Device and system that identifies cardiovascular insufficiency

• US 8,423,108 B2
• Filed: 03/15/2010
• Issued: 04/16/2013
• Est. Priority Date: 03/24/2005
• Status: Active Grant

• Current Assignee: Intelomed, Inc.
• Original Assignee: Intelomed, Inc.
• Inventors: Berkow, Jan
• Primary Examiner(s): Mallari, Patricia
• Assistant Examiner(s): D'ANGELO, MICHAEL J
• Application Number:
  US12/723,913
• Publication Number:
  US 20110152651A1
• Time in Patent Office: 1,128 Days
• Field of Search: 600/309, 600/310, 600322-324, 600/481, 600/484, 600/485, 600/500, 600501-502, 600/504, 600/507
• US Class Current: 600/324
• CPC Class Codes: A61B 5/0002 Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network A61B5/07 takes precedence; transmission systems for measured values G08C; transmission H04B; transmission of digital information H04L; wireless communication networks H04W
• CPC Class Codes: A61B 5/02 Detecting, measuring or recording pulse, heart rate, blood pressure or blood flow; Combined pulse/heart-rate/blood pressure determination; Evaluating a cardiovascular condition not otherwise provided for, e.g. using combinations of techniques provided for in this group with electrocardiography or electroauscultation; Heart catheters for measuring blood pressure
• CPC Class Codes: A61B 5/02416 using photoplethysmograph signals, e.g. generated by infrared radiation A61B5/14552 takes precedence
• CPC Class Codes: A61B 5/412 Detecting or monitoring sepsis
• CPC Class Codes: A61B 5/7207 of noise induced by motion artifacts
• CPC Class Codes: G16H 40/63 for local operation

Abstract

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.

Claims

1. A computer-assisted method for identifying a volume status of a patient, the method comprising:

administering a cardiovascular preload to the patient;

continuously recording, prior to, during, and after the step of administering the cardiovascular preload to the patient, a pulse density signal from a non-invasive transducer transmitting data from the patient;

applying, using a processor, a first filter to the pulse density signal to identify a first respiration sampling period recorded prior to the step of administering the cardiovascular preload and a second respiration sampling period recorded after the step of administering the cardiovascular preload;

applying, using the processor, a second filter to the pulse density signal to identify a first plurality of cardiac cycles occurring during the first respiration sampling period and a second plurality of cardiac cycles occurring during the second respiration sampling period; and

calculating, using the processor, a variation of the pulse density signal before and after the step of administering the cardiovascular preload, wherein the variation is used as an index of the volume status of the patient, wherein the variation is a quotient of a difference between a mean pulse density signal between the second and the first respiration sampling periods to a sum of the mean pulse density signal of the second and the first respiration sampling periods, wherein the mean pulse density signal for each respiration sampling period is a quotient of a sum of a difference between a maximum point on the pulse density signal and a minimum point on the pulse density signal for each cardiac cycle occurring during such respiration sampling period to a total number of cardiac cycles occurring during such respiration sampling period.

2. The method as in claim 1, further comprising calculating a peak blood flow velocity for at least one of the respiration sampling periods, wherein the peak blood flow velocity is a difference between a mean minimum point on the pulse density signal for the at least one of the respiration sampling periods and the mean pulse density signal for the at least one of the respiration sampling periods.

3. The method as in claim 2, further comprising calculating a change in peak blood flow velocity between the first and second respiration sampling periods.

4. The method as in claim 3, further comprising:

classifying the change in peak blood flow velocity into a classification system; and

translating the classified change in peak blood flow velocity to identify the volume status of the patient.

5. The method as in claim 1, further comprising:

classifying the variation of the pulse density signal into a classification system; and

translating the classified variation of the pulse density signal to identify the volume status of the patient.

6. The method as in claim 1, further comprising initiating a treatment protocol.

7. A system for identifying a volume status of a patient, the system comprising:

an activator that administers a cardiovascular preload to the patient;

a sensor that records a pulse density signal from a non-invasive transducer transmitting data from the patient prior to, during, and after the cardiovascular preload is administered to the patient;

a controller that controls the sensor to initiate the record of the pulse density signal;

a processor that is configured to;

(i) apply a first filter to filter the pulse density signal to identify a first respiration sampling period and a second respiration sampling period, (ii) apply a second filter to filter the pulse density signal to identify a first plurality of cardiac cycles occurring during the first respiration sampling period and a second plurality of cardiac cycles occurring during the second respiration sampling period, and (iii) calculate a variation of the pulse density signal before and after the cardiovascular preload is administered to the patient, wherein the variation is used as an index of the volume status of the patient, wherein the variation is a quotient of a difference between a mean pulse density signal between the second and the first respiration sampling periods to a sum of the mean pulse density signal of the second and the first respiration sampling periods, wherein the mean pulse density signal for each respiration sampling period is a quotient of a sum of a difference between a maximum point on the pulse density signal and a minimum point on the pulse density signal for each cardiac cycle occurring during such respiration sampling period to a total number of cardiac cycles occurring during such respiration sampling period.

8. The system as in claim 7 wherein the processor is further configured to calculate a peak blood flow velocity for at least one of the respiration sampling periods, wherein the peak blood flow velocity is a difference between a mean minimum point on the pulse density signal for the at least one of the respiration sampling periods and the mean pulse density signal for the at least one of the respiration sampling periods.

9. The system as in claim 8 wherein the processor is further configured to calculate a change in peak blood flow velocity between the first and second respiration sampling periods.

10. The system as in claim 7 wherein the controller is selected from the group consisting of a manual switch, an automated switch, and software rules.

