Method and apparatus for an extracorporeal control of blood glucose

• US 20060009727A1
• Filed: 04/08/2005
• Published: 01/12/2006
• Est. Priority Date: 04/08/2004
• Status: Abandoned Application

• Current Assignee: Gambro UF Solutions, Inc. (Baxter International Inc.)
• Original Assignee: CHF Solutions, Inc.
• Inventors: Landry, Donald W., O'Mahony, John J.
• Application Number:
  US11/101,439
• Publication Number:
  US 20060009727A1
• Time in Patent Office: Days
• US Class Current: 604/4.10
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• 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 5/150366 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 5/150389 Hollow piercing elements, e.g. canulas, needles, for piercing the skin
• CPC Class Codes: A61B 5/150503 Single-ended needles hollow piercing element tip design A61B5/150396, needle sets for catheters A61M25/06, needles for bringing media into the body A61M5/32
• 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 5/150946 Means for varying, regulating, indicating or limiting the speed or time of blood collection
• 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 5/153 Devices specially adapted for taking samples of venous or arterial blood, e.g. with syringes
• CPC Class Codes: A61B 5/157 Devices characterised by integrated means for measuring characteristics of blood
• CPC Class Codes: A61B 5/412 Detecting or monitoring sepsis
• CPC Class Codes: A61M 1/34 Filtering material out of the blood by passing it through a membrane, i.e. hemofiltration or diafiltration
• CPC Class Codes: A61M 1/3406 Physical characteristics of the filtrate, e.g. urea
• CPC Class Codes: A61M 1/3468 using treated filtrate as substitution fluid
• CPC Class Codes: A61M 1/3687 Chemical treatment A61M1/3675 takes precedence
• CPC Class Codes: A61M 2205/3306 Optical measuring means
• CPC Class Codes: A61M 2205/3334 Measuring or controlling the flow rate
• CPC Class Codes: A61M 2205/50 with microprocessors or computers
• 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

A method for controlling the blood glucose level of a patient and periodically calibrating the glucose sensor using a calibration solution. The method controls the level of blood glucose in a patient through an extracorporeal blood circuit by: withdrawing blood from a vascular system in the patient to the extracorporeal circuit; removing ultrafiltrate from the withdrawn blood in the circuit; determining a level of glucose present in the blood based on the removed ultrafiltrate; infusing at least a portion of the removed ultrafiltrate and the withdrawn blood into the vascular system, and infusing insulin into the patient based on the determined level of glucose.

Claims

1. A method for controlling the level of blood glucose in a patient through an extracorporeal blood circuit, said method comprising:

a. withdrawing blood from a vascular system in the patient to the extracorporeal circuit;

b. removing ultrafiltrate from the withdrawn blood in the circuit;

c. determining a level of glucose present in the blood based on the removed ultrafiltrate;

d. infusing at least a portion of the removed ultrafiltrate and the withdrawn blood into the vascular system, and

e. infusing insulin into the patient based on the determined level of glucose.

2. A method as in claim 1 where the rate of infusion is adjusted based on a current level of glucose and a prior level of glucose.

3. A method as in claim 1 wherein another portion of the removed ultrafiltrate is collected externally of the patient and is not infused.

4. A method as in claim 1 wherein the portion of the removed ultrafiltrate is returned to the withdrawn blood upstream of a filter removing the ultrafiltrate.

5. A method as in claim 1 further comprising introducing a calibration solution into the withdrawn blood and upstream of a filter removing ultrafiltrate, and determining a level of glucose present in the blood based on the removed ultrafiltrate.

6. A method as in claim 1 further comprising introducing a calibration solution into the withdrawn blood and upstream of a filter removing ultrafiltrate and determining a level of glucose present in the blood based on the removed ultrafiltrate, wherein a return of removed ultrafiltrate to the withdrawn blood is interrupted while the calibration solution is introduced into the withdrawn blood.

7. A method as in claim 1 further comprising introducing a calibration solution into the withdrawn blood and upstream of a filter removing ultrafiltrate and determining a level of glucose present in the blood based on the removed ultrafiltrate, wherein the introduction of the calibrated solution is at a controlled rate.

