Disposable set and system for dialysis

• US 10,363,352 B2
• Filed: 02/27/2018
• Issued: 07/30/2019
• Est. Priority Date: 07/19/2002
• Status: Expired due to Term

• Current Assignee: Baxter Healthcare SA (Baxter International Inc.), Baxter International Inc.
• Original Assignee: Baxter International Inc.
• Inventors: Childers, Robert W., Brown, David S., Wariar, Ramesh, Karoor, Sujatha, Din, Shahid, Martis, Leo, Buchmann, Cody, Soltys, Paul
• Primary Examiner(s): Eisenberg, Rebecca E
• Application Number:
  US15/905,944
• Publication Number:
  US 20180185561A1
• Time in Patent Office: 518 Days
• 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 1/154 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 1/1565 Details of valves
• CPC Class Codes: A61M 1/159 specially adapted for peritoneal dialysis
• 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 1/1696 with dialysate regeneration
• CPC Class Codes: A61M 1/28 Peritoneal dialysis ; Other peritoneal treatment, e.g. oxygenation
• CPC Class Codes: A61M 1/284 Continuous flow peritoneal dialysis [CFPD]
• CPC Class Codes: A61M 1/285 Catheters therefor
• CPC Class Codes: A61M 1/287 Dialysates therefor
• CPC Class Codes: A61M 1/288 Priming priming in extracorporeal blood circuits A61M1/3643
• CPC Class Codes: A61M 2202/0413 Blood
• CPC Class Codes: A61M 2205/12 with interchangeable cassettes forming partially or totally the fluid circuit
• CPC Class Codes: A61M 2205/3306 Optical measuring means
• CPC Class Codes: A61M 2205/3327 Measuring

Abstract

A disposable set and system for dialysis are disclosed. An example peritoneal dialysis system includes an automated peritoneal dialysis (“APD”) machine comprising a pumping mechanism and a peritoneal dialysis fluid heater. The example peritoneal dialysis system also includes a disposable set comprising a disposable cassette operable with the pumping mechanism and a heater bag operable with the heater. The example peritoneal dialysis system additionally includes a conductivity sensor positioned and arranged to provide feedback to the APD machine. The example APD machine is configured to mix a peritoneal dialysis fluid for treatment in the heater bag using a plurality of peritoneal dialysis constituent fluids. In addition, the example APD machine is configured to use feedback from the conductivity sensor to evaluate the mixed peritoneal dialysis fluid for treatment.

Claims

1. A peritoneal dialysis system comprising:

a peritoneal dialysis machine including

a fluid pumping mechanism,

a concentrate pumping mechanism, and

a sensor configured to measure a property of peritoneal dialysis fluid; and

a disposable cassette operable with the peritoneal dialysis machine, the disposable cassette including

a fluid source inlet for accepting fluid from a fluid source,

a fluid flow path in fluid communication with the fluid source inlet, the fluid flow path including a fluid pump chamber operable with the fluid pumping mechanism to pump fluid through the fluid flow path,

a concentrate inlet for fluidly communicating concentrate to the fluid flow path,

a concentrate pump chamber operable with the concentrate pumping mechanism to pump concentrate from the concentrate inlet to the fluid flow path, and

a sensor chamber located along the fluid flow path and operable with the sensor, wherein the sensor is configured to provide feedback to the peritoneal dialysis machine, and wherein the peritoneal dialysis machine is configured to use the feedback to mix the concentrate for forming peritoneal dialysis fluid.

2. The peritoneal dialysis system of claim 1, wherein the peritoneal dialysis machine further includes a heater located downstream from an outlet of the disposable cassette, the heater configured to warm the peritoneal dialysis fluid.

3. The peritoneal dialysis system of claim 1, wherein the peritoneal dialysis machine further includes a temperature sensor and the disposable cassette includes a temperature chamber operable with the temperature sensor to measure a temperature of the at least partially mixed peritoneal dialysis fluid.

4. The peritoneal dialysis system of claim 3, wherein the peritoneal dialysis machine is configured to adjust the feedback from the sensor based on the temperature measured by the temperature sensor.

5. The peritoneal dialysis system of claim 1, wherein the sensor includes at least one of an ammonia sensor, an ammonium sensor, a pH sensor, or an optical sensor.

6. The peritoneal dialysis system of claim 1, wherein the peritoneal dialysis machine includes a controller, and wherein the feedback from the sensor is sent to the controller.

7. The peritoneal dialysis system of claim 6, wherein the controller is configured to control operation of at least one of the fluid pumping mechanism and the concentrate pumping mechanism based on the feedback from the sensor.

8. The peritoneal dialysis system of claim 1, which includes a sorbent container, and wherein the disposable cassette includes a sorbent outlet and a sorbent inlet in fluid communication with opposite sides of the sorbent cartridge, and wherein the sorbent outlet and the sorbent inlet are in further fluid communication with the fluid flow path.

