User interface and monitoring functions for automated peritoneal dialysis systems

• US 5,438,510 A
• Filed: 03/03/1993
• Issued: 08/01/1995
• Est. Priority Date: 03/03/1993
• Status: Expired due to Term

• Current Assignee: Deka Products Limited Partnership
• Original Assignee: Deka Products Limited Partnership
• Inventors: Finkelstein, Jeffrey, Kamen, Dean, Miller, Bradley D., Spencer, Geoffrey P., Bryant, Robert J., Lanigan, Richard
• Primary Examiner(s): Harvey, Jack B.
• Assistant Examiner(s): CHUNG TRANS, XUONG MY
• Application Number:
  US08/025,531
• Time in Patent Office: 881 Days
• Field of Search: 604/28, 604/29, 604/65, 604/67, 604/31, 604/118, 412/45, 412/63, 128/DIG. 13, 128/DIG. 3, 128/DIG. 12, 364/413.02, 364/413.03
• US Class Current: 604/29
• 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 2205/12 with interchangeable cassettes forming partially or totally the fluid circuit
• CPC Class Codes: F04B 2205/03 Pressure in the compression chamber
• CPC Class Codes: F04B 43/0736 with two or more pumping chambers in parallel
• CPC Class Codes: F04B 49/106 Responsive to pumped volume
• CPC Class Codes: F04B 53/06 Venting
• CPC Class Codes: F04B 7/0275 and being deformable, e.g. membranes
• CPC Class Codes: G16H 20/40 relating to mechanical, radiation or invasive therapies, e.g. surgery, laser therapy, dialysis or acupuncture
• CPC Class Codes: G16H 40/63 for local operation

Abstract

Systems for performing peritoneal dialysis having an improved user interface functions and monitoring capabilities. In one respect, the systems discriminate between alarm conditions that require user intervention to correct and alarm conditions that reflect conditions that are anomalies but typically correct themselves with minimum or no user intervention. In another respect, the systems identify occluded liquid flow paths and discriminate whether the flow path is associated with a liquid source or a liquid destination.

Claims

1. An automated peritoneal dialysis system including

means for establishing flow communication with the patient'"'"'s peritoneal cavity catheter through a pumping mechanism,

actuator means for operating the pumping mechanism to emulate gravity flow conditions independent of head height conditions and:

(i) drain spent peritoneal dialysis liquid from the peritoneal cavity, and

(ii) infuse fresh dialysis liquid from a source into the peritoneal cavity,

control means for directing operation of the actuator means to conduct a peritoneal dialysis modality, and

means for monitoring system operation including

means for generating a first alarm signal when system operation fails to satisfy a first predetermined set of criteria,

means for generating a second alarm signal when system operation fails to satisfy a second predetermined set of criteria different than the first set of criteria,

means for (i) suspending system operation in response to the first alarm signal; and

(ii) requiring user intervention to resume system operation, and

means for (i) continuing system operation for a predetermined time period in response to the second alarm signal;

(ii) canceling the second alarm condition without user intervention when, after the predetermined time period, system operation satisfies the second set of criteria; and

(iii) initiating a first alarm condition when, after the predetermined time period, system operation fails to satisfy the second set of criteria.

2. A system according to claim 1

wherein the first set of criteria includes the lack of supply liquid.

3. A system according to claim 1

wherein the first set of criteria includes the pump mechanism not being in a desired orientation.

4. A system according to claim 1

wherein the second set of criteria includes a low liquid flow condition.

5. A system according to claim 1

wherein the second set of criteria includes an occluded liquid flow condition.

6. A system according to claim 1

wherein the means responsive to first alarm signal includes an interface having input means through which the user intervenes.

7. A system according to claim 1

wherein the pumping mechanism comprises a diaphragm overlying a pump chamber and at least one valve communicating with the pump chamber, and

wherein the actuator means applies pneumatic pressure variations to the diaphragm to operate the pump chamber.

8. A system according to claim 7

wherein the pump chamber has, when oriented vertically, an upper region for venting air,

wherein the actuator means includes a holder to orient the pump chamber vertically while applying pneumatic pressure variations to the diaphragm, and

wherein the first set of criteria includes sensing when the pump chamber is not oriented vertically.

