Device for automatically inserting a medical tool into a body lumen

Abstract

The miniature robotic device is a miniature robotic device for driving and manipulating the movement of one or more elongated surgical tools, comprising at least one motor, at least one tool movement element driven by the at least one motor and positioned and configured to be in at least partial operative contact with the elongated surgical tool that is received within the robotic device and that advances, retracts, and / or rotates, and a device housing shaped and sized to encase the at least one motor and the at least one tool movement element.

Description

Technical Field

[0001] This application claims the benefit of priority of U.S. Provisional Patent Application No. 62 / 941,842, filed on November 28, 2019, and U.S. Provisional Patent Application No. 63 / 082,508, filed on September 24, 2020, the entire contents of which are incorporated herein by reference.

[0002] This application also relates to a co-pending and co-assigned PCT application entitled "Robotic Manipulation of a Surgical Tool Handle" (Attorney Docket No. 83117), and a PCT application entitled "Modular Robot System for Driving the Motion of a Surgical Tool" (Attorney Docket No. 84910), the entire contents of which are incorporated herein by reference.

Background Art

[0003] The present invention, in some of its embodiments, relates to the automatic operation of a surgical tool inserted into a body lumen.

[0004] U.S. Patent No. 10,543,047 discloses that "a robotic instrument driver for an elongate member includes a first elongate member, at least one manipulator mechanism configured to manipulate the first elongate member, and at least one articulation drive device configured to articulate the first elongate member, which can be positioned adjacent to a patient access site on a bed, the manipulator and the articulation drive device being positioned relative to each other by a distance shorter than the insertable length of the first elongate member and being stationary in a fixed position."

Summary of the Invention

Means for Solving the Problems

[0005] According to one aspect of some embodiments, a miniaturized robotic device is provided for driving and manipulating the movement of one or more extension surgical tools. The miniaturized robotic device includes at least one motor, at least one tool movement element that is driven by the at least one motor and is disposed and configured to at least partially operably contact an extension surgical tool that is received within the robotic device and moves forward, backward, and / or rotates, and a device housing having a shape and size that encloses the at least one motor and the at least one tool movement element.

[0006] In some embodiments, the at least one motor and the at least one tool movement element are received within the wall of the housing, and only the one or more extension surgical tools extend outwardly from the wall of the housing when received within the device.

[0007] In some embodiments, the wall of the housing defines an internal volume of less than 2800 cm 3 and the device has a weight of less than 850 grams.

[0008] In some embodiments, the wall of the housing defines at least one inlet opening through which an extension surgical tool is inserted into the device and at least one outlet opening through which the extension surgical tool exits the device.

[0009] In some embodiments, the wall of the housing defines at least two inlet openings and at least two outlet openings for at least two extension surgical tools.

[0010] In some embodiments, the device has a fixation site for the proximal portion of the extension surgical tool, and the extension surgical tool segments that extend outside the housing and between the fixation site and the inlet opening form a U-shaped curve outside the housing, and the fixation site of the extension surgical tool and the inlet opening are arranged along the wall of the housing.

[0011] In some embodiments, the housing has a designated extension shaft for the extension surgical tool to extend through, and at least one tool movement element is disposed adjacent to the shaft and protrudes into the shaft to operably contact the extension surgical tool.

[0012] In some embodiments, at least one tool movement element has a set of opposing wheels configured to rotate to advance or retract the extension surgical tool within the shaft.

[0013] In some embodiments, the shaft is connected to a gear that rotates the shaft along at least one tool movement element when rotated, and the extension surgical tool is housed at a location along the longitudinal axis of the shaft, such that the extension surgical tool rotates with at least one tool movement element.

[0014] In some embodiments, the inner contour of the shaft has a shape that matches the outer contour at the contact surface of at least one tool movement element.

[0015] In some embodiments, the device has a fixation site for the proximal portion of the extension surgical tool, the fixation site includes a holder for holding the proximal portion of the extension surgical tool, and the more distal portion of the extension surgical tool is housed within the designated extension shaft.

[0016] In some embodiments, at least one motor is configured to drive the rotation of the holder and the extension shaft, thereby rotating the extension surgical tool at two spaced positions along the length of the extension surgical tool.

[0017] In some embodiments, the bottom wall of the housing is saddle-shaped.

[0018] In some embodiments, the bottom wall of the housing is planar.

[0019] In some embodiments, the dimensions of the housing include a height of less than 30 cm, a width of less than 30 cm, and a length of less than 30 cm.

[0020] In some embodiments, the housing includes a cylindrical protrusion with a curved outer lip at the inlet opening and / or the outlet opening.

[0021] In some embodiments, the housing has a removable or movable cover provided to access one or more extension surgical tools mounted on the device.

[0022] In some embodiments, the device is configured to drive and manipulate the movement of at least one guide wire and a microcatheter.

[0023] According to one aspect of some embodiments, a surgical system is provided that includes, for example, a robotic device as described herein and an add-on unit that drives the movement of a guide catheter, and the add-on unit can be mechanically attached to the housing of the robotic device.

[0024] In some embodiments, the system has a remote control device that communicates with the controller of the robotic device.

[0025] In some embodiments, the system has an imaging modality that communicates with the controller of the robotic device.

[0026] According to one aspect of some embodiments, an assembly is provided that drives linear and rotational movement of an extension surgical tool. The assembly includes a shaft having a slot that communicates with a central lumen extending along the long axis of the shaft, and a set of wheels disposed opposite each other and aligned on both sides of the slot, the wheels extending at least partially into an extension surgical tool that is received therein through an opening of the extension shaft, and a gear arranged and configured to rotate the shaft together with the set of wheels about the long axis of the shaft during rotation.

[0027] In some embodiments, the gear is linearly aligned with the shaft and coaxial with the shaft.

[0028] In some embodiments, the assembly includes a motor arranged and configured to drive rotation of the wheels, and the motor is arranged and configured to rotate with the shaft when the shaft is rotated.

[0029] In some embodiments, the gear has a slot around it, and the slot is linearly aligned with the slot of the shaft.

[0030] In some embodiments, the inner wall of the shaft defining the central lumen is formed to match at least a portion of the outer contour of at least one wheel of the set of wheels.

[0031] In some embodiments, the assembly includes a motor transmission configured to contact and rotate the gear.

[0032] In some embodiments, each wheel of the set of wheels is arranged to be on a plane substantially perpendicular to the plane defined by the slot.

[0033] In some embodiments, as the assembly rotates about the long axis of the shaft, the set of wheels rotates such that each wheel of the set of wheels remains on a plane that is substantially perpendicular to the plane defined by the slots.

[0034] According to one aspect of some embodiments, a method of using a surgical robotic device for operating at least one elongating surgical tool is provided. The method includes providing a robotic device shaped and sized to be placed adjacent to or on an operating table; mounting at least one elongating surgical tool on the device; controlling the operation of the at least one elongating surgical tool by the robotic device via a remote control interface for performing a surgical procedure; and discarding the robotic device together with the at least one elongating surgical tool following the surgical procedure.

[0035] In some embodiments, the robotic device includes one or more motors and one or more tool movement elements driven by the one or more motors, and in the mounting step, the at least one elongating surgical tool is brought into direct operable contact with the one or more tool movement elements, and the one or more tool movement elements are in direct operable contact with the one or more motors.

[0036] In some embodiments, the robotic device is not covered by a sterile drape.

[0037] In some embodiments, the method includes guiding at least one elongating surgical tool into the body and introducing body fluid into the robotic device via the elongating surgical tool.

[0038] According to one aspect of some embodiments, a method of using a surgical robot device for operating at least one lengthening surgical tool is provided. The method includes providing a robot device of a shape and size adapted to be attached to a limb of a patient, attaching the robot device onto the limb of the patient, mounting the at least one lengthening surgical tool onto the device, and controlling the operation of the at least one lengthening surgical tool by the robot device to perform a surgical procedure.

[0039] In some embodiments, the limb is one of a patient's foot to which the robot device is attached to the thigh and a patient's arm to which the robot device is attached to the wrist.

[0040] In some embodiments, the method includes forming an incision in the groin of the patient and introducing at least one lengthening surgical tool through the groin using the robot device.

[0041] In some embodiments, the attaching step includes connecting the robot device onto the limb.

[0042] According to one aspect of some embodiments, a method of controlling the available length of a lengthening surgical tool is provided. The method includes providing a robot device including a housing, mounting the lengthening surgical tool onto the robot device such that a segment of the lengthening surgical tool held at a first location along the length of the lengthening surgical tool and slidably held at a second location along the length of the lengthening surgical tool forms a curve between the first location and the second location, and sliding the lengthening surgical tool at the second location to shorten or lengthen the distance between the maximum point of the curve and the housing of the robot device to control the length of the lengthening surgical tool.

[0043] In some embodiments, the method includes controlling the length of a distal segment of an elongate surgical tool extending from a housing of a robotic device to a target point within a patient's body via steps of shortening or lengthening.

[0044] According to one aspect of some embodiments, a small robotic device is provided for driving and manipulating the movement of at least two elongate surgical tools. The small robotic device includes a housing having at least one motor and at least two assemblies, each assembly being configured for driving linear movement and / or rotation of one of the at least two elongate surgical tools, each assembly having a tool movement element driven by at least one motor or an associated transmission, and the housing defining a volume of less than 2800 cm 3 and having a weight of less than 850 grams.

[0045] According to one aspect of some embodiments, a small robotic device is provided for driving and manipulating the movement of at least one elongate surgical tool. The small robotic device includes a housing including at least one motor, a first tool movement element driven by the at least one motor and arranged and configured to be operably in contact with an elongate surgical tool that moves forward or backward and is at least partially housed in the robotic device, and a second tool movement element driven by the at least one motor and configured to rotate the elongate surgical tool about its longitudinal axis.

[0046] In some embodiments, the housing includes a shaft for expanding the elongate surgical tool, and the first tool movement element projects at least partially into the shaft and contacts the elongate surgical tool.

[0047] In some embodiments, the inner wall of the shaft is formed to conform to at least a portion of the outer contour of the first tool movement element.

[0048] In some embodiments, the first tool movement element has at least one set of wheels, and the wheels advance or retract the extension surgical tool according to the direction of rotation.

[0049] In some embodiments, the second tool movement element has gears arranged linearly along the shaft and configured to rotate the shaft.

[0050] According to some embodiments, advantageous medical devices are provided for inserting and advancing a medical tool into a body lumen. These devices are configured to advance the medical tool in a linear and / or rotational motion. In some embodiments, the advantageous devices disclosed herein enable the insertion and advancement of two or more medical tools, either separately or simultaneously, while being small in size, thereby being configured to be mounted on or at least proximate to the subject's body. In some embodiments, the devices disclosed herein are configured to operate automatically and / or be manually controlled by a user using a remote controller. In some embodiments, a system including the disclosed device and methods of using it in various medical procedures are further provided.

[0051] According to some embodiments, a medical device is provided for advancing and inserting a medical tool into a body lumen. The medical device includes a housing configured to be mounted on or disposed proximate to the subject's body, at least one actuator configured to linearly advance the medical tool, and at least one movement control unit including at least one rotational actuator configured to rotate the medical tool, wherein the at least one rotational actuator and the at least one linear actuator are activated simultaneously and / or independently of each other.

[0052] According to some embodiments, the device may further include a controller configured to operate at least one linear actuator and at least one rotary actuator. According to some embodiments, the controller may be configured for manual operation by a user. According to some embodiments, the controller may be configured to receive commands from a processor. In some embodiments, the device may be autonomously computer-controlled.

[0053] According to some embodiments, at least one linear actuator and at least one rotary actuator may have one or more common actuators.

[0054] According to some embodiments, at least one linear actuator may include an actuator selected from a DC motor, an AC motor, a stepper motor, an electromagnetic actuator, a piezoelectric actuator, a pneumatic actuator, a hydraulic actuator, or any combination thereof.

[0055] According to some embodiments, at least one rotary actuator may include an actuator selected from a DC motor, an AC motor, a stepper motor, an electromagnetic actuator, a piezoelectric actuator, a pneumatic actuator, a hydraulic actuator, or any combination thereof. In some embodiments, the medical device is disposable. In some embodiments, the medical device is small in size. In some embodiments, the medical device is lightweight.

[0056] According to some embodiments, the medical tool may be selected from a guide wire, a microcatheter, a balloon catheter, a guide catheter, a stenting catheter, an embolization catheter, a stent retrieval device, etc., or any combination thereof.

[0057] According to some embodiments, the body lumen may be selected from blood vessels, urethra, trachea, gastric anatomical structures, etc. According to some embodiments, the device may include two or more movement control units, and each control unit may be configured to linearly advance and / or rotate a separate medical tool, or a combination of two or more motors may be capable of performing separated or combined movements of the medical tool.

[0058] According to some embodiments, the device can include two movement control units. The first movement control unit is configured to linearly advance and / or rotate the first medical tool, and the second movement control unit is configured to linearly advance and / or rotate the second medical tool.

[0059] According to some embodiments, the first medical tool may be a guide wire, and the second medical tool may be a catheter.

[0060] According to some embodiments, the first medical tool may be configured to advance through the lumen of the second medical tool.

[0061] According to some embodiments, the device may be further configured to enable control of the tip parameters of the medical tool.

[0062] According to some embodiments, the movement control unit can include at least two disks facing each other along a portion of the outer periphery, such that the medical tool can be disposed within the space formed therebetween while maintaining at least partial contact with at least one of the disks, whereby, upon rotation of the disks, the medical tool advances linearly. The surface of the outer periphery of the disk may be rough, soft, smooth, coated, spongy, hydrophilic, hydrophobic, or may have other properties that can optimize the interaction with the medical tool. The drive disks can be assembled such that the medical tool is actuated along a curved path rather than a straight line, thus enabling a higher driving force and a higher rotational moment.

[0063] According to some embodiments, the medical device may further include a power source.

[0064] According to some embodiments, the device may be configured to linearly advance the medical tool at a constant or various amounts of change (speed).

[0065] According to some embodiments, the device may be configured to automatically insert and advance the medical tool into a body lumen.

[0066] According to some embodiments, a system for inserting a medical tool into a body lumen is provided, the system including a medical device for inserting a medical tool into a body lumen, the medical device being configured to be disposed on or proximate to a subject's body. The medical device includes at least one movement control unit including at least one actuator configured to linearly advance the medical tool and at least one rotational actuator configured to rotate the medical tool, and a controller configured to operate at least one linear actuator and at least one rotational actuator and configured to operate at least one rotational actuator and at least one linear actuator simultaneously and independently of each other, and a processor configured to provide commands to the controller.

[0067] According to some embodiments, the controller may be configured for manual operation by a user.

[0068] According to some embodiments, the controller can include activating a button selected from push buttons, slide buttons, joysticks, or any combination thereof.

[0069] According to some embodiments, the system disclosed herein is used to automatically insert and advance a medical tool into a body lumen during a medical procedure.

