Method and apparatus for kidney dialysis

• US 20050242034A1
• Filed: 07/05/2005
• Published: 11/03/2005
• Est. Priority Date: 04/19/1991
• Status: Active Grant

• Current Assignee: Bruce A. Peterson, Dalibor J. Smejtek, Harley D. Johnson, Jean M. Long, Mark E. Connell, Michael E. Hogard, Raymond Elsen, Robert A. Bedient, Thomas D. Kelly, William G. Preston Jr
• Original Assignee: Bruce A. Peterson, Dalibor J. Smejtek, Harley D. Johnson, Jean M. Long, Mark E. Connell, Michael E. Hogard, Raymond Elsen, Robert A. Bedient, Thomas D. Kelly, William G. Preston Jr
• 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 7,318,892 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

1-41. -41. (canceled)

42. A hemodialysis apparatus, comprising:

(a) means for delivering extracorporeal blood to a hemodialyzer and for controlling at least one extracorporeal-blood parameter selected from the group consisting of (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.

43. 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 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.

44. 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.

45. 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 an indicium corresponding to a parameter pertinent to operation of the first and second systems and to permit a user, by touching the indicium, to cause a change in the parameter.

46. 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 an indicium permitting the user to perform, using the touch screen, at least one step of a procedure for changing the setting of the parameter.

47. The apparatus of claim 46, wherein the parameter can have a value that changes with time.

48. The apparatus of claim 46, 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.

49. A hemodialysis apparatus, comprising:

(a) an extracorporeal-blood-delivery system for supplying extracorporeal blood to a hemodialyzer, the extracorporeal-blood-delivery system comprising at least one unit selected from the group consisting of (i) a blood-circulating unit, and (ii) a blood-monitoring unit; and

(b) a user/machine interface operably connected to the extracorporeal-blood-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 an indicium permitting the user to perform, using the touch screen, at least one step of a procedure for changing the setting of the parameter.

50. The apparatus of claim 49, wherein the blood-circulating unit comprises a blood pump.

51. The apparatus of claim 49, wherein the blood-monitoring unit comprises at least one of a blood-flowrate controller, a venous pressure monitor, and an arterial pressure monitor.

52. 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 user/machine interface operably connected to the dialysate-delivery system and the extracorporeal-blood-delivery system, the user/machine interface comprising a touch screen that displays information corresponding to a setting of a parameter pertinent to the hemodialysis machine, the touch screen being operable to display an indicium permitting the user to perform, using the touch screen, at least one step of a procedure for changing the setting of the parameter.

53. A hemodialysis machine, comprising:

(a) means for controlling a dialysate parameter selected from a group consisting of dialysate temperature and dialysate concentration, and means for delivering the dialysate to a dialysate compartment of a hemodialyzer; and

(b) a user/machine interface operably connected to said means for controlling the dialysate parameter, 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.

54. A hemodialysis apparatus, comprising:

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, the first and second systems each including a pump to deliver the respective extracorporeal blood and dialysate;

a touch screen connected to the first and second systems, the touch screen adapted to display an indicium corresponding to a parameter pertinent to operation of the first and second systems and to permit a user, by touching the indicium, to cause a change in the parameter.

55. A hemodialysis machine, comprising:

means for controlling a dialysate parameter selected from a group consisting of dialysate temperature and dialysate concentration, and means for delivering the dialysate to a dialysate compartment of a hemodialyzer;

a user/machine interface operably connected to said means for controlling the dialysate parameter, 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; and

a memory storing at least one of firmware and software that enables the user/machine to interface and control the means for controlling the dialysate parameter.