Dialysate conductivity adjustment in a batch dialysate preparation system

• US 5,932,110 A
• Filed: 12/09/1996
• Issued: 08/03/1999
• Est. Priority Date: 02/13/1995
• Status: Expired due to Term

• Current Assignee: Baxter Healthcare SA (Baxter International Inc.), Baxter International Inc.
• Original Assignee: Aksys Ltd.
• Inventors: Shah, Dilip H., Feldsien, Thomas M.
• Primary Examiner(s): KIM, SUN U
• Application Number:
  US08/762,072
• Time in Patent Office: 967 Days
• Field of Search: 210/85, 210/97, 210/117, 210/143, 210/252, 210/258, 210/257.1, 210/257.2, 210/321.71, 210/321.72, 210/321.75, 210/321.84, 210/321.65, 210/645 , 210/646, 210/647, 210/739, 210/746
• US Class Current: 210/739
• CPC Class Codes: A61L 2/04 Heat A61L2/08 takes precedence
• CPC Class Codes: A61L 2/18 Liquid substances or solutions comprising solids or dissolved gases
• CPC Class Codes: A61M 1/16 with membranes
• CPC Class Codes: A61M 1/1601 Control or regulation
• 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 1/1649 with pulsatile dialysis fluid flow
• CPC Class Codes: A61M 1/165 with a dialyser bypass on the dialysis fluid line
• CPC Class Codes: A61M 1/1656 Apparatus for preparing dialysates
• CPC Class Codes: A61M 1/1658 Degasification
• CPC Class Codes: A61M 1/166 Heating for sterilisation A61M1/1686
• CPC Class Codes: A61M 1/1662 with heat exchange between fresh and used dialysate
• CPC Class Codes: A61M 1/1666 by dissolving solids
• CPC Class Codes: A61M 1/1668 Details of containers
• CPC Class Codes: A61M 1/1672 using membrane filters, e.g. for sterilising the dialysate
• CPC Class Codes: A61M 1/1682 both machine and membrane module, i.e. also the module blood side
• CPC Class Codes: A61M 1/1684 Checking the module characteristics before reuse
• CPC Class Codes: A61M 1/1686 by heat
• CPC Class Codes: A61M 1/1688 with recirculation of the sterilising fluid
• CPC Class Codes: A61M 1/169 using chemical substances
• CPC Class Codes: A61M 1/1692 : Detection of blood traces in dialysate
• CPC Class Codes: A61M 1/1694 : with recirculating dialysing liquid
• CPC Class Codes: A61M 1/28 : Peritoneal dialysis ; Other peritoneal treatment, e.g. oxygenation
• 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 1/3462 : Circuits for the preparation thereof
• CPC Class Codes: A61M 1/3465 : using dialysate as substitution fluid
• CPC Class Codes: A61M 1/3626 : Gas bubble detectors
• CPC Class Codes: A61M 1/3627 : Degassing devices; Buffer reservoirs; Drip chambers; Blood filters
• CPC Class Codes: A61M 1/3629 : degassing by changing pump speed, e.g. during priming
• CPC Class Codes: A61M 1/3639 : Blood pressure control, pressure transducers specially adapted therefor
• CPC Class Codes: A61M 1/3641 : Pressure isolators
• CPC Class Codes: A61M 1/3643 : Priming, rinsing before or after use
• CPC Class Codes: A61M 1/3644 : Mode of operation
• CPC Class Codes: A61M 1/3646 : Expelling the residual body fluid after use, e.g. back to the body
• CPC Class Codes: A61M 1/3647 : with recirculation of the priming solution
• CPC Class Codes: A61M 1/3649 : using dialysate as priming or rinsing liquid
• CPC Class Codes: A61M 1/365 : through membranes, e.g. by inverted trans-membrane pressure [TMP]
• CPC Class Codes: A61M 2205/12 : with interchangeable cassettes forming partially or totally the fluid circuit
• CPC Class Codes: A61M 2205/15 : Detection of leaks
• CPC Class Codes: A61M 2205/17 : with redundant control systems
• 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 2205/3382 : Upper level detectors
• CPC Class Codes: A61M 2205/3386 : Low level detectors
• CPC Class Codes: A61M 2205/505 : Touch-screens; Virtual keyboard or keypads; Virtual buttons; Soft keys; Mouse touches
• CPC Class Codes: A61M 2205/6072 : Bar codes
• CPC Class Codes: A61M 2205/705 : Testing of filters for leaks
• CPC Class Codes: A61M 2205/707 : Testing of filters for clogging
• CPC Class Codes: A61M 2205/7554 : with means for unclogging or regenerating filters
• CPC Class Codes: A61M 2205/7581 : with means for switching over to a fresh filter on clogging or saturation
• CPC Class Codes: A61M 2206/11 : Laminar flow
• CPC Class Codes: A61M 39/16 : having provision for disinfection or sterilisation A61M39/143 takes precedence; methods or apparatus for disinfection or sterilisation A61L2/00
• CPC Class Codes: B01D 2311/04 : Specific process operations in the feed stream; Feed pretreatment
• CPC Class Codes: B01D 2311/10 : Temperature control
• CPC Class Codes: B01D 2321/08 : Use of hot water or water vapor
• CPC Class Codes: B01D 61/02 : Reverse osmosis; Hyperfiltration ; Nanofiltration
• CPC Class Codes: B01D 61/025 : Reverse osmosis; Hyperfiltration
• CPC Class Codes: B01D 61/04 : Feed pretreatment
• CPC Class Codes: B01D 61/12 : Controlling or regulating
• CPC Class Codes: B01D 65/022 : Membrane sterilisation
• CPC Class Codes: B01D 65/102 : Detection of leaks in membranes
• CPC Class Codes: C02F 1/441 : by reverse osmosis
• CPC Class Codes: F16K 17/0453 : the member being a diaphragm

