IP Library Granted Patent US 12702741
Granted Patent B2
US 12702741 · App. 18/547,419 · Granted Aug 11, 2026

Method for assessing a measured pressure value, and apparatuses

Inventor: Pascal Kopperschmidt (Bad Homburg, DE)
Assignee: Fresenius Medical Care Deutschland GmbH
A61M1/3639A61M1/3656A61M2205/18A61M2205/3331A61M2205/50
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Quick Facts
Patent No.
US 12702741
App. No.
18/547,419
Granted
Aug 11, 2026
Kind
B2
Abstract

The present disclosure relates to a method for assessing a measured pressure value, with the provision of a blood treatment apparatus, connectable to a blood tubing set which includes an arterial blood line and a venous blood line, wherein the blood treatment apparatus further includes a blood pump, pressure meter for measuring the pressure in the blood lines, in each case with the determination of at least one pressure measurement value, an alarm output device for outputting an alarm based on the pressure measurement value and a control device for controlling or regulating the blood pump. The method includes providing an alarm criterion memory for defining an alarm event and providing a reference data memory. The method encompasses measuring the prevailing pressures, assessing the determined pressure measurement values using alarm criteria, and repeating the pressure measuring processes at certain conveying rates of the blood pump to assess whether it is a false alarm.

Claims (47)

1 . A method for assessing a measured pressure value, the method comprising:

providing a blood treatment apparatus, connectable to a blood tubing set comprising an arterial blood line and a venous blood line, the blood treatment apparatus comprising:

a blood pump for conveying blood extracorporeally along the arterial blood line, an arterial pressure meter for measuring an arterial pressure in the arterial blood line and/or a venous pressure meter for measuring a venous pressure in the venous blood line, wherein the arterial pressure meter and/or the venous pressure meter are configured to determine at least one pressure measurement value,

an alarm output device to output an alarm based on the at least one pressure measurement value, in an alarm event, and

a control device for controlling or regulating the blood pump;

providing an alarm criterion memory for storing a predetermined alarm criterion which defines an alarm event;

providing a reference data memory which comprises at least one data set which contains one or more reference pressure profiles or reference pressure values or reference pressure ranges, wherein providing the reference data memory comprises:

at a beginning of or a distinctive point of a treatment session, controlling the blood pump to convey blood along the arterial blood line at one or more reference conveying rates;

at the beginning of or the distinctive point of the treatment session, measuring the pressure prevailing at the one or more reference conveying rates of the blood pump in the arterial blood line and/or venous blood line via the arterial pressure meter and/or the venous pressure meter while or for determining a reference pressure measurement value; and

storing at least one data set in the reference data memory, the data set containing the one or more reference pressure measurement values, or at least one reference pressure profile created therefrom;

measuring a prevailing pressure at an initial conveying rate of the blood pump in the arterial blood line and/or in the venous blood line via the arterial pressure meter and/or the venous pressure meter while determining the at least one pressure measurement value;

assessing the at least one pressure measurement value based on the predetermined alarm criterion stored in the alarm criterion memory while or for determining whether the at least one pressure measurement value meets the alarm criterion and that, therefore, there is an alarm event;

controlling the blood pump in order to convey at the one or more reference conveying rates along the arterial blood line, when the pressure measurement value meets the alarm criterion, wherein the one or more reference conveying rates, or at least one of the one or more reference conveying rates is less than the initial conveying rate;

measuring the arterial pressure in the arterial blood line and/or the venous pressure in the venous blood line, respectively prevailing at the one or more reference conveying rates of the blood pump, using the arterial pressure meter and/or the venous pressure meter while determining at least one assessment pressure measurement value;

evaluating the at least one assessment pressure measurement value based on, or via a comparison with, the data set stored in the reference data memory while determining at least one evaluation result; and

outputting an alarm via the alarm output device only in the case that the evaluation result satisfies predetermined requirements for outputting an alarm.

2 . The method according to claim 1 , further comprising stopping the blood pump if or when the predetermined alarm criterion is met before the blood pump is activated to convey the at least one reference conveying rate.

