Method and apparatus for kidney dialysis

• US 20040084372A1
• Filed: 10/27/2003
• Published: 05/06/2004
• Est. Priority Date: 04/19/1991
• Status: Abandoned Application

• Current Assignee: Bruce A. Peterson, Dalibor J. Smejtek, Harley D. Johnson, Jean M. Long, Mark E. Connell, Michael E. Hogard, Raymond Elsen, Robert A. Bedient, Thomas D. Kelly, William G. Preston Jr
• Original Assignee: Bruce A. Peterson, Dalibor J. Smejtek, Harley D. Johnson, Jean M. Long, Mark E. Connell, Michael E. Hogard, Raymond Elsen, Robert A. Bedient, Thomas D. Kelly, William G. Preston Jr
• Inventors: Hogard, Michael E., Kelly, Thomas D., Elsen, Raymond, Smejtek, Dalibor J., Connell, Mark E., Johnson, Harley D., Preston, William G. Jr., Bedient, Robert A., Peterson, Bruce A., Long, Jean McEvoy
• Application Number:
  US10/695,526
• Publication Number:
  US 20040084372A1
• Time in Patent Office: Days
• US Class Current: 210/646
• CPC Class Codes: A61M 1/16 with membranes
• 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 1/165 with a dialyser bypass on the dialysis fluid line
• CPC Class Codes: A61M 1/1656 Apparatus for preparing dialysates
• CPC Class Codes: A61M 1/1664 with temperature control
• CPC Class Codes: A61M 1/1666 by dissolving solids
• 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 1/1686 by heat
• CPC Class Codes: A61M 1/1688 with recirculation of the sterilising fluid
• 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 2205/3313 used specific wavelengths
• 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 2205/3334 : 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: G06F 3/0482 : Interaction with lists of selectable items, e.g. menus
• CPC Class Codes: G06F 3/04847 : Interaction techniques to control parameter settings, e.g. interaction with sliders or dials
• 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
• CPC Class Codes: Y10S 210/929 : Hemoultrafiltrate volume measurement or control processes

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 a treatment parameter, the improvement comprising:

providing a touch screen interface with an indicia thereon corresponding to a treatment parameter;

touching the indicia;

in response to said touching, invoking a new keypad display on a region of the touch screen;

entering a numeric parameter corresponding to the treatment parameter by touching one or more buttons of the displayed keypad;

touching a first region of the keypad to signal end of entry of the numeric parameter;

displaying on the touch screen a button soliciting verification of the newly entered numeric parameter;

touching the button soliciting verification; and

in response to said actions, causing the treatment parameter to be changed;

wherein erroneous changes of treatment parameters are minimized.

2. The method of claim 1 which further includes removing the button soliciting verification from the screen if it is not touched within a predetermined period, said predetermined period being less than fifteen seconds.

3. The method of claim 1 which further includes:

establishing upper and lower limits for the parameter; and

displaying said limits on the screen when the keypad display is invoked to change the parameter, said limits being displayed at the location on the screen where the indicia corresponding to said parameter was displayed prior to the touching of said indicia.

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

providing a touch screen interface;

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

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

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

selecting one of said bars for alteration;

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

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

touching the screen at a third location to signify completion of the programming; and

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

5. The method of claim 4 which further includes:

presenting on the screen a first series of bars corresponding to historical values of the 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 parameter, said second series of bars being displayed with a second visually perceptible character different than the first; and

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

6. The method of claim 5 in which the process control system is a dialysis machine.

7. The method of claim 6 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 the total ultrafiltrate programmed to be removed from a patient.

8. A method of operating a dialysis machine to establish desired treatment parameters, the method comprising the steps:

providing first and second data card interface devices, the first device being associated with a computer, the second device being associated with the dialysis machine;

operating the computer in conjunction with the first data card interface device to load into a data card a set of desired treatment parameters, said set including parameters relating to three or more of the following;

ultrafiltration profile;

sodium profile;

bicarbonate profile;

blood pump flow rate;

treatment time;

dialysate flow rate;

dialysate temperature;

blood pressure measurement schedule;

blood pressure alarm limits; and

heparin prescription

operating the dialysis machine in conjunction with the second data card interface device to read from said data card said treatment parameters; and

for each of said parameters;

displaying on a display device associated with the dialysis machine said parameter;

querying, via the display device, whether the displayed parameter is correct and soliciting operator verification of same; and

establishing the displayed parameter as a treatment parameter only if the operator verifies said parameter.

