IP Library Granted Patent US 9,254,356
Granted Patent B2
US 9,254,356 · App. 14/269,602 · Granted Feb 9, 2016

Dialysis system for preparing a citrate dialysate from a base concentrate and an acid concentrate

Inventors: Dilip H. Shah (Buffalo Grove, IL); Todd Ing (Wilmette, IL)
Assignees: Baxter International Inc.; Baxter Healthcare SA
A61M1/1654A61K31/19A61K33/00A61K33/14A61K45/06A61M1/1656A61M5/16827A61K2300/00Y10T137/2499
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Quick Facts
Patent No.
US 9,254,356
App. No.
14/269,602
Granted
Feb 9, 2016
Kind
B2
Abstract

The present invention constitutes dialysate formulations that are suitable for use in preparing dialysate solutions for use in batch and/or proportioning systems and for improving dialysis efficiency by reducing or preventing clotting of the dialysis flow paths. The dialysate chemical formulations for one batch of dialysate comprise an acid concentrate stored in a first vessel, and a citrate-containing bicarbonate concentrate stored in a second vessel. The contents of the first and second vessels are emptied into a dialysate preparation tank and mixed with water to form a batch quantity of dialysate solution. Alternately, a dry acid and/or a dry citrate-containing base concentrates are dissolved separately in measured quantities of water to form liquid concentrates which are then used in conjunction with a proportioning machine to generate on-line a final dialysis solution stream.

Claims (26)

1. A dialysis system for preparing a citrate dialysate from a base concentrate and an acid concentrate, said system comprising:

a conductivity sensor for measuring conductivity of a solution;

a dialyzer having a dialysate side and a blood side;

a dialysate preparation tank for holding a base concentrate, an acid concentrate, and a pre-determined amount of water to produce a batch quantity of citrate dialysate from the base concentrate and the acid concentrate;

a pump to circulate the citrate dialysate from the dialysate preparation tank to the dialysate side of the dialyzer; and

a controller which controls the pump to circulate the dialysate to the dialysate side of the dialyzer based on measurement of the conductivity of the dialysate by the conductivity sensor,

wherein said base concentrate comprises a citrate, bicarbonate and a salt, wherein a sodium contribution of the base concentrate to the dialysate ranges from 100 to 150 mEq/L;

wherein said acid concentrate comprises an acid selected from the group consisting of acetic acid, citric acid and lactic acid, wherein (i) a sodium contribution of the acid concentrate to the dialysate ranges from 10 to 20 mEq/L, (ii) the combination of the sodium contributions of the base concentrate and the acid concentrate to the dialysate ranges from 125 to 150 mEq/L; and

wherein the system circulates said dialysate to said dialysate side of said dialyzer if conductivity of said dialysate ranges from between about 12.5 and about 15.7 mS/cm and does not circulate the dialysate if said conductivity falls outside of said conductivity range.

2. The system of claim 1 , wherein said citrate is selected from the group consisting of citric acid, a salt of citric anion, and a partial ester of citric anion.

3. The system of claim 1 , wherein said citrate is trisodium citrate, disodium hydrogen citrate or monosodium dihydrogen citrate.

4. The system of claim 3 , wherein the base concentrate is in a first vessel and the acid concentrate is in a second vessel, the first and second vessels containing an amount of said base and acid concentrates for preparation of a dialysate for treatment of a single patient.

5. The system of claim 1 , wherein said acid in said acid concentrate is acetic acid.

6. The system of claim 1 , wherein said salt is selected from the group consisting of sodium chloride, potassium chloride, calcium chloride and magnesium chloride.

7. The system of claim 1 , wherein said citrate is provided in a quantity to provide a concentration from about 1 to about 8 mEq/L in said dialysate.

8. The system of claim 1 , wherein said bicarbonate is provided in a quantity to provide a concentration from about 15 to about 50 mEq/L in said dialysate.

9. The system of claim 1 , wherein said salt is provided in a quantity to provide a concentration from about 1.5 to about 150 mEq/L in said dialysate.

10. The system of claim 1 , wherein said acid in said acid concentrate being provided in a quantity sufficient to provide a concentration from about 1 to about 8 mEq/L in said dialysate.

