Methods, apparatus and articles-of-manufacture for noninvasive measurement and monitoring of peripheral blood flow, perfusion, cardiac output biophysic stress and cardiovascular condition
First Claim
1. A method of continuous, noninvasive, hemodynamic monitoring, comprising:
- receiving a signal related to pressure pulsations in a patient'"'"'s artery;
processing said signal, at least in part in the frequency domain, to obtain pressure and flow waveforms, and a composite phase lag between peaks in the pressure and flow waveforms.
0 Assignments
0 Petitions
Accused Products
Abstract
The invention relates to methods, apparatus, articles-of-manufacture, and coded data signals for measuring cardiac output, limb blood flow, perfusion, blood pressure, artery elasticity, and cardiovascular deterioration and disease, including performing these measurements on a continuous heart beat-by-beat basis, for humans and animals. Unlike empirical methods of other noninvasive blood pressure concepts, the invention is grounded on scientifically appropriate hemodynamic principles that studies have validated as accurate, and is practical for wide clinical use. Devices constructed in accordance with the invention can be comfortably employed for numerous applications, including hospital monitoring, physician'"'"'s office cardiovascular disease management and drug therapy monitoring, home monitoring, and athletic applications.
The invention may be implemented in a variety of single or multi-sensor embodiments, such as: invasive pressure cannula sensor systems; non invasive pressure transducer arrays and piezo or other strain sensing materials that are placed against the skin above arteries; “upstream” pulsing-sensors (that apply single or multi-frequency vibrations that are measured “downstream” from the first placement location); other types of plethysmographic sensors; sonic/ultrasonic/Doppler sensors; MRI blood spin magnetizer/sensors; oxygen sensors; and electrocardiographic sensors, etc.
-
Citations
173 Claims
-
1. A method of continuous, noninvasive, hemodynamic monitoring, comprising:
-
receiving a signal related to pressure pulsations in a patient'"'"'s artery;
processing said signal, at least in part in the frequency domain, to obtain pressure and flow waveforms, and a composite phase lag between peaks in the pressure and flow waveforms. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10)
-
-
11. A method of estimating blood flow velocity, using a noninvasive pressure cuff, comprising:
-
receiving a pulsatile, pressure-related signal from said pressure cuff; and
,computing, for each heartbeat cycle and each harmonic of interest, a first-pass estimate of harmonic phase velocity. - View Dependent Claims (12, 13, 14)
-
-
15. A method of estimating blood flow velocity, using a noninvasive pressure cuff, comprising:
-
receiving a pulsatile, pressure-related signal from said pressure cuff;
computing, at least in part from said pressure-related signal, a pressure gradient-related waveform, for each heartbeat cycle;
computing harmonic component(s) of said pressure gradient-related signal, for each harmonic of interest; and
,computing a first-pass estimate of blood flow, for each harmonic of interest, from, at least in part, said computed harmonic component(s). - View Dependent Claims (16, 17, 18, 19)
-
-
20. A method for non invasively determining the longitudinal pressure gradient in a patient'"'"'s artery, comprising:
-
sampling a pressure-related signal obtained from an externally-mounted pressure-sensitive device;
computing said pressure gradient as a function, at least in part, of the difference between successive samples of said pressure-related signal. - View Dependent Claims (21, 22, 23, 24, 25)
-
-
26. A method for computing blood flow in a patient'"'"'s artery, from a sequence of cuff pressure samples, comprising:
-
computing, for at least the first three harmonics of the patient'"'"'s heart rate, a first-pass harmonic phase velocity for each of said harmonic frequencies;
computing, from said sequence of cuff pressure samples, a first-pass pressure gradient waveform;
computing, for each of said at least first three harmonics, a frequency-domain modulus and phase of the first-pass pressure gradient waveform;
computing, for each of said at least first three harmonics, a first-pass harmonic flow waveform from, at least in part, the corresponding frequency-domain modulus and phase of said first-pass pressure gradient waveform;
computing, for each of said at least first three harmonics, a first-pass pressure-flow phase shift;
computing, for each of said at least first three harmonics, a second-pass estimate of harmonic phase velocity by correcting the corresponding first-pass harmonic phase velocity to account for the corresponding first-pass pressure-flow phase shift;
computing a final-pass pressure gradient waveform from, at least in part, said second-pass harmonic phase velocities; and
,computing a final-pass flow velocity waveform from, at least in part, said final-pass pressure gradient waveform. - View Dependent Claims (27, 28, 29, 30, 31, 32, 33, 34, 36, 37, 38, 39)
-
-
35. A method, as defined in claim 35, wherein computing said first-pass harmonic flow waveforms involves, for each harmonic, further involves scaling the magnitude of the corresponding sinusoidal waveform by a corresponding Womersley modulus and offsetting the phase of said corresponding sinusoidal waveform by a corresponding Womersley phase factor.
