Method as well as apparatuses for testing at least one function of a medical functional device

• US 20130028788A1
• Filed: 07/27/2012
• Published: 01/31/2013
• Est. Priority Date: 07/29/2011
• Status: Active Grant

• Current Assignee: Fresenius Medical Care Deutschland GmbH (Fresenius Medical Care AG)
• Original Assignee: Fresenius Medical Care Deutschland GmbH (Fresenius Medical Care AG)
• Inventors: Gronau, Soeren, Manke, Joachim, Mueller, Ralf, SCHAEFER, Ingo
• Granted Patent: US 9,393,358 B2
• Time in Patent Office: Days
• US Class Current: 422/44
• CPC Class Codes: A61M 1/14 Dialysis systems; Artificial kidneys; Blood oxygenators semi-permeable membranes characterised by the material, manufacturing processes therefor B01D71/00 ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
• CPC Class Codes: A61M 1/1605 Physical characteristics of the dialysate fluid
• CPC Class Codes: A61M 1/1621 Constructional aspects thereof semi-permeable membranes for separation processes characterised by their properties B01D69/00; semi permeable membranes characterised by their material B01D71/00
• CPC Class Codes: A61M 1/34 Filtering material out of the blood by passing it through a membrane, i.e. hemofiltration or diafiltration
• CPC Class Codes: A61M 1/3413 Diafiltration
• CPC Class Codes: A61M 1/3434 with pre-dilution and post-dilution
• CPC Class Codes: A61M 1/3607 Regulation parameters
• CPC Class Codes: A61M 1/36224 with sensing means or components thereof
• CPC Class Codes: A61M 1/36225 with blood pumping means or components thereof
• CPC Class Codes: A61M 1/362262 Details of incorporated reservoirs
• CPC Class Codes: A61M 1/362264 the filter being a blood filter
• CPC Class Codes: A61M 1/362265 Details of valves
• CPC Class Codes: A61M 2205/12 with interchangeable cassettes forming partially or totally the fluid circuit
• CPC Class Codes: A61M 2205/15 Detection of leaks
• CPC Class Codes: A61M 2205/18 with alarm
• CPC Class Codes: A61M 2205/27 preventing use
• CPC Class Codes: A61M 2205/3306 Optical measuring means
• CPC Class Codes: A61M 2205/3331 Pressure; Flow
• CPC Class Codes: A61M 2205/3368 Temperature
• CPC Class Codes: A61M 2205/50 with microprocessors or computers
• CPC Class Codes: A61M 2205/70 : with testing or calibration facilities
• CPC Class Codes: A61M 39/24 : Check- or non-return valves

Abstract

The invention relates to a method for testing at least one function of a medical functional device which is inserted in and connected and compressed with a medical treatment apparatus, and/or a function of this treatment apparatus, wherein between a hydraulic device or a pneumatic unit of the treatment apparatus and the functional device at least one fluid communication is established. It further relates to a detection device which is programmed and/or configured for executing the method according to the invention as well as a medical treatment apparatus which comprises at least one detection device and/or is in signal transmission or is connected for signal transmission with it, a digital storage medium, a computer program product as well as a computer program.

Claims

1. A method for testing at least one function of a medical functional device which is inserted in and connected and pressed with a medical treatment apparatus, and/or a function of this treatment apparatus, wherein between a hydraulic device or a pneumatic unit of the treatment apparatus and the functional device at least one fluid communication is established, wherein the method comprises the steps:

a) building up a pressure by means of the hydraulic device or a pneumatic unit within the fluid communication;

b) measuring a pressure prevailing within the fluid communication or a pressure change; and

c) making a statement about the tested function of the functional device based on a comparison of the prevailing pressure or the measured pressure change with previously saved values, threshold values, ranges or developments.

2. The method according to claim 1, wherein the step a) is only executed when or if with a pre-pressure which was previously applied and which is lower than the pressure to be built up, no function deviation was identified.

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

filling a blood filter the functional device is connected with.

4. The method according to claim 1, further comprising the step:

building up the pressure by means of a substituate pump of the treatment apparatus.

5. The method according to claim 4, further comprising the step:

building up the pressure against the substituate pump when it is not running.

6. The method according to claim 1, further comprising the steps:

determining a pressure drop or a pressure rise within the fluid communication;

determining a patency of the fluid communication or of the functional device based on a comparison of the determined pressure drop or pressure rise with previously saved values, threshold values, ranges or developments.

