Method for the determination of at least one characteristic figure relating to a patient's glucose metabolism, and apparatus therefor

• US 10,226,562 B2
• Filed: 11/11/2008
• Issued: 03/12/2019
• Est. Priority Date: 11/12/2007
• Status: Expired due to Fees

• Current Assignee: Fresenius Medical Care Deutschland GmbH (Fresenius SE & Co. KGaA)
• Original Assignee: Fresenius Medical Care Deutschland GmbH (Fresenius SE & Co. KGaA)
• Inventors: Schulte, Elke, Muller, Carsten
• Primary Examiner(s): Mensh, Andrew J
• Application Number:
  US12/742,415
• Publication Number:
  US 20100298751A1
• Time in Patent Office: 3,773 Days
• Field of Search: 604 401, 604 609, 604 504, 604316, 210645, 210646, 210739, 356 39
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61M 1/1609 after use, i.e. downstream of dialyser
• 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 1/342 Adding solutions to the blood, e.g. substitution solutions for preventing coagulation A61M1/3672
• CPC Class Codes: A61M 1/3434 with pre-dilution and post-dilution
• CPC Class Codes: A61M 1/3437 downstream of the filter, e.g. post-dilution with filtrate
• CPC Class Codes: A61M 1/3458 having electrolytes not present in the dialysate
• CPC Class Codes: A61M 2230/201 Glucose concentration
• 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: B01D 61/32 Controlling or regulating
• CPC Class Codes: C12Q 1/54 involving glucose or galactose

Abstract

The present invention relates to a method for detecting at least one characteristic relating to a patient'"'"'s glucose metabolism, having steps to be performed during an extracorporeal treatment of the patient'"'"'s blood, particularly during a dialysis treatment, of the extracorporeal addition of glucose and/or insulin and extracorporeal measurement of a glucose concentration and/or an insulin concentration. The invention further proposes a corresponding device. In addition, the invention proposes a method for determining the composition of the dialysate for the extracorporeal treatment of a patient'"'"'s blood having the steps of determining a glucose level in the patient'"'"'s blood during the dialysis session and adapting the amount of glucose added to the dialysate or blood based on the glucose level determined. To this end, the invention proposes a corresponding device. The invention further proposes a blood treatment device.

Claims

1. A method, comprising:

starting a hemodialysis, hemofiltration, or hemodiafiltration treatment of a patient using a blood treatment apparatus, a dialysate circuit, and an extracorporeal blood circuit;

adding, during the treatment, a particular quantity of glucose to the extracorporeal blood circuit to mix with blood of the patient;

after the adding, measuring glucose concentration values at different points in time during the treatment, wherein the measuring is performed at least in part by one or more sensors measuring the blood of the patient at one or more locations along the extracorporeal blood circuit;

adjusting, during the treatment, a glucose concentration of a dialysate liquid within the dialysate circuit such that a glucose shift across a dialysis filter is reduced;

characterizing, using the blood treatment apparatus, the patient'"'"'s metabolization of the particular quantity of glucose based on;

(i) the measured glucose concentration values, (ii) the different points in time that the glucose concentration values were measured, and (iii) the particular quantity of glucose added to the extracorporeal blood circuit;

outputting, using the blood treatment apparatus, a result of the characterizing; and

detecting diabetes or a pathological glucose tolerance of the patient based on the result of the characterizing.

2. The method according to claim 1, further comprising:

changing the glucose concentration of the dialysate liquid while monitoring the measured glucose concentration.

3. The method according to claim 2, wherein a change in the glucose concentration of the dialysate liquid is used to determine at least one characteristic figure relating to the patient'"'"'s metabolization of the particular quantity of glucose.

4. The method according to claim 1, wherein the characterizing the patient'"'"'s metabolization of the particular quantity of glucose includes determining a glucose shift across the dialysis filter after the extracorporeal addition of glucose, wherein the glucose shift across the dialysis filter is used to determine at least one characteristic figure relating to the patient'"'"'s metabolization of the particular quantity of glucose.

