System for Controlling Blood Flow Rate in an Extracorporeal Blood Oxygenation Circuit

Abstract

A control system in a blood line (12) of a cardiopulmonary bypass perfusion system (1) comprises a flow sensor (26) to determine a flow value indicative of the flow rate, a controller configured to process the flow value, and an adjustable restriction (28) responsive to the controller, to reduce the flow rate in the venous blood line (12) to maintain a flow rate to the venous blood reservoir that does not exceed a restriction threshold. As the adjustable restriction (28) is responsive to the flow sensor (26), this provides a closed loop control mechanism that avoids restricting the blood line (12) of the perfusion system (1) more than intended.

Claims

1. A control system to restrict the flow rate of blood in a blood line in which blood is permitted to flow from an inlet towards an outlet, wherein the control system comprises: a first flow sensor configured to determine a first flow value indicative of the flow rate in the blood line, a controller configured to process the first flow value, and an adjustable restriction responsive to the controller, wherein the adjustable restriction is configured to reduce the flow rate in the blood line to maintain a flow rate that does not exceed a restriction threshold.

2. The control system in accordance with claim 1, further configured to determine if the first flow value exceeds the restriction threshold by a pre-determined margin, and configured to effect an adjustment of the adjustable restriction to maintain the flow rate below the restriction threshold.

3. The control system according to claim 1, wherein the adjustable restriction comprises a gradually actuatable occlusive device.

4. The control system according to claim 1, wherein the blood line comprises a venous line for draining blood into a reservoir, and wherein the first flow sensor is configured to determine the first flow value indicative of the venous flow rate and wherein the adjustable restriction is configured to maintain the venous flow rate in the venous line.

5. The control system according to claim 1 for use in a perfusion system comprising a pump to circulate blood from the reservoir via a main blood line towards an outlet, wherein the pump is responsive to the controller, and wherein the controller is configured to modulate operation of the pump to maintain the throughput towards the outlet at a pre-determined output flow rate, wherein the control system further comprises: a second flow sensor configured to determine a second flow value indicative of the flow rate in the main blood line, and wherein the controller is configured to determine a difference between the second flow value and the pre-determined output flow rate, and to adjust pump parameters to reduce the difference.

6. The control system according to claim 5, wherein the control system is configured to allow the restriction threshold and the pre-determined output flow rate to be set independently.

7. The control system according to claim 5, wherein the controller is configured to adjust the pre-determined output flow rate relative to the restriction threshold.

8. The control system according to claim 7, wherein the controller is configured to maintain the pre-determined output flow rate at a level selected from the group consisting of: above the restriction threshold, at the restriction threshold, and below the restriction threshold.

9. (canceled)

10. The control system according to claim 5, further configured to receive as an input a pressure value indicative of the physiological blood pressure of a patient, and to adjust the output flow rate in response to the physiological blood pressure.

11. The control system according to claim 1, further configured to receive as an input a pressure value indicative of the physiological blood pressure of a patient, and to adjust the restriction threshold in response to the pressure value.

12. The control system according to claim 10, wherein the pressure value comprises a value selected from the group consisting of: the Central Venous Pressure (CVP) and the Pulmonary Artery Diastolic Pressure (PAD).

13. The control system according to claim 1, further comprising a processor and software instructions implemented by the processor permitting it to control the adjustable restriction in response to the first flow value.

14. A method of restricting the flow rate of blood in a blood line in which blood is permitted to flow from an inlet towards an outlet, the method comprising the steps of providing a first flow sensor to determine a first flow value indicative of the flow rate in the blood line, providing an adjustable restriction configured to reduce the flow rate in the blood line, and in response to the first flow value, controlling the adjustable restriction to reduce the flow rate in the blood line to maintain a flow rate that does not exceed a restriction threshold.

15. The method in accordance with claim 14, further comprising the steps of: determining if the first flow value exceeds the restriction threshold by a pre-determined margin, and adjusting the adjustable restriction to maintain the flow rate below the restriction threshold.

16. (canceled)

17. The method according to claim 14, used in a control system for a perfusion system comprising a pump to circulate blood at a pre-determined output flow rate from the reservoir via a main blood line towards an outlet, the method further comprising the steps of: providing a second flow sensor to determine a second flow value indicative of the flow rate in the main blood line, determining if there is an output difference between the second flow value and the pre-determined output flow rate, and adjusting parameters of the pump to reduce the output difference.

18. The method according to claim 17, further comprising adjusting the pre-determined output flow rate relative to the restriction threshold.

19. The method according to claim 17, further comprising synchronously adjusting the pre-determined output flow rate and the restriction threshold.

20. The method according to claim 14, further comprising the steps of: monitoring a pressure value indicative of the physiological blood pressure of a patient, determining if the pressure value exceeds a pre-determined pressure threshold, and adjusting at least one of the adjustable restriction and the parameters of the pump depending on whether the pressure value exceeds the pre-determined pressure threshold.

21. The method in accordance with claim 20, comprising, while the pressure value is below the pre-determined pressure threshold, increasing the restriction threshold.

