Fluid control system for multiple conduit stacks

Abstract

A fluidic system includes a cartridge having a brine subsystem, a contrast agent subsystem, and a vacuum subsystem. The fluidic system further includes a diverter and a first set of conduits coupled to the cartridge and the diverter, the first set of conduits having a single saline channel, a single contrast agent channel, and a single vacuum channel. The fluidic system further includes two or more hub assemblies, at least one of the two or more hub assemblies configured to have a third saline flow path, a third contrast agent flow path, and a third vacuum flow path, the two or more hub assemblies are coupled to one another to provide saline, contrast agent, and vacuum to a lumen of a catheter coupled to at least one of the two or more hub assemblies. The fluid system further includes a second tubing set having a plurality of tubing sets, each tubing set coupled to the diverter and one of the two or more hub assemblies.

Description

[0001] Cross-reference to related applications

[0002] Pursuant to 37 CFR 1.57, any and all applications with foreign or domestic priority claims identified in the application data sheets filed together with this application are incorporated herein by reference. This application claims priority to U.S. Provisional Patent Application No. 63 / 467251, filed May 17, 2023, entitled "FLUIDICS CONTROL SYSTEM FOR MULTI CATHETER STACK"; U.S. Provisional Patent Application No. 63 / 528038, filed July 20, 2023, entitled "FLUIDICS CONTROL SYSTEM FOR MULTI CATHETER STACK"; and U.S. Provisional Patent Application No. 63 / 550926, filed February 7, 2024, entitled "FLUIDICS CONTROL SYSTEM FOR MULTI CATHETER STACK", the entire contents of which are incorporated herein by reference for all purposes and constitute a part of this specification. Technical Field

[0003] This disclosure generally relates to the field of fluid infrastructure, and more specifically, to the field of fluid management and delivery during manually or robotically driven medical procedures. Systems and methods for fluid management and delivery are described herein. Background Technology

[0004] Any of the various endovascular or intravascular medical procedures may involve the simultaneous or sequential introduction of multiple instruments, such as catheters, into the body. Each catheter may require a unique connection to any of a variety of aspiration, flushing, drug, saline, or contrast agent infusion sources. Such sources are typically communicated with the catheter via tubing at the end of a connector for releasable connection to complementary ports on the catheter hub (seat).

[0005] Catheter replacement typically involves disconnecting the tubing from the first catheter that has been removed and reconnecting it to a second replacement catheter. Furthermore, catheters usually have a Luer connector port for both injection and aspiration. During the procedure, multiple different fluids and / or fluid volumes may be injected at different times, in addition to aspiration. Therefore, fluid sources, such as syringes, are frequently connected and disconnected from the Luer connector port. This routine switching of components, syringes, and fluid connections during the procedure can lead to risks of air bubble introduction, incorrect connection points, and / or incorrect fluid selection.

[0006] Therefore, there is still a need for improved fluid and tool management systems that overcome one or more of the drawbacks of traditional fluid management and conduit exchange systems. Summary of the Invention

[0007] A suction system with integrated fluid management includes an elongated, flexible tubular body having a proximal end, a distal end, and at least one lumen; a seat at the proximal end of the tubular body; a valve system, which may be in the form of a valve manifold communicating with the seat; 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 blocking communication between the other two ports and the lumen. The fluid management system can be used with stacks of two, three, four, or more interventional devices (e.g., catheters concentrically mounted on a guidewire) for manual or robotic interventions.

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

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

[0010] The first, second, and third ports may include connectors for detachable connection to conduits extending away from the seat. Alternatively, the first, second, and third ports may include conduits that are non-detachably attached to the seat and extend away from the seat.

[0011] The aspiration system may further include a hemostatic valve, which is permanently or removably carried by the seat. The hemostatic valve is adjustable at least between a low-sealing mode and a high-sealing mode. In the low-sealing mode, the catheter can slide through the valve, and the valve prevents backflow of low-pressure fluid. In the high-sealing mode, the valve is tightly clamped onto the catheter to prevent backflow of high-pressure fluid. The control system may be configured to adjust the hemostatic valve between the low-sealing mode and the high-sealing mode.

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

[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 agent source.

[0014] In response to a human command to enter contrast agent injection mode, the control system can be configured to adjust the hemostatic valve to a high-sealing-force mode and adjust the valve manifold to selectively connect the third port to the lumen while blocking the first and second ports from connecting to the lumen.

[0015] A fluid control system is also provided. The system includes a processor; a valve manifold having a vacuum valve, a saline valve, and a contrast agent valve, the vacuum valve configured to connect a catheter to a vacuum source, the saline valve configured to connect the catheter to a saline source, and the contrast agent valve configured to connect the catheter to a contrast agent source; and a contrast agent control element for initiating the introduction of contrast agent into the catheter. The processor can be configured to open the contrast agent valve and close the saline valve and the suction valve in response to operation of the contrast agent control element.

[0016] The fluid control system may further include a catheter seat in fluid communication with the contrast agent valve, saline valve, and aspiration valve. The hemostatic valve may be carried by the seat or by an assembly (e.g., a hub) connected to the seat.

[0017] The fluid 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 also be configured to increase the sealing strength of the hemostatic valve in response to operation of the contrast agent control element for introducing contrast agent into the catheter. The processor may further be configured to decrease the sealing strength of the hemostatic valve in response to operation of the contrast agent control element for stopping the introduction of contrast agent into the catheter.

[0018] The valve manifold may be carried by the seat. Alternatively, the valve manifold may be located away from the seat and communicate with the seat via a piping assembly having vacuum, saline, and contrast agent lines.

[0019] A degassing method for a multi-catheter fluid management system is also provided. The method includes injecting a first fluid from a first fluid source into a first fluid source connection of a hemostatic valve under low pressure, and closing a first valve at the first fluid source connection. A vacuum is applied to a groove connection of the hemostatic valve to remove residual first fluid into the groove. The groove valve is closed, and a second fluid is injected from a second fluid source into a second fluid source connection of the hemostatic valve.

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

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

[0022] A catheter system with integrated fluid 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 seat at the proximal end of the tubular body and a valve system communicating with the seat. The catheter system also includes a first port, a second port, and a third port communicating 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 blocking communication between the other two ports and the lumen.

[0023] A first elongated flexible tubular body may include an aspiration catheter. The valve system may include a first valve communicating with the first port, a second valve communicating with the second port, and a third valve communicating with the third port. The first port may be configured to connect to a vacuum source. The second port may be configured to connect to a saline source. The third port may be configured to connect to a contrast agent source. The catheter system may include a control system configured to adjust the valve system to an aspiration mode, wherein the first port communicates with the lumen, and the communication between the second port and the lumen and between the third port and the lumen is blocked. The control system may be configured to adjust the valve system to a contrast agent injection mode, wherein the third port communicates with the lumen, and the communication between the first port and the lumen and between the second port and the lumen is blocked. The control system may be configured to control the volume of contrast agent delivered. The valve system may include a valve manifold including the first port, the second port, and the third port. Each of the first port, the second port, and the third port may include a connector for detachable connection to a tube extending away from the seat. Each of the first, second, and third ports may include a conduit attached to the seat and extending away from the hub. The catheter system may include a hemostatic valve carried by the seat. The hemostatic valve may be adjustable at least between a low-sealing force mode and a high-sealing force mode. The control system may be configured to adjust the hemostatic valve between the low-sealing force mode and the high-sealing force mode. The system may include a contrast agent injection control. The control system may be configured to adjust the hemostatic valve to a high-sealing force mode in response to human input and to adjust the valve system to selectively communicate the third port with the lumen while blocking communication between the first and second ports and the lumen. Human input may be received via a contrast agent control on a user interface. The catheter system may include a second elongated flexible tubular body extending through the hemostatic valve. The control system may be configured to adjust the valve system to a contrast agent injection mode in response to human input, wherein the third port communicates 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 to determine the sealing force of the hemostatic valve around the second elongated flexible tubular body in response to human input. 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 fluid control system is also provided. The fluid control system includes a first processor, a valve system, and a first contrast agent control element. The valve system includes a first vacuum valve configured to connect a first catheter to a first vacuum source, a first saline valve configured to connect the first catheter to a first saline source, and a first contrast agent valve configured to connect the first catheter to the first contrast agent source. The first contrast agent control element is configured to initiate the introduction of contrast agent into the first catheter. The first processor is configured to open the first contrast agent valve and close the first saline valve and the first vacuum valve in response to actuation of the first contrast agent control element.

[0025] The fluid control system may include the first catheter. The first catheter may include a first catheter seat in fluid communication with the first contrast agent valve, the first saline valve, and the first vacuum valve. The fluid control system may include a first hemostatic valve on the first catheter seat. The fluid control system may include a second catheter configured to axially receive the first catheter through which it passes (in its lumen). The second catheter may include a second catheter seat. The second catheter seat may include a second hemostatic valve. The second hemostatic valve may be adjustable between a low-compression state and a high-compression state of the first catheter. The first processor or the second processor may be configured to adjust the second hemostatic valve to a high-compression state of the first catheter in response to actuation of the first contrast agent control. The first processor may be configured to adjust the second hemostatic valve to a high-compression state of the first catheter in response to actuation of the first contrast agent control. The first processor may be configured to introduce contrast agent into the first catheter in response to actuation of the first contrast agent control and when the second hemostatic valve is in a high-compression state of the first catheter. The first processor may be configured to activate a first contrast agent pump in response to actuation of the first contrast agent controller. The fluid control system may further include drive circuitry configured to adjust the compression state of the second hemostatic valve between the high compression state and the low compression state in response to a signal from the first processor. The first processor may be additionally configured to confirm that the second hemostatic valve is in a high compression state in response to actuation of the first contrast agent controller for introducing contrast agent into the first catheter. The first processor may also be additionally configured to adjust the second hemostatic valve to a low compression state in response to stopping actuation of the first contrast agent controller for introducing contrast agent into the first catheter. The valve system may include a valve manifold carried by the first catheter hub. The first vacuum valve, the first saline valve, and the first contrast agent valve may be located remotely from the first catheter hub and communicate with the first catheter hub via a conduit assembly having a vacuum line, a saline line, and a contrast agent line.

[0026] A fluid control system for multi-catheter procedures is also provided. The fluid control system includes a first catheter, a second catheter, a saline solution source, a contrast agent source, and a processor. The first catheter includes a hemostatic valve adjustable between a low-compression mode and a high-compression mode. The second catheter extends through the hemostatic valve and through the first catheter. The saline solution source is connected to the first catheter via a saline valve. The contrast agent source is connected to the first catheter via a contrast valve. The processor is configured to, in response to human instructions, send a first control signal to place the hemostatic valve in a high-compression mode and send a second control signal to open the contrast agent valve.

[0027] The processor may be further configured to send a third control signal in response to a human instruction to place the hemostatic valve in a low-compression mode, and to send a fourth control signal to the robotic catheter drive system to adjust the second catheter relative to the first catheter axis. The processor may be further configured to send a fifth control signal to the robotic catheter drive system in response to a human instruction to withdraw the guidewire axially proximally from the second catheter before dispensing the contrast agent.

[0028] A degassing method for a multi-catheter fluid management system is also provided. The degassing method includes injecting a first fluid from a first fluid source into a first fluid source connector of a hemostatic valve under low pressure; closing a first valve at the first fluid source connector; applying a vacuum to a slot connector of the hemostatic valve to remove residual first fluid into a slot connected to the slot connector; closing a slot valve at the slot connector; and injecting a second fluid from a second fluid source into a second fluid source connector of the hemostatic valve.

[0029] The first fluid may be heparinized saline. The second fluid source may be a contrast agent. The method may further include actuating the plunger of the hemostatic valve to a high-compression state before injecting the second fluid. The method may further include actuating the plunger of the hemostatic valve to a low-compression state before injecting the first fluid. The method may further include, before injecting the first fluid, applying a vacuum to the grooved connection of the hemostatic valve while the first valve at the first fluid source connection of the hemostatic valve is closed, to remove air from the lumen of the conduit fluidly connected to the hemostatic valve, and closing the grooved valve at the grooved connection. 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 under high pressure. The method may further include detecting air bubbles in at least one of the first fluid or the second fluid using an air bubble sensor.

[0030] A degassing method for a multi-catheter fluid management system is also provided. The method includes applying a vacuum to a groove connection of a hemostatic valve when a first valve at a first fluid source connection of the hemostatic valve is closed to remove lumen air from a catheter fluidly connected to the hemostatic valve; closing a groove valve at the groove connection; opening a first valve at the first fluid source connection of the hemostatic valve; and injecting a first fluid from a first fluid source into the first fluid source connection of the hemostatic valve under low pressure.

[0031] The first fluid may be heparinized saline. The method may further include applying a vacuum to the groove connection of the hemostatic valve to remove residual first fluid into a groove connected to the groove connection, and injecting a second fluid from a second fluid source into a second fluid source connection of the hemostatic valve. The second fluid may be a contrast agent. 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 under high pressure. The method may further include detecting air bubbles in at least one of the first fluid or the second fluid using an air bubble sensor.

[0032] A degassing method for a multi-catheter fluid management system is also provided. The method includes receiving a first input via communication coupling to a hemostatic valve on a catheter hub, instructing the injection of a first fluid from a first fluid source into a first fluid source connection of the hemostatic valve at low pressure; transmitting a first output signal via the processor to close a first valve at the first fluid source connection; transmitting a second output signal via the processor to initiate a vacuum at a slot connection of the hemostatic valve to remove residual first fluid into a slot; transmitting a third output signal to close a slot valve at the slot connection; and receiving a second input instructing the injection of a second fluid from a second fluid source into a second fluid source connection of the hemostatic valve.

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

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

[0035] The first fluid may be heparinized saline. The second fluid may be a contrast agent. The system may further include a manifold comprising a saline valve, a contrast agent valve, and a vacuum valve, the saline valve being configured to connect a first fluid source connection of the first hemostatic valve to a saline source, the contrast agent valve being configured to connect a second fluid source connection of the first hemostatic valve to a contrast agent source, and the vacuum valve being configured to connect a slot connection of the first hemostatic valve to a vacuum source. The system may include a first catheter having a first catheter hub including the first hemostatic valve. The system may include a second catheter hub configured to receive the first catheter passing through it axially movably. The second catheter hub may include a second hemostatic valve. The second hemostatic valve may be adjustable between a low-compression state and a high-compression state of the first catheter. The first hemostatic valve may include a plunger. The first processor may be further configured to transmit a fourth output to the plunger to actuate the plunger to a high-compression state before receiving a second input instructing the injection of a second fluid. The first processor may be further configured to transmit a fifth output to the plunger so that the plunger is actuated to a low-compression state before receiving a first input instructing the injection of a first fluid.

[0036] A fluid management system for a robot-driven interventional device is also provided. The system includes a hub configured to be positioned at the proximal end of a first elongated body and to operate the first elongated body, and a first hemostatic valve at least partially disposed within the hub, wherein the hemostatic valve includes a first fluid source connection, a second fluid source connection, and a groove connection. The hemostatic valve is configured to be fluidly connected simultaneously to a first fluid source, a second fluid source, and a third fluid source via the first fluid source connection, the second fluid source connection, and the groove connection, such that the system is configured to automatically switch between allowing only fluid from the first fluid source or from the second fluid source to enter the lumen of the first elongated body through the hemostatic valve, or allowing fluid removed from the lumen to be collected in the groove.

[0037] The hemostatic valve may include a three-way connector comprising a first fluid source connection, a second fluid source connection, and a groove connection. The first fluid source may include saline, heparinized saline, or a drug. The second fluid source may include a contrast agent. The system may include a first manifold comprising 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 may include a second hub and a second hemostatic valve, the second hub being configured to receive and operate a second elongated body at least partially disposed in the lumen of the first elongated body, the second hemostatic valve being at least partially disposed in the second hub, wherein the second hemostatic valve includes a third fluid source connection, a fourth fluid source connection, and a second groove connection, wherein the first manifold includes 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, the first output line, and the second output line may include one or more of a drip rate sensor, a bubble sensor, a bubble filter, or an in-line pump. The system may further include a second manifold comprising a second input line configured to connect to the second fluid source and a third output line configured to connect to a second fluid source connector of the first hemostatic valve. The system may further include a second hub and a second hemostatic valve, the second hub being configured to receive and operate a second elongated body at least partially disposed in the lumen of the first elongated body, the second hemostatic valve being at least partially disposed in the second hub, wherein the second hemostatic valve includes a third fluid source connector, a fourth fluid source connector, and a second groove connector, wherein the second manifold further includes a fourth output line configured to connect to the fourth fluid source connector. One or more of the second input line or the third output line includes one or more of a bubble sensor or a bubble filter. The system may include a third manifold comprising a groove output line configured to connect to the groove and a groove input line configured to connect to the groove connector of the hemostatic valve. The system may further include a second hub and a second hemostatic valve, the second hub being configured to receive and operate a second elongated body at least partially disposed in the lumen of the elongated body, the second hemostatic valve being at least partially disposed in the second hub, wherein the second hemostatic valve includes a third fluid source connection, a fourth fluid source connection, and a second slot connection, wherein the second manifold further includes a second slot inlet line configured to be connected to the second slot connection. The slot inlet line may include an in-line local filter. The slot may include a suction container such that the slot outlet line includes the suction container configured to be fluidly connected to a suction pump.The hemostatic valve may include an actuable washer movable between a first open configuration, a second low-sealing configuration, and a third high-sealing configuration, the second low-sealing configuration for low-pressure fluid transfer from a first fluid source or a second fluid source, and the third high-sealing configuration for high-pressure fluid transfer from a second fluid source. The first fluid source may include saline, and the second fluid source may include a contrast agent. The system may include a driven magnet on the hub configured to cooperate with a drive magnet such that the driven magnet moves in response to movement of the drive magnet. The drive magnet may be axially movably supported by a support platform. The system may include a second hub and a second hemostatic valve, the second hub being configured to receive and operate a second elongated body at least partially disposed in the lumen of the first elongated body, the second hemostatic valve being at least partially disposed in the second hub, wherein the second valve includes a third fluid source connection, a fourth fluid source connection, and a second groove connection. The second hemostatic valve can be configured to be fluidly connected to the first fluid source via the third fluid source connector, fluidly connected to the second fluid source via the fourth fluid source connector, and fluidly connected to the groove via the second groove connector, such that the second hemostatic valve is configured to allow fluid from the first fluid source or the second fluid source to enter the lumen of the second elongated body through the hemostatic valve, or to allow fluid removed from the lumen of the second elongated body to be collected in the groove. The second hemostatic valve may include a second tee connector, which includes the third fluid source connector, the fourth fluid source connector, and the second groove connector.

[0038] A fluid management system for a robot-driven medical device 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 and a second port. The first port includes a tee connector configured to simultaneously fluidly connect to a first fluid source, a second fluid source, and a channel. The second port includes an actuable hemostatic gasket configured to seal around a second interventional device configured to be disposed within the lumen of the interventional device. The gasket is actuable between a first open state, a second low-sealing state, and a third high-sealing state. The second low-sealing state is used to receive a low-pressure fluid injection from the first or second fluid source through the first port, or to allow fluid to flow through the first port into the channel. The third high-sealing state is used to receive a high-pressure fluid injection from the second fluid source through the first port.

[0039] A method is also provided for administering contrast agent injection from a selected catheter in a robotic catheterization system having at least a first catheter and a second catheter, the second catheter being configured to be positioned within the lumen of the first catheter (e.g., within a portion of the lumen or along its entire length). The method may include receiving a signal from a controller indicating the selection of a first or second catheter for contrast agent injection; controlling the position of a valve via the controller to bring the lumen of the selected catheter into fluid communication with a contrast agent subsystem; determining, via the controller, that the valve of an unselected catheter of at least the first and second catheters is aligned such that the unselected catheter is not in fluid communication with the contrast agent subsystem; and actuating, via the controller, a contrast agent pump in fluid communication with the lumen of the selected catheter to inject the contrast agent. Determining that the valve of the unselected catheter of the at least the first and second catheters is aligned such that the unselected catheter is not in fluid communication with the contrast agent subsystem may include using stored information about the position of the valve connecting the unselected catheter to the contrast agent subsystem. Determining that the valve of the unselected catheter of the at least the first and second catheters is aligned such that the unselected catheter is not in fluid communication with the contrast agent subsystem may include using information from a sensor on the valve of the unselected catheter.

[0040] A fluid system is also provided, which may include a cartridge configured to be releasably coupled to a pumping station and configured to receive brine from a brine source, contrast agent from a contrast agent source, and vacuum from a vacuum source. The cartridge includes a brine subsystem having a first brine flow path, a contrast agent subsystem having a first contrast agent flow path, and a vacuum subsystem including a first vacuum flow path. The system may further include a splitter having a second brine flow path, a second contrast agent flow path, and a second vacuum flow path, each of the second brine flow path, the contrast agent flow path, and the vacuum flow path having a single proximal end and multiple distal ends. The system may further include a first conduit assembly having a first length and coupled to the cartridge and the splitter, the first conduit assembly including a single brine channel coupled to the proximal ends of the first and second brine flow paths, a single contrast agent channel coupled to the proximal ends of the first and second contrast agent flow paths, and a single vacuum channel coupled to the proximal ends of the first and second vacuum flow paths. The system may further include two or more hub assemblies, at least one of which is configured to have a third saline flow path, a third contrast agent flow path, and a third vacuum flow path to provide saline, contrast agent, and vacuum to the lumen of a catheter coupled to at least one of the two or more hub assemblies. The system may also include a second conduit group having a second length shorter than the first length, the second conduit group comprising multiple conduit groups, each conduit group being coupled to a shunt at its proximal end and to one of the two or more hub assemblies at its distal end. At least one of the multiple conduit groups includes a saline subchannel at the distal end of the second saline flow path coupled to the shunt, a contrast agent subchannel at the distal end of the second contrast agent flow path coupled to the shunt, and a vacuum subchannel at the distal end of the second vacuum flow path coupled to the shunt.

[0041] In such a fluid system, at least one of two or more hub assemblies includes a seat, wherein the seat includes a third saline flow path, a third contrast agent flow path, and a third vacuum flow path. The seat may include a connector, wherein the seat is configured to supply saline, contrast agent, and vacuum to the lumen of the catheter via the connector. At least one of the two or more hub assemblies may include one or more robot-actuated control valves controlled by a control system to selectively align the third saline flow path, the third contrast agent flow path, and the third vacuum flow path, thereby achieving fluid communication with the lumen of the catheter. A first length of the first tubing group may be at least twice the second length of the second tubing group to minimize the length of tubing requiring visual inspection. In some examples, the ratio of the first length to the second length is greater than 1:4. The saline subsystem may be configured to receive saline from a first saline source and a second saline source, and the saline subsystem includes a robot-actuated valve controlled by a control system to achieve fluid communication between the first saline flow path and either the first or second saline source. The control system may control the robot-actuated valve to switch based on signals received from sensors to receive saline from a different of the first and second saline sources. The sensor may be, for example, a weight sensor configured to detect the weight of a first saline source and a second saline source, or an air sensor configured to detect air in the first saline flow path. The contrast agent subsystem may include a contrast agent pump actuated by a control system to provide contrast agent to at least one of two or more hub assemblies. The vacuum subsystem may include a clot chamber. The clot chamber may include at least one transparent surface positioned such that the contents of the clot chamber are visible from the outside of the cartridge. The vacuum subsystem may include a drip chamber in fluid communication with a first vacuum flow path, the vacuum subsystem including one or more robotically actuated valves controlled to collect fluid aspirated by the vacuum subsystem in the drip chamber. The drip chamber may include at least one transparent surface positioned such that the contents of the drip chamber are visible from the outside of the cartridge. The drip chamber may be positioned in the first vacuum flow path between the clot chamber and the first tubing assembly. The vacuum subsystem may further include a plurality of robotically actuated valves configured to be controlled by a control system for controlling the vacuum flow path through the drip chamber and the clot chamber. The vacuum subsystem includes multiple robotically actuated valves, including a first valve positioned in a first vacuum flow path between a drip chamber and a clot chamber, and a second valve positioned on the opposite side of the drip chamber in the first vacuum flow path between the drip chamber and a first conduit assembly. The first and second valves are selectively controlled to control the flow of fluid and material from two or more hub assemblies to the drip chamber and the clot chamber. The fluid system may further include multiple conduits, one of which is coupled to each of the two or more hub assemblies. Each of the two or more hub assemblies may include a brine air sensor positioned to detect air in a third brine flow path, and a contrast agent air sensor positioned to detect air in a third contrast agent flow path.Saline and contrast agent air sensors can be positioned separately in the saline and contrast agent third flow paths, located between multiple robot-actuated control valves and a second piping group, for detecting air in the saline and contrast agent flow paths before they reach the multiple robot-actuated control valves. One or more of the multiple robot-actuated control valves are controlled by a control system to block the saline and contrast agent flow paths to the connector based on a signal from one of the saline and contrast agent air sensors. In such a fluid system, each of the two or more hub assemblies may include multiple sensors, and each piping group of the first piping group, the splitter, and the second piping group further includes an electrical channel coupled to the multiple sensors in the two or more hub assemblies, the electrical channel being configured to communicate electrical signals from the multiple sensors to an electrical interface on a housing, the housing being configured to electrically connect to a corresponding electrical interface on a pump station to provide signals from the multiple sensors in the hub assembly to the control system. The plurality of sensors may include a saline air sensor positioned to detect air in a third saline flow path, a contrast agent air sensor positioned to detect air in a third contrast agent flow path, and a pressure sensor configured to sense the pressure of the fluid supplied to the lumen of the catheter.

[0042] A fluid system is also provided, comprising two or more hub assemblies, each hub assembly including one or more robot-actuated control valves; a saline channel, an contrast agent channel, and a vacuum channel; and a main channel configured to couple to a catheter, wherein the one or more robot-actuated control valves are controlled by a control system to selectively connect one or both of the saline channel and the contrast agent channel to fluid communication with the main channel, or connect the vacuum channel to fluid communication with the main channel, for supplying saline, contrast agent, or vacuum to the catheter. At least one of the two or more hub assemblies may be a two-part hub assembly, comprising a hub (first sub-assembly) and a seat (second sub-assembly). In the fluid system, at least one of the two or more hub assemblies may include one or more robot-actuated control valves, a saline channel, a contrast agent channel, a vacuum channel, and a main channel. At least one of the two or more hub assemblies may further include a connector configured to couple to the catheter for supplying fluid to the catheter through the connector. Such a fluid system may further include a catheter coupled to each of the two or more hub assemblies. The one or more robot-actuated control valves may include two robot-actuated valves. Each of the two or more hub assemblies may include a seat, and the two robot-actuated valves are located in the seats of each of the two or more hub assemblies. In the fluid system, the two or more hub assemblies may include three hub assemblies. Such a fluid system may further include a housing configured to be releasably coupled to a pump station, the housing including a brine subsystem configured to receive brine from a brine source, a contrast agent subsystem configured to receive contrast agent from a contrast agent source, and a vacuum subsystem configured to receive vacuum from a vacuum source; and a communication channel coupled to the housing and the two or more hub assemblies for supplying brine, contrast agent, and vacuum to the hub assemblies. The housing may include a portion of the brine subsystem, and the pump station includes at least one actuator configured to be operatively coupled to the housing to operate a portion of the brine subsystem within the housing. The fluid system may further include a controller configured to control the pump station in part based on first user input received from an interface communicating with the fluid system. The interface may be located near the fluid system. The controller can be further configured to control the pump station in part based on first user input received from a console in communication with the fluid system. The console can be located in the same room as the fluid system. Alternatively, the console can be located away from the fluid system.

[0043] A fluid system is also provided, comprising two or more hub assemblies configured to couple to a conduit. At least one of the two or more hub assemblies includes a robot-actuated first control valve; a saline channel in fluid communication with the first control valve; a saline contrast agent channel in fluid communication with the first control valve; and a saline flow-restricting channel bypassing the first control valve and in fluid communication with the saline channel and the saline contrast agent channel. At least one of the two or more hub assemblies may further include a contrast agent channel in fluid communication with the first control valve, wherein the first control valve is robot-controlled to selectively connect one or both of the saline channel and the contrast agent channel, or not connect to either the saline channel or the contrast agent channel, to be in fluid communication with the saline contrast agent channel via the first control valve. At least one of the two or more hub assemblies further includes a vacuum channel; a robot-actuated second control valve coupled to a saline contrast agent channel and a main channel for supplying saline, contrast agent, and vacuum to the catheter, the robot-actuated second control valve being controlled by a control system to connect and disconnect the vacuum channel and the main channel; a first air sensor positioned to detect air in the saline channel and configured to generate a signal indicating air detected in the saline channel; and a second air sensor positioned to detect air in the contrast agent channel and configured to generate a signal indicating air detected in the contrast agent channel, wherein the second control valve is robot-actuated to disconnect the saline contrast agent channel from the first channel, at least in part based on a signal from the first air sensor or the second air sensor. At least one of the two or more hub assemblies may further include a check valve positioned in the saline channel between the first air sensor and the first control valve, the check valve being configured to restrict fluid flow in the saline channel in a direction from the first air sensor toward the first control valve. In such a fluid system, each hub assembly may further include a robot-actuated second control valve in fluid communication with the saline contrast agent channel and a vacuum channel in fluid communication with the second control valve, wherein the second valve is robot-actuated to selectively connect the vacuum channel or the saline contrast agent channel to a main channel in fluid communication with a conduit coupled to the hub assembly.

[0044] Each hub assembly may further include a main channel in fluid communication with the lumen of a catheter coupled to the seat, wherein the fluid system includes a pressure sensor positioned to detect pressure in the main channel and generate a signal indicating the detected pressure, wherein the fluid system is configured to determine whether to inject contrast agent based at least in part on the signal indicating pressure in the main channel.