[0070] According to some embodiments, the medical procedure may include an endovascular procedure selected from coronary, peripheral, and cerebral vascular surgeries, gastric surgeries, surgeries in the urinary tract, and surgeries in the airways.

[0071] According to some embodiments, the system may further include an imaging device or may be configured to operate with an imaging device. According to some embodiments, the imaging device may be selected from an X-ray device, a fluoroscopy device, a CT device, a cone beam CT device, a CT fluoroscopy device, an MRI device, and an ultrasonic device. According to some embodiments, a method for inserting and advancing a medical tool into a body lumen is provided, the method including attaching and fixing the medical device disclosed herein to the subject's body or disposing the medical device in proximity to the subject's body, and advancing the medical tool into the subject's body lumen. In some embodiments, the method is automatic (i.e., the advancement of the medical tool is automatically performed by the medical device).

[0072] According to some embodiments, a body-worn medical device for inserting a medical tool into a body lumen is provided, the device including a housing configured to be disposed on and fixed to the subject's body, at least one linear actuator configured to linearly advance the medical tool, at least one rotary actuator configured to rotate the medical tool, and a controller configured to operate at least one linear actuator and at least one rotary actuator, the controller being configured to operate at least one rotary actuator and at least one linear actuator simultaneously and independently of each other.

[0073] According to some embodiments, a guide wire and a microcatheter enter and exit the device from the rear end and the front end, and advantageously enable movement of the microcatheter on the guide wire without impairing the driving of the guide wire.

[0074] Certain embodiments of the present disclosure may include some, all, or none of the above advantages. One or more other technical advantages will be readily apparent to those skilled in the art from the drawings, description, and claims included herein. Further, although specific advantages are listed above, various embodiments may include all, some, or none of the listed advantages.

[0075] According to aspects of some embodiments, a medical device is provided for advancing and inserting a medical tool into a body lumen, the medical device comprising a housing configured to be disposed on and secured to a subject's body or in proximity thereto, at least one actuator configured to linearly advance the medical tool, and at least one movement control unit comprising at least one rotational actuator configured to rotate the medical tool, wherein the at least one rotational actuator and the at least one linear actuator are actuated simultaneously and / or independently of each other.

[0076] In some embodiments, the device comprises a controller configured to actuate the at least one linear actuator and the at least one rotational actuator.

[0077] In some embodiments, the controller is configured for manual operation by a user.

[0078] In some embodiments, the controller is configured to receive commands from a processor.

[0079] In some embodiments, the at least one linear actuator and the at least one rotational actuator have one or more common actuators.

[0080] In some embodiments, at least one linear actuator includes an actuator selected from a DC motor, an AC motor, a stepper motor, an electromagnetic actuator, a piezoelectric actuator, a pneumatic actuator, a hydraulic actuator, or any combination thereof.

[0081] In some embodiments, at least one rotary actuator includes an actuator selected from a DC motor, an AC motor, a stepper motor, an electromagnetic actuator, a piezoelectric actuator, a pneumatic actuator, a hydraulic actuator, or any combination thereof.

[0082] In some embodiments, the medical device is disposable.

[0083] In some embodiments, the medical tool is selected from a guide wire, a micro catheter, a balloon catheter, a guide catheter, a stent, a retrieval device, or any combination thereof.

[0084] In some embodiments, the body lumen is selected from a blood vessel, a urethra, a trachea, and a gastrointestinal tract.

[0085] In some embodiments, the device comprises two or more movement control units, each control unit being configured to linearly advance and / or rotate a separate medical tool.

[0086] In some embodiments, the device comprises two movement control units, the first movement control unit being configured to linearly advance and / or rotate a first medical tool, and the second movement control unit being configured to linearly advance and / or rotate a second medical tool.

[0087] In some embodiments, the first medical tool is a guide wire and the second medical tool is a catheter.

[0088] In some embodiments, the first medical tool is configured to advance through the lumen of the second medical tool.

[0089] In some embodiments, the device is further configured to enable control of the tip parameters using additional actuators of the medical tool.

[0090] In some embodiments, the movement control unit comprises at least two disks facing each other along a portion of the outer circumference, such that the medical tool can be positioned within the space formed therebetween while maintaining at least partial contact with at least one of the wheels, whereby the medical instrument advances linearly when the disks rotate. In some embodiments, the device includes a power source.

[0091] In some embodiments, the device is configured to linearly advance the medical tool at a constant or varying amount (speed).

[0092] In some embodiments, the device is configured to automatically insert and advance the medical tool into a body lumen.

[0093] According to aspects of some embodiments, a system for inserting a medical tool into a body lumen is provided, the system comprising: a medical device for inserting a medical tool into a body lumen, the medical device having a housing configured to be placed on and fixed to the subject's body or in proximity to the subject; at least one movement control unit comprising at least one actuator configured to linearly advance the medical tool and at least one rotational actuator configured to rotate the medical tool; a controller configured to operate at least one linear actuator and at least one rotational actuator and configured to operate at least one rotational actuator and at least one linear actuator simultaneously and independently of each other; and a processor configured to provide commands to the controller.

[0094] In some embodiments, the controller is configured for manual operation by a user.

[0095] In some embodiments, the controller includes an activation button selected from a push button, a slide button, a joystick, or any combination thereof.

[0096] In some embodiments, at least one linear actuator and at least one rotary actuator have one or more common actuators.

[0097] In some embodiments, at least one linear actuator includes an actuator selected from a DC motor, an AC motor, a stepper motor, an electromagnetic actuator, a piezoelectric actuator, a pneumatic actuator, a hydraulic actuator, or any combination thereof.

[0098] In some embodiments, at least one rotary actuator includes an actuator selected from a DC motor, an AC motor, a stepper motor, an electromagnetic actuator, a piezoelectric actuator, a pneumatic actuator, a hydraulic actuator, or any combination thereof.

[0099] In some embodiments, the medical device is disposable.

[0100] In some embodiments, the medical tool is selected from a guide wire, a microcatheter, a guide catheter, and a balloon catheter.

[0101] In some embodiments, the body lumen is selected from a blood vessel, a urethra, a stomach, and a trachea.

[0102] In some embodiments, the system comprises two movement control units, the first movement control unit is configured to linearly advance and / or rotate a first medical tool, and the second movement control unit is configured to linearly advance and / or rotate a second medical tool. In some embodiments, the first medical tool is a guide wire and the second medical tool is a catheter.

[0103] In some embodiments, the system is configured to automatically insert and advance a medical tool into a body lumen during a medical procedure.

[0104] In some embodiments, the medical procedure is selected from coronary, peripheral, and cerebrovascular procedures, gastric procedures, urinary tract procedures, and airway procedures.

[0105] In some embodiments, the system further comprises an imaging device.

[0106] In some embodiments, the imaging device is selected from an X-ray device, a fluoroscopy device, a CT device, a cone beam CT device, a CT fluoroscopy device, an MRI device, and an ultrasonic device.

[0107] According to aspects of some embodiments, a method for inserting and advancing a medical tool into a body lumen is provided, the method comprising the step of disposing a medical device on or proximate to a subject's body, the medical device comprising a housing configured to be disposed on or proximate to the subject's body and secured thereto, at least one actuator configured to linearly advance the medical tool, and at least one rotational actuator configured to rotate the medical tool, at least one movement control unit comprising the at least one rotational actuator and the at least one linear actuator being operable simultaneously and / or independently of each other; and advancing the medical tool into the subject's body lumen.

[0108] In some embodiments, the medical tool is selected from a guide wire, a microcatheter, a guide catheter, and a balloon catheter.

[0109] In some embodiments, the body lumen is selected from a blood vessel, a urethra, and a trachea.

[0110] In some embodiments, the advancement of the medical tool is automatically performed by the medical device.

[0111] According to one aspect of some embodiments, a medical device for inserting a medical tool into a body lumen is provided, the housing being configured to be placed on and fixed to the subject's body or in proximity to the subject, at least one linear actuator being configured to linearly advance the medical tool, at least one rotational actuator being configured to rotate the medical tool, the controller being configured to operate at least one linear actuator and at least one rotational actuator, and the controller being configured to operate at least one rotational actuator and at least one linear actuator simultaneously and independently of each other.

[0112] In some embodiments, the controller is configured for manual operation by the user.

[0113] In some embodiments, the controller is configured to receive commands from a processor.

[0114] In some embodiments, the controller is configured to receive commands from a wireless remote controller.

[0115] In some embodiments, the wireless remote is a Wi-Fi remote and a Bluetooth remote.

[0116] In some embodiments, at least one linear actuator and at least one rotary actuator have one or more common actuators.

[0117] In some embodiments, at least one linear actuator comprises at least one piezoelectric actuator.

[0118] In some embodiments, at least one rotary actuator includes at least one piezoelectric actuator.

[0119] Unless otherwise defined, all technical and / or scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention pertains. Although methods and materials similar or equivalent to those described herein can be used in the practice or testing of embodiments of the present invention, exemplary methods and / or materials are described below. In case of conflict, the patent specification, including definitions, will control. Further, the materials, methods, and examples are illustrative only and not intended to be limiting necessarily.

[0120] The implementation of the methods and / or systems of embodiments of the present invention can include performing or completing selected tasks manually, automatically, or a combination thereof. Further, depending on the actual instrumentation and equipment of the methods and / or system embodiments of the present invention, some selected tasks can be implemented by hardware, software, or firmware, or a combination thereof using an operating system.

[0121] For example, the hardware for performing a selected task according to an embodiment of the present invention can be implemented as a chip or a circuit. As software, a selected task according to an embodiment of the present invention can be implemented as a plurality of software instructions executed by a computer using any suitable operating system. In an exemplary embodiment of the present invention, one or more tasks according to an exemplary embodiment of the method and / or system described herein are executed by a data processor such as a computing platform for executing a plurality of instructions. Optionally, the data processor includes volatile memory for storing instructions and / or data, and / or non-volatile storage devices such as magnetic hard disks and / or removable media for storing instructions and / or data. Optionally, a network connection is provided as well. A display and / or user input devices such as a keyboard and a mouse are also optionally provided.

Brief Description of the Drawings

[0122] Some embodiments of the present invention are described herein by way of example only with reference to the accompanying drawings. Referring now particularly to the drawings in detail, it is emphasized that the details shown are by way of example and for purposes of illustrative discussion of embodiments of the present invention. In this regard, the description with reference to the drawings makes it apparent to those skilled in the art how embodiments of the present invention may be practiced.

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[0123] In some embodiments, the present invention relates to the automatic operation of an elongated surgical tool inserted into a body lumen.

[0124] In a broad aspect of some embodiments, it relates to a compact robotic device for manipulating the movement of an elongated surgical intraluminal tool that extends and curves outside a device housing. Some embodiments described herein relate to structural, functional, and / or design features suitable for manipulating a tool using a compact-sized robotic device whose dimensions are not affected by the length of the tool being manipulated. In some embodiments, the characteristics of the robotic device, such as volume, weight, etc., are dictated only by the electrical and mechanical components of the device and not substantially by the tool being operated.

[0125] One aspect of some embodiments relates to a compact robotic device shaped and sized to be mounted on a patient's body and / or on an operating table. In some embodiments, the volume of the device is less than 3000 cm 3 , 2800 cm 3 , 2500 cm 3 or an intermediate, larger, or smaller volume. In some embodiments, the weight of the device is less than 1000 grams, less than 850 grams, less than 500 grams, or an intermediate, larger, or smaller weight.

[0126] In some embodiments, the device comprises a plurality of actuation mechanisms for moving one or more extension surgical tools (e.g., guide wires, microcatheters), for example, for linearly advancing or retracting the tools and for rotating the tools. In some embodiments, the device housing encloses the actuation mechanisms, while the outside of the housing defines a plurality of inlet and / or outlet apertures and / or fixation sites for the tools. In some embodiments, a fixation site (e.g., a holder) to which the proximal end portion of the tool is coupled to the housing and an inlet aperture for the tool that communicates with the inside of the housing are aligned with respect to each other along a similar horizontal or vertical axis, such that a tool segment extending between the fixation site and the inlet aperture forms a bend outside the device housing. In some embodiments, the fixation site and the inlet aperture of the tool are defined on a similar face (or wall) of the device housing. In some embodiments, the inlet aperture and the outlet aperture for the same tool are configured on opposite walls of the housing, such that a tool entering the housing extends across the internal space defined by the housing to the outlet aperture.

[0127] In some embodiments, no device portion protrudes outwardly from the housing, and optionally, only the tools loaded in the device extend outwardly from the housing.

[0128] In some embodiments, the maximum dimension of the robot device housing (e.g., width, height such as within a box-shaped device) is a function of the distance between the exit opening and the entrance opening of a tool that curves externally with respect to the device. The distance between the exit opening and the entrance opening may be set, for example, according to the minimum radius of curvature that the tool can withstand. In one example, the maximum dimension of the device housing is between 2 to 6 times, 2 to 10 times, 2 to 5 times or intermediate, higher or lower multiples of the minimum radius of curvature of a tool that is operated by the device and curves outside the housing. The potential advantage of a device housing whose maximum dimension is determined according to the minimum radius of curvature of a tool that bends when exiting and re-entering the housing may include providing a compact and minimized-size housing. In one example, for a tool having a minimum radius of curvature X, the minimum distance between the entrance opening and the exit opening of the tool is 2X. In such a situation, the walls of the housing through which the tool enters and exits include, for example, widths of 2X, 2.1X, 3X, 5X or intermediate, larger or smaller dimensions.

[0129] In some embodiments, the minimum radius of curvature of the extension tool includes the maximum bend of the tool that allows the tool to still function, for example, allowing torque transmission along the length of the tool. In some embodiments, the minimum radius of curvature of the extension tool includes bends where the tool remains intact (e.g., not damaged).

[0130] In some embodiments, the exit and entrance openings from and to the housing are shaped, for example, by having a conical contour of the opening and / or a rounded lip, to reduce or avoid friction between the tool and the edge of the opening. The potential advantage of an opening formed without sharp edges may include reducing frictional contact between the tool and the wall of the housing, which can reduce the risk of wear or breakage of the tool, especially when the tool extends and bends externally to the housing before re-entering the housing.

[0131] In some embodiments, the shape and / or size of the housing is determined by mechanical and / or electrical components within the housing, such as a motor, a motor transmission (e.g., gears), and a tool actuation mechanism (e.g., a tool movement element such as a wheel). In some embodiments, the housing is sized to be as small as possible while completely containing the mechanical components therein. Optionally, the mechanical components of the robotic device do not protrude outward from the housing. Optionally, no additional mechanical parts are required from outside the housing to operate the tool. In some embodiments, the housing is shaped and configured such that only the elongating surgical tool extends in and out of the housing.

[0132] In some embodiments, the housing of the robotic device is not limited to a particular orientation, such that, for example, the housing can be arranged in at least a first direction and in a second direction, where the second direction is, for example, 90 degrees or 180 degrees relative to the first direction. In some embodiments, there is symmetry such that at least two opposing faces of the housing are similar in contour and size, allowing the device to be placed in one of two "flipped" orientations.

