Patent Application
20250032201
The present application relates to neurovascular procedures, and more particularly, to catheter assemblies and robotic control systems for neurovascular site access.
A variety of neurovascular procedures can be accomplished via a transvascular access, including thrombectomy, diagnostic angiography, embolic coil deployment, and stent placement. However, the delivery of neurovascular care is limited or delayed by a variety of challenges. For example, there are not enough trained interventionalists and centers to meet the current demand for neuro interventions. Neuro interventions are difficult, with complex set up requirements and demands on the surgeon's dexterity. With two hands, the surgeon must exert precise control over 3-4 coaxial catheters plus manage the fluoroscopy system and patient position.
Long, tortuous anatomy, requires delicate, precise maneuvers. Inadvertent catheter motion can occur due to energy storage and release caused by frictional interplay between coaxial shafts and the patient's vasculature. Supra-aortic access necessary to reach the neurovasculature is challenging to achieve, especially Type III arches. Once supra-aortic access is achieved, adapting the system for neurovascular treatments is time consuming and requires guidewire and access catheter removal and addition of a procedure catheter (and possibly one or more additional catheters) to the stack.
Further, draping for the segregation of sterile and non-sterile zones is cumbersome and time consuming, especially with robotic healthcare devices. Other considerations with medical devices are the size and footprint, since space, especially in an operating room, can be limited.
During the course of a procedure, multiple different fluids and/or fluid volumes may be injected at different times in addition to aspiration. As such, fluid sources such as syringes are frequently connected and disconnected from the Luer connection port. This conventional switching of components, syringes, and fluidic connections during a procedure can lead to a risk of air bubble introduction, errors at connection points, and/or errors in fluid selection.
Thus, there remains a need for a supra-aortic access system that addresses some or all of these challenges and increases the availability of neurovascular procedures. Preferably, the system is additionally capable of driving devices further distally through the supra-aortic access to accomplish procedures in the intracranial vessels. Additionally, there remains a need for an improved fluid and tool management system that overcomes one or more of the drawbacks of conventional fluid management and catheter exchange systems.
In some aspects, the techniques described herein relate to a robotic device drive system including: a plurality of robotic arms arranged on a rail and configured to be axially translated along the rail from a contracted configuration to an expanded configuration, wherein at least one of the plurality of robotic arms include: a fluidics system configured to be fluidly coupled to a hemostasis valve; and a catheter hub coupled to a catheter, the catheter hub including the hemostasis valve, wherein axial translation of the at least one of the plurality of robotic arms causes axial translation of the catheter.
In some aspects, the techniques described herein relate to a robotic device drive control system including: a robotic arm configured to move axially along a rail, the robotic arm including: a catheter hub coupled to a catheter and configured to roll the catheter; and a valve system in communication with the catheter hub and configured to administer fluids to a hemostasis valve coupled to a portion of the catheter.
In some aspects, the techniques described herein relate to a robotic device drive control system including: at least one processor; and a robotic arm including a catheter hub and a valve system in fluid communication with the catheter hub, the catheter hub including a hemostasis valve and the at least one processor configured to execute instructions to: move the robotic arm axially along a rail of a patient support device, roll a catheter coupled to the hemostasis valve of the catheter hub, and administer fluids through the valve system in fluid communication with the hemostasis valve.
In some aspects, the techniques described herein relate to a robotic device drive control system including: at least one robotic arm operatively coupled to a rail, the at least one robotic arm including a fluidics system and a catheter hub; a controller configured to be in electrical communication with the fluidics system and the catheter hub; an adapter configured to couple both the fluidics system and the catheter hub to at least one catheter, wherein the adapter enables manipulation of the at least one catheter based on signals received from the controller.
In some aspects, the techniques described herein relate to a robotic device drive control system including: a first robotic arm including a first catheter hub and a first valve system in communication with the first catheter hub; a second robotic arm including a second catheter hub and a second valve system in communication with the second catheter hub; and a rail, wherein the first robotic arm and second robotic arm are operatively coupled to the rail, wherein the first catheter hub is configured to be in communication with a first hemostasis valve through a first interface, the first interface being configured to: receive movement control signals to move a first catheter associated with the first hemostasis valve, and receive fluid control signals for administering fluid from the first valve system to the first catheter.
In some aspects, the techniques described herein relate to a robotic device drive control system including: a rail; a rail adjustment system configured to manipulate a position of the rail between a stored configuration to a procedure configuration; a fluidics system; and a plurality of catheter hubs operatively coupled to the rail and configured to be axially translated along a longitudinal axis of the rail, wherein at least one of the plurality of catheter hubs is in fluid communication with the fluidics system, the at least one of the plurality of catheter hubs comprising a hemostasis valve and a catheter in communication with the hemostasis valve.
The fluidics system can be configured to selectively supply or vacuum to the hemostasis valve. The fluidics system can be configured to selectively supply fluid from a saline source and a contrast source.
In some aspects, the techniques described herein relate to a method of performing thrombectomy with a robotic device drive system, the method including: translating a first robotic arm operatively coupled to a first catheter axially along a rail and toward an access point vasculature of a patient to introduce the first catheter into the access point vasculature of the patient; translating a second robotic arm operatively coupled to a second catheter positioned concentrically within a lumen of the first catheter axially along the rail; and selectively supplying one or more fluids to or aspirating fluids from to one or both of the first catheter and the second catheter by a fluidics system.
In some aspects, the techniques described herein relate to a method of performing a thrombectomy procedure with a robotic device system, the method including: positioning a rail to approximately align a device stack profile to an access point vasculature of a patient; translating a first hub operatively coupled to a first catheter axially along the rail and toward the access point vasculature to introduce the first catheter into the access point vasculature; translating axially along the rail a second hub operatively coupled to a second catheter positioned within a first lumen of the first catheter; and selectively supplying one or more fluids to or aspirating fluids from one or both of: the first catheter or the second catheter by a fluidics system.
In some aspects, there is provided a robotic medical system for performing a vascular procedure. The robotic medical system includes a procedure rail having a drive surface oriented along a generally vertical plane, a rail adjustment system configured to couple to a patient support table and including one or more movable arm segments, the rail adjustment system configured to manipulate a position of the procedure rail relative to the patient support table, a fluidics system, and a plurality of catheter hubs operatively coupled to the procedure rail and configured to be axially translated along the drive surface along a longitudinal axis of the procedure rail. At least one of the plurality of catheter hubs is in fluid communication with the fluidics system, the at least one of the plurality of catheter hubs having a hemostasis valve and a catheter in communication with the hemostasis valve.
The fluidics system can be configured to selectively supply fluid or vacuum to the hemostasis valve. The fluidics system can be configured to selectively supply saline from a saline source and contrast from a contrast source to the hemostasis valve. The fluidics system can include a cassette configured to receive saline from a saline source, receive contrast from a contrast source, and receive vacuum from a vacuum source. The cassette can include one or more robotically actuated valves configured to be controlled by a control system. The robotic medical system can include a primary fluid line between the fluidics system and a junction point and a plurality of secondary fluid lines extending from the junction point, each of the plurality of secondary fluid lines coupled with one of the plurality of catheter hubs to supply fluid or vacuum thereto. The junction point can be coupled to the procedure rail. The plurality of catheter hubs can include at least one guidewire hub, at least one guide catheter hub, at least one access catheter hub, and at least one procedure catheter hub. When in a procedure position, a proximal end of the procedure rail can be positioned vertically above a distal end of the procedure rail, the distal end of the procedure rail being closer to a patient access point than the proximal end of the procedure rail. The procedure rail can be moveable from a retracted position to an extended position, wherein a distal end of the procedure rail is positioned closer to a patient access point in the extended position.