[0045] A method is also provided for selectively supplying saline, contrast agent, and vacuum to a plurality of catheters from a cartridge releasably coupled to a pump station, each catheter being coupled to one of a plurality of hub assemblies in fluid communication with a main channel in a corresponding hub assembly. The method includes: supplying saline via a saline communication channel coupled to the cartridge and to each of the plurality of hub assemblies, wherein a portion of the saline communication channel coupled to each of the plurality of hub assemblies is identical; supplying contrast agent via a contrast agent communication channel coupled to the cartridge and to each of the plurality of hub assemblies, wherein a portion of the contrast agent communication channel coupled to each of the plurality of hub assemblies is identical; and supplying vacuum via a vacuum communication channel coupled to the cartridge and to each of the plurality of hub assemblies, wherein a portion of the vacuum communication channel coupled to each of the plurality of hub assemblies is identical. In such a method, the plurality of hub assemblies may include three hub assemblies. At least one of the plurality of hub assemblies may include a hub and a seat. The method of supplying saline, contrast agent, and vacuum to multiple catheters from a box releasably coupled to a pump station may further include, for each of the multiple hub assemblies, controlling one or more robot-actuated control valves located in the hub assembly via a control system to selectively connect a main channel to a saline channel, a contrast agent channel, or a vacuum channel to supply saline, contrast agent, or vacuum to the catheters. Attached Figure Description

[0046] The above description is only a summary, and therefore requires detailed explanation. The above-described aspects, as well as other aspects, features, and advantages of this technology, are described below with reference to the accompanying drawings and various embodiments.

[0047] Figure 1A An implementation scheme of a single-channel fluid management system is shown.

[0048] Figure 1B An implementation scheme of a three-channel fluid management system is shown.

[0049] Figure 2 A schematic diagram of a three-channel fluid system is shown.

[0050] Figure 3 Another schematic diagram of the fluid system is shown.

[0051] Figure 4 Another schematic diagram of the fluid system is shown.

[0052] Figure 5A and Figure 5B A cross-sectional view of an exemplary rotary hemostatic valve is shown, in which a gasket is configured in the open position.

[0053] Figure 6A and Figure 6BA cross-sectional view of a rotary hemostatic valve is shown, in which the gasket is configured in the low-pressure position.

[0054] Figure 7A and Figure 7B A cross-sectional view of an exemplary rotary hemostatic valve is shown, in which a gasket is configured in a high-pressure position.

[0055] Figures 8A to 8C Various views of exemplary gaskets used in the hemostatic valve described herein are shown.

[0056] Figure 9 A perspective view of the actuation mechanism used with the rotary hemostatic valve described herein is shown.

[0057] Figures 10A to 10B It shows Figure 9 The two different positions of the actuation mechanism.

[0058] Figure 10C A linear actuator assembly is shown.

[0059] Figure 11 A perspective view of an example assembly is shown, in which a rotary hemostatic valve is integrated with a manifold.

[0060] Figure 12 This is a flowchart of a method for degassing the fluid management system of a robot-driven medical device.

[0061] Figure 13 A schematic diagram of the control system is shown.

[0062] Figure 14 An example of a fluid system is shown.

[0063] Figure 15 An example implementation of the brine subsystem is shown.

[0064] Figure 16A An example implementation of the contrast agent subsystem is shown.

[0065] Figure 16B Another example of an implementation scheme for the contrast agent subsystem is shown.

[0066] Figure 17 An example implementation of a vacuum / vacuum (“V / A”) subsystem (“vacuum subsystem”) is shown.

[0067] Figure 18Examples of conduits coupled to a hub are shown, as well as a tubing assembly connected to the hub at a distal end and to a cartridge at a proximal end. The tubing assembly includes saline tubing, contrast agent tubing, and vacuum tubing, and may include electrical connections. The tubing assembly forms part of a fluid communication system connecting the hub to the saline subsystem, contrast agent subsystem, and vacuum subsystem, for example, such as... Figure 15 Figure 16 and Figure 17 The saline subsystem, contrast agent subsystem, and vacuum subsystem are shown respectively.

[0068] Figure 19 Another example of a conduit coupled to a hub is shown.

[0069] Figure 20 An example of a piping assembly is shown, which is part of a fluid communication system that provides a channel for exchanging substances (e.g., air, fluid, and / or materials) between multiple conduits and saline subsystems, contrast agent subsystems, and vacuum subsystems. The piping assembly is coupled to a housing at its proximal end and to multiple hubs at its distal end. In this example, the piping assembly also includes electrical connections between the housing and the hubs.

[0070] Figure 21 Schematic diagrams of examples of robotic conduit systems, including a remote positioning system (“remote system”) and a local positioning system (“local system”), are shown according to some embodiments. Examples of certain components of the local system, including certain components of a fluid management system (“fluid system”), are also shown. The fluid management system (“fluid system”) includes actuable components actuated by a controller and sensors that provide information to the controller for controlling other aspects of the fluid system and the robotic conduit system.

[0071] Figure 22 An example of an implementation of a box and a pump station is shown, illustrating certain components of the box (e.g., valves, electrical connections) and corresponding components of the pump station (e.g., motors, electrical connections).

[0072] Figure 23 A process for a pre-filled fluid communication system is shown, which includes a pre-filled box, a pipe assembly, and a hub, as well as a fluid communication channel in a conduit coupled to the hub.

[0073] Figure 24A A process for prefilling a portion of a fluid communication system is shown, which includes prefilling a brine box, a pipe / pipe assembly, a hub, and a fluid communication channel in a conduit coupled to the hub.

[0074] Figure 24BThe process for a portion of a pre-filled fluid communication system is shown, which includes pre-filling a contrast agent cartridge and fluid communication channels in a tubing assembly.

[0075] Figure 25 An example of a brine subsystem 706 in a dry configuration is shown, wherein the brine bag 751 is not yet coupled to the brine subsystem 706.

[0076] Figure 26 An example of the configuration of the brine subsystem after the brine bag has been coupled to the brine subsystem is shown.

[0077] Figure 27 Examples of hubs are shown according to some implementation schemes.

[0078] Figure 28 The configuration shown is such that after the fluid communication system has been configured with a discharge path for brine, the controller actuates a peristaltic pump to prefill the channels of the brine subsystem in the cartridge with brine.

[0079] Figure 29 An example of the contrast agent subsystem configured before the contrast agent container is coupled to the contrast agent subsystem is shown.

[0080] Figure 30 It shows in Figure 29 The contrast agent subsystem now coupled to the contrast agent container is shown.

[0081] Figure 31 An example of a contrast agent pump is shown, which is actuated to fill a portion of a chamber in a contrast agent pump with contrast agent.

[0082] Figure 32 An example of a contrast agent pump is shown, which is actuated to expel contrast agent and air from the contrast agent chamber.

[0083] Figure 33 An example of a contrast agent pump actuated to draw contrast agent into a contrast agent chamber is shown.

[0084] Figure 34 An example of a contrast agent pump is shown, which is actuated to begin the fluid communication channel of the contrast agent subsystem in the prefill cartridge.

[0085] Figure 35 and Figure 36 Another part of the pre-filling process is shown, in which multiple peristaltic pumps of the brine subsystem are actuated to pre-fill the brine communication channel between the pre-fill box and the hub.

[0086] Figure 37 An actuated saline / contrast agent connection valve is shown to connect the saline subsystem to the contrast agent subsystem to prefill the fluid communication channels in the contrast agent subsystem with saline.

[0087] Figure 38 An example configuration for pre-filling a fluid communication channel that supplies contrast agent to the hub is shown.

[0088] Figure 39 A pre-filled fluid communication channel is shown, which supplies contrast agent from the contrast agent system to the catheter using saline.

[0089] Figure 40 An example configuration for pre-filling a fluid communication channel is shown, which supplies contrast agent to a catheter from a contrast agent subsystem.

[0090] Figure 41 An example of a configuration for a pre-filled fluid communication channel is further shown, which provides contrast agent from a contrast agent system to a catheter.

[0091] Figure 42 and Figure 43 The configuration for prefilling the hub with brine and coupling the conduit to the hub is shown.

[0092] Figure 44 Examples of state diagrams for robotic conduit systems are shown according to some implementation schemes, illustrating different operational states in which the controller can operate the fluid system after setup is complete.

[0093] Figure 45 Examples of hub configurations for a fluid system in a state of brine droplets are shown according to some implementation schemes.

[0094] Figure 46 An example of a contrast agent injection procedure that can be performed when the fluid system is in the contrast agent injection state is shown.

[0095] Figure 47 The procedure for determining whether injecting contrast agents is safe for the system is illustrated.

[0096] Figure 48 An example of a contrast agent subsystem configuration is shown, in which an insertion catheter coupled to a seat has been selected for contrast agent injection.

[0097] Figure 49 An example of the configuration of the seat corresponding to the selected catheter when the contrast agent is injected is shown.

[0098] Figure 50 An example of the configuration of the seat of the selected catheter for saline injection is shown.

[0099] Figure 51 An example of the suction process that the robotic catheter system can perform when it is in the suction state is shown.

[0100] Figure 52 An example of the hub configuration during the suction state is shown, wherein the tip of the conduit is positioned adjacent to the clotting mass, and a three-way valve is positioned to connect the hub fluid passage line to the vacuum line of the fluid communication system.

[0101] Figure 53 It shows Figure 52 An alternative implementation scheme shown in this embodiment, wherein the clotting chamber is positioned as... Figure 52 The configuration shown (e.g., the clot chamber is located in a box or part of a piping assembly) is closer to the vacuum tank.

[0102] Figure 54 The configuration of the hub and vacuum system during clot suction is shown.

[0103] Figure 55 Another configuration of the hub and vacuum system is shown during clod suction.

[0104] Figure 56 The configuration of the hub and vacuum system during clot suction is shown.

[0105] Figure 57 The configuration of the hub and vacuum system during clot suction is shown.

[0106] Figure 58 An example of a procedure for returning blood to a catheter, which can be performed by a robotic catheter system, is shown.

[0107] Figure 59 An example of a hub in a configuration where a brine flushing chamber is used is shown.

[0108] Figure 60 An example with a vacuum pump actuation is shown, and the fluid communication channel is aligned to connect the lumen of the conduit to a low vacuum provided by the vacuum subsystem.

[0109] Figure 61 The illustration shows a configuration of a portion of an implementation of a fluid system with a flow sensor (e.g., an ultrasonic flow sensor) positioned to detect the flow rate of a substance discharged into a vacuum tank within the box along a line in the box.

[0110] Figure 62 An example configuration of the hub and vacuum subsystem is shown, in which the vacuum supplied to the hub has been shut off, for example, in preparation for blood return to the catheter via a hemostatic valve.

[0111] Figure 63 The configuration of the hub for backflowing the catheter from the hemostatic valve is further shown.

[0112] Figure 64This is a schematic diagram illustrating an example of a robotic conduit system that includes another embodiment of a fluid system.

[0113] Figure 65 This is a schematic diagram illustrating an example of a fluid assembly (e.g., a disposable or recyclable fluid assembly) including a housing coupled to a pump station and to a saline source, a contrast agent source, and a vacuum source. The fluid assembly also includes multiple fluid communication channels to supply saline, contrast agent, and vacuum to a seat and a catheter coupled to the seat.

[0114] Figure 66 This is a schematic diagram illustrating an example of a fluid assembly, which includes a housing, a distributor and one or more seats, a first conduit assembly coupled to the housing and the distributor, and a second conduit assembly coupled between the distributor and one or more seats. The first conduit assembly has channels for supplying saline, contrast agent and vacuum to the distributor, and the second conduit assembly has multiple sets of channels (or sub-channels) for supplying saline, contrast agent and vacuum to each of the one or more seats. The first and second conduit assemblies and the distributor also provide electrical connections between the housing and one or more seats.

[0115] Figure 67 This is a schematic diagram illustrating an example of a box for a fluid assembly, the box including a housing that can support all or part of a saline subsystem, a contrast agent subsystem, and a vacuum subsystem.

[0116] Figure 68A This is a schematic diagram showing an example of a drip chamber and a clump chamber assembly.

[0117] Figure 68B This is a schematic diagram showing another example of the drip chamber and clot chamber assembly.

[0118] Figure 69 This is a schematic diagram illustrating an example of a fluid system assembly in one or more seats that can be coupled to a second piping group. This particular example includes three seats, each having fluid connections for saline, contrast agents, and vacuum, and electrical connections including one or more electrical leads coupled to one or more sensors in the seat to communicate signals from the one or more sensors to the cartridge, and ultimately to the station (e.g., a pumping station) when the cartridge is coupled to it.

[0119] Figures 70A to 70C This is a schematic diagram illustrating another example of a contrast agent subsystem that can be contained in a box.

[0120] Figures 70D to 70E This is a schematic diagram illustrating another example of a contrast agent subsystem that can be contained in a box.

[0121] Figure 71 It is shown Figure 69The schematic diagram shows an example configuration of a fluid system component, in which two three-way valves are configured in "saline drip mode" to provide saline drips to a connector coupled to a conduit for providing a saline flow path to a lumen coupled to the conduit.

[0122] Figure 72 It is shown Figure 69 The schematic diagram illustrates an example configuration of a fluid system component, wherein two three-way valves are configured in "saline drip or contrast agent mode" to provide saline drip or contrast agent to a connector coupled to a catheter for providing a saline flow path and / or a contrast agent flow path to the lumen coupled to the catheter.

[0123] Figure 73 It is shown Figure 69 The schematic diagram shows an example configuration of a fluid system component, in which two three-way valves are configured in "aspiration or return mode" to provide atmospheric pressure or vacuum to a connector coupled to a catheter for aspiration or return to the lumen of the catheter.

[0124] Figure 74 It is shown Figure 69 The schematic diagram shows an example configuration of the fluid system components, in which two three-way valves are configured in "brine flushing mode" to provide a brine flow path with a relatively high brine flow rate (i.e., higher than the brine flow path when in "brine dripping mode") to the lumen coupled to the conduit for flushing the fluid passage and / or conduit with brine.

[0125] Figure 75 It is shown Figure 69 The schematic diagram illustrates an example configuration of a fluid system component, wherein two three-way valves are configured in "saline drip or contrast agent mode" to provide a saline drip or contrast agent flow to a connector coupled to a catheter for providing saline and / or coupled to the lumen of the catheter.

[0126] Figure 76 It is shown Figure 69 The schematic diagram shows an example configuration of the fluid system components, in which two three-way valves are configured in a "pre-filled brine mode" to align the brine flow path with a relatively large volume of brine flow (e.g., a volume higher than the brine flow from the brine restrictor channel) to pre-fill the seat with brine.

[0127] Figure 77 It is shown Figure 69 The diagram shows an example configuration of the fluid system components, in which two three-way valves are configured in "contrast prefill mode" to align the contrast flow path for use with the contrast prefill seat.

[0128] Figure 78This is a flowchart illustrating the process of monitoring brine flow and switching from a first brine source to a second brine source using a fluid system.

[0129] Figure 79A This is a schematic diagram illustrating an example of a fluid system configuration for monitoring brine flow and switching from a first brine source to a second brine source.

[0130] Figure 79B This is a schematic diagram illustrating an example of a process for monitoring brine flow based on signals from a weight sensor and switching from a first brine source to a second brine source, and references... Figure 67 The implementation scheme of the box shown is described.

[0131] Figure 80 This is a flowchart illustrating a process for injecting contrast agent into a selected catheter in a robotic catheter system having multiple catheters coupled to movable seats, each of which is supplied with fluid saline, contrast agent, and vacuum by the fluid system.

[0132] Figures 81 to 86 The configuration of the fluid system during the blood return process is shown. Figure 81 An example configuration of a fluid system is shown, in which brine is supplied to a conduit, for example, before the clot is taken up.

[0133] Figure 82 An example configuration of a fluid system is shown, in which a “high” vacuum is provided to the conduit (e.g., when the distal end of the conduit is positioned near the clot), such that the clot can be taken up by the vacuum subsystem and captured in the clot chamber.

[0134] Figure 83 An example configuration of a fluid system is shown, in which a “high” vacuum is provided to the catheter, and blood flow is shown through the catheter toward the clot chamber assembly, where air bubbles are formed in the aspirated blood due to the applied high vacuum.

[0135] Figure 84 An example configuration of the fluid system is shown, in which a “high” vacuum is provided to the conduit, and the clump has been brought back through the conduit, seat, and vacuum line and captured in the clump chamber of the clump chamber assembly.

[0136] Figure 85 An example configuration of the fluid system is shown, in which a “high” vacuum is provided to the conduit, and the clot has been aspirated and captured in the clot chamber, and the system is configured to perform brine flushing of the vacuum communication channel between the clot chamber and the seat and the clot chamber.

[0137] Figure 86An example configuration of the fluid system during blood return is shown, wherein a “low” vacuum is provided to the catheter and a vacuum flow path is created from the catheter to the clot chamber to remove fluid containing air bubbles from the catheter and hub without reducing the solubility of the blood to the point where (additionally) the dissolved air escapes from the blood or saline in the catheter, hub, and / or seat.

[0138] Figure 87 An example configuration of the fluid system is shown during a catheter patency check. Detailed Implementation

[0139] The above description is merely a summary and therefore requires detailed explanation. The foregoing and other aspects, features, and advantages of this technology will now be described in conjunction with various embodiments. The inclusion of the following embodiments is not intended to limit this disclosure to these embodiments, but rather to enable any person skilled in the art to make and use the contemplated invention. Other embodiments may be utilized, and modifications may be made without departing from the spirit or scope of the subject matter presented herein. The aspects of this disclosure as described and illustrated herein can be arranged, combined, modified, and designed in a variety of different concepts, all of which are clearly contemplated and form part of this disclosure.

[0140] Without the aid of a fluid management system, accurately and predictably injecting fluids into the blood vessels of a living human body can be challenging. This required precision in fluid administration, combined with the risks of delivering improperly sized volumes of fluid or fluids containing air bubbles, has led the medical industry to train physicians with a tactile sense of fluid administration, along with visual volume and air bubble assessment. For example, when learning to inject fluid into the brain, physicians are trained to press the syringe with specific coordinated pressure, and to manually prepare and check the volume and air bubbles of the fluid when injecting and / or removing it during specific surgical procedures.

[0141] Air embolism poses a significant and even fatal risk to patients during catheter insertion procedures. Air can be introduced during fluid infusion, catheter switching or manipulation, or any other event that creates a pressure gradient that allows air to flow into the catheter and subsequently into the blood vessel. Reducing the number of disconnections and creations in the system during catheter insertion procedures can decrease the likelihood of air embolism. The fluid management system and methods described herein are configured to reduce the likelihood of air embolism during catheter insertion procedures.

[0142] Furthermore, in cases of ischemic stroke or other occlusive or thrombotic conditions, even a one-minute delay in treatment can lead to a decrease in patient recovery rates. During catheter insertion procedures, for example, using a fluid management system to reduce manual switching between fluid administration and removal (e.g., aspiration) of the catheter, and to reduce the time required for fluid preparation, can improve patient survival and recovery rates after a stroke event. In some embodiments, reducing manual switching between fluid administration and catheter removal by using the fluid management system described herein can provide the advantage of reduced workload for the operator. In some embodiments, reducing manual switching between fluid administration and catheter removal by using the fluid management system described herein can provide the advantage of being able to perform remotely controlled procedures in a simplified manner (where the interventional physician is not in the vicinity of the fluid management system and / or the catheter), because when using the fluid management system, changes in connectivity may not be part of the procedure. In some embodiments, reducing manual switching between fluid administration and catheter removal by using the fluid management system described herein provides the advantage of improved safety and reliability (e.g., continuity of surgical procedures). Furthermore, the risk of air embolism is reduced by using a continuous fluid management system.

[0143] This document discloses systems and methods for managing fluid administration and removal during medical procedures. The fluid systems described herein can be used with robotic catheter systems. The fluid systems can also be used with other devices and methods. The fluid systems can be coupled to robotically driven interventional devices, manually driven interventional devices, or any combination thereof. In particular, the systems and methods can be configured to control fluid delivery devices to ensure the delivery of appropriate diagnosis and / or treatment.

[0144] The systems and methods described herein may include programmable and / or automated fluid injection and removal systems that can assist physicians (e.g., surgeons, interventional physicians, etc.) in performing procedures involving fluids. For example, apparatus, systems, and methods for operating the fluid management systems described herein can automate fluid injection using programmable pumps, vacuum devices, catheter hubs, etc., to allow for coherent, precise, and timely injections. In some embodiments, the fluid lines are not exchanged or disconnected during surgery, but instead are configured once before surgery and kept intact throughout the procedure to avoid errors at connection points (e.g., valve errors), errors in fluid selection, and / or problems caused by air bubble introduction due to air introduced when switching between fluids.

[0145] In operation, the fluid management system described herein may include multiple fluid systems, each for a different fluid source and / or fluid collection container. The multiple fluid systems may be configured to flow from the same fluid management system and couple to an interventional device or medical instrument. For example, each fluid system may be configured to connect to a respective catheter hub (manual catheter hub or robot-driven hub) associated with the fluid management system. Each catheter hub (“hub”) may be connected to at least one interventional device, such as a catheter. Control interfaces for hubs or removal from hubs may include controls for controlling fluid administration steps and / or catheter manipulation steps.

[0146] In some implementations, the apparatus, systems, and methods described herein can be configured to provide the advantage of reduced time and pneumatic effort for degassing fluid systems. For example, keeping fluid lines and fluid conduit connections fully filled during surgery (i.e., avoiding switching of fluid components) ensures that degassing procedures for each fluid are performed in a single procedure prior to surgery. The methods described herein may include configuration methods, degassing methods, processing methods, fluid injection and / or fluid removal methods, etc.

[0147] 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 surgical procedure. For example, because additional catheters, fluid lines, hubs, and / or other fluid-connecting components are configured to be connected to and remain connected to the system prior to surgery, these components can be packaged together, or at least multiple packages can be opened and the components assembled at once prior to surgery, and additional packages or components may not need to be opened or installed during surgery. For example, in some embodiments, one or more catheters, hubs, and fluid lines can be provided in a single sterile package. In some embodiments, one or more catheters, hubs, and fluid lines can be provided in a single sterile package with a shunt and / or a cassette. In other embodiments, any of the components described above can be packaged in a separate sterile package.

[0148] In some implementations, the apparatus, systems, and methods described herein can be configured to reduce the time and / or steps required for flushing fluid lines, as such steps can be automated and performed automatically when requested by the fluid management system.

[0149] In some implementations, the apparatus, systems, and methods described herein can be configured to display fluid management steps on a user interface to simplify the configuration of the fluid system. For example, a particular user interface can be configured for a specific surgical procedure. Each user interface can present instructions, information, or other data to the surgical personnel as the fluid management system automatically executes the next step of the procedure related to fluid management.

[0150] Systems and devices

[0151] Figure 1A An embodiment of a single channel of a multi-channel fluid management system 10 is shown. The fluid management system 10 can be configured as an automated system to manage the delivery of fluid to or aspiration of material from a patient via one or more interventional devices such as catheters. As shown, the system 10 can manage the fluid delivered to a patient during a medical procedure. The fluid management system 10 includes at least one fluid source and / or channel 12 coupled to a valve 14, which is coupled to a manifold 16. The manifold 16 is remote (e.g., on a support table or cabinet outside a sterile area) or coupled to a catheter hub 18, which is coupled to at least one source and / or channel line 17. The source and / or channel line 17 is coupled to at least one catheter 19 via the hub.

[0152] Some embodiments of the hub assembly described herein, such as hub assembly (“hub”) 18, include a housing for coupling an interventional device thereto, components (e.g., rollers) for direct coupling to and movement along a drive stage, and a magnet for magnetic coupling to a hub connector across a sterile barrier. A hub (or hub assembly) may refer to a single assembly having a housing, or a hub (or hub assembly) may generally refer to a device having two (or more) sub-assemblies (e.g., a first sub-assembly and a second sub-assembly). In some embodiments of a hub assembly having two sub-assemblies, the hub may refer to a first sub-assembly configured to couple to and receive an interventional device, and the first sub-assembly may be removably attached to a second sub-assembly (or seat) configured to magnetically couple to a hub connector across a sterile barrier and move along a drive stage. Such a hub and seat may together form a hub assembly. Such a hub assembly allows the hub (first sub-assembly) to be removed from the seat (second sub-assembly), which is advantageous, for example, allowing different hubs to be coupled to the same seat, or allowing the hub to be used separately from the seat (e.g., for manual surgery). Reference Figures 64 to 87 Some components of an advantageous example configuration of the seat are shown and described. An arrangement of a hub assembly having a hub releasably coupled to the seat allows for hub replacement with different hubs having different interventional devices coupled thereto, without disrupting the magnetic connection with the hub connector. For example, such an arrangement allows a hub coupled to an access catheter to be removed from the seat, and a hub coupled to a surgical catheter to be replaced, without disrupting the magnetic connection between the active and passive magnetic sides of the coupling between the hub connector and the hub assembly (e.g., between the hub connector and the seat). In some embodiments, the seat may be a magnetically driven member, an axially driven member, a small puck, a slider, a shuttle, or a stage. The fluid systems described herein can relate to various embodiments of systems including hubs or hubs and seats, whether described with reference to hubs or hubs and seats, unless explicitly indicated or indicated by the context.

[0153] The fluid management system 10 can supply multiple fluids (e.g., saline, contrast agent) and vacuum to one or more hubs. An elongated device can be attached to each of the one or more hubs for use in medical procedures. For example, a catheter can be coupled to each of the one or more hubs that receive fluid and vacuum from the fluid management system 10, and a guidewire can be coupled to a hub that does not receive fluid or vacuum. The one or more hubs can be controlled by a controller of the robotic catheter system to move along a drive platform to correspondingly move the attached elongated device toward or into the patient, or move the attached elongated device away from or out of the patient. In some preferred embodiments, during use in medical procedures, the one or more hubs move in a longitudinal direction (e.g., along a linear or straight tubing diameter).

[0154] As indicated above, in some embodiments, the hub is a two-part hub. The two hubs may include a first part (hub or first subassembly) and a second part (seat or second subassembly). An elongated device (e.g., catheter, guidewire, etc.) may be coupled to the hub. In use, the hub may and typically is mechanically coupled to the hub assembly. In some preferred embodiments, the first and second subassemblies may be decoupled if necessary during the medical procedure. In embodiments where the hub includes both first and second subassemblies, different components may be included in each of the first and second subassemblies. In some embodiments, the first subassembly may include a hemostatic valve, which may be controlled by a controller of the robotic catheter system to open or close during the medical procedure. For example, the hemostatic valve may be controlled to close during the injection of contrast agent using the first catheter to control the flow of contrast agent through the catheter lumen to the distal tip of the first catheter and to prevent the injected contrast agent from flowing in the opposite direction along the surface of another elongated device at least partially positioned in the lumen of the first catheter. The first subassembly may include a rotation mechanism for rotating the elongated device coupled to the first subassembly. When the first subassembly is coupled to the second subassembly, the rotation mechanism can be driven by an actuator in the second assembly coupled to the rotation mechanism. In various embodiments, the second subassembly may include fluid components (e.g., air sensor, fluid connector, air bubble filter, pressure sensor, control valve, channel, brine flow restriction channel, etc.) for supplying fluid and vacuum to a conduit attached to the first subassembly. Figure 18 An example of two hubs is shown, wherein the two hubs 724 include a first part (hub or first subassembly) 727 and a second part (seat or second subassembly) 725. Figure 69Another example of a two-component hub is shown, illustrating an implementation of a system comprising three second sub-assemblies (seats) 1400a-c that supply fluid and vacuum to connectors 1434a-c, which can be connected to a first sub-assembly (not shown) coupled to conduit 1402a-c to supply saline, contrast agent, and vacuum to the conduit 1402a-c. Whether the hub comprises a “single” hub assembly or includes both a first and a second sub-assembly, all or almost all fluid operations are identical when the first and second sub-assemblies are coupled together. For ease of reference, both hubs may be simply referred to herein as a hub. In some cases, for a hub having both a first and a second sub-assembly, the first sub-assembly may be referred to herein as a “hub” and the second sub-assembly as a “seat” to distinguish the two sub-assemblies.

[0155] In some embodiments, the fluid source and / or tank 12 includes a fluid volume storage device and means for propelling such fluid to another component of system 10 or for recovering fluid back to the source. Example propulsion means may include one or more propellers, impellers, and / or pumps to circulate and / or recover fluid throughout system 10. In some embodiments, the propulsion means may be used to control volume, flow rate, and / or pressure. In some embodiments, the propulsion means may be activated to propel fluid to another component of the system or recover fluid from the system, or deactivated to stop the movement of the fluid.

[0156] In some implementations, the fluid management channels are substantially repeatable for each catheter configured for a particular medical procedure. The different channels may vary in the sensors, pumps, and / or valves employed based on the interventional device connected to each fluid channel. For example, a fluid system for a surgical catheter (e.g., for aspiration) may include an in-line vacuum pump and filter. Further, for example, a fluid system for guiding, entering, or inserting a catheter may include an in-line drip rate sensor, an air bubble sensor, a pressure sensor, and / or an air bubble filter.

[0157] Source and / or tank 12 refers to a fluid source or fluid tank (e.g., a waste container). For example, a fluid source may include a container adapted to contain fluids (e.g., saline, contrast agents, drugs, blood, plasma, or other fluids) used with the fluid management system 10. The container may be configured to release fluid into a fluid delivery line (e.g., a fluid delivery tube) using active means (e.g., a pump, vacuum, etc.) or passive means (e.g., gravity). A fluid tank may include a container adapted to receive fluids (e.g., aspirates, thrombi, particles, saline, contrast agents, drugs, blood, or other fluids, or combinations thereof) from a patient and / or from other fluid infrastructure within the fluid management system 10.

[0158] Valve 14 represents one or more valves coupled to a source and / or channel 12 on a first side of valve 14 and coupled to manifold 16 on a second side of valve 14. Manifold 16 is configured to connect each valve 14 to a specific hub 18. In some embodiments, valve 14 may alternatively be directly coupled to hub 18 to avoid using a different manifold 16. In some embodiments, manifold 16 may be integrated into the hub. In some embodiments, a second valve 14 may connect manifold 16 to hub 18. For example, a second valve 14 may be coupled to manifold 16 on a first side and to hub 18 on a second side.

