Extracorporeal dialysis ready peritoneal dialysis machine

• US 8,512,553 B2
• Filed: 07/05/2007
• Issued: 08/20/2013
• Est. Priority Date: 07/05/2007
• Status: Active Grant

• Current Assignee: Baxter Healthcare SA (Baxter International Inc.), Baxter International Inc.
• Original Assignee: Baxter Healthcare SA (Baxter International Inc.), Baxter International Inc.
• Inventors: Cicchello, Gino, Bernard, Christian, Childers, Robert W., Simiele, Anthony
• Primary Examiner(s): BASS, DIRK R
• Application Number:
  US11/773,634
• Publication Number:
  US 20090008306A1
• Time in Patent Office: 2,238 Days
• Field of Search: 210/645, 210/646, 210/109, 210/143, 210/195.2, 210/741, 604/4, 604/5, 604/34
• US Class Current: 210/98
• CPC Class Codes: A61M 1/153 the cassette being adapted for heating or cooling the treating fluid, e.g. the dialysate or the treating gas
• CPC Class Codes: A61M 1/154 with sensing means or components thereof
• CPC Class Codes: A61M 1/155 with treatment-fluid pumping means or components thereof
• CPC Class Codes: A61M 1/1561 at least one cassette surface or portion thereof being flexible, e.g. the cassette having a rigid base portion with preformed channels and being covered with a foil
• CPC Class Codes: A61M 1/15625 the reservoirs acting as balance chambers
• CPC Class Codes: A61M 1/1565 Details of valves
• CPC Class Codes: A61M 1/159 specially adapted for peritoneal dialysis
• CPC Class Codes: A61M 1/16 with membranes
• CPC Class Codes: A61M 1/1601 Control or regulation
• CPC Class Codes: A61M 1/1603 Regulation parameters
• CPC Class Codes: A61M 1/1611 Weight of the patient
• CPC Class Codes: A61M 1/1639 linked by membranes
• CPC Class Codes: A61M 1/168 Sterilisation or cleaning before or after use
• CPC Class Codes: A61M 1/1682 both machine and membrane module, i.e. also the module blood side
• 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 1/1694 with recirculating dialysing liquid
• CPC Class Codes: A61M 1/1696 with dialysate regeneration
• CPC Class Codes: A61M 1/28 Peritoneal dialysis ; Other peritoneal treatment, e.g. oxygenation
• CPC Class Codes: A61M 1/282 : Operational modes
• CPC Class Codes: A61M 1/284 : Continuous flow peritoneal dialysis [CFPD]
• CPC Class Codes: A61M 1/288 : Priming priming in extracorporeal blood circuits A61M1/3643
• CPC Class Codes: A61M 1/30 : Single needle dialysis ; Reciprocating systems, alternately withdrawing blood from and returning it to the patient, e.g. single-lumen-needle dialysis or single needle systems for hemofiltration or pheresis
• CPC Class Codes: A61M 1/34 : Filtering material out of the blood by passing it through a membrane, i.e. hemofiltration or diafiltration
• CPC Class Codes: A61M 1/3417 : using distinct filters for dialysis and ultra-filtration
• CPC Class Codes: A61M 1/3427 : back through the membrane, e.g. by inverted trans-membrane pressure [TMP]
• CPC Class Codes: A61M 1/3431 : upstream of the filter
• CPC Class Codes: A61M 1/3437 : downstream of the filter, e.g. post-dilution with filtrate
• CPC Class Codes: A61M 1/3444 : in which the collected ultra-filtrate expels an equal volume of substitution fluid from a reservoir
• CPC Class Codes: A61M 1/36224 : with sensing means or components thereof
• CPC Class Codes: A61M 1/36225 : with blood pumping means or components thereof
• CPC Class Codes: A61M 1/362262 : Details of incorporated reservoirs
• CPC Class Codes: A61M 1/362265 : Details of valves
• CPC Class Codes: A61M 2205/12 : with interchangeable cassettes forming partially or totally the fluid circuit
• CPC Class Codes: A61M 2205/128 : with incorporated valves
• CPC Class Codes: A61M 2205/3331 : Pressure; Flow
• CPC Class Codes: A61M 2205/3344 : Measuring or controlling pressure at the body treatment site
• CPC Class Codes: A61M 2205/3368 : Temperature
• CPC Class Codes: A61M 2205/3379 : Masses, volumes, levels of fluids in reservoirs, flow rates
• CPC Class Codes: A61M 2205/50 : with microprocessors or computers
• CPC Class Codes: A61M 2205/502 : User interfaces, e.g. screens or keyboards
• CPC Class Codes: A61M 2210/1017 : Peritoneal cavity
• CPC Class Codes: A61M 60/279 : Peristaltic pumps, e.g. roller pumps
• CPC Class Codes: G16H 20/40 : relating to mechanical, radiation or invasive therapies, e.g. surgery, laser therapy, dialysis or acupuncture

Abstract

A dialysis system includes: (i) a dialysate pump; (ii) a patient line having a connector configured to be attached to a peritoneal patient part; (iii) an extracorporeal circuit; (iv) a blood pump in fluid communication with the extracorporeal circuit; (v) a blood filter in fluid communication with the extracorporeal circuit; and (vi) a control unit configured and arranged to selectively perform a therapy which (a) the blood pump is deactivated and the dialysate pump is caused to pump dialysate through the patient line or (b) the blood pump is activated to pump blood to the blood filter and the dialysate pump is caused to pump dialysate to the filter/extracorporeal circuit and/or remove fluid from the filter.

