Withdrawal of priming fluid from extracorporeal circuit of hemodialysis machines or the like

• US 5,932,103 A
• Filed: 09/26/1997
• 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: Kenley, Rodney S., Schroeder, Christine F.
• Primary Examiner(s): KIM, SUN U
• Application Number:
  US08/938,111
• Time in Patent Office: 676 Days
• Field of Search: 210/85, 210/108, 210/134, 210/136, 210/143, 210/411, 210/252, 210/258, 210/645, 210/646, 210/647, 210/739, 210/321.69, 604/4, 604/5, 604/6
• US Class Current: 210/646
• 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 1/165 with a dialyser bypass on the dialysis fluid line
• CPC Class Codes: A61M 1/1668 Details of containers
• CPC Class Codes: A61M 1/1692 Detection of blood traces in dialysate
• CPC Class Codes: A61M 1/3427 back through the membrane, e.g. by inverted trans-membrane pressure [TMP]
• CPC Class Codes: A61M 1/3434 with pre-dilution and post-dilution
• CPC Class Codes: A61M 1/3441 Substitution rate control as a function of the ultrafiltration rate
• CPC Class Codes: A61M 1/3465 using dialysate as substitution fluid
• 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 1/3647 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 2205/17 with redundant control systems
• CPC Class Codes: A61M 2205/505 Touch-screens; Virtual keyboard or keypads; Virtual buttons; Soft keys; Mouse touches
• CPC Class Codes: B01D 2311/04 Specific process operations in the feed stream; Feed pretreatment
• CPC Class Codes: B01D 2311/2649 Filtration
• CPC Class Codes: B01D 2321/04 Backflushing
• 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: C02F 1/441 : by reverse osmosis

Abstract

A method for withdrawing priming fluid from the extracorporeal circuit of a dialysis machine is described which substantially prevents return of the priming fluid back to the patient. In accordance with the method, priming fluid is drawn from the extracorporeal circuit through the dialyzer membrane and into the dialysate circuit. Blood is introduced into the extracorporeal circuit as the priming fluid is withdrawn through the dialyzer. Withdrawal of the priming fluid may be accomplished by pumping the blood pump in the forward direction at a first rate and operating a pump in the dialysate circuit at a second rate. Valves in the dialysate circuit are operated such that the pump in the dialysate circuit draws priming fluid across the dialyzer membrane into the dialysate circuit, and thereby prevents the priming fluid from being returned to the patient. In a preferred embodiment, the fluid volumes of the arterial and venous portions of the extracorporeal circuit, and the fluid volume of the blood side of the dialyzer, are known in advance. With this information, it is possible to operate the blood and dialysate pumps such that the blood progresses into the arterial and venous lines at different rates such that blood reaches the dialyzer via both lines at about the same time, while at the same time the priming fluid is withdrawn through the dialyzer. Thus, in this embodiment, blood fills the extracorporeal circuit after priming with only a small amount of priming fluid remaining in the blood compartment of the dialyzer being returned to the patient.

Claims

1. A method of removing a priming fluid from an extracorporeal circuit of a dialysis machine, said extracorporeal circuit comprising arterial and venous lines filled with said priming fluid and a dialyzer connected to said arterial and venous lines, said dialyzer having a membrane separating said extracorporeal circuit from a dialysate circuit and a blood side in said extracorporeal circuit and a dialysate side in said dialysate circuit, the method comprising the steps of:

transporting at least a portion of said priming fluid from said extracorporeal circuit across said dialyzer membrane into said dialysate circuit; and

simultaneously introducing blood from a patient connected to said arterial and venous lines into at least one of said arterial and venous lines as said priming fluid is being transported across said dialyzer membrane,

whereby the introduction of said blood into said arterial and venous lines and withdrawal of said priming fluid from said extracorporeal circuit prevents said portion of priming fluid from being substantially returned to said patient or disposed of in a receptacle externally of the extracorporeal circuit.

2. The method of claim 1, wherein said at least a portion of said priming fluid comprises at least 50 percent of the fluid volume of said extracorporeal circuit.

4. The method of claim 1, wherein the blood from said patient is introduced into both said arterial and venous lines so as to fill said arterial and venous lines as said portion of priming fluid is transported across said dialyzer membrane.

5. The method of claim 1, wherein said extracorporeal circuit further comprises a blood pump and said dialysate circuit comprises a pump in said dialysate circuit, and wherein the method further comprises the steps of:

operating said blood pump to pump blood into the extracorporeal circuit, and

creating a pressure differential at the dialyzer membrane in combination with operating said pump in said dialysate circuit so as to draw said priming fluid across said dialyzer membrane.

6. The method of claim 1, wherein said extracorporeal circuit further comprises a blood pump and said dialysate circuit comprises a pump in said dialysate circuit, said arterial line and said venous line each have a known predetermined fluid volume, and wherein said blood side of said dialyzer has a known predetermined volume, and wherein the method further comprises the step of:

operating said blood pump and said pump in said dialysate circuit at predetermined flow rates for a predetermined amount of time based on the fluid volumes of said arterial line, venous line, and blood side of said dialyzer.

