Robotic actuation of an elongate medical device

Abstract

A system includes an EMD and is coupled to a robotic drive. The EMD includes an outer member defining an internal lumen and an inner member disposed in the internal lumen and coupled to a distal portion of the outer member, and a linear and rotary actuatable element coupled to the outer member. The robotic drive includes a plurality of device modules, each of which is independently linearly movable by the robotic drive, a first cassette is coupled to a first of the plurality of device modules and the linear and rotary actuatable element of the outer member, and a second cassette is coupled to a second of the plurality of device modules and the inner member.

Description

[0001] Cross-references to related applications

[0002] This application claims priority to U.S. Provisional Application No. 63 / 262,108, filed October 5, 2021, the contents of which are incorporated herein by reference for all purposes. Technical Field

[0003] The embodiments generally relate to the field of robotic medical surgical systems, and in particular, to systems, apparatus, and methods for robotically controlling the movement of one or more elongated medical devices (EMDs) during robotic interventional medical surgery. Background Technology

[0004] Catheters and other EMDs can be used during medical procedures for the diagnosis and / or treatment of various vascular system diseases, including neurovascular intervention (NVI), percutaneous coronary intervention (PCI), and peripheral vascular intervention (PVI). These procedures typically involve guiding a guidewire through the patient's vascular system and advancing catheters, valves, stents, etc., via the guidewire to deliver treatment.

[0005] Physicians can use imaging systems to obtain enhanced-contrast images for diagnosis, identifying lesion locations, and determining the path through which a guidewire or catheter can be advanced to a target location (such as a lesion). Enhanced-contrast images can also be obtained when physicians manipulate the proximal end of a guidewire or catheter to guide its distal end into a vessel located on the path to the target location and avoid advancing into collateral branches of the vascular system, while monitoring for complications such as perforation and anatomy.

[0006] The flexibility of catheters or other medical devices is expected to facilitate negotiation of the vascular system. It is also desirable for the distal end to be more flexible than the rest of the device, while still allowing torque to be applied to the distal end. Some conventional "manipulated" catheters include multiple cables (sometimes called push / pull wires) integrated into the catheter wall. By applying tension to the cables at the proximal end of such catheters, the distal end can bend in various directions to assist in navigation of the vascular system as the catheter is advanced.

[0007] Some EMDs include an outer component and an inner component attached to the distal portion of the outer component. The distal end bends or otherwise deforms by causing relative movement between the outer and inner components. These EMDs advantageously exhibit a smaller cross-section than the cable-based maneuverable EMDs described above.

[0008] Control of the distal end requires manipulating handheld features to manually rotate the outer component relative to the inner component and / or manually retract and insert the inner component relative to the outer component. An improved system for controlling this EMD is desired, which can provide improved precision and / or accuracy of the relative movement between the outer and inner components, and thus provide improved control of the distal end or other actuable devices connected thereto. This improvement can lead to increased surgical speed and improved safety. Attached Figure Description

[0009] The embodiments will be more fully understood from the following detailed description in conjunction with the accompanying drawings, wherein reference numerals denote similar parts, wherein:

[0010] Figure 1 This is a perspective view of an exemplary catheter-based surgical system according to some embodiments;

[0011] Figure 2 This is a schematic block diagram of an exemplary catheter-based surgical system according to some embodiments;

[0012] Figure 3 This is a perspective view of a robot actuator for a catheter-based surgical system according to some embodiments;

[0013] Figure 4A and 4B This is a perspective view of the EMD;

[0014] Figure 5 This is a perspective view of an EMD configured for robot activation according to some embodiments;

[0015] Figure 6 This is a schematic diagram of robot actuation of an EMD according to some embodiments;

[0016] Figure 7 This is a schematic diagram of robot actuation of an EMD according to some embodiments;

[0017] Figure 8 This is a schematic diagram of robot actuation of an EMD according to some embodiments;

[0018] Figure 9 This is a schematic diagram of robot actuation of an EMD according to some embodiments;

[0019] Figure 10 This is a schematic diagram of robot actuation of an EMD according to some embodiments;

[0020] Figure 11 This is a schematic diagram of the fully inserted position of the EMD during robot actuation, according to some embodiments;

[0021] Figure 12This is a schematic diagram of an EMD according to some embodiments, wherein actuable elements are mounted to the EMD in a first alternative arrangement;

[0022] Figure 13 This is a schematic diagram of an EMD according to some embodiments, wherein actuable elements are mounted to the EMD in a second alternative arrangement;

[0023] Figure 14 This is an isometric view of an actuable element coupled to a drive member and rotatably coupled a hemostatic valve to a Luer connector, which is coupled to an internal member; and

[0024] Figure 15 yes Figure 14 Exploded view of the internal components, Luer connector, actuating elements, and hemostatic valve. Detailed Implementation

[0025] The following description is provided to enable anyone in the art to make and use the described embodiments. However, various modifications will be apparent to those skilled in the art.

[0026] As used herein, EMD refers to, but is not limited to, catheters (e.g., guiding catheters, microcatheters, balloon / stent catheters), wire-based devices (e.g., guidewires, microwires, proximal pushers for embolization coils, stent retrieval devices, self-expanding stents, flow deflectors, etc.), and any combination of these medical devices.

[0027] Some embodiments facilitate the operation of an EMD in a robotic system, the EMD including an inner member disposed within a cavity of an outer member defined by an outer member, and wherein relative movement between the inner member and the outer member causes action at a distal portion of the EMD. In some embodiments, the outer member cavity does not need to extend the full length of the outer member. The outer member may include a tube, but embodiments are not limited thereto. Either or both of the inner member and the outer member may include multiple components.

[0028] Examples of actions produced at the distal end include, but are not limited to, bending the distal portion, expanding or compressing the diameter of the distal portion of an adjustable stent retriever (e.g., Tigertriever, manufactured by Rapid Medical), controlling the distal and proximal elements of a stent retriever (e.g., ThrombX retriever, manufactured by ThrombX Medical), or an adjustable remodeling device (e.g., Comaneci, manufactured by Rapid Medical, and Cascade, manufactured by Perflow Medical). Internal and external components may comprise separate, respective EMDs. These separate EMDs may be selectively operably coupled at their distal portions.

