METHOD AND APPARATUS FOR CONTROLLING AN EXTRA-CORPOREAL BLOOD TREATMENT IN A MEDICAL DEVICE

• US 20120010554A1
• Filed: 07/01/2011
• Published: 01/12/2012
• Est. Priority Date: 07/08/2010
• Status: Active Grant

• Current Assignee: Gambro Lundia AB (Baxter International Inc.)
• Original Assignee: Gambro Lundia AB (Baxter International Inc.)
• Inventors: BENE, Bernard, VANTARD, Georges
• Granted Patent: US 9,162,020 B2
• Time in Patent Office: Days
• US Class Current: 604/6.04
• 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 1/1609 after use, i.e. downstream of dialyser
• CPC Class Codes: A61M 1/3609 Physical characteristics of the blood, e.g. haematocrit, urea
• CPC Class Codes: A61M 2205/33 Controlling, regulating or measuring
• CPC Class Codes: A61M 2205/3331 Pressure; Flow
• CPC Class Codes: A61M 2205/3334 Measuring or controlling the flow rate
• CPC Class Codes: A61M 2205/52 with memories providing a history of measured variating parameters of apparatus or patient
• CPC Class Codes: A61M 2205/60 with identification means

Abstract

Apparatus for controlling an extra-corporeal blood treatment in a medical device, comprising a blood treatment device (7), an extra-corporeal blood transport line (4), a fluid transport line (3) for a treatment fluid for the blood, at least a sensor adapted to provide a measure (M) correlated to at least a treatment parameter of the extra-corporeal blood treatment and/or of the treatment device (7) in the medical device (1), at least one storage memory (29), and at least a control device (28), operatively connected at least with the storage memory (29) and with the sensor, and configured for receiving the measure (M) from the sensor, correlating the measure (M) with referential data (R) of the treatment device for the treatment parameter provided by the at least one storage memory (29), and correlating the measure (M) with patient historical data (H) for the treatment parameter for obtaining an information representative of the quality of the extra-corporeal blood treatment.

Claims

1. Apparatus for controlling an extra-corporeal blood treatment in a medical device, comprising:

a blood treatment device;

an extra-corporeal blood transport line, having at least an arterial line configured to bring blood from a first access of a patient under treatment to said blood treatment device, a venous line configured to bring blood from said blood treatment device to a second access of the patient, and at least a first pump for moving blood in said extra-corporeal blood transport line;

a fluid transport line for a treatment fluid for said blood, the fluid transport line adapted to bring the treatment fluid from a source to said blood treatment device and from said blood treatment device to an exit, and at least a second pump for moving the treatment fluid in the fluid transport line;

at least a sensor adapted to provide a measure correlated to at least a treatment parameter of the extra-corporeal blood treatment or of the treatment device in the medical device;

at least one storage memory; and

at least a control device operatively connected at least with said storage memory and with said sensor;

wherein said control device is configured for receiving said measure from said sensor, correlating said measure at least with referential data of said treatment device for said treatment parameter provided from said at least one storage memory, and correlating said measure with patient historical data for said treatment parameter during an extra-corporeal blood treatment of said patient under treatment, provided from said at least one storage memory, for obtaining at least an information representative of the quality of the extra-corporeal blood treatment.

2. Apparatus according to claim 1, wherein said at least one storage memory comprises at least said referential data of said treatment parameter at least for a disposable part of said treatment device and said patient historical data of said treatment parameter for at least a specific patient.

3. Apparatus according to claim 1, wherein said blood treatment device is a dialyzer and said extra-corporeal blood treatment comprises ultrafiltration, haemodialysis, haemofiltration, haemodiafiltration, plasmapheresis, blood component separation or blood oxygenation.

4. Apparatus according to claim 1, wherein said treatment parameter is selected from the group consisting of a ionic dialysance of a dialyzer, a clearance of a dialyzer, a water permeability (UF coefficient) of a dialyser membrane, and a blood pressure drop of a dialyzer.

5. Apparatus according to claim 1, wherein said control device is configured for correlating said measure with said referential data for obtaining a first deviation value (DV1) and for comparing said first deviation value (DV1) with a first threshold (T1), and is further configured for correlating said measure with patient historical data for obtaining a second deviation value (DV2) and for comparing said second deviation value (DV2) with a second threshold (T2).

6. Apparatus according to claim 1, wherein said control device is configured for providing a message to an operator or a control signal or a feedback signal or an alarm signal or for automatically varying predetermined treatment parameters and to re-adjust the blood treatment, when said information representative of the quality of the extra-corporeal blood treatment corresponds to a predetermined alarm value, or when said first or second deviation value (DV1, DV2) have a predetermined correlation respectively with said respective first and second threshold (T1, T2).