Claims

1. A dialysis system comprising:

a first membrane dialysate pump;

a second membrane dialysate pump;

a patient connector configured to be attached to a peritoneal patient port;

an extracorporeal circuit;

a blood pump in fluid communication with the extracorporeal circuit;

a blood filter in fluid communication with the extracorporeal circuit;

a control unit;

a memory device that stores a plurality of instructions which, when executed by the control unit, cause the control unit to selectively perform a therapy in which (i) at least one of the first and second membrane dialysate pumps is caused to pump dialysate to or from the patient connector to perform a peritoneal dialysis therapy or (ii) the blood pump is caused to pump blood to the blood filter and the dialysate pumps are caused to pump dialysate to the blood filter/extracorporeal circuit and remove used dialysate from the filter to perform a blood treatment therapy; and

a user interface operable with the control unit and the memory, the user interface including at least one of;

(i) an input device configured to enable a patient to select to perform the peritoneal dialysis therapy or the blood treatment therapy, or (ii) a message displayed to inform the patient which of the peritoneal dialysis therapy or the blood treatment therapy is to be performed.

2. The dialysate system of claim 1, wherein (i) the selected blood treatment therapy is hemodialysis and the filter is a hemodialyzer;

(ii) the selected blood treatment therapy is hemofiltration and the filter is a hemofilter;

or (iii) the selected blood treatment therapy is hemodiafiltration and the filter is a hemodialyzer.

3. The dialysis system of claim 1, wherein the control unit is further operable with the user interface to display a message concerning at least one set-up procedure for the therapy being performed.

4. The dialysis system of claim 1, wherein the first and second membrane dialysate pumps are activated pneumatically, mechanically or hydraulically.

5. The dialysate system of claim 1, wherein the blood pump is deactivated and the first and second dialysate pumps are caused at different times, by the control unit according to the instructions, to pump dialysate through the patient connector to or from the patient to perform the peritoneal dialysis therapy.

6. The dialysis system of claim 1, which includes a patient line having the patient connector configured to be attached to the peritoneal patient port.

7. The dialysis system of claim 1, wherein the memory device stores a plurality of additional instructions which, when executed by the control unit, cause the blood pump to push blood into a patient through an arterial line by pumping fluid from a blood cassette through the arterial line, and to push blood into a patient through a venous line by pumping fluid from the blood cassette through the venous line when the blood pump is activated.

8. The dialysis system of claim 1, which includes a third dialysate pump and the memory device stores a plurality of additional instructions which, when executed by the control unit, cause the third dialysate pump to pump from the filter.

9. The dialysis system of claim 1, wherein at least one of (i) the first dialysate pump is configured to pump fresh dialysate to a first compartment of at least one balance chamber or (ii) the second dialysate pump is configured to pump spent dialysate to a second compartment of the at least one balance chamber.

10. The dialysis system of claim 1, wherein the extracorporeal circuit, blood pump and blood filter are provided with a blood unit that is added optionally to a dialysate unit including the dialysate pumps and the control unit.

11. The dialysis system of claim 1, which includes a fluid volume delivery control mechanism selected from the group consisting of:

(i) a weigh scale;

(ii) one configured to use an equation based on the ideal gas law;

(iii) at least one balancing chamber; and

(iv) a membrane pump.

12. The dialysis system of claim 1, which is configured to place the dialysate pumps in fluid communication with at least one supply bag and to pump one of a plurality of fluids from the supply bag, including peritoneal dialysis dialysate, hemodialysis dialysate and hemofiltration substitution fluid.

13. The dialysis system of claim 1, wherein the memory device stores a plurality of additional instructions which, when executed by the control unit, cause the system to reuse dialysate that has been removed from the filter during the blood treatment therapy.

14. The dialysis system of claim 1, which includes at least one supply container and at least one empty container at the beginning of therapy.

15. The dialysis system of claim 1, wherein the memory device stores a plurality of additional instructions which, when executed by the control unit, cause the dialysate pumps to push fluid into the filter in a first portion of the blood treatment therapy and to pull fluid from the filter in a second portion of the blood treatment therapy.

16. The dialysis system of claim 15, wherein the memory device stores a plurality of additional instructions which, when executed by the control unit, cause the system to occlude a from-filter line during the first portion of the blood therapy and to occlude a to-filter line during the second portion of the therapy.

17. The dialysis system of claim 1, wherein the control unit and dialysate pumps are located within a first housing and the blood pump is located within the first housing or a second housing.

18. The dialysis system of claim 17, which includes a controller located within the second housing and configured to control the blood pump, the controller in communication with the control unit.

19. The dialysis system of claim 1, which includes at least one of a pressure sensor, air detector and line occluder configured to operate with the extracorporeal circuit.

20. A dialysis system comprising:

At least one pump actuator positioned within a cassette interface for receiving either a peritoneal dialysis cassette or an extracorporeal blood treatment cassette;

A control unit;

A memory device;

A user interface configured to operate with the control unit, the user interface configured to selectively display at least one parameter particular to a peritoneal dialysis treatment, and at least one parameter particular to an extracorporeal blood treatment; and

Wherein the memory device stores a plurality of instructions which, when executed by the control unit, cause (i) the pump actuator to operate with a peritoneal dialysis cassette during a peritoneal dialysis treatment and (ii) the pump actuator to operate with an extracorporeal blood treatment cassette during an extracorporeal blood treatment.

21. The dialysis system of claim 20, wherein the peritoneal dialysis (“

PD”

) parameter is selected from the group consisting of;

(i) PD treatment type;

(ii) volume of PD dialysate to be delivered;

(iii) PD dialysate temperature;

(iv) PD dialysate pressure;

(v) fill time;

(vi) dwell time;

(vii) drain time;

(viii) number of cycles to be performed; and

(ix) PD dialysate type.

22. The dialysis system of claim 20, wherein the extracorporeal blood treatment parameter is selected from the group consisting of:

(i) extracorporeal blood treatment type;

(ii) dialysate temperature;

(iii) dialysate pressure;

(iv) dialysate type;

(v) blood temperature alarm limit;

(vi) blood pressure alarm limit;

(vii) transmembrane pressure alarm limit;

(viii) dialysate conductivity alarm limit; and

(ix) blood pump speed.

23. The dialysis system of claim 20, wherein the control unit includes at least one of:

(i) random access memory;

(ii) read only memory;

(iii) a processor;

(iv) an application specific integrated circuit; and

(v) a printed circuit board.

24. The dialysis system of claim 20, wherein the user interface includes at least one of:

(i) a membrane switch; and

(ii) a touch screen overlay; and

(iii) a choice between the peritoneal dialysis treatment and the extracorporeal blood treatment which is determined manually or automatically.

25. The dialysis system of claim 20, wherein the extracorporeal blood treatment is of a type selected from the group consisting of:

hemodialysis, hemofiltration and hemodiafiltration.

26. The dialysis system of claim 20, wherein the pump actuator is a dialysate pump actuator that pumps dialysate for both the peritoneal dialysis treatment and the extracorporeal blood treatment, and which further includes a blood pump for pumping blood during the extracorporeal blood treatment.

27. A dialysis system comprising:

A dialysate cycler configured to perform a peritoneal dialysis therapy;

A blood pumping unit;

A control unit; and

A memory device that stores a plurality of instructions which, when executed by the control unit, cause the blood pumping unit to operate optionally with the dialysate cycler such that the cycler and blood pumping unit collectively perform a blood treatment therapy.

28. The dialysis system of claim 27, which includes at least one of:

(i) a data link between the cycler and the blood pumping unit;

(ii) an electrical connection between the cycler and the blood pumping unit;

(iii) a single power supply for the cycler and blood pumping unit;

(iv) separate power supplies for the cycler and blood pumping unit;

(v) a single user interface for the cycler and the blood pumping unit; and

(vi) a single data logging interface for the cycler and blood pumping unit.

29. A dialysis system comprising:

a dialysate supply;

a blood pump;

a dialysate pump;

a dialyzer;

a control unit; and

a memory device that stores a plurality of instructions which, when executed by the control unit, (i) cause the blood pump to pump blood through a blood portion of the dialyzer and the dialysate pump to pump from the dialysate supply through a dialysate portion of the dialyzer and (ii) perform hemodialysis the first time the dialysate is pumped from the dialysate supply through the dialyzer and hemofiltration the second time the dialysate is pumped from the dialysate supply through the dialyzer.

30. The dialysis system of claim 29, wherein during hemofiltration the dialysate is pumped through the dialyzer using a push-pull method.

31. The dialysis system of claim 29, wherein the memory device stores a plurality of additional instructions which, when executed by the control unit, cause the dialysate pump to perform peritoneal dialysis in a subsequent treatment.

32. The dialysis system of claim 29, wherein the dialysate supply is a fixed volume supply, and wherein the plurality of instructions which, when executed by the control unit, perform hemodialysis the first time the fixed volume of dialysate is pumped through the dialyzer and hemofiltration the second time the fixed volume of dialysate is pumped through the dialyzer.