5. The method according to claim 1, wherein the extracorporeal addition of glucose includes an addition on at least one of a dialysate side and on a substituate side.

6. The method according to claim 1, wherein at least one of a) the addition of the particular quantity of glucose and b) the measuring of the glucose concentration values is automated.

7. The method according to claim 1, wherein the adjusting the glucose concentration of the dialysate liquid comprises:

adjusting the glucose concentration of the dialysate liquid within the dialysate circuit in coordination with the measured glucose concentration of the blood of the patient such that the glucose shift across the dialysis filter is reduced.

8. A method, comprising:

starting a hemodialysis, hemofiltration, or hemodiafiltration treatment of a patient using a blood treatment apparatus, a dialysate circuit, and an extracorporeal blood circuit;

adding, during the treatment, a particular quantity of at least one of a) glucose and b) insulin to the extracorporeal blood circuit to mix with blood of the patient;

after the adding, measuring at different points in time during the treatment a concentration of at least one substance comprised of at least one of a) glucose and b) insulin, wherein the measuring is performed at least in part by one or more sensors measuring the blood of the patient at one or more locations along the extracorporeal blood circuit;

adding, during the treatment, at least one of a) glucose and b) insulin to the dialysate circuit such that a glucose shift or an insulin shift across a dialysis filter is reduced;

characterizing, via the blood treatment apparatus, the patient'"'"'s metabolization of the particular quantity of the at least one of a) glucose and b) insulin by evaluation of a curve over time that is based on;

(i) the measured concentration of the at least one substance, (ii) the different points in time that the concentration of the at least one substance was measured, and (iii) the particular quantity of the at least one of a) glucose and b) insulin added to the extracorporeal blood circuit;

outputting, using the blood treatment apparatus, a result of the characterizing; and

detecting diabetes or a pathological glucose tolerance of the patient based on the result of the characterizing.

9. The method according to claim 8, further comprising:

changing a dialysate glucose concentration while monitoring the measured concentration.

10. The method according to claim 9, wherein a change in the dialysate glucose concentration is used for determination of at least one characteristic figure relating to the characterizing the patient'"'"'s metabolization of the particular quantity of the at least one or a) glucose and b) insulin.

11. The method according to claim 9, further comprising:

determining the glucose shift across the dialysis filter after the adding of the particular quantity of at least one of a) glucose and b) insulin, wherein the glucose shift across the dialysis filter is used for determination of at least one characteristic figure relating to the characterizing the patient'"'"'s metabolization of the particular quantity of the at least one or a) glucose and b) insulin.

12. The method according to claim 8, wherein at least one of a) the addition of the particular quantity of at least one of glucose and insulin, and b) the measuring the concentration of at least one substance comprised of at least one of glucose and insulin is automated.

13. The method according to claim 8, further comprising:

displaying at least one determined characteristic figure relating to the result of the characterizing.

14. A hemodialysis, hemofiltration, or hemodiafiltration system, comprising:

an extracorporeal blood circuit for circulating blood of a patient during a hemodialysis, hemofiltration, or hemodiafiltration treatment;

a dialysate circuit for circulating dialysate liquid during the hemodialysis, hemofiltration, or hemodiafiltration treatment;

a dialyzer comprising a dialyzer membrane and defining a blood chamber in fluid communication with the extracorporeal blood circuit and a dialysate chamber in fluid communication with the dialysate circuit;

a measurement instrument configured to extracorporeally measure, at different points in time during the hemodialysis, hemofiltration, or hemodiafiltration treatment, at least one of glucose concentration and insulin concentration of the blood of the patient at one or more locations along the extracorporeal blood circuit;

a first input line configured for extracorporeally adding at least one of glucose and insulin during the hemodialysis, hemofiltration, or hemodiafiltration treatment to the extracorporeal blood circuit to mix with the blood of the patient;

a second input line configured for adding at least one of glucose and insulin to the dialysate circuit such that a glucose shift or an insulin shift across the dialyzer membrane is reduced;

a blood treatment apparatus configured for characterizing the patient'"'"'s metabolization of a particular quantity of glucose or insulin added to the extracorporeal blood circuit based on;

(i) glucose or insulin concentrations measured by the measurement instrument, (ii) differing points in time at which the glucose or insulin concentrations were measured by the measurement instrument, and (iii) the particular quantity of glucose or insulin added to the extracorporeal blood circuit; and

an output for providing a result of the characterizing.