There is also be provided a method of performing a vascular procedure with a robotic medical system. The method includes positioning a procedure rail via a rail adjustment system to approximately align a device stack profile to an access point vasculature of a patient, the procedure rail having a drive surface oriented along a generally vertical plane, the rail adjustment system coupled to a patient support table and having one or more movable arm segments, translating a first hub operatively coupled to a first catheter axially along the drive surface of the procedure rail and toward the access point vasculature to introduce the first catheter into the access point vasculature, translating a second hub operatively coupled to a second catheter axially along the drive surface of the procedure rail, the second catheter positioned within a first lumen of the first catheter, and selectively supplying one or more fluids to or aspirating fluids from one or both of the first catheter and the second catheter by a fluidics system.
The method can include translating a third hub operatively coupled to a third catheter axially along the drive surface of the procedure rail, the third catheter positioned within a second lumen of the second catheter, and selectively supplying one or more fluids to or aspirating fluids from one or more of the first catheter, the second catheter, and the third catheter by the fluidics system. The method can include translating a fourth hub axially along the drive surface of the procedure rail, the fourth hub operatively coupled to a guidewire positioned within a third lumen of the third catheter. The method can include translating a third hub axially along the drive surface of the procedure rail, the third hub operatively coupled to a guidewire positioned within a second lumen of the second catheter. Selectively supplying one or more fluids to or aspirating fluids from one or both of the first catheter and the second catheter by the fluidics system can include selectively supplying saline from a saline source and contrast from a contrast source to one or both of the first catheter and the second catheter. The fluidics system can include a cassette configured to receive saline from a saline source, receive contrast from a contrast source, and receive vacuum from a vacuum source. The method can include actuating one or more robotically actuated valves by a control system. The robotic medical system can include a primary fluid line between the fluidics system and a junction point, and a first secondary fluid line extending from the junction point to the first hub to supply fluid and vacuum thereto and a second secondary fluid line extending from the junction point to the second hub to supply fluid or vacuum thereto. The junction point can be coupled to the procedure rail. When the device stack profile is approximately aligned with the patient access point, a proximal end of the procedure rail can be positioned vertically above a distal end of the procedure rail, the distal end of the procedure rail being closer to a patient access point than the proximal end of the procedure rail.
The above-mentioned aspects, as well as other aspects, features, and advantages of the present technology are described below in connection with various embodiments, with reference made to the accompanying drawings.
The illustrated embodiments are merely examples and are not intended to limit the disclosure. The schematics are drawn to illustrate features and concepts and are not necessarily drawn to scale.
The foregoing is a summary, and thus, necessarily limited in detail. The above-mentioned aspects, as well as other aspects, features, and advantages of the present technology will now be described in connection with various embodiments. The inclusion of the following embodiments is not intended to limit the disclosure to these embodiments, but rather to enable any person skilled in the art to make and use the contemplated invention(s). Other embodiments may be utilized, and modifications may be made without departing from the spirit or scope of the subject matter presented herein. Aspects of the disclosure, as described and illustrated herein, can be arranged, combined, modified, and designed in a variety of different formulations, all of which are explicitly contemplated and form part of this disclosure.
Disclosed herein are systems and methods for robotic systems with standalone and integrated fluidics management systems. Reference to a fluidics system may be interpreted to specify a fluidics system integrated into a robotic arm or multiple robotic arms of robotic systems as described herein, a standalone fluidics system as described herein, or a combination of the aforementioned.
The various embodiments described herein provide systems for advancing and retracting one or more procedure or interventional devices, for example one or more catheters and/or a guidewire, into a patient's vasculature for performing various intravascular procedures. For example, various procedures may include, but are not limited to: aspiration, thrombectomy, diagnostic, endoscopic, biopsy, etc. In some implementations, these procedures (some requiring supra-aortic vessel access) may be robotic, with further embodiments having remote-control operations.
A side mounted robotic system can be positioned alongside, above, or near the patient, and configured to axially advance, retract, and in some cases rotate and/or laterally deflect one or two or three or more (e.g., concentrically, side by side oriented, rapid exchange configuration, etc.) intravascular devices. In certain implementations, each interventional device has a proximal end attached to a hub. Alternatively, in certain implementations, two or more interventional devices may be attached to a hub at a proximal end of each interventional device.
In certain embodiments, each hub can be mechanically coupled to a corresponding robotic arm. The robotic arms may translate along a patient support device to axially advance and retract one or more interventional devices (in some instances to gain supra-aortic vessel access). Additional functionality contained in a robotic arm when it is attached to a hub, attached to the interventional device, may further enable rotation and/or deflection or articulation of a distal end of the interventional device, among other optional functionality described elsewhere herein. Manipulating the interventional device hubs (e.g., via a robotic arm), in turn manipulating the interventional devices, in the described degrees of freedom can provide advancement of the interventional device, retraction of the interventional device, and the execution of procedures, e.g., clot engagement, by the interventional device. Various features and configurations of the hubs are described in U.S. patent application Ser. No. 17/527,393, filed Nov. 16, 2021, and U.S. patent application Ser. No. 18/060,935, filed Dec. 1, 2022, each of which is herein incorporated by reference in its entirety.
Controllers described herein may include one or more processors. Controllers may include the capability of multiple inputs and multiple outputs. Controllers described herein may receive one or more inputs (e.g., user activated control inputs, measurements from one or more sensors, etc.) and respond with one or more outputs (e.g., actuating pumps, actuating valves, translating/adjusting robotic arms, etc.). Control inputs may be local or remote and may be connected to the controller via wires or wirelessly. Examples of local control inputs include control inputs located on embodiments of robotic device drive systems, or near embodiments of robotic device drive systems (e.g., a control console within the operating room or within an adjacent room that the robotic device drive system is in). Examples of remote control inputs include control inputs performed from outside of the proximity of the robotic device drive system embodiment (e.g., outside the operating room, at another location, at a remote location, etc.). Remote control inputs may be performed by a user hundreds or even thousands of miles away from the robotic device drive system embodiment. Remote control inputs may be performed on a user interface and transmitted to the robotic device drive system embodiment by communication networks known in the art. Further, data, such as video signals, from robotic device drive system embodiments may be transmitted to the user interface and displayed for the user on the user interface.
Proximal and distal are used herein to describe directions with respect to embodiments of robotic device drive systems described herein. Proximal is defined herein as the direction away from a patient being treated by the robotic device drive system. Distal is defined herein as the direction towards the patient being treated by the robotic device drive system.
The first robotic arm 14 can translate or move along the rail 4 via a first robotic arm bottom portion 6a and its associated drive mechanism. The bottom portion 6a of the first robotic arm 14 can be operatively coupled to a first robotic arm intermediate portion 8a, which can be attached to a first robotic arm head portion 10a. This configuration can move along the rail 4 and/or along the elongate side 28 of the patient support device 2 to a position predefined for the pending procedure.
The second robotic arm 16 can have a second robotic arm bottom portion 6b, a second robotic arm intermediate portion 8b, and a second robotic arm head portion 10b. The second robotic arm 16 can move along the rail 4, similar to the first robotic arm 14 as described above, to a position predefined for the pending procedure.
The third robotic arm 18 can have a third robotic arm bottom portion 6c, a third robotic arm intermediate portion 8c, and a third robotic arm head portion 10c. The third robotic arm 18 can move along the rail 4, similar to the first robotic arm 14 as described above, to a position predefined for the pending procedure.
The fourth robotic arm 20 can have a fourth robotic arm bottom portion 6d, a fourth robotic arm intermediate portion 8d, and a fourth robotic arm head portion 10d, The fourth robotic arm 20 can move along the rail 4, similar to the first robotic arm 14 as described above, to a position predefined for the pending procedure.
The fifth robotic arm 22 can have a fifth robotic arm bottom portion 6e, a fifth robotic arm intermediate portion 8e, and fifth robotic arm head portion 10e. The firth robotic arm 22 can move along the rail 4, similar to the first robotic arm 14 as described above, to a position predefined for the pending procedure. Although five arms are shown in a procedure configuration in
The first robotic arm 14, in some embodiments, may be used as an introducer arm. As an introducer arm, the first robotic arm 14 may provide for placement of a guide tube 48. The guide tube 48, can guide an interventional device (e.g., a guidewire or catheter) or an interventional device assembly (e.g., a concentrically oriented interventional device assembly) into the access point vasculature of the patient 1. The guide tube 48 may be rigid in some embodiments.
