Fluid Engineering Management System

Abstract

The fluidics management system includes a cassette configured to receive saline from a saline source, contrast from a contrast source, and vacuum from a vacuum source; a plurality of saline connectors, each configured to couple to one of a plurality of catheters to provide saline to one of the plurality of catheters; a plurality of contrast connectors, each configured to couple to one of the plurality of catheters to provide contrast to one of the plurality of catheters; and a plurality of vacuum connectors, each configured to couple to one of the plurality of catheters to provide vacuum to one of the plurality of catheters.

Description

[Technical Field]

[0001] Incorporation by reference of priority applications All applications to which a foreign or domestic priority claim is identified in the Application Data Sheet filed with this application are incorporated herein by reference under 37 CFR 1.57. This application claims the benefit of priority to U.S. Application No. 17 / 879,614, entitled MULTI CATHETER SYSTEM WITH INTEGRATED FLUIDICS MANAGEMENT, filed August 2, 2022; U.S. Application No. 17 / 879,616, entitled FLUIDICS CONTROL SYSTEM FOR MULTI CATHETER STACK, filed August 2, 2022; and U.S. Application No. 17 / 879,573, entitled METHODS AND DEVICES FOR DEGASSING A MULTI CATHETER STACK, filed August 2, 2022, the entire contents of each of which are incorporated herein by reference and form a part hereof for all purposes.

[0002] The present disclosure relates generally to the field of fluidics infrastructure, and more particularly to the field of fluid management and delivery during either manual or robotically driven medical procedures. Systems and methods for fluidics management and delivery are described herein. [Background technology]

[0003] Any of a variety of intraluminal or intravascular medical procedures may involve the simultaneous or sequential introduction of multiple tools, such as catheters, into the body. Each catheter may require its own connection to any of a variety of sources of suction, irrigation, medication, saline, or contrast injection. Such sources are conventionally placed in communication with the catheter via tubing that terminates in connectors for releasable connection to complementary ports on the catheter hub.

[0004] Catheter exchange typically involves disconnecting the tubing from a first catheter that is removed and reconnecting that tubing to a second, replacement catheter. Additionally, catheters typically have a single Luer connection port for all fluid infusions and aspiration. During the course of a procedure, multiple different fluids and / or fluid volumes may be infused at different times in addition to aspiration. Therefore, fluid sources, such as syringes, are frequently connected and disconnected to Luer connection ports. This conventional switching of components, syringes, and fluid connections during a procedure can lead to the risk of introducing air bubbles, errors in connection points, and / or errors in fluid selection. [Prior art documents] [Patent documents]

[0005] [Patent Document 1] U.S. Patent Application No. 17 / 816,669 [Patent Document 2] U.S. Provisional Patent Application No. 63 / 256743 Summary of the Invention [Problem to be solved by the invention]

[0006] Therefore, there remains a need for an improved fluid and tool management system that overcomes one or more of the shortcomings of conventional fluid management and catheter exchange systems. [Means for solving the problem]

[0007] The aspiration system with integrated fluidics management includes an elongated, flexible tubular body having a proximal end, a distal end, and at least one lumen, a hub at the proximal end of the tubular body, a valve system that may be in the form of a valve manifold in communication with the hub, and first, second, and third ports on the manifold. The valve manifold is configured to selectively communicate any one of the first, second, and third ports with the lumen while simultaneously blocking communication of the other two ports with the lumen. The fluidics management system can be used with two, three, or four or more interventional device stacks (e.g., catheters concentrically mounted on guidewires) for either manually operated or robotically driven interventions.

[0008] The valve manifold can include a first valve in communication with the first port, a second valve in communication with the second port, and a third valve in communication with the third port. The first port can be configured to connect to a vacuum source, the second port can be configured to connect to a saline source, and the third port can be configured to connect to a contrast source. The valves can be electronically controlled.

[0009] The aspiration system can further include a control system having a processor configured to adjust the valve manifold in response to human input. In one implementation, the control system is configured to adjust the manifold to an aspiration mode in which the aspiration port is in communication with the lumen of the catheter and communication between the lumen and the saline and contrast ports is blocked. The control system can be further configured to adjust the valve manifold to a contrast injection mode in which the contrast port is in communication with the lumen and communication between the lumen and the saline and aspiration ports is blocked. The control system can be further configured to control the amount and rate of delivery of contrast or other fluid delivered.

[0010] The first port, the second port, and the third port can include connectors for removably connecting to tubing extending away from the hub. Alternatively, the first port, the second port, and the third port can include tubing that is non-removably attached to the hub and extends away from the hub.

[0011] The aspiration system can further include a hemostasis valve permanently or removably carried by the hub. The hemostasis valve is adjustable between at least a low sealing force mode in which the catheter can slide through the valve and the valve prevents retrograde leakage of low-pressure fluid, and a high sealing force mode in which the valve clamps the catheter tightly to prevent retrograde escape of high-pressure fluid. The control system can be configured to adjust the hemostasis valve between the low sealing force mode and the high sealing force mode.

[0012] The aspiration system may further include a contrast injection control.

[0013] The first port can be configured to connect to a vacuum source, the second port can be configured to connect to a saline source, and the third port can be configured to connect to a contrast source.

[0014] In response to a human instruction to enter the contrast injection mode, the control system can be configured to adjust the hemostasis valve to a high sealing force mode and adjust the valve manifold to selectively communicate the third port with the lumen while preventing the first port and the second port from communicating with the lumen.

[0015] A fluidics control system is also provided that includes a processor, a valve manifold having a vacuum valve configured to connect between the catheter and a vacuum source, a saline valve configured to connect between the catheter and a saline source, and a contrast valve configured to connect between the catheter and a contrast source, and a contrast control for initiating the introduction of contrast into the catheter, wherein the processor can be configured to open the contrast valve and close the saline and aspiration valves in response to operation of the contrast control.

[0016] The fluidics control system may further include a catheter hub in fluid communication with the contrast valve, the saline valve, and the suction valve. A hemostasis valve may be carried by the hub.

[0017] The fluidics control system may further include a drive mechanism configured to adjust the sealing strength of the hemostatic valve in response to a signal from the processor. The processor may additionally be configured to increase the sealing strength of the hemostatic valve in response to operation of the contrast control to introduce contrast into the catheter. The processor may additionally be configured to decrease the sealing strength of the hemostatic valve in response to operation of the contrast control to stop introducing contrast into the catheter.

[0018] The valve manifold can be carried by the hub, or it can be separate from the hub and communicate with the hub by a tubing set having vacuum, saline, and contrast lines.

[0019] A degassing method for a multiple catheter fluid management system is also provided. The method includes the steps of injecting a first fluid at low pressure from a first fluid source into a first fluid source connection of a hemostasis valve and closing a first valve at the first fluid source connection. A vacuum is applied to a sink connection of the hemostasis valve to remove any remaining first fluid into the sink. The sink valve is closed, and a second fluid is injected from a second fluid source into the second fluid source connection of the hemostasis valve.

[0020] The first fluid may include heparinized saline, and the second fluid may include a contrast agent.

[0021] The degassing method can further include actuating a gasket of the hemostatic valve to a high pressure configuration before injecting the second fluid. The method can further include actuating a gasket of the hemostatic valve to a low pressure configuration before injecting the first fluid.

[0022] A catheter system with integrated fluidics management is also provided. The catheter system includes a first elongated, flexible tubular body having a proximal end, a distal end, and at least one lumen. The catheter system also includes a hub at the proximal end of the tubular body and a valve system in communication with the hub. The catheter system also includes a first port, a second port, and a third port in communication with the valve system. The valve system is configured to selectively communicate any one of the first port, the second port, and the third port with the lumen while simultaneously preventing the other two ports from communicating with the lumen.

[0023] The first elongated, flexible tubular body can comprise a suction catheter. The valve system can comprise a first valve in communication with the first port, a second valve in communication with the second port, and a third valve in communication with the third port. The first port can be configured to connect to a vacuum source. The second port can be configured to connect to a saline source. The third port can be configured to connect to a contrast source. The catheter system can comprise a control system configured to adjust the valve system to an aspiration mode in which the first port is in communication with the lumen and communication between the second port and the lumen and between the third port and the lumen is blocked. The control system can be configured to adjust the valve system to a contrast injection mode in which the third port is in communication with the lumen and communication between the first port and the lumen and between the second port and the lumen is blocked. The control system can be configured to control the amount of contrast delivered. The valve system can comprise a valve manifold, the valve manifold comprising a first port, a second port, and a third port. Each of the first port, the second port, and the third port can include a connector for detachably connecting to tubing extending away from the hub. Each of the first port, the second port, and the third port can include tubing attached to the hub and extending away from the hub. The catheter system can include a hemostasis valve carried by the hub. The hemostasis valve can be adjustable between at least a low sealing force mode and a high sealing force mode. The control system can be configured to adjust the hemostasis valve between the low sealing force mode and the high sealing force mode. The system can include a contrast injection control. The control system can be configured to adjust the hemostasis valve to the high sealing force mode and adjust the valve system to selectively place the third port in communication with the lumen while preventing the first port and the second port from communicating with the lumen in response to human input. The human input can be received through a contrast control on the user interface.The catheter system can include a second elongated, flexible tubular body extending through the hemostatic valve. The control system can be configured, in response to human input, to adjust the valve system to a contrast injection mode in which the third port is in communication with the lumen and communication between the second port and the lumen and between the first port and the lumen is blocked. The control system can be configured, in response to human input, to determine a sealing force of the hemostatic valve around the second elongated, flexible tubular body. If the control system determines that the sealing force of the hemostatic valve around the second elongated, flexible tubular body is low, the control system can be configured to increase the sealing force of the hemostatic valve.

[0024] A fluidics control system is also provided, including a first processor, a valve system including a first vacuum valve configured to connect between the first catheter and a first vacuum source, a first saline valve configured to connect between the first catheter and a first saline source, and a first contrast valve configured to connect between the first catheter and a first contrast source, and a first contrast control for initiating introduction of contrast into the first catheter, wherein the first processor is configured to open the first contrast valve and close the first saline valve and the first vacuum valve in response to actuation of the first contrast control.

[0025] The fluidics control system can include a first catheter. The first catheter can include a first catheter hub in fluid communication with a first contrast valve, a first saline valve, and a first vacuum valve. The fluidics control system can include a first hemostasis valve on the first catheter hub. The fluidics control system can include a second catheter configured to axially movably receive the first catheter. The second catheter can include a second catheter hub. The second catheter hub can include a second hemostasis valve. The second hemostasis valve can be adjustable between a low compression state and a high compression state for the first catheter. The first processor or the second processor can be configured to adjust the second hemostasis valve for the first catheter to a high compression state in response to actuating the first contrast control. The first processor can be configured to adjust the second hemostasis valve for the first catheter to a high compression state in response to actuating the first contrast control. The first processor can be configured to introduce contrast into the first catheter in response to actuation of the first contrast control and when the second hemostasis valve is in a high compression state relative to the first catheter. The first processor can be configured to activate the first contrast pump in response to actuation of the first contrast control. The fluidics control system can further include a drive circuit configured to adjust a compression state of the second hemostasis valve between a high compression state and a low compression state in response to a signal from the first processor. The first processor can additionally be configured to confirm that the second hemostasis valve is in a high compression state in response to actuation of the first contrast control to introduce contrast into the first catheter. The first processor can additionally be configured to adjust the second hemostasis valve to a low compression state in response to actuation of the first contrast control to stop introduction of contrast into the first catheter. The valve system can include a valve manifold carried by the first catheter hub.The first vacuum valve, the first saline valve, and the first contrast valve can be separate from the first catheter hub and in communication with the first catheter hub by a tubing set having a vacuum line, a saline line, and a contrast line.

[0026] A fluidics control system for a multi-catheter procedure is also provided, the fluidics control system including: a first catheter including a hemostasis valve adjustable between a low compression mode and a high compression mode; a second catheter extendable through the hemostasis valve and through the first catheter; a saline source in communication with the first catheter through a saline valve; a contrast source in communication with the first catheter through a contrast valve; and a processor configured, in response to a human command, to send a first control signal to place the hemostasis valve in the high compression mode and a second control signal to open the contrast valve.

[0027] The processor can be further configured, in response to a human instruction, to send a third control signal to place the hemostasis valve into a low compression mode and a fourth control signal to the robotic catheter drive system to axially adjust the second catheter relative to the first catheter. The processor can be further configured, in response to a human instruction, to send a fifth control signal to the robotic catheter drive system to axially retract the guidewire proximally from the second catheter before opening the contrast valve.

[0028] A degassing method for a multiple-catheter fluid management system is also provided, comprising the steps of injecting a first fluid at low pressure from a first fluid source into a first fluid source connection of a hemostasis valve, closing the first valve at the first fluid source connection, applying a vacuum to a sink connection of the hemostasis valve to remove any remaining first fluid into a sink connected to the sink connection, closing the sink valve at the sink connection, and injecting a second fluid from a second fluid source into the second fluid source connection of the hemostasis valve.

[0029] The first fluid can be heparinized saline. The second fluid source can be a contrast agent. The method can further include actuating a plunger of a hemostasis valve to a high compression state before injecting the second fluid. The method can further include actuating a plunger of a hemostasis valve to a low compression state before injecting the first fluid. The method can further include applying a vacuum to a sink connection of the hemostasis valve to remove intraluminal air from a catheter fluidly connected to the hemostasis valve while a first valve is closed at a first fluid source connection of the hemostasis valve, and closing the sink valve at the sink connection before injecting the first fluid. Injecting the second fluid from the second fluid source into the second fluid source connection can include injecting the second fluid from the second fluid source into the second fluid source connection at high pressure. The method can further include detecting air bubbles in at least one of the first fluid or the second fluid with an air bubble sensor.

[0030] A degassing method for a multiple-catheter fluid management system is also provided, the method including the steps of applying a vacuum to a sink connection of a hemostasis valve to remove intraluminal air from a catheter fluidly connected to the hemostasis valve while a first valve at a first fluid source connection of the hemostasis valve is closed, closing the sink valve at the sink connection, opening the first valve at the first fluid source connection of the hemostasis valve, and infusing a first fluid at low pressure from the first fluid source into the first fluid source connection of the hemostasis valve.

[0031] The first fluid may be heparinized saline. The method may further include applying a vacuum to a sink connection of the hemostasis valve to remove any remaining first fluid in a sink connected to the sink connection, and injecting a second fluid from a second fluid source into the second fluid source connection of the hemostasis valve. The second fluid may be a contrast medium. Injecting the second fluid from the second fluid source into the second fluid source connection may include injecting the second fluid from the second fluid source into the second fluid source connection at high pressure. The method may further include detecting air bubbles in at least one of the first fluid or the second fluid with an air bubble sensor.