9. A kidney dialysis machine comprising:

a dialyzer with a dialysate compartment, a blood to compartment separated from the dialysate compartment by a dialysis membrane, a dialysate input, a dialysate output, a blood input, and a blood output;

means for preparing dialysate and means for circulating the dialysate through a dialysate circuit, the dialysate circuit including the dialysate compartment, the dialysate input and the dialysate output of the dialyzer;

means for effecting extracorporeal circulation of blood from a dialysis patient through a blood circuit, the blood circuit including the blood compartment, the blood input, and the blood output of the dialyzer; and

means for effecting a preselected net passage of liquid from the blood compartment through the dialysis membrane to the dialysate compartment.

10. A kidney dialysis machine as recited in claim 9 further comprising:

a bypass valve in the dialysate circuit for automatically shunting dialysate flow away from the dialysate compartment; and

a flow sensor in the dialysate circuit for sensing that no dialysate is flowing to the dialysate compartment from the kidney dialysis machine whenever the bypass valve is shunting dialysate flow away from the dialysate compartment.

11. A kidney dialysis machine as recited in claim 9 further comprising:

a valve in the dialysate circuit adapted to automatically shunt dialysate away from the dialysate compartment; and

a flow sensor in the dialysate circuit for sensing that no net passage of liquid from the blood compartment to the dialysate compartment or from the dialysate compartment to the blood compartment occurs whenever said valve is shunting dialysate away from the dialysate compartment.

12. A kidney dialysis machine as recited in claim 9 wherein said means for effecting a preselected net passage of liquid from the blood compartment through the dialysis membrane to the dialysate compartment comprises means for delivering a first volume of dialysate to the dialysate compartment of the dialyzer, means for simultaneously removing a second volume of dialysate equal to the first volume from the dialysate compartment of the dialyzer, and an ultrafiltration flow meter situated in the dialysate circuit between said means for delivering the first volume and said means for delivering the second volume, the ultrafiltration flow meter operable to remove a preselected volume of liquid from the dialysate circuit between said means for delivering the first volume of dialysate and said means for removing a second volume of dialysate.

13. A kidney dialysis machine as recited in claim 12 including;

means for creating a volumetrically closed hydraulic loop in the dialysate circuit between said means for delivering the first volume and means for removing the second volume; and

pressure-monitoring means for monitoring hydraulic pressure in the closed loop against pressure alarm limits.

14. A kidney dialysis machine as recited in claim 13 operable to perform a self-test of said means for effecting a preselected net passage of liquid from the blood compartment through the dialysis membrane to the dialysate compartment, wherein the ultrafiltration flow meter removes a preset volume of liquid from the closed loop, and said pressure monitoring means monitors a corresponding drop in pressure in the closed loop for a preset amount of time against the pressure alarm limits.

15. A kidney dialysis machine as recited in claim 9 including means for individually preparing a first type of dialysate and means for individually preparing a second type of dialysate, wherein said means for preparing the first type of dialysate comprises a first concentrate pump, a first concentrate line coupled to the first concentrate pump and having a connector end, and a first rinse fitting adapted to receive the connector end of the first concentrate line;

and

said means for preparing the second type of dialysate comprises both said means for preparing the first type of dialysate and a second concentrate pump, a second concentrate line coupled to the second concentrate pump and having a connector end, and a second rinse fitting adapted to receive the connector end of the second concentrate line.

16. A kidney dialysis machine as recited in claim 15 further comprising proportioning-mode control means interfaced with said means for preparing the first type of dialysate and said means for preparing the second type of dialysate, said proportioning-mode control means operable to engage said means for preparing the first type of dialysate whenever the connector end of the second concentrate line is coupled to the second rinse fitting and to engage said means for preparing the second type of dialysate whenever the connector of the second concentrate line is not coupled to the second rinse fitting.

17. A kidney dialysis machine as recited in claim 16 wherein said proportioning-mode control means further comprises a proximity sensor provided in each of the first and second rinse fittings for sensing whether or not the connector end of the first concentrate line is connected to the first rinse fitting and whether or not the connector end of the second concentrate line is connected to the second rinse fitting.

18. A kidney dialysis machine as recited in claim 9 further comprising control means operable to determine an expected conductivity reading of the dialysate prepared by said means for preparing dialysate and to automatically set conductivity alarm limits around said expected conductivity reading.

19. A kidney dialysis machine as recited in claim 12 wherein said means for delivering a first volume of dialysate to the dialysate compartment of the dialyzer and said means for simultaneously removing a second volume of dialysate equal to the first volume from the dialysate compartment of the dialyzer collectively comprise a flow equalizer comprising a first chamber and a second chamber substantially equal in volume to the first chamber, each chamber divided by a flexible impermeable membrane into a “

pre-dialyzer”

compartment and a “

post-dialyzer”

compartment, the “

pre-dialyzer”

compartment of the first chamber and the “

post-dialyzer”

compartment of the second chamber operable to alternately fill and empty simultaneously, and the “

post-dialyzer”

compartment of the first chamber and the “

pre-dialyzer”

compartment of the second chamber operable to alternately fill and empty simultaneously alternately with the “

pre-dialyzer”

compartment of the first chamber and the “

post-dialyzer”

compartment of the second chamber.

