Fluid management system

Abstract

A fluid management system includes a cartridge configured to receive brine from a brine source, a contrast agent from a contrast agent source, and a vacuum from a vacuum source, a plurality of brine connectors, a plurality of contrast agent connectors, and a plurality of vacuum connectors, the cartridge configured to receive brine from the brine source, contrast agent from the contrast agent source, and vacuum from the vacuum source. Each of the plurality of saline connectors is configured to be coupled to one of a plurality of conduits to provide saline thereto, and each of the plurality of contrast agent connectors is configured to be coupled to one of the plurality of conduits to provide contrast agent thereto, each of the plurality of vacuum connectors is configured to couple to one of the plurality of conduits to provide a vacuum thereto.

Description

[0001] Incorporation by reference into any priority application

[0002] Any and all applications claiming foreign or domestic priority identified in the Application Data Sheet filed with this application are incorporated herein by reference pursuant to 37 CFR 1.57. This application is an international application to and claims priority to U.S. Application No. 17 / 879,614, filed on August 2, 2022, entitled MULTICATHETER SYSTEM WITH INTEGRATED FLUIDICS MANAGEMENT, U.S. Application No. 17 / 879,616, filed on August 2, 2022, entitled FLUIDICS CONTROL SYSTEM FOR MULTI CATHETER STACK, and U.S. Application No. 17 / 879,573, filed on August 2, 2022, entitled METHODS AND DEVICES FOR DEGASSING AMULTIC CATHETER STACK, each of which is incorporated herein by reference in its entirety for all purposes and constitutes a part of this specification. Technical Field

[0003] The present disclosure relates generally to the field of fluid infrastructure, and more particularly to the field of fluid management and delivery during manual or robotically driven medical procedures.Described herein are systems and methods for fluid management and delivery. Background Art

[0004] Any of a variety of intraluminal or intravascular medical procedures may involve the introduction of multiple tools, such as catheters, into the body either simultaneously or sequentially. Each catheter may require a unique connection to any of a variety of suction, irrigation, drug, saline, or contrast infusion sources. Such sources are typically communicated with the catheter by tubing that terminates in a connector in order to be releasably connected to a complementary port on the catheter hub.

[0005] Catheter exchange typically involves disconnecting tubing from the first catheter being removed and reconnecting the tubing to a second replacement catheter. In addition, catheters typically have a Luer connection port for injection of all fluids as well as suction. During surgery, in addition to suction, multiple different fluids and / or fluid volumes may be injected at different times. Therefore, fluid sources such as syringes are often connected and disconnected from the Luer connection port. Conventional switching of such components, syringes, and fluid connections during surgery may result in the risk of air bubble introduction, incorrect connection points, and / or incorrect fluid selection.

[0006]

[0006] Thus, there remains a need for improved fluid and tool management systems that overcome one or more of the shortcomings of conventional fluid management and catheter 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 hub on the proximal end of the tubular body; a valve system, which can be in the form of a valve manifold in communication with the hub; and first, second, and third ports on the manifold. The valve manifold is configured to selectively connect any one of the first, second, and third ports to the lumen while blocking the other two ports from communicating with the lumen. The fluid management system can be used with two or three or four or more interventional device stacks (e.g., catheters mounted concentrically on a guidewire) for manually operated or robotically driven interventions.

[0008] The valve manifold may include a first valve in communication with the first port, a second valve in communication with the second port, and a third valve in communication with the third port. The first port 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 having 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 communication between the lumen and the saline port and the contrast port is blocked. The control system may be further configured to adjust the valve manifold to a contrast injection mode, wherein the contrast port is in communication with the lumen and 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 contrast or other fluid delivered.

[0010] The first, second and third ports may comprise connectors for removably connecting to conduits extending away from the hub.The first, second and third ports may alternatively comprise conduits non-removably attached to and extending away from the hub.

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

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

[0013] The first port may be configured for connection to a vacuum source, the second port may be configured for connection to a saline source, and the third port may be configured for connection to a contrast media source.

[0014] In response to a human command to enter a contrast injection mode, the control system can be configured to adjust the hemostasis valve to a high sealing force mode and adjust the valve manifold to selectively connect the third port to the lumen while blocking the first and second ports from communicating with 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 valve, wherein the vacuum valve is configured to connect the catheter to a vacuum source, the saline valve is configured to connect the catheter to a saline source, and the contrast valve is configured to connect the catheter to a contrast source; and a contrast control for initiating the introduction of contrast media into the catheter. The processor can be configured to open the contrast valve and close the saline valve and the aspiration valve in response to operation of the contrast control.

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

[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 be further configured to increase the sealing strength of the hemostatic valve in response to operation of the contrast medium control member to introduce contrast medium into the catheter. The processor may be further configured to decrease the sealing strength of the hemostatic valve in response to operation of the contrast medium control member to stop introducing contrast medium into the catheter.

[0018] The valve manifold may be carried by the hub. Alternatively, the valve manifold may be remote from the hub and communicate with the hub via a tubing set having vacuum, saline and contrast 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 slot connection of the hemostatic valve to remove the remaining first fluid into the slot. The slot 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 a gasket of the hemostatic valve to a high pressure configuration prior to injecting the second fluid. The method may further include actuating a gasket of the hemostatic valve to a low pressure configuration prior to 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 hub on the proximal end of the tubular body, and a valve system in communication with the hub. The catheter system also includes a first port, a second port, and a third port in communication with the valve system. The valve system is configured to selectively connect any one of the first port, the second port, and the third port to the lumen while blocking the other two ports from communicating with the lumen.

[0023] The first elongated flexible tubular body may include an aspiration catheter. The valve system may include a first valve in communication with the first port, a second valve in communication with the second port, and a third valve in communication with the third port. The first port may be configured to be connected to a vacuum source. The second port may be configured to be connected to a saline source. The third port may be configured to be connected 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 is in communication 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 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 control system may be configured to control the volume of contrast agent delivered. The valve system may include a valve manifold, the 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 removably connecting to a conduit extending away from the hub. Each of the first port, the second port, and the third port may include a conduit attached to the hub and extending away from the hub. The catheter system may include a hemostatic valve carried by the hub. The hemostatic valve may be adjustable between at least 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 medium 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 adjust the valve system to selectively connect the third port to the lumen while blocking the first port and the second port from communicating with the lumen. Human input may be received through a contrast medium 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 medium injection mode in response to human input, wherein the third port is in communication with the lumen, and the communication between the second port and the lumen and between the first port and the lumen is blocked. The control system may be configured to determine a 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 may 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 medium control, the valve system including a first vacuum valve configured to connect a first conduit with a first vacuum source, a first saline valve configured to connect the first conduit with a first saline source, and a first contrast medium valve configured to connect the first conduit with a first contrast medium source, the first contrast medium control being used to initiate introduction of contrast medium into the first conduit. The first processor is configured to open the first contrast medium valve and close the first saline valve and the first vacuum valve in response to actuation of the first contrast medium control.

[0025] The fluid control system may include the first catheter. The first catheter may include a first catheter hub in fluid communication with the first contrast medium valve, the first saline valve, and the first vacuum valve. The fluid control system may include a first hemostasis valve on the first catheter hub. The fluid control system may include a second catheter configured to axially movably receive the first catheter therethrough. The second catheter may include a second catheter hub. The second catheter hub may include a second hemostasis valve. The second hemostasis 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 hemostasis valve to a high compression state of the first catheter in response to actuation of the first contrast medium control. The first processor may be configured to adjust the second hemostasis valve to a high compression state of the first catheter in response to actuation of the first contrast medium control. The first processor may be configured to introduce contrast medium into the first catheter in response to actuation of the first contrast medium control and when the second hemostasis valve is in a high compression state of the first catheter. The first processor may be configured to activate a first contrast medium pump in response to actuation of the first contrast medium controller. The fluid control system may further include a drive circuit 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 further configured to confirm that the second hemostatic valve is in the high compression state in response to actuation of the first contrast agent controller to introduce contrast agent into the first catheter. The first processor may be further configured to adjust the second hemostatic valve to the low compression state in response to actuation of the first contrast agent controller to stop 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 remote from the first catheter hub and communicated with the first catheter hub via a tubing set having a vacuum line, a saline line, and a contrast agent line.

[0026] A fluid control system for multi-catheter surgery 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 including a hemostatic valve adjustable between a low compression mode and a high compression mode, the second catheter extending through the hemostatic valve and through the first catheter, the saline solution source communicating with the first catheter through the saline valve, the contrast agent source communicating with the first catheter through the contrast agent valve, and the processor being configured to send a first control signal to place the hemostatic valve in the high compression mode and send a second control signal to open the contrast agent valve in response to a human command.

[0027] The processor may be further configured to send a third control signal in response to a human command to place the hemostatic valve in a low compression mode and send a fourth control signal to a robotic catheter drive system to axially adjust the second catheter relative to the first catheter. The processor may be further configured to send a fifth control signal to the robotic catheter drive system in response to a human command to axially proximally withdraw a guidewire from the second catheter before opening 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 connection piece of a hemostatic valve under low pressure, closing a first valve at the first fluid source connection piece, applying a vacuum to a slot connection piece of the hemostatic valve to remove the residual first fluid into a slot connected to the slot connection piece, closing the slot valve at the slot connection piece, and injecting a second fluid from a second fluid source into a second fluid source connection piece 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 a plunger of the hemostatic valve to a high compression state prior to injecting the second fluid. The method may further include actuating a plunger of the hemostatic valve to a low compression state prior to injecting the first fluid. The method may further include, prior to injecting the first fluid, applying a vacuum to a slot connector of the hemostatic valve while a first valve at a first fluid source connector of the hemostatic valve is closed to remove luminal air from a catheter fluidly connected to the hemostatic valve, and closing the slot valve at the slot connector. Injecting the second fluid from the second fluid source into the second fluid source connector may include injecting the second fluid from the second fluid source into the second fluid source connector under high pressure. The method may further include detecting air bubbles in at least one of the first fluid or the second fluid by 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 slot connection of the hemostatic valve when a first valve at a first fluid source connection of the hemostatic valve is closed to remove luminal air from a catheter fluidly connected to the hemostatic valve, closing the slot valve at the slot connection, opening the 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 at a low pressure.

[0031] The first fluid may be heparinized saline. The method may further include applying a vacuum to a trough connector of the hemostatic valve to remove residual first fluid into a trough connected to the trough connector, and injecting a second fluid from a second fluid source into a second fluid source connector 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 connector may include injecting the second fluid from the second fluid source into the second fluid source connector under high pressure. The method may further include detecting air bubbles in at least one of the first fluid or the second fluid via 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 by a processor of a hemostatic valve communicatively coupled to a catheter hub, which indicates injecting a first fluid from a first fluid source at a low pressure into a first fluid source connection of the hemostatic valve, transmitting a first output signal by the processor to close a first valve at the first fluid source connection, transmitting a second output signal by 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 the slot valve at the slot connection, and receiving a second input indicating injecting 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, by the processor, a fourth output signal to actuate the plunger to a high compression state prior to receiving a second input indicative of injecting the second fluid. The method may further include transmitting, by the processor, a fifth output signal to actuate the plunger to a low compression state prior to receiving a first input indicative of injecting the first fluid. The method may further include detecting, by an air bubble sensor, air bubbles in at least one of the first fluid or the second fluid.

[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 slot connection, the first fluid source connection including a first valve, the second fluid source connection including a second valve, and the slot connection including a slot 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 indicating that a first fluid is injected into the first fluid source connection from a first fluid source at a 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 slot connection to remove residual first fluid into the slot, transmit a third output to close the slot valve at the slot connection, and receive a second input indicating that a second fluid is injected into the second fluid source connection from a second fluid source.

[0035] The first fluid may be heparinized saline. The second fluid may be a contrast agent. The system may further include a manifold including a saline valve, a contrast agent valve, and a vacuum valve, the saline valve being configured to connect a first fluid source connector of the first hemostatic valve to a saline source, the contrast agent valve being configured to connect a second fluid source connector of the first hemostatic valve to a contrast agent source, and the vacuum valve being configured to connect a slot connector 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 axially movably receive the first catheter therethrough. 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 for the first catheter. The first hemostatic valve may include a plunger. The first processor may further be configured to transmit a fourth output to the plunger so that the plunger is actuated to a high compression state before receiving a second input indicating the injection of a second fluid. The first processor may be further configured to transmit a fifth output to the plunger to cause the plunger to actuate to a low compression state prior to receiving a first input indicative of injecting a first fluid.

[0036] A fluid management system for a robotically driven interventional device is also provided. The system includes a hub configured to be positioned on a proximal end of a first elongated body and to operate the first elongated body, and a first hemostatic valve at least partially disposed in the hub, wherein the hemostatic valve includes a first fluid source connector, a second fluid source connector, and a trough connector. The hemostatic valve is configured to be simultaneously and fluidly connected to a first fluid source, a second fluid source, and a third fluid source via the first fluid source connector, via the second fluid source connector, and via the trough connector, 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 trough.