[0032] A degassing method for a multiple-catheter fluid management system is also provided, comprising the steps of: receiving, by a processor communicatively coupled to a hemostasis valve on a catheter hub, a first input indicative of infusion of a first fluid at low pressure from a first fluid source to a first fluid source connection of the hemostasis valve, sending a first output signal by the processor to close the first valve at the first fluid source connection, sending a second output signal by the processor to initiate a vacuum at a sink connection of the hemostasis valve to remove residual first fluid into the sink, sending a third output signal to close the sink valve at the sink connection, and receiving a second input indicative of infusion of a second fluid from a second fluid source to the second fluid source connection of the hemostasis valve.

[0033] The first fluid can be heparinized saline. The second fluid can be a contrast agent. The hemostatic valve can include a plunger. The method can further include transmitting a fourth output signal by the processor to actuate the plunger to a high compression state before receiving a second input indicative of injection of the second fluid. The method can further include transmitting a fifth output signal by the processor to actuate the plunger to a low compression state before receiving a first input indicative of injection of the first fluid. The method can further include detecting air bubbles in at least one of the first fluid or the second fluid with an air bubble sensor.

[0034] A fluidics degassing system is also provided. The fluidics degassing system includes a first hemostatic valve on a first catheter hub. The first hemostatic valve includes a first fluid source connection including a first valve, a second fluid source connection including a second valve, and a sink connection including a sink valve. The fluidics degassing system also includes a first processor communicatively coupled to the first hemostatic valve. The first processor is configured to receive a first input indicating an injection of a first fluid at low pressure from the first fluid source to the first fluid source connection, send a first output to close the first valve at the first fluid source connection, send a second output to initiate a vacuum at the sink connection to remove residual first fluid into the sink, send a third output to close the sink valve at the sink connection, and receive a second input indicating an injection of a second fluid from the second fluid source to the second fluid source connection.

[0035] The first fluid can be heparinized saline. The second fluid can be a contrast agent. The system can further include a manifold including a saline valve configured to connect between a first fluid source connection of the first hemostatic valve and a saline source, a contrast valve configured to connect between a second fluid source connection of the first hemostatic valve and a contrast agent source, and a vacuum valve configured to connect between a sink connection of the first hemostatic valve and a vacuum source. The system can include a first catheter having a first catheter hub including the first hemostatic valve. The system can include a second catheter hub configured to axially movably receive the first catheter. The second catheter hub can include a second hemostatic valve. The second hemostatic valve can be adjustable between a low compression state and a high compression state with respect to the first catheter. The first hemostatic valve can include a plunger. The first processor can be further configured to send a fourth output to the plunger to actuate the plunger to a high compression state before receiving the second input indicative of the injection of the second fluid, and the first processor can be further configured to send a fifth output to the plunger to actuate the plunger to a low compression state before receiving the first input indicative of the injection of the first fluid.

[0036] A fluid management system for a robotically-driven interventional device is also provided, including a hub disposed at a proximal end of a first elongate body and configured to manipulate the first elongate body, and a first hemostatic valve at least partially disposed on the hub, the hemostatic valve including a first fluid source connection, a second fluid source connection, and a sink connection. The hemostatic valve is configured to be simultaneously fluidly connected to a first fluid source via the first fluid source connection, a second fluid source via the second fluid source connection, and a sink via the sink connection, such that the system is configured to automatically switch between allowing fluid only from the first fluid source or only from the second fluid source through the hemostatic valve into the lumen of the first elongate body or removing fluid from the lumen and collecting it in the sink.

[0037] The hemostatic valve can include a three-way connector including a first fluid source connection, a second fluid source connection, and a sink connection. The first fluid source can include one of saline, heparinized saline, or a pharmaceutical agent. The second fluid source can include a contrast agent. The system can include a first manifold including a first input line configured to connect to the first fluid source and a first output line configured to connect to the first fluid source connection of the hemostatic valve. The system can include a second hub configured to receive and manipulate a second elongate body at least partially disposed in the lumen of the first elongate body, and a second hemostatic valve at least partially disposed in the second hub, the second hemostatic valve including a third fluid source connection, a fourth fluid source connection, and a second sink connection, and the first manifold including a second output line configured to connect to the third fluid source connection. The first manifold may include a valve configured to activate one or both of the first and second output lines. One or more of the first input line, first output line, and second output line may include one or more of a drip rate sensor, a foam sensor, a foam filter, or an in-line pump. The system may further include a second manifold including a second input line configured to be connected to a second fluid source and a third output line configured to be connected to a second fluid source connection of the first hemostasis valve. The system may further include a second hub configured to receive and manipulate a second elongate body at least partially disposed in the lumen of the first elongate body, and a second hemostasis valve at least partially disposed in the second hub, the second hemostasis valve including a third fluid source connection, a fourth fluid source connection, and a second sink connection, the second manifold further including a fourth output line configured to connect to the fourth fluid source connection. One or more of the second input line or the third output line includes one or more of a foam sensor or a foam filter.The system can include a third manifold including a sink output line configured to connect to a sink and a sink input line configured to connect to a sink connection of the hemostasis valve. The system can further include a second hub configured to receive and manipulate a second elongate body at least partially disposed in the lumen of the elongate body, and a second hemostasis valve at least partially disposed in the second hub, the second hemostasis valve including a third fluid source connection, a fourth fluid source connection, and a second sink connection, the second manifold further including a second sink input line configured to connect to the second sink connection. The sink input line can include an in-line local filter. The sink can include a suction receptacle, the sink output line configured to include a suction receptacle configured to be fluidly connected to the suction pump. The hemostasis valve can include an actuatable gasket movable between a first open configuration, a second low sealing force configuration for low-pressure fluid transfer from the first fluid source or the second fluid source, and a third high sealing force configuration for high-pressure fluid transfer from the second fluid source. The first fluid source can include saline, and the second fluid source can include a contrast agent. The system can include a driven magnet on a hub configured to cooperate with the drive magnet, such that the driven magnet moves in response to movement of the drive magnet. The drive magnet can be axially movably carried by a support table. The system can include a second hub configured to receive and manipulate a second elongate body at least partially disposed in the lumen of the first elongate body, and a second hemostatic valve at least partially disposed on the second hub, the second hemostatic valve including a third fluid source connection, a fourth fluid source connection, and a second sink connection.The second hemostatic valve can be configured to be fluidly connected to the first fluid source via the third fluid source connection, to the second fluid source via the fourth fluid source connection, and to the sink via the second sink connection, such that the second hemostatic valve is configured to allow fluid to flow from the first fluid source or the second fluid source through the hemostatic valve into the lumen of the second elongate body or to remove fluid from the lumen of the second elongate body and collect in the sink. The second hemostatic valve can include a second three-way connector including the third fluid source connection, the fourth fluid source connection, and the second sink connection.

[0038] A fluid management system for a robotically driven medical instrument is also provided. The system includes a hub configured to receive and operate an interventional device and a hemostatic valve carried by the hub. The hemostatic valve includes a first port including a three-way connector configured to be simultaneously fluidly connected to a first fluid source, a second fluid source, and a sink, and a second port including an actuatable hemostatic gasket configured to seal around a second interventional device configured to be disposed in the lumen of the interventional device. The gasket is actuatable between a first open state, a second low sealing force state for receiving low-pressure fluid infusion from the first fluid source or the second fluid source through the first port or for allowing fluid to flow through the first port to the sink, and a third high sealing force state for receiving high-pressure fluid infusion from the second fluid source through the first port.

[0039] Also provided is a fluidics management system that includes a cassette configured to receive saline from a saline source, receive contrast from a contrast source, and receive vacuum from a vacuum source, the cassette including: a plurality of saline connectors, each configured to couple to one of a plurality of catheters to provide saline to one of the plurality of catheters; a plurality of contrast connectors, each configured to couple to one of the plurality of catheters to provide contrast to one of the plurality of catheters; and a plurality of vacuum connectors, each configured to couple to one of the plurality of catheters to provide vacuum to one of the plurality of catheters.

[0040] The cassette can include a plurality of contrast valves, each configured to selectively place one of a plurality of contrast connectors in fluid communication with a contrast source. The cassette can include a plurality of vacuum valves, each configured to selectively place one of a plurality of vacuum connectors in fluid communication with a vacuum source. The cassette can include a contrast flow path including a plurality of branches, each of the plurality of contrast connectors being disposed along one of the plurality of branches. The cassette can include a plurality of contrast valves, each of the plurality of contrast valves being disposed along one of the plurality of branches. The plurality of contrast valves can be robotically actuated valves configured to be controlled by a control system. The cassette can include a vacuum flow path including a plurality of branches, each of the plurality of vacuum connectors being disposed along one of the plurality of branches. The cassette can include a plurality of vacuum valves, each of the plurality of vacuum valves being disposed along one of the plurality of branches. The plurality of vacuum valves can be robotically actuated valves configured to be controlled by a control system. The system can include a plurality of saline pumps configured to drive a flow of saline from a saline source to the plurality of catheters. The plurality of saline pumps can be external to the cassette. The system can include a contrast pump configured to drive a flow of contrast from a contrast source to the plurality of catheters. The system can include a suction canister, where a vacuum source is configured to drive suction from the plurality of catheters to the suction canister. The cassette can be disposable.

[0041] A fluidics management system is also provided that includes a saline source configured to provide saline to the cassette, a contrast source configured to provide contrast to the cassette, a vacuum source configured to provide vacuum to the cassette, and a plurality of catheter hubs, each of the plurality of catheter hubs configured to receive the saline, the contrast, and the vacuum from the cassette.

[0042] The system can include a plurality of catheters, each of which is coupled to one of a plurality of catheter hubs, the plurality of catheters being arranged in a concentric catheter assembly. The system can include a plurality of tubing sets, each of which is configured to couple to the cassette and to one of the plurality of catheter hubs. Each of the plurality of tubing sets can include a saline tube, a contrast tube, and a vacuum tube. The system can include a plurality of saline pumps, each of which is configured to drive a flow of saline from a saline source into the cassette. The system can include a contrast pump, each of which is configured to drive a flow of contrast from the contrast source to the plurality of catheter hubs.

[0043] The foregoing is a summary and is therefore necessarily limited in detail. The above aspects, as well as other aspects, features, and advantages of the present technology, are described below in connection with various embodiments and with reference to the accompanying drawings. [Brief explanation of the drawings]

[0044] [Figure 1A] FIG. 1 illustrates an embodiment of a one-channel fluidics management system. [Figure 1B] FIG. 1 illustrates an embodiment of a three-channel fluidics management system. [Figure 2] FIG. 1 is a schematic diagram of a three-channel fluidics system. [Figure 3] FIG. 2 is another schematic diagram of a fluidics system. [Figure 4] FIG. 2 is another schematic diagram of a fluidics system. [Figure 5A] FIG. 10 is a cross-sectional view of an exemplary rotary hemostatic valve with the gasket configured in an open position. [Figure 5B] FIG. 10 is a cross-sectional view of an exemplary rotary hemostatic valve with the gasket configured in an open position. [Figure 6A]FIG. 10 is a cross-sectional view of a rotating hemostatic valve with the gasket configured in a low pressure position. [Figure 6B] FIG. 10 is a cross-sectional view of a rotating hemostatic valve with the gasket configured in a low pressure position. [Figure 7A] FIG. 10 is a cross-sectional view of an exemplary rotating hemostatic valve with the gasket configured in a high pressure position. [Figure 7B] FIG. 10 is a cross-sectional view of an exemplary rotating hemostatic valve with the gasket configured in a high pressure position. [Figure 8A] 1A-1D are various views of an exemplary gasket for use in the hemostasis valves described herein. [Figure 8B] 1A-1D are various views of an exemplary gasket for use in the hemostasis valves described herein. [Figure 8C] 1A-1D are various views of an exemplary gasket for use in the hemostasis valves described herein. [Figure 9] FIG. 1 is a perspective view of an actuation mechanism for use with a rotary hemostatic valve described herein. [Figure 10A] 10A-B show two different positions of the actuation mechanism of FIG. 9. [Figure 10B] 10A-B show two different positions of the actuation mechanism of FIG. 9. [Figure 10C] FIG. 1 illustrates a linear actuator assembly. [Figure 11] FIG. 1 is a perspective view of an example assembly incorporating a rotating hemostatic valve and a manifold. [Figure 12] FIG. 1 is a flow diagram of a method for degassing a fluid management system of a robotically driven medical device. [Figure 13] FIG. 1 is a schematic diagram of a control system. DETAILED DESCRIPTION OF THE INVENTION

[0045] The depicted embodiments are merely examples and are not intended to limit the disclosure. The schematic diagrams are drawn to illustrate features and concepts and are not necessarily drawn to scale.

[0046] The foregoing is a summary and is therefore necessarily limited in detail. The above aspects, as well as other aspects, features, and advantages of the present technology, are now described in connection with various embodiments. The inclusion of the following embodiments is not intended to limit the disclosure to these embodiments, but rather to enable one of ordinary skill in the art to make and use the contemplated invention. Other embodiments may be utilized, and changes may be made without departing from the spirit or scope of the subject matter presented herein. Aspects of the disclosure described and illustrated herein can be arranged, combined, modified, and designed in a variety of different configurations, all of which are expressly contemplated and form part of this disclosure.

[0047] Properly injecting fluids into the blood vessels of a living human body in a precise and predictable manner can be difficult without a supporting fluid management system. Because such precision in administering fluids is desirable, coupled with the risk of delivering an inappropriate amount of fluid or fluid containing air bubbles, the medical industry has trained physicians using a combination of tactile and visual volume and bubble assessment for fluid administration. For example, when learning to inject fluid into the brain, physicians are trained to press a syringe with specific, calibrated pressures when injecting and / or removing fluid during a particular procedure, as well as how to manually prepare the fluid and check for volume and bubbles.

[0048] During catheterization procedures, air embolism represents a serious, even fatal, risk to the patient. Air can be introduced during fluid injection, catheter switching or manipulation, or any other event that creates a pressure gradient that can cause air to flow into the catheter and subsequently into the blood vessel. Reducing the number of times connections are broken and made in the system during a catheterization procedure can reduce the likelihood of air embolism. The fluidics management systems and methods described herein are configured to reduce the likelihood of air embolism during catheterization procedures.

[0049] Furthermore, in the case of ischemic stroke or other occlusive or thrombus-related conditions, the passage of time without treatment can delay patient recovery. For example, using a fluid management system to reduce manual switching between fluid administration and removal (e.g., aspiration) catheters and reduce the time required for fluid preparation during catheterization procedures can improve patient survival and recovery after a stroke event. In some embodiments, reducing manual switching between fluid administration and removal catheters by using a fluid management system described herein can provide the advantage of reducing the workload of surgical staff. In some embodiments, reducing manual switching between fluid administration and removal catheters by using a fluid management system described herein can provide the advantage of allowing remotely controlled procedures (when an interventionalist is not on-site near the fluid management system and / or catheters) to be performed in a streamlined manner, as connection changes may not be part of the procedure when using a fluid management system described herein. In some embodiments, reducing manual switching between fluid administration and removal catheters by using a fluid management system described herein can provide the advantage of improving safety and reliability (e.g., consistency of procedural steps). Additionally, using a consistent fluid management system reduces the risk of air embolism.

