Two-way blood pump and one-way filter trap and system comprising two-way blood pump and one-way filter trap

Abstract

A blood pump system switchable between a first flow direction and a second flow direction includes a filter trap and a blood pump. The blood pump has an impeller configured to rotate in a first rotational direction at a predetermined speed to generate a fluid flow in the first flow direction having a first pressure and a first flow rate. The impeller is configured to rotate in a second rotational direction at the predetermined pump speed to generate a fluid flow having a second pressure and a second flow rate in the second flow direction. When the impeller is operated at the predetermined pump speed, the first flow rate and the first pressure are different from the second flow rate and the second pressure. The filter trap includes a one-way valve configured to remain closed when fluid flows in the first direction and open when fluid flows in the second direction.

Description

Technical Field

[0001] The present application relates generally to blood pumps and, more particularly, to bidirectional blood pumps and unidirectional filter traps. Background Art

[0002] When treating a patient, it is sometimes necessary to generate blood flow using an artificial pump. In a perfusion arrangement, blood is pumped from one compartment of the circulation to another compartment by a blood pump. Typically, blood is pumped in an antegrade flow, meaning pumped in the natural direction of blood flow. This can be in series or parallel with the autologous blood flow, depending on the connections of the pump inflow and outflow. The blood can then undergo some treatment or therapy within the artificial circuit and then return to circulate in the patient's body. In retrograde flow, blood is pumped in the opposite direction to the natural blood flow direction. Regardless of the direction of flow, the blood pump needs to roughly match the pressure of the veins and arteries to which the blood pump fluid is connected. Failure to do so may result in vascular damage. Normal pressures within systemic veins are typically in the range of 2-10 mmHg, and normal pressures within arteries are typically in the range of 100-140 mmHg, with an average pressure in the range of 65-95 mmHg.

[0003] Perfusion requires pumping fluid with a physiologically normal flow rate to flow in the body to provide gas exchange and nutrient delivery to tissues and organs. Retrograde perfusion requires pumping fluid with a physiologically abnormal flow rate to flow in the body. Existing methods for performing perfusion and retrograde perfusion are complex and are accompanied by the risk of human error. For example, many blood pumps operate only in a single direction. In order to change the direction of flow (e.g., from antegrade flow to retrograde flow), the lead to the pump must be disconnected and reconnected. The current continuous flow pump capable of bidirectional operation needs to change the pump speed between antegrade flow and retrograde flow to consider the pressure difference of the normal range between veins and arteries. When switching from antegrade flow or perfusion to retrograde flow or retrograde perfusion, the additional problem worthy of attention is the possibility of technical complications caused by the operation, the most important of which is bleeding and thrombosis. Summary of the invention

[0004] The present application is directed to a bidirectional blood pump system for perfusion and retrograde perfusion. The bidirectional blood pump system can operate at the same pump speed for both perfusion and retrograde perfusion. The bidirectional blood pump system can include a filter trap, an alarm, a gas exchanger, a vacuum device, or a heat exchanger.

[0005] In one aspect of the present application, a blood pump includes a pump housing and an impeller. The pump housing has a first connector and a second connector, the first connector being configured as a fluid inlet flowing into the pump housing in a first flow direction and as a fluid outlet flowing out of the pump housing in a second flow direction, and the second connector being configured as a fluid inlet flowing into the pump housing in the second flow direction and as a fluid outlet flowing out of the pump housing in the first flow direction. The impeller is arranged in the pump housing. The impeller is configured to rotate at a predetermined speed in a first rotation direction to generate a fluid flow (fluid flow) having a first pressure and a first flow velocity in the first flow direction. The impeller is configured to rotate in a second rotation direction opposite to the first rotation direction at a predetermined pump speed to generate a fluid flow having a second pressure and a second flow velocity in the second flow direction. The first flow velocity is greater than the second flow velocity, and the first pressure is greater than the second pressure.

[0006] In various aspects, the impeller includes a body and blades. The body may have a first section and a second section. The blades may extend radially outward from the body and be helically wound around the second section of the body. The blades may have an inclination angle so that a radially outer portion of the blade is farther away from the first section than a radially inner portion of the blade. The blades may be helically wound around the second section of the body with a variable pitch so that a portion of the blade closer to the first section has a smaller pitch than a portion of the blade farther away from the first section. The first section may be generally oval and the second section may be frustoconical. The product of the first flow rate and the first pressure may be different from the product of the second flow rate and the second pressure. The product of the first flow rate and the first pressure may be greater than the product of the second flow rate and the second pressure.

[0007] In certain aspects, the first pressure of the fluid flow generated by the blood pump is greater than the second pressure. The first flow rate of the fluid flow generated by the blood pump can be greater than the second flow rate. The second flow rate can be between 30% and 50% of the first flow rate. The first pressure can be in the range of 100 mmHg to 140 mmHg. The first flow rate can be in the range of 2.8 L / min to 3.5 L / min. The second pressure can be in the range of 2 mmHg to 10 mmHg. The second flow rate can be 1.2 L / min to 1.5 L / min.

