Device and system that identifies cardiovascular insufficiency

A system and method for identifying volume status of a patient are disclosed. A pulse density signal is recorded from the patient. The pulse density signal is filtered to capture a respiration sampling period and a plurality of cardiac cycles occurring during the respiration sampling period. Mean pulse pressure and peak blood flow velocity for the respiration sampling period are calculated and are used as indices of volume status of the patient.

BACKGROUND

Despite the development of regional trauma centers, improved emergency transport systems to reduce the total time in shock, and aggressive resuscitation treatments, trauma patient mortality and morbidity remains high. Traumatic injury is the leading cause of death in subjects <44 years of age, resulting in over 150,000 deaths annually. Severe hypovolemia due to hemorrhage is a major factor in nearly half of those deaths. Furthermore, patients who survive the initial injury are at a high risk of developing subsequent multiple organ dysfunction syndrome and sepsis with a significant rate of late mortality in the ICU. More effective patient monitoring technology would identify patients at risk to develop organ failure and guide appropriate therapy.

Current monitoring required to assess hemodynamic function is often invasive and is limited to high acuity settings. Non-invasive monitoring conducive to lower acuity settings (i.e., areas of care where invasive and cumbersome monitoring techniques cannot be practically implemented) currently provides static, unidimensional, and isolated information of questionable utility.

Severe shock associated with trauma is characterized by a decreased circulatory blood flow that does not meet the metabolic demands of the body. Shock is the result of a vast array of processes with different time courses, degrees of cardiovascular compensation, monitoring needs, pathophysiologies, treatments, and outcomes. However, in all cases, prolonged and unrecognized impaired tissue perfusion will cause organ injury, increased morbidity, and death. Circulatory shock occurs from any of a variety of causes, but has as its hallmark inadequate tissue perfusion such that ischemic dysfunction and organ injury inevitably develop. If tissue hypoperfusion is not reversed by intravascular fluid resuscitation and/or pharmacologic support aimed at restoring normal cardiac performance and vasomotor tone, organ failure and death occur. However, only half of the patients with cardiovascular insufficiency increase their cardiac output in response to volume loading. Thus, it is important to identify which patients are preload-responsive (i.e. they will increase their cardiac output in response to fluid resuscitation) because giving fluid resuscitation to a patient who is not preload-responsive will not improve their circulatory status and delays effective treatment. Delaying treatment results in organ injury and intravascular volume overload, which induces acute right ventricular failure (acute cor pulmonale) and pulmonary edema, both of which can compromise normal homeostatic mechanisms and induce circulatory shock and death.

The prior art has at least three major deficiencies. First, the devices available to monitor a patient's systemic stability are quite insensitive. Second, the mechanisms for monitoring such patients requires that patients are either mechanically ventilated or are in an environment in which only crude maneuvers may be implemented to perturb the cardiovascular system, such as by raising a leg or abdominal compressions. Finally, the output generated by currently available devices requires skilled care providers to interpret the output and to decide appropriate actions or treatment protocols.

Thus, there is a need for a device that can transform insensitive signals into something meaningfully related to the subject's systemic state. There is also a need for a method that can be implemented in a spontaneously breathing subject and/or avoids the inconvenience of physical maneuvers to perturb the cardiovascular system. Finally, there is a need for a device that can be used by a less skilled care provider, such as emergency response personnel, so that critically ill patients receive effective treatment quickly.

SUMMARY

A method for identifying volume status of a patient is disclosed. The method comprises the steps of recording a pulse density signal from the patient and filtering the pulse density signal to capture a respiration sampling period and a plurality of cardiac cycles occurring during the respiration sampling period. A mean pulse pressure for the respiration sampling period is calculated using a computer as the quotient of the sum of the pulse pressure for each cardiac cycle occurring during the respiration sampling period to the total number of cardiac cycles occurring during the respiration sampling period. Optionally, a peak blood flow velocity is calculated as a difference between the mean minimum pressure for the respiration sampling period and a mean pulse pressure for the respiration sampling period. The mean pulse pressure and peak blood flow velocity are used as indices of volume status of the patient. In examples, changes in mean pulse pressure and peak blood flow velocity between first and second respiration sampling periods in response to a cardiovascular pre-load are classified and translated to identify a volume status of the patient.

A system for identifying volume status of a patient is also disclosed. In an embodiment, the system comprises a sensor that records a pulse density signal from the patient. A controller controls the sensor to initiate a record of the pulse density signal. A processor is configured to filter the pulse density signal to capture a respiration sampling period and filter the pulse density signal to capture a respiration sampling period and a plurality of cardiac cycles occurring during the respiration sampling period. The processor is also configured to calculate a mean pulse pressure for the respiration sampling period as the quotient of the sum of the pulse pressure for each cardiac cycle occurring during the respiration sampling period to the total number of cardiac cycles occurring during the respiration sampling period. Optionally, the processor is also configured to calculate a peak blood flow velocity, which is calculated as a difference between the mean minimum pressure for the respiration sampling period and a mean pulse pressure for the respiration sampling period. Mean pulse pressure and peak blood flow velocity are used as indices of volume status of the patient. Optionally, changes in mean pulse pressure and peak blood flow velocity between first and second respiration sampling periods are classified and translated to identify a volume status of the patient.