[0050] Disclosed herein are systems and methods for managing fluidics systems that administer and remove fluids during medical procedures. The fluidics systems can be coupled to robotically driven interventional devices, manually driven interventional devices, or any combination thereof. In particular, these systems and methods can be configured to control the fluid administration devices to ensure that appropriate diagnosis and / or treatment is provided.

[0051] The systems and methods described herein can include programmable and / or automated fluid injection and removal systems that can assist physicians (e.g., surgeons, interventionalists, etc.) in performing procedures when fluidics are involved. For example, the devices, systems, and methods for operating fluid management systems described herein can automate infused fluids using programmable pumps, vacuums, catheter hubs, etc., allowing for consistent, accurate, and timely infusion. In some embodiments, fluid lines are not replaced or disconnected during a procedure, but instead are configured once prior to the procedure and left in place throughout the procedure to avoid problems with air bubble introduction due to errors at connection points (e.g., valving errors), errors in fluid selection, and / or air introduction when switching between fluids.

[0052] In operation, the fluid management systems described herein can include multiple fluidics systems, each system serving a separate fluid source and / or fluid collection container. Multiple fluidics systems can be configured to flow from the same fluid management system and couple to interventional devices or medical tools. For example, each fluidics system can be configured to connect to a respective catheter hub (manual catheter hub or robotically driven hub) associated with the fluid management system. Each catheter hub can connect to at least one interventional device, e.g., a catheter. The catheter hub, or a control interface detached from the catheter hub, can include controls for controlling fluid administration steps and / or catheter manipulation steps.

[0053] In some embodiments, the devices, systems, and methods described herein can be configured to provide the advantage of reducing the time and effort used to degas a fluidics system. For example, maintaining fully filled fluid lines and fluid tubing connections during a procedure (i.e., avoiding switching fluidics components) can ensure that a single degassing procedure can be performed for each fluid prior to a procedure. Methods described herein can include configuration methods, degassing methods, treatment methods, fluid injection and / or fluid removal methods, etc.

[0054] In some embodiments, the devices, systems, and methods described herein can be configured to reduce the number of sterile packages that must be opened for a particular procedure. For example, additional catheters, fluid lines, catheter hubs, and / or other fluid connection components may be configured to connect and remain connected to the system prior to the procedure, so that these components can be packaged together, or at least multiple packages can be opened, and the components can be assembled once prior to the procedure, eliminating the need to open additional packages or install additional components during the procedure.

[0055] In some embodiments, the devices, systems, and methods described herein can be configured to reduce the time and / or steps used to clean fluid lines because such steps can be automated and performed automatically when requested by the fluid management system.

[0056] In some embodiments, the devices, systems, and methods described herein can be configured to display fluidics management steps on a user interface to streamline configuration of the fluidics system. For example, specific user interfaces can be configured for specific procedures. Each user interface can present instructions, information, or other data to the procedure staff while the fluidics management system automatically performs the next step of the procedure related to fluidics management.

[0057] Systems and Devices FIG. 1A illustrates one embodiment of one channel of a multi-channel fluidics management system 10. The fluidics management system 10 can be configured as an automated system for managing the delivery of fluids to or aspirating substances from a patient via one or more interventional devices, such as catheters. As shown, the system 10 can manage fluid delivery to a patient during a medical procedure. The fluidics management system 10 includes at least one fluid source and / or sink 12 coupled to a valve 14 that is coupled to a manifold 16. The manifold 16 is either remote (e.g., on a support table or tower outside the sterile field) or coupled to a catheter hub 18 that is coupled to at least one source and / or sink line 116. The source and / or sink line 116 is coupled through the hub to at least one catheter 120.

[0058] In some embodiments, fluid source and / or sink 12 includes both a reservoir of fluid volume and a means for propelling such fluid to another component of system 10 or returning the fluid to the source. Example propelling means include one or more propellers, impellers, and / or pumps for circulating and / or withdrawing fluid throughout system 10. In some embodiments, the propelling means can be used to control volume, flow rate, and / or pressure. In some embodiments, the propelling means can be activated to propel fluid to another component of the system or withdraw fluid from the system, or deactivated to stop fluid movement.

[0059] In some embodiments, the fluidics management channels are substantially replicated for each catheter configured for use in a particular medical procedure. Different channels may differ in the sensors, pumps, and / or valves used based on the interventional device connected to each fluidics channel. For example, a fluidics system for a treatment catheter (e.g., for aspiration) may include an in-line vacuum pump and filter. Furthermore, a fluidics system for a guide, access, or insertion catheter, for example, may include an in-line drip rate sensor, bubble sensor, pressure sensor, and / or bubble filter.

[0060] Sources and / or sinks 12 represent either fluid sources or fluid sinks (e.g., waste canisters). For example, a fluid source may include a container adapted to contain a fluid (e.g., saline, contrast, medication, blood, plasma, or other fluid) for use with the fluidics management system 10. The container may be configured to expel the fluid into a fluid delivery line (e.g., fluid delivery tubing) using active means (e.g., pump, vacuum, etc.) or passive means (e.g., gravity). A fluid sink may include a container adapted to receive a fluid (e.g., aspirate, clot, particles, saline, contrast, medication, blood, or other fluid, or a combination thereof) from a patient and / or from other fluidics infrastructure within the fluidics management system 10.

[0061] Valve 14 represents one or more valves coupled to a source and / or sink 12 on a first side of the valve 14 and coupled to a manifold 16 on a second side of the valve 14. The manifold 16 is configured to connect each valve 14 to a specific hub 18. In some embodiments, the valve 14 can instead be coupled directly to the hub 18 to avoid the use of a separate manifold 16. In some embodiments, the manifold 16 can be integrated into the hub. In some embodiments, a second valve 14 can connect the manifold 16 to the hub 18. For example, the second valve 14 can be coupled to the manifold 16 on a first side and to the hub 18 on a second side.

[0062] The hubs 18 are configured to releasably or non-releasably couple to an interventional device (catheter or other medical device). For example, a catheter 120 has a proximal end attached to a unique hub 18, sometimes referred to as a “puck.” In some embodiments, the hubs 18 are movable along a path along the surface of a robotic drive table to advance or retract the catheter 120 (or other medical and / or interventional device). Each hub 18 can also include a mechanism to rotate or deflect the catheter 120 or guidewire as desired. The hubs 18 can be connected to fluid delivery tubing (e.g., source / sink lines 116) to provide fluid release or fluid capture. Each hub 18 can be in electrical communication with an electronic control system via either a wired connection, an RF wireless connection, or a combination of both. Additional details of the hubs, drive tables, and associated systems can be found in U.S. Patent Application No. 17 / 816,669, entitled “Method of Supra-Aortic Access for a Neurovascular Procedure,” filed August 1, 2022, and expressly incorporated herein in its entirety.

[0063] Any of the hubs disclosed herein can further include one or more fluid injection ports and / or a wireless RF transceiver for communication and / or power transmission. In some embodiments, the hub 18 can also include a wired electrical communication port and a power port.

[0064] In some embodiments, the hub 18 or the line 116 leading to the hub 18 can include a visual indicator to indicate the presence of aspirated clots. The visual indicator can include a clot chamber having a transparent window. The clot chamber can be provided with a filter. Additional details of the clot capture filter and related features can be found in U.S. Provisional Patent Application No. 63 / 256,743, filed October 18, 2021, entitled Device for Clot Retrieval, which is expressly incorporated herein in its entirety.

[0065] Any of the hubs or interventional devices disclosed herein can further include sensors for detecting parameters of interest, such as the location or orientation of the distal tip of the interventional device or the condition of the distal tip. The condition of the distal tip can include, but is not limited to, detecting interaction between the vessel wall and the distal tip, detecting interaction between the vessel wall and a thrombus, or detecting an unoccluded distal tip. The sensors, in some cases, can be disposed on the flexible body of the interventional device. The sensors can include a pressure sensor that captures an arterial blood pressure waveform at the distal end of the catheter, or an optical sensor that determines trapped thrombus or air bubbles. In some embodiments, the sensors can include one or more of a force sensor, a positioning sensor, a temperature sensor, a torque sensor, a strain sensor, and / or an oxygen sensor. In some embodiments, the sensors can include a fiber Bragg grating sensor. For example, a fiber Bragg grating sensor (e.g., an optical fiber) can locally detect strain, which can facilitate detection and / or determination of applied force.

[0066] FIG. 1B shows a schematic diagram of a multi-channel fluidics management system 10 having a first supply source 12a, a second supply source 12b, and a sink 12c. The first supply source 12a is coupled to a valve 14a. The second supply source 12b is coupled to a valve 14b. The sink 12c is coupled to a valve 14c. The valves 14a, 14b, and 14c are part of a valve manifold 16. The valve manifold 16 is coupled to a hub 18. In some embodiments, the valve manifold 16 is part of the hub 18 or is directly connected to the hub 18. In other embodiments, the valve manifold 16 is located remotely from the hub 18 and is connected to the hub 18 via one or more fluid lines. In other embodiments, the valve manifold is part of a hemostasis valve or is directly connected to the hemostasis valve. In other embodiments, the valve manifold 16 is located remotely from the hemostasis valve and is connected to the hemostasis valve via one or more fluid lines. Valves 14a, 14b, and 14c can be opened or closed to selectively place first fluid source 12a, second fluid source 12b, and sink 12c in communication with the lumen of catheter 120. For example, valve manifold 16 can include fluid ports (e.g., first port 15a associated with valve 14a, second fluid port 15b associated with valve 14b, and third port 15c associated with valve 14c) that can be selectively placed in communication with or blocked from communication with the lumen of catheter 120. For example, in some embodiments, one of the first port, second port, and third port can be in communication with the lumen of catheter 120, while the other two ports are blocked from communication with catheter 120.

[0067] In some embodiments, first source 12a can be a source of heparinized saline. Source 12b can be a source of contrast agent solution. In some embodiments, one or more of sources 12a, 12b, and 12c can be coupled to multiple manifolds 16, each coupled to a unique interventional device 18. The valve manifolds 16 shown herein can be utilized in any of the systems described herein.

[0068] 2 shows a schematic diagram of a three-channel fluidics system 100 for use with a fluidics management system 10 including a stack of four concentric interventional devices. The illustrated fluidics system 100 includes a fluid management portion 102 and an interventional portion 104. In some embodiments, the interventional portion 104 includes a concentric catheter and guidewire stack configured for manual manipulation by a physician. In some embodiments, the interventional portion 104 includes a concentric catheter and guidewire stack configured for manipulation by a robotically driven system. In some embodiments, the interventional portion 104 includes a combination of both robotically driven and manually operated medical devices.

[0069] The components of the fluid management portion 102 can be located outside the sterile field or within the sterile field. In some embodiments, the fluid management portion 102 is located outside the sterile field but is coupled by flexible tubing and flexible electrical conductors to the interventional portion 104, which is located within the sterile field.

[0070] The fluid management portion 102 can include at least two or more channels (e.g., parallel channels) of the type shown in FIG. 1A, each for a separate fluid source or fluid sink. In the illustrated embodiment, the fluid management portion 102 includes three channels, each in communication with each of three catheters via a corresponding catheter hub. Two channels provide delivery of two separate fluids to each of the catheters, each at a controllable pressure, volume, and delivery rate. A third channel provides suction from each catheter into a sink.

[0071] Each of the two or more fluid channels can be primed by completely evacuating and filling with the respective fluid in preparation for delivery into the catheter and into the body cavity. In some embodiments, the fluid lines, catheter, and / or catheter lumen can be simultaneously flushed and primed with a fluid (e.g., saline).

[0072] In some embodiments, the systems 100, 200 can be configured to backfill each sink connection to each catheter with fluid (e.g., saline) at the beginning of a procedure and / or between fluidics steps. This can, for example, provide a backfilled column of saline downstream of the sink connection to ensure that contrast injection flows to the distal tip of a particular catheter and not to the sink. In some embodiments, the systems 100, 200 can be configured, for example, to provide a backfilled column of saline upstream of the hub's saline valve to ensure that contrast injection flows to the distal tip of a particular catheter or to the sink without passing through the saline valve.

[0073] As shown in FIG. 2 , the fluid management portion 102 of the fluidics system 100 includes a first supply source 110a, a second supply source 110b, and a sink 112. Sources 110a and 110b can each be configured to hold and dispense at least one fluid (e.g., saline, contrast, medication, blood, or other fluids, or a combination thereof). Sink 112 can be configured to receive waste and / or reject fluid from a selected aspiration line leading to a corresponding catheter. While two fluid sources and one fluid sink are shown, any number of fluid sources and / or fluid sinks are possible (e.g., one fluid source and one fluid sink, two fluid sources with no fluid sink, more than two fluid sources, etc.) to accommodate the fluid delivery and / or aspiration needs of a particular procedure.

[0074] A number of valves (and / or valve arrays) are provided to stop and start the flow of respective fluids to or through one or more fluid lines and / or hubs in sections 102 and / or 104. In the illustrated implementation, a first valve array 116a (e.g., with three valves) is carried by a first manifold 118a, a second valve array 116b (e.g., with three valves) is carried by a second manifold 118b, and a third valve array 116c (e.g., with three valves) is carried by a third manifold 118c. While a valve array with three valves is shown, any number of valves is possible and may correspond to the number of catheters and / or fluid sources used in the procedure or a subset of interventional devices used in the procedure. For example, in some situations, each valve array may include at least one valve, two valves, three valves, or four or more valves.

[0075] In some embodiments, each valve in a valve array (e.g., valve array 116a) can be configured to independently control and / or adjust the fluid resistance, flow rate, and / or pressure of the fluid flowing through the valve and corresponding tubing. In some embodiments, each valve in a valve array can be adjusted independently and / or simultaneously for each catheter and / or for more than one catheter.

[0076] In the illustrated implementation, the fluidics channels are replicated for each catheter and are therefore described below only in relation to source 110a. A first outlet valve 117a communicates with a first catheter 126 via a unique source line 120a. A second outlet valve 117b communicates with a second catheter 128 via a unique source line 120b. A third outlet valve 117c communicates with a third catheter 130 via a unique source line 120c. Each valve 117a-117c is preferably electronically actuated between a fully closed, fully open, or partially open position in response to signals from a control system. Any of a variety of valve mechanisms can be utilized, such as ball valves, solenoids, stopcock valves (e.g., rotary stopcock valves), rotary valves, or other actuation mechanisms known in the art, driven by stepper motors. The actuation mechanism can provide automated control and sequencing of the valves. For example, valve actuation can be achieved using a stepper motor with built-in encoding to provide consistent switching and sequencing. The drive mechanism can be controlled using a motor controller in a user control interface (e.g., or a computer system). The control system can include modules that read values ​​from sensors (e.g., flow rate, bubbles, pressure, etc.) and display these values ​​to control the behavior of the fluid system.

