Devices, systems, and methods for measuring blood loss

• US 10,041,960 B2
• Filed: 05/09/2014
• Issued: 08/07/2018
• Est. Priority Date: 05/10/2013
• Status: Active Grant

• Current Assignee: University of Utah Research Foundation (State of Utah)
• Original Assignee: University of Utah Research Foundation (State of Utah)
• Inventors: MacIntyre, Annette, Brewer, Lara, Wendelken, Suzanne, Tate, Quinn, Hoehne, Soeren
• Primary Examiner(s): Soderquist, Arlen
• Application Number:
  US14/890,098
• Publication Number:
  US 20160123998A1
• Time in Patent Office: 1,551 Days
• Field of Search: 356 40, 436 66, 436164-165
• CPC Class Codes: A61B 5/02042 Determining blood loss or bleeding, e.g. during a surgical procedure
• CPC Class Codes: A61B 5/14546 for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• CPC Class Codes: A61B 5/1455 using optical sensors, e.g. spectral photometrical oximeters
• CPC Class Codes: A61M 1/777 Determination of loss or gain of body fluids due to suction-irrigation, e.g. during surgery
• CPC Class Codes: G01N 21/31 Investigating relative effect of material at wavelengths characteristic of specific elements or molecules, e.g. atomic absorption spectrometry G01N21/72 takes precedence
• CPC Class Codes: G01N 2333/805 Haemoglobins; Myoglobins
• CPC Class Codes: G01N 33/49 Blood chemical methods for determining blood cell populations G01N33/5094; chemical analysis of blood groups or blood types G01N33/80
• CPC Class Codes: G01N 33/721 Haemoglobin

Abstract

Devices, systems, and methods for measuring the blood loss of a subject during a medical procedure. Blood and other fluids are received within a container, and a blood measurement device determines the hemoglobin concentration of the fluid within the container. The blood measurement device can also calculate the estimated blood loss of the subject based upon the determined hemoglobin concentration and the volume of the fluid within the container and the patient'"'"'s hemoglobin.

Claims

1. A blood measurement device for determining the amount of blood of a subject within a fluid sample, the fluid sample having a volume and being positioned within a container having a vertical axis, the blood measurement device comprising:

at least one light source configured to selectively generate light at a first wavelength and at a second wavelength different from the first wavelength;

at least one light detector, wherein the at least one light source and the at least one light detector are configured for positioning in an operative position within the container, wherein, in the operative position, the at least one light source is configured to transmit light at a plurality of locations spaced along the vertical axis of the container and the at least one light detector is configured to receive at least a portion of the light generated by the at least one light source, and wherein upon positioning of the at least one light source and the at least one light detector in the operative position, the at least one light detector is configured to produce a first signal indicative of the absorbance of the fluid sample at the first wavelength and a second signal indicative of the absorbance of the fluid sample at the second wavelength; and

a processor operatively coupled to the at least one light detector, wherein the processor is configured to receive the first and second signals from the at least one light detector, and wherein, based upon the received first and second signals, the processor is configured to repeatedly determine the concentration of hemoglobin within the fluid sample as blood from the subject is added to the fluid sample,

wherein the processor is configured to determine a current volume of blood within the fluid sample based upon a previously measured hemoglobin concentration of the subject, the determined hemoglobin concentration within the fluid sample, and the volume of the fluid sample.

2. The blood measurement device of claim 1, wherein the first wavelength ranges from about 500 nm to about 600 nm, and wherein the second wavelength ranges from about 850 nm to about 900 nm.

3. The blood loss measurement device of claim 1, wherein the first wavelength is about 525 nm, and wherein the second wavelength is about 870 nm.

4. The blood measurement device of claim 1, wherein each light source of the at least one light source comprises a plurality of light emitting diodes (LEDs), wherein at least one LED of the plurality of LEDs is configured to emit light at the first wavelength, and wherein at least one LED of the plurality of LEDs is configured to emit light at the second wavelength, and wherein each LED of the plurality of LEDs is configured for selective activation.

5. The blood measurement device of claim 1, wherein the processor is configured to determine the concentration of hemoglobin within the fluid sample based upon the equation:

Hgb=(A₁−

A₂)*k₁+k₂, where;

Hgb=the total hemoglobin concentration within the fluid sample;

A₁=the measured absorbance of the light within the fluid sample the first wavelength;

A₂=the measured absorbance of the light within the fluid sample at the second wavelength;

k₁=the calibration coefficient for light at the first wavelength; and

k₂=the calibration coefficient for light at the second wavelength.

6. The blood measurement device of claim 1, wherein the processor is configured to receive at least one input indicative of the volume of the sample fluid.

7. The blood measurement device of claim 1, wherein the at least one light detector comprises an array of a plurality of light detectors, and wherein each light detector of the array of light detectors is configured to produce a transmittance signal indicative of the transmittance of light measured by the light detector, and wherein the processor is configured to receive the transmittance signal from each light detector.