[0133] One aspect of some embodiments relates to a disposable robotic device for operating an elongating surgical tool. In some embodiments, the device is disposed (optionally, together with the tool it operates) following a surgical procedure. In some embodiments, the disposable device need not be covered by a sterile drape or cover. In some embodiments, no additional mechanical components are operably connected to the disposable robotic device to drive and / or operate the tool loaded therein. In some embodiments, the device is packaged and pre-sterilized, optionally using one or more pre-loaded tools. In addition to, or instead of, this, the tool is mounted on the device in the operating room.

[0134] In some embodiments, the tool mounted on the device is in direct operable contact with one or more tool moving elements that operate it. In some embodiments, the one or more tool moving elements are in direct operable contact with one or more motors. In some embodiments, the one or more motors and the one or more tool moving elements are housed within a single housing, and the housing, along with its contents, is discarded when the clinical procedure is complete. Optionally, there is no boundary element or barrier between the tool and its moving element and / or the drive motor within the housing. This enables, in some embodiments, the device to be discarded after use, thus avoiding the risk of contamination that could occur, for example, during reuse. Some potential advantages of a device in which the mounted tool can be in direct contact with the tool moving element (and / or other device components such as a motor) of the device include simplifying use, potentially shortening the mounting time, potentially improving the mechanical engagement with the tool (e.g., because no "edging" element is required), thereby reducing or avoiding unwanted tool movement such as slipping, twisting, or torsion of the tool.

[0135] In some embodiments, the device is constructed from a durable, lightweight, disposable, and optionally recyclable material such as plastic, aluminum, steel, copper, and / or other suitable metals.

[0136] One aspect of some embodiments relates to a dual-function assembly in which both linear and rotational movement (e.g., rolling) of an elongating tool occur at the same physical location. In some embodiments, the assembly is configured to move the tool linearly while the tool is being rotated, or to rotate the tool while the tool is being moved linearly.

[0137] In some embodiments, the assembly comprises an elongate shaft having a central lumen into which the tool is received. A set of wheels is disposed adjacent to the shaft, and each wheel extends at least partially into the central lumen and is operably in contact with the inside of the tool. In some embodiments, a motor that drives the rotation of the wheels is attached, for example, adjacent to the wheels and under the shaft. In some embodiments, the rotation of the wheels pushes or retracts the tool depending on the direction of rotation.

[0138] In some embodiments, the inner wall of the shaft that defines the central lumen is contoured to conform to the outer profile of at least some of the wheels. In such a configuration, the central lumen extends into the space between the wheels and serves to supply the tool in close contact with the wheels. In one example, in a four-wheel assembly, the inner wall of the shaft may be contoured to conform to at least one, two, three, or all four of the wheels at the central lumen segment closest to the contact point where the tool contacts the wheels.

[0139] In some embodiments, a gear that is coaxial with the shaft is connected along the shaft and / or at the proximal or distal end of the shaft, such that upon rotation of the gear, the shaft and wheel set are rotated by the gear as a single unit, thereby rolling a tool (e.g., a guide wire, an operable microcatheter) that is within the central lumen of the shaft.

[0140] The potential advantages of an assembly that drives the linear and rotational movement of a tool at the same physical location (such as a specific physical location within the device housing and / or a specific location of engagement with a tool) can include reducing or avoiding undesirable tool movements such as slippage, kinking, twisting, etc., which can occur, for example, when two separate mechanisms drive linear and rotational movement respectively, and the tool needs to extend to a location where such undesirable movement can occur. Another potential advantage is a compact design enabled by assigning two functions such as rotation and forward / backward movement of the tool to the same site.

[0141] Aspects of some embodiments relate to driving the rotation (roll) of an extensible tool at two spaced-apart engagement sites along the length of the tool using the same motor. In some embodiments, the tool is engaged at two or more points along the length of the tool, for example, at a proximal portion of the tool (e.g., adjacent to the handle of the tool), by an element that rotates the tool at a more distal portion. In an exemplary configuration, a first gear rotates a holder that holds the proximal portion of the tool, and then the rotation of the first gear rotates a second gear that is part of a linear movement assembly (as described herein), where the second gear rotates a shaft into which the more distal portion of the tool is received. In such an arrangement, the operation of a single motor drives the rotation of both the first and second gears, generating rotation (roll) of the tool at both engagement sites.

[0142] The potential advantages of using a single motor to drive rotational movement at two spaced-apart engagement sites along the length of a tool can include, for example, improved control over the tool compared to the use of two different motors for driving rotation at two positions, and the operating timing and / or speed and / or direction of the two motors need to be synchronized to ensure a uniform roll of the tool along its length.

[0143] In some embodiments, one or more tools operated by the device are engaged and manipulated only from their proximal portions (e.g., from the tool handle), while one or more additional tools are engaged at their more distal segments (i.e., not from the tool handle).

[0144] One aspect of some embodiments relates to controlling the usable length of an elongating surgical tool by modifying the curvature size of a tool outside a robotic device. In some embodiments, a tool operated by the device extends (bends) one or more times outside the housing. In some embodiments, when the length of a more distal segment (e.g., a tool segment extending between an exit opening from the device housing and a target within a patient's body) changes, the curved portion expands or contracts in size. In some embodiments, the tool enters and exits the device housing several times, forming multiple curves outside the housing. For example, a guide wire is optionally curved independently once or twice between a proximal handle and a distal portion while received within the lumen of a curved microcatheter. In some embodiments, the curved portion is a "U" - shaped curve, which can be modified, for example, by making the distance of the maximum point of the "U" - shape longer or shorter relative to the closest wall of the device housing.

[0145] According to some embodiments, the present invention relates to an automated device for inserting an elongating surgical medical tool into a body lumen, and more particularly, to a body - mountable automated device for inserting an elongating surgical medical tool, such as a guide wire and a microcatheter, into a blood vessel.

[0146] Many medical procedures, such as catheterization for diagnostic and / or therapeutic purposes, require the insertion of a catheter into a patient's blood vessels and other body lumens.

[0147] Typically, a physician first inserts a guidewire into an artery, such as the femoral artery or vein, and navigates the guidewire through the tortuous vasculature until it reaches a target, which can be the heart, artery, peripheral vessels, brain, etc. Once appropriately positioned, the physician places a catheter over the guidewire and pushes the catheter until it also reaches the target. In some cases, this procedure requires the use of a catheter with a small radius, typically known as a microcatheter. In such cases, the physician can insert the microcatheter directly without using a guidewire. Manual insertion and navigation of a guidewire / microcatheter through a tortuous vasculature is not only difficult for the physician, but can also be dangerous for the patient as even a slight mismovement can result in an unintended perforation of the vessel wall. Additionally, manual procedures require the physician and additional medical staff to be present in the procedure room throughout the procedure. Since most invasive procedures are performed under imaging such as X-ray, CT, etc., medical staff as well as patients are exposed to radiation.

[0148] Remote-operated automated (robotic) devices have been developed in recent years, but existing robotic devices are cumbersome and expensive. Therefore, there is a need for a small, inexpensive, and easy-to-use automated device for inserting a guidewire and / or microcatheter into a body lumen such as a blood vessel and navigating it to a target area.

[0149] According to some embodiments, the insertion device can include a power source. In some embodiments, the power source may be a battery, a power supply, etc. In some embodiments, the battery is disposable. In some embodiments, the battery is reusable. In some embodiments, the battery is rechargeable. In some embodiments, the power source may be directly or indirectly connected to a main power source. In some embodiments, the insertion device may include one or more printed circuit boards (PCBs) configured to relay / process / convey commands and / or electrical connections between various components of the device.

[0150] According to some embodiments, the insertion device may enable linear and / or rotational advancement / movement of a medical instrument. In some embodiments, the insertion device can be configured to automatically advance the insertion device and / or further automatically enable its rotational movement by rotating the insertion device. In some embodiments, when the medical tool is a guide wire, the insertion device may be capable of controlling the linear and / or rotational and / or tip parameters of the guide wire. In some embodiments, when the medical tool is a guide wire, the insertion device may be capable of automatically and / or remotely controlling the linear and / or rotational and / or tip parameters of the guide wire. In some embodiments, the medical instrument may be pre-mounted on the medical device before being used for a medical procedure. In some embodiments, the medical instrument may be pre-loaded on the medical device before being placed on the subject's body.

[0151] According to some embodiments, there is provided an insertion device configured to remotely and automatically linearly advance one or more medical tools (such as guide wires and catheters) into and within a body lumen, such as a blood vessel, for intravascular procedures, including coronary, peripheral, and cerebrovascular intravascular procedures. In some embodiments, the insertion device is configured to further automatically and / or remotely control / enable the rotational movement of one or more medical tools. In some embodiments, the insertion device is further configured to control parameters of one or more medical tools, such as tip stiffness. In some embodiments, the device is configured to control the force applied by the distal tip of the tool, for example, by controlling one or more of the tool's advancement speed, tool stiffness. Optionally, the tool is operated such that its distal tip applies a constant or varying force to a structure (such as tissue, e.g., a blood vessel wall) that the tip encounters.

[0152] According to some embodiments, an insertion device is provided that is configured to remotely and automatically linearly advance one or more medical tools (such as guidewires and catheters) linearly within a body lumen for various intraluminal procedures. According to some embodiments, when the first tool is a guidewire and the second medical tool is a catheter, the insertion device can enable linear, rotational, and / or tip parameter control of the guidewire, as well as linear movement of the catheter (on the guidewire) and its rotational movement (with respect to the insertion device).

[0153] According to some embodiments, the linear speed of advancement of the medical instrument may be in the range of about 0 to 100 mm / second, or any sub-range thereof. In some exemplary embodiments, the linear speed of the medical instrument may be in the range of about 0 to 50 mm / second, 1 to 100 mm / second, 5 to 50 mm / second, or intermediate, higher, or lower speed ranges. The speed may be constant and / or variable increments and may be adjusted (manually and / or automatically) during the procedure. In some embodiments, the speed may be in the range of about 0 to 25 mm / second and may be in increments of about 0.1 mm / second. In some embodiments, the speed may be in increments of about 1 mm / second and in the range of about 25 to 50 mm / second. In some embodiments, the position holding stability in the actuator is about 0.1 mm. According to some embodiments, the rotational movement may be anywhere in the range of 360 degrees.

[0154] According to some embodiments, the rotational movement may be continuous in the range of 360 degrees. In some embodiments, the total number of rotations may be limited. In some embodiments, the total number of rotations may be limited to about 5 to 10 rotations in each direction from a neutral (starting) setting.

[0155] According to some embodiments, the rotational position resolution may be 1 to 5 degrees, 0.5 to 10 degrees, 0.1 to 1 degree, or increments of higher or lower resolution. In some exemplary embodiments, the rotational position resolution may be about + / -2 degrees, + / -1 degree, + / -0.5 degrees or increments of higher or lower resolution.

[0156] According to some embodiments, the controller of the device may be a remote controller. In some embodiments, the controller of the device may be integrated with the device. In some embodiments, the controller of the device may be connected by wired or wireless means. In some embodiments, the controller may be configured to enable control over the operation of the medical device. In some embodiments, the controller may be configured to enable control over the advancement of the medical instrument, including but not limited to the forward linear direction, forward speed, forward increment, rotational movement, degree of rotational movement, etc., or any combination thereof. In some embodiments, the controller may include one or more operation buttons. In some embodiments, the buttons may include pressure buttons, slider buttons, joysticks, etc., or any combination thereof. In some embodiments, the system may have means for injecting a contrast agent into a lumen, such as the vascular system. The injection mechanism may be remotely operated to enable a surgeon / physician to perform the entire procedure from a remote location. In some embodiments, the system may be configured to control the linear and / or rotational movement of a guide catheter when used in a procedure.

[0157] As referred to herein, a "robotic device" or "device" can refer to a device housing that includes mechanical and / or electrical components housed within the housing. In some embodiments, a "device" does not cover add-on or external components such as a guide catheter drive unit (when externally coupled to and not integrated within the housing), device attachment, remote control of the device, etc.

[0158] Before describing in detail at least one embodiment of the present invention, it should be understood that the present invention is not necessarily limited to the details of the construction and arrangement of the components and / or methods described in the following description and / or shown in the drawings and / or examples in its application. The present invention is capable of other embodiments and can be practiced or carried out in various ways.

[0159] Before describing in detail at least one embodiment of the present invention, it should be understood that the present invention is not necessarily limited to the details described in the following description or illustrated by the examples in its application. The present invention is capable of other embodiments and can be practiced or carried out in various ways.

[0160] Refer to FIG. 1, which shows a schematic diagram of an exemplary medical system according to some embodiments. As shown in FIG. 1, the system 2 includes a small automatic insertion device 4 attachable to the body, configured to insert a medical instrument, such as a guidewire 6, into a lumen (such as a blood vessel) of a subject 8. According to some embodiments, depending on the location of the target tissue (e.g., heart, peripheral blood vessels of the lower extremities, brain, liver, etc.) and the purpose of the treatment, the entry point can be selected from the patient's groin (i.e., femoral artery), arm (i.e., radial artery), or neck (i.e., jugular vein), but is not limited thereto. Thus, the position of the insertion device 4 on the patient's body can vary. In the example shown in FIG. 1, the device is attached to the patient's thigh to enable access to the patient's femoral artery. It can be understood that the device may be additionally or alternatively attached to the patient's arm or any other desired location on the patient's body, depending on the selected entry point. According to some embodiments, the device may be attached / implemented / fixed to the patient's body using any suitable attachment element. For example, the device can be attached to the patient's body using a band, which can be pulled up the patient's leg to the thigh. The band may be flexible to stretch along the circumference of the thigh, or may be substantially rigid or semi-flexible and may include a length adjustment mechanism. Alternatively, one or more straps may be directly wrapped around the patient's thigh. Such a strap may have a length adjustment mechanism and may be substantially rigid or semi-flexible, with a connector (e.g., buckle) at the opposite end to secure the strap and fix it to the patient's thigh. The band / strap can include one or more sensors, such as a force sensor disposed thereon.

[0161] According to some embodiments, the insertion device is not body-wearable, but is configured to be disposed in proximity to the patient's body using, for example, a robotic arm, a base structure configured to be fixed to the patient's bed, etc.

[0162] In some embodiments, the insertion device may be disposable, i.e., some of its components may be discarded and replaced during the procedure, partially, or the entire insertion device may be discarded after the procedure is completed, i.e., completely. In other embodiments, the insertion device may be reusable so that it can be used repeatedly with new medical instruments (e.g., guidewires and / or catheters).

[0163] In some embodiments, the device may be configured to be used to insert various different medical instruments of various lengths and diameters, including, for example, guidewires, catheters, microcatheters, etc., into a body lumen. In some exemplary embodiments, without limitation, the device may be adapted to insert a guidewire as disclosed in U.S. Patent No. 9,586,029, Issue 15, entitled "Guidewire Having Selectively Adjustable Stiffness and Tip Curvature," and / or U.S. Patent Application Publication No. 2018 / 214,675, co-owned, entitled "Double Concentric Guidewire" (both of which are incorporated herein by reference in their entirety by Shekalim et al.) into a blood vessel.