9. The peritoneal dialysis system of claim 1, wherein at least one of the fluid pumping mechanism or the concentrate pumping mechanism is an electromechanical pumping mechanism.

10. The peritoneal dialysis system of claim 1, wherein the peritoneal dialysis machine includes a valve actuator and the disposable cassette includes a valve chamber operable with the valve actuator.

11. The peritoneal dialysis system of claim 10, wherein the valve actuator and the valve chamber are operable to control fluid communication with the fluid source or a concentrate source.

12. A peritoneal dialysis system comprising:

a peritoneal dialysis machine including

a fluid pumping mechanism,

a concentrate pumping mechanism,

a valve actuator, and

a sensor configured to measure a property of peritoneal dialysis fluid; and

a disposable cassette operable with the peritoneal dialysis machine, the disposable cassette including

a fluid source inlet for accepting fluid from a fluid source,

a fluid flow path in fluid communication with the fluid source inlet, the fluid flow path including a fluid pump receptacle operable with the fluid pumping mechanism to pump fluid through the fluid flow path,

a concentrate inlet for fluidly communicating concentrate to the fluid flow path,

a concentrate pump chamber operable with the concentrate pumping mechanism to pump concentrate from the concentrate inlet to the fluid flow path,

a valve chamber in fluid communication with the pump chamber, the valve chamber operable with the valve actuator to control a flow of at least partially mixed peritoneal dialysis fluid from the pump chamber, and

a sensor chamber located along the fluid flow path and operable with the sensor, wherein the sensor is configured to provide feedback to the peritoneal dialysis machine, and wherein the peritoneal dialysis machine is configured to use the feedback to mix the concentrate for forming peritoneal dialysis fluid.

13. The peritoneal dialysis system of claim 12, wherein the valve chamber is a first valve chamber and the valve actuator is a first valve actuator, and

wherein the disposable cassette further includes a second valve chamber located between the fluid pumping receptacle and the fluid source inlet, the second valve chamber configured to operate with a second valve actuator to control a flow of fluid from the fluid source.

14. The peritoneal dialysis system of claim 13, wherein the peritoneal dialysis machine includes a controller, and wherein the feedback from the sensor is sent to the controller.

15. The peritoneal dialysis system of claim 14, wherein the controller is configured to control operation of at least one of the fluid pumping mechanism, the concentrate pumping mechanism, the first valve actuator, or the second valve actuator based on the feedback from the sensor.

16. The peritoneal dialysis system of claim 12, wherein the fluid source is a peritoneal dialysis fluid source.

17. The peritoneal dialysis system of claim 12, wherein the fluid pump receptacle is located upstream from the concentrate pump chamber.

18. A peritoneal dialysis disposable cassette operable with a peritoneal dialysis machine, the disposable cassette comprising:

a fluid source inlet for accepting fluid from a fluid source;

a fluid outlet for outputting at least partially mixed peritoneal dialysis fluid;

a fluid flow path in fluid communication with the fluid source inlet, the fluid flow path including a fluid pump chamber operable with the fluid pumping mechanism to pump the peritoneal dialysis fluid through the fluid flow path;

a concentrate inlet for fluidly communicating concentrate to the fluid flow path,

a concentrate pump chamber operable with the concentrate pumping mechanism to pump concentrate from the concentrate inlet to the fluid flow path; and

a sensor chamber located along the fluid flow path and operable with a sensor of the peritoneal dialysis machine,

wherein fluid from the fluid source is mixed with concentrate within the fluid flow path, and

wherein the sensor chamber is located downstream from the concentrate pump chamber to enable the sensor to provide feedback to the peritoneal dialysis machine regarding at least partially mixed peritoneal dialysis fluid.

19. The peritoneal dialysis disposable cassette of claim 18, which includes a rigid portion forming at least part of at least one of the fluid source inlet, the fluid outlet, the concentrate inlet, the fluid pump chamber, the concentrate pump chamber, or the sensor chamber.

20. The peritoneal dialysis disposable cassette of claim 19, which includes at least one flexible membrane secured to the rigid portion to collectively form at least one of the fluid pump chamber, the concentrate pump chamber, the fluid flow path, or the sensor chamber.

21. The peritoneal dialysis disposable cassette of claim 18, which operates as part of a disposable set including a concentrate source, wherein the concentrate source is an electrolyte fluid source or an osmotic agent fluid source.

22. The peritoneal dialysis disposable cassette of claim 18, wherein the fluid pump chamber is a pumping receptacle or pumping tube.

23. The peritoneal dialysis cassette of claim 18, wherein the fluid source is a peritoneal dialysis fluid source.