8. The blood measurement device of claim 7, wherein the processor is configured to associate the transmittance signal produced by each respective light detector of the array of light detectors with a position relative to the vertical axis of the container, and wherein the processor is configured to determine the highest position corresponding to a light detector of the array of light detectors that produced a transmittance signal indicative of a transmission of light within the fluid sample.

9. The blood measurement device of claim 8, wherein the highest position corresponding to a light detector of the array of light detectors that produced a transmittance signal indicative of a transmission of light within the fluid sample corresponds to the height of the fluid sample, and wherein the processor is configured to determine the volume of the fluid sample based upon the height of the fluid sample.

10. The blood measurement device of claim 1, wherein the processor is configured to determine the volume of blood within the fluid sample according to the equations:

EBL(t)=EBL(t−

1)+[V_C(t)−

V_C(t−

1)]*[Hgb_C(t)/Hgb_P(t−

1)];

EBV(t)≈

EBV(t−

1)+[V_IV(t)−

V_IV(t−

1)]−

[EBL(t)−

EBL(t−

1)]; and

Hgbp(t)=(EBV(t−

1)*Hgbp(t−

1)−

[Vc(t)−

Vc(t−

1)]*Hgbc(t))/EBV(t), where;

EBL(t)=Estimated Blood Loss at current time (t);

EBL(t−

1)=Estimated Blood Loss at previously measured time (t−

1);

V_C(t)=Volume of Fluid Sample within Suction Canister at current time (t);

V_C(t−

1)=Volume of Fluid Sample within Suction Canister at previously measured time (t−

1);

Hgb_C(t)=Hemoglobin Concentration of Fluid Sample within Suction Canister at current time (t);

Hgb_C(t−

1)=Hemoglobin Concentration of Fluid Sample within Suction Canister at previously measured time (t−

1);

Hgb_P(t)=Hemoglobin Concentration of Blood of the subject at current time (t);

Hgb_P(t−

1)=Hemoglobin Concentration of Blood as it Left the Subject at previously measured time (t−

1);

EBV(t)=Estimated Blood Volume of the subject at current time (t);

EBV(t−

1)=Estimated Blood Volume of the subject at previously measured time (t−

1);

V_IV (t)=Volume of IV Fluid within the subject at current time (t); and

V_IV (t−

1)=Volume of IV Fluid within the subject at previously measured time (t−

1).

11. The blood measurement device of claim 10, wherein the processor is configured to receive at least one input indicative of a previously measured hemoglobin concentration of the blood of the subject.

12. The blood measurement device of claim 10, wherein the processor is configured to receive at least one input indicative of a previously estimated blood loss of the subject.

13. The blood measurement device of claim 1, wherein the processor is configured to determine the volume of blood within the fluid sample according to the equation:

EBL(t)=EBL(t−

1)+[V_C(t)−

V_C(t−

1)]*[Hgb_C(t)/Hgb_P(t−

1)], where;

EBL(t)=Estimated Blood Loss at current time (t);

EBL(t−

1)=Estimated Blood Loss at previously measured time (t−

1);

V_C(t)=Volume of Fluid Sample within Suction Canister at current time (t);

V_C(t−

1)=Volume of Fluid Sample within Suction Canister at previously measured time (t−

1);

Hgb_C(t)=Hemoglobin Concentration of Fluid Sample within Suction Canister at current time (t); and

Hgb_P(t−

1)=Hemoglobin Concentration of Blood as it Left the Subject at previously measured time (t−

1).

14. The blood measurement device of claim 1, wherein the at least one light source is coupled to a base element that is configured for selective insertion within the fluid sample, and wherein the at least one light source is configured to transmit light at a plurality of locations spaced along a length of the base element.

15. The blood measurement device of claim 1, wherein the at least one light source is coupled to a first base element, wherein the at least one light detector is coupled to a second base element, wherein the first and second base elements are configured for selective insertion within the fluid sample, and wherein the at least one light source is configured to transmit light at a plurality of locations spaced along a length of the first base element.

16. A blood measurement system comprising:

a blood measurement device for determining the amount of blood of a subject within a fluid sample, the fluid sample having a volume, the blood measurement device comprising;

at least one light source configured to selectively generate light at a first wavelength and at a second wavelength different from the first wavelength;

at least one light detector; and

a processor operatively coupled to the at least one light detector; and

a suction canister, the suction canister having a vertical axis and an outer wall having an internal surface and an external surface, the internal surface of the outer wall defining an interior space configured to receive the fluid sample,

wherein the at least one light source and the at least one light detector are configured for positioning in an operative position within the container, wherein, in the operative position, the at least one light source is configured to transmit light at a plurality of locations spaced along the vertical axis of the container and the at least one light detector is configured to receive at least a portion of the light generated by the at least one light source, and wherein upon positioning of the at least one light source and the at least one light detector in the operative position, the at least one light detector is configured to produce a first signal indicative of the absorbance of the fluid sample at the first wavelength and a second signal indicative of the absorbance of the fluid sample at the second wavelength,

wherein the processor is configured to receive the first and second signals from the at least one light detector, and wherein, based upon the received first and second signals, the processor is configured to repeatedly determine the concentration of hemoglobin within the fluid sample as blood from the subject is added to the fluid sample, and

wherein the processor is configured to determine a current volume of blood within the fluid sample based upon a previously measured hemoglobin concentration of the subject, the determined hemoglobin concentration within the fluid sample, and the volume of the fluid sample.