[0159] Hub 18 is configured to be releasably or non-releasably coupled to an interventional device (i.e., a catheter, guidewire, or other medical device). For example, catheter 19 has a proximal end attached to hub 18. In some embodiments, hub 18 is movable along a path along the surface of a robotic drive stage to push or retract catheter 19 (or other medical and / or interventional device). Each hub 18 may also contain a mechanism for rotating or deflecting catheter 19 or guidewire as needed. Hub 18 may be connected to a fluid delivery line (e.g., source / slot line 17) to provide fluid release or fluid capture. Each hub 18 may be in electrical communication with an electronic control system via hardwired connection, RF wireless connection, or a combination of both. Further details of the hubs, drive stage, and associated systems can be found in U.S. Patent Application Serial No. 17 / 816,669, filed August 1, 2022, entitled "Method of Supra-Aortic Access for a Neurovascular Procedure," which is expressly incorporated herein by reference in its entirety.

[0160] Any of the hubs disclosed herein may further include one or more fluid injection ports and / or wireless RF transceivers for communication and / or power transmission. In some embodiments, hub 18 may also include wired communication ports and power ports.

[0161] In some embodiments, hub 18 or conduit 17 leading to hub 18 may include a visual indicator for indicating the presence of aspirated clots. The visual indicator may include a clot chamber with a transparent window. A filter may be provided in the clot chamber. Further details of the clot-catching filter and related features can be found in U.S. Provisional Patent Application Serial No. 63 / 256743, filed October 18, 2021, entitled Device for Clot Retrieval, which is expressly incorporated herein by reference in its entirety.

[0162] Any of the hubs or interventional devices disclosed herein may further include sensors for detecting target parameters, such as the position or orientation of the distal tip of the interventional device, or the state of the distal tip. The state of the distal tip may include, but is not limited to: detecting the interaction between the vessel wall and the distal tip, detecting the interaction between the vessel wall and a clot, or detecting a patent distal tip. In some cases, the sensor may be positioned on a flexible body of the interventional device. The sensor may include a pressure sensor to capture arterial blood pressure waveforms at the distal end of the catheter, or an optical sensor to identify captured clots or air bubbles. In some embodiments, the sensor may 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 sensor may include a fiber Bragg grating sensor. For example, a fiber Bragg grating sensor (e.g., an optical fiber) can locally detect strain, which helps to detect and / or determine the applied force.

[0163] Figure 1BA schematic diagram of a multi-channel fluid management system 10 with a first source 12a, a second source 12b, and a channel 12c is shown. The first source 12a is coupled to valve 14a. The second source 12b is coupled to valve 14b. The channel 12c is coupled to valve 14c. Valves 14a, 14b, and 14c (hereinafter referred to as "valve 14a-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 or directly connected to the hub 18. In other embodiments, the valve manifold 16 is located away 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 or directly connected to a hemostatic valve. In other embodiments, the valve manifold 16 is located away from the hemostatic valve and is connected to the hemostatic valve via one or more fluid lines. Valves 14a-14c can be opened and closed to selectively connect the first fluid source 12a, the second fluid source 12b, and the channel 12c to the lumen of conduit 19. For example, valve manifold 16 may include fluid ports (e.g., a first port 15a associated with valve 14a, a second fluid port 15b associated with valve 14b, and a third port 15c associated with valve 14c) that can be selectively connected to or blocked from the lumen of conduit 19. For example, in some embodiments, one of the first, second, and third ports may be connected to the lumen of conduit 19, while the other two ports are blocked from communication with conduit 19.

[0164] In some embodiments, the first source 12a may be a source of heparinized saline. Source 12b may be a source of contrast agent solution. In some embodiments, one or more of sources 12a, 12b, and 12c may be coupled to a plurality of manifolds 16, each manifold being coupled to a unique interventional device 18. The valve manifold 16 as shown herein can be used in any system described herein.

[0165] Figure 2 A schematic diagram of a three-channel fluid system 100 for use with a fluid management system 10 is shown, the three-channel fluid system 100 comprising a stack of four concentric interventional devices. The fluid system 100 shown herein includes a fluid management unit 102 and an interventional unit 104. In some embodiments, the interventional unit 104 may include a stack of concentric catheters and guidewires configured for manual operation by a physician. In some embodiments, the interventional unit 104 may include a stack of concentric catheters and guidewires configured for operation by a robot-driven system. In some embodiments, the interventional unit 104 includes a combination of robot-driven medical devices and manually operated medical devices.

[0166] The components of the fluid management unit 102 may be located outside or inside the sterile area. In some embodiments, the fluid management unit 102 is located outside the sterile area but is coupled to the intervention unit 104 located inside the sterile area via flexible conduits and flexible electrical conductors.

[0167] Fluid management unit 102 may include at least two or three or more Figure 1A The channels shown are of the type shown (e.g., parallel channels), each channel being used for a different fluid source or fluid tank. In the illustrated embodiment, the fluid management unit 102 includes three channels, each channel communicating with a respective conduit of the three conduits via a corresponding conduit hub. Two channels are used to deliver two different fluids to the respective conduits, with the pressure, volume, and delivery rate of each conduit controllable. The third channel provides suction from the respective conduits to the tank.

[0168] Each of two or more fluid channels can be pre-filled by complete degassing and filling with the corresponding fluid to prepare it for transport into catheters and body cavities. In some embodiments, fluid lines, catheters, and / or catheter lumens can be simultaneously flushed and pre-filled with fluid (e.g., saline).

[0169] In some embodiments, fluid systems 100, 200 may be configured to backfill the respective groove connections of the respective catheters with fluid (e.g., saline) at the start of the procedure and / or between fluid steps. This can provide a backfilled column of saline downstream of the groove connection, for example, to ensure that contrast agent injection flows to the distal tip of a particular catheter, rather than through the groove. In some embodiments, fluid systems 100, 200 may be configured to provide a backfilled column of saline upstream of the saline valve at the hub, for example, to ensure that contrast agent injection flows to the distal tip or groove of a particular catheter, rather than through the saline valve.

[0170] like Figure 2 As shown, the fluid management unit 102 of the fluid system 100 includes a first source 110a, a second source 110b, and a tank 112. The first source 110a and the second source 110b can each be configured to hold and dispense at least one fluid (e.g., saline, contrast agent, drug, blood, or other fluids, or combinations thereof). The tank 112 can be configured to receive waste fluid and / or waste products from selected aspiration lines leading to corresponding catheters. Although two fluid sources and one fluid tank are shown, any number of fluid sources and / or fluid tanks corresponding to the fluid delivery and / or aspiration requirements of a particular procedure are possible (e.g., one fluid source and one fluid tank, two fluid sources without a fluid tank, more than two fluid sources, etc.).

[0171] Multiple valves (and / or valve arrays) are provided to stop and start the flow of each corresponding fluid to or through one or more fluid lines and / or hubs within the fluid management section 102 and / or intervention section 104. In the illustrated embodiment, a first valve array 116a (e.g., having three valves) is carried by a first manifold 118a, a second valve array 116b (e.g., having three valves) is carried by a second manifold 118b, and a third valve array 116c (e.g., having three valves) is carried by a third manifold 118c. Although 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 sub-kit of interventional devices used in the procedure. For example, in some cases, each valve array may include at least one valve, two valves, three valves, or four or more valves.

[0172] In some embodiments, each valve in the valve array (e.g., the first valve array 116a) can be configured to independently control and / or regulate the fluid resistance, flow rate, and / or pressure of the fluid flowing through the valve and the corresponding conduit. In some embodiments, each valve in the valve array can regulate independently and / or simultaneously for a corresponding conduit and / or for more than one conduit.

[0173] In the illustrated embodiment, the fluid passage is repeated for each conduit, and therefore will be described below only in conjunction with the first source 110a. A first outlet valve 117a is connected to the first conduit 126 via a single first fluid source line 120a. A second outlet valve 117b is connected to the second conduit 128 via a single second fluid source line 120b. A third outlet valve 117c is connected to the third conduit 130 via a single third fluid source line 120c. Fluid source lines 120a, 120b, and 120c are hereinafter referred to as "fluid source lines 120a-120c". Each of the outlet valves 117a, 117b, and 117c (hereinafter referred to as "outlet valves 117a-117c") is electronically actuated in response to a signal from the control system, preferably between a fully closed, fully open, or partially open position. Any of a variety of valve mechanisms can be used, such as ball valves, solenoids, plug valves (e.g., rotary plug valves), rotary valves, or other actuation mechanisms known in the art, driven by a stepper motor. The actuation mechanism can provide automatic control and sequencing of the valves. For example, a stepper motor with built-in coding can be used to actuate the valves to provide consistent switching and sequencing. The actuation mechanism can be controlled using a motor controller with a user control interface (e.g., or a computer system). The control system may include a module that reads values ​​from sensors (e.g., flow rate, bubbles, pressure, etc.) and displays said values ​​to control the behavior of the fluid system.

[0174] In some implementations, a stopcock valve mechanism (e.g., a rotary stopcock valve) can be used in the manifold described herein. For example, one or more stopcock valves can be placed near the hub (or integrated into the hub) to avoid managing the fluid column in a particular pipeline. Such pipeline can be disposable sterile pipeline that can be used once. Placing the manifold with the stopcock valve near the hub or integrating it into the hub has the advantage of simplicity, eliminating the need to manage the fluid column in the pipeline. Keeping the manifold and stopcock valve away from the hub allows the manifold and stopcock valve to be used with non-sterile equipment outside the sterile area. Such a configuration can provide the advantage of maintaining the sterility of the components within the sterile area.

[0175] In some embodiments, the fluid 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 control system, such as a processor of the control system. The control system (e.g., the processor) may be configured to increase the sealing strength of the hemostatic valve in response to operation of a contrast agent controller to introduce contrast agent into the catheter. The control system (e.g., the processor) may also be configured to decrease the sealing strength of the hemostatic valve in response to operation of the contrast agent controller to stop the introduction of contrast agent into the catheter. In some embodiments, the control system (e.g., the processor) may be configured to decrease the sealing strength of the hemostatic valve in response to a received signal indicating that the catheter or guidewire has passed through the hemostatic valve. For example, this feature can provide the advantage of reduced friction between the hemostatic valve and the moving catheter shaft.

[0176] In operation, all three outflow valves 117a-117c may be in the open configuration to allow brine flow through each of the three conduits. The forward flow of brine (in the direction of arrow 122a) can be driven by pump 114, such as an electronically controlled peristaltic infusion pump or a rotary piston pump. Alternatively, depending on the desired performance, any one valve can be opened while the other two are closed. Alternatively or additionally, other volumetric and / or pressure sources (e.g., pump 114) can be deactivated or disconnected to prevent flow.

[0177] exist Figure 2 In the concentric catheter stack shown, the first catheter 126 may be a "large-bore" inlet catheter having a diameter of at least about 0.075 or at least about 0.080 inches. The second catheter 128 may be a suction catheter having a diameter of about 0.060 to about 0.075 inches. The third catheter 130 may be a maneuverable catheter with a deflectable distal tip having a diameter of about 0.025 to about 0.050 inches. The guidewire 132 may have a diameter of about 0.014 to about 0.020 inches. In one example, the first catheter has a diameter of about 0.088 inches, the second catheter about 0.071 inches, the third catheter about 0.035 inches, and the guidewire about 0.018 inches.

[0178] 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 differ from the available 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 available lumen in the second catheter 128 may differ from the available lumen in 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 delivery infusion rate through each catheter, the control system may be configured to regulate each of the pumps 114 and / or the outflow valves 117a-117c to compensate for the difference in the effective cross-section of each respective flow path, thereby achieving the same delivery flow rate through each catheter. As used herein, “flow path” is a broad term that can refer to a path for connecting fluids through one or more channels, lines, conduits, lumens, and other structures (e.g., portions of valves, pumps communicating fluids) that may communicate blood, saline, contrast agents, vacuum, or other fluids and gases. "Flow path" can also refer to the structure itself (i.e., a portion of one or more channels, lines, pipes, lumens, valves, pumps communicating with fluids, and other structures communicating with fluids), and can be considered synonymous with and used interchangeably with "channel," unless based on context or as explicitly stated. In the example, the brine subsystem can be described as having a brine flow path that receives brine from a brine source and supplies brine to downstream brine communication channels and seats / hubs, a contrast agent subsystem (e.g., for pre-filling the contrast agent subsystem and downstream communication channels), and a vacuum subsystem (for a portion of the pre-filling brine subsystem), involving multiple branches of the brine flow path formed by channels, pipes, etc. In the example, the contrast agent subsystem can be described as having a contrast agent flow path that receives contrast agent from a contrast agent source and supplies contrast agent to downstream contrast agent communication channels and seats / hubs, as well as a vacuum subsystem (for starting the contrast agent subsystem), involving one or more branches of the contrast agent subsystem formed by channels, pipes, etc. In another example, the vacuum subsystem can be described as having a vacuum flow path having a vacuum from a vacuum source and providing a vacuum to the saline and contrast agent subsystem (for prefilling the saline and contrast agent subsystem) and providing a vacuum to the connecting channel and seat / hub, involving one or more branches of the vacuum subsystem formed by channels, pipes, etc.

[0179] In one embodiment of the invention, the conduit can be assembled before flushing the conduit to remove air by displacing it with a fluid such as saline. Figure 2The concentric stacking direction is shown. This is preferably achieved in each fluid lumen, such as, for example, the annular lumen between the first conduit 126 and the second conduit 128, and between each additional concentric interventional device in the stacking direction. Infusing saline under pressure can substantially displace all air, but some small air bubbles may remain or adhere to, for example, the inner wall of the first conduit 126, the outer wall of the second conduit 128, or both.

[0180] When saline solution is introduced under pressure into the proximal end of an annular lumen between two interventional devices (e.g., an annular lumen between first catheter 126 and second catheter 128), the inner catheter may move relative to the outer catheter (e.g., the second catheter 128 may move relative to the outer catheter) to disrupt the holding forces between microbubbles and adjacent walls, allowing the bubbles to be carried downstream and discharged through the distal opening of the lumen. The catheters may move axially, rotatably, or both axially and rotatably relative to each other. In one embodiment, the first catheter reciprocates relative to an adjacent catheter or guidewire, for example, at a reciprocating frequency of no more than about 5 cycles per second or two cycles per second or less, axially traversing a range of about 0.5 inches to about 10 inches or about 1 inch to about 5 inches.

[0181] When delivering pressurized brine, the reciprocating motion of adjacent catheters can be manually achieved to disrupt microbubbles by grasping the respective catheter hubs and manually moving the catheters axially or rotationally relative to each other. Alternatively, for example in a robot-driven system, the processor can be configured to robotally drive at least one hub of two adjacent catheters (e.g., at least one of the first catheter hub 124a and the second catheter hub 124b) to achieve relative movement between the adjacent catheters, thereby, for example, disrupting and expelling microbubbles in response to user activation of the flushing controller.

[0182] The second source 110b is in fluid communication with the second manifold 118b, allowing fluid to flow to any number of valves (e.g., three) within the second valve array 116b, as indicated by arrow 122b. Forward flow of the contrast agent (in the direction of arrow 122b) can be driven by a pump 136, such as an injection pump, a high-pressure positive displacement pump, a contrast agent injection pump, etc. Depending on the desired performance, any one valve in the second valve array 116b can be opened while the other two are closed. Alternatively or additionally, other volumetric and / or pressure sources (e.g., pump 136) can be deactivated or disconnected to prevent flow. The proximal opening of each fluid source line 121a, 121b, 121c can be coupled to a corresponding output port on the corresponding valve within the second valve array 116b. The distal opening of each fluid source line 121a, 121b, 121c (hereinafter referred to as "fluid source lines 121a-121c") can be coupled to each of the corresponding catheter hubs 124a, 124b, 124c (hereinafter referred to as "catheter hubs 124a-124c"), and thus coupled to the corresponding first catheter 126, second catheter 128, and / or third catheter 130. The corresponding first catheter 126, second catheter 128, third catheter 130, and / or guidewire 132 can be guided into a patient (not shown). Additional hubs and / or catheters can be added to the fluid system 100, and corresponding fluid management system components (e.g., system 10) can be added to the fluid system 100. In other embodiments, the fluid system 100 may include fewer hubs and / or catheters, such as two hubs and / or catheters.

[0183] Channel 112 is coupled to a third manifold 118c to receive fluid from aspiration lines 123a, 123b, 123c (hereinafter referred to as "aspiration lines 123a-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 corresponding catheters 126, 128, and 130 based on input from a physician to the control system. Once the physician determines which catheter(s) will be placed in aspiration mode and actuates the corresponding aspiration controller, in response to the control system activating aspiration pump 115, the corresponding valves within the third valve array 116c can be opened to allow fluid flow through the corresponding catheter and into channel 112. Depending on the desired performance, any one valve in the third valve array 116c can be opened while the other two are closed. Alternatively or additionally, other volumetric and / or pressure sources (e.g., aspiration pump 115) can be deactivated or disconnected to prevent flow.

[0184] In an example implementation, fluid system 100 represents an aspiration configuration where a first source 110a contains heparinized saline and a second source 110b contains a contrast agent solution. In this example, tank 112 may contain waste blood / saline / embolic material aspirated from a patient (not shown). Other additional sources and / or tanks may be used in combination with the corresponding fluids.

[0185] Similarly, the contrast agent solution contained in the second source 110b can flow in the direction of arrow 122b and can flow into the second manifold 118b. During a given procedure, at a given injection time, the physician can decide to inject the contrast agent through any of the three catheters, typically through the most distal catheter. In response to the instruction to inject the contrast agent, the control system will open the valve corresponding to the selected catheter, while the other two valves typically remain closed. In some embodiments, the physician can inject contrast agent into two or more catheters simultaneously. In some embodiments, for example, contrast agent or aspiration can be applied simultaneously while actuating a catheter or guidewire.

[0186] In some embodiments, each valve (or valve array) may be housed within or carried by a corresponding conduit hub 124a-124c. In some embodiments, each valve (or valve array) may be housed near or away from a corresponding hub. In such examples, additional fluid lines (e.g., fluid source lines 120a-120c, fluid source lines 121a-121c, and suction lines 123a-123c) may be added between each manifold and its corresponding valve. Fluid source lines 120a-120c, 121a-121c, and suction lines 123a-123c may be pipes. In some embodiments, any one of fluid source lines 120a-120c, 121a-121c, and suction lines 123a-123c may be detachably coupled to its respective hub. Alternatively, any of the fluid source lines 120a-120c, 121a-121c and suction lines 123a-123c may be inseparably connected to the hub and detachably coupled to other components of the fluid management unit 102, such as valve arrays 116a, 116b, 116c (hereinafter referred to as "valve arrays 116a-116c") or manifolds 118a, 118b, 118c (hereinafter referred to as "manifolds 118a-118c").

[0187] In some embodiments, such as those discussed below, the fluid system 100 may also include any number of pressure sensors, volume sensors, flow rate sensors, pipe assemblies, connectors, and bubble sensors / detectors. In the illustrated embodiment, pressure transducer 134a is in pressure sensing communication with first conduit 126 via first conduit hub 124a. As shown, additional pressure transducers 134b and 134c may be in communication with their respective conduits.

[0188] The control system can be configured to automatically adjust various manifold valves, pumps, and hemostatic valves (discussed below) in response to physician input instructions. For example, the physician may input an instruction to inject contrast agent through a third catheter 130. The control system can trigger a series of response events to occur automatically. At least the saline valve (e.g., the third outflow valve 117c) will close. Outflow valves 117a and 117b may close, or may remain open to provide positive pressure through the first and second catheters to prevent contrast agent backflow.

[0189] A control signal will be sent to the hemostatic valves in each of the first catheter hub 124a and the second catheter hub 124b to tighten from a low-pressure sliding fit around the second catheter 128 and the third catheter 130 to a high-pressure clamping fit. This will prevent contrast agent from escaping proximally through the first catheter 126 and the second catheter 128. A control signal will also be sent to valve 119c to establish fluid communication between the third catheter 130 and a second source 110b containing the contrast agent solution.

[0190] If the space between the OD of guidewire 132 and the ID of the third catheter 130 is insufficient to allow the desired contrast agent infusion rate, a further signal will be sent from the control system to the drive system controlling the guidewire hub 124d to retract the guidewire 132 proximally from the third catheter 130 a distance sufficient to allow contrast agent flow through the third catheter 130. Additional control signals may be sent to the hemostatic valve carried by the third catheter hub 124c to clamp around a portion of the distal end of the guidewire 132 in high-pressure mode, or to a fully closed configuration if the guidewire 132 is fully retracted. Further control signals may be sent to an electronically activated high-pressure pump 136, such as an infusion pump, a high-pressure positive displacement pump, a contrast agent infusion pump, etc., to deliver the contrast agent solution through the third catheter 130.

[0191] If a physician initiates a command to perform aspiration via, for example, the first catheter 126, the control system can automatically transmit another series of control signals to execute that command. Signals will be sent to each hemostatic valve to move it from a high-pressure configuration to a low-pressure configuration, in which friction on the axis of the catheter or guidewire is reduced. Such a configuration allows for relative movement of the various devices and retraction of the second catheter 128 and the third catheter 130 proximally from the first catheter 126, while still suppressing proximal blood loss through the hemostatic valves. Signals will be sent to the drive system to retract each of the catheter hubs 124a-124c and the guidewire hub 124d proximally. Check valve 113c will be opened to place the first catheter 126 in fluid communication with the groove 112. Signals will be sent to actuate the aspiration pump 115, thereby aspirating blood and thrombus into the groove 112. In some embodiments, when aspiration is performed using the first catheter 126, for example, communication between the first catheter 126 and the first source 110a and the second source 110b may be obstructed. For example, the corresponding valves of valve arrays 116a, 116b can be closed to block manifolds 118a, 118b. Alternatively, volume and / or pressure sources (e.g., pumps 114 and 136) can be deactivated or disconnected.

[0192] All fluid lines between the first source 110a and the second source 110b and each catheter, as well as all fluid lines between the groove 112 and each catheter, are preferably thoroughly flushed free of any air bubbles and filled with a fluid such as saline during preoperative system preparation. This allows for a seamless transition between catheter and guidewire infusion, aspiration, and manipulation without disconnecting and reconnecting any fluid lines between the sources, grooves, and catheters, eliminating the risk of introducing air embolism during such exchanges.

[0193] It may also be desirable to be able to confirm the absence of air bubbles in any fluid lines. This can be achieved by placing bubble sensors in the bubble-sensing proximal end of each fluid line, such as within or upstream of each hub, or at the manifold. This can be particularly desirable in telemedicine applications where the physician is at a remote workstation and not in the direct line of sight of the patient.

[0194] This can be achieved using a non-contact ultrasonic fluid sensor that measures the intensity and Doppler shift of reflected ultrasound waves passing through the sidewalls of a fluid conduit to detect bubbles and measure fluid velocity or level. The ultrasonic or optical sensor can be positioned near the inlet fluid path within the hub or in the supply line leading to the hub.

[0195] For example, to detect the presence of air bubbles in an infusion line (which is formed of an ultrasonic or optically transmissive material), a 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 the transmission of liquid through the pipe to detect the bubbles. Alternatively, since bubbles have relatively high echo-generating properties, reflected ultrasonic signals can be detected from the same side of the flow path as the source.

[0196] Alternatively, optical sensors can be provided to detect changes in optical transmission or reflection attributable to the presence of bubbles, or to transmit visual signals to a display at a remote workstation where a physician can visually observe the presence of bubbles moving through the tubing. In systems with bubble detectors, the control system can be configured to automatically cut off all fluid flow in response to bubble detection, giving personnel the opportunity to plan subsequent steps.

[0197] In one implementation, the bubble removal system is automatically activated when an air bubble is detected in the pipeline. The processor can be configured to activate a valve located downstream of the bubble detector in the flow path upon bubble detection. The valve diverts the fluid column containing the detected bubble from the flow path leading to the patient and instead directs it into a bypass flow path or reservoir. Once no more bubbles are detected in the flow path, and after the fluid volume 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 implementations, the flow path may include any number of bubble filters and / or traps to remove bubbles from the flow path.

[0198] Interventional unit 104 may include a drive stage configured to receive (e.g., coupled to) any number of hubs (e.g., a first catheter hub 124a, a second catheter hub 124b, a third catheter hub 124c, a guidewire hub 124d, etc.). Further details of the hubs, drive stage, and associated systems can be found in U.S. Patent Application No. 17 / 816,669 entitled Neurovascular Procedure, filed August 1, 2022, which is expressly incorporated herein by reference in its entirety. Each hub is configured to couple to a catheter or guidewire, one or more fluid lines, one or more wires, one or more controllers, and / or one or more displays. For example, the drive stage may be positioned above or beside the patient and is configured to support axial advance, retraction, and in some cases rotation and / or lateral deflection of two or three or more different (e.g., concentric or side-by-side oriented) devices (e.g., catheters, guidewires, etc.).

[0199] The drive system independently drives each hub to move independently across the surface of the stage in a proximal or distal direction to move the corresponding interventional device (e.g., first catheter 126, second catheter 128, third catheter 130 and / or guidewire 132) proximal or distally within the patient's vascular system.

[0200] As discussed elsewhere herein, in response to movement of the respective catheter hubs 124a-124c, the respective first catheter 126, second catheter 128, third catheter 130, and / or guidewire 132 can be guided into the body cavity (not shown) as a single concentric catheter stack. The fluid system 100 may also include a guidewire hub 124d for controlling the guidewire 132, which may also be introduced into the body cavity together with one or more of the first catheter 126, second catheter 128, and / or third catheter 130.

[0201] In some implementations, a driven magnet is provided on each hub. Each driven magnet is configured to cooperate with a drive magnet associated with the stage, such that the driven magnet moves in response to movement of the drive magnet. In such an example, the drive magnet may be axially movably supported by a support stage.

[0202] Because multiple sources and / or channels are configured to be coupled (and remain coupled) to each of the respective catheter hubs (e.g., first catheter hub 124a, second catheter hub 124b, and third catheter hub 124c), fluid system 100 offers the advantage of enabling faster procedures compared to conventional fluid systems that require manual removal, addition, and / or switching of fluids, catheters, hubs, etc., during surgery. For example, fluid system 100 allows each fluid line / catheter hub to be connected to its respective fluid source and / or channel before the start of the procedure. When the interventional physician (or other medical practitioner) performing the procedure is ready to use a specific fluid source or channel, fluid system 100 is already configured and ready to allow the use of said specific fluid source or channel without having to switch between different fluid lines for a particular catheter. In some embodiments, fluid system 100 can be used to deliver treatments in which it is not necessary to connect and / or disconnect fluid sources from the medical device more than once during the procedure.

[0203] Therefore, the interventional physician can inject any fluid contained in the fluid source (e.g., first source 110a, second source 110b), and / or collect aspirate from any of the catheters 126, 128 and / or 130 at any time during the procedure, since each catheter hub 124a-124c provides access to all fluid lines at all times.

[0204] Because multiple sources designated for a specific procedure are pre-configured to connect to individual catheters / catheter hubs, interventional physicians (or other medical practitioners) can ensure that there is no repeated connection and disconnection of syringes or other fluid source containers, fluid lines, etc., during the procedure. This assurance eliminates the possibility of introducing air bubbles into the catheter flow during the procedure, as the use of fluid system 100 does not require connecting or disconnecting fluid sources. Instead, each fluid source and reservoir is connected and tested before the procedure and is not removed until after the procedure. In some embodiments, the continuous connection of the fluid sources and reservoirs to the catheter hubs associated with the operation of fluid system 100 eliminates the variability and risk for interventional physicians in remote procedures in a control room rather than an operating room.

[0205] Valves within valve arrays 116a-116c of fluid system 100 are depicted at corresponding manifolds 118a-118c. In such a configuration, the valves are located close to the corresponding sources and / or channels, with approximately 2 to approximately 3 meters (e.g., approximately 6 to approximately 10 feet) of fluid line between the valves of valve arrays 116a-116c and the corresponding conduit hubs 124a-124c. In some embodiments, the valves of valve arrays 116a-116c may alternatively be located at a source / channel (e.g., a first source 110a, a second source 110b, and / or channel 112). In some embodiments, valve arrays 116a-116c are coupled to the fluid line at a location between the source / channel and the hub. In some embodiments, one or more of valve arrays 116a-116c may be located at conduit hubs 124a-124c. In some embodiments, the valves located at or near the hub may be single-use valves. Other components of fluid systems 100 and 200 may also be disposable and / or reprocessable for reuse.

[0206] In some embodiments, the fluid system 200 may additionally include check valves 113a, 113b, 113c, 113d, 113e, 113f, 113g, 113h, 113i (hereinafter referred to as "check valves 113a-113i") between valve arrays 116a-116c and corresponding conduit hubs 124a-124c. Check valves 113a, 113b, 113c may be valve manifolds (e.g., such as...). Figure 1B The valve manifold 16 is part of the hub 124a, or is directly or indirectly coupled to the first conduit hub 124a. Check valves 113d-113f may be part of the valve manifold (e.g., such as...). Figure 1B The valve manifold 16 is part of, or is directly or indirectly coupled to, the first conduit hub 124b. Check valves 113g-113i may be part of the valve manifold (e.g., such as...). Figure 1BPart of the valve manifold 16), which is part of hub 124c or directly or indirectly coupled to the third conduit hub 124c. Check valves 113a-113i can be one-way check valves. Figure 2 As shown, the one-way check valves 113a-113i allow flow in the direction indicated by their respective arrows.

[0207] like Figure 3 As shown, each catheter hub 124a-124c may be provided with a hemostatic valve to accommodate the introduction of another device through it. The hemostatic valve includes a variable diameter orifice, such as an orifice through a resilient washer.