[0029] Some embodiments facilitate the application of this relative motion between an external component and an internal component disposed within the external component in a robotic system. The internal component may be partially disposed within the external component such that a portion of the internal component extends from one or both ends of the external component. The relative motion can be linear, rotational, or a combination of both. In some embodiments, relative rotational motion is achieved by rotating the proximal end of the external component and / or the proximal portion of the internal component in different directions and / or at different speeds. Relative linear motion is achieved by advancing or retracting the proximal portion of the external component and / or the internal component in different directions and / or at different speeds. Rotation of the entire EMD without causing relative rotational motion is achieved by rotating the proximal ends of both the external and internal components in the same direction (i.e., clockwise or counterclockwise) at the same angular rate. Advancement or retraction of the entire EMD is achieved by moving the proximal ends of both the external and internal components in the same direction at the same speed without causing relative linear motion.

[0030] According to some embodiments, relative rotational movement is facilitated by attaching a rotatable element (such as, but not limited to, a gear) to the outer surface of one or both of the outer and inner components. The rotatable element may be attached to the outer surface at a location that results in engagement with a drive mechanism of the housing, into which either the outer or inner component is loaded.

[0031] Relative linear movement can be facilitated by attaching a positioning feature with front and rear support surfaces to one or both of the outer and inner components. The positioning feature can be attached to a location that results in engagement with a feature of the housing to which the outer or inner component is loaded, such that the feature engages with the support surface to move the outer or inner component back and forth as a result of linear movement of the housing. In some embodiments, the support surface is integral with or otherwise coupled to the rotary actuated element.

[0032] According to some embodiments, when the internal member is not under tension to cause action at the distal portion of the EMD, the length by which the internal member protrudes from the external member can differ from the length used for handheld operation. In particular, and according to some embodiments, the length of the internal member can be determined such that the distance between its proximal end and the proximal end of the external member is at least as long as the minimum operating distance between the corresponding mounting features of adjacent boxes in which the external and internal members are loaded.

[0033] By simultaneously manipulating the external and internal components of such an EMD at the same or different rates, the action (e.g., bending, expansion, compression) at the distal portion can be faster than the action caused by moving the external component while the internal component is fixed or moving the internal component while the external component is fixed.

[0034] The robotic system can be calibrated to the input device to accurately control the distal end of the EMD. For example, rotating a knob on the input device by 60 degrees can cause a 60-degree bend, or the input device can be moved to precisely correspond to the desired radius of curvature at the distal end of the EMD. A specific radius of curvature can be used to match the radius of curvature of the blood vessel to maintain the device in a specific position (e.g., when deploying treatments that may require moving other devices).

[0035] Tracking the distal portion of the EMD using an imaging system (e.g., a fluorescence fluoroscopy system) allows for automated control to advance the EMD and bend its distal portion, enabling navigation to the target without human intervention. If the three-dimensional centerline of the desired vascular path to the target is known, the robotic system can programmatically bend the distal end of the EMD as it is advanced to follow the vascular path to the target.

[0036] Robotic actuation of an EMD typically allows for the coordination of multiple successive and / or simultaneous insertion, bending, and / or rotational movements to navigate the EMD to select vessels, advance through tortuous or narrow vessels, or remain on a desired path (i.e., avoid movement into unwanted collateral branches). According to some embodiments, robotic actuation can cause undulation of the distal end of the EMD (with or without rotation, reciprocating rotation, or reciprocating advance) to reduce friction on the vessel wall, thereby facilitating the advancement or retraction of the EMD and / or another adjacent or coaxial EMD through tortuous or narrow vessel segments.

[0037] According to some embodiments, the robotically actuated motion of the distal end of an EMD, as described herein, can be coordinated with other EMDs. For example, the EMD can be positioned within the lumen of a suction catheter and controlled as described herein to assist in the advancement of the suction catheter to the clot without requiring the suction catheter to pass through the clot and risk clot breakage.

[0038] As described in this article, the distal end of the curved EMD can be used to avoid vascular injury. For example, when the distal end of the guidewire is curved into a J-shape, it prevents the end from entering collateral vessels and penetrating arteries during advancement, which may not be visible on angiography in NVI. The J-shape can also be used as an artery to perform subintimal anatomy to facilitate movement through CTO (chronic total occlusion) during coronary procedures.

[0039] The relative motion facilitated by some embodiments can be mechanically and / or via software limitation to prevent either vascular injury or damage to the EMD itself. In some embodiments, sensors mounted on the EMD or in rotational and / or linear motion actuators are used to measure force, and this measurement is used to limit the amount of force applied to the blood vessel or device. The sensors can measure strain, for example, using strain gauges or fiber Bragg gratings integrated into the EMD or actuator.

[0040] Figure 1 This is a perspective view of an exemplary catheter-based surgical system 10 according to some embodiments. The catheter-based surgical system 10 can be used to perform catheter-based medical procedures, such as percutaneous interventional procedures, such as PCI (e.g., for STEMI treatment), NVI (e.g., for emergency large vessel occlusion (ELVO)), PVI (e.g., for severe limb ischemia (CLI)), etc.). Catheter-based medical procedures may include diagnostic catheter insertion procedures during which one or more catheters or other EMDs are used to aid in the diagnosis of a patient's condition. For example, during one embodiment of a catheter-based diagnostic procedure, a contrast agent is injected through a catheter into one or more arteries, and images of the patient's vascular system are acquired throughout the residence of the contrast agent.

[0041] Catheter-based medical procedures can also include catheter-based therapeutic procedures (e.g., angioplasty, stent placement, treatment of peripheral vascular disease, clot removal, treatment of arteriovenous malformations, aneurysm treatment, etc.), during which a catheter (or other EMD) is used to treat the disease. The therapeutic procedure can be performed by including ancillary devices 54 (such as... Figure 2Enhancements can be achieved using techniques such as intravascular ultrasound (IVUS), optical coherence tomography (OCT), fractional flow reserve (FFR), etc. However, it should be noted that those skilled in the art will recognize that certain specific percutaneous interventional devices or components (e.g., the type of guidewire, the type of catheter, etc.) can be selected based on the type of procedure to be performed. The catheter-based surgical system 10 can perform any number of catheter-based medical procedures with only minor adjustments to accommodate the specific percutaneous interventional device to be used in that procedure.

