Method and apparatus for kidney dialysis

• US 20030217972A1
• Filed: 06/13/2003
• Published: 11/27/2003
• Est. Priority Date: 04/19/1991
• Status: Active Grant

• 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
• Granted Patent: US 7,303,680 B2
• 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. A method of operating a dialysis machine, the machine including a user/machine interface used in changing a treatment parameter, the method comprising:

providing the dialysis machine with a data card interface as a portion of the user/machine interface that is configured to receive a value for the treatment parameter from a data card;

downloading the value from the data card; and

changing the treatment parameter to the downloaded value.

2. The method according to claim 1, wherein the treatment parameter includes at least one of an ultrafiltration profile, a sodium profile, a bicarbonate profile, a blood pump flow rate, a treatment time, a desired ultrafiltration removal volume, a dialysate flow rate, a dialysate temperature, a blood pressure measurement schedule and alarms, and a heparin prescription.

3. The method according to claim 1, further comprising:

providing a touch screen interface as part of the user/machine interface.

4. The method according to claim 3, further comprising:

prompting for a verification after downloading the treatment parameter; and

changing a previous treatment parameter stored in the machine to the treatment parameter only when the verification is received via the touch screen interface.

5. The method according to claim 4, wherein prompting for the verification includes displaying the treatment parameter on the touch screen.

6. The method according to claim 5, wherein the treatment parameter is displayed in a window corresponding to the particular treatment parameter and an indicium is displayed to indicate that the particular treatment parameter is presently being changed.

7. The method according to claim 1, wherein the data interface is configured to download patient parameters to the data card.

8. The method according to claim 7, wherein the patient parameters includes at least one of temporal data relating to dialysate temperature and conductivity, venous pressure, arterial pressure, dialysate pressure, systolic pressure, diastolic pressures, blood flow rate, total blood processed, ultrafiltration rate, total ultrafiltrate removed, an ultrafiltrate goal, and machine state.

9. The method according to claim 1, wherein the data card interface is further configured to receive a machine code that effects a special operation within the dialysis machine.

10. The method according to claim 9, wherein the special operation includes at least one of a calibration mode, a technician mode, enabling a blood pressure monitoring function, and modifying the parameters transmitted over a serial port for diagnostics.

11. The method according to claim 1, wherein the data card is a memory card including an EEPROM.

20. The apparatus according to claim 1, wherein the data card interface is further configured to receive a machine code that effects a special operation within the apparatus.

21. The apparatus according to claim 20, wherein the special operation includes at least one of a calibration mode, a technician mode, enabling a blood pressure monitoring function, and modifying the parameters transmitted over a serial port of the apparatus for diagnostics.

22. The apparatus according to claim 1, wherein the data card is a memory card including an EEPROM.

12. A kidney dialysis apparatus comprising:

a user/machine interface including a data card interface configured to read a treatment parameter from a data card; and

a controller configured to control reading and storing the treatment parameter from the data card and change an existing treatment parameter to the read treatment parameter.

13. The apparatus according to claim 12, wherein the treatment parameter includes at least one of an ultrafiltration profile, a sodium profile, a bicarbonate profile, a blood pump flow rate, a treatment time, a desired ultrafiltration removal volume, a dialysate flow rate, a dialysate temperature, a blood pressure measurement schedule and alarms, and a heparin prescription.

14. The apparatus according to claim 12, wherein the man/machine interface further includes a touch screen interface.

15. The apparatus according to claim 14, wherein the touch screen interface is configured to display a prompt for a verification after downloading the treatment parameter;

and change a previous treatment parameter stored in the apparatus to the treatment parameter only when the verification is received via the touch screen interface.

16. The apparatus according to claim 14, wherein prompting for the verification includes displaying the treatment parameter on the touch screen.

17. The apparatus according to claim 16, wherein the touch screen is further configured to display the treatment parameter in a window corresponding to the particular treatment parameter and display an indicium to indicate that the particular treatment parameter that is presently being changed.

18. The apparatus according to claim 12, wherein the data card interface is configured to download patient parameters to the data card.

19. The apparatus according to claim 18, wherein the patient parameters includes at least one of temporal data relating to dialysate temperature and conductivity, venous pressure, arterial pressure, dialysate pressure, systolic pressure, diastolic pressures, blood flow rate, total blood processed, ultrafiltration rate, total ultrafiltrate removed, an ultrafiltrate goal, and a state of the apparatus.