[0037] The hemostatic valve may include a three-way connector including the first fluid source connector, the second fluid source connector, and the tank connector. The first fluid source may include one of saline, heparinized saline, or a drug. The second fluid source may include a contrast agent. The system may include a first manifold including a first input line configured to connect to the first fluid source and a first output line configured to connect to the first fluid source connector of the hemostatic valve. The system may include a second hub configured to receive and operate a second elongated body at least partially disposed in a lumen of the first elongated body, and a second hemostatic valve 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 tank connector, wherein the first manifold includes a second output line configured to connect to the third fluid source connector. The first manifold may include a valve configured to activate one or both of the first output line and the second output line. 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 including a second input line configured to connect to the second fluid source and a third output line configured to connect to the second fluid source connector of the first hemostatic valve. The system may further include a second hub configured to receive and operate a second elongated body at least partially disposed in the lumen of the first elongated body, and a second hemostatic valve 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 tank 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 include one or more of a bubble sensor or a bubble filter. The system may include a third manifold including a tank output line configured to connect to the tank and a tank input line configured to connect to the tank connector of the hemostatic valve. The system may further include a second hub configured to receive and operate a second elongated body at least partially disposed in the lumen of the elongated body, and a second hemostatic valve 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 tank connection, wherein the second manifold further includes a second tank input line configured to be connected to the second tank connection. The tank input line may include an in-line local filter. The tank may include a suction reservoir, such that the tank output line includes the suction reservoir configured to be fluidly connected to a suction pump.The hemostasis valve may include an actuatable gasket movable between a first open configuration, a second low sealing force configuration for low pressure transfer of fluid from the first fluid source or the second fluid source, and a third high sealing force configuration for high pressure transfer of fluid from the 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 so that the driven magnet moves in response to movement of the drive magnet. The drive magnet may be axially movably carried by a support table. The system may include a second hub and a second hemostasis 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 hemostasis valve being at least partially disposed in the second hub, wherein the second valve includes a third fluid source connector, a fourth fluid source connector, and a second slot connector. The second hemostasis valve can be configured to be fluidly connected to the first fluid source via the third fluid source connection, to the second fluid source via the fourth fluid source connection, and to the trough via the second trough connection, such that the second hemostasis valve is configured to allow fluid from the first fluid source or from the second fluid source to enter the lumen of the second elongated body through the hemostasis valve, or to allow fluid removed from the lumen of the second elongated body to be collected in the trough. The second hemostasis valve can include a second three-way connector including a third fluid source connection, a fourth fluid source connection, and a second trough connection.

[0038] A fluid management system for a robotically 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 including a three-way connector configured to be simultaneously fluidically connected to a first fluid source, a second fluid source, and a groove, the second port including an actuatable hemostatic gasket configured to seal around a second interventional device, the second interventional device being configured to be disposed in the lumen of the interventional device. The gasket is actuatable between a first open state, a second low sealing force state, and a third high sealing force state, the second low sealing force state being used to receive a low-pressure fluid injection from the first fluid source or the second fluid source through the first port, or to allow fluid to flow to the groove through the first port, and the third high sealing force state being used to receive a high-pressure fluid injection from the second fluid source through the first port.

[0039] A fluid management system is also provided, comprising a box configured to receive saline from a saline source, contrast media from a contrast media source, and vacuum from a vacuum source, the box comprising a plurality of saline connectors, a plurality of contrast media connectors, and a plurality of vacuum connectors, each of the plurality of saline connectors being configured to couple to one of a plurality of conduits to provide saline thereto, each of the plurality of contrast media connectors being configured to couple to one of the plurality of conduits to provide contrast media thereto, and each of the plurality of vacuum connectors being configured to couple to one of the plurality of conduits to provide vacuum thereto.

[0040] The cassette may include a plurality of contrast agent valves, each of which is configured to selectively connect one of the plurality of contrast agent connectors to the contrast agent source fluid. The cassette may include a plurality of vacuum valves, each of which is configured to selectively connect one of the plurality of vacuum connectors to the vacuum source fluid. The cassette may include a contrast agent flow path, which includes a plurality of branches, wherein each of the plurality of contrast agent connectors is positioned along one of the plurality of branches. The cassette may include a plurality of contrast agent valves, each of which is positioned along one of the plurality of branches. The plurality of contrast agent valves may be robotically actuated valves configured to be controlled by a control system. The cassette may include a vacuum flow path, which includes a plurality of branches, wherein each of the plurality of vacuum connectors is positioned along one of the plurality of branches. The cassette may include a plurality of vacuum valves, each of which is positioned along one of the plurality of branches. The plurality of vacuum valves may be robotically actuated valves configured to be controlled by a control system. The system may include a plurality of saline pumps, wherein the plurality of saline pumps are configured to drive saline from a saline source to the plurality of catheters. The plurality of saline pumps may be positioned outside the cassette. The system may include a contrast agent pump, wherein the contrast agent pump is configured to drive contrast agent from a contrast agent source to the plurality of conduits. The system may include an aspiration reservoir, wherein the vacuum source is configured to drive aspiration from the plurality of conduits to the aspiration reservoir. The cassette may be disposable.

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

[0042] The system may include a plurality of catheters, each of the plurality of catheters being coupled to one of the plurality of catheter hubs, wherein the plurality of catheters are arranged in a concentric catheter fitting. The system may include a plurality of tubing sets, wherein each of the plurality of tubing sets is configured to be coupled to the box and one of the plurality of catheter hubs. Each of the plurality of tubing sets may include a saline tube, a contrast medium tube, and a vacuum tube. The system may include a plurality of saline pumps, wherein the plurality of saline pumps are configured to drive saline from a saline source into the box. The system may include a contrast medium pump, wherein the contrast medium pump is configured to drive contrast medium from a contrast medium source to the plurality of catheter hubs. BRIEF DESCRIPTION OF THE DRAWINGS

[0043] The foregoing is merely an overview, and therefore it is necessary to define in detail. The above aspects and other aspects, features and advantages of the present technology are described below in conjunction with various embodiments with reference to the accompanying drawings.

[0044] Figure 1A One embodiment of a single channel fluid management system is shown.

[0045] Figure 1B One embodiment of a three-channel fluid management system is shown.

[0046] Figure 2 A schematic diagram of the three-channel fluidic system is shown.

[0047] Figure 3 Another schematic diagram of the fluid system is shown.

[0048] Figure 4 Another schematic diagram of the fluid system is shown.

[0049] Figure 5A and Figure 5B A cross-sectional view of an exemplary rotary hemostatic valve is shown with the gasket configured in an open position.

[0050] Fig. 6A and Figure 6B A cross-sectional view of a rotary hemostatic valve is shown with the gasket configured in a low-pressure position.

[0051] Fig. 7A and Figure 7B A cross-sectional view of an exemplary rotary hemostatic valve is shown with the gasket configured in a high pressure position.

[0052] FIG. 8A to FIG. 8C Various views of exemplary gaskets for use with the hemostatic valves described herein are shown.

[0053] Fig. 9 Shown is a perspective view of an actuation mechanism for use with the rotary hemostatic valve described herein.

[0054] FIG. 10A to FIG. 10B Shows Fig. 9 Two different positions of the actuating mechanism.

[0055] Fig. 10C A linear actuator assembly is shown.

[0056] Fig.11 A perspective view of an example fitting is shown in which a rotary hemostasis valve is integrated with a manifold.

[0057] Fig.12 is a flow chart of a method for degassing a fluid management system of a robotically driven medical device.

[0058] Fig.13 A schematic diagram of the control system is shown.

[0059] The embodiments shown are examples only and are not intended to limit the disclosure. Schematic diagrams are drawn to illustrate features and concepts and are not necessarily drawn to scale. DETAILED DESCRIPTION

[0060] The foregoing is merely an overview, and therefore it is necessary to define in detail. The above-mentioned aspects and other aspects, features and advantages of the present technology will now be described in conjunction with various embodiments. The inclusion of the following embodiments is not intended to limit the present disclosure to these embodiments, but rather to enable any person skilled in the art to make and use the intended 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 the present disclosure as described and illustrated herein may be arranged, combined, modified and designed with various different conceptions, all of which are clearly intended and form a part of the present disclosure.

[0061] Without the aid of a fluid management system, it can be difficult to properly inject fluids into a living human's blood vessels in a precise and predictable manner. This desired precision in fluid administration, combined with the dangers of delivering an improper volume of fluid or fluid containing air bubbles, has led the medical industry to train physicians to have a tactile sense of fluid administration along with visual volume and air bubble assessment. For example, physicians are trained to press a syringe with a specific coordinated pressure when learning to inject a fluid into the brain, as well as how to manually prepare and check for volume and air bubbles when injecting and / or removing fluids during certain procedures.

[0062] Air embolism is a significant and even fatal risk to patients during catheterization procedures. Air may be introduced during fluid injection, catheter switching or operation, or any other event that creates a pressure gradient that enables air to flow into the catheter and subsequently into the blood vessel. Reducing the number of disconnections and creations in the system during catheterization procedures can reduce the possibility of air embolism. The fluid management system and method described herein are configured to reduce the possibility of air embolism during catheterization procedures.

[0063] Further, in the case of ischemic stroke or other occlusive or thrombotic related conditions, every minute of treatment per night may result in a reduced patient recovery rate. During catheterization surgery, for example, using a fluid management system to reduce the manual switching between fluid administration and removal (e.g., suction) of the catheter, as well as reducing the time required for fluid preparation, can improve the survival and recovery rate of patients after a stroke event. In some embodiments, by using the fluid management system described herein to reduce the manual switching between fluid administration and removal of the catheter, the advantage of reducing the workload for the operator can be provided. In some embodiments, by using the fluid management system described herein to reduce the manual switching between fluid administration and removal of the catheter, the advantage of being able to implement remote control surgery (wherein the interventional physician is not on site near the fluid management system and / or catheter) in a simplified manner can be provided, because when the fluid management system is used, the change of connection may not be part of the surgery. In some embodiments, by using the fluid management system described herein to reduce the manual switching between fluid administration and removal of the catheter, the advantages of improved safety and reliability (e.g., continuity of surgical steps) are provided. In addition, by using a consistent fluid management system, the risk of air embolism is reduced.

[0064] Disclosed herein are systems and methods for managing a fluid system for administering and removing fluids during medical procedures. The fluid system can be coupled to a robotically driven interventional device, a manually driven interventional device, or any combination thereof. In particular, the systems and methods can be configured to control a fluid administration device to ensure that a correct diagnosis and / or treatment is provided.

[0065] The systems and methods described herein may include programmable and / or automated fluid injection and removal systems that can assist physicians (e.g., surgeons, interventionalists, etc.) in performing procedures when fluids are involved. For example, the devices, systems, and methods for operating the fluid management systems described herein can automate fluid injections using programmable pumps, vacuums, catheter hubs, etc. to allow for consistent, precise, and timely injections. In some embodiments, fluid lines are not swapped or disconnected during surgery, but are instead configured once prior to surgery and remain intact throughout the surgery to avoid errors at connection points (e.g., valve errors), errors in fluid selection, and / or air bubble introduction issues due to the introduction of air when switching between fluids.

[0066] In surgery, the fluid management system described herein may include multiple fluid systems, each of which is used for a different fluid source and / or fluid collection container. The multiple fluid systems can be configured to flow out of the same fluid management system and be coupled to an interventional device or medical tool. For example, each fluid system can be configured to be connected to a respective catheter hub (a manual catheter hub or a robot-driven hub) associated with the fluid management system. Each catheter hub can be connected to at least one interventional device, such as a catheter. The catheter hub or a control interface removed from the catheter hub can include controls for controlling fluid administration steps and / or catheter operation steps.

[0067] In some embodiments, the devices, systems, and methods described herein can be configured to provide advantages of reducing the time and effort for degassing a fluid system. For example, keeping fluid lines and fluid conduit connectors fully filled during surgery (i.e., avoiding switching of fluid components) can ensure that a one-time degassing procedure for each fluid is performed before surgery. The methods described herein can include configuration methods, degassing methods, processing methods, fluid injection and / or fluid removal methods, etc.

[0068] 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 surgery. For example, because additional catheters, fluid lines, catheter hubs, and / or other fluidly connected components are configured to be connected to the system and remain connected prior to surgery, the components can be packaged together, or at least multiple packages can be opened at once and the components assembled prior to surgery, and no additional packages need to be opened or additional components installed during surgery.

[0069] In some embodiments, the devices, systems, and methods described herein may be configured to reduce the time and / or steps used to flush fluid lines because such steps may be automated and performed in an automatic manner when requested by the fluid management system.

[0070] In some embodiments, the devices, systems, and methods described herein can be configured to display fluid management steps on a user interface to simplify configuration of the fluid system. For example, a particular user interface can be configured for a particular surgery. Each user interface can present instructions, information, or other data to the surgical staff as the fluid management system automatically performs the next step of a procedure related to fluid management.