[0042] The catheter-based surgical system 10 includes a bedside unit 20 and a control station 26 (not shown), as well as other components. The bedside unit 20 includes a robot actuator 24 positioned adjacent to the patient 12 and a positioning system 22. The patient 12 is supported on a patient table 18. The positioning system 22 is used to position and support the robot actuator 24. The positioning system 22 can be, for example, a robotic arm, an articulated arm, a retainer, etc. The positioning system 22 can be attached at one end to, for example, a track on the patient table 18 (e.g., a...). Figure 1 (as shown), base or trolley. The other end of the positioning system 22 is attached to the robot actuator 24. The positioning system 22 can be removed (together with the robot actuator 24) to allow the patient 12 to be placed on the patient table 18. Once the patient 12 is positioned on the patient table 18, the positioning system 22 can be used to position or position the robot actuator 24 relative to the patient 12 for surgery. In some embodiments, the patient table 18 is operatively supported by a base 17 fixed to the floor and / or ground. The patient table 18 is capable of moving with multiple degrees of freedom relative to the base 17, such as tilting, pitching, and yawing. The bedside unit 20 may also include controls and a display 46 ( Figure 2 (As shown in the diagram). For example, controls and displays can be located on the housing of robot driver 24.

[0043] The term "front" will refer to the side of the robot actuator 24 facing the patient 12 and away from the positioning system 22, while the term "rear" will refer to the side of the robot actuator 24 closest to the positioning system 22. The terms "top," "up," and "above" refer to the approximate direction away from gravity, and the terms "bottom," "down," and "below" refer to the approximate direction along gravity.

[0044] Typically, the robot actuator 24 may be equipped with appropriate percutaneous intervention devices and accessories 48. Figure 2(As shown herein) (e.g., EMDs, guidewires, various types of catheters including, but not limited to, balloon catheters, stent delivery systems, stent retrieval devices, embolization coils, liquid embolization agents, aspiration pumps, contrast agent delivery devices, drugs, hemostatic valve adapters, syringes, stopcocks, expansion devices, etc.) to allow a user or operator 11 to perform catheter-based medical procedures via a robotic system by operating various controls of the control system as described herein (such as controls and input modules located at control station 26). Bedside unit 20, and in particular robot actuator 24, may include any number of components and / or combinations of components to provide the functionality described herein to bedside unit 20. The user or operator 11 at control station 26 is referred to herein as control station user, control station operator, user, or operator. The user or operator at bedside unit 20 is referred to herein as bedside unit user or bedside unit operator.

[0045] The robotic actuator 24 includes multiple device modules 32a-d mounted to a track or linear member 60. The track or linear member 60 guides and supports the device modules. Each device module 32a-d can be used to drive an EMD, such as a catheter or guidewire. For example, the robotic actuator 24 can be used to automatically feed a guidewire into a diagnostic catheter and a guiding catheter in an artery of patient 12. One or more devices (such as EMDs) are inserted into the body (e.g., a blood vessel) of patient 12 at insertion point 16 via, for example, a guide sheath.

[0046] The bedside unit 20 communicates with a control station 26 (not shown), allowing signals generated by controls on the control station 26 to be transmitted wirelessly or via hardwired to the bedside unit 20 to control various functions of the bedside unit 20, including the functions of the robot actuator 24. As discussed below, the control station 26 may include a control computing system 34 (such as...). Figure 2 (as shown), or connected to the bedside unit 20 via the control computing system 34. The bedside unit 20 can also connect to the control station 26, the control computing system 34 (as shown), or the bedside unit 20 via the control computing system 34. Figure 2 The control computing system 34 and the various components of the catheter-based surgical system 10 provide feedback signals (e.g., load, speed, operating conditions, warning signals, error codes, etc.). Communication between the control computing system 34 and the various components of the catheter-based surgical system 10 can be provided via a communication link, which can be a wireless connection, a cable connection, or any other means that allows communication between the components.

[0047] The term "local" is used to refer to the location of patient 12 and bedside unit 20. The catheterization system 10 can be operated by a control station 26 at a local site, a control station 26 at a remote site, or both simultaneously. At the local site, the user or operator 11 and control station 26 are located in the same room as or adjacent to patient 12 and bedside unit 20. As used herein, the local site is the location of bedside unit 20 and patient 12 or an object (e.g., an animal or cadaver), and the remote site is the location of user or operator 11 and control station 26 for remotely controlling bedside unit 20. The term "remote" is used to refer to a location where bedside unit 20 and / or patient 12 cannot be physically accessed at the local site.

[0048] In some embodiments, the remote site and the local (patient) site are located far apart from each other, for example, in different rooms in the same building, in different buildings in the same city, in different cities, or in other different locations where the remote site cannot physically access the bedside unit 20 and / or the patient 12.

[0049] Control station 26 includes input module 28, which includes controls configured, according to some embodiments, to receive user-manipulated controls for controlling robot actuator 24 and / or various other components or systems of catheter-based surgical system 10. In the illustrated embodiment, control station 26 allows a user or operator 11 to control bedside unit 20 to perform catheter-based medical procedures. For example, input module 28 may be configured to use a percutaneous interventional device (e.g., EMD) docked with robot actuator 24 to cause bedside unit 20 to perform various tasks (e.g., advance, retract, or rotate guidewire; advance, retract, or rotate catheter; inflate or deflate balloon located on catheter; position and / or deploy stent; position and / or deploy stent retrieval device; position and / or deploy coil; inject contrast agent into catheter; inject liquid embolizing agent into catheter; inject medication or saline into catheter; perform aspiration on catheter; or perform any other function that may be performed as part of catheter-based medical procedures). The robot actuator 24 includes various drive mechanisms to cause movement (e.g., linear and rotational movement) of the components of the bedside unit 20, including the percutaneous intervention device, in response to user manipulation of the controls of the input module 28.