[0164] According to some embodiments, the system may further include a controller 10 for controlling the operation of the device, in particular, the insertion and / or manipulation of a medical instrument (e.g., a guidewire and / or a catheter) towards a target (e.g., a heart chamber, an occluded artery, etc.). The controller 10 may be coupled to the insertion device 4 via a wired or wireless connection, may be manually operated by a physician (e.g., the controller may be in the form of a joystick), or may be automatically operated using dedicated software. In the latter case, the system may further comprise a computer 12 that can include at least one processor, a user interface, and a display. The computer 12 may be a personal computer, a laptop, a tablet, a smartphone, or any other processor-based device. In some embodiments, the controller 10 is disposable. In some embodiments, the controller 10 is reusable. In some embodiments, the controller 10 is configured to interact / couple with two or more insertion devices.

[0165] In some embodiments, system 2 may further include an imaging device or may be used in conjunction with an imaging device. The image modality utilized can be any of fluoroscopy, CT, cone beam CT, CT fluoroscopy, MRI, ultrasound, or any other suitable image modality. According to some embodiments, the insertion device may be capable of linearly advancing a medical instrument within a body lumen. In some embodiments, the device may be capable of rotating a medical instrument within the lumen instead of or in addition to linearly advancing the medical instrument. In some embodiments, the device may be capable of separately and / or simultaneously rotating a medical instrument within a blood vessel while linearly advancing the medical instrument. For example, in some exemplary embodiments, the insertion device may be capable of linearly advancing a guidewire and / or catheter within a blood vessel. In some embodiments, the device may be capable of rotating a guidewire and / or catheter within a blood vessel instead of or in addition to linearly advancing the guidewire and / or catheter. In some embodiments, the device may be capable of separately and / or simultaneously rotating a guidewire and / or catheter within a blood vessel while linearly advancing the guidewire and / or catheter. According to some embodiments, as further illustrated herein, the insertion device is configured to enable linear advancement of a medical instrument along a rotational movement of the medical instrument by utilizing one or more actuators that more advantageously enable smooth movement of the medical instrument without deforming the medical instrument (i.e., without creating tension or torsion along the length of the medical instrument). According to some embodiments, as further illustrated herein, the linear and rotational movements of a medical instrument (such as a guidewire and / or microcatheter) may be generated by separate actuators or by one or more dual-purpose actuators configured to enable both rotational and linear movement of the instrument.

[0166] Referring now to FIGS. 2A-2B, which show schematic perspective views (front and rear views, respectively) of an insertion device according to some embodiments. As shown in FIG. 2A, the insertion device includes elements for advancing a first medical instrument (shown as guidewire 22) in a linear direction and optionally in a rotational direction (indicated by the movement arrow). As shown in FIG. 2A, the proximal end of guidewire 22 may be fixed to a dedicated holder 34, which may further enable control of the tip parameters of guidewire 22 as described below. Guidewire 22 advances from a first opening 35 (front face of device 20) within the holder, enters insertion device 20 through a second opening 36, and exits device 20 again through a different opening (a first rear opening not shown) on the back (rear) face of device 20. The guidewire 22 can then re-enter the insertion device 20 through another opening (a second rear opening (not shown)) on the rear face of device 20 and exit the insertion device 20 again through a third (front) opening 37, such that the distal end 24 of guidewire 22 can be configured to be inserted into the body of the subject, more specifically, into a body lumen such as a blood vessel, after exiting the third opening 37.

[0167] In some embodiments, as shown in FIG. 2A, the guide wire 22 exits the insertion device 20 into the lumen of a second medical instrument (shown as catheter 32) that can be connected / attached / associated with the first rear opening, re-enters the insertion device 20 through the second rear opening, and exits from the front face of the insertion device 20 through the third front opening 37. In some embodiments, the second medical instrument is configured to be inserted into a body lumen. In some embodiments, the second medical instrument (e.g., catheter 32) may be inserted into the body lumen together with and / or subsequent to the advancement of the first medical instrument (e.g., guide wire 22) by the automated medical device 20. The above-described routing of the guide wire 22 and / or catheter 32 enables a compact spatial arrangement (e.g., side-by-side) of the movement control unit (described below), and thus minimizes the overall size of the device. In some embodiments, the paths (e.g., shafts) through which the tools extend within the housing are arranged side-by-side and optionally parallel to each other. The lateral alignment in which the movement actuating mechanisms are substantially arranged side-by-side can provide a smaller device size, such as a thinner device width.

[0168] In some embodiments, the small size of the device enables the device to be placed on the subject's body.

[0169] In some embodiments, the medical device 20 includes one or more actuators / elements configured to enable linear and / or rotational movement / advancement of the medical instrument. In some embodiments, as shown in FIG. 2A, the device 20 includes a first movement control unit 26 configured to enable linear and / or rotational movement of the guide wire 22. The first movement control unit 26 may include one or more actuators / motors that enable movement of the guide wire 22, as will be described in further detail below. The device 20 can further include a second movement control unit 28 configured to enable linear and / or rotational movement of the catheter 32. The second movement control unit 32 can include one or more actuators / motors that enable movement of the catheter 32, as will be described in further detail below.

[0170] Optionally, the device 20 can further include at least one additional movement control unit, for example, as disclosed in U.S. Patent Application Publication No. 2018 / 214,675 mentioned above, for example, when the guide wire is composed of a hollow outer wire and an inner wire disposed within the lumen of the outer wire. In such a case, an additional movement control unit 29 can be used to enable control of the movement of the inner wire of the guide wire 22 relative to the outer wire of the guide wire 22 and to control the tip parameters of the guide wire 22 such as stiffness and / or curvature. The movement of the inner wire relative to the outer wire can be achieved by an adjuster / slider 33 attached to the inner wire, a non-rotating nut 30, and a parent screw 31 threaded therein. Rotation of the screw 31 by a motor / actuator causes linear movement of the nut 30 along the length of the parent screw 31, which in turn causes linear movement of the adjuster / slider 33 and the inner wire attached thereto. In some embodiments, the movement control unit 29 can enable one or more of the following relative states between the inner wire and the outer wire of the guide wire 22. 1) The distal tip of the inner wire extends distally beyond the distal tip of the outer wire. 2) The distal tip of the inner wire is translated proximally so as to be present within the outer wire (i.e., the distal tip of the outer wire extends beyond the distal tip of the inner wire), and / or 3) The distal tips of the inner wire and the outer wire are aligned. In some embodiments, the rotation of the guide wire 22 and the holder 34 to which it is attached can be controlled by the movement control unit 26 at its proximal end. In some embodiments, to prevent twisting / kinking of the guide wire 22 (so that the guide wire 22 cannot rotate relative to the holder 34) and to ensure that the holder 34 rotates smoothly with the guide wire 22, the movement control unit 29 includes, for example, an additional actuator / motor coupled to the proximal end of the holder 34 and can further control the rotation of the holder 34.

[0171] Referring now to FIG. 2B, which shows a rear perspective view of the insertion device 20. As shown in FIG. 2B, the insertion device 20 includes elements / units for advancing a first medical instrument (shown as guide wire 22) in a linear direction and optionally in a rotational direction (indicated by the movement arrow). As shown in FIG. 2B, the proximal end of the guide wire 22 can be fixed to a dedicated holder 34. The guide wire 22 enters the holder 34 (front of the device) from the first opening 35, enters the insertion device 20 through a second opening (not shown in FIG. 2B), and exits the insertion device 20 again through the first rear opening 38 on the rear (back) surface of the device 20. The guide wire 22 then re-enters the insertion device 20 through the second rear opening 39 on the rear surface of the device 20, and then exits the insertion device 20 again through a third (front) opening (not shown in FIG. 2B), such that the distal end 24 of the guide wire 22 can be configured to be inserted into the subject's body, more specifically into a body lumen such as a blood vessel, after exiting the third opening.

[0172] In some embodiments, as shown in FIG. 2B, the guide wire 22 can exit the insertion device 20 into the lumen of another second medical instrument (shown as catheter 32) that can be connected / attached / associated with the first rear opening 38, re-enter the insertion device 20 through the second rear opening 39, and exit the front of the insertion device 20 through the third front opening. In some embodiments, the second medical instrument 32 is configured to be inserted into a body lumen. In some embodiments, the second medical instrument (e.g., catheter 32) may be inserted into the body lumen along with and / or subsequent to the advancement of the first medical instrument (e.g., guide wire 22) by an automated medical device.

[0173] Referring now to FIGS. 3A - 3B, which show a schematic perspective top view of an insertion device according to some embodiments. As shown in FIG. 3A, the insertion device 50 includes a casing 52 and a top cover 53, which are shown in an open configuration. Further, a holder 54 is shown that holds the proximal end of the guide wire 58 and, in some embodiments, may further enable adjustment of the tip parameters of the guide wire 58. In some embodiments, the top cover 53 is intended to allow access 14 to the holder 54, and in this way the holder 54 can attach, insert into, and / or remove the guide wire 58 from the casing 52. As shown in FIG. 3A, the guide wire 58 enters through a first front opening 55 in the holder 54, enters the casing 52 through a second front opening 56, and may exit the casing 52 again through a first rear opening (not shown) on the back of the casing. The guide wire 58 may then re - enter the casing through a second rear opening (not shown) on the rear surface of the casing 52 and exit the casing 52 again through a third front opening 57. In some embodiments, as shown in FIG. 3A, the guide wire 58, while exiting the first rear opening of the casing 52, may be screwed into the lumen of another medical device (shown as catheter 62) that can be connected / attached / associated with the first rear opening, re - enter the casing 52 through the second rear opening, and exit the front surface of the casing 52 through the third front opening 57. In some embodiments, the second medical device 62 is configured to be inserted into a body lumen. In some embodiments, the second medical device (e.g., catheter 62) may be inserted into the body lumen together with and / or subsequent to the advancement of the first medical device (e.g., guide wire 58) by an automated medical device, i.e., the guide wire 58 may serve as a rail for the catheter 62 to ride on.

[0174] The above-described winding paths of the guide wire 58 and / or the catheter 62 enable a compact spatial arrangement of the movement control unit of the device 50, as described below, and thus minimize the overall size of the device. Due to the small size of the device, in some embodiments, it becomes possible to place the device 50 on the subject's body. In some embodiments, the medical device includes one or more actuators / elements / units configured to enable linear and / or rotational movement / advancement of the first and second medical instruments.

[0175] Referring to FIG. 3B, which schematically shows the medical device of FIG. 3A with the top cover 53 and the upper part of the casing 52 removed. As shown in FIG. 3B, the device 50 may include a first movement control unit 66 configured to enable linear and / or rotational movement of the guide wire 58. The device 50 can further include a second movement control unit 68 configured to enable linear and / or rotational movement of the catheter. The first movement control unit 66 and the second movement control unit 68 can each include one or more actuators / motors, gears, rack shafts, rotating screws that enable movement (linear and / or rotational) of the guide wire and / or the catheter, as will be described in more detail below. In some embodiments, the device 50 may include one or more additional movement control units. For example, if the guide wire is fixed to the holder 54 at its proximal end, the device 50 can further include a movement control unit having at least a motor / actuator and a gear 65 that controls the rotation of the holder 54 about its axis.

[0176] As shown in FIG. 3B, the guide wire 58 includes a hollow outer wire and an inner wire disposed within the lumen of the outer wire. The device is attached to the adjuster / slider 61 of the holder and includes a non-rotating nut 63 rigidly attached to the proximal portion of the inner wire and a parent screw (not shown) threaded into the nut 63 and enabling control of the movement of the inner wire relative to the outer wire. Thus, the tip parameters of the guide wire are controlled (e.g., its stiffness and / or curvature is adjusted). Rotation of the parent screw by a motor / actuator (not shown) causes linear movement of the nut 63 along the length of the parent screw, which in turn causes linear movement of the adjuster / slider 61 and the inner wire attached thereto.

[0177] In some embodiments, one or more of the following relative states between the inner and outer wires of the guide wire may be enabled by the movement control unit described above. 1) The distal tip of the inner wire extending distally beyond the distal tip of the outer wire, 2) The distal tip of the inner wire translated proximally so as to be disposed within the outer wire (i.e., the distal tip of the outer wire extending beyond the distal tip of the inner wire), and / or 3) The distal tips of the aligned inner and outer wires.

[0178] Here, refer to FIGS. 4A - 4B showing perspective cross - sectional views of the insertion device of FIGS. 3A - 3B according to some embodiments. FIG. 4A shows a longitudinal cross - sectional view of the insertion device 50 (shown in FIGS. 3A - 3B), cut along a line between the first movement control unit (66 in FIG. 3B) and the second movement control unit (68 in FIG. 3B). As shown in FIG. 4A, the first movement control unit 66 includes at least one motor (shown as motor 75) and a shaft 76 through which a first medical instrument (shown as guide wire 58) is moved. Also shown are gears (such as exemplary gear 78). Further, a movement element 80 is shown. As will be described in more detail below, the movement element 80 includes at least two opposing circular disks / wheels / rings that are arranged one on top of the other and / or adjacent to each other on top of the other and have a space therebetween, such that the medical instrument (shown as guide wire 58) is disposed in this space.

[0179] Furthermore, shown in FIG. 4A is a rear - end opening 82 through which the guide wire 58 can exit the device, for example, into a catheter lumen configured to be connected to the rear - end opening. Here, refer to FIG. 4B showing a longitudinal cross - section of the first movement control unit 66.

[0180] As shown in FIG. 4B, the moving element 80 includes two opposing spinning wheels / discs / rings (86A, 86B) that are arranged such that one is above the other and / or above one adjacent to the other, with a space therebetween. A guide wire 58 is disposed within the space formed between the wheels, facilitating linear movement towards the rear opening 82 of the guide wire 58 within the shaft 76 when the wheels spin (e.g., actuated by various interconnected gears). By controlling the speed during spinning, the forward speed of the guide wire 58 can be controlled. In some embodiments, the movement control unit 66 and / or the moving element 80 can be rotated along the longitudinal axis, thereby further enabling rotational movement of the guide wire 58. In some embodiments, the wheels may be the same or different in size, shape, rigidity, material, or composition.

[0181] As further seen in FIGS. 4A - 4B in some embodiments, the tool forms an opening through which it passes inside and / or outside the housing, reducing the friction between the tool and the housing wall. For example, the opening 81 (through which the guide wire 48 re - enters the housing) defines a conical protrusion that terminates in a rounded lip. A potential advantage of the housing opening, having a rounded shape and no sharp corners, may include reducing the friction between the tool and the housing wall, thereby potentially reducing the risk of tool breakage or wear (e.g., due to the tool rubbing against the wall). This can be particularly advantageous for the devices described herein where the tool extends outside the housing and curves, and thus is more likely to contact the opening wall compared to, for example, a tool that is held only along a single straight - line axis.