20. A kidney dialysis machine as recited in claim 19 wherein each “

pre-dialyzer”

compartment has an inlet and an outlet and each “

post-dialyzer”

compartment has an inlet and an outlet, the flow equalizer further comprising inlet valves each having an outlet coupled to the inlet of a corresponding “

pre-dialyzer” and

“

post-dialyzer”

compartment, and outlet valves each having an inlet coupled to the outlet of a corresponding “

pre-dialyzer” and

“

post-dialyzer”

compartment, where the inlets of the valves coupled to the inlets of the “

pre-dialyzer”

compartments are coupled together and the inlets of the valves coupled to the inlets of the “

post-dialyzer”

compartments are coupled together so as to form a flow-equalizer inlet, and where the outlets of the valves coupled to the outlets of the “

pre-dialyzer”

compartments are coupled together and the outlets of the valves coupled to the outlets of the “

post-dialyzer”

compartments are coupled together so as to form a flow-equalizer outlet.

21. A kidney dialysis machine as recited in claim 20 further comprising first pressure equalizing means coupled to the inlet of the flow equalizer for equilibrating hydraulic pressures at the inlets of the “

pre-dialyzer” and

“

post-dialyzer”

compartments and second pressure equalizing means coupled to the outlet of the flow equalizer for equilibrating hydraulic pressures at the outlets of the “

pre-dialyzer” and

“

post-dialyzer”

compartments.

22. A kidney dialysis machine as recited in claim 21 further comprising sensing means for automatically determining end-of-stroke times for the first and second chambers of the flow equalizer.

23. A kidney dialysis machine as recited in claim 9 further comprising means for automatically turning on preselected machine functions after a preselected duration of a power-off condition.

24. A kidney dialysis machine as recited in claim 9 further comprising means for automatically preserving machine operating parameters during a power-off condition, the machine operating parameters including a value representing a net volume of liquid passed from the blood compartment through the dialyzer membrane to the dialysate compartment.

25. A kidney dialysis machine as recited in claim 9 adapted to effect extracorporeal circulation of blood using a blood-line set having at least one drip chamber for containing a volume of blood up to a preselected level in the chamber, the machine further comprising a drip chamber level adjuster including an automatically actuated valve having a first end coupled to the drip chamber and a second end coupled to a reversible positive-displacement pump, the pump and valve controllably actuatable to permit a machine operator to selectively raise and lower the level in the chamber.

26. A kidney dialysis machine as recited in claim 9 further comprising means for circulating the dialysate through the dialysate circuit at a preselected flow rate and means for circulating the dialysate through the dialysate compartment at a flow velocity in excess of a flow velocity corresponding to the preselected flow rate.

27. A kidney dialysis machine as recited in claim 9 further comprising:

means for circulating dialysate through the dialysate circuit at a preselected flow rate;

a blood-leak detector in the dialysate circuit located downstream of the dialysate compartment, the blood-leak detector including an LED for generating light for passing through the dialysate passing through the blood-leak detector, and a photodetector for receiving light from the LED that has passed through the dialysate in the blood-leak detector, where the LED generates light at an intensity that is proportional to the flow rate of the dialysate.

28. A kidney dialysis machine as recited in claim 9 further comprising electronic memory operable to store information selected from a group consisting of machine calibration data, past machine calibration dates, future machine calibration dates, and machine calibration procedures, and to retrieve said information on demand by a machine operator.

29. A kidney dialysis machine as recited in claim 29 further comprising a microprocessor operable to control operation of activatable machine components, receive data from said machine components pertaining to operational status of said machine components, generate warning messages if the machine components operate outside preset operational limits, store said warning messages in the electronic memory, and recall and display said warning messages on demand by a machine operator.

30. A hemodialysis apparatus, comprising:

(a) means for delivering extracorporeal blood to a hemodialyzer and for controlling at least one extracorporeal-blood parameter selected from the group consisting of (i) blood-flow rate, (ii) arterial pressure, (iii) venous pressure, and (iv) anticoagulant delivery to the extracorporeal blood; and

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

31. A hemodialysis apparatus, comprising:

(a) a dialysate-delivery system for supplying dialysate to a hemodialyzer, the dialysate-delivery system comprising at least one unit selected from the group consisting of (i) a dialysate preparation unit, (ii) a dialysate-circulation unit, (iii) an ultrafiltrate-removal unit, and (iv) a dialysate-monitoring unit; and