11. The system of claim 1 , wherein the base concentrate comprises: (a) sodium bicarbonate; (b) sodium citrate, wherein molar ratio of sodium bicarbonate to sodium citrate ranges from 50:1 to 15:9; and (c) sodium chloride in an amount sufficient to provide final concentration in the said dialysate of sodium in the range of 125 to 150 mEq/L when the base concentrate and acid concentrate are mixed with water.

12. The system of claim 1 , wherein the base concentrate comprises: (a) bicarbonate in sufficient amount to provide about 36.5 mEq/L in said dialysate; (b) sodium in sufficient amount to provide about 127 mEq/L in said dialysate; (c) chloride in sufficient amount to provide about 88 mEq/L in said dialysate; and (d) citrate in sufficient amount to provide about 2.5 mEq/L in said dialysate.

13. The system of claim 1 , wherein the base concentrate comprises: (a) bicarbonate in sufficient amount to provide about 31.5 mEq/L in said dialysate; (b) sodium in sufficient amount to provide about 123 mEq/L in said dialysate; (c) chloride in sufficient amount to provide about 89 mEq/L in said dialysate; and (d) citrate in sufficient amount to provide about 2.5 mEq/L in said dialysate.

14. The system of claim 1 , wherein the base concentrate comprises: (a) bicarbonate in sufficient amount to provide about 36.5 mEq/L in said dialysate; (b) sodium in sufficient amount to provide about 123 mEq/L in said dialysate; (c) chloride in sufficient amount to provide about 84 mEq/L in said dialysate; and (d) citrate in sufficient amount to provide about 2.5 mEq/L in said dialysate.

15. The system of claim 1 , wherein the base concentrate comprises: (a) bicarbonate in sufficient amount to provide about 35 mEq/L in said dialysate; (b) sodium in sufficient amount to provide about 127 mEq/L in said dialysate; (c) chloride in sufficient amount to provide about 88 mEq/L in said dialysate; and (d) citrate in sufficient amount to provide about 4 mEq/L in said dialysate.

16. The system of claim 1 , wherein the base concentrate comprises: (a) bicarbonate in sufficient amount to provide about 30.0 mEq/L in said dialysate; (b) sodium in sufficient amount to provide about 123 mEq/L in said dialysate; (c) chloride in sufficient amount to provide about 89 mEq/L in said dialysate; and (d) citrate in sufficient amount to provide about 4 mEq/L in said dialysate.

17. The system of claim 1 , wherein the base concentrate comprises: (a) bicarbonate in sufficient amount to provide about 35 mEq/L in said dialysate; (b) sodium in sufficient amount to provide about 123 mEq/L in said dialysate; (c) chloride in sufficient amount to provide about 84 mEq/L in said dialysate; and (d) citrate in sufficient amount to provide about 4 mEq/L in said dialysate.

18. The system of claim 1 , wherein said base concentrate, said acid concentrate or both are solutions.

Assignments (5)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Sep 15, 2015
From: BAXTER HEALTHCARE SA, SINGAPORE BRANCH
To: BAXTER INTERNATIONAL INC.; BAXTER HEALTHCARE SA
Reel/Frame 036620/0856 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jul 21, 2014
From: SHAH, DILIP H.; ING, TODD
To: AKSYS LTD.
Reel/Frame 033349/0458 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jul 21, 2014
From: AKSYS LTD.
To: DURUS LIFE SCIENCES MASTER FUND, LTD., A CAYMEN ISLANDS EXEMPTED COMPANY C/O INTERNATIONAL FUND SERVICES (IRELAND), LTD.
Reel/Frame 033349/0745 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jul 21, 2014
From: DURUS LIFE SCIENCES MASTER FUND, LTD., A CAYMEN ISLANDS EXEMPTED COMPANY C/O INTERNATIONAL FUND SERVICES (IRELAND), LTD.
To: HHD LLC, A DELAWARE LIMITED LIABILITY COMPANY C/O PEPE & HAZARD LLC
Reel/Frame 033350/0416 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jul 21, 2014
From: HHD, LLC
To: BAXTER HEALTHCARE SA, SINGAPORE BRANCH
Reel/Frame 033350/0535 →
Continuity (6)
Continuation 13786806 · Mar 6, 2013
Continuation 13493106 · Jun 11, 2012
Continuation 13007863 · Jan 17, 2011
Continuation 12474658 · May 29, 2009
Continuation 10921677 · Aug 19, 2004
Related Publication 20140319030A1 · Oct 30, 2014