In another embodiment, the system comprises a sensor that records a pulse density signal from the patient. A controller controls the sensor to initiate the record of the pulse density signal. A signal conditioning module comprises an amplifier that amplifies the pulse density signal and a converter that converts the amplified signal to a digital signal. The signal conditioning module transmits the converted, amplified signal to a signal processing module. The signal processing module is configured to filter the signal to capture a respiration sampling period and a plurality of cardiac cycles occurring during the respiration sampling period. The signal processing module also calculates a mean pulse pressure for the respiration sampling period as the quotient of the sum of the pulse pressure for each cardiac cycle occurring during the respiration sampling period to the total number of cardiac cycles occurring during the respiration sampling period. The signal processing module is also configured to calculate a peak blood flow velocity as a difference between the mean minimum pressure for the respiration sampling period and a mean pulse pressure for the respiration sampling period. Optionally, mean pulse pressure and peak blood flow velocity are used as indices of volume status of the patient. Optionally, a pattern recognition module is configured to calculate changes in mean pulse pressure and peak blood flow velocity between first and second respiration sampling periods which are classified and translated to identify a volume status of the patient.

A non-invasive apparatus for use to identify volume status of a patient is also disclosed. The device comprises means for recording a pulse density signal from the patient and means for filtering the pulse density signal to capture a respiration sampling period and a plurality of cardiac cycles occurring during the respiration sampling period. There is also means for calculating a mean pulse pressure for the respiration sampling period, wherein the mean pulse pressure is the quotient of the sum of the pulse pressure for each cardiac cycle occurring during the respiration sampling period to the total number of cardiac cycles occurring during the respiration sampling period. There is also means for calculating a peak blood flow velocity as a difference between the mean minimum pressure for the respiration sampling period and a mean pulse pressure for the respiration sampling period. Mean pulse pressure and peak blood flow velocity are used as indices of volume status of the patient. Optionally, there is also means for calculating changes in mean pulse pressure and peak blood flow velocity between first and second respiration sampling periods which are classified and translated to identify a volume status of the patient.

A computer-readable medium is also disclosed. Instructions cause the processor to calculate a mean pulse pressure for a respiration sampling period, wherein the mean pulse pressure is the quotient of the sum of the pulse pressure for each cardiac cycle occurring during the respiration sampling period to the total number of cardiac cycles occurring during the respiration sampling period. Instructions also cause the processor to calculate a peak blood flow velocity as a difference between the mean minimum pressure for the respiration sampling period and a mean pulse pressure for the respiration sampling period. Mean pulse pressure and peak blood flow velocity are used as indices of volume status of the patient. Optionally, changes in mean pulse pressure and peak blood flow velocity between first and second respiration sampling periods are classified and translated to identify a volume status of the patient.

These and other details, objects, and advantages of the disclosed system and method will become better understood or apparent from the following descriptions, examples, and figures showing embodiments thereof.

DETAILED DESCRIPTION

The pulse density signal generated by a photoplethysmograph such as from the near infrared channel of a pulse oximeter correlates with the pulsatile changes in arterial blood pressure in the same subject. This relationship is illustrated inFIG. 1A. The top chart recording is an arterial pressure trace, the middle chart recording shows aortic flow, and the bottom chart recording shows pulse density from a pulse oximeter. These data were collected from a subject undergoing coronary bypass surgery. The arterial pressure data were obtained using a femoral artery catheter and aortic flow data were obtained using a Cineflo® electromagnetic flow meter, with the flow probe positioned in the aorta. These graphs are shown to depict the strong correlation between the beat-to-beat variations in flow and arterial pressure compared to the variation in pulse density recorded from a photoplethysmograph.

FIG. 1Bshows a graph that illustrates the significant correlation between the pulse pressure variation signal obtained from a photoplethysmograph and stroke volume as measured by a Cineflo® flow probe.

Embodiments of the claimed systems100,200are shown inFIGS. 6 and 8, respectively. In the embodiment shown inFIG. 6, the system100is a computer system, although the system may be implemented in any combination of hardware and software, as long as the combination does not interfere with the scope and intended use of the claimed system. In an example, the system comprises a subject50, a device10such as the one described above, and a healthcare provider90, researcher, or leader, such as a lead fire-fighter or a military superior. The device has a storage medium that stores instructions (not shown), a controller11that initiates data collection from the subject, a sensor13that collects and transfers data, and a processor15unit that reduces the data and uses the instructions to carry out at least one of a plurality of steps. In an example, the instructions carry out at least one of the steps of initiating the controller11to collect data, instructing the sensor13to collect data and transfer a data signal, perturbing the subject50, processing the data into at least one output20, analyzing the output20, displaying the output20, or deciding how to use the output20. In an example, the healthcare provider90or researcher review the output and/or use the output to institute a treatment protocol, such as where the subject is cardiovascularly insufficient or hypovolemic. In other examples, the healthcare provider monitors or manages the subject50, for example, from a remote location, as described above.

The processor15,215may contain a single microprocessor, or may contain a plurality of microprocessors for configuring the computer as a multi-processor system. The storage medium, or main memory, stores in part instructions and data for execution by the processor unit. If the method is implemented in software, the main memory stores the executable code when in operation. The main memory may be in the form of dynamic random access memory or any storage medium known in the art.

