Method and apparatus for kidney dialysis

• US 7,318,892 B2
• Filed: 07/05/2005
• Issued: 01/15/2008
• Est. Priority Date: 04/19/1991
• Status: Expired due to Fees

• Current Assignee: Baxter International Inc.
• Original Assignee: Baxter International Inc.
• 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
• Primary Examiner(s): DRODGE, JOSEPH W
• Application Number:
  US11/175,072
• Publication Number:
  US 20050242034A1
• Time in Patent Office: 924 Days
• Field of Search: 210/85, 210/87, 210/90, 210/96.1, 210/96.2, 210/103, 210/134, 210/137, 210/143, 210/257.2, 210/259, 210/321.6, 210/321.65, 210645-647, 210/650, 210/739, 210/767, 345/173, 700/83, 604/4.01, 604/5.01, 604/65, 604/67
• US Class Current: 210/94
• 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. A hemodialysis apparatus, comprising:

(a) means for delivering extracorporeal blood to a hemodialyzer and for monitoring or controlling (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, the touch screen also adapted to display a time-variable profile of the parameter, the profile being representable as a plot of coordinates, the plot being with respect to an ordinate of values of the parameter and a time-based abscissa, the touch screen being further adapted to distinguish past from future time intervals of the parameter during treatment by coloring the past and future time intervals within the plot of the time-variable profile differently.

2. The apparatus of claim 1, the touch screen further enabling future but not past time intervals of the parameter of the plot to be modified.

3. 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, the touch screen also adapted to display a time-variable profile of the parameter, the profile being representable as a plot of coordinates, the plot being with respect to an ordinate of values of the parameter and a time-based abscissa, the touch screen being further adapted to distinguish past from future time intervals of the parameter during treatment by coloring the past and future time intervals within the plot of the time-variable profile differently.

4. 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 a time-variable profile of an operational parameter, the profile being representable as a plot of coordinates, the plot being with respect to an ordinate of values of the operational parameter and a time-based abscissa, and wherein the touch screen is further adapted to distinguish past from future time intervals of the operational parameter during treatment within the plot of the time-variable profile.

5. 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 a time-variable profile of the operational parameter, the profile being representable as a plot of coordinates, the plot being with respect to an ordinate of values of the operational parameter and a time-based abscissa, and wherein the touch screen is further adapted to distinguish past from future time intervals of the operational parameter during treatment within the plot of the time-variable profile.

6. The apparatus of claim 5, wherein the touch screen is adapted to distinguish the intervals by coloring the past and future time intervals within the plot of the time-variable profile differently.

7. The apparatus of claim 5, 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.