Machine and procedure for extracorporeal treatment of blood

• US 8,105,260 B2
• Filed: 05/27/2005
• Issued: 01/31/2012
• Est. Priority Date: 07/23/2004
• Status: Active Grant

• Current Assignee: Gambro Lundia AB (Baxter International Inc.)
• Original Assignee: Gambro Lundia AB (Baxter International Inc.)
• Inventors: Tonelli, Claudio, Wittner, Bernd, Beck, Werner, Hildwein, Helmut, Deppisch, Reinhold, Svensson, Jonas, Ericson, Bjorn
• Primary Examiner(s): DEAK, LESLIE R
• Application Number:
  US11/632,751
• Publication Number:
  US 20080215247A1
• Time in Patent Office: 2,440 Days
• Field of Search: 604/4.01, 604/5.01, 604/5.04, 604/6.09, 604/6.11, 210/645, 210/646, 210/739, 210/741
• US Class Current: 604/5.04
• CPC Class Codes: A61M 1/16 with membranes
• CPC Class Codes: A61M 1/1613 Profiling or modelling of patient or predicted treatment evolution or outcome
• CPC Class Codes: A61M 1/1615 using measurements made at different flow rates
• CPC Class Codes: A61M 1/1647 with flow rate measurement of the dialysis fluid, upstream and downstream of the dialyser
• CPC Class Codes: A61M 1/341 by measuring the filtrate rate or volume
• CPC Class Codes: A61M 1/3431 upstream of the filter
• 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 1/3441 Substitution rate control as a function of the ultrafiltration rate
• CPC Class Codes: A61M 1/3465 using dialysate as substitution fluid
• CPC Class Codes: A61M 1/3639 Blood pressure control, pressure transducers specially adapted therefor
• CPC Class Codes: A61M 2205/52 with memories providing a history of measured variating parameters of apparatus or patient
• CPC Class Codes: A61M 2205/60 with identification means

Abstract

A machine (1) for extracorporeal blood treatment comprises a device (2) for ultrafiltration of a liquid through a semi-permeable membrane (3) of a blood treatment device (4), a first sensor (11) for ultrafiltration rate through the membrane, a second group of sensors (13) for measuring a trans-membrane pressure, and a programmed controller (14) for calculating a maximum ultrafiltration rate as a function of the transmembrane pressure. The machine is suitable for kidney failure treatments, such as hemofiltration and hemodiafiltration. In a relatively short time the machine enables a large quantity of corporeal blood to be removed from the patient.

Claims

1. A machine for extracorporeal blood treatment, comprising:

a device for ultrafiltration of a liquid through a semipermeable membrane of a blood treatment device;

a controller configured to perform the following operations;

changing a transmembrane pressure across the semipermeable membrane of the blood treatment device;

detecting a plurality of values of an ultrafiltration flow rate through said membrane on changing said transmembrane pressure; and

evaluating an optimal value of said ultrafiltration flow rate from a comparison of said plurality of values, the optimal value comprising at least one of equal to, and proximal to a maximum value of ultrafiltration flow rate through said membrane as a function of said transmembrane pressure.

2. The machine of claim 1, wherein said controller is configured to perform the operation of selecting an optimal operating situation of said ultrafiltration device from said optimal value.

3. The machine of claim 2, wherein said controller is configured to perform the operation of setting said ultrafiltration device on said optimal operating situation.

4. The machine of claim 1, wherein said optimal value comprises the maximum value of ultrafiltration flow rate through said membrane as a function of a transmembrane pressure.

5. The machine of claim 4, wherein said controller is configured to perform an operation of setting the transmembrane pressure as a function of the transmembrane pressure corresponding to said maximum of ultrafiltration flow rate.

6. The machine of claim 5, wherein the transmembrane pressure is set to a transmembrane pressure corresponding to said maximum of ultrafiltration flow rate lowered by a predetermined percentage or by a predetermined amount if said transmembrane pressure is within a predetermined range.

7. The machine of claim 5, wherein said controller is configured to perform the following algorithm:

i. pUFR=cUFR;

ii. Wait until TMPset is reached;

iii. Sample cUFR;

iv. If cUFR<

pUFR then change sign of step and reduce entity of step;

v. TMPset=TMPset+step;

vi. Repeat from i) until step<

predefined value;

where pUFR=previous UF rate as saved in previous iteration, cUFR=current UF rate, and step initial value is predefined.

8. The machine of claim 1, wherein:

said ultrafiltration device comprises at least one ultrafiltration actuator.

9. The machine of claim 1, comprising a device configured to infuse a substitution liquid into the blood.

10. The machine of claim 9, wherein before said operation of changing the transmembrane pressure across the semipermeable membrane, said controller is configured to perform the operation of imposing a volume control mode for a predetermined time period with an infusion rate of substitution liquid determined as a set value or as a function of the blood flow rate.

11. The machine of claim 1, wherein:

said ultrafiltration device comprises at least one ultrafiltration actuator; and

said operation of changing the transmembrane pressure across the semipermeable membrane comprises a changing of at least one operating parameter of said ultrafiltration actuator.