A data signal is transferred to the processor15,215by the sensor13,213, such as for example a photoplethysmograph, that supplies data regarding a physiological condition of the subject. In an embodiment, the processor15reduces the data and uses instructions (not shown) to carry out at least one of the steps of the claimed method, shown inFIG. 4and described in detail below. In another embodiment, the processor215reduces the data and uses instructions (not shown) to carryout out at least one of the steps of the claimed method, shown inFIGS. 9-11and described in detail below. These steps generate an output20,220. Output20,220may be any output that a researcher90or a healthcare provider uses to either identify, treat, manage, or monitor a subject. Output20,220includes at least the examples described below but may be in any form that could be used in a clinical or research setting.

The sensor13provides a portion of the user interface for a user of the computer system. The components contained in the computer system are those typically found in general purpose computer systems, and in fact, these components are intended to represent a broad category of such computer components that are well known in the art.

Another embodiment of the system200is shown inFIG. 8. The system200has a sensor213that records a pulse density signal from the patient. The recording is either continuous or continuously intermittent. In an example, the sensor213is a photoplethysmograph, which is a device that operates by capturing changes in light absorption affected primarily by pulsatile blood density. In examples where the sensor213is a photoplethysmograph, the sensor213is either a dedicated optical sensor that operates in the near infrared frequency range or may be a near infrared sensor that is shared by another device such as the use of a near infrared channel of a pulse oximeter. An example of an unfiltered pulse density signal captured by a photoplethysmograph is shown inFIG. 12A.

The processor215receives the data signal from the sensor213and reduces or processes the data signal into at least one output220by at least calculating a variation of the data signal across the respiration periods over which data were collected. In an example, the processor215applies a first filter to obtain the respiration signal and a second filter to obtain the cardiac pulse signal.

As shown inFIG. 8, the system200also has a signal conditioning module250that includes an amplifier252and an analog-to-digital converter254. The steps carried out by the signal conditioning module250are set forth inFIG. 9. The signal conditioning module250captures the pulse density signal from the sensor213. The signal is amplified via hardware or software as shown in step310ofFIG. 9. The signal is converted from a continuous analog signal to a series of digital values per a defined sampling rate as shown in step320. The sampling rate of the converter254translates the data signal to a series of digital values over time. The higher the sampling rate, the more precise the resolution and exactness of the digital representation of the analog waveform. The converted signal is then inverted as shown in step330because an increase in pulse density that corresponds to an increase in pulsatile strength corresponds to an increased amount of absorbed light and a smaller corresponding value through the skin. The signal is inverted so that the increased absorption and corresponding increase in blood density appear in an upward or positive direction. As shown in step340, the inverted signal is then transmitted via either a hardwired circuit or wirelessly to a remote receiver for further processing.

The system200also has a signal processing module260that is configured to receive and filter the converted signal to identify each respiration sampling period and the plurality of cardiac cycles occurring during each respiration sampling period. The steps carried out by the signal processing module260are set forth inFIG. 10. The converted pulse density signal is received from the signal conditioning module, as shown in step410. A band pass filter is applied to the signal to capture the respiratory signal, as shown in step420. The process of respiration increases chest pressure during inspiration and reduces it during exhalation, thereby creating a modulating effect on the cardiac measures. In spontaneously breathing patients, the erratic nature of breathing cycles creates undesirable variability in the pulse density signal due to this modulating effect. The effects of spontaneous breathing are addressed by obtaining the mean of these derived values over each respiration sampling period in order to remove this modulating effect. In an example, respiration sampling periods are identified by filtering the inverted pulse density signal into frequency bands of possible respiration frequencies. In an example, the following bands are used: 0.12 to 0.28 Hz; 0.16 to 0.32 Hz; 0.20 to 0.36 Hz; 0.24 to 0.40 Hz; and 0.28 to 0.44 Hz. Next, an algorithm, such as a power analysis, is applied to each band in order to identify which band is the strongest (i.e., has the highest dB) in order to select the optimum respiration frequency range. See step425. Next, a maximum detection algorithm is applied to the optimum respiration frequency range to identify respiration period start and end sampling points that correspond to the selected respiration sampling period. See step435.FIG. 12Bshows the filtered respiration sampling period derived from the pulse density signal shown inFIG. 12A. In another embodiment, respiration frequency is obtained via wavelet analysis. Wavelet analysis is useful where the pulse density signal is obtained from a population where the frequency is more variable, such as from a mobile population.

The signal processing module260also identifies cardiac cycles that occur during each respiration sampling period. Cardiac cycles are identified by applying a low pass filter to the converted signal in order to obtain a cardiac pulse waveform, as shown in step440. In an example, the filter range is 2.3 to 0.8 Hz, although other ranges may be appropriate depending upon the intended use population (i.e., infants and trauma patients may require higher ranges). In another example, wavelet analysis is used to define the optimum cardiac frequency. Next, a peak and valley detection algorithm is applied to the cardiac pulse waveform to identify the minimum and maximum values. Pulse pressure for each cardiac cycle is calculated by subtracting the minimum pressure of the filtered cardiac pulse for the cardiac cycle within a respiration sampling period from the maximum pressure of the filtered cardiac pulse waveform for that cardiac cycle. The mean pulse pressure value for each cardiac cycle is calculated according to Equation 3 (below). The signal processing module also calculates the mean minimum pressure for each respiration sampling period according to Equation 6 (below) and the peak blood flow velocity for each respiration sampling period according to Equation 5 (below).FIG. 12Cshows the filtered cardiac pulse signal and the cardiac cycles derived from the pulse density signal shown inFIG. 12A.

