METHOD FOR DETECTION OF FLOW OBSTRUCTION IN AN EXTRACORPOREAL CIRCUIT, APPARATUS AND COMPUTER PROGRAM

Abstract

An extracorporeal circulation blood or treatment device (100) comprising an arterial pressure sensor (112) and a blood pump (111) is set up to determine amplitude variation and frequency of the pressure signals received from said arterial pressure sensor (112), calculate a parameter value based on said amplitude variation and said frequency, and issue an alarm if the parameter value exceeds a pre-set threshold value. Such detection aims at monitoring the occurrence of oscillating pressure signals. Such signals indicate an increased risk for hemolysis.

Claims

1-11. (canceled)

12. An extracorporeal circulation blood or treatment device comprising: a filter having a blood compartment and a dialysate compartment separated by a semipermeable membrane, said blood compartment having an inlet and an outlet, and said dialysate compartment having an inlet and an outlet; an arterial blood line adapted for transporting blood from the patient to the inlet of the blood compartment of the filter, the arterial blood line having an arterial connection adapted for being connected to a patient, a peristaltic arterial blood pump and an arterial pressure sensor located between the arterial connection and the arterial blood pump; a venous blood line adapted for returning blood from the blood compartment of the filter, the venous blood line having a venous connection adapted for being connected to the patient; a dialysate line for forwarding dialysate liquid from a dialysate source to the inlet of the dialysate compartment of the filter; a spent dialysate line for removing spent dialysate from the outlet of the dialysate compartment of the filter; and a controller in operable communication with the arterial blood pump and the arterial pressure sensor, wherein said controller is configured to receive pressure signals from said arterial pressure sensor when the blood pump is running, wherein the controller is configured to: determine amplitude variation and frequency of the pressure signals received from the arterial pressure sensor, determine whether the frequency of the pressure signals from the arterial pressure sensor is the same as an occlusion frequency of the peristaltic arterial blood pump, calculate a parameter value based on (i) said amplitude variation and (ii) whether the frequency of the pressure signals is the same as the occlusion frequency, and issue an alarm if the parameter value exceeds a pre-set threshold value.

13. The extracorporeal circulation blood or treatment device according to claim 12, wherein the venous blood line includes at least one of a venous pressure sensor, a venous drip chamber containing a level detector, and a priming detector, wherein each included sensor or detector is configured to send information to said controller, and wherein calculating said parameter value is further based on said information.

14. The extracorporeal circulation blood or treatment device according to claim 12, wherein the spent dialysate line comprises a pressure sensor and an ultrafiltration-measuring cell, the ultrafiltration-measuring cell configured to measure the liquid flows through the dialysate line and the spent dialysate line, wherein said sensor and said ultrafiltration-measuring cell are each configured to send information to said controller, and wherein calculating said parameter value is further based on said information.

15. The extracorporeal circulation blood or treatment device according to claim 12, wherein the control unit is configured to continuously determine the amplitude variation and frequency of the pressure signals received from the arterial pressure sensor.

16. A method for determining occlusions in blood lines mounted on an extracorporeal blood or treatment device, said device including: a filter having a blood compartment and a dialysate compartment separated by a semipermeable membrane, said blood compartment including an inlet and an outlet, and said dialysate compartment including an inlet and an outlet; an arterial blood line adapted for transporting blood from the patient to the inlet of the blood compartment of the filter, the arterial blood line having an arterial connection adapted for being connected to a patient, a peristaltic arterial blood pump and an arterial pressure sensor located between the arterial connection and the arterial blood pump; a venous blood line adapted for returning blood from the blood compartment of the filter, the venous blood line having a venous connection adapted for being connected to the patient; a dialysate line for forwarding dialysate liquid from a dialysate source to the inlet of the dialysate compartment of the filter; a spent dialysate line for removing spent dialysate from the outlet of the dialysate compartment of the filter; and a controller in operable communication with the arterial blood pump and the arterial pressure sensor, wherein said controller is configured to receive signals from said arterial pressure sensor when the blood pump is running, the method comprising: receiving pressure signals from said arterial pressure sensor; determining amplitude variation and frequency of the pressure signals received from said arterial pressure sensor; comparing an occlusion frequency of the peristaltic arterial blood pump with the frequency of the pressure signals from the arterial pressure sensor; calculating a parameter value based on said amplitude variation and said comparison of the occlusion frequency of the peristaltic arterial blood pump with the frequency of the pressure signals; and issuing an alarm if the parameter value exceeds a pre-set threshold value,

17. The method according to claim 16, wherein calculating said parameter value is further based on information from at least one of a venous pressure sensor, a level detector located in a venous drip chamber, and a priming detector.

18. The method according to claim 16, wherein calculating said parameter value is further based on pressure signals from a pressure sensor of a spent dialysate line and an ultrafiltration measuring cell.

