System for monitoring and controlling peritoneal dialysis

• US 8,206,339 B2
• Filed: 03/20/2009
• Issued: 06/26/2012
• Est. Priority Date: 02/10/2000
• Status: Expired due to Term

• Current Assignee: Baxter International Inc.
• Original Assignee: Baxter International Inc.
• Inventors: Childers, Robert W., Eerlingen, Vital, Balteau, Patrick, Belongie, Duane
• Primary Examiner(s): Desanto, Matthew F
• Application Number:
  US12/408,432
• Publication Number:
  US 20090198174A1
• Time in Patent Office: 1,194 Days
• Field of Search: 604/19, 604/27, 604/28, 604/29, 604/4.01, 604 501- 504
• US Class Current: 604/29
• 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 1/1562 Details of incorporated reservoirs
• 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 1/282 Operational modes
• CPC Class Codes: A61M 1/285 Catheters therefor
• CPC Class Codes: A61M 2205/123 with incorporated reservoirs
• CPC Class Codes: A61M 2205/128 with incorporated valves
• CPC Class Codes: A61M 2205/17 with redundant control systems
• CPC Class Codes: A61M 2205/3331 Pressure; Flow
• CPC Class Codes: A61M 2205/3344 Measuring or controlling pressure at the body treatment site
• CPC Class Codes: A61M 2205/3351 Controlling upstream pump pressure
• CPC Class Codes: A61M 2205/3355 Controlling downstream pump pressure
• CPC Class Codes: A61M 5/14224 Diaphragm type

Abstract

A peritoneal dialysis system includes a cycler operable with a disposable cassette, the cassette connected to a patient line, the cassette capable of fluid communication with a catheter having access to a patient'"'"'s peritoneal cavity, the cycler configured to: (i) convey dialysis fluid to the peritoneal cavity through the patient line and the catheter during a patient fill phase; (ii) allow the dialysis fluid to dwell within the peritoneal cavity during a patient dwell phase; (iii) convey dialysis fluid away from the peritoneal cavity through the patient line and the catheter during a patient drain phase; and (iv) sense, at first and second sensing locations of the disposable cassette via first and second pressure sensors, an intraperitoneal pressure through the catheter to optimize an amount of fluid conveyed during the patient fill phase, so that the peritoneal cavity is not overpressurized during the patient dwell phase.

Claims

1. A peritoneal dialysis system comprising:

a cycler including first and second pressure sensors, the cycler being operable with a disposable cassette including first and second sensing locations, the cassette connected to a patient line, which is capable of being placed in fluid communication with a catheter having access to a patient'"'"'s peritoneal cavity, the cycler constructed and arranged to;

convey dialysis fluid to the peritoneal cavity through the patient line and the catheter during a patient fill phase;

allow the dialysis fluid to dwell within the peritoneal cavity during a patient dwell phase;

convey dialysis fluid away from the peritoneal cavity through the patient line and the catheter during a patient drain phase; and

sense, at the first and second sensing locations on the disposable cassette via the first and second pressure sensors contacting the first and second sensing locations, respectively, a pressure through the catheter to optimize an amount of fluid conveyed during the patient fill phase, so that the peritoneal cavity is not overpressurized during the patient dwell phase.

2. The peritoneal dialysis system of claim 1, the cycler further constructed and arranged to repeat the conveying, dwelling, and sensing operations at least once.

3. The peritoneal dialysis system of claim 1, the cycler including first and second pump actuators cooperating with first and second pump chambers, respectively, to (i) convey dialysis fluid to the peritoneal cavity and (ii) convey dialysis fluid away from the peritoneal cavity.

4. The peritoneal dialysis system of claim 1, wherein the cycler is constructed and arranged to sense the pressure, which includes an intraperitoneal pressure (IPP), during the fill phase.

5. The peritoneal dialysis system of claim 1, wherein the first and second pump actuators are alternating pump actuators to convey dialysis fluid substantially continuously.

6. A peritoneal dialysis system comprising:

source of dialysis fluid;

a disposable cassette including a sensing location;

a first flow path from the source of dialysis fluid to the disposable cassette and from the disposable cassette to a patient;

a second flow path from the patient to the disposable cassette and from the disposable cassette to a dialysis fluid drain;

a cycler including a pressure sensor, the cycler being constructed and arranged to operate with the disposable cassette to;

(i) convey dialysis fluid from the source of dialysis fluid through the first flow path to the patient and from the patient through the second flow path to the dialysis fluid drain using a pair of membrane pumps alternating to form an at least substantially continuous flow; and

(ii) sense, at the sensing location on the disposable cassette via the pressure sensor contacting the sensing location, a pressure to optimize an amount of fluid flowing through at least one of the first flow path and the second flow path.

7. The peritoneal dialysis system of claim 6, the cycler including two sensors for sensing the pressure, which includes an intraperitoneal pressure, to perform the at least one optimization.