[0008] In another aspect of the present application, a filter trap includes a housing, a first trap connector, a second trap connector, a perforated wall, and a one-way valve. The perforated wall is disposed within the housing and defines an inner chamber and an outer chamber within the housing. The one-way valve separates the inner chamber into an inlet section and a trap chamber.

[0009] In some aspects, the perforated wall defines a plurality of perforations. The diameter of the perforations may be in the range of 50 μm to 100 μm. The one-way valve may be configured to remain closed when the fluid flows through the pump housing in a first flow direction and to open when the fluid flows through the pump housing in a second flow direction. The one-way valve may have two flexible members attached to the perforated wall. The two flexible members may be configured to engage with each other in a closed position and separate from each other in an open position. The two flexible members are self-biased toward the closed position. The perforated wall may include a first perforated portion and a second perforated portion. The first perforated portion may be separated from the second perforated portion by an unperforated portion. The two flexible members may each have a wall engaging portion configured to engage the unperforated portion when the two flexible members are in an open position. When each flexible member is in an open position and engages with the unperforated portion of the perforated wall, each flexible member may define a capture chamber having a perforated wall. The second perforated portion may be separated from the capture chamber by a flexible member in a corresponding capture chamber. The fluid flow through the filter trap in the second flow direction may be blocked from flowing through the second perforated portion by the flexible member engaged with the non-perforated portion. The perforated wall may include a third perforated portion configured to allow direct fluid communication between the external chamber and the inlet section. The filter trap may include a third trap connector in direct fluid communication with the trap chamber. The third trap connector may be configured to fluidly connect the filter trap to the vacuum device.

[0010] In another aspect of the present application, a blood pump system includes any blood pump detailed herein and any filter trap detailed herein. The blood pump system can be switched between a first flow direction and a second flow direction, including a filter trap and a blood pump. The blood pump system includes a pump housing. The pump housing has a first connector and a second connector, the first connector being configured as a fluid inlet flowing into the pump housing in the first flow direction and as a fluid outlet flowing out of the pump housing in the second flow direction, the second connector being in fluid communication with the filter trap and configured as a fluid inlet flowing into the pump housing in the second flow direction and as a fluid outlet flowing out of the pump housing in the first flow direction. The blood pump housing has an impeller disposed in the pump housing. The impeller is configured to rotate at a predetermined speed in a first rotational direction to generate a fluid flow in the first flow direction at a first pressure and a first flow rate. The impeller is configured to rotate in a second rotational direction opposite to the first rotational direction at a predetermined pump speed to generate a fluid flow in the second flow direction at a second pressure and a second flow rate. The product of the first flow rate and the first pressure is different from the product of the second flow rate and the second pressure.

[0011] In some aspects, the blood pump system includes a first tube that is fluidly connected to the pump housing around a first connector. The first tube can be configured to be fluidly connected to a first blood vessel of a human body. The blood pump system may include a second tube that is fluidly connected to the pump housing around a second connector and is configured to be fluidly connected to a second blood vessel of a human body.

[0012] In various aspects, the blood pump system includes a gas exchanger connected to the blood pump fluid. The blood pump system may include a heat exchanger connected to the pump housing. The heat exchanger may be configured to maintain a desired temperature of the fluid. The blood pump system may include a vacuum device. The vacuum device may be connected to the filter trap fluidically.

[0013] In another aspect of the present application, a kit includes a blood pump system sealed in a sterile package. The kit may include any of the blood pump systems described herein. Any of the blood pumps, blood pump systems, and kits described herein may be operated according to any of the methods described herein.

[0014] In another aspect of the present application, a method of pumping blood in a first direction and a second direction includes inserting a first tube into a first blood vessel of a patient, the first tube being fluidically connected to a blood pump. Inserting a second tube into a second blood vessel of a second blood vessel of the patient, the second tube being fluidically connected to the blood pump. Operating the blood pump at a first operating pump speed so that blood flows through the blood pump at a first pressure and a first flow rate in a first flow direction into the first blood vessel of the patient. Operating the blood pump at a first operating pump speed so that blood flows through the pump at a second pressure and a second flow rate in a second flow direction into the second blood vessel. The product of the first pressure and the first flow rate is different from the product of the second pressure and the second flow rate.

[0015] Furthermore, any embodiment or aspect described herein may be used in combination with any or all other embodiments or aspects described herein, to the extent consistent. BRIEF DESCRIPTION OF THE DRAWINGS

[0016] Various aspects of the present application are described below with reference to the accompanying drawings, which are not necessarily drawn to scale, and are incorporated into and constitute a part of this specification, in which:

[0017] Figure 1 is an isometric view of a bidirectional blood pump according to aspects of the present application;

[0018] Figure 2 According to aspects of this application Figure 1 A cross-sectional side view of a bidirectional blood pump;

[0019] Figures 3A-3E are multiple views of an impeller according to aspects of the present application;

[0020] Figure 4is an isometric view of a filter trap according to aspects of the present application;

