Method and apparatus for kidney dialysis

• US 5,247,434 A
• Filed: 04/19/1991
• Issued: 09/21/1993
• Est. Priority Date: 04/19/1991
• Status: Expired due to Term

• Current Assignee: Baxter International Inc.
• Original Assignee: Althin Medical, Inc.
• Inventors: Hogard, Michael E., Kelly, Thomas D., Johnson, Harley D., Preston, William G. Jr., Peterson, Bruce A., Long, Jean M.
• Primary Examiner(s): Smith, Jerry
• Assistant Examiner(s): GORDON, PAUL P
• Application Number:
  US07/688,174
• Time in Patent Office: 886 Days
• Field of Search: 364/188, 364/189, 364/413.02, 364/413.04, 364/413.07, 364/413.09, 340/712, 340/722, 340/711, 210/646, 604/65, 604/66
• US Class Current: 700/83
• CPC Class Codes: A61M 1/16 with membranes
• CPC Class Codes: A61M 1/1601 Control or regulation
• CPC Class Codes: A61M 1/1607 before use, i.e. upstream of dialyser
• CPC Class Codes: A61M 1/1613 Profiling or modelling of patient or predicted treatment evolution or outcome
• CPC Class Codes: A61M 1/1639 linked by membranes
• CPC Class Codes: A61M 1/165 with a dialyser bypass on the dialysis fluid line
• CPC Class Codes: A61M 1/1656 Apparatus for preparing dialysates
• CPC Class Codes: A61M 1/166 Heating for sterilisation A61M1/1686
• CPC Class Codes: A61M 1/1662 with heat exchange between fresh and used dialysate
• CPC Class Codes: A61M 1/1664 with temperature control
• CPC Class Codes: A61M 1/168 Sterilisation or cleaning before or after use
• CPC Class Codes: A61M 1/1684 Checking the module characteristics before reuse
• CPC Class Codes: A61M 1/169 using chemical substances
• CPC Class Codes: A61M 1/1692 Detection of blood traces in dialysate
• CPC Class Codes: A61M 1/1694 with recirculating dialysing liquid
• CPC Class Codes: A61M 1/341 by measuring the filtrate rate or volume
• CPC Class Codes: A61M 1/3626 Gas bubble detectors
• CPC Class Codes: A61M 2039/1005 Detection of disconnection
• CPC Class Codes: A61M 2205/18 with alarm
• CPC Class Codes: A61M 2205/3317 Electromagnetic, inductive or dielectric measuring means
• CPC Class Codes: A61M 2205/3324 : PH measuring means
• CPC Class Codes: A61M 2205/3331 : Pressure; Flow
• CPC Class Codes: A61M 2205/3334 : Measuring or controlling the flow rate
• CPC Class Codes: A61M 2205/3368 : Temperature
• CPC Class Codes: A61M 2205/505 : Touch-screens; Virtual keyboard or keypads; Virtual buttons; Soft keys; Mouse touches
• CPC Class Codes: A61M 2205/52 : with memories providing a history of measured variating parameters of apparatus or patient
• CPC Class Codes: A61M 2205/705 : Testing of filters for leaks blood in dialysate A61M1/1692
• CPC Class Codes: G06F 3/0482 : Interaction with lists of selectable items, e.g. menus
• CPC Class Codes: G06F 3/0488 : using a touch-screen or digitiser, e.g. input of commands through traced gestures

Abstract

A number of improvements relating to methods and apparatuses for kidney dialysis are disclosed. These include checking of dialysate bypass status using flow measurement; using a flow sensor to confirm the absence of ultrafiltration during bypass; automatic testing of ultrafiltration function by removal of a discrete volume from a portion of the dialysate flow path coupled with a pressure test of that part of the flow path; using a touch screen user interface; bar graph profile programming of ultrafiltration, sodium, and bicarbonate parameters; using a RAM card to upload treatment instructions to, and to download treatment data from, the machine; automatic setting of proportioning mode (acetate or bicarbonate) based on connections of concentrate lines; predicting dialysate conductivity values based on brand and formulation of concentrates; minimizing no-flow dead time between dialysate pulses; initiating operation in a timed mode from a machine power-off condition; preserving machine mode during machine power-fail condition; calibration scheduling and reminding; automatic level adjusting; and blood leak flow rate detecting.

Claims

1. In a method of operating a hemodialysis machine, an improvement in a man/machine interfacing process used in changing and setting a treatment parameter, the improvement comprising:

(a) providing a touch screen interface with an indicium thereon corresponding to a treatment parameter;

(b) touching the indicium;

(c) in response to said touching, invoking a data-entry display on a region of the touch screen;

(d) entering a parametric value corresponding to the treatment parameter by touching one or more buttons of the data-entry display;

(e) touching a first region of the data-entry display to signal entry of the parametric value;

(f) displaying on the touch screen a button soliciting verification of the newly entered parametric value;

(g) touching the button soliciting verification; and

(h) in response to steps (b)-(g), causing the parametric value corresponding to the treatment parameter to be changed, wherein erroneous changes of said parametric values are minimized.