[0077] In some embodiments, stopcock valve mechanisms (e.g., rotary stopcock valves) can be used with the manifolds described herein. For example, one or more stopcock valves can be located adjacent to (or integrated into) the hub to avoid managing fluid columns within a particular tubing. Such tubing can be sterile, disposable tubing that can be provided for single use. Locating a manifold with stopcock valves near or integrated into a hub has the advantage of simplicity, eliminating the need to manage fluid columns within the tubing. Keeping the manifold and stopcock valves away from the hub can allow both the manifold and stopcock valves to be used with non-sterile equipment outside the sterile field. Such a configuration can provide the advantage of maintaining the sterility of components within the sterile field.

[0078] In some embodiments, the fluidics control system can further include a drive mechanism configured to adjust the sealing strength of the hemostasis valve in response to a signal from the control system, e.g., a processor of the control system. The control system (e.g., processor) can be configured to increase the sealing strength of the hemostasis valve in response to operation of the contrast control to introduce contrast into the catheter. The control system (e.g., processor) can additionally be configured to decrease the sealing strength of the hemostasis valve in response to operation of the contrast control to stop introducing contrast into the catheter. In some embodiments, the control system (e.g., processor) can be configured to decrease the sealing strength of the hemostasis valve in response to a signal received to drive the catheter or guidewire through the hemostasis valve. Such a feature can provide an advantage, for example, of reducing friction between the hemostasis valve and a moving catheter shaft.

[0079] During operation, all three valves 117a-117c can be in an open configuration to allow saline to flow through each of the three catheters. The forward flow of saline (in the direction of arrow 122a) can be driven by pump 114, such as an electronically controlled peristaltic infusion pump or rotary piston pump. Alternatively, any one of the valves can be open and the other two closed, depending on the desired performance. Alternatively, or in addition, other volume and / or pressure sources (e.g., pump 114) can be stopped or disconnected to prevent flow.

[0080] In the concentric catheter stack shown in FIG. 2, the first catheter 126 can be a "large bore" access catheter having a diameter of at least about 0.075 inches or at least about 0.080 inches. The second catheter 128 can be an aspiration catheter having a diameter ranging from about 0.060 inches to about 0.075 inches. The third catheter 130 can be a steerable catheter with a deflectable distal tip having a diameter ranging from about 0.025 inches to about 0.050 inches. The guidewire 132 can have a diameter ranging from about 0.014 inches to about 0.020 inches. In one example, the first catheter can have a diameter of about 0.088 inches, the second catheter can have a diameter of about 0.071 inches, the third catheter can have a diameter of about 0.035 inches, and the guidewire can have a diameter of about 0.018 inches.

[0081] The available lumen in the first catheter 126 is the difference between the inner diameter (ID) of the first catheter 126 and the outer diameter (OD) of the second catheter 128. The available lumen in the first catheter 126 may be different from the effective lumen in the second catheter 128 (which may be the difference between the ID of the second catheter 128 and the OD of the third catheter 130), and the effective lumen in the second catheter 128 may be different from the effective lumen of the third catheter 130 (which may be the ID of the third catheter 130 or the difference between the ID of the third catheter 130 and the OD of the guidewire 132). To produce the same delivered infusion flow rate through each of the catheters, the control system may be configured to adjust the pump 114 and / or each of the valves 117a-117c to compensate for the difference in the effective cross-sections of the respective flow paths to achieve the same delivered flow rate through each catheter.

[0082] In one implementation of the invention, the catheters can be assembled in the concentric stack orientation shown in Figure 2 before flushing the catheters and removing air by replacing them with a fluid such as saline. This is preferably accomplished in each fluid lumen, for example, the annular lumen between the first catheter 126 and the second catheter 128 and between each of the additional concentric interventional devices in the stack orientation. While substantially all of the air can be replaced by injecting saline under pressure, some small bubbles may remain and may, for example, adhere to the inner wall of the first catheter 126, the outer wall of the second catheter 128, or both.

[0083] While saline is introduced under pressure into the proximal end of the annular lumen between the two interventional devices (e.g., the annular lumen between the first catheter 126 and the second catheter 128), the inner catheter can be moved relative to the outer catheter (e.g., the second catheter 128 can be moved relative to the outer catheter), breaking the holding forces between the microbubbles and the adjacent wall and allowing the bubbles to be carried downstream and out through the distal opening of the lumen. The catheters can be moved axially, rotationally, or both relative to each other. In one implementation, the first catheter is moved axially back and forth relative to the adjacent catheter or guidewire, for example, over a range of about 0.5 inches to about 10 inches, or about 1 inch to about 5 inches, at a reciprocating frequency of about 5 cycles per second or less, or 2 cycles per second or less.

[0084] Shutting adjacent catheters back and forth to destroy microbubbles can be accomplished manually by grasping the corresponding catheter hubs and manually moving the catheters axially or rotationally relative to one another while delivering pressurized saline. Alternatively, for example, in a robotic drive system, a processor can be configured to robotically drive at least one hub of two adjacent catheters (e.g., at least one of hubs 124a and 124b) to achieve relative movement between the adjacent catheters to destroy and expel microbubbles, for example, in response to activation of an irrigation control by a user.

[0085] Source 110b is in fluid communication with manifold 118b, providing fluid to any number of valves (e.g., three) in valve array 116b, as indicated by arrow 122b. The forward flow of contrast (in the direction of arrow 122b) can be driven by pump 136, such as a syringe pump, high-pressure positive displacement pump, contrast injection pump, or the like. Depending on the desired performance, any one of the valves in valve array 116b can be opened and the other two closed. Alternatively, or in addition, other volume and / or pressure sources (e.g., pump 136) can be stopped or disconnected to prevent flow. The proximal opening of each source line 121a, 121b, 121c can be coupled to a respective output port on a corresponding valve in valve array 116b. The distal opening of each source line 121 a, 121 b, 121 c can be coupled to a respective hub 124 a, 124 b, 124 c, and thus to a corresponding catheter 126, catheter 128, and / or catheter 130. Each catheter 126, catheter 128, catheter 130, and / or guidewire 132 can be guided into a patient (not shown). Additional hubs and / or catheters can be added to system 100, and corresponding fluidics management system components (e.g., system 10) can be added to system 100. In other embodiments, system 100 can include fewer hubs and / or catheters, for example, two hubs and / or catheters.

[0086] Sink 112 is coupled to manifold 118c and receives fluid from aspiration lines 123a, 123b, and 123c in the direction indicated by arrow 122c. The aspiration lines are configured to receive fluid and embolic material from one, two, or all three respective catheters 126, 128, and 130, depending on input from the physician to the control system. When the physician determines which catheter to place in aspiration mode and activates the corresponding aspiration control, the control system activates aspiration pump 115, responsive to which the corresponding valve in valve array 116c opens to allow fluid to flow through the corresponding catheter and into sink 112. Depending on the desired performance, any one of the valves in valve array 116c can be opened and the other two closed. Alternatively, or in addition, other volume and / or pressure sources (e.g., pump 115) can be stopped or disconnected to prevent flow.

[0087] In one embodiment, fluidics system 100 represents an aspiration configuration in which source 110a contains heparinized saline and source 110b contains contrast agent solution. Sink 112 in this example can contain waste blood / saline / embolic material aspirated from a patient (not shown). Other additional sources and / or sinks can be used in combination with the respective fluids.

[0088] Similarly, contrast solution contained by source 110b can flow in the direction of arrow 122b and into manifold 118b. For a given procedure, a physician can decide to inject contrast through any of three catheters, typically the most distal catheter, at a given injection time. In response to a contrast injection command, the control system will open the valve corresponding to the selected catheter and typically maintain the other two valves closed. In some embodiments, a physician can inject contrast into two or more catheters simultaneously. In some embodiments, for example, contrast or suction can be applied simultaneously while a catheter or guidewire is being actuated.

[0089] In some embodiments, each valve (or valve array) can be housed within or carried by a respective hub 124a, 124b, 124c. In some embodiments, each valve (or valve array) can be housed adjacent to or remote from a respective hub. In such examples, additional fluid lines (e.g., 120, 121, 123) can be added between each manifold and the corresponding valve. Fluid lines 120a-c, 121a-c, and 123a-c can be tubing. In some embodiments, any of fluid lines 120a-c, 121a-c, and 123a-c can be removably coupled to its respective hub. Alternatively, any of fluid lines 120a-c, 121a-c, and 123a-c can be inseparably connected to a hub and removably coupled to other components of fluid management portion 102, such as valve arrays 116a-c or manifolds 118a-c.

[0090] In some embodiments, the fluidics system 100 can also include any number of pressure sensors, volume sensors, flow sensors, tubing sets, connectors, and bubble sensors / detectors, as discussed. In the illustrated implementation, a pressure transducer 134a is in pressure-sensing communication with the first catheter 126 by way of the hub 124a. Additional pressure transducers 134b, 134c can be placed in communication with their corresponding catheters, as shown.

[0091] The control system can be configured to automatically adjust various manifold valves, pumps, and hemostasis valves (discussed below) in response to commands entered by the physician. For example, the physician may enter a command to inject contrast through the third catheter 130. The control system can automatically generate a series of response events. At least saline valve 117c will close. Valves 117a and 117b may be closed or may remain open to provide positive pressure through the first and second catheters and prevent backflow of contrast.

[0092] A control signal is sent to the hemostatic valves in each of the first and second catheter hubs 124a and 124b to compress around the second and third catheters 128 and 130, respectively, from a low-pressure snug fit to a high-pressure snug fit, thereby preventing the contrast from escaping proximally through the first and second catheters 126 and 128. In addition, a control signal is sent to valve 119c to place the third catheter 130 in fluid communication with a second source 110b containing a contrast solution.

[0093] If the space between the OD of the guidewire 132 and the ID of the third catheter 130 is insufficient to allow the desired contrast injection rate, a further signal is sent from the control system to the drive system control hub 124d to retract the guidewire 132 proximally from the third catheter 130 a sufficient distance to allow the flow of contrast through the catheter 130. An additional control signal can be sent to a hemostatic valve carried by hub 124c to clamp around the distal portion of the guidewire 132 in a high pressure mode, or to clamp into a fully closed configuration once the guidewire 132 is fully retracted. An additional control signal can also be sent to an electronically actuated high pressure pump 136, such as a syringe pump, high pressure positive displacement pump, contrast injection pump, or the like, to deliver the contrast solution through the third catheter 130.

[0094] If the physician initiates a command to perform suction through the first catheter 126, for example, the control system can automatically send another series of control signals to execute that command. A signal is sent to each of the hemostatic valves to move them from a high-pressure configuration to a low-pressure configuration, which creates less friction against the catheter or guidewire shaft. Such a configuration may allow relative movement of the various devices and proximal retraction of the second catheter 128 and the third catheter 130 from the first catheter 126 while still limiting proximal blood loss through the hemostatic valves. A signal is sent to the drive system to proximally retract each of the hubs 124b, 124c, and 124d. Valve 123a is opened to place the first catheter 126 in fluid communication with the sink 112. A signal is sent to activate the vacuum pump 115, which draws blood and clots into the sink 112. In some embodiments, for example, when performing aspiration of the first catheter 126, communication between the catheter 126 and the first and second fluid sources 110a, 110b can be blocked. For example, corresponding valves in the valve arrays 116a, 116b can be closed to block the manifolds 118a, 118b. Alternatively, these volume and / or pressure sources (e.g., pumps 114, 136) can be stopped or disconnected.

[0095] All of the fluid lines between the first and second sources 110a and 110b and each of the catheters, and between the sink 112 and each of the catheters, are preferably completely cleared of any bubbles and filled with a fluid, such as saline, during pre-treatment system preparation. This allows for seamless transitions between infusion, aspiration, and manipulation of the catheters and guidewires without the need to disconnect and reconnect any of the fluid lines between the sources, sinks, and catheters, eliminating the risk of introducing air emboli during such exchanges.

[0096] It may also be desirable to be able to verify that there are no bubbles in any of the fluid lines. This can be achieved by placing bubble sensors in bubble-sensing proximity to each of the fluid lines, such as in or upstream of each of the hubs or manifolds. This may be particularly desirable in telemedicine applications where the physician is at a remote workstation and not in direct line of sight with the patient.

[0097] This can be accomplished using a non-contact ultrasonic sensor that measures the intensity and Doppler shift of ultrasonic waves reflected through the sidewall of the fluid tubing to detect bubbles and measure fluid flow rate or fluid level. Ultrasonic or optical sensors can be placed adjacent to the inlet fluid flow path in the hub or in the supply line leading to the hub.

[0098] For example, to detect the presence of air bubbles in an infusion line (formed of an ultrasound or optically transparent material), the sensor may include a signal source on a first side of the flow path and a receiver on a second side of the flow path to measure transmission through the liquid passing through the tubing to detect bubbles. Alternatively, because bubbles are relatively echogenic, a reflected ultrasound signal may be detected from the same side of the flow path as the source.

[0099] Alternatively, an optical sensor can be provided to detect a change in light transmission or reflection due to the presence of bubbles, or to send a visual signal to a display at a remote workstation where the physician can visually observe the presence of bubbles migrating through the tubing. In systems having a bubble detector, the control system can be configured to automatically stop all fluid flow in response to the detection of a bubble, allowing personnel an opportunity to plan next steps.

[0100] In one implementation, a bubble removal system is automatically activated upon detection of an in-line bubble. Upon detection of a bubble, the processor can be configured to activate a valve located in the flow path downstream of the bubble detector. The valve diverts the column of fluid containing the detected bubble from the flow path leading to the patient and instead flows into a bypass flow path or reservoir. After bubbles are no longer detected in the flow path and an amount of fluid in the flow path between the detector and the valve has passed through the valve, the valve can be activated to reconnect the fluid source to the patient through the flow path. In some embodiments, the flow path can include any number of bubble filters and / or traps to remove bubbles from the flow path.

[0101] The robotic system portion 104 can include a drive table configured to receive (e.g., couple to) any number of hubs (124a, 124b, 124c, 124d, etc.). Additional details of the hubs, drive tables, and associated systems can be found in U.S. Patent Application No. 17 / 816,669, entitled "Method of Supra-Aortic Access for a Neurovascular Procedure," filed August 1, 2022, and expressly incorporated herein in its entirety. Each hub is configured to couple to a catheter or guidewire, one or more fluidics lines, one or more electrical lines, one or more controls, and / or one or more displays. For example, a drive table can be positioned above or beside the patient and configured to support axial advancement, retraction, and in some cases rotation and / or lateral deflection of two or more different (e.g., concentric or laterally oriented) devices (e.g., catheters, guidewires, etc.).