[0182] Referring now to FIG. 5, which shows a schematic perspective top view of a movement control unit of an exemplary insertion device according to some embodiments. As shown in FIG. 5, the insertion device 100 includes a number of movement control units. The first movement control unit 110 is configured to enable the advancement of the guide wire 108, which is later re-inserted into the insertion device (as detailed above). The second movement control unit 120 is configured to enable the advancement of a second medical tool (catheter) while being screwed through the lumen of the second medical tool (catheter) through a second rear opening and towards the front face of the insertion device (through a corresponding front opening) after the guide wire 108 has re-entered the insertion device. An optional third movement control unit 102 is configured to enable the control of the rotation of the holder 104, where the holder 104 is used to hold the proximal ends of 30 guide wires 108 depending on the type of guide wire being used, and to prevent the twisting / tangling / kinking of the guide wire 108 while the guide wire is being rotated.

[0183] As shown in FIG. 5, the first movement control unit 110 may include a channel / shaft 113 through which the guide wire 108 passes and a movement element 114. Further, a motor 111 and one or more gears (a representative gear 112 is shown) are shown, which enable the control of the operation of the movement control unit 110. The movement element 114 can include a rotating disk / ring / wheel 115 arranged to contact the guide wire 108, such that the guide wire 108 can advance linearly along its path during its spin / rotation. The guide wire 108 can be pushed towards the rotating disk / ring / wheel 115 by a spring / screw with a pre-incorporated pinion. In some embodiments, the guide wire is pushed out towards the rotating disk / ring / wheel 115 by a pair of springs / screws with pre-incorporated pinions.

[0184] As shown in FIG. 5, the groove facing the wheel 115 may be a groove that forms a bent portion within the guide wire 108. The bent portion incorporated in the path of the guide wire increases the perpendicular distance of the line of action of the force from the axis of rotation, which would be equal to the radius of the guide wire if the guide wire followed a straight path, and thus can provide sufficient rotational moment (torque) to the thin guide wire without applying a high perpendicular force to the guide wire.

[0185] As further shown in FIG. 5, the channel / shaft 113 has an opening / slit 116 along its length, which allows access to the guide wire 108 and, further, may allow the placement / removal of the guide wire 108 as needed. In some embodiments, the first movement control unit 110 may rotate about an axis (e.g., by controlling the actuator 118), thereby enabling rotational movement of the guide wire 108 (and the holder 104). When the rotational movement is actuated, the opening 113 can face in a different direction accordingly.

[0186] As further shown in FIG. 5, the second movement control unit 120 includes at least one channel 123 through which a medical device passes and a moving element 124. The moving element 124 can include a rotating disk / ring / wheel 125 that contacts a medical device (e.g., a catheter into which a guide wire is screwed) disposed within the channel 123, whereby the medical device can proceed along its path.

[0187] As shown in FIG. 5, the channel 123 has an opening / slit 126 along its length to allow access to the medical device and, if necessary, further allow the placement / removal of the medical device. In some embodiments, the second movement control unit 120 may be configured to rotate about its axis, thereby enabling rotational movement of the second medical device (e.g., a catheter).

[0188] As further shown in FIG. 5, optionally, the third movement control unit 102 may include at least one gear 130 and may enable rotation of the holder 104. In some embodiments where the guide wire 108 comprises a double concentric guide wire (i.e., an inner wire disposed within the lumen of an outer hollow wire), the apparatus 100 may further include an actuator / element that enables control of the relative movement between the inner and outer wires of the guide wire so as to control parameters (e.g., stiffness and / or curvature) of the tip of the guide wire. In some embodiments, the apparatus includes a non-rotating nut 103 attached to a regulator / slider of the holder 104 that is firmly attached to the proximal end of the inner wire, and a parent screw 105 threaded into the nut 103, enabling control of the movement of the inner wire relative to the outer wire, and thus enabling control of the tip parameters (e.g., adjustment of its stiffness and / or curvature) of the guide wire. Rotation of the parent screw 105 causes linear movement of the nut 103 along the length of the parent screw 105, which in turn causes linear movement of the regulator / slider and the inner wire attached thereto.

[0189] In some embodiments, one or more of the following relative states between the inner and outer wires of the guide wire may be enabled by the above-described movement mechanism. 1) The distal tip of the inner wire extending distally beyond the distal tip of the outer wire, 2) The distal tip of the inner wire translated proximally so as to be disposed within the outer wire (i.e., the distal tip of the outer wire extending beyond the distal tip 20 of the inner wire), and / or 3) The distal tips of the aligned inner and outer wires.

[0190] Now, refer to FIG. 6A, which shows a schematic perspective view of an exemplary insertion device according to some embodiments. As shown in FIG. 6A, the insertion device 150 can include a housing (shown as translucent housing 158) that houses a movement control unit 156 configured to advance a medical instrument (such as guide wire 154) linearly and, optionally, with a rotational movement. As shown in FIG. 6A, the proximal end of the guide wire 154 can be fixed to a dedicated holder 152 that can further enable control of the tip parameters of the guide wire 154. The guide wire 154 can proceed from the holder 152, enter the insertion device through an opening, and exit the device again through a different opening on the opposite side of the device. In some embodiments, the guide wire 154 can exit the insertion device 150 and enter the lumen of another medical instrument (such as a catheter) that can be connected / attached / associated with the opening of the device.

[0191] Next, refer to FIG. 6B, which shows a perspective view of the movement control unit 156. As shown in FIG. 6B, the movement control unit 156 can include a shaft / channel 162 through which a medical tool (such as guide wire 154) can pass / advance. The movement control unit 156 further includes a linear drive device (168) for the medical instrument and, optionally, a rotational drive device (164). The movement control unit 156 may further include a slip ring 160 configured to enable rotational movement. The movement control unit 156 may further include one or more rotational / rotational elements (such as wheels and gears) configured to mediate the mechanical movement of various moving parts, as detailed below. Next, refer to FIG. 6C, which shows a side view of the movement control unit 156. Shown in FIG. 6C are the shaft 162, the guide wire 154, the rotational drive device 164, and the slip ring 160.

[0192] Now, refer to FIG. 7. FIG. 7 shows a longitudinal cross-sectional view of the linear drive device 168 of the movement control unit shown in FIG. 6C, essentially along the center of the shaft 162.

[0193] As shown in FIG. 7, the linear drive device 168 can include at least two rings / wheels / disks (170A, 170B) that are placed / located / installed one above the other and have a restricted space therebetween. A medical instrument (such as the guide wire 154) is configured to pass through the tight space between the wheels 170A and 170B, and the guide wire that is at least partially in contact with both wheels during the spin / rotation of the wheels is adapted to move linearly forward.

[0194] In some embodiments, the wheels / rings / disks 170A and 170B may be identical in size, shape, composition, or form. In some embodiments, the wheels / rings / disks 170A and 170B may differ in size, shape, composition, rigidity, material, or form. In some embodiments, the space between the wheels 170A and 170B is formed as a groove so that the medical instrument 154 can bend slightly, enabling better rotation of the medical instrument. A potential advantage of the bend incorporated within the path of the guide wire includes increasing the perpendicular distance of the line of action of the force from the axis of rotation (which would be equal to the radius of the guide wire if the guide wire follows a straight path), and thus may include enabling sufficient rotational moment (torque) to be applied to a thin guide wire without applying a high perpendicular resistance force to the guide wire.

[0195] Next, refer to FIG. 8, which schematically shows a movement control unit according to some embodiments. As shown in FIG. 8, the movement control unit is configured to enable linear forward and / or rotational movement of a medical instrument (such as the guide wire 202). In some embodiments, the medical instrument 202 can move forward along a path defined, for example, by a channel or a shaft (shown as the channel 204). To enable linear movement of the medical instrument 202, the movement control unit may include a linear drive element 200 that can include two or more spin / rotation elements shown as wheels / disks / rings 206A and 206B in FIG. 8.

[0196] As shown in FIG. 8, wheels can be arranged side by side to form a tight space therebetween. The medical instrument 202 may be passed between the wheels so that it can pass under the first wheel 206A and over the second wheel 206B and can form a shape or substantially a shape. In this way, since the medical instrument 202 is at least partially in contact with the wheels, the spin / rotation of the wheels in opposite directions causes the instrument 202 to move linearly forward. The relative rotational directions of the wheels 206A and 206B can determine the direction of the linear movement of the medical instrument 202.

[0197] In some embodiments, the movement control unit can further include a rotational drive element 210 that enables rotation of the linear drive element 200 and thus the medical instrument 202 (e.g., in direction 212) engaged therein. By utilizing the winding of the medical instrument around the wheels in an S-shaped path as detailed above, the medical instrument can rotate freely about its axis without slipping and without forming a bend along its length. In some embodiments, the movement control unit is positioned / placed on a platform (shown as platform 214) to enable free rotation of the unit.

[0198] Refer to FIGS. 9A-9B showing a moving unit for linear forward and / or rotational movement of a medical instrument according to some embodiments. In some embodiments, as shown in FIGS. 9A-9B, the linear and / or rotational movement of the guide wire may be generated by a piezoelectric actuator. The piezoelectric element is composed of a ceramic material that changes its geometric dimensions as a function of the applied voltage. The piezoelectric element can be activated, for example, at a high frequency of 50-150 kHz and can generate a relatively large force that is linearly correlated with the degree of elongation (stroke) of the element. Using piezoelectric actuators in an automated medical device is advantageous because their operation does not generate magnetic fields that are undesirable in medical applications. Further, piezoelectric actuators are MRI compatible. In some embodiments, other types of actuators, such as electromagnetic actuators (solenoids), DC motors, stepper motors, or AC motors, may be used.

[0199] According to some embodiments, the insertion device may include two separate parts / units, namely, a first part for generating linear movement (hereinafter also referred to as the "linear part") and a second part for generating rotational movement (hereinafter also referred to as the "rotational part"), enabling each type of movement, namely, linear and rotational, to be generated independently of each other. A combined movement, namely, simultaneous rotation and linear forward movement, can be generated by activating the two parts in an ordered or alternating manner.

[0200] In some embodiments, the linear portion may be in the form of an inchworm motor and may include three piezoelectric actuators as shown in FIG. 9A. Piezoelectric actuators 301 and 303 are used to grip a medical device 304 (e.g., a guide wire), and movement is achieved by piezoelectric actuator 302 that extends (long) and relaxes (short) along the vertical axis upon power supply, causing the medical device to extend and contract along the horizontal axis upon power supply. In some embodiments, piezoelectric actuator 301 and / or 303 may include a single actuator that presses the guide wire 304 against a static element when extending to grip the guide wire 304. In other embodiments, piezoelectric actuator 301 and / or 303 are in fact a pair of piezoelectric actuators disposed on both sides of the guide wire 304, such that they extend and relax to grip and release the guide wire 304, respectively. The operating process of the linear portion is a periodic process. To move the device 304 from left to right, for example, piezoelectric actuator 303, which is the piezo of the front clutch in this example, is first extended to grip the device as shown in FIG. 9A. Next, piezoelectric actuator 302, the lateral piezo, is extended, such that piezoelectric actuator 1003 moves a short distance to the right with the device. Note that the center of piezoelectric actuator 302 is fixed such that its extensions are symmetric on both sides, left and right, when power is supplied to piezoelectric actuator 302. In this example, piezoelectric actuator 301, which is the piezo of the rear clutch, is in a relaxed state and does not grip the device at this process stage, so the device gripped by piezoelectric actuator 303 moves to the right. Next, piezoelectric actuator 301 is extended to grip the device, and subsequently, piezoelectric actuator 303 is relaxed and extended to release the grip on the device. Next, piezoelectric actuator 302 is relaxed. Next, piezoelectric actuator 303 is extended to grip the device again, and subsequently, piezoelectric actuator 301 is relaxed.

[0201] As shown in FIG. 9B, the rotating / moving unit of the device may include a pair of piezoelectric actuators 306, 307 that contact the device 308 on opposing sides that are parallel to each other. When the two piezoelectric actuators extend in opposite directions, 309A and 309B rotate the instrument. In some embodiments, at least one of the clutch piezoelectric actuators / a pair, i.e., piezoelectric actuator 301 and / or piezoelectric actuator 303, may be part of not only the linear portion of the device but also the rotating portion of the device, as described above. In other embodiments, an additional pair of piezoelectric actuators may be used to rotate the guide wire.

[0202] Referring now to FIG. 10, which shows a schematic view of an exemplary apparatus that can impart both linear and rotational motion to a medical tool, according to some embodiments. In some embodiments, the linear motion can be achieved in an inchworm fashion using piezoelectric motors 401, 402, 403, substantially as described above with respect to FIGS. 9A-9B, but with additional piezoelectric motors 404, 405 that function as clutches toward and away from the medical tool (shown as guide wire 408). To rotate the guide wire clockwise (“CW”), for example, piezoelectric motor 403 is relaxed / contracted until it grips the guide wire on the opposite side such that piezoelectric motors 404, 405 move toward the guide wire 408. Then, piezoelectric motor 405 is extended (moved downward), while piezoelectric motor 404 is simultaneously relaxed / contracted (moved upward) to rotate the guide wire. Next, piezoelectric motor 401 is extended to grip the guide wire, and piezoelectric motor 403 is extended to release the grip on the guide wire by moving piezoelectric motors 404, 405 away from the guide wire. In an alternative embodiment, instead of piezoelectric motor 403, an additional piezoelectric motor can be coupled to one of piezoelectric motors 404, 405 to move toward and away from the guide wire. In such an embodiment, rotation of the guide wire may be achieved by both piezoelectric motors 404, 405 extending (or contracting) in opposite directions. The piezoelectric actuators utilized may be, for example, PICMA® Monolithic Multilayer PZT actuators manufactured by PI Ceramic GmbH of Germany. In some embodiments, the rotary piezoelectric actuator can rotate the entire linear advancement assembly.

[0203] Referring to FIG. 11, according to some embodiments, a movement control unit having two concentric components that can be rotated relative to each other is shown. As shown in FIG. 11, the movement control unit 500 includes a first movement control element 502 (such as a piezoelectric motor) configured to enable linear movement (forward movement) of a medical instrument (such as a guide wire 510) in any desired linear direction 505. The first movement control element 502 is fixed to an inner concentric component 530 (see also FIG. 12). The movement control unit 500 further includes a second movement control element 504 configured to enable rotational movement of the first movement control element 502 by rotating the inner concentric component in any desired clockwise or counterclockwise direction 507.

[0204] Further, FIG. 11 shows an optional arrangement in which the proximal end of the medical instrument is fixed to a dedicated holder 520. In some embodiments, for example, if the guide wire includes a double concentric guide wire (i.e., an inner wire disposed within the lumen of an outer hollow wire), the holder can include a mechanism that enables control of parameters of the medical instrument such as tip stiffness, and this mechanism includes at least one regulator / slider 503 configured to linearly move the inner wire relative to the outer wire. Additionally, an additional movement control unit 506 may be present, which enables control of the rotation of the holder 520 to which the instrument is attached.

