Device and method for hemorrhage detection and guided resuscitation and applications of same

• US 10,456,046 B2
• Filed: 11/13/2015
• Issued: 10/29/2019
• Est. Priority Date: 09/12/2014
• Status: Active Grant

• Current Assignee: Vanderbilt University
• Original Assignee: Vanderbilt University
• Inventors: Eagle, Susan, Brophy, Colleen, Hocking, Kyle, Baudenbacher, Franz, Boyer, Richard
• Primary Examiner(s): Layno, Carl H
• Assistant Examiner(s): Lau, Michael J
• Application Number:
  US15/525,748
• Publication Number:
  US 20170332919A1
• Time in Patent Office: 1,446 Days
• Field of Search: 600301
• 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 5/02007 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 5/02042 Determining blood loss or bleeding, e.g. during a surgical procedure
• CPC Class Codes: A61B 5/02152 specially adapted for venous pressure
• CPC Class Codes: A61B 5/02438 with portable devices, e.g. worn by the patient
• CPC Class Codes: A61B 5/0816 Measuring devices for examining respiratory frequency measuring frequency of electric signals G01R23/00
• CPC Class Codes: A61B 5/4875 Hydration status, fluid retention of the body
• CPC Class Codes: A61B 5/681 Wristwatch-type devices
• CPC Class Codes: A61B 5/7221 Determining signal validity, reliability or quality A61B5/7207 and A61B5/7217 take precedence
• CPC Class Codes: A61B 5/7257 using Fourier transforms

Abstract

Aspects of the invention relates to systems and methods for detecting volume status, volume overload, dehydration, hemorrhage and real time assessment of resuscitation, as well as organ failure including but not limited cardiac, renal, and hepatic dysfunction, of a living subject using non-invasive vascular analysis (NIVA). In one embodiment, a non-invasive device, which includes at least one sensor, is used to acquire vascular signals from the living subject in real time. The vascular signals are sent to a controller, which processes the vascular signals to determine at least one hemodynamic parameter, such as the volume status of the living subject. In certain embodiments, the vascular signals are processed by a spectral fast Fourier transform (FFT) analysis to obtain the peripheral vascular signal frequency spectrum, and the volume status of the living subject may be determined by comparing amplitudes of the peaks of the peripheral vascular signal frequency spectrum.

Claims

1. A non-invasive vascular analysis (NIVA) system, comprising:

at least one sensor, configured to acquire, for a time period from T₀ to T₂, vascular signals from at least one peripheral vein, artery or perfused tissue of a living subject, wherein the time period is divided into a first time period from T₀ to T₁ and a second time period from T₁ to T₂, wherein the at least one sensor comprises a piezoelectric sensor, a resistive pressure/force sensor, a tonometer, an ultrasound sensor, a bioimpedance sensor, or a pressure transducer and is configured to acquire the vascular signals while positioned externally to the living subject; and

a processing device communicatively coupled to the at least one sensor, configured to receive the vascular signals transmitted from the at least one sensor, and perform a spectral analysis on the vascular signals, wherein the spectral analysis comprises the steps of;

processing the vascular signals acquired at the first time period to obtain a first peripheral vascular signal frequency spectrum;

obtaining a plurality of baseline peaks {B<sub>N−

1</sub>} on the first peripheral vascular signal frequency spectrum, wherein N is a positive integer, and the plurality of baseline peaks {B<sub>N−

1</sub>} respectively corresponds to a plurality of frequencies {F₀, F₁, . . . , F_N}, such that B<sub>N−

1</sub> is a function of F<sub>N−

1</sub> satisfying B<sub>N−

1</sub>=B<sub>N−

1</sub> (F<sub>N−

1</sub>), wherein F_N is greater than F<sub>N−

1</sub>;

processing the vascular signals acquired at the second time period to obtain a second peripheral vascular signal frequency spectrum;

obtaining a plurality of peaks {P<sub>N−

1</sub>} on the second peripheral vascular signal frequency spectrum, wherein the plurality of peaks {P<sub>N−

1</sub>} correspond to the plurality of frequencies{F₀, F₁, . . . , F_N}, such that P<sub>N−

1</sub> is a function of F<sub>N−

1</sub> satisfying P<sub>N−

1</sub>=P<sub>N−

1</sub> (F<sub>N−

1</sub>); and

determining whether hypovolemia or hypervolemia is present within the living subject by determining whether at least one amplitude of the peaks {P<sub>N−

1</sub>} differs by more than a threshold amount when compared to a corresponding amplitude of the baseline peaks {B<sub>N−

1</sub>}.