[0208] The gasket can be actuated between a first fully open state, a second partially open state, and a third tightly closed state; the second partially open state is used to seal low-pressure fluid injection from a first or second fluid source through the first port (as described herein), allowing fluid to flow through the first port into the slot while allowing the interventional device to advance or retract; the third tightly closed state is used to resist backflow of high-pressure fluid (e.g., contrast agent) injection from a second fluid source through the first port, or to allow fluid to flow through the first port into the slot. The gasket can be manually actuated or automatically actuated, for example, based on user input corresponding to the operation of one or more interventional devices of the system.

[0209] Figure 3 Another embodiment of a fluid system 200 for use with a fluid management system is shown. Generally, the fluid system 200 includes two or more fluid channels providing 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 having any quantity of fluid material. The two or more fluid channels can allow different fluid materials supplied by different fluid sources (of different volumes and / or at different pressures) to flow into or out of body cavities. Each of the two or more fluid channels can be pre-filled with a corresponding fluid to prepare it for transport to a single fluid line and into the body. Valves and / or valve arrays can be employed to switch between the use of the two or more fluid channels.

[0210] like Figure 3As shown, the fluid system 200 may include a sterile clot capture container within a sterile area, a vacuum chamber, and / or controls 202. The vacuum chamber may have a clot filter with a window for observing the trapped clots and a valved vent that, when momentarily opened, allows air to enter, enabling direct observation of the clots through the window. To allow for remote physician examination, a CCD or CMOS sensor may be mounted such that the upstream surface 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. The entry of air to clear the light path from the window to the filter can be remotely controlled using an electronically actuated valve.

[0211] An air bubble filter 204 may be provided in the tubing between the needle injection port 206 and the conduit 226. The fluid system 200 further includes a tubing branch point 208 (e.g., a Y-shaped connector) in fluid communication with the first source 210a and the second source 210b. The tubing branch point 208 may include a Luerlock connector or a Y-shaped connector that interfaces with multiple fluid sources.

[0212] Fluid system 200 may also include pump 234, such as a peristaltic pump or a rotary piston pump, which drives fluid under pressure from a second source 210b to a line branch point 208 in the direction of arrow 222c.

[0213] Air bubble sensors can be provided upstream or downstream of pump 234. Air bubble sensors 236a and 236b can be non-contact ultrasonic flow sensors that measure the intensity and Doppler shift of reflected ultrasound waves through the sidewall of the fluid conduit, as discussed, to detect bubbles and measure fluid velocity or fluid level. In some embodiments, air bubble sensor 236a can also be a pressure sensor, or a separate pressure sensor can be provided.

[0214] A third valve 216c, such as a ball valve or a rotary valve, can selectively open or close the fluid communication between the second source 210b and the conduit 226. A flow rate detector, such as a drip rate sensor 238, enables the determination and display of the flow rate from the second source 210b.

[0215] Fluid flow from the first source 210a is directed through a one-way check valve 214 and to a high-pressure pump 252, which may be an injection pump, a high-pressure positive displacement pump, a contrast agent injection pump, etc. The high-pressure fluid (e.g., a contrast agent solution) is directed through an air bubble sensor 236a and through a second valve 216b to a pipeline branch point 208. Arrow 222b indicates the direction of fluid flow.

[0216] Based on the available lumen cross-sectional area, the resistance to fluid flow through different catheters in a concentric catheter stack varies. For example, the resistance measurement within an inner catheter with a fully open lumen (e.g., where a guidewire has been removed) may be lower than the resistance measurement within an outer catheter with a second catheter (or guidewire) extending through it. Therefore, when performing a saline flushing step, the fluid system 200 can be configured to ensure that the flow rate through each inner and outer catheter is similar or suitable for the procedure to avoid clogging or other problems within the catheters. To this end, valves can be adjusted for each catheter to ensure that the flow rate across all catheters remains constant during saline flushing. The fluid system 200 can determine this flow rate in real time based on a flow rate sensor, 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.

[0217] In some implementations, fluid resistance can be varied by adjusting the length of each axis inserted into its concentric adjacent lumen. As described herein, fluid resistance within the lumen may be greater when the cross-sectional area of ​​the lumen used for flow is reduced, for example, when a second catheter (or guidewire) extends into the lumen. The amount of fluid resistance may be affected by the narrowing of the cross-sectional length, for example, due to the placement of the second catheter (or guidewire) within the lumen. A second catheter (or guidewire) that partially extends through the lumen of the first catheter will provide less narrowing of the cross-sectional length and, correspondingly, may result in lower fluid resistance within the lumen of the first catheter compared to the case where the second catheter (or guidewire) extends fully through the lumen of the first catheter. Therefore, fluid resistance can be reduced by partially retracting the second catheter (or guidewire) from the depth into the lumen of the fluid to be injected.

[0218] The fluid system 200 further includes a suction tank 240 coupled upstream of the filter 244. Downstream of the filter 244 is coupled to a vacuum pump 242. The suction tank 240 is connected to a first valve 216a, which can communicate with the sterile area clot capture container, vacuum chamber, and / or control unit 202 discussed elsewhere herein. Arrows on the fluid line 222a indicate the direction of fluid flow.

[0219] An optional pressure sensor 246 is depicted at the proximal end of a conduit 226 or hub coupled to a hemostatic valve such as a rotary hemostatic valve (RHV) 248. In other embodiments, a different type of hemostatic valve (e.g., a non-rotary hemostatic valve) may be used instead of the RHV 248.

[0220] In this example, the RHV 248 is connected to two different fluid sources. The RHV 248 can be constructed from a hub (e.g., Figure 2The first conduit hub 124a) is carried and at least partially disposed within the hub. RHV 248 may include a first fluid source connection, a second fluid source connection, and a channel connection. For example, the first, second, and third connections may include respective valves (e.g., valves 216a, 216b, 216c) connected to RHV 248 via fluid lines. In some embodiments, the connection point may be formed as part of RHV 248 itself, and the fluid line may be directly connected to the connection point at the proximal end of the fluid line and connected to a source and / or channel at the corresponding distal end of the fluid line. In some embodiments, valves 216a, 216b, 216c may be arranged in a valve manifold or valve manifold box. In some embodiments, pump 234 may also be arranged in a valve manifold or valve manifold box. In some embodiments, any one of valves 216a, 216b, 216c may be a ball valve, plug valve, rotary valve, solenoid valve, or any other suitable valve. Any one of valves 216a, 216b, and 216c can be controlled by one or more actuators 217.

[0221] RHV 248 can be configured to allow catheters or other instruments to be introduced into a living body while preventing accidental backflow. In some embodiments, each RHV described herein can be configured to have at least a fully closed configuration, a low-sealing state through which the device can advance without leakage, and a high-sealing state (e.g., mode) that prevents fluid escape under high pressure and prevents axial movement of the device through it.

[0222] RHV 248 is configured to be simultaneously and fluidly connected to a first fluid source (e.g., first source 210a) via a first fluid source connection (e.g., second valve 216b). RHV 248 is further configured to be simultaneously and fluidly connected to a second fluid source (e.g., second source 210b) via a second fluid source connection (e.g., third valve 216c). Furthermore, RHV 248 is further configured to be simultaneously and fluidly connected to a tank (e.g., suction tank 240) via a tank connection (e.g., first valve 216a).

[0223] In operation, the fluid system 200 is configured to automatically switch between introducing fluid from a first fluid source (e.g., first source 210a) or from a second fluid source (e.g., second source 210b) via RHV 248 into the lumen of an elongated body (e.g., conduit 226), or to allow fluid removed from the lumen to be collected in a tank (e.g., suction tank 240).

[0224] In some implementations, the optional pressure sensor 246 is located upstream or downstream of the RHV 248 (e.g. Figure 3(As shown). In some embodiments, an optional pressure sensor 246 is located within the catheter (e.g., in the sidewall of the catheter) to measure arterial pressure at the distal end of the catheter. This pressure can be assessed by an interventional physician to confirm that the catheter is not misaligned within the blood vessel and / or thrombus.

[0225] For example, if the catheter is misaligned with the vessel wall, the detected pressure (e.g., waveform) may be attenuated. This detection can be fed into an algorithm executed by a processor associated with the fluid system 200, for example, to determine the patency of the catheter lumen or the distal tip of the catheter. This pressure sensor and algorithm can provide an improved alternative to conventional pressure determination, in which there is fluid dynamic manipulation and the interventional physician can retract (e.g., pull back) the syringe coupled to the catheter to confirm blood capture and assess tactile feedback from the catheter.

[0226] Such blood capture and tactile feedback assessment can indicate the patency of the lumen or distal tip before injection or aspiration. However, pressure sensor 246 can provide an automated and improved method for assessing lumen or distal tip patency. That is, adding pressure sensor 246 (e.g., a blood pressure sensor) to the proximal end of the catheter can capture arterial pressure waveforms. In the absence of direct visual or tactile feedback, the waveforms can be used to determine whether the distal tip of the catheter is pressed against the vessel wall, whether the catheter tip is pressed against a thrombus, whether the catheter tip is fully patent, or whether the catheter lumen is blocked or fully patent. In some embodiments, the waveforms can be used to determine the adhesion of the distal tip of the catheter to a clot and / or the viscosity of the clot.

[0227] In some embodiments, the fluid system described herein (e.g., fluid system 100, fluid system 200) includes a hemostatic valve (e.g., RHV 248) comprising a first tee connector having a first fluid source connection (e.g., a first valve array 116a or a second valve 216b), a second fluid source connection (e.g., a second valve array 116 or a third valve 216c), and a groove connection (e.g., the first valve 216a).

[0228] In some embodiments, the fluid systems described herein (e.g., fluid system 100, fluid system 200) use a first fluid source comprising one of saline, heparinized saline, or a drug. In some embodiments, a second fluid source (e.g., second source 110b, 210b) comprises a contrast agent.

[0229] Fluid systems 100 and 200 may further include a second hemostatic valve, which is in communication with and at least partially disposed within a second hub (e.g., a second catheter hub 124b). The second hemostatic valve may include a third fluid source connection (e.g., a second valve array 116b), a fourth fluid source connection (second valve array 116b), and a second groove connection (e.g., a third valve array 116c). In this example, the first manifold 118a may include a second output line configured to connect to the third fluid source connection (not shown).

[0230] Figure 4 Another embodiment of a fluid system 300 for use with a fluid management system is shown. Typically, the fluid system 300 includes a housing that can couple multiple fluid sources and / or tanks to multiple interventional devices. Multiple fluid lines may extend between the source or tank and the housing for coupling to different interventional devices. For other sources and tanks, a single fluid line may extend between the source or tank and the housing and may be separated within the housing to connect to different interventional devices. In some embodiments, the housing may include a connector array formed by connectors from multiple fluid sources and / or tanks for coupling to a single interventional device (e.g., in a row or column). Each connector array may be coupled to a pipe group having a pipe corresponding to each connector in the connector array.

[0231] The housing 341 may be a separate unit including a housing having multiple valves, pipes, and connectors as described below. A first connector array includes multiple releasable connectors, such as Luer connectors, for fluid communication between the housing and a complementary connector, which is in fluid communication with a suction source and at least one or more fluids. A second connector array is configured for releasable connection to a pipe assembly configured to extend between the housing and at least one, two, or three intervention devices.

[0232] Box 341 thus forms a bridging module, which, after assembly, is located between various fluid and vacuum sources and the corresponding intervention devices. Box 341 can be configured for single use, or it can be sterilizable and reusable.

[0233] like Figure 4 As shown, the fluid system 300 may include a first fluid source 310a and a second fluid source 310b. Fluid flow from the first fluid source 310a is guided through a one-way check valve 314 and reaches a high-pressure pump 352, which may be an injection pump, a high-pressure positive displacement pump, a contrast agent injection pump, etc. The fluid from the first fluid source 310a may be a contrast agent solution preferably injected under high pressure.

[0234] Fluid flow from the injection pump is directed into a housing 341, which may include multiple valves, manifolds, and / or connectors. Within the housing 341, fluid flow can be branched along multiple branches 318b to multiple connectors 317b for coupling with different interventional devices (e.g., such as...). Figure 4 The four connectors 317b shown. The housing may include a valve 316b (e.g., a ball valve) and various branches 318b upstream of the connectors 317b. In some embodiments, any one of the unique valves 316a, 316b may be a ball valve, plug valve, rotary valve, solenoid valve, or any other suitable valve.

[0235] Fluid flow from the second fluid source 310b can be directed into multiple branches 318c to reach multiple pumps 334 (e.g., such as...). Figure 4 The four pumps 334 shown are, for example, peristaltic pumps or rotary piston pumps. Each of the plurality of pumps 334 can drive fluid (e.g., brine) under pressure from a second fluid source 310b to a unique connector 317c for each intervention device within the housing 341.

[0236] The system further includes a suction tank 340 in communication with the upstream side of the filter 344. The downstream side of the filter 344 is in communication with a vacuum pump 342. The suction tank receives fluid from a cartridge 341, which includes a plurality of connectors 317a, each connector 317a being configured to couple to a unique intervention device. Unique valves 316a (at least two, and in the illustrated example, four) may be located upstream of each of the plurality of connectors 317a. Each unique valve 316a may be positioned along a branch 318a.

[0237] In some implementations, one or more connector arrays 346 may be arranged, each connector array 346 being configured to couple an intervention device. For example, Figure 4 Connector array 346 is indicated by dashed lines. (Example) Figure 4 As shown, connector array 346 may include one of a plurality of connectors 317a, one of a plurality of connectors 317b, and connector 317c. As... Figure 4 As shown, connector array 346 can be organized such that all connectors face the same direction on a common plane, for example, in a linear row.

[0238] Connector array 346 can be releasably coupled to tubing assembly 343, which includes a suction tube 354, a first fluid tube 355, and a second fluid tube 356. In some embodiments, the plurality of connectors 317a, 317b, and 317c may be Luer lock connectors. Suction tube 354 can be coupled to one of the plurality of connectors 317a in connector array 346 via complementary connector 317d for aspiration from the interventional device to the aspiration container. First fluid tube 355 can be coupled to one of the plurality of connectors 317b in connector array 346 via complementary connector 317e to provide fluid flow from a first fluid source 310a to the interventional device. Second fluid tube 356 can be coupled to connector 317c in connector array 346 via complementary connector 317f to provide fluid flow from a second fluid source 310b to the interventional device. Tubes 354, 355, and 356 may be joined together for most of their length. Pipes 354, 355, and 356 may each have a length of at least about three or four feet, and in some embodiments about six to about eight feet.

[0239] like Figure 4 As shown, the piping assembly 343 includes a line branch point 308 (e.g., a two-to-one or three-to-one Y-shaped connector) that provides fluid communication between the intervention device and the suction line 354, the first fluid line 355, and the second fluid line 356. The line branch point 308 may include a Luerlock connector or a Y-shaped connector that connects to a complementary connector on the piping assembly. In some embodiments, a one-way valve 345 may be positioned upstream of the line branch point 308 and downstream of the housing 341 along the flow path of the second fluid.

[0240] In some embodiments, fluid system 300 (or other systems described herein) may use two different flow modes to guide the flow of a second fluid (e.g., saline). In a low-flow-rate drip mode, for example, a flow rate of approximately 1-2 drops per second or 3-6 mL / min may be provided by multiple pumps 334. In some embodiments, a low-flow-rate mode rate of 1-8 mL / min may be provided. As described herein, the individual conduits coupled to the system may experience different fluid resistances.

[0241] Pumps (e.g., multiple pumps 334) can be operated to provide the same flow rate in each catheter. In some embodiments, the fluid pressure within the catheter can be at least about 330 mmHg or 6.5 psi. This pressure may be sufficient to overcome arterial pressure while delivering the required drip rate. In some embodiments, the pressure within the catheter can be greater than 330 mmHg. In some embodiments, the volume of fluid delivered over the entire operative length can be at least about 1 liter. In some embodiments, the fluid volume can be up to 2 liters.

[0242] In high-flow-rate flushing mode, all fluid lines can be flushed to remove air. Flow rates can range from 100 mL / min to 1000 mL / min. Fluid pressures can range from 5 psi to 10 psi. The delivery volume per procedure can range from 0.5 to 1 liter. Volume may depend on tubing length and diameter. In some implementations, the high-flow-rate flushing is at least about 20 times that of the low-flow-rate drip mode, and in some cases 30 to 150 times.

[0243] In some embodiments, the first fluid (e.g., a contrast agent solution) can be supplied, for example, via pump 352 at a flow rate of 3 to 8 mL / s (e.g., about 4 mL / s). In some embodiments, the flow rate can be up to about 8 mL / s. In other embodiments, the flow rate can be up to about 20 mL / s. In some embodiments, for a flow rate of about 4 mL / s, a pressure of about 400 psi can be provided for the first fluid. The required pressure may depend on the flow rate and flow limitations of the flow path. For higher flow rates, the pressure can be increased proportionally to the flow rate. In some embodiments, the pressure can be up to 1200 psi.

[0244] In some embodiments, the high-pressure pump, such as pump 352, can provide a delivery volume of 5 mL to 15 mL per high-pressure injection. In some embodiments, the pump can provide 5 mL to 15 mL per high-pressure injection in increments of approximately 1 mL per aspiration. In some embodiments, the second fluid source can provide a total volume of approximately 200 mL per procedure. In some embodiments, the infusion pump is sized to maintain at least approximately 150 mL or 200 mL to provide uninterrupted flow throughout the procedure without the need to add additional contrast agent solution. In other embodiments, the second fluid source can provide a total volume of 150 mL to 250 mL per procedure.

[0245] In some implementations, the flow rate can be varied depending on the anatomical location of the distal end of the catheter. For example, in the aortic arch, the flow rate can be approximately 20 mL / s. A total delivery volume of approximately 25 mL can be infused into the aortic arch. In the common carotid artery, the flow rate can be approximately 20 mL / s. A total delivery volume of approximately 12 mL can be infused into the common carotid artery. In the subclavian artery, the flow rate can be approximately 6 mL / s. A total delivery volume of approximately 15 mL can be infused into the subclavian artery. In the internal carotid artery, the flow rate can be approximately 6 mL / s. A total delivery volume of approximately 8 mL can be infused into the internal carotid artery. In the external carotid artery, the flow rate can be approximately 3 mL / s. A total delivery volume of approximately 6 mL can be infused into the external carotid artery. In the vertebral artery, the flow rate can be approximately 6 mL / s. A total delivery volume of 8 mL can be infused into the vertebral artery.

[0246] In some embodiments, a motor may be provided to drive a high-pressure pump, such as pump 352, which may be controlled by a position and speed control loop that uses a potentiometer as a measurement to close the loop. In some embodiments, current control may be applied to provide approximate pressure limiting. In some embodiments, the second fluid may be a contrast agent solution, such as Omnipaque 300, Omnipaque 350, or Visipaque 320.

[0247] In some embodiments, the vacuum pump, such as vacuum pump 342, can provide pressures of approximately -29.5 inHg or up to -29.5 inHg (-999 mbar). In some embodiments, the tubing for aspiration can have an inner diameter of 0.11 inches (approximately 2.8 mm). In some embodiments, the volume of the aspiration container 340 can be at least approximately 0.5 L. In some embodiments, the volume of the aspiration container can include approximately 0.5 L for blood and an additional volume for saline flushing. In some embodiments, the aspiration container can have a volume of 0.25 L to 0.75 L. In some embodiments, the vacuum pump can be configured to operate to additionally provide a low pressure / flow setting to assist the flushing process, as it may be desirable for the aspiration line to be filled with saline at all times (except when aspirating clots). In some embodiments, a separate pump can be provided for the low pressure / flow setting.

[0248] Figure 5A and Figure 5B A perspective and cross-sectional view of an example rotary hemostatic valve (RHV) 448 are shown, in which a double-membrane gasket is configured in the open position. That is, both the distal and proximal membranes are provided with slits, and a support tube is positioned through the two membranes to keep the slits in an open, confined configuration (e.g., see...). Figure 8B RHV 448 may represent RHV 248 in fluid system 200, or the hemostatic valve in any of catheter hubs 124a-124c may be configured for use with manual surgical and fluid systems, robotic surgical and fluid systems, or combinations thereof.

[0249] RHV 448 includes a side port 420, a double-diaphragm gasket 452, and a plunger 476 having a housing 482 and a support tube 479 configured to reversibly advance distally through the gasket to maintain patency through the gasket. RHV 448 is coupled to the proximal end of a first interventional device and is adapted to receive a second interventional device (e.g., catheter 426) passing therethrough. The plunger includes a proximal end 476a and a distal end 476b.

[0250] The second interventional device is disposed within the lumen defined by the first interventional device. As shown, catheter 426 advances through support tube 479 of RHV 448. The proximal end 450 of RHV 448 includes a housing coupled to plunger 476. Gasket 452 is configured to couple to gasket housing 472 surrounding the plunger circumference.

[0251] Gasket 452 is actuable between a first fully open state, a second low-sealing-force state, a third state, and a fourth fully closed state, wherein the second low-sealing-force state is used to seal around the conduit but allows the conduit to slide, the third state is used to seal around the conduit for high-pressure management, and the fourth fully closed state has no second device extending through it.

[0252] The first open state indicates a blood return position or an interventional device loading or unloading position, which configures RHV 448 to allow gasket 452 to fully open. The second partially open state indicates a position that configures RHV 448 to allow gasket 452 to close within RHV 448 with sufficient sealing around catheter 426, such that blood or saline solution pumped at relatively low pressure will not leak when catheter 426 advances or retracts within RHV 448 with low resistance. The third state indicates a tightly sealed configuration for enabling the injection of high-pressure fluid (contrast agent) from a fluid source. In some embodiments, the control system may be configured to determine the sealing force of the hemostatic valve around catheter 426 (e.g., in response to human input). If the sealing force is determined to be too high or too low, the control system may be configured to change the sealing force. For example, if the sealing force is too low, the control system may increase the sealing force.

[0253] like Figure 5B As shown, in the first open state, gasket 452 is constrained by the support tube. The first open state ensures that gasket 452 is configured in the blood return position or the interventional device loading or unloading position. The open position configures RHV 448 such that the tubular support of the movable plunger 476 passes through gasket 452, forcibly opening the tubular support and restricting the gasket to provide an open central lumen, thereby opening gasket 452. This movement allows arterial blood pressure to push blood proximally through catheter 426 until blood is visible at RHV 448. Moving the gasket to the open position where blood return is possible allows visual and / or tactile confirmation that there are no air bubbles in RHV 448, 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 unobstructed.

[0254] In some implementations, the RHV 448 may include a side port 420. The side port 420 may be releasably connected to a tee connector configured for fluid connection to a first fluid source (e.g., first source 110a), a second fluid source (e.g., second source 110b), and a slot (e.g., slot 112). Alternatively or additionally, the RHV 448 may further include one or more additional ports for connection to fluid sources and / or slots. See, for example, [link to relevant documentation]. Figure 11 This will be described in further detail elsewhere in this article.

[0255] Figure 6A and Figure 6B Cross-sectional and enlarged cross-sectional views of the rotary hemostatic valve are shown, wherein a gasket (e.g., gasket 456) is configured in a partially open or low-sealing-pressure position. In this position, the distal end 476b of the plunger 476 has retracted proximally, such that the distal slit 464 of the gasket 456 (see...) Figure 8B The catheter 426 makes sliding contact, but the proximal slits 468 and 470 (see...) Figure 8C It remains in an open configuration restricted by the support tube. The low-pressure state of gasket 456 allows brine (e.g., from the second source 110b) to be burst-infused through the side port 420 of RHV 448 at pressures up to about 276 kPa (i.e., about 40 psi).

[0256] like Figure 6B As shown, gasket 456 is in a partially open state, with plunger 476 partially advanced into gasket 456. This position represents a low-pressure position, where blood or saline solution will not leak as catheter 426 advances or retracts through RHV 448 with low resistance. The second partially open state configures RHV 448 for receiving low-pressure fluid injection from a first fluid source (e.g., first source 110a) or a second fluid source (e.g., second source 110b) through a first port, or for allowing fluid to flow through the first port into a tank (e.g., tank 112).

[0257] Figure 7A and Figure 7B A cross-sectional view of an example rotary hemostatic valve is shown, where the gasket is configured in a high-sealing-force (mode) or high-pressure position. Figure 7A As shown, the distal membrane 460 includes a thickened sidewall in the form of a cross-shaped material 466, which aligns with the transverse slit of the proximal membrane 462. The cross-shaped material 466 provides additional gasket contact around the conduit 426 in a tightly closed (e.g., high-pressure) state.

[0258] A tightly closed configuration indicates a setup for high-pressure fluid transfer from a fluid source (e.g., contrast agent / secondary source 110b). The closed position of gasket 458 allows contrast agent (e.g., from secondary source 110b) to be injected through side port 420 of RHV 448 at pressures up to approximately 2.76 MPa (i.e., approximately 400 psi). Figure 7B As shown, in the closed state, the plunger 476 retracts proximally, so that the distal slit 464 and the proximal slit are no longer supported by the support tube, and can provide a seal to the conduit 426. In other words, the proximal end 476a and the distal end 476b of the plunger 476 both move away from the washer 458 to achieve the closed state of the washer 458.

[0259] Figures 8A to 8C Various views of example gaskets used in the fluid system described herein are shown. Figure 8A A perspective view of gasket 458 is shown. Gasket 458 includes a distal membrane 460 and a proximal membrane 462. A cross-shaped slit on the proximal membrane 462 of gasket 458 (a substantially horizontal slit 470 intersecting a substantially vertical slit 468) can be compressed against a conduit for high-pressure sealing or the closed position of gasket 458. A vertically oriented distal slit 464 on the distal membrane 460 of gasket 458 can be compressed against a conduit for low-pressure sealing or the closed position of gasket 458.

[0260] Figure 8B A distal end view of washer 458 is shown. The distal membrane 460 of washer 458 includes a distal slit 464 vertically positioned at the center of the washer portion having thickened sidewalls, which may be configured as a cross-shaped material 466.

[0261] Figure 8C A proximal end view of washer 458 is shown. The vertical slit 468 of washer 458 is substantially perpendicular to the horizontal slit 470 on the proximal membrane 462 of washer 458.

[0262] In some embodiments, the rotary hemostatic valve described herein can be configured to have an open setting during which the catheter can be manually and freely inserted into or removed from the lumen. Furthermore, in the open setting, the system can be freely flushed with saline to remove air bubbles from the system. In some embodiments, the open setting may additionally allow retrograde blood flow to remove air bubbles from the system.

[0263] Figure 9A perspective view of an actuation mechanism 800 used in conjunction with the rotary hemostatic valve described herein is shown. The actuation mechanism 800 includes at least one linear actuator 474 coaxially connected about a tubular drive shaft 477 coupled to the proximal end 450 of an RHV 448 to drive one or more gears to rotate the RHV 448. For operation of a catheter (e.g., catheter 226), the linear actuator 474 drives a tang (not shown) that can engage a circular flange fixed to the outer shaft of the catheter. In some embodiments, the RHV 448 is coupled to a hub (e.g., a first catheter hub 124a) capable of rotating, translating, and / or deflecting the catheter (or lead).

[0264] Figure 10A This illustrates limiting the valve to, for example Figure 5B The RHV drive mechanism is shown in its open position. The linear actuator 474 has driven the drive shaft 475 to its proximal travel limit, where the support tubes extend through the washers, holding them open. Figure 10B In this configuration, the support tubes have been advanced beyond the gaskets, allowing them to close tightly around any inner conduits extending through them in a high-pressure position.

[0265] Figure 10C This is a schematic diagram of one embodiment of the linear actuator 474. A housing 471 supports a motor 473, which rotates a gear train 481, which in turn rotates a lead screw 483. A helical thread 485 on the lead screw 483 slidably engages complementary protrusions on the inner surface of a tubular drive shaft 477, causing axial reciprocating motion of the drive shaft 473 and corresponding axial displacement of the support tube relative to the washer.

[0266] The aseptic clot capture container, filter, RHV, pressure sensor, etc., can all be part of the hub and move with the catheter. If the clot is captured using a clot chamber close to the hub, the piping between the hub and the fluid management cabinet does not need to be large-diameter (saline will be infused at a pressure higher than arterial pressure and subsequently drawn back through the clot chamber to make the clot more visible). Regardless of design details, the valve manifold can be configured to handle large clots passing 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 located away from the hub and communicate with the hub via a piping assembly with vacuum, saline, and contrast agent lines.

[0267] If the first conduit 126 remains in place, pulling out the second conduit 128 creates a pressure gradient from the outside in. If the valve is not tight enough, there is a risk of air being drawn in. However, the valve cannot be too tight to prevent the second conduit 128 from being pulled out. Therefore, the brine delivery flow rate can be set to generate positive pressure so as not to introduce air bubbles.

[0268] Figure 11 A perspective view of an example component 500 is shown, which includes a rotary hemostatic valve (RHV) 502 integrated with a manifold 504. Figure 11 The example shown depicts an implementation in which the manifold is located near or inside a specific RHV associated with the hub. Such an implementation can replace the separate manifolds 118a-118c in the fluid system 100.

[0269] The RHV 502 is depicted as a tapered tube having a rotating portion 506 and a port 508 for receiving one or more conduits (not shown) passing through it. One or more conduits may be attached to a portion of the RHV 502 adjacent to port 508. This portion may include a Luer lock swivel nut or another valve or inlet valve.

[0270] RHV 502 may be fixedly attached to manifold 504. In some embodiments, RHV 502 may be detachably attached to manifold 504. Manifold 504 is configured with any number of ports for receiving fluid lines attached to the hub. For example, manifold 504 includes at least a first port 510 for receiving one or more fluid source lines 120a, 120b, 120c from at least one manifold valve (e.g., at least one valve in the first valve array 116a). Manifold 504 includes at least a second port 512 for receiving one or more fluid source lines 121a, 121b, 121c from at least one manifold valve (e.g., at least one valve in the second valve array 116b).

[0271] Manifold 504 is further configured with any number of ports for receiving fluid lines connected to a particular fluid source. For example, manifold 504 includes a port 514 for receiving contrast agent fluid via a fluid line connected to a contrast agent source (e.g., second source 110b). Manifold 504 also includes a port 516 for receiving brine fluid via a fluid line connected to a brine source (e.g., first source 110a). Manifold 504 additionally includes a port 518 for receiving (e.g., discharging) waste via a fluid line connected to a tank (e.g., tank 112). Manifold 504 may include optional clips 520 for attaching RHV 502 to the hub.

