Extracorporeal blood treatment apparatus and method of setting an extracorporeal blood treatment

• US 10,391,218 B2
• Filed: 09/27/2013
• Issued: 08/27/2019
• Est. Priority Date: 09/28/2012
• Status: Active Grant

• Current Assignee: Gambro Lundia AB (Baxter International Inc.)
• Original Assignee: Gambro Lundia AB (Baxter International Inc.)
• Inventors: Carpani, Michela, Mercier, Guy, Nepote-Vesino, David
• Primary Examiner(s): Menon, Krishnan S
• Assistant Examiner(s): Spies, Bradley R
• Application Number:
  US14/431,535
• Publication Number:
  US 20150238675A1
• Time in Patent Office: 2,160 Days
• Field of Search: None
• CPC Class Codes: A61M 1/16 with membranes
• CPC Class Codes: A61M 1/1601 Control or regulation
• CPC Class Codes: A61M 1/1603 Regulation parameters
• 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 1/3403 Regulation parameters
• CPC Class Codes: A61M 1/3406 Physical characteristics of the filtrate, e.g. urea
• CPC Class Codes: A61M 1/341 by measuring the filtrate rate or volume
• CPC Class Codes: A61M 1/3413 Diafiltration
• CPC Class Codes: A61M 1/3431 upstream of the filter
• CPC Class Codes: A61M 1/3434 with pre-dilution and post-dilution
• CPC Class Codes: A61M 1/3437 downstream of the filter, e.g. post-dilution with filtrate
• CPC Class Codes: A61M 1/3441 Substitution rate control as a function of the ultrafiltration rate
• CPC Class Codes: A61M 1/3626 Gas bubble detectors
• CPC Class Codes: A61M 2205/3334 Measuring or controlling the flow rate
• CPC Class Codes: A61M 2205/3393 by weighing the reservoir
• 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

Abstract

It is described an extracorporeal blood treatment apparatus (1) with a user interface (12) device capable configuring and allowing execution of one or more isolated ultrafiltration tasks during the course of a dialysis treatment. The extracorporeal blood treatment apparatus (1) is controlled in a normal mode, where dialysis fluid is fed to the blood treatment unit (2), and in an isolated ultrafiltration mode, where fresh dialysis fluid is no longer fed to the blood treatment unit (2).

Claims

1. An extracorporeal blood treatment apparatus comprising:

a blood treatment unit having a primary chamber configured to receive blood of a patient to be treated, and a secondary chamber separated from the primary chamber by a semi-permeable membrane;

an hydraulic circuit having a fresh fluid line configured to connect to an inlet of the secondary chamber, a spent fluid line configured to connect to an outlet of said secondary chamber and configured to remove spent liquid from the secondary chamber and convey it to at least one waste, and a bypass line configured to connect to the fresh fluid line and the spent fluid line such that fresh treatment liquid passing through the bypass line does not pass through the secondary chamber,

the hydraulic circuit comprising a fluid intercepting organ configured to selectively connect the fresh fluid line to the spent fluid line through the bypass line, wherein a control unit operably connected to the fluid intercepting organ is configured to control the fluid intercepting organ such that the hydraulic circuit selectively operates in a normal mode, where the fresh fluid line is connected to the inlet of the secondary chamber of the treatment unit to convey fresh treatment liquid only to the secondary chamber, and wherein the control unit is further configured to control the fluid intercepting organ such that the hydraulic circuit selectively operates in an isolated ultrafiltration mode, where the fresh fluid line is connected to the spent fluid line through the bypass line and the fresh fluid line does not convey fresh treatment liquid to the secondary chamber,

the control unit further configured to execute a setup phase before starting treatment, the setup phase comprising;

receiving at least two general setup values selected from;

a prescription value for a total treatment time during which the patient is to be submitted to blood treatment,

a prescription value for a total patient fluid removal to be achieved by the end of total treatment time,

a prescription value for an average patient fluid removal rate to be kept across total treatment time;