2. The system of claim 1, wherein the vascular signals are processed by a spectral fast Fourier transform (FFT) analysis to obtain the first peripheral vascular signal frequency spectrum and the second peripheral vascular signal frequency spectrum.

3. The system of claim 1, wherein the at least one sensor and the processing device form a non-invasive device, wherein the non-invasive device is a wearable band, an adhesive, or an attachment being in contact with a surface of skin of the living subject overlying the at least one peripheral vein, artery or perfused tissue.

4. The system of claim 3, wherein the processing device comprises:

a processor configured to receive vascular signals transmitted from the at least one sensor, wherein the at least one sensor and the processor form the non-invasive device; and

a monitoring device configured to communicate with the processor to receive vascular signals, and to perform the spectral analysis for monitoring a condition of the living subject.

5. The system of claim 4, wherein the monitoring device is further configured to display results of the spectral analysis on the non-invasive device.

6. The system of claim 4, wherein the monitoring device is configured to communicate with the processor via a wireless protocol, and is a smartphone, a tablet computing device, a laptop computing device, a desktop computing device, or any combination thereof.

7. The system of claim 1, wherein:

the plurality of peaks {P<sub>N−

1</sub>} comprises a first peak P₀ corresponding to a first frequency F₀, a second peak P₁ corresponding to a second frequency F₁, a third peak P₂ corresponding to a third frequency F₂ and a fourth peak P₃ corresponding to a fourth frequency F₃;

the first peak P₀ corresponding to the first frequency F₀ is associated with a respiratory rate of the living subject;

the second peak P₁ corresponding to the second frequency F₁ is associated with a heart rate of the living subject; and

the third peak P₂ corresponding to the third frequency F₂ and the fourth peak P₃ corresponding to the fourth frequency F₃ are associated with harmonics of the living subject.

8. The system of claim 1, further comprising:

an administration device configured to control, based on the determining whether hypovolemia or hypervolemia is present within the living subject, administration of a drug or fluid to the living subject, or a rate or ultrafiltration of fluid removal from the living subject.

9. The system of claim 8, wherein the administration device comprises an intravenous (IV) pump for controlling the administration of the drug or fluid.

10. The system of claim 1, wherein the at least one sensor comprises a piezoelectric sensor.

11. A non-transitory computer readable medium storing instructions that, when executed by a non-invasive vascular analysis (NIVA) system, cause the system to perform functions comprising:

processing vascular signals acquired by at least one sensor during a first time period T₀ to T₁ to obtain a first peripheral vascular signal frequency spectrum, wherein the at least one sensor comprises a piezoelectric sensor, a resistive pressure/force sensor, a tonometer, an ultrasound sensor, a bioimpedance sensor, or a pressure transducer and is configured to acquire the vascular signals while positioned externally to the living subject;

obtaining a plurality of baseline peaks {B<sub>N−

1</sub>} on the first peripheral vascular signal frequency spectrum, wherein N is a positive integer, and the plurality of baseline peaks {B<sub>N−

1</sub>} respectively corresponds to a plurality of frequencies {F₀, F₁, . . . , F_N}, such that B<sub>N−

1</sub> is a function of F<sub>N−

1</sub> satisfying B<sub>N−

1</sub>=B<sub>N−

1</sub> (F<sub>N−

1</sub>), wherein F_N is greater than F<sub>N−

1</sub>;

processing vascular signals acquired by the at least one sensor at a second time period T₁ to T₂ that follows the first time period to obtain a second peripheral vascular signal frequency spectrum;

obtaining a plurality of peaks {P<sub>N−

1</sub>} on the second peripheral vascular signal frequency spectrum, wherein the plurality of peaks {P<sub>N−

1</sub>} correspond to the plurality of frequencies{F₀, F₁, . . . , F_N}, such that P<sub>N−

1</sub> is a function of F<sub>N−

1</sub> satisfying P<sub>N−

1</sub>=P<sub>N−

1</sub> (F<sub>N−

1</sub>); and

determining whether hypovolemia or hypervolemia is present within the living subject by determining whether at least one amplitude of the peaks {P<sub>N−

1</sub>} differs by more than a threshold amount when compared to a corresponding amplitude of the baseline peaks {B<sub>N−

1</sub>}.

12. The non-transitory computer readable medium of claim 11, wherein the vascular signals are processed by a spectral fast Fourier transform (FFT) analysis to obtain the first peripheral vascular signal frequency spectrum and the second peripheral vascular signal frequency spectrum.