[0102] The drive system independently drives the movement of each hub proximally or distally across the surface of the table, moving the corresponding interventional device (e.g., catheter 126, catheter 128, catheter 130, and / or guidewire 132) proximally or distally within the patient's vasculature.

[0103] Each of catheters 126, 128, 130, and / or guidewire 132 can be navigated into a body cavity (not shown) as a single concentric catheter stack in response to movement of each of hubs 124a, 124b, and 124c, as discussed elsewhere herein. System 100 can also include guidewire hub 124d for controlling guidewire 132, which can also be introduced into the body cavity along with one or more of catheters 126, 128, and / or 130.

[0104] In some embodiments, each hub is provided with a driven magnet, each driven magnet configured to cooperate with a drive magnet associated with the table such that the driven magnet moves in response to movement of the drive magnet, In such an example, the drive magnet may be carried axially movably by the support table.

[0105] Because multiple sources and / or sinks are configured to be coupled (and remain coupled) to each catheter hub (e.g., hubs 124a, 124b, and 124c), fluidics system 100 provides the advantage of allowing for faster treatment than conventional fluidics systems that utilize manual removal, addition, and / or switching of fluids, catheters, hubs, etc., during a treatment. For example, fluidics system 100 allows for each fluid line / catheter hub to be connected to each fluid source and / or sink before a treatment begins. When the interventionalist (or other medical personnel) performing the treatment is ready to use a particular fluid source or sink, system 100 is already configured and ready to enable use of that particular fluid source or sink without having to switch between different fluid lines for a particular catheter. In some embodiments, system 100 can be used to provide a method of treatment that does not require connecting and / or disconnecting a fluid source from a medical device more than once during a treatment.

[0106] Thus, because each catheter hub 124a, 124b, 124c is provided with access to all fluid lines at all times, the interventionalist can inject any of the fluids contained in the fluid sources 110a, 110b and / or collect aspirate from any of the catheters 126, 128, and / or 130 at any point during the procedure.

[0107] Because multiple sources required for a particular procedure are pre-configured to connect to each catheter / catheter hub, the interventionist (or other medical personnel) can be confident that there will be no repeated connection and disconnection of syringes or other fluid source containers, fluid lines, etc. during the procedure. This confidence eliminates the possibility of introducing bubbles into the catheter flow during the procedure, since use of system 100 does not require connecting or disconnecting fluid sources. Instead, each fluid source and sink is connected and tested before the procedure and not disconnected until after the procedure is completed. In some embodiments, the constant connection of fluid sources and sinks to catheter hubs associated with the operation of system 100 eliminates the variability and risk of remote procedures when the interventionist is in a control room rather than a procedure room.

[0108] The valves in valve arrays 116a, 116b, and / or 116c of system 100 are depicted as respective manifolds 118a, 118b, and 118c. In such a configuration, the valves are located near their respective sources and / or sinks, and there is about 2 to about 3 meters (e.g., about 6 to about 10 feet) of fluid line between the valves in valve arrays 116a, 116b, and 116c and their respective catheter hubs 124a, 124b, and 124c. In some embodiments, the valves in valve arrays 116a, 116b, and / or 116c can instead be located at the source / sink (e.g., 110a, 110b, and / or 112). In some embodiments, valve arrays 116a, 116b, and / or 116c are coupled to the fluid line at a location between the source / sink and the hub. In some embodiments, the valve arrays 116a, 116b, and / or 116c can be located in the catheter hubs 124a, 124b, and / or 124c. In some embodiments, the valves located at or near the hubs can be disposable valves. Other components of the systems 100, 200 can also be disposable and / or reprocessable for reuse.

[0109] In some embodiments, system 100 may additionally include valves 113a-113i between valve arrays 116a, 116b, and 116c and respective hubs 124a, 124b, and 124c. Valves 113a-113c may be part of hub 124a or part of a valve manifold directly or indirectly coupled to hub 124a (e.g., valve manifold 16 in FIG. 1B). Valves 113d-113f may be part of hub 124b or part of a valve manifold directly or indirectly coupled to hub 124b (e.g., valve manifold 16 in FIG. 1B). Valves 113g-113i may be part of hub 124c or part of a valve manifold directly or indirectly coupled to hub 124c (e.g., valve manifold 16 in FIG. 1B). Valves 113a-113i may be one-way check valves. As shown in FIG. 2, one-way check valves 113a-113i may allow flow in the direction indicated by their respective arrows.

[0110] Each hub 124a, 124b, and 124c can be provided with a hemostatic valve to accommodate the introduction of another device, as shown in Figure 3. The hemostatic valve includes a variable diameter opening, such as an opening through an elastomeric gasket.

[0111] The gasket can be actuable between a first fully open state, a second partially open state for sealing against low-pressure fluid injection from a first or second fluid source through the first port (described herein) and allowing the interventional device to be advanced or retracted while allowing fluid flow through the first port to a sink, and a third sealed state for resisting backflow of high-pressure fluid (e.g., contrast) injection from the second fluid source through the first port or allowing fluid flow through the first port to a sink. The gasket can be manually actuable or automatically actuable based on user input, for example, corresponding to one or more manipulations of an interventional device of the system.

[0112] FIG. 3 illustrates another embodiment of a fluidics system 200 for use with a fluidics management system. Generally, the fluidics system 200 includes two or more fluid channels that feed one or more fluid lines configured to interface with a rotary hemostatic valve. The two or more fluid channels can receive fluid from a fluid source with any number of fluid materials. The two or more fluid channels can allow different fluid materials provided by different fluid sources (at various volumes and / or under different pressures) to flow into or out of a body cavity. Each of the two or more fluid channels can be primed with a respective fluid in preparation for delivery into a single fluid line and into the body. Valves and / or valve arrays can be used to switch between the use of the two or more fluid channels.

[0113] As shown in FIG. 3, the fluidics system 200 can include a vacuum chamber and / or control unit 202 within the sterile field. The vacuum chamber can have a clot filter with a window for visualization of trapped clots and a valved vent that can be temporarily opened to allow air ingress and direct visualization of the clot through the window. To enable remote physician inspection, a CCD or CMOS sensor can be mounted so that the upstream face of the clot filter is within the sensor's field of view. This allows the contents of the filter to be viewed on a remote monitor. An electronically actuated valve can be used to remotely control the air intake to clear the optical path from the window to the filter.

[0114] A bubble filter 204 can be provided in the line between the needle injection port 206 and the catheter 226. The system 200 further includes a line junction 208 (e.g., a Y-shaped) in fluid communication with the first and second fluid sources 210 a, 210 b. The line junction 208 can include a luer lock connector or a Y-shaped connector that interfaces with multiple fluid sources.

[0115] The system 200 may also include a pump, such as a peristaltic pump 234 or rotary piston pump, that propels fluid under pressure from the second source 210b to the line junction 208 in the direction of arrow 222c.

[0116] Air bubble sensors can be provided upstream or downstream of pump 234. Air bubble sensors 236a, 236b can be non-contact ultrasonic sensors that measure the intensity and Doppler shift of ultrasonic waves reflected through the sidewall of the fluid tubing to detect bubbles and measure fluid flow rate or fluid level, as discussed. In some embodiments, sensor 236a can be a pressure sensor, or a separate pressure sensor can be provided.

[0117] A valve 216c, such as a ball valve or rotary valve, can selectively open and close fluid communication between the second source 210b and the catheter 226. A flow detector, such as a drip rate sensor 238, allows for the determination and indication of the flow rate from the second source 210b.

[0118] Fluid flow from first source 210a is directed through one-way check valve 214 to high-pressure pump 252, which may be a syringe pump, a high-pressure positive displacement pump, a contrast injection pump, etc. High-pressure fluid (e.g., contrast solution) is directed through air bubble sensor 236a through valve 216b to junction 208. Arrow 222b indicates the direction of fluid flow.

[0119] Resistance to fluid flow through different catheters in a concentric catheter stack varies based on the available lumen cross-sectional area. For example, the measured resistance in an inner catheter whose lumen is fully open (e.g., the guidewire is removed) may be lower than the measured resistance in an outer catheter through which a second catheter (or guidewire) extends. Thus, when performing a saline flush step, the fluidics system 200 can be configured to ensure similar flow rates or a treatment-appropriate flow rate through each of the inner and outer catheters to avoid clotting or other problems within the catheters. To achieve this, valves can be adjusted for each catheter to ensure a consistent flow rate across all catheters during the saline flush. The system 200 can determine such flow rates in real time based on flow sensors, and the control system can be configured to automatically adjust valve settings and / or pump parameters to maintain the desired flow rate through each catheter.

[0120] In some embodiments, fluid resistance can be altered by adjusting the insertion length of each shaft into its concentrically adjacent lumen. As described herein, for example, when a second catheter (or guidewire) extends into a lumen, the cross-sectional area of ​​the lumen for flow decreases, resulting in increased fluid resistance within the lumen. The amount of fluid resistance can be affected, for example, by the length of narrowing of the cross-sectional area caused by placing the second catheter (or guidewire) within the lumen. A second catheter (or guidewire) extending partially through the lumen of a first catheter will have a shorter length of narrowing of the cross-sectional area, and therefore may result in lower fluid resistance within the lumen of the first catheter than if the second catheter (or guidewire) extended completely through the lumen of the first catheter. Therefore, fluid resistance can be reduced by partially retracting the insertion depth of the second catheter (or guidewire) into the lumen into which fluid is to be infused.

[0121] System 200 further includes an aspiration canister 240 coupled upstream of filter 244. The downstream side of filter 244 is coupled to a vacuum pump 242. Aspiration canister 240 is connected to valve 216a, which can communicate with sterile field clot capture container 202, discussed elsewhere herein. Arrow 222a indicates the direction of fluid flow.

[0122] An optional pressure sensor 246 is depicted at the proximal end of the catheter 226 or hub coupled to a hemostatic valve, such as a rotating hemostatic valve (RHV) 248 .

[0123] In this example, the RHV 248 is connected to two different fluid sources. The RHV 248 can be carried by and at least partially disposed in a hub (e.g., hub 124a in FIG. 2). The RHV 248 can include a first fluid source connection, a second fluid source connection, and a sink connection. For example, the first connection, the second connection, and the third connection can include respective valves (e.g., valves 216a, 216b, and 216c) connected to the RHV 248 via fluid lines. In some embodiments, the connection points can be formed as part of the RHV 248 itself, and the fluid lines can connect directly to the connection points at the proximal ends of the fluid lines and connect to the sources and / or sinks at the respective distal ends of the fluid lines. In some embodiments, the valves 216a, 216b, and 216c can be disposed in a valve manifold or a valve manifold cassette. In some embodiments, the pump 234 can also be disposed in the valve manifold or a valve manifold cassette. In some embodiments, any of valves 216 a, 216 b, and 216 c may be a ball valve, a stopcock valve, a rotary valve, a solenoid valve, or any other suitable valve. Any of valves 216 a, 216 b, and 216 c may be controlled by one or more actuators 217.

[0124] The RHV 248 can be configured to allow for the introduction of a catheter or other instrument into a living subject while preventing unintended backflow of blood. In some embodiments, each RHV described herein can be configured in at least a fully closed configuration, a low sealing force state that allows for the advancement of a device without leakage, and a high sealing force state (e.g., mode) that prevents fluid leakage under high pressure and prevents axial movement of a device therethrough.

[0125] The RHV 248 is configured to be simultaneously fluidly connected to a first fluid source (e.g., source 210a) via a first fluid source connection (e.g., valve 216b). The RHV 248 is further configured to be simultaneously fluidly connected to a second fluid source (e.g., source 210b) via a second fluid source connection (e.g., valve 216c). Additionally, the RHV 248 is further configured to be simultaneously fluidly connected to a sink (e.g., suction canister 240) via a sink connection (e.g., valve 216a).

[0126] During operation, system 200 is configured to automatically switch between introducing fluid from a first fluid source (e.g., source 210a) or a second fluid source (e.g., source 210b) into the lumen of the elongate body (e.g., catheter 226) through RHV 248, or to allow fluid to be removed from the lumen and collected in a sink (e.g., suction canister / sink 240).

[0127] In some embodiments, optional pressure sensor 246 is located either upstream or downstream of RHV 248 (as shown in FIG. 3). In some embodiments, optional pressure sensor 246 is located on the catheter (e.g., on the sidewall of the catheter) to measure arterial pressure at the distal end of the catheter. The interventionalist can assess the pressure to ensure the catheter is not dislodged within the vessel and / or thrombus.

[0128] For example, if the catheter is misaligned relative to the vessel wall, the detected pressure (e.g., waveform) may be muted. Such detection may be provided to an algorithm executed by a processor associated with system 200 to determine, for example, the patency of the catheter lumen or the patency of the catheter's distal tip. Such pressure sensors and algorithms may provide an improved alternative to traditional pressure determinations in which manual manipulation of the fluidics is performed and the interventionist assesses tactile feedback from the catheter to confirm blood capture by retracting (e.g., pulling back) a syringe coupled to the catheter.

[0129] Such blood capture and tactile feedback assessment can indicate the patency of the lumen or distal tip before injection or aspiration is performed. However, a pressure sensor 246 can provide an automated and improved method for assessing the patency of the lumen or distal tip. That is, by adding a pressure sensor 246 (e.g., a blood pressure sensor) to the proximal end of the catheter, an arterial pressure waveform can be captured. The waveform can be used to determine whether the catheter distal tip is pressing against the vessel wall, whether the catheter tip is pressing against a thrombus, whether the catheter tip is fully patent, or whether the catheter lumen is clogged or fully patent, without direct visual or tactile feedback. In some embodiments, the waveform can be used to determine the state of engagement of the catheter distal tip with the thrombus and / or the hardness of the thrombus.

[0130] In some embodiments, the fluidics systems described herein (e.g., system 100, system 200) include a hemostatic valve (e.g., RHV248) including a first three-way connector having a first fluid source connection (e.g., one-way valve 116a, 216b), a second fluid source connection (e.g., one-way valve 116b, 216c), and a sink connection (e.g., one-way valve 216a).

[0131] In some embodiments, the fluidics systems described herein (e.g., system 100, system 200) utilize a first fluid source that includes one of saline, heparinized saline, or a pharmaceutical agent. In some embodiments, the second fluid source (e.g., source 110b, 210b) includes a contrast agent.

[0132] Systems 100, 200 can further include a second hemostatic valve in communication with a second hub (e.g., 124b) and can be at least partially disposed in the second hub. The second hemostatic valve can include a third fluid source connection (e.g., valve 116b), a fourth fluid source connection (valve 116b), and a second sink connection (e.g., valve 116c). In this example, first manifold 118a can include a second output line configured to connect to the third fluid source connection (not shown).