[0071] Systems and devices

[0072] 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 fluids to a patient or the extraction of substances from a patient via one or more interventional devices such as catheters. As shown, the system 10 can manage fluids delivered to a patient during a medical procedure. The fluid management system 10 includes at least one fluid source and / or sink 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 sink line 116. The source and / or sink line 116 is coupled to at least one catheter 120 through the hub.

[0073] In some embodiments, the fluid source and / or tank 12 includes a fluid volume reservoir and a means for advancing such fluid to another component of the system 10 or for recovering the fluid to the source. Example propulsion means may include one or more propellers, impellers, and / or pumps to circulate and / or recover fluid throughout the system 10. In some embodiments, the propulsion means may be used to control volume, flow rate, and / or pressure. In certain embodiments, the propulsion means may be activated to advance the fluid to another component of the system or to recover the fluid from the system, or may be deactivated to stop the movement of the fluid.

[0074] In some embodiments, the fluid management channel is substantially repeated for each catheter configured for a specific medical operation. Different channels can be different in the sensors, pumps and / or valves used based on the interventional devices connected to each fluid channel. For example, the fluid system for a surgical catheter (e.g., for suction) can include an in-line vacuum pump and a filter. Further, for example, the fluid system for guiding, entering or inserting a catheter can include a drip rate sensor, a bubble sensor, a pressure sensor and / or a bubble filter in the pipeline.

[0075] Source and / or trough 12 represents a fluid source or fluid trough (e.g., a waste tank). For example, a fluid source may include a container suitable for containing a fluid (e.g., saline, contrast media, drugs, blood, plasma, or other fluids) used with the fluid management system 10. The container can be configured to release the 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 trough may include a container suitable for receiving a fluid (e.g., an aspirate, thrombus, particles, saline, contrast media, drugs, blood, or other fluids, or a combination thereof) from a patient and / or from other fluid infrastructure within the fluid management system 10.

[0076] The valve 14 represents one or more valves that are coupled to the source and / or sink 12 on a first side of the valve 14 and coupled to the manifold 16 on a second side of the valve 14. The manifold 16 is configured to connect each valve 14 to a specific hub 18. In some embodiments, the valve 14 can instead be directly coupled to the hub 18 to avoid using a different manifold 16. In some embodiments, the manifold 16 can be integrated into the hub. In some embodiments, the second valve 14 can connect the manifold 16 to the hub 18. For example, the second valve 14 can be coupled to the manifold 16 on a first side and to the hub 18 on a second side.

[0077] The hub 18 is configured to be releasably or non-releasably coupled to an interventional device (catheter or other medical device). For example, the catheter 120 has a proximal end attached to a unique hub 18, sometimes referred to as a "puck". In some embodiments, the hub 18 is movable on a path along the surface of the robot drive table to push or retract the catheter 120 (or other medical and / or interventional device). Each hub 18 may also contain a mechanism for rotating or deflecting the catheter 120 or guidewire as needed. The hub 18 may be connected to a fluid delivery tube (e.g., source / slot line 116) to provide fluid release or fluid capture. Each hub 18 may be electrically connected to an electronic control system via a hardwired connection, an RF wireless connection, or a combination of the two. Additional details of the hub, drive table, and related systems are provided in U.S. patent application serial number 17 / 816,669, entitled Method of Supra-Aortic Access fora Neurovascular Procedure, filed on August 1, 2022, which is expressly incorporated herein in its entirety.

[0078] Any of the hubs disclosed herein may further include one or more fluid injection ports and / or a wireless RF transceiver for communication and / or power transfer. In some embodiments, the hub 18 may also include a wired electrical communication port and a power supply port.

[0079] In some embodiments, the hub 18 or the line 116 leading to the hub 18 may include a visual indicator for indicating the presence of an aspirated clot. The visual indicator may include a clot chamber having a transparent window. A filter may be provided in the clot chamber. Additional details of the clot capture filter and related features may be found in U.S. Provisional Patent Application Serial No. 63 / 256,743, entitled Device for Clot Retrieval, filed on October 18, 2021, which is hereby expressly incorporated herein in its entirety.

[0080] Any of the hubs or interventional devices disclosed herein may further include a sensor for detecting a parameter of interest, 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 the clot, or detecting an unobstructed distal tip. In some cases, the sensor may be positioned on the flexible body of the interventional device. The sensor may include a pressure sensor to capture the arterial blood pressure waveform at the distal end of the catheter, or an optical sensor to determine a captured clot or bubble. 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) may locally detect strain, which helps to detect and / or determine the applied force.

[0081] Figure 1BA schematic diagram of a multi-channel fluid management system 10 having a first source 12a, a second source 12b, and a sink 12c is shown. The first source 12a is coupled to a valve 14a. The second source 12b is coupled to a valve 14b. The sink 12c is coupled to a valve 14c. The valves 14a, 14b, and 14c are part of a valve manifold 16. The valve manifold 16 is coupled to a hub 18. In certain 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. The valves 14a, 14b, and 14c can be opened and closed to selectively connect the first fluid source 12a, the second fluid source 12b, and the sink 12c to the lumen of the catheter 120. For example, the 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 may selectively communicate with or be blocked from communication with the lumen of the catheter 120. For example, in some embodiments, one of the first port, the second port, and the third port may communicate with the lumen of the catheter 120, while the other two ports are blocked from communication with the catheter 120.

[0082] In some embodiments, first source 12a can be a source of heparinized saline. Source 12b can be a source of contrast medium solution. In some embodiments, one or more of source 12a, source 12b, and source 12c can be coupled to multiple manifolds 16, each manifold coupled to a unique interventional device 18. Valve manifolds 16 as shown herein can be used in any system described herein.

[0083] 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 including a stack of four concentric interventional devices. The fluid system 100 shown here includes a fluid management section 102 and an interventional section 104. In some embodiments, the interventional section 104 may include a stack of concentric catheters and guidewires configured for manual operation by a physician. In some embodiments, the interventional section 104 may include a stack of concentric catheters and guidewires configured for operation by a robotic drive system. In some embodiments, the interventional section 104 includes a combination of robotically driven medical devices and manually operated medical devices.

[0084] Components of the fluid management section 102 may be located outside the sterile field or within the sterile field. In some embodiments, the fluid management section 102 is located outside the sterile field but is coupled to the access section 104 located within the sterile field via flexible tubing and flexible electrical conductors.

[0085] The fluid management unit 102 may include at least two or three or more Figure 1A The fluid management unit 102 includes channels 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 being connected to each of the three catheters via a corresponding catheter hub. Two channels are used to deliver two different fluids to each catheter, and the pressure, volume, and delivery rate of each catheter are controllable. The third channel provides suction from each catheter to the tank.

[0086] Each of the two or more fluid channels can be prepared by completely degassing and filling with the corresponding fluid to prepare for transport into the catheter and body cavity. In some embodiments, the fluid line, catheter and / or catheter lumen can be flushed and primed with a fluid (e.g., saline) at the same time.

[0087] In some embodiments, the system 100, 200 can be configured to backfill each slot connector of each catheter with fluid (e.g., saline) at the beginning of the procedure and / or between fluid steps. This can provide a backfill column of saline downstream of the slot connector, for example, to ensure that contrast injection flows to the distal tip of a particular catheter, rather than the slot. In some embodiments, the system 100, 200 can be configured to provide a backfill column of saline upstream of a saline valve at the hub, for example, to ensure that contrast injection flows to the distal tip or slot of a particular catheter, rather than through the saline valve.

[0088] 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 groove 112. Sources 110a and 110b can each be configured to hold and distribute at least one fluid (e.g., saline, contrast media, drugs, blood or other fluids, or a combination thereof). Groove 112 can be configured to receive waste fluids and / or waste products from a selected suction line leading to a corresponding catheter. Although two fluid sources and one fluid groove are shown, any number of fluid sources and / or fluid grooves corresponding to the fluid delivery and / or suction requirements of a specific operation are possible (e.g., one fluid source and one fluid groove, two fluid sources without a fluid groove, more than two fluid sources, etc.).

[0089] A plurality of valves (and / or valve arrays) are provided to stop and start the flow of each respective fluid to or through one or more fluid lines and / or hubs within sections 102 and / or 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 having three valves is shown, any number of valves is possible and may correspond to the number of catheters and / or fluid sources used in a procedure, or a sub-set of interventional devices used in a procedure. For example, in some cases, each valve array may include at least one valve, two valves, three valves, or four or more valves.

[0090] In some embodiments, each valve in a valve array (e.g., valve array 116a) can be configured to independently control and / or adjust the fluid resistance, flow rate, and / or pressure of a fluid flowing through the valve and the corresponding conduit. In some embodiments, each valve in a valve array can be independently and / or simultaneously adjusted for a corresponding conduit and / or for more than one conduit.

[0091] In the illustrated embodiment, the fluid passage is repeated for each conduit, and therefore will be described below only in conjunction with source 110a. The first outflow valve 117a is communicated with the first conduit 126 through a unique source pipeline 120a. The second outflow valve 117b is communicated with the second conduit 128 through a unique source pipeline 120b. The third outflow valve 117c is communicated with the third conduit 130 through a unique source pipeline 120c. Each valve 117a to 117c is preferably electronically actuated between fully closed, fully open or partially open positions in response to a signal from a control system. Any of a variety of valve mechanisms can be used, such as a ball valve driven by a stepper motor, a solenoid, a plug valve (e.g., a rotary plug valve), a rotary valve or other drive mechanisms known in the art. The drive mechanism can provide automatic control and sequencing of the valve. For example, a stepper motor with built-in encoding can be used to achieve valve actuation to provide consistent switching and sequencing. The drive mechanism can be controlled using a motor controller of a user control interface (e.g., or a computer system). The control system may include modules that read values ​​(eg, flow, bubbles, pressure, etc.) from sensors and display the values ​​to control the behavior of the fluid system.

[0092] In some embodiments, a stopcock mechanism (e.g., a rotary stopcock) can be used in the manifold described herein. For example, one or more stopcocks can be placed near the hub (or integrated into the hub) to avoid the management of fluid columns in a particular pipeline. Such a pipeline can be a disposable sterile pipeline that can provide a single use. Placing a manifold with a stopcock near the hub or integrated into the hub has the advantage of simplicity, without the need to manage the fluid columns in the pipeline. Keeping the manifold and stopcock away from the hub can allow the manifold and stopcock to be used with non-sterile equipment outside the sterile field. Such a configuration can provide the advantage of maintaining the sterility of the assembly in a sterile field.

[0093] 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 a control system, such as a signal from a processor of the control system. The control system (e.g., a processor) may be configured to increase the sealing strength of the hemostatic valve in response to the operation of the contrast agent controller to introduce the contrast agent into the catheter. The control system (e.g., a processor) may be further configured to reduce the sealing strength of the hemostatic valve in response to the operation of the contrast agent controller to stop introducing the contrast agent into the catheter. In some embodiments, the control system (e.g., a processor) may be configured to reduce the sealing strength of the hemostatic valve in response to a received signal that drives the catheter or guidewire through the hemostatic valve. For example, this feature can provide the advantage of reducing friction between the hemostatic valve and the moving catheter shaft.

[0094] In operation, all three valves 117a to 117c may be in an open configuration to allow saline to flow through each of the three conduits. The forward flow of saline (in the direction of arrow 122a) may be driven by a pump 114, such as an electronically controlled peristaltic infusion pump or a rotary piston pump. Alternatively, any one valve may be opened while the other two are closed, depending on the desired performance. Alternatively or additionally, other volume and / or pressure sources (e.g., pump 114) may be deactivated or disconnected to prevent flow.

[0095] exist Figure 2 In the stack of concentric catheters shown, the first catheter 126 can be a "large bore" access catheter having a diameter of at least about 0.075 or at least about 0.080 inches in diameter. The second catheter 128 can be an aspiration catheter having a diameter of about 0.060 to about 0.075 inches in diameter. The third catheter 130 can be a steerable catheter having a deflectable distal tip having a diameter of about 0.025 to about 0.050 inches in diameter. The guidewire 132 can have a diameter of about 0.014 to about 0.020 inches in diameter. In one example, the first catheter has a diameter of about 0.088 inches, the second catheter is about 0.071 inches, the third catheter is about 0.035 inches, and the guidewire has a diameter of about 0.018 inches.

[0096] The available lumen in the first catheter 126 is the difference between the inner diameter (ID) of the first catheter 126 and the outer diameter (OD) of the second catheter 128. The available lumen in the first catheter 126 may be different from the available lumen in the second catheter 128 (which may be the difference between the ID of the second catheter 28 and the OD of the third catheter 130), and the available lumen in the second catheter 128 may be different from the available lumen in the third catheter 139 (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). In order to produce the same delivery infusion flow rate through each catheter, the control system may be configured to adjust each of the pumps 114 and / or valves 117a to 117c to compensate for the difference in the effective cross-section of each corresponding flow path so as to achieve the same delivery flow rate through each catheter.