In some embodiments, the guide tube 48 can be configured to guide a first interventional device (e.g., a first concentric catheter) into the access point vasculature of the patient 1. The first catheter can be manipulated by the second robotic arm 16. In some cases, a second interventional device (e.g., a second smaller outer diameter catheter or a guidewire) is concentrically positioned inside the first catheter that is manipulated by the second robotic arm 16. The second interventional device can be can be manipulated by the third robotic arm 18. In some embodiments, when the second interventional device is a second catheter, a third interventional device (e.g., a third smaller outer diameter catheter or a guidewire) is concentrically placed inside the second catheter that is manipulated by the third robotic arm 18. The third interventional device can be manipulated by the fourth robotic arm 20. In some embodiments, a fourth interventional device (e.g., a fourth a smaller outer diameter catheter or a guidewire) is concentrically positioned inside the third catheter that is manipulated by the fourth robotic arm 20. The fourth interventional device can be manipulated by by the fifth robotic arm 22.
In certain embodiments, each more proximal concentric interventional device gains access to an adjacent distal device via a hemostasis valve or the like in the adjacent distal device's hub. The axial movement of each of the devices is accomplished via the translation of the corresponding arm along the rail 4.
Although five robotic arms 14, 16, 18, 20, 22 are illustrated, embodiments comprising more or less arms, for example one arm, two arms, three arms, four arms, or five arms, are further contemplated. For example, for a diagnostic procedure, robotic arm 14 and robotic arm 16 may be used. In further examples, for a peripheral vasculature procedure, robotic arm 14, robotic arm 16, and robotic arm 18 may be used. In still further example, for a coronary procedure, robotic arm 14, robotic arm 16, robotic arm 18, and optionally robotic arm 20 may be used. For example, for a neurovasculature procedure, robotic arm 14, robotic arm 16, robotic arm 18, robotic arm 20, and robotic arm 22 may be used.
A patient draping boundary 30 and a separation of the sterile area 32 and a non-sterile area 34 are shown in
In some embodiments, at least a portion of an arm can be draped and in a non-sterile area while the hub and associated interventional device above the patient is in sterile area. A sterile adapter between the hub and the arm may provide an interface between sterile area and non-sterile area.
In an embodiment shown in
In addition, as shown in
The mechanical outputs may be used during different portions of a procedure or for different procedures. In this embodiment, an arm comprises four control outputs (e.g., that are transmitted through the interface to the hub), although any number and arrangement of control outputs are contemplated herein. One output may be an actuator 38 of hemostasis valve 40. The hemostasis valve actuator 38, being powered by a drive system housed within any one of the robotic arms described herein, is capable of actuating the hemostasis valve 40 in the catheter hub (not shown). The hemostasis valve 40 may be manipulated between an open configuration to allow for removal of a device or introduction of an additional device (e.g., a microcatheter or guidewire) into the stack; an intermediate configuration for example for low pressure contrast injections; or closed configuration to isolate internal working pressures and/or to allow high pressure contrast injections, for example. Although three positions of the hemostasis valve are described, any number of positions or configurations are contemplated. Mechanisms for hemostasis valve 40 actuation may be similar to those described in U.S. patent application Ser. No. 17/879,614, filed Aug. 2, 2022, which is herein incorporated by reference in its entirety. Another output may be a roll actuator 70 for rotational control of an interventional device being manipulated by the hub (not shown), which translates into rotation control of the interventional device (e.g., catheters, guidewires, and etc.) coupled to the respective hub. The drive mechanism for the roll actuator 70 may be housed within any one of the robotic arms described herein and have a coupling interface on the hub side of the disposable sterile adapter 36. Mechanisms for roll actuation may be include a magnetic gear train, a mechanical gear train, and the like. A further output may be an articulating interventional device mechanism 66. Articulation mechanisms 66 for articulating an interventional device may include pullwire mechanisms, manipulation of concentrically disposed tubes that are at least partially bonded to one another, or other mechanisms known in the art. Another output may be an anti-buckling assist 68 with an associated drive mechanism housed within any one of robotic arms or hubs described herein. The deployable assembly of the anti-buckling assist 68 may be mounted in, onto, or integrated with the hub (not shown) of the disposable sterile adapter 36. For example, the anti-buckling assist 68 may be a telescoping tube assembly, a scissoring assembly, a spring-based assembly, a reel with a split tube, or the like. The split tube, of stiffer construction than the catheter for intended sleeving, can be operationally slid over a device (e.g., a catheter) for assistance against buckling. Furthermore, during advancement and retraction of the assisted device, the control system may control the advancement and retraction of the split tube via the reel and associated drive mechanism.
Turning now to various fluidic system configurations that are integrated in various ways with any of the robotic device drive systems described elsewhere herein.
The overhead rail 58 can be parallel to the elongate side 28 of the patient support device 2. The overhead robotic arms 50, 52, 54, 56 may move along the overhead rail 58. While not shown in
The robotic arms 50, 52, 54, 56 can move along the rail 58 to advance and retract interventional devices that are coupled to each of the respective arms. Each of the robotic arms 50, 52, 54, 56 may have a base portion 114 with a respective translation mechanism for movement along the rail 58. In addition, the use of an intermediate portion 116, operatively coupled to the base portion 114 via an adjustment drive mechanism, may be used for adjustment along a vertical 112 axis. A third translational degree of freedom may be performed by the manipulation of a head portion 118. The head portion 118, operatively coupled to the intermediate portion 116 via a corresponding adjustment mechanism, may accomplish adjustment in the translational axis perpendicular to both the horizontal 110 and vertical 112 axes. Although illustrated with four robotic arms 50, 52, 54, 56, embodiments with less or more arms are further contemplated. Further, as described elsewhere herein, although three portions of each arm are shown, an arm of the system may include one portion, two portions, or a plurality of portions. Further, although adjustment of the head portion relative to the intermediate portion is shown and adjustment of the intermediate portion relative to the base portion is shown, neither of these adjustments may be implemented, one of the adjustments may be implemented, or both of the adjustments may be implemented.
An input depicted in the user interface 84 is an enablement input 82. This enablement input 82 may be a momentary depression button or other input type acting as a prerequisite for any other inputs of the user interface 84. Acting as a safety against accidental manipulation of other control inputs, the enablement input 82 may reduce unintended control outputs.
Another contemplated input is one or more device actuation input controls 80. When actuated, a device actuation input control 80 may cause a drive mechanism to axially translate and/or rotate an interventional device coupled to a respective hub of the corresponding arm. Although a wheel mechanism is shown, one of skill in the art will appreciate that a joystick, a series of buttons, a touchpad, or the like may function as a device actuation input control. As described elsewhere herein, additionally, or alternatively, a device may be axially translated based on arm movement relative to the patient support device.
One or more fluid injection controls 72 may be used for the injection control of appropriate fluids, for example contrast or saline. An injection control 72 may comprise a depressible button or other control element such that, when activated, causes a valve in the line, hub, or hemostasis valve to be opened to release the desired fluid into a lumen of an interventional device coupled to the line, hub, or hemostasis valve.
An aspiration control 74 may also be within the user interface 84. The aspiration control 74 may comprise a depressible button or other control element, such that when activated, causes opening of a valve in a vacuum line and/or activation of vacuum pump so that suction is applied through a lumen of an interventional device coupled to the line, hub, or hemostasis valve.
