Optical and ultrasound probe for monitoring blood volume changes

• US 6,740,036 B1
• Filed: 10/18/2002
• Issued: 05/25/2004
• Est. Priority Date: 07/18/2000
• Status: Expired due to Term

• Current Assignee: Jen-Shih Lee, Lian-Pin Lee
• Original Assignee: Jen-Shih Lee, Lian-Pin Lee
• Inventors: Lee, Jen-Shih, Lee, Lian-Pin
• Primary Examiner(s): Lateef, Marvin M.
• Assistant Examiner(s): PATEL, MAULIN M
• Application Number:
  US10/274,086
• Time in Patent Office: 585 Days
• Field of Search: 600/437, 600/443, 600/447, 600/448, 600/449, 210/739, 210/646, 738/610.2, 128/916
• US Class Current: 600/437
• CPC Class Codes: A61B 5/02042 Determining blood loss or bleeding, e.g. during a surgical procedure
• CPC Class Codes: A61B 8/06 Measuring blood flow measuring volume flow in general G01F, e.g. G01F1/66, G01F1/72; measuring speed of fluids in general G01P5/00
• CPC Class Codes: A61M 1/342 Adding solutions to the blood, e.g. substitution solutions for preventing coagulation A61M1/3672
• CPC Class Codes: A61M 1/3437 downstream of the filter, e.g. post-dilution with filtrate
• CPC Class Codes: A61M 1/361 before treatment
• CPC Class Codes: A61M 1/367 Circuit parts not covered by the preceding subgroups of group A61M1/3621
• CPC Class Codes: A61M 2205/3313 used specific wavelengths
• CPC Class Codes: A61M 2205/3375 Acoustical, e.g. ultrasonic, measuring means
• CPC Class Codes: A61M 2230/20 Blood composition characteristics
• CPC Class Codes: A61M 2230/207 hematocrit
• CPC Class Codes: G01N 2291/02818 Density, viscosity

Abstract

An apparatus and method to assess the compressibility, density, and hematocrit of blood including an optical ultrasound probe clipped onto tubing in which blood is flowing. The probe includes a combination of ultrasound transducers, a light emitting diode, and photodiodes. An indicator medium is injected into the bloodstream of the subject over one or more time points. Ultrasound waves are emitted by a transducer and received by another transducer, and a novel signal-processing unit and a computer with a novel computation scheme process the ultrasound signals to assess the phase shift of ultrasound as it transmitted across the blood stream. Based on the linear relationship between compressibility and density, changes in blood density are calculated from changes in phase shift. The optical part of the probe assesses the hematocrit of blood. Two fluid media are used to calibrate the probe on the relationship between phase shift and density in the factory. Before clinical assessment, an on-line saline injection procedure and the resulting change in density is employed to calibrate the optical density of the optical probe in terms of hematocrit and to establish the interrelation between density and hematocrit on fluid dilution of the circulating blood. One clinical protocol to monitor blood volume and microvascular pooling employs saline infusion to determine the blood volume hourly and the density and hematocrit measurements to determine the change in blood volume and the volume pooled to the microcirculation. Another clinical protocol assesses the time course of hematocrit and density over hemodialysis treatment for the prediction of hypovolemia and microvascular pooling. This cardiovascular monitoring is useful for evaluating how complications are developed during hemodialysis or the adequacy of any post-trauma fluid replacement or therapy to alleviate the complications.

Claims

1. A process for monitoring changes in blood volume and microvascular pooling in animals, comprising:

an extracorporeal blood treatment device in which blood from a blood system is conducted through a first branch of said extracorporeal system which is connected by tubing to an arterial segment of said blood system into a dialyzer or filter and returned via a second branch of said extracorporeal system with the said second branch connected by tubing to a venous segment of said blood system;

a diagnostic apparatus attached to said tubing wherein said diagnostic apparatus emits and receives an ultrasound wave and a light wave through blood flowing through said extracorporeal system;

a signal processing system, wherein said signal processing system initiates and records ultrasound waves and light transmissions, determines phase shift between emitting and receiving ultrasound waves, monitors with high resolution sound velocity, density, compressibility, and optical density of blood, hematocrit, and plasma protein concentration, and assesses changes in said sound velocity, density, compressibility, optical density, hematocrit, and plasma protein concentration of modified blood at an equivalent temperature

an infusion system, wherein a known amount of an indicator fluid is infused into said blood system at an injection connection located downstream of said diagnostic apparatus, and wherein infusion of said indicator fluid into said blood system changes the density of said blood system as measured through said diagnostic apparatus and said signal processing system;

a calibration procedure; and

a computing system for determining blood volume, changes in blood volume, changes in plasma protein concentration, and microvascular pooling from said hematocrit and density change.