12. The machine of claim 11, wherein said changing of at least one operating parameter comprises commanding a change of predetermined entity of said at least one operating parameter.

13. The machine of claim 11, wherein said ultrafiltration actuator operates on a line of ultrafiltered liquid.

14. The machine of claim 11, wherein said ultrafiltration actuator comprises at least one fluid circulation pump.

15. The machine of claim 1, comprising at least a first sensor for measuring said ultrafiltration flow rate.

16. The machine of claim 1, wherein said operation of evaluating an optimal value of ultrafiltration flow rate comprises phases of:

determining at least one change in ultrafiltration flow rate caused by said change in transmembrane pressure across the semipermeable membrane;

checking whether said change in ultrafiltration flow rate and said change in transmembrane pressure across the semipermeable membrane agree with a predetermined relation with a reference value;

generating a signal consequent to said checking phase.

17. The machine of claim 16, wherein said predetermined relation comprises a quotient between said change in ultrafiltration flow rate and said change in transmembrane pressure across the semipermeable membrane.

18. The machine of claim 17, wherein said predetermined relation is satisfied if said quotient is less than a reference value.

19. The machine of claim 16, wherein said controller is configured to repeat said phases if said relation is not satisfied.

20. The machine of claim 16 comprising at least a second sensor for measuring said transmembrane pressure across the semipermeable membrane.

21. The machine of claim 1, wherein said controller is configured to periodically repeat said operations.

22. The machine of claim 1, wherein said controller is configured to:

circulate a liquid to be ultrafiltered to said membrane at a first value of a circulation flow rate;

perform said operations of changing, detecting and evaluating a first optimal value of said ultrafiltration flow rate at said first value of a circulation flow rate;

circulate a liquid to be ultrafiltered to said membrane at a second value of a circulation flow rate;

perform said operations of changing, detecting and evaluating a second optimal value of said ultrafiltration flow rate at said second value of a circulation flow rate;

evaluating an optimal value of said ultrafiltration flow rate from a comparison of said first optimal value and said second optimal value.

23. The machine of claim 1, configured to perform hemofiltration or hemodiafiltration.

24. A machine for extracorporeal treatment of blood, comprising:

a blood treatment device having a blood chamber and a fluid chamber separated by a semipermeable membrane;

at least a first actuator configured for ultrafiltration of a liquid through the semipermeable membrane of the blood treatment device;

at least a second actuator configured for supplying a flow of liquid to the blood chamber of said blood treatment device;

at least one sensor configured for measuring an ultrafiltration flow rate through said semipermeable membrane;

a controller configured for performing the following operations;

i. changing a first operating parameter of said first actuator;

ii. detecting two or more ultrafiltration flow rate values on changing of said first operating parameter;

iii. comparing said ultrafiltration flow rate values in order to evaluate a first optimal value of said ultrafiltration flow rate which is at least one of equal to, and proximal to a first maximum of the ultrafiltration flow rate on changing of said first operating parameter.

25. The machine of claim 24, wherein said controller is configured to evaluate a set value of said first parameter on the basis of said first optimal value.

26. The machine of claim 24, wherein said controller is configured to perform the following further operations:

iv. changing a second operating parameter of said second actuator;

v. repeating operations i., ii., and iii. in order to evaluate at least a second optimal value of said first parameter which is at least one of equal to, and proximal to a second maximum of the ultrafiltration flow rate on changing of said first operating parameter;

vi. comparing said first maximum and said second maximum, or said first optimal value and said second optimal value;

vii. evaluate a set value for said first parameter and a set value for said second parameter from said comparison.

27. The machine of claim 26, wherein:

said liquid to be ultrafiltered comprises a liquid component and a solid component;

a change of said second operating parameter influences at least a flow rate of said liquid component.

28. The machine of claim 27, comprising an arterial line connected to an inlet of the blood chamber, a venous line connected to an outlet of the blood chamber, and a pre-infusion line connected to the arterial line, wherein said second actuator comprises at least a pre-infusion actuator arranged on the pre-infusion line and wherein said second operating parameter comprises a pre-infusion flow rate of a liquid infused in the blood upstream said blood treatment device.

29. The machine of claim 24, comprising an arterial line connected to an inlet of the blood chamber and a venous line connected to an outlet of the blood chamber, wherein the arterial line, venous line and blood chamber form an extracorporeal circuit, wherein said second actuator comprises at least a blood pump placed along the extracorporeal circuit and wherein a second operating parameter comprises the flow rate of blood removed from a patient.

30. The machine of claim 24, comprising a discharge line connected to an outlet of the fluid chamber and wherein said first actuator comprises at least a fluid circulation pump arranged on the discharge line, and wherein said first parameter comprises a velocity of said at least a fluid circulation pump.