13. The non-transitory computer readable medium of claim 11, the functions further comprising displaying results of the determining whether hypovolemia or hypervolemia is present within the living subject.

14. The non-transitory computer readable medium of claim 11, wherein:

the plurality of peaks {P<sub>N−

1</sub>} comprises a first peak P₀ corresponding to a first frequency F₀, a second peak P₁ corresponding to a second frequency F₁, a third peak P₂ corresponding to a third frequency F₂ and a fourth peak P₃ corresponding to a fourth frequency F₃;

the first peak P₀ corresponding to the first frequency F₀ is associated with a respiratory rate of the living subject;

the second peak P₁ corresponding to the second frequency F₁ is associated with a heart rate of the living subject; and

the third peak P₂ corresponding to the third frequency F₂ and the fourth peak P₃ corresponding to the fourth frequency F₃ are associated with harmonics of the living subject.

15. The non-transitory computer readable medium of claim 11, wherein the at least one sensor comprises a piezoelectric sensor.

16. A method comprising:

processing vascular signals acquired by at least one sensor during a first time period T₀ to T₁ to obtain a first peripheral vascular signal frequency spectrum, wherein the at least one sensor comprises a piezoelectric sensor, a resistive pressure/force sensor, a tonometer, an ultrasound sensor, a bioimpedance sensor, or a pressure transducer and is configured to acquire the vascular signals while positioned externally to the living subject;

obtaining a plurality of baseline peaks {B<sub>N−

1</sub>} on the first peripheral vascular signal frequency spectrum, wherein N is a positive integer, and the plurality of baseline peaks {B<sub>N−

1</sub>} respectively corresponds to a plurality of frequencies {F₀, F₁, . . . , F_N}, such that B<sub>N−

1</sub> is a function of F<sub>N−

1</sub> satisfying B<sub>N−

1</sub>=B<sub>N−

1</sub> (F<sub>N−

1</sub>), wherein F_N is greater than F<sub>N−

1</sub>;

processing vascular signals acquired by the at least one sensor at a second time period T₁ to T₂ that follows the first time period to obtain a second peripheral vascular signal frequency spectrum;

obtaining a plurality of peaks {P<sub>N−

1</sub>} on the second peripheral vascular signal frequency spectrum, wherein the plurality of peaks {P<sub>N−

1</sub>} correspond to the plurality of frequencies {F₀, F₁, . . . , F_N}, such that P<sub>N−

1</sub> is a function of F<sub>N−

1</sub> satisfying P<sub>N−

1</sub>=P<sub>N−

1</sub> (F<sub>N−

1</sub>); and

determining whether hypovolemia or hypervolemia is present within the living subject by determining whether at least one amplitude of the peaks {P<sub>N−

1</sub>} differs by more than a threshold amount when compared to a corresponding amplitude of the baseline peaks {B<sub>N−

1</sub>}.

17. The method of claim 16, wherein the vascular signals are processed by a spectral fast Fourier transform (FFT) analysis to obtain the first peripheral vascular signal frequency spectrum and the second peripheral vascular signal frequency spectrum.

18. The method of claim 16, wherein the at least one sensor and the processing device form a non-invasive device, wherein the non-invasive device is a wearable band, an adhesive, or an attachment being in contact with a surface of skin of the living subject overlying the at least one peripheral vein, artery or perfused tissue.

19. The method of claim 16, further comprising displaying results of the determining whether hypovolemia or hypervolemia is present within the living subject.

20. The method of claim 16, wherein:

the plurality of peaks {P<sub>N−

1</sub>} comprises a first peak P₀ corresponding to a first frequency F₀, a second peak P₁ corresponding to a second frequency F₁, a third peak P₂ corresponding to a third frequency F₂ and a fourth peak P₃ corresponding to a fourth frequency F₃;

the first peak P₀ corresponding to the first frequency F₀ is associated with a respiratory rate of the living subject;

the second peak P₁ corresponding to the second frequency F₁ is associated with a heart rate of the living subject; and

the third peak P₂ corresponding to the third frequency F₂ and the fourth peak P₃ corresponding to the fourth frequency F₃ are associated with harmonics of the living subject.

21. The method of claim 16, further comprising controlling, based on the determining whether hypovolemia or hypervolemia is present within the living subject, administration of a drug or fluid to the living subject, or a rate or ultrafiltration of fluid removal from the living subject.

22. The method of claim 16, wherein the at least one sensor comprises a piezoelectric sensor.