Detection of bubbles during hemodynamic monitoring when performing automated measurement of blood constituents

• US 8,323,194 B2
• Filed: 12/18/2009
• Issued: 12/04/2012
• Est. Priority Date: 12/18/2009
• Status: Expired due to Fees

• Current Assignee: Inlight Solutions, Inc.
• Original Assignee: Inlight Solutions, Inc.
• Inventors: Robinson, Mark Ries
• Primary Examiner(s): LaBalle, Clayton E
• Assistant Examiner(s): REISNER, NOAM S
• Application Number:
  US12/641,411
• Publication Number:
  US 20110152642A1
• Time in Patent Office: 1,082 Days
• Field of Search: 600/309
• US Class Current: 600/309
• CPC Class Codes: A61B 5/14503 invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors A61B5/1459, A61B5/1464, A61B5/1473, A61B5/1482, A61B5/14865 take precedence
• CPC Class Codes: A61B 5/15003 for venous or arterial blood
• CPC Class Codes: A61B 5/150221 Valves
• CPC Class Codes: A61B 5/150229 Pumps for assisting the blood sampling
• CPC Class Codes: A61B 5/150236 Pistons, i.e. cylindrical bodies that sit inside the syringe barrel, typically with an air tight seal, and slide in the barrel to create a vacuum or to expel blood
• CPC Class Codes: A61B 5/150244 Rods for actuating or driving the piston, i.e. the cylindrical body that sits inside the syringe barrel, typically with an air tight seal, and slides in the barrel to create a vacuum or to expel blood
• CPC Class Codes: A61B 5/150961 Means for the detection of the presence or absence of a module, a component or an abnormal condition; detection of leaks
• CPC Class Codes: A61B 5/150992 Blood sampling from a fluid line external to a patient, such as a catheter line, combined with an infusion line; blood sampling from indwelling needle sets, e.g. sealable ports, luer couplings, valves tubing connectors and couplings A61M39/00
• CPC Class Codes: A61B 5/153 Devices specially adapted for taking samples of venous or arterial blood, e.g. with syringes
• CPC Class Codes: A61B 5/155 Devices specially adapted for continuous or multiple sampling, e.g. at predetermined intervals devices loaded with multiple lancets simultaneously A61B5/15146
• CPC Class Codes: A61B 5/157 Devices characterised by integrated means for measuring characteristics of blood
• CPC Class Codes: A61M 5/16854 by monitoring line pressure
• CPC Class Codes: A61M 5/36 with means for eliminating or preventing injection or infusion of air into body dialysis systems, blood oxygenators A61M1/14; haemofiltration equipment A61M1/34; automatic tube cut-off A61M39/281

Abstract

Example embodiments of the present invention provide methods and apparatuses that enable the detection of bubbles so that hemodynamic performance can be assured following an automated blood analyte measurement. An example apparatus according to the present invention comprises a blood access system, adapted to remove blood from a body and infuse at least a portion of the blood back into the body. The infusion of at least a portion of the blood back in to the body can be done in a manner to assure that no bubbles of clinical significance are injected into the patient. Additionally an example embodiment can assess for the presence of bubbles in the fluid column that can affect hemodynamic monitoring performance. If a condition exists where hemodynamic monitoring performance cannot be assured, an example embodiment can provide appropriate warning or corrective actions.

Claims

1. A method of determining the presence of a bubble in a blood access system comprising at least one pressure detector, comprising:

a. Using the pressure detector to determine a first frequency response of the system at a first time;

b. Using the pressure detector to determine a second frequency response of the system at a second time;

c. Determining if a bubble is present in the system by comparing the first and second frequency responses.

2. A method as in claim 1, wherein the blood access system is in fluid communication with the circulatory system of a patient.

3. A method as in claim 2, wherein

a. determining a first frequency response comprises determining a frequency-dependent characteristic of the output of the pressure detector responsive to changes in blood pressure in the circulatory system, and

b. determining a second frequency response comprises determining a frequency-dependent characteristic of the output of the pressure detector responsive to changes in blood pressure in the circulatory system.

