Method and apparatus for efficient hemodiafiltration

• US 6,303,036 B1
• Filed: 03/01/2000
• Issued: 10/16/2001
• Est. Priority Date: 07/31/1998
• Status: Expired due to Term

• Current Assignee: Nephros, Inc.
• Original Assignee: Nephros, Inc.
• Inventors: Collins, Gregory R., Spence, Edward C.
• Primary Examiner(s): KIM, SUN U
• Application Number:
  US09/485,778
• Time in Patent Office: 594 Days
• Field of Search: 210/252, 210/434, 210/321.6, 210/87, 210/321.72, 210/90, 210/323.1, 210/97, 210/645, 210/646, 210/929, 210/143, 210/650, 210/739, 210/416.1, 604/4.01, 604/5.04
• US Class Current: 210/646
• 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 1/3465 using dialysate as substitution fluid
• CPC Class Codes: A61M 1/3623 Means for actively controlling temperature of blood
• CPC Class Codes: Y10S 210/929 Hemoultrafiltrate volume measurement or control processes

Abstract

An apparatus and method for hemodiafiltration are disclosed. The apparatus includes a first dialyzer cartridge containing a semi-permeable membrane that divides the dialyzer into a blood compartment and a dialysate compartment. Fluid discharged from the blood compartment of the first dialyzer cartridge is mixed with sterile substitution fluid to form a fluid mixture and the mixture enters a second dialyzer cartridge. The second dialyzer cartridge contains a second semi-permeable membrane which divides the second dialyzer cartridge into a blood compartment and a dialysate compartment. Hemodiafiltration occurs in both cartridges.

Claims

1. In a blood dialysis system including a source of substitution fluid and a blood dialysis machine, a hemodiafiltration device comprising:

a first dialyzer including;

a first membrane;

said first membrane defining a first blood compartment having a first blood inlet which receives blood and a first blood outlet which discharges partially diafiltered blood; and

said first membrane defining a first dialysate compartment having a first dialysate inlet and a first dialysate outlet;

means for mixing said partially diafiltered blood with a substitution fluid to obtain a blood/substitution fluid mixture;

a second dialyzer including;

a second membrane;

said second membrane defining a second blood compartment having a second blood inlet which receives said blood/substitution fluid mixture and a second blood outlet which discharges diafiltered blood; and

said second membrane defining a second dialysate compartment having a second dialysate inlet and a second dialysate outlet;

at least one sterility filter which receives dialysate from said dialysis machine and provides sterilized dialysate fluid to said means for mixing; and

a control unit which controls the flow of blood through said first and second dialyzers and the circulation of dialysate fluid between the dialysis machine, said first and second dialysate compartments and said at least one sterility filter.

2. A hemodiafiltration device according to claim 1, wherein said first and second dialyzers comprise first and second dialyzer cartridges, respectively, wherein the first membrane in the first dialyzer cartridge is a semi-permeable membrane between said first blood compartment and said first dialysate compartment, and wherein the second membrane in the second dialyzer cartridge is a semi-permeable membrane between said second blood compartment and said second dialysate compartment.

3. A hemodiafiltration device according to claim 1, wherein dialysate fluid is delivered through a first conduit from said dialysis machine to said second dialysate inlet of said second dialyzer where it flows through said second dialysate compartment and exits through a second conduit which connects said second dialysate outlet to said first dialysate inlet, the dialysate fluid flowing through said first dialysate compartment to said first dialysate outlet.

4. A hemodiafiltration device according to claim 1, wherein a first stream of dialysate fluid flows from said dialysis machine through a first conduit to said second dialysate inlet, a portion of said first stream being diverted through a second conduit to said at least one sterility filter.

5. A hemodiafiltration device according to claim 1, wherein said at least sterility filter comprises a first sterility filter and a second sterility filter, said first sterility filter containing a third semi-permeable membrane partitioning said first sterility filter into a first upstream compartment and a first downstream compartment, said second sterility filter containing a fourth semi-permeable membrane partitioning said second sterility filter into a second upstream compartment and a second downstream compartment.

6. A hemodiafiltration device according to claim 5, wherein said dialysate fluid flows through a first conduit to said first upstream compartment from said dialysis machine, said dialysate fluid being filtered across said third semi-permeable membrane before flowing into said second upstream compartment through a second conduit connecting said first and second sterility filters, said dialysate fluid being filtered across said fourth semi-permeable membrane, said second downstream compartment being fluidly connected with said means for mixing by a third conduit so that said sterilized dialysate fluid is introduced thereto.