[0205] Now referring to FIG. 12, an assembly of movement control units for controlling the movement of two or more medical instruments according to some embodiments is shown. As shown in FIG. 12, the movement control assembly 600 includes two separate movement control units 602 and 604, which can be used in conjunction, such that each unit is configured to enable actuation and control of the movement of different medical instruments.

[0206] As shown in FIG. 12, the first movement control unit 602 includes various movement elements that enable linear movement (forward movement) and / or rotational movement of the first medical instrument (such as the guide wire 610), essentially as detailed above with respect to FIG. 11. The second movement control unit 604 includes various movement elements that enable linear movement (forward movement) and / or rotational movement of the second medical instrument (such as the micro catheter 612). In some embodiments, the movement (linear and / or rotational) of the first medical instrument 610 may be independent of the movement (linear and / or rotational) of the second medical instrument 612.

[0207] In some embodiments, the movement (linear and / or rotational) of the first and second medical instruments may be synchronized. In some exemplary embodiments, as shown in FIG. 12, the first medical instrument (e.g., the guide wire) can advance through the lumen of the second medical instrument (e.g., the catheter). According to some embodiments, any suitable actuator type can be used in any of the movement control units, devices, and systems disclosed herein, including but not limited to motors (DC motors, AC motors, stepper motors, etc.), electromagnetic actuators (solenoids), piezoelectric actuators, pneumatic actuators, hydraulic actuators, etc.

[0208] FIG. 13 is a block diagram of a surgical robot system according to some embodiments.

[0209] In some embodiments, the robot system 1301 is suitable for use in an operating room. Optionally, one or more system components (control components, imaging components, etc.) can be physically separated from the rest of the system and used remotely.

[0210] In some embodiments, the system 1301 is configured to receive one or more surgical tools (e.g., guide wires, micro catheters, guide catheters, intermediate catheters, and / or other elongated surgical tools) and actuate the movement of the tools.

[0211] In some embodiments, the system is configured to drive linear movement (e.g., forward and / or backward) of a tool received therein and / or to drive rotational movement (e.g., axial rotation) of a tool received therein. In some embodiments, the linear movement and the rotational movement are actuated simultaneously.

[0212] In some embodiments, system 1301 includes a robotic device 1303 for driving the movement of one or more tools. In some embodiments, the device housing houses and / or is operably connected to one or more of the following components. · One or more actuators, such as one or more motors 1305, and optionally, a transmission of the associated motor. · A tool movement element 1317, such as a wheel, configured to operably contact a tool received by the system to move the tool (e.g., move the tool forward, backward, rotate). In some embodiments, the tool movement element is driven directly (e.g., by contact) or indirectly (e.g., via one or more gears or other transmissions) by the motor 1305. Optionally, only some of the tool movement elements are driven (directly or indirectly) by the motor, while other tool movement elements move in response to the movement of the tool and / or in response to the movement of the motor-driven tool movement elements. · A controller 1307 configured to transmit and receive operating signals with a general-purpose control unit 1309. The general-purpose control unit 1309 can be configured as a remote control device, a console, a control unit physically attached to the system base, or a combination thereof. In some embodiments, the controller 1307 is configured to adjust the operation (e.g., linear movement, rotation) of a tool received and operated by the robotic system. · Power supply means 1311 including connection means for, for example, a battery and / or a commercial power supply. · For example, one or more detection means 1315 configured to detect whether a tool is inserted, the relative position of the tool, the position of a tool movement element (e.g., a wheel), the actual movement of the tool movement element (e.g., counted by a counter that counts the number of rotations of the wheel), sensors for communicating with other system sensors and / or for other measurements and / or indications. In some embodiments, the sensors are configured to detect motor status, e.g., motor position, motor rotation rate. Various types of sensors may be used, such as optical sensors, pressure sensors, force measurement sensors, velocity sensors, sensors for detecting current, flow sensors, position sensors (e.g., optical, magnetic, electrical position sensors). · A memory 1313 storing parameters related to tool movement such as movement speed, rotation, translation, angle formation, deflection angle, etc., measurement values of forces acting on the tool, indicators obtained by one or more system sensors such as the rigidity of the tool, and parameters related to the patient's body and detected by the inserted tool (e.g., heart rate, blood pressure, temperature, oxygenation level, and / or other detected parameters).

[0213] In some embodiments, the robotic device (also referred to herein as an insertion device) is compact and dimensioned small enough to reduce interference with operating room personnel (e.g., nurses, surgeons) and / or operating room equipment and / or the patient. In some embodiments, the footprint of the device is less than 500 cm 2 , 250 cm 2 , 180 cm 2 , or smaller than an intermediate, larger, or smaller area. In some embodiments, the volume of the device is less than 3500 cm 3 , less than 2800 cm 3 , less than 2000 cm 3 , or an intermediate, larger, or smaller volume. In some embodiments, the weight of the device is less than 1.5 kg, less than 1 kg, less than 800 grams, less than 500 grams, or an intermediate, higher, or lower weight.

[0214] In some embodiments, the robotic device is substantially block-shaped and has, for example, a box-shaped, compact configuration. Other configurations can include cylindrical configurations, rounded (e.g., ball-shaped) configurations, saddle-shaped configurations, and / or others.

[0215] In some embodiments, system 1301 includes an integrated imaging modality 1319. Alternatively, the system is configured to be operably attached to (e.g., communicate with) an existing imaging modality. The imaging modality can include, for example, fluoroscopy, CT, cone beam CT, CT fluoroscopy, MRI, ultrasound, or any other suitable imaging modality.

[0216] In some embodiments, system 1301 includes a platform 1321 for positioning device 303 relative to the patient and / or relative to the operating table. In some embodiments, the platform is configured to include adjustable fixtures or to be attached to adjustable fixtures. Optionally, the height and / or angle and / or distance of the system relative to the patient (e.g., relative to the position of the body entry) and / or the height and / or angle and / or distance of the system relative to the table are adjustable.

[0217] In some embodiments, system 1301 includes or is configured to engage an adapter 1323 for operably engaging a proximal portion of a tool, such as a handle.

[0218] In some embodiments, the adapter defines a mechanical engagement between one or more motors 1305 and one or more components of the handle that move the tool. For example, the adapter connects one or more motors or associated transmissions to a slider component of the handle that deflects the tool tip during sliding, a knob component of the handle that rotates the tool during rotation, and / or other handle components. Further, or alternatively, the adapter itself includes one or more integrated motors for driving the movement of the handle components.

[0219] Figure 14 is a flowchart of a general method of using a surgical robot apparatus according to some embodiments.

[0220] In some embodiments, for example, an operation is determined (1401) by a physician, surgeon, and / or other clinical personnel. In some embodiments, the operation is for therapeutic purposes. In addition to, or instead of, this, the operation is for diagnostic purposes.

[0221] In some embodiments, the operation includes a catheterization method. In some embodiments, the operation includes inserting one or more tools into the vasculature and / or through the vasculature and / or into other non-vascular luminal structures. Examples of tools can include guidewires, microcatheters, rapid exchange catheters, guiding catheters, balloon catheters, stents or coils, resection tools, intermediate catheters, aspiration catheters, ultrasonic catheters, pressure catheters, and / or other tools. In some embodiments, the operation is a trans-luminal procedure. In some embodiments, the operation is an over-the-wire based procedure.

[0222] In some embodiments, the device is positioned (1403) relative to the patient. In some embodiments, the device is attached to the surgical bed, for example, via fixation. In some embodiments, the device is attached to the patient, for example, to the patient's leg (e.g., thigh), the patient's arm, and / or other body parts. The attachment of the device to the surgical bed and / or the patient may be performed using straps, bands, rigid attachments, and / or other attachment means.

[0223] In some embodiments, attachment to the bed is accomplished using a stand that is stabilized relative to the mattress and / or the rails of the bed and / or the floor. The system can then be attached to the stand, for example, via a snap-fit mechanism, magnetic means, straps (e.g., Velcro®), and / or others. In some embodiments, the stand is adjustable to enable use with patients of various sizes and / or different bed heights. In some embodiments, alignment of the device with respect to the patient is selected when setting one or more of the position of the device, the height relative to the body, and the entry angle. The position of the device may be defined relative to the patient's body or a portion thereof (e.g., relative to a surgical entry point), and / or relative to the surgical bed, and / or relative to other surgical room equipment, e.g., relative to an imaging module.

[0224] Potential advantages of attaching the device to the patient's body, such as the limbs and / or other body parts (e.g., legs, arms (optionally with a hand snuffbox), neck, feet, etc.), can include being able to position the device closer to the entry opening into the body. In such a configuration, it may be possible to shorten the length of the tool segment that extends between the device and the body, potentially enabling more efficient use of the tool length. In some embodiments, the device is sufficiently compact to conform to the top of the patient's limb, e.g., without protruding laterally from the limb when the device is attached to the limb (e.g., the device is sized so as not to extend laterally from the patient's thigh).

[0225] In some embodiments, tool loading is performed (1405). In some embodiments, tool loading is performed after the device position (e.g., relative to the patient and / or the bed) is set, or alternatively, tool loading is performed before the device position is set. Optionally, one or more tools are pre-loaded onto the device and optionally provided with the device. In one example, the device is provided in a sterilized package while one or more tools are already loaded. In addition to or instead of this, the tool is rewound in the operating room and loaded onto the device, for example, by a nurse, technician, and / or other clinical staff. In some embodiments, for example, when switching from a navigation tool (e.g., a guidewire) to a treatment tool such as an embolization tool, a catheter balloon, and / or other treatment tools, the tool is loaded and / or exchanged during operation.

[0226] In some embodiments, the device is configured such that no or no shielding (e.g., physical separation by a wall, wrap, drape) is present or required between the tool movement element and the tool to be loaded, for example, direct contact is formed between the tool and the tool movement element (e.g., a wheel, gear, and / or other actuator). Optionally, draping with a sterile drape or other cover is not required. For example, in disposable use placed after surgery, since there are no permanent components, there is no need to cover specific components of the device that come into contact with the device and / or the tool with a sterile drape. The potential advantages of a device configured to directly engage a surgical tool without separation or cover may include a simpler, more efficient, time and / or cost-effective preparation process and / or cleaning process after operation.

[0227] Alternatively, in some embodiments, the device (and / or selected components of the device such as the tool movement element) is at least partially covered by a sterile drape or sheath.

[0228] In some embodiments, the operation is performed by controlling the movement of a surgical tool received within the unit via the user interface of the device (1407). Exemplary operations of the tool controlled by the device can include linear advancement and / or retraction of the tool, rotation of the tool (e.g., roll about the tool axis), torsion of the tool, angular orientation of the tool (e.g., by curving the distal tip of the tool), articulation (e.g., of the distal tip of the tool), and changes in mechanical properties of the tool such as stiffness, for example, by controlling the distal tip structure or internal configuration from the proximal end of the tool.

[0229] In some embodiments, the operation of the tool is performed remotely. Optionally, the surgeon operates the system from a different room. Alternatively, the surgeon can remain in the operating room and operate the system while adjacent to or far from the bed.

[0230] In some embodiments, the manipulation of the tools includes the manipulation of tools that are attached to each other and / or inserted into each other and / or otherwise assembled such that the movement of one tool can affect the other. For example, where a guidewire extends within the lumen of a microcatheter. In such a situation, controlling the movement may involve performing “compensatory” movements of the guidewire and / or the microcatheter relative to each other (either via user control and / or automatically by the system upon identification of the movement), which may be required when both are driven together in an assembled configuration (e.g., where the guidewire is within the microcatheter lumen at the position of the tool movement element of the unit in which the tool is being operated). In one example, it may be desirable to hold the guidewire in a predetermined position without moving the guidewire with the microcatheter when the microcatheter is advanced or retracted. This may be accomplished, for example, by driving the linear motion mechanisms of both tools, but in opposite directions (e.g., by driving the guidewire mechanism so as to retract the guidewire proximally while advancing the microcatheter distally). A potential advantage of synchronized and controlled movement of tools used together (e.g., a guidewire extending within the lumen of a microcatheter) may include the ability to hold one tool while advancing the other by driving the actuation mechanisms of the tools in opposite directions such that while one tool is advanced or retracted, the other tool effectively remains in a predetermined position.

[0231] In some embodiments, the user interface is configured on the device itself (e.g., as a screen and / or buttons and / or joystick attached to the system unit and / or base), and / or on a separate physician console, and / or on a separate remote control device. Control signals may be communicated to the device via wired and / or wireless communication (e.g., network-based communication).

[0232] In some embodiments, the device (e.g., a device controller) is programmed to include a mounting mode for insertion and / or calibration of the tool and / or the device motor, and an operating mode in which movement of the tool is performed.

[0233] In some embodiments, the device or a particular component thereof is discarded (1409) after an operation. Optionally, the device is discarded as a whole, optionally including the tool mounted on the device.

[0234] FIG. 15 is a flowchart of a method for mounting a plurality of surgical tools on a surgical robot device according to some embodiments.

[0235] In some embodiments, for example, a robotic device as described herein is provided (1501). In some embodiments, one or more elongating surgical tools such as a guide wire, a microcatheter, a guide catheter, a rapid exchange catheter, and / or other surgical tools are provided (1503).

[0236] In some embodiments, the proximal handle of a tool such as a guide wire is arranged in engagement with a designated adapter or holder (1505) as described in a co-pending PCT application named "ROBOTIC MANIPULATION OF A SURGICAL TOOL HANDLE" (Attorney Docket No. 83117), which is incorporated herein by reference.

[0237] In some embodiments, the guide wire is passed (e.g., from the distal end direction) into a designated shaft of the guide wire drive mechanism of the robotic device (1507). Next, at least a portion of the guide wire length exiting the shaft (existing device housing) is passed into the lumen of the microcatheter (1509).

[0238] In some embodiments, the proximal end of the microcatheter (not yet physically attached to the device) is secured to the device at the exit port of the guidewire from the housing (1511). Next, at least a portion of the length of the microcatheter, including the guidewire received therein, is passed through the designated shaft of the microcatheter drive mechanism of the device (1513). The microcatheter is then passed through the lumen of the guide catheter (along with the guidewire received therein) (1515).

[0239] Optionally, the guide catheter may be received or engaged by a guide catheter drive mechanism that may be operatively coupled externally to the device housing or alternatively integrated within the device.

[0240] Next, in some embodiments, one or more tools are introduced into the patient's body and manipulated using the device (1517).

[0241] In an exemplary use, the robotic device is equipped with a guide wire and optionally a microcatheter. Optionally, the guide catheter (its distal portion) is manually inserted into the patient's body. The robotic device is then positioned adjacent to the proximal end of the guide catheter, and the guide catheter (optionally together with a microcatheter that receives the guide wire) is inserted into the lumen of the guide catheter. In some embodiments, the insertion into the guide catheter lumen is performed via a seal element, which may be an integral part of the robotic device or alternatively may be separate therefrom. In some embodiments, the user then connects the proximal end of the guide catheter to the robotic device. From this point forward, the manipulation of the guide wire and / or the microcatheter within the lumen of the guide catheter (e.g., linear forward / backward and / or rotation), and optionally the manipulation when the guide wire and / or microcatheter exits the guide catheter (e.g., into the lumen of a blood vessel), may be performed robotically using the device (e.g., via a remote control interface). In some embodiments, the robotic device is used to perform, for example, linear forward and / or backward movement of the guide catheter up to a limited extent.