receiving instructions to execute a selected plurality of isolated ultrafiltration tasks during the total treatment time, wherein the control unit is configured to;

receive, for each isolated ultrafiltration task of the plurality of isolated ultrafiltration tasks, values of at least two isolated ultrafiltration parameters selected from;

an isolated ultrafiltration time, which is a time interval during which the apparatus is requested to operate in said isolated ultrafiltration mode,

an isolated ultrafiltration volume, which is a volume of fluid to be removed from the patient while the apparatus is requested to operate in said isolated ultrafiltration mode,

an isolated ultrafiltration rate which is a rate of fluid removal from the patient while the apparatus is requested to operate in said isolated ultrafiltration mode;

determining, during the setup phase, at least one of;

a remaining treatment time based on said isolated ultrafiltration time of each isolated ultrafiltration task of the plurality of isolated ultrafiltration tasks, the remaining treatment time being a treatment time during which the patient shall be submitted to blood treatment with the apparatus operating in normal mode after operation in isolated ultrafiltration mode,

a remaining patient fluid removal based on said isolated ultrafiltration volume of each isolated ultrafiltration task of the plurality of isolated ultrafiltration tasks, the remaining patient fluid removal being a volume of fluid to be extracted from the patient with the apparatus operating in normal mode after operation in isolated ultrafiltration mode,

a remaining patient fluid removal rate based on said isolated ultrafiltration rate of each isolated ultrafiltration task of the plurality of isolated ultrafiltration tasks, the remaining patient fluid removal rate being a rate of fluid to be extracted from the patient with the apparatus operating in normal mode after operation in isolated ultrafiltration mode;

wherein the control unit is configured to control the fluid intercepting organ such that the hydraulic circuit operates in isolated ultrafiltration mode during the total treatment time corresponding to the selected plurality of isolated ultrafiltration tasks and based on the values of at the least two isolated ultrafiltration parameters received for each isolated ultrafiltration task of the plurality of isolated ultrafiltration tasks;

wherein, when the hydraulic circuit is operating in the isolated ultrafiltration mode, the control unit is further configured to control the fluid intercepting organ to switch the hydraulic circuit from operating in the isolated ultrafiltration mode to the normal mode upon the first of;

passage of all of said isolated ultrafiltration time;

withdrawal from a patient of said isolated ultrafiltration volume;

or

receipt of a command from a user interface connected to the control unit indicating to end the isolated ultrafiltration mode;

and wherein, when operating the hydraulic circuit in the normal mode after operating in the isolated ultrafiltration mode, the control unit is configured to operate the hydraulic circuit in the normal mode based on the values of two of;

the remaining treatment time, the remaining patient fluid removal, and the remaining patient fluid removal rate determined during the setup phase for each isolated ultrafiltration task of the plurality of isolated ultrafiltration tasks.

2. An apparatus according to claim 1, wherein during the setup phase, the control unit is configured to:

receive, as two general setup values, the prescription value for the total treatment time and the prescription value for the total patient fluid removal;

receive, as two isolated ultrafiltration parameters for each isolated ultrafiltration task of the plurality of isolated ultrafiltration tasks, the isolated ultrafiltration time and the isolated ultrafiltration volume;

determine the remaining treatment time at least based on the isolated ultrafiltration time of each isolated ultrafiltration task of each of the plurality of isolated ultrafiltration tasks and on said prescription value for a total treatment time;

determine the remaining patient fluid removal based on the isolated ultrafiltration volume of each isolated ultrafiltration task of the plurality of isolated ultrafiltration tasks and on the prescription value for a total patient fluid removal;

wherein causing the hydraulic circuit to operate in the isolated ultrafiltration mode for each isolated ultrafiltration task of the plurality of isolated ultrafiltration tasks comprises controlling at least one ultrafiltration actuator of the hydraulic circuit based on the isolated ultrafiltration time and the isolated ultrafiltration volume for each isolated ultrafiltration task of the plurality of isolated ultrafiltration tasks;

and wherein causing the hydraulic circuit to operate in the normal mode after operating the hydraulic circuit in isolated ultrafiltration mode for each isolated ultrafiltration task of the plurality of isolated ultrafiltration tasks comprises

controlling at least one ultrafiltration actuator of the hydraulic circuit based on the values of the remaining treatment time and the remaining patient fluid removal.