4. A method as in claim 1, wherein comparing the first and second frequency responses comprises subtraction, division, Fourier transform analysis, wavelet analysis, vector comparison, derivative processing, or a combination thereof.

5. A method as in claim 1, wherein

a. determining a first frequency response comprises determining the power spectral density of the output of the pressure detector during a first time interval, and

b. determining a second frequency response comprises determining the power spectral density of the output of the pressure detector during a second time interval, and

c. determining if a bubble is present comprises determining whether the second frequency response indicates more power at frequencies corresponding to presence of a bubble than does the first frequency response.

6. A method of determining the presence, concentration, or both of an analyte in the blood of a patient, comprising:

a. Placing a blood access system in fluid communication with the circulatory patient, wherein the blood access system comprises at least one pressure sensor, at least one analye sensor, and at least one pump;

b. Using the pressure sensor to determine the frequency response of the blood access system at a first time before step c;

c. Operating the pump to withdraw blood from the patient to the analyte sensor;

d. Operating the analyte sensor to determine the presence, concentration, or both of an analyte in the withdrawn blood;

e. Using the pressure sensor to determine the frequency response of the blood access system at a second time after step c;

f. Determining if a bubble is present in the blood access system by comparing the frequency response determined at the first time with the frequency response determined at the second time.

7. A method as in claim 6, further comprising operating the pump to move the bubble out of portions of the blood access system where the bubble has an effect on the frequency response of the blood access system.

8. A method as in claim 6, further comprising initiating an alert signal indicating the presence of a bubble if a bubble is determined to be present.

9. A method as in claim 6, wherein comparing the frequency response determined at the first time with the frequency response determined at the second time comprises subtraction, division, Fourier transform analysis, wavelet analysis, vector comparison, derivative processing, or a combination thereof, of the frequency responses.

10. A method as in claim 6, wherein

a. Step b comprises determining the power spectral density of the output of the pressure detector during a first time interval, and

b. Step e comprises determining the power spectral density of the output of the pressure detector during a second time interval, and

c. Step f comprises determining whether the frequency response from step e indicates more power at frequencies corresponding to presence of a bubble than does the frequency response from step b.

11. A method of detecting bubbles in a hemodynamic monitoring system, comprising:

a. Determining a frequency response of the system;

b. Determining if a bubble is present in the system by comparing the frequency response determined in step a with a baseline frequency response, wherein the baseline frequency response is either (a) a frequency response of the system determined at an earlier time when the system was determined to be free of bubbles, or (b) a combination of frequency responses determined at a plurality of earlier times when the system was determined to be free of bubbles.

12. A method as in claim 11, wherein comparing the frequency response determined in step a with a baseline frequency response comprises subtraction, division, Fourier transform analysis, wavelet analysis, vector comparison, derivative processing, or a combination thereof, of the frequency responses.

13. A method as in claim 11, further comprising initiating an alert signal indicating the presence of a bubble if a bubble is determined to be present.

14. A method as in claim 11, wherein comparing the frequency response determined in step a with a baseline frequency response comprises determining if the frequency response determined in step a indicates more power in frequencies corresponding to presence of a bubble than does the baseline frequency response.

15. An apparatus for the measurement of an analyte in the circulatory system of a patient, comprising:

a. A patient interface element, adapted to be placed in fluid communication with the circulatory system of a patient;

b. An analyte sensor, mounted in fluid communication with the patient interface element;

c. A pressure sensor, mounted in fluid communication with the patient interface element;

d. A pumping subsystem, mounted in fluid communication with the analyte sensor and with the patient interface element;

e. A control subsystem, responsive to the pressure sensor and controlling the pumping subsystem, wherein the control subsystem operates the pump to draw blood from the circulatory system to the analyte sensor, and wherein the control subsystem implements the method of claim 11 after each such draw.