[0050] Input module 28 may include device selection buttons as described below, allowing operator 11 to select which percutaneous interventional devices loaded into robot actuator 24 are controlled via user-manipulated input controls. Automatic movement buttons can be used to enable algorithmic movement of the catheter-based surgical system 10 on percutaneous interventional devices without direct commands from the user or operator 11.

[0051] Input module 28 may also include balloon or stent controls configured to inflate or deflate a balloon and / or deploy a stent. Input module 28 may include one or more buttons, scroll wheels, joysticks, touchscreens, etc., dedicated to indicating control of one or more specific components. Additionally, one or more touchscreens may display one or more icons (not shown) representing the relative position of input module 28 or various components of the catheter-based surgical system 10. Such one or more touchscreens may present a user interface for specifying and / or presenting the configuration of controls and one or more functions of input module 28, including but not limited to linear and / or rotational locking functions.

[0052] Control station 26 may include displays 30. In some embodiments, control station 26 may include two or more displays 30. Displays 30 may be configured to display information or patient-specific data to a user or operator 11 located at control station 26. For example, displays 30 may be configured to display image data (e.g., X-ray images, MRI images, CT images, ultrasound images, etc.), hemodynamic data (e.g., blood pressure, heart rate, etc.), patient record information (e.g., medical history, age, weight, etc.), and lesion or treatment assessment data (e.g., IVUS, OCT, FFR, etc.). Additionally, displays 30 may be configured to display surgery-specific information (e.g., surgery list, recommendations, surgery duration, catheter or guidewire position, volume of delivered medication or contrast agent, etc.). Furthermore, displays 30 may be configured to display information to provide information to the control computing system 34 ( Figure 2 (As shown) the associated functions. The display 30 may include touchscreen capability to provide some user input capabilities for the system.

[0053] The catheter-based surgical system 10 also includes an imaging system 14. The imaging system 14 can be any medical imaging system that can be used in conjunction with catheter-based medical procedures (e.g., non-digital X-ray, digital X-ray, CT, MRI, ultrasound, etc.). In an exemplary embodiment, the imaging system 14 is a digital X-ray imaging device that communicates with a control station 26. In one embodiment, the imaging system 14 may include a C-arm (such as...) Figure 1 As shown), the C-arm allows the imaging system 14 to rotate partially or completely around the patient 12 to obtain images at different angular positions relative to the patient 12 (e.g., sagittal view, tail view, anterior and posterior view, etc.). In one embodiment, the imaging system 14 is a fluorescence fluoroscopy system including a C-arm with an X-ray source 13 and a detector 15, also referred to as an image intensifier.

[0054] Imaging system 14 can be configured to acquire X-ray images of appropriate areas of the patient 12 during surgery. For example, imaging system 14 can be configured to acquire one or more X-ray images of the head to diagnose neurovascular conditions. Imaging system 14 can also be configured to take one or more X-ray images (e.g., real-time images) during catheter-based medical procedures to assist operator 11 of control station 26 in correctly positioning guidewires, guiding catheters, microcatheters, stent retrieval devices, coils, stents, balloons, etc., during surgery. One or more images can be displayed on display 30. For example, images can be displayed on the display to allow the user or operator 11 to accurately move the guiding catheter or guidewire into the appropriate position.

[0055] To define the directions, a Cartesian coordinate system with X, Y, and Z axes is introduced. The positive X-axis is oriented longitudinally (axially) in the distal direction (i.e., from proximal to distal). The Y and Z axes lie in the transverse plane of the X-axis, with the positive Z-axis oriented upwards, i.e., in the direction opposite to gravity, and the Y-axis automatically determined by the right-hand rule.

[0056] Figure 2 This is a block diagram of a catheter-based surgical system 10 according to an exemplary embodiment. The catheter-based surgical system 10 may include a control computing system 34. The control computing system 34 may physically be, for example, part of a control station 26. Figure 1 (As shown in the diagram). The control computing system 34 may typically include a computer processing unit suitable for providing the various functions described herein for the catheter-based surgical system 10. For example, the control computing system 34 may be an embedded system, a dedicated circuit, a general-purpose system programmed with the functions described herein, etc. The control computing system 34 communicates with the bedside unit 20, the control station 38, an additional communication system 40 (e.g., a telepresence system), and patient sensors 56 (e.g., an electrocardiogram (ECG) device, an electroencephalogram (EEG) device, a blood pressure monitor, a temperature monitor, a heart rate monitor, a respiratory monitor, etc.).

[0057] The control computing system also communicates with the imaging system 14, patient table 18, additional medical system 50, contrast agent injection system 52, and auxiliary devices 54 (e.g., IVUS, OCT, FFR, etc.). The bedside unit 20 includes a robot actuator 24, a positioning system 22, and may include additional controls and a display 46. As described above, the additional controls and display may be located on the housing of the robot actuator 24. Interventional devices and accessories 48 (e.g., guidewires, catheters, etc.) interface with the bedside unit 20. In some embodiments, the interventional devices and accessories 48 may include dedicated devices (e.g., EMDs, IVUS catheters, OCT catheters, FFR wires, diagnostic catheters for contrast imaging, etc., as described herein, including internal and external components) that interface with their respective auxiliary devices 54, i.e., the IVUS system, OCT system, and FFR system, etc.

[0058] In various embodiments, the control computing system 34 is configured to receive and generate control signals based on user manipulation of the input module 28 of the control station 26 and / or based on information accessible to the control computing system 34, enabling the use of the catheter-based surgical system 10 to perform medical procedures.

[0059] The catheter-based surgical system 10 may be connected to or configured to include any other systems and / or devices not explicitly shown. For example, the catheter-based surgical system 10 may include an image processing engine, a data storage and archiving system, an automated balloon and / or stent inflation system, a drug injection system, a drug tracking and / or recording system, a user log, an encryption system, a system for restricting access to or use of the catheter-based surgical system 10, etc.

[0060] Figure 3 This is a perspective view of a robot actuator 24 for a catheter-based surgical system 10 according to some embodiments. The embodiments are not limited to... Figure 3 Robot driver 24. Figure 3 The robot actuator 24 includes a plurality of device modules 32a-d coupled to the linear member 60. Each device module 32a-d is coupled to the linear member 60 via a platform 62a-d movably mounted to the linear member 60. The device modules 32a-d can be connected to the platform 62a-d using connectors such as offset brackets 78a-d. In another embodiment, the device modules 32a-d are mounted directly to the platform 62a-d.