[0272] although Figure 11 The diagram depicts two source ports and one slot port, but any number of source ports or slot ports may be possible on component 500. Furthermore, any number of valve ports may be provided, and these may correspond to multiple conduit hubs configured to function in a particular fluid system.

[0273] Figure 12An example of a method 550 for degassing a fluid management system for a robot-driven medical device is described. Implementations of the method for degassing a fluid management system can remove gas (e.g., dissolved gas from one or more fluids) from the lumen of the robot-driven medical device (e.g., the catheter described herein), one or more fluid lines of the fluid management system, and / or one or more fluids. In some implementations, the method for degassing can be used to construct a fluid wall or column by removing gas from one or more portions of the fluid management system (e.g., one or more fluid lines).

[0274] Therefore, in some embodiments, the method for degassing may be referred to as a method for forming a fluid column, or a method for arranging fluid within a fluid management system. For example, a first fluid, such as saline, from a first fluid source can be driven through a first fluid line into a first fluid source connection coupled to a hemostatic valve of a medical device. A first valve at the first fluid source connection can be closed, resulting in the fluid column in the first fluid line connection being devoid of gas or containing only a relatively small amount of gas.

[0275] Aspiration can then be applied to the grooved connection of the hemostatic valve to remove any residual first fluid from the valve. This can result in an empty hemostatic valve while the fluid column remains in the first fluid line. The hemostatic valve can then be prepared to receive a second fluid, such as a contrast agent, which can be infused under high pressure. When the second fluid is infused, for example, through the second fluid connection of the hemostatic valve, the fluid column in the first fluid line can prevent or inhibit the flow of the second fluid into the first fluid line. The second fluid can then travel along the path of least resistance, for example, through the lumen of the medical device, rather than through the first fluid line.

[0276] In some embodiments, a fluid column or wall may be formed in the channel line extending from the channel connector to the channel. For example, when a fluid, such as a first fluid, is aspirated through the channel line via the channel connector, the channel valve at the channel connector can be closed and aspiration can be stopped, such that at least some fluid remains in the channel line rather than flowing into the channel, resulting in a fluid column or wall in the channel line at the channel connector location. In some embodiments, the first fluid may be driven into the hemostatic valve during aspiration to form a fluid wall or column in the channel line. The fluid wall or column in the channel line prevents or inhibits the inflow of fluids, such as the first or second fluid, into the channel line. For example, as described herein, a fluid column or wall may be formed in the first fluid line and the channel line. The second fluid (e.g., a contrast agent) can then be infused into the hemostatic valve, and the second fluid can flow through the lumen of the medical device rather than into the first fluid line or the channel line. By preventing unwanted inflow of fluid into the first fluid line and / or the channel line, fluid waste can be prevented, and the amount of fluid flowing to the patient can be known and controlled.

[0277] In some embodiments where a fluid wall or column is desired within the tubing, various methods can be employed to prevent or inhibit retrograde aspiration of air through the lumen of the medical device (e.g., a catheter) while simultaneously constructing a fluid wall or column within the tubing. In some embodiments, the medical device may be inserted into the patient prior to aspiration, allowing blood to be drawn through the lumen of the medical device and into the tubing. The fluid column within the tubing may be formed of blood and / or a primary fluid.

[0278] In some embodiments, if the medical device is positioned externally to the body, the tip of the medical device can be placed into a container of a fluid such as saline, which can then be aspirated into the channel line. In other embodiments, the tip of the medical device can be sealed (e.g., using a plug) so that air is not aspirated from the distal end when the first fluid is aspirated to build a fluid column in the channel line. In other embodiments, a valve (e.g., in the valve manifold described herein) can be closed to block the connection between the lumen and the hemostatic valve or the connection between the lumen and the channel connection to prevent backflow of air into the channel line during fluid column construction.

[0279] In one embodiment, the method includes infusing a first fluid from a first fluid source into a first fluid source connection of a hemostatic valve under low pressure, closing a first valve at the first fluid source connection, applying a vacuum to a groove connection of the hemostatic valve to remove residual first fluid, closing a groove valve at the groove connection, and infusing a second fluid from a second fluid source into the second fluid source connection of the hemostatic valve under high pressure. Method 550 is used to remove dissolved gases from fluids and fluid lines in a fluid management system. The method is used for catheter and fluid preparation, but may be additionally or alternatively used for any suitable clinical or other application. Method 550 may be configured and / or adapted for use with any suitable fluid degassing technique.

[0280] In some embodiments, instead of infusing the first fluid from a first fluid source into the first fluid source connection of the hemostatic valve under low pressure and closing the first valve at the first fluid source connection, the method can be replaced by evacuating a specific port and / or fluid line, and then injecting the first fluid from the first fluid source into the first fluid source connection of the hemostatic valve. In some embodiments, evacuating the specific port and / or fluid line before fluid injection can provide negative pressure, which can help the fluid subsequently flow through the fluid management system.

[0281] During the operation of the fluid system 100, the interventional physician can access the fluid management unit 102 and the intervention unit 104 to perform method 550. Method 550 may be part of the degassing method for the initial configuration of the fluid system 100. For example, method 550 may be performed for all or part of the fluid management system of a manually driven medical device, a robot-driven medical device, or a combination thereof.

[0282] In some embodiments, the degassing method includes injecting a first fluid from a first fluid source into a first fluid source connector of the hemostatic valve and closing a first valve at the first fluid source connector. In some embodiments, the degassing method includes injecting the first fluid under low pressure. A vacuum is applied to the groove connector of the hemostatic valve to remove residual first fluid into the groove. The groove valve is closed, and a second fluid is injected from a second fluid source into the second fluid source connector of the hemostatic valve. In some embodiments, the first fluid source connector of the hemostatic valve may not be integrated with the hemostatic valve, but instead may be integrated via a Y-joint to integrate the fluid connector with the hemostatic valve. In other embodiments, the first fluid connector may be integrated separately with the hub in other ways.

[0283] In some embodiments, the degassing method described herein can be a predetermined function that can be achieved in several ways. In a first example, the degassing function can be achieved using positive pressure, wherein system 10 can inject saline into a fluid port connected to the catheter lumen. In such an example, the saline can then fill the lumen space in an anterograde direction (i.e., toward the catheter tip distally) and also in a retrograde direction (i.e., through an open hemostatic valve located proximally). In a second example, the degassing function can be performed before performing the first example and can include closing the hemostatic valve and applying aspiration through the fluid port or through a fixation temporarily attached to the distal end of the catheter. In either example, the distal end of the catheter can be temporarily sealed. After the air in the lumen is removed using aspiration, system 10 can close the vacuum valve and then open the saline valve to fill the channel with potentially degassed saline. Optionally, the distal tip seal can be removed, and the first example can be repeated to complete the degassing function. Although referenced... Figure 12 Methods for degassing are described, but the methods described herein can be generally used to purge fluids (including gases, liquids, and / or combinations of gases and liquids) before introducing another fluid.

[0284] like Figure 12 As shown, one embodiment of degassing the fluid management system of a robot-driven medical device includes block 552, which describes injecting a first fluid from a first fluid source into a first fluid source connection of a hemostatic valve under low pressure. For example, fluid (e.g., saline) from a second source 210b can be injected under low pressure into a first fluid line at a line branch point 208 coupled to RHV 248 and / or one or more catheters associated with RHV 248. In some embodiments, the first fluid source comprises heparinized saline.

[0285] At block 554, method 550 includes closing a first valve at the first fluid source connection. For example, a third valve 216c may 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, the third valve 216c is placed near or within a manifold that may serve as the first fluid source connection.

[0286] At block 556, method 550 includes applying a vacuum (e.g., a pump) to a slotted connection of a hemostatic valve to remove residual first fluid. For example, a sterile area clot capture container, vacuum chamber, and / or control 202 may be triggered to remove residual first fluid into aspiration tank 240 via a connection such as RHV 248 of a first valve 216a.

[0287] At block 558, method 550 includes closing a slot valve at the slot connection. For example, a first valve 216a may be used as a slot valve to block fluid flow within fluid line 222a.

[0288] At block 560, method 550 includes a second fluid source connection for injecting a second fluid from a second fluid source into a hemostatic valve under high pressure. For example, fluid (e.g., contrast agent) from a first source 210a can be injected under high pressure from the first source 210a and into a second fluid line at a line branch point 208 coupled to RHV 248 and / or one or more catheters associated with RHV 248. In some embodiments, the second fluid is a contrast agent. In some embodiments, the second fluid source connection may not be directly integrated with the hemostatic valve, but may instead be integrated via a Y-joint to integrate the fluid connection with the hemostatic valve. In other embodiments, the second fluid source connection may be otherwise integrated separately with the hub.

[0289] In some embodiments, method 550 further includes actuating the gasket of the hemostatic valve to a high-pressure position before the injection of the second fluid or before applying a vacuum. For example, gasket 458 ( Figure 7A It can be part of RHV 248, 448. Gasket 458 can be actuated to open to the high-pressure position before the contrast agent is injected or before a vacuum is applied at RHV 248, 448.

[0290] In some embodiments, method 550 may further include actuating the gasket of the hemostatic valve to a low-pressure position prior to the injection of the first fluid. For example, gasket 456 ( Figure 6A It can be part of RHV 248, 448. Before injecting brine, gasket 456 can be actuated to open to the low-pressure position.

[0291] Figure 13A schematic diagram of an example fluid control system 600 is shown, which can be used to electronically control the fluid systems or components described herein, and / or perform the methods described herein. The fluid control system 600 can be configured to automatically adjust various manifold valves, pumps, hemostatic valves, hubs, and / or catheters described herein in response to operator input, such as from a physician. In response to operator input, the fluid control system 600 can cause a series of responsive events to occur automatically.

[0292] In some embodiments, the fluid control system 600 may include one or more processors 602. The one or more processors 602 may be configured to automatically adjust various manifold valves, pumps, hemostatic valves, hubs, and / or catheters described herein in response to operator input, such as using one or more controls of the fluid control system 600. In some embodiments, the fluid control system 600 includes a first control 604a, a second control 604b, and a third control 604c; however, any suitable number of controls may be provided to correspond to the various functions of the fluid system described herein.

[0293] For example, in some embodiments, the first control 604a may be a contrast agent control that can be activated by a user to introduce contrast agent into the catheter. The second control 604b may be a saline control that can be activated by a user to introduce saline into the catheter. The third control 604c may be a vacuum control configured to activate the application of a vacuum to the catheter. In some embodiments, each unique catheter may have its own unique first control 604a, second control 604b, and / or third control 604c. Alternatively, each of the controls 604a, 604b, and 604c (hereinafter referred to as "controls 604a-604c") may be actuated to elicit a specific response in multiple catheters of the fluid system.

[0294] Processor 602 may receive signals from controls 604a-604c and, in response, initiate corresponding actions in components of the fluid system. For example, processor 602 may be configured to generate an output signal that causes components of the fluid system to perform responsive actions. For example, in some embodiments, in response to user activation of first control 604a, processor 602 may be configured to open a first contrast agent valve, close a first saline valve, and close a first vacuum valve associated with a single catheter. In some embodiments, processor 602 may also actuate a first contrast agent pump in response to actuation of first control 604a or a separate unique control.

[0295] In some embodiments, processor 602 may also adjust the hemostatic valve of the single catheter to a high compression state as discussed herein, in response to actuation of a control such as first control 604a or a single unique control. Although in Figure 13 The diagram illustrates a processor 602; in other embodiments, multiple processors 602 may be used to control the fluid system described herein. For example, each of the controls 604a-604c may communicate with a single processor.

[0296] As described in this article, for example, refer to Figure 1B In some embodiments, the catheter system may have a valve manifold in hub communication with the catheter. The valve manifold may include a first port configured for connection to a vacuum source, a second port configured for connection to a saline source, and a third port configured for connection to a contrast agent source. A fluid control system 600 (e.g., via processor 602) may be configured to adjust the valve manifold (e.g., in response to operation of one or more controls such as controls 604a-604c) to an aspiration mode, wherein the first port is in communication with the lumen of the catheter, and the communication between the second port and the lumen, and between the third port and the lumen, is blocked. In some embodiments, the fluid control system 600 (e.g., via processor 602) may be configured to adjust the valve manifold to a contrast agent injection mode, wherein the third port is in communication with the lumen, and the communication between the first port and the lumen, and between the second port and the lumen, is blocked. The fluid control system 600 (e.g., via processor 602) may be configured to control the volume of contrast agent delivered.

[0297] In some embodiments, the fluid control system 600 (e.g., via processor 602) may be configured to adjust the hemostatic valve of the first catheter between a low sealing force mode or a low compression mode and a high sealing force mode or a high compression mode. In some embodiments, the fluid control system 600 (e.g., via processor 602) may be configured to adjust the hemostatic valve to a high sealing force mode or a high compression mode and to adjust the valve manifold to selectively communicate a third port with the lumen while preventing communication between the first and second ports with the lumen (e.g., in response to human input, such as operation of one of the controls of the control system).

[0298] In some embodiments, the fluid control system 600 (e.g., via processor 602) may be configured to determine the sealing force of the hemostatic valve surrounding a second catheter or guidewire extending through the valve (e.g., in response to human input, such as operation of one of the controls of the control system). In some embodiments, if the fluid control system 600 determines that the sealing force of the hemostatic valve surrounding the second catheter or guidewire is low, the fluid control system 600 (e.g., via processor 602) may be configured to increase the sealing force of the hemostatic valve.

[0299] In some embodiments, processor 602 may be configured to send a first control signal to place the hemostatic valve in a high-sealing-force mode or a high-compression mode (e.g., in response to human input, such as operation of one of the controls of a control system). In some embodiments, processor 602 may be configured to send a second control signal to open the contrast agent valve (e.g., in response to human input, such as operation of one of the controls of a control system). In some embodiments, processor 602 may be configured to send a third control signal to place the hemostatic valve in a low-sealing-force mode or a low-compression mode (e.g., in response to human input, such as operation of one of the controls of a control system).

[0300] In some embodiments, processor 602 may be configured to send a fourth control signal to the robotic catheter drive system to adjust the second catheter axially relative to the first catheter (e.g., in response to human input, such as operation of one of the controls of the control system). In some embodiments, processor 602 may be configured to send a fifth control signal to the robotic catheter drive system to withdraw the guidewire axially proximally from the second catheter before opening the contrast agent valve (e.g., in response to human input, such as operation of one of the controls of the control system). One or more of the first, second, third, fourth, or fifth control signals may be sent in response to a single human input. Any one of the first, second, third, fourth, or fifth control signals may be sent in response to a single human input.

[0301] Figures 14 to 63Implementations of systems, components, and methods for managing the administration and removal of fluids during medical procedures are disclosed. These systems and methods may also include programmable and / or automated (or semi-automated) fluid injection and removal systems to perform the procedure and may be coupled to robotically driven interventional devices, manually driven interventional devices, or any combination thereof. A controller in the system may be configured to control the fluid delivery device of the robotic catheter system to ensure the delivery of appropriate diagnosis and / or treatment. Such a controller may include one or more hardware processors capable of executing instructions for controlling the fluid delivery device (e.g., actuating valves and pumps). When used herein, “controller” may refer to one or more controllers. When referring to one or more controllers, for ease of reference, “controller” or “one or more controllers” may simply be referred to herein as “controller” or “the controller” unless otherwise indicated by the context, and therefore, reference to “controller” or “the controller” should be understood to include the disclosure of one or more controllers.

[0302] Figure 14 Examples of certain aspects of a portion of a robotic catheter system are shown, which includes an embodiment of a system 700 for managing fluids. As further described below, in some embodiments, system 700 may include a pump station 702 and a housing 704. Housing 704 may include components and fluid communication channels for a saline subsystem 706, a contrast agent subsystem 708, and a vacuum subsystem 710. For example, housing 704 may include connectors / ports connecting to tubing assemblies and sources of saline, contrast agent, and vacuum; one or more peristaltic pumps; one or more valves; one or more sensors; one or more contrast agent pumps; one or more vacuum tanks; one or more clot chambers; and fluid communication channels for communicating the saline, contrast agent, and vacuum sources from the saline, contrast agent, and vacuum sources to the hub and catheter. When housing 704 is coupled to pump station 702, pump station 702 may include components that interact with the subsystems within the housing. In the example, pump station 702 may include one or more valve actuators, one or more peristaltic pump drive mechanisms, and one or more contrast agent pump drive mechanisms, configured to actuate and drive valves and pumps in the cartridge as part of a saline, contrast agent, and vacuum subsystem. Pump station 702 may also include one or more sensors configured to sense fluid flowing in certain fluid communication channels of cartridge 704.

[0303] In some embodiments, when housing 704 is coupled to pump station 702 to connect electrical components (e.g., sensors) in housing 704 to pump station 702, housing 704 and pump station 702 include corresponding connected electrical contacts or connections (both referred to as "contacts"). Electrical contacts may include contacts for providing information from components in the housing (or hubs coupled to the housing) to a controller in the pump station or a controller configured to operate a fluid system in communication with the pump station, or another system utilizing such information. Electrical contacts may include contacts for providing power to components in the housing. In some embodiments, electrical contacts may also electrically connect pump station 702 to one or more hubs 724 via housing 704. Thus, electrical contacts can provide power to components in one or more hubs via the housing (and via electrical connections between the housing and one or more hubs). Some components of system 700 may be configured to be disposable, and some components may be configured to be reusable. For example, one or more hubs 724 and conduits coupled to hubs, pipe assemblies 716, and / or housing 704 may be configured to be disposable. For ease of reference, the valves in system 700 relating to the control of fluid supply and vacuum supply may be collectively referred to as “valve assemblies.” Valve assemblies may include, but are not limited to, valves located in the brine subsystem 706, contrast agent subsystem 708, and vacuum subsystem 710 in pump station 702, housing 704, and / or one or more hubs 724. As illustrated in the examples below, system 700 supplies brine, contrast agent, and vacuum sources (respectively) to one or more hubs 724 and conduits coupled to hubs 724 via fluid communication channels. Fluid communication channels may include channels, pipes, ports, line connectors, and other structures for fluid communication and vacuum supply. Unless otherwise explicitly stated or indicated by the context, “channel,” “pipe,” “line,” molded orifices and structures, and portions of other structures or components through which fluid or gas flows, may be used herein synonymously to refer to fluid communication channels, or simply as “channel” for ease of reference. For example, a fluid communication channel may include a channel in housing 704, one or more pipes as part of pipe assembly 716, and pipes and / or channels located in hub 724, and the fluid communication channel may be collectively referred to as a fluid communication system.

[0304] Figure 15 Figure 16 and Figure 17 Embodiments of a saline subsystem 706, a contrast agent subsystem 708, and a vacuum subsystem 710 that can be used to perform methods for controlling fluid drug delivery devices are shown respectively. Figure 18 and Figure 19 An example of the configuration of the fluid system associated with the hub is shown. Figure 20 An example of a pipe assembly 716 is shown, which is coupled to a housing 704 at one end and to one or more hubs 724 and sheaths 726 at the other end. Figure 21Some components of a robotic catheter system are shown. These components are part of or associated with a fluid system. These components can be actuated by a controller or provide information to the controller. The controller performs a method of controlling the fluid delivery device by actuating such components and (at least in part) based on such information. Figures 23 to 63 Flowcharts and examples of configurations of fluid subsystems and components that can be controlled to perform fluid methods on a robotic catheter system are shown, including, for example, a pre-filled saline subsystem, a pre-filled contrast agent subsystem, contrast agent injection, clot aspiration, and a blood return hemostatic valve. Such processes are at least partially controlled by a controller (e.g., system controller 2220). Figure 22 Control. Valves, pumps, and other actuated (or movable) components can be driven to a certain state or position by a controller. In some embodiments, the state or position of an actuated component can be determined by a sensing mechanism on the component, allowing the controller to determine the current position of the component before, during, or after the process. In some examples, the sensing mechanism may include a switch, encoder, etc. In some embodiments, the current state or position of a component may be electronically stored information (e.g., in a table or document), and the controller is configured to determine the position of one or more components by accessing the stored information. In an example, before injecting a contrast agent using a selected catheter in a system with multiple catheters, it can be determined that a valve coupling the selected catheter to the contrast agent subsystem is aligned in the open position to provide contrast agent to the selected catheter, and it can be determined that one or more valves coupling an unselected catheter to the contrast agent subsystem are aligned in the closed position to decouple the unselected catheter from the contrast agent subsystem. Such determination can be made using stored information or by using information from the sensing mechanism. The processes described herein are examples of processes in which a controller can be configured to automatically or semi-automatically control fluid devices based on one or more user inputs, sensing information, and / or other information.

[0305] As indicated above, Figure 14 An example of a fluid system 700 is shown, which is configured to supply brine, contrast agent, and vacuum to one or more hubs 724 and to a sheath 726. The one or more hubs 724 may include a first hub 724a, a second hub 724b, and a third hub 724c, hereinafter collectively referred to as "hubs 724a-724c". Figure 14 As shown, the catheter is coupled to each of one or more hubs, and each of hubs 724a-724c is configured to supply saline, contrast agent, and vacuum (e.g., as shown in Figure 700) from the fluid system 700 to the lumen of the catheter coupled to the hub. Figure 18 and Figure 19(As shown). To simplify this disclosure, unless the context specifically indicates otherwise, providing saline, contrast agent, or vacuum to the hub also refers to providing saline, contrast agent, or vacuum to the catheter coupled to the hub. Figure 14 An example is a multichannel fluid system configured to individually supply controlled amounts of saline, contrast agent, and vacuum to each of one or more hubs 724a-724c and sheath 726 as needed during a medical procedure. Because the different inner diameters of the catheters result in different lumen sizes for each catheter, and the required amounts of saline, contrast agent, and / or vacuum can vary based on lumen size, it is advantageous to be able to control the saline, contrast agent, and vacuum to each hub separately. Each catheter may also have a different effective lumen size, which can change at certain times during the procedure based on the presence of another catheter or guidewire nested within its lumen. Because different amounts of saline, contrast agent, or vacuum may be required at each catheter during a medical procedure, depending on the intended use of a particular catheter, it is also advantageous to be able to control the saline, contrast agent, and vacuum to each hub separately. In other embodiments, such a fluid system can be configured as a single-channel fluid system that provides controlled amounts of saline, contrast agent, and vacuum to one hub, or as a multi-channel fluid system that provides controlled amounts of saline, contrast agent, and vacuum to two, four, or more hubs.

[0306] In various embodiments, fluid system 700 may have similar or identical features to other fluid systems described herein. In this example, fluid system 700 includes a pump station 702 and a releasably coupleable cartridge 704 to the pump station. Pump station 702 may include components that may be asset equipment. Cartridge 704 may include components that may be designed for single use, and the cartridge is disposable. In an example of use, cartridge 704 is a sterile, single-use component that is coupled to pump station 702 prior to the procedure and is removed and discarded after the procedure. Fluid system 700 may include multiple valves that control saline, contrast agent, or vacuum (e.g., as shown in the image) located in the cartridge, pump station, or hub. Figures 2 to 4 , Figures 14 to 19 , Figure 21 The fluid system 700 may also include sensors in the brine, contrast agent, and vacuum subsystems, and these sensors may be collectively referred to as a sensor assembly. In various embodiments, multiple portions of the valve assembly may be located in pump station 702 or housing 704. Various embodiments of the valve assembly may include more, fewer, or different valves than shown in the figures.

[0307] In this example, fluid system 700 includes saline subsystem 706, contrast agent subsystem 708, and vacuum subsystem 710. In some embodiments, vacuum subsystem 710 may be a vacuum / vacuum (“V / A” or simply “vacuum”) subsystem. Figure 15 An example of a brine subsystem 706 is shown. Figure 16A An example implementation of the contrast agent subsystem 708 is shown. Figure 16B Another example of an implementation scheme for the contrast agent subsystem is shown. Figure 17 An example of one implementation of the vacuum subsystem 710 is shown. Figure 15 Figure 16 and Figure 17 The illustrated embodiments may include additional components (e.g., valves, fluid passages / pipes, connectors, etc.) (e.g., check valves) not shown for clarity of the drawings. In various embodiments, some components of the fluid system 700 may be part of the pump station 702, while others may be part of the housing 704. For example, a portion of the brine subsystem 706 may be in the housing 704, and a portion of the brine subsystem may be in the pump station 702. As a specific example, a portion of the peristaltic brine pump controlling the brine flow may be in the housing 704, and the drive mechanism of the peristaltic brine pump (e.g., actuator / drive motor, drive member) may be in the pump station 702. When the housing is coupled to the pump station 702, the drive mechanism is coupled to a portion of the peristaltic pump within the housing, thereby controlling the flow of brine through the peristaltic pump. In another example, the housing 704 may include a brine port to receive brine from a brine bag positioned outside the housing, and a weight sensor sensing the weight of the brine bag may be part of the pump station.

[0308] Similarly, the contrast agent subsystem 708 or a portion thereof may be located in cartridge 704. For example, a contrast agent infusion pump or a portion thereof may be located in cartridge 704, and cartridge 704 may include a contrast agent port for receiving contrast agent from a contrast agent container located outside cartridge 704. Pump station 702 may include an air column detector configured to detect air in the fluid communication channel (e.g., a pipe) between the contrast agent container and the infusion pump.

[0309] Furthermore, the vacuum subsystem 710 or a portion thereof may be included in housing 704, and a portion of the vacuum subsystem may be included in a pump station. For example, a vacuum tank and a vacuum control valve may be located in housing 704, and a vacuum pump and an actuator for the vacuum control valve may be located in pump station 702. As another example, housing 704 may also include a vacuum port for coupling to a vacuum source of the pump station. Other configurations are also possible, where certain components of the saline subsystem 706, contrast agent subsystem 708, and vacuum subsystem 710 are located in pump station 702, and other components of the saline subsystem 706, contrast agent subsystem 708, and vacuum subsystem 710 are located in housing 704.

[0310] The saline, contrast agent, and vacuum ports are part of a fluid communication system that includes fluid communication channels (e.g., channels, tubes, lines, etc.) to couple conduits to the saline, contrast agent, and vacuum sources. Container 704 includes a portion of the fluid communication system that can be coupled to the saline, contrast agent, and vacuum sources, and a valve within the container partially controls the flow of fluid through the channels of the fluid communication system within the container. The fluid communication system also includes a conduit assembly 716. Conduit assembly 716 may include fluid communication channels for connecting saline, contrast agent, and / or vacuum to hubs 724a-724c and / or connecting saline to a sheath 726. In this example, conduit assembly 716 includes a saline tube 718, a contrast agent tube 719, and a vacuum tube 720. In a preferred embodiment, the conduit assembly includes flexible tubing for supplying saline, contrast agent, and vacuum to the hub. For example, according to some embodiments, the tubing may be 4' to 10' long. Figure 14 As shown in the embodiments, the brine subsystem 706 includes a first connector array 712a, a second connector array 712b, and a third connector array 712c, which represent locations for providing brine, contrast agent, or vacuum. Depending on the configuration of the housing 704, in some embodiments, the first connector array 712a, the second connector array 712b, and the third connector array 712c may be arranged within a second connector array 714, wherein the conduit assembly 716 may be coupled to the second connector array 714. An electrical channel 717 can connect the first hub 724a, the second hub 724b, and the third hub 724c to the housing 704 or to the pump station 702, and can be used to provide control signals to or receive information from the hubs. Although the illustrated electrical channel 717 is a physical communication channel (e.g., including wires, cables, or optical fibers), in some embodiments where the electrical channel 717 is configured to provide control signals to or receive information from the hubs 724a-724c, the electrical channel 717 may be a wireless communication channel.

[0311] Each of hubs 724a-724c may include multiple components related to supplying saline, contrast agent, and vacuum to the catheter, as well as components related to axial movement of the hub and the interventional device attached to the hub, and rotation of the catheter. The tubing assembly 716 may also include electrical connections for communicating control information to one or more hubs 724 and / or receiving information (e.g., sensor information) from the components of hubs 724a-724c. The proximal end 734 of tubing assembly 716 may be coupled to housing 704, and the distal end 732 of tubing assembly 716 may be coupled to hubs 724a-724c and sheath 726. In the example shown, each of hubs 724a-724c is coupled to housing 704 via electrical channel 717, saline tubing 718, contrast agent tubing 719, and vacuum tubing 720. Figure 18 Examples of fluid components in embodiments of the hub are shown. In some embodiments, hubs 724a-724c may include additional components. For example, the hub may include components associated with coupling the interventional device to the hub, moving the hub and the interventional device along the axial direction, and rotating the interventional device. Figure 20 An example of pipe assembly 716 is further shown.

[0312] Figure 15 Some components and connectors of an example brine subsystem 706 are shown, which may be Figure 14 The saline subsystem 706 is shown. In this embodiment, the saline subsystem 706 includes a saline weight sensor 750 coupled to a saline bag 751. A contrast agent needle 752 is used to puncture the saline bag 751 and allow saline to flow through a saline tube 753 into a saline chamber 754. A vent 755 on the chamber allows air to escape from the saline chamber 754 when it is filled with saline. A chamber level detector 756 is positioned to sense the saline level in the chamber. A line 757 connects the saline from the saline chamber 754 to a saline manifold 758. Four peristaltic pumps 762a, 762b, 762c, 762d (hereinafter referred to as "peristaltic pumps 762a-762d") receive saline from the saline manifold 758 via lines 760a, 760b, 760c, 760d (hereinafter referred to as "lines 760a-760d"). Each peristaltic pump 762a-762d is driven by actuators 763a, 763b, 763c, and 763d (hereinafter referred to as "actuators 763a-763d"). Including Figure 15In some embodiments of the examples, the peristaltic pump is located in housing 704, and actuators 763a-763d are located in pump station 702. When the peristaltic pumps 762a-762d are driven by actuators 763a-763d, brine flows through lines 764a, 764b, 764c, and 764d (hereinafter referred to as "lines 764a-764d") to ports S1-S4, which may be located at a connector array that can be coupled to the pipe assembly 716.