7. The method according to claim 1, further comprising the steps:

determining a pressure drop or a pressure rise within the fluid communication;

determining a tightness of the fluid communication or of the functional device based on a comparison of the determined pressure drop or pressure rise with previously saved values, threshold values, ranges or developments.

8. The method according to claim 1, further comprising the steps:

conveying a predetermined feed volume (MAX FEED VOLUME) within the fluid communication with the substituate pump running in reverse against a non-return valve which is provided within a substituate channel;

determining a pressure change within the fluid communication;

determining a non-return function of the non-return valve, if a determined pressure drop is not equal to or higher than a maximum pressure drop (MAX PRESSURE DROP) or not higher than a predetermined absolute value of a pressure change (MAXIMUM PRESSURE CHANGE).

9. The method according to claim 1, further comprising the steps:

conveying a predetermined feed volume (MAX FEED VOLUME) within the fluid communication with the substituate pump running in reverse against a non-return valve which is provided within a substituate channel;

determining a pressure change within the fluid communication;

determining that the substituate pump conveys or conveyed forwards, if a determined pressure rise is higher than a maximum pressure rise (MAX PRESSURE RISE) or higher than a predetermined absolute value of a pressure change (MAXIMUM PRESSURE CHANGE).

10. The method according to claim 1, further comprising the step:

detecting a current pressure value (VALUE_new) based on an already present pressure value (VALUE_old), on a measured value (MEASURED VALUE) and on a predetermined smoothing factor (SF) according to the formula;

VALUE_new=VALUE_old*SF+MEASURED VALUE*(1−

SF)

wherein it applies that;

VALUE_new is a current pressure value;

VALUE_old is the pressure value which is already present;

SF is a smoothing factor; and

MEASURED VALUE is a current measured value of the pressure.

11. The method according to claim 10, wherein the smoothing factor (SF) is in a range between 0.9 to 0.96.

12. The method according to claim 1, further comprising the step:

filling an extracorporeal blood circuit which is connected with the functional device before building up the pressure.

13. The method according to claim 1, wherein at least one function, selected from opening, closing and sealing, of at least one of the following components is tested:

valve for an addition point for substituate in predilution;

valve for an addition point for substituate in postdilution;

single-needle valve;

non-return valve in the substituate channel; and

/or

automatic substituate connector.

14. The method according to claim 1, wherein the method is executed before the beginning of a treatment of a patient during which the functional device is used.

15. The method according to claim 1, further comprising the step:

blocking treatment modalities and/or restricting treatment parameters of the treatment method taking into account a result of the test of at least one function of the medical functional device and/or the treatment apparatus, wherein the result was achieved by means of the present method.

16. The method according to claim 1, wherein the medical functional device is a blood cassette, and wherein the treatment apparatus is a blood treatment apparatus.

17. A detection device, programmed and/or configured for executing or prompting the method according to claim 1.

18. The detection device according to claim 17, comprising at least one displaying device for displaying a result of the execution of the method according to claim 1.

19. The detection device according to claim 17, comprising at least one alarm device for outputting an alarm, wherein the alarm device is provided for outputting an alarm in the event that the result of the execution of the method according to claim 1 is not in a predetermined range or value range.

20. The detection device according to claim 17, which is programmed and/or configured to influence or prompt the treatment apparatus such that at least one treatment option for which the tested functional device is usable due to its construction, and/or treating under predetermined treatment parameters by means of the concrete, tested functional device is not executable if a lacking functionality of the functional device and/or the treatment apparatus or of a component of the device or the apparatus was recognized.

21. The detection device according to claim 20, wherein the detection device effects the treatment apparatus or is programmed therefore such that the treatment option(s) hemofiltration and/or hemodiafiltration are not executable by means of the concrete, tested functional device.

22. The detection device according to claim 17, which is or comprises a control apparatus and/or a function test monitor.

23. A medical treatment apparatus which comprises at least one detection device according to claim 17 and/or is in signal transmission or is connected for signal transmission with it.

24. The medical treatment apparatus according to claim 23 which is embodied as a blood treatment apparatus for apheresis dialysis, hemodialysis, hemofiltration, or hemodiafiltration.

25. A digital storage medium, with electronically readable control signals, configured for interacting with a programmable computer system such that the mechanical steps of the method according to claim 1 are prompted.

26. The digital storage medium according to claim 25, wherein the digital storage medium is in the form of a disk, CD, DVD, or EPROM.

27. A computer program product with a program code saved on a machine-readable medium for prompting the mechanical steps of the method according to claim 1 when the computer program product runs on a computer.

28. A computer program with a program code for prompting the mechanical steps of a method according to claim 1 when the computer program runs on a computer.