[0061] Each platform 62a-d can be independently actuated to move linearly along the linear member 60. Therefore, each platform 62a-d (and its corresponding device module 32a-d coupled to it) can move independently relative to each other and to the linear member 60. A drive mechanism is used to actuate each platform 62a-d. Figure 3In the illustrated embodiments, the drive mechanism includes independent platform translation motors 64a-d and platform drive mechanism 76 coupled to each platform 62a-d. These mechanisms may be, for example, lead screws via rotating nuts, racks via pinions, belts via pinions or pulleys, chains via sprockets, or the platform translation motors 64a-d themselves may be linear motors. In some embodiments, the platform drive mechanism 76 may be a combination of these mechanisms; for example, each platform 62a-d may employ a different type of platform drive mechanism. In some embodiments where the platform drive mechanism is a lead screw and a rotating nut, the lead screw is rotatable, and each platform 62a-d can engage and disengage with the lead screw to move, such as advance or retract. Figure 3 In the embodiment shown, the platform 62a-d and the device module 32a-d are in a serial drive configuration.

[0062] Each device module 32a-d includes a device module 68a-d and a box 66a-d mounted on and connected to the device module 68a-d. Figure 3 In the illustrated embodiment, each box 66a-d is mounted to the device module 68a-d in a vertical orientation. In other embodiments, each box 66a-d may be mounted to the device module 68a-d in other mounting orientations. Each box 66a-d is configured to abut and support a proximal portion of the EMD (not shown). Additionally, each box 66a-d may include elements for providing one or more degrees of freedom beyond the linear motion provided by actuation of the corresponding platform 62a-d to move linearly along the linear member 60. For example, box 66a-d may include elements that can be used to rotate the EMD when the box is coupled to the device module 68a-d.

[0063] Each device module 68a-d includes at least one connector to provide a drive interface to the mechanism in each box 66a-d, thereby providing additional degrees of freedom. Each box 66a-d also includes a channel in which device supports 79a-d are positioned, and each device support 79a-d is used to prevent EMD buckling. Support arms 77a, 77b, and 77c are attached to each device module 32a, 32b, and 32c, respectively, to provide fixation points for supporting the proximal ends of device supports 79b, 79c, and 79d. The robot actuator 24 may also include a device support connector 72 connected to the device support 79, the distal support arm 70, and the support arm 770. The support arm 770 is used to provide fixation points for supporting the proximal end of the distal support arm 79a housed in the distal device module 32a. Additionally, a guide interface support (steering mechanism) 74 may be connected to the device support connector 72 and the EMD (e.g., guide sheath). The configuration of the robot actuator 24 has the advantage of reducing the size and weight of the robot actuator 24 by using an actuator on a single linear component.

[0064] To prevent pathogen contamination of patients, healthcare staff should ensure that bedside units 20 and patients 12 or other objects (such as...) are properly arranged. Figure 1 Aseptic techniques are used in the room (shown). The room housing the bedside unit 20 and the patient 12 can be, for example, a catheterization laboratory or a vascular suite. Aseptic techniques include the use of sterile barriers, sterile equipment, appropriate patient preparation, environmental control, and contact guidelines. Therefore, all EMDs and interventional accessories are sterilized and can only come into contact with sterile barriers or sterile equipment. In some embodiments, a sterile drape (not shown) is placed on a non-sterile robotic actuator 24. Each cartridge 68-74 is sterilized and serves as a sterile interface between the draped robotic actuator 24 and at least one EMD. Each cartridge 68-74 can be designed to be sterile for single use or can be resterilized wholly or partially, such that cartridge 68-74 or its components can be used in multiple procedures.

[0065] As used herein, the term "box" generally refers to a component of a robot drive system, including components that support and move (e.g., rotate and / or translate) at least one EMD. A device module generally refers to a component of a robot drive system, which includes one or more motors with drive couplings that interface with the moving elements of the box's EMD. The box may provide a sterile interface between at least one EMD and the device module, either directly or via a device adapter. The term "drive module" refers to a combination of the device module and the box.

[0066] In some embodiments, the EMD is a conduit having a hub at a proximal end of the conduit and a flexible shaft extending from the hub toward a distal end of the conduit, wherein the shaft is more flexible than the hub. In one embodiment, the conduit includes an intermediate portion transitioning between the hub and the shaft, the intermediate portion having intermediate flexibility that is less rigid than the hub but more rigid than the shaft. In some embodiments, the intermediate portion is a strain relief element.

[0067] The longitudinal axis of a component (e.g., an EMD or other element in a catheter-based surgical system) is a line or axis along the length of the component that passes through the center of the transverse cross-section of the component in a direction from the proximal portion to the distal portion of the component. For example, the longitudinal axis of a guidewire is a central axis in a direction from the proximal portion of the guidewire toward the distal portion of the guidewire, even if the guidewire may be non-linear in the relevant portion.

[0068] Linear movement of a component refers to translation of the component along its longitudinal axis. An EMD is advanced when its distal end moves linearly into or further into the patient's body along its longitudinal axis in a distal direction. An EMD is withdrawn when its distal end moves axially out of the patient's body along its longitudinal axis in a proximal direction.

[0069] In this respect, linear insertion refers to inserting the first component into the second component along the longitudinal axis of the second component. For example, an EMD linearly loaded in a clamp is linearly inserted into the clamp. An example of linear insertion can be described as back-mounting a catheter onto the proximal end of a guidewire. Lateral insertion refers to inserting the first component into the second component along a direction perpendicular to the longitudinal axis of the second component. Lateral insertion can also be referred to as radial loading or lateral loading.

[0070] Rotational motion of a component refers to the change in angular orientation of the component about its local longitudinal axis. For example, the rotational movement of an EMD corresponds to the clockwise or counterclockwise rotation of the EMD about its longitudinal axis due to an applied torque. Continuous motion refers to motion that does not require resetting and is uninterrupted, while discrete motion refers to motion that requires resetting and is interrupted.

