Device and method for monitoring an extracorporeal blood treatment

• US 10,022,485 B2
• Filed: 12/27/2010
• Issued: 07/17/2018
• Est. Priority Date: 12/28/2009
• Status: Expired due to Fees

• Current Assignee: Fresenius Medical Care Deutschland GmbH (Fresenius SE & Co. KGaA)
• Original Assignee: Fresenius Medical Care Deutschland GmbH (Fresenius SE & Co. KGaA)
• Inventors: Peters, Arne, Wiktor, Christoph
• Primary Examiner(s): Scherbel, Todd J
• Assistant Examiner(s): Townsend, Guy K
• Application Number:
  US13/519,223
• Publication Number:
  US 20120330214A1
• Time in Patent Office: 2,759 Days
• Field of Search: 604 611
• CPC Class Codes: A61M 1/1603 Regulation parameters
• CPC Class Codes: A61M 1/3656 Monitoring patency or flow at connection sites; Detecting disconnections
• CPC Class Codes: A61M 1/3663 Flow rate transducers; Flow integrators
• CPC Class Codes: A61M 2205/18 with alarm
• CPC Class Codes: A61M 2205/3375 Acoustical, e.g. ultrasonic, measuring means

Abstract

A device and method for monitoring an access to a patient, an extracorporeal blood circuit and/or a dialyzing fluid system includes a centrifugal pump for conveying blood or dialyzing fluid instead of an occluding pump. Centrifugal pumps bring about a large change in flow rate by even a small change in pressure difference across the pump. The device includes a measuring unit for measuring the flow rate of blood or dialyzing fluid conveyed by the centrifugal pump, and a control and computing unit configured to determine an incorrect vascular access or malfunction if a change in measured flow rate Q is more than a predetermined amount. For example, a small drop in pressure in the venous blood line leads to a marked increase in the flow rate of the centrifugal pump, which is used as a basis for the detection of an incorrect vascular access.

Claims

1. A device for monitoring an extracorporeal blood treatment apparatus with an extracorporeal blood circuit having an arterial blood line with an arterial patient connection and a venous blood line with a venous patient connection, and a dialyzing fluid system, wherein a dialyzer is in fluid communication with the extracorporeal blood circuit and the dialyzing fluid system, and a centrifugal pump for conveying blood in the extracorporeal blood circuit is disposed in the arterial blood line between the dialyzer and the arterial patient connection of the extracorporeal blood circuit, the device comprising

a flow sensor configured to measure a flow rate Q of the blood conveyed by the centrifugal pump in the extracorporeal blood circuit, wherein the flow sensor is positioned to measure flow in the venous blood line,

pressure sensors comprising a first arterial line pressure sensor, a second arterial line pressure sensor, and a venous line pressure sensor, wherein the first arterial line pressure sensor is configured to measure the pressure in the arterial blood line between the arterial patient connection and the centrifugal pump, and the second arterial line pressure sensor is configured to measure the pressure in the arterial blood line between the centrifugal pump and the dialyzer, and

a control and computing unit configured to monitor the rate of change of the measured flow rate such that, in the event that the rate of change of the measured flow rate is more than a specific threshold value, at least one of an incorrect vascular access or a malfunction in the extracorporeal blood circuit is determined,

wherein the control and computing unit is further configured to:

distinguish between specific malfunctions based on (1) the rate of the change of the measured flow rate, (2) whether the flow rate is dropping or increasing, (3) the pressure measured by at least one of the pressure sensors, and (4) whether the pressure measured is dropping, increasing, or remaining constant;

compare the rate of change of the measured flow rate with the specific threshold value; and

determine that the venous patient connection has slipped out when the rate of change of the measured flow rate is more than the specific threshold value and there is a drop in pressure in the venous blood line.

5. The device according to claim 1, wherein the control and computing unit is further configured to generate a control signal when the rate of change of the measured flow rate is greater than the specific threshold value.

7. An apparatus for extracorporeal blood treatment with an extracorporeal blood circuit, comprising:

an extracorporeal blood circuit having an arterial blood line with an arterial patient connection and a venous blood line with a venous patient connection, wherein a centrifugal pump configured to convey blood in the extracorporeal blood circuit is disposed in the arterial blood line,

a dialyzing fluid system,

a dialyzer in fluid communication with the extracorporeal blood circuit and the dialyzing fluid system, wherein the centrifugal pump is disposed in the arterial blood line between the dialyzer and the arterial patient connection, and

the monitoring device according to claim 1.

9. The apparatus according to claim 7, further comprising a central control unit configured such that the control unit intervenes in the machine control when the control and computing unit of the monitoring device generates a control signal.

10. The apparatus according to claim 9, wherein the control unit of the blood treatment apparatus is configured such that the centrifugal pump disposed in the extracorporeal blood circuit is stopped as an intervention into the machine control.

11. The apparatus according to claim 9, wherein the control unit of the blood treatment apparatus is configured such that a shut-off element disposed in or on the venous blood line is closed as an intervention in the machine control.

12. The apparatus according to claim 7, wherein the centrifugal pump is disposed in the arterial blood line.

13. The device according to claim 1, wherein the control and computing unit is configured to determine that the arterial or venous blood line is kinked or nipped if the measured flow rate falls at a rate that is greater than a preset first flow rate threshold value and the pressure measured by the first arterial pressure sensor falls below a preset first pressure threshold value.

14. The device according to claim 1, wherein the control and computing unit is configured to determine that the dialyzer is clogged if the measured flow rate falls at a rate that is greater than a preset third flow rate threshold value that is less than the preset first flow rate threshold value, and the pressure measured by the second arterial pressure sensor increases above a preset third pressure threshold value.

