Ionic enhanced dialysis/diafiltration system

• US 20050098500A1
• Filed: 09/24/2004
• Published: 05/12/2005
• Est. Priority Date: 01/11/2000
• Status: Active Grant

• Current Assignee: Nephros, Inc.
• Original Assignee: Nephros, Inc.
• Inventors: Summerton, James, Collins, Gregory R., Spence, Edward
• Granted Patent: US 7,067,060 B2
• Time in Patent Office: Days
• US Class Current: 210/645
• CPC Class Codes: A61M 1/1656 Apparatus for preparing dialysates
• CPC Class Codes: A61M 1/1666 by dissolving solids
• CPC Class Codes: A61M 1/1668 Details of containers
• CPC Class Codes: A61M 1/1676 containing proteins, e.g. albumin
• CPC Class Codes: A61M 1/3413 Diafiltration
• CPC Class Codes: A61M 1/3417 using distinct filters for dialysis and ultra-filtration
• 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 1/3458 having electrolytes not present in the dialysate
• CPC Class Codes: A61M 1/3462 Circuits for the preparation thereof
• CPC Class Codes: A61M 1/3465 using dialysate as substitution fluid
• CPC Class Codes: A61M 1/3472 with treatment of the filtrate
• CPC Class Codes: B01D 61/146 comprising multiple ultrafiltration steps
• CPC Class Codes: B01D 61/243 Dialysis
• CPC Class Codes: B01D 61/244 comprising multiple dialysis steps

Abstract

A dual-stage system and methods for using the same include first and second filtration cartridges is provided and is particularly suited for hemodiafiltration and/or hemodialysis. As fluid enters the first filtration cartridge, the hydroxyl ion concentration and hence pH is increased by exposing it to either a strong base or a salt of a weak acid across a filter membrane. This stage allows for improved removal of certain toxins in the fluid, such as protein-bound substances that disassociate more readily from proteins at higher pH. As the filtered fluid enters the second filtration cartridge, the pH of the fluid is restored to normal levels prior to infusion to a patient.

Claims

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

a source of a first dialysate fluid having a first pH and a source of a second dialysate fluid having a second pH;

a first dialyzer including;

a first semi-permeable membrane partitioning said first dialyzer into;

a first blood compartment having a first blood inlet which receives blood to be cleaned and a first blood outlet which expels partially diafiltered blood; and

a first dialysate compartment having a first dialysate inlet connected to said source of the first dialysate fluid and a first dialysate outlet, said first dialysate inlet for accepting said first dialysate fluid having a first pH;

a chamber for mixing said partially diafiltered blood with substitution fluid from said source to obtain a blood/substitution fluid mixture; and

a second dialyzer including;

a second semi-permeable membrane partitioning said second dialyzer into;

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

a second dialysate compartment having a second dialysate inlet connected to said source of the second dialysate fluid and a second dialysate outlet, said second dialysate inlet for accepting a second dialysate fluid having a second pH, said first pH of said first dialysate fluid being greater than said second pH of said second dialysate fluid.

2. A device according to claim 1, wherein said first pH of said first dialysate fluid is greater than a pH of said blood in said first blood compartment, said second pH of said second dialysate fluid being less than a pH of said blood/substitution fluid mixture.

3. A device according to claim 1, further comprising:

a source of second dialysate fluid, said first dialysate fluid comprising a portion of said second dialysate fluid from said source which is treated with a pH modifying agent which increases the pH of said second dialysate to form said first dialysate fluid.

4. A device according to claim 3, wherein said pH modifying agent is a one of a strong base and a salt of a weak acid.

5. A device according to claim 3, wherein said pH modifying agent is selected from the group consisting of sodium hydroxide, sodium acetate, sodium citrate, and sodium bicarbonate.

6. A device according to claim 3, wherein said first dialysate fluid is formed by diverting said portion of said second dialysate fluid to a container holding said pH modifying agent, whereby the pH of said second dialysate fluid is increased due to contact with said pH modifying agent to form said first dialysate fluid.

7. A device according to claim 1, further comprising:

a mixing chamber for receiving a base solution comprising a portion of said second dialysate fluid treated with a strong base or a salt of a weak acid, said mixing chamber receiving said second dialysate fluid from said second dialysate outlet so that said base solution and said second dialysate fluid are mixed to form said first dialysate fluid.

8. A device according to claim 1, wherein said first dialysate outlet is connected to a drain so that said first dialysate fluid flows through said first dialysate outlet to said drain after flowing through said first dialysate compartment.

