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US 12,661,069 B2Granted
System and method for validating cardiovascular parameter monitors
AssigneeMidmark Corporation
InventorTuhin Sinha
Life of this patent
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Abstract
A system or method for validating an unvalidated cardiovascular parameter monitor can include receiving a plurality of reference cardiovascular parameter datasets, each reference cardiovascular parameter dataset associated with a patient of a plurality of patients; receiving a plurality of test cardiovascular parameter measurements, each test cardiovascular parameter measurement includes a cardiovascular parameter measured for a patient of the plurality of patients; and validating the cardiovascular parameter monitor based on an analysis of the plurality of reference cardiovascular measurements and the plurality of test cardiovascular parameter measurement.
Claims7
A method for determining a validation status for a blood pressure monitor comprising:
- for a plurality of patients:
- (a) at a first time, measuring a validated blood pressure for each patient of the plurality by:
- (i) inflating and deflating a blood pressure cuff disposed on a first arm of the patient;
- (ii) contemporaneously with inflating and deflating the blood pressure cuff, measuring an audio signal at a frequency of at least 10 kHz using a digital stethoscope;
- and
- (iii) contemporaneously with inflating and deflating the blood pressure cuff, measuring a pressure dataset using a digital pressure gauge, wherein the pressure dataset comprises an instantaneous pressure of the blood pressure cuff measured at a frequency of at least 10 Hz;
- (b) contemporaneously with measuring the validated blood pressure, (b) measuring an unvalidated blood pressure using the blood pressure monitor for each patient comprising:
- (i) recording a time series of images of a finger region of the respective patient on a second arm of the respective patient;
- (ii) determining a pulse waveform from the time series of images;
- and
- (iii) extracting a set of fiducials from the pulse waveform, wherein the set of fiducials comprise fit parameters associated with a set of fitting functions used to fit the pulse waveform;
- and
- (iv) transforming the set of fiducials into the unvalidated blood pressure;
- (c) at a second time, comparing the validated blood pressure to the unvalidated blood pressure;
- and
- (d) determining the validation status of the blood pressure monitor based on the comparison;
- wherein the validated blood pressure comprises a systolic blood pressure approximately equal to a pressure of the pressure dataset measured when a first Korotkoff sound is detected in the audio signal and a diastolic blood pressure approximately equal to a pressure of the pressure dataset measured when a fourth or fifth Korotkoff sound is detected in the audio signal.
14 more elements
A method for determining a validation status for a photoplethysmography-based blood pressure monitor comprising:
- (a) at a first time, measuring a validated blood pressure for a patient by:
- (i) inflating and deflating a blood pressure cuff disposed on a first arm of the patient,
- (ii) contemporaneously with inflating and deflating the blood pressure cuff, measuring an audio signal at a frequency of at least 10 kHz using a digital stethoscope, and
- (iii) contemporaneously with inflating and deflating the blood pressure cuff, measuring a pressure dataset using a digital pressure gauge, wherein the pressure dataset comprises an instantaneous pressure of the blood pressure cuff measured at a frequency of at least 10 Hz;
- (b) contemporaneously with measuring the validated blood pressure, measuring an unvalidated blood pressure using a photoplethysmography-based blood pressure monitor for the patient comprising:
- (i) recording a time series of images of a finger region of a second arm of the patient,
- (ii) determining a pulse waveform from the time series of images,
- (iii) extracting a set of fiducials from the pulse waveform, wherein the set of fiducials comprise fit parameters associated with a set of fitting functions used to fit the pulse waveform, and
- (iv) transforming the set of fiducials into the unvalidated blood pressure;
- (c) at a second time, comparing the validated blood pressure to the unvalidated blood pressure;
- (d) determining the validation status of the photoplethysmography-based blood pressure monitor based on the comparison;
- and
- (e) outputting the validation status, wherein the validation status enables or disables the photoplethysmography-based blood pressure monitor for clinical use,
- wherein the validated blood pressure comprises a systolic blood pressure approximately equal to a pressure of the pressure dataset measured when a first Korotkoff sound is detected in the audio signal and a diastolic blood pressure approximately equal to a pressure of the pressure dataset measured when a fourth or fifth Korotkoff sound is detected in the audio signal.
11 more elements
A method for determining a validation status for a blood pressure monitor comprising:
- (a) at a first time, measuring a validated blood pressure for a patient by:
- (i) inflating and deflating a blood pressure cuff disposed on a first arm of the patient,
- (ii) contemporaneously with inflating and deflating the blood pressure cuff, measuring an audio signal at a frequency of at least 10 kHz using a digital stethoscope, and
- (iii) contemporaneously with inflating and deflating the blood pressure cuff, measuring a pressure dataset using a digital pressure gauge, wherein the pressure dataset comprises an instantaneous pressure of the blood pressure cuff measured at a frequency of at least 10 Hz;
- (b) contemporaneously with measuring the validated blood pressure, measuring an unvalidated blood pressure using the blood pressure monitor for the patient comprising:
- (i) recording a time series of images of a finger region of a second arm of the patient,
- (ii) determining a pulse waveform from the time series of images,
- (iii) extracting a set of fiducials from the pulse waveform, wherein the set of fiducials comprise fit parameters associated with a set of fitting functions used to fit the pulse waveform, and
- (iv) transforming the set of fiducials into the unvalidated blood pressure;
- (c) using a computing system, automatically processing the validated blood pressure and the unvalidated blood pressure by comparing the validated blood pressure to the unvalidated blood pressure;
- and
- (d) using the computing system, automatically determining the validation status of the blood pressure monitor based on the comparison,
- wherein the validated blood pressure comprises a systolic blood pressure approximately equal to a pressure of the pressure dataset measured when a first Korotkoff sound is detected in the audio signal and a diastolic blood pressure approximately equal to a pressure of the pressure dataset measured when a fourth or fifth Korotkoff sound is detected in the audio signal.
10 more elements
Dependencies are inferred from the claim text.