APPARATUS FOR EXTRA-CORPOREAL BLOOD TREATMENT AND METHOD OF PRESETTING AN INITIAL MODE OF TREATMENT FOR AN EXTRA-CORPOREAL BLOOD TREATMENT APPARATUS

• US 20130327713A1
• Filed: 06/06/2013
• Published: 12/12/2013
• Est. Priority Date: 06/06/2012
• Status: Active Grant

• Current Assignee: Fresenius Medical Care-Ds SRO (Fresenius SE & Co. KGaA)
• Original Assignee: Fresenius Medical Care Deutschland GmbH (Fresenius SE & Co. KGaA), Fresenius Medical Care-Ds SRO (Fresenius SE & Co. KGaA)
• Inventors: Nier, Volker, Wehmeyer, Wolfgang, Jirka, Tomas, Jonas, Joerg
• Granted Patent: US 10,532,146 B2
• Time in Patent Office: Days
• US Class Current: 210/646
• CPC Class Codes: A61M 1/16 with membranes
• CPC Class Codes: A61M 1/1601 Control or regulation
• CPC Class Codes: A61M 1/3403 Regulation parameters
• CPC Class Codes: A61M 1/3413 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 1/3441 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 1/3663 Flow rate transducers; Flow integrators
• CPC Class Codes: A61M 2205/3334 Measuring or controlling the flow rate
• CPC Class Codes: A61M 2205/50 with microprocessors or computers

Abstract

An apparatus for extra-corporeal blood treatment and a method of presetting an initial mode of treatment in the opening phase of an extra-corporeal blood treatment are controlled based on the opening phase of a haemodiafiltration, in which particularly fast removal of electrolytes such as potassium or of urea occurs. The apparatus has a control and computing unit for presetting an initial mode of treatment, in which over a preset interval of time, substituate is fed to the extra-corporeal blood circuit, dialysis fluid is not fed through the dialyser and instead only ultrafiltrate is withdrawn from the dialyser and, on expiry of the preset interval of time, dialysis fluid is fed through the dialyser. Alternatively, dialysis fluid is provided during the preset interval of time through the dialyser at a dialysis fluid flow rate that is smaller than the dialysis fluid flow rate after the preset interval of time has elapsed.

Claims

1. An apparatus for extra-corporeal blood treatment having an extra-corporeal blood circuit which includes a first chamber of a dialyser or filter, which is divided into the first chamber and a second chamber by a semi-permeable membrane, and a blood pump configured for feeding blood through the first chamber of the dialyser or filter, and having a fluid system which includes the second chamber of the dialyser or filter, the apparatus comprising:

a dialysis-fluid pump configured for feeding dialysis fluid through the second chamber of the dialyser or filter, and a shut-off member configured for interrupting fluid flow into the second chamber of the dialyser or filter, wherein the dialysis-fluid pump and the shut-off member are configured so that in a first operating mode, ultrafiltrate is withdrawn from the second chamber of the dialyser or filter and the fluid flow into the second chamber of the dialyser or filter is interrupted and, in a second operating mode, dialysis fluid is fed through the second chamber of the dialyser or filter;

a substituate pump configured for feeding substituate into the extra-corporeal blood circuit upstream or downstream of the dialyser or filter; and

a control and computing unit having means for presetting an initial mode of treatment only during an opening phase of the treatment, the means for presetting the initial mode of treatment being configured such that;

within a preset first interval of time, the substituate pump is operated such that substituate is fed to the extra-corporeal blood circuit at a preset substituate flow rate or a preset progression of the substituate flow rate;

the dialysis-fluid pump and the shut-off member are operated in the first operating mode over the preset first interval of time, ultrafiltrate thus being withdrawn from the second chamber of the dialyser or filter when the fluid flow into the second chamber of the dialyser or filter is interrupted; and

on expiry of the preset first interval of time, a switch is made to a mode of treatment which follows on from the initial mode of treatment and in which the dialysis-fluid pump and the shut-off member are operated in the second operating mode, dialysis fluid thus being fed through the second chamber of the dialyser or filter.

3. The apparatus according to claim 1, wherein the means for presetting the initial mode of treatment are configured such that the substituate pump is operated such that the substituate flow rate is increased within the preset first interval of time.

4. The apparatus according to claim 3, wherein the substituate pump is operated such that the substituate flow rate is increased continuously over the preset first interval of time at a constant rate of increase.

5. The apparatus according to claim 3, wherein the substituate pump is operated such that the substituate flow rate is increased continuously over the preset first interval of time at an increasing rate of increase.

6. The apparatus according to claim 1, wherein the means for presetting the initial mode of treatment are configured such that on expiry of the preset first interval of time, the dialysis-fluid pump and the shut-off member are operated such that, over a preset second interval of time, a dialysis fluid flow rate is increased to a preset value.