[0097] In one embodiment of the invention, the catheter may be assembled into a Figure 2 This is preferably achieved in each fluid lumen, such as, for example, the annular lumen between the first catheter 126 and the second catheter 128, and between each additional concentric interventional device in the stacking direction. Infusing saline under pressure can displace substantially all of the air, but may leave some small bubbles, for example, on the inner wall of the first catheter 126, the outer wall of the second catheter 128, or both, adhering to the inner wall of the first catheter 126, the outer wall of the second catheter 128, or both.

[0098] When saline is introduced under pressure into the proximal end of the annular lumen between two interventional devices (e.g., the annular lumen between the first catheter 126 and the second catheter 128), the inner catheter can move relative to the outer catheter (e.g., the second catheter 128 can move about the outer catheter) to break the holding force between the microbubbles and the adjacent walls and allow the bubbles to be carried downstream and discharged through the distal opening of the lumen. The catheters can move axially, rotationally, or axially and rotationally relative to each other. In one embodiment, the first catheter reciprocates relative to an adjacent catheter or guidewire, for example, axially through a range of about 0.5 inches to about 10 inches or about 1 inch to about 5 inches at a reciprocating frequency of no more than about 5 cycles per second or two cycles per second or less.

[0099] Reciprocating motion of adjacent catheters to destroy microbubbles may be manually achieved by grasping the respective catheter hubs and manually moving the catheters axially or rotationally relative to each other while delivering pressurized saline. Alternatively, for example, in a robotically driven system, the processor may be configured to robotically drive at least one hub (e.g., at least one of hub 124a and hub 124b) in two adjacent catheters to destroy and expel microbubbles, for example, in response to user activation of an irrigation controller.

[0100] Source 110b is in fluid communication with manifold 118b, allowing fluid to flow to any number of valves (e.g., three) within valve array 116b as shown by arrow 122b. The forward flow of contrast agent (in the direction of arrow 122b) can be driven by pump 136, such as a syringe pump, a high pressure positive displacement pump, a contrast agent injection pump, etc. Depending on the desired performance, any one valve in valve array 116b can be opened while the other two valves are closed. Alternatively or additionally, other volume and / or pressure sources (e.g., pump 136) can be deactivated or disconnected to prevent flow. The proximal opening of each source line 121a, 121b, 121c can be coupled to a corresponding output port on a corresponding valve within valve array 116b. The distal opening of each source line 121a, 121b, 121c can be coupled to each corresponding hub 124a, 124b, 124c, and therefore coupled to a corresponding conduit 126, conduit 128, and / or conduit 130. Corresponding catheters 126, 128, 130, and / or guidewires 132 may be introduced into a patient (not shown). Additional hubs and / or catheters may be added to system 100, and corresponding fluid management system components (e.g., system 10) may be added to system 100. In other embodiments, system 100 may include fewer hubs and / or catheters, such as two hubs and / or catheters.

[0101] The slot 112 is coupled to the manifold 118c to receive fluid from the suction lines 123a, 123b, 123c in the direction indicated by the arrow 122c. The suction 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 the physician to the control system. Once the physician determines which catheter(s) will be placed in suction mode and actuates the corresponding suction controller, in response to the control system starting the suction pump 115, the corresponding valves within the valve array 116c can be opened to allow fluid to flow through the corresponding catheter and enter the slot 112. Depending on the desired performance, any one of the valves in the valve array 116c can be opened, while the other two valves are closed. Alternatively or additionally, other volume and / or pressure sources (e.g., pump 115) can be deactivated or disconnected to prevent flow.

[0102] In an exemplary embodiment, fluid system 100 represents an aspiration configuration, wherein source 110a contains heparinized saline and source 110b contains contrast medium 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 corresponding fluids.

[0103] Similarly, the contrast medium solution contained in source 110b can flow in the direction of arrow 122b and can flow into manifold 118b. In a given operation, at a given injection time, the doctor can decide to inject contrast medium through any of the three catheters and usually through the most distal catheter. In response to the instruction to inject contrast medium, the control system will open the valve corresponding to the selected catheter, and the other two valves will usually remain closed. In some embodiments, the doctor can inject contrast medium into two or more catheters at the same time. In some embodiments, for example, when driving a catheter or guidewire, contrast medium or suction can be applied simultaneously.

[0104] In some embodiments, each valve (or valve array) can be contained in or carried by corresponding hubs 124a, 124b, 124c. In some embodiments, each valve (or valve array) can be contained near or away from the corresponding hub. In such an example, additional fluid lines (e.g., 120, 121, 123) can be added between each manifold and the corresponding valve. Fluid lines 120a to 120c, 121a to 121c, and 123a to 123c can be tubes. In some embodiments, any one of fluid lines 120a to 120c, 121a to 121c, and 123a to 123c can be detachably coupled to its respective hub. Alternatively, any of the fluid lines 120a-120c, 121a-121c, and 123a-123c may be inseparably connected to the hub and removably coupled to other components of the fluid management portion 102, such as the valve arrays 116a-116c or the manifolds 118a-118c.

[0105] In some embodiments, as will be discussed, the fluid system 100 may also include any number of pressure sensors, volume sensors, flow rate sensors, tubing sets, connectors, bubble sensors / detectors. In the illustrated embodiment, the pressure transducer 134a is in pressure sensing communication with the first conduit 126 via the hub 124a. As shown, additional pressure transducers 134b, 134c may be in communication with their respective conduits.

[0106] The control system can be configured to automatically adjust the various manifold valves, pumps, and hemostasis valves (discussed below) in response to instructions input by the physician. For example, the physician can input an instruction to inject contrast media through the third catheter 130. The control system can cause a series of responsive events to occur automatically. At least the saline valve 117c will close. Valves 117a and 117b can be closed, or remain open to provide positive pressure through the first and second catheters to prevent backflow of contrast media.

[0107] A control signal will be sent to the hemostatic valve in each of the first catheter hub 124a and the second catheter hub 124b to tighten from a low pressure slip fit to a high pressure clamp around the second catheter 128 and the third catheter 130, respectively. This will prevent contrast media from escaping proximally through the first catheter 126 and the second catheter 128. A control signal will additionally be sent to valve 119c to place the third catheter 130 in fluid communication with the second source 110b containing a contrast media solution.

[0108] If the space between the OD of the guidewire 132 and the ID of the third catheter 130 is insufficient to allow the desired contrast infusion rate, a further signal will be sent from the control system to the drive system of the control hub 124d to retract the guidewire 132 proximally from the third catheter a distance sufficient to allow contrast to flow through the catheter 130. Additional control signals may be sent to the hemostatic valve carried by the hub 124c to clamp around a portion of the distal end of the guidewire 132 in a 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 a syringe pump, a high pressure positive displacement pump, a contrast medium injection pump, etc., to deliver contrast medium solution through the third catheter 130.

[0109] If the doctor initiates an instruction to perform aspiration through, for example, the first catheter 126, the control system can automatically transmit another series of control signals to execute the instruction. A signal will be sent to each hemostatic valve to move it from a high pressure configuration to a low pressure configuration, in which the friction generated on the axis of the catheter or guidewire is less. Such a configuration can allow the relative movement of various devices and the retraction of the second catheter 128 and the third catheter 130 from the first catheter 126 to the proximal end, while still inhibiting proximal blood loss through the hemostatic valve. A signal will be sent to the drive system to retract each of the hubs 124b, 124c, and 124d to the proximal end. Valve 123a will be opened to place the first catheter 126 in fluid communication with the groove 112. A signal will be sent to actuate the vacuum pump 115, thereby aspirating blood and thrombus into the groove 112. In some embodiments, when aspiration of the first catheter 126 is performed, for example, the communication between the catheter 126 and the first fluid source 110a and the second fluid source 110b may be blocked. For example, the corresponding valves of valve arrays 116a and 116b may be closed to block manifolds 118a and 118b.Alternatively, the volume and / or pressure sources (eg, pumps 114 and 136) may be deactivated or disconnected.

[0110] All fluid lines between the first source 110a and the second source 110b and each catheter, and all fluid lines between the tank 112 and each catheter are preferably completely flushed free of any air bubbles and filled with a fluid such as saline during system preparation prior to surgery. This allows for seamless transitions between infusion, aspiration, and manipulation of catheters and guidewires without disconnecting and reconnecting any fluid lines between the sources, tanks, and catheters, eliminating the risk of introducing air emboli during such exchanges.

[0111] It may also be desirable to be able to confirm the absence of bubbles in any fluid line. This can be accomplished by placing a bubble sensor in the bubble sensing proximal end of each fluid line, such as within or upstream of each hub, or at the manifold. This may be particularly desirable in telemedicine applications where the physician is at a remote workstation and not in direct line of sight of the patient.

[0112] This can be accomplished using a non-contact ultrasonic sensor that measures the intensity and Doppler shift of reflected ultrasound passing through the sidewalls of the fluid conduit to detect bubbles and measure fluid flow rate or fluid level. Ultrasonic or optical sensors can be positioned near the incoming fluid flow path within the hub, or in a supply line leading to the hub.

[0113] For example, to detect the presence of bubbles in an infusion line (which is formed of an ultrasonic or optically transmissive material), the sensor may include a signal source on a first side of the flow path and a receiver on a second side of the flow path to measure the transmission through the liquid passing through the tube to detect the bubble. Alternatively, since the echogenicity of the bubble is relatively high, the reflected ultrasonic signal may be detected from the same side of the flow path as the source.

[0114] Alternatively, an optical sensor may be provided to detect changes in optical transmission or reflection due to the presence of bubbles, or to transmit a visual signal to a display at a remote workstation where the physician can visually observe the presence of bubbles moving through the tubing. In a system with a bubble detector, the control system may be configured to automatically shut off all fluid flow in response to detection of bubbles to give personnel an opportunity to plan subsequent steps.

[0115] In one embodiment, when bubbles are detected in the pipeline, the bubble removal system is automatically activated. The processor can be configured to activate a valve in the flow path downstream of the bubble detector when bubbles are detected. The valve diverts the fluid column containing the detected bubbles from the flow path leading to the patient and enters a bypass flow path or a reservoir instead. Once bubbles are no longer 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 embodiments, the flow path can include any number of bubble filters and / or traps to remove bubbles from the flow path.

[0116] The robotic system portion 104 may include a drive station configured to receive (e.g., coupled to) any number of hubs (124a, 124b, 124c, 124d, etc.). Additional details of the hubs, drive stations, and related systems are provided in U.S. patent application Ser. No. 17 / 816,669, entitled Neurovascular Procedure, filed on August 1, 2022, which is hereby expressly incorporated herein in its entirety. Each hub is configured to be coupled 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 station may be positioned above or beside the patient and configured to support axial advancement, retraction, and in some cases rotation and / or lateral deflection of two or three or more different (e.g., concentrically or side-by-side oriented) devices (e.g., catheters, guidewires, etc.).

[0117] The drive system independently drives each hub to independently move in a proximal or distal direction across the surface of the table to move a corresponding interventional device (e.g., catheter 126, catheter 128, catheter 130 and / or guidewire 132) proximally or distally within the patient's vasculature.

[0118] As discussed elsewhere herein, in response to the movement of the corresponding hubs 124a, 124b, and 124c, the corresponding catheters 126, 128, 130, and / or guidewires 132 can be stacked as a single concentric catheter and guided into a body cavity (not shown). The system 100 can also include a guidewire hub 124d for controlling the guidewire 132, which can also be introduced into the body cavity with one or more of the catheters 126, 128, and / or 130.

[0119] In some embodiments, a driven magnet is provided on each hub. Each driven magnet is configured to cooperate with a drive magnet associated with the table so that the driven magnet moves in response to movement of the drive magnet. In such an example, the drive magnet can be axially movably carried by the support table.

[0120] Because multiple sources and / or slots are configured to each be coupled (and remain coupled) to each catheter hub (e.g., hubs 124a, 124b, and 124c), the fluid system 100 provides the advantage of being able to perform faster surgery than conventional fluid systems that manually remove, add, and / or switch fluids, catheters, hubs, etc. during surgery. For example, the fluid system 100 enables each fluid line / catheter hub to be connected to each fluid source and / or slot before surgery begins. When the interventional physician (or other medical practitioner) performing the surgery is ready to use a specific fluid source or slot, the system 100 has been configured and is ready to allow the use of the specific fluid source or slot without having to switch between different fluid lines for a specific catheter. In some embodiments, the system 100 can be used to provide a treatment method in which a fluid source does not need to be connected to and / or disconnected from a medical device more than once during surgery.

[0121] Thus, the interventionalist can inject any fluid contained in fluid sources 110a, 110b, and / or collect aspirate from any of catheters 126, 128 and / or 130 at any time during the procedure because access to all fluid lines is provided to each catheter hub 124a, 124b, 124c at all times.