11. The system as in claim 7 wherein the sensor is a photoplethysmograph.

12. A system for identifying a volume status of a patient, the system comprising:

an activator that administers a cardiovascular preload to the patient;

a sensor that records a pulse density signal from a non-invasive transducer transmitting data from the patient prior to, during, and after the cardiovascular preload is administered to the patient;

a controller that controls the sensor to initiate the record of the pulse density signal;

a signal conditioning module comprising an amplifier that amplifies the pulse density signal and a converter that converts the amplified signal to a digital signal, the signal conditioning module being configured to transmit the converted, amplified signal;

a signal processing module configured to;

(i) receive the converted, amplified signal from the signal conditioning module, (ii) apply a first filter to filter the signal to identify a first respiration sampling period and a second respiration sampling period, (iii) apply a second filter to filter the signal to identify a first plurality of cardiac cycles occurring during the first respiration sampling period and a second plurality of cardiac cycles occurring during the second respiration sampling period, and (iv) calculate a variation of the pulse density signal before and after the cardiovascular preload is administered to the patient, wherein the variation is used as an index of the volume status of the patient, wherein the variation is a quotient of a difference between a mean pulse density signal between the second and the first respiration sampling periods to a sum of the mean pulse density signal of the second and the first respiration sampling periods, wherein the mean pulse density signal for each respiration sampling period is a quotient of a sum of a difference between a maximum point on the pulse density signal and a minimum point on the pulse density signal for each cardiac cycle occurring during such respiration sampling period to a total number of cardiac cycles occurring during such respiration sampling period.

13. The system as in claim 12, further comprising a pattern recognition module configured to:

(i) classify the variation in the pulse density signal into a classification system, and (ii) translate the classified variation in the pulse density signal to identify the volume status of the patient.

14. The system as in claim 12 wherein the signal processing module is further configured to calculate a peak blood flow velocity for at least one of the respiration sampling periods, wherein the peak blood flow velocity is a difference between a mean minimum point on the pulse density signal for the at least one of the respiration sampling periods and a mean pulse density signal for the at least one of the respiration sampling periods.

15. The system as in claim 14 further comprising a pattern recognition module configured to calculate a change in peak blood flow velocity between the first and second respiration sampling periods.

16. The system as in claim 15 wherein the pattern recognition module is further configured to:

(i) classify the change in peak blood flow velocity into a classification system, and (ii) translate the classified change in peak blood flow velocity to identify the volume status of the patient.

17. A non-invasive apparatus configured to identify a volume status of a patient, the apparatus comprising:

means for administering a cardiovascular preload to the patient

means for recording a pulse density signal from a non-invasive transducer transmitting data from the patient prior to, during, and after administering the cardiovascular preload to the patient;

means for applying a first filter to the pulse density signal to identify a first respiration sampling period recorded prior to the step of administering the cardiovascular preload and a second respiration sampling period recorded after the step of administering the cardiovascular preload;

means for applying a second filter to the pulse density signal to identify a first plurality of cardiac cycles occurring during the first respiration sampling period and second plurality of cardiac cycles occurring during the second respiration sampling period; and

means for calculating a variation of the pulse density signal before and after administering the cardiovascular preload, wherein the variation is used as an index of the volume status of the patient, wherein the variation is a quotient of a difference between a mean pulse density signal between the second and the first respiration sampling periods to a sum of the mean pulse density signal of the second and the first respiration sampling periods, wherein the mean pulse density signal for each respiration sampling period is a quotient of a sum of a difference between a maximum point on the pulse density signal and a minimum point on the pulse density signal for each cardiac cycle occurring during such respiration sampling period to a total number of cardiac cycles occurring during such respiration sampling period.

18. The apparatus as in claim 17 further comprising means for calculating a peak blood flow velocity for at least one of the respiration sampling periods, wherein the peak blood flow velocity is as a difference between a mean minimum point on the pulse density signal for the at least one of the respiration sampling periods and the mean pulse density signal for the at least one of the respiration sampling periods.

19. The apparatus as in claim 18 further comprising means for calculating a change in peak blood flow velocity between the first and second respiration sampling periods.

20. The apparatus as in claim 17 further comprising an output display.

21. The apparatus as in claim 17 wherein means for recording is a photoplethysmograph.

22. A computer-readable medium having stored therein instructions which, when executed by a processor, cause the processor to calculate a variation of a pulse density signal before and after administering a cardiovascular preload, wherein the variation is used as an index of the volume status of the patient, wherein the variation is a quotient of a difference between a mean pulse density signal between a second and a first respiration sampling period to a sum of the mean pulse density signal second and the first respiration sampling periods, wherein the mean pulse density signal for each respiration sampling period is a quotient of a sum of a difference between a maximum point on the pulse density signal and a minimum point on the pulse density signal for each cardiac cycle occurring during such respiration sampling period to a total number of cardiac cycles occurring during such respiration sampling period.

23. The computer-readable medium as in claim 22 having stored therein instructions which, when executed by the processor, cause the processor to calculate a peak blood flow velocity for at least one of the respiration sampling periods, wherein the peak blood flow velocity is a difference between a mean minimum signal for the at least one of the respiration sampling periods and the mean pulse density signal for the at least one of the respiration sampling periods.

24. The computer-readable medium as in claim 23 having stored therein instructions which, when executed by the processor, cause the processor to calculate a change in mean pulse pressure between the first and second respiration sampling periods.

25. The computer-readable medium as set forth in claim 22 having stored therein instructions which, when executed by the processor, cause the processor to generate an output.