Method and system for estimating momentary cardiovascular performance reserve

• US 9,603,534 B2
• Filed: 01/31/2013
• Issued: 03/28/2017
• Est. Priority Date: 02/13/2012
• Status: Active Grant

• Current Assignee: Cardio Scale Ltd.
• Original Assignee: Cardio Scale Ltd.
• Inventors: Gabbay, Uri, Bobrovsky, Ben Zion
• Primary Examiner(s): Cheng, Jacqueline
• Assistant Examiner(s): PREMRAJ, ANGELINE L
• Application Number:
  US14/375,355
• Publication Number:
  US 20150005647A1
• Time in Patent Office: 1,517 Days
• US Class Current: 1/1
• CPC Class Codes: A61B 2505/01 Emergency care
• CPC Class Codes: A61B 5/0004 characterised by the type of physiological signal transmitted
• CPC Class Codes: A61B 5/02007 Evaluating blood vessel condition, e.g. elasticity, compliance
• CPC Class Codes: A61B 5/02028 Determining haemodynamic parameters not otherwise provided for, e.g. cardiac contractility or left ventricular ejection fraction
• CPC Class Codes: A61B 5/0205 Simultaneously evaluating both cardiovascular conditions and different types of body conditions, e.g. heart and respiratory condition
• CPC Class Codes: A61B 5/021 Measuring pressure in heart or blood vessels A61B5/0205 takes precedence
• CPC Class Codes: A61B 5/0215 by means inserted into the body catheters A61M25/00
• CPC Class Codes: A61B 5/024 Detecting, measuring or recording pulse rate or heart rate A61B5/0205, A61B5/021 take precedence
• CPC Class Codes: A61B 5/029 Measuring or recording blood output from the heart, e.g. minute volume A61B8/065 takes precedence
• CPC Class Codes: A61B 5/08 Detecting, measuring or recording devices for evaluating the respiratory organs A61B5/0205 takes precedence
• CPC Class Codes: A61B 5/107 Measuring physical dimensions, e.g. size of the entire body or parts thereof
• CPC Class Codes: A61B 5/1135 by monitoring thoracic expansion
• CPC Class Codes: A61B 5/4842 Monitoring progression or stage of a disease

Abstract

The invention relates to a method for determining a cardiovascular performance reserve for each individual patient, comprising the steps of: a) receiving input physiological data from the patient for obtaining a parameter Z which is or approximates the product of the Stroke Volume (SV) by the Systemic Vascular Resistance (SVR); b) providing a value representing the Respiratory Rate (RR) of said patient, wherein the Respiratory Rate (RR) value is provided by measurements using dedicated device(s), calculations from the input physiological data or manually by using best estimate; c) providing anthropometric data of said patient for calculating the Body Surface Area (BSA) of said individual, wherein the anthropometric data includes at least body dimensions (such as height and weight) of said patient; d) calculating the Cardiovascular Reserve (CVR) by using said Z parameter and said RR according to following formula: CVR=(Z/RR); e) calculating a Cardiovascular Reserve Index (CVRI) by standardizing said CVR (by said BSA) and normalizing it to a scale of 1 according to the following formula: CVRI=CVR/(BSA*4); and outputting said Cardiovascular Reserve Index.

Claims

1. A method for determining a cardiovascular performance reserve for an individual using a medical system that includes at least one data source and a computerized analysis unit in communication with the at least one data source, the computerized analysis unit employing a processor and a memory, comprising the steps of:

a. receiving, by the analysis unit from the at least one data source, input physiological data from the individual for obtaining a parameter Z which is or approximates the product of the Stroke Volume (SV) by the Systemic Vascular Resistance (SVR);

b. providing a value, to the analysis unit from the at least one data source, representing the Respiratory Rate (RR) of said individual;

c. providing anthropometric data, to the analysis unit from the at least one data source, of said individual for calculating the Body Surface Area (BSA) of said individual;

d. processing, by the analysis unit, the input physiological data signals to provide a normalized Cardiovascular Reserve Index (CVRI) by using said Z parameter, said RR and said BSA, according to the following formula;

CVRI=((Z/RR)/(BSA*4));

e. outputting said CVRI and estimating the individual'"'"'s medical condition therefrom; and

f. outputting a notification of cardiovascular status of the individual based on the CVRI, and prioritizing medical assistance or triage for the individual based on the cardiovascular status notification indicating a heart failure and/or shock condition over other individuals awaiting medical assistance or triage.