[0122] Because multiple sources designated for a particular procedure are preconfigured to connect to individual catheters / catheter hubs, the interventionalist (or other medical practitioner) 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 bubbles into the catheter flow during the procedure because no fluid sources need to be connected or disconnected using the system 100. Instead, each fluid source and tank is connected and tested before the procedure and not removed until the procedure is complete. In some embodiments, the continuous connection of the fluid sources and tanks to the catheter hub associated with the operation of the system 100 eliminates the variability and risk of the interventionalist in remote surgery in a control room rather than in the operating room.

[0123] The valves within the valve arrays 116a, 116b, and / or 116c of the system 100 are depicted at the respective manifolds 118a, 118b, and 118c. In such a configuration, the valves are proximate to the respective sources and / or sinks, with about 2 meters to about 3 meters (e.g., about 6 inches to about 10 feet) of fluid line between the valves of the valve arrays 116a, 116b, and 116c and the respective catheter hubs 124a, 124b, and 124c. In some embodiments, the valves of the valve arrays 116a, 116b, and / or 116c may alternatively be located at the source / sink (e.g., 110a, 110b, and / or 112). In some embodiments, the valve arrays 116a, 116b, and / or 116c are coupled to the fluid line at a location between the source / sink and the hub. In some embodiments, the valve arrays 116a, 116b, and / or 116c can be located at the catheter hub 124a, 124b, and / or 124c. In some embodiments, the valves located at or near the hub can be disposable valves. Other components of the systems 100, 200 can also be disposable and / or reprocessable for reuse.

[0124] In some embodiments, the system 200 can further include valves 113a to 113i between the valve arrays 116a, 116b, and 116c and the corresponding hubs 124a, 124b, and 124c. The valves 113a to 113c can be valve manifolds (e.g., such as Figure 1B The valves 113d to 113f may be a valve manifold (e.g., such as a valve manifold 16) that is part of the hub 124a or is directly or indirectly coupled to the hub 124a. Figure 1B The valves 113g-i may be part of a valve manifold 16 of the hub 124b, which is part of the hub 124b or is directly or indirectly coupled to the hub 124b. The valves 113g-i may be part of a valve manifold (e.g., such as Figure 1B The valve manifold 116 is a part of the hub 124c, which is a part of the hub 124c or is directly or indirectly coupled to the hub 124c. The valves 113a to 113i may be one-way check valves. Figure 2 As shown, one-way check valves 113a to 113i can allow flow in the direction indicated by their respective arrows.

[0125] like Figure 3 As shown, each hub 124a, 124b and 124c may be provided with a hemostatic valve to accommodate the introduction of another device therethrough. The hemostatic valve includes a variable diameter hole, such as a hole through an elastomeric gasket.

[0126] The gasket may be actuatable between a first fully open state, a second partially open state for sealing low pressure fluid injection from a first fluid source or a second fluid source through the first port (as described herein), for allowing fluid to flow through the first port to the slot while allowing advancement or retraction of the interventional device, and a third tightly closed state for resisting backflow of high pressure fluid (e.g., contrast media) injection from the second fluid source through the first port, or for allowing fluid to flow through the first port to the slot. The gasket may be manually actuatable or automatically actuatable, for example based on user input corresponding to operation of one or more interventional devices of the system.

[0127] 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, which provide one or more fluid lines configured to interface with a rotary hemostatic valve. The two or more fluid channels can receive fluids with any number of fluid materials from a fluid source. The two or more fluid channels can allow different fluid materials provided by different fluid sources (of different volumes and / or at different pressures) to flow into or out of a body cavity. Each of the two or more fluid channels can be prepared with a corresponding fluid to be ready for transport to a single fluid line and to the body. Valves and / or valve arrays can be used to switch between the use of the two or more fluid channels.

[0128] like Figure 3 As shown, the fluid system 200 may include a vacuum chamber and / or controller 202 within the sterile field. The vacuum chamber may have a clot filter having a window for viewing trapped clots, and a vent with a valve that, when momentarily opened, allows air to enter to allow direct viewing of the clot through the window. To allow inspection by a remote physician, a CCD or CMOS sensor may be mounted so that the upstream surface of the clot filter is within the field of view of the sensor. This allows the contents of the filter to be viewed on a remote monitor. The entry of air to clear the optical path from the window to the filter may be remotely controlled using an electronically actuated valve.

[0129] An air bubble filter 204 may be provided in the line between the needle injection port 206 and the catheter 226. The system 200 further includes a line branch point 208 (e.g., a Y-shaped object) in fluid communication with the first source 210a and the second source 210b. The line branch point 208 may include a Luer lock connector or a Y-shaped connector that interfaces with multiple fluid sources.

[0130] The system 200 may also include a pump, such as a peristaltic pump 234 or a rotary piston pump, that drives fluid under pressure from the second source 210b to the line branch point 208 in the direction of arrow 222c.

[0131] An air bubble sensor may be provided on the upstream or downstream side of the pump 234. The air bubble sensors 236a, 236b may be non-contact ultrasonic sensors that measure the intensity and Doppler shift of reflected ultrasound through the sidewalls of the fluid conduit, as discussed, to detect bubbles and measure fluid flow rate or fluid level. In some embodiments, the sensor 236a may also be a pressure sensor, or a separate pressure sensor may be provided.

[0132] A valve 216c, such as a ball valve or a rotary valve, can selectively open or close fluid communication between the second source 210b and the conduit 226. A flow rate detector, such as a drip rate sensor 238, enables the flow rate from the second source 210b to be determined and displayed.

[0133] Fluid flow from the first source 210a is directed through the one-way check valve 214 and to the high pressure pump 252, which may be a syringe pump, a high pressure positive displacement pump, a contrast agent syringe pump, etc. The high pressure fluid (e.g., contrast agent solution) is directed through the air bubble sensor 236a and through the valve 216b to the branch point 208. Arrow 222b indicates the direction of fluid flow.

[0134] Based on available lumen cross-sectional area, the resistance of different conduits in the stack of concentric conduits is different.For example, the resistance measurement value in the inner conduit with a fully opened lumen (for example, wherein the guide wire is removed) may be lower than the resistance measurement value in the outer conduit with a second conduit (or guide wire) extending therethrough.Therefore, when performing the saline flushing step, fluid system 200 can be configured to ensure that the flow rate by each inner conduit and outer conduit is similar or the flow rate is suitable for surgery, to avoid coagulation or other problems in the conduit.For this reason, a valve can be adjusted for each conduit to ensure that the flow rate of all conduits remains constant during the saline flushing.System 200 can determine this flow rate in real time based on a flow rate sensor, and a control system can be configured to automatically adjust the valve settings and / or pump parameters to keep the desired flow rate by each conduit.

[0135] In some embodiments, the length change fluid resistance can be inserted in its concentric adjacent lumen by regulating each shaft.As described herein, when the cross-sectional area of ​​the lumen for flow is reduced, for example, when the second conduit (or guide wire) extends into the described lumen, the fluid resistance in the described lumen may be larger.The amount of fluid resistance may be subject to cross-sectional length narrowing, for example, due to the influence of the placement of the second conduit (or guide wire) in the described lumen.The second conduit (or guide wire) that partially extends through the lumen of the first conduit will provide less cross-sectional length narrowing, and accordingly, compared with the situation that the second conduit (or guide wire) fully extends through the lumen of the first conduit, may cause lower fluid resistance in the first conduit lumen.Therefore, fluid resistance can be partially retracted to reduce by the second conduit (or guide wire) being inserted into the lumen of fluid to be injected.

[0136] The system 200 further includes a suction canister 240 coupled to the upstream side of a filter 244. The downstream side of the filter 244 is coupled to a vacuum pump 242. The suction canister 240 is connected to a valve 216a, which can communicate with a sterile field clot capture container 202 discussed elsewhere herein. Arrow 222a indicates the direction of fluid flow.

[0137] An optional pressure sensor 246 is depicted at the proximal end of the catheter 226 or hub coupled to a hemostasis valve such as a rotary hemostasis valve (RHV) 248 .

[0138] In this example, RHV 248 is connected to two different fluid sources. RHV 248 can be formed by a hub (e.g., Figure 2 The hub 124a of the embodiment of the present invention is carried and at least partially arranged in the hub. RHV 248 may include a first fluid source connector, a second fluid source connector and a groove connector. For example, the first connector, the second connector and the third connector may include respective valves (e.g., valves 216a, 216b and 216c) connected to RHV 248 via a fluid line. In some embodiments, the connection point may be formed as a 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 the source and / or groove at the corresponding distal end of the fluid line. In certain embodiments, valves 216a, 216b and 216c may be arranged in a valve manifold or a valve manifold box. In certain embodiments, pump 234 may also be arranged in a valve manifold or a valve manifold box. In certain embodiments, any one of valves 216a, 216b and 216c may be a ball valve, a plug valve, a rotary valve, a solenoid valve or any other suitable valve. Any of valves 216 a , 216 b , and 216 c may be controlled by one or more actuators 217 .

[0139] RHV 248 can be configured to enable the introduction of a catheter or other instrument into a living body while excluding accidental blood flashback. In some embodiments, each RHV described herein can be configured to have at least a fully closed configuration, a low sealing force state through which the device can be advanced without leaking, and a high sealing force state (e.g., mode) through which fluid is prevented from escaping at high pressure and axial movement of the device can be prevented.

[0140] RHV 248 is configured to simultaneously and fluidly connect to a first fluid source (e.g., source 210a) via a first fluid source connection (e.g., valve 216b). RHV 248 is further configured to simultaneously and fluidly connect to a second fluid source (e.g., source 210b) via a second fluid source connection (e.g., valve 216c). In addition, RHV 248 is further configured to simultaneously and fluidly connect to a sink (e.g., suction tank 240) via a sink connection (e.g., valve 216a).

[0141] In operation, system 200 is configured to automatically switch between introducing fluid into a lumen of an elongated body (e.g., catheter 226) from a first fluid source (e.g., source 210a) or from a second fluid source (e.g., source 210b) through RHV 248, or to allow fluid removed from the lumen to be collected in a trough (e.g., suction can / trough 240).

[0142] In some embodiments, optional pressure sensor 246 is located on the upstream or downstream side of RHV 248 (eg, Figure 3 In some embodiments, an optional pressure sensor 246 is located in the catheter (e.g., in the side wall of the catheter) to measure the arterial pressure at the distal end of the catheter. The pressure can be assessed by the interventional physician to confirm that the catheter is not misplaced within the vessel and / or thrombus.

[0143] For example, if the catheter is misaligned with the vessel wall, the detected pressure (e.g., waveform) may be attenuated. Such detection can be provided to an algorithm executed by a processor associated with the system 200, for example, to determine the patency of the lumen of the catheter or the patency of the distal tip of the catheter. Such a pressure sensor and algorithm can provide an improved alternative to traditional pressure determinations in which there is manual manipulation of fluidics and the interventionalist can retract (e.g., pull back) a syringe coupled to the catheter to confirm that blood capture has occurred as well as to evaluate tactile feedback of the catheter.

[0144] This blood capture and tactile feedback assessment can indicate the patency of the lumen or distal tip before performing injection or suction. However, pressure sensor 246 can provide an automated and improved method to assess lumen or distal tip patency. That is, adding a pressure sensor 246 (e.g., a blood pressure sensor) at the proximal end of the catheter can capture arterial pressure waveforms. Without direct visual or tactile feedback, the waveform can be used to determine whether the distal tip of the catheter is pressed on the vessel wall, whether the catheter tip is pressed on the thrombus, whether the catheter tip has complete patency or whether the catheter lumen is in a blocked or completely unobstructed state. In some embodiments, the waveform can be used to determine the engagement state of the distal tip of the catheter with a clot and / or the viscosity of the clot.

[0145] In some embodiments, the fluid systems described herein (e.g., system 100, system 200) include a hemostasis valve (e.g., RHV 248), which includes a first three-way connector having a first fluid source connector (e.g., one-way valves 116a, 216b), a second fluid source connector (e.g., one-way valves 116, 216c), and a slot connector (e.g., one-way valve 216a).

[0146] In some embodiments, the fluid systems described herein (e.g., system 100, 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., source 110b, 210b) comprises a contrast agent.

[0147] The system 100, 200 can further include a second hemostasis valve that is in communication with the second hub (e.g., 124b) and can be at least partially disposed in the second hub. The second hemostasis valve can include a third fluid source connection (e.g., valve 116b), a fourth fluid source connection (valve 116b), and a second tank connection (e.g., valve 116c). In this example, the first manifold 118a can include a second output line configured to be connected to the third fluid source connection (not shown).