7. The apparatus according to claim 6, wherein the dialysis-fluid pump and the shut-off member are operated such that the dialysis fluid flow rate is increased continuously over the preset second interval of time at a constant rate of increase.

8. The apparatus according to claim 6, wherein the dialysis-fluid pump and the shut-off member are operated such that the dialysis fluid flow rate is increased continuously over the preset second interval of time at an increasing rate of increase.

9. The apparatus according to claim 1, further comprising:

an input unit configured for input of a length of the preset first interval of time and/or for changing the length of the preset first interval of time.

10. The apparatus according to claim 1, wherein the extra-corporeal blood circuit includes a blood infeed line which runs to the first chamber of the dialyser or filter, and a blood outfeed line which leads from the first chamber of the dialyser or filter, and the fluid system includes a dialysis-fluid infeed line which runs to the second chamber of the dialyser or filter, and a dialysis-fluid outfeed line which leads from the second chamber of the dialyser or filter, the shut-off member being arranged in the dialysis-fluid infeed line and the dialysis-fluid pump being arranged in the dialysis-fluid outfeed line.

11. The apparatus according to claim 10, wherein the fluid system includes a substituate line running to the blood infeed line or blood outfeed line, the substituate pump being arranged in the substituate line.

2. An apparatus for extracorporeal blood treatment, comprising:

an extra-corporeal blood circuit which includes a first chamber of a dialyser or filter, which is divided into the first chamber and a second chamber by a semi-permeable membrane, and a fluid system which includes the second chamber of the dialyser or filter;

a blood pump configured for feeding blood into the extracorporeal blood circuit through the first chamber of the dialyser or filter;

a dialysis-fluid pump and a shut-off member configured for feeding dialysis fluid through the second chamber of the dialyser or filter, wherein the dialysis-fluid pump and the shut-off member are configured so that in a first operating mode, ultrafiltrate is withdrawn from the second chamber of the dialyser or filter and dialysis fluid is fed through the second chamber of the dialyser or filter at a first dialysis fluid flow rate and, in a second operating mode, dialysis fluid is fed through the second chamber of the dialyser or filter at a second dialysis fluid flow rate, wherein the first dialysis fluid flow rate is smaller than the second dialysis fluid flow rate;

a substituate pump configured for feeding substituate to the extracorporeal blood circuit upstream or downstream of the dialyser or filter; and

a control and computing unit having means for presetting an initial mode of treatment only during an opening phase of the treatment, the means for presetting the initial mode of treatment being configured such that;

within a preset first interval of time, the substituate pump is operated such that substituate is fed to the extra-corporeal blood circuit at a preset substituate flow rate or a preset progression of the substituate flow rate;

the dialysis-fluid pump and the shut-off member are operated in the first operating mode over the preset first interval of time, ultrafiltrate thus being withdrawn from the second chamber of the dialyser or filter and dialysis fluid being fed at the first dialysis fluid flow rate; and

after the preset first interval of time has elapsed, a switch is made to an operating mode following the initial mode of treatment, in which the dialysis-fluid pump and the shut-off member are operated in the second operating mode, dialysis fluid thus being fed through the second chamber of the dialyser or filter at the second dialysis fluid flow rate.

12. The apparatus according to claim 2, wherein the means for presetting the initial mode of treatment are configured such that the substituate pump is operated such that the substituate flow rate is increased within the preset first interval of time.

13. The apparatus according to claim 12, wherein the substituate pump is operated such that the substituate flow rate is increased continuously over the preset first interval of time at a constant rate of increase.

14. The apparatus according to claim 12, wherein the substituate pump is operated such that the substituate flow rate is increased continuously over the preset first interval of time at an increasing rate of increase.

15. The apparatus according to claim 2, wherein the means for presetting the initial mode of treatment are configured such that on expiry of the preset first interval of time, the dialysis-fluid pump and the shut-off member are operated such that, over a preset second interval of time, a dialysis fluid flow rate is increased to a preset value.

16. The apparatus according to claim 15, wherein the dialysis-fluid pump and the shut-off member are operated such that the dialysis fluid flow rate is increased continuously over the preset second interval of time at a constant rate of increase.

17. The apparatus according to claim 15, wherein the dialysis-fluid pump and the shut-off member are operated such that the dialysis fluid flow rate is increased continuously over the preset second interval of time at an increasing rate of increase.

18. The apparatus according to claim 2, further comprising:

an input unit configured for input of a length of the preset first interval of time and/or for changing the length of the preset first interval of time.

19. The apparatus according to claim 2, wherein the extra-corporeal blood circuit includes a blood infeed line which runs to the first chamber of the dialyser or filter, and a blood outfeed line which leads from the first chamber of the dialyser or filter, and the fluid system includes a dialysis-fluid infeed line which runs to the second chamber of the dialyser or filter, and a dialysis-fluid outfeed line which leads from the second chamber of the dialyser or filter, the shut-off member being arranged in the dialysis-fluid infeed line and the dialysis-fluid pump being arranged in the dialysis-fluid outfeed line.