The system200also has a pattern recognition module270that is configured to calculate a change in peak blood flow velocity and a change in mean pulse pressure between two respiration sampling periods. The steps performed by the pattern recognition module270are shown inFIG. 11. The respiration sampling periods are optionally consecutive. As shown inFIG. 11A, the pattern recognition module270receives the mean pulse pressure values for each respiration sampling period from the signal processing module260. See step510. In order to assess a time series of mean pulse pressure values, as shown in step520, an algorithm is applied to each consecutive mean pulse pressure value to calculate an absolute or a relative change in mean pulse pressure between two respiration sampling periods. In an example, an absolute change in mean pulse pressure between two respiration sampling periods is calculated. In another example, a relative change in mean pulse pressure between two respiration sampling periods is calculated, such as percent change of the peak amplitude, or the percentage change in the average or root-mean-square given the oscillating nature of the mean pulse pressure. The algorithm removes outlier mean pulse pressure values to account for unplanned or physiological artifacts (i.e., coughing, moving, etc). The pattern recognition module270classifies the change in mean pulse pressure into a classification system. See step530. The classified change in mean pulse pressure is then translated into a graphic such as a gauge or a set of textually defined conditions to identify the volume status of the patient, such as to determine if the patient has a volume deficiency, as shown in step540. Optionally, the translation is entered into a database or file as part of the patient record.

As shown inFIG. 11B, the pattern recognition module270also receives the peak blood flow velocity values for each respiration sampling period from the signal processing module260. See step550. In order to assess a time series of peak blood flow velocity values, as shown in step560, an algorithm is applied to each consecutive peak blood flow velocity value to calculate an absolute or a relative change in peak blood flow velocity between two respiration sampling periods. In an example, an absolute change in peak blood flow velocity between two respiration sampling periods is calculated. In another example, a relative change in peak blood flow velocity between two respiration sampling periods is calculated, such as percent change of the peak amplitude average or root-mean-square given the oscillating nature of the mean pulse pressure. The algorithm removes outlier peak blood flow velocity values to account for unplanned or physiological artifacts (i.e., coughing, moving, etc). The pattern recognition module270classifies the change in peak blood flow velocity into a classification system, as shown in step570. The classified change in peak blood flow velocity is then translated into a graphic such as a gauge or a set of textually defined conditions to identify the volume status of the patient, such as to determine if the patient has a volume deficiency. See step580. Optionally, the translation is entered into a database or file as part of the patient record.

The systems100,200may further include a mass storage device, peripheral devices, portable storage medium drives, input control device, a graphics subsystem, and an output display (not shown). The systems100,200may be connected through one or more data communications means. For example, the processor and the main memory may be connected via a local microprocessor bus, and the mass storage device, peripheral devices, portable storage medium drives, graphics subsystem may be connected via one or more input/output (I/O) busses. The mass storage device, which may be implemented with a magnetic disk drive or an optical disk drive, is a non-volatile storage device for storing data and instructions for use by the processor. In the software embodiment, the mass storage device stores the information software for loading to the main memory.

FIGS. 2 and 3show schematics of embodiments of the claimed device10. In an example, device10is portable such that device10may be carried into challenging settings outside of the hospital such as in far forward military applications, in ambulances, and/or by emergency response personnel. In examples, device10may be attached to a hospital bed70(seeFIG. 2A), a gurney (not shown), a wheelchair (not shown), or a part of the subject's50body (seeFIG. 2B, described in greater detail below). As shown in the figures, and referring particularly toFIGS. 2-3, the claimed device10is comprised of a controller or a control11, a sensor13, and a processor15. The controller11initiates collection of a plurality of data related to a physiological condition. In an example, the physiological condition is related to the subject's50cardiovascular system or is indicative of dysfunction of the subject's50cardiovascular system, either directly or indirectly, such as is illustrated in the chart recordings and graph shown inFIG. 1. In this way, collected data related to the physiological condition provide an indirect index of cardiovascular dysfunction such that relative changes in the physiological condition may indicate cardiovascular dysfunction.

In examples, the controller11is a switch or a trigger that initiates data collection by the sensor13,213and that may be operated manually, automatically, or both. In another example, the controller11is a plurality of software rules that manage the data collection process. In another example, the controller11is a combination of the software rules and at least one of the switches.

The sensor13,213continuously collects data over a plurality of cycles80(seeFIG. 7) or over a respiratory sampling range R(Y) (seeFIG. 12). In an example, there is also a plurality of subcycles85within each cycle80or a plurality of cardiac cycles “c” occurring during each respiratory sampling range R(Y). In the example shown inFIG. 7, cycles80are respiratory cycles. Sensor13,213transfers or transmits data to the processor15,215. Sensor13,213may be any component that is capable of converting energy into a useable physiological signal. In examples, sensor13,213is comprised of analog-to-digital converter processing and algorithms to convert energy into a usable physiological signal, such as for example the measure of oxygenated hemoglobin as represented by a pulse pressure chart recording of pulse oximeter density (seeFIGS. 1A and 1B). In examples, the sensor13,213is a photoplethysmograph (seeFIG. 3) that utilizes either absorbed (FIG. 3A) or reflected (FIG. 3B) light waves. Other examples of sensors13,213include impedance cardiographs, ultra wide-band radar, esophageal pulse Doppler, or thermodilution. This list is not intended to be limiting however, and sensor13,213may include any component that does not interfere with the intended purpose of the claimed system.