9. A device according to claim 1, wherein said second pH is less than about 7.8.

10. A device according to claim 1, wherein said first pH is greater than about 7.8.

11. A device according to claim 1, wherein said first pH is greater than about 7.8 but less than about 11.

12. A device according to claim 1, wherein a pH of said blood in said second dialyzer is less than a pH of said blood/substitution fluid mixture due to said blood in said second dialyzer being in diffusion communication with said second dialysate.

13. A blood cleansing system comprising:

a source of a first dialysate fluid having a first pH and a source of a second dialysate fluid having a second pH;

a first dialyzer including;

a first semi-permeable membrane partitioning said first dialyzer into;

a first blood compartment having a first blood inlet which receives blood to be cleaned and a first blood outlet which expels partially cleansed blood; and

a first dialysate compartment having a first dialysate inlet connected to said source of the first dialysate fluid and a first dialysate outlet, said first dialysate inlet for accepting a first dialysate fluid having a first pH; and

a second dialyzer including;

a second semi-permeable membrane partitioning said second dialyzer into;

a second blood compartment having a second blood inlet which receives said partially cleansed blood and a second blood outlet which expels cleaned blood; and

a second dialysate compartment having a second dialysate inlet connected to said source of the second dialysate fluid and a second dialysate outlet, said second dialysate inlet for accepting a second dialysate fluid having a second pH, said first pH of said first dialysate fluid being greater than said second pH of said second dialysate fluid.

14. A system according to claim 13, further comprising:

a source of substitution fluid, said substitution fluid being mixed with said partially cleansed blood to form a blood/substitution fluid mixture which is delivered to said second blood inlet, said second pH being less than a pH of said blood/substitution fluid mixture and said first pH being greater than a pH of said blood in said first dialyzer.

15. A system according to claim 14, wherein said blood undergoes diafiltration in said first dialyzer and said blood/substitution fluid mixture undergoes diafiltration in said second dialyzer.

16. A system according to claim 14, wherein said second dialysate fluid flows from said second dialysate outlet to a chamber where said pH of said second dialysate fluid is increased from said second pH to said first pH to form said first dialysate fluid, said first dialysate fluid being delivered to said first dialysate inlet.

17. A method of cleansing blood comprising:

supplying a blood inflow;

dialyzing said blood inflow in a first dialyzer to provide partially dialyzed blood, said first dialyzer receiving a first dialysate fluid having a first pH; and

dialyzing said partially dialyzed blood in a second dialyzer, said second dialyzer receiving a second dialysate having a second pH, said first pH being greater than said second pH.

18. A method according to claim 17, wherein said first pH is greater than a pH of said blood inflow and said second pH is less than a pH of said partially dialyzed blood.

19. A method according to claim 17, wherein a pH of said blood inflow is substantially equal to a pH of cleaned blood exiting said second dialyzer.

20. A method of hemodiafiltration comprising:

supplying a blood inflow;

diafiltering said blood inflow in a first dialyzer to provide partially diafiltered blood, said first dialyzer receiving a first dialysate fluid having a first pH;

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

diafiltering said blood/substitution fluid mixture in a second dialyzer, said second dialyzer receiving a second dialysate having a second pH, said first pH being greater than said second pH.

21. A method according to claim 20, wherein said diafiltering said blood inflow comprises diffusing a portion of said blood inflow by a first countercurrent flow of said first dialysate fluid in diffusion communication with said blood inflow, and wherein said diafiltering of said blood/substitution fluid mixture comprises diffusing a portion of said blood/substitution fluid mixture by a second countercurrent flow of said second dialysate fluid in diffusion communication with said blood/substitution fluid mixture.

22. A method according to claim 20, wherein said first dialysate fluid is formed by contacting a portion of said second dialysate fluid with a pH modifying agent so that said pH of said second dialysate fluid is increased.

23. A method according to claim 20, wherein said first pH is greater than about 7.8.

24. A method according to claim 20, wherein said second pH is less than about 7.8.

25. A method according to claim 20, wherein said first dialysate fluid is formed by:

diverting a portion of said second dialysate fluid to a container;

disposing a concentrated base within said container so that said pH of said second dialysate fluid is increased as said second dialysate fluid contacts said concentrated base to form a basic dialysate solution; and

selectively mixing a predetermined amount of said basic dialysate solution with said second dialysate fluid to form said first dialysate fluid.

26. A method according to claim 25, further comprising:

providing a mixing chamber in fluid communication with said container for receiving said basic dialysate solution and said second dialysate fluid, said second dialysate fluid being delivered to said mixing chamber after flowing through said second dialyzer.

27. A method according to claim 20, wherein said substitution fluid has a pH substantially equal to said second pH.