Peritoneal dialysis systems and methods employing a liquid distribution and pump cassette with self-contained air isolation and removal

• US 5,628,908 A
• Filed: 03/09/1995
• Issued: 05/13/1997
• Est. Priority Date: 03/03/1993
• Status: Expired due to Term

• Current Assignee: Deka Products Limited Partnership
• Original Assignee: Deka Products Limited Partnership
• Inventors: Kamen, Dean, Vincent, Douglas E., Lanigan, Richard
• Primary Examiner(s): Kim, John
• Application Number:
  US08/401,352
• Time in Patent Office: 796 Days
• Field of Search: 210/646, 210/650, 210/195.1, 210/195.2, 210/252, 210/258, 210/175, 210/180, 210/416.1, 210/645, 417/383, 417/384, 417/385, 417/395, 604/28, 604/29, 604/30, 73/149, 364/509, 364/510, 364/564
• US Class Current: 210/646
• 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 1/154 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 1/166 Heating for sterilisation A61M1/1686
• 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 2205/12 with interchangeable cassettes forming partially or totally the fluid circuit

Abstract

Systems and methods for peritoneal dialysis establish flow communication between a patient'"'"'s peritoneal cavity and a drain through a pump chamber having generally vertically spaced upper and lower regions andt a diaphragm. The systems and methods operate the pump chamber, with the upper and lower regions oriented generally vertically, by applying fluid pressure to the diaphragm. The systems and methods direct liquid to the patient'"'"'s peritoneal cavity only from the lower region of the pump chamber. In this way, the improved systems and methods collect air in the upper region of the vertically oriented pump chamber, while isolating the patient'"'"'s peritoneal cavity from air in the pump chamber.

Claims

1. A method for performing peritoneal dialysis comprising steps of

establishing flow communication with a patient'"'"'s peritoneal cavity through a pump chamber having spaced ends, the pump chamber being oriented for use in a generally vertical plane so that one end which comprises a non-critical gas-liquid extracorporeal circuit end is spaced generally above the other end which comprises a critical liquid patient circuit end to form within the pump chamber an upper noncritical gas-liquid extracorporeal circuit region for pumping fluid and a lower critical liquid patient circuit region for pumping liquid and a diaphragm on the pump chamber,

operating the pump chamber with the upper noncritical gas-liquid extracorporeal circuit region and the lower critical liquid patient circuit region oriented generally vertically, by applying fluid pressure to the diaphragm,

pumping liquid to the patient'"'"'s peritoneal cavity only from the lower critical liquid patient circuit region of the pump chamber in an infusion direction through the pump chamber to deliver liquid dialysate to the patient, and

directing dialysate in a direction reverse to the infusion direction through the pump chamber and from the upper non-critical gas-liquid extracorporeal circuit region of the pump chamber in an outgoing flow to a destination outside the patient'"'"'s peritoneal cavity so that the outgoing flow of dialysate carries gas from the upper circuit region of the pump chamber.

2. A method for performing peritoneal dialysis comprising steps of

establishing flow communication among a patient'"'"'s peritoneal cavity, a source of fresh dialysis solution, and a drain through a pump chamber having spaced ends, the pump chamber being oriented for use in a generally vertical plane so that one end which comprises a non-critical gas-liquid extracorporeal circuit end is spaced generally above the other end which comprises a critical liquid patient circuit end to form within the pump chamber an upper non-critical gas-liquid extracorporeal circuit region and a lower critical liquid patient circuit region and a diaphragm on the pump chamber,

operating the pump chamber, with the upper non-critical gas-liquid extracorporeal region and the lower critical liquid patient circuit region oriented generally vertically, by applying fluid pressure to the diaphragm, the pump chamber being operable in an infusion direction through the pump chamber to deliver fresh dialysis solution to the patient'"'"'s peritoneal cavity and also being operable in a direction reverse to the infusion direction,

directing spent dialysis solution from the patient'"'"'s peritoneal cavity into the lower critical liquid patient circuit region of the pump chamber,

directing the spent dialysis solution in the direction reverse to the infusion direction through the pump chamber and from the upper non-critical gas-liquid extracorporeal circuit region of the pump chamber to a drain so that outgoing flow of spent dialysis solution carries gas from the pump chamber to the drain,

directing fresh dialysis solution from the source into the upper non-critical gas-liquid extracorporeal circuit region of the pump chamber and

pumping the fresh dialysis solution from the pump chamber to the patient'"'"'s peritoneal cavity only from the lower critical liquid patient circuit region of the pump chamber in the infusion direction through the pump chamber to deliver fresh dialysis solution to the patient'"'"'s peritoneal cavity so that the fresh dialysis solution directed to the patient'"'"'s peritoneal cavity is isolated from gas in the pump chamber.

3. A method according to claim 2

wherein, in the step of applying fluid pressure, pneumatic pressure is applied.

4. A method according to claim 2

wherein, in the step of applying fluid pressure, a fluid pressure that is below atmospheric pressure is applied.

5. A method according to claim 2

wherein, in the step of applying fluid pressure, a fluid pressure that is above atmospheric pressure is applied.