23. A dialysis apparatus, comprising:

a dialysate-delivery system configured to supply dialysate to a hemodialyzer, the dialysate-delivery system including at least one of a dialysate-preparation unit, a dialysate-circulation unit, an ultrafiltrate-removal unit, and a dialysate-monitoring unit; and

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 at least one treatment parameter pertinent to operation of the dialysis apparatus, the touch screen being operable to display an indicium at least one step of a procedure for changing the setting of the at least one treatment parameter; and

a data card interface configured to read at least one treatment parameter from a data card.

24. The apparatus according to claim 23 wherein the indicium is an icon that a user may select by touch on the touch screen interface to indicate initiation of a change the setting of the at least one treatment parameter.

25. The apparatus according to claim 23 wherein the user/machine interface is operable to display further indicia on the touch screen that permits the user to perform, using the touch screen, a procedure for changing the setting of the at least one treatment parameter.

26. The apparatus according to claim 23, wherein the at least one treatment parameter includes at least one of an ultrafiltration profile, a sodium profile, a bicarbonate profile, a blood pump flow rate, a treatment time, a desired ultrafiltration removal volume, a dialysate flow rate, a dialysate temperature, a blood pressure measurement schedule and alarms, and a heparin prescription.

27. The apparatus according to claim 23 wherein the touch screen is operable to display a plurality of indicia, each corresponding to a different treatment parameter.

28. The apparatus according to claim 23 wherein the touch screen is operable to display values for the treatment parameter.

29. The apparatus according to claim 23 wherein the user/machine interface is operable to prompt the user to verify a parameter after a value of the parameter is selected.

30. The apparatus according to claim 29, wherein the user/machine interface requires the user to verify the parameter using an indicium displayed on the touch screen.

31. The apparatus according to claim 23, wherein the touch screen interface is configured to display a prompt for a verification after downloading the treatment parameter from the data card;

and change a previous treatment parameter stored in the apparatus to the treatment parameter only when the verification is received via the touch screen interface.

32. The apparatus according to claim 31, wherein prompting for the verification includes displaying the treatment parameter on the touch screen.

33. The apparatus according to claim 23, wherein the touch screen is further configured to display the treatment parameter in a window corresponding to the particular treatment parameter and display an indicium to indicate that the particular treatment parameter that is presently being changed.

34. The apparatus according to claim 23, wherein the data card interface is configured to download patient parameters to the data card.

35. The apparatus according to claim 34, wherein the patient parameters includes at least one of temporal data relating to dialysate temperature and conductivity, venous pressure, arterial pressure, dialysate pressure, systolic pressure, diastolic pressures, blood flow rate, total blood processed, ultrafiltration rate, total ultrafiltrate removed, an ultrafiltrate goal, and a state of the apparatus.

36. The apparatus according to claim 23, wherein the data card interface is further configured to receive a machine code that effects a special operation within the apparatus.

37. The apparatus according to claim 36, wherein the special operation includes at least one of a calibration mode, a technician mode, enabling a blood pressure monitoring function, and modifying the parameters transmitted over a serial port of the apparatus for diagnostics.

38. The apparatus according to claim 23, wherein the data card is a memory card including an EEPROM.

39. A kidney dialysis machine comprising:

a dialyzer with a dialysate compartment, a blood 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;

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

means for controlling at least a portion of the dialysis machine and for receiving parameters from at least one of a touch screen interface and a data card.

40. The kidney dialysis machine according to claim 39, wherein the means for controlling is operably connected to a data card interface that is configured to download one or more of the parameters from a data card to a memory in the means for controlling.

41. The kidney dialysis machine according to claim 39, wherein the parameters include at least one of an ultrafiltration profile, a sodium profile, a bicarbonate profile, a blood pump flow rate, a treatment time, a desired ultrafiltration removal volume, a dialysate flow rate, a dialysate temperature, a blood pressure measurement schedule and alarms, and a heparin prescription.

42. The apparatus according to claim 39, wherein the touch screen interface is operable to display a plurality of indicia, each corresponding to a different treatment parameter.

43. The apparatus according to claim 39 wherein the touch screen interface is operable to display values for the parameter.

44. The apparatus according to claim 39 wherein the touch screen interface is operable to prompt the user to verify a parameter after a value of the parameter is selected.

45. The apparatus according to claim 39, wherein the touch screen interface requires the user to verify the parameter using an indicium displayed on the touch screen interface.

46. The apparatus according to claim 40, wherein the touch screen interface is configured to display a prompt for a verification after downloading parameters from the data card;

and the means for controlling changes a previous particular parameter stored in the memory to a downloaded parameter only after the verification is received via the touch screen interface.

47. The apparatus according to claim 46, wherein displaying the prompt for the verification includes displaying the treatment parameter on the touch screen.

48. The apparatus according to claim 39, wherein the touch screen is further configured to display the treatment parameter in a window corresponding to the particular treatment parameter and display an indicium to indicate that the particular treatment parameter that is presently being changed.

