Method of preparation of batch of physiologic solution

• US 6,136,201 A
• Filed: 11/04/1998
• Issued: 10/24/2000
• Est. Priority Date: 12/09/1996
• Status: Expired due to Term

• Current Assignee: Baxter Healthcare SA (Baxter International Inc.), Baxter International Inc.
• Original Assignee: Aksys Ltd.
• Inventors: Maliekkal, Shincy, Shah, Dilip H., Wiebenson, Derek, Brose, Tom L.
• Primary Examiner(s): KIM, SUN U
• Application Number:
  US09/186,501
• Time in Patent Office: 720 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, 366/131, 366/136, 366/152.1, 366/159.1
• 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 blood in dialysate A61M1/1692
• 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 batch of dialysate solution is made from a mixture of bicarbonate formulation and a liquid acid formulation. The liquid acid formulation is introduced into a dialysate tank and then removed from the tank and stored elsewhere, such as in an ultrafiltration tank, where it is diluted with a few litres of water. The dialysate tank is then filled with water and the bicarbonate formulation is added to the dialysate tank. The bicarbonate formulation is mixed and dissolved by circulation in a closed loop, with the liquid acid formulation kept separate. When the bicarbonate solution has been prepared, the liquid acid solution and the bicarbonate solution are mixed together and stored in the dialysate preparation tank. An additional quantity of dilution water is introduced into the dialysate system to bring the final conductivity down to the desired range. The excess dialysate solution can be used for several purposes, such as an endotoxin flush of the blood tubing set or a dialyzer clearance test.

Claims

1. A method for preparing a batch of a dialysis solution from batch quantities of first and second chemical formulations stored in respective first and second batch quantity chemical vessels, comprising the steps of:

opening said first batch quantity vessel and placing said first chemical formulation in a solution preparation tank;

removing said first chemical formulation from said solution preparation tank;

opening said second batch quantity vessel, placing said second chemical formulation into said solution preparation tank and diluting said second chemical formulation with water, while maintaining said first chemical formulation sequestered from said second chemical formulation; and

mixing said dilute solution of said second chemical formulation with said first chemical formulation to form said dialysis solution and storing the said dialysis solution in said dialysate solution tank.

2. The method of claim 1, wherein said dialysis solution comprises a substitution fluid.

3. The method of claim 1, wherein said dialysis solution comprises a peritoneal dialysis solution.

4. The method of claim 1, wherein said dialysis solution comprises a hemodialysis solution.

5. The method of claim 1, wherein said first chemical formulation comprises a liquid acid formulation and said second chemical formulation comprises a bicarbonate formulation.

7. The method of claim 1, wherein said method is performed in a dialysis machine and wherein said first chemical formulation is removed from a dialysate solution preparation tank and stored in an ultrafiltration tank.

8. The method of claim 1, further comprising the step of diluting said dialysis solution with a predetermined amount of water to form a final physiologic solution having a desired conductivity level.

15. The method of claim 1, wherein said method is performed in a dialysis machine having an extracorporeal circuit and a dialysate flow path encompassing an ultrafiltration tank and a dialysate tank, and wherein the method further comprises the step of withdrawing a volume of said resulting physiologic solution from said dialysate flow path and introducing at least a portion of said withdrawn volume of physiologic solution into said extracorporeal circuit.

6. A method for preparing a batch of a physiologic solution for use during a surgical procedure from batch quantities of first and second chemical formulations stored in respective first and second batch quantity chemical vessels, comprising the steps of:

opening said first batch quantity vessel and placing said first chemical formulation in a solution preparation tank;

removing said first chemical formulation from said solution preparation tank;

opening said second batch quantity vessel, placing said second chemical formulation into said solution preparation tank and diluting said second chemical formulation with water, while maintaining said first chemical formulation sequestered from said second chemical formulation; and

mixing said dilute solution of said second chemical formulation with said first chemical formulation to form a physiologic solution and storing the said physiologic solution in said dialysate solution tank.

9. A method for preparation of a batch of dialysate solution from batch quantities of liquid acid and bicarbonate chemical formulations stored in respective first and second batch quantity chemical vessels, comprising the steps of:

opening said first batch quantity vessel and placing said liquid acid chemical formulation in a solution preparation tank;

maintaining said bicarbonate chemical formulation separate from said solution preparation tank;

removing said liquid acid chemical formulation from said solution preparation tank and storing said solution in an ultrafiltration tank;

diluting said liquid acid formulation with water to form a dilute acid solution in said ultrafiltration tank;

while storing said dilute acid solution in said ultrafiltration tank, opening said second batch quantity vessel, placing said bicarbonate chemical formulation into said solution preparation tank and diluting said bicarbonate chemical formulation with water to form a dilute bicarbonate solution therein; and

mixing said dilute bicarbonate and dilute acid solutions together within said dialysate preparation tank to form a physiologic solution and storing said physiologic solution in said dialysate solution tank.

10. The method of claim 9, further comprising the step of adding a predetermined volume of water to said resulting mixture to decrease the conductivity of said resulting physiologic solution.

11. The method of claim 10, wherein the method is performed on a daily basis for a patient on a daily dialysis regimen.

12. The method of claim 11, wherein said method further comprises the step of storing in memory final conductivity values of said resulting physiologic solution and using said stored final conductivity values to adjust said predetermined volume of water.

13. The method of claim 10, wherein said method is performed in a dialysis machine having a dialysate preparation module having a dialysate flow path total system volume, and wherein a predetermined volume of water is based on a measurement of said total system volume.

14. The method of claim 9, wherein said method is performed in a dialysis machine having an extracorporeal circuit and a dialysate flow path encompassing said ultrafiltration tank and said dialysate solution tank, and wherein the method further comprises the step of withdrawing a volume of said physiologic solution from said dialysate flow path and introducing at least a portion of said withdrawn volume of physiologic solution into said extracorporeal circuit.