The processor15receives the data signal from the sensor13and reduces or processes the data signal into at least one output20by at least calculating a variation of the data signal across the cycles over which data were collected. In an example, the processor15applies a filter to capture the maximum and minimum data signal in each subcycle85to assess and treat cardiovascularly unstable patients85and the mean of the maximum data signals and minimum data signals across all cycles80, and uses a formula to calculate the deviation of the signal across all cycles80. The use of this formula imparts on the device10a level of sensitivity to detect change in the physiologic condition previously unavailable to non-invasive devices.

In an example, the formula is embodied in software rules. In one embodiment, the formula is as follows:
percent deviationdata signal=(Pmeanmax−Pmeanmin)/[(Pmeanmax+Pmeanmin)/2]×100.  [Equation 1]

In this formula, percent deviationdata signalis a variation in a data signal received from the sensor13. Pmeanmaxis a maximum mean value of the data signal across the plurality of cycles80, and Pmeanminis a minimum mean value of the data signal across the cycles80. A mean value of the data signal is calculated for each subcycle (c)85as follows:
Pmeanc=Pmaxc+Pminc/2.  [Equation 2]

In this formula, and referring to the example chart recording shown inFIG. 7, Pmaxcis the maximum data signal in a given subcycle (c) and Pmincis the minimum data signal in a given subcycle (c). Pmeanmaxand Pmeanminare the highest and lowest mean value of the data signal, respectively, out of all of the Pmeanccalculated (i.e., one Pmeancfor each of the subcycles (c)).

In another embodiment, volume status of a patient is identified by calculating a change in mean pulse pressure between two respiration sampling periods R(Y), R(Y+1). In an example, a positive change in mean pulse pressure between two respiration sampling periods indicates that the patient is volume insufficient. Optionally, the respiration sampling periods R(Y), R(Y+1) are consecutive. Mean pulse pressure for a respiration sampling period (PPmeanR(Y)) is calculated as the quotient of the sum of the pulse pressure for each cardiac cycle occurring during the respiration sampling period to the total number of cardiac cycles occurring during the respiration sampling period and is used as an index of a patient's volume status. The formula for calculating mean pulse pressure for a respiration sampling period R(Y) having x cardiac cycles is:
PPmeanR(Y)=((Pmax1R(Y)−Pmin1R(Y))+ . . . +(PmaxxR(Y)−PminxR(Y))/x,[Equation 3]where Pmax1R(Y)is the maximum pressure of the filtered cardiac signal for the first cardiac cycle within the respiration sampling period R(Y),where Pmin1R(Y)is the minimum pressure of the filtered cardiac signal for the first cardiac cycle within the respiration sampling period R(Y),where PmaxxR(Y)is the maximum pressure of the filtered cardiac signal for the last cardiac cycle within the respiration sampling period R(Y), andwhere PminxR(Y)is the minimum pressure of the filtered cardiac signal for the last cardiac cycle within the respiration sampling period R(Y).

The change in mean pulse pressure between two respiration sampling periods R(Y) and R(Y+1) is calculated as follows:
ΔPPmean=(PPmeanR(Y+1)−PPmeanR(Y))/(PPmeanR(Y+1)+PPmeanR(Y)).  [Equation 4]

In another embodiment, peak blood flow velocity is used as an index of a patient's volume status. In another embodiment, volume status of a patient is identified by calculating a change in peak blood flow velocity between two respiration sampling periods. Optionally, the respiration sampling periods are consecutive. In an example, a positive change in peak blood flow velocity between two respiration sampling periods indicates that the patient is volume insufficient. Peak blood flow velocity for a respiration sampling period (PBFV) is calculated as the difference between a mean minimum pressure for the respiration sampling period and a mean pulse pressure for the respiration sampling period. The formula for calculating peak blood flow velocity for a respiration sampling period R(Y) is:
PBFV=Pmin(mean)R(Y)−PPmeanR(Y),  [Equation 5]
where Pmin(mean)R(Y)is the mean minimum pressure for the respiration sampling period and is calculated as the quotient of the sum of the minimum pressure for each cardiac cycle occurring during the respiration sampling period to the total number of cardiac cycles x occurring during the respiration sampling period R(Y), calculated as:
Pmin(mean)R(Y)=(Pmin1R(Y)+ . . . +PminxR(Y))/x,[Equation 6]where Pmim1R(Y)is the minimum pressure of the filtered cardiac signal for the first cardiac cycle within the respiration sampling period R(Y), andwhere PminxR(Y)is the minimum pressure of the filtered cardiac signal for the last cardiac cycle within the respiration sampling period R(Y).

While an embodiment of the present invention contemplates that the output20,220is a percent deviation in the data signal, output20,220may also be the plurality of data collected, the data signal itself, an information set, an interface, or a combination thereof. In other examples, output20,220is an interpretation of data signal and may optionally suggest action or treatment protocols. Any output may be graphical, numerical, or textual.