[0021] Figure 5 According to aspects of this application Figure 4 A disassembled assembly of a bidirectional blood pump; and

[0022] Figure 6 yes Figure 4 An isometric view of the interior of a filter trap with the check valve in a closed position;

[0023] Figure 7 yes Figure 4 An isometric view of the interior of a filter trap with the check valve in an open position;

[0024] Figure 8 is a view of a blood pump system according to aspects of the present application;

[0025] Fig. 9 is a view of a blood pump kit according to aspects of the present application; and

[0026] Fig.10 is a flow chart illustrating a method of pumping blood according to aspects of the present application. DETAILED DESCRIPTION

[0027] The present application will now be described more fully with reference to the exemplary embodiments of the present application with reference to the drawings below, in which the same reference numerals represent the same or corresponding elements in each of the several views. These exemplary embodiments are described so that the present application will be comprehensive and complete, and the scope of the present application will be fully conveyed to those skilled in the art. Features from one embodiment or aspect may be combined with features from any other embodiment or aspect in any appropriate combination. For example, any individual or collective features of the method aspect or embodiment may be applied to the device, product or component aspect or embodiment, and vice versa. The present application may be embodied in many different forms and should not be interpreted as being limited to the embodiments set forth herein; in fact, these embodiments are provided so that the present application will meet applicable legal requirements. As used in the specification and the appended claims, the singular forms "one", "an", "said", etc. include plural referents unless the context clearly indicates otherwise. In addition, although quantitative measurements, values, geometric relationships, etc. may be referred to herein, any one or more of these (if not all) may be absolute or approximate unless otherwise indicated, to take into account acceptable changes that may occur, such as changes caused by manufacturing or engineering tolerances, etc.

[0028] As used herein, "antegrade flow" refers to the physiologically normal flow of a fluid through the human body. Additionally, "retrograde flow" refers to the physiologically abnormal flow through the human body. Additionally, "patient" refers to the recipient of perfusion or retrograde perfusion. As used herein, "practitioner," "user," or "clinician" refers to the operator of the pump. Additionally, the term "proximal" refers to the portion of the device or its components that is closer to the clinician, and the term "distal" refers to the portion of the device or its components that is farther from the clinician.

[0029] Figure 1 is an isometric view of a bidirectional blood pump 100 according to aspects of the present application. Figure 2 is a cross-sectional side view of a pump 100 according to aspects of the present application. Figure 1 and 2 , the pump 100 includes a connector 102, a connector 104, a motor 106, and an impeller shaft 108. When the pump 100 is operated for perfusion or antegrade flow, the connector 102 is an inlet for receiving blood from a patient's vein. The blood is drawn into the pump 100 by the rotation of the impeller shaft 108, which includes an impeller 110 (see Figure 2 and 4 A-4E). Blood exits the pump 100 via the connector 104 at a pressure that is approximately equal to the pressure of the artery of the patient to which the pump 100 is connected. For example, the pressure of blood exiting the pump 100 operated for perfusion can be between 100 mmHg-140 mmHg. The volumetric flow rate of the pump 100 operated for perfusion can be between 2.8 L / min-3.5 L / min. In an example aspect, a tube connects a vein of the patient to the connector 102, and a tube connects an artery of the patient to the connector 104.

[0030] The flow characteristics of the pump 100 can be expressed in terms of hydraulic power, which is the product of volume flow rate and pressure. For example, the pump 100 operates at a first pump speed when the impeller 110 rotates in a first direction, and generates a flow with a first hydraulic power. When the pump 100 operates at a first pump speed when the impeller 110 rotates in a second direction opposite to the first direction, the pump 100 generates a flow with a second hydraulic power. In some embodiments, the first hydraulic power may be greater than the second hydraulic power. In an embodiment, the first hydraulic power may correspond to a directional flow, and the second hydraulic power may correspond to a retrograde flow.

[0031] When the pump 100 is operated for retrograde perfusion, blood flows through the pump 100 in the opposite direction or retrograde flow, and the connector 104 is an inlet that receives blood from the patient's artery, and the connector 102 is an outlet that directs the blood to the patient's vein. When operated for retrograde perfusion, the pressure output to the vein is approximately equal to the pressure of the vein if the impeller shaft 108 is operated at the same speed as during perfusion (but in the opposite direction). In other words, when rotating in a first direction, the impeller 110 outputs blood having a flow rate and pressure that are approximately equal to the natural flow rate and pressure of the artery, and when rotating in an opposite second direction, the impeller 110 outputs blood having a flow rate and pressure that are approximately equal to the natural flow rate and pressure of the vein. Specifically, operating the pump 100 for retrograde perfusion at the same pump speed will produce a retrograde flow having a pressure and a flow rate that is 30%-50% of the antegrade flow rate value of the pump 100 operated for perfusion. For example, the pressure of blood leaving the pump 100 operating for retrograde perfusion may be 2 mmHg-10 mmHg, and the flow rate may be 1.2 L / min-1.5 L / min. This unique behavior is achieved by the design of the impeller 110, which will be referred to below. Figures 3A-3E Discuss in more detail.

