Detection of progressive central hypovolemia

• US 10,342,437 B2
• Filed: 11/27/2013
• Issued: 07/09/2019
• Est. Priority Date: 08/08/2006
• Status: Active Grant

• Current Assignee: Empirical Technologies Corporation
• Original Assignee: Empirical Technologies Corporation
• Inventors: Baruch, Martin, Gerdt, David, Adkins, Charles
• Primary Examiner(s): Berhanu, Etsub D
• Assistant Examiner(s): Catina, Michael A
• Application Number:
  US14/092,745
• Publication Number:
  US 20150148694A1
• Time in Patent Office: 2,050 Days
• CPC Class Codes: A61B 5/02042 Determining blood loss or bleeding, e.g. during a surgical procedure
• CPC Class Codes: A61B 5/02125 of pulse wave propagation time
• CPC Class Codes: A61B 5/7275 Determining trends in physiological measurement data; Predicting development of a medical condition based on physiological measurements, e.g. determining a risk factor
• CPC Class Codes: G16H 20/40 relating to mechanical, radiation or invasive therapies, e.g. surgery, laser therapy, dialysis or acupuncture
• CPC Class Codes: G16H 40/63 for local operation
• CPC Class Codes: G16H 50/20 for computer-aided diagnosis, e.g. based on medical expert systems
• CPC Class Codes: G16H 50/30 for calculating health indices; for individual health risk assessment
• CPC Class Codes: G16H 50/50 for simulation or modelling of medical disorders
• CPC Class Codes: Y02A 90/10 Information and communication technologies [ICT] supporting adaptation to climate change, e.g. for weather forecasting or climate simulation

Abstract

A system for detecting dehydration, hemorrhaging, and increases in blood volume comprising monitors the time difference between the arrival of the primary left ventricular ejection pulse (pulse T1) and the arrival of the iliac reflection (pulse T3) to determine an arterial pulse parameter which is the time difference between T1 T3. Changes in T3 minus T1 are indicative of something happening to blood volume. If the T1-3 value goes up and the patient is on an infusion system, it can be an indication of having too much fluid pumped and if T1-3 is lower than it should be for an individual, they are either dehydrated (which can result in decreases in blood volume), they are hemorrhaging, or they have hemorrhaged. A downtrend in T13 can tell whether someone is continuing to hemorrhage.

Claims

1. A method of early detection of total blood volume changes in an animate being by time based, real time monitoring of arterial pressure pulse waveforms as an immediate indicator of blood volume change comprising the steps of:

positioning a noninvasive sensor at a single arterial pulse detection site of said animate being;

recording, with said sensor, arterial pressure pulse waveforms generated by said animate being;

gathering, in real time, with a microprocessor, arterial pressure pulse waveform data from said sensor;

storing said arterial pressure pulse waveform data on a non-transitory computer readable medium as said data is received from said sensor;

running a pulse decomposition analysis algorithm, with said microprocessor, as said data is received from said sensor, said pulse decomposition algorithm capable of monitoring arrival time differences of pulses within said arterial pressure pulse waveform, in order to;

a) locate within each of said arterial pressure pulse waveforms a primary constituent systolic pulse, renal constituent reflection pulse, and iliac reflection constituent pulse,

b) extract from each of said primary constituent systolic pulse, and said iliac reflection constituent pulse a primary constituent systolic peak, and iliac reflection constituent peak, respectively, and

c) identify in real time a millisecond time of arrival of said primary systolic constituent peak and said iliac reflection constituent peak within each of said arterial pressure pulse waveforms recorded;

calculating in real time, with said microprocessor, a millisecond time difference between said arrival time of said primary systolic constituent peak and said arrival time of said constituent iliac reflection peak,

generating, with said microprocessor, real time arterial pressure pulse time difference data based on said time difference between arrival time of said primary systolic constituent peak and arrival time of said constituent iliac reflection peak;

storing on a non-transitory computer readable medium said arterial pulse time difference data,

comparing in real time, with said microprocessor, said arterial pressure pulse time difference data generated with previously stored arterial pressure pulse time difference data to monitor change in said arterial pulse time difference data;

monitoring, with said microprocessor, said arterial pressure pulse time difference of each and arterial pressure pulse recording in real time over a predetermined period of time, and

displaying said time difference data for observation;

wherein said arterial pressure pulse time difference data indicates a real-time time difference between said arrival time of said primary systolic constituent peak and said arrival time of said constituent iliac reflection peak of each of said arterial pressure pulse waveforms read, and wherein said arterial pressure pulse time difference directly corresponds to changes in blood volume in said animate being that predict in real time the onset of hypovolemia or hypervolemia.