[0242] Figures 16A - D are various configurations of a remote control device of a surgical robotic system according to some embodiments.

[0243] In some embodiments, the remote control device is shaped to be manually held by a user, such as a physician. Optionally, the remote control device is lightweight and small enough to be held by the user without obstructing the user's view of visual aids such as a screen showing the results of imaging during operation. In some embodiments, the remote control device includes one or more portions shaped to be gripped by the user's palm and / or engaged by the user's fingers.

[0244] In some embodiments, the remote control device communicates with a modular robot system. In some embodiments, the communication is wireless and is performed via, for example, Wi-Fi, infrared, Bluetooth, RF, and / or other wireless modules.

[0245] In some embodiments, the remote control device includes or communicates with a controller of the modular robot system. In some embodiments, the operation of the tool received by the system is performed via the remote control device. Examples of tool movement and / or other operational actions of the tool controlled by the remote control device can include linear forward and / or backward movement of the tool, axial rotation of the tool, control of the tool distal tip, movement speed, control of the inherent tool function (e.g., inflation / deflation of a balloon within a balloon catheter, stent deployment and / or advancement), and / or other tool operations.

[0246] Other functions that can be controlled via the remote control device include, for example, automatic injection of materials (e.g., contrast agent, cleaning solution) within the tool lumen and through the tool lumen, linear and / or angular movement of the assembled system as a whole (e.g., sliding of the assembled system relative to the attachment), safe stop of the system, on / off operation of the system, power supply to the system or specific components, and / or other system functions.

[0247] Figures 16A - B show a first example of a remote control device 1601, and Figures 16C - D show a second example of a remote control device 1603. In some embodiments, the device includes an interface in one or more forms such as push buttons 1605, joystick handle 1607, manual slider 1609, rotary knob 1611, etc.

[0248] In some embodiments, the remote control device includes a screen for notifying the user about current control and / or receiving commands from the user, etc.

[0249] In some embodiments, the remote control device includes an interface (e.g., a button) for quickly retracting the tool. Such an interface can be used in case of an emergency, device failure, etc., and / or for deliberately retracting the tool, such as to replace the tool with a new one.

[0250] In some embodiments, the remote control device is modular. Optionally, specific buttons and / or add-on interfaces are selectively attached (and / or the cover is removed to enable their use). For example, a button for controlling the movement of a guide catheter (when a guide catheter receiving unit is attached to the system) is exposed for use only when needed (e.g., placed under a removable or movable cover). In another example, an interface for controlling the injection of material through one or more system junctions is attached to the remote control device and / or is not covered for use as needed.

[0251] The remote control device can be operated from a location remote from the system. Optionally, the remote control device is operated by a surgeon in a different room. Optionally, the remote control device is operated by a surgeon located in the operating room (adjacent to or away from the bed).

[0252] In some embodiments, the remote control may be configured as a screen interface for use, for example, with a mobile phone, tablet, computer, etc., as described below.

[0253] FIG. 17 is a schematic example of a screen interface associated with a surgical robot system according to some embodiments.

[0254] In some embodiments, for example, in addition to or instead of the remote control device as described above, a screen interface 1701 that communicates with the system can be used. In some embodiments, the screen interface is configured to receive data (e.g., from the device, and / or from the imaging means, and / or from the physician, and / or from the hospital system), present the data, send commands to and / or receive commands from the robotic device.

[0255] In some embodiments, the screen interface may be configured as a computer, laptop, tablet, mobile phone application and / or others.

[0256] The user interface screen shown in this figure presents, but is not limited to, examples of the functions and / or instructions of the operation of the tool by the robotic device. Examples of the functions and / or instructions of the operation of the tool include tool movement types (e.g., guide wire rotation, guide wire forward / backward, microcatheter forward / backward, guide catheter rotation, guide catheter forward / backward), guide wire tip control (e.g., guide wire tip deflection), tool speed and / or movement direction (e.g., increasing the speed using the "turbo" mode, starting a high-speed or partially high-speed backward movement), emergency stop (in some embodiments, in the case of device failure, medical emergency, etc., the emergency stop button stops the power supply to the robotic device), controlling the combined movement of two (or more) tools, controlling accessories including devices and / or add-on accessories used with the system, e.g., injection of materials through a port, balloon inflation, stent expansion, tip curvature, customized control of tool movement such as tool stiffness, etc.

[0257] Figures 18A - B are different views of a robotic device according to some embodiments.

[0258] In some embodiments, the robotic device 1801 is shaped and sized to be positioned adjacent to (e.g., attached to a bed) and / or on the patient, such as on the patient's limbs (e.g., on the patient's thighs). In the illustrated example, the device 1801 includes a compact housing 1802 having a saddle-shaped bottom 1803. Optionally, the saddle-shaped portion is shaped and sized to seat on the patient's limbs, the rails of the bed, a designated stand (e.g., a stand having a flat bottom for placement on a flat surface (not shown)), and / or other objects. In some embodiments, a second portion 1805 of the housing extends from the saddle bottom surface, and the second portion houses one or more tool drive mechanisms.

[0259] In some embodiments, the guide wire is mounted on the device 1801 as follows. In some embodiments, the proximal portion (e.g., the handle) of the guide wire is received within an accessible compartment 1807 and optionally covered by a lid 1809 (the compartment 1807 may also be referred to herein as an "adapter" or "holder"). Optionally, the operation of one or more guide wire handle components is performed within the compartment 1807 by one or more movers that engage the handle (e.g., slide the handle, rotate a knob of the handle, and / or engage other handle components).

[0260] In some embodiments, the more distal portion of the guide wire (adjacent the handle) exits compartment 1807 through aperture 1813. Then, in some embodiments, an even more distal portion of the guide wire (optionally, the most distal end of the guide wire) is then inserted into the device housing through inlet aperture 1811, where the inserted guide wire is received within a designated shaft (not shown) of its drive mechanism. In some embodiments, the guide wire exits the housing again, optionally through the opposite wall of the housing, via aperture 1815. In some embodiments, the location of aperture 1815 also functions as a fixed point for the proximal end of the microcatheter. Optionally, the microcatheter is passed through knob 1817 and / or other suitable protrusions fixed to the housing. When the guide wire exits through aperture 1815, it is received within the lumen of the microcatheter.

[0261] In some embodiments, the microcatheter (along with the inner extending guide wire) curves outside the housing (e.g., in a "U" shape) and is inserted through aperture 1819 into a designated shaft of the microcatheter drive mechanism. The microcatheter then (along with the inner guide wire) exits the housing through the opposite wall via aperture 1820.

[0262] In some embodiments, the device housing is shaped and sized only to accommodate the tool drive mechanism without being affected by tool size considerations such as tool length, tool width (e.g., diameter). Optionally, the housing protects the internal tool drive mechanism while maintaining the tool itself in a visible and / or accessible state relative to the housing. Optionally, the drive mechanism is not visible. Potential advantages of such a structure can include reducing the risk of damage to the tool drive mechanism (e.g., by unwanted contact).

[0263] In some embodiments, a portion of the tool that extends within the housing itself is less than 25%, less than 20%, less than 10%, less than 5%, or an intermediate, greater, or lesser percentage of the total length of the tool. Potential advantages of a housing that houses a drive mechanism and does not require a long portion of the tool to be housed internally may include enabling a relatively compact housing having small dimensions and / or small weight.

[0264] In some embodiments, the housing includes a removable or movable part, such as a lid. Optionally, the lid is opened, for example, to manually release the tool in case of an emergency and / or malfunction of the robot. Alternatively, the lid is opened when the tool needs to be replaced.

[0265] In some embodiments, the opening of the lid returns the motor of the device to its initial (home) position and / or direction automatically. Optionally, the operating mechanism of the tool, for example, the designated shaft into which the tool is received, is rotated so as to be aligned such that the slot extending along the shaft faces upward in the direction of the open lid. Potential advantages of the motor and / or the tool shaft include being automatically aligned when the lid of the device housing is opened, and including a tool that can be more easily accessed to adjust and / or remove the tool from its mechanism.

[0266] Exemplary dimensions of the upper portion 1805 of the device (which may alternatively be formed as a flat surface and does not have a saddle-shaped bottom) may include an axial length 1821 of less than 12 cm, a width 1823 of less than 7 cm, and a height 1825 of less than 9 cm.

[0267] In some embodiments, the housing 1802 is formed of a relatively lightweight but durable material such as plastic, aluminum, composite material, etc. Optionally, the material is recyclable, such that a discarded device (e.g., a single-use device) may be at least partially recycled.

[0268] Figures 19A - B schematically show a surgical robot device that includes or is attached to a guide catheter drive unit according to some embodiments.

[0269] Figures 19A - B show robot devices having different shaped housings. Figure 19A shows a robot device housing 1900 as described above in the figure. 18A - B are seated on a base 1921 that defines a plane. Figure 19B shows a substantially box - shaped housing 1902 having a square or rectangular cross - sectional profile.

[0270] In some embodiments, the guide catheter drive mechanism 1901 is configured as a separate add - on unit that is operably coupled to the robot device, for example, to be attached to the device housing 1903.

[0271] In some embodiments, the guide catheter drive unit is attached to the housing such that a micro - catheter present in the housing enters the lumen of a guide catheter mounted on the guide catheter unit (via an opening 1905 etc.). In some embodiments, the attachment of the guide catheter unit to the housing is by one or more of an interference fit coupling (e.g., respective protrusions and depressions of the device housing and via the housing of the guide catheter drive unit), a sliding attachment (including rails 1906 as shown in Figure 19A).

[0272] In some embodiments, the rail 1906 movably couples the guide catheter drive unit 1901 to one or more motors disposed within the housing of the device such that, for example, the motors drive the forward and backward movement of the unit to move the guide catheter. In some embodiments, the guide catheter drive mechanism is configured to drive the linear and / or rotational movement (i.e., roll) of the guide catheter. In some embodiments, the guide catheter drive unit is configured to be electrically connected to the robotic device and receive power from the robotic device. Alternatively, the guide catheter drive unit includes an independent power source (e.g., a battery).

[0273] In some embodiments, the guide catheter drive unit is connected to the robotic device via a mechanical connection such as a snap fit connection, an interference fit connection, a pin and socket, and / or other suitable mechanical coupling.

[0274] Alternatively, in some embodiments, the guide catheter drive mechanism is inside the robotic device housing and forms an integrated part of the robotic device.

[0275] In some embodiments, the guide catheter drive mechanism is configured to drive the linear movement of the guide catheter within a selected distance range, for example, to advance and / or retract the catheter by distances such as 3 cm, 5 cm, 10 cm, or intermediate, longer, or shorter distances. In some embodiments, this provides fine adjustment of the position of a guide catheter previously inserted into a patient.

[0276] In some embodiments, to ensure that the microcatheter within the guide catheter moves with the guide catheter, the microcatheter drive mechanism is controlled to compensate for its movement such that, for example, the microcatheter is actuated to move in a direction opposite to the guide catheter. Optionally, the guide wire within the microcatheter moves with the microcatheter as a single unit and does not require independent actuation.

[0277] Figures 20A - C are examples of isolated mechanisms of a guide catheter drive unit, an example of a guide catheter drive unit housing, and a guide catheter drive unit assembled on a robotic surgical system, according to some embodiments.

[0278] In some embodiments, the guide catheter mechanism (see FIG. 20A) includes one or more motors such as motor 2001 for driving linear motion and motor 2003 for driving rotation. In some embodiments, the proximal portion of the guide catheter 2005 is attached to the connector 2009. In some embodiments, during operation, the motor 2001 rotates the lead screw 2007 that advances or retracts the connector 2009, thereby advancing or retracting the guide catheter 2005. In some embodiments, the motor 2003 moves linearly with the connector 2009.

[0279] In some embodiments, the operation of the motor 2003 rotates the connector 2009, thereby rotating (twisting) the guide catheter 2005.

[0280] FIG. 20B is an external view of the guide catheter unit 2000. In some embodiments, the unit includes an extension housing 2011, and the lead screw 2007 (as shown in FIG. 20A) extends throughout the housing. In some embodiments, the housing includes one or more ports that communicate with the guide catheter lumen. For example, an injection port 2010 through which a material (e.g., a liquid drug, saline, etc.) can be injected into and through the lumen of the guide catheter.

[0281] In some embodiments, the housing 2011 is shaped for attachment to a robotic device. In one example, the housing can be inclined relative to the outer housing of the robotic device and / or can be at least partially connected to the outer housing of the robotic device by being received within respective recesses or depressions defined in the robotic device housing, defining a contact portion 2012.

[0282] FIG. 20C shows a guide catheter unit 2000 connected to a robotic device 2013. In some embodiments, the guide catheter unit is coupled to the outer wall of the device housing 2015. Optionally, the guide catheter unit extends distally in the direction of insertion into a patient.

[0283] As further shown in this example, the guide wire 2019 extends from a guide wire holder 2021 into a designated shaft of a guide wire drive mechanism and then exits the housing at 2025 and also serves as a fixed point for a microcatheter 2027, with the guide wire entering the microcatheter lumen. The microcatheter is then bent and enters the device housing at 2029 and is received within a designated shaft of a microcatheter drive mechanism. When the microcatheter exits the housing (along with the guide wire received therein), the microcatheter is held by the guide catheter unit 2000 and is received within the lumen of a guide catheter 2005 that is manipulated.

[0284] FIGS. 21A - C show mechanisms for actuating rotational (roll) and / or linear motion of a tool actuated by a robotic surgery system, according to some embodiments.

[0285] In some embodiments, as shown in the exemplary mechanism of FIG. 21A, a guide wire 2101 inserted into a designated shaft is engaged by at least one pair of drive wheels 2103 that are disposed opposite one another and contact the guide wire passing therebetween. A motor 2105 for driving the linear motion of the tool actuates the rotation of the wheels, which axially move the guide wire in the proximal or distal direction depending on the direction of rotation.

[0286] In some embodiments, a motor 2107 is configured to drive the rotation of a first gear 2109, which interferes with and rotates a second gear 2111 (disposed adjacent to or on the gear 2109). In some embodiments, the rotation of the second gear 2111 causes the rotation of an assembly including the drive wheels 2103 and the linear motor 2105, rotating the assembly as a whole (along with the guide wire held therein).