[0071] The terms "distal" and "proximal" define the relative positions of two distinct features. Regarding the robotic actuator, the terms "distal" and "proximal" are defined by the position of the robotic actuator relative to the patient in its intended use.

[0072] When used to define relative position, distal features are those of the robotic actuator that are closer to the patient than proximal features when the robotic actuator is in its intended use position. Within the patient, any vascular system landmarks further away from the access point along the path are considered distal than landmarks closer to the access point, where the access point is the point at which the EMD enters the patient's body. Similarly, proximal features are those of the robotic actuator that are farther from the patient than distal features when the robotic actuator is in its intended use position.

[0073] When used to define orientation, distal orientation refers to the path on which an object is moving or intended to move, or along which an object points or faces from a proximal feature toward a distal feature and / or the patient, when the robot actuator is in its intended position of use. Proximal orientation is the opposite of distal orientation. For example, see reference... Figure 1 The robotic device is shown from the operator's viewpoint towards the patient. In this arrangement, the distal direction is along the positive X-axis, and the proximal direction is along the negative X-axis.

[0074] Regarding the movement of modules, please refer to... Figure 3 The EMD moves distally along a path toward the patient, passing through the guide interface support 74 that defines the distal end of the robot actuator 24. The proximal end of the robot actuator 24 is the point furthest from the distal end along the negative X-axis.

[0075] Regarding the location of each module, and also referencing Figure 3 The farthest device module is device module 32a, which is the farthest end closest to the robot actuator 24. The closest device module is device module 32d, which is the farthest end located along the negative X-axis from the robot actuator 24. The relative positions of the device modules are determined by their relative positions to the far end of the robot actuator. For example, device module 32b is farthest from device module 32c.

[0076] Regarding the distal / proximal portions, segments, or ends of the EMD or robot actuator, portions of cassette 66a and device module 68a are defined by their relative positions to the distal end of the robot actuator. For example, when the cassette is in the use position on device module 68a, the distal end of cassette 66a is the portion of the cassette closest to the distal end of the robot actuator, and the proximal end of cassette 66a is the portion of the cassette furthest from the distal end of the robot actuator along the negative X-axis. In other words, the distal end of cassette 66a is a portion of the cassette through which the EMD most closely approaches the path to the patient in the use position.

[0077] As previously discussed, embodiments of control station 26 may include various input modules for controlling bedside unit 20. Input modules may include various input controls (e.g., buttons, wheels, joysticks, etc.) that can be manipulated by a user to control (or instruct) the operation of robot actuator 24. These input controls may be arranged in different layouts or patterns on the input modules to facilitate their desired functions and collaborative sequencing to perform desired tasks requiring independent (and sometimes simultaneous) movement of multiple EMDs and / or independent (and possibly simultaneous) movement of different parts of the same EMD, as described herein.

[0078] Figure 4A and 4B This is a perspective view of an EMD 400 that may be used in conjunction with some embodiments. Embodiments are not limited to the EMD 400. The EMD 400 includes an inner member 410 disposed within an outer member 420. A distal portion 412 of the inner member 410 is coupled to a distal portion 422 of the outer member 420. The term "coupled" encompasses any attachment method, including but not limited to welding, ultrasonic welding, thermal bonding, adhesive bonding, molding, etc. The coupling can occur at any surface disposed toward the distal ends of the inner member 410 and the outer member 420. Although the distal portion 412 of the inner member is shown as substantially flush with the distal end of the outer member 420, in some embodiments, the distal portion of the inner member 410 may extend beyond the distal end of the outer member 420. In some embodiments, a proximal portion of the inner member 410 may extend beyond the proximal end of the outer member 420. A portion of the inner member 410 may be operatively coupled to an actuable element extending beyond the proximal end of the outer member 420.

[0079] Each of the inner member 410 and the outer member 420 is linearly movable in both proximal and distal directions, and rotates clockwise and counterclockwise. This linear movement allows for relative movement between them in the longitudinal direction. This relative movement, and the connection of their distal portions, results in distal bending, as is known in the art. According to some embodiments, the inner member 410 and the outer member 420 are also, or alternatively, configured for relative rotational movement. This rotational movement can result in bending or other deformation of their distal ends.

[0080] As is known in the art, at least one of the inner member 410 and the outer member 420 may be slotted to increase flexibility toward its distal end, thereby improving maneuverability. The degree of flexibility can be determined by the number of slots, the spacing between slots, the shape of the slots, the angle at which the slots face, the thickness of the material, and other factors. Some embodiments use flexible materials instead of the aforementioned slotted portions and use rigid reinforcements instead of non-slotted portions to achieve the desired flexibility.

[0081] In some embodiments, the internal component 410 and the external component 420 are made of suitable flexible, appropriately biocompatible materials, including but not limited to stainless steel (e.g., AISI 316), nickel-titanium, cobalt-chromium alloys, nickel-titanium alloys, and others, plastics (e.g., nylon, polypropylene, etc.) or combinations thereof. The composition of the internal component 410 may differ from that of the external component 420. Either or both of the internal component 410 and the external component 420 may include machined features and / or component assemblies.

[0082] In some embodiments, the internal member 410 defines a lumen along its entire length, which can define a lumen over the entire length of the EMD. During the procedure, fluid can be injected into the lumen from the proximal end of the internal member 410. Fluids and substances can also be extracted from the vascular system via the lumen (e.g., aspiration). A connector, such as a Luer connector, can be attached to the proximal end of the internal member 410. Such a connector facilitates a suitable fluid-impermeable connection between the lumen and injection / inhalation / other systems, such as, but not limited to, syringes, hemostatic valves, tubing, or other devices.

[0083] Figure 5 This is a perspective view of an EMD 500 configured for robot activation according to some embodiments. As described with respect to EMD 400, EMD 500 includes an inner member 510 disposed within an outer member 520, and its distal portion is coupled to facilitate bending in response to relative movement. The inner member 510 and the outer member 520 of EMD 500 may exhibit the characteristics described above. Figure 4A and 4B Any of the features described in EMD 400.