49. The apparatus according to claim 40, wherein the data card interface is configured to download patient parameters stored in the memory to the data card.

50. The apparatus according to claim 49, wherein the patient parameters include at least one of temporal data relating to dialysate temperature and conductivity, venous pressure, arterial pressure, dialysate pressure, systolic pressure, diastolic pressures, blood flow rate, total blood processed, ultrafiltration rate, total ultrafiltrate removed, an ultrafiltrate goal, and a state of the apparatus.

51. The apparatus according to claim 40, wherein the data card interface is further configured to receive a machine code that effects a special operation within the apparatus under the control of the means for controlling.

52. The apparatus according to claim 51, wherein the special operation includes at least one of a calibration mode, a technician mode, enabling a blood pressure monitoring function, and modifying the parameters transmitted over a serial port of the apparatus for diagnostics.

53. The apparatus according to claim 39, wherein the data card is a memory card including an EEPROM.

54. A method of using a memory data card to download and upload parameters to and from a dialysis machine having a user/machine interface that includes a touch screen and a memory card interface, the method comprising:

storing one or more parameters on a memory data card;

downloading the one or more parameters to the dialysis machine via the memory card interface;

displaying the downloaded parameters on the touch screen;

displaying a prompt for verification on the touch screen for each of the downloaded parameters;

receiving input verifications via the user/machine interface for each parameter desired to be changed; and

changing each existing parameter to a corresponding downloaded treatment parameter based on a corresponding received input verification.

55. The method according to claim 54, wherein the parameters comprise at least one of an ultrafiltration profile, a sodium profile, a bicarbonate profile, a blood pump flow rate, a treatment time, a desired ultrafiltration removal volume, a dialysate flow rate, a dialysate temperature, a blood pressure measurement schedule and alarms, and a heparin prescription.

56. The method according to claim 54, wherein the parameters include codes to initiate special operations where an input verification is not required to change the parameter.

57. The method according to claim 56, wherein the special operations includes at least one of a calibration mode, a technician mode, enabling a blood pressure monitoring function, and modifying the parameters transmitted over a serial port for diagnostics.

58. The method according to claim 54, further comprising:

uploading patient data to the memory card via the card reader interface.

59. The method according to claim 58, wherein the patient data include at least one of temporal data relating to dialysate temperature and conductivity, venous pressure, arterial pressure, dialysate pressure, systolic pressure, diastolic pressures, blood flow rate, total blood processed, ultrafiltration rate, total ultrafiltrate removed, an ultrafiltrate goal, and a state of the dialysis machine.

60. A method of operating a dialysis machine, the machine including a user/machine interface used in changing a treatment parameter, the method comprising:

providing the dialysis machine with a data card interface as a portion of the user/machine interface that is configured to receive a value for the treatment parameter from a data card, wherein the treatment parameter includes at least one of an ultrafiltration profile, a sodium profile, a bicarbonate profile, a blood pump flow rate, a treatment time, a desired ultrafiltration removal volume, a dialysate flow rate, a dialysate temperature, a blood pressure measurement schedule and alarms, and a heparin prescription;

downloading the value from the data card; and

changing of the treatment parameter to the downloaded value.

61. The method according to claim 60, further comprising:

providing a touch screen interface as part of the user/machine interface.

62. The method according to claim 61, further comprising:

prompting for a verification after downloading the treatment parameter; and

changing a previous treatment parameter stored in the machine to the treatment parameter only when the verification is received via the touch screen interface.

63. The method according to claim 62, wherein prompting for the verification includes displaying the treatment parameter on the touch screen.

64. The method according to claim 63, wherein the treatment parameter is displayed in a window corresponding to the particular treatment parameter and an indicium is displayed to indicate that the particular treatment parameter is presently being changed.

65. The method according to claim 60, wherein the data interface is configured to download patient parameters to the data card.

66. The method according to claim 65, wherein the patient parameters includes at least one of temporal data relating to dialysate temperature and conductivity, venous pressure, arterial pressure, dialysate pressure, systolic pressure, diastolic pressures, blood flow rate, total blood processed, ultrafiltration rate, total ultrafiltrate removed, an ultrafiltrate goal, and machine state.

67. The method according to claim 60, wherein the data card interface is further configured to receive a machine code that effects a special operation within the dialysis machine.

68. The method according to claim 67, wherein the special operation includes at least one of a calibration mode, a technician mode, enabling a blood pressure monitoring function, and modifying the parameters transmitted over a serial port for diagnostics.

69. The method according to claim 60, wherein the data card is a memory card including an EEPROM.