Automated dialysis system

• US 7,153,286 B2
• Filed: 05/24/2002
• Issued: 12/26/2006
• Est. Priority Date: 05/24/2002
• Status: Expired due to Term

• Current Assignee: Baxter Healthcare SA (Baxter International Inc.), Baxter International Inc.
• Original Assignee: Baxter Healthcare SA (Baxter International Inc.), Baxter International Inc.
• Inventors: Din, Shahid, Bowman, Joseph H. Jr., Busby, Don, Lauman, Brian, Shang, Sherwin, Kienman, Rick, Richardson, Ian, Hopping, Peter, Childers, Robert, Lundtveit, Loren M., Eu, Bruce Ming-Da, Alvaro, Jose
• Primary Examiner(s): Zalukaeva, Tatyana
• Assistant Examiner(s): Deak, Leslie R.
• Application Number:
  US10/155,603
• Publication Number:
  US 20030220598A1
• Time in Patent Office: 1,677 Days
• Field of Search: 210645-646, 210/252, 210/257.2, 210/600, 210/634, 210175-178, 210/258, 210/282, 604 501- 504, 604/6.09, 604/6.1, 604/6.11, 604/6.13, 604/151, 604/153, 604 28- 29, 604/131, 604/141, 422/44, 422/46, 165/168, 417/477.2, 417/437
• US Class Current: 604/6.11
• 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 portable hardware unit, the hardware unit including an enclosure defining an interior and including a pump shell, a valve actuator and a heater;

a disposable unit removably and operably positionable with respect to 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; and

a pump actuator configured to pneumatically and mechanically move the pump portion of the disposable unit with respect to the pump shell of the enclosure.

2. The dialysis system of claim 1, which includes a processor that coordinates operation of the pump actuator, the valve actuator and the heater.

3. The dialysis system of claim 2, 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.

4. The dialysis system of claim 1, wherein the hardware unit includes a display device that provides dialysis system information.

5. The dialysis system of claim 1, wherein the valve actuator includes a camshaft and a plurality of cams.

6. The dialysis system of claim 1, wherein the heater includes at least one of:

a heating plate, an infrared heating source and a configuration suitable for in-line heating.

7. The dialysis system of claim 1, wherein the disposable unit includes an at least substantially rigid member bonded to first and second flexible membranes, the member and membranes defining at least part of the valve portion of the disposable unit.

8. The dialysis system of claim 1, wherein the pump portion of the disposable unit is formed from first and second membranes, and the valve portion includes an at least semi-rigid member connected to the first second membranes.

9. The dialysis system of claim 1, wherein the heating portion of the disposable unit includes a fluid heating pathway in fluid communication with the pump portion and the valve portion.

10. The dialysis system of claim 1, wherein the hardware unit is configured to 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.

11. The dialysis system of claim 1, wherein the disposable unit is configured so that at least one of:

(i) the disposable unit in operation resides between first and second portions of the heater; and

(ii) in operation dialysis fluid within the disposable unit expands at least a portion of the unit to contact the first and second portions of the heater.

12. A dialysis system comprising:

a disposable unit removably and operably positionable with respect to a hardware unit, the disposable unit including a heating portion, a valve portion and a pump portion; and

wherein the hardware unit houses a heater operable with the heating portion of the disposable unit, a valve actuator operable with the valve portion of the disposable unit, and a pump actuator including a pump shell operable with the pump portion of the disposable unit, the pump actuator configured to pneumatically and mechanically operate with the pump portion of the disposable unit.

13. The dialysis system of claim 12, which includes a processor that coordinates operation of the pump actuator, the valve actuator and the heater.

14. The dialysis system of claim 13, 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.

15. The dialysis system of claim 12, wherein the hardware unit includes a display device that provides dialysis system information.

16. The dialysis system of claim 12, wherein the valve actuator includes a camshaft and a plurality of cams.

17. The dialysis system of claim 12, wherein the heater includes at least one of:

a heating plate, an infrared heating source and a configuration suitable for in-line heating.

18. The dialysis system of claim 12, wherein the disposable unit includes an at least substantially rigid member bonded to first and second flexible membranes, the member and membranes defining at least part of the valve portion of the disposable unit.

19. The dialysis system of claim 12, wherein the pump portion of the disposable unit is formed from first and second membranes, and the valve portion includes an at least semi-rigid member connected to the first second membranes.

20. The dialysis system of claim 12, wherein the heating portion of the disposable unit includes a fluid heating pathway in fluid communication with the pump portion and the valve portion.

21. The dialysis system of claim 12, wherein the hardware unit is configured to 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.

22. The dialysis system of claim 12, wherein the disposable unit is configured so that at least one of:

(i) the unit in operation resides between first and second portions of the heater; and

(ii) in operation dialysis fluid within the disposable unit expands at least a portion of the disposable unit to contact the first and second portions of the heater.