-
40. A method of non invasively monitoring blood pressure and flow in a patient, comprising:
-
wrapping an inflatable cuff, having predetermined inflation characteristics, around the patient'"'"'s upper arm or a leg;
performing an oscillometric run by inflating the cuff to a flow-occluding pressure, then monitoring pressure pulsations over a series of successively lower inflation pressures;
using the predetermined inflation characteristics to convert the monitored pressure pulsations into equivalent volumetric pulsations;
determining initial-flow and zero-stress cuff inflation pressures; and
,determining, at least in part from said initial-flow and zero-stress cuff inflation pressures, parameters related to arterial wall thickness and radius. - View Dependent Claims (41)
-
-
42. A method of continuously monitoring a plurality of hemodynamic parameters using a combination of time-domain and frequency-domain processing techniques, said method comprising:
-
computing, on a beat-by-beat basis, at least one time-domain parameter, selected from the list of;
volume displacement amplitude, average external arterial radius, radial distention, incremental elasticity, relative wall thickness, pulse pressure, pressure gradient, diastolic pressure, systolic pressure, and, mean arterial pressure;
wherein said at least one time-domain parameter is computed using time-domain processing techniques; and
,computing, on a beat-by-beat basis, at least one frequency-domain parameter, selected from the list of;
harmonic phase velocity, harmonic pressure gradient, harmonic flow velocity, harmonic flow rate, harmonic flow-based elasticity, and, harmonic pressure-flow phase lag;
wherein said at least one frequency-domain parameter is computed using, at least in part, frequency-domain processing techniques. - View Dependent Claims (43, 44, 45, 46, 47, 48, 49)
-
-
50. A method of continuous, non invasive patient monitoring, comprising:
-
affixing a cuff to the upper arm or a leg of the patient;
performing a system calibration;
entering a beat-by-beat monitoring cycle, which includes;
providing a real-time blood pressure waveform; and
,providing a real-time blood flow waveform computed, at least in part, in the frequency domain. - View Dependent Claims (51, 52, 53, 54)
-
-
55. A continuous, non invasive, hemodynamic monitoring system, comprising:
-
a pressure transducer, affixed to a patient'"'"'s upper arm or a leg, providing a signal related to pressure pulsations in a patient'"'"'s artery;
a signal processor, adapted to process said signal, at least in part in the frequency domain, to obtain pressure and flow waveforms, including a composite phase lag between peaks in the pressure and flow waveforms. - View Dependent Claims (56, 57, 58, 59, 60, 61, 62, 63, 64)
-
-
65. A non invasive system for estimating blood flow velocity, comprising:
-
a pressure cuff, providing a pulsatile, pressure-related signal; and
,a signal processor, programmed to compute a first-pass estimate of harmonic phase velocity, for each heartbeat cycle and each harmonic of interest. - View Dependent Claims (66, 67, 68)
-
-
69. A non invasive system for estimating blood flow velocity, comprising:
-
a pressure cuff, mounted to provide a pulsatile, pressure-related signal;
a pressure gradient processing module, programmed to compute, using, at least in part, said pressure-related signal, a pressure gradient-related waveform, for each heartbeat;
a harmonic processing module, programmed to compute harmonic component(s) of said pressure gradient-related signal, for each harmonic of interest; and
,a flow processing module, programmed to compute a first-pass estimate of blood flow, for each harmonic of interest, using, at least in part, said computed harmonic component(s). - View Dependent Claims (70, 71, 72, 73)
-
-
74. A system for non invasively determining the longitudinal pressure gradient in a patient'"'"'s artery, comprising:
-
an externally-mounted pressure-sensitive device, providing a pressure-related signal;
a sampler, connected to provide samples of said pressure-related signal; and
,a signal processor, programmed to compute said pressure gradient as a function, at least in part, of the difference between successive samples of said pressure-related signal. - View Dependent Claims (75, 76, 77, 78, 79)
-
-
80. A computer-based system for computing blood flow in a patient'"'"'s artery, from a sequence of cuff pressure samples, comprising:
-
a first-pass velocity processing module, programmed to compute, for at least the first three harmonics of the patient'"'"'s heart rate, a first-pass harmonic phase velocity for each of said harmonic frequencies;
a first-pass pressure gradient processing module, programmed to computed, from said sequence of cuff pressure samples, a first-pass pressure gradient waveform;