17. The blood measurement system of claim 16, further comprising a drip counter configured for communication with an intravenous (IV) fluid delivery element, the drip counter being configured to produce a volume signal indicative of the volume of IV fluid dispensed from the IV fluid delivery element and a delivery rate signal indicative of the rate at which IV fluid is dispensed from the IV fluid delivery element, wherein the drip counter is positioned in operative communication with the processor such that the processor is configured to receive the volume signal and the delivery rate signal.

18. The blood measurement system of claim 16, wherein the processor is configured to receive at least one user input, wherein each user input is indicative of one of:

a volume of one or more intravenous (IV) fluids dispensed from an IV fluid delivery element; and

a rate at which the one or more IV fluids is dispensed from the IV fluid delivery element.

19. The blood measurement system of claim 16, wherein the at least one light source of the blood measurement device is coupled to a base element that is configured for selective insertion within the fluid sample, and wherein the at least one light source of the blood measurement device is configured to transmit light at a plurality of locations spaced along a length of the base element.

20. The blood measurement system of claim 16, wherein the at least one light source of the blood measurement device is coupled to a first base element, wherein the at least one light detector of the blood measurement device is coupled to a second base element, wherein the first and second base elements are configured for selective insertion within the fluid sample, and wherein the at least one light source is configured to transmit light at a plurality of locations spaced along a length of the first base element.

21. A method of measuring the amount of blood of a subject within a fluid sample, comprising:

operatively positioning a blood measurement device relative to a fluid sample within a container having a vertical axis, the blood measurement device comprising;

at least one light source, wherein the at least one light source selectively generates light at a first wavelength and at a second wavelength different from the first wavelength;

at least one light detector, wherein following operative positioning of the blood measurement device, the at least one light source transmits light at a plurality of locations spaced along the vertical axis of the container; and

a processor operatively coupled to the at least one light detector;

using the at least one light detector to receive at least a portion of the light generated by the at least one light source, wherein the at least one light detector produces a first signal indicative of the absorbance of the fluid sample at the first wavelength and a second signal indicative of the absorbance of the fluid sample at the second wavelength;

using the processor to receive the first and second signals from the at least one light detector;

using the processor of the blood measurement device to repeatedly determine the concentration of hemoglobin within the fluid sample as blood from the subject is added to the fluid sample; and

using the processor of the blood measurement device to determine a current volume of blood within the fluid sample based upon a previously measured hemoglobin concentration of the subject, the determined hemoglobin concentration within the fluid sample, and the volume of the fluid sample.

22. The method of claim 21, further comprising administering one or more reagents to the fluid sample, wherein the one or more reagents are configured to convert hemoglobin within the fluid sample into one of methemoglobin and sulphemoglobin.

23. The method of claim 21, further comprising delivering an anti-coagulant to the fluid sample.

24. The method of claim 23, wherein the anti-coagulant is heparin.

25. The method of claim 21, wherein the at least one light source is coupled to a base element that is inserted within the fluid sample, and wherein the at least one light source transmits light at a plurality of locations spaced along a length of the base element.

26. The method of claim 21, wherein the at least one light source is coupled to a first base element, wherein the at least one light detector is coupled to a second base element, wherein the first and second base elements are inserted within the fluid sample, and wherein the at least one light source transmits light at a plurality of locations spaced along a length of the first base element.

27. The method of claim 21, wherein the processor determines the concentration of hemoglobin within the fluid sample based upon the equation:

Hgb=(A₁−

A₂)*k₁+k₂, where;

Hgb=the total hemoglobin concentration within the fluid sample;

A₁=the measured absorbance of the light within the fluid sample the first wavelength;

A₂=the measured absorbance of the light within the fluid sample at the second wavelength;

k₁=the calibration coefficient for light at the first wavelength; and

k₂=the calibration coefficient for light at the second wavelength.

28. The method of claim 27, wherein the processor determines the volume of blood within the fluid sample according to the equation:

EBL(t)=EBL(t−

1)+[V_C(t)−

V_C(t−

1)]*[Hgb_C(t)/Hgb_P(t−

1)], where;

EBL(t)=Estimated Blood Loss at current time (t);

EBL(t−

1)=Estimated Blood Loss at previously measured time (t−

1);

V_C(t)=Volume of Fluid Sample within Suction Canister at current time (t);

V_C(t−

1)=Volume of Fluid Sample within Suction Canister at previously measured time (t−

1);

Hgb_C(t)=Hemoglobin Concentration of Fluid Sample within Suction Canister at current time (t); and

Hgb_P(t−

1)=Hemoglobin Concentration of Blood as it Left the Subject at previously measured time (t−

1).