2. The method of claim 1 which further includes removing the button soliciting verification from the screen if said button is not touched within a predetermined period.

3. The method of claim 2 wherein the predetermined period is less than fifteen seconds.

4. The method of claim 1 which further includes:

establishing upper and lower limits corresponding to a range of permissible parametric values of the treatment parameter; and

displaying said limits on the screen when the data-entry display is invoked to change the parametric value, said limits being displayed at the location on the screen where the indicium corresponding to said treatment parameter was displayed prior to the touching of said indicium.

5. The method of claim 1 wherein step (f) further comprises prompting verification of the newly entered parametric value.

6. The method of claim 5 wherein said prompting comprises highlighting said button.

7. The method of claim 1 wherein, in steps (c), (d), and (e), the data-entry display is a keypad displayed on the touch screen.

9. The method of claim 6 which further includes:

presenting on the screen a first series of bars corresponding to historical values of the time-varying parameter, said first series of bars being displayed with a first visually perceptible character;

displaying on the screen a second series of bars corresponding to upcoming programmed values of the time-varying parameter, said second series of bars being displayed with a second visually perceptible character different from the first visually perceptible character; and

permitting only bars of the second series to be selected for alteration.

10. The method of claim 9 in which the process control system is a dialysis machine.

11. The method of claim 10 in which the time-varying parameter is ultrafiltration, and in which the method further includes displaying on the screen a numeric parameter corresponding to an area under the parameter-versus-time curve, said area representing a total amount of ultrafiltrate to be removed from a patient.

8. A method of programming a time-varying parameter in a process-control system, the method comprising the steps:

(a) providing a touch screen interface;

(b) displaying on the touch screen first and second axes, the first axis corresponding to the time-varying parameter, the second axis corresponding to time;

(c) touching the touch screen at a plurality of points to define points on a parameter-versus-time curve;

(d) presenting on the touch screen a series of bars corresponding to said curve;

(e) selecting one of said bars for alteration;

(f) displaying on the screen a numeric parameter corresponding to the selected bar;

(g) touching the screen at first or second locations to increase or decrease, respectively, the displayed numeric parameter and thereby alter the value of the numeric parameter to which the selected bar corresponds;

(h) touching the screen at a third location to signify completion of steps (b)-(g); and

(i) storing data corresponding to the bars in a memory to which the process-control system can refer in changing the time-varying parameter with time.

12. In a method of operating a hemodialysis machine, an improvement in a user/machine interfacing process, the improvement comprising:

(a) providing a touch screen operably coupled to the machine, the touch screen adapted to display an indicium soliciting a user of the machine to touch a region on the screen so as to select a machine-operation parameter;

(b) touching the region to select the machine operation parameter;

(c) in response to said touching, invoking on the screen a data-entry display associated with the machine-operation parameter, the data-entry display including a display of a permissibly settable range of the machine-operation parameter, so as to allow the user to select and enter a parametric value associated with the machine-operation parameter within said range; and

(d) touching the data-entry display to select and enter the parametric value so as to cause the machine to operate in conformance with the selected machine-operation parameter and the entered parametric value.

13. The method of claim 12 wherein the data-entry display of step (c) comprises a keypad display comprising multiple buttons each corresponding to a discrete numerical digit, the buttons adapted to enable the user to select a numerical value of the machine-operation parameter.

14. The method of claim 12 further comprising the step, after step (d), of invoking on the screen a display of the value of the machine-operation parameter selected by the user in step (d).

15. The method of claim 14 wherein the step of involving on the screen a display of the value of the machine-operation parameter comprises involving a digital display of said parameter.

16. The method of claim 14 wherein the step of invoking on the screen a display of the value of the machine-operation parameter comprises invoking a graphical display of said parameter.

17. The method of claim 16 wherein the step of involving on the screen a display of the value of the machine-operational parameter comprises involving a bargraph display of said parameter.

18. The method of claim 14 wherein the step of invoking on the screen a display of the value of the machine-operation parameter comprises involving an analog display of said parameter.

19. In a method of operating a hemodialysis machine capable of operating in any of plurality operating modes, an improvement in a user/machine interfacing process, the improvement comprising:

(a) providing a touch screen operably coupled to the machine, the touch screen adapted to display a mode-select indicium soliciting a user of the machine to touch a first region on the screen corresponding to an operating mode;

(b) touching the first region to select the corresponding operating mode;

(c) prompting the user to confirm the operating mode selected in step (b) so as to prevent unintentional changing of machine operating modes;

(d) confirming selection of the operating mode so as to cause the machine to operate in said operating mode.