19. The method according to claim 16, which includes continuously determining the amplitude variation and frequency of the pressure signals received from said arterial pressure sensor.

20. A non-transitory, computer-readable medium storing instructions, which when executed by a processor of an extracorporeal circulation blood or treatment device, cause the processor to: receive pressure signals from an arterial pressure sensor; determine amplitude variation and frequency of the pressure signals received from the arterial pressure sensor; compare an occlusion frequency of a peristaltic pump with the frequency of the pressure signals received from the arterial pressure sensor; calculate a parameter value based on said amplitude variation and said frequency and said comparison of the occlusion frequency of the peristaltic pump with the frequency of the pressure signals; and issue an alarm if the parameter value exceeds a pre-set threshold value.

21. The non-transitory, computer-readable medium of claim 20, wherein the processor is cause to continuously determine amplitude variation and frequency of the pressure signals received from the arterial pressure sensor.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0041] The present invention relates to a method of detecting occlusions, such as kinks in an extracorporeal blood circuit. In particular, the method is particularly suited for detecting kinks in the part of the arterial blood line between the arterial peristaltic blood pump and the blood chamber of the blood filter.

[0042] The present invention will now be described with reference to the enclosed drawings in which:

[0043] FIG. 1 schematically discloses an example of an extracorporeal blood or treatment device on which the method for determining occlusions according to the present invention has been implemented;

[0044] FIG. 2 illustrates occlusion of the blood pump segment of the arterial bloodline of the extracorporeal blood circuit. FIG. 2a shows a non-occluded segment and FIG. 2b discloses a fully occluded segment;

[0045] FIG. 3 discloses pressure signals from the arterial pressure sensor of an extracorporeal blood circuit during treatment of a patient in a situation where there is no occlusion in the arterial blood line between the arterial peristaltic blood pump and the blood filter;

[0046] FIG. 4 shows pressure signals from the arterial pressure sensor of an extracorporeal blood circuit during treatment of a patient in a situation where there is an occlusion, such as a kink, in the arterial blood line between the arterial peristaltic pump and the blood filter; and

[0047] FIG. 5 illustrates the detection of an oscillating signal by determining the variance.

[0048] The extracorporeal blood or treatment device 100, disclosed in FIG. 1, comprises a filter 101 having a blood compartment 102 and a dialysate compartment 103. These compartments are separated by a semipermeable membrane 104. An arterial blood line 109 is connected to the vascular system of a patient P by a connection 110, typically an arterial needle and suitable connection means. The blood then passes an arterial pressure sensor 112 on its way to the blood pump 111. The blood pump 111 forwards the blood to the inlet 105 of the blood compartment 102 of the blood filter 101. In the blood compartment 102, the blood is dialyzed over the semipermeable membrane 104 against dialysate liquid in the dialysate compartment 103. The blood then continues through the outlet 106 of the blood compartment 102 to the venous blood line 113 and passes through a venous drip chamber 120 including a level detector 121 and a venous pressor sensor 119, and finally a priming detector 122 until it reaches the venous connection 114, typically a venous needle and suitable connection means.

[0049] The dialysate liquid is transported from a dialysate source 116 through a dialysate line 115 to the inlet 107 of the dialysate compartment of the blood filter 101. The dialysate source 116 could be a dialysate preparation device where dialysate liquid prepared by mixing concentrates with water. Alternatively, the dialysate source 116 could be a bag containing ready-to-use dialysate liquid. The spent dialysate leaves the dialysate compartment 103 through outlet 108 and continues through the spent dialysate line 117. There is a pressure sensor 123 along the spent dialysate line 117. Furthermore, there is an ultrafiltration measuring cell 124 set up to measure the liquid flows throw the dialysate line 115 and the spent dialysate line 117. The spent dialysate line ends at a drain 125.

[0050] The extracorporeal blood or treatment device 100 also comprises a controller 118 for controlling and supervising the device. Specifically, the arterial blood sensor 112 and the peristaltic arterial blood pump 111 are connected to the controller 118 and are typically continuously transferring data to it. Other parts of the device 100 that also may send data to the controller 118 are venous pressure sensor 119, the level detector 121 of the venous drip chamber 120, priming detector 122, spent dialysate line pressure sensor 123, and the ultrafiltration measuring cell 124. The controller is set up to initiate alarms from alarm means 126 under certain conditions.

[0051] When detecting flow obstructions such as kinks in the part of the arterial blood line 109 between the arterial peristaltic blood pump 111 and inlet 105 to the blood compartment 102 of the blood filter 101, it turns out to be important to monitor the pressure detected by the arterial pressure sensor 112.

[0052] In principle, all hemodialysis machines currently in the market have a peristaltic pump to pump the blood through the blood lines. The arterial pressure that is measured in front of the pump, that is, by the arterial pressure sensor 112, is normally within the range of −50 to −200 mm Hg and the negative pressure is caused by the blood pump sucking the blood through the needle and pumping the blood through the blood filter 101 and back again to the patient P through the venous blood line 113.