[0032] Retrograde perfusion is physiologically abnormal, but provides some ability to perfuse and control organ and / or tissue temperature. Tissue and organ temperature regulation is an additional feature of perfusion discussed above. In some applications, retrograde perfusion can be used to flush emboli and other debris from the vasculature. Retrograde perfusion can provide better blood distribution in the case of chronic or acute obstruction in the arterial circulation. The most common acute obstruction is thromboembolism. Retrograde perfusion can be performed to remove emboli from the patient's body, which has improved results compared to perfusion.

[0033] Antegrade or retrograde perfusion can be used to selectively perfuse organs or tissues with drugs (e.g., anticoagulants, thrombolytics, agents that improve cellular function, or chemotherapeutic agents for regional cancer treatment.) This includes isolating malignant tumors within the perfused organ.

[0034] The motor 106 is connected to the impeller shaft 108 and is configured to drive the impeller shaft 108 bidirectionally (e.g., clockwise for perfusion and counterclockwise for retrograde perfusion, but the opposite configuration is also contemplated depending on the direction of the impeller's blades). The motor 106 is connected to the controller via leads 112, which provide power to the motor 106 to control its operating parameters (e.g., speed, torque, etc.). The motor 106 includes an output shaft 114, which is connected to the impeller shaft 108 via a coupling 116. In some aspects, the output shaft 114 and / or the impeller shaft 108 may include a keyway, etc., to rotationally connect these components together. The impeller shaft 108 is supported by bearings 118 and includes an impeller 110. The impeller shaft 108 extends through an impeller housing 120, in which the impeller 110 is located. The seal 122 seals the impeller housing 120 to prevent blood from leaking from where the impeller shaft 108 enters the impeller housing 120.

[0035] Connector 102 is in fluid communication with impeller housing 120 via tubing 124, and connector 104 is in fluid communication with impeller housing 120 via tubing 126. During perfusion, blood flows from connector 102 through tubing 124 and into impeller housing 120. Impeller 110 forces the blood from impeller housing 120 to a pressure substantially equal to the pressure of the artery to which pump 100 is connected. The blood then flows through tubing 126 and exits via connector 104.

[0036] Figures 3A-3E Multiple views of an impeller 110 according to aspects of the present application are shown. Impeller 110 includes a body 140 having a first section 128 and a second section 132. The first section 128 is relatively oval with a flat surface 130. The second section 132 is in the shape of a frustoconical cone having blades 134 spiraling around it. In some embodiments, impeller 110 may include a plurality of blades 134. Blades 134 are designed to provide a first flow rate and a first pressure when operating in a first direction (e.g., clockwise), and to provide a second flow rate and a second pressure when operating in a second direction (e.g., counterclockwise). In various aspects, the first pressure is 2 mmHg-10 mmHg, and the second pressure is 100-140 mmHg. In some aspects, the first flow rate is 1.2 L / min-1.5 L / min and the second flow rate is 2.8 L / min-3.5 L / min. The first and second pressures and the first and second flow rates can be achieved by operating the pump 100 at a single pump speed, but with the impeller 110 rotating in opposite directions. The pump speed can be in the range of 4,000 RPM-8,000 RPM, for example 6,000 RPM. Different flow characteristics are made possible by the design of the impeller 110.

[0037] like Figures 3A-3CAs best shown in FIG. 1 , the blades 134 may have an inclination angle such that the blades 134 are angled in the axial direction such that a radially outer portion of the blades 134 is closer to the plane 136 than a radially inner portion of the blades 134. The inclination angle may be in the range of 30 degrees to 65 degrees relative to the central axis of the impeller 110, such as 48.6 degrees. The inclination angle of the blades 134 relative to the central axis of the impeller 110 may be constant or variable. The inclination angle of the blades 134 may be greater at the axial side portions of the blades 134 and less at the axial middle portions of the blades 134. The blades 134 may protrude from the second segment 132 with variable radial lengths. At the axial middle point, the blades 134 may protrude from the second segment 132 by a smaller radial length, and at the axial side points, the blades 134 may protrude from the second segment 132 by a larger radial length. For example, the leading edge of a blade 134 positioned medially along the body of the impeller 110 may have a smaller or larger inclination angle relative to the central axis of the impeller 110 and may protrude radially from a section of the impeller 110 by a smaller or larger length than the trailing edge of a blade 134 positioned laterally along the body of the impeller 110. In some embodiments, the inclination angles and radial protrusion lengths of the leading and trailing edges of the blades 134 may be switched. The blades 134 may be helically wound around the body of the impeller 110 at a constant pitch or at a variable pitch. For example, the blades 134 may have a pitch in the range of 1-6 mm (e.g., 4 mm) at the leading edge and may have a pitch in the range of 50-80 mm (e.g., 64 mm) at the trailing edge.