[0148] Figure 4Another embodiment of a fluid system 300 for use with a fluid management system is shown. Typically, the fluid system 300 includes a box that can couple multiple fluid sources and / or slots to multiple interventional devices. Multiple fluid lines can extend between the source or slot and the box for coupling to different interventional devices. For other sources and slots, a single fluid line can extend between the source or slot and the box and can be separated within the box to be connected to different interventional devices. In certain embodiments, the box can include an array of connectors formed by connectors from multiple fluid sources and / or slots for coupling to a single interventional device (e.g., in rows or columns). Each array of connectors can be coupled to a tubing set having a tube corresponding to each connector in the array of connectors.

[0149] The box 341 can be a stand-alone unit including a housing having a plurality of valves, tubing, and connectors as described below. A first connector array includes a plurality of releasable connectors, such as Luer connectors, for fluidly connecting the box to a complementary connector, which is fluidly connected to a suction source and at least one or two or more fluids. A second connector array is configured to releasably connect to a tubing set, which is configured to extend between the box and at least one or two or three interventional devices.

[0150] The cartridge 341 thus forms a bridging module that, when assembled, is located between the various fluid and vacuum sources and the corresponding interventional devices.The cartridge 341 may be configured for single use, or may be resterilizable and reusable.

[0151] like Figure 4 As shown, the system 300 may include a first fluid source 310a and a second fluid source 310b. The fluid flow from the first source 310a is directed through a one-way check valve 314 and reaches a high-pressure pump 352, which may be a syringe pump, a high-pressure positive displacement pump, a contrast medium injection pump, etc. The fluid from the first fluid source 310a may be a contrast medium solution that is preferably injected under high pressure.

[0152] The fluid flow from the syringe pump is directed into a cassette 341, which may include a plurality of valves, manifolds, and / or connectors. Within the cassette 341, the fluid flow may be split along a plurality of branches 318b to a plurality of connectors 317b (e.g., Figure 4 The cartridge may include a valve 316b (e.g., a ball valve) and branches 318b upstream of the connector 317b. In some embodiments, any one of the valves 316a or 316b may be a ball valve, a plug valve, a rotary valve, a solenoid valve, or any other suitable valve.

[0153] Fluid flow from the second fluid source 310b may be directed into a plurality of branches 318c to reach a plurality of pumps 334 (eg, Figure 4 Four pumps 334 are shown, such as peristaltic pumps or rotary piston pumps. Each pump 334 can drive fluid (e.g., saline) under pressure from the second source 310b to a unique connector 317c of a respective interventional device within the cassette 341.

[0154] The system further includes a suction canister 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 canister receives fluid from a cassette 341, which includes a plurality of connectors 317a, each of which is configured to be coupled to a unique interventional device. A unique valve 316a (at least two, and four in the illustrated example) can be provided upstream of each connector 317a. Each unique valve 316a can be positioned along a branch 318a.

[0155] In some embodiments, one or more connector arrays 346 may be arranged, each connector array 346 being configured to couple to an interventional device. Figure 4 The connector array 346 is indicated by dashed lines in FIG. Figure 4 As shown, the connector array 346 may include a connector 317a, a connector 317b, and a connector 317c. Figure 4 As shown, array 346 may be organized with all connectors facing the same direction on a common plane, such as a linear row.

[0156] Connector array 346 can be releasably coupled to pipeline group 343, and described pipeline group 343 comprises suction tube 354, first fluid tube 355 and second fluid tube 356.In some embodiments, connector 317a, 317b and 317c can be Luer lock connector.Suction tube 354 can be coupled to connector 317a of array 346 by complementary connector 317d, for suction from interventional device to suction container.First fluid tube 355 can be coupled to connector 317b of array 346 by complementary connector 317e, to provide fluid flow from first fluid source 310a to interventional device.Second fluid tube 356 can be coupled to connector 317c of array 346 by complementary connector 317f, to provide fluid flow from second fluid source 310b to interventional device.Tube 354,355 and 356 can be connected together over most of their length. Tubes 354, 355, and 356 may each have a length of at least about three or four feet, and in certain embodiments about 6 feet to about 8 feet.

[0157] like Figure 4As shown, tubing set 343 includes a line branch point 308 (e.g., a two-to-one or three-to-one Y-shaped object) that can provide fluid communication between the interventional device and tubes 354, 355, and 356. The line branch point 308 can include a Luer lock connector or a Y-shaped connector that interfaces with a complementary connector on the tubing set. In some embodiments, a one-way valve 345 can be positioned upstream of the branch point 308 and downstream of the box 341 along the flow path of the second fluid.

[0158] In some embodiments, the system 300 (or other systems described herein) can use two different flow modes to direct the flow of the second fluid (e.g., saline). In the low flow drip mode, for example, a flow rate of about 1-2 drops per second or 3-6 mL / min can be provided by the pump 334. In some embodiments, a low flow mode rate of 1-8 mL / min can be provided. As described herein, each catheter coupled to the system may experience different fluid resistances.

[0159] Can operate pumps such as pump 334, to provide identical flow rate in each conduit.In certain embodiments, the fluid pressure in the conduit can be at least about 330mmHg or 6.5psi.This pressure may be enough to overcome arterial pressure, while delivering required drip rate.In certain embodiments, the pressure in the conduit can be greater than 330mmHg.In certain embodiments, over the entire operation length, the fluid volume delivered can be at least about 1 liter.In some embodiments, the fluid volume can be up to 2 liters.

[0160] In high flow irrigation mode, all fluid lines can be flushed to remove air. The flow rate can be 100mL / min to 1000mL / min. The fluid pressure can be 5psi to 10psi. The delivery volume per operation can be 0.5 to 1 liter. The volume may depend on the length and diameter of the tubing. In some embodiments, the high irrigation flow rate is at least about 20 times the flow rate of the low flow drip mode, and in some cases 30 to 150 times.

[0161] In certain embodiments, the first fluid (e.g., contrast agent solution) can be provided, for example, by pump 352 at a flow rate of 3 to 8 mL / s (e.g., about 4 mL / s). In certain 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 certain 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 amount of pressure may depend on the flow restriction of the flow rate and the flow path. For higher flow rates, the pressure can be increased in proportion to the flow rate. In certain embodiments, the pressure can be up to 1200 psi.

[0162] In certain embodiments, high pressure pump, such as pump 352, can provide 5mL to 15mL of delivery volume for each high pressure injection. In certain embodiments, each high pressure injection of the pump can provide 5mL to 15mL with an increment of about 1mL of suction each time. In certain embodiments, the second fluid source can provide a total volume of about 200mL for each operation. In certain embodiments, the size of the syringe pump is set to keep at least about 150mL or 200mL, so that uninterrupted flow is provided throughout the operation, and there is no need to add additional contrast medium solution. In other embodiments, the second fluid source can provide a total volume of 150mL to 250mL for each operation.

[0163] In certain embodiments, the flow rate can vary depending on the anatomical location of the distal end of the catheter. For example, in the aortic arch, the flow rate can be about 20 mL / s. A total volume of about 25 mL can be infused into the aortic arch. In the common carotid artery, the flow rate can be about 20 mL / s. A total volume of about 12 mL can be infused into the common carotid artery. In the subclavian artery, the flow rate can be about 6 mL / s. A total volume of about 15 mL can be infused into the subclavian artery. In the internal carotid artery, the flow rate can be about 6 mL / s. A total volume of about 8 mL can be infused into the internal carotid artery. In the external carotid artery, the flow rate can be about 3 mL / s. A total volume of about 6 mL can be infused into the external carotid artery. In the vertebral artery, the flow rate can be about 6 mL / s. A total volume of 8 mL can be infused into the vertebral artery.

[0164] In some embodiments, a motor can be provided to drive a high pressure pump, such as pump 352, which can 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 can be applied to provide an approximate pressure limit. In some embodiments, the second fluid can be a contrast medium solution, such as Omnipaque 300, Omnipaque 350, or Visipaque 320.

[0165] In certain embodiments, vacuum pump, for example pump 342, can provide about -29.5inHg or up to -29.5inHg (-999mbar) pressure.In certain embodiments, the pipeline for suction can have an inner diameter of 0.11 inches (about 2.8mm).In certain embodiments, the volume of the suction container such as container 340 can be at least about 0.5L.In certain embodiments, the volume of the suction container can include about 0.5L for blood and other volume for saline flushing.In certain embodiments, the suction container can have a volume of 0.25L to 0.75L.In certain embodiments, vacuum pump can be configured to run to provide low pressure / flow setting in addition to assist flushing process, because it may be desired that the suction line is full of saline (except when suctioning clots) at any time.In certain embodiments, a separate pump can be provided for low pressure / flow setting.

[0166] Figure 5A and Figure 5B A perspective view and a cross-sectional view of an example rotary hemostatic valve 448 are shown, wherein the dual membrane gasket is configured in an open position. That is, both the distal and proximal membranes are provided with slits, and a support tube is positioned through both membranes to maintain the slits in an open, restricted configuration (see, for example, Figure 8B RHV 448 may represent the hemostatic valve 248 in the fluid system 200, or a hemostatic valve in any of the catheter hubs 124a, 124b, 124c, and may be configured for use with a manual surgery and fluid system, a robotic surgery and fluid system, or a combination thereof.

[0167] RHV 448 includes a side port 420, a dual membrane gasket 452, and a plunger 476 having a housing 482 and a support tube 479 configured to be reversibly advanced 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) therethrough. The plunger includes a proximal end 476a and a distal end 476b.

[0168] The second interventional device is disposed in the lumen defined by the first interventional device. As shown, the catheter 426 is advanced through the support tube 479 of the RHV 448. The proximal end 450 of the RHV 448 includes a housing coupled to the plunger 476. The gasket 452 is configured to be coupled to the gasket housing 472 around the circumference of the plunger.

[0169] The gasket 452 can be actuatable 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 catheter but allow the catheter to slide, the third state is used to seal around the catheter for high pressure management, and the fourth fully closed state does not have any second device extending therethrough.

[0170] The first open state represents the blood return position or the intervention device loading or unloading position, and it is configured to allow the gasket 452 to be fully opened by RHV 448. The second part of the open state represents such a position, and the position is configured to allow the gasket 452 to be closed around the conduit 426 with enough sealing in the RHV 448, so that when the conduit 426 advances or retracts in the RHV448 with low resistance, the blood or saline solution pumped under relatively low pressure will not leak. The third state represents a tightly sealed configuration, which is used to enable the injection of high-pressure fluid (contrast agent) from a fluid source. In certain embodiments, the control system can be configured to determine the sealing force (for example, in response to human input) of the hemostatic valve around the conduit 426. If it is determined that the sealing force is too high or too low, the control system can be configured to change the sealing force. For example, if the sealing force is too low, the control system can increase the sealing force.

[0171] like Figure 5B As shown, in the first open state, the gasket 452 is constrained by the support tube. The first open state ensures that the gasket 452 is configured in a blood return position or an interventional device loading or unloading position. The open position configures the RHV 448 to pass through the gasket 452 by moving the tubular support portion of the plunger 476 so that the tubular support forces the gasket to open and restrict the gasket to provide an open central lumen to open the gasket 452. The movement can allow arterial blood pressure to push blood through the catheter 426 proximally until blood can be seen at the RHV448. Moving the gasket to an open position that allows blood return allows visual and / or tactile confirmation that there are no bubbles in the RHV448, and / or the distal tip of the catheter is not against the vessel wall and / or the lumen defined by the catheter is unobstructed.

[0172] In some embodiments, RHV 448 can include a first port 420. First port 420 can be releasably connected to a three-way connector configured to be fluidically connected to a first fluid source (e.g., source 110a), a second fluid source (e.g., source 110b), and a tank (e.g., tank 112). Alternatively or additionally, RHV 448 can further include one or more additional ports for connecting to a fluid source and / or tank. For example, see Fig.11 , which will be described in further detail elsewhere in this document.

[0173] Fig. 6A and Figure 6BThe cross-sectional view and enlarged cross-sectional view of the rotary hemostatic valve are shown, wherein the 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 been retracted proximally so that the distal slit 464 (see Figure 8B ) is in sliding contact with the catheter 426, but the proximal slits 468, 470 (see Figure 8C ) is held in an open configuration constrained by the support tube. The low pressure state of gasket 456 enables a burst infusion of saline (eg, from source 110b) through side port 420 of RHV 448 at a pressure of up to about 276 kPa (ie, about 40 psi).

[0174] like Figure 6B 4, the gasket 456 is shown in a partially open state, wherein the plunger 476 is partially advanced into the gasket 456. This position represents a low pressure position, wherein blood or saline solution does not leak when the catheter 426 is advanced or retracted with low resistance through the RHV 448. The second partially open state configures the RHV 448 to receive a low pressure fluid injection from a first fluid source (e.g., source 110a) or a second fluid source (e.g., 110b) through the first port, or to allow fluid to flow through the first port to the slot (e.g., slot 112).

