Blood monitoring system

• US 20060229531A1
• Filed: 03/21/2006
• Published: 10/12/2006
• Est. Priority Date: 02/01/2005
• Status: Abandoned Application

• Current Assignee: IntelliDx, Inc.
• Original Assignee: IntelliDx, Inc.
• Inventors: Pesach, Benny, Argaman, Dalia, Johnson, Larry, Siebrecht, Wayne, Nagar, Ron, Shreve, Eric, Larson, Robert, Klomhaus, Jill, Bitton, Gabby, Pesach, Gidi, Bellomo, Stephen, Goldberger, Daniel
• Application Number:
  US11/386,078
• Publication Number:
  US 20060229531A1
• Time in Patent Office: Days
• US Class Current: 600/573
• CPC Class Codes: A61B 5/145 Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissuemeasuring of blood pressure or blood flow A61B5/02; non-radiation detecting or locating of foreign bodies in blood A61B5/06
• 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 5/14539 for measuring pH
• CPC Class Codes: A61B 5/14546 for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• CPC Class Codes: A61B 5/14557 specially adapted to extracorporeal circuits
• 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 5/150358 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 5/150862 intermediate range, e.g. within room or building
• CPC Class Codes: A61B 5/15087 short range, e.g. between console and disposable using implanted devices A61B5/150877
• CPC Class Codes: A61B 5/150946 Means for varying, regulating, indicating or limiting the speed or time of blood collection
• 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 2005/1726 the body parameters being measured at, or proximate to, the infusion site
• 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: G16H 20/40 : relating to mechanical, radiation or invasive therapies, e.g. surgery, laser therapy, dialysis or acupuncture
• CPC Class Codes: G16H 40/63 : for local operation

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;

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

a processor for processing a plurality of instructions that define said predetermined time schedule;

a pressure sensing apparatus attached to the pump; and

a disposable cassette comprising

a first storage area for storing at least one unused test substrate;

a fluid dispensing mechanism for dispensing blood onto one unused test substrate;

a plurality of tubing to bring said fluid received via said access device into physical contact with said fluid dispensing mechanism; and

a second storage area for storing said at least one used test substrate.

2. The device of claim 1 further comprising a signal processor to measure a signal produced by analyzing at least one test substrate having said blood sample, where the signal is indicative of said at least one predetermined parameter.

3. The device of claim 1 wherein said plurality of tubing has a lumen with a narrow diameter.

4. The device of claim 3 wherein said narrow diameter is less than 0.06 inches.

5. The device of claim 1 wherein said plurality of tubing has a thick outer wall.

6. The device of claim 5 wherein said thick outer wall has an outer diameter of less than 0.15 inches.

7. The device of claim 1 wherein said plurality of tubing comprises flexible PVC tubing softened with a non-DEHP plasticizer.

8. The device of claim 1 wherein said pump is a syringe pump.

9. The device of claim 8 wherein said pressure sensing apparatus measures pressure changes at said syringe pump.

10. The device of claim 1 wherein said predetermined time schedule is based on physiological data of said patient.

11. The device of claim 1 wherein said predetermined time schedule is based on prior glucose measurements.

12. The device of claim 1 wherein said predetermined time schedule is triggered by a physiological event.

13. 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 using a pump;

dispensing a small amount of blood through a dispenser;

bringing at least one test substrate in contact with the dispensed blood wherein said test substrate is contained in a disposable cassette comprising a first storage area for storing at least one unused test substrate, a fluid dispensing mechanism for dispensing fluid onto one unused test substrate, a plurality of tubing to bring said fluid into physical contact with said fluid dispensing mechanism; and

a second storage area for storing said at least one used test substrate; and

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

14. The method of claim 13 further comprising the step of monitoring pressure changes.

15. The method of claim 14 wherein said pressure changes are monitored using a pressure sensing apparatus in physical communication with said pump.

16. The method of claim 14 further comprising the step of modifying an operation of said pump in response to said pressure changes.

17. The method of claim 13 wherein said predetermined time schedule is based on physiological data of said patient.

18. The method of claim 13 wherein said predetermined time schedule is based on prior glucose measurements.

19. The method of claim 13 wherein said predetermined time schedule is triggered by a physiological event.

21. The device of claim 14 further comprising a pathway extending between said first sealed compartment and said second sealed compartment.

22. The device of claim 15 further comprising a sample dispenser in fluid communication with said pathway.

23. The device of claim 14 further comprising a signal processor to measure a signal produced by analyzing at least one sensor having said blood sample, where the signal is indicative of said at least one predetermined parameter.

24. The device of claim 14 wherein said plurality of tubing has a lumen with a narrow diameter.

25. The device of claim 18 wherein said narrow diameter is less than 0.06 inches.

26. The device of claim 14 wherein said plurality of tubing has a thick outer wall.

20. A device for monitoring glucose levels in blood, comprising:

a syringe pump in fluid communication with a plurality of tubing to withdraw blood from the patient in a predetermined time schedule;

a processor for processing a plurality of instructions that define said predetermined time schedule;

a pressure sensing apparatus attached to the pump wherein said pressure sensing apparatus provides a signal indicative of an occlusion in said plurality of tubing; and

a plurality of sensors packaged in a plurality of sealed compartments wherein a first substantially sealed compartment stores a plurality of unused sensors and a second substantially sealed compartment stores a plurality of used sensors.

27. The device of claim 20 wherein said predetermined time schedule is based on physiological data of said patient.

28. The device of claim 20 wherein said predetermined time schedule is based on prior glucose measurements.

29. The device of claim 20 wherein said predetermined time schedule is triggered by a physiological event.