6. A method for performing peritoneal dialysis comprising steps of

establishing flow communication among a patient'"'"'s peritoneal cavity, a source of fresh dialysis solution, a reservoir for heating the fresh dialysis solution, and a drain through a pump chamber having spaced ends, the pump chamber being oriented for use in a generally vertical plane so that one end which comprises a non-critical gas-liquid extracorporeal circuit end is spaced generally above the other end which comprises a critical liquid patient circuit end to form within the pump chamber an upper non-critical gas-liquid extracorporeal circuit region and a lower critical liquid patient circuit region and a diaphragm on the pump chamber,

operating the pump chamber, with the upper noncritical gas-liquid extracorporeal circuit region and the lower critical liquid patient circuit region oriented generally vertically, by applying fluid pressure to the diaphragm, the pump chamber being operable in an infusion direction through the pump chamber to deliver fresh dialysis solution to the patient'"'"'s peritoneal cavity and also being operable in a direction reverse to the infusion direction,

directing spent dialysis solution from the patient'"'"'s peritoneal cavity into the lower critical liquid patient circuit region of the pump chamber,

directing the spent dialysis solution in the direction reverse to the infusion direction through the pump chamber and from the upper non-critical gas-liquid extracorporeal circuit region of the pump chamber to a drain, so that the outgoing flow of spent dialysis solution carries air from the pump chamber to the drain,

directing fresh dialysis solution from the source into the upper non-critical gas-liquid extracorporeal region of the pump chamber,

directing the fresh dialysis solution from the upper non-critical gas-liquid extracorporeal region of the pump chamber to the reservoir for heating in the reservoir, the fresh dialysis solution being directed to the reservoir from the upper non-critical gas-liquid extracorporeal circuit region of the pump chamber to carry air from the pump chamber to the reservoir,

directing the heated fresh dialysis solution from the reservoir into the upper non-critical gas-liquid extracorporeal region of the pump chamber, and

pumping the heated fresh dialysis solution only from the lower critical liquid patient circuit region of the pump chamber in the infusion direction through the pump chamber to deliver heated fresh dialysis solution to the patient'"'"'s peritoneal cavity so that the heated fresh dialysis solution directed to the patient'"'"'s peritoneal cavity is isolated from gas in the pump chamber.

7. A method according to claim 6

wherein, in the step of applying fluid pressure, pneumatic pressure is applied.

8. A method according to claim 6

wherein, in the step of applying fluid pressure, a fluid pressure that is below atmospheric pressure is applied.

9. A method according to claim 6

wherein, in the step of applying fluid pressure, a fluid pressure that is above atmospheric pressure is applied.

10. A system for performing peritoneal dialysis comprising

a pump including a pump chamber having generally spaced ends including an upper non-critical gas-liquid extracorporeal circuit end and a lower critical liquid patient circuit end and a diaphragm on the pump chamber, the pump operating the chamber in an infusion direction through the pump chamber to deliver liquid dialysate to the patient'"'"'s peritoneal cavity and in a direction reverse to the infusion direction through the pump chamber,

a conduit for establishing flow communication with a patient'"'"'s peritoneal cavity through the pump chamber,

an actuator for holding the pump chamber generally vertically so that the upper non-critical gas-liquid extracorporeal circuit end is spaced generally above the lower critical liquid patient circuit end to form within the pump chamber an upper non-critical gas-liquid extracorporeal circuit region and a lower critical liquid patient region while applying fluid pressure to the diaphragm to move liquid through the pump chamber, and

paths for directing liquid flow through the pump chamber including

a path for directing liquid dialysate in the direction reverse to the infusion direction through the pump chamber and removing gas from the upper non-critical gas-liquid extracorporeal circuit region of the pump chamber, and

a path for directing liquid dialysate in the infusion direction through the pump chamber to deliver the dialysate to the patient'"'"'s peritoneal cavity only from the lower critical liquid patient circuit region of the pump chamber.

11. A system according to claim 10

wherein the actuator applies pneumatic pressure.

12. A system according to claim 10

wherein the actuator applies a fluid pressure that is below atmospheric pressure.

13. A system according to claim 10

wherein the actuating means applies a fluid pressure that is above atmospheric pressure.

14. A system for performing peritoneal dialysis comprising

a pump including a pump chamber having generally spaced ends including an upper non-critical gas-liquid extracorporeal circuit end and a lower critical liquid patient circuit end and a diaphragm on the pump chamber, the pump operating the chamber in an infusion direction throuqh the pump chamber to deliver liquid dialysate to the patient'"'"'s peritoneal cavity and in a direction reverse to the infusion direction through the pump chamber,

conduits for establishing flow communication among a patient'"'"'s peritoneal cavity, a source of fresh dialysis solution, and a drain through the pump chamber,

an actuator holding the pump chamber generally vertically so that the upper non-critical gas-liquid extracorporeal end is spaced generally above the lower critical liquid circuit end to form within the pump chamber an upper non-critical gas-liquid extracorporeal region and a lower critical liquid patient circuit region while applying fluid pressure to the diaphragm to move liquid through the pump chamber, and,

paths to direct flow through the pump chamber including

a path to direct spent dialysis solution from the patient'"'"'s peritoneal cavity into the lower critical liquid patient circuit region. of the pump chamber,

a path to direct the spent dialysis solution from the upper non-critical gas-liquid extracorporeal circuit region of the pump chamber in the direction reverse to the infusion direction through the pump chamber to the drain, and

a path to direct the fresh dialysis solution only from the lower critical patient circuit region of the pump chamber in the infusion direction through the pump chamber to deliver the fresh dialysis solution to the patient'"'"'s peritoneal cavity.