22. The method in accordance with claim 20, comprising, while the pressure value exceeds the pre-determined pressure threshold, reducing the restriction threshold.

23. (canceled)

24. (canceled)

25. (canceled)

Description

DESCRIPTION OF THE FIGURES

[0083] Exemplary embodiments of the invention will now be described with reference to the Figures, in which:

[0084] FIG. 1 shows a schematic arrangement of components of a control system to restrict the flow rate in a blood line in accordance with embodiments of the present invention; and

[0085] FIG. 2 shows steps of an exemplary sequence of method steps of a method for restricting the flow rate in a blood line accordance with embodiments of the present invention.

DESCRIPTION

[0086] FIG. 1 shows, schematically, components of a perfusion system 1. The perfusion system comprises a venous line 12 provided to receive venous blood V from a patient. Via the venous line 12, venous blood is permitted to flow into a reservoir 10 via a reservoir inlet 14. Venous blood is held in the reservoir 10 at atmospheric pressure.

[0087] The venous blood may be drawn from the reservoir 10 via a reservoir outlet 16 through the main line 22 of the perfusion system. The blood is pumped by a pump 20, which may be any suitable type of pump, such as a peristaltic pump (e.g., a roller pump) or a centrifugal pump. The pump causes blood to flow through the main line 22 in a direction indicated by arrows 18, via an oxygenator 30 and towards an outlet 24 of the perfusion system 1.

[0088] At the outlet 24, the blood is in a condition for administration to a patient. For instance, the blood may have been oxygenated in the oxygenator 30, and the blood will have a flow rate and line pressure sufficient to permit safe administration to a patient. In the absence of losses, it can be assumed that the flow rate and the line pressure are determined by the pump 20. If the pump 20 generates higher throughput, the arterial flow rate is faster. Conversely, if the pump 20 generates lower throughput, the arterial flow rate is slower.

[0089] The venous line 12 and the main line 22 may be constituted by flexible tubing. The tubes may have a different length and/or diameter. The tubes may have different strength or flexibility characteristics.

[0090] In the venous line 12, the control system comprises a venous flow sensor 26 and a flow-restricting arrangement 28. The venous flow sensor 26 is configured to provide a flow value indicative of the flow rate in the venous line 12, and may be constituted by a mass flow meter. The flow-restricting arrangement 28 may be configured to allow the flow to be restricted gradually. For instance, the flow-restricting arrangement 28 may be constituted by a motorised clamp suitable to squeeze a flexible tube.

[0091] In an embodiment, the venous line V constitutes a blood line, the venous line upstream of the flow-restricting arrangement 28 constitutes an inlet of a blood line, the reservoir inlet 14 constitutes an outlet of the blood line, the venous flow sensor 26 constitutes a first flow sensor, and the flow-restricting arrangement 28 constitutes an adjustable restriction.

[0092] The motorised clamp is responsive to a controller (controller not shown in FIG. 1) and allows the flow rate in the venous line to be prevented from exceeding a restriction threshold. For instance, the controller may issue a control signal to the motorised clamp to squeeze the venous line 12 until the flow rate, as determined by the flow sensor 26, no longer exceeds the restriction threshold.

[0093] Due to the closed loop control, it is not necessary to know by how much the tube was squeezed, or which type of equipment was used, in order to maintain the restriction threshold.

[0094] Partially clamping the flexible tube to a sufficient extent allows the flow rate in the venous line 12 to be restricted. By gradually opening the clamp, the degree of restriction of the flow rate in the venous line 12 can be reduced until there is no flow rate restriction by the flow-restricting arrangement 28.

[0095] Downstream of the reservoir 10, (in FIG. 1 also downstream of the oxygenator 30), the perfusion system is provided with a main flow sensor 32. The main flow sensor 32 allows the flow rate of the blood provided towards the patient to be measured. The flow rate towards the patient may be regarded as output flow rate. The flow sensor 32 is configured to provide a second flow value indicative of the flow rate in the main blood line, i.e., of the flow rate through the outlet 24.

[0096] A controller (not shown in FIG. 1) is configured to receive as an input a restriction threshold to indicate the maximum flow rate through the venous line 12. For instance, the restriction threshold may be set via an interface. The restriction threshold may be set as an absolute value (e.g., 2 lpm) or as a relative value (e.g., half of the current flow). The current flow rate may be determined by the venous flow sensor 26 or by the main flow sensor 32. For instance, the restriction threshold may be set to half the second flow value.

[0097] The controller is configured to receive a venous flow value indicative of the venous flow rate, as determined by the flow sensor 26. The controller comprises decision logic to determine whether or not the venous flow rate exceeds the restriction threshold. If the venous flow value does not exceed the set restriction threshold, the flow-restricting arrangement 26 is not actuated. If the venous flow value exceeds the set restriction threshold, the controller may issue a control signal to the flow-restricting arrangement 28 to increase the flow restriction until the venous flow rate no longer exceeds the restriction threshold.

[0098] After the flow-restricting arrangement has been set, the controller continues to monitor the venous flow as determined by the flow sensor 26. If, for any reason, the flow value exceeds the restriction threshold despite a previously appropriate restriction setting, the controller issues a control signal to the flow-restricting arrangement 28 to adjust the restriction threshold.