7. Apparatus according to claim 1, further comprising an auxiliary sensor configured to provide an auxiliary measure correlated to at least an auxiliary treatment parameter of the extra-corporeal blood treatment or of the treatment device in the medical device, said control device being configured for receiving said auxiliary measure from said auxiliary sensor and for selecting referential data, of said treatment device for said treatment parameter, correlated with said auxiliary measure, or being configured for receiving said auxiliary measure from said auxiliary sensor and for evaluating the result of the correlation between said measure and said referential data of said treatment device or between said measure and said patient historical data in view of said auxiliary measure.

8. Apparatus according to claim 1, comprising two of said storage memories operatively connected with said control device, a first storage memory comprising said referential data and a second storage memory comprising said patient historical data.

9. Apparatus according to claim 1, in which said control device is further configured for automatically recognizing the type of said treatment device or the type of a disposable part of said treatment device and for automatically selecting, from said storage memory, referential data of said treatment parameter for said type of said treatment device or of said disposable part or referential data of said treatment parameter for said type of said treatment device or of said disposable part when mounted to said medical device.

10. Method of controlling an extra-corporeal blood treatment in a medical device comprising:

a blood treatment device;

an extra-corporeal blood transport line, having at least an arterial line configured to bring blood from a first access of a patient under treatment to said blood treatment device, a venous line configured to bring blood from said blood treatment device to a second access of the patient, and at least a first pump for moving blood in said extra-corporeal blood transport line, a fluid transport line for a treatment fluid for said blood, said fluid transport line adapted to bring the treatment fluid from a source to said blood treatment device and from said blood treatment device to an exit, and at least a second pump for moving the treatment fluid in the fluid transport line, at least a sensor adapted to provide a measure correlated to at least a treatment parameter of the extra-corporeal blood treatment or of the treatment device in the medical device, at least one storage memory, and at least a control device operatively connected at least with said storage memory and with said sensor;

wherein said control device is configured for receiving said measure from said sensor, correlating said measure at least with referential data of said treatment device for said treatment parameter provided by said at least one storage memory, and correlating said measure with patient historical data for said treatment parameter during an extra-corporeal blood treatment of said patient under treatment, provided by said at least one storage memory, for obtaining at least an information representative of the quality of the extra-corporeal blood treatment, the method comprising;

pumping blood of a patient under treatment through an extra-corporeal blood transport line and through a blood treatment device, connected to said extra-corporeal blood transport line and to a fluid transport line for a blood treatment fluid,

sensing a measure correlated to at least a treatment parameter of the extra-corporeal blood treatment in the medical device,

obtaining referential data of said treatment device, or of a disposable part of said treatment device, for said treatment parameter,

obtaining historical data of said patient under treatment for said treatment parameter,

correlating said measure at least with said referential data of said treatment device and correlating said measure with said patient historical data of said patient, for obtaining at least an information representative of the quality of the extra-corporeal blood treatment of said patient.

11. Method according to claim 10, in which said sensing a measure correlated to at least a treatment parameter comprises sensing a measure correlated to a ionic dialysance of a dialyzer, or to a clearance of a dialyzer, or to a water permeability (UF coefficient) of a dialyser membrane, or to a blood pressure drop of a dialyzer.

12. Method according claim 10, further comprising comparing said measure with said referential data for obtaining a first deviation value (DV1) and comparing said first deviation value (DV1) with a first threshold (T1), and the steps of comparing said measure with patient historical data for obtaining a second deviation value (DV2), and comparing said second deviation value (DV2) with a second threshold (T2).

13. Method according to claim 10, further comprising generating a message to an operator or a control signal or a feedback signal an alarm signal or the step of automatically varying predetermined treatment parameters, to re-adjust the blood treatment, when said information representative of the quality of the extra-corporeal blood treatment corresponds to a predetermined alarm value, or when said first or second deviation value (DV1, DV2) have a predetermined correlation respectively with said respective first and second threshold (T1, T2).

14. Method according to claim 10, in which said referential data of said treatment device for said treatment parameter are defined with respect to the treatment device in combination with the specific medical device to which said treatment device is applied or with respect to an auxiliary measure of an auxiliary parameter influencing said treatment parameter.

15. Method according to claim 10, further comprising automatically recognizing the type of said treatment device or the type of a disposable part of said treatment device and of automatically selecting referential data of said treatment parameter for said type of said treatment device or of said disposable part or referential data of said treatment parameter for said type of said treatment device or of said disposable part when mounted to said medical device.