[0084] The inner member 510 and the outer member 520 are movable relative to each other in the longitudinal direction. According to some embodiments, the inner member 510 and the outer member 520 are also or alternatively configured for relative rotational movement. Relative movement and engagement of their distal portions result in bending and / or other deformation at the distal ends.

[0085] Actuable elements 515 and 525 are respectively connected to the inner member 510 and the outer member 520. In some embodiments, each of the actuable elements 515 and 525 can be independently driven to rotate the corresponding member / tube to which it is connected. Such rotation can result in relative rotational movement between the inner member 510 and the outer member 520.

[0086] Advantageously, assuming the same rotational speed, rotation of the inner member 510 and the outer member 520 in opposite directions can result in a relative rotation of a certain magnitude that is faster than rotation of only one of the inner member 510 and the outer member 520. However, as will be described below, some embodiments may include rotation of one of the inner member 510 and the outer member 520 while the other is fixed to prevent its rotation. Such embodiments may omit the element that actuates rotational movement from the rotationally held relatively fixed inner / outer member.

[0087] Although the rotational actuation features of actuated elements 515 and 525 are depicted as gear teeth, the embodiments are not limited thereto. In a non-exhaustive embodiment, one or both of actuated elements 515 and 525 include a pulley or O-ring comprising a surface frictionally engaged by a drive such as a belt. In some embodiments, no rotational actuated element is coupled to the inner member 510 and the outer member 520; instead, a drive element is used to impart rotation to the inner member 510 and / or the outer member 520 via contact with the surfaces of the inner member 510 and / or the outer member 520. The embodiments are not limited to one rotational actuated element per member / tube.

[0088] Each of the actuable elements 515 and 525 includes linearly actuable features 516, 517 and 526, 527 to facilitate linear movement of the respective inner member 510 and outer member 520. For example, assuming the longitudinal position of the outer member 520 remains fixed, when the box moves in the proximal direction, a feature of the box in which the inner member 510 is mounted can engage abutment feature 516, causing the inner member 510 to retract from the outer member 520. Conversely, again assuming the longitudinal position of the outer member 520 remains fixed, when the box moves in the distal direction, a feature of the box in which the inner member 510 is mounted can engage abutment feature 517, causing the inner member 510 to advance into the outer member 520.

[0089] When the box moves in the proximal direction, the feature of the box in which the outer member 520 is mounted can engage abutment feature 526, thereby causing the inner member 510 to move in the proximal direction. When the box moves in the distal direction, the feature of the box can engage abutment feature 527, thereby causing the outer member 520 to move in the distal direction. Any of the above-described linear movements can be used to change the relative longitudinal relationship between the inner member 510 and the outer member 520.

[0090] In some embodiments, a wire torque device (pin clamp) or chuck fixed to the internal member 510 is used as a linear and / or rotationally actuated element to facilitate linear and / or rotational movement of the internal member 510. In some embodiments, such a linear and / or rotationally actuated element is coupled to such a wire torque device (pin clamp) or chuck fixed to the internal member 510.

[0091] The embodiments are not limited to a single actuated element that provides rotational and linear motion features. Nor are the embodiments limited to rotational and linear motion of both the internal member 510 and the external member 520. For example, each of the internal member 510 and the external member 520 may be coupled to corresponding zero or more actuated elements that can be driven by the robot to rotate, and to corresponding zero or more actuated elements that can be driven by the robot to move linearly. As will be explained below, rotational and / or linear actuated elements may be coupled to any suitable location on the internal member 510 and / or the external member 520.

[0092] Figure 6 This is a schematic diagram of robot actuation of an EMD according to some embodiments. The external component 520 is loaded into a housing 620 of the robot conduit system, as described above with respect to housings 66a-66d of the robot actuator 24. As described, the mechanism in housing 620 is driven by a drive module. This drive of the mechanism can actuate the actuable element 525 to rotate the external component 520 relative to the internal component 510. Figure 6 In one embodiment, the box 620 can be moved linearly to move the outer member 520 linearly relative to the inner member 510.

[0093] Figure 7 This is a schematic diagram of robot actuation of an EMD according to some embodiments. An internal component 510 is loaded into a housing 710 of a robot conduit system, such that this mechanism of the housing 710 can drive an actuable element 515 to rotate the internal component 510 relative to an external component 525. The housing 710 can move linearly to move the internal component 510 linearly relative to the external component 520.

[0094] Figure 8 This is a schematic diagram of robot actuation of an EMD according to some embodiments. An external member 520 is loaded into a housing 820 of the robot conduit system, and mechanisms within housing 820 can be driven to actuate an actuated element 525 to rotate the external member 520 relative to an internal member 510. Figure 8 In one embodiment, the box 810 can be moved linearly to move the internal member 510 linearly relative to the external member 520.

[0095] like Figure 9As shown, the internal component 510 can be loaded into the housing 910 of the robotic conduit system, such that this mechanism of the housing 910 can drive the actuated element 515 to rotate the internal component 510 relative to the external component 520. The housing 920 can move linearly to move the external component 520 linearly relative to the internal component 510.

[0096] Figure 10 The illustration shows an internal component 510 loaded into a housing 1010 and an external component 520 loaded into a housing 1020. Each of housings 1010 and 1020 includes a mechanism for driving corresponding actuated elements 515 and 525, as described above. Figure 5 Each of the boxes 1010 and 1020 is linearly movable in both proximal and distal directions, such that the inner member 510 and the outer member 520 move relative to each other. This linear movement, as described herein, can be facilitated by features of corresponding characteristics of the engaging linearly actuated elements of the boxes, which are coupled to the respective inner member 510 or outer member 520, as described above regarding... Figure 5 In some embodiments, the box features may include features that keep the inner member 510 or the outer member 520 fixed relative to the box when the box moves linearly.

[0097] As described above, the relative linear and / or rotational movement of the internal and external components of the EMD can induce a desired action at its distal portion. Some embodiments operate to receive a single operator command to perform a desired action (e.g., bending the end by a certain amount, unfolding the clot retriever), and in response, control motors associated with each of the respective two housings supporting the internal and external components to move the internal and external components linearly and / or rotationally, thereby inducing the desired relative movement between the internal and external components, resulting in the desired action.

