METHOD AND DEVICE FOR DETECTING A CONFIGURATION OF WITHDRAWAL AND RETURN DEVICES

• US 20130150766A1
• Filed: 12/22/2010
• Published: 06/13/2013
• Est. Priority Date: 12/28/2009
• Status: Active Grant

• Current Assignee: Gambro Lundia AB (Baxter International Inc.)
• Original Assignee: Gambro Lundia AB (Baxter International Inc.)
• Inventors: Olde, Bo, Solem, Kristian
• Granted Patent: US 9,289,544 B2
• Time in Patent Office: Days
• US Class Current: 604/4.01
• CPC Class Codes: A61M 1/30 Single needle dialysis ; Reciprocating systems, alternately withdrawing blood from and returning it to the patient, e.g. single-lumen-needle dialysis or single needle systems for hemofiltration or pheresis
• CPC Class Codes: A61M 1/3653 Interfaces between patient blood circulation and extra-corporal blood circuit
• CPC Class Codes: A61M 1/3656 Monitoring patency or flow at connection sites; Detecting disconnections
• CPC Class Codes: A61M 1/3659 Cannulae pertaining to extracorporeal circulation
• CPC Class Codes: A61M 1/3661 for haemodialysis
• CPC Class Codes: A61M 2205/13 with means for the detection of operative contact with patient, e.g. lip sensor
• CPC Class Codes: A61M 2205/3331 Pressure; Flow
• CPC Class Codes: A61M 2230/04 Heartbeat characteristics, e.g. ECG, blood pressure modulation
• CPC Class Codes: A61M 5/16859 Evaluation of pressure response, e.g. to an applied pulse

Abstract

A device is arranged to detect a configuration of withdrawal and return devices (1, 14, 111, 112, 211, 212, 702, 703, 802, 803) coupling an extracorporeal blood flow circuit (20) to a cardiovascular system of a subject. The device comprises a signal processor (29), which is configured to receive a primary measurement signal obtained by a primary pressure sensor (4a, 4b, 4c) in the extracorporeal blood flow circuit (20). The device is further configured to process the primary measurement signal for extraction of primary pressure data originating from a subject pulse generator (3′) in the cardiovascular system or extracorporeal blood flow circuit (20), the primary pressure data comprising at least a part of a first pulse from the subject pulse generator (3′). The device is also configured to calculate a parameter value from the primary pressure data and to determine the configuration based at least partly on the parameter value.

Claims

1. A device for detecting a reversed configuration of withdrawal and return devices coupling an extracorporeal blood flow circuit to a cardiovascular system of a subject, the device comprising a signal processor configured to:

receive a primary measurement signal obtained by a primary pressure sensor in the extracorporeal blood flow circuit;

process the primary measurement signal for extraction of primary pressure data originating from a subject pulse generator in the cardiovascular system, the primary pressure data comprising at least a part of a subject pulse from the subject pulse generator;

calculate a parameter value from the primary pressure data; and

determine the reversed configuration based at least partly on the parameter value.

2. The device of claim 1, wherein the reversed configuration is determined by comparing the parameter value with a reference parameter value.

3. The device of claim 1, wherein the signal processor is further configured to receive a secondary measurement signal obtained from a secondary pressure sensor.

4. The device of claim 3, wherein the secondary pressure sensor is a pressure sensor in the extracorporeal blood flow circuit, and wherein said secondary measurement signal is processed for extraction of secondary pressure data originating from said subject pulse generator, and wherein said parameter value is calculated from the primary pressure data and the secondary pressure data.

5. The device of claim 4, wherein the primary pressure sensor is located on a venous side of the extracorporeal blood flow circuit and the secondary pressure sensor is located on an arterial side of the extracorporeal blood flow circuit.

6. The device of claim 1, wherein the parameter value is represented by a pressure amplitude measure of the primary pressure data.

7. The device of claim 6, wherein said pressure amplitude measure comprises an arterial pressure amplitude Ha or a venous pressure amplitude Hv.

8. The device of claim 4, wherein the parameter value is represented by a pressure amplitude ratio R of said primary pressure data and the pressure amplitude ratio R in a reversed configuration is greater than the pressure amplitude ratio R in a normal configuration.

9. The device of claim 3, wherein the parameter value represents a time delay of a pressure pulse detected by said primary pressure sensor at a first instance in time and said pressure pulse subsequently detected by said secondary pressure sensor at a second instance in time.

10. The device of claim 1, wherein the parameter value has been derived from one or more of a plurality of monitoring sessions of one subject, a plurality of monitoring sessions of two or more subjects, and a mathematical model.

11. The device of claim 1, wherein the withdrawal and return devices comprise single or double lumen needles or catheters.

12. The device of claim 1, wherein further to calculating, the signal processor is further configured to extract shape indicative data from the primary pressure data and matching the shape indicative data with shape reference data and the parameter value represents a deviation between the shape indicative data and the shape reference data.

13. The device of claim 12, wherein the shape reference data represents a temporal pulse profile of the subject pulse generator.