3 . The method according to claim 1 , further comprising lowering the conveying rate of the blood pump to one of the at least one reference conveying rates, where the one of the at least one reference conveying rates is below the initial conveying rate.

4 . The method according to claim 1 , further comprising preventing output of the alarm in the event that the pressure measurement value satisfies the alarm criterion stored in the alarm criterion memory, but the evaluation result does not satisfy the predetermined requirements for outputting an alarm.

5 . The method according to claim 1 , further comprising controlling the blood pump to again convey at the initial conveying rate or a conveying rate related thereto in the event that the evaluation result does not satisfy the predetermined requirements for outputting an alarm.

6 . The method according to claim 1 , wherein the reference pressure measurement values are determined for the pressures prevailing in both the arterial blood line and the venous blood line, and whereby the evaluation is carried out using the sum and/or the average value of the pressures prevailing in the arterial blood line and venous blood line, based on a corresponding reference pressure value, or via a comparison with the corresponding reference pressure value, which was obtained when evaluating the pressure prevailing in the arterial blood line and venous blood line.

7 . The method according to claim 6 , wherein the evaluation is carried out after a statistical evaluation.

8 . The method according to claim 6 , wherein evaluating the pressure prevailing in the arterial blood line and venous blood line comprises a statistical evaluation the sum and/or the average value.

9 . The method according to claim 1 , wherein the determined reference pressure measurement values are compared with at least one data set from at least one previous treatment session of a same patient and/or reference pressure values recorded from previous treatment sessions of other patients.

10 . The method according to claim 9 , wherein the determined reference pressure values are used as reference pressure values for the treatment, provided that the comparison with data sets for or from previous treatment sessions satisfies predetermined criteria.

11 . The method according to claim 10 , wherein the predetermined criteria comprises expected values or ranges obtained from the data sets.

12 . The method according to claim 1 , wherein evaluating to achieve the evaluation result comprises forming a difference between the at least one assessment pressure measurement value measured by the pressure meter and the one or more reference pressure values contained in the data set, or the reference pressure profile/profiles created from the reference pressure measurement values.

13 . A control device, configured to work in interaction with:

a provided blood treatment apparatus, which is connected to a blood tubing set which has an arterial blood line and a venous blood line, wherein the blood treatment apparatus comprises:

a blood pump for extracorporeally conveying blood along the arterial blood line,

an arterial pressure meter for measuring an arterial pressure in the arterial blood line and/or a venous pressure meter for measuring a venous pressure in the venous blood line, wherein the arterial pressure meter and/or the venous pressure meter are configured to determine at least one pressure measurement value,

an alarm output device for outputting an alarm based on the at least one pressure measurement value in the event of an alarm, and

the control device to control or regulate the blood pump;

an alarm criterion memory for storing a predetermined alarm criterion which defines an alarm event;

a reference data memory which comprises at least one data set which contains one or more reference pressure profiles or reference pressure values or reference pressure ranges;

in order to carry out or initiate the method of claim 1 .

14 . A blood treatment apparatus, comprising:

a blood pump for extracorporeally conveying blood along the arterial blood line, and

an arterial pressure meter for measuring an arterial pressure in the arterial blood line and/or a venous pressure meter for measuring a venous pressure in the venous blood line, wherein the arterial pressure meter and/or the venous pressure meter are configured to determine at least one pressure measurement value; and

wherein the blood treatment apparatus further comprises or is in signal communication with:

an alarm output device for outputting an alarm based on the at least one pressure measurement value in the event of an alarm;

an alarm criterion memory for storing a predetermined alarm criterion which defines an alarm event;

a reference data memory which comprises at least one data set which contains one or more reference pressure profiles or reference pressure values; and

a control device according to claim 13 .

15 . The blood treatment apparatus according to claim 14 , designed as a blood purification apparatus or dialysis apparatus, for hemodialysis, hemofiltration, or hemodiafiltration, or as a plasmapheresis apparatus.

16 . A digital storage medium in the form of a floppy disk, CD or DVD or EPROM, with electronically readable control signals, configured to configure a control device into a control device according to claim 13 .

17 . A computer program product with a program code stored on a machine-readable carrier in order to configure a control device into a control device according to claim 13 .