Abstract

A method of adjusting the final conductivity of a batch of dialysate to bring the conductivity down to a desired level is described. The batch of dialysate is prepared by mixing excess quantities (e.g., 5%) of dialysate solution chemicals with water to form a solution with a conductivity greater than that required for the particular batch. A measurement of the dialysate solution is taken. A precise volume of water is added to the dialysate solution to dilute the dialysate to the proper level. The precise volume of water is calculated from a known or estimated total system, the desired conductivity level and the actual conductivity. The resulting diluted dialysate is at the desired conductivity level. Excess dialysate which may be present in the dialysate circuit or associated tanks is then flushed to a drain. In a hemodialysis embodiment, the excess dialysate may be flushed through the dialyzer into the blood lines to rinse any pyrogens from the extracorporeal circuit.

Claims

1. A method of adjusting the conductivity of a batch of dialysate in a dialysis machine, said machine having a substantially noncompliant, closed volume dialysate solution flow path comprising a dialysate solution tank for storing said batch of dialysate and a dialysate circuit conducting said dialysate from said dialysate solution tank to a dialyzer, said dialysate solution flow path having a predetermined estimated volume, comprising the steps of:

opening one or more batch chemical vessels containing concentrated dialysate solution chemicals and introducing substantially the entire contents of said concentrated dialysate solution chemicals to said tank, said entire contents of said concentrated dialysate solution chemicals in said batch chemical vessels intentionally overfilled in excess of the amount required to prepare a batch of dialysate at a predetermined desired conductivity level, said predetermined desired conductivity level associated with a dialysis prescription for a patient being dialyzed by said machine;

thereafter mixing said dialysate solution chemicals with water to form a dialysate solution;

measuring the conductivity of said dialysate solution;

calculating, from said measured conductivity, predetermined estimated volume and predetermined desired conductivity level, a volume of water needed to be added to said dialysate solution to dilute said dialysate solution to at least approximate said predetermined desired conductivity level;

introducing said volume of water into said dialysate solution flow path;

mixing said volume of water with said dialysate solution to thereby dilute said dialysate solution and lower the conductivity of said dialysate solution to said predetermined desired conductivity level, and subsequently

draining a quantity of said dialysate solution from said dialysate solution flow path.