14. The device of claim 12, wherein the shape reference data represents a frequency spectrum of the subject pulse generator.

15. The device of claim 1, wherein the withdrawal and return devices are configurable in a normal configuration and the reversed configuration and wherein in said normal configuration a withdrawal device is in an upstream position of said cardiovascular system for withdrawal of fluid and a return device is in a downstream position of said cardiovascular system for return of fluid and wherein in said reversed configuration the positioning of the access devices is reversed.

16. The device of claim 1, wherein the signal processor is further configured to aggregate a plurality of pulses within an aggregation time window in the measurement signal.

17. The device of claim 1, further comprising an alarm device being configured to issue an alarm subsequent to determining a reverse configuration of access devices.

18. The device of claim 3, wherein the parameter value represents a deviation in transit time of the subject pulse from the subject pulse generator to the primary pressure sensor and the secondary pressure sensor.

19. A method for detecting a configuration of withdrawal and return devices coupling an extracorporeal blood flow circuit to a cardiovascular system of a subject, the method comprising:

receiving a primary measurement signal obtained by a primary pressure sensor in the extracorporeal blood flow circuit;

processing the primary measurement signal for extraction of primary pressure data originating from a subject pulse generator in the cardiovascular system, the primary pressure data comprising at least a part of a subject pulse from the subject pulse generator;

calculating a parameter value from the primary pressure data; and

determining the configuration based at least partly on the parameter value.

20. The method of claim 19, wherein the configuration is determined by comparing the parameter value with a reference parameter value.

21. The method of claim 19, further comprising receiving a secondary measurement signal obtained from a secondary pressure sensor.

22. The method of claim 19, further comprising extracting shape indicative data from the primary pressure data and matching the shape indicative data with shape reference data.

23. The method of claim 22, further comprising receiving a secondary measurement signal obtained from a secondary pressure sensor and extracting the shape reference data from the secondary measurement signal received from the secondary pressure sensor.

24. The method of claim 19, further comprising aggregating a plurality of pulses within an aggregation time window in the measurement signal.

25. The method of claim 19, further comprising issuing an alarm subsequent to determining a reverse configuration of access devices.

26. The method of claim 21, wherein the parameter represents a deviation in transit time of the subject pulse from the subject pulse generator to the primary pressure sensor and the secondary pressure sensor.

27. A computer-readable medium comprising computer instructions which, when executed by a processor, cause the processor to detect a configuration of withdrawal and return devices coupling an extracorporeal blood flow circuit to a cardiovascular system of a subject by:

receiving a primary measurement signal obtained by a primary pressure sensor in the extracorporeal blood flow circuit;

processing the primary measurement signal for extraction of primary pressure data originating from a subject pulse generator in the cardiovascular system, the primary pressure data comprising at least a part of a subject pulse from the subject pulse generator;

calculating a parameter value from the primary pressure data; and

determining the configuration based at least partly on the parameter value.

28. A device for detecting a configuration of withdrawal and return devices coupling an extracorporeal blood flow circuit to a cardiovascular system of a subject, said device comprising:

means for receiving a primary measurement signal obtained by a primary pressure sensor in the extracorporeal blood flow circuit;

means for processing the primary measurement signal for extraction of primary pressure data originating from a subject pulse generator in the cardiovascular system, the primary pressure data comprising at least a part of a subject pulse from the subject pulse generator;

means for calculating a parameter value from the primary pressure data; and

means for determining the configuration based at least partly on the parameter value.

29. A device for detecting a reversed configuration of withdrawal and return devices coupling an extracorporeal blood flow circuit to a cardiovascular system of a subject, the device comprising a signal processor configured to:

receive a primary measurement signal obtained by a primary pressure sensor in the extracorporeal blood flow circuit;

process the primary measurement signal for extraction of primary pressure data originating from a pump pulse generator in the extracorporeal blood flow circuit, the primary pressure data comprising at least a part of a pump pulse from the pump pulse generator;

calculate a parameter value from the primary pressure data, the parameter value being indicative of a cross-talk pressure pattern generated from a combination of pressure pulses from the pump pulse generator obtained by the primary pressure sensor from two directions, one passing through the cardiovascular system of the subject and the other from the pump pulse generator within the extracorporeal circuit; and

determine the reversed configuration based at least partly on the parameter value.

30. A method for detecting a reversed configuration of withdrawal and return devices coupling an extracorporeal blood flow circuit to a cardiovascular system of a subject, the method comprising:

receiving a primary measurement signal obtained by a primary pressure sensor in the extracorporeal blood flow circuit;

processing the primary measurement signal for extraction of primary pressure data originating from a pump pulse generator in the extracorporeal blood flow circuit;

calculating a parameter value from the primary pressure data, the parameter value being indicative of a cross-talk pressure pattern generated from a combination of pressure pulses from the pump pulse generator obtained by the primary pressure sensor from two directions, one passing through the cardiovascular system of the subject and the other from the pump pulse generator within the extracorporeal circuit; and

determining the reversed configuration based at least partly on the parameter value.