a harmonic processing module, programmed to compute, for each of said at least first three harmonics, a frequency-domain modulus and phase of the first-pass pressure gradient waveform;
a first-pass flow processing module, programmed to compute, for each of said at least first three harmonics, a first-pass harmonic flow waveform from, at least in part, the corresponding frequency-domain modulus and phase of said first-pass pressure gradient waveform;
a visco-elastic shift processing module, programmed to compute, for each of said at least first three harmonics, a first-pass pressure-flow phase shift;
a second-pass velocity processing module, programmed to compute, for each of said at least first three harmonics, a second-pass estimate of harmonic phase velocity by correcting the corresponding first-pass harmonic phase velocity to account for the corresponding first-pass pressure-flow phase shift;
a final-pass pressure gradient processing module, programmed to compute a final-pass pressure gradient waveform from, at least in part, said second-pass harmonic phase velocities; and
,a final-pass flow processing module, programmed to compute final-pass flow velocity waveform from, at least in part, said final-pass pressure gradient waveform. - View Dependent Claims (81, 82, 83, 84, 85, 86, 87, 88, 89, 90, 91, 92, 93)
-
-
94. A system for non invasively monitoring blood pressure and flow in a patient, comprising:
-
an inflatable cuff, having predetermined inflation characteristics, wrapped around the patient'"'"'s upper arm or a leg;
an oscillometric control module, programmed to inflate the cuff to flow-occluding pressure, then monitor pressure pulsations over a series of successively lower inflation pressures;
a volumetric processing module, programmed to use the predetermined inflation characteristics to convert the monitored pressure pulsations into equivalent volumetric pulsations;
a vda envelope processing module, programmed to determine initial-flow and zero-stress cuff inflation pressures, from said volumetric pulsation data; and
,an arterial calibration parameter processing module, programmed to determine parameters related to arterial wall thickness and radius, using, at least in part said initial-flow and zero-stress cuff inflation pressures. - View Dependent Claims (95)
-
-
96. A system for continuously monitoring a plurality of hemodynamic parameters using a combination of time-domain and frequency-domain processing techniques, said system comprising:
-
a time-domain processing module programmed to compute, on a beat-by-beat basis, at least one time-domain parameter, selected from the list of;
volume displacement amplitude, average external arterial radius, radial distention, incremental elasticity, relative wall thickness, pulse pressure, pressure gradient, diastolic pressure, systolic pressure, and, mean arterial pressure. a frequency-domain processing module, programmed to compute, on a beat-by-beat basis, at least one frequency-domain parameter, selected from the list of;
harmonic phase velocity, harmonic pressure gradient, harmonic flow velocity, harmonic flow rate, harmonic flow-based elasticity, and, harmonic pressure-flow phase lag. - View Dependent Claims (97, 98, 99, 100, 101, 102, 103)
-
-
104. A system for continuous, noninvasive patient monitoring, comprising:
-
a cuff affixed to the upper arm or a leg of the patient;
a system calibration module; and
,a beat-by-beat monitoring module, including;
means for providing a real-time blood pressure waveform; and
,means for providing a real-time blood flow waveform computed, at least in part, in the frequency domain. - View Dependent Claims (105, 106, 107, 108)
-
-
109. An article-of-manufacture, for use in connection with a computer-based method of continuous, noninvasive, hemodynamic monitoring, said article-of-manufacture comprising a computer-readable medium containing instructions which, when executed, cause said computer to:
-
receive a signal related to pressure pulsations in a patient'"'"'s artery; and
,process said signal, at least in part in the frequency domain, to obtain pressure and flow waveforms, including a composite phase lag between peaks in the pressure and flow waveforms.
-
-
110. An article-of-manufacture, for use in connection with a computer-based method of estimating blood flow velocity, using a non invasive pressure cuff, said article-of-manufacture comprising a computer-readable medium containing instructions which, when executed, cause said computer to:
-
receive a pulsatile, pressure-related signal from said pressure cuff; and
,compute, for each heartbeat cycle and each harmonic of interest, a first-pass estimate of harmonic phase velocity.
