Device and Method for Hemorrhage Detection and Guided Resuscitation and Applications of Same

• US 20170332919A1
• Filed: 11/13/2015
• Published: 11/23/2017
• 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
• Granted Patent: US 10,456,046 B2
• Time in Patent Office: Days
• 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, continuously for a time period from T₀ to T₂, vascular signals from at least one peripheral vein, artery or perfused tissue of a living subject in real time, wherein the time period is divided into a first time period from T₀ to T₁, and a second time period from T₁ to T₂; 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 baseline peripheral vascular signal frequency spectrum;

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

1</sub>} on the baseline 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 peripheral vascular signal frequency spectrum;

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

1</sub>} on the peripheral vascular pressure 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 at least one hemodynamic parameter of the living subject at the second time period by comparing amplitudes of the peaks {P<sub>N−

1</sub>} to those of the baseline peaks {B<sub>N−

1</sub>} respectively.

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

3. The system of claim 1, wherein each of the at least one sensor is a piezoelectric sensor, a resistive pressure/force sensor, an optical wavelength selective reflectance or absorbance measurement system, a tonometer, an ultrasound, bioimpedence, plethysmography, or pressure transducer, or any combination thereof.

4. 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.

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

a processor configured to receive the 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 the vascular signals, and to perform the spectral analysis for monitoring condition of the living subject in real time.

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

7. The system of claim 5, 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.

8. The system of claim 5, wherein the at least one hemodynamic parameter of the living subject comprises information of volume status, heart rate, heart rate variability, oximetry, blood pressure, pulse pressure variability, temperature, and respiratory rate of the living subject.

9. The system of claim 8, wherein the volume status of the living subject at the second time period indicates hypovolemia or hypervolemia when amplitude changes greater than a threshold are detected from the baseline peaks {B_N−

1} to the peaks {B<sub>N−

1</sub>}.

10. The system of claim 1, wherein:

the plurality of peaks {B<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.

33. The method of claim 26, wherein the non-invasive device comprises the NIVA device of claim 1.

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

a non-invasive device, comprising;

at least one sensor, configured to acquire vascular signals from a living subject in real time; and

a controller communicatively coupled to the at least one sensor, configured to receive the vascular signals transmitted from the at least one sensor, and process the vascular signals to determine at least one hemodynamic parameter of the living subject.

36. The NIVA system of claim 11, further comprising:

an administration device communicatively connected to the NIVA system, for controlling, based on the at least one hemodynamic parameter of the living subject provided by the NIVA system, administration of a drug or fluid to the living subject, or for controlling a rate or ultrafiltration of fluid removal from the living subject.

37. The NIVA system of claim 36, wherein the administration device comprises an intravenous (IV) pump for controlling the administration the drug or fluid.

38. The NIVA system of claim 36, wherein the administration device is configured to control the administration of the drug or fluid to the living subject based on the at least one hemodynamic parameter of the living subject to maintain a specific physiological condition of the living subject.

12-25. -25. (canceled)

26. A non-invasive method for detecting or monitoring intravascular volume status, volume overload, dehydration, hemorrhage, cardiac/renal/hepatic function, pulmonary embolism, vascular endothelial function, vascular compliance, and real time assessment of resuscitation of a living subject, comprising:

acquiring, from at least one peripheral vein, artery or perfused tissue of the living subject using a non-invasive device, vascular signals in real time; and

processing the acquired vascular signals to obtain a peripheral vascular pressure frequency spectrum to determine at least one hemodynamic parameter of the living subject.

27. The method of claim 26, 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.

28. The method of claim 26, wherein the non-invasive device comprises:

at least one sensor, configured to acquire the vascular signals in real time; and

a controller 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 to determine the at least one hemodynamic parameter of the living subject.

29. The method of claim 28, wherein the at least one hemodynamic parameter comprises volume status, heart rate, heart rate variability, oximetry, blood pressure, pulse pressure variability, temperature, and respiratory rate of the living subject.

30. The method of claim 29, wherein the at least one sensor is configured to acquire, continuously for a time period from T₀ to T₂, the vascular signals from the at least one peripheral vein, artery or perfused tissue of the 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, and wherein the spectral analysis comprises:

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

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

1</sub>} on the baseline 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 peripheral vascular signal frequency spectrum;

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

1</sub>} on the peripheral vascular pressure 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 the volume status of the living subject at the second time period by comparing amplitudes of the peaks {P<sub>N−

1</sub>} to those of the baseline peaks {B<sub>N−

1</sub>} respectively,

wherein the volume status of the living subject at the second time period indicates hypovolemia or hypervolemia when amplitude changes greater than a threshold are detected from the baseline peaks {B<sub>N−

1</sub>} to the peaks {P<sub>N−

1</sub>}.

31. The method of claim 30, wherein the vascular signals are processed by a spectral fast Fourier transform (FFT) analysis to obtain the baseline peripheral vascular signal frequency spectrum and the peripheral vascular signal frequency spectrum, respectively.

32. The method of claim 30, 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.

34. The method of claim 26, wherein the non-invasive device is a mobile device.

35. A non-transitory computer-readable medium storing instructions which, when executed by one or more processors, cause a system to perform the method of claim 26.