[0038] It is contemplated that other means for achieving bidirectional flow are possible. For example, by means of a control system designed to rotate the impeller at different speeds for antegrade and retrograde flow. This can be accomplished by using a standard blood pump and modulating the shaft speed based on the direction of flow, either continuously or by switching between discrete speed set points. The speed modulation can be passive, such as encoded in the mechanism, circuitry, or programming. Alternatively, the speed modulation can be active. Active speed modulation can be open loop, such as via switch or dial control; or closed loop, such as deriving feedback from flow and pressure sensors.

[0039] Figure 4 is an isometric view of a filter trap 200 according to aspects of the present application. Figure 5 is a disassembled assembly of the filter trap 200 according to aspects of the present application. Figure 6 is an isometric view of a filter trap 200 according to aspects of the present application. Figure 7is an isometric view of a filter trap 200 according to aspects of the present application. In some aspects, the filter trap 200 can be used in combination with the pump 100. In other aspects, the filter trap 200 can be used with other devices. Arrow F R The direction of reverse flow through the filter trap 200 is shown. Arrow F A The direction of forward flow through the filter trap 200 is shown. Arrow F V The direction of vacuum flow leaving the filter trap 200 is shown.

[0040] Filter trap 200 includes housing 202 and connectors 204, 206, and 208. Connectors 204 and 206 attach filter trap 200 to a tube carrying, for example, blood. In some aspects, filter trap 200 is placed inline with pump 100, with connector 206 connected to connector 204 via a tube, and connector 206 connected to an artery of the patient. Connector 208 is an outlet that allows, for example, emboli that have entered housing 202 to be removed from the blood flowing through filter trap 200.

[0041] exist Figure 4-6 In the aspect of the present invention, the housing 202 is formed by a first half body 210 and a second half body 212. The body 210 includes connectors 204, 206 and 208. The body 212 includes a perforated wall 214 and a one-way valve 216. The perforated wall 214 includes a plurality of perforations 230, 232, 234, which are sized to allow blood to flow but prevent embolism from passing. For example, the diameter of the perforations 230, 232, 234 can be in the range of 50 μm to 100 μm. The perforated wall 214 can have a first perforated portion 230, a second perforated portion 232, a third perforated portion 234 and an unperforated portion 238. In some embodiments, the entire surface of the perforated wall 214 includes perforations. The perforated wall 214 separates the housing 202 into an external chamber 220 and an internal chamber 222, and the external chamber 220 is formed between the wall of the housing 202 and the outside of the perforated wall 214.

[0042] The valve 216 is formed of two flexible members 228, each of which may include a wall engaging portion 218. The flexible members 228 of the valve 216 may each be self-biased toward a closed position of the valve 216, such as Figure 6 When the flow is from connector 204 to 206, the flexible member 228 is pushed open, and when the flow is from connector 206 to 204, the flexible member 228 is pushed toward the closed position, as shown in FIG. Figure 7As shown. Two flexible parts 228 of valve 216 are attached to the perforated wall 214 within the internal chamber 222 and further define a capture chamber 224 and an inlet section 240 therein. Valve 216 can be made of silicone rubber, polycarbonate, etc. This configuration can help capture emboli that have been displaced from the artery during retrograde perfusion. For example, an embolism can be displaced from the artery during retrograde perfusion and flow into the filter trap 200 along with the blood, which enters via connector 204. In the case where blood flows from connector 204 to connector 206 during retrograde perfusion, the embolism enters the filter trap 200, flows through valve 216 (which is opened due to the flow), and eventually settles on the perforated wall 214 due to the embolism being larger than the perforations in the perforated wall 214. Once the pump 100 is turned off and the flow stops, valve 216 will close via its self-biasing, and any emboli in the filter trap 200 will be captured inside. These emboli can be sucked out via connector 208. However, even if the embolus is not removed and priming is performed, the embolus will not be able to leave the filter trap 200 because the valve 216 is in the closed position during priming. Blood can still pass through the filter trap 200 and simply exit through the perforated wall 214 and via the connector 204.

[0043] The filter trap 200 is configured to collect a large volume or number of emboli such that when fluid flow through the first perforated portion 230 and the second perforated portion 232 of the perforated wall 214 is impeded, the fluid can continue to flow through other portions of the third perforated portion 234. This flow bypasses the capture chamber 224, which facilitates the outer chamber 220 to maintain flow parameters. During retrograde flow, the flexible member 228 of the valve 216 can be pushed by the flow so that the wall engaging portion 218 engages the first non-perforated portion 238 of the perforated wall 214, such that flow through the second perforated portion 232 is restricted. With the wall engaging portion 218 of the flexible member 228 engaged with the non-perforated portion 238, the flexible member 228 can form the capture chamber 226. During retrograde flow F R During this time, the capture chamber 226 can capture the embolus in the capture room 224 .