-
-
111. An article-of-manufacture, for use in connection with a computer-based method of estimating blood flow velocity, using a non invasive pressure cuff, said article-of-manufacture comprising a computer-readable medium containing instructions which, when executed, cause said computer to:
-
receive a pulsatile, pressure-related signal from said pressure cuff;
compute, at least in part from said pressure-related signal, a pressure gradient-related waveform, for each heartbeat cycle;
compute harmonic component(s) of said pressure gradient-related signal, for each harmonic of interest; and
,compute an estimate of blood flow, for each harmonic of interest, from, at least in part, said computed harmonic component(s).
-
-
112. An article-of-manufacture, for use in connection with a computer-based method for noninvasively determining the longitudinal pressure gradient in a patient'"'"'s artery, said article-of-manufacture comprising a computer-readable medium containing instructions which, when executed, cause said computer to:
-
sample a pressure-related signal obtained from an externally-mounted pressure-sensitive device; and
,compute said pressure gradient as a function, at least in part, of the difference between successive samples of said pressure-related signal.
-
-
113. An article-of-manufacture, for use in connection with a computer-based method for computing blood flow in a patient'"'"'s artery, from a sequence of cuff pressure samples, said article-of-manufacture comprising a computer-readable medium containing instructions which, when executed, cause said computer to:
-
compute, for at least the first three harmonics of the patient'"'"'s heart rate, a first-pass harmonic phase velocity for each of said harmonic frequencies;
compute, from said sequence of cuff pressure samples, a first-pass pressure gradient waveform;
compute, for each of said at least first three harmonics, a frequency-domain modulus and phase of the first-pass pressure gradient waveform;
compute, for each of said at least first three harmonics, a first-pass harmonic flow waveform from, at least in part, the corresponding frequency-domain modulus and phase of said first-pass pressure gradient waveform;
compute, for each of said at least first three harmonics, a first-pass pressure-flow phase shift;
compute, for each of said at least first three harmonics, a second-pass estimate of harmonic phase velocity by correcting the corresponding first-pass harmonic phase velocity to account for the corresponding first-pass pressure-flow phase shift;
compute a final-pass pressure gradient waveform from, at least in part, said second-pass harmonic phase velocities; and
,compute a final-pass flow velocity waveform from, at least in part, said final-pass pressure gradient waveform.
-
-
114. An article-of-manufacture, for use in connection with a computer-based method of non invasively monitoring blood pressure and flow in a patient, using an inflatable cuff, having predetermined inflation characteristics, wrapped around the patient'"'"'s upper arm or a leg, said article-of-manufacture comprising a computer-readable medium containing instructions which, when executed, cause said computer to:
-
perform an oscillometric run by inflating the cuff to a flow-occluding pressure, then monitoring pressure pulsations over a series of successively lower inflation pressures;
use the predetermined inflation characteristics to convert the monitored pressure pulsations into equivalent volumetric pulsations;
determine initial-flow and zero-stress cuff inflation pressures; and
,determine, at least in part from said initial-flow and zero-stress cuff inflation pressures, parameters related to arterial wall thickness and radius.
