Dialysis machine with safety monitoring and a corresponding method for monitoring safety

• US 5,472,614 A
• Filed: 08/20/1993
• Issued: 12/05/1995
• Est. Priority Date: 12/30/1991
• Status: Expired due to Term

• Current Assignee: Gambro Hospal Schweiz AG
• Original Assignee: Hospal Ltd.
• Inventors: Rossi, Andrea
• Primary Examiner(s): Drodge, Joseph W.
• Application Number:
  US08/104,157
• Time in Patent Office: 837 Days
• Field of Search: 364/413.01, 364/413.02, 364/413.07, 364/550, 364/552, 364/579, 364/580, 210/85, 210/143, 210/321.71, 210/739, 210/646, 210/929, 210/96.2, 604/4-6
• US Class Current: 210/646
• CPC Class Codes: A61M 1/16 with membranes
• CPC Class Codes: A61M 1/1601 Control or regulation
• CPC Class Codes: A61M 2205/17 with redundant control systems
• CPC Class Codes: A61M 2205/18 with alarm
• CPC Class Codes: A61M 2205/50 with microprocessors or computers

Abstract

A dialysis machine (1) includes dialysis equipment (4), a control unit (2) controlling normal operation of the machine and a safety unit (3) for monitoring the machine with a view to the problem of patient safety. The control unit controls actuators (6) and receives information from its own sensors (13). The safety unit is connected to the control unit and receives from it parameters relevant to safety which have been measured by the sensors (13) of the control unit and its own sensors (15) to receive values of the parameters and other parameters. If any abnormality is found in the parameters measured, the safety unit sends commands (SSR) relating to safe states which have to be established to the control unit (2) which controls the actuators (6) in a corresponding way. The condition of the actuators is monitored by the safety unit (3) which uses suitable sensors (17) to determine whether the actuators have carried out the required actions, and if not, Switches off the machine with its own actuators (8).

Claims

1. A system for providing monitored treatment to a patient, comprising:

a dialysis unit for providing treatment to a patient;

a first group of actuators adapted for operating the dialysis unit;

a second group of actuators operative for shutting off operation of the dialysis unit when the system is set to a general safe condition;

a control unit operative for controlling the first group of actuators in accordance with set values of control parameters, set values of safety parameters, and actual values of the safety parameters determined using a first group of sensors;

a safety unit operatively connected to the dialysis unit and operative for monitoring at regular intervals actual values of the safety parameters and for selectively setting the system in the general safe condition;

the first group of sensors being communicatively connected to the control unit and operative for providing the control unit with information indicative of both the actual values of the safety parameters and treatment progress parameters, wherein at least a subgroup of the first group of sensors provides, through the control unit, the actual values of the safety parameters to the safety unit;

a second group of sensors communicatively connected to the safety unit and operative for providing the safety unit with information indicative of the actual values of both the safety parameters and parameters indicative of an operative condition of the safety unit; and

a third group of sensors communicatively connected to the safety unit operative for providing the safety unit with information indicative of an actual operative condition of the first group of actuators when the system is in the general safe condition, the third group of sensors being operative for communication with the safety unit in response to the safety unit detecting a patient endangering anomalous situation resulting from inconsistent information detected by one or more sensors of the first group or the second group.

2. The system according to claim 1, wherein the safety unit includes means for setting the system in the general safe condition in accordance with the actual values of the parameters indicative of an operative condition of the safety unit.

3. The system according to claim 1, wherein the safety unit includes means for setting the system in the general safe condition in accordance with the information indicative of an actual operative condition of the first group of actuators.

4. The system according to claim 1, wherein the safety unit includes means for receiving the set values of the control parameters.

5. The system according to claim 1, wherein the safety unit includes means for controlling the second group of actuators to shut off operation of the dialysis unit when the system is set in the general safe condition.

6. The system according to claim 1, further comprising an alarm actuator, connected to the safety unit, for producing an alarm upon occurrence of a preset alarm condition.

7. The system according to claim 1, further comprising an override unit connected to the safety unit for preventing the safety unit from setting the system in the general safe condition for a predetermined period of time upon command of an operator.

8. A method for monitoring a progressive extracorporeal blood treatment using a dialysis unit, a method comprising the steps of:

providing preset values of operating parameters and safety parameters;

treating a patient based on the preset values of the operating parameters and the safety parameters;

determining actual values of the operating parameters and the safety parameters using a first group of sensors;

determining actual values of the operating parameters and the safety parameters using a second group of sensors;

checking whether the actual values of the safety parameters determined using the first group of sensors are consistent with the preset values of the safety parameters and the actual values of the safety parameters determined using the second group of sensors;

setting the dialysis unit to a predetermined safety state when there exists an inconsistency between a preset safety parameter value, an actual safety parameter value determined using at least one of the first group of sensors, and an actual safety parameter value determined using at least one of the second group of sensors;

determining the treatment'"'"'s progress based on actual values of operating parameters determined using a third group of sensors; and

shutting off the dialysis unit at times when the treatment'"'"'s progress does not reach a predetermined level.

9. The method according to claim 8, further comprising, the step of triggering at least a first alarm upon determining that the determined values of the safety parameters using the first group of sensors are not consistent with the preset values of the safety parameters.

10. The method according to claim 9, further comprising, the step of triggering a second alarm upon determining that the determined values of the safety parameters using the first group of sensors are not consistent with the determined values of the safety parameters using the second group of sensors.

11. The method according to claim 10, wherein the first alarm is associated with a first safety state and the second alarm is associated with a second safety state.

12. The method according to claim 11, further comprising, determining a priority between the first safety state and the second safety state upon triggering of at least two alarms, and setting the dialysis unit to the one having a higher priority of the first safety state and second safety state.

13. The method according to claim 9, further comprising the step of overriding at least the first alarm.

14. The method according to claim 8, wherein a predetermined period of time is caused to lapse before the step of determining the treatment'"'"'s progress based on the determined values of the operating parameters using the third group of sensors and after the step of setting the dialysis unit to the safety state.

15. A system for providing monitored treatment to a patient, the system comprising:

a dialysis unit;

means for storing preset values of operating parameters and safety parameters;

means for controlling the dialysis unit to treat a patient based on the preset values of the operating parameters and the safety parameters;

a first group of sensors operative for determining actual values of the operating parameters, indicative of treatment progress, and the safety parameters;

a second group of sensors operative for determining actual values of the operating parameters and the safety parameters;

means for checking consistency between the actual values of the safety parameters determined using the first group of sensors, the preset values of the safety parameters, and the actual values of the safety parameters determined using the second group of sensors;

means for setting the dialysis unit to a predetermined safety state when the checking means detects an inconsistency between a preset safety parameter value, an actual safety parameter value determined using at least one of the first group of sensors, and an actual safety parameter value determined using at least one of the second group of sensors;

means for determining, when the dialysis unit is in the safety state, the treatment'"'"'s progress based on actual values of operating parameters determined using a third group of sensors; and

means for shutting off the dialysis unit at times when the treatment'"'"'s progress does not reach a predetermined level.