[0175] Fig. 7A and Figure 7B A cross-sectional view of an example rotary hemostatic valve is shown with the gasket configured in a high sealing force (mode) or high pressure position. Fig. 7A As shown, the distal membrane 460 includes a thickened sidewall in the form of a cross material 466 that aligns with the transverse slits of the proximal membrane 462. The cross material 466 provides additional gasket contact around the catheter 426 in a tight closure (eg, high pressure) condition.

[0176] The tightly closed state represents a configuration for high pressure fluid transfer from a fluid source (e.g., contrast agent / source 110b). The closed state of gasket 458 enables contrast agent (e.g., from source 110b) to be infused through side port 420 of RHV 448 at a pressure of up to about 2.76 MPa (i.e., about 400 psi). Figure 7B As shown, in the closed state, the plunger 476 is retracted 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 catheter 426. In other words, the proximal end 476a and the distal end 476b of the plunger 476 are both away from the gasket 458 to achieve the closed state of the gasket 458.

[0177] FIG. 8A to FIG. 8C Various views of example gaskets for use with the fluid systems described herein are shown. Fig. 8AA perspective view of a gasket 458 is shown. The gasket 458 includes a distal membrane 460 and a proximal membrane 462. The cross slits (substantially horizontal slits 470 intersecting substantially vertical slits 468) on the proximal membrane 462 of the gasket 458 can be allowed to compress against the catheter for a high pressure seal or a closed position of the gasket 458. The vertical slits 464 on the distal membrane 460 of the gasket 458 can be allowed to compress against the catheter for a low pressure seal or a closed position of the gasket 458.

[0178] Figure 8B A distal end view of the gasket 458 is shown. The distal membrane 460 of the gasket 458 includes a vertical slit 464 in the center of the gasket portion having thickened sidewalls, which may be configured as a cross material 466.

[0179] Figure 8C A proximal end view of the gasket 458 is shown. The vertical slits 468 of the gasket 458 are substantially perpendicular to the horizontal slits 470 on the proximal membrane 462 of the gasket 458.

[0180] In some embodiments, the rotary hemostatic valve described herein can be configured to have an open setting during which a catheter can be freely inserted into or removed from the lumen manually. Additionally, in the open setting, a free flush of the system with saline can be performed to clear air bubbles in the system. In some embodiments, the open setting can additionally allow retrograde return of blood to clear air bubbles in the system.

[0181] Fig. 9 A perspective view of an actuation mechanism 800 for use with the rotary hemostatic valve described herein is shown. The actuation mechanism 800 includes at least one linear actuator 474 coaxially connected around a collar 475 that is coupled to the proximal end 450 of the RHV 448 to drive one or more gears to rotate the RHV 448. To operate 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., hub 124a) that is capable of rotating, translating, and / or deflecting a catheter (or guidewire).

[0182] Fig. 10A The valve is shown to be restricted to Figure 5B RHV drive mechanism shown in the open position. Linear actuator 474 has driven drive shaft 475 to the proximal end travel limit, where the support tube extends through the gasket, holding them open. Fig. 10B In the embodiment of the present invention, the support tubes have been advanced outside the gaskets, allowing them to close tightly around any inner conduit extending therethrough in the high pressure position.

[0183] Fig. 10C4 is a schematic diagram of one embodiment of a linear actuator 474. Housing 471 supports a motor 473 which rotates a gear train 481 which in turn rotates a lead screw 483. Helical threads 485 on lead screw 483 slidably engage complementary projections on the inner surface of tubular drive shaft 477, causing axial reciprocation of drive shaft 473 and corresponding axial displacement of the support tube relative to the washer.

[0184] The sterile area 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 with a clot cabin close to the hub, the pipe between the hub and the fluid management cabinet does not need a large diameter (saline will be infused at a pressure higher than the arterial pressure and then sucked back through the clot cabin to make the clot more visible). Regardless of the design details, the valve manifold can be configured to handle large clots that pass through the manifold. In some embodiments, the valve manifold can be carried by the hub. In some embodiments, the valve manifold can be integrated into the hub. Alternatively, the valve manifold can be away from the hub and connected to the hub through a pipe group with vacuum, saline and contrast agent lines.

[0185] If the first catheter 126 is left in place, pulling out the second catheter 128 creates a pressure gradient from outside to inside, which creates a risk of air inhalation if the valve is not tight enough, but the valve cannot be so tight as to hinder the pulling out of the second tube 128, so the saline delivery flow rate can be set so that it creates a positive pressure without introducing air bubbles.

[0186] Fig.11 A perspective view of an example assembly 500 including a rotary hemostatic valve 502 integrated with a manifold 504 is shown. Fig.11 The illustrated example depicts an embodiment in which a manifold is located near or within a particular RHV associated with a hub.Such an embodiment may replace the separate manifolds 118a, 118b, and 118c in system 100.

[0187] RHV 502 is depicted as a tapered tube having a swivel 506 and a port 508 for receiving one or more catheters (not shown) therethrough. One or more catheters may be attached to a portion of RHV 502 adjacent port 508. The portion may include a Luer lock swivel nut or another valve or introducer valve.

[0188] The RHV 502 can be fixedly attached to the manifold 504. In some embodiments, the RHV 502 is removably attached to the manifold 504. The manifold 504 is configured with any number of ports for receiving fluid lines attached to the hub. For example, the manifold 504 includes at least a first port 510 for receiving one or more fluid lines 120a, 120b, 120c from at least one manifold valve (e.g., at least one valve in the valve array 116a). The manifold 504 includes at least a second port 512 for receiving one or more fluid lines 121a, 121b, 121c from at least one manifold valve (e.g., at least one valve in the valve array 116b).

[0189] 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 port 514 for receiving contrast fluid via a fluid line connected to a contrast source (e.g., source 110b). Manifold 504 also includes port 516 for receiving saline fluid via a fluid line connected to a saline source (e.g., source 110a). Manifold 504 additionally includes port 518 for receiving (e.g., draining) waste via a fluid line connected to a tank (e.g., tank 112). Manifold 504 may include an optional clip 520 for attaching RHV 502 to the hub.

[0190] although Fig.11 Two source ports and one sink port are depicted in FIG, but any number of source ports or sink ports may be possible on assembly 500. Further, any number of valve ports may also be provided and may correspond to multiple catheter hubs configured to function in a particular fluid system.

[0191] Fig.12 Methods for degassing a fluid management system for a robotically driven medical device are shown. Embodiments of methods for degassing a fluid management system can remove gas from a lumen of a robotically driven medical device (e.g., a catheter described herein), one or more fluid lines of a fluid management system, and / or one or more fluids (e.g., remove dissolved gas from one or more fluids). In certain embodiments, methods for degassing can be used to construct a fluid wall or column by removing gas therefrom in one or more portions of a fluid management system (e.g., one or more fluid lines).

[0192] Thus, in certain embodiments, the method for degassing can 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 connector coupled to a hemostatic valve of a medical device. A first valve at the first fluid source connector can be closed, resulting in a fluid column in the first fluid line connector with no gas or a relatively small amount of gas.

[0193] Suction can then be applied to the groove connector of the hemostatic valve to remove residual first fluid from the hemostatic 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 ready 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 connector of the hemostatic valve, the fluid column in the first fluid line can prevent or inhibit the second fluid from flowing into the first fluid line. The second fluid can traverse the path of least resistance, for example, through the lumen of the medical device, rather than through the first fluid line.

[0194] In certain embodiments, a fluid column or wall can be formed in a slot line extending from a slot connector to a slot. For example, when a fluid such as a first fluid is sucked through a slot line via a slot connector, the slot valve at the slot connector can be closed and suction can be stopped so that at least some fluids remain in the slot line instead of flowing to the slot, resulting in a fluid column or wall in the slot line at the slot connector position. In some embodiments, the first fluid can be driven into a hemostatic valve during suction to form a fluid wall or column in the slot line. The fluid wall or column in the slot line can prevent or inhibit a fluid such as a first fluid or a second fluid from flowing into the slot line. For example, as described herein, a fluid column or wall can be formed in the first fluid line and the slot line. Then the second fluid (e.g., a contrast agent) can be infused into the hemostatic valve, and the second fluid can flow through the lumen of the medical device instead of flowing into the first fluid line or the slot line. By preventing the unwanted inflow of fluid to the first fluid line and / or the slot line, fluid waste can be prevented, and the amount of fluid flowing to the patient can be known and controlled.

[0195] In certain embodiments where a fluid wall or column is desired in the slot line, various methods can be used to prevent or inhibit retrograde suction of air through the lumen of a medical device (e.g., a catheter) while constructing a fluid wall or column in the slot line. In certain embodiments, the medical device can be inserted into the patient before suction so that blood is drawn through the lumen of the medical device and into the slot line. The fluid column in the slot line can be formed by blood and / or a first fluid.

[0196] In certain embodiments, if the medical device is positioned outside the body, the tip of the medical device can be placed into a container of a fluid, such as saline, which can then be drawn into the tank line. In other embodiments, the tip of the medical device can be closed (e.g., using a plug) so that air is not drawn from the distal end when the first fluid is drawn to form a fluid column in the tank line. In other embodiments, a valve (e.g., in a valve manifold described herein) can be closed to block a connector between a lumen and a hemostatic valve or a connector between a lumen and a tank connector to prevent retrograde air from entering the tank line when the fluid column is constructed.

[0197] In one embodiment, the method includes infusing a first fluid from a first fluid source at low pressure into a first fluid source connection of a hemostatic valve, closing a first valve at the first fluid source connection, applying a vacuum to a slot connection of the hemostatic valve to remove residual first fluid, closing the slot valve at the slot connection, and infusing a second fluid at high pressure from a second fluid source into a second fluid source connection of the hemostatic valve. Method 1200 is used to remove dissolved gases from fluids and fluid lines of a fluid management system. The method is used for catheter and fluid preparation, but may additionally or alternatively be used for any suitable clinical or other application. Method 1200 may be configured and / or adapted for use with any suitable fluid degassing technique.

[0198] In some embodiments, rather than infusing the first fluid from the first fluid source into the first fluid source connection of the hemostasis valve at low pressure and closing the first valve at the first fluid source connection, the method can instead evacuate specific ports and / or fluid lines and then inject the first fluid from the first fluid source into the first fluid source connection of the hemostasis valve. In certain embodiments, evacuating specific ports and / or fluid lines prior to fluid injection can provide negative pressure, which can help the fluid subsequently flow through the fluid management system.

[0199] In operation of the system 100, the interventionalist can access the fluid management section 102 and the robotic system section 104 to perform a degassing method 1200. The degassing method 1200 can be part of an initial configuration of the system 100. For example, the degassing method 1200 can be performed for all or a portion of a fluid management system for a manually driven medical device, a robotically driven medical device, or a combination thereof.

[0200] In some embodiments, the degassing method includes injecting a first fluid from a first fluid source into a first fluid source connector of a 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 slot connector of the hemostatic valve to remove the residual first fluid into the slot. The slot 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 separately integrated with the hub in other ways.

[0201] In some embodiments, the degassing methods described herein may be a predetermined function that may be achieved in several ways. In a first example, the degassing function may be achieved using positive pressure, wherein the system 10 may inject saline into a fluid port connected to the catheter lumen. In such an example, the saline may then fill the lumen space in an antegrade 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 may be completed prior to performing the first example and may include closing the hemostatic valve and applying suction through the fluid port or through a fixture temporarily connected to the distal end of the catheter. In either example, the distal end of the catheter may be temporarily sealed. After clearing the lumen air using suction, the system 10 may close the vacuum valve and then open the saline valve to fill the channel with saline that may be degassed. Optionally, the distal tip seal may be removed and the first example may be repeated to complete the degassing function. Although with reference to Fig.12 A degassing method is described, but the methods described herein may be generally used to purge a fluid (including gases, liquids, and / or combinations of gases and liquids) prior to the introduction of another fluid.

[0202] like Fig.12 1 , one embodiment of degassing a fluid management system for a robotically driven medical device includes block 1202, which depicts injecting a first fluid from a first fluid source at low pressure into a first fluid source connection of a hemostasis valve. For example, a fluid (e.g., saline) from source 210b can be injected at low pressure into a first fluid line at a line branch point 208 coupled to a RHV 248 and / or one or more catheters associated with the RHV 248. In some embodiments, the first fluid source includes heparinized saline.

[0203] At block 1204, method 1200 includes closing a first valve at a first fluid source connection. For example, valve 216c can be closed to prevent the flow of the first fluid. In some embodiments, the fluid source connection is a fluid line connected to a fluid source via a ball valve. In some embodiments, valve 216c is placed near or within a manifold, which can serve as the first fluid source connection.

[0204] At block 1206, method 1200 includes applying a vacuum (e.g., a pump) to the groove connection of the hemostatic valve to remove the remaining first fluid. For example, vacuum 202 can be triggered to remove the remaining first fluid to groove 240 through a connection such as RHV 248 of valve 216a.

[0205] At block 1208, method 1200 includes closing a slot valve at the slot connection. For example, valve 216a may be used as a slot valve that may block fluid flow within fluid line 222a.