[0044] In some aspects, the pump 100 can be operated in antegrade flow F during a single operation. A and retrograde flow F R In some cases, the filter trap 200 can be switched between reverse flow F R The embolus has been collected in the capture chamber 224 during the previous period. In the case where the embolus remains in the capture chamber 224, the antegrade flow F AThe first perforated portion 230 may be backflushed so that plugs trapped against the first perforated portion 230 move out of the first perforated portion 230 and toward the flexible member 228 and / or the second perforated portion 232 of the valve 216 in the closed position. A Return to retrograde flow F R The flexible member 228 of the valve 216 can be caused to capture previously trapped emboli between the flexible member 228 of the valve 216 and the perforated wall 214 in a capture chamber 226 defined between the flexible member 228 and the section of the perforated wall 214 defining the third perforated portion 234. In some embodiments, the emboli are removed from the retrograde flow F R To antegrade flow F A The switching of F may be interrupted by a pause in flow to allow the flexible member 228 of the valve 216 to self-bias back to the closed position. R and antegrade flow F A Providing a flow pause in between can prevent the release of captured emboli.

[0045] In some cases, the embolus may be removed by perfusion. In this case, the embolus may be captured in the third perforated portion 234 of the perforated wall 214. R Initially, the angle of the third perforated portion 234 of the perforated wall 214 can cause the flow to pass through the third perforated portion 234, which facilitates direct flow through the valve 216 to force the wall engaging surface 218 of the valve 216 to contact the non-perforated portion 238 of the perforated wall 214, so that the flow is directed through the first perforated portion 230 of the perforated wall 214. In this way, in the retrograde flow F R During this time, the flow can be restricted from passing through the third perforated portion 234 and prevented from passing through the second perforated portion 232. The trap chamber 226 defined between the flexible member 228 of the valve 216 and the perforated wall 214 can trap the flow from the previous antegrade flow F A of embolism.

[0046] The filter trap 200 may include a seal or gasket to better form a fluid-tight seal. The housing 202 may have a two-piece construction as shown, or may have a unitary construction. The bodies 210 and 212 of the housing may be fused together by any suitable method, such as ultrasonic welding or bonding by an adhesive.

[0047] The filter-trap 200 may be used with or without the bidirectional pump 100 for purposes including, but not limited to, collecting thromboemboli, other embolic materials, non-embolic in situ thrombi, or other debris. Relevant conditions when the filter-trap 200 may be used with or without the pump 100 include, but are not limited to: acute myocardial infarction / coronary syndrome, acute aortic occlusion, atheroembolism, thrombotic / embolic stroke, pulmonary embolism, or deep vein thrombosis.

[0048] Figure 8 3 is a diagram of a blood pump system 300 according to aspects of the present application. The blood pump system 300 includes a bidirectional blood pump 100, an arterial cannula 310, and a vascular cannula 320. The blood pump system 300 may include a filter trap 200, an alarm 330, a vacuum device 340, a gas exchanger or oxygenator 350, and a heat exchanger 360.

[0049] As described above, the arterial cannula 310 is fluidly connected to the bidirectional blood pump 100 at the connector 104, and the vascular cannula 320 is fluidly connected to the bidirectional blood pump 100 at the connector 102. The filter trap 200 can be spliced ​​inline with the bidirectional blood pump 100 between the arterial cannula 310 and the connector 104. As described above, the filter trap 200 operates in the blood pump system 300, wherein the one-way valve 216 is opened only during retrograde perfusion.

[0050] The alarm 330 can be connected to the bidirectional blood pump 100 and configured to sound or warn in response to the impeller 110 operating outside the set rotational speed range or outside the limit of the desired rotational speed (e.g., between 4,000 and 8,000 RPM, or 5,000 RPM ± 500 RPM, or 5,000 RPM ± 10%). When the alarm 330 is set, only one operating speed value needs to be set for both perfusion and retrograde perfusion. Setting the alarm 330 at a single alarm point for both perfusion and retrograde perfusion is because the bidirectional blood pump 100 operates at the same rotational speed for both perfusion and retrograde perfusion. The alarm 330 can be configured to warn in response to a change in pressure or a change in flow rate exceeding a desired parameter. In an embodiment, the alarm 330 can be connected to a pressure sensor to measure the pressure of the flow through the blood vessel. For example, when the pressure drops below 100 mmHg or exceeds 140 mmHg during antegrade flow, the alarm 330 can sound. In an embodiment, the alarm 330 can be connected to a flow meter to measure the flow rate through the blood vessel. For example, when the flow rate drops below 2.8 L / min or exceeds 3.5 L / min in antegrade flow, the alarm can sound. The alarm 330 can be configured to warn the practitioner with an audible sound, a visual indication, tactile feedback, or any other appropriate indication.

[0051] The blood pump system 300 may include a vacuum device 340. The vacuum device 340 may be fluidly connected to the filter trap 200 at the connector 208. The vacuum device 340 may allow for the generation of a vacuum flow F during retrograde perfusion. v To remove emboli trapped within the filter trap 200. Removing debris from the filter trap 200 during operation of the pump 100 can allow for extended priming operations, or to remove large amounts of debris from a patient. Removing collected debris from the filter trap 200 can allow for better flow through the pump 100 and help maintain the flow rate and pressure output by the pump 100.