The user interface 84 may optionally include a bubble detection and/or removal system comprising one or more bubble sensors 78. A bubble sensor 78, installed on or in proximity of a corresponding fluid line, can detect the presence of a bubble in the line. When a bubble is detected, the control system may alert the user or enter an autonomous bubble removal protocol for the respective fluid line. Use of a bubble sensor 78 may greatly reduce the introduction of a bubble into a patient's vasculature. Any of the embodiments described herein may benefit from a bubble removal system and such has been contemplated. For example, a bubble removal system can be automatically activated upon detection of in line bubbles. A controller may be configured to activate a valve positioned in the flow path downstream of the bubble detector, upon the detection of bubbles. The valve can divert a column of fluid containing the detected bubble out of the flow path leading to the patient and instead into a bypass flow path or reservoir. Once bubbles are no longer detected in the flow path and after the volume of fluid in the flow path between the detector and the valve has passed through the valve, the valve may be activated to reconnect the source of fluid with the patient through the flow path. In some embodiments, the flow path may include any number of bubble filters and/or traps to remove bubbles from the flow path.
The user interface may optionally further include one or more drip rate controls 76 for selecting flow rates of appropriate fluids (e.g., saline). A drip rate control 76 may be used to control the rate fluid is introduced through the corresponding line into a lumen of an interventional device that is fluidly connected to the line. A drip rate control 76 may include a feedback display illustrating the selected fluid rate. A positive display rate may be for normal fluid rates and a negative display rate may be for negative pressure. The various controls discussed herein as well as any other controls may be embodied in a local user interface 84 as discussed above or located remotely.
The uses and actions described herein may be controlled manually, through use of a user interface, may be performed autonomously via the control system (e.g. programmable logic), or a combination of both. Robotic arm or hub movements described herein may be performed independently of other arms or hubs, or in an orchestrated manner with other arms or hubs (e.g., master/slave protocols). Embodiments exploiting programmable logic may incorporate master/slave protocols for the movement of the arms. For example, if any one of the arms have a change in position of their corresponding head portion, one or more of the other arms, not under active user control, may mimic the movements either proportionally or to scale. This method may be used in step elimination, further simplifying use, or as avoidance of unwanted scenarios. Unwanted scenarios may include device stack profiles with steep changes that add to the possibility of kinking or buckling.
Additionally, or alternatively, a fluidics system (source system) and/or aspiration system (sink system) may be integrated into a body of an arm, such as any of the arms described elsewhere herein. For example, a vacuum reservoir 88 (for expelled fluid from an interventional device) 88 and vacuum pump 86 may be housed within the arm 402. The vacuum reservoir 88 and vacuum pump 86 may be fluidly connected (e.g., via tubing running at least partially in the body of the arm) to the hub and thus fluidly connected (e.g., via a hemostasis valve) to a lumen of an interventional device. Alternatively, one or both of the vacuum reservoir 88 and pump 86 may be located outside of the body of the arm, for example for easy emptying of the reservoir or visualization of fluid or particulate coming through the line or reservoir. Aspiration may be controlled by aspiration control 74 described above.
Further contemplated, a peristaltic saline pump 98 may be used to supply appropriate fluid to the corresponding hub and associated interventional device. The pump and fluid rate may be controlled, at least in part, by drip rate sensor 76. Some embodiments may include an external fluid reservoir 96 for storage of procedural fluids. The external fluid reservoir 96 may include a load sensor or other weight sensor to monitor fluid use during a procedure. The saline pump 98 may be connected to an external fluid reservoir 96 to supply fluid (i.e., administer fluid).
Further, a contrast injection system 90 (e.g., comprising a contrast fluid reservoir and charge pump) may be housed within the arm 402 for the supply of contrast fluid to a corresponding hub connected to an interventional device. The contrast injection system may be fluidly connected (e.g., via tubing at least partially installed within a body of the arm) to a hub of the system and thus fluidly connected (e.g., via a hemostasis valve) to a lumen of a catheter.
Further, any of the fluid systems (e.g., contrast, saline, etc.) described herein may be tilted at an angle away from an output fluid line, such that any bubbles that may be in the fluid system have an increased likelihood of remaining in the reservoir near a top of the fluid, away from the output line.
Optionally, any of the systems described herein may include a camera 60 that may be mounted in a suitable position for observation of a procedure. For example, a camera may be integrated into a portion of the arm. The use of one or more cameras can provide visualization when operations are performed remotely. Alternatively, one or more cameras may be installed in a procedure room, separate from the robotic device drive system.
Additionally depicted in this embodiment are drive mechanisms 120 for the one or more valves in the manifold 101. For example, the drive mechanisms may be electric motors with appropriate gear trains operatively coupled to the valves of the manifold 101 to manipulate the valves between open or closed states. With the electric drive mechanisms 120, the control system of certain embodiments may autonomously actuate valves or actuate after certain conditions and/or inputs are realized. The drive mechanisms 120 of certain embodiments may have gear ratios appropriate (e.g., low ratios) to allow a user to back drive the motor when manual manipulation of the one or more valves is desired. The one or more valves of these embodiments have both drive mechanisms 120 and manual levers. Some embodiments may use a disposable, single-use manifold 101 attached to the arm 52 with a sterile adapter and under draping. It is further contemplated, that the output line 128 may pass through the draping to connect to the hemostasis valve 40 in the hub.
The embodiments of fluidic systems described above may drastically improve the efficiency of procedures and reduce inherent risks. The proximity of one or more fluid reservoirs, one or more fluid pumps (e.g., peristaltic pump), and/or one or more vacuum pumps may greatly reduce the lengths of fluid lines required. Reducing fluid line lengths can reduce the probability of bubble propagation, and thus, improves the patient safety. Additionally, the reduction of fluid lines can improve the organization of the system. With self-contained fluidic systems within the arms, many external fluid lines are eliminated. Additional details of fluidic systems and related features may be found in U.S. patent application Ser. No. 17/879,614, entitled Multi Catheter System with Integrated Fluidics Management, filed Aug. 2, 2022, which is herein incorporated by reference in its entirety.
Illustrated in
As illustrated in
The first mechanism 212a can operatively couple the first rigid support 210a and the second rigid support 210b. The first mechanism 212a (e.g., a scissor mechanism) may include a mechanism for adjusting the distance 218 between the first rigid support 210a and the second rigid support 210b. Adjusting the distance 218 can adjust the height of the procedure rail 206 with respect to the y-axis (e.g., as shown in
The second mechanism 212b may operatively couple the second rigid support 210b to the third rigid support 210c. The second mechanism 212b (e.g., a revolute joint) may allow for rotation of the third rigid support 210c about the axis 262 (illustrated in
The third mechanism 212c may operatively couple the third rigid support 210c to the fourth rigid support 210d. The third mechanism 212c (e.g., a revolute joint) may allow for rotation of the fourth rigid support 210d about the axis 256 (illustrated in
The fourth mechanism 212d may operatively couple the fourth rigid support 210d to the fifth rigid support 210e. The fourth mechanism 212d (e.g., a revolute joint) may allow for rotation of the fifth rigid support 210e about the axis 260 (illustrated in
The fifth mechanism 212e may operatively couple the fifth rigid support 210e to the procedure rail 206. The fifth mechanism 212e (e.g., a revolute joint) may allow for rotation of the procedure rail 206 about the axis 258 (also shown in
The rail adjustment assembly 246 may support at least a portion of the weight of the procedure rail 206 and rail components (e.g., hubs 208a, 208b, 208c, 208d, etc.). The rail adjustment assembly 246 may be used to position the procedure rail 206 in a stowed position, in a procedure position, or any point therebetween. The stowed position of the robotic drive system 250 may be a position in which the rail adjustment assembly 246 is contracted and the procedure rail 206 is no longer above the patient support device 2 and/or the patient. The procedure position may include the procedure rail 206 being above the patient support device 2 and/or the patient, and with a device stack profile 24 (illustrated in
As illustrated in
As described, the procedure rail 206, via the rail adjustment assembly 246, may be positioned next to, or above, the patient 1 and in a position appropriate for a pending procedure. With the described capabilities of the rail adjustment assembly 246, the procedure rail 206 may be positioned while avoiding anatomical features of the patient 1 (e.g., avoiding contact with the feet 264 illustrated in
The hubs 208a, 208b, 208c, 208d may be operatively coupled to the procedure rail 206 and may include drive mechanisms to translate the hubs 208a, 208b, 208c, 208d along the rail longitudinal axis 220. For example, in some embodiments, the hubs 208a-d may translate along a drive surface 211 of the procedure rail.
