Haemodialysis device

• US 7,563,240 B2
• Filed: 02/17/2004
• Issued: 07/21/2009
• Est. Priority Date: 04/11/2003
• Status: Expired due to Term

• Current Assignee: Fresenius Medical Care Deutschland GmbH (Fresenius Medical Care AG)
• Original Assignee: Fresenius Medical Care Deutschland GmbH (Fresenius Medical Care AG)
• Inventors: Gross, Malte, Wuepper, Andreas
• Primary Examiner(s): Stephens; Jacqueline F.
• Application Number:
  US10/552,716
• Publication Number:
  US 20060200064A1
• Time in Patent Office: 1,981 Days
• Field of Search: 604/6.11, 604/6.14, 604/4.01, 604/5.01, 604/5.02, 422/44, 422/45
• US Class Current: 604/5.01
• CPC Class Codes: A61M 1/16 with membranes
• CPC Class Codes: A61M 1/1607 before use, i.e. upstream of dialyser
• CPC Class Codes: A61M 1/1609 after use, i.e. downstream of dialyser
• CPC Class Codes: A61M 1/1617 using measurements made during a temporary variation of a characteristic of the fresh dialysis fluid
• CPC Class Codes: A61M 2205/3317 Electromagnetic, inductive or dielectric measuring means
• CPC Class Codes: A61M 2205/3324 PH measuring means
• CPC Class Codes: A61M 2205/52 with memories providing a history of measured variating parameters of apparatus or patient
• CPC Class Codes: A61M 2230/65 Impedance, e.g. conductivity, capacity
• CPC Class Codes: B01D 61/32 Controlling or regulating

Abstract

A blood purification device has a blood purification element divided into two chambers by a semipermeable membrane, with a first chamber as part of a dialysis fluid loop and a second chamber as part of an extracorporeal blood loop. By virtue of an analysis unit operatively connected to a sensor in the dialysis fluid loop, the device provides simple and uncomplicated determination of the blood purification performance of the blood purification element for a second material by derivation from a previously established blood purification performance for a first material. In this way, the device also determines the blood concentration of the second material during the blood treatment through measurements in the dialysis fluid without intervention in the treatment sequence.

Claims

1. A blood treatment device comprising a blood purification element, divided into two chambers by a semipermeable membrane, whose first chamber is part of a dialysis fluid loop and whose second chamber is part of an extracorporeal blood loop,

a dialysis fluid supply line for supplying fresh dialysis fluid to the first chamber and/or into the blood loop,

a dialysis fluid removal line for removing used dialysis fluid from the first chamber,

a control unit for controlling the blood treatment device,

at least one sensor on at least one of the blood loop or the dialysis fluid loop, the sensor being configured to detect and measure a concentration of a first material capable of penetrating the semipermeable membrane, and

an analysis unit operatively connected to the at least one sensor and configured to determine i) a blood purification performance L1 of the blood purification element for the first material based on the measurement values of the at least one sensor and ii) a blood purification performance L2 of the blood purification element for a second material, which is different from the blood purification performance L1 for the first material, based on data stored in the analysis unit that define a relationship between the blood purification performance L1 for the first material and the blood purification performance L2 for the second material.

2. The blood treatment device according to claim 1, wherein the blood purification performance L is the effective dialysis Deff.

3. The blood treatment device according to claim 2, wherein the analysis unit is configured to derive an effective mass exchange coefficient k0A1eff from a measured dialysance D1eff for the first material, to determine an effective mass exchange coefficient k0A2 eff for the second material from a stored ratio f between a theoretical mass exchange coefficient k0A1th of the second material and a theoretical mass exchange coefficient k0A1th of the first material by multiplying with k0A1eff, and to derive an effective dialysance D2eff for the second material from k0A2eff.

4. The blood treatment device according to claim 2, wherein the analysis unit is configured to derive from a stored theoretical mass exchange coefficient k0A1th for the first material and a stored theoretical mass exchange coefficient k0A2th for the second material, values corresponding thereto for theoretical dialysances D1th and D2th, and to determine an effective dialysance D2eff for the second material from a measured dialysance D1eff for the first material multiplied by a ratio D2th to D1th.

5. The blood treatment device according to claim 1, wherein the at least one sensor is a first downstream sensor on the dialysis fluid removal line and is configured to measure the concentration of the first material in the used dialysis fluid.

6. The blood treatment device according to claim 5, further comprising a dialysis fluid preparation unit connected to the control unit.