3. An apparatus according to claim 2, wherein the control unit is configured to:

calculate the value of the remaining patient fluid removal rate based on the following equation;

remaining patient fluid removal rate =(remaining patient fluid removal)/(remaining treatment time), and

control at least one ultrafiltration actuator of the hydraulic circuit in the normal mode is based on the calculated value of the remaining patient fluid removal rate.

4. An apparatus according to claim 1, wherein receiving the value of the isolated ultrafiltration time comprises either receiving a prefixed value pre-stored in a memory connected to the control unit, or receiving an entered value for the isolated ultrafiltration time via a data entry unit connected to the control unit.

5. An apparatus according to claim 1, wherein receiving the value of the isolated ultrafiltration volume comprises either receiving a prefixed value pre-stored in a memory connected to the control unit, or receiving an entered value for the isolated ultrafiltration volume via a data entry unit connected to the control unit.

6. An apparatus according to claim 1, wherein receiving the value of the isolated ultrafiltration rate comprises either receiving a prefixed value pre-stored in a memory connected to the control unit, or receiving an entered value for the isolated ultrafiltration rate via a data entry unit connected to the control unit.

7. An apparatus according to claim 1, wherein the control unit is configured to execute each isolated ultrafiltration task of the plurality of isolated ultrafiltration tasks with each isolated ultrafiltration task of the plurality of isolated ultrafiltration tasks being executed at distinct and timely spaced time intervals during said total treatment time.

8. An apparatus according to claim 1, wherein the control unit is configured to start a treatment controlling the hydraulic circuit in said normal mode, detect an activation command entered via a data entry unit connected to the control unit, and request execution of the isolated ultrafiltration task in response to detection of said activation command.

9. An apparatus according to claim 1, wherein the control unit is configured to calculate:

an accumulated isolated ultrafiltration volume which is the isolated ultrafiltration volume removed from the patient during the ultrafiltration task under execution;

an elapsed isolated ultrafiltration time which is the time interval since initiation of the ultrafiltration task under execution;

or

an accumulated isolated ultrafiltration volume which is the isolated ultrafiltration volume removed from the patient during the ultrafiltration task under execution and an elapsed isolated ultrafiltration time which is the time interval since initiation of the ultrafiltration task under execution.

10. An apparatus according to claim 1, wherein the control unit is configured to calculate at least one of:

a total isolated ultrafiltration volume which is the sum of the isolated ultrafiltration volumes removed from the patient after execution of the plurality of isolated ultrafiltration tasks, and

a total isolated ultrafiltration time which is the sum of the time intervals of execution of the plurality of isolated ultrafiltration tasks.

11. An apparatus according to claim 1, wherein the control unit is further configured to conduct a safety check comprising comparing the received values of the isolated ultrafiltration parameters against at least one respective safety threshold and preventing operation of the hydraulic circuit in the isolated ultrafiltration mode if the safety check is not positively passed.

12. An apparatus according to claim 1, wherein the hydraulic circuit comprises at least one ultrafiltration actuator acting on the spent fluid line or on an ultrafiltration line branching off the spent fluid line, and wherein the control unit is configured to:

drive said at least one ultrafiltration actuator, and

cause, during at least one isolated ulrafiltration task of the plurality of isolated ultrafiltration tasks, said at least one ultrafiltration actuator to extract fluid from the secondary chamber.