Output20,220may be displayed remotely, on the device itself, and/or may be integrated with an interface such as the one shown inFIG. 4and described in detail below. In examples, the output20,220is displayed on a handheld device, a monitor screen25(seeFIG. 4), a display window27(seeFIG. 2B), and/or any other display means known in the art that does not interfere with the intended use of the claimed device. As shown in the example inFIG. 4, output is displayed on a monitor25and is integrated with an interface system that provides, for example, subject-specific information such as direct cardiovascular measurements, analytics, sensor signal quality, and patient status. In an example, output20,220is interpretations of gauges and measures that would enable a caregiver at any level of competency to interpret the analysis and to determine an appropriate action, such as treatment protocol. In an example, the interpretation indicates that the subject is deficient and the form of the deficiency related to norms. Other examples of information that may be displayed as part of the interface include biographical information about subject such as name, patient number, age, gender, medical history, and known allergies to pharmacological agents. In an example, the output20,220is an objective directive for at least one proposed treatment protocol for treating the subject.

In an example, the device10of the claimed invention further comprises an activator30,230. In an example, the activator30perturbs the cardiovascular system of the subject50in order to assess the cardiovascular system's response (i.e., the percent deviationdata signal) to the perturbation and to use that response or percent deviationdata signalto identify cardiovascular insufficiency. In other examples, mean pulse pressure or peak blood flow velocity are as indices of the volume status of a patient. In this way, in an example, the claimed device collects the data signal before, at the beginning of, and/or after the perturbation. In examples, the activator30,230is administration of an agent, a physical maneuver, and/or mechanical ventilation of the subject. Where the activator30,230is an agent, examples include but are not limited to administration of a bolus volume infusion or a pharmacologic agent such as a vasoconstrictor, a vasodilator, or a vasoactive agent, including for examples norepinephrine, epinephrine, and atropine. Where the activator30,230is administering a physical maneuver, examples include but are not limited to raising a subject's leg about 30% from resting position, compression of a part of the subject's body, such as a calf (see compression device shown inFIG. 2Band described below) or the abdomen, the Valsalva maneuver, or a change in physical position of the subject, such as going from a sitting to a standing position. The activator30,230may be activated by an automatic or manual switch or trigger, or by a motion sensor to recognize physical maneuvers.

In the example shown inFIG. 2A, the device10is portable and may be attached to a hospital bed70. The device10(i.e., the controller11, the sensor13, and the processor15) is embodied within a small box, and in an example, the activator30and the output display, shown here as a monitor25, are embodied within the same box. In other examples, the activator30and/or output display are remote.

In the example shown inFIG. 2B, the device10is an inflatable cuff12that may be worn around the subject's calf. In an example, an automated or manual controller11initiates collection of data by the sensor13continuously over a plurality of cycles80. The sensor transfers13the data to the processor15as a data signal and the processor15reduces the data signal into at least one output, as described above. In an example, an activator30inflates the cuff12(i.e., a cardiovascular perturbation) such that the inflation causes an intravascular volume load equivalent to a change of approximately 300 mL of volume in the subject's cardiovascular system. The percent deviationdata signal, mean pulse pressure, or peak blood flow velocity are calculated by the processor15in response to the perturbation as described above. As shown in the example inFIG. 2B, the activator30is remotely connected to the device10by wired or wireless communication. In another example, the activator is not remote (not shown). In this example, the output display is a display window27.

Another schematic of an example of the claimed device10is shown inFIG. 3. In this example, the sensor13is a photoplethysmographic device comprised of a photosource14and a photodetector16. A controller11initiates collection of pulse oximeter density, which is a measure of the amount of oxygenated hemoglobin present in the subject's blood. The activator30perturbs the cardiovascular system55. The photosource14emits light waves18of a known wavelength that pass through the vascular bed of a part of the subject's body such as a fingertip52, as shown inFIG. 3A. As shown inFIG. 3B, in another example light waves are reflected off a surface of the fingertip52. The photodetector16measures the amount of oxygenated hemoglobin in the subject's blood over the plurality of cycles80.

In an embodiment, the claimed method uses the device10described above to identify cardiovascular insufficiency of a subject50. In other examples, the claimed device is used to monitor a subject50(remotely or non-remotely), identify when the subject is hypovolemic or dehydrated (i.e., has decreased circulatory blood volume), manage a subject50, and/or to institute a treatment protocol. Examples of use are provided in detail below. A schematic outlining the steps of an example of the claimed invention is depicted inFIG. 5.

In an example, the claimed method comprises the first step of initiating the collection of a plurality of data. In an example, data relate to a physiological condition of the subject50, as described above. Data collection may be initiated by the controller11described above. In the example shown inFIG. 5, data collection need only be initiated one time because collection occurs continuously over the plurality of cycles80. In other examples, such as where initiation is manually driven, the step of initiating data collection will be required every time data collection is desired or required.

The claimed method also comprises the step of collecting data. Collection is made by a sensor13such as the one described above. Examples of cycles80and subcycles85are identified in the chart recording shown inFIG. 7. As shown, data are collected across a plurality of cycles80, such as respiratory cycles, and across sub-cycles85within each cycle, such as cardiac cycles.