9. A peritoneal dialysis system comprising

a source of liquid including tubing communicating with the liquid source,

pumping means for moving liquid in the tubing from the source toward the pumping means,

monitor means for generating a first command signal when the pumping means fails to move liquid in the tubing from the source toward the pumping means, and

control means operative, in response to the first command signal, for operating the pumping means to attempt to move liquid in the tubing from the pumping means toward the source and, if successful, registering an empty source condition and, if not successful, registering an occluded source tubing condition.

10. A system according to claim 9

wherein the monitor means derives a liquid flow rate by measuring liquid volume moved by the pumping mechanism over a prescribed time period and generates the first command signal when the derived flow rate is less than a predetermined value.

11. A system according to claim 9

wherein the pumping means comprises a diaphragm overlying a pump chamber and operable in response to applied fluid pressure for moving liquid through the pump chamber.

12. A system according to claim 11

wherein the monitor means senses fluid pressure variations during operation of the pump chamber over a prescribed time period to derive a liquid flow rate, and

wherein the monitor means generates the first command signal when the derived flow rate is less than a predetermined value.

13. A system according to claim 12

wherein the tubing is free of external liquid and pressure sensors.

14. A system according to claim 9

wherein the pumping means is operative for moving liquid from the pumping means toward a destination other than the source,

wherein the monitor means is further operative for generating a second command signal when the pumping means fails to move liquid from the pumping means toward the destination, and

wherein the control means is further operative, in response to the second command signal, for operating the pump means to attempt to move liquid from the destination toward the pumping means and, if successful, registering a full destination condition and, if not successful, registering an occluded destination condition.

15. A system according to claim 14

wherein the monitor means derives a liquid flow rate by measuring liquid volume moved by the pumping mechanism toward the destination over a prescribed time period and generates the second command signal when the derived flow rate is less than a predetermined value.

16. A system according to claim 14

wherein the pumping means comprises a diaphragm overlying a pump chamber and operable in response to applied fluid pressure for moving liquid through the pump chamber.

17. A system according to claim 16

wherein the monitor means senses fluid pressure variations during operation of the pump chamber over a prescribed time period to derive a liquid flow rate toward the destination, and

wherein the monitor means generates the secondcommand signal when the derived flow rate is less than a predetermined value.

18. A system according to claim 17

wherein the tubing is free of external liquid and pressure sensors.

19. In a peritoneal dialysis system comprising a source of liquid including source tubing communicating with the liquid source and a destination reservoir for collecting liquid including destination tubing communicating with the destination reservoir, liquid pumping apparatus including

a pump linking the source tubing to the destination tubing and operable:

in a first mode to draw liquid from the source through the source tubing and to expel the source liquid toward the destination reservoir through the destination tubing, and

in a second mode to draw collected liquid from the destination reservoir through the destination tubing and to expel the collected liquid toward the source through the source tubing,

means for operating the pump in the first mode to move source liquid from the source to the destination reservoir,

monitor means for generating a first command signal when the pump fails to draw liquid from the source through the source tubing and for generating a second command signal when the pump fails to expel liquid through the destination tubing toward the destination,

control means operative, in response to the first signal, for switching operation of the pump to the second mode to detect whether the pump expels liquid through the source tubing and, if so, registering an empty source condition and, if not, registering an occluded source tubing condition, the control means being further operative, in response to the second signal, for switching operation of the pump to the second mode to detect whether the pump draws liquid through the destination tubing and, if so, registering a full destination condition and, if not, registering an occluded destination tubing condition.

20. A method of monitoring liquid flow in a peritoneal dialysis system from a source to a destination through tubing using a pumping mechanism comprising the steps of

generating a first command signal when the pumping mechanism fails to move liquid from the source in the tubing toward the pumping mechanism, and

operating the pump mechanism in response to the first command signal to attempt to move liquid in the tubing from the pumping mechanism toward the source and, if successful, registering an empty source condition and, if not successful, registering an occluded source condition.

21. A method according to claim 20 and further including the steps of

generating a second command signal when the pumping mechanism fails to move liquid in the tubing from the pumping mechanism toward the destination, and

operating the pump mechanism, in response to the second command signal, to attempt to move liquid from the destination in the tubing toward the pumping mechanism and, if successful, registering a full destination condition and, if not successful, registering an occluded destination condition.

22. A method according to claim 20

wherein in the step of generating the first command signal, a liquid flow rate is derived by measuring liquid volume moved by the pumping mechanism over a prescribed time period and the first command signal is generated when the derived flow rate is less than a predetermined value.