In some embodiments, the drive surface 211 may be a generally vertical drive surface. For example, the drive surface 211 may be a generally planar surface oriented in a vertical plane, for example, relative to a ground surface or a top surface of a patient support table which may be described as being oriented in a horizontal plane. The vertical plane may extend perpendicularly to the ground surface or top surface of the patient support table. The vertical plane may be a Y-Z plane with reference to the illustrated cartesian coordinate system. The patient support table 2 may be oriented in a horizontal plane (for example, an X-Z plane with reference to the illustrated cartesian coordinate system). In some embodiments, the drive surface 211 may be oriented along a generally vertical plane, which may be at an angle of less than about 5 degrees or less than about 10 degrees from a vertical plane (for example, about the Z-axis or about the axis 220). In some embodiments, the drive surface my be oriented at an angle of less than about 15 degrees, less than about 20 degrees, less than about 25 degrees, or less than about 30 degrees from a vertical plane (for example, about the Z-axis or about the axis 220). The foregoing angles between the plane of the drive surface 211 and the vertical plane may be dihedral angles about the Z-axis or about the longitudinal axis 220.
In some embodiments, during performance of a procedure, the procedure rail 206 may be oriented so that the longitudinal axis 220 extends partially vertically downward from a proximal end of the procedure rail 206 to distal end of the procedure rail 206 during a procedure. In other words, a proximal end of the procedure rail 206 can be positioned vertically (in the Y direction) above the distal end of the procedure rail 206 (for example, to provide a desired device stack profile).
Examples of drive mechanisms utilized by the hubs 208a, 208b, 208c, 208d may include a rack and pinion system, lead screw system, ball bearing based system, or any other suitable mechanism known in the art. The first hub 208a may be operatively coupled to a guidewire, a catheter, or another interventional device. The second hub 208b may be operatively coupled to a guidewire, catheter, or another interventional device. The third hub 208c may be operatively coupled to a guidewire, a catheter, or another interventional device. The fourth hub 208d may be operatively coupled to a guidewire, a catheter, or another interventional device. Some embodiments may include more than four hubs 208a, 208b, 208c, 208d, and the additional hubs may be operatively coupled to, respectively, a guidewire, a catheter, or another interventional device. The hubs 208a, 208b, 208c, 208d may include rotating hemostasis valves (referred to as RHV) 216a, 216b, 216c, 216d, respectively. RHV 216a, 216b, 216c, 216d may be used to operatively couple interventional devices (e.g., a catheter, or a guidewire) to respective hubs 208a, 208b, 208c, 208d. RHV 216a, 216b, 216c, 216d may include the capability to control of fluids or aspiration to each respective interventional device.
In certain embodiments, contrast fluid, saline, or and/or aspiration can be independently supplied to the RHV 216a, 216b, 216c of each respective hub, from the fluidics system 200, and as such, independently to the interventional devices coupled to RHV 216a, 216b, 216c. A guidewire coupled to the fourth hub 208d may be inserted within a catheter (which may be a third catheter in an interventional device assembly) coupled to the third hub 208c. The catheter coupled to the third hub 208c may be inserted into a catheter (which may be a second catheter in an interventional device assembly) coupled to the second hub 208b. The catheter coupled to the second hub 208b may be inserted into a catheter (which may be a first catheter in an interventional device assembly) coupled to the first hub 208a. As such, the outer diameter of the guidewire (not shown) would be less than inner diameter of the third catheter (not shown), the outer diameter of the third catheter (not shown) would be less than the inner diameter of the second catheter (not shown), and the outer diameter of the second catheter (not shown) would be less than the inner diameter of the first catheter (not shown). The described device stack profile (including the guidewire of the fourth hub 208d) can be manipulated by the robotic device drive system 250 for procedural requirements. For example, the distal end of the first catheter (not shown) may be axially adjusted, with respect to the device stack profile, by the first hub 208a advancing distally or retracting proximally along the procedure rail 206. The distal end of the second catheter (not shown) may be axially adjusted, with respect to the device stack profile, by the second hub 208d advancing distally or retracting proximally along the procedure rail 206. The distal end of the third catheter (not shown) may be axially adjusted, with respect to the device stack profile, by the third hub 208c advancing distally or retracting proximally along the procedure rail 206. The distal end of the guidewire (not shown) may be axially adjusted, with respect to the catheter stack, by the fourth hub 208d advancing distally or retracting proximally along the procedure rail 206. Contrast, saline, any other fluid, or aspiration can be supplied to the first, second and third catheter at any adjusted position.
Although
The first robotic arm 226a, the second robotic arm 226b, the third robotic arm 226c, the fourth robotic arm 226d, and the fifth robotic arm 226e may be operatively coupled to interventional devices (e.g., catheters, guidewires, etc.) as described herein. For example, the first robotic arm 226a, the second robotic arm 226b, the third robotic arm 226c, the fourth robotic arm 226d, and the fifth robotic arm 226e may include RHV 216a, 216b, 216c, 216d as described with respect to
The robotic device drive system 270 may include at least some of the capabilities of the robotic device drive system 100 described for
The first robotic arm 226a can translate or move along the rail 4 via a first robotic arm bottom portion 6a (illustrated in
The second robotic arm 226b can have a second robotic arm bottom portion 6b (illustrated in
The third robotic arm 226c can have a third robotic arm bottom portion 6c (illustrated in
The fourth robotic arm 226d can have a fourth robotic arm bottom portion 6d (illustrated in
The fifth robotic arm 226e can have a fifth robotic arm bottom portion 6e (illustrated in
The first robotic arm 660a, the second robotic arm 660b, the third robotic arm 660c, the fourth robotic arm 660d, and the fifth robotic arm 660e may be operatively coupled to interventional devices (e.g., catheters, guidewires, etc.) as described herein. For example, one or more of the first robotic arm 660a, the second robotic arm 660b, the third robotic arm 660c, the fourth robotic arm 660d, and the fifth robotic arm 660e may include respective RHVs (such as RHV 216a, 216b, 216c, 216d as described for
Although the robotic device drive system 950 may include at least some of the capabilities of the robotic device drive system 100 described for
The robotic device drive system 950 may include or may be fluidly connected to fluidics system as described herein. Although using dissimilar mechanisms (e.g., rotational instead of translational), the described robotic device drive system 950 can manipulate and position interventional devices (e.g., catheters, guidewires, etc.) as described for the robotic device drive system 100 in
The procedure rail 206 may include one or more hubs, such as hubs 208a-d and mechanisms as described for
It has been contemplated herein that two or more robotic drive systems (i.e., a dual assembly) may work in unison, in tandem, synchronously, asynchronously, or otherwise to perform certain procedures. As shown in
Several embodiments described herein utilize a rail 4 which is parallel to the elongate side 28 of the patient support device 2 (e.g., shown in
Several embodiments described herein utilize a rail 4 which is parallel to the elongate side 28 of the patient support device 2 (e.g., embodiments described with respect to
The cassette 341 may be a self-contained unit comprising a housing having a plurality of valves, tubing and connectors as described below. A first connector array comprises a plurality of releasable connectors such as luer connectors, for placing the cassette in fluid communication with complementary connectors in fluid communication with sources of aspiration and at least one or two or more fluids. A second connector array is configured for releasable connection to a tubing set configured to extend between the cassette and at least one or two or three interventional devices.
The cassette 341 thus forms a bridge module that, when assembled, resides between the various fluid and vacuum sources, and the corresponding interventional devices. The cassette 341 may be configured for a single use, or may be resterilizable and reusable.
