Method and apparatus for kidney dialysis using machine with programmable memory

• US 5,326,476 A
• Filed: 11/12/1992
• Issued: 07/05/1994
• Est. Priority Date: 04/19/1991
• Status: Expired due to Term

• Current Assignee: Baxter International Inc.
• Original Assignee: Althin Medical, Inc. (Baxter International Inc.)
• Inventors: Wolfe, Alan G., Grogan, Jeffrey B., Falkvall, Thore, Kelly, Thomas D., Johnson, Harley D.
• Primary Examiner(s): Drodge, Joseph W.
• Application Number:
  US07/975,523
• Time in Patent Office: 600 Days
• Field of Search: 364/188, 364/413.01, 364/413.02, 364/413.07, 364/502, 364/510, 364/190, 210/87, 210/143, 210/321.65, 210/321.71, 210/645, 210/646, 210/647, 210/729, 210/929, 422/48, 604/5, 604/65, 604/66, 364/190, 395/140, 395/155, 395/157, 395/924
• 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 1/1639 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 1/1666 by dissolving solids
• CPC Class Codes: A61M 1/1668 Details of containers
• CPC Class Codes: A61M 1/168 Sterilisation or cleaning before or after use
• CPC Class Codes: A61M 1/1682 both machine and membrane module, i.e. also the module blood side
• 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 2205/18 : with alarm
• 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 2205/3331 : 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
• 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: G06F 3/0488 : using a touch-screen or digitiser, e.g. input of commands through traced gestures
• CPC Class Codes: G16H 20/17 : delivered via infusion or injection
• CPC Class Codes: G16H 20/40 : relating to mechanical, radiation or invasive therapies, e.g. surgery, laser therapy, dialysis or acupuncture
• CPC Class Codes: Y10S 210/929 : Hemoultrafiltrate volume measurement or control processes

Abstract

Methods are disclosed for providing certain operational instructions to a hemodialysis machine. The hemodialysis machine possesses a programmable memory and a capability of operating according to a time-varying parameter such as variable ultrafiltration. According to the methods, the machine operator enters into the memory a desired time period, a target cumulative value of the time-varying parameter, such as target UF volume, and a proposed time-varying profile of the time-varying parameter that is representable as a plot of coordinates in a region defined by an ordinate of values of the parameter and a time-based abscissa, wherein the plot defines a profile cumulative value of the parameter. If the profile cumulative value is not equal to the target cumulative value, then the proposed time-varying profile is changed along the ordinate so that the profile cumulative value is made equal to the target cumulative value. The machine then operates according to the changed profile to enable the apparatus to achieve, while operating, the entered target cumulative value within the time period.

Claims

1. A method of providing operational instructions to a hemodialysis machine, having a programmable memory and having ultrafiltration capability, so as to enable the machine to perform ultrafiltration of fluid from a patient according to a time-variable ultrafiltration profile, the method comprising:

(a) entering into the programmable memory a prescribed time for dialysis;

(b) entering into the programmable memory a target ultrafiltration volume of fluid to be removed from the patient;

(c) entering into the programmable memory a proposed ultrafiltration profile being representable as a plot of coordinates on an ultrafiltration rate axis and a time axis and defining a profile ultrafiltration volume; and

(d) shifting the proposed ultrafiltration profile along the ultrafiltration rate axis to the degree necessary to make the profile ultrafiltration volume equal to the target ultrafiltration volume, so as to allow the hemodialysis machine to achieve, while ultrafiltrating the fluid according to the shifted ultrafiltration profile, the entered target ultrafiltration volume within the entered prescribed time.

2. A method of providing operational instructions to a hemodialysis machine having a programmable memory and having ultrafiltration capability so as to enable the machine to perform ultrafiltration of fluid from a patient according to a time-variable ultrafiltration profile, the method comprising:

(a) providing a user/machine interface configured as a touch screen operably connected to the hemodialysis machine;

(b) using the touch screen, entering into the programmable memory a prescribed time for dialysis;

(c) using the touch screen, entering into the programmable memory a target ultrafiltration volume of fluid to be removed from the patient;

(d) displaying on the touch screen first and second intersecting axes defining a ultrafiltration profile region, the first axis corresponding to ultrafiltration rate, and the second axis corresponding to time;

(e) touching the touch screen at a plurality of points within the ultrafiltration profile region so as to define a proposed continuous ultrafiltration rate-versus time profile defining a profile ultrafiltration volume; and

(f) shifting the proposed profile along the first axis to the degree necessary to make the profile ultrafiltration volume equal to the target ultrafiltration volume so as to allow the hemodialysis machine to achieve, while ultrafiltrating the fluid according to the shifted profile, the entered target ultrafiltration volume within the entered prescribed time.