7. The blood treatment device according to claim 6, the analysis unit and the control unit being configured to determine the blood purification performance L1 for the first material by a method comprising

storing a concentration C1di1 of the first material in the fresh dialysis fluid in the analysis unit,

measuring a concentration C1do1 of the first material in the used dialysis fluid using the first downstream sensor and storing C1do1 in the analysis unit,

altering a concentration C1di of the first material in the fresh dialysis fluid by the dialysis fluid preparation unit at the command of the control unit,

storing a changed concentration C1di2 of the first material in the fresh dialysis fluid in the analysis unit,

measuring a changed concentration C1do2 of the first material in the used dialysis fluid using the first downstream sensor and storing C1do2 in the analysis unit, and

determining by the analysis unit the blood purification performance L1 on the basis of the concentrations C1di1, C1do1 and changed concentrations C1di2, C1do2 of the first material in the fresh and used dialysis fluid.

8. The blood treatment device according to claim 7, wherein the dialysis fluid preparation unit is configured to perform the change of the concentration C1di in the form of a step or bolus.

9. The blood treatment device according to claim 7, further comprising a first upstream sensor, connected to the analysis unit and located on the dialysis fluid supply line, that is configured to measure the concentrations C1di1 and C1di2 in the fresh dialysis fluid.

10. The blood treatment device according to claim 1, further comprising a second downstream sensor, connected to the analysis unit and located on the dialysis fluid removal line, that is configured to measure the concentration C2do of the second material in the used dialysis fluid.

11. The blood treatment device according to claim 10, wherein the analysis unit is configured to determine a concentration C2bi of the second material in the blood flowing to the second chamber based on the measured concentration C2do of the second material in the used dialysis fluid and the stored concentration C2di of the second material in the fresh dialysis fluid and the established blood purification performance L2 of the second material.

12. The blood treatment device according to claim 1, wherein the first material is sodium.

13. The blood treatment device according to claim 1, wherein the second material is potassium, glucose, creatinine, calcium, or phosphate.

14. A hemodialysis device comprising:

a blood purification element having a semipermeable membrane, a first chamber connected to a dialysis fluid loop, and a second chamber connected to an extracorporeal blood loop;

a dialysis fluid supply line to supply fresh dialysis fluid to the first chamber and/or into the blood loop;

a dialysis fluid removal line to remove used dialysis fluid from the first chamber;

a control unit to control the hemodialysis device;

a sensor on the dialysis fluid removal line to measure a concentration of a first material in the used dialysis fluid; and

an analysis unit operatively connected to the sensor and configured to determine i) a blood purification performance L1 of the blood purification element for the first material based on the measured concentration, and ii) a blood purification performance L2 of the blood purification element for a second material based on data stored in the analysis unit that define a relationship between the performance Li for the first material and the performance L2 for the second material, the performance L2 being different from the performance L1,

the analysis unit being configured to derive from a stored theoretical mass exchange coefficient k0A1th for the first material and a stored theoretical mass exchange coefficient k0A2th for the second material, values corresponding thereto for theoretical dialysances D1th and D1th, and to determine an effective dialysance D2eff for the second material from a measured dialysance D1eff for the first material multiplied by a ratio D2th to D1th.

15. A hemodialysis device comprising:

a blood purification element having a semipermeable membrane, a first chamber connected to a dialysis fluid loop, and a second chamber connected to an extracorporeal blood loop;

a dialysis fluid supply line to supply fresh dialysis fluid to the first chamber and/or into the blood loop;

a dialysis fluid removal line to remove used dialysis fluid from the first chamber;

a control unit to control the hemodialysis device;

a sensor on the dialysis fluid removal line to measure a concentration of a first material in the used dialysis fluid; and

an analysis unit operatively connected to the sensor and configured to determine i) a blood purification performance L1 of the blood purification element for the first material based on the measured concentration, and ii) a blood purification performance L2 of the blood purification element for a second material based on data stored in the analysis unit that define a relationship between the performance L1 for the first material and the performance L2 for the second material, the performance L2 being different from the performance L1,

the analysis unit being configured to derive an effective mass exchange coefficient k0A1eff from a measured dialysance D1eff for the first material, to determine an effective mass exchange coefficient k0A2eff for the second material from a stored ratio f between a theoretical mass exchange coefficient k0A2th of the second material and a theoretical mass exchange coefficient kOA1th of the first material by multiplying with k0A1eff, and to derive an effective dialysance D2eff for the second material from k0A2eff.

16. The hemodialysis device according to claim 15, wherein the sensor is configured to detect an electrical conductivity of the first material in the used dialysis fluid.

17. The hemodialysis device according to claim 15, further comprising a second sensor on the dialysis fluid removal line that is configured to measure a concentration of the second material in the used dialysis fluid.