8. A method as in claim 1 wherein the insulin is infused into the patient by first introducing the insulin into the withdrawn blood in the circuit.

9. A method for controlling the level of blood glucose in a patient through an extracorporeal blood circuit, said method comprising:

a. withdrawing blood from a vascular system in the patient to the extracorporeal circuit;

b. controlling a withdrawn blood pressure by adjustment of a blood flow rate through the circuit;

c. removing ultrafiltrate from the blood withdrawn to an ultrafiltrate circuit;

d. using the withdrawn ultrafiltrate to sense a level of glucose present in the blood;

e. infusing at least a portion of the removed ultrafiltrate and the withdrawn blood into the vascular system;

f. controlling a infusion pressure of the infused blood and ultrafiltrate by adjustment of a flow rate of the removed ultrafiltrate and withdrawn blood, and

g. adjusting a rate of infusion of insulin into withdrawn blood based on the sensed level of glucose.

10. A method as in claim 9 wherein the adjustment to the rate of infusion is based on a comparison of a current glucose level measurement to an earlier glucose level measurement.

11. A method as in claim 9 wherein the adjustment of the rate infusion is performed manually in response to an alarm issued when the sensed level of glucose is outside a predetermined glucose range.

12. A method as in claim 9 wherein the portion of the removed ultrafiltrate is returned to the withdrawn blood upstream of a filter removing the ultrafiltrate.

13. A method as in claim 9 further comprising introducing a calibration solution into the withdrawn blood and upstream of a filter removing ultrafiltrate and determining a level of glucose present in the blood based on the removed ultrafiltrate, wherein a return of removed ultrafiltrate to the withdrawn blood is interrupted while the calibration solution is introduced into the withdrawn blood.

14. A system for controlling a blood glucose level in a patient comprising:

a withdrawal blood line in fluid communication with a vascular system of patient;

a filter having an input to receive blood connected to the withdrawal blood line, a blood output, a filter membrane adjacent on one side to a blood passage in the filter, and a ultrafiltrate output on an opposite side of a filter membrane, wherein the ultrafiltrate from the withdrawn blood, passes through the membrane, through the ultrafiltrate output and to an ultrafiltrate line;

a blood glucose sensor monitoring the ultrafiltrate passing through ultrafiltrate line;

an infusion line connected to the blood output of the filter and in fluid communication with the vascular system of the patient;

an ultrafiltrate valve connecting an output of the ultrafiltrate line to the withdrawal blood line, and

an insulin valve connecting an insulin line to said infusion line.

15. The system as in claim 14 wherein the system is an extracorporeal blood circuit connectable to a pump console.

16. The system as in claim 14 wherein the ultrafiltrate valve is a three port valve having a first position to direct ultrafiltrate to the withdrawal blood line and a second position to direct ultrafiltrate to a container.

17. The system as in claim 14 further comprising a calibration fluid valve connecting a calibration fluid line to the ultrafiltrate line.

18. A device for calibrating a glucose sensor in an ultrafiltrate line comprising:

an ultrafiltrate pump connected to an ultrafiltrate line;

a glucose calibration solution source connected to the ultrafiltrate line downstream of the ultrafiltrate pump when the pump is drawing ultrafiltrate from the filter, wherein a one way valve connects the ultrafiltrate line to the ultrafiltrate line to allow the calibration solution to flow out of the calibration solution bag and into the ultrafiltrate line while the pump reverses the flow in the ultrafiltrate line;

a blood glucose sensor connected to said ultrafiltrate line, and

a second one way valve down stream of the ultrafiltrate pump and glucose calibration solution which only allows flow downstream of the ultrafiltrate pump.

19. A method for calibrating a glucose sensor in an ultrafiltrate line connected to an ultrafiltrate pump, said method comprising:

a. periodically reversing the ultrafiltrate pump to withdraw a calibration solution of glucose across the glucose sensor;

b. preventing other fluids from entering the ultrafiltrate line while the pump has reversed the ultrafiltrate flow, and

c. calibrating the glucose sensor to read the same level of glucose as the level of glucose known to be in the calibration solution.