15. The device according to claim 1, wherein the control and computing unit is configured to determine that:

the arterial or venous blood line is kinked or nipped if the measured flow rate falls at a rate that is greater than a preset second flow rate threshold value and the pressure measured by the second arterial pressure sensor increases above a preset second pressure threshold value.

16. The device according to claim 1, wherein the venous line pressure sensor is configured to measure the pressure in the venous blood line between the dialyzer and the venous patient connection, and the control and computing unit is configured to determine that a disconnection of the venous patient connection is present if the measured flow rate increases at a rate that is greater than a preset fourth flow rate threshold value, and the pressure measured by the venous pressure sensor remains constant or falls.

17. The device according to claim 1, wherein the control and computing unit comprises an input unit and a comparison unit, the input unit being configured to input data records characteristic of a hose set used, the comparison unit being configured to compare the data records to stored data records to which specific threshold values are assigned, to determine the specific threshold value.

2. A device for monitoring an extracorporeal blood treatment apparatus with an extracorporeal blood circuit, and a dialyzing fluid system having a dialyzing fluid supply line and a dialyzing fluid discharge line, wherein a centrifugal pump for conveying dialyzing fluid is disposed in one of the dialyzing fluid supply line or the dialyzing fluid discharge line of the dialyzing fluid system, the device comprising:

a flow sensor configured to measure a flow rate Q of the dialyzing fluid conveyed by the centrifugal pump in the dialyzing fluid system,

at least one dialyzing fluid pressure sensor configured to measure pressure in (a) the dialyzing fluid discharge line, or (b) both the dialyzing fluid supply line and the dialyzing fluid discharge line, and

a control and computing unit configured to monitor the rate of change of the measured flow rate such that, in the event that the rate of change of the measured flow rate is more than a specific threshold value, a malfunction in the dialyzing fluid system is determined, the control and computing unit comprising an input unit and a comparison unit, the input unit being configured to input data records characteristic of a hose set used, the comparison unit being configured to compare the data records to stored data records to which specific threshold values are assigned, to determine the specific threshold value,

wherein the control and computing unit is further configured to distinguish between specific malfunctions based on the rate of the change of the measured flow rate, whether the flow rate is dropping or increasing, the pressure measured by the at least one dialyzing fluid pressure sensor, and whether the dialyzing fluid pressure measured is dropping, increasing, or remaining constant.

6. The device according to claim 2, wherein the control and computing unit is further configured to compare the rate of change of the measured flow rate with the specific threshold value and to generate a control signal when the rate of change of the measured flow rate is greater than the specific threshold value.

8. An apparatus for extracorporeal blood treatment with an extracorporeal blood circuit and a dialyzing fluid system, comprising:

a dialyzing fluid supply line and a dialyzing fluid discharge line, wherein a centrifugal pump configured to convey dialyzing fluid is disposed in one of the dialyzing fluid supply line or the dialyzing fluid discharge line of the dialyzing fluid system, and

the monitoring device according to claim 2.

3. A method for monitoring an extracorporeal blood treatment apparatus with an extracorporeal blood circuit having an arterial blood line with an arterial patient connection and a venous blood line with a venous patient connection, and a dialyzing fluid system, wherein a dialyzer is in fluid communication with the extracorporeal blood circuit and the dialyzing fluid system, and a centrifugal pump for conveying blood in the extracorporeal blood circuit is disposed in the arterial blood line between the dialyzer and the arterial patient connection, the method comprising:

measuring a flow rate Q of the blood conveyed by the centrifugal pump in the extracorporeal blood circuit and monitoring a rate of change of the flow rate Q,

measuring a pressure in the arterial blood line and measuring a pressure in the venous blood line, wherein the measuring of pressure in the arterial blood line comprises i) measuring pressure in the arterial blood line between the arterial patient connection and the centrifugal pump or ii) measuring pressure in the arterial blood line between the centrifugal pump and the dialyzer,

determining at least one of an incorrect vascular access or a malfunction in the extracorporeal blood circuit in the event that the rate of change of the measured flow rate Q is more than a specific threshold value,

distinguishing between specific malfunctions based on the rate of change, whether the flow rate is dropping or increasing, the measured pressure in the arterial blood line or in the venous blood line, and whether the pressure measured is dropping, increasing, or remaining constant, and

determining that the venous patient connection has slipped out when the rate of change of the measured flow rate is more than a specific threshold value and there is a drop in pressure in the venous blood line.

4. A method for monitoring an extracorporeal blood treatment apparatus with an extracorporeal blood circuit having an arterial blood line with an arterial patient connection and a venous blood line with a venous patient connection, and a dialyzing fluid system having a dialyzing fluid supply line and a dialyzing fluid discharge line, wherein a centrifugal pump for conveying dialyzing fluid is disposed in one of the dialyzing fluid supply line or the dialyzing fluid discharge line of the dialyzing fluid system, the method comprising:

inputting data records characteristic of a hose set being used,

comparing the data records to stored data records to which specific threshold values are assigned,

determining, from the comparison, a specific threshold value to be used,

measuring flow rate Q of the dialyzing fluid conveyed by the centrifugal pump in the dialyzing fluid system and monitoring a rate of change of the flow rate Q,

measuring a dialyzing fluid pressure in at least the dialyzing fluid discharge line,

determining a malfunction in the dialyzing fluid system in the event that the rate of change of the measured flow rate Q is more than the specific threshold value, and

distinguishing between specific malfunctions based on the rate of change, whether the rate of change is dropping or increasing, the measured dialyzing fluid pressure, and whether the measured dialyzing fluid pressure is dropping, increasing, or remaining constant.