[0052] A gas exchanger or oxygenator 350 may be included in the blood pump system 300 to supplement the perfused or retrograde perfused blood with oxygen. The oxygenator 350 may be added inline with the bidirectional blood pump 100. Including the oxygenator 350 may be beneficial when perfusion is performed over an extended duration.

[0053] The blood pump system 300 may include a heat exchanger 360 to regulate the perfusate temperature. Regulating the temperature of the perfusate can prevent thermal damage to tissues and organs, and can prevent the patient from becoming hypothermic or hyperthermic. The heat exchanger 360 can heat or cool the perfusate. For example, for short duration perfusion, the bidirectional blood pump 100 can act as a heat sink, thereby reducing the temperature of the blood to below the required temperature for perfusion. Conversely, for long duration perfusion, the bidirectional blood pump 100 can warm up due to extended operation and heat the perfused blood to above the desired temperature.

[0054] The above-mentioned accessories of the blood pump system 300, such as the oxygenator 350, may modify the flow rate and pressure characteristics of the pump 100. Such accessories may require a change in the operating speed of the pump 100. For example, the inclusion of the oxygenator 350 may require an increase in the operating speed of the pump 100, such as by 50 RPM.

[0055] Fig. 9 400. The kit 400 can be sterilized and provided to the clinician so that it can be opened for use in a sterile area in an operating room or near a patient. The kit 400 includes a pump 100, a filter trap 200, an arterial cannula 310, a vascular cannula 320, and a vacuum device 340. The kit 400 may include an alarm 330, an oxygenator 350, and / or a heat exchanger 360. The components of the kit 400 may be hermetically sealed, for example, in a plastic package 410 by any appropriate means. The components of the kit 400 may be hermetically sealed together or individually. The kit 400 may be assembled and operated as described above with respect to the blood pump system 300.

[0056] Fig.101 is a flow chart showing a method of pumping blood according to aspects of the present application. Method 1000 includes inserting a first cannula into a first blood vessel (e.g., an artery) (step 1010), and inserting a second cannula into a second blood vessel (e.g., a vein) (step 1020). With the first cannula and the second cannula inserted into the first blood vessel and the second blood vessel, the bidirectional blood pump 100 can generate blood flow in a first direction (step 1030). The flow direction can be selectively switched to a second flow direction (step 1040). For example, the bidirectional blood pump 100 can selectively switch between operating in an antegrade flow and operating in a retrograde flow. Generating blood flow in the first direction (step 1030) can be an antegrade flow or a retrograde flow, and generating blood flow in the second direction (step 1040) can be an antegrade flow or a retrograde flow. The pump 100 can operate in only one direction throughout the process, or can operate in both the first direction (step 1040) and the second direction (step 1040). In some embodiments, the filter trap 200 can be spliced ​​inline with the bidirectional rotary pump 100. When operating in retrograde flow, the filter trap 200 can collect debris dislodged during retrograde perfusion (step 1032), such as thromboemboli. When the filter trap 200 is included, the method may include removing the collected debris from the filter trap 200 (step 1034). In certain embodiments, a vacuum device 340 can be connected to the filter trap 200 to remove the debris collected therein (step 1034). The vacuum device 340 can be operated continuously or intermittently during retrograde flow (step 1034).

[0057] Although several embodiments of the present application have been shown in the drawings, it is not intended to limit the present application to these embodiments, as it is desired that the present application have as wide a scope as the art will allow and the same is true for the understanding of the specification. Any combination of the above embodiments is also contemplated and is within the scope of the appended claims. Therefore, the above description should not be interpreted as limiting, but merely as an example of a particular embodiment. Those skilled in the art will envision other modifications within the scope of the claims appended hereto.

Claims

1. A blood pump system, characterized in that: The blood pump system is capable of switching between a first flow direction and a second flow direction, and the blood pump system comprises: filter trap; and A blood pump, comprising: A pump housing, the pump housing comprising: a first connector configured as an inlet for fluid into the pump housing in the first flow direction and as an outlet for fluid out of the pump housing in the second flow direction; and a second connector in fluid communication with the filter-trap, the second connector being configured to serve as an inlet for fluid into the pump housing in the second flow direction and as an outlet for fluid out of the pump housing in the first flow direction; and An impeller is disposed in the pump housing, the impeller being configured to rotate in a first rotational direction at a predetermined pump speed to generate a fluid flow having a first pressure and a first flow velocity in a first flow direction, the impeller being configured to rotate in a second rotational direction opposite to the first rotational direction at the predetermined pump speed to generate a fluid flow having a second pressure and a second flow velocity in the second flow direction, the first flow velocity being greater than the second flow velocity, and the first pressure being greater than the second pressure.

2. The blood pump system according to claim 1, characterized in that: The impeller comprises: a body having a first section and a second section; and A blade extends radially outward from the body and is helically wrapped around the second section of the body.

3. The blood pump system according to claim 2, characterized in that: The blade has an inclination angle such that a radially outer portion of the blade is further away from the first segment than a radially inner portion of the blade.