[0206] At box 1210, method 1200 includes injecting a second fluid from a second fluid source under high pressure into a second fluid source connector of the hemostasis valve. For example, a fluid (e.g., a contrast agent) from source 210a can be injected from source 210a under high pressure and enter a second fluid line of a line branch point 208, which is 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 connector may not be directly integrated with the hemostasis valve, but may instead be integrated via a Y-joint to integrate the fluid connector with the hemostasis valve. In other embodiments, the second fluid source connector may be separately integrated with the hub in other ways.

[0207] In some embodiments, method 1200 further includes actuating a gasket of the hemostatic valve to a high pressure position prior to injecting the second fluid or prior to applying the vacuum. For example, gasket 458 ( Fig. 7A ) may be part of the RHV 248, 448. Prior to injection of contrast media or prior to application of vacuum 202 at the RHV 248, 448, the gasket 458 may be actuated to open to the high pressure position.

[0208] In some embodiments, method 1200 can further include actuating a gasket of the hemostatic valve to a low pressure position prior to injecting the first fluid. For example, gasket 456 ( Fig. 6A ) may be part of the RHV 248, 448. Prior to injection of saline, the gasket 456 may be actuated to open to a low pressure position.

[0209] Fig.13A schematic diagram of an example of a 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 control system 600 can be configured to automatically adjust the various manifold valves, pumps, hemostasis valves, hubs, and / or catheters described herein in response to instructions input by an operator, such as a physician. In response to the instructions input by the operator, the control system 600 can cause a series of response events to occur automatically.

[0210] In certain embodiments, the control system 600 can include one or more processors 602. The one or more processors 602 can be configured to automatically adjust the various manifold valves, pumps, hemostasis valves, hubs, and / or catheters described herein in response to instructions input by an operator, for example, using one or more controls of the control system 600. In certain embodiments, the control system 600 includes a first control 604a, a second control 604b, and a third control 604c, although any suitable number of controls can be provided to correspond to the various functions of the fluid systems described herein.

[0211] For example, in certain embodiments, the first control 604a can be a contrast agent control that can be operated by a user to initiate the introduction of contrast agent into the catheter. The second control 604b can be a saline control that can be operated by a user to initiate the introduction of saline into the catheter. The third control 604c can be a vacuum control that is configured to initiate the application of a vacuum to the catheter. In some embodiments, each unique catheter can have its own unique first control 604a, second control 604b, and / or third control 604c. Alternatively, each control 604a, 604b, and / or 604c can be actuated to cause a specific response in multiple catheters of the fluid system.

[0212] The processor 602 can receive signals from the controls 604a, 604b, and 604c and, in response, initiate corresponding actions in the components of the fluid system. For example, the processor 602 can be configured to generate an output signal that causes the components of the fluid system to perform a responsive action. For example, in certain embodiments, in response to a user activating the first control 604a, the processor 602 can be configured to open the first contrast agent valve, close the first saline valve, and close the first vacuum valve associated with the sole catheter. In certain embodiments, the processor 602 can also actuate the first contrast agent pump in response to actuation of the first control 604a or a separate unique control.

[0213] In certain embodiments, the processor 602 can also adjust the hemostasis valve of the sole catheter to a high compression state as discussed herein in response to actuation of a control, such as the first control 604a or a separate sole control. Fig.13 , a processor 602 is shown, in other embodiments, multiple processors 602 can be used to control the fluid system described herein. For example, each control 604a, 604b, and 604c can communicate with a unique processor.

[0214] As described herein, for example, with reference to Figure 1B In some embodiments, the catheter system may have a valve manifold in communication with the hub of the catheter. The valve manifold may include a first port configured to be connected to a vacuum source, a second port configured to be connected to a saline source, and a third port configured to be connected to a contrast agent source. The control system 600 (e.g., via the processor 602) may be configured to adjust the valve manifold (e.g., in response to the operation of one or more control members such as control members 604a, 604b, and 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 the third port and the lumen is blocked. In some embodiments, the control system 600 (e.g., via the 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 the communication between the second port and the lumen is blocked. The control system 600 (e.g., by the processor 602) may be configured to control the volume of the delivered contrast agent.

[0215] In some embodiments, the control system 600 (e.g., via the processor 602) can be configured to adjust the hemostasis valve of the first catheter between a low sealing force mode or a low compression mode and a high sealing force mode or a high compression mode. In some embodiments, the control system 600 (e.g., via the processor 602) can be configured to adjust the hemostasis valve to a high sealing force mode or a high compression mode and adjust the valve manifold to selectively connect the third port to the lumen while preventing the first port and the second port from communicating with the lumen (e.g., in response to human input, such as, for example, operation of one of the controls of the control system).

[0216] In some embodiments, the control system 600 (e.g., via the processor 602) can be configured to determine the sealing force of the hemostatic valve around a second catheter or guidewire extending through the hemostatic 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 control system 600 determines that the sealing force of the hemostatic valve around the second catheter or guidewire is low, the control system 600 (e.g., via the processor 602) can be configured to increase the sealing force of the hemostatic valve.

[0217] In some embodiments, the processor 602 can be configured to send a first control signal to place the hemostasis valve in a high sealing force mode or a high compression mode (e.g., in response to a human input, such as operation of one of the controls of the control system). In some embodiments, the processor 602 can be configured to send a second control signal to open the contrast agent valve (e.g., in response to a human input, such as operation of one of the controls of the control system). In some embodiments, the processor 602 can be configured to send a third control signal to place the hemostasis valve in a low sealing force mode or a low compression mode (e.g., in response to a human input, such as operation of one of the controls of the control system).

[0218] In some embodiments, the processor 602 can be configured to send a fourth control signal to the robotic catheter drive system to axially adjust the second catheter relative to the first catheter (e.g., in response to human input, such as operation of one of the control components of the control system). In some embodiments, the processor 602 can be configured to send a fifth control signal to the robotic catheter drive system to axially withdraw the guidewire from the second catheter proximally before opening the contrast agent valve (e.g., in response to human input, such as operation of one of the control components of the control system). One or more of the first control signal, the second control signal, the third control signal, the fourth control signal, or the fifth control signal can be sent in response to a single human input. Any of the first control signal, the second control signal, the third control signal, the fourth control signal, or the fifth control signal can be sent in response to a unique human input.

[0219] The systems and methods of the preferred embodiments and variants thereof may be embodied and / or implemented, at least in part, as a machine configured to receive a computer-readable medium storing computer-readable instructions. The instructions are preferably executed by a computer-executable component, which is preferably integrated with one or more portions of the system and processor on a hub, RHV, and / or computing device associated with the fluid management system described herein. The computer-readable medium may be stored on any suitable computer-readable medium, such as RAM, ROM, flash memory, EEPROM, optical devices (e.g., CD or DVD), hard drives, floppy disk drives, or any suitable device. The computer-executable component is preferably a general-purpose or application-specific processor, but any suitable dedicated hardware or hardware / firmware combination may alternatively or additionally execute instructions.

[0220] Various systems and methods are described herein primarily in the context of neurovascular access or surgery. However, the inventors contemplate the applicability of the disclosed catheters, systems, and methods to any of a variety of alternative applications, including within the coronary artery or peripheral vascular system and other hollow organs or tubular structures in the body.

[0221] As used in this specification and the claims, the singular forms "a", "an", and "the" include singular and plural references unless the context clearly dictates otherwise. At times, the claims and the disclosure may include terms such as "plurality", "one or more", or "at least one"; however, the absence of these terms does not mean, and should not be interpreted to mean, that a plurality is not contemplated.

[0222] When the term "about" or "approximately" is used before a numerical name or range (e.g., defining a length or pressure), it indicates an approximate value that may vary by (+) or (-) 5%, 1%, or 0.1%. All numerical ranges provided herein include the stated beginning and ending numbers. The term "substantially" means a majority (i.e., greater than 50%) or substantially all of a device, substance, or composition.

[0223] As used herein, the terms "comprising" or "comprises" are intended to mean that devices, systems and methods include the described elements and may additionally include any other elements. "Consisting essentially of" shall mean that devices, systems and methods include the described elements and exclude other elements that are significant to the combination for the described purpose. Thus, a system or method consisting essentially of the elements defined herein will not exclude other materials, features, or steps that do not materially affect the basic and novel characteristics of the claimed disclosure. "Consisting of" shall mean that devices, systems and methods include the described elements and exclude anything other than trivial or insignificant elements or steps. Embodiments defined by each of these transition terms are within the scope of the present disclosure.

[0224] The examples and illustrations included herein show, by way of illustration and not limitation, specific embodiments in which this subject matter may be practiced. Other embodiments may be utilized and derived therefrom so that structural and logical replacements and changes may be made without departing from the scope of this disclosure. These embodiments of the subject matter of the present invention may be referred to herein individually or collectively by the term "invention", merely for convenience, and are not intended to voluntarily limit the scope of this application to any single invention or inventive concept, if more than one is in fact disclosed. Therefore, although specific embodiments have been shown and described herein, any arrangement planned for achieving the same purpose may replace the specific embodiments shown. This disclosure is intended to cover any and all adaptations or changes of various embodiments. For those skilled in the art, upon reviewing the above description, the combination of the above embodiments and other embodiments not specifically described herein will be apparent.

Claims

1. Fluid management system, including: box, The cassette is configured to receive saline from a saline source, contrast media from a contrast media source, and vacuum from a vacuum source, the cassette comprising: a plurality of saline connectors, each of the plurality of saline connectors configured to couple to one of the plurality of conduits to provide saline thereto; a plurality of contrast media connectors, each of the plurality of contrast media connectors being configured to couple to one of the plurality of catheters to provide contrast media thereto; and A plurality of vacuum connectors, each of the plurality of vacuum connectors being configured to couple to one of the plurality of conduits to provide a vacuum thereto.

2. The system of claim 1, wherein the cassette comprises a plurality of contrast agent valves, each of the plurality of contrast agent valves being configured to selectively connect one of the plurality of contrast agent connectors to the contrast agent source fluid.

3. The system of claim 1, wherein the cartridge comprises a plurality of vacuum valves, each of the plurality of vacuum valves being configured to selectively connect one of the plurality of vacuum connectors to fluid communication with the vacuum source.

4. The system of claim 1, wherein the box includes a contrast agent flow path comprising a plurality of branches, wherein each of the plurality of contrast agent connectors is positioned along one of the plurality of branches.

5. The system of claim 4, wherein the cassette comprises a plurality of contrast agent valves, each of the plurality of contrast agent valves being positioned along one of the plurality of branches.

6. The system of claim 5, wherein the plurality of contrast agent valves comprises robotically actuated valves configured to be controlled by a control system.

7. The system of claim 1, wherein the cartridge comprises a vacuum flow path comprising a plurality of branches, wherein each of the plurality of vacuum connectors is positioned along one of the plurality of branches.

8. The system of claim 7, wherein the cartridge further comprises a plurality of vacuum valves, each of the plurality of vacuum valves being positioned along one of the plurality of branches.

9. The system of claim 8, wherein the plurality of vacuum valves comprises robotically actuated valves configured to be controlled by a control system.

10. The system of claim 1, further comprising a plurality of saline pumps, wherein the plurality of saline pumps are configured to drive saline from the saline source to the plurality of conduits.

11. The system of claim 10, wherein the plurality of saline pumps are positioned external to the cassette.

12. The system of claim 1, further comprising a contrast media pump, wherein the contrast media pump is configured to drive contrast media from the contrast media source to the plurality of catheters.

13. The system of claim 1, further comprising a suction reservoir, wherein the vacuum source is configured to drive suction from the plurality of conduits to the suction reservoir.

14. The system of claim 1, wherein the cartridge is disposable.

15. Fluid management system, including: a saline source configured to provide saline to the cassette; a contrast agent source configured to provide contrast agent to the cassette; a vacuum source configured to provide a vacuum to the cartridge; as well as A plurality of catheter hubs, each of the plurality of catheter hubs being configured to receive saline, contrast media, and vacuum from the cassette.

16. The system of claim 15, further comprising a plurality of catheters, each of the plurality of catheters coupled to one of the plurality of catheter hubs, wherein the plurality of catheters are arranged in a concentric catheter fitting.

17. The system of claim 15, further comprising a plurality of tubing sets, wherein each of the plurality of tubing sets is configured to be coupled to the cassette and to one of the plurality of catheter hubs.

18. The system of claim 17, wherein each of the plurality of tubing sets comprises a saline tube, a contrast media tube, and a vacuum tube.

19. The system of claim 15, further comprising a plurality of saline pumps, wherein the plurality of saline pumps are configured to drive saline from the saline source into the cassette.

20. The system of claim 15, further comprising a contrast media pump, wherein the contrast media pump is configured to drive contrast media from the contrast media source to the plurality of catheter hubs.

21. A fluid management system comprising one or more of the features described above.

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