The claimed method also comprises the step of reducing the received data signal into output. In an example, data are collected and subsequently reduced before, at the initiation of, and/or after a perturbation (described below). The processor15,215calculates at least a variation to generate an output and may make additional calculations. In the claimed method, the processor15,215uses at least one of the formulae described above to process the data signal.

In a next step, the subject's cardiovascular system is perturbed, for example by an activator30. In another example, a healthcare provider90or a researcher perturbs the subject's cardiovascular system by performing a physical maneuver on the patient or by instructing the subject to perform such a maneuver. In other examples, an agent such as a bolus volume load or a pharmacological agent is administered to the subject. Perturbations include but are not limited to those described above.

Referring still toFIG. 4, the next step of an example of a method of using the claimed invention is analyzing the output. In an example, the step of analyzing the data may be carried out by the processor15or by the healthcare provider90or both. For example, a physician treating the subject may analyze the data signal, and/or the calculations. In another example, the processor15analyzes the signal and sends graphics that portray analytics or trends, gauges or meters, alarms, or any combination thereof, to a display monitor. In another example, the processor15recommends a treatment protocol that suggests how subject50should be treated. This recommendation may be displayed on an output interface such as the one shown inFIG. 4. In examples, analysis comprises the steps of comparing data or calculations and deciding how to use the output.

Another step in an example of the claimed method is using the output to treat, monitor, or manage a subject50, or to identify a physiological insufficiency in the subject, such as a cardiovascular insufficiency.

Another example of the method of using device10is shown inFIG. 5B. As shown, in a first step controller11operates using a set of rules. Controller11is manually initiated and a motion sensor is activated. Sensor13collects data and acquires and conditions the signal to be transferred to processor15. Processor15reduces the signal such as by using at least one of the formulae described above and provides an output. In a next step, the analyzed signal is translated into any type of output, including the examples described above. The output is then used by a system or user, such as a physician90, researcher, or leader.

Although the schematics inFIG. 5show examples of the claimed method, the steps of the claimed method may be carried out in any order and may optionally be repeated at least one time.

EXAMPLES

The following examples are intended to illustrate the claimed invention and should not be construed as limiting the invention in any way.

Unattended Monitoring in an Active Individual

A military war-fighter is in a combat situation in a hot, dry climate such as a desert. The war-fighter is clothed in a military combat uniform and is carrying on his back weapons and packs full of supplies and ammunition. He has not had fluids for more than three hours and is therefore susceptible to dehydration. The claimed device continuously and periodically monitors the soldier. The war-fighter is equipped with a motion sensor somewhere on his person that indicates when a physical motion has been performed initiating data collection. Either software rules applied to the motion sensor signal, software rules applied to the sensor, or a combination thereof provide a data quality indicator software bit to the device rules for when an ample physical motion provides an adequate perturbation to the cardiovascular system. Based on this quality indicator, the claimed continuously-monitoring device applies the classification algorithm to current sampled values of mean pulse pressure or peak blood flow velocity over five respiratory cycles in order to monitor the soldier's vascular volume. When the output from the claimed device indicates that the soldier is near or in a dehydrated or hypovolemic state, an alarm is initiated (e.g. a vibration, a sound, a light) to either alert the warfighter that he needs to rehydrate himself or is communicated to others.

The device may be similarly used in other situations in which individuals are subjected to extreme environments, such as fire-fighters and astronauts.

Unattended or Attended Monitoring of an Immobile Patient

A patient afflicted with a chronic cardiovascular condition requires home healthcare where a telehomecare service is provided for remote caregiver monitoring. In another instance an individual has an acute cardiovascular condition and requires emergency medical technician assistance. The claimed device, such as the one shown inFIG. 3, is equipped with a compressible cuff (i.e. sequential compression device or SCD), commonly employed in hospitals to limit venous stasis to mimic the perturbation from passive leg raising) that the patient wears around his calf when in bed, on a stretcher or gurney such as the ones shown inFIG. 2B, above. The cuff is automatically inflated periodically to create a perturbation to the cardiovascular system. The device monitors oxygenated hemoglobin levels continuously over five respiratory cycles beginning at the point in time of the perturbation in order to monitor the change of pressure or volume of the vasculature and assessed for cardiovascular insufficiency and potentially contributions to cardiovascular insufficiency using the entire hemodynamic algorithm and additional devices (e.g. blood pressure). An output is continuously periodically updated with a current output every time the medical device performs a volume-loading perturbation followed by an assessment.

One form of the output could be a graphical display of a “patient dashboard” that provides interpreted results in easy-to-understand graphic metaphors such as a visual of a gauge or meter. This will allow caregivers of lesser competencies to apply complex hemodynamic concepts that indicate cardiovascular dysfunction such that more metabolically precise treatment protocols may be applied in a more responsive manner. Another output of the device may be an alarm of some type when the device has determined an extreme measure of cardiovascular dysfunction.

The output may be displayed at the bedside in the instance that the immobile patient is being attended to by a caregiver such as in an emergency transport. In addition or alternatively, the continually refreshed output may be transmitted via a wireless data communication, telecommunication, or satellite link to a remote location for continuous monitoring.

