Granted Patent B2

US 12,661,069 · App. 18/224,174 · Granted Jun 23, 2026

Inventor: Tuhin Sinha (Burlingame, CA)

Assignee: Midmark Corporation

A61B5/7221A61B5/02208A61B5/02233A61B5/0295

Abstract

Claims (45)

1 . 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.

2 . The method of claim 1 , wherein the first time and the second time differ by at least one hour.

3 . The method of claim 1 , wherein the systolic blood pressure and the diastolic blood pressure are determined in a post-hoc analysis of the audio signal and the pressure dataset, via a computing system.

4 . The method of claim 1 , wherein comparing the validated blood pressure to the unvalidated blood pressure comprises performing a mixed model repeated analysis, via computing system, wherein the validation status is positive when a mean error of the unvalidated blood pressure is about ±5 mmHg or a standard deviation of at most about 8 mmHg.

5 . The method of claim 1 , further comprising, for each patient of the plurality of patients, contemporaneously with inflating and deflating the blood pressure cuff, measuring an ECG dataset.

6 . 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.

7 . 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.

Assignments (2)

Continuity (3)

References Cited (132)