15. A system according to claim 14 and further including a path to remove air from the pump chamber.

16. A system according to claim 14

wherein the actuator means applies pneumatic pressure.

17. A system according to claim 14

wherein the actuator applies a fluid pressure that is below atmospheric pressure.

18. A system according to claim 14

wherein the actuator applies a fluid pressure that is above atmospheric pressure.

19. A system for performing peritoneal dialysis comprising

a pump including.a pump chamber having generally spaced ends including an upper non-critical gas-liquid extracorporeal circuit end and a lower critical liquid patient circuit end and a diaphragm on the pump chamber,

conduit means for establishing flow communication among a patient'"'"'s peritoneal cavity, a source of fresh dialysis solution, a reservoir for heating the fresh dialysis solution, and a drain through the pump chamber,

an actuator holding the pump chamber generally vertically so that the upper non-critical gas-liquid extracorporeal circuit end is spaced generally above the lower critical liquid patient circuit end to form within the pump chamber an upper non-critical gas-liquid extracorporeal circuit region and a lower critical liquid patient circuit region while applying fluid pressure to the diaphragm to move liquid through the pump chamber, and

paths to direct liquid flow through the pump chamber including

a path to direct spent dialysis solution from the patient'"'"'s peritoneal cavity into the lower critical liquid patient circuit region of the pump chamber,

a path to direct. the spent dialysis solution from the upper non-critical gas-liquid extracorporeal circuit region of the pump chamber to the drain,

a path to direct fresh dialysis solution from the source into the upper non-critical gas-liquid extracorporeal circuit region of the pump chamber,

a path to direct the fresh dialysis solution from the upper non-critical gas-liquid extracorporeal circuit region of the pump chamber to the reservoir for heating,

a path to direct the heated fresh dialysis solution from the reservoir into the upper non-critical gas-liquid extracorporeal circuit region of the pump chamber, and

a path to direct the heated fresh dialysis solution only from the lower critical liquid patient circuit region of the pump chamber to the patient'"'"'s peritoneal cavity.

20. A system according to claim 19 and further including a path to remove air from the pump chamber.

21. A system according to claim 19

wherein the actuator applies pneumatic pressure.

22. A system according to claim 19

wherein the actuator means applies a fluid pressure that is below atmospheric pressure.

23. A system according to claim 19

wherein the actuator applies a fluid pressure that is above atmospheric pressure.

24. A peritoneal dialysis system comprising

a liquid distribution set including a patient conduit in communication with a patient'"'"'s peritoneal cavity for conveying liquid to and from the patient'"'"'s peritoneal cavity and a second conduit,

a liquid distribution cassette comprising,

a cassette body,

a pump chamber in the cassette body having spaced ends including an upper non-critical gas-liquid extracorporeal circuit end and a lower critical liquid patient circuit end, the pump chamber being oriented in use in a generally vertical plane so that the upper non-critical gas-liquid extracorporeal circuit end is spaced generally above the lower critical liquid patient circuit end to form within the pump chamber an upper non-critical gas-liquid extracorporeal circuit region and a lower critical liquid patient circuit region,

a diaphragm on the pump chamber and responsive to fluid pressure for moving liquid through the pump chamber in an infusion direction and a reverse direction,

a first liquid. distribution pathway in the cassette body connecting the patient conduit in flow communication with the lower critical liquid patient circuit region, and

a second liquid distribution pathway in the cassette body connecting the second conduit in flow communication only with the upper non-critical gas-liquid extracorporeal circuit region of the pump chamber to remove air from the upper non-critical gas-liquid extracorporeal circuit reregion of the pump chamber with liquid flow in the reverse direction, and

an actuating station for the cassette including

a support receiving the cassette body only when the upper non-critical gas-liquid extracorporeal circuit region is generally vertically oriented above the lower critical liquid patient circuit region so that the upper non-critical gas-liquid extracorporeal circuit region of the pump chamber is in a higher gravity position than the lower critical liquid patient circuit region, and

a fluid pressure conveying element conveying fluid pressure to the diaphragm only when the cassette body is received by the support.

25. A system according to claim 24

wherein the fluid conveying pressure conveying element conveys pneumatic pressure.

26. A system according to claim 24

wherein the fluid pressure conveying element conveys a fluid pressure that is below atmospheric pressure.

27. A system according to claim 24

wherein the fluid pressure conveying element applies a fluid pressure that is above atmospheric pressure.