As shown in
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 split along a plurality of branches 318b to a plurality of connectors 317b (for example, four connectors 317b as shown in
Fluid flow from the second fluid source 310b may be directed into a plurality of branches 318c to a plurality of pumps 334 (for example, four pumps 334 as shown in
The system further includes an aspiration canister 340 in communication with an upstream side of a filter 344. A downstream side of the filter 344 is in communication with a vacuum pump 342. The aspiration canister receives fluid from the cassette 341 which includes a plurality of connectors 317a each being configured to couple to a unique interventional device. A unique valve 316a (at least two, and four in the illustrated example) may be positioned upstream of each connector 317a. Each unique valve 316a may be positioned along a branch 318a.
In certain embodiments, one or more connector arrays 346 may be arranged, each connector array 346 configured to couple an interventional device. For example, a connector array 346 is indicated by dashed lines in
The connector array 346 can releasably couple to a tubing set 343 including an aspiration tube 354, a first fluid tube 355, and a second fluid tube 356. In some embodiments, the connectors 317a, 317b, and 317b can be Luer lock connectors. The aspiration tube 354 can couple to the connector 317a of the array 346 by way of a complementary connector 317d for aspiration from the interventional device to the aspiration container. The first fluid tube 355 can couple to the connector 317b of the array 346 by way of a complementary connector 317e to provide fluid flow from the first fluid source 310a to the interventional device. The second fluid tube 356 can couple to the connector 317c of the array 346 by way of a complementary connector 317f to provide fluid flow from the second fluid source 310b to the interventional device. The tubes 354, 355, and 356 may be joined together over a majority of their lengths. The tubes 354, 355, and 356 can each have a length of at least about three or four feet, and in certain embodiments between about 6 feet and about 8 feet.
As shown in
In certain embodiments, the system 300 (or other systems described herein) can direct the flow of the second fluid (for example, saline) using two different flow modes. In a low flow drip mode, a flow rate of about 1-2 drips per second or 3-6 mL/min may be provided, for example, by the pumps 334. In some embodiments, a low flow mode rate of 1-8 mL/min may be provided. Each catheter coupled to the system may experience a different fluid resistance as described herein.
The pumps, for example pumps 334, can be operated to provide the same flow rate in each catheter. In certain embodiments the fluid pressure within the catheter can be at least about 330 mmHg or 6.5 psi. This pressure may be enough to overcome arterial pressure while delivering the desired drip rate. In certain embodiments, the pressure within the catheter can be greater than 330 mmHg. In certain embodiments, the delivered fluid volume can be at least about 1 liter over the length of a procedure. In some embodiments, the fluid volume can be up to 2 liters.
In a high flow flush mode, all of the fluid lines may be flushed to remove air. The flow rate can be between 100-1000 ml/min. The fluid pressure may be between 5-10 psi. The volume delivered can be between 0.5-1 liters per procedure. Volume may depend on tubing length and diameter. In some embodiments, the high flush flow rate is at least about 20 times and in some cases between 30 to 150 times the low flow drip mode flow rate.
In certain embodiments, the first fluid (for example, contrast solution) can be provided at a flow rate of between 3-8 L/s (for example, about 4 mL/s), for example, by the pump 352. 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, the first fluid can be provided with a pressure of about 400 psi for a flow rate of about 4 mL/s. The amount of pressure needed may depend on flow rate and flow restriction of the fluid path. The pressure may increase proportionally with the flow rate for higher flow rates. In certain embodiments, the pressure may be up to 1200 psi.
In certain embodiments, the high pressure pump, such as pump 352, can provide a delivered volume of between 5-15 mL per high pressure injection. In certain embodiments, the pump can provide the 5-15 mL per high pressure injection in increments of about 1 mL per puff. In certain embodiments, the second fluid source can provide a total volume of about 200 mL per procedure. In certain embodiments, the syringe pump is sized to hold at least about 150 mL or 200 mL so as to provide uninterrupted flow throughout the procedure without the need to add additional contrast solution. In other embodiments, the second fluid source can provide a total volume of between 150-250 mL per procedure.
In certain embodiments, the flow rate may vary depending upon the anatomical location at the distal end of the catheter. For example, within the aortic arch, the flow rate may be about 20 mL/s. A total delivered volume of about 25 mL may be infused in the aortic arch. Within the common carotid artery, the flow rate may be about 20 mL/s. A total delivered volume of 12 mL may be infused in the common carotid artery. Within the subclavian artery, the flow rate may be about 6 mL/s. A total delivered volume of about 15 mL may be infused in the subclavian artery. Within the internal carotid artery, the flow rate may be about 6 mL/s. A total delivered volume of about 8 mL may be infused in the internal carotid artery. Within the external carotid artery, the flow rate may be about 3 mL/s. A total delivered volume of about 6 mL may be infused in the external carotid artery. Within the vertebral artery, the flow rate may be about 6 mL/s. A total delivered volume of 8 mL may be infused in the vertebral artery.
In certain embodiments, a motor may be provided to drive the high pressure pump, such as pump 352, which can be controlled with a position and velocity control loop using a potentiometer as a measurement to close the loop. In certain embodiments, current control may be applied to provide approximate pressure limiting. In certain embodiments, the second fluid can be a contrast solution such as Omnipaque 300, Omnipaque 350, or Visipaque 320.
In certain embodiments, a vacuum pump, such as pump 342, can provide a pressure of about −29.5 inHg or up to −29.5 inHg (−999 mbar). In certain embodiments, tubing used for aspiration can have an inner diameter of 0.11 inches (about 2.8 mm). In certain embodiments, the volume of the aspiration container, such as canister 340, can be at least about 0.5 L. In certain embodiments, the volume of the aspiration container can include about 0.5 L for blood and additional volume for a saline flush. In certain embodiments, the aspiration container can have a volume between 0.25-0.75 L. In certain embodiments, the vacuum pump can be configured to operate to additionally provide a low pressure/flow setting to assist a flushing process as it may be desirable that an aspiration line is full of saline at all times (except when aspirating a clot). In certain embodiments, a separate pump may be provided for the low pressure/flow setting.
In certain embodiments, one or more of the hubs (e.g., hubs 208a-d) and/or interventional devices described herein may be magnetically driven. For example, in certain embodiments, one or more hubs may be magnetically driven along a drive table or procedure rail (e.g., procedure rail 206).
Referring to
To reduce friction in the system, the hub 436 may be provided with at least a first roller 453 and a second roller 455 which may be in the form of wheels or rotatable balls or drums. The rollers space the sterile barrier apart from the surface of the driven magnet 469 by at least about 0.02 centimeters (about 0.008 inches) and generally no more than about 0.08 centimeters (about 0.03 inches). In some implementations, the space is within the range of from about 0.03 centimeters (about 0.010 inches) and about 0.041 centimeters (about 0.016 inches). The space between the drive magnet 467 and driven magnet 469 is generally no more than about 0.38 centimeters (about 0.15 inches) and in some implementations is no more than about 0.254 centimeters (about 0.10 inches) such as within the range of from about 0.216 centimeters (about 0.085 inches) to about 0.229 centimeters (about 0.090 inches). The hub adapter 448 may similarly be provided with at least a first hub adapter roller 459 and the second hub adapter roller 463, which may be positioned opposite the respective first roller 453 and second roller 455 as illustrated in
Example 1. A robotic device drive system comprising: a plurality of robotic arms arranged on a rail and configured to axially translate along the rail from a contracted configuration to an expanded configuration, wherein at least one of the plurality of robotic arms comprises: a fluidics system configured to be fluidly coupled to a hemostasis valve; and a catheter hub coupled to a catheter, the catheter hub comprising the hemostasis valve, wherein axial translation of the at least one of the plurality of robotic arms causes axial translation of the catheter.
Example 2. The robotic device drive system of any one of the preceding examples, but particularly Example 1, wherein the fluidics system further comprises: tubing that fluidly connects the hemostasis valve to a sink and a source, the source being stored within the at least one of the plurality of robotic arms; and a bubble removal system configured to be activated upon detection of bubbles in a portion of the tubing.