2. The method of claim 1, wherein said dialyzer is connected to an arterial line and a venous line, and wherein said step of draining comprises the step of flushing dialysate solution through said dialyzer into said arterial and venous lines connected to said dialyzer and out of said arterial and venous lines into a drain, said step of draining performed prior to a conducting a dialysis session using said dialysate solution.

3. The method of claim 1, wherein said dialysis machine further comprises an extracorporeal circuit having an arterial line and a venous line connected to said dialyzer, and wherein said step of draining comprises the steps of:

pumping said quantity of dialysate solution into said arterial line;

circulating said quantity of dialysate solution through the arterial line and a blood side of said dialyzer and through said venous line; and

directing said dialysate solution from said venous line to a drain;

said steps of pumping, circulating and directing performed prior to conducting a dialysis session using said dialysate solution.

4. A method of adjusting the conductivity of a batch of dialysate in a dialysis machine, said machine having a dialysate solution flow path comprising a dialysate solution tank and a dialysate circuit conducting said dialysate from said dialysate solution tank to a dialyzer, said dialysate solution flow path having a predetermined estimated volume, comprising the steps of:

introducing concentrated dialysate solution chemicals to said tank in excess of the amount required to prepare a batch of dialysate at a predetermined desired conductivity level, said predetermined desired conductivity level associated with a dialysis prescription for a patient being dialyzed by said machine;

mixing said dialysate solution chemicals with water to form a dialysate solution;

measuring the conductivity of said dialysate solution;

calculating, from said measured conductivity, predetermined estimated volume and predetermined desired conductivity level, a volume of water needed to be added to said dialysate solution to dilute said dialysate solution to at least approximate said predetermined desired conductivity level;

introducing said volume of water into said dialysate solution flow path; and

mixing said volume of water with said dialysate solution to thereby dilute said dialysate solution and lower the conductivity of said dialysate solution to said predetermined desired conductivity level;

wherein said dialysis machine further comprises an ultrafiltration tank in fluid communication with said dialysate solution flow path, and wherein said step of introducing said volume of water into said dialysate solution in accordance with said calculation comprises the step of supplying said volume of water to said ultrafiltration tank and directing said dialysate solution through said ultrafiltration tank.

5. Apparatus for adjusting the conductivity of a batch of dialysate, comprising:

a dialysis machine, said machine having a dialysate solution flow path comprising a dialysate solution tank and a dialysate circuit conducting said dialysate solution from said dialysate solution tank to a dialyzer, said dialysate solution flow path having a predetermined estimated volume, said dialysate solution made from a mixture of water with concentrated dialysate solution chemicals in a quantity in excess of the amount required to generate a batch of dialysate to a predetermined desired conductivity level for said predetermined estimated volume, said predetermined desired conductivity level associated with a dialysis prescription for a patient being dialyzed by said dialysis machine, said dialysis machine further comprising;

a conductivity sensor in said dialysate solution flow path measuring the conductivity of said dialysate solution;

a control system calculating from said measured conductivity, predetermined estimated volume and a predetermined desired conductivity level for said dialysate solution a volume of water needed to be added to said dialysate solution flow path to dilute said dialysate solution to at least approximate said predetermined desired conductivity level;

a water preparation circuit in fluid communication with said dialysate solution flow path, responsive to said control system, for introducing said volume of water into said dialysate solution flow path in accordance with said calculation,

wherein said dialysate solution flow path further comprises a pump operative to mix said volume of water with said dialysate solution to thereby lower the conductivity of said dialysate solution to said predetermined conductivity level;

wherein said dialysis machine further comprises an ultrafiltration tank in fluid communication with said dialysate solution flow path, and wherein said volume of water is directed into said ultrafiltration tank and thereafter mixed with said dialysate solution.