METHOD AND DEVICE TO EARLY PREDICT THE Kt/V PARAMETER IN KIDNEY SUBSTITUTION TREATMENTS

• US 20110163034A1
• Filed: 09/15/2009
• Published: 07/07/2011
• Est. Priority Date: 09/15/2008
• Status: Active Grant

• Current Assignee: B. Braun Avitum AG (B. Braun Holding GmbH & Co. KG)
• Original Assignee: B. Braun Avitum AG (B. Braun Holding GmbH & Co. KG)
• Inventors: Castellarnau, Alex
• Granted Patent: US 8,568,595 B2
• Time in Patent Office: Days
• US Class Current: 210/646
• CPC Class Codes: A61M 1/16 with membranes
• CPC Class Codes: A61M 1/1609 after use, i.e. downstream of dialyser
• CPC Class Codes: A61M 1/1613 Profiling or modelling of patient or predicted treatment evolution or outcome
• CPC Class Codes: A61M 2202/0498 Urea
• CPC Class Codes: A61M 2205/15 Detection of leaks
• 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 2205/3344 Measuring or controlling pressure at the body treatment site
• CPC Class Codes: A61M 2205/50 with microprocessors or computers
• CPC Class Codes: A61M 2230/65 Impedance, e.g. conductivity, capacity

Abstract

A method for determining or predicting the adequacy parameters that will be achieved at the end of a kidney substitution treatment during said kidney substitution treatment wherein the kidney substitution treatment is provided by a machine, which has an extracorporeal blood system pumping the patient blood through the blood chamber of a dialyzer, wherein the dialyzing fluid collects the waste products from the patient after flowing through the dialyzing fluid chamber of the dialyzer and wherein a device able to measure a adequacy parameter is coupled with the kidney substitution treatment machine and wherein the slope of a preferable linear guideline for the adequacy parameter is compared to the slope of the delivered adequacy parameter and if the slope of both are equal a linearization is performed to determine or predict the adequacy parameter at the end of the kidney substitution treatment.

Claims

1-20. -20. (canceled)

21. A method for determining or predicting the adequacy parameters that will be achieved at the end of a kidney substitution treatment during said kidney substitution treatment, the method comprising the steps of:

providing the kidney substitution treatment by a machine having an extracorporeal blood system for pumping blood of a patient at a preset blood flow rate through a blood chamber of a dialyzer, the dialyzer divided by a semi-permeable membrane into the blood chamber and a dialyzing fluid chamber,

flowing the dialyzing fluid at a preset flow rate through the dialyzing fluid chamber of the dialyzer to collect waste products from the patient after flowing through the dialyzing fluid chamber of the dialyzer,

measuring continuously with a device any kidney substitution treatment related waste product to deliver together with data provided by the kidney substitution treatment machine an adequacy parameter, wherein the device is coupled with the dialyzer of the kidney substitution treatment machine, and

comparing the slope of a preferable linear guideline for the adequacy parameter, which ends at a target adequacy parameter at the end of the kidney substitution treatment, to the slope of the delivered adequacy parameter and if the slopes are equal with the next delivered adequacy parameters a linearization is performed to determine or predict the adequacy parameter at the end of the kidney substitution treatment.

22. The method according to claim 21, wherein the kidney substitution treatment is selected from a group consisting of double needle hemodialysis, single needle hemodialysis, single needle cross over hemodialysis, post-dilution hemodiafiltration, pre-dilution hemodiafiltration, pre-post-dilution hemodiafiltration, post-dilution hemofiltration, pre-dilution hemofiltration, pre-post-dilution hemofiltration, and sequential hemodialysis.

23. The method according to claim 21, wherein the adequacy parameter is selected from a group consisting of Kt/V, single pool Kt/V, and equilibrated Kt/V of any waste product present in the dialyzing fluid of the kidney substitution treatment.

24. The method according to claim 21, wherein the adequacy parameter is selected from a group consisting of the reduction ratio of any waste product present in the dialyzing fluid of the kidney substitution treatment, the single pool reduction ratio of any waste product present in the dialyzing fluid of the kidney substitution treatment, and the equilibrated reduction ratio of any waste product present in the dialyzing fluid of the kidney substitution treatment.

25. The method according to claim 21, wherein the device is a UV-Sensor.

26. The method according to claim 21, wherein the preferable linear guideline for the adequacy parameter is displayed on a user interface of the kidney substitution treatment machine.

27. The method according to claim 26, wherein the adequacy parameter represented by the guideline is selected from a group consisting of Kt/V, single pool KW, and equilibrated Kt/V of any waste product present in the dialyzing fluid of the kidney substitution treatment.

28. The method according to claim 26, wherein the adequacy parameter represented by the guideline is selected from a group consisting of the reduction ratio of any waste product present in the dialyzing fluid of the kidney substitution treatment, the single pool reduction ratio of any waste product present in the dialyzing fluid of the kidney substitution treatment, and the equilibrated reduction ratio of any waste product present in the dialyzing fluid of the kidney substitution treatment.

