BLOOD MONITORING SYSTEM

• US 20090156922A1
• Filed: 01/09/2009
• Published: 06/18/2009
• Est. Priority Date: 02/01/2005
• Status: Abandoned Application

• Current Assignee: IntelliDx, Inc.
• Original Assignee: IntelliDx, Inc.
• Inventors: Johnson, Larry, Larson, Robert, Klomhaus, Jill, Bitton, Gabby, Pesach, Gidi, Argaman, Dalia, Bellomo, Stephen, Goldberger, Daniel, Pesach, Benny, Siebrecht, Wayne, Nagar, Ron, Shreve, Eric
• Application Number:
  US12/351,761
• Publication Number:
  US 20090156922A1
• Time in Patent Office: Days
• US Class Current: 600/364
• 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

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 monitoring at least one parameter of blood comprising:

a blood withdrawal system comprising;

a patient access device configured to access blood in a patient;

a fluid channel system connectable to the patient access device; and

a pump connectable to the fluid channel system;

a blood parameter sensor configured to produce a sensor signal indicative of a least one blood parameter;

a pressure sensor configured to provide a pressure sensor signal indicative of a measured pressure at a position of the blood withdrawal system wherein the signal indicative of the measured pressure is indicative of a occlusion or malfunction associated with the blood withdrawal system; and

a controller configured to control the pump in response to said signal indicative of a measured pressure to address the occlusion or malfunction.

2. The device of claim 1, wherein the controller is configured to halt pump actuation and then actuate the pump in response to said signal indicative of a occlusion or malfunction.

3. The device of claim 1, wherein the occlusion is a partial occlusion.

4. The device of claim 1, wherein the controller is configured to respond to the pressure signal by subsequently modulating the pressure or volume in the fluid channel system.

5. A device for monitoring at least one parameter of blood, comprising:

a blood withdrawal system comprising;

a patient access device configured to access blood in a patient;

a fluid channel system connectable to the patient access device;

a variable volume pump connectable to the fluid channel system; and

a blood parameter sensor configured to produce a sensor signal indicative of a least one blood parameter;

a pressure sensor configured to provide a pressure sensor signal indicative of a measured pressure at a position of the blood withdrawal system; and

a controller configured to receive the pressure sensor signal, compare the measured pressure with a threshold value range, and transmit a signal to the variable volume pump to modulate the variable volume pump if the measure pressure is outside of the threshold value range.

6. The device of claim 5, wherein the controller is configured to respond to the pressure sensor signal by subsequently modulating the pressure or volume in the fluid channel system.

7. The device of claim 5, wherein the threshold value range is predetermined.

8. The device of claim 5, wherein the threshold value range is determined by an algorithm.

9. The device of claim 5, wherein the pressure sensor is connectable to the variable volume pump.

10. The device of claim 5, wherein the pressure sensor is connectable to the fluid channel system.

11. The device of claim 5, wherein the variable volume pump is a syringe pump.

12. The device of claim 5, wherein the blood parameter sensor is a single use sensor.

13. The device of claim 12, wherein the blood parameter sensor comprises a plurality of sensors in a cassette or cartridge.

14. The device of claim 5, wherein the at least one parameter is a blood glucose level, ketone level, hemoglobin level, lactate level, electrolyte level, blood gas level, cholesterol level, or bilirubin level.

15. A device for monitoring at least one parameter of blood comprising:

a blood withdrawal system comprising;

a patient access device configured to access blood in a patient;

a fluid channel system connectable to the patient access device; and

a pump connectable to the fluid channel system;

a blood parameter sensor configured to produce a sensor signal indicative of a least one blood parameter;

a pressure sensing apparatus configured to provide a pressure sensor signal indicative of a measured pressure at a position of the blood withdrawal system; and

a controller configured to control the pump in response to said signal indicative of a measured pressure, wherein the controller is configured to change the operation of the pump and wherein the pressure sensing apparatus is configured to provide a second pressure signal indicative of a pressure in the blood withdrawal system corresponding to the change of operation of the pump.

16. The device of claim 15, wherein the controller is configured to control the operation of the pump based on the second pressure signal.

17. A device for monitoring a blood parameter comprising:

a patient access device configured to access blood in a patient;

a fluid channel system connectable to the patient access device;

a bidirectional pump connectable to the fluid channel system;

a valve positioned between the patient access device and the pump;

a blood parameter sensor configured to produce a sensor signal indicative of at least one blood parameter;

a pressure sensing apparatus connectable to the pump, wherein the pressure sensing apparatus is configured to provide a signal indicative of an occlusion or malfunction associated with the fluid channel system; and

a controller configured to regulate the valve and the pump to permit infusion to a patient, withdrawal of a fluid from a patient using the pump in a first direction, and re-infusion of at least a fraction of the fluid back to the patient by using the pump in a second direction opposite the first direction.

18. The device of claim 17, wherein not all of the fluid is re-infused back to the patient.

19. The device of claim 17, wherein the pressure sensing apparatus sensor is configured to transmit a signal to control the syringe pump.

20. The device of claim 19, wherein the controller is configured to respond to the signal indicative of an occlusion or malfunction by subsequently modulating the pressure or volume in the fluid channel system.

21. The device of claim 17, wherein the pressure sensing apparatus sensor is configured to be used in conjunction with the syringe pump to remove the occlusion or malfunction.

22. The device of claim 17, wherein the pressure sensing apparatus sensor is attached to the syringe pump.

23. The device of claim 17, wherein the syringe pump comprises a plunger and a reservoir.

24. The device of claim 23, wherein the pressure sensing apparatus sensor is attached to the plunger and is configured to measure a force on the plunger.

25. The device of claim 17, wherein the blood parameter sensor is a single use sensor.

26. The device of claim 25, wherein the blood parameter sensor comprises a plurality of sensors contained in a cassette or cartridge.

27. The device of claim 17, wherein the at least one parameter is a blood glucose level, ketone level, hemoglobin level, lactate level, electrolyte level, blood gas level, cholesterol level, or bilirubin level.