31. The machine of claim 24, comprising a device for infusing a substitution liquid into the blood.

32. The machine of claim 24, configured to perform hemofiltration or hemodiafiltration.

33. A machine for extracorporeal blood treatment, comprising:

an actuator configured for ultrafiltration of a liquid through a semipermeable membrane of a blood treatment device;

at least a first sensor configured for sensing an ultrafiltration flow rate through said membrane;

at least a second sensor configured for sensing a transmembrane pressure of said semipermeable membrane;

a controller configured for performing the following operations;

determining at least one value of an ultrafiltration flow rate and at least one value of a transmembrane pressure in a first operating situation of said actuator;

commanding said actuator to change into a second operating situation which is different from the first operating situation thereof;

determining at least one value of an ultrafiltration flow rate and at least one value of a transmembrane pressure in said second operating situation;

checking whether said values related to two different operating situations satisfy a predetermined relation with a reference value;

generating a signal in consequence of said check;

depending upon the outcome of said check repeating or not the above-described operations; and

finding a maximum or nearly-maximum value for the ultrafiltration flow rate as a function of the transmembrane pressure.

34. The machine of claim 33, wherein said operation of checking comprises phases of:

calculating a quotient between a change in said ultrafiltration flow rate and a change in said transmembrane pressure;

checking whether said quotient agrees with a predetermined relation with a reference value.

35. The machine of claim 34, wherein said relation is agreed with if said quotient is close to zero or less than a small value.

36. The machine of claim 33, wherein said second sensor comprises at least four pressure gauges arranged respectively:

in an arterial line conveying extracorporeal blood to the blood treatment device;

in a venous line removing the extracorporeal blood from the blood treatment device;

in a supply line conveying a fresh treatment fluid to the blood treatment device; and

in a discharge line removing used treatment fluid from the blood treatment device.

37. The machine of claim 33, comprising a device for infusing a substitution liquid into the blood.

38. The machine of claim 33, configured to perform hemofiltration or hemodiafiltration.

39. A control procedure of an ultrafiltration device for ultrafiltration of a liquid through a semipermeable membrane of a blood treatment device, the procedure comprising the phases of:

changing a transmembrane pressure across the semipermeable membrane of the blood treatment device;

detecting a plurality of values of an ultrafiltration flow rate through said membrane on changing said transmembrane pressure;

comparing said detected values;

evaluating an optimal value of said ultrafiltration flow rate from said comparison of said detected values;

setting said ultrafiltration device at an optimal operating situation selected on the basis of the optimal value evaluated from said comparison of said detected values.

40. The procedure of claim 39, wherein said optimal value is at least one of equal to, and proximal to a maximum value of ultrafiltration flow rate as a function of transmembrane pressure.

41. The procedure of claim 39, wherein during the ultrafiltration a substitution liquid is infused into the blood.

42. The procedure of claim 39, wherein said phase of changing a transmembrane pressure across the semipermeable membrane of the blood treatment device comprises a modification of at least one operating parameter of an ultrafiltration actuator of said ultrafiltration device.

43. The procedure of claim 42, wherein said ultrafiltration actuator operates on a line of ultrafiltered liquid.

44. The procedure of claim 39, wherein said first quantity comprises a circulation flow rate of a fluid at least partially containing the ultrafiltered liquid.

45. The procedure of claim 39, wherein said phases are repeated periodically.

46. The procedure of claim 39, wherein said phases are performed at at least two different values of a flow rate of said liquid to be ultrafiltered, in order to compare results obtained in at least two different cases and in order to emit a signal in consequence of said comparison.

47. The procedure of claim 39, wherein said ultrafiltration device is part of a machine which is predisposed to perform one or more of following treatments:

hemodialysis, pure ultrafiltration, hemofiltration and hemodiafiltration.

48. Controller configured to perform the control procedure of claim 39.

49. A control procedure of an ultrafiltration device for ultrafiltation of a liquid through a semipermeable membrane of a blood treatment device, comprising phases of:

changing an operating condition of said ultrafiltration device;

determining at least one change of transmembrane pressure across the semipermeable membrane by effect of said change in the operating situation;

determining at least one change of ultrafiltration flow rate through said semipermeable membrane by effect of said change in the operating situation;

checking whether said changes of said transmembrane pressure and ultrafiltration flow rate are in agreement with a predetermined relation with a reference value, and

finding a maximum or nearly-maximum value for the ultrafiltration flow rate as a function of the transmembrane pressure.

50. The procedure of claim 49, wherein said phases are repeated if said relation is not agreed with.

51. Controller configured to perform the control procedure of claim 49.

52. The procedure of claim 49, wherein said phases are repeated periodically.

53. The procedure of claim 49, wherein said phases are performed at at least two different values of a flow rate of said liquid to be ultrafiltered, in order to compare results obtained in at least two different cases and in order to emit a signal in consequence of said comparison.

54. The procedure of claim 49 wherein said phase of changing an operating condition of said ultrafiltration device comprises a modification of at least one operating parameter of an ultrafiltration actuator of said ultrafiltration device.

55. The procedure of claim 54, wherein said ultrafiltration actuator operates on a line of ultrafiltered liquid.

56. The procedure of claim 54, wherein said ultrafiltration actuator comprises at least one ultrafiltration pump and changing the operating parameter of the ultrafiltration device comprises changing the speed of the ultrafiltration pump.