Apparatus for kidney dialysis

• US 5,744,027 A
• Filed: 06/07/1995
• Issued: 04/28/1998
• Est. Priority Date: 04/19/1991
• Status: Expired due to Term

• Current Assignee: Baxter International Inc.
• Original Assignee: Althin Medical, Inc.
• Inventors: Smejtek, Dalibor J., Bedient, Robert A., Hogard, Michael E., Kelly, Thomas D., Elsen, Raymond, Connell, Mark E., Johnson, Harley D., Preston, William G. Jr., Peterson, Bruce A., Long, Jean McEvoy
• Primary Examiner(s): Drodge, Joseph W.
• Application Number:
  US08/479,688
• Time in Patent Office: 1,056 Days
• Field of Search: 210/85, 210/96.2, 210/138, 210/139, 210/140, 210/143, 210/195.2, 210/321.6, 210/636, 210/645, 210/646, 210/746, 210/929, 210/321.69, 210/321.71, 210/647, 604/4-6, 73/1-3
• US Class Current: 210/96.2
• 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 kidney dialysis machine comprising:

(a) means for circulating dialysate at a dialysate conductivity through a dialysate circuit including a dialysate compartment for a dialyzer;

(b) means for circulating blood from a dialysis patient through an extracorporeal blood circuit including a blood compartment of the dialyzer; and

(c) control means operable to receive chemical-composition data reflecting a particular selection of dialysate to be circulated and to calculate from the data an expected conductivity reading of the dialysate and to automatically set conductivity alarm limits around the expected conductivity reading.

2. A kidney dialysis machine as recited in claim 1 wherein said control means comprises means for receiving data regarding expected conductivity values of dialysates made from various concentrates, and means for processing the data so as to compare actual dialysate conductivity values against the corresponding expected conductivity value.

3. A kidney dialysis machine comprising:

(a) means for circulating dialysate at a dialysate conductivity through a dialysate circuit including a dialysate compartment for a dialyzer;

(b) means for circulating blood from a dialysis patient through an extracorporeal blood circuit including a blood compartment of the dialyzer; and

(c) control means operable to determine an expected conductivity reading of the dialysate and to automatically set conductivity alarm limits around the expected conductivity reading, wherein said control means comprises means for receiving a response from a machine operator indicating that the actual conductivity value for a dialysate is correct and, if the actual conductivity is different from the corresponding calculated conductivity value, to determine a ratio of the actual conductivity value over the calculated conductivity value, and to apply said ratio to setting the conductivity alarm limits.

4. A kidney dialysis machine comprising:

(a) means for circulating dialysate through a dialysate circuit including a dialysate compartment of a dialyzer;

(b) means for circulating blood from a dialysis patient through an extracorporeal blood circuit including a blood compartment of the dialyzer; and

(c) a memory, the machine being operable to periodically save in said memory parameters associated with operation of the machine, the machine including means for automatically recalling from the memory, after a preselected duration of a power-off condition, the parameters according to which the machine was operating at the onset of the power-off condition.

5. A kidney dialysis machine as recited in claim 4 wherein the parameters include operational modes selected from a group consisting of machine disinfection, machine rinsing, and beginning production of dialysate.

6. A kidney dialysis machine comprising:

(a) means for circulating dialysate through a dialysate circuit including a dialysate compartment of a dialyzer;

(b) means for circulating blood from a dialysis patient through an extracorporeal blood circuit including a blood compartment of the dialyzer; and

(c) a memory for storing data including a value representing a net cumulative volume of liquid passed from the blood compartment to the dialysate compartment during a dialysis treatment performed using the machine, the machine being operable to automatically preserve in the memory, during a preselected duration of a power-off condition, said value and to restore machine operation according to said value when power is restored to the machine.

7. A kidney dialysis machine, comprising:

(a) a dialysate pump for circulating dialysate at a dialysate conductivity through a dialysate circuit including a dialysate compartment for a dialyzer; and

(b) a controller operable to receive non-conductivity data concerning a particular selection of dialysate to be circulated and to calculate from the data an expected conductivity reading of the dialysate.

8. The kidney dialysis machine of claim 7, wherein the controller automatically sets conductivity alarm limits around the expected conductivity reading.

9. The kidney dialysis machine of claim 8, wherein the conductivity alarm limits automatically set by the controller are at ±

5 percent of the expected conductivity reading.

10. The kidney dialysis machine of claim 7, further comprising a data input device connected to the controller, the data input device being for use by an operator of the machine to provide the data to the controller.

11. The kidney dialysis machine of claim 10, wherein the data input device comprises a touch screen.

12. The kidney dialysis machine of claim 7, further comprising a memory connected to the controller, the memory being operable to store data concerning an electrolytic profile of the dialysate resulting from a baseline dilution of a respective dialysate concentrate with water, the controller recalling the data from the memory when called upon to calculate the expected conductivity of the dialysate made using the dialysate concentrate.

13. The kidney dialysis machine of claim 12, wherein the memory stores an algorithm for calculating the expected conductivity of the dialysate made from the dialysate concentrate, the algorithm being recalled from the memory by the controller when the controller is called upon to calculate the expected conductivity of the dialysate made from the dialysate concentrate.

14. The kidney dialysis machine of claim 7, further comprising a proportioning pump for diluting a dialysate concentrate at a proportioning ratio with water to make the dialysate.

15. The kidney dialysis machine of claim 14, wherein the proportioning ratio is variable.

16. The kidney dialysis machine of claim 15, wherein the controller recalculates the expected dialysate conductivity and sets new conductivity alarm limits around the recalculated expected dialysate conductivity whenever the proportioning ratio is changed.