2. A method according to claim 1, wherein the input physiological data are measurable hemodynamics-related data of the individual which yield the actual SV and SVR of said individual.

3. A method according to claim 1, wherein Z is approximated by the formula Z=80*(MABP−

CVP)/HR, wherein the input physiological data are measurable either from non invasive vital signs measurements or from an invasive measurement through an arterial catheter, and wherein these measurements are used for obtaining one or more of the Mean Arterial Blood Pressure (MABP), the Heart Rate (HR), and the Central Venous Pressure (CVP) of said individual.

4. A method according to claim 3, wherein the cardiovascular reserve index is calculated by using the difference (MABP-CVP) or a best estimate of the difference if CVP is not available.

5. A method according to claim 1, wherein the Respiratory Rate (RR) value is provided by measurements using dedicated device(s), calculations from the input physiological data or manually by using a best estimate.

6. A method according to claim 1, wherein outputting a notification of cardiovascular status of the individual comprises using a diagnostic test to quantitatively diagnose heart failure and/or shock, to quantify the severity of the diagnosis and to monitor a severity dynamic, wherein the notification includes quantitative heart failure and/or shock severity information.

7. A method according to claim 1, further comprising providing an indication of cardiovascular status by a trend over time for a cardiovascular dynamics indication, and determining whether medical attention is required for the individual based on the outputted index and the indication.

8. A method according to claim 1, wherein outputting the index includes displaying the index for at least one individual, and creating a graph including the current index and a plurality of past indexes for said individual with or without indication on the trend over time.

9. A system for estimating momentary cardiovascular reserve, comprising:

a) at least one data source capable of being connected to an individual for obtaining physiological data from said individual, for obtaining anthropometric data related to said individual and for obtaining a value representing the Respiratory Rate (RR) of said individual, wherein said physiological data is used for obtaining a parameter Z which is or approximates the product of the Stroke Volume (SV) by the Systemic Vascular Resistance (SVR), and wherein said anthropometric data is used for a calculation of the Body Surface Area (BSA) of said individual; and

b) an analysis unit, employing a processor and a memory, in communication with said at least one data source adapted for processing the data received from said at least one data source, in order to determine an index representing said momentary cardiovascular reserve by calculating a normalized Cardiovascular Reserve Index (CVRI) by using said Z parameter, said RR and said BSA, according to the following formula;

CVRI=((Z/RR)/(BSA*4)),

 

wherein the analysis unit is configured to output a notification of cardiovascular status of the individual based on the CVRI, the notification providing heart failure and/or shock information for prioritizing medical assistance or triage for the individual over other individuals awaiting medical assistance or triage.

10. A system according to claim 9, in which the at least one data source includes a vital sign monitor, wherein said vital sign monitor is configured to be in communication with the individual wherein communication includes having said vital sign monitor affixed, attached, implanted, coupled, abutting-tissue of the individual, resident in clothing or equipment worn by said individual, and/or proximate to said individual.

11. A system according to claim 9, in which the analysis unit is in communication with the at least one data source through a wired connection and/or wireless connection.

12. A system according to claim 9, wherein the analysis unit is a separate component not present on the individual on whom the at least one data source is present or in communication with.

13. A system according to claim 9, in which the at least one data source is connected to a transmitter and/or receiver that allows physiological data and anthropometric data to be communicated to the analysis unit, thereby allowing remote monitoring of the individual or monitoring during a medical event such as triage, transport, treatment or telemedicine decision.

14. A system according to claim 9, wherein the analysis unit is configured to provide a diagnostic test to quantitatively diagnose heart failure and/or shock, to quantify the severity of the diagnosis and to monitor a severity dynamic, and the notification of cardiovascular status of the individual includes quantitative heart failure and/or shock severity information.