3. A method of providing operational instructions to a hemodialysis machine having a programmable memory and having a capability of ultrafiltrating fluid from a patient according to a time-variable ultrafiltration profile, the method comprising:

(a) providing a user/machine interface configured as a touch screen operably connected to the hemodialysis machine;

(b) using the touch screen, entering into the programmable memory a prescribed time for dialysis;

(c) using the touch screen, entering into the programmable memory a target ultrafiltration volume of fluid to be removed from the patient;

(d) displaying the target ultrafiltration volume;

(e) while displaying the target ultrafiltration volume, displaying on the touch screen first and second intersecting axes defining an ultrafiltration profile region, the first axis corresponding to ultrafiltration rate, and the second axis corresponding to time;

within which ultrafiltration profile region an ultrafiltration rate-versus-time profile can be displayed which defines a profile ultrafiltration volume;

(f) providing a display of profile ultrafiltration volume; and

(g) while observing the displayed target ultrafiltration and profile ultrafiltration volumes, touching the touch screen at a plurality of points within the ultrafiltration profile region so as to define a ultrafiltration rate-versus time profile defining a profile ultrafiltration volume equal to the target ultrafiltration volume.

4. A method of providing operational instructions to a dialysate-producing machine having a user-programmable memory, a capability of changing sodium concentration in the dialysate according to a time-variable sodium profile, and a capability of ultrafiltrating fluid from a patient according to a time-variable ultrafiltration profile, so as to enable the machine to produce dialysate having particular sodium and ultrafiltration characteristics at various times during use of the machine for a dialysis procedure, the method comprising:

(a) providing a user/machine interface configured as a touch screen operably connected to the dialysate-producing machine;

(b) programming into the user-programmable memory a desired sodium profile;

(c) providing on the touch screen an indicium enabling a user of the machine to create an ultrafiltration profile that substantially conforms to the sodium profile;

(d) using the touch screen, displaying on the touch screen first and second intersecting axes defining a ultrafiltration profile region, the first axis corresponding to ultrafiltration rate, and the second axis corresponding to time; and

(e) touching the indicium provided in step (c) to cause the touch screen to display within the ultrafiltration profile region an ultrafiltration profile substantially conforming to the sodium profile programmed in step (b).

5. A method of providing operational instructions to a dialysate-producing machine having a memory and a capability of ultrafiltrating fluid from a patient according to a time-variable ultrafiltration profile, so as to enable the machine to produce dialysate having particular ultrafiltration characteristics at various times during use of the machine for a dialysis procedure, the method comprising:

(a) providing a user/machine interface configured as a touch screen operably connected to the dialysate-producing machine;

(b) programming into the memory a first ultrafiltration profile;

(c) providing on the touch screen an indicium enabling a user of the machine to recall the first ultrafiltration profile from the memory;

(d) using the touch screen, displaying on the touch screen first and second intersecting axes defining a ultrafiltration profile region, the first axis corresponding to ultrafiltration rate, and the second axis corresponding to time; and

(e) touching the indicium provided in step (c) to cause the touch screen to display within the ultrafiltration profile region a second ultrafiltration profile substantially conforming to the first ultrafiltration profile.

6. A method of providing operational instructions to a hemodialysis machine equipped with a programmable memory, so as to enable the machine to operate according to an operational parameter that can vary overtime, the method comprising:

(a) entering into the programmable memory a time period;

(b) entering into the programmable memory a target cumulative value corresponding to the operational parameter to be achieved while operating the machine during the time period;

(c) entering into the programmable memory a proposed time-varying profile of the operational parameter to be executed by the machine during the time period, the profile being representable as a plot of coordinates in a region defined by an ordinate of values of the parameter and a time-based abscissa, the plot defining a profile cumulative value of the parameter; and

(d) changing the proposed time-varying profile along the ordinate to the degree needed to make the profile cumulative value equal to the target cumulative value, so as to allow the hemodialysis machine to achieve, while operating, the entered target cumulative value within the time period.

7. In an apparatus for performing hemodialysis comprising means for circulating dialysate through a dialysate compartment of a hemodialyzer and means for effecting extracorporeal circulating of blood through a blood compartment of the hemodialyzer, an improvement comprising:

(a) programmable memory means;

(b) means for entering a time period into said memory means;

(c) means for entering into said memory means a target cumulative value of a time-varying parameter to be achieved while operating the apparatus during the time period;

(d) means for entering into said programmable memory means a proposed time-varying profile of the operational parameter to be executed by the apparatus during the time period, the proposed profile being representable as a plot of coordinates in a region defined by an ordinate of values of the parameter and a time-based abscissa, the plot defining a profile cumulative value of the parameter;

(e) means, responsive to the entered time period and entered proposed profile, for comparing the profile cumulative value with the target cumulative value;

(f) means, responsive to said means defined in (e), for changing the proposed profile along the ordinate so that the profile cumulative value is made equal to the target cumulative value;

(g) means for entering the changed profile into said memory means in place of the proposed profile; and

(h) means, responsive to said means defined in (g), for causing the apparatus to operate according to the changed shifted profile so as to enable the apparatus to achieve, while operating, the entered target cumulative value within the time period.