7. A method of hemodiafiltration comprising the steps of:

supplying a blood inflow;

diafiltering said blood inflow to provide a partially diafiltered blood outflow;

mixing said partially diafiltered blood outflow with a substitution fluid to provide a blood/substitution fluid mixture; and

diafiltering said blood/substitution fluid mixture.

8. A method according to claim 7 wherein the step of diafiltering said blood inflow comprises the step of diffusing a portion of said blood inflow by a first countercurrent of a dialysate solution in diffusion communication with said blood inflow, and wherein the step of diafiltering said blood/substitution fluid mixture comprises the step of diffusing a portion of said blood/substitution fluid mixture by a second countercurrent of the dialysate solution in diffusion communication with said blood/substitution fluid mixture.

9. A method according to claim 8 and further comprising the step of sterilizing said dialysate solution.

10. A method according to claim 8, wherein said substitution fluid is formed by diverting a portion of said dialysate solution to at least one sterilizing filter which sterilizes said dialysate solution to form said substitution fluid.

11. A method according to claim 8, further comprising the step of controlling the flow of blood in said diafiltration steps and circulation of said dialysate fluid using a controller.

12. A method according to claim 7, wherein said blood is diafiltered in a first dialyzer and said blood/substitution fluid mixture is diafiltered in a second dialyzer, said substitution fluid being added and mixed between said diafiltration steps.

13. A method according to claim 12, further comprising the steps of disposing an interstage pump between said first and second dialyzers and adjustably setting a flow rate of the dialysate fluid from said second dialyzer to said first dialyzer at a predetermined rate by manipulating said interstage pump, said dialysate fluid flowing through a conduit from said second dialyzer to said first dialyzer.

14. A hemodiafiltration device comprising:

a source of substitution fluid;

a first dialyzer including;

a first membrane;

said first membrane defining a first blood compartment having a first inlet which receives blood and a first outlet which discharges partially diafiltered blood;

said first membrane defining a first dialysate compartment having a first dialysate inlet for receiving dialysate fluid and a first dialysate outlet;

means for mixing said partially diafiltered blood with said substitution fluid to form a blood/substitution fluid mixture; and

a second dialyzer including;

a second membrane;

said second membrane defining a second blood compartment having a second inlet which receives said blood/substitution fluid mixture and a second outlet which discharges diafiltered blood; and

said second membrane defining a second dialysate compartment having a second dialysate inlet for receiving dialysate fluid and a second dialysate outlet.

15. A hemodiafiltration device according to claim 14, wherein said substitution fluid comprises a portion of said dialysate fluid which flows through a first conduit from a source of dialysate fluid to at least one sterility filter where said portion of said dialysate fluid is sterilized by passing through said at least one sterility filter to form said substitution fluid.

16. A hemodiafiltration device according to claim 15, wherein said first conduit is connected to a dialysis machine which provides dialysate fluid to said at least one sterility filter through said first conduit, said dialysis machine being connected to said second dialysate inlet by a second conduit so that a portion of said dialysate fluid is provided to said second dialysate compartment from said dialysis machine.

17. A hemodiafiltration device according to claim 14, further including:

a control unit operatively connected to said first and second dialyzers for controlling the flow of blood through said first and second dialyzers and the circulation of dialysate fluid through said first and second dialyzers.

18. A hemodiafiltration device according to claim 14, further including:

a dialysis machine for producing dialysate fluid, said dialysis machine being in fluid communication with said second dialysate compartment by a first conduit, a second conduit extending between said second dialysate outlet and said first dialysate inlet permitting said dialysate fluid to flow from the second dialysate compartment to the first dialysate compartment of said first and second dialyzers.

19. A hemodiafiltration device according to claim 14, further including:

an interstage pump disposed between said first and second dialyzers and in fluid communication with said first and second dialysate compartments, said interstage pump being controllable so that a flow rate of the dialysate fluid from said second dialyzer to said first dialyzer is adjustably set at a predetermined rate.

20. A hemodiafiltration device comprising:

a source of substitution fluid;

a first dialyzer including;

a first membrane defining a first blood compartment and a first dialysate compartment;

said first blood compartment having a first inlet which receives blood and a first outlet which discharges blood having a first concentration of toxins;

said first dialysate compartment having a first dialysate inlet for receiving dialysate fluid and a first dialysate outlet;

means for mixing said blood having said first concentration of toxins with said substitution fluid to form a blood/substitution fluid mixture; and

a second dialyzer including;

a second membrane defining a second blood compartment and a second dialysate compartment;

said second blood compartment having a second inlet which receives said blood/substitution fluid mixture and a second outlet which discharges blood having a second concentration of toxins, the first concentration of toxins being greater than the second concentration of toxins; and

said second dialysate compartment having a second dialysate inlet for receiving dialysate fluid and a second dialysate outlet.