Peritoneal dialysis methods that emulate gravity flow

• US 5,421,823 A
• Filed: 06/01/1994
• Issued: 06/06/1995
• 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, Spencer, Geoffrey P.
• Primary Examiner(s): Rosenbaum, C. Fred
• Assistant Examiner(s): VANOVER, PERRY
• Application Number:
  US08/252,184
• Time in Patent Office: 370 Days
• Field of Search: 604/27-33, 210/929
• US Class Current: 604/28
• 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 1/155 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 1/28 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 2205/12 with interchangeable cassettes forming partially or totally the fluid circuit
• CPC Class Codes: A61M 5/1486 the bags being substantially completely surrounded by fluid
• CPC Class Codes: Y10S 210/929 Hemoultrafiltrate volume measurement or control processes

Abstract

Peritoneal dialysis systems and methods apply fluid pressure to move liquid. The systems and methods can emulate either a fixed head height condition or different head height conditions, independent of the actual head height differential between the patient'"'"'s peritoneal cavity and the external liquid source or destination. The systems and methods can also switch between low-relative pressure flow mode when considerations of patient comfort and safety predominate and a high-relative pressure flow mode when considerations of processing speed predominate.

Claims

1. A method for performing peritoneal dialysis comprising the steps of

establishing flow communication with the patient'"'"'s peritoneal cavity through a pumping mechanism that comprises a pump chamber and a diaphragm, and

emulating a selected gravity flow condition by applying fluid pressure to the diaphragm to operate the pump chamber to either move dialysis solution fluid from the peritoneal cavity or move dialysis solution into the peritoneal cavity.

2. A method according to claim 1

wherein, in applying fluid pressure, a fixed head height condition is emulated.

3. A method according to claim 1

wherein, in applying fluid pressure, the magnitude of the applied fluid pressure is changed to emulate different head height conditions.

4. A method according to claim 1

wherein, in applying fluid pressure, pneumatic fluid pressure is applied.

5. A method according to claim 1

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

6. A method according to claim 1

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

7. A method according to claim 1 and further including the steps of

normally isolating the patient'"'"'s peritoneal cavity from the pump chamber by a valve, and

selectively opening the valve to accommodate movement of the dialysis solution to and from the patient'"'"'s peritoneal cavity.

8. A method according to claim 7

wherein, in the step of opening and closing the valve, fluid pressure is applied.

9. A method according to claim 7

wherein, in opening and closing the valve, pneumatic pressure is applied.

10. A method for performing peritoneal dialysis comprising the steps of

establishing flow communication with the patient'"'"'s peritoneal cavity through a pumping mechanism that comprises a pump chamber, at least one valve communicating with the pump chamber, and a diaphragm, and

emulating a selected gravity flow condition by applying fluid pressure to the diaphragm to operate the pump chamber and valve to move dialysis solution from the peritoneal cavity to a drain or move fresh dialysis solution from a source into the peritoneal cavity.

11. A method according to claim 10

wherein, in applying fluid pressure, a fixed head height condition is emulated.

12. A method according to claim 10

wherein, in applying fluid pressure, the magnitude of the applied fluid pressure is changed to emulate different head height conditions.

13. A method according to claim 10

wherein, in applying fluid pressure, pneumatic pressure is applied.

14. A method according to claim 10

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

15. A method according to claim 10

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

16. A method for performing peritoneal dialysis comprising the steps of

establishing flow communication between the patient'"'"'s peritoneal cavity and an external component through a pumping mechanism that comprises a pump chamber and a diaphragm, and

applying fluid pressure to the diaphragm to operate the pump chamber to move dialysis solution between the external component and the patient'"'"'s peritoneal cavity at a flow condition that emulates a selected head height differential between the external component and the patient'"'"'s peritoneal cavity independent of the actual head height differential between the external component and the patient'"'"'s peritoneal cavity.

17. A method according to claim 16

wherein, in applying fluid pressure, the magnitude of the applied fluid pressure is changed to emulate different head height differentials independent of the actual head height differential between the external component and the patient'"'"'s peritoneal cavity.

18. A method according to claim 16

wherein, in applying fluid pressure, pneumatic pressure is applied.