[0287] In some embodiments, when the gear 2109 rotates, it rotates a holder 2121 of the guide wire, rotating (rolling) the guide wire. Thus, in some embodiments, the rotation (roll) of the guide wire occurs at two locations along the guide wire, namely, a first location at the holder 2121 and a second location in an assembly including the drive wheels and the linear motor that rotates as a whole along with the guide wire. Potential advantages of rotating the guide wire at two locations along the guide wire can optionally include reducing the twist of the rotating guide wire, for example, by synchronous operation of the rotations at both locations, optionally by performing the rotational motion at both positions by a single motor.

[0288] The potential advantages of driving the rotation of the guide wire at two positions along the guide wire length using the same single motor (e.g., via motor 2107 that moves gear 2109) can include, for example, improved control over the rotation of the guide wire as compared to driving the rotation at two (or more) positions using different motors, which may require synchronization between the direction and / or speed and / or actuation timing of the motors. Another potential advantage of using the same single motor to drive rotation at two different guide wire length sites can include providing a more compact and smaller device housing.

[0289] Further, or alternatively, the rotation of gear 2109 actuates the rotation of the guide wire only starting from the point of an assembly rotated by gear 2111 (since gear 2111 is rotated by gear 2109), without directly rotating the guide wire (such as by not rotating holder 2121).

[0290] In some embodiments, one or more slip rings are used to supply current to the motor regardless of the current direction (e.g., rotational direction) of the assembly. For example, a slip ring composed of reel 2117 and base 2119 is located at the attachment of the second gear 2111 to the drive wheel and linear motor assembly. In some embodiments, the slip ring maintains an electrical coupling to the linear motor, such that the linear motor can be actuated regardless of the rotational direction of the assembly.

[0291] In another exemplary structure shown in FIG. 21B, the motor that drives the rotation and / or the gear 2113 that transmits the rotation from the motor can directly interface with the assembly of the drive wheel and motor 2105 that drives the linear motion. For example, gear 2113 is arranged along the same major axis as the assembly.

[0292] In some embodiments, the gear 2113 is formed with a slot 2123 through which a guide wire passes. Optionally, the slot 2123 forms a direct extension of a slot 2125 within a designated shaft 2127 in which the guide wire is received. In some embodiments, the slot extends along an arc of 5 degrees, 10 degrees, 20 degrees of the gear circumference. Potential advantages of the slot through the gear can include that removal of the guide wire from the actuating mechanism can be facilitated.

[0293] FIG. 21C is a cross-sectional view showing a shaft 2127 and a wheel 2103 that drive the linear movement of a guide wire. In some embodiments, the shaft 2127 defines an elongate inner lumen 2129 in which the guide wire is received, and the lumen is in communication with the slot 2125. In some embodiments, the inner wall of the shaft 2127 is configured to conform to the contour of the wheel (see, e.g., the curvature 2128), such that the guide wire within the lumen 2129 is guided to the right (and then from) within the path between the wheels. In some embodiments, the lumen 2129 extends proximate to the outer contour of the wheel to bring the guide wire directly between the wheels.

[0294] In some embodiments, the wheel 2103 is disposed (exists) on a plane that is substantially perpendicular to the plane defined by the slot 2125.

[0295] Alternatively, the wheel may be disposed on a plane parallel to the plane defined by the slot 2125.

[0296] Potential advantages of a shaft configured to conform to the contour of the wheel can include improved control of the guide wire as it is fed into (and out of) the path between the drive wheels. Another potential advantage can include reducing the risk of slippage and / or other movement of the guide wire out of its designated path.

[0297] Including a wheel for driving the linear motion of a guide wire, a potential advantage of an assembly configured to rotate as a whole to generate rotation of the guide wire may include that the linear motion can be performed during the rotational motion (or vice versa). Another potential advantage of a dual-motion assembly where linear movement and rotation operate at the same physical location (inside a robotic device) may include reducing slippage or other undesirable guide wire movement that can occur, for example, when two spaced-apart mechanisms each drive linear and rotational movement and the guide wire needs to extend between them. In a spaced-apart mechanism where one mechanism actuates rotation and another spaced-apart mechanism actuates linear motion, rotation of the guide wire can cause slippage of the guide wire between the rotational mechanism and the linear motion mechanism (or, conversely, linear motion of the guide wire can cause the guide wire to slip from the rotational mechanism). Another drawback of a separated distinct mechanism is the potential for induction of friction in the empty space (i.e., applying friction to the tool segment with a mechanism that is not currently in use), which may require some type of release mechanism that will disengage one mechanism while the other is operating.

[0298] FIG. 22 shows an exemplary arrangement of a mechanism for driving the movement of a guide wire according to some embodiments.

[0299] In some embodiments, rotation of the guide wire is performed by two or more mechanisms. Optionally, two or more mechanisms that engage the guide wire are configured to cause rotation (roll) of the guide wire. In such a situation, the two mechanisms are controlled synchronously, for example, to ensure that the guide wire does not twist or kink.

[0300] In some embodiments, the guide wire proximal portion or handle is held within an adapter or holder 2201 suitable for generating rotation of the guide wire by rotating the handle as a whole and / or by actuating a handle component such as a rotatable knob (not shown) that generates rotation (roll) of the guide wire (optionally, rotation of the distal tip of the guide wire). The guide wire extends from the holder 2201 along an axis 2203 about which it rotates until it exits the housing. When the guide wire re-enters the housing, it can pass through a second mechanism suitable for actuating rotation (this can be linear motion as well in this example). The second mechanism, such as the one shown in FIG. 21B, can be configured to actuate rotation (roll) of the guide wire about an axis 2205 along which the guide wire extends. Optionally, the axis 2205 is parallel to the axis 2203 and defines a parallel path along which tool actuation occurs. Alternatively, the paths of the tool defined along the axes 2205 and 2203 are not parallel, for example, are angled or angled with respect to each other.

[0301] In some embodiments, the mechanisms extend to similar heights and / or axial lengths such that these mechanisms can fit within a compact housing.

[0302] FIGS. 23A - B are schematic diagrams and flowcharts related to controlling the length and / or position of a tool by adjusting a curved portion of the tool according to some embodiments.

[0303] In some embodiments, as schematically shown in FIG. 23A, a tool 2301 operated by a robotic device 2302 is engaged at two or more sites 2303, 2305 that are spaced apart from each other (along the length of the device), such that a segment 2307 of the tool extending between the two sites can be adjusted (lengthened or shortened). In some embodiments, sites 2303, 2305 define attachment points of the tool 2301 to the robotic device housing 2302, while segment 2307 extends outside the device (i.e., outside the device housing).

[0304] In some embodiments, sites 2303, 2305 are arranged relative to each other to cause bending or curving of segment 2307, for example, into a "U" - shaped curve as shown in the illustration. In one example, sites 2303 and 2305 are arranged in alignment with each other.

[0305] Alternatively, sites 2303 and 2305 are not arranged in alignment with each other.

[0306] In some embodiments, to control the length of the tool, the curve (e.g., "U" - shape) changes in size (e.g., expands or contracts) and varies the maximum distance 2309 between the peak of the curve and the housing of device 2302.

[0307] In some embodiments, the degree of the curve (e.g., defined by the radius of curvature 2310) is set by linear movement of the tool (e.g., the extent to which the tool is advanced or retracted) and / or manual mounting of the tool, where a particular segment of the tool length is mounted within the system. In some embodiments, the range of the curve depends on the overall length of the tool.

[0308] In some embodiments, the distance 2312 between the attachment points of the tool to the housing is a function of the radius of curvature 2310 of the tool. Optionally, the distance 2312 is twice the minimum radius of curvature at which the tool can be bent.

[0309] In some embodiments, the dimensions of the housing 2302, such as the extent of the wall of the housing in which the inlet opening and the outlet opening for the tool are formed, are sized according to the radius of curvature of the tool, e.g., at least twice the minimum radius of curvature of the tool, but 5 times, 6 times, 8 times, 10 times, or an intermediate multiple, greater than, or less than the minimum radius of curvature of the tool for which operation by the device is intended.

[0310] In some embodiments, the maximum dimension of the housing (such as the width or height of the housing) is 5 - 10 cm, 8 - 20 cm, 12 - 40 cm, or intermediate, longer or shorter.

[0311] In some embodiments, the device includes three or more engagement sites with the tool, allowing a plurality of curves (e.g., a "U" curve) to be formed between these sites.

[0312] The potential advantages of a device that defines tool engagement sites such that the length of the tool segment extending between the sites is adjustable can include improving control over the length of the tool being operated. Optionally, the length of the most distal tool segment, such as the segment extending between the last exit from the robotic device housing and the target point within the patient's body, can be controlled, thereby potentially allowing for fine control of the tool distal tip position. In some embodiments, by advancing the tool towards a target point inside the body of the main body, the size of the curve of the tool outside the housing becomes smaller, and conversely, by retracting the tool from the target point, the size of the curve becomes larger.

[0313] Another potential advantage of a device that defines tool engagement sites such that the length of the tool segment extending between positions is adjustable can include the ability to accept and operate tools of various lengths.

[0314] Another potential advantage of an apparatus that defines a tool engagement site such that a tool segment extending between sites is length adjustable is that the curved segment can extend externally relative to the apparatus housing, potentially enabling an apparatus of relatively small dimensions (e.g., axial length) that is not substantially affected by tool length, enabling a compact housing of small dimensions.

[0315] The flowchart of FIG. 23B is an example of the mechanism illustrated by the figure of FIG. 23A. In some embodiments, the proximal end of the tool is secured (2321) to the robotic device. For example, the handle of the tool is received and / or attached by a designated adapter or holder of the device. This attachment can be referred to as a first engagement site, for example, as described above. In some embodiments, the more distal portion of the tool is passed or inserted (2323) through the robotic device. For example, the more distal portion of the tool is passed through a designated shaft of the operating mechanism (e.g., a guide wire is inserted and engaged by a tool movement wheel). This second attachment can be referred to as a second engagement site, for example, as described above.

[0316] Optionally, a tool segment (e.g., by a tool movement wheel) extending between the fixed site of the proximal end of the tool and the engagement site of the tool is then adjusted in length (2325).

[0317] FIG. 24 shows a system configuration defining an arrangement of a tool whose length can be adjusted, according to some embodiments.

[0318] In the illustrated example, the robotic device 2401 that includes and / or is coupled to the guide catheter unit 2403 is configured to receive and drive the movement of the guide wire 2405, the micro catheter 2407, and the guide catheter 2409. In some embodiments, as shown in this example, the two "U" shaped curves 2411 and 2413 are defined by a tool passing through the system. Curve 2411 is the curve of the guide wire alone, and curve 2413 is the curve of the guide wire when extending inside the lumen of the curved micro catheter. In some embodiments, the change in the size of curve 2413 results in articulation of the micro catheter and the guide wire in the segment distal to the curve. In some embodiments, the movement (forward or backward) of the micro catheter changes the size of curve 2413.

[0319] As seen in FIG. 24, the device housing 2402 (i.e., the wall of the housing) defines the following openings through which the tool enters and exits the internal device space defined by the housing. In some embodiments, the proximal end portion of the guide wire 2405 is fixed to the device by the holder 2404, and then the guide wire enters the housing at the opening 2406 and exits through the opening 2408, which is optionally located on the opposite wall of the housing with respect to the wall where the opening 2406 is defined. In some embodiments, the proximal portion of the micro catheter 2407 is fixed to the device by the holder 2410, and again, the guide wire is received within the micro catheter lumen. Then, in some embodiments, the micro catheter enters the housing at the opening 2412 and optionally exits the housing at the opening 2414, which is formed in the wall opposite to the opening 2412 of the housing.

[0320] FIG. 25 schematically shows a tool movement drive mechanism of the system according to some embodiments.

[0321] In some embodiments, as shown in this example, the tool movement mechanisms are arranged parallel to each other, for example, arranged side by side in alignment. A potential advantage of the tool movement mechanisms being parallel to each other (and optionally aligned along a similar axial range) is that a tool extending across the entire mechanism can be adjustably bent, and thus can include providing a variable tool length. A potential advantage of the tool movement mechanisms being parallel to each other (and optionally aligned along a similar axial range) can include that the device housing that houses these mechanisms can be maintained in relatively small, compact dimensions that are not determined by the actual length of the tool.

[0322] The tool movement mechanism shown herein includes a mechanism 2501 for holding and optionally rotating a guide wire 2502 (see, for example, the description of FIG. 21A), a mechanism 2503 for actuating the linear movement of the guide wire, including for example a set of wheels 2505, and a mechanism 2507 for actuating the linear movement of a microcatheter 2508, including for example a set of wheels 2509.

[0323] In some embodiments, the rotation of the guide wire may optionally (such as by a device controller) be performed under synchronization in one or both of the mechanisms 2501, 2503.

[0324] FIGS. 26A - B are examples of device configurations including an elastic element (such as a spring) for selectively engaging a tool received by a system according to some embodiments.

[0325] In some embodiments, the elastic element (such as a spring, band) is arranged and configured to move (such as push) a drive wheel towards a tool received within the device and bring the wheel into close contact with the tool. Additionally or alternatively, the elastic element is arranged and configured to move (such as push, center) a tool received within the device into operative contact with the drive wheel.

[0326] In the illustrated example, spring 2601 is attached onto lever 2603 that holds drive wheel 2605. When force is applied to the spring, the lever moves the wheel to contact the tool. In some embodiments, force is applied to the spring by closing a part of the housing, such as closing the lid. In some embodiments, the spring is configured to retract the lever to move the wheel away from the tool, for example, to enable removal of the tool. Optionally, when the lid (or other part of the housing) is opened or otherwise moved, the spring is pulled, thereby moving the wheel away from the tool.

[0327] In some embodiments, the spring is preconfigured to place the wheel in contact with a tool of a selected force for a particular tool or tool size (e.g., tool diameter), such as a tool of a constant thickness.

[0328] As used herein, the terms "insertion device" and "medical device", "robotic device", "robotic system", "device", "system", etc. may be used interchangeably. In some cases, a device is referred to as part of a system.

[0329] As used herein, the terms "medical instrument" and "medical tool", "surgical tool", "elongation tool", etc. may be used interchangeably.

[0330] Some of the examples described throughout this disclosure mainly relate to the insertion of a guidewire into a patient's blood vessel, which is done for reasons of simplicity only. The scope of this disclosure is not limited to devices for guidewire insertion only and may include the insertion of additional medical tools / instruments such as microcatheters, balloon catheters, etc. Furthermore, the scope of this disclosure is not limited to the insertion of medical tools into blood vessels and may also include the insertion of medical tools into other body lumens such as the urethra, gastrointestinal tract, and trachea. In the description and claims of this application, the words "include" and "have" and their forms are not limited to the members in the list to which the word may be associated.

[0331] The terms "comprise", "comprising", "include", "including", "have", and their composites mean "include but are not limited to".

[0332] The term "consisting of" means "including but limited to".

[0333] The term "consisting essentially of" means that a composition, method, or structure may include additional components, steps, and / or parts, but only if the additional components, steps, and / or parts do not substantially change the basic and novel features of the claimed composition, method, or structure.

[0334] As used herein, the singular forms "a", "an", and "the" include plural references unless the context clearly indicates otherwise. For example, the term "compