Automated dialysis system

• US 20030220598A1
• Filed: 05/24/2002
• Published: 11/27/2003
• Est. Priority Date: 05/24/2002
• Status: Active Grant

• Current Assignee: Baxter Healthcare SA (Baxter International Inc.), Baxter International Inc.
• Original Assignee: Baxter International Inc.
• Inventors: Bowman, Joseh H. Jr., Din, Shahid, Busby, Don, Lauman, Brian, Shang, Sherwin, Kienman, Rick, Richardson, Ian, Hopping, Peter, Childers, Robert, Lundtveit, Loren M., Eu, Bruce Ming-Da, Alvaro, Jose
• Granted Patent: US 7,153,286 B2
• Time in Patent Office: Days
• US Class Current: 604/5.01
• CPC Class Codes: A61M 1/1522 the interface being evacuated interfaces to enhance contact
• CPC Class Codes: A61M 1/1524 the interface providing means for actuating on functional elements of the cassette, e.g. plungers
• 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 1/155 with treatment-fluid pumping means or components thereof
• CPC Class Codes: A61M 1/156 Constructional details of the cassette, e.g. specific details on material or shape
• 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 1/1565 Details of valves
• CPC Class Codes: A61M 1/159 specially adapted for peritoneal dialysis
• CPC Class Codes: A61M 1/166 Heating for sterilisation A61M1/1686
• CPC Class Codes: A61M 1/267 used for pumping
• CPC Class Codes: A61M 1/28 Peritoneal dialysis ; Other peritoneal treatment, e.g. oxygenation
• CPC Class Codes: A61M 1/281 Instillation other than by gravity
• CPC Class Codes: A61M 1/288 Priming priming in extracorporeal blood circuits A61M1/3643
• CPC Class Codes: A61M 2205/127 with provisions for heating or cooling
• CPC Class Codes: A61M 2205/50 with microprocessors or computers
• CPC Class Codes: A61M 2205/581 by audible feedback
• CPC Class Codes: A61M 2205/583 by visual feedback

Abstract

The present invention provides automated peritoneal dialysis systems, methods of operating the systems and devices for performing same. A typical therapy performed by the present invention begins by draining dialysis solution that is already in the patient'"'"'s peritoneal cavity. The system pumps fresh dialysate from one of a plurality of supply bags, through an in-line heater to the patient'"'"'s peritoneal cavity. After a dwell period, the spent dialysate in the cavity is pumped out of the patient to a drain or other disposal means. The system then pumps fresh dialysate from the supply bags to the patient and the procedure is repeated as defined in the therapy protocol. The system can pump a last bag of dialysate to the peritoneal cavity for an extended dwell, such as a daytime dwell.

Claims

1. A dialysis system comprising:

a fluid supply line;

a disposable unit in fluid communication with the fluid supply line, the disposable unit having at least two flexible membranes secured together at selected locations and which define a fluid pump receptacle and a fluid heating pathway;

a patient line in fluid communication with the disposable unit;

a drain line in fluid communication with the disposable unit;

a pump actuator that moves the fluid pump receptacle; and

a heater that heats the fluid heating pathway.

2. The dialysis system of claim 1, wherein the disposable unit includes a valve manifold that defines a plurality valve chambers, the system including a valve actuator that sequentially presses against selected one or more of the valve chambers.

3. The dialysis system of claim 2, wherein the valve actuator includes a camshaft and a plurality of cams.

4. The dialysis system of claim 1, wherein the heater includes a heating plate.

5. The dialysis system of claim 1, wherein the heater includes an infrared heating source.

6. The dialysis system of claim 1, wherein the fluid heating pathway and the heater define an in-line heater.

7. A dialysis system comprising:

a portable hardware unit, the hardware unit including an enclosure defining an interior and including a pump shell, a valve actuator and a heater; and

a disposable unit removably positioned within the interior of the enclosure, the disposable unit having a pump portion that forms a pump chamber with the shell of the hardware unit, a valve portion that is moved by the valve actuator and a heating portion that is heated by the heater.

8. The dialysis system of claim 7, which includes a processor that coordinates operation of a pump actuator, the valve actuator and the heater.

9. The dialysis system of claim 8, wherein the processor communicates with a plurality of sensors, wherein the sensors are selected from the group consisting of:

a capacitance fluid volume sensor, a dialysis fluid temperature sensor, a pressure sensor, a vacuum sensor, an air detection sensor and a mechanical positioning sensor.

10. The dialysis system of claim 7, wherein the hardware unit includes a display device that provides dialysis system information.

11. A dialysis system comprising:

a hardware unit including a pump actuator;

a disposable unit fluidly coupled to a supply line, a drain line and a patient line, the disposable unit including a pump receptacle;

the hardware unit and the receptacle forming a pump chamber; and

a capacitance fluid volume sensor coupled to the pump chamber and capable of indicating a volume of fluid in the chamber.

12. The dialysis system of claim 11, wherein the capacitance fluid volume sensor generates a signal that is indicative of a volume of fluid in the receptacle.

13. The dialysis system of claim 11, which includes a controller operably coupled to the capacitance fluid volume sensor which can quantify an amount of fluid or an amount of air within the receptacle.

14. A disposable unit for a dialysis system comprising:

a first flexible membrane and a second flexible membrane bonded together at selected locations to form

a pump receptacle, and

a fluid heating path in fluid communication with the pump receptacle; and

a rigid member bonded to the first and second flexible membranes, the rigid member and the membranes defining at least part of a valve manifold that is in fluid communication with the pump receptacle and the fluid heating path.

15. The disposable unit of claim 14, wherein the first and second membranes are heat sealed together to form the pump receptacle and fluid heating path.

16. The disposable unit of claim 14, wherein the first and second membranes are heat sealed to the rigid member to form at least the part of the valve manifold.

17. The disposable unit of claim 14, wherein the first membrane is pressed against the rigid member to disallow fluid flow through a portion of the valve manifold.

18. The disposable unit of claim 14, wherein the valve manifold includes means for connecting to a supply line, a drain line and a patient line.

19. A disposable unit for a dialysis system comprising:

a first portion having first and second membranes bonded together and defining a pump receptacle; and

a second portion having first and second membranes distinct from the membranes of the first portion, the first and second membranes of the second portion bonded together and defining a fluid heating path, wherein the first portion fluidly communicates with the second portion.

20. The disposable unit of claim 19, wherein the first portion further comprises a valve manifold disposed between the first and second flexible membranes and in fluid communication with the pump receptacle and the fluid heating path.

21. The disposable unit of claim 19, which includes medical grade tubing that connects the first portion to the second portion.

22. A disposable unit for a dialysis system comprising:

a first flexible membrane and a second flexible membrane forming a pump receptacle, a fluid heating path and a valve manifold; and

a rigid frame attached to at least one of the first and second flexible membranes, the rigid frame providing rigidity for placement of the disposable unit into an enclosure of the dialysis system.

23. The disposable unit of claim 22, wherein the rigid frame extends around the pump receptacle, fluid heating path and valve manifold.

24. The disposable unit of claim 22, wherein the rigid frame is sized to securely fit into an enclosure for housing the disposable unit.

25. The disposable unit of claim 22, wherein the rigid frame is plastic.

26. A method of performing automated dialysis comprising the steps of:

providing a disposable unit that is placed into an enclosure so that the unit and enclosure form a pump chamber and providing a port on the disposable unit for a patient to connect a dialysis container; and

automatically pumping dialysate through the pump chamber and the port to the patient.

27. The method of claim 26, which includes providing an operator input that enables the patient to initiate automatic flow of the dialysate through the disposable unit.

28. The method of claim 26, which includes pneumatically pumping the dialysate through the pump chamber.

29. The method of claim 26, which includes pneumatically and mechanically pumping the dialysate through the pump chamber.

30. The method of claim 26, which includes automatically pumping dialysate through the pump chamber while the patient sleeps.

31. The method of claim 26, which includes automatically pumping dialysate through the pump chamber at night.

32. A method of moving fluid in a peritoneal dialysis system comprising the steps of:

maintaining a negative pressure on first and second membranes at a pump receptacle portion of the membranes;

pulling the first membrane away from the second membrane to draw dialysis fluid into the pump receptacle portion; and

pushing the first membrane towards the second membrane to dispel the dialysis fluid from the pump receptacle portion.

33. The method of claim 32, which includes sensing the position of the first membrane relative to a home position.

34. The method of claim 32, which includes positioning the first membrane based on a sensed position relative to a home position.

35. The method of claim 32, which includes providing a first motor to mechanically move the first membrane and providing a second motor to operate a valve manifold portion of the first and second membranes.

36. The method of claim 32, which includes providing a motor to operate a valve manifold portion of the first and second membranes and sensing the position of a member moved by the motor relative to a home position.

37. The method of claim 32, which includes providing a motor to operate a valve manifold portion of the first and second membranes and positioning a member moved by the motor relative to a home position.

38. The method of claim 32, which includes mechanically pulling away from the second membrane while applying the negative pressure to the first membrane.

39. The method of claim 32, which includes mechanically pushing the first membrane while applying the negative pressure to same.

40. A method of moving dialysate in a dialysis system comprising the steps of:

mechanically and pneumatically operating a fluid pump to transfer dialysate from a supply container to a patient;

allowing the dialysate to dwell inside the patient for an amount of time; and

mechanically and pneumatically operating the pump to transfer the dialysate from the patient to a drain.

41. The method of claim 40, which includes heating the dialysate while pumping the dialysate to the patient.

42. The method of claim 40, which includes purging air from the dialysate.

43. The method of claim 40, which includes sensing a volume of fluid pumped to the patient.

44. A method of performing automated dialysis comprising the steps of:

providing a dialysis unit that can be manually transported to a patient'"'"'s home and opened so that the patient can place a disposable unit therein and closed so that the dialysis unit and the disposable unit cooperatively form a pump chamber that enables dialysis fluid to be pumped to and from the patient.

45. A dialysis system comprising:

a disposable unit including first and second membranes; and

a heater including first and second portions, the disposable unit residing between the portions, and the first and second membranes expanding upon receiving dialysis fluid so that the first membrane contacts the first portion and the second membrane contacts the second portion.

46. The dialysis system of claim 45, wherein the disposable unit includes a fluid heating portion, the membranes in the fluid heating portion expanding to contact the heater portions.

47. A dialysis system comprising:

a disposable unit including a plurality of membranes, the unit having a thickness;

a heater having first and second portions spaced apart by a gap, the gap larger than the thickness when no dialysis fluid resides in the disposable unit, the dialysis fluid filling at least a portion of the membranes so that the portion of the membranes fill a portion of the gap.

48. The dialysis system of claim 47, wherein the dialysis fluid fills a fluid heating pathway provided by the membrane, the membranes and the fluid in the pathway filling the gap.