2. The process of claim 1 wherein said signal processing system includes an ultrasound signal processing unit, an optical signal processing unit, an ultrasound and light generator, and two dual channel A/D converters.

3. The process of claim 2, wherein said calibration procedure employs two fluids of known sound velocity to determine the relationship between the phase shift generated by the transmission of the ultrasound through the blood and the sound velocity of blood for the assessment of compressibility and density of blood.

4. The process of claim 2, wherein said calibration procedure employs a saline injection process to match the optical density measured by said optical processing unit with the density measurements made by said ultrasound signal processing unit as a procedure to calibrate optical density in terms of hematocrit.

5. The process of claim 1 wherein said animal is a human.

6. The process of claim 1 wherein said diagnostic apparatus is a clip-on probe having mounted thereon at least one ultrasound emitting transducer, at least one ultrasound receiving transducer, at least one light emitting diode, and at least two photodiodes.

7. The process of claim 6 wherein said diagnostic apparatus further comprises a thermistor, wherein said thermistor takes a temperature measurement that is incorporated into a computation to convert measured sound velocity to density of blood.

8. The process of claim 6 wherein said diagnostic apparatus is clipped onto the tubing of said extracorporeal blood treatment system.

9. The process of claim 1 wherein said indicator fluid is isotonic saline or dialysate.

10. The process of claim 9 further comprising a dilution procedure wherein a known volume of said saline or dialysate is infused into said blood system for use in computing blood volume of the animal.

11. The process of claim 6 wherein said at least one ultrasound emitting transducer, said at least one ultrasound receiving transducer, said at least one light emitting diode, and said at least two photodiodes are tightly clipped onto said tubing of said extracorporeal system for transmission of ultrasound and light.

12. The process of claim 2 wherein said ultrasound wave of specific frequency is processed by said ultrasound signal-processing unit and said computer memory unit using a novel computation scheme to determine the phase shift between emitting and receiving ultrasound.

13. A method for monitoring a patient'"'"'s cardiovascular function through use of an optical ultrasound probe.

14. The method of claim 13 wherein said monitoring comprises calculating blood volume from density changes in blood flowing through an extracorporeal system as detected by said optical ultrasound probe.

15. The method of claim 14 wherein repeated dilutions are introduced into said blood to assess blood volume changes on hourly basis over the course of treatment.

16. The method of claim 13 wherein said monitoring comprises calculating microvascular pooling from changes in density and hematocrit produced by redistribution of blood and plasma volume in a patient'"'"'s circulation as detected by an optical ultrasound probe.

17. A process for monitoring changes in blood volume and microvascular pooling in animals, comprising:

a diagnostic apparatus attached to a blood system wherein said diagnostic apparatus emits and receives an ultrasound wave and a light wave through blood flowing through an extracorporeal system;

a signal processing system, wherein said signal processing system determines a phase shift between said emitting and receiving ultrasound wave, and determines absorbance and reflectance of said light wave;

at least two control units within said signal processing system for detecting compressibility, density, hematocrit and plasma protein concentration with high resolution, for assessing changes in said compressibility, density, hematocrit, and plasma protein concentration at an equivalent temperature, for initiating and recording ultrasound and light waves, and for monitoring physical parameters of modified blood; and

a computer memory unit for determining blood volume and microvascular pooling from said hematocrit and density change.

18. The process of claim 17 wherein said animal is a human.

19. The process of claim 17 wherein said diagnostic apparatus is a clip-on probe having mounted thereon at least one ultrasound emitting transducer, at least one ultrasound receiving transducer, at least one light emitting diode, and at least two photodiodes.

20. The process of claim 19 further comprising a thermistor attached to said diagnostic apparatus.

21. The process of claim 19 wherein said diagnostic apparatus is clipped onto said a tubing of said extracorporeal system connecting an artery and a vein of said animal.