4. The blood pump system according to claim 2, characterized in that: The blade is helically wound around the second section of the body at a variable pitch such that a portion of the blade closer to the first section has a smaller pitch than a portion of the blade farther from the first section.

5. The blood pump system according to claim 2, characterized in that: The first segment is generally oval and the second segment is frustoconical.

6. The blood pump system according to claim 1, characterized in that: The filter trap includes a one-way valve configured to remain closed when fluid flows through the pump housing in the first flow direction and to open when fluid flows through the pump housing in the second flow direction.

7. The blood pump system according to claim 6, characterized in that: The blood pump system further includes a vacuum device fluidly connected to the filter trap.

8. The blood pump system according to claim 1, characterized in that: A product of the first flow rate and the first pressure is different from a product of the second flow rate and the second pressure.

9. The blood pump system according to claim 8, characterized in that: A product of the first flow rate and the first pressure is greater than a product of the second flow rate and the second pressure.

10. The blood pump system according to claim 6, characterized in that: The filter trap comprises: case; a first catcher connector; a second catcher connector; a perforated wall disposed within the housing, the perforated wall defining an interior chamber and an exterior chamber within the housing; and The one-way valve separates the internal chamber into an inlet section and a capture chamber.

11. The blood pump system according to claim 10, characterized in that: The perforated wall defines a plurality of perforations, each perforation having a diameter in a range of 50 μm to 100 μm.

12. The blood pump system according to claim 10, characterized in that The one-way valve includes two flexible members attached to the perforated wall, the two flexible members being configured to engage with each other in a closed position and to separate from each other in an open position.

13. The blood pump system according to claim 12, characterized in that: The two flexible members are self-biased toward the closed position.

14. The blood pump system according to claim 12, characterized in that: The perforated wall includes a first perforated portion and a second perforated portion, the first perforated portion being separated from the second perforated portion by a non-perforated portion.

15. The blood pump system according to claim 14, characterized in that The two flexible members each include a wall engaging portion configured to engage the non-perforated portion when the two flexible members are in the open position.

16. The blood pump system according to claim 15, characterized in that Each flexible member defines a capture chamber together with the perforated wall when each flexible member is in the open position and engages the non-perforated portion of the perforated wall.

17. The blood pump system according to claim 16, characterized in that The second perforated portion is separated from the capture chamber by the flexible member within the corresponding capture chamber.

18. The blood pump system according to claim 17, characterized in that Fluid flow through the filter-trap in the second flow direction is prevented from flowing through the second perforated portion by the flexible member engaging the non-perforated portion.

19. The blood pump system according to claim 14, characterized in that The perforated wall includes a third perforated portion configured to place the outer chamber and the inlet section in direct fluid communication.

20. The blood pump system according to claim 10, characterized in that The blood pump system further includes a third trap connector in direct fluid communication with the capture chamber.

21. The blood pump system according to claim 20, characterized in that The blood pump system further includes a vacuum device, and the third trap connector is configured to fluidly connect the filter trap to the vacuum device.

22. The blood pump system according to claim 1, characterized in that The blood pump system further includes a first tube fluidly connected to the pump housing around the first connector and configured to be fluidly connected to a first blood vessel of a human body.

23. The blood pump system according to claim 22, characterized in that The blood pump system further includes a second tube fluidly connected to the pump housing around the second connector, and the second tube is configured to be fluidly connected to a second blood vessel of the human body.

24. The blood pump system according to claim 1, characterized in that The blood pump system further includes a gas exchanger fluidly connected to the pump housing.

25. The blood pump system according to claim 1, characterized in that The blood pump system further includes a heat exchanger fluidly connected to the pump housing, the heat exchanger configured to maintain a desired temperature of the fluid.

26. The blood pump system according to claim 1, characterized in that The first pressure is greater than the second pressure, and the first flow rate is greater than the second flow rate.

27. The blood pump system according to claim 1, characterized in that The second flow rate is between 30% and 50% of the first flow rate.

28. The blood pump system according to claim 1, characterized in that The first pressure is in the range of 100 mmHg to 140 mmHg, and the first flow rate is in the range of 2.8 L / min to 3.5 L / min.

29. The blood pump system according to claim 1, characterized in that The second pressure is in the range of 2 mmHg to 10 mmHg, and the second flow rate is in the range of 1.2 L / min to 1.5 L / min.

30. A kit, characterized in that: The kit includes: A blood pump system according to any one of claims 1 to 29, sealed in a sterile package.

31. A method of pumping blood in a first direction and a second direction, characterized in that: The method comprises: inserting a first tube into a first blood vessel of the patient, the first tube being fluidly connected to a blood pump; inserting a second tube into a second blood vessel of the patient, the second tube being fluidly connected to the blood pump; operating the blood pump at a first operating pump speed so that blood flows through the blood pump in a first flow direction at a first pressure and a first flow rate into the first blood vessel of the patient; and The blood pump is operated at the first operating pump speed so that blood flows through the blood pump in a second flow direction at a second pressure and a second flow rate into the second blood vessel, the first flow rate being greater than the second flow rate, and the first pressure being greater than the second pressure.

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