2. The method of claim 1, wherein multiple arterial pressure pulse time difference data readings are produced within the predetermined period of time in order to allow comparisons between the multiple arterial pressure pulse time difference data readings.

3. The method of claim 2, further comprising the step of determining blood volume trends for a person by monitoring said multiple arterial pressure pulse time difference data readings constantly for a predetermined period of time of at least several hours.

4. The method of claim 2, wherein the microprocessor uses the arterial pulse time difference data gathered during said predetermined period of time to establish an arterial pulse parameter baseline value for said animate being from which to determine deviations from said baseline.

5. The method of claim 1, where said predetermined period of time is at least about fifteen seconds.

6. The method of claim 1, wherein said predetermined period of time is constant and during said period of time said animate being is undergoing a surgical procedure.

7. The method of claim 1, wherein said predetermined period of time is followed by multiple subsequent predetermined periods of time, each of said subsequent predetermined periods time being discontinuous from a prior predetermined period of time and a successive period of time over a period of at least a half hour.

8. The method of claim 1, further comprising the step of indicating changing trends in blood volume by monitoring and storing constantly said arterial pressure pulse time difference data for a predetermined period of time to indicate in real time the presence of decreasing time differences in said arterial pulse time difference data predictive of progressive hypovolemia or increasing arterial pulse time difference data predictive of hypervolemia.

9. The method of claim 1, wherein said previously stored arterial pressure pulse time difference data comprises arterial pressure pulse time difference data for said animate being, and/or a comparable animate being group.

10. The method of claim 1, wherein storing the data further comprises the step of determining, using said microprocessor, said changes in blood volume based on said time difference data gathered during said predetermined period of time.

11. A computerized method of early detection of blood volume changes by time based, real time monitoring of arterial pressure pulse waveforms for indication of hypovolemia or hypervolemia in an animate being, comprising the steps of:

positioning a noninvasive sensor at a single arterial pulse detection site;

reading with said sensor, arterial pressure pulse waveforms generated by said animate being;

gathering, in real time, with a microprocessor, arterial pressure pulse waveform data from said sensor;

storing said arterial pressure pulse waveform data on a non-transitory computer readable medium as said data is received from said sensor;

locating within said arterial pulse pressure waveform data a primary constituent systolic pulse, renal constituent reflection pulse, and an iliac reflection constituent pulse,

identifying in real time a millisecond arrival time of said primary systolic constituent peak and said constituent iliac reflection peak,

calculating in real time, with said microprocessor, a time difference in milliseconds between said arrival time of said primary systolic constituent peak and said arrival time of said constituent iliac reflection peak,

determining an arterial pulse parameter based on said time difference between arrival of said primary systolic constituent peak and arrival of said constituent iliac reflection peak, to create arterial pulse parameter data,

storing said arterial pulse parameter data, and

comparing each of said arterial pulse parameter data with previously stored arterial pulse parameter data for an increase or decrease,

wherein calculating, with a microprocessor, a change in said arterial pulse parameter data compared to prior, stored, arterial pulse parameter data indicates a real-time change in blood volume with an increase between said arterial pulse parameter data over time indicating hypervolemia and a decrease between said arterial pulse parameter data over time indicating hypovolemia, each of said arterial pulse parameter data being stored in a computer.

12. The method of claim 11, wherein said previously stored arterial pressure pulse time difference data comprises arterial pressure pulse time difference data for said animate being, and/or a comparable group of animate beings.

13. The method of claim 12, wherein said previously stored arterial pressure pulse time difference data is stored on a non-transitory computer readable medium, and the method further comprises the steps of the computer generating output data, wherein said output data comprises time difference data for the time difference between said arterial pulse parameter data over a predetermined continuous period of time, said predetermined continuous period of time producing multiple time difference data readings for comparison, to predict in real time onset of progressive central hypovolemia or hypervolemia.

14. The method of claim 11, wherein the method further comprises the step of determining, using the microprocessor, trends and/or base lines for said animate being by monitoring for a plurality of intermittent testing intervals for extended periods of time.