20. The method of claim 19 further comprising the step, after step (d), of invoking on the screen a display comprising an operating indicium, corresponding to said operating mode, that solicits the user to touch a second region on the screen so as to select a machine-operation parameter corresponding to said operating mode.

21. The method of claim 20 further comprising the step, of touching the second region to select the machine operation parameter.

22. The method of claim 21 further comprising the step, in response to touching the second region, of invoking on the screen a data-entry display associated with the machine-operation parameter, the data-entry display soliciting the user to select and enter a parametric value associated with the parameter.

23. The method of claim 22 further comprising the step, after invoking the data-entry display, of touching the data-entry display to select an enter the parametric value so as to cause the machine to operate in conformance wit the selected machine-operation parameter and the entered parametric value associated with the parameter.

24. The method of claim 19 wherein step (c) comprises invoking on the screen a mode-verify indicium.

25. The method of claim 24 wherein step (d) comprises touching the mode-verify indicium to confirm selection of the corresponding operating mode.

26. A hemodialysis machine comprising:

(a) means for controlling a dialysate parameter selected from a group consisting of dialysate temperature and dialysate concentration, and means for delivering the dialysate to a dialysate compartment of a hemodialyzer; and

(b) a user/machine interface operably coupled to said dialysate-delivery means, the user/machine interface comprising a touch screen adapted to display an indicium corresponding to a parameter pertinent to operation of the hemodialysis machine for performing hemodialysis and to permit the user, by touching the indicium, to cause a change in the parameter.

27. The hemodialysis machine according to claim 26 wherein the touch screen further provides an indicium soliciting, from the user, programmed settings of a time-varying machine-operating parameter.

28. The hemodialysis machine according to claim 26 further comprising means for delivering blood at a prescribed flow rate from a patient, through a blood compartment of a hemodialyzer, and back to the patient, wherein the touch screen further provides a visual display of a parameter associated with said means for delivering blood.

29. The hemodialysis machine according to claim 28 wherein the parameter associated with said means for delivering blood is selected from a group consisting of blood flow rate, arterial blood pressure, and venous blood pressure.

30. The hemodialysis machine according to claim 26 further comprising means for delivering an anticoagulant to a patient. wherein the touch screen further provides an indicium soliciting input from the user corresponding to a rate of anticoagulant delivery.

31. The hemodialysis machine according to claim 26 wherein the touch screen further provides an indicium soliciting, from the user, a programmed setting of an alarm limit about the machine-operating parameter.

32. In a method of operating a hemodialysis machine, an improvement in a man/machine interfacing process used in changing and setting a treatment parameter, the improvement comprising:

(a) providing a touch screen interface with a parameter-select indicium thereon;

(b) touching the parameter-select indicium;

(c) in response to said touching, invoking on the touch screen a value-select indicium and a value-enter indicium;

(d) touching the value-select indicium to select a parametric value corresponding to the treatment parameter;

(e) touching the value-enter indicium to enter the parametric value; and

(f) in response to steps (b)-(e), comparing the entered parametric value against preset limits corresponding to a permissible operational range for said parametric value and, if the entered parametric value is within said limits, causing the treatment parameter to operate in accordance with the entered parametric value.

33. In a method of operating a hemodialysis machine, an improvement in a man/machine interfacing process used in changing and setting a treatment parameter, the improvement comprising:

(a) providing a touch screen interface with a parameter-select indicium thereon;

(b) touching the parameter-select indicium;

(c) in response to said touching, invoking on the touch screen a value-select indicium and a value-enter indicium;

(d) touching the value-select indicium to select a parametric value corresponding to the treatment parameter;

(e) touching the value-enter indicium to enter the parametric value; and

(f) in response to steps (b)-(e), invoking an alarm limit to be set at a preset increment relative to the entered parametric value so as to enable an alarm signal to be triggered whenever, during subsequent operation of the hemodialysis machine, the parametric value passes outside the alarm limit.

34. In a method of operating a hemodialysis machine, an improvement in a user/machine interfacing process, the improvement comprising:

(a) providing a touch screen operably coupled to the machine, the touch screen adapted to display an indicium soliciting a user of the machine to touch a region on the screen so as to cause the screen to display a machine-operation parameter;

(b) touching the region on the screen;

(c) in response to said touching, invoking on the screen an analog display associated with the machine-operation parameter, the analog display including a display of a previously set value of the machine-operation parameter and allowing the suer to select and enter a desired value associated with the machine-operation parameter; and

(d) touching the data-entry display to select and enter the desired value of the machine-operation parameter so as to cause the machine to operate in conformance with the desired value.