13. An extracorporeal blood treatment apparatus comprising:

a blood treatment unit having a primary chamber configured to receive blood of a patient to be treated, and a secondary chamber separated from the primary chamber by a semi-permeable membrane;

a hydraulic circuit having a fresh fluid line configured to connect to an inlet of the secondary chamber, a spent fluid line configured to connect to an outlet of said secondary chamber and configured to remove spent liquid from the secondary chamber and convey it to at least one waste, and a bypass line configured to connect to the fresh fluid line and the spent fluid line such that fresh treatment liquid passing through the bypass line does not pass through the secondary chamber,

the hydraulic circuit comprising a fluid intercepting organ configured to selectively connect the fresh fluid line to the spent fluid line through the bypass line, wherein a control unit operably connected to the fluid intercepting organ is configured to control the fluid intercepting organ such that the hydraulic circuit selectively operates in a normal mode, where the fresh fluid line is connected to the inlet of the secondary chamber of the treatment unit to convey fresh treatment liquid only to the secondary chamber, and wherein the control unit is further configured to control the fluid intercepting organ such that the hydraulic circuit selectively operates in an isolated ultrafiltration mode, where the fresh fluid line is connected to the spent fluid line through the bypass line and the fresh fluid line does not convey fresh treatment liquid to the secondary chamber,

the control unit further configured to execute a setup phase before starting treatment, the setup phase comprising;

receiving at least two general setup values selected from;

a prescription value for a total treatment time during which the patient is to be submitted to blood treatment,

a prescription value for a total patient fluid removal to be achieved by the end of total treatment time,

a prescription value for an average patient fluid removal rate to be kept across total treatment time;

receiving instructions to execute one or more isolated ultrafiltration tasks during the total treatment time, wherein the control unit is configured to;

receive, for each isolated ultrafiltration task of the one or more isolated ultrafiltration tasks, values of at least two isolated ultrafiltration parameters selected from;

an isolated ultrafiltration time, which is a time interval during which the apparatus is requested to operate in said isolated ultrafiltration mode,

an isolated ultrafiltration volume, which is a volume of fluid to be removed from the patient while the apparatus is requested to operate in said isolated ultrafiltration mode,

an isolated ultrafiltration rate which is a rate of fluid removal from the patient while the apparatus is requested to operate in said isolated ultrafiltration mode;

determining, during the setup phase, at least one of;

a remaining treatment time based on said isolated ultrafiltration time of each isolated ultrafiltration task of the one or more isolated ultrafiltration tasks, the remaining treatment time being a treatment time during which the patient shall be submitted to blood treatment with the apparatus operating in normal mode after operation in isolated ultrafiltration mode,

a remaining patient fluid removal based on said isolated ultrafiltration volume of each isolated ultrafiltration task of the one or more isolated ultrafiltration tasks, the remaining patient fluid removal being a volume of fluid to be extracted from the patient with the apparatus operating in normal mode after operation in isolated ultrafiltration mode,

a remaining patient fluid removal rate based on said isolated ultrafiltration rate of each isolated ultrafiltration task of the one or more isolated ultrafiltration tasks, the remaining patient fluid removal rate being a rate of fluid to be extracted from the patient with the apparatus operating in normal mode after operation in isolated ultrafiltration mode;

wherein the control unit is configured to control the fluid intercepting organ such that the hydraulic circuit operates in isolated ultrafiltration mode during the total treatment time corresponding to the one or more isolated ultrafiltration tasks and based on the values of at the least two isolated ultrafiltration parameters received for each isolated ultrafiltration task of the one or more isolated ultrafiltration tasks;

wherein, when the hydraulic circuit is operating in the isolated ultrafiltration mode, the control unit is further configured to control the fluid intercepting organ to switch the hydraulic circuit from operating in the isolated ultrafiltration mode to the normal mode upon the first of;

passage of all of said isolated ultrafiltration time;

withdrawal from a patient of said isolated ultrafiltration volume;

or

receipt of a command from a user interface connected to the control unit indicating to end the isolated ultrafiltration mode;

and wherein, when operating the hydraulic circuit in the normal mode after operating in the isolated ultrafiltration mode, the control unit is configured to operate the hydraulic circuit in the normal mode based on the values of two of;

the remaining treatment time, the remaining patient fluid removal, and the remaining patient fluid removal rate determined during the setup phase for each isolated ultrafiltration task of the one or more isolated ultrafiltration tasks.