15. The system according to claim 14, wherein the blood treatment apparatus is configured to change a dialysate glucose concentration while monitoring the measured glucose concentration.

16. The system according to claim 15, wherein the blood treatment apparatus is configured to calculatorily reflect a change in a determination of at least one characteristic figure relating to the patient'"'"'s metabolization of the particular quantity of glucose or insulin.

17. The system according to claim 14, wherein the blood treatment apparatus is:

configured to determine a glucose shift across the dialysis membrane after an extracorporeal addition of glucose; and

configured to calculatorily reflect the glucose shift across the dialysis membrane in the determination of the at least one characteristic figure relating to the patient'"'"'s metabolization of the particular quantity of glucose or insulin.

18. The system according to claim 14, wherein the first input line is configured for extracorporeally adding the at least one of glucose and insulin into a substituate supply.

19. The system according to claim 14, wherein the system is automated to at least one of a) add at least one of glucose and insulin and b) measure at least one of the glucose concentration and the insulin concentration.

20. The system according to claim 14, further comprising:

a display configured for displaying at least one determined characteristic figure relating to the patient'"'"'s metabolization of the particular quantity of glucose or insulin.

21. The system according to claim 14, wherein the blood treatment apparatus comprises a dialysis apparatus.

22. A hemodialysis, hemofiltration, or hemodiafiltration system, comprising:

a measurement instrument configured to measure, at different points in time during a hemodialysis, hemofiltration, or hemodiafiltration treatment, a concentration of at least one substance comprised of at least one of a) glucose and b) insulin in blood of a patient at one or more locations along an extracorporeal blood circuit of the system;

a first input line configured for extracorporeally adding at least one substance comprised of at least one of a) glucose and b) insulin to the extracorporeal blood circuit to mix with the blood of the patient;

a second input line configured for adding at least one of a) glucose and b) insulin to a dialysate circuit of the system such that a glucose shift or an insulin shift across a dialyzer membrane of the system is reduced;

a blood treatment apparatus configured for characterizing the patient'"'"'s metabolization of a particular quantity of glucose or insulin added to the extracorporeal blood circuit by evaluation of a curve over time that is based on;

(i) the concentration of the at least one substance measured by the measurement instrument, (ii) the different points in time that the concentration of the at least one substance was measured by the measurement instrument, and (iii) the particular quantity of glucose or insulin added to the extracorporeal blood circuit; and

an output for providing a result of the characterizing.

23. The system according to claim 22, wherein the blood treatment apparatus is:

configured to change a dialysate glucose concentration while monitoring the measured glucose concentration.

24. The system according to claim 23, wherein the blood treatment apparatus is:

configured to calculatorily reflect a change in a determination of at least one characteristic figure relating to the patient'"'"'s metabolization of the particular quantity of glucose or insulin.

25. The system according to claim 22, wherein the blood treatment apparatus is:

configured to determine a glucose shift across the dialysis membrane after the extracorporeal addition of the particular quantity of glucose or insulin; and

configured to calculatorily reflect the glucose shift across the dialysis membrane in the determination of at least one characteristic figure relating to the patient'"'"'s metabolization of the particular quantity of glucose or insulin.

26. The system according to claim 22, wherein the system is automated to at least one of a) add at least one of glucose and insulin and b) measure at least one of the glucose concentration and the insulin concentration.

27. The system according to claim 22, further comprising:

a display configured for displaying at least one determined characteristic figure relating to the patient'"'"'s metabolization of the particular quantity of glucose or insulin.

28. The system according to claim 22, wherein the blood treatment apparatus comprises a dialysis apparatus.