29. The method according to claim 23, wherein the prediction of the adequacy parameter is done by building a prediction model based on the data provided by the kidney substitution treatment machine and the device able to measure continuously any kidney substitution treatment waste product.

30. The method according to claim 29, wherein the prediction model is done by using:

at least one dialysis machine related parameter selected from a group consisting of;

Achieved Kt/V, spKt/V, eKt/V, URR, spURR or eURR value, Alarm and/or warnings, Arterial bolus, Arterial bolus volume and flow, Arterial pressure on the machine'"'"'s arterial pressure sensor, Bag weight in case of hemodiafiltration with substitution fluid in bags, Balance chamber ultrafiltration removal, Blood flow and/or blood pumps revolutions, Blood hematocrit, Blood oxygen saturation, Blood pressure at dialyzer inlet, Blood temperature, Concentrate pumps revolutions, Dialysate composition, Dialysate conductivity, Dialysate flow status of the machine;

bypass or treatment, Dialysate flow and/or dialysate pumps revolutions, Dialysate temperature, Dialyzer'"'"'s transmembrane pressure, Heparin bolus event and quantity of injected heparin, Heparin rate, Heparin syringe type, Ultrafiltration volume, Ultrafiltration rate, Used dialysis concentrates, UV absorbance on spent dialysate, Sequential dialysis periods;

duration, ultrafiltrated volume and timestamp, Signals recorded by an UV spectrophotometer coupled with the dialysate flow system, Substitution fluid bolus in hemodiafiltration (HDF), Substitution fluid volume in HDF, Substitution fluid rate in HDF, Substitution fluid composition, Substitution pump revolutions, Therapy time, Type of HDF;

pre-dilution, post-dilution or pre-post-dilution, and Venous pressure on the machine'"'"'s venous pressure sensor,

wherein any of the dialysis machine related parameters is usable with or without association with its timestamp,

wherein in case of an event, the treatment time when the event took place may be recorded and used in the prediction model,

wherein in case of a quantitative variable, the treatment time when the variable reached certain value may be recorded and used in the prediction model and any combination of the dialysis machine related parameters may be used on the prediction model any mathematical operation using as operands any of the above listed parameters may deliver a new parameter that may be used on the prediction model, and

at least one patient related parameter selected from a group consisting of;

Access recirculation, Age, Blood pressure during the treatment, Blood urea concentration pre dialysis, Blood urea concentration post dialysis, Concomitant diseases, Clinical history data, Date of first hemodialysis, Dialysis per week, Dialyzer surface, Dialyzer type;

High flux or low flux, Dry weight, Ethnic origin, Glomerular filtration rate, Hematological disorders, Height, Kidney disease, Life expectancy, Modality of kidney substitution treatment, Patient'"'"'s clinical history, Psychological status of the patient, Residual diuresis, Sex, Stability of the vascular access, Time in chronic dialysis, Type of vascular access, UV absorbance at treatment begin, UV absorbance at treatment end, Weight after dialysis, and Weight pre dialysis,

wherein any combination of the patient related parameters may be used on the prediction model, and

wherein any mathematical operation using as operands any of the patient related parameters may deliver a new parameter that may be used on the prediction model.

31. The method according to claim 21, wherein one or more parameters of the kidney substitution treatment are adjusted in dependence of the prediction result.

32. The method according to claim 31, wherein the adjustment of the treatment parameters is effected manually.

33. The method according to claim 31, wherein the adjustment of the treatment parameters is effected automatically.

34. The method according to claim 31, wherein the adjusted parameters include at least one of blood flow, dialysate flow and therapy time.

35. A kidney substitution treatment machine configured to implement the method according to claim 21,

wherein the machine is operable to allow a user to set a planned adequacy parameter at the end of the kidney substitution treatment, and

wherein an alarm or warning system is implemented to let the user know that the planned adequacy parameter at the end of the kidney substitution treatment will not be achieved.

36. A kidney substitution treatment machine according to claim 35, wherein a graphic system in combination with an alarm or warning system is implemented to let the user know that the planned adequacy parameter at the end of the kidney substitution treatment will not be achieved.

37. A kidney substitution treatment machine according to claim 35, wherein treatment data and patient data are sent to a central server by an implemented software, said central server comprising a computer connected to one of the internet, a wide area network or a local area network.

38. A kidney substitution treatment machine according to claim 35, wherein before any kidney substitution treatment the machine sends a request to a central server and gets an updated prediction model by an implemented software, wherein said central server comprises a computer connected to one of the internet, a wide area network or a local area network and wherein said updated prediction model will be used on the ensuing kidney substitution treatment to predict the adequacy parameter.

39. A control system using a Kt/V value as a target, a predicted Kt/V value as a control variable, and parameters influencing the Kt/V value as actuating variables, wherein said control system allows an individualized adjustment of a therapy to each patient.

40. The control system described in claim 39, wherein the parameters influencing the Kt/V value include at least one of blood flow, dialysate flow, substitution flow and therapy time;

and

wherein the actuating variables include at least one of revolutions of the blood, dialysate, and/or substitution pump, and software control of therapy time.