[0313] In the illustrated embodiment, a saline / contrast agent valve 766 is included in line 764c. The saline / contrast agent valve 766 can be moved to a first position or a second position by a saline / contrast agent valve actuator 767, which can be located in pump station 702. The saline / contrast agent valve 766 is configured such that when it is placed in the first position (… Figure 15 When (as shown), the saline / contrast agent valve 766 connects line 764c to line 770 to direct saline from peristaltic pump 762c to contrast agent manifold 818. Figure 16A , Figure 16B ), for pre-filling contrast agent subsystem 708. When saline / contrast agent valve 766 is placed in the second position ( Figure 25 When (as shown), the saline / contrast agent valve 766 connects line 764c to line 768 and then to port S3.

[0314] Figure 16A Some components and connections of an embodiment of the contrast agent subsystem 708 are shown. In this embodiment, the contrast agent subsystem 708 includes a contrast agent container 802, a connection 804 to the contrast agent container (e.g., a "contrast agent needle"), and a line 805 coupled to the connection 804 and a contrast agent inlet valve 807. The contrast agent inlet valve 807 is opened and closed by a contrast agent inlet valve actuator 808. The line 809 is coupled to the contrast agent inlet valve 807 and also to a contrast agent pump 810, such that the line 809, the contrast agent inlet valve 807, the line 805, and the connection 804 form a fluid communication channel between the contrast agent pump 810 and the contrast agent container 802, wherein the contrast agent inlet valve 807 is configured to open or close this fluid communication channel. An air column detector 806 is positioned to detect air in line 805 and generate corresponding information (e.g., a signal) that the system controller 2220 can use as an input to the execution process.

[0315] The contrast agent pump 810 includes a housing 811 that surrounds a contrast agent chamber 813 that receives contrast agent from a contrast agent container 802. The contrast agent pump 810 includes a wall or movable portion 812 movable to increase or decrease the size of the contrast agent chamber 813. The movable portion 812 is coupled to a movable member 814, which can be moved by a linear contrast agent pump actuator 815 including a motor. In some embodiments, the contrast agent inlet valve actuator 808, the contrast agent pump actuator 815, and the air column detector 806 (jump sensor) may be located in the pump station 702, and the contrast agent inlet valve 807 (between the connector 804 and the contrast agent pump 810), the contrast agent pump 810, the contrast agent control valves 822a, 822b, and 822c (hereinafter referred to as "contrast agent control valves 822a-822c"), and the piping and assemblies connecting the contrast agent to ports C1, C2, and C3 may be located in the housing 704, such as... Figure 22 As shown.

[0316] Contrast agent is supplied from contrast agent pump 810 to contrast agent manifold 818 via line 816. Contrast agent manifold 818 is provided with fluid communication channels to contrast agent ports C1, C2 and C3 via lines 820a, 820b, 820c (hereinafter referred to as "lines 820a-820c"), contrast agent control valves 822a-822c and lines 826a, 826b, 826c (hereinafter referred to as "lines 826a-826c"). When cartridge 704 is coupled to pump station 702, contrast agent valve actuators 824a, 824b, 824c (hereinafter referred to as "actuators 824a-824c") are coupled to contrast agent control valves 822a-822c and controlled by system controller 2220 to open and close contrast agent control valves 822a-822c for performing preparation procedures (e.g., pre-filling) or for performing medical procedures (e.g., injection of contrast agent). Line 770 is a fluid communication passage connected to the saline subsystem 706 connection and allows saline to flow from saline subsystem 706 to contrast agent manifold 818 controlled by saline / contrast agent valve 766.

[0317] Figure 16B Another example of an embodiment of the contrast agent subsystem 708a is shown. In this embodiment, the contrast agent subsystem 708a includes... Figure 16AThe contrast agent subsystem shown has a similar structure. For example, this embodiment may include a contrast agent container 802, a connector 804 to the contrast agent container (e.g., a "contrast agent needle"), and a line 805 coupled to the connector 804 and the contrast agent inlet valve 807. The contrast agent inlet valve 807 can be opened and closed by a contrast agent inlet valve actuator 808. The line 809 can be coupled to the contrast agent inlet valve 807 and can also be coupled to the contrast agent pump 810 via a connector 819a and a contrast agent inlet line 817a, such that the line 817a, connector 819a, line 809, contrast agent inlet valve 807, line 805, and connector 804 form a fluid communication channel between the contrast agent pump 810 and the contrast agent container 802, wherein the contrast agent inlet valve 807 is configured to open or close this fluid communication channel. An air column detector 806 can be positioned in line 805 to detect air and generate corresponding information (e.g., a signal) that the system controller 2220 can use as an input to the execution process. In this embodiment, the contrast agent subsystem 708a includes two fluid communication channels (lines 817a, 817b) located above the contrast agent pump 810 (i.e., when...). Figure 16B When oriented as shown, lines 817a and 817b are coupled to a contrast agent pump 810, such that lines 817a and 817b are in fluid communication with a contrast agent chamber 813. Line 817b may be coupled to a connector 819b, which may be open to the atmosphere or may be coupled to a vacuum source. In operation, for example, when the movable member 814 is moved to increase the size of the contrast agent chamber 813, contrast agent flows out of the contrast agent container 802 and into the contrast agent chamber 813 through line 817a. The contrast agent inlet valve 807 may be closed, and the movable member (“plunger”) 814 may be moved to decrease the size of the contrast agent chamber 813, which forces any air or other gas in the contrast agent chamber 813 into line 817b and out through connector 819b. In some embodiments, a vacuum source is coupled to connector 819b and applies a vacuum. When plunger 814 moves to reduce the size of the contrast agent chamber, a vacuum can be applied to remove any air or other gas from the movable chamber 813 through line 817b and connector 819b. A valve (not shown) can be coupled to connector 819b to close the line when the contrast agent pump 810 is in use.

[0318] The contrast agent pump 810 includes a housing 811 that surrounds a contrast agent chamber 813 that receives contrast agent from a contrast agent container 802. The contrast agent pump 810 includes a wall or movable portion 812 movable to increase or decrease the size of the contrast agent chamber 813. The movable portion 812 is coupled to a movable member 814, which can be moved by a linear contrast agent pump actuator. In some embodiments, the contrast agent inlet valve actuator 808, the contrast agent pump actuator 815, and the air column detector 806 (jump sensor) may be located in the pump station 702, and the contrast agent inlet valve 807 (between the connector 804 and the contrast agent pump 810), the contrast agent pump 810, the contrast agent control valves 822a, 822b, and 822c (hereinafter referred to as "contrast agent control valves 822a-822c"), and the piping and assemblies connecting the contrast agent to ports C1, C2, and C3 may be located in the housing 704, such as... Figure 22 As shown.

[0319] Contrast agent is supplied from contrast agent pump 810 to contrast agent manifold 818 via lines 816 and 817a. Contrast agent manifold 818 provides fluid communication to contrast agent ports C1, C2, and C3 via lines 820a, 820b, 820c (hereinafter referred to as "lines 820a-820c"), contrast agent control valves 822a-822c, and other downstream lines. This embodiment may include, when coupled to pump station 702, contrast agent valve actuators coupled to contrast agent control valves 822a-822c and controlled by system controller 2220 to open and close contrast agent control valves 822a-822c for performing preparation procedures (e.g., pre-filling) or for performing medical procedures (e.g., contrast agent injection). In some implementations, the contrast agent subsystem 708a may have a fluid communication channel in fluid communication with a contrast agent manifold 818 connected to the saline subsystem 706, allowing saline to flow from the saline subsystem 706 to the contrast agent manifold 818 controlled by a saline / contrast agent valve, similar to Figure 16A The configuration shown.

[0320] Figure 17 An example embodiment of a vacuum subsystem 710 is shown, which includes a vacuum source (vacuum pump 888), a communication channel that can be aligned to provide a vacuum from the vacuum source to a conduit, and components for controlling the supply of vacuum to the conduit. Various configurations of the vacuum subsystem are capable of selectively supplying vacuum to multiple parts of the fluid system and conduits at varying amounts of vacuum (e.g., at a first level (e.g., a lower level) and a second level (e.g., a higher level)). Figure 17In the illustrated embodiment, vacuum pump 888 is coupled to lines 885, 889, and 883, which provide access to vacuum tank 882. Specifically, in this example, vacuum pump 888 is coupled to line 885, which is coupled to vacuum regulator 890, which can be controlled by a controller to provide a desired level of vacuum. Line 889 is coupled to vacuum regulator 890 and also to sterile filter 886. Line 883 is coupled to sterile filter and vacuum tank 882, which provides a reservoir for collecting aspirated material 899. Line 873 is also coupled to vacuum tank 882 and to vacuum manifold 875, which is further coupled to channels providing vacuum to multiple hubs / ducts of the robotic catheter system, e.g., as... Figure 18 and Figure 19 As shown. In this example, line 873 is coupled to vacuum regulator valve 877, which can be controlled by a controller to provide a desired vacuum level to downstream vacuum subsystems (e.g., vacuum manifold 875, ports V1-V3, etc.). Vacuum pressure sensor 871 can be positioned between vacuum regulator valve 877 and ports V1-V3 to measure the vacuum supplied to the hub and conduits. In this example, vacuum pressure sensor 871 is positioned on line 873 between vacuum regulator valve 877 and clumping chamber 927b, which is positioned on line 873 between vacuum manifold 875 and vacuum regulator valve 877 to receive clumping aspirated by any of a plurality of conduits connected to vacuum subsystem 710. In some embodiments, clumping chamber 927 includes clumping chamber sensor 932, which communicates with a controller to provide information about the contents of clumping chamber 927 (e.g., when it contains clumping). In some embodiments, clumping chamber sensor 932 includes one or more imaging devices. For example, the implementation may include a camera. Images generated by one or more imaging devices may be displayed on a monitor at a remote control station and / or on a monitor in a local control room. A flow sensor 880 (e.g., an ultrasonic flow sensor) is located between the clotting chamber 927 and the vacuum manifold 875 to sense the material flow through the line 873 and provide flow information to the controller.

[0321] Vacuum manifold 875 can be coupled to lines 879a, 879b, 879c (hereinafter referred to as "lines 879a-879c") and lines 878a, 878b, 878c (hereinafter referred to as "lines 878a-878c"), which provide vacuum channels to the hub / duct via ports V1-V3. Vacuum control valves 874a, 874b, and 874c (hereinafter referred to as "vacuum control valves 874a-874c") can be one-way valves and are coupled between lines 879a-879c and lines 878a-878c to control the supply of vacuum to ports V1-V3. Vacuum control valves 874a-874c are opened and closed by vacuum control valve actuators 876a, 876b, and 876c (hereinafter referred to as "vacuum control valve actuators 876a-876c") of pump station 702, which are controlled by a controller. To provide a vacuum to one or more of ports V1-V3 and the hubs and conduits coupled to ports V1-V3, the controller opens vacuum control valves 874a-874c corresponding to the desired port, actuates vacuum pump 888, and controls vacuum regulator 890 and vacuum regulator valve 877 to generate the desired vacuum and monitors the supplied vacuum using vacuum pressure sensor 871. Some implementations may include a flow sensor 880 associated with each port V1-V3 and / or a vacuum pressure sensor 871 associated with each port V1-V3. However, in most procedures, a vacuum is provided to one conduit at a time, and in such cases, multiple flow and pressure sensors do not provide any operational advantage, and as... Figure 17 As shown, having a single flow sensor 880 and a single vacuum pressure sensor 871 positioned upstream of the vacuum manifold 875 reduces costs. In some embodiments, the vacuum pump 888, vacuum regulator 890, vacuum control valve actuators 876a-876c, and flow sensor 880 are part of pump station 702, and sterile filter 886, vacuum tank 882, vacuum regulator valve 877, vacuum pressure sensor 871, clumping chamber 927, and vacuum control valves 874a-874c are located in box 704.

[0322] Figure 18 An example of a conduit 730 is shown, which is coupled to an embodiment of a tubing assembly 716 in a hub 910 of a fluid management system. The distal end 732 of the tubing assembly 716 is coupled to the hub 724 and the conduit 930, and the proximal end 734 of the tubing assembly 716 may be coupled to a housing 704, which may include all or part of a saline subsystem, all or part of a contrast agent subsystem, and / or all or part of a vacuum subsystem of the fluid management system. Figure 18Certain components shown may be described as part of tubing assembly 716, even if they are in hub 724 or part of sterile connector, because they operate to perform part of the fluid and vacuum connectivity functions facilitated by the configuration of the tubing assembly. Tools for providing fluid and electrical connections to the catheter may include one or more of the saline subsystem, contrast agent subsystem, vacuum subsystem, and / or electrical connections described herein.

[0323] like Figure 18 As shown, conduit 930 can be coupled to a portion of piping assembly 716 of the fluid management system via Luer connector 926. In this example, a portion of piping assembly 716 includes a contrast agent tube 937 connected to port / connection point C1, a saline tube 939 connected to port / connection point S1, and a suction tube 935 connected to port / connection point V1. One or more electrical channels 717 are connected to port / connection point E1, which may be on housing 704 or on pump station 702. In some embodiments, electrical channels 717 are part of piping assembly 716 such that piping assembly 716 includes tubes for communicating saline, contrast agent, and vacuum tubes from housing to hub, and electrical connections to hub, and such embodiments are advantageous for wire / tube management. Piping assembly 716 may include branch points in the form of two-to-one Y-connectors 920 that couple the upstream of contrast agent tube 937 and saline tube 939 of piping assembly 716 to a single downstream saline / contrast agent tube 940. The piping assembly may further include a three-way valve 923, which can be actuated by a three-way valve actuator 924 to selectively connect the conduit 930 to a single downstream saline / contrast agent tubing 940 or aspiration tubing 935. In some embodiments, the piping assembly 716 may further include a conduit coupling tube 933 downstream of the three-way valve 923 to couple the three-way valve 923 to the conduit 930. The three-way valve actuator 924 may be actuated by a controller. In some embodiments, the three-way valve actuator 924 includes a drive assembly configured to move the three-way valve 723. In some embodiments, the three-way valve actuator 924 includes an electromechanical tool for moving the three-way valve 923, said electromechanical tool being controlled by a controller. In some embodiments, the three-way valve actuator 924 includes a motor controlled by a controller.

[0324] In some embodiments, the three-way valve 923 may be a three-way stopcock. The three-way valve 923 may be actuated (e.g., rotated) to selectively provide or prevent fluid communication between ports coupled to the saline / contrast agent tubing 940, the aspiration tubing 935, and the catheter coupling tubing 933. The three-way valve 923 may be actuated to a first position to open the fluid communication passage between the aspiration tubing 935 and the catheter coupling tubing 933, and to a second position to open the fluid communication passage between the saline / contrast agent tubing 940 and the catheter coupling tubing 933. In some embodiments, the three-way valve 923 may be actuated to a third position where the aspiration tubing 935, the saline / contrast agent tubing 940, and the catheter coupling tubing 933 are all in fluid communication. In some embodiments, the three-way valve may be actuated to a fourth position where the vacuum tubing 935 and the saline / contrast agent tubing 940 are in fluid communication. In some implementations, the three-way valve 723 can be actuated to a fifth position where the suction tube 935, saline / contrast agent tube 940, and catheter coupling tube 933 are not in fluid communication.

[0325] Despite Figure 18 The diagram shows a three-way valve 923, but other valve arrangements can be used to selectively position the conduit 930 in communication with the saline / contrast agent tube 940 or the suction tube 935.

[0326] like Figure 18 As shown, an air bubble filter 922 can be positioned between the Y-connector 920 and the three-way valve 923. In some embodiments, a clumping chamber 927 can be positioned upstream of the three-way valve 923 along the suction pipe 935. A clumping chamber sensor 932 (in communication with a controller) can be positioned to detect material on the clumping chamber 927. In some embodiments, the clumping chamber 927 can be positioned in the hub 724 along the suction pipe 935 upstream of the three-way valve 923. In some embodiments, multiple portions of the Y-connector 920, three-way valve 923, three-way valve actuator 924, clumping chamber 927a, and / or pipe assembly can be accommodated within a magnetic sterile fitting that can be coupled to the hub 724 (also referred to as a seat) and can be considered part of the hub assembly. In some embodiments, a clumping chamber 927b can be positioned. The clumping chamber 927a can be positioned along the suction pipe 935 near the vacuum tank 882, for example, between the vacuum manifold 875 and the vacuum tank 882, such as... Figure 17 The implementation plan is shown below.

[0327] A hemodynamic pressure sensor 929 may be positioned between a three-way valve 923 and a catheter 930, for example, on a catheter coupling tube 933. The hemodynamic pressure sensor 929 is configured to detect the hemodynamic pressure of a patient in which the catheter 930 is inserted and to provide information related to the detected pressure to a controller. Figure 19Another embodiment of components and fluid communication channels that can be coupled to and / or positioned in the hub is shown, and an example of another interventional device 931 (e.g., catheter, guidewire) that can be coupled to another hub and positioned to extend through the hemostatic valve 928 and at least partially enter the lumen of the catheter 930 is also shown.

[0328] Figure 20 An example embodiment of a conduit assembly 716 is shown, which provides communication pathways from the cartridge to one or more hubs and sheaths. The conduit assembly 716 has a distal end 732 and a proximal end 734. In this example, different portions of the distal end 732 are coupled to a first hub 724a, a second hub 724b, a third hub 724c, and a sheath 726. Different portions of the proximal end 734 are coupled to contrast agent, saline, vacuum, and electrical connections on the cartridge. In this example, different portions of the proximal end 734 are coupled to contrast agent ports (C1, C2, C3) of the contrast agent subsystem, saline ports (S1, S2, S3, S4) of the saline subsystem, vacuum ports (V1, V2, V3) of the vacuum subsystem, or a vacuum subsystem to provide fluid communication pathways from the contrast agent, saline, and vacuum sources to the hubs, and to the saline subsystem to the sheath. In this example, the conduit assembly 716 also includes electrical communication channels connecting connectors E1, E2, and E3 to hubs 724a-724c and housing 704. These electrical communication channels can provide power to the hub to operate its components and / or provide signals / information from the hub (e.g., from a hemodynamic sensor located in or on the hub) to the housing. The housing may include electrical connections that, when attached to a pump station, couple to corresponding electrical connections on the pump station, allowing the pump station to provide power to the hub via the electrical communication channels of the housing and conduit assembly, and / or receive signals / information from the hub via the electrical communication channels of the conduit assembly and housing.

[0329] Figure 21 and Figure 64 A schematic diagram of an example robotic catheterization system is shown, which includes a remote positioning system (“remote system”) and a local positioning system (which may be referred to as a “local system”, “bedside system”, or “patient-near system”). Figure 21 Broadly speaking, it involves Figure 22-63 The implementation plans and processes in the plan, but multiple aspects of these implementation plans may also be involved. Figure 64-87 The implementation plan. Figure 64 Broadly speaking, it involves Figures 65 to 87 Examples of implementation schemes and processes described herein are provided, but other implementation schemes may also be involved in multiple aspects. Figure 21 and Figure 64Examples of certain components of a local system are also shown according to some embodiments, the local system including certain components of a fluid management system (“fluid system”) including actuable components actuated by a controller and sensors that provide information to the controller so that the controller controls other aspects of the fluid system and the robotic catheter system. The remote portion includes a control system 2210 located remotely from the patient's position. As used herein, “local,” “bedside,” or “local location” refers to the location of the “local” portion of the robotic catheter system, i.e., the actual location where the patient is receiving medical treatment using the robotic catheter system. As used herein, “remote,” “remote location,” or “remote portion” are broad terms and generally refer to a location other than the patient / local system location when the patient is undergoing medical treatment using the robotic catheter system. In some cases, the remote location is within the same building as the patient. For example, in a different part of the patient's room (e.g., on the other side of a barrier or at the bedside), or in an adjacent room within the same building, in a different room from the patient within the same building, or in a different building, or even in a different town or city or country. In some implementations, the remote portion is located a few feet, or hundreds or thousands of miles, away from the local portion. Control system 2210 is configured to communicate with system controller 2220, which is part of the local portion of the system. System controller 2220 may include multiple controllers, each having one or more processors. In this example, system controller 2220 includes interface 2235. Interface 2235 may include multiple interfaces and may be a user interface. Interface 2235 may be configured to communicate with the remotely located control system 2210. For example, interface 2235 may be configured to receive control signals from control system 2210 and communicate corresponding signals to a controller (e.g., controller 2230 or pump station 2240) to perform fluid actions (e.g., injecting contrast agent from a catheter, providing aspiration from a catheter), or axially moving one or more hubs (724, ...). Figure 21 ), (1400, Figure 64 The interface 2235 can be configured to move an attached elongated device (e.g., catheter, guidewire) axially, or to move an attached elongated device by causing one or more hubs to rotate about their longitudinal axis. Interface 2235 can also be configured to receive control information (e.g., for fluid manipulation or control of hub movement and coupling to the interventional device) from a local user and to provide information (status, images, etc.) to the local user. Interface 2235 may include multiple interfaces, such as one or more displays and displays related to the robotic catheter system, medical procedure, and / or patient. Interface 2235 may also include one or more user input devices, such as switches, buttons, touchscreen controls, etc.

[0330] Interface 2235 can also be configured to communicate information to remote positioning control system 2210. The communicated information may relate to received control actions, fluid information, catheter position information, status information, images or video, audio, and other communications from the robotic system or a user located locally on the patient, as well as any other information that may require control of the robotic catheter system from control system 2210. Interface 2235 can also be configured to receive user input from the robotic catheter system located on the patient.

[0331] System controller 2220 may include a pump station 2240 for performing fluid-related actions, and a controller 2230 configured to process user input received locally or from control system 2210, process sensor information, and control pump station 2240 and other parts of the robot control system based on user input and sensed information to perform medical procedures, including supplying saline, contrast agents, and vacuum to the hub. In some embodiments, system controller 2220 may also control the supply of saline to the femoral sheath.

[0332] Figure 21 The illustrated robotic catheter system may include actuable components of a fluid management system movable, as controlled by a controller, to align fluid communication channels to supply saline, contrast agent, and vacuum (respectively) to hubs 724a-724c, and includes sensors configured to sense configurations related to the supply of saline, contrast agent, and vacuum to hubs 724a-724c, and to provide the sensed information to the controller. The controller may be configured to use the sensed information, user input, and / or stored information to control the movement of the fluid system to perform a medical procedure. In various embodiments, pump station 2240 may include a controller to control actuators of pump station 2240 to perform fluid-related actions (e.g., supplying saline, contrast agent, and vacuum to hubs 724a-724c). In other embodiments, controller 2230 and / or system controller 2220 may be configured to control actuators and other components of pump station 2240 to perform fluid-related actions. For clarity, Figure 21 Many components and systems of the robotic duct system are not shown (e.g., hub axial drive system, check valve, duct rotation system, controller of remote control system 2210, etc.).

[0333] A cartridge configured to be releasably attached to a pump station may include all or part of a saline subsystem 706, a contrast agent subsystem 708, and a vacuum subsystem 710. Determining what is disposable may be based on contact or proximity to patient materials (cells, blood, removed clots, etc.). In some embodiments, the cartridge and its components are disposable, and the pump station 702 and its components are non-disposable (e.g., asset equipment). In an example of saline subsystem 706, pump station 702 may include a saline weight sensor 750 and a saline drip rate sensor 759, peristaltic pump actuators 763a-763d, and a saline / contrast agent valve actuator 767, and cartridge 704 may include a saline level detector 745, peristaltic pumps 762a-762d, and a saline / contrast agent valve 766. Figure 15 In an example of the contrast agent subsystem 708, pump station 702 may include a contrast agent inlet valve actuator 808, a contrast agent pump actuator 815, contrast agent valve actuators 824a-824c, and an air column detector 806, and cartridge 704 may include contrast agent valves 822a-822c, a contrast agent pump 810, and a contrast agent inlet valve 807 (e.g., Figure 16A , Figure 16B In an example of vacuum subsystem 710, pump station 702 may include vacuum pump 888, vacuum regulator 890, vacuum control valve actuators 876a-876c, and flow sensor 880 (e.g., ultrasonic flow sensor), and housing 704 may include vacuum regulator valve 877, vacuum pressure sensor 871, clump chamber sensor 932, and vacuum control valves 874a-874c. In various embodiments, pump station 702 and housing 704 may include additional or fewer components. Furthermore, in some embodiments, certain components shown and / or described herein as part of the housing may be located in the pump station, and certain components shown and described herein as part of or supported by the housing may be located in the pump station.

[0334] exist Figure 21 In the diagram, solid lines represent actuable components and sensors, where the actuable components can be directly or indirectly controlled by the controller, and the sensors provide information to the controller. Dashed lines represent components that are neither sensors nor actuable components (e.g., ports S1-S4, C1-C3, V1-V3; saline chamber, vacuum tank, sheath). In this embodiment, the actuable components of the saline subsystem 706 may include peristaltic pump actuators 763a-763d and a saline / contrast agent valve actuator 767, which can be operated to actuate the saline / contrast agent valve 766 (…). Figure 15The system is positioned at a first or second location to open or close the fluid communication channel between the saline subsystem 706 and the contrast agent subsystem 708. Sensors for the saline subsystem 706 may include a saline weight sensor 750, a saline level detector 745 that detects the saline level in the saline chamber 754, and a saline drip rate sensor 759. In this embodiment, actuable components for the contrast agent subsystem 708 may include a contrast agent inlet valve actuator 808, a contrast agent pump actuator 815, and contrast agent valve actuators 824a-824c; sensors for the contrast agent subsystem may include an air column detector 806. In some embodiments, the contrast agent subsystem may include multiple air column detectors 806a, 806b. In this implementation, the actuable components of the vacuum subsystem 710 may include a vacuum pump 888, a vacuum regulator 890, a vacuum regulator valve 877, and vacuum control valve actuators 876a-876c; the sensors of the vacuum subsystem may include a vacuum pressure sensor 871, a clotting chamber sensor 932, and a flow sensor 880 (e.g., an ultrasonic flow sensor).

[0335] The fluid system may also include channels and components in one or more hubs 724. For example, such as Figure 18 and Figure 19 The implementation plan is shown below. Figure 21 Examples of actuable components associated with hubs are also shown, which can be actuated by a controller for managing fluid or providing a vacuum. In this embodiment, the robotic catheter system includes three hubs 724a-724c and a fourth hub 724D, with catheters coupled thereto in hubs 724a-724c and guidewires coupled thereto in hub 724D. In some embodiments, the guidewire is releasably coupled to the fourth hub 724d. Hubs 724a-724c include a hemostatic valve 928 and a valve 923 (e.g., a three-way valve) for coupling the catheter lumen to fluid or a vacuum. Hubs 724a-724d have an actuation mechanism 2202 that can function to move the hub (and the interventional device coupled thereto) back and forth along a common line (“axial”). Hubs 724a-724d also have an actuation mechanism 2204 that can be rotatably coupled to the interventional device of the hub about the longitudinal axis of the hub. In various embodiments, the drive mechanism in hub 724 can be coupled to a drive mechanism outside the hub (e.g., magnetically, mechanically, etc.) such that the drive mechanisms interact to move the hub axially and rotate the intervention device.

[0336] Figure 22 An illustration of an embodiment of housing 704 and pump station 702 is shown, illustrating certain components of the housing (e.g., valves, electrical connections, etc.) and corresponding components of the pump station (e.g., motors, electrical connections, etc.). Figure 22 The boxes and components shown in the pump station can correspond to, for example, those described in this document. Figures 2 to 4 , Figures 14 to 17 , Figure 20 and Figure 21 And many other components described and shown in the accompanying drawings.

[0337] Figure 23 This is a flowchart illustrating a fluid process 2300 that can be performed using a robotic conduit system. At block 2305, a housing and tubing assembly are coupled to the robotic conduit system. In some embodiments, the housing may be... Figure 22 The box 704 shown, the pipe assembly can be Figure 20 The piping assembly 716 is shown. Although the embodiments herein generally describe a box coupled to a pumping station, in alternative embodiments, the box can be coupled to any system configured to provide actuation of the box's actuable components. For ease of reference, the phrase "pumping station" is used herein to refer to a system or pumping station configured to receive the box and provide actuation of the box's actuable components, and to connect to the box's sensors as needed. For example, a pumping station or system configured with... Figure 22 Other systems for the actuator shown. In some embodiments, coupling the housing and piping assembly to the pump station can be done automatically or manually.

[0338] At box 2310, the process verification box is installed. Verification may include verifying that the box is properly installed such that the pump station's actuators are coupled to actuable components within the box, and sensors are coupled to a connector (e.g., an electrical connector) of the pump station configured to receive signals from the sensors. Verification may include verifying information about the box, such as the type of box, its compatibility with the pump station, or that it is a genuine box from a particular manufacturer. In one example, verification may be performed by a user. In another example, verification may be performed by a controller that receives information about the box and verifies the box based on stored information, such as mechanical or electrical components of the box (e.g., RFID tags, chips, transducers, electrical or electronic circuitry, mechanical keys, etc.).

[0339] At box 2350, fluid process 2300 pre-fills the fluid system to prepare it for operation during medical procedures. In some embodiments, a user may use a robotic catheter system to pre-fill the cartridge, tubing assembly, hub, and catheter. This can be achieved, for example, by providing user input controls to interface 2235. In some embodiments, the robotic catheter system may automatically perform fluid operations based on stored execution instructions for executing the fluid process and inputs from components of the robotic catheter system, such as sensors, feedback signals from actuators, etc. The pre-filling fluid system may include filling the fluid communication channels of the fluid system with saline and / or contrast agent to remove air from the fluid communication channels. Fluid process 2300 may be a pre-filling process that may include a pre-fill cartridge 2352, a pre-fill tubing assembly 2354, and a pre-fill hub and catheter 2356. (Reference) Figure 24A and Figure 24B The flowchart and Figures 25 to 43 The schematic diagram of the pre-filling process illustrates examples of certain pre-filling processes, schematically showing the process for pre-filling a fluid communication system that supplies saline, contrast agent, and aspiration to the lumen of one or more hubs and conduits coupled to one or more hubs.