20. The apparatus according to claim 19, wherein the fluid system includes a substituate line running to the blood infeed line or blood outfeed line, the substituate pump being arranged in the substituate line.

21. A method of presetting an initial mode of treatment in an opening phase of an extra-corporeal blood treatment performed by an extra-corporeal blood treatment apparatus, the apparatus comprising an extra-corporeal blood circuit which includes a first chamber of a dialyser or filter which is divided into the first chamber and a second chamber by a semi-permeable membrane, a fluid system which includes the second chamber of the dialyser or filter, and a blood pump configured for feeding blood through the first chamber of the dialyser or filter in the extra-corporeal blood circuit, the method comprising:

in a first operating mode, withdrawing, by a dialysis-fluid pump, ultrafiltrate from the second chamber of the dialyser or filter when a fluid flow into the second chamber of the dialyser or filter is interrupted by a shut-off member, and in a second operating mode, feeding dialysis fluid through the second chamber of the dialyser or filter;

in the initial mode of treatment during the opening phase of the treatment, feeding in substituate, by a substituate pump, to the extra-corporeal blood circuit upstream or downstream of the dialyser or filter over a preset first interval of time at a preset substituate flow rate or a preset progression of the substituate flow rate;

over the preset first interval of time, operating the dialysis-fluid pump and the shut-off member in the first operating mode, ultrafiltrate thus being withdrawn from the second chamber of the dialyser or filter when the fluid flow into the second chamber is interrupted; and

on expiry of the preset first interval of time, switching to a mode of treatment which follows on from the initial mode of treatment and operating the dialysis-fluid pump and the shut-off member in the second operating mode, dialysis fluid thus being fed through the second chamber of the dialyser or filter.

23. The method according to claim 21, wherein the substituate flow rate is increased over the preset first interval of time.

24. The method according to claim 23, wherein the substituate flow rate is increased continuously over the preset first interval of time at a constant rate of increase.

25. The method according to claim 23, wherein the substituate flow rate is increased continuously over the preset first interval of time at an increasing rate of increase.

26. The method according to claim 21, wherein, on expiry of the preset first interval of time, a dialysis fluid flow rate is increased to a preset value over a preset second interval of time.

27. The method according to claim 26, wherein the dialysis fluid flow rate is increased continuously over the preset second interval of time at a constant rate of increase.

28. The method according to claim 26, wherein the dialysis fluid flow rate is increased continuously over the preset second interval of time at an increasing rate of increase.

22. A method of presetting an initial mode of treatment in an opening phase of an extra-corporeal blood treatment performed by an extra-corporeal blood treatment apparatus, the apparatus comprising an extra-corporeal blood circuit which includes a first chamber of a dialyser or filter, which is divided into the first chamber and a second chamber by a semi-permeable membrane, a fluid system which includes the second chamber of the dialyser or filter, and a blood pump configured for feeding blood through the first chamber of the dialyser or filter in the extra-corporeal blood circuit, the method comprising:

in a first operating mode, withdrawing, by a dialysis-fluid pump, ultrafiltrate from the second chamber of the dialyser or filter at a first dialysis fluid flow rate and in a second operating mode, feeding dialysis fluid through the second chamber of the dialyser or filter at a second dialysis fluid flow rate, wherein the first dialysis fluid flow rate is smaller than the second dialysis fluid flow rate;

in the initial mode of treatment during the opening phase of the treatment, feeding in substituate, by a substituate pump, to the extra-corporeal blood circuit upstream or downstream of the dialyser or filter over a preset first interval of time at a preset substituate flow rate or a preset progression of the substituate flow rate;

over the preset first interval of time, operating the dialysis-fluid pump and the shut-off member in the first operating mode, ultrafiltrate thus being withdrawn from the second chamber of the dialyser or filter and dialysis fluid being fed at the first dialysis fluid flow rate; and

after the preset first interval of time has elapsed, switching to a mode of treatment following the initial mode of treatment and operating the dialysis-fluid pump and the shut-off member in the second operating mode, dialysis fluid thus being fed though the second chamber of the dialyser or filter at the second dialysis fluid flow rate.

29. The method according to claim 22, wherein the substituate flow rate is increased over the preset first interval of time.

30. The method according to claim 29, wherein the substituate flow rate is increased continuously over the preset first interval of time at a constant rate of increase.

31. The method according to claim 29, wherein the substituate flow rate is increased continuously over the preset first interval of time at an increasing rate of increase.

32. The method according to claim 22, wherein, on expiry of the preset first interval of time, a dialysis fluid flow rate is increased to a preset value over a preset second interval of time.

33. The method according to claim 32, wherein the dialysis fluid flow rate is increased continuously over the preset second interval of time at a constant rate of increase.

34. The method according to claim 32, wherein the dialysis fluid flow rate is increased continuously over the preset second interval of time at an increasing rate of increase.