[0098] Figure 11 The illustration shows housings 1110 and 1120 of a robot actuator, positioned close to each other as permitted by the robot actuator. This positioning determines the minimum length of the proximal portion of the inner member 510 extending from the outer member 520. This length should be sufficient to allow the inner member to be loaded within housing 1110. This requirement may necessitate increasing the length of the inner member 510 relative to conventionally available maneuverable conduits that include both the inner and outer members.

[0099] Figure 12 and 13The illustrations show various locations where rotary actuating elements 515 and 525, according to some embodiments, can be coupled to the inner member 510 and the outer member 520. As described above, zero or more actuating elements can be coupled to any location of the inner member 510 and / or the outer member 520. The actuating elements are coupled to facilitate engagement with corresponding drive elements of the housings 1210, 1220, 1310, and 1320.

[0100] Figure 14 This is an isometric view of an actuable element assembly 158 coupled to an internal member 122 including a cavity, according to some embodiments. Figure 15 This is an exploded view. The gear teeth 160 of the actuable element assembly 158 engage with the drive member 58 of the housing, and rotatably connect assembly 158 to the inner member 122. This arrangement forms a fluid-impermeable rotary seal with the male Luer 41 of the rotating element 40, and creates a continuous fluid path from the hemostatic valve 176 to the interior cavity of the inner member 122. If the inner member 122 does not include the interior cavity, the hemostatic valve 176 and the Luer connector can be omitted.

[0101] The gear teeth 160 of the actuable element assembly 150 are driven by the drive gear 58 to give rotation to the internal member 122 while isolating the rotational movement of the body of the hemostatic valve 176, such that the position of the second leg 178 of the valve 176 does not rotate when the internal member 122 rotates. When the assembly 158 rotates, the bracket 190 interacts with the groove 182 to support the assembly 158, and the bracket 190 is itself fixed to the base 32 or the wall 74. The hemostatic valve 176 is supported by the bracket 192, which is itself fixed to the base 32 or the wall 74. The brackets 190 and 192 provide stability to the longitudinal axis 50 of the valve 176 and also serve as a feature that causes linear movement of the internal member 122 when the housing in which the brackets 190 and 192 are disposed moves linearly.

[0102] Computer-executable program code, as described herein, for controlling a catheter-based surgical system or presenting a user interface, may be stored on a non-transitory computer-readable medium. Computer-readable media include volatile and non-volatile, removable and non-removable media implemented in any method or technique for storing information such as computer-readable instructions, data structures, program modules, or other data. Computer-readable media include, but are not limited to, random access memory (RAM), read-only memory (ROM), electrically erasable programmable ROM (EEPROM), flash memory or other storage technologies, compact disc ROM (CD-ROM), digital versatile disc (DVD) or other optical storage, magnetic tape cassettes, magnetic tape, disk storage or other magnetic storage devices, or anything that can be used to store desired instructions and can be transmitted by system 10 (…). Figure 1(as shown) any other medium for access, including access via the Internet or other computer networks.

Claims

1. A system comprising: EMD, which includes an external member defining an inner cavity and an internal member disposed in the inner cavity and connected to a distal portion of the external member; A linearly actuable element connected to one of the external component and the internal component; and A first box, which supports one of the external and internal components, and moves linearly in response to a first command. The linear movement of the first box causes a feature of the first box to engage with the linearly actuated element, thereby causing a relative linear movement between the outer and inner components. The system further includes: A second linearly actuable element connected to the other of the external component and the internal component; and The second box supports the other of the outer and inner components and moves linearly in response to the second command. The linear movement of the second box causes a feature of the second box to engage with the second linearly actuated element, thereby causing a second relative linear movement between the outer member and the inner member.

2. The system according to claim 1, further comprising: A rotationally actuable element connected to one of the external component and the internal component; and The first box includes a first drive element to drive the rotary actuated element in response to a third command, thereby causing relative rotational movement between the outer component and the inner component.

3. The system according to claim 2, further comprising: A second rotationally actuable element connected to the other of the external component and the internal component; and The second box includes a second drive element to drive the second rotationally actuated element in response to a fourth command, thereby causing a second relative rotational movement between the outer member and the inner member.

4. The system according to claim 2, wherein, The linearly actuated element and the rotary actuated element each comprise a single element, the single element comprising a linearly actuated feature and a rotary actuated feature.

5. The system according to claim 1, further comprising: A rotationally actuable element connected to the other of the external component and the internal component; and The second box supports the other of the outer component and the inner component, and includes a drive element to drive the rotationally actuated element in response to a second command, thereby causing relative rotational movement between the outer component and the inner component.

6. The system according to claim 5, further comprising: A second rotationally actuated element connected to one of the external component and the internal component. The first box includes a second drive element to drive the second rotationally actuated element in response to a third command, thereby causing relative rotational movement between the outer component and the inner component.

7. The system according to claim 6, wherein, The linearly actuated element and the second rotary actuated element each include a single element, the single element including a linearly actuated feature and a rotary actuated feature.

8. A system for controlling the end of an EMD, comprising: EMD, including: An external member defining the cavity and an internal member disposed within the cavity and connected to the distal portion of the external member; and Linear and rotationally actuated elements connected to the internal components; and Robot actuators, including: Multiple device modules, each of which is capable of independent linear movement via the robot actuator; The first box, which is connected to the first of the plurality of device modules, and connected to the linear and rotationally actuated elements of the internal components; and The second box is connected to the second of the plurality of device modules and to the external component.

9. The system according to claim 8, wherein, The linear and rotary actuated elements include linearly actuated features and rotary actuated features.

10. The system according to claim 8, wherein the EMD further comprises: A second linearly and rotaryly actuated element connected to the external component. The second box is connected to a second linear and rotationally actuated element of the external component.

11. The system according to claim 10, wherein, The linearly and rotaryly actuated element includes linearly actuated features and rotaryly actuated features, and The second linear and rotary actuated element includes a second linear actuated feature and a second rotary actuated feature.

12. The system according to claim 10, wherein, The first box is configured to drive the linear and rotationally actuated elements to rotate, and The second box is configured to drive the second linear and rotary actuated element to rotate independently of the rotation of the linear and rotary actuated element.

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