-
-
115. A noninvasive method for measuring physical parameters of an artery, comprising:
-
applying an inflatable cuff around the artery;
inflating the cuff to a pressure sufficient to substantially occlude blood flow through the artery;
deflating the cuff to ascertain a pressure, F, at which pulsations in said cuff first become detectable;
further deflating the cuff to ascertain a pressure, C, at which the rate-of-increase of pulsations in said cuff decreases with further cuff deflation; and
,using F and C to determine a physical parameter of the artery. - View Dependent Claims (116, 117, 118, 119, 120, 121)
-
-
122. A method for non invasively monitoring blood flow through an artery, comprising:
-
placing a band or cuff around a limb of a patient;
undertaking an initial calibration phase by controllably constricting and/or relaxing the band or cuff, while measuring pulsations from said artery;
computing, from measurements made during said calibration phase, a plurality of arterial parameters, including parameters related to the internal radius, external radius and elasticity of the artery;
adjusting the band or cuff to a reduced pressure or tension where it does not substantially constrict or deform the artery and undertaking a continuous flow monitoring phase by computing blood flow through the artery from pulsations measured with the band or cuff at said reduced pressure or tension. - View Dependent Claims (123, 124, 125, 126, 127, 128, 129, 130)
-
-
131. A method for computing a Young'"'"'s elasticity of an artery from noninvasive measurements, comprising:
-
determining a pulse pressure-related parameter from noninvasive measurements;
determining an arterial radius-related parameter from noninvasive measurements;
determining an arterial wall thickness-related parameter from noninvasive measurements;
determining a pulsatile radial displacement-related parameter from noninvasive measurements; and
using said pulse pressure-related, arterial radius-related, arterial wall thickness-related and pulsatile radial displacement-related parameters to compute a Young'"'"'s elasticity for said artery. - View Dependent Claims (132, 133, 134, 135, 136, 137, 138)
-
-
139. A method of computing blood flow in an artery, comprising:
-
using measurements received from a controllably restrictive band or cuff to determine a plurality of calibration parameters; and
,using measurements received from an invasive pressure sensor, along with said plurality of calibration parameters, to compute blood flow in said artery. - View Dependent Claims (140, 141, 142)
-
-
143. A method for continuously and non invasively determining blood pressure, comprising:
-
determining a plurality of radius- and elasticity-related parameters through measurements taken during an OCD cycle; and
,continuously determining blood pressure from non-occlusive measurements and said radius- and elasticity-related parameters. - View Dependent Claims (144, 145)
-
-
146. A noninvasive method for determining cardiac stroke volume, comprising:
-
utilizing a frequency-domain process to determine flow at an externally accessible arterial site; and
,iteratively applying a flow-continuity analysis, or flow-resistance circuit concepts, to determine cardiac stroke volume. - View Dependent Claims (147)
-
-
148. A noninvasive system for determining cardiovascular parameters, comprising:
-
at least one sensor that generates a pulsatile signal based on pulsations in an artery;
at least one controllable flow-restrictive member that can be used to selectively limit blood flow through said artery;
said system further characterized in that it includes at least two characterizing features selected from the list of;
computation of both an internal radius and an external radius of said artery;
computation of an elasticity of said artery wall;
beat-by-beat computation of blood flow in said artery using a frequency-domain process;
beat-by-beat computation of blood pressure in said artery using at least one pressure-flow phase lag correction factor; and
,beat-by-beat comparison of parameters computed in the frequency and time domains to determine whether system recalibration is needed. - View Dependent Claims (149)
-
-
150. A method of non invasively determining cardiovascular parameters, comprising:
-
positioning at least two longitudinally separated sensors along an exterior conduit artery;
performing an OCD cycle to determine at least a parameter related to the internal radius of said conduit artery;
monitoring, at a low external applied pressure of approximately 10-25 mmHg, pressure pulsations received from said at least two longitudinally separated sensors; and
,determining, from (i) said monitored pulsations, (ii) said at least a parameter related to the internal radius and (iii) the longitudinal separation between said at least two sensors, additional cardiovascular parameter(s). - View Dependent Claims (151, 152, 153, 154, 155, 156, 157, 158)
-
-
159. A noninvasive method for determining an oxygen perfusion parameter, comprising:
-
utilizing a frequency-domain or shadow monitoring waveform contour process to determine flow at an externally accessible arterial site; and
,acquiring a hemoglobin oxygen saturation measurement, and computing a product of said blood flow and said hemoglobin oxygen saturation measurement. - View Dependent Claims (160, 161, 162, 163)
-
-
164. A method for noninvasive determination of oxygen perfusion latency time comprising:
-
utilizing a frequency-domain or shadow monitoring waveform contour process to determine flow at an externally accessible arterial site;
obtaining a noninvasive measure of oxygen saturation at said externally accessible site;
computing an internal radius and mean flow velocity of said artery;
computing a latency parameter related to the total travel time of blood flow from the heart to the externally accessible arterial site.
-
-
165. A replaceable sensor assembly for use in connection with a non-invasive patient monitoring system, the sensor assembly including:
-
one or more sensor(s) capable of measuring or sensing conditions at the periphery of a patient'"'"'s body and generating signal(s) in response thereto;
an energy pathway capable of connecting the sensor(s) to the monitoring system; and
,one or more non-volatile data storage elements capable of storing information indicative of the age, number of uses, and/or total hours of use of the replaceable sensor assembly. - View Dependent Claims (166, 167, 168, 169, 170, 171, 172, 173)
-
Specification