Blood monitoring system

• US 20060079809A1
• Filed: 02/01/2005
• Published: 04/13/2006
• Est. Priority Date: 09/29/2004
• Status: Active Grant

• Current Assignee: Intellectual Discovery Co., Ltd.
• Original Assignee: IntelliDx, Inc.
• Inventors: Pesach, Gidon, Siebrecht, Wayne, Bitton, Gabriel, Nagar, Ron, Shreve, Eric, Goldberger, Daniel, Pesach, Benny
• Granted Patent: US 7,608,042 B2
• Time in Patent Office: Days
• US Class Current: 600/576
• CPC Class Codes: A61B 5/0215 by means inserted into the body catheters A61M25/00
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14535 for measuring haematocrit
• CPC Class Codes: A61B 5/14546 for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• 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 5/150305 Packages specially adapted for piercing devices or blood sampling devices kits for diabetes A61M5/003; packaging in general B65D
• CPC Class Codes: A61B 5/150358 Strips for collecting blood, e.g. absorbent optical reagent test strips G01N21/8483; chemical reagent test strips G01N33/4875, G01N33/52
• CPC Class Codes: A61B 5/150366 Blood collection bags, e.g. connected to the patient by a catheter comprising means for removing a small sample of collected blood from the bag collection bags as such A61J1/05, A61M1/0209
• CPC Class Codes: A61B 5/150755 Blood sample preparation for further analysis, e.g. by separating blood components or by mixing
• 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 5/155 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 2005/1726 the body parameters being measured at, or proximate to, the infusion site
• CPC Class Codes: A61M 2205/12 with interchangeable cassettes forming partially or totally the fluid circuit
• CPC Class Codes: A61M 2230/201 Glucose concentration
• CPC Class Codes: A61M 5/14232 Roller pumps
• CPC Class Codes: A61M 5/1723 using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00
• CPC Class Codes: Y10T 436/11 Automated chemical analysis
• CPC Class Codes: Y10T 436/117497 : with a continuously flowing sample or carrier stream

Abstract

The present invention is directed towards apparatuses and methods for the automated measurement of blood analytes and blood parameters for bedside monitoring of patient blood chemistry. Particularly, the current invention discloses a programmable system that can automatically draw blood samples at a suitable programmable time frequency (or at predetermined timing), can automatically analyze the drawn blood samples and immediately measure and display blood parameters such as glucose levels, hematocrit levels, hemoglobin blood oxygen saturation, blood gases, lactate or any other blood parameter.

Claims

1. A device for periodically monitoring at least one predetermined parameter of blood from a patient, comprising:

access device for gaining access to said blood with a catheter;

a pump to withdraw blood from the patient in a predetermined time schedule;

a dispenser to dispense a small amount of blood and provide a blood sample;

at least one sensor in contact with said blood sample; and

a signal processor to measure a signal produced by the at least one sensor upon contact with the blood sample where the signal is indicative of said at least one predetermined parameter.

2. The device of claim 1 wherein the dispenser and the at least one sensor are contained in a disposable cassette or cartridge.

3. The device of claim 2 wherein the at least one sensor is a single use sensor.

4. The device of claim 3 wherein the at least one single use sensor is a component of a manual test system.

5. The device of claim 3 wherein the at least one predetermined parameter is blood glucose and the at least one single use sensor is a glucose test strip.

6. The device of claim 3 wherein the at least one single use sensor is pre-calibrated.

7. The device of claim 3 wherein the at least one single use sensor produces measurements and said measurements are corrected by independent optical measurements of at least one blood parameter.

8. The device of claim 1 wherein said device automatically withdraws blood through the catheter and measures said signal from an undiluted blood sample and wherein said catheter is connected in parallel to at least one external line capable of being used for external infusion or capable of being used by an external pressure transducer.

9. The device of claim 1 wherein the device is connected to a first lumen of a multiple lumen catheter having at least a first and second lumen and wherein flow in at least the second lumen is not stopped while withdrawing blood through said first lumen.

10. The device of claim 1 wherein the signal processor produces measurements and wherein information derived from said measurements is automatically communicated to another device which can modify a therapy based on the measurement.

11. A method for periodically monitoring at least one predetermined parameter of blood from a patient by accessing blood with a catheter, comprising the steps of:

automatically withdrawing blood from the patient in a predetermined time schedule;

dispensing a small amount of blood through a dispenser;

bringing at least one sensor in contact with the dispensed blood; and

processing a signal produced by the sensor upon contact with the dispensed blood to measure said at least one parameter.

12. The method of claim 11 wherein the dispenser and the at least one sensor are contained in a disposable cassette or cartridge.

13. The method of claim 12 wherein the at least one sensor is a single use sensor.

14. The method of claim 13 wherein the at least one single use sensor is a component of a manual test system.

15. The method of claim 13 wherein at least one predetermined parameter is blood glucose and the at least one single use sensor is a glucose test strip.

16. The method of claim 13 wherein the at least one single use sensor is pre-calibrated.

17. The method of claim 13 wherein the at least one single use sensor generates measurements and wherein said measurements are corrected by independent optical measurements of at least one blood parameter.

18. The method of claim 11 wherein said device automatically withdraws blood through the catheter and measures said signal from an undiluted blood sample and wherein said catheter is connected in parallel to at least one external line capable of being used for external infusion or capable of being used by an external pressure transducer.

19. The method of claim 11 wherein the device is connected to a first lumen of a multiple lumen catheter having at least a first and second lumen and wherein flow in at least the second lumen is not stopped while withdrawing blood through said first lumen.

20. The method of claim 11 wherein the signal processor produces measurements and wherein information derived from said measurements is automatically communicated to another device which can modify a therapy based on the measurement.