[0053] The working principle of a peristaltic pump is to forward liquid in a segment of a tube (the pump segment) by occluding the tube and pushing forward. This is typically carried out by arranging spring-loaded rollers on the periphery of a rotating wheel and letting said rollers press on the pump segment.

[0054] It is important to have the right occlusion of the pump segment in order to obtain correct and predictable blood flow rates, especially if blood flow is determined based on the rotational speed of the pump wheel.

[0055] FIG. 2a discloses a completely non-occluded pump segment 200. Typically, a pump segment 200 has a wall thickness between the outer wall 206 and the inner wall 208 of about 2 mm, an inner diameter of about 8 mm and an outer diameter of about 12 mm. The pump segment 200 is arranged between a pump track 202 and a pump roller 204.

[0056] FIG. 2b shows a fully occluded pump segment 200, which is an ideal situation. Here, the pump segment 200 is occluded but the walls are not deformed. Accordingly, the thickness of the occluded segment 200 is double the wall thickness. If the wall thickness is 2 mm, the thickness of the occluded segment 200 would be 4 mm.

[0057] However, in practice, and in order to ensure that the pump segment 200 always is occluded on operation, the spring-loaded blood pump rollers 204 press harder. The pump segment 200 is therefore normally over-occluded. Typically, the pump segment walls are flattened to about 70% of the original thickness. In the following, the distance between a blood pump roller 204 and the pump track 202 (that distance is filled by the occluded blood pump segment 200) is referred to as the occlusion.

[0058] A diagram of arterial pressure over time measured by the arterial pressure sensor 112 located on the suction side of arterial blood pump 111 are shown in FIGS. 3 and 4. FIG. 3 shows a curve representing a normal treatment. The arterial pressure is negative and stable. The occlusion of the blood pump segment 200 is normal and there are no kinks on the blood line. The blood is stably forwarded from the suction side to the pressure side.

[0059] If the occlusion of the pump segment 200 is incorrect or the blood pump 111 for any other reason cannot be occluded properly, there might be a back flow in the blood pump 111 when the rollers 204 engage or disengage. FIG. 4 shows an oscillating arterial pressure caused by back flow in the blood pump 111. The effective blood flow rate is reduced and the red blood cells may be damaged and hemolysis occurs.

[0060] There is another situation where backflow may occur, and that is when there is a kink on the blood line 109 after the peristaltic arterial blood pump 111 and before the blood filter 101. Such a kink may lead to counter pressures as high as >1000 mm Hg. These high counter pressures and the associated backflow are dangerous to blood cells and may lead to hemolysis.

[0061] The present invention therefore aims at detecting this oscillating pressure by determining frequency and amplitude. As the oscillation is caused by backflow in the blood pump, its frequency must be the oscillation frequency, which is an integer multiple of the pump speed expressed as revolutions per minute. Furthermore, a large pressure amplitude is associated with a higher risk for hemolysis than a low amplitude. The controller 118 is set up to continuously monitor these two parameters and determines a parameter value based up on the outcome. In case the frequency value could be regarded as an integer multiple of the pump speed, and the pressure amplitude exceeds a threshold value, the control parameter is assigned a value indicating alarm conditions. An alarm may be issued by alarm means 126 and the blood pump 111 may be stopped.

[0062] In a preferred embodiment, the controller 118 continuously determines the variance of the amplitude of the pressure for a time segment of specific length. In case the variance is higher than a pre-set threshold value, the controller may issue an alarm and the blood pump 111 may be stopped. FIG. 5 shows oscillating pressure signals approximated as sinus curves. The brighter curve has a maximum amplitude of 20 mm Hg, whereas the darker curve has a maximum amplitude of 200 mm Hg. The frequencies of the two curves are the same and correspond to a typical blood pump frequency. The variance of the brighter low-amplitude curve amounts to 47, and the variance of darker high-amplitude curve amounts to as much as 4659. Accordingly, calculating the variance value renders it easier to differentiate between meaningful signals and noise. Moreover, the variance value is not dependent of the average signal level. The value is the same irrespective of whether the average level is zero, or above or below that level.

[0063] The controller 118 may rely upon more data when assessing alarm conditions. In case of incorrect occlusion or kinks, the data from at least pressure sensor 119 will differ from expected levels. For instance, in case of an obstruction of the blood line, the venous pressure sensor 119 will detect a pressure that is below what could have been expected.

[0064] Similarly, data from pressure sensor 123 and ultrafiltration measuring cell 124 may also diverge from expected levels. Such extra data may further support and increase reliability of the monitoring process. Additionally, if clearance measurements are made on-line, a reduction of clearance or an abnormally low blood flow rate to clearance ratio could indicate a reduced effective blood flow rate caused by an obstruction in the blood line.