Method and apparatus for kidney dialysis

• US 7,303,680 B2
• Filed: 06/13/2003
• Issued: 12/04/2007
• 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:
  US10/461,272
• Publication Number:
  US 20030217972A1
• Time in Patent Office: 1,635 Days
• Field of Search: 210/85, 210/87, 210/90, 210/96.2, 210/321.65, 210/321.69, 210/321.72, 210/636, 210/646, 210/647, 210/739, 210/745, 210/929, 210/94, 210/143, 604/4.01, 604/5.01, 604/6.01, 604/6.09, 345/173, 700/273, 705/2, 705/3
• 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. A hemodialysis machine comprising:

at least one dialysate pump configured to move dialysate to a dialyzer;

a blood pump configured to move blood to the dialyzer; and

a video screen and at least one processor configured to

(a) enter a total time and a cumulative ultrafiltration value,

(b) automatically calculate a constant ultrafiltration rate from the cumulative ultrafiltration value and the total time,

(c) display the constant rate on the video screen,

(d) enable a plurality of ultrafiltration values as steps over time forming an ultrafiltration profile to be entered thereafter via selection of a profile ultrafiltration option displayed on the video screen,

(e) use the constant calculated rate so that the cumulative ultrafiltration value is removed, through the dialyzer, within or over the total time, according to the constant rate, or

(f) display a shape of the ultrafiltration profile on the video screen and use the ultrafiltration profile alternatively so that thereafter the cumulative ultrafiltration value is removed, within or over the total time, according to the values as steps over time of the ultrafiltration profile.

2. The hemodialysis machine of claim 1, wherein the video screen displays indicia corresponding to the ultrafiltration profile, the indicia selectable to enable the ultrafiltration profile to be entered.

3. The hemodialysis machine of claim 2, wherein the video screen is further configured to enable the total time and the cumulative ultrafiltration value to be entered after selection of the profile ultrafiltration option and before entry of the ultrafiltration profile.

4. The hemodialysis machine of claim 1, wherein the at least one processor is further configured to use the constant ultrafiltration rate unless the ultrafiltration profile is entered.

5. The hemodialysis machine of claim 1, which is configured to display the total time, cumulative ultrafiltration value and profile ultrafiltration option on a same screen of the video screen.

6. The hemodialysis machine of claim 1, which includes digits selectable to enter at least one of the cumulative ultrafiltration value and the total time.

7. The hemodialysis machine of claim 1, wherein the cumulative ultrafiltration value includes at least one of (i) a total ultrafiltration volume and (ii) a total amount of fluid loss per the treatment time.

8. The hemodialysis machine of claim 1, wherein the total time is a total treatment time.

9. The hemodialysis machine of claim 1, wherein the video screen is configured to display (i) a first screen showing the constant rate and (ii) a second screen showing the ultrafiltration profile.

10. The hemodialysis machine of claim 1, wherein the video screen is configured to display each of the entered total time, an entered cumulative ultrafiltration value, the constant ultrafiltration rate and the entered ultrafiltration profile.

11. A method of operating a dialysis machine including at least one dialysate pump configured to move dialysate to a dialyzer, a blood pump configured to move blood to the dialyzer, a video screen and at least one processor, the method comprising:

enabling a total time and a cumulative ultrafiltration value to be entered;

calculating a constant ultrafiltration rate by which the dialysis machine operates to remove the cumulative ultrafiltration value over the total time;

displaying the rate on the video screen;

displaying a profile ultrafiltration option on the video screen;

enabling a plurality of ultrafiltration values as steps over time forming an ultrafiltration profile to be entered thereafter via a selection of the profile ultrafiltration option;

removing the cumulative ultrafiltration value, through the dialyzer, within or over the total time, according to the constant ultrafiltration rate; and

if the ultrafiltration profile is entered, displaying a shape of the ultrafiltration profile on the video screen and removing the cumulative ultrafiltration value, within or over the total time, alternatively according to the values as steps over time of the ultrafiltration profile.

12. The method of claim 11, which includes displaying each of the entered total time, an entered cumulative ultrafiltration value, the calculated ultrafiltration rate and the entered ultrafiltration profile on the video screen.

13. The method of claim 11, which includes enabling the total time and the cumulative ultrafiltration value to be entered after selection of the profile ultrafiltration option and before entry of the ultrafiltration profile.

14. The method of claim 11, which includes enabling at least one of the total time and cumulative ultrafiltration value to be entered digitally.

15. The method of claim 11, wherein the cumulative ultrafiltration value includes at least one of (i) a total ultrafiltration volume and (ii) a total amount of fluid loss per the treatment time.

16. The method of claim 11, wherein entering the total time includes entering a total treatment time.

17. The method of claim 11, which includes at least one of:

calculating the constant ultrafiltration rate (i) automatically and (ii) from the entered total time and the cumulative ultrafiltration value, wherein the cumulative ultrafiltration value is a total ultrafiltration volume.

18. The method of claim 11, which includes enabling the ultrafiltration profile to be entered separately from an entry of the cumulative ultrafiltration value.

19. The method of claim 11, which includes removing the cumulative ultrafiltration value via the dialyzer, within or over the total time, according to the constant ultrafiltration rate unless the ultrafiltration profile is entered.