14. An apparatus according to claim 13, wherein during the setup phase, the control unit is configured to:

receive, as two general setup values, the prescription value for the total treatment time and the prescription value for the total patient fluid removal;

receive, as two isolated ultrafiltration parameters for each isolated ultrafiltration task of the one or more isolated ultrafiltration tasks, the isolated ultrafiltration time and the isolated ultrafiltration volume;

determine the remaining treatment time at least based on the isolated ultrafiltration time of each isolated ultrafiltration task of each of the one or more isolated ultrafiltration tasks and on said prescription value for a total treatment time;

determine the remaining patient fluid removal based on the isolated ultrafiltration volume of each isolated ultrafiltration task of the one or more isolated ultrafiltration tasks and on the prescription value for a total patient fluid removal;

wherein causing the hydraulic circuit to operate in the isolated ultrafiltration mode for each isolated ultrafiltration task of the one or more isolated ultrafiltration tasks comprises controlling at least one ultrafiltration actuator of the hydraulic circuit based on the isolated ultrafiltration time and the isolated ultrafiltration volume for each isolated ultrafiltration task of the one or more isolated ultrafiltration tasks;

and wherein causing the hydraulic circuit to operate in the normal mode after operating the hydraulic circuit in isolated ultrafiltration mode for each isolated ultrafiltration task of the one or more isolated ultrafiltration tasks comprises controlling at least one ultrafiltration actuator of the hydraulic circuit based on the values of the remaining treatment time and the remaining patient fluid removal.

15. An apparatus according to claim 14, wherein the control unit is configured to:

calculate the value of the remaining patient fluid removal rate based on the following equation;

remaining patient fluid removal rate =(remaining patient fluid removal)/(remaining treatment time), and

control at least one ultrafiltration actuator of the hydraulic circuit in the normal mode is based on the calculated value of the remaining patient fluid removal rate.

16. An apparatus according to claim 13, wherein receiving the value of the isolated ultrafiltration volume comprises either receiving a prefixed value pre-stored in a memory connected to the control unit, or receiving an entered value for the isolated ultrafiltration volume via a data entry unit connected to the control unit.

17. An apparatus according to claim 13, wherein the control unit is configured to execute each isolated ultrafiltration task of the one or more isolated ultrafiltration tasks with each isolated ultrafiltration task of the one or more isolated ultrafiltration tasks being executed at distinct and timely spaced time intervals during said total treatment time.

18. An apparatus according to claim 13, wherein the control unit is configured to calculate:

an accumulated isolated ultrafiltration volume which is the isolated ultrafiltration volume removed from the patient during the ultrafiltration task under execution;

an elapsed isolated ultrafiltration time which is the time interval since initiation of the ultrafiltration task under execution;

or

an accumulated isolated ultrafiltration volume which is the isolated ultrafiltration volume removed from the patient during the ultrafiltration task under execution and an elapsed isolated ultrafiltration time which is the time interval since initiation of the ultrafiltration task under execution.

19. An apparatus according to claim 13, wherein the control unit is configured to calculate at least one of:

a total isolated ultrafiltration volume which is the sum of the isolated ultrafiltration volumes removed from the patient after execution of the one or more isolated ultrafiltration tasks, and

a total isolated ultrafiltration time which is the sum of the time intervals of execution of the one or more isolated ultrafiltration tasks.

20. An apparatus according to claim 13, wherein the control unit is further configured to conduct a safety check comprising comparing the received values of the isolated ultrafiltration parameters against at least one respective safety threshold and preventing operation of the hydraulic circuit in the isolated ultrafiltration mode if the safety check is not positively passed.