Attended Immobile Patient Management

A hemodynamically unstable immobile critical care patient is being continuously monitored in a hospital acute care setting. The patient is spontaneously breathing making a mechanical ventilator unnecessary. A protocol is being administered to correct the patient's hemodynamic instability via a pharmacologic agent based protocol. The compressible cuff is worn around the patient's calf as in Example 2. In addition to a sensor to obtain a measure of the change in arterial pressure, cardiac output, or intravascular flow, other sensors are also captured such as measures of mean arterial pressure (i.e. an automated blood pressure cuff) to enable both output of all traditional vitals and analyses of the contributions of hemodynamic dysfunction such as disclosed in U.S. Pat. No. 6,776,764 to Pinsky. An output may be in the form of a patient dashboard at the bedside, communicated via a wireless communications method to caregiver's hand held device or to a clinical information system, or any combination. In this example the device is used for ongoing assessment of an instituted protocol to enable protocol optimization and responsive patient management.

Peak Blood Flow Velocity vs. Peak Audio Doppler Recording

FIG. 13shows a calculated peak blood flow velocity waveform generated by the disclosed system and method. In this example, a patient was placed in a lower body negative pressure chamber that is used to simulate centralized hypovolemia.

The lower body negative pressure chamber consists of a sealed wooden box that encloses the lower body to above the hip (iliac crest). A neoprene wrap was place around the waist of the subject to ensure an adequate pressure seal. A vacuum was then operated continuously via a variable voltage control to adjust pressure in the chamber. A pressure transducer was attached via tygon tubing and calibrated to obtain current pressure in the chamber measured in mm of Hg. A protocol was employed of capturing baseline values and then to reduce pressure in 5 steps of −10 mm Hg holding each step for 3 minutes then releasing the pressure to return the chamber back to 0 mm Hg. The negative pressure sequesters blood to the lower extremities removing it from circulation. A decrease of 10 to 20 mm Hg has been shown to correlated to hemodynamic responses from a blood loss of 400 to 550 mL while a decrease of 20 to 40 mm Hg has been shown to correlate to a loss of 550 to 1,000 mL. The pulse density signal was recorded by a photoplethysmograph and was converted, inverted, and filtered as described above in order to generate the peak blood flow velocity waveform. Mean arterial pressure (MAP) was captured from a sensor placed on the finger using the volume clamp method (Finometer) to indicate how average pressure responds during controlled hypovolemia. As shown byFIG. 13, the peak blood flow velocity signal is superimposed on top of a converted peak audio Doppler recorded from an ultrasound device placed on a patient's brachial artery. These data confirm that the calculated peak blood flow velocity waveform correlates with the derived peak blood flow velocity. In both instances, an upward movement indicates an increased velocity. These changes correspond to the time course changes of the autoregulatory system. When the lower body negative pressure initially drops, there is a quick response from the baroreceptors that immediately sense changes in blood vessel pressure and activate a change in the compliance of the blood vessels causing the cardiac pulse wave to travel faster. After about 40 seconds to 1 minute, the cardiovascular system comes to a new steady state at which point it has adapted to the new level of blood loss. The cycle of immediate response and adaptation is evident at −30, −40, and again at −50 mm Hg.

Volume Insufficiency Measurements

FIG. 14shows a calculated peak blood flow velocity waveform generated by the disclosed system and method. In this example, the pulse density signal was recorded from a heart failure patient who was undergoing catheter laboratory testing. These data show what occurred in this patient in response to a passive leg raise used as the cardiovascular pre-load. The patient had not ingested any fluids since the evening before in preparation for the catheter lab testing and, as often the case, was dehydrated during testing. In this experiment, an accelerometer was placed on the patient's leg to indicate the initiation and conclusion of the passive leg raise (indicated as “Cardiovascular Pre-load” onFIG. 14).

The mean arterial pressure waveform was derived from a Finapres (Datex Ohmeda) device that employs a volume clamp method. A common artifact that occurs in the Finapres signal when a patient is volume insufficient (i.e., this patient was dehydrated) is a continual set of signal peaks as the volume clamp has little residual circulating volume in the finger to clamp down on as shown inFIG. 14as “A.” These peaks continue for approximately 30-40 seconds after the passive leg raise is performed, indicating the length of time required to affect the cardiovascular pre-load and resulting in a volume related change on the Starling curve. The additional circulating volume created by the leg raise provided this increased central venous return and cardiac pre-load effect.

The pulse density signal was recorded by a photoplethysmograph and was converted, inverted, and filtered as described above in order to generate the mean arterial pressure waveform and the peak blood flow velocity waveform. The increased cardiac pulse pressure is shown by the pulse pressure derived from the photoplethysmograph and is consistent with pulse pressure that could alternatively have been derived from an arterial pressure signal. Alternatively, studies have shown that an increase in the peak brachial blood flow velocity signal can also be used to identify volume insufficiency in response to a volume loading exercise. These data confirm this correlation.

Recognizing a Patency or Stenosis

In end-stage renal disease, patients undergoing hemodialysis with long-term vascular access have an occlusion rate of 17-45% per year. Measured changes or ratios of elevated systolic velocity via Doppler ultrasound over time has been shown as a means to recognize changes in patency of a graft or fistula used as the access port for hemodialysis. Given that changes in peak blood flow velocity have been shown to correlate well to the peak Doppler ultrasound in Example 4, one example of use of the system is to measure this signal over time when placed on the finger or the arm where the access port is located.

While certain embodiments and applications have been described above, the skilled artisan will appreciate that there may be other applications to which the invention is well suited.