7. The method of claim 6, wherein said predetermined flow rates comprise a blood pump flow rate and a dialysate-side pump flow rate, and wherein said blood pump flow rate (BPF) and dialysate-side pump flow rates (DPF) are determined according to the relationship:

##EQU3## .

8. The method of claim 6, wherein said predetermined amount of time is selected so as to remove at least 90 percent of the priming fluid from said arterial and venous lines.

9. The method of claim 1, wherein said dialysis machine further comprises a computer control system having a memory storing a table of at least one commercially available dialyzer for installation into said extracorporeal circuit, each of said commercially available dialyzers having a blood side and a predetermined fluid volume of said blood side of said dialyzers, and wherein said computer control system operates a blood pump in said extracorporeal circuit and a pump in said dialysate circuit based on the particular commercially available dialyzer installed in said extracorporeal circuit in accordance with said table stored in said memory so as to control the withdrawal of said priming fluid across said dialyzer membrane into said dialysate circuit.

10. The method of claim 9, wherein said blood pump and said pump in said dialysate circuit are operated so as to transport at least 90 percent of said priming fluid across said dialyzer.

11. The method of claim 9, wherein said arterial line and said venous line each have a known predetermined fluid volume, and wherein said blood side of said dialyzer has a known predetermined volume, and wherein the method further comprises the step of

operating said blood pump and said pump in said dialysate circuit at predetermined flow rates for predetermined amount of time based on the fluid volumes of said arterial line, venous line, and blood side of said dialyzer.

22. The method of claim 1, wherein said method is performed in a machine for treating a patient suffering from inadequate liver function.

23. The method of claim 1, wherein said method is performed in a machine for treating a patient suffering from inadequate kidney function.

3. The method of clam 1, wherein said at least a portion of said priming fluid comprises at least 90 percent of the fluid volume of said extracorporeal circuit.

12. A dialysis machine having an extracorporeal circuit which prevents priming fluid from substantially being returned to a patient connected to said dialysis machine via arterial and venous lines, comprising:

a blood pump in said extracorporeal circuit for circulating fluid in said extracorporeal circuit;

a dialyzer separating said extracorporeal circuit from a dialysate circuit, said dialyzer having a dialyzer membrane with a blood side thereof in said extracorporeal circuit and a dialysate side in said dialysate circuit;

a pump in said dialysate circuit in fluid communication with said dialyzer;

first and second valves in said dialysate circuit positioned upstream and downstream from said dialyzer, respectively; and

a computer control system operative of said blood pump, pump in said dialysate circuit and said first and second valves, wherein when said extracorporeal circuit is filled with said priming fluid and a patient is connected to said arterial and venous lines, said computer control system operates said blood pump so as to pump blood into said extracorporeal circuit and said pump in said dialysate circuit and said first and second valves for a predetermined amount of time so as to transport said priming fluid across said dialyzer membrane into said dialysate circuit.

13. The dialysis machine of claim 12, wherein said dialysis machine further comprises an ultrafiltration tank for storing ultrafiltrate from a patient connected to said dialysis machine, and wherein a volume of fluid in said dialysate circuit commensurate with the volume of priming fluid transported across said dialyzer is transported into said ultrafiltration tank as said priming fluid is transported across said dialyzer.

14. The dialysis machine of claim 13, wherein said volume of fluid is pumped into said ultrafiltration tank by an ultrafiltration pump.

15. The dialysis machine of claim 13, wherein said arterial line and said venous line each have a known predetermined fluid volume, and wherein said blood side of said dialyzer has a known predetermined volume, and wherein said computer control system operates said blood pump and said pump in said dialysate circuit at predetermined flow rates for predetermined amount of time based on the fluid volumes of said arterial line, venous line, and blood side of said dialyzer.

16. The dialysis machine of claim 15, wherein said predetermined flow rates comprise a blood pump flow rate and a dialysate-side pump flow rate, and wherein said blood pump flow rate (BPF) and dialysate-side pump flow rates (DPF) are determined according to the relationship:

##EQU4## .

17. The dialysis machine of claim 12, wherein said predetermined amount of time is selected so as to remove at least 90 percent of the priming fluid from said arterial and venous lines.

18. The dialysis machine of claim 15, wherein said dialysis machine further comprises a computer control system having a memory storing a table of at least one commercially available dialyzer for installation into said extracorporeal circuit, each of said commercially available dialyzers having a blood side and a predetermined fluid volume of said blood side of said dialyzers, and wherein said computer control system operates said blood pump and said pump in said dialysate circuit based on the particular commercially available dialyzer installed in said extracorporeal circuit in accordance with said table stored in said memory.

19. The dialysis machine of claim 13, wherein said volume of fluid stored in said ultrafiltration tank is backflushed into said extracorporeal circuit during a dialysis session with said machine.

20. The dialysis machine of claim 13, wherein said volume of fluid stored in said ultrafiltration tank is used to adjust the transmembrane pressure of said dialyzer either before or during a dialysis session with said dialysis machine.

21. The dialysis machine of claim 12, wherein said control system is operative of said blood pump and said pump and said first and second valves in said dialysate circuit so as remove a substantial majority of priming fluid from said extracorporeal circuit, while retaining a quantity of said priming solution in said blood side of said dialyzer so as to prevent hemoconcentration of blood being returned to said patient upon the initiation of dialysis.