19. A method according to claim 16

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

20. A method according to claim 16

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

21. A method for performing peritoneal dialysis comprising the steps of

establishing flow communication among the patient'"'"'s peritoneal cavity, a source of dialysis solution, and a drain through a pumping mechanism that comprises a pump chamber, at least one valve communicating with the pump chamber, and a diaphragm, and

emulating a selected gravity flow condition by applying fluid pressure to the diaphragm to operate the pump chamber and valve to:

(i) direct spent dialysis solution from the patient'"'"'s peritoneal cavity into the pump chamber,

(ii) direct the spent dialysis solution from the pump chamber to the drain,

(iii) direct fresh dialysis solution from the source into the pump chamber, and

(iv) direct the fresh dialysis solution from the pump chamber to the patient'"'"'s peritoneal cavity.

22. A method according to claim 21

wherein, in at least one of the steps (i) and (iv), the magnitude of the applied fluid pressure is different than the magnitude of the applied fluid pressure in another one of the steps (ii) or (iii).

23. A method according to claim 21

and further including the step of varying the magnitude of the applied fluid pressure to emulate different head height conditions.

24. A method according to claim 21

wherein, in applying fluid pressure, pneumatic pressure is applied.

25. A method for performing peritoneal dialysis comprising the steps of

establishing flow communication among the patient'"'"'s peritoneal cavity, a source of fresh dialysis solution, a reservoir for heating the fresh dialysis solution, and a drain through a pumping mechanism that comprises a pump chamber, at least one valve communicating with the pump chamber, and a diaphragm, and

emulating a selected gravity flow condition by applying fluid pressure to the diaphragm to operate the pump chamber and valve to

(i) direct spent dialysis solution from the patient'"'"'s peritoneal cavity into the pump chamber,

(ii) direct the spent dialysis solution from the pump chamber to the drain,

(iii) direct fresh dialysis solution from the source into the pump chamber,

(iv) direct the fresh dialysis solution from the pump chamber to the reservoir for heating,

(v) direct the heated fresh dialysis solution from the reservoir into the pump chamber, and

(vi) direct the heated fresh dialysis solution from the pump chamber to the patient'"'"'s catheter.

26. A method according to claim 25

wherein, in at least one of the steps (i) and (vi), the magnitude of the applied fluid pressure is less than the magnitude of the fluid pressure applied in another one of the steps (ii) to (v).

27. A method according to claim 25

and further including the step of varying the magnitude of the applied fluid pressure to emulate different head height conditions.

28. A method according to claim 25

wherein, in applying fluid pressure, pneumatic pressure is applied.

29. A method according to claim 25

wherein steps (i) to (vi) are cycled in succession at least two times.

30. A method according to claim 29

wherein, in the last cycle of steps, the dialysis solution directed into the patient'"'"'s peritoneal cavity in steps (iii) to (vi) has a different composition than the composition of the dialysis solution directed into the patient'"'"'s peritoneal cavity during steps (iii) to (vi) in the first cycle of steps.

31. A method for performing peritoneal dialysis comprising the steps of

establishing flow communication with the patient'"'"'s peritoneal cavity through a pumping mechanism that comprises a pump chamber and a diaphragm, and

emulating a selected gravity flow condition by applying pneumatic pressure to the diaphragm through an actuator to operate the pump chamber to draw dialysis solution into the pump chamber and to expel dialysis solution from the pump chamber to either move dialysis solution from the peritoneal cavity or move dialysis solution into the peritoneal cavity, and

deriving a measurement of liquid volume pumped through the pump chamber by deriving an initial air volume measurement V_i after operating the actuator to draw fluid into the pumping chamber;

deriving a final air volume measurement V_f after operating the actuator to expel fluid from the pumping chamber; and

deriving the liquid volume delivered (V_d) by the pumping chamber as follows;

space="preserve" listing-type="equation">V.sub.d =V.sub.f -V.sub.i, and

wherein V_i and V_f are derived by controlling communication between a reference chamber having a known air volume V_s and the actuator by;

(i) when liquid is either drawn into or expelled from the pump chamber, closing communication between reference chamber and the actuator to initialize the reference chamber to a measured initial air pressure (IP_s1) while applying a measured pressure to the actuator (IP_d1);

(ii) then opening communication between the reference chamber and the actuator to allow pressure equilibration at a measured new air pressure in the actuator (IP_d2) and a measured new air pressure in the reference chamber (IP_s2), and (iii) then deriving the air volume measurement V_i or V_f as follows;

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