Method and device for detecting a configuration of withdrawal and return devices

• US 9,289,544 B2
• Filed: 12/22/2010
• Issued: 03/22/2016
• 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
• Primary Examiner(s): DEAK, LESLIE R
• Application Number:
  US13/519,146
• Publication Number:
  US 20130150766A1
• Time in Patent Office: 1,917 Days
• Field of Search: 604/4.01, 604/5.04, 210/739, 210/741
• US Class Current: 1/1
• 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, wherein the withdrawal and return devices are configurable in a normal configuration and the reversed configuration, wherein in the normal configuration the withdrawal device is in an upstream position of said cardiovascular system for withdrawal of fluid and the return device is in a downstream position of the cardiovascular system for return of fluid, and further wherein in the reversed configuration the positioning of the return and withdrawal devices is reversed, the device comprising:

a primary pressure sensor in the extracorporeal blood flow circuit, the primary pressure sensor configured to provide a primary measurement signal comprising at least a subject pulse from a subject pulse generator in the cardiovascular system;

a signal processor configured to;

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

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

a notification apparatus to provide a notification when the reversed configuration has been determined.

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 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.

7. 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.

8. 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.

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

10. The device of claim 9, wherein said pressure amplitude measure comprises an arterial pressure amplitude Ha or a venous pressure amplitude Hv.

11. 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.

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

13. 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.

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

15. The device of claim 13, wherein the shape reference data represents a frequency spectrum of the subject pulse generator.

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. 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, wherein the withdrawal and return devices are configurable in a normal configuration and the reversed configuration, wherein in the normal configuration the withdrawal device is in an upstream position of said cardiovascular system for withdrawal of fluid and the return device is in a downstream position of the cardiovascular system for return of fluid, and further wherein in the reversed configuration the positioning of the return and withdrawal devices is reversed, the method comprising:

receiving a primary measurement signal obtained by a primary pressure sensor in the extracorporeal blood flow circuit, wherein the primary measurement signal comprises at least a subject pulse from a subject pulse generator in the cardiovascular system;

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

calculating a parameter value from the primary pressure data;

determining the reversed configuration based at least partly on the parameter value calculated from the primary pressure data comprising at least a part of the subject pulse from the subject pulse generator; and

providing a notification when the reversed configuration has been determined.

19. The method of claim 18, wherein the configuration is determined by comparing the parameter value with a reference parameter value.

20. The method of claim 18, further comprising receiving a secondary measurement signal obtained from a secondary pressure sensor.

21. The method of claim 20, 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.

22. The method of claim 18, 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 18, further comprising aggregating a plurality of pulses within an aggregation time window in the measurement signal.

25. The method of claim 18, further comprising issuing an alarm subsequent to determining a reverse configuration of access devices.

26. A computer-readable medium comprising computer instructions which, when executed by a processor in an extracorporeal blood treatment system, cause the processor to detect a reversed 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, wherein the primary measurement signal comprises at least a subject pulse from a subject pulse generator in the cardiovascular system;

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

calculating a parameter value from the primary pressure data;

determining the reversed configuration based at least partly on the parameter value calculated from the primary pressure data comprising at least a part of the subject pulse from the subject pulse generator, wherein the withdrawal and return devices are configurable in a normal configuration and the reversed configuration, wherein in the normal configuration the withdrawal device is in an upstream position of said cardiovascular system for withdrawal of fluid and the return device is in a downstream position of the cardiovascular system for return of fluid, and further wherein in the reversed configuration the positioning of the return and withdrawal devices is reversed; and

generating a signal to initiate notification of determination of the reversed configuration.

27. 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, wherein the withdrawal and return devices are configurable in a normal configuration and the reversed configuration, wherein in the normal configuration the withdrawal device is in an upstream position of said cardiovascular system for withdrawal of fluid and the return device is in a downstream position of the cardiovascular system for return of fluid, and further wherein in the reversed configuration the positioning of the return and withdrawal devices is reversed, said device comprising:

primary pressure sensing means in the extracorporeal blood flow circuit, the primary pressure sensing means for providing a primary measurement signal comprising at least a subject pulse from a subject pulse generator in the cardiovascular system;

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

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

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

means for determining the reversed configuration based at least partly on the parameter value calculated from the primary pressure data comprising at least a part of the subject pulse from the subject pulse generator; and

means for providing a notification when the reversed configuration has been determined.

28. 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, wherein the withdrawal and return devices are configurable in a normal configuration and the reversed configuration, wherein in the normal configuration the withdrawal device is in an upstream position of said cardiovascular system for withdrawal of fluid and the return device is in a downstream position of the cardiovascular system for return of fluid, and further wherein in the reversed configuration the positioning of the return and withdrawal devices is reversed, the device comprising:

a primary pressure sensor in the extracorporeal blood flow circuit, the primary pressure sensor configured to provide a primary measurement signal comprising at least a pump pulse from a pump pulse generator;

a signal processor configured to;

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

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

a notification apparatus to provide a notification when the reversed configuration has been determined.

29. 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, wherein the withdrawal and return devices are configurable in a normal configuration and the reversed configuration, wherein in the normal configuration the withdrawal device is in an upstream position of said cardiovascular system for withdrawal of fluid and the return device is in a downstream position of the cardiovascular system for return of fluid, and further wherein in the reversed configuration the positioning of the return and withdrawal devices is reversed, the method comprising:

receiving a primary measurement signal obtained by a primary pressure sensor in the extracorporeal blood flow circuit, wherein the primary measurement signal comprises at least a pump pulse from a pump pulse generator;

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

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 calculated from the primary pressure data; and

providing a notification when the reversed configuration has been determined.