulse Oximetry Plethysmographic Waveform Amplitude to Predict Fluid Responsiveness in the Operating Room, Anesthesiology, V 106, No. 6, Jun. 2007, pp. 1105-1111.
Cannesson et al., Respiratory variations in pulse oximeter waveform amplitude are influenced by venous return in mechanically ventilated patients under general anaesthesia, European Journal of Anaesthesiology 2007, vol. 24, pp. 245-251.
Cannesson et al., New Algorithm for Automatic Estimation of the Respiratory Variations in the Pulse Oxymeter Waveform, ASA Annual Meeting Abstracts Oct. 13, 2007.
Brian L. Partridge, MD, DPhil., Use of Pulse Oximetry as a noninvasive indicator of intravascular volume status, Journal of Clinical Monitoring 1987 vol. 3 No. 4, pp. 263-268.
Shamir et al., Pulse Oximetry plethysmographic waveform during changes in blood volume, British Journal of Anaesthesia 1999 vol. 82 No. 2, pp. 178-181.
Murray et al., The Peripheral Pulse Wave: Information Overlooked, Journal of Clinical Monitoring 1996, vol. 12, pp. 365-377.
Natalini et al., Variations in Arterial Blood Pressure and Photoplethysmography During Mechanical Ventilation, Anesth Analg Nov. 2006 vol. 103 No. 5, pp. 1182-1188.
Natalini et al., Arterial Versus Plethysmographic Dynamic Indices to Test Responsiveness for Testing Fluid Administration in Hypotensive Patients: A Clinical Trial, Anesth Analg Dec. 2006 vol. 103 No. 6, pp. 1478-1484.
Cannesson et al., New Algorithm for Automatic Estimation of the Respiratory Variations in the Pulse Oximeter Waveform in Mechanically Ventilated Patients, Crit Care Med 2007 Abstract vol. 35 No. 12 (Suppl), p. A87.
Cannesson et al., New Algorithm for Automatica Estimation of the Respiratory Variations in the Pulse Oximeter Waveform in Spontaneously Breathing Patients, Crit Care Med 2007 Abstract vol. 35 No. 12 (Suppl), p. A87.
Dorlas, J.C. and J.A. Nijboer (1985) “Photo-electric plethysmography as a monitoring device in anaesthesia. Application and interpretation.” British Journal of Anaesthesia 57 (5): 524-30.
James D. and R. Brown (1990). “Vascular volume monitoring with pulse oximetry during pediatric anesthesia [correspondence].” Can J Anaesth 37: 266-7.
Jespersen, L. T. and O. Lederballe (1986). “Quantitative photoplethysmography.” Surgery 99(1): 130.
Jespersen, L.T. and O.L. Pedersen (1986). “The quantitative aspect of photoplethysmography revised.” Heart Vessels 2(3): 186-90.
Kim, J. M., K. Arakawa, et al (1986). “Pulse oximetry and circulatory kinetics associated with pulse volume amplitude measured by photoelectric plethysmography.” Anesth Analg 65 (12): 1333-9.
Lherm. T., T. Chevalier, et al. (1995). “Correlation between plethysmography curve variation (dpleth) and pulmonary capillary wedge pressure (pcwp) in mechanically ventilated patients.” British Journal of Anaesthesia Suppl. 1 (74): 41.
Mooser V, Regamey C, Stauffer “Le pouls paradoxal” Schweiz. Rundschau Med. (PRAXIS) 83, Nr. 6 (1994) : pp. 158-162 (with English Abstract).
Maxime Cannesson, MD. “Use of the Pulse Oximeter Waveform as a Non Invasive Functional Hemodynamic Monitoring”. Claude Bernard University, Louis Pradel Hospital, undated Power Point presentation in 44 slides.
Paul Barach, MD. “Pulsus Paradoxus”. Hospital Physician, Jan. 2000, pp. 49-50.
Shelley, et al., Pulse Oximeter Waveform: Photoelectric Plethysmography, in Clinical Monitoring, Carol Lake, R. Hines, and C. Blitt, Eds.: W.B. Saunders Company, 2001, pp. 420-428.
Shelley, et al., Arterial—Pulse Oximetry Loops: A New Method of Monitoring Vascular Tone, Journal of Clinical Monitoring, Jul. 1997, pp. 223-228.
Awad, et al., How Does the Plethysmogram Derived from the Pulse Oximeter Relate to Arterial Blood Pressure in Coronary Artery Bypass Graft Patients?, The International Anesthesia Research Society, 2001, pp. 1466-1471.
Translation of Japanese Office Action in JP App. No. 2009-540509, dated Aug. 23, 2012, 3 pgs.
Related Publications (1)
Number Date Country
20080188760 A1 Aug 2008 US
Provisional Applications (2)
Number Date Country
60873663 Dec 2006 US
60998782 Oct 2007 US