[0133] FIG. 4 illustrates another embodiment of a fluidics system 300 for use with a fluidics management system. Generally, the fluidics system 300 includes a cassette capable of coupling multiple fluid sources and / or sinks to multiple interventional devices. Multiple fluid lines can extend between the sources or sinks and the cassette for coupling to different interventional devices. For other sources and sinks, a single fluid line can extend between the source or sink and the cassette and split within the cassette to connect to different interventional devices. In some embodiments, the cassette can include a connection array (e.g., in rows or columns) formed with connections from multiple fluid sources and / or sinks for coupling to a single interventional device. Each connection array can be coupled to a tubing set having tubing corresponding to each connection in the connection array.

[0134] The cassette 341 can be a self-contained unit including a housing with multiple valves, tubing, and connectors, as described below. A first connector array includes multiple releasable connectors, such as Luer connectors, for fluidly connecting the cassette to a source of suction and a complementary connector in fluid communication with at least one or more fluids. A second connector array is configured to releasably connect to a tubing set configured to extend between the cassette and at least one, two, or three interventional devices.

[0135] Cassette 341, when assembled, thus forms a bridge module that resides between various fluid and vacuum sources and corresponding interventional devices. Cassette 341 may be configured for single use or may be resterilizable and reusable.

[0136] 4, system 300 may include a first fluid source 310a and a second fluid source 310b. Fluid flow from first fluid source 310a is routed through one-way check valve 314 to high-pressure pump 352, which may be a syringe pump, a high-pressure positive displacement pump, a contrast injection pump, etc. The fluid from first fluid source 310a may be a contrast solution that is preferably injected under high pressure.

[0137] The fluid flow from the syringe pump is routed to a cassette 341, which may include multiple valves, manifolds, and / or connectors. Within the cassette 341, the fluid flow may split along multiple branches 318b to multiple connectors 317b (e.g., four connectors 317b as shown in FIG. 4) for coupling with different interventional devices. The cassette may include valves 316b (e.g., ball valves) with each branch 318b upstream of the connectors 317b. In some embodiments, either valve 316a or 316b may be a ball valve, a stopcock valve, a rotary valve, a solenoid valve, or any other suitable valve.

[0138] The fluid flow from the second fluid source 310b can be routed to multiple branches 318c and reach multiple pumps 334 (e.g., four pumps 334 as shown in FIG. 4), such as peristaltic or rotary piston pumps. Each pump 334 can propel fluid (e.g., saline) under pressure from the second source 310b to a unique connector 317c for each interventional device in the cassette 341.

[0139] The system further includes an aspiration canister 340 in communication with the upstream side of a filter 344. The downstream side of the filter 344 is in communication with a vacuum pump 342. The aspiration canister receives fluid from a cassette 341 that includes a plurality of connectors 317a, each configured to couple to a unique interventional device. A unique valve 316a (at least two, four in the illustrated example) can be located upstream of each connector 317a. Each unique valve 316a can be located along a branch 318a.

[0140] In some embodiments, one or more connector arrays 346 can be arranged, with each connector array 346 configured to couple to an interventional device. For example, connector array 346 is shown by the dashed lines in FIG. 4. As shown in FIG. 4, connector array 346 can include connector 317a, connector 317b, and connector 317c. As shown in FIG. 4, array 346 can be arranged, for example, in a linear row, such that all connectors are oriented in the same direction on a common plane.

[0141] The connector array 346 can be releasably coupled to a tubing set 343 including a suction tube 354, a first fluid tube 355, and a second fluid tube 356. In some embodiments, connectors 317a, 317b, and 317b can be luer lock connectors. The suction tube 354 can be coupled to connector 317a of the array 346 by complementary connector 317d for suction from the interventional device to the suction reservoir. The first fluid tube 355 can be coupled to connector 317b of the array 346 by complementary connector 317e to provide fluid flow from the first fluid source 310a to the interventional device. The second fluid tube 356 can be coupled to connector 317c of the array 346 by complementary connector 317f to provide fluid flow from the second fluid source 310b to the interventional device. The tubes 354, 355, and 356 can be joined to each other along the majority of their lengths. Tubes 354, 355, and 356 may each have a length of at least about 3 or 4 feet, and in some embodiments, between about 6 and about 8 feet.

[0142] 4, tubing set 343 includes a line junction 308 (e.g., a 2-to-1 or 3-to-1 Y-shape) that can provide fluid communication between the interventional device and tubing 354, tubing 355, and tubing 356. Line junction 308 can include a luer lock connector or a Y-shape connector that connects with a complementary connector on the tubing set. In some embodiments, a one-way valve 345 can be positioned along the flow path of the second fluid upstream of junction 308 and downstream of cassette 341.

[0143] In some embodiments, system 300 (or other systems described herein) can deliver a flow of the second fluid (e.g., saline) using two different flow modes. In a low-flow drip mode, for example, pump 334 can provide a flow rate of approximately 1 to 2 drops per second or 3 mL / min to 6 mL / min. In some embodiments, a low-flow mode rate of 1 mL / min to 8 mL / min can be provided. Each catheter coupled to the system can experience a different flow resistance as described herein.

[0144] The pumps, e.g., pump 334, can be operated to provide the same flow rate in each catheter. In some embodiments, the fluid pressure in the catheters can be at least about 330 mmHg or 6.5 psi. This pressure can be sufficient to overcome arterial pressure while delivering the desired drip rate. In some embodiments, the pressure in the catheters can be greater than 330 mmHg. In some embodiments, the amount of fluid delivered can be at least about 1 liter over the length of the procedure. In some embodiments, the amount of fluid can be up to 2 liters.

[0145] In the high-flow irrigation mode, all of the fluid lines can be flushed to remove air. The flow rate can be between 100 mL / min and 1000 mL / min. The fluid pressure can be between 5 psi and 10 psi. The volume delivered can be between 0.5 liters and 1 liter per treatment. The volume can depend on the length and diameter of the tubing. In some embodiments, the high-flow irrigation flow rate is at least about 20 times the flow rate of the low-flow drip mode, and in some cases between 30 and 150 times.

[0146] In some embodiments, the first fluid (e.g., contrast agent solution) can be provided at a flow rate of 3 L / sec to 8 L / sec (e.g., about 4 mL / sec), for example, by pump 352. In some embodiments, the flow rate can be up to about 8 mL / sec. In other embodiments, the flow rate can be up to about 20 mL / sec. In some embodiments, the first fluid can be provided at a pressure of about 400 psi at a flow rate of about 4 mL / sec. The amount of pressure required can depend on the flow rate and flow restrictions in the fluid path. The pressure can increase proportionally with the flow rate at higher flow rates. In some embodiments, the pressure can be up to 1200 psi.

[0147] In some embodiments, a high-pressure pump, such as pump 352, can provide a delivery volume of between 5 mL and 15 mL per high-pressure injection. In some embodiments, the pump can provide 5 mL to 15 mL in approximately 1 mL increments per high-pressure injection. In some embodiments, the second fluid source can provide a total volume of about 200 mL per procedure. In some embodiments, the syringe pump is sized to hold at least about 150 mL or 200 mL to provide uninterrupted flow throughout the procedure without the need to add additional contrast solution. In other embodiments, the second fluid source can provide a total volume of between 150 mL and 250 mL per procedure.

[0148] In some embodiments, the flow rate may vary depending on the anatomical location of the distal end of the catheter. For example, within the aortic arch, the flow rate may be approximately 20 mL / s. A total delivery volume of approximately 25 mL may be injected in the aortic arch. Within the common carotid artery, the flow rate may be approximately 20 mL / s. A total delivery volume of 12 mL may be injected in the common carotid artery. Within the subclavian artery, the flow rate may be approximately 6 mL / s. A total delivery volume of approximately 15 mL may be injected in the subclavian artery. Within the internal carotid artery, the flow rate may be approximately 6 mL / s. A total delivery volume of approximately 8 mL may be injected in the internal carotid artery. Within the external carotid artery, the flow rate may be approximately 3 mL / s. A total delivery volume of approximately 6 mL may be injected in the external carotid artery. Within the vertebral artery, the flow rate may be approximately 6 mL / s. A total delivery volume of 8 mL may be injected in the vertebral artery.

[0149] In some embodiments, a motor can be provided to drive a high-pressure pump, such as pump 352, which is controlled with a position and velocity control loop, using a potentiometer as a measurement to close the loop. In some embodiments, current control can be applied to provide an approximate pressure limit. In certain embodiments, the second fluid can be a contrast agent solution, such as Omnipaque 300, Omnipaque 350, or Visipaque 320.

[0150] In some embodiments, a vacuum pump, such as pump 342, can provide a pressure of approximately -29.5 inHg or up to -29.5 inHg (-999 mbar). In some embodiments, the tubing used for aspiration can have an inner diameter of 0.11 inches (approximately 2.8 mm). In some embodiments, the capacity of the aspiration container, such as container 340, can be at least approximately 0.5 L. In some embodiments, the capacity of the aspiration container can include approximately 0.5 L for blood and additional volume for saline flushing. In some embodiments, the aspiration container can have a volume between 0.25 L and 0.75 L. In some embodiments, because it may be desirable for the aspiration line to remain filled with saline at all times (except when aspirating clots), the vacuum pump can be configured to operate to provide an additional low pressure / flow setting to assist in the flushing process. In some embodiments, a separate pump can be provided for the low pressure / flow setting.

[0151] 5A and 5B show perspective and cross-sectional views of an example rotating hemostatic valve 448 with a dual membrane gasket configured in an open position. That is, slits are provided in both the distal and proximal membranes, and a support tube is placed through both membranes to hold the slits in an open, constrained configuration (see, for example, FIG. 8B). RHV 448 can represent hemostatic valve 248 in fluidics system 200 or a hemostatic valve in any of catheter hubs 124a, 124b, 124c, and can be configured for use with a manual procedure and fluidics system, a robotic procedure and fluidics system, or a combination thereof.

[0152] The RHV 448 includes a side port 420, a double-membrane gasket 452, a housing 482, and a plunger 476 having a support tube 479 configured to be reversibly advanced distally through the gasket to maintain its patency. The RHV 448 is coupled to the proximal end of a first interventional device and adapted to receive a second interventional device (e.g., catheter 426) therethrough. The plunger includes a proximal end 476a and a distal end 476b.

[0153] A second interventional device is disposed in the lumen defined by the first interventional device. As shown, a catheter 426 is advanced through a support tube 479 of the RHV 448. A proximal end 450 of the RHV 448 includes a housing coupled to a plunger 476. A gasket 452 is configured to be coupled to a gasket housing 472 that surrounds the plunger.

[0154] The gasket 452 can be operable between a first fully open state, a second low sealing force state to seal around the catheter but allow sliding movement of the catheter, a third state to seal around the catheter for high pressure management, and a fourth fully closed state without any secondary device passing therethrough.

[0155] The first, open state represents a backflow position or an interventional device loading or removal position that configures the RHV 448 to fully open the gasket 452. The second, partially open state represents a position that configures the RHV 448 to close the gasket 452 around the catheter 426 within the RHV 448 with a sufficient seal to prevent leakage of blood or saline pumped at relatively low pressures, but to allow the catheter 426 to be advanced or retracted with low resistance through the RHV 448. The third state represents a sealing configuration to allow high-pressure fluid (contrast media) injection from a fluid source. In some embodiments, the control system can be configured to determine (e.g., in response to human input) the sealing force of the hemostasis valve around the catheter 426. The control system can be configured to modify the sealing force if it is determined that the sealing force is too high or too low. For example, if the sealing force is too low, the control system can increase the sealing force.

[0156] As shown in FIG. 5B , gasket 452 is constrained by a support tube in a first open state. The first open state ensures that gasket 452 is configured in a blood return position or an interventional device loading or removal position. The open position configures RHV 448 to open gasket 452 by moving the tubular support portion of plunger 476 through gasket 452, forcing the tubular support to open and constrain the gasket, providing an open central lumen. This movement can allow arterial blood pressure to push blood proximally through catheter 426 until blood is visible in RHV 448. Moving the gasket to the open position allows blood return and allows visual and / or tactile confirmation that the RHV 448 is free of air bubbles and / or that the distal tip of the catheter is not against the vessel wall and / or that the lumen defined by the catheter is not occluded.

[0157] In some embodiments, the RHV 448 can include a first port 420. The first port 420 can be releasably connected to a three-way connector configured to be fluidly connected to a first fluid source (e.g., source 110a), a second fluid source (e.g., source 110b), and a sink (e.g., sink 112). Alternatively, or in addition, the RHV 448 can further include one or more additional ports for connecting with the fluid sources and / or sinks. See, for example, FIG. 11 , which is described in further detail elsewhere herein.

[0158] 6A and 6B show cross-sectional and enlarged cross-sectional views of a rotary hemostatic valve with a gasket (e.g., gasket 456) configured in a partially open or low sealing pressure position. In this position, the distal end 476b of the plunger 476 is retracted proximally, and the distal slit 464 (see FIG. 8B) of the gasket 456 is in sliding contact with the catheter 426, while the proximal slits 468, 470 (see FIG. 8C) remain constrained in an open configuration by the support tube. The low-pressure state of the gasket 456 allows for burst injection of saline (e.g., from source 110b) through the side port 420 of the RHV 448 at a pressure of up to approximately 276 kPa (i.e., approximately 40 psi).

[0159] 6B, with plunger 476 partially advanced into gasket 456, gasket 456 is in a partially open state. This position represents a low-pressure position in which blood or saline solution does not leak while catheter 426 is advanced or retracted with low resistance through RHV 448. The second partially open state configures RHV 448 to receive low-pressure fluid injection from a first fluid source (e.g., source 110a) or a second fluid source (e.g., source 110b) through the first port, or for fluid to flow to a sink (e.g., sink 112) through the first port.

[0160] 7A and 7B show cross-sectional views of an example rotary hemostatic valve with the gasket configured in a high sealing force (mode) or high pressure position. As shown in FIG. 7A, the distal membrane 460 includes a thickened sidewall in the form of cross material 466 that matches a lateral slit in the proximal membrane 462. The cross material 466 provides additional gasket contact around the catheter 426 in the sealed (e.g., high pressure) state.

[0161] The sealed state represents a configuration for high-pressure fluid transfer from a fluid source (e.g., contrast / supply source 110b). The closed state of gasket 458 allows for the injection of contrast (e.g., from source 110b) at pressures up to approximately 2.76 MPa (i.e., approximately 400 psi) through side port 420 of RHV 448. As shown in FIG. 7B , in the closed state, plunger 476 retracts proximally, and both distal slit 464 and proximal slit 466 are no longer supported by the support tube and can provide a seal against catheter 426. In other words, both proximal end 476a and distal end 476b of plunger 476 are disengaged from gasket 458, achieving the closed state of gasket 458.