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

32. A hemodialysis apparatus, comprising:

(a) a dialysate-delivery system connectable to a hemodialyzer for supplying dialysate to the hemodialyzer, the dialysate-delivery system comprising at least one unit selected from the group consisting of (i) a dialysate-preparation unit, (ii) a dialysate-circulation unit, (iii) an ultrafiltrate-removal unit, and (iv) a dialysate-monitoring unit;

(b) an extracorporeal blood-delivery system connectable to the hemodialyzer for routing extracorporeal blood to the hemodialyzer in coordination with the dialysate-delivery system, the extracorporeal blood-delivery system comprising at least one unit selected from a group consisting of (i) a blood-circulating unit, and (ii) a blood-monitoring unit;

(c) a controller connected to and controllably operating the dialysate-delivery system and the extracorporeal blood-delivery system; and

(d) a touch screen connected to the controller, the touch screen adapted to display an indicium corresponding to a parameter pertinent to operation of the hemodialysis apparatus and to permit a user, by touching the indicium, to cause a change in the parameter.

33. A hemodialysis apparatus, comprising:

(a) first and second systems operably connected with each other, the first system being operable to deliver extracorporeal blood from a source to a blood compartment of a hemodialyzer, and the second system being operable to deliver dialysate from a source to a dialysate compartment of the hemodialyzer; and

(b) a touch screen connected to the first and second systems, the touch screen adapted to display an indicium corresponding to a parameter pertinent to operation of the first and second systems and to permit a user, by touching the indicium, to cause a change in the parameter.

34. A hemodialysis apparatus, comprising:

(a) a dialysate-delivery system for supplying dialysate to a hemodialyzer, the dialysate-delivery system comprising at least one unit selected from the group consisting of (i) a dialysate-preparation unit, (ii) a dialysate-circulation unit, (iii) an ultrafiltrate-removal unit, and (iv) a dialysate-monitoring unit; and

(b) a user/machine interface operably connected to the dialysate-delivery system, the user/machine interface comprising a touch screen that displays information corresponding to a setting of a parameter pertinent to operation of the hemodialysis machine, the touch screen being operable to display an indicium permitting the user to perform, using the touch screen, at least one step of a procedure for changing the setting of the parameter.

35. The apparatus of claim 34, wherein the parameter can have a value that changes with time.

36. The apparatus of claim 34, wherein the touch screen, responsive to an operator touching the indicium, is operable to display a numerical keypad that is touchable by the operator in performing the procedure for changing the setting of the parameter.

37. A hemodialysis apparatus, comprising:

(a) an extracorporeal-blood-delivery system for supplying extracorporeal blood to a hemodialyzer, the extracorporeal-blood-delivery system comprising at least one unit selected from the group consisting of (i) a blood-circulating unit, and (ii) a blood-monitoring unit; and

(b) a user/machine interface operably connected to the extracorporeal-blood-delivery system, the user/machine interface comprising a touch screen that displays information corresponding to a setting of a parameter pertinent to operation of the hemodialysis machine, the touch screen being operable to display an indicium permitting the user to perform, using the touch screen, at least one step of a procedure for changing the setting of the parameter.

38. The apparatus of claim 37, wherein the blood-circulating unit comprises a blood pump.

39. The apparatus of claim 37, wherein the blood-monitoring unit comprises at least one of a blood-flowrate controller, a venous pressure monitor, and an arterial pressure monitor.

40. A hemodialysis apparatus, comprising:

(a) a dialysate-delivery system connectable to a hemodialyzer for supplying dialysate to the hemodialyzer, the dialysate-delivery system comprising at least one unit selected from the group consisting of (i) a dialysate-preparation unit, (ii) a dialysate-circulation unit, (iii) an ultrafiltrate-removal unit, and (iv) a dialysate-monitoring unit;

(b) an extracorporeal-blood-delivery system connectable to the hemodialyzer for routing extracorporeal blood to the hemodialyzer in coordination with the dialysate-delivery system, the extracorporeal blood-delivery system comprising at least one unit selected from a group consisting of (i) a blood-circulating unit, and (ii) a blood-monitoring unit;

(c) a controller connected to and controllably operating the dialysate-delivery system and the extracorporeal-blood-delivery system; and

(d) a user/machine interface operably connected to the dialysate-delivery system and the extracorporeal-blood-delivery system, the user/machine interface comprising a touch screen that displays information corresponding to a setting of a parameter pertinent to the hemodialysis machine, the touch screen being operable to display an indicium permitting the user to perform, using the touch screen, at least one step of a procedure for changing the setting of the parameter.

41. 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 connected to said means for controlling the dialysate parameter, the user/machine interface comprising a touch screen adapted to display an indicium corresponding to a parameter pertinent to operation of the hemodialysis machine and to permit the user, by touching the indicium, to cause a change in the parameter.