Example 3. The robotic device drive system of any one of the preceding examples, but particularly Example 2, wherein the fluidics system further comprises: a first valve in communication with a first port; a second valve in communication with a second port; and a third valve in communication with a third port, wherein the fluidics system is configured to selectively place the third port in communication with a portion of the catheter while simultaneously blocking the first port and the second port from communication with the portion of the catheter.
Example 4. The robotic device drive system of any one of the preceding examples, but particularly Example 3, wherein the fluidics system further comprises a source of vacuum, and the first port is configured to connect to the source of vacuum, the second port is configured to connect to a source of saline, and the third port is configured to connect to a source of contrast media.
Example 5. The robotic device drive system of any one of the preceding examples, but particularly Example 1, wherein the rail is coupled to an elongate side of a patient support device and the at least one of the plurality of robotic arms respectively comprises: a bottom arm portion configured to axially move along the rail; an intermediate arm adjustable from a first height relative to a lateral surface of the patient support device to a second height relative to the lateral surface of the patient support device; and a head portion configured to extend away from the intermediate arm portion and suspend above at least a portion of the patient support device.
Example 6. The robotic device drive system of any one of the preceding examples, but particularly Example 5, wherein the first height is a storage height and the second height is a procedure height.
Example 7. The robotic device drive system of any one of the preceding examples, but particularly Example 5, wherein the intermediate arm portion is height configurable between the first height and the second height to avoid contact of the at least of the plurality of robotic arms with one or more first patient body portions while another of the plurality of the plurality of robotic arms is attached to a first end of a patient introducer, the patient introducer being coupled to a second patient body portion at the second end.
Example 8. The robotic device drive system of any one of the preceding examples, but particularly Example 1, wherein the robotic device drive system is installed on an elongate side of a patient support device and the plurality of robotic arms comprise: a patient introducer arm; at least one guidewire arm; at least one guide catheter arm; at least one access catheter arm; and at least one procedure catheter arm.
Example 9. The robotic device drive system of any one of the preceding examples, but particularly Example 1, wherein: at least some of the plurality of robotic arms are independently adjustable in a vertical direction perpendicular to the rail; and at least some of the plurality of robotic arms are configured to move in tandem when axially translated along the rail from the expanded configuration to the contracted configuration.
Example 10. A robotic device drive control system comprising: a robotic arm configured to move axially along a rail, the robotic arm comprising: a catheter hub coupled to a catheter and configured to roll the catheter; and a valve system in communication with the catheter hub and configured to administer fluids to a hemostasis valve coupled to a portion of the catheter
Example 11. The robotic device drive control system of any one of the preceding examples, but particularly Example 10, further comprising an anti-buckling control configured to perform anti-buckling operations for the catheter.
Example 12. The robotic device drive control system of any one of the preceding examples, but particularly Example 10, wherein the robotic arm comprises a bottom arm portion, an intermediate arm portion and a head arm portion, the intermediate arm portion having a proximal end coupled to the bottom arm portion and a distal end coupled to the head arm portion, the head arm portion having a proximal end coupled to at least one portion of the intermediate arm portion and a distal end coupled to an interface to the catheter.
Example 13. The robotic device drive control system of any one of the preceding examples, but particularly Example 10, wherein the robotic arm is configured to move along the rail in a first horizontal direction that is substantially parallel to the rail and in a second vertical direction that is substantially perpendicular to the rail.
Example 14. A robotic device drive control system comprising: at least one processor; and a robotic arm comprising a catheter hub and a valve system in fluid communication with the catheter hub, the catheter hub comprising a hemostasis valve and the at least one processor configured to execute instructions to: move the robotic arm axially along a rail of a patient support device, roll a catheter coupled to the hemostasis valve of the catheter hub, and administer fluids through the valve system in fluid communication with the hemostasis valve coupled to a portion of the catheter.
Example 15. A robotic device drive control system comprising: at least one robotic arm operatively coupled to a rail, the at least one robotic arm comprising a fluidics system and a catheter hub; a controller configured to be in electrical communication with the fluidics system and the catheter hub; an adapter configured to couple both the fluidics system and the catheter hub to at least one catheter, wherein the adapter enables manipulation of the at least one catheter based on signals received from the controller.
Example 16. The robotic device drive control system of any one of the preceding examples, but particularly Example 15, wherein a first side of the adapter is in a sterile field and a second side of the adapter is in a nonsterile field.
Example 17. The robotic device drive control system of any one of the preceding examples, but particularly Example 15, further comprising: a camera coupled to the at least one robotic arm; a plurality of motors coupled to portions of the fluidics system and configured to control a plurality of ports and valves of the fluidics system; a hemostasis valve coupled to the catheter hub and the at least one catheter, wherein the controller is installed in the catheter hub and is configured to control the camera, the plurality of motors, the hemostasis valve, and the at least one catheter.
Example 18. The robotic device drive control system of any one of the preceding examples, but particularly Example 15, wherein the fluidics system further comprises: tubing that fluidly connects a hemostasis valve, in communication with the at least one catheter, to a sink and a source, the source being stored within the at least one robotic arm; and a bubble removal system configured to be activated upon detection of bubbles in a portion of the tubing.
Example 19. The robotic device drive control system of any one of the preceding examples, but particularly Example 18, wherein the fluidics system further comprises: a first valve in communication with a first port; a second valve in communication with a second port; and a third valve in communication with a third port, wherein the fluidics system is configured to selectively place the third port in communication with a portion of the at least one catheter while simultaneously blocking the first port and the second port from communication with the portion of the at least one catheter.
Example 20. The robotic device drive control system of any one of the preceding examples, but particularly Example 19, wherein the fluidics system further comprises a source of vacuum, and the first port is configured to connect to the source of vacuum, the second port is configured to connect to a source of saline, and the third port is configured to connect to a source of contrast media.
Example 21. A robotic device drive control system comprising: a first robotic arm comprising a first catheter hub and a first valve system in communication with the first catheter hub; a second robotic arm comprising a second catheter hub and a second valve system in communication with the second catheter hub; and a rail, wherein the first robotic arm and second robotic arm are operatively coupled to the rail, wherein the first catheter hub is configured to be in communication with a first hemostasis valve through a first interface, the first interface being configured to: receive movement control signals to move a first catheter associated with the first hemostasis valve, and receive fluid control signals for administering fluid from the first valve system to the first catheter.
Example 22. The robotic device drive control system of any one of the preceding examples, but particularly Example 21, wherein the second catheter hub is configured to be in communication with a second hemostasis valve through a second interface, the second interface being configured to: receive movement control signals to move a second catheter associated with the second hemostasis valve, and receive fluid control signals for administering fluid from the second valve system to the second catheter.
Example 23. The robotic device drive control system of any one of the preceding examples, but particularly Example 21, wherein the first robotic arm and the second robotic arm are configured to axially translate along the rail.
Example 24. The robotic device drive control system of any one of the preceding examples, but particularly Example 21, further comprising a rail adjustment assembly for positional adjustments of the rail.
Example 25. The robotic device drive control system of any one of the preceding examples, but particularly Example 21, wherein the first robotic arm and the second robotic arm are configured to axially translate along the rail from a contracted configuration to an expanded configuration or from an expanded configuration to a contracted configuration.
Example 26. The robotic device drive control system of any one of the preceding examples, but particularly Example 21, wherein the robotic device drive control system is configured to gain supra-aortic vessel access, the robotic device drive control system further comprising: a guidewire arm comprising a guidewire hub being configured to adjust an axial position of a guidewire and a rotational position of the guidewire, wherein the guidewire arm is operatively coupled to the rail, and wherein: the first catheter hub is configured to adjust an axial position of the first catheter; and the second catheter hub is configured to adjust an axial position of the second catheter and a rotational position of the second catheter, the second catheter hub being further configured to laterally deflect a distal deflection zone of the second catheter.
