Blood monitoring system

• US 7,608,042 B2
• Filed: 02/01/2005
• Issued: 10/27/2009
• Est. Priority Date: 09/29/2004
• Status: Active Grant

• Current Assignee: Intellectual Discovery Co., Ltd.
• Original Assignee: IntelliDx, Inc.
• Inventors: Pesach, Gidon, Pesach, Benny, Siebrecht, Wayne, Bitton, Gabriel, Nagar, Ron, Shreve, Eric, Goldberger, Daniel
• Primary Examiner(s): Marmor, II; Charles A.
• Assistant Examiner(s): Natnithithadha; Navin
• Application Number:
  US11/048,108
• Publication Number:
  US 20060079809A1
• Time in Patent Office: 1,729 Days
• Field of Search: 600/309, 600345-366, 204/193, 204/194, 204/400, 20440301-40315, 204/409, 204/196.02, 436 43- 54
• US Class Current: 600/366
• 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 parameter of blood from a patient, comprising:

an access device configured to access blood in a patient;

a fluid channel system connectable to the access device;

a pump configured to transport blood through the fluid channel system;

a dispenser connectable to the fluid channel system and configured to dispense a blood sample; and

a plurality of test substrates in a cassette or cartridge;

at least one movable sample reservoir configured to separate from the dispenser and to transport the blood sample towards a test substrate in the cassette or cartridge;

a sensor configured to analyze the test substrate and produce a sensor signal indicative of at least one parameter; and

a signal processor configured to receive the sensor signal.

2. The device of claim 1, wherein the dispenser is contained in the cassette or cartridge.

3. The device of claim 2, wherein the plurality of test substrates are single use test substrates.

4. The device of claim 3, wherein the at least one parameter is a blood glucose level, ketone level, hemoglobin level, lactate level, electrolyte level, blood gas level, cholesterol level.

5. The device of claim 3, wherein the sensor is pre-calibrated.

6. The device of claim 1, further comprising at least two sensors of different modalities, and wherein at least two sensor signals are configured to produce at least two sensor signals and the signal processor is configured to generate a measurement signal from the at least two sensor signals.

7. The device of claim 1, wherein said device is configured to automatically withdraw blood and wherein the fluid channel system is configured to connect to at least one external line capable of being used for external infusion.

8. The device of claim 1, wherein a portion of the fluid channel system comprises a multiple-lumen tube.

9. The device of claim 1, wherein the signal processor is configured to generate a measurement signal and communicate said measurement signal to a therapy device configured to deliver therapy based on said measurement signal.

10. The device of claim 1, further comprising a test substrate advancing mechanism.

11. A method for periodically monitoring at least one parameter of blood from a patient, comprising:

withdrawing blood from a patient;

transporting the blood through a fluid channel system to a dispenser;

dispensing a sample of the blood through a dispenser to a movable sample reservoir;

separating the movable sample reservoir and the sample from the dispenser;

subsequently transporting the sample via the movable sample reservoir to a first test substrate located in a cassette or cartridge;

analyzing the test substrate with a sensor and producing a sensor signal indicative of at least one parameter; and

receiving and processing the sensor signal.

12. The method of claim 11, wherein the dispenser is contained in the cassette or cartridge.

13. The method of claim 12, wherein the first test substrate is a single use test substrate.

14. The method of claim 13, wherein at least one parameter is a blood glucose level, ketone level, hemoglobin level, hematocrit level, lactate level, electrolyte level, blood gas level, cholesterol level, or bilirubin level.

15. The method of claim 13, wherein the sensor is pre-calibrated.

16. The method of claim 11 further comprising at least two sensors of different modalities, and wherein the at least two sensor signals are configured to produce at least two sensor signals and the signal processor is configured to generate a measurement signal from the at least two sensor signals.

17. The method of claim 11, wherein said device is configured to automatically withdraw blood and wherein the fluid channel system is configured to connect to at least one external line capable of being used for external infusion.

18. The method of claim 11, wherein a portion of the fluid channel system comprises a multiple-lumen tube.

19. The method of claim 11, wherein the signal processor is configured to generate a measurement signal and communicate said measurement signal to a therapy device configured to deliver therapy based on said measurement signal.

20. The method of claim 11, further comprising advancing a second test substrate to the dispensing position.

21. The method of claim 11, wherein the withdrawing of blood from the patient is done in a predetermined time schedule.