[0340] A fluid communication system (or fluid system) may include fluid communication channels (“channels”) in a housing, one or more piping assemblies, splitters, manifolds, and / or one or more seats and hubs to supply saline, contrast agent, and vacuum from one or more saline sources, one or more contrast agent sources, and / or one or more vacuum sources to one or more hubs. Multiple parts of the fluid system may be integrated into other system components, such as in seats coupled to conduits. Fluid communication channels may include pipes, channels, sub-channels, manifolds, valves, and other components through which saline and contrast agent flow and through which vacuum is provided in the housing, splitter, piping assemblies, seats, hubs, and conduits.

[0341] For ease of reference, providing fluid (saline, contrast agent) to the hub is used synonymously with providing fluid to the catheter coupled to the hub, unless otherwise specifically indicated or indicated by the context. Furthermore, for ease of reference, techniques relating to providing vacuum or aspiration to the seat / hub / catheter may also be described as providing fluid to the seat / hub / catheter, unless otherwise specifically indicated or indicated by the context. For example, fluid communication channels, lines, subchannels, etc., may be described as providing saline, contrast agent, and / or vacuum to the seat / hub / catheter.

[0342] Although the embodiments described herein have one saline source, one contrast agent source, and one vacuum source, those skilled in the art will understand that other embodiments may include those that may include multiple saline sources, multiple contrast agent sources, and / or multiple vacuum sources. In some embodiments, as examples, the saline subsystem may include multiple saline sources supplied to a single fluid communication channel to provide saline to the saline chamber. In some embodiments, as examples, the contrast agent subsystem may include multiple contrast agent sources supplied to a single fluid communication channel to provide contrast agent to the contrast agent pump. Embodiments of fluid systems that supply saline to multiple hubs (e.g., three) and sheaths and to multiple hubs (e.g., three) may require larger volumes of saline and contrast agent compared to fluid systems that supply saline and / or contrast agent to a single catheter. Therefore, having multiple saline sources, multiple contrast agent sources, and / or multiple vacuum sources is advantageous for redundancy purposes, increasing the safety of medical procedures (e.g., the vacuum pump becoming inoperable) and also preventing them from becoming new contrast agent or saline sources during prolonged medical procedures.

[0343] Figure 24A and Figure 24B The process of prefilling channels in cartridges, tubing assemblies, and hubs with saline and contrast agent is illustrated. As shown herein, the operations of prefilling channels with saline and contrast agent can be interrelated; for example, a contrast agent channel can be prefilled with saline to remove air, and then prefilled with contrast agent. Figure 24A Process 2400 is shown for pre-filling a portion of a fluid communication system that supplies brine to one or more hubs. At block 2405, a container containing brine (e.g., a bag, bottle, or other container) is coupled to a brine subsystem for fluid communication with the brine subsystem. Although block 2405 can be performed manually, in some embodiments, a controller controls the fluid system to perform this operation. At block 2410, process 2400 pre-fills a cartridge with brine. At block 2415, process 2400 pre-fills a tubing assembly with brine. At block 2420, process 2400 pre-fills a hub and conduit with brine. In process 2402, at block 2435, a container containing contrast agent (e.g., a bag, bottle, or other container) is coupled to a contrast agent subsystem for fluid communication with the contrast agent subsystem. Although block 2435 can be performed manually, in some embodiments, a controller controls the fluid system to perform this operation. At block 2440, process 2402 pre-fills a contrast agent pump with contrast agent. At box 2445, process 2402 prefills the contrast agent cartridge. At box 2450, process 2402 prefills the contrast agent channel hub of the tubing assembly with contrast agent. Examples of these operations are shown in... Figures 25 to 43 .

[0344] Figure 25An example of a brine subsystem 706 in a dry configuration is shown, wherein the brine bag 751 is not yet coupled to the brine subsystem 706. Figure 25 The brine subsystem 706 shown has the same characteristics as... Figure 15 The brine subsystem 706 shown has the same components. In a fully dry (pre-charge) configuration, the channels and components of the brine subsystem 706 do not contain brine, but rather contain, for example, air or an inert gas. The positioning of these components and other components of the brine subsystem 706 can be determined by a controller to ensure that they are correctly aligned before the pre-charge operation begins.

[0345] Figure 26 The diagram illustrates the configuration of the saline subsystem 706 after the saline bag 751 has been coupled to the saline subsystem 706 via the contrast agent needle 752, such that saline from the saline bag 751 begins to flow into the saline chamber 754 via the saline tubing 753. As saline flows into the saline chamber 754, air escapes from the chamber through an air outlet 755, which includes a check valve configured to pass through the air outlet 755 in one direction. The saline level in the saline chamber 754 is detected by a chamber level detector 756, which provides this information to a controller. In this configuration, the peristaltic pumps 762a-762d are not yet activated, and the saline / contrast agent valve 766 is positioned to connect tubing 764c to port S3.

[0346] Figure 27 An example of a hub (similar to) is shown. Figure 19 As part of the brine prefilling process, a three-way valve actuator 924 positions a three-way valve 923 to connect the brine line 939 to the suction line 935 and controls the vacuum subsystem to provide a vacuum on the suction line 935. Connecting the brine line 939 to the suction line 935 facilitates the prefilling of the brine box and piping assembly because it provides the flow of brine through the box and piping assembly. Figure 27 A single configuration is shown. In a system configuration with multiple hubs, a similar configuration can be arranged at each hub, such that all hubs have brine lines in fluid communication with their vacuum lines.

[0347] After the fluid communication system has been configured with a discharge path for brine, the controller actuates peristaltic pumps 762a-762d to prefill the brine subsystem channels in the cartridge with brine, such as... Figure 28As shown. The saline / contrast agent valve 766 remains positioned to connect line 764c to port S3. In this example, actuation of peristaltic pumps 762a-762d provides saline through line 757 from saline chamber 754 to saline manifold 758, then through peristaltic pumps 762a-762d to lines 760a-760d, and through lines 764A-764d to ports S1-S4 (which are coupled to the tubing assembly and hub), such that saline manifold 758 and lines 757, 760a-760d, 764A-764d, and 768 are filled with saline. The controller continues to actuate peristaltic pumps 762a-762d to provide a continuous flow of saline through these lines.

[0348] Figure 29 An example of the contrast agent subsystem 708 in a configuration prior to coupling the contrast agent container 802 to the contrast agent subsystem 708 is shown. In a fully dry (pre-fill) configuration, the channels and components of the contrast agent subsystem 708 do not contain contrast agent, but rather contain, for example, air or an inert gas. In this configuration, contrast agent control valves 822a-822c are in the closed position, and the contrast agent inlet valve 807, located upstream of the contrast agent pump 810, is in the open position. The positioning of these components, as well as other components of the contrast agent subsystem 708, can be determined by a controller to ensure they are correctly aligned before initiating the pre-fill operation.

[0349] Figure 30 This shows the current coupling to the contrast agent container 802. Figure 29 The contrast agent subsystem 708. In some embodiments, a user can perform the operation of coupling contrast agent container 802 to contrast agent subsystem 708. In other embodiments, a controller can control the coupling of contrast agent container 802 to contrast agent subsystem 708. For example, contrast agent container 802 may be located near a pump station (e.g., attached to a pump station, located in a compartment of a pump station, etc.), and the controller may operate the pump station to couple line 805 to contrast agent container 802 (“piercing” contrast agent container 802).

[0350] Now for reference Figure 31The contrast agent pump 810 is actuated to fill a portion of the contrast agent chamber 813 with contrast agent. In this example, the actuator of the pump station is coupled to and moves the movable member 814 to correspondingly move the movable portion 812, thereby increasing the size of the contrast agent chamber 813 and allowing contrast agent to flow from the contrast agent container 802 through line 805, through contrast agent inlet valve 807, through line 809, and into the contrast agent chamber 813. In some examples, the contrast agent chamber 813 may be filled with about 50% of its capacity of contrast agent during this portion of the process. In some examples, the contrast agent chamber 813 may be filled with about 20% to 80% of its capacity of contrast agent. Still in other examples, the contrast agent chamber 813 may be filled with about 5% to 95% of its capacity of contrast agent. During this portion of the pre-filling process, the contrast agent chamber 813 may contain air and contrast agent. In this configuration, contrast agent control valves 822a-822c are closed, and saline / contrast agent valve 766 ( Figure 28 The saline subsystem 706 and the contrast agent subsystem 708 are also aligned, so that they are not connected.

[0351] like Figure 32 As shown, next, the contrast agent pump 810 can be actuated to move the movable part 812, thereby reducing the size (volume) of the contrast agent chamber 813. This allows contrast agent and air to be expelled from the contrast agent chamber 813 via line 809 (first line), contrast agent inlet valve 807, and line 805, and returned to the contrast agent container 802, thus removing all air from the contrast agent chamber 813. Line 809 is coupled to the upper part of the contrast agent chamber 813 such that any air in the contrast agent chamber 813 flows out through line 809. The mixture of air and contrast agent flowing out of the contrast agent pump 810 can flow through the air column detector 806, which is configured to detect air bubbles and provide information to the controller, allowing the controller to determine when all air has been removed from the contrast agent chamber 813. In this configuration, contrast agent control valves 822a-822c are closed, and saline / contrast agent valve 766 ( Figure 28 The saline subsystem 706 and the contrast agent subsystem 708 are also aligned, so that they are not connected.

[0352] like Figure 33 As shown, next, the contrast agent pump 810 can be actuated to move the movable part 812, thereby increasing the size of the contrast agent chamber 813 to draw contrast agent into the contrast agent chamber 813 through line 809 (first line), contrast agent inlet valve 807, and line 805. In some examples, during a portion of this process, the contrast agent chamber 813 may be filled with, for example, 90% to 100% of its capacity with contrast agent. In this configuration, contrast agent control valves 822a-822c are closed, and saline / contrast agent valve 766 ( Figure 28The saline subsystem 706 and the contrast agent subsystem 708 are also aligned, so that they are not connected.

[0353] Now for reference Figure 34 To initiate fluid communication with the pre-filled contrast agent subsystem 708, the contrast agent inlet valve 807 is closed to prevent contrast agent flow between the contrast agent container 802 and the contrast agent pump 810, and the first contrast agent control valve 822a is opened to provide fluid communication from the contrast agent pump 810 to port C1. The contrast agent pump 810 is then actuated to push contrast agent into line 816 to the contrast agent manifold 818. In this configuration, the saline / contrast agent valve 766 ( Figure 28 The two systems remain aligned, preventing the saline subsystem 706 and the contrast agent subsystem 708 from connecting.

[0354] Figure 35 and Figure 36 Another part of the pre-charge process is shown, in which all peristaltic pumps 762a-762d are running, and the brine communication channel is between the pre-charge box and the hub. Figure 35 The diagram illustrates a configuration in which brine flow is supplied from brine chamber 754 to ports S1-S4 via lines 757, brine manifold 758, lines 760a-760d, peristaltic pumps 762a-762d, and lines 764A-764d and 768. Figure 35 In the configuration shown, the saline / contrast agent valve 766 ( Figure 28 The saline subsystem 706 and the contrast agent subsystem 708 are aligned so that they are not connected. For example... Figure 36 As shown, in the hub configuration example, a three-way valve 923 is aligned to connect the brine line 939 to the suction line 935, which provides a low vacuum. In this configuration, brine flows through the brine line 939, check valve 921, Y-connector 920, air bubble filter 922, brine / contrast agent line 940, three-way valve 923, and line 936 to the suction line 935. In this example, the brine also flows through a clot chamber 927 located between line 936 and the suction line 935. In other examples, the clot chamber 927 may be located upstream of the vacuum tank, or in another location. In some embodiments, for example, as... Figure 53 As shown, line 936 may be part of suction tube 935.

[0355] like Figure 37 As shown, when all peristaltic pumps 762a-762d are running, the saline / contrast agent valve 766 can be actuated to connect the saline subsystem 706 to the contrast agent subsystem 708 to pre-fill the fluid communication channels in the contrast agent subsystem 708 with saline. In this example, the saline / contrast agent valve 766 can be positioned to connect line 764c to line 770, which is connected to the contrast agent manifold 818, as... Figure 38 As shown. Figure 38 As shown, contrast agent lines are pre-filled with saline. In this embodiment, the contrast agent lines are pre-filled with saline one at a time. In this example configuration, the saline supplied to the contrast agent manifold 818 comes from a single peristaltic pump 762c, and the volume of saline supplied by a single pump is unlikely to be sufficient to flush multiple contrast agent lines simultaneously. In other embodiments, if the peristaltic pump output is sufficient, or in a configuration with multiple peristaltic pumps, each peristaltic pump can be positioned in fluid communication with the contrast agent manifold 818, more than one contrast agent line can be pre-filled simultaneously. Figure 38 In this configuration, the first contrast agent control valve 822a is opened to pre-fill the contrast agent communication channel into the first hub 724a. Contrast agent control valves 822a-822c are opened one at a time, while the saline / contrast agent valve 766 remains open, to provide saline flow from line 770 through contrast agent manifold 818, through lines 820a-820c, contrast agent control valves 822a-822c, lines 826a-826c, ports C1-C3, and tubing group 716 to one or more hubs 724 to pre-fill the contrast agent lines in the cassette and tubing group with saline. In this example, the Zoom 88 conduit is coupled to the first hub 724a, the Zoom 71 conduit is coupled to the second hub 724b, and the insertion conduit is coupled to the third hub 724c. Figure 39 The hub is shown, and the fluid communication channel of the contrast agent pre-filled with saline solution subsystem 708 is further shown. (See diagram.) Figure 39 As shown, the fluid system is configured to supply saline to the suction tube 935 via the contrast agent tube 937 and Y-connector 920, air bubble filter 922, saline / contrast agent tube 940, and three-way valve 923, while a vacuum pump provides a vacuum on the suction tube 935 to facilitate saline flow through these lines and components.

[0356] Once the contrast agent fluid communication channels (or "contrast agent channels") in the cartridge and tubing assembly are pre-filled with saline, the controller can operate the fluid system to pre-fill each of the contrast agent channels in the cartridge and tubing assembly with contrast agent to remove air from the contrast agent channels. For example, as Figure 40 As shown, with contrast agent inlet valve 807 closed and one of contrast agent control valves 822a-822c (e.g., the first contrast agent control valve 822a) open, contrast agent can flow from lines 820a and 826a, and three-way valve 923 ( Figure 39 When the saline / contrast agent tubing 940 is connected to the suction tubing 935, the contrast agent pump 810 is actuated and pushes the contrast agent out of the contrast agent chamber 813 through line 816, contrast agent manifold 818, line 820a, first contrast agent control valve 822a, line 826a to port C1, and then through the contrast agent tubing if the tubing assembly 716 leads to the first hub 724a. Figure 41 As shown (depicting an example of the first hub 724a), the contrast agent is received via contrast agent tubing 937 through tubing assembly 716, and it flows through Y-connector 920, through air bubble filter 922, through saline / contrast agent tubing 940, and is guided by three-way valve 923 to suction tubing 935 (vacuum passage of tubing assembly 716), where it is discharged into vacuum tank 882. Figure 17 The saline tube 939 remains filled with saline solution, and the check valve 921 prevents saline solution and contrast agent from being pushed back into the saline tube 939 from the Y-connector 920. Figure 41 In the example shown, catheter 930 can be a Zoom 88 catheter, while interventional device 931 can be a Zoom 71 catheter.

[0357] like Figure 41 As shown, interventional device 931 is an inner catheter relative to catheter 930. That is, interventional device 931 can be positioned within the lumen of catheter 930. To continue prefilling the contrast agent channels of cassette 704 and tubing assembly 716, after the contrast agent channel associated with first hub 724a is prefilled with contrast agent, first contrast agent control valve 822a is closed, and second contrast agent control valve (e.g., second contrast agent control valve 822b) can be opened to similarly prefill the contrast agent channel associated with third hub 724c. After the contrast agent channel associated with second hub 724b is prefilled with contrast agent, second contrast agent control valve 822b is closed, and third contrast agent control valve (e.g., third contrast agent control valve 822c) can be opened to similarly prefill the contrast agent channel associated with hub 724c. This sequence of prefilling contrast agent channels is an example; contrast agent channels can be prefilled in any order. After the contrast agent channels of cartridge 704 and tubing assembly 716 are pre-filled, contrast agent control valves 822a-822c can be moved to the closed position. Additionally, after the contrast agent channels of cartridge 704 and tubing assembly 716 are pre-filled, saline / contrast agent valve 766 can be moved to the closed position.

[0358] Figure 42 and Figure 43 The configuration of pre-filling the hub with saline and the conduit coupled to the hub (“hub / conduit”) is shown. The controller can be configured to pre-fill the hub / conduit one at a time with saline, or to pre-fill two or more hubs / conduits simultaneously with saline. After the contrast agent channel and saline channel box 704 and tubing assembly 716 have been pre-filled, the peristaltic pump can operate continuously to provide a continuous flow of saline. Figure 42As shown, a three-way valve 923 is positioned such that a saline / contrast agent tubing 940, which receives contrast agent and saline, is connected to a catheter coupling tubing 933. In this configuration, peristaltic pumps 762a-762d can supply saline to the catheter coupling tubing 933 via a Y-connector 920, an air bubble filter 922, the three-way valve 923, and the saline tubing 939 via a Luer connector 926. In this configuration, a hemostatic valve 928 can be opened to allow saline to flow out of the hemostatic valve 928, thereby removing air from the catheter coupling tubing 933, the Luer connector 926, and the hemostatic valve 928, flushing the catheter coupling tubing 933, the Luer connector 926, and the hemostatic valve 928. In this embodiment, an interventional device 931 extends through the hemostatic valve 928 and into the catheter 930. The catheter 930 can be an external catheter, and the interventional device 931 can be an internal catheter. The interventional device 931 can be positioned within the catheter 930. Saline solution flows out of the hemostatic valve 928 through a portion of the lumen of catheter 930, through the space between the outer surface of interventional device 931 and the inner surface (the surface of the lumen) of catheter 930.

[0359] exist Figure 43 In the illustrated configuration, the three-way valve 923 remains aligned to guide saline received in the saline / contrast agent tubing 940 to the catheter coupling tubing 933 and the hemostatic valve 928, but the hemostatic valve 928 is now closed. In this configuration, to prevent saline from draining through the hemostatic valve 928, it flows through the catheter 930, from its proximal portion to its tip, and drains from the tip, thereby removing air from the catheter 930. To aid in removing smaller air bubbles that may be present in the lumen of the catheter 930 between the interventional device 931 and the catheter 930, the interventional device 931 and the catheter 930 can be moved, for example, in a reciprocating motion. In one example, the first hub to which the external catheter 930 is coupled and the second hub to which the interventional device 931 is coupled can move toward and away from each other. In another example, the first hub to which the catheter 930 is coupled can remain stationary, and the second hub to which the interventional device 931 is coupled can move toward and away from the first hub. In another example, the first hub to which the catheter 930 is coupled can move toward and away from the second hub, while the second hub to which the intervention device 931 is coupled remains stationary.

[0360] Figure 44Examples of state diagrams for robotic catheter systems are shown according to some embodiments, illustrating different operational states where a controller can operate the fluid system after setup is complete. The controller can operate the fluid system based on system information. As used herein, system information may include, but is not limited to, user input from a local control interface, user input from a remote control system, information received from one or more sensors, and / or previously stored information that can be executed by the controller. These states represent examples of fluid system operation during medical procedures. Setup can be “completed,” for example, after the cassette attachment to the robotic catheter system (e.g., attachment to a pump station), and after the pre-filling of the contrast agent subsystem and saline subsystem, including the cassette 704, tubing assembly 716, and hub components and fluid communication channels. In this example, states can be represented by one or more distinct blocks. For example, first block 970, second block 972, third block 974, fourth block 976, fifth block 978, and sixth block 980. First block 970 may represent a saline drip state. Second block 972 may represent a contrast agent injection state. Third block 974 may represent an aspiration state. Box 976 can represent the state of removal from the patient and flushing. Box 978 can represent the state of blood return. Box 980 can represent the safety device for the state of contrast agent injection. For ease of reference, these blocks can be referred to as their states, for example, as "saline drip," "contrast agent injection," "aspiration," "removal from the patient and flushing," "blood return," and / or "injection safety." The state diagram also includes a seventh box 982 representing the state of changed saline or contrast agent parameters. For ease of reference, box 982 can be referred to as its state, for example, as "changing saline or contrast agent parameters." This can be, for example, a state of changed saline or contrast agent parameters, such that the controller uses the changed parameters to influence the flow of saline or contrast agent through the fluid system. In the example, during the state of changed saline and contrast agent parameters shown in box 982, the saline and / or contrast agent parameters can be changed based on system information. Previously stored information can be in Figure 44 Information shown during any state and / or during specific parts of a medical procedure (e.g., involving catheter insertion, removal, movement through specific parts of the patient's vascular system, aspiration, etc.). During a medical procedure, the fluid system state can transition from one state to another. Figure 44In the example shown, when the fluid system is in the first box 970, the fluid system can transition from a saline drip state to a contrast agent injection state or an aspiration state, as indicated by the second box 972 and the third box 974, respectively. When the fluid system is in the second box 972, the fluid system can transition from a contrast agent injection state to a saline drip state or an aspiration state, as indicated by the first box 970 and the third box 974, respectively. When the fluid system is in the third box 974, the fluid system can transition from an aspiration state to a state of removal and flushing from the patient or a blood return state, as indicated by the fourth box 976 and the fifth box 978, respectively. The goal of the blood return state, indicated in the fifth box 978, is to clear the catheter lumen for subsequent injection while the catheter is in the body, thereby replicating the process of pulling back the syringe in a non-robotic catheter system, and is referred to below. Figures 58 to 63 The following description is provided. When the fluid system is in the fourth box 976, the state of fluid system removal and flushing from the patient transitions to the injection-safe state represented by the seventh box 980. When the fluid system is in the fifth box 978, the fluid system transitions from the blood return state to the injection-safe state represented by the seventh box 980. And when the fluid system is in the seventh box 980, the fluid system can transition from the injection-safe state to the saline drip state or contrast agent injection state represented by the first box 970 and the second box 972, respectively. Each of the states corresponds to a configuration of the fluid system. For example, the configuration of the saline subsystem 706, contrast agent subsystem 708, and vacuum subsystem 710 in box 704 or hub 724. When the fluid system enters a certain state, the controller can control the pump station and / or hub to actuate valves and components to align the fluid communication channels to the configuration of that state, so that the robotic catheter system can perform saline drip, contrast agent injection, aspiration, or other desired actions. Reference Figures 45 to 63 These various states will be described further.

[0361] Figure 45 Examples of hub configurations for a fluid system in a brine droplet state, represented by the first block 970, are shown according to some embodiments. In the examples, the hub can be one or more hubs 724a-724c ( Figure 14 One of them. Although Figure 45A hub is shown, and the saline dripping state is described with reference to the hub; however, in a system with multiple hubs, one or more hubs may be positioned in this configuration during the saline dripping state when the fluid system is in the first block 970. In this configuration, the hemostatic valve 928 is closed, and the peristaltic pumps 762a-762d corresponding to the hub are actuated to provide a continuous saline flow to the hub via the saline line 939. A three-way valve 923 is positioned to connect the saline / contrast agent line 940 and the catheter coupling line 933, thereby providing a passage for saline to flow through the catheter 930 and out of the catheter tip. The saline flow passes through an air bubble filter 922, which filters air bubbles from the saline flow.

[0362] Figure 46 Examples of the process are shown according to some embodiments, the process may include sub-processes, the sub-processes may be performed in a fluid system where a second contrast agent is injected (972). Figure 44 This occurs when the contrast agent is injected, as indicated by the diagram. The process includes actions that can be determined or performed using a robotic catheter system (or the "system"), and the description of the actions relates to performing the actions using the robotic catheter system. For example, these actions may be controlled by a controller based in part on, for example, system information (e.g., user input from a local control interface, user input from a remote control system, information received from one or more sensors, previously stored information, and / or previously stored procedures that can be performed by the controller).

[0363] exist Figure 46 In the middle, the system determines whether the injection of contrast agent is safe at box 981. Figure 47 The procedure for determining whether it is safe to inject a contrast agent for the system is illustrated. In this example, the system cannot continue injecting the contrast agent until it has been determined that the injection is safe. (See reference...) Figure 47 The system determines at frame 991 whether a good hemodynamic waveform exists. The system can determine the presence of a "good" hemodynamic waveform based on information received from a pressure sensor in the mount. For example, hemodynamic pressure sensor 929 (e.g., Figure 46 and Figure 69This corresponds to the selected catheter (e.g., located in the hub coupled to the selected catheter). The system can determine the presence of a “good” hemodynamic waveform by comparing information received from the hemodynamic pressure sensor 92 with predetermined hemodynamic pressure information (e.g., waveform) indicating the desired hemodynamic waveform. Using the hemodynamic pressure sensor information, the system can determine whether the tip of the selected catheter is blocked, making contrast agent injection unsafe. The predetermined pattern dynamic pressure information can be stored on the robotic catheter system or in another storage location accessible to the robotic catheter system. If the system determines that a good hemodynamic waveform is not present, the system can initiate other actions indicated in boxes 995, 996, and 997 to clear the blocked catheter tip. For example, the process can proceed to box 995, where the system moves the selected catheter to release the catheter tip while it is against the vessel wall. The process can also proceed to box 996, where the system returns blood to the catheter to remove clots or errors in the catheter. The process can also proceed from box 991 to box 997, where the catheter is removed from the flushed patient to, for example, remove large clots in the selected catheter.

[0364] After performing any of the actions represented in blocks 995, 996, and 997, the process can return to block 991, where the system determines whether a good hemodynamic waveform exists. If, after the system performs one of the actions represented in blocks 995, 996, and 997 and still no good hemodynamic waveform exists, the system can proceed to the other of the actions represented in blocks 995, 996, and 997, performing the indicated action to return to block 991 and again determine whether a good hemodynamic waveform exists. During this process, the system can provide status to a remote control system 2210 and / or at an interface with a local system controller 2220 to indicate the actions taken. In some embodiments, the system receives input from a user indicating which action or the other of the actions represented in blocks 995, 996, and 997 was performed to ensure the catheter tip is clean. In some implementations, the system determines, for example, which action or action represented in boxes 995, 996, and 997 should be performed based on historical data, system information, physician preferences, patient information, or other information. After the system determines that a good hemodynamic waveform exists, the process can move to box 992, where the system determines / verifies whether it is equipped and ready to inject contrast agent. For example, whether the contrast agent pump 810 is ready to inject contrast agent. After the system determines that it is ready, the process proceeds to box 993, where it determines whether the catheter is backfilled and / or prefilled. If not, the process proceeds to box 994, where the system backfills the selected catheter, such as... Figure 58As shown. After the system determines that the catheter has received blood or been pre-filled, the process proceeds to box 998, where contrast agent injection can continue, and the process continues to... Figure 46 The seventh box, 982.

[0365] At box 982, the system determines whether a catheter has been selected for contrast agent injection. If a catheter has been selected, the process proceeds to box 984, where the user (e.g., a physician) initiates the contrast agent injection. If a catheter has not been selected, the process proceeds to box 983, where a catheter is selected for contrast agent injection, for example, based on user input. Figure 48 An example configuration of the contrast agent subsystem 708 is shown, in which an insertion catheter coupled to hub 724c is selected for contrast injection. When the insertion catheter is selected, the system moves the third contrast agent control valve 822c to the open position of connecting lines 826c and 820c to provide a contrast agent communication path from contrast agent pump 810 to the insertion catheter. The system also moves the first and second contrast agent control valves 822a, 822b and contrast agent inlet valve 807 to the closed position if they are not already closed. The system may perform other actions to prepare for contrast agent injection. After catheter selection, the process proceeds to block 984, where the user initiates contrast agent injection by providing input to the system to inject contrast agent, for example, from remote control system 2210.

[0366] The contrast agent injection process proceeds to box 985, where the system can determine, based on system information, whether the volume of the selected catheter is greater than a predetermined amount (e.g., if the catheter volume is greater than 2 ml). In some cases, the system determines the volume of the selected catheter at least in part based on whether the lumen of the selected catheter contains another catheter or guidewire; these can be determined based on information related to the hub's position when performing the contrast agent injection. If the volume of the selected catheter is not greater than the predetermined amount, at box 986, the system injects the contrast agent, for example, until the required volume is reached.

[0367] If the catheter volume is greater than the predetermined amount, the system injects contrast agent at box 987, for example, until the required amount is reached. Figure 49 An example configuration corresponding to the hub of the selected catheter is shown when contrast agent is injected. The system actuates the contrast agent pump 810 to provide contrast agent to the hub via the contrast agent tubing 937. A three-way valve 923 is positioned to connect the saline / contrast agent tubing 940 and the catheter coupling tubing 933, so that the provided contrast agent flows through the catheter coupling tubing 933, through the Luer connector 926, through the catheter 930, and exits at the catheter tip. In some embodiments, the system closes the hemostatic valve 928 around the interventional device 931 at a more forceful level than during saline dripping to prevent contrast agent leakage from the hemostatic valve 928.

[0368] Refer again Figure 46 The process then proceeds to frame 988, where the system flushes the hub and catheter with a saline mass equal to the catheter volume to drain the contrast agent solution from the catheter. Figure 50 An example configuration of a hub of a selected catheter, configured to inject a saline bolus, is shown. Associated peristaltic pumps 763a-763d supply a quantity of saline to the hub via contrast agent tubing 937. The amount of saline supplied to the hub can be based on the volume of the selected catheter (which may be part of system information). A three-way valve 923 connects the saline / contrast agent tubing 940 to the catheter coupling tubing 933, allowing saline to flow through the catheter coupling tubing 933, through the Luer connector 926, through the catheter 930, and expel any contrast agent remaining in the catheter 930 due to contrast agent injection. (See again) Figure 46 After the contrast agent is injected to the desired volume and in box 986, and after the catheter is flushed with a saline bolus, the procedure can be indicated in box 988 to complete the specific injection procedure in box 989, if necessary. In this example, the procedure then proceeds to box 990, where the physician can release the contrast agent injection button indicating that the contrast agent injection is complete.