[0162] 8A-8C show various views of an example gasket for use in the fluidics systems described herein. FIG. 8A shows a perspective view of gasket 458. Gasket 458 includes a distal membrane 460 and a proximal membrane 462. A cross slit (a substantially horizontal slit 470 intersecting a substantially vertical slit 468) on the proximal membrane 462 of gasket 458 can be compressed against the catheter for a high-pressure seal or a closed position of gasket 458. A vertical slit 464 on the distal membrane 460 of gasket 458 can be compressed against the catheter for a low-pressure seal or a closed position of gasket 458.

[0163] 8B shows a distal end view of gasket 458. Distal membrane 460 of gasket 458 includes a vertical slit 464 in the center of the gasket portion with thickened sidewalls that may be configured as an intersection 466 of material.

[0164] 8C shows a proximal end view of gasket 458. Vertical slit 468 in gasket 458 is substantially perpendicular to horizontal slit 470 on proximal membrane 462 of gasket 458.

[0165] In some embodiments, the rotary hemostatic valves described herein can be configured with an open setting, allowing a catheter to be freely manually inserted or removed from the lumen. Additionally, in the open setting, free flushing of the system with saline can be performed to expel air bubbles from the system. In some embodiments, the open setting can also allow backflow of blood to expel air bubbles from the system.

[0166] 9 shows a perspective view of an actuation mechanism 800 for use with the rotary hemostatic valves described herein. The actuation mechanism 800 includes at least a linear actuator 474 coaxially connected about a collar 475, which couples to the proximal end 450 of the RHV 448 and drives one or more gears to rotate the RHV 448. To manipulate the catheter (e.g., catheter 226), the linear actuator 474 drives a tang (not shown) that can engage a circular flange secured to the outer shaft of the catheter. In some embodiments, the RHV 448 is coupled to a hub (e.g., hub 124a) that allows for the rotation, translation, and / or deflection of the catheter (or wire).

[0167] Figure 10A shows the RHV drive mechanism restraining the valve in the open position as shown in Figure 5B. Linear actuator 474 drives drive shaft 475 to the limit of proximal travel, where the support tube extends across the gasket, holding it open. In Figure 10B, the support tube has been advanced from the gasket, allowing the gasket to seal around the inner catheter extending through it in a high-pressure position.

[0168] 10C is a schematic diagram of one implementation of linear actuator 474. Housing 471 supports motor 473, which rotates gear train 481, which in turn rotates lead screw 483. Helical threads 485 on lead screw 483 slidably engage complementary protrusions on the interior surface of tubular drive shaft 477, causing axial reciprocating motion of drive shaft 477 and corresponding axial displacement of the support tube relative to the gasket.

[0169] The sterile clot capture vessel, filter, RHV, pressure sensor, etc. are all part of the hub and can move with the catheter. By capturing the clot in a clot pod close to the hub, the diameter of the tubing between the hub and the fluidics management tower does not need to be very large (saline is injected at a pressure higher than arterial pressure and then aspirated through the clot pod to make the clot more visible). The valve manifold can be configured regardless of design details to handle large clot fragments that pass through the manifold. In some embodiments, the valve manifold can be carried by the hub. In some embodiments, the valve manifold can be integrated into the hub. Alternatively, the valve manifold can be separate from the hub and communicate with the hub through a tubing set with vacuum, saline, and contrast lines.

[0170] If the first catheter 126 remains in place, withdrawing the second catheter 128 creates an outside-to-inside pressure gradient that risks aspirating air if the valve is not tight enough, but the valve will not tighten enough to prevent withdrawal of the second catheter 128, so the saline delivery flow rate can be set to create a positive pressure that prevents air bubbles from being introduced.

[0171] 11 shows a perspective view of an example assembly 500 including a rotating hemostatic valve 502 integrated with a manifold 504. The example shown in FIG. 11 illustrates an embodiment in which the manifold is located adjacent to or within a particular RHV associated with the hub. Such an embodiment can replace the individual manifolds 118a, 118b, and 118c in system 100.

[0172] The RHV 502 is shown as a tapered tube with a rotating portion 506 and a port 508 for receiving one or more catheters (not shown) threaded therethrough. The catheter or catheters can be attached to the portion of the RHV 502 adjacent the port 508. This portion can include a luer lock rotating nut or another valve or introducer valve.

[0173] The RHV 502 can be fixedly attached to the manifold 504. In some embodiments, the RHV 502 is removably attached to the manifold 504. The manifold 504 is configured with any number of ports for receiving fluid lines attached to the hub. For example, the manifold 504 includes at least a first port 510 for receiving one or more fluid lines 120a, 120b, 120c from at least one manifold valve (e.g., at least one valve in the valve array 116a). The manifold 504 includes at least a second port 512 for receiving one or more fluid lines 121a, 121b, 121c from at least one manifold valve (e.g., at least one valve in the valve array 116b).

[0174] Manifold 504 may further be configured with any number of ports for receiving fluid lines connected to particular fluid sources. For example, manifold 504 may include port 514 for receiving contrast fluid via a fluid line connected to a contrast source (e.g., source 110b). Manifold 504 may also include port 516 for receiving saline fluid via a fluid line connected to a saline source (e.g., source 110a). Manifold 504 may additionally include port 518 for receiving (e.g., draining) waste via a fluid line connected to a sink (e.g., sink 112). Manifold 504 may include an optional clip 520 for attaching RHV 502 to a hub.

[0175] 11 shows two source ports and one sink port, any number of source or sink ports may be possible on assembly 500. Additionally, any number of valve ports may be provided to correspond to the number of catheter hubs configured to function in a particular fluidics system.

[0176] 12 illustrates a method for degassing a fluid management system of a robotically driven medical device. Embodiments of the method for degassing a fluid management system can remove gas from (e.g., remove dissolved gas from) a lumen of a robotically driven medical device (e.g., a catheter described herein), one or more fluid lines of the fluid management system, and / or one or more fluids. In some embodiments, the degassing method can be used to remove gas from one or more sections (e.g., one or more fluid lines) of the fluid management system to build a wall or column of fluid therein.

[0177] Thus, in some embodiments, a method for degassing can be referred to as a method for forming a fluid column or a method for arranging a fluid within a fluid management system. For example, a first fluid, such as saline, from a first fluid source can be propelled through a first fluid line to a first fluid source connection of a hemostasis valve coupled to a medical device. A first valve on the first fluid source connection can be closed, resulting in a gas-free or gas-containing column of fluid at the first fluid line connection.

[0178] Suction can then be applied to the sink connection of the hemostatic valve to remove any remaining first fluid from the hemostatic valve. This can result in the hemostatic valve being emptied while a column of fluid is maintained in the first fluid line. The hemostatic valve is then ready to receive a second fluid, such as a contrast agent, which can be injected at high pressure. When the second fluid is injected, for example, through the second fluid connection of the hemostatic valve, the column of fluid in the first fluid line can prevent or inhibit the second fluid from flowing into the first fluid line. The second fluid can take the path of least resistance, for example, through a lumen of the medical device, rather than through the first fluid line.

[0179] In some embodiments, a column or wall of fluid can be formed in a sink line extending from the sink connection to the sink. For example, while aspirating a fluid, such as a first fluid, through the sink line via the sink connection, the sink valve at the sink connection can be closed, and aspirating can be stopped, causing at least some fluid to be retained in the sink line instead of flowing to the sink, resulting in a column or wall of fluid in the sink line at the sink connection. In some embodiments, the first fluid can be propelled toward the hemostasis valve during aspirating to form a wall or column of fluid in the sink line. The wall or column of fluid in the sink line can prevent or inhibit fluid, such as the first fluid or the second fluid, from flowing into the sink line. For example, as described herein, a column or wall of fluid can be formed in both the first fluid line and the sink line. A second fluid (e.g., a contrast agent) can then be injected into the hemostasis valve, allowing the second fluid to flow through the lumen of the medical device rather than into the first fluid line or the sink line. By preventing the unwanted flow of fluid into the first fluid line and / or the sink line, fluid waste can be prevented and the amount of fluid flowing to the patient can be known and controlled.

[0180] In some embodiments where a wall or column of fluid is desired in the sinkline, various methods can be used to prevent or inhibit retrograde drawing of air through the lumen of the medical device (e.g., catheter) while building the wall or column of fluid in the sinkline. In some embodiments, the medical device can be inserted into the patient before aspiration so that blood is drawn through the lumen of the medical device and into the sinkline. The column of fluid in the sinkline can be formed of blood and / or the first fluid.

[0181] In some embodiments, if the medical device is positioned outside the body, the tip of the medical device can be placed into a container of fluid, such as saline, and the fluid can then be aspirated into the sink line. In other embodiments, the tip of the medical device can be plugged (e.g., with a plug) to prevent air from being aspirated from the distal end while aspirating a first fluid to build a column of fluid in the sink line. In other embodiments, a valve (e.g., in a valve manifold described herein) can be closed to block the connection between the lumen and the hemostatic valve or the lumen and the sink connection, preventing retrograde air from entering the sink line while building a column of fluid.

[0182] In one embodiment, the method includes injecting a first fluid at low pressure from a first fluid source into a first fluid source connection of a hemostasis valve, closing the first valve at the first fluid source connection, applying a vacuum to a sink connection of the hemostasis valve to remove any remaining first fluid, closing the sink valve at the sink connection, and injecting a second fluid at high pressure from a second fluid source into the second fluid source connection of the hemostasis valve. Method 1200 functions to remove dissolved gases from fluids and fluid lines of a fluid management system. This method is used for catheter and fluid preparation, but may additionally or alternatively be used in clinical or any other suitable applications. Method 1200 may be configured and / or adapted to function with any suitable fluid degassing technique.

[0183] In some embodiments, instead of injecting a first fluid at low pressure from a first fluid source into a first fluid source connection of the hemostasis valve and closing the first valve at the first fluid source connection, the method can involve applying a vacuum to certain ports and / or fluid lines and then injecting the first fluid from the first fluid source into the first fluid source connection of the hemostasis valve. In some embodiments, applying a vacuum to certain ports and / or fluid lines prior to fluid injection can provide a negative pressure that can assist in subsequent fluid flow through the fluid management system.

[0184] During operation of system 100, an interventionalist can access fluid management portion 102 and robotic system portion 104 to perform degassing method 1200. Degassing method 1200 can be part of the initial configuration of system 100. For example, degassing method 1200 can be performed on all or part of the fluid management system of a manually driven medical device, a robotically driven medical device, or a combination thereof.

[0185] In some embodiments, the degassing method includes injecting a first fluid from a first fluid source into a first fluid source connection of the hemostasis valve and closing a first valve at the first fluid source connection. In some embodiments, the degassing method includes injecting the first fluid at low pressure. A vacuum is applied to a sink connection of the hemostasis valve to remove any remaining first fluid to the sink. The sink valve is closed, and a second fluid is injected from a second fluid source into the second fluid source connection of the hemostasis valve. In some embodiments, the first fluid source connection of the hemostasis valve is not integrated with the hemostasis valve, but instead can be integrated via a Y-adapter to integrate the fluid connection with the hemostasis valve. In other embodiments, the first fluid connection can be separately integrated with the hub in other ways.

[0186] In some embodiments, the degassing method described herein can be a scheduled function that can be accomplished in several ways. In a first example, the degassing function can be accomplished using positive pressure, which allows the system 10 to inject saline into a fluid port connecting to the catheter's lumen. In such an example, saline can then fill the lumen space in an antegrade direction (i.e., distally toward the tip of the catheter) and also in a retrograde direction (i.e., through a proximally positioned open hemostatic valve). In a second example, the degassing function can be accomplished before performing the first example and can include closing the hemostatic valve and applying suction through the fluid port or through a fixture temporarily connecting to the distal end of the catheter. In either example, the distal end of the catheter can be temporarily sealed. After using suction to evacuate the lumen, the system 10 can close the vacuum valve and then open the saline valve to fill the channel with, possibly degassed, saline. Optionally, the seal at the distal tip can be removed, and the first example can be repeated to complete the degassing function. Although the degassing method is described with respect to FIG. 12, the methods described herein can generally be used to remove fluids (including gases, liquids, and / or combinations of gases and liquids) prior to the introduction of another fluid.

[0187] 12 , one embodiment of degassing a fluid management system of a robotically driven medical device includes block 1202, which provides for injecting a first fluid at low pressure from a first fluid source into a first fluid source connection of a hemostasis valve. For example, a fluid (e.g., saline) from source 210 b can be infused at low pressure into a first fluid line of line junction 208 coupled to RHV 248 and / or one or more catheters associated with RHV 248. In some embodiments, the first fluid source includes heparinized saline.

[0188] At block 1204, the method 1200 includes closing a first valve at a first fluid source connection. For example, valve 216c can be closed to stop the flow of the first fluid. In some embodiments, the fluid source connection is a fluid line connected to a fluid source via a ball valve. In some embodiments, valve 216c is located adjacent to or within a manifold, and the manifold can function as the first fluid source connection.

[0189] At block 1206, the method 1200 includes applying a vacuum (e.g., a pump) to a sink connection of the hemostasis valve to remove any remaining first fluid. For example, a vacuum 202 can be induced to remove any remaining first fluid through a connection to the RHV 248, such as valve 216a, to the sink 240.

[0190] At block 1208, the method 1200 includes closing a sink valve at the sink connection. For example, the valve 216a can function as a sink valve that can block the flow of fluid in the fluid line 222a.

[0191] At block 1210, method 1200 includes injecting a second fluid at high pressure from a second fluid source into a second fluid source connection of the hemostasis valve. For example, fluid (e.g., contrast agent) from source 210a can be injected at high pressure from source 210a into a second fluid line at line junction 208 coupled to RHV 248 and / or one or more catheters associated with RHV 248. In some embodiments, the second fluid is contrast agent. In some embodiments, the second fluid source connection is not directly integrated with the hemostasis valve, but instead can be integrated via a Y-adapter to integrate the fluid connection with the hemostasis valve. In other embodiments, the second fluid source connection can be separately integrated with the hub in other ways.

[0192] In some embodiments, the method 1200 further includes actuating a gasket of the hemostatic valve to a high pressure position before injecting the second fluid or applying the vacuum. For example, the gasket 458 (FIG. 7A) can be part of the RHV 248, 448. The gasket 458 can be actuated to open to the high pressure position before injecting the contrast agent or applying the vacuum 202 in the RHV 248, 448.

[0193] In some embodiments, method 1200 can further include actuating a gasket of the hemostasis valve to a low-pressure position before injecting the first fluid. For example, gasket 456 (FIG. 6A) can be part of RHV 248, 448. Gasket 456 can be actuated to open to the low-pressure position before injecting saline.