8. The peritoneal dialysis system of claim 7, the two sensors sensing pressure at the disposable cassette.

9. The peritoneal dialysis system of claim 6, the cycler constructed and arranged to reverse a direction of flow in at least one of the first and second flow paths.

10. The peritoneal dialysis system of claim 6, the cycler further constructed and arranged to sense the pressure while conveying the dialysis fluid.

11. The peritoneal dialysis system of claim 6, the cassette including a plurality of pressure sensing locations.

12. A peritoneal dialysis system comprising:

a disposable cassette including first and second sensing locations; and

a cycler including first and second pressure sensors, the cycler being constructed and arranged to;

(i) a convey dialysis fluid from a dialysis fluid container through a catheter to a patient;

(ii) allow the dialysis fluid to dwell within the patient;

(iii) reverse a direction of dialysis fluid flow in the catheter away from the patient; and

(iv) sense, at the first and second sensing locations on the disposable cassette using the first and second pressure sensors provided by the cycler and placed in contact with the first and second sensing locations, respectively, the sensing locations in fluid communication with the catheter, a pressure to optimize at least one of an amount of fluid flowing towards or away from the patient, so that the patient is comfortable while the dialysis fluid dwells within the patient.

13. The peritoneal dialysis of claim 12, the cycler operating a fluid control valve to reverse the direction of dialysis fluid.

14. The peritoneal dialysis system of claim 12, the disposable cassette including a flexible membrane, the two sensors placed in contact with the membrane at the first and second sensing locations for sensing the pressure to perform the at least one optimization.

15. The peritoneal dialysis system of claim 12, the cycler constructed and arranged to flow fluid away from the patient by pumping fluid towards a disposable cassette operating with the cycler.

16. The peritoneal dialysis system of claim 12, the cycler constructed and arranged to repeat the conveying, dwelling, reversing and sensing operations at least once.

17. The peritoneal dialysis system of claim 12, the cycler constructed and arranged to perform the sensing operation during the conveying or reversing operations.

18. The peritoneal dialysis system of claim 12, the cycler including a pair of medical fluid pumps alternating to pump dialysis fluid substantially continuously for the conveying and reversing operations.

19. A peritoneal dialysis system comprising:

a disposable cassette including a sensing location; and

a cycler including a pressure sensor, the cycler being constructed and arranged to;

(i) pump substantially continuously using a pair of alternating pumps to convey dialysis fluid to a peritoneal cavity through a catheter during a patient fill phase;

(ii) allow the dialysis fluid to dwell within the peritoneal cavity during a patient dwell phase;

(iii) pump substantially continuously using the pair of alternating pumps to convey dialysis fluid away from the peritoneal cavity through the catheter during a patient drain phase; and

(iv) measure, at the sensing location on the disposable cassette via the pressure sensor contacting the sensing location, a pressure through the catheter to optimize an amount of fluid conveyed during the patient fill phase, so that the peritoneal cavity is not overpressurized during the patient dwell phase.

20. The peritoneal dialysis system of claim 19, the cycler including two pressure sensors, each pressure sensor operable with a respective sensing location of a disposable cassette to measure the pressure.

21. A peritoneal dialysis system comprising:

a cycler;

a disposable cassette operable with the cycler;

a patient line extending from the disposable cassette, the patient line connectable to a catheter having access to a patient'"'"'s peritoneal cavity;

first and second pressure sensors provided by the cycler;

corresponding first and second sensing locations on the disposable cassette located, in operation, directly adjacent to and contacting the first and second pressure sensors;

a patient fill phase performed by the cycler;

a patient dwell phase performed by the cycler;

a patient drain phase performed by the cycler; and

wherein the patient fill phase is controlled by the cycler and at lease one of the pressure sensors, so that the peritoneal cavity is not overpressurized during the dwell phase.

22. The peritoneal dialysis system of claim 21, wherein the cycler is configured to sense the intraperitoneal pressure during the fill phase.

23. A peritoneal dialysis system comprising:

a cycler;

a disposable cassette operable with the cycler;

a patient line extending from the disposable cassette, the patient line connectable to a catheter having access to a patient'"'"'s peritoneal cavity;

first and second pressure sensors provided by the cycler;

corresponding first and second sensing locations on the disposable cassette that are in contact with first and second pressure sensors of the cycler and are separate from pumping locations and valving locations of the disposable cassette;

a patient fill phase performed by the cycler;

a patient dwell phase performed by the cycler;

a patient drain phase performed by the cycler; and

wherein the patient drain phase is controlled by the cycler and one of the pressure sensors so as not to apply too much negative pressure during the patient drain phase.

24. The peritoneal dialysis system of claim 23, wherein the pressure sensor used during the drain phase is a vacuum pressure sensor, the other pressure sensor a positive pressure sensor.