[0099] In one embodiment, the controller is configured to operate the pump 20 to maintain a pre-determined output flow rate. The second flow value may be derived from operational parameters of the pump 20. The second flow value may be determined by the flow sensor 32.

[0100] The pre-determined output flow rate and the restriction threshold may each be set independently, e.g., in absolute values, via an input interface.

[0101] The controller may be configured to adjust the output flow rate through the outlet 24 relative to the restriction threshold in the venous line 12.

[0102] For instance, the restriction threshold and the pre-determined output flow rate may be matched. The venous flow threshold may be set to 2 lpm, and venous blood can be expected not to flow into the reservoir 10 faster than at a rate of 2 lpm. The controller may adjust the operation of the pump 20 such that the flow rate through the outlet, as measured by the main flow sensor 32, is not more than 2 lpm.

[0103] In the venous line 12, the actual venous flow rate is monitored by the first flow sensor 26. If, for any reason, the actual venous flow rate exceeds the threshold of 2 lpm, the controller is configured to respond by increasing the flow restriction, until the venous flow rate is at, or below, 2 lpm.

[0104] If the pre-determined output flow rate and the restriction threshold are set independently, a change of the pre-determined output flow rate will not affect the restriction threshold.

[0105] While the controller is set to match the main flow rate and the venous flow rate, the pump parameters may be changed according to the venous flow threshold. For instance, the venous flow restriction may be reduced by setting the venous flow threshold from 2 lpm to 3 lpm. The controller may increase the pump speed until the main flow rate is 3 lpm. Likewise, the venous flow restriction may be increased (the restriction threshold may be lowered), e.g., from 2 lpm to 1 lpm. The controller may reduce the pump speed to reduce the main flow rate to 1 lpm.

[0106] The restriction threshold may be below or above the pre-determined output flow rate. This provides a control over the blood supply during the different end phases of extracorporeal perfusion.

[0107] To initiate the end of extracorporeal perfusion support, the restriction threshold may be reduced to restrict the venous flow, e.g., to 2 lpm. At this stage, the output flow rate as determined by the pump may continue to be governed by normal perfusion requirements. Such requirements may include cardiac index values and venous saturation. The output flow rate may be in the region of 5 lpm. As the output flow rate exceeds the venous flow, this results in a gradual filling of the vascular system.

[0108] When the vascular system is filled to a sufficient extent (this may be determined by a physiological blood pressure), the restriction threshold may be maintained and the pre-determined output flow rate may be set to match the restriction threshold. The output flow rate is no longer governed exclusively by normal perfusion requirements. For instance, the pre-determined output flow rate and the restriction threshold may be adjusted to such that the CVP is close to, but not exceeding 15 mmHg, and/or such that the PAD is close to, but not exceeding 20 mmHg.

[0109] The restriction threshold of the venous line and the pre-determined output flow rate of the main line may be adjusted synchronously. If the heart performs satisfactorily at a perfusion flow rate of 2 lpm, the restriction threshold and the pre-determined output flow rate may be reduced further, e.g., from 2 lpm to 1 lpm, to further encourage heart activity. This may affect the pressure levels, such as CVP and/or PAD. If a pressure level is too low, the pre-determined output flow rate may be temporarily increased relative to the restriction threshold in order to increase the CVP or PAD value. If a pressure level is too high, the output flow rate may be temporarily decreased, and/or the restriction threshold may be partially lifted.

[0110] The restriction threshold and the pre-determined output flow rate may be adjusted independently. For instance, a clinician may wish to adjust these thresholds manually according to other blood values, such as venous oxygen saturation.

[0111] If heart performance at the reduced output flow rate is insufficient, extracorporeal perfusion may be resumed by increasing the output flow rate and/or by lifting the restriction threshold.

[0112] If the heart performs well with a reduced extracorporeal perfusion support, extracorporeal perfusion support may be further reduced, by setting a the pre-determined output flow rate to a lower level, until a decision can be made to completely cease extracorporeal perfusion and to let the heart take over circulation.

[0113] In FIG. 2, steps of a control method 40 or restricting the flow rate in a blood line, such as a venous line, are shown. In step 42, blood is permitted to flow through a blood line. In step 44, a blood flow sensor is provided in the blood line, to provide a blood flow value indicative of the flow rate in the blood line. In step 46, an adjustable restriction is provided to allow the flow through the blood line to be reduced. In step 48, a restriction threshold is set. The restriction threshold may be regarded as a maximum blood flow rate level. In step 50, the blood flow value (e.g., of venous blood) is determined by the blood flow sensor. In step 52, the blood flow is reduced, using the adjustable restriction, to below the restriction threshold. The restriction threshold remains responsive to the flow rate. I.e., if a blood flow value is determined to be higher than the restriction threshold, the adjustable restriction is re-adjusted to limit the flow rate to the restriction threshold.

[0114] Threshold values described herein, such as the restriction threshold, the output flow rate, and pressure thresholds, may include a margin to avoid an overshooting response.