[0369] Figure 51 This shows when the system is composed of the third block 974 ( Figure 44 Examples of suction processes that the system can perform when indicated by the suction state. At box 1002, the system can engage the clotting material with the conduit. For example, the system is used to move a specific hub and its corresponding conduit (now referred to as the "suction conduit") such that the tip of the suction conduit is positioned adjacent to or near the clotting material. At box 1004, the system configures the hub to connect the lumen of the suction conduit to a vacuum line. For example, the system configures the hub and a vacuum subsystem including a vacuum pump to provide a high vacuum to the hub. Figure 52 An example configuration of a hub coupled to catheter 930 is shown, catheter 930 having a distal end 944 and a proximal end 943. The proximal end 943 is coupled to a hemostatic valve 928, and catheter tip 944 is positioned adjacent to clot 941, and a three-way valve 923 is positioned to connect catheter coupling tube 933 to aspiration tube 935. Catheter 930 can be used for aspiration. Figure 52A first embodiment of a vacuum subsystem is also shown, configured to provide a high vacuum to a hub. In this embodiment, the vacuum subsystem includes a vacuum pump 888, a vacuum tank 882, a line 885 connecting the vacuum pump 888, a sterile filter 884 in the vacuum tank 882 and the line 885. In this embodiment, a separation subsystem includes a low-vacuum line 872 and a high-vacuum line 870 connected between the vacuum tank 882 and a three-way vacuum control valve 874. A first vacuum pressure sensor 871a is positioned to sense the pressure on the high-vacuum line 870, and a second vacuum pressure sensor 871b is positioned to sense the pressure on the low-vacuum line 872. The low-vacuum line 872 also includes a check valve 887, which allows material in the low-vacuum line 872 to flow only into the vacuum tank 882. The suction tube 935 is connected to a three-way vacuum control valve 874 and a clotting chamber 927, and a flow sensor 880 (e.g., an ultrasonic flow sensor) is positioned along the suction tube 935 to sense the flow rate or material passing through it. The three-way vacuum control valve 874 is aligned with it to connect the high vacuum line 870 and the suction tube 935 to provide a high vacuum to the suction tube 935. Figure 53 Showing from Figure 52 An alternative embodiment of the illustrated embodiment is provided in which the clumping chamber 927 is not located in the hub, but is located closer to the vacuum tank 882 (e.g., in a box or in part of the piping assembly 716).

[0370] Back Figure 51 The process can proceed to box 1006, where it determines whether a high flow rate of material (e.g., blood, clots, saline, etc.) is present in the vacuum line. A high flow rate indicates that material has been successfully aspirated through the catheter. If no high flow rate is present, the process proceeds to box 1016, where the system can wait for a period of time (e.g., 1-2 minutes) while providing a high vacuum. The system can continuously check to see if a high flow rate condition has begun to occur. Figure 54 and Figure 55 This illustrates an example of monitoring vacuum and suction pipe 935 under high flow conditions. The system can use vacuum pressure sensor 871 to monitor the vacuum in high vacuum line 870 and suction pipe 935, and the system can further use flow sensor 880 (e.g., ultrasonic flow sensor) to monitor the material flow through clotting chamber 927 and through suction pipe 935 to vacuum tank 882. Figure 54In this configuration, vacuum pump 888 is actuated, and a high vacuum of -14.0 psi (as detected by vacuum pressure sensor 871) is maintained in high vacuum line 870 near vacuum tank 882, and a high vacuum of -14.0 psi (as detected by hemodynamic pressure sensor 929) is maintained in catheter coupling tube 933 near hemostatic valve 928 and catheter 930. Catheter tip 944 is located near clot 941. In this configuration, there is no high flow rate, and this can be detected by flow sensor 880. Figure 55 In the process, clot 941 has moved through catheter 930 toward Luer connector 926. The high-vacuum line 870 near vacuum vessel 882 has a (high) vacuum of -14.0 psi, but now the catheter coupling tube 933 and catheter 930 near hemostatic valve 928 have a vacuum of -12.3 psi, indicating that clot 941 is being aspirated. This indicates a high flow rate of material, which can also be detected by flow sensor 880.

[0371] Once the system determines that a high flow rate has occurred, the process can proceed to frame 1008 and the vacuum to conduit 930 can be shut off. At this point, clot 941 can be trapped in clot chamber 927, as... Figure 56 and 57 As shown. Figure 56 A system for positioning a three-way valve 923 and a vacuum control valve 874 to stop the supply of a high vacuum to the conduit 930 is also shown. At block 1010, the process can flush the clot chamber 927, which can be accomplished by positioning the three-way valve 923 to connect the saline / contrast agent tubing 940 to the suction tubing 935, allowing saline to be supplied to the clot chamber 927 to flush it, as shown. Figure 57 As shown. The process can then proceed to block 1012, where the system determines whether the flocculant chamber 927 contains flocculants 941. In some embodiments, the system uses a flocculant chamber sensor 932 ( Figure 21 The presence of clot 941 in the clot chamber 927 is sensed. An example of the clot chamber sensor 932 is an optical sensor. In some embodiments, the user can visually inspect the clot chamber to see if it contains a clot. If, at block 1012, the process determines that the clot is not in the clot chamber 927, the process proceeds to block 1002, where the system is used to re-engage the clot with the catheter. If the system determines that the clot is in the clot chamber 927, the process proceeds to block 1014, where additional blood return, contrast agent injection, and aspiration can be performed.

[0372] Refer again Figure 51If, at box 1016, the process determines that no flow has occurred, the process proceeds to box 1018, where the system can slowly pull the (first) catheter back away from the clot. Optionally, aspiration (e.g., double aspiration) from a second catheter may be provided, the second catheter nested within or containing the first catheter in its lumen. The process can then proceed to box 1020, where the vacuum is closed, then to box 1022, where the catheter is removed from the patient and flushed, then to box 1024, where the catheter is re-infused with blood, pre-filled, and reinserted to continue the procedure.

[0373] As indicated above, the purpose of blood return is to clear the catheter lumen while the catheter is in the body for subsequent injection, to replicate the procedure of pulling back the syringe during the manual process of clearing the catheter lumen. Figures 58 to 63 This demonstrates that the system can be used in the fifth box 978 ( Figure 44 The ) indicates the action performed while in the health recovery state. Figure 58 An example of a procedure flow for backflowing blood through a catheter is shown. At box 1030, the procedure determines whether a favorable hemodynamic waveform is present at the catheter designated for backflow. This can be achieved, for example, using a hemodynamic pressure sensor 929 positioned on a catheter coupling tube 933 located between the Luer connector 926 and the three-way valve 923. Figure 59 This is achieved through [the following steps]. If a good hemodynamic waveform is not present, the process can proceed to box 1032, where the system can be used to pull the catheter back to prevent the catheter tip from being blocked, for example, when the catheter tip is against the vessel wall or the catheter has a diameter that matches or nearly matches the vessel wall's diameter. The process can return to box 1030, where the system again determines whether a good hemodynamic waveform is present. If the physician is not satisfied with the return catheter, and if a good hemodynamic waveform is not present, the process can also proceed to box 1032, where the catheter is removed from the patient and flushed. The process can also proceed to box 1036, where the hemostatic valve can be opened to return the catheter to verify that the lumen is not against the vessel wall, and then proceed to box 1038, where saline is pumped into the vacuum line to prefill the vacuum line. If a good hemodynamic waveform is indeed present, and even in some countermeasures where a good hemodynamic waveform is not present, the process continues to box 1038, where saline is pumped into the vacuum line for prefill return.

[0374] Still referencing Figure 58 At box 1038, brine is pumped into the vacuum line to pre-fill the vacuum line. Figure 59 An example of a hub in configuration is shown, where brine is drawn from an actuated peristaltic pump 762a-762d (e.g., Figure 15The brine is supplied to brine line 939 and flows through check valve 921, Y-connector 920, air bubble filter 922, and brine / contrast agent line 940 to reach three-way valve 923, which is positioned to align brine / contrast agent line 940 with suction line 935. A vacuum subsystem connected to suction line 935 can be actuated to provide a low vacuum, allowing brine to flow through three-way valve 923, through suction line 935, and through clot chamber 927 back to vacuum tank 882 to pre-charge suction line 935 with brine. Reference Figure 58 The process can proceed from box 1038 to box 1040 and activate the vacuum pump 888 of the vacuum subsystem 710 to provide a low vacuum in the suction tube 935. Figure 60 The system structure for starting the vacuum pump 888 is shown. The three-way vacuum control valve 874 is positioned to connect the low vacuum line 872 to the suction line 935, while the three-way valve 923 is positioned to connect the suction line 935 and the conduit coupling tube 933, thereby connecting the lumen of the conduit 930 to the low vacuum.

[0375] refer to Figure 58 The process can proceed to block 1042, where the system measures the flow in the suction tube 935 for a period of time. In some embodiments, the time duration is a predetermined duration that can be part of the system information. The time duration can be a relatively short duration, for example, approximately 1 second, 2 seconds, 3 seconds, 4 seconds, 5 seconds, 6 seconds, 7 seconds, 8 seconds, 9 seconds, or 10 seconds, plus or minus half a second. In some embodiments, the time duration can be from 10 seconds to 30 seconds.

[0376] Figure 61 A configuration of a portion of an implementation of a fluid system with a flow sensor (e.g., an ultrasonic flow sensor) is shown, the flow sensor being positioned to sense the flow rate of a substance in a line within a cartridge, discharging the substance into a vacuum container within the cartridge, wherein the cartridge may be disposable and configured to be releasably coupled to part of a robotic conduit system (e.g., a pumping station), and the flow sensor may be an assembly of the cartridge or the pumping station. Figure 61 As shown, a flow sensor 880 (e.g., an ultrasonic flow sensor) is positioned at cartridge 704 between three-way valves 923 and 84 to detect the movement of material through suction tube 935 and into vacuum tank 882. In some embodiments, cartridge 704 includes an orifice in which flow sensor 880 is located to measure the flow of material through a portion of suction tube 935 within the cartridge. In some embodiments, flow sensor 880 is positioned to measure the flow rate of material through a portion of suction tube 935 located outside cartridge 704 between cartridge 704 and hub 724. After measuring the flow rate at cartridge 1042 for a period of time, the vacuum to hub is closed at cartridge 1044. Figure 62An example configuration in one or more hubs 724 and vacuum subsystem 710 is shown, wherein the vacuum supplied to hub 724 has been shut off by moving three-way valve 923 to a position where suction pipe 935 and conduit coupling pipe 933 are no longer connected, and by moving three-way valve 723 to a position where suction pipe 935 and low vacuum line 872 are no longer connected.

[0377] Figure 63 A further configuration of the hub for backflowing blood from catheter 930 through hemostasis valve 928 is shown, for example, for performing backflow during the process described herein. This can be done, for example, to remove blood foam or material from the lumen of catheter 930. In some examples, a signal from hemodynamic pressure sensor 929 indicates that a normal blood pressure waveform is not present in catheter coupling tube 933, which alerts a controller, such as on a user interface on a remote system display and / or to a medical practitioner on a local display. In this configuration, three-way actuated valve 923 is robotically actuated to have alignment that prevents fluid communication between catheter coupling tube 933 and aspiration tube 935, and also prevents fluid communication between catheter coupling tube 933 and saline / contrast agent tube 940. Hemostasis valve 928 is robotically controlled to open, exposing the lumen of catheter 930 to atmospheric pressure, allowing material including fluid (e.g., blood foam) to flow out of the catheter lumen through the hemostasis valve. In some examples, the hemostatic valve 928 can be actuated by a robot to close when the blood flowing out of the hemostatic valve 928 is consistent and does not appear to contain blood foam indicating that the catheter lumen has been cleared of material and blood foam.

[0378] Figures 64 to 87 The diagram illustrates the configuration, schematics, and flowcharts of fluid subsystems and components that can be controlled to perform fluid processes on a robotic catheter system. These fluid processes include, for example, a pre-filled saline subsystem, a pre-filled contrast agent subsystem, operation of hemostatic valves, injection of contrast agent, aspiration of clots, and blood return. The processes performed by the robotic catheter system are at least partially controlled by a controller. Figure 22 , Figure 78 Furthermore, it can be controlled based on user input, a pre-defined programming process, parameter information, and / or conditions sensed by the system. Figures 64 to 70EAn example configuration of a fluid system is shown, which can be used in a remotely controlled robotic conduit system to perform such a process. For example, to perform such a process, valves, pumps, and other actuated (or movable) components can be driven to a certain state or position by a controller. In some embodiments, the state or position of the actuated component can be determined by a position sensing mechanism on the component, allowing the controller to determine the component's current position before, during, or after processing. In some embodiments, the position sensing mechanism can include a switch, encoder, etc. The sensing mechanism can be integrated into a housing or socket to determine the position of a movable component (e.g., a valve, pump) or the position on an actuator that drives the movable component. In some embodiments, the current state or position of the component can be stored electronically (e.g., in a table or file), and the controller is configured to determine the position of one or more components by accessing the stored information. In the example, before injecting a contrast agent using a selected catheter in a system with multiple catheters, it can be determined that the valves coupling the selected catheter to the contrast agent subsystem are aligned in the open position to provide a flow path for the contrast agent with the selected catheter, and it can be determined that one or more valves coupling unselected catheters to the contrast agent subsystem are aligned in the closed position to close the flow path for the contrast agent with the unselected catheter. This determination can be made using stored information and / or by using information from a sensing mechanism. The processes described herein are some of the processes that a controller can be configured to perform automatically or semi-automatically by controlling a fluid device based on one or more user inputs, sensing information, and / or other information. Examples of processes that can be partially or fully controlled by a controller using the embodiments described herein include, but are not limited to: - Provide a continuous "low" saline flow, for example, at about 1 mL / min, to each of one or more catheters; - Provide a "high" saline flow to flush individual catheters in one or more catheters during the procedure, for example, at approximately 6 mL / s; - Contrast agent injection is provided in any of the selected catheters of the system (e.g., in any of the three catheters of the system), the contrast agent injection having minimal delay after receiving a signal from the medical practitioner to inject the contrast agent, and up to, for example, up to about 4 mL / s at up to 500 psi; - Determine the patency of any one of the one or more catheters upon request from a healthcare professional; - Provide high (e.g., complete) vacuum suction over one or more catheters; - Select one of the one or more catheters for low-vacuum blood return; - Pre-charged saline subsystem without user interaction; - Pre-filled contrast agent subsystem without user interaction; - Pre-charged fluid communication channels between the box and multiple seats -Pre-charge multiple seats with saline flow path - Contrast agent flow path in pre-filled multiple seats - Detect air bubbles in the saline subsystem and / or seat and perform correction actions; - Detect air bubbles in the contrast agent subsystem and / or seat and perform correction actions; and - Perform actions related to the refilling of fluids (such as contrast agents, saline).

[0379] Figure 64 The illustrated robotic conduit system may include actuable components of a fluid management system movable, as controlled by a controller, to align fluid communication channels to supply saline, contrast agent, and vacuum from saline, contrast agent, and vacuum sources (respectively) to hub assemblies 1400a-1400c. As indicated above, in some examples, hub assembly 1400 may include a hub (first sub-assembly) and a seat (second sub-assembly). Although some examples described herein relate to assemblies of seats and seats, this specification is not limited to embodiments of hub assemblies including a hub and a seat, but the disclosed components and processes may also be implemented in hub assemblies that do not include the first sub-assembly and the second hub assembly but are housed as a single hub assembly. Therefore, references to one (or more) seats should be understood to also refer to multi-component hub assemblies (e.g., two-component hub assemblies having a hub and a seat) or part of a single-component hub assembly, unless specifically indicated or indicated by the context. Correspondingly, references to hub assemblies should be understood as referring to multiple hub assemblies (e.g., a two-component hub assembly with a hub and a seat) or a single hub assembly.

[0380] The robotic catheter system may include sensors configured to sense conditions related to the supply of saline, contrast agent, and vacuum to seats 1400a-1400c and provide the sensed information to a controller. Examples include valve position, information from a pressure sensor, information from an air bubble sensor, etc. The controller may be configured to use the sensed information, user input, and / or stored information to control the movement of the fluid system to perform a medical procedure. In various embodiments, pump station 2240 may include a controller to control the actuators of pump station 2240 to perform fluid-related actions (e.g., supplying saline, contrast agent, and vacuum to seats 1400a-1400c). In other embodiments, controller 2230 and / or system controller 2220 may be configured to control the actuators and other components of pump station 2240 to perform fluid-related actions. For clarity, Figure 64 Some components and systems of the robotic duct system are not shown (e.g., hub axial drive system, check valve, duct rotation system, controller of remote control system 2210, etc.).

[0381] exist Figure 64 In the illustrated embodiment, the robotic catheter system includes a fluid assembly 1100, which includes a housing 1200 configured for releasable attachment to a pump station 2240. The housing 1200 includes a housing 1209 supporting a saline subsystem 1201, a contrast agent subsystem 1202, and a vacuum subsystem 1203. The saline subsystem 1201, contrast agent subsystem 1202, and vacuum subsystem 1203 may be wholly or partially enc...

Claims

1. A fluid system, comprising: A cartridge, configured to be releasably coupled to a pump station and configured to receive brine from a brine source, contrast agent from a contrast agent source, and vacuum from a vacuum source, the cartridge comprising: The brine subsystem has a first brine flow path. The contrast agent subsystem has a first contrast agent flow path, and A vacuum subsystem, which includes a first vacuum flow path; The shunt has a second saline flow path, a second contrast agent flow path, and a second vacuum flow path, each of the second saline, contrast agent, and vacuum flow paths having a single proximal end and multiple distal ends; A first conduit assembly having a first length and coupled to the housing and the splitter, the first conduit assembly comprising: A single saline channel coupled to the proximal ends of the first and second saline flow paths. A single contrast agent channel, coupled to the proximal ends of the first and second contrast agent flow paths, and A single vacuum channel coupled to the proximal ends of the first vacuum flow path and the second vacuum flow path; Two or more hub assemblies, at least one of which is configured to have a third saline flow path, a third contrast agent flow path, and a third vacuum flow path to supply saline, contrast agent, and vacuum to the lumen of a catheter coupled to at least one of the two or more hub assemblies; and A second pipe assembly having a second length shorter than the first length, the second pipe assembly comprising a plurality of pipe assemblies, each pipe assembly being coupled to the splitter at its proximal end and to one of the two or more hub assemblies at its distal end, at least one of the plurality of pipe assemblies comprising: A brine subchannel, which is coupled to the distal end of the second brine flow path of the splitter. The contrast agent subchannel, coupled to the distal end of the second contrast agent flow path of the shunt, and A vacuum subchannel coupled to the distal end of the second vacuum flow path of the splitter.

2. The fluid system of claim 1, wherein at least one of the two or more hub assemblies includes a seat, and wherein the seat includes the third saline flow path, the third contrast agent flow path, and the third vacuum flow path.

3. The fluid system of claim 2, wherein the seat further comprises a connector, wherein the seat is configured to provide saline, contrast agent and vacuum to the lumen of the catheter via the connector.

4. The fluid system of claim 1, wherein at least one of the two or more hub assemblies includes one or more robot-actuated control valves controlled by a control system to selectively align the third saline flow path, the third contrast agent flow path, and the third vacuum flow path to achieve fluid communication with the lumen of the catheter.

5. The fluid system of claim 1, wherein the first length of the first pipe assembly is at least twice the second length of the second pipe assembly.

6. The fluid system of claim 1, wherein the ratio of the first length to the second length is greater than 1:

4.

7. The fluid system of claim 1, wherein the brine subsystem is configured to receive brine from a first brine source and a second brine source, the brine subsystem including a robot-actuated valve controlled by a control system to place a first brine flow path in fluid communication with the first brine source or the second brine source.

8. The fluid system of claim 7, wherein the control system controls the robot actuation valve based on signals received from sensors, thereby switching to receive brine from different brine sources, the first brine source and the second brine source.

9. The fluid system of claim 8, wherein the sensor is a weight sensor configured to sense the weight of the first brine source and the second brine source.

10. The fluid system of claim 8, wherein the sensor is an air sensor configured to detect air in the first brine flow path.

11. The fluid system of claim 1, wherein the contrast agent subsystem includes a contrast agent pump actuated by a control system to provide contrast agent to at least one of the two or more hub assemblies.

12. The fluid system of claim 1, wherein the vacuum subsystem includes a clotting chamber.

13. The fluid system of claim 12, wherein the clot chamber includes at least one transparent surface, the at least one transparent surface being positioned such that the contents of the clot chamber are visible from the outside of the container.

14. The fluid system of claim 1, wherein the vacuum subsystem includes a droplet chamber in fluid communication with the first vacuum flow path, the vacuum subsystem including one or more robot-actuated valves controlled such that fluid drawn by the vacuum subsystem is collected in the droplet chamber.

15. The fluid system of claim 14, wherein the droplet chamber includes at least one transparent surface, the at least one transparent surface being positioned such that the contents of the droplet chamber are visible from the outside of the container.

16. The fluid system of claim 14, wherein the drip chamber is located in a first vacuum flow path between the clumping chamber and the first piping assembly.

17. The fluid system of claim 14, wherein the vacuum subsystem further comprises a plurality of robotically actuated valves configured to be controlled by a control system to control the vacuum flow path through the dripping chamber and the clotting chamber.

18. The fluid system of claim 17, wherein the plurality of robotic actuation valves of the vacuum subsystem include a first valve positioned in a first vacuum flow path between the dripping chamber and the clump chamber, and a second valve positioned on the opposite side of the dripping chamber in the first vacuum flow path between the dripping chamber and the first piping assembly, wherein the first and second valves are selectively controlled to control the flow of fluid and material from the two or more hub assemblies to the dripping chamber and the clump chamber.

19. The fluid system of claim 1, further comprising a plurality of conduits, one of which is coupled to each of the two or more hub assemblies.

20. The fluid system of claim 1, wherein each of the two or more hub assemblies includes a saline air sensor and a contrast agent air sensor, the saline air sensor being positioned to detect air in the third saline flow path, and the contrast agent air sensor being positioned to detect air in the third contrast agent flow path.

21. The fluid system of claim 20, wherein the vacuum subsystem further comprises a plurality of mechanically actuated control valves, wherein the saline and contrast agent air sensors are respectively located in the saline and contrast agent third flow path, the saline and contrast agent third flow path being located between the plurality of mechanically actuated control valves and the second piping group, for detecting air in the saline and contrast agent flow path before the saline and contrast agent flow path reaches the plurality of mechanically actuated control valves.

22. The fluid system of claim 21, wherein the at least one hub assembly further includes a connector for supplying saline, contrast agent, and vacuum to the lumen of the conduit via the connector, wherein one or more of the plurality of robot-actuated control valves are controlled by a control system to block the saline and contrast agent flow path to the connector based on a signal from one of the saline and contrast agent air sensors.

23. The fluid system of claim 1, wherein each of the two or more hub assemblies includes a plurality of sensors, and each of the first pipe group, the splitter, and the second pipe group further includes an electrical channel coupled to the plurality of sensors in the two or more hub assemblies, the electrical channel being configured to transmit electrical signals from the plurality of sensors to an electrical interface on the housing, the electrical interface being configured to electrically connect to a corresponding electrical interface on a pump station to provide signals from the plurality of sensors in the hub assembly to the control system.

24. The fluid system of claim 23, wherein the plurality of sensors includes a saline air sensor positioned to detect air in the third saline flow path, a contrast agent air sensor positioned to detect air in the third contrast agent flow path, and a pressure sensor configured to sense the pressure of fluid supplied to the lumen of the catheter.

25. A fluid system, comprising: Two or more hub assemblies, each hub assembly comprising: One or more robot actuation control valves; Saline channel, contrast channel, and vacuum channel; and The main channel, which is configured to couple to the catheter; The one or more robot-actuated control valves are controlled by a control system to selectively connect one or both of the saline channel and the contrast agent channel to the main channel in fluid communication, or to connect the vacuum channel to the main channel in fluid communication, for supplying saline, contrast agent or vacuum to the catheter.

26. The fluid system of claim 25, wherein at least one of the two or more hub assemblies comprises a hub and a seat.

27. The fluid system of claim 25, wherein at least one of the two or more hub assemblies comprises the one or more robot actuation control valves, the saline channel, the contrast agent channel, the vacuum channel, and the main channel.

28. The fluid system of claim 27, wherein at least one of the two or more hub assemblies further includes a connector configured to couple to the conduit for supplying fluid to the conduit via the connector.

29. The fluid system of claim 28, further comprising a conduit coupled to each of the two or more hub assemblies.

30. The fluid system of claim 25, wherein the one or more robot actuation control valves comprise two robot actuation valves.

31. The fluid system of claim 25, wherein each of the two or more hub assemblies includes a seat, and the two robot-actuated valves are located in the seat of each of the two or more hub assemblies.

32. The fluid system of claim 25, wherein the two or more hub assemblies comprise three hub assemblies.

33. The fluid system of claim 25, further comprising: A box configured to be releasably coupled to a pump station, the box comprising a brine subsystem configured to receive brine from a brine source, a contrast agent subsystem configured to receive contrast agent from a contrast agent source, and a vacuum subsystem configured to receive vacuum from a vacuum source. and A connecting channel, coupled to the housing and the two or more hub assemblies, is used to provide brine, contrast agent, and vacuum to the hub assemblies.

34. The fluid system of claim 33, wherein the housing includes a portion of the brine subsystem, and wherein the pumping station includes at least one actuator configured to be operatively coupled to the housing to operate the portion of the brine subsystem within the housing.

35. The fluid system of claim 33, further comprising a controller configured to control the pumping station in part based on first user input received from an interface communicating with the fluid system.

36. The fluid system of claim 35, wherein the interface is located near the fluid system.

37. The fluid system of claim 35, wherein the controller is further configured to control the pumping station in part based on first user input received from a console in communication with the fluid system.

38. The fluid system of claim 37, wherein the control console is located in the same room as the fluid system.

39. The fluid system of claim 37, wherein the control console is located remotely from the fluid system.

40. A fluid system, comprising: Two or more hub assemblies configured to couple to a duct, at least one of the two or more hub assemblies comprising: Robot actuation of the first control valve; A brine channel, which is in fluid communication with the first control valve; A saline contrast agent channel, which is in fluid communication with the first control valve; and A saline flow restriction channel is fluidly connected to the saline channel and the saline contrast agent channel, bypassing the first control valve.

41. The fluid system of claim 40, wherein at least one of the two or more hub assemblies further comprises a contrast agent channel in fluid communication with the first control valve, wherein the first control valve is robotically controlled to selectively connect one or both of the saline channel and the contrast agent channel to the saline contrast agent channel via the first control valve, or neither of them to the saline contrast agent channel via the first control valve.

42. The fluid system of claim 41, wherein at least one of the two or more hub assemblies further comprises: Vacuum channel; A robot-actuated second control valve, coupled to the saline contrast agent channel and the main channel, is used to supply saline, contrast agent, and vacuum to the catheter. The robot-actuated second control valve is configured to be controlled by the control system to connect and disconnect the vacuum channel and the main channel. A first air sensor is positioned to detect air in the saline channel and is configured to generate a signal indicating the air detected in the saline channel; and A second air sensor is positioned to detect air in the contrast agent channel and is configured to generate a signal indicating the air detected in the contrast agent channel. The second control valve is actuated by the robot at least in part based on signals from the first air sensor or the second air sensor to disconnect the saline contrast agent channel from the main channel.

43. The fluid system of claim 42, wherein at least one of the two or more hub assemblies further comprises a check valve located in the brine passage between the first air sensor and the first control valve, the check valve being configured to restrict fluid flow in the brine passage in a direction from the first air sensor toward the first control valve.

44. The fluid system of claim 40, wherein each hub assembly further comprises: The robot actuates the second control valve, which is in fluid communication with the saline contrast agent channel; and A vacuum channel, which is in fluid communication with the second control valve; The second valve is actuated by a robot to selectively connect the vacuum channel or the saline contrast agent channel to a main channel, which is in fluid communication with a conduit coupled to the hub assembly.

45. The fluid system of claim 40, wherein each hub assembly further includes a main channel in fluid communication with a lumen of a conduit coupled to the hub assembly, wherein the fluid system further includes a pressure sensor positioned to detect pressure in the main channel and generate a signal indicating the detected pressure, wherein the fluid system is configured to determine whether to inject a contrast agent based at least in part on the signal indicating pressure in the main channel.

46. ​​A method for selectively supplying saline, contrast agent, and vacuum from a cartridge releasably connected to a pump station to a plurality of catheters, each catheter coupled to one of a plurality of hub assemblies in fluid communication with a main channel in a respective hub assembly, the method comprising: Brine is provided through brine communication channels coupled to the housing and to each of the plurality of hub assemblies, wherein a portion of the brine communication channels coupled to each of the plurality of hub assemblies is identical; Contrast agent is provided through contrast agent communication channels coupled to the housing and to each of the plurality of hub assemblies, wherein a portion of the contrast agent communication channels coupled to each of the plurality of hub assemblies is identical; and Vacuum is provided through vacuum communication channels coupled to the housing and to each of the plurality of hub assemblies, wherein a portion of the vacuum communication channels coupled to each of the plurality of hub assemblies is identical.

47. The method of claim 46, wherein the plurality of hub assemblies comprises three hub assemblies.

48. The method of claim 46, wherein at least one of the plurality of hub assemblies comprises a hub and a seat.

49. The method of claim 46, further comprising controlling one or more robot-actuated control valves located in each of the plurality of hub assemblies via a control system to selectively connect the main channel to the saline channel, the contrast channel, or the vacuum channel to supply saline, contrast agent, or vacuum to the catheter.

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