Example 27. The robotic device drive control system of any one of the preceding examples, but particularly Example 21, wherein: the first catheter hub is a guide catheter hub; and the second catheter hub is a procedure catheter hub.
Example 28. A robotic device drive control system comprising: a rail; a rail adjustment system configured to manipulate a position of the rail between a stored configuration to a procedure configuration; a fluidics system; and a plurality of catheter hubs operatively coupled to the rail and configured to be axially translated along a longitudinal axis of the rail, wherein at least one of the plurality of catheter hubs is in fluid communication with the fluidics system, the at least one of the plurality of catheter hubs comprising a hemostasis valve and a catheter in communication with the hemostasis valve.
Example 29. The robotic device drive control system of any one of the preceding example, but particularly Example 28, wherein the fluidics system is configured to selectively supply fluid or vacuum to the hemostasis valve.
Example 30. The robotic device drive control system of any one of the preceding example, but particularly Example 29, wherein the fluidics system is configured to selectively supply fluid from a saline source and a contrast source.
Example 31. The robotic device drive system of any one of the preceding examples, but particularly Example 28, wherein the plurality of catheter hubs comprise: at least one guidewire hub; at least one guide catheter hub; at least one access catheter hub; and at least one procedure catheter hub.
Example 32. A method of performing a thrombectomy with a robotic device drive system, the method comprising: translating a first robotic arm operatively coupled to a first catheter axially along a rail and toward an access point vasculature of a patient to introduce the first catheter into the access point vasculature of the patient; translating a second robotic arm operatively coupled to a second catheter positioned concentrically within a lumen of the first catheter axially along the rail; and selectively supplying one or more fluids to or aspirating fluids from to one or both of the first catheter and the second catheter by a fluidics system.
Example 33. The method of any one of the preceding examples, but particularly Example 32, further comprising translating axially along the rail a third robotic arm operatively coupled to a third catheter positioned concentrically within a lumen of the second catheter; and selectively supplying one or more fluids to or aspirating fluids from one or more of the first catheter, the second catheter, and the third catheter by the fluidics system.
Example 34. The method of any one of the preceding examples, but particularly Example 33, further comprising translating axially along the rail a fourth robotic arm operatively coupled to a guidewire positioned within a third lumen of the third catheter.
Example 35. The method of any one of the preceding examples, but particularly Example 32, further comprising translating axially along the rail a third robotic arm operatively coupled to a guidewire positioned within a second lumen of the second catheter.
Example 36. The method of any one of the preceding examples, but particularly Example 32, further comprising translating axially along the rail an introducer arm operatively coupled to a guide tube to position the guide tube near the access point vasculature, wherein the first catheter is positioned within a lumen of the guide tube.
Example 37. A method of performing a thrombectomy procedure with a robotic device system, the method comprising: positioning a rail to approximately align a device stack profile to an access point vasculature of a patient; translating a first hub operatively coupled to a first catheter axially along the rail and toward the access point vasculature to introduce the first catheter into the access point vasculature; translating axially along the rail a second hub operatively coupled to a second catheter positioned within a first lumen of the first catheter; and selectively supplying one or more fluids to or aspirating fluids from one or both of the first catheter and the second catheter by a fluidics system.
Example 38. The method of any one of the preceding examples, but particularly Example 37, wherein the rail is positioned by a rail adjustment assembly.
Example 39. The method of any one of the preceding examples, but particularly Example 37, further comprising translating axially along the rail a third hub operatively coupled to a third catheter positioned within a second lumen of the second catheter; and selectively supplying one or more fluids to or aspirating fluids from one or more of the first catheter, the second catheter, and the third catheter by the fluidics system.
Example 40. The method of any one of the preceding examples, but particularly Example 39, further comprising translating axially along the rail a fourth hub operatively coupled to a guidewire positioned within a third lumen of the third catheter.
Example 41. The method of any one of the preceding examples, but particularly Example 37, further comprising translating axially along the rail a third hub operatively coupled to a guidewire positioned within a second lumen of the second catheter.
Example 42. The method of any one of the preceding examples, but particularly Example 37, further comprising translating axially along the rail an introducer hub operatively coupled to a guide tube to position the guide tube in the access point vasculature, wherein the first catheter is positioned within a lumen of the guide tube.
Various systems and methods are described herein primarily in the context of a neurovascular access or procedure (e.g., neurothrombectomy). However, the catheters, systems (e.g., drive systems), and methods disclosed herein can be readily adapted for any of a wide variety of other diagnostic and therapeutic applications throughout the body, including particularly intravascular procedures such as in the peripheral vasculature (e.g., deep venous thrombosis), central vasculature (pulmonary embolism), and coronary vasculature, as well as procedures in other hollow organs or tubular structures in the body.
The systems and methods of the preferred embodiment and variations thereof can be embodied and/or implemented at least in part as a machine configured to receive a computer-readable medium storing computer-readable instructions. The instructions are preferably executed by computer-executable components preferably integrated with the system and one or more portions of the processor on the controller and/or computing device. The computer-readable medium can be stored on any suitable computer-readable media such as RAMs, ROMs, flash memory, EEPROMs, optical devices (e.g., CD or DVD), hard drives, floppy drives, or any suitable device. The computer-executable component is preferably a general or application-specific processor, but any suitable dedicated hardware or hardware/firmware combination can alternatively or additionally execute the instructions.
As used in the description and claims, the singular form “a”, “an” and “the” include both singular and plural references unless the context clearly dictates otherwise. For example, the term “arm” may include, and is contemplated to include, a plurality of arms. At times, the claims and disclosure may include terms such as “a plurality,” “one or more,” or “at least one;” however, the absence of such terms is not intended to mean, and should not be interpreted to mean, that a plurality is not conceived.
The term “about” or “approximately,” when used before a numerical designation or range (e.g., to define a length or pressure), indicates approximations which may vary by (+) or (−) 5%, 1% or 0.1%. All numerical ranges provided herein are inclusive of the stated start and end numbers. The term “substantially” indicates mostly (i.e., greater than 50%) or essentially all of a device, substance, or composition.
As used herein, the term “comprising” or “comprises” is intended to mean that the devices, systems, and methods include the recited elements, and may additionally include any other elements. “Consisting essentially of” shall mean that the devices, systems, and methods include the recited elements and exclude other elements of essential significance to the combination for the stated purpose. Thus, a system or method consisting essentially of the elements as defined herein would not exclude other materials, features, or steps that do not materially affect the basic and novel characteristic(s) of the claimed disclosure. “Consisting of” shall mean that the devices, systems, and methods include the recited elements and exclude anything more than a trivial or inconsequential element or step. Embodiments defined by each of these transitional terms are within the scope of this disclosure.
The examples and illustrations included herein show, by way of illustration and not of limitation, specific embodiments in which the subject matter may be practiced. Other embodiments may be utilized and derived therefrom, such that structural and logical substitutions and changes may be made without departing from the scope of this disclosure. Such embodiments of the inventive subject matter may be referred to herein individually or collectively by the term “invention” merely for convenience and without intending to voluntarily limit the scope of this application to any single invention or inventive concept, if more than one is in fact disclosed. Thus, although specific embodiments have been illustrated and described herein, any arrangement calculated to achieve the same purpose may be substituted for the specific embodiments shown. This disclosure is intended to cover any and all adaptations or variations of various embodiments. Combinations of the above embodiments, and other embodiments not specifically described herein, will be apparent to those of skill in the art upon reviewing the above description.
Any and all applications for which a foreign or domestic priority claim is identified in the Application Data Sheet filed with the present application are hereby incorporated by reference under 37 C.F.R. § 1.57. The present application claims priority to U.S. Provisional Patent Application No. 63/529,115, filed Jul. 26, 2023, tilted BEDSIDE ROBOTICS DRIVE SYSTEM, the entire content of which is incorporated by reference herein for all purposes and forms a part of this specification.
| Number | Date | Country | |
|---|---|---|---|
| 63529115 | Jul 2023 | US |