[0194] 13 shows a schematic diagram of one example of a fluidics control system 600 that can be used to electronically control the fluidics systems or components described herein and / or to perform the methods described herein. The control system 600 can be configured to automatically adjust the various manifold valves, pumps, hemostasis valves, hubs, and / or catheters described herein in response to command input by an operator, such as a physician. In response to command input by the operator, the control system 600 can automatically cause a series of response events to occur.

[0195] In some embodiments, the control system 600 can include one or more processors 602. The one or more processors 602 can be configured to automatically adjust the various manifold valves, pumps, hemostasis valves, hubs, and / or catheters described herein using one or more controllers of the control system 600, for example, in response to commands entered by an operator. In some embodiments, the control system 600 includes a first controller 604a, a second controller 604b, and a third controller 604c, although any suitable number of controllers can be provided to accommodate the various functions of the fluidics systems described herein.

[0196] For example, in some embodiments, the first control 604a can be a contrast control that can be operated by a user to initiate the introduction of contrast into the catheter. The second control 604b can be a saline control that can be operated by a user to initiate the introduction of saline into the catheter. The third control 604c can be a vacuum control configured to initiate the application of a vacuum to the catheter. In some embodiments, each unique catheter can have its own unique first control 604a, second control 604b, and / or third control 604c. Alternatively, each control 604a, 604b, and / or 604c can be activated to cause a particular response in multiple catheters of a fluidics system.

[0197] Processor 602 can receive signals from controls 604a, 604b, and 604c and, in response, initiate corresponding actions in components of the fluidics system. For example, processor 602 can be configured to generate output signals that cause responsive actions to be performed by components of the fluidics system. For example, in some embodiments, in response to initiation of first control 604a by a user, processor 602 can be configured to open a first contrast valve, close a first saline valve, and close a first vacuum valve associated with a specific catheter. In some embodiments, processor 602 can also activate a first contrast pump in response to activation of first control 604a or a separate specific control.

[0198] In some embodiments, the processor 602 may also adjust the hemostasis valve of a unique catheter to a highly compressed state as discussed herein in response to activation of a controller, such as the first controller 604a or a separate unique controller. Although one processor 602 is shown in FIG. 13, in other embodiments, multiple processors 602 may be used to control the fluidics systems described herein. For example, each controller 604a, 604b, and 604c may be in communication with its own processor.

[0199] As described herein, for example, with reference to FIG. 1B , in some embodiments, a catheter system can have a valve manifold in communication with a catheter hub. The valve manifold can include a first port configured to connect to a vacuum source, a second port configured to connect to a saline source, and a third port configured to connect to a contrast source. The control system 600 (e.g., via the processor 602) can be configured to adjust the valve manifold (e.g., in response to operation of one or more controllers, such as controllers 604 a, 604 b, and 604 c) to an aspiration mode in which the first port is in communication with the catheter lumen and communication between the second port and the lumen and the third port and the lumen is blocked. In some embodiments, the control system 600 (e.g., via the processor 602) can be configured to adjust the valve manifold to a contrast injection mode in which the third port is in communication with the lumen and communication between the first port and the lumen and the second port and the lumen is blocked. The control system 600 (eg, via the processor 602) can be configured to control the amount of contrast agent delivered.

[0200] In some embodiments, the control system 600 (e.g., via the processor 602) can be configured to adjust the hemostasis valve of the first catheter between a low sealing force or low compression mode and a high sealing force or high compression mode. In some embodiments, the control system 600 (e.g., via the processor 602) can be configured to adjust the hemostasis valve to a high sealing force or high compression mode and adjust the valve manifold to selectively place the third port in communication with the lumen while preventing the first port and the second port from communicating with the lumen (e.g., in response to human input, such as operation of one of the controls of the control system).

[0201] In some embodiments, the control system 600 (e.g., via the processor 602) can be configured to determine the sealing force of the hemostatic valve around the second catheter or guidewire extending through the hemostatic valve (e.g., in response to a human input, such as the operation of one of the controls of the control system). In some embodiments, the control system 600 (e.g., via the processor 602) can be configured to increase the sealing force of the hemostatic valve if the control system 600 determines that the sealing force of the hemostatic valve around the second catheter or guidewire is low.

[0202] In some embodiments, the processor 602 can be configured to send a first control signal to place the hemostasis valve in a high sealing force mode or a high compression mode (e.g., in response to a human input such as the operation of one of the controls of the control system). In some embodiments, the processor 602 can be configured to send a second control signal to open the contrast valve (e.g., in response to a human input such as the operation of one of the controls of the control system). In some embodiments, the processor 602 can be configured to send a third control signal to place the hemostasis valve in a low sealing force mode or a low compression mode (e.g., in response to a human input such as the operation of one of the controls of the control system).

[0203] In some embodiments, processor 602 can be configured to send a fourth control signal to the robotic catheter drive system to axially adjust the second catheter relative to the first catheter (e.g., in response to human input, such as the operation of one of the controls of the control system). In some embodiments, processor 602 can be configured to send a fifth control signal to the robotic catheter drive system to axially retract the guidewire proximally from the second catheter before opening the contrast valve (e.g., in response to human input, such as the operation of one of the controls of the control system). One or more of the first control signal, the second control signal, the third control signal, the fourth control signal, or the fifth control signal can be sent in response to a single human input. Any of the first control signal, the second control signal, the third control signal, the fourth control signal, or the fifth control signal can be sent in response to a unique human input.

[0204] The systems and methods of the preferred embodiments and variations thereof can be embodied and / or implemented at least in part as a machine configured to receive a computer-readable medium storing computer-readable instructions. The instructions are preferably executed by computer-executable components preferably integrated with one or more portions of the systems and processors on the hub, RHV, and / or computing device associated with the fluidics management system described herein. The computer-readable medium can be stored on any suitable computer-readable medium, such as RAM, ROM, flash memory, EEPROM, optical device (e.g., CD or DVD), hard drive, floppy drive, or any suitable device. The computer-executable component is preferably a general-purpose or application-specific processor, although any suitable dedicated hardware or hardware / firmware combination can alternatively or additionally execute the instructions.

[0205] Although the various systems and methods are described herein primarily in the context of neurovascular access or procedures, the inventors contemplate the applicability of the disclosed catheters, systems, and methods to any of a variety of alternative uses, including within the coronary or peripheral vasculature, as well as other hollow organs or tubular structures within the body.

[0206] As used in the description and claims, the singular forms "a," "an," and "the" include both singular and plural references unless the context clearly dictates otherwise. Although the claims and disclosure may include terms such as "plurality," "one or more," or "at least one," the absence of such terms is not intended, and should not be interpreted, to mean that a plurality is not contemplated.

[0207] The terms "about" or "approximately," when used before a numerical designation or range (e.g., to define a length or pressure), indicate an approximation that may vary by (+) or (-) 5%, 1%, or 0.1%. All numerical ranges provided herein are inclusive of the stated beginning and ending numerical values. The term "substantially" refers to most (i.e., more than 50%) or essentially all of a device, substance, or composition.

[0208] As used herein, the terms "comprising" or "comprises" are intended to mean that devices, systems, and methods include the specified elements and may, in addition, include other elements. "Consisting essentially of" is intended to mean that the devices, systems, and methods include the specified elements and exclude other elements that are essential to the combination for the described purpose. Thus, a system or method consisting essentially of the elements defined herein does not exclude other materials, features, or steps that do not materially affect the basic and novel characteristics of the claimed disclosure. "Consisting of" is intended to mean that the devices, systems, and methods include the specified elements and exclude all but minor or inconsequential elements or steps. Embodiments defined by each of these transitional terms are within the scope of this disclosure.

[0209] The examples and figures included herein illustrate, by way of illustration and not limitation, specific embodiments in which the subject matter may be practiced. Other embodiments may be utilized and derived therefrom, and structural and logical substitutions and changes may be made without departing from the scope of the present disclosure. Such embodiments of the inventive subject matter may be referred to herein, individually or collectively, by the term "invention" merely for convenience, where more than one invention or inventive concept is actually disclosed, without any intention to spontaneously limit the scope of the present application to any single one. Thus, although specific embodiments have been illustrated and described herein, any configuration calculated to achieve the same purpose may be substituted for the specific embodiment shown. The present disclosure is intended to cover any and all adaptations or variations of the various embodiments. Combinations of the above embodiments, as well as other embodiments not specifically described herein, will be apparent to those skilled in the art upon reviewing the above description. [Explanation of symbols]

[0210] 10 Fluid Engineering Management System 12. Sink 12a First fluid source 12b Secondary fluid source 12c sink 14 Valves 14a, 14b, 14c valves 15a First port 15b Second Port 15c Third Port 16 Manifold 18 Hub 116 Syncline 120 Catheter 100 Fluid Engineering Systems 102 Fluid management part 104 Intervention part 110a Primary Source 110b Secondary Source 112 Sink 113a~113i valves 114 Pump 115 Pump 116a First valve array 116b Second valve array 116c Third Valve Array 117a First Outlet Valve 117b Second Outlet Valve 117c Third Outlet Valve 118a First manifold 118b Second manifold 118c Third Manifold 120a~c Fluid lines 121a~c Fluid lines 123a~c Fluid lines 124a, 124b, 124c, 124d Hubs 126 First Catheter 128 Second Catheter 130 Third Catheter 132 Guidewire 134a Pressure Transducer 134b, 134c Additional pressure transducers 136 Pump 200 Fluid Engineering Systems 202 Sterile Thrombus Capture Container 204 Bubble Filter 206 Needle Injection Port 208 Junction 210a Primary Source 210b Secondary Source 214 One-way check valve 216a, 216b, 216c valves 217 Actuator 226 Catheter 234 Pump 236a, 236b Air bubble sensor 238 Droplet Speed ​​Sensor 240 Suction Canister 242 Vacuum Pump 244 filters 246 Pressure Sensor 248 Rotating Hemostatic Valve 252 High-pressure pump 300 Fluid Engineering Systems 308 Junction 310a First fluid source 310b Second fluid source 314 One-way check valve 316a Valve 316b valve 317a, 317b, 317c Connectors 317d Complementary Connector 317e complementary connector 317f complementary connector 318a Branch 318b Branch 318c Branch 334 Pump 340 Suction Canister 341 cassette 342 Pump 343 Tubing Set 344 filters 345 One-way valve 346 Connector Array 352 Pump 354 Suction tube 355 First Fluid Tube 356 Second fluid tube 420 Side Port 426 Catheter 448 Rotating Hemostatic Valve 450 proximal end 452 Gasket 456 Gasket 458 Gasket 460 Distal membrane 462 Proximal membrane 464 Distal Slit 466 Cross Material 468 Vertical Slit 470 horizontal slit 471 Housing 472 Gasket Housing 473 Motor 474 Linear Actuator 475 Color 476 Plunger 476a proximal end 476b distal end 477 Drive Shaft 479 Support Tube 481 Gear Train 482 Housing 483 Lead Screw 485 threads 500 Assembly 502 Rotating Hemostatic Valve 504 Manifold 506 Rotating part 508 port 510 Primary Port 512 Secondary Port 514 port Port 516 Port 518 520 clips 800 Operating Mechanism

Claims

1. A cassette configured to receive saline solution from a saline source, contrast agent from a contrast agent source, and vacuum from a vacuum source, A saline channel configured to fluidly communicate with at least one of a plurality of catheters and to supply saline solution to at least one of the plurality of catheters, A contrast agent channel is configured to communicate fluidly with at least one of the plurality of catheters and to supply a contrast agent to at least one of the plurality of catheters, A vacuum channel configured to fluidly communicate with at least one of the plurality of catheters and to provide a vacuum to at least one of the plurality of catheters, Cassette A fluid dynamics management system including

2. The system according to claim 1, wherein the cassette includes one or more robotically operated contrast valves arranged along the contrast agent flow path and configured to be controlled by a control system.

3. The system according to claim 1, wherein the cassette includes one or more robotically operated vacuum valves arranged along the vacuum flow path and configured to be controlled by a control system.

4. The system according to claim 1, wherein the contrast agent channel includes a plurality of branches.

5. The system according to claim 4, wherein the cassette further comprises a plurality of contrast agent valves, each of the plurality of contrast agent valves arranged along one of the plurality of branches.

6. The system according to claim 5, wherein the plurality of contrast agent valves include robot-operated valves configured to be controlled by a control system.

7. The system according to claim 1, wherein the vacuum channel includes a plurality of branches.

8. The system according to claim 7, wherein the cassette further includes a plurality of vacuum valves, each of which is arranged along one of the plurality of branches.

9. The system according to claim 8, wherein the plurality of vacuum valves include robot-operated valves configured to be controlled by a control system.

10. The system according to claim 1, further comprising a plurality of saline pumps, wherein the plurality of saline pumps are configured to propel the flow of saline from the saline source to the plurality of catheters.

11. The system according to claim 10, wherein the plurality of saline pumps are located outside the cassette.

12. The system according to claim 1, further comprising a contrast agent pump, wherein the contrast agent pump is configured to propel the flow of contrast agent from the contrast agent source to the plurality of catheters.

13. The system according to claim 1, further comprising a suction container, wherein the vacuum source is configured to propel suction from the plurality of catheters to the suction container.

14. The system according to claim 1, wherein the cassette is disposable.

15. The system according to claim 1, further comprising a plurality of hubs, at least one of which is in fluid communication with at least one of the saline flow path, the contrast agent flow path, and the vacuum flow path.

16. The system according to claim 15, wherein at least one of the plurality of hubs includes a hemostatic valve that is in fluid communication with at least one of the saline flow path, the contrast agent flow path, and the vacuum flow path.

17. The system according to claim 15, further comprising the plurality of catheters, each of which catheters is coupled to one of the plurality of hubs.

18. A saline source configured to supply saline solution to a cassette, A contrast agent source configured to supply a contrast agent to the aforementioned cassette, A vacuum source configured to provide vacuum to the aforementioned cassette, Multiple catheter hubs, each configured to receive saline solution, contrast agent, and vacuum from the cassette, A fluid dynamics management system including

19. The system according to claim 18, further comprising a plurality of catheters, each of the plurality of catheters being coupled to one of the plurality of catheter hubs, and the plurality of catheters being arranged in a concentric catheter assembly.

20. The system according to claim 18, further comprising a plurality of tubing sets, each of which is configured to be coupled to the cassette and to one of the plurality of catheter hubs.

21. The system according to claim 20, wherein each of the plurality of tubing sets includes a saline tube, a contrast agent tube, and a vacuum tube.

22. The system according to claim 18, further comprising a plurality of saline pumps, wherein the plurality of saline pumps are configured to propel the flow of saline from the saline source into the cassette.

23. The system according to claim 18, further comprising a contrast agent pump, wherein the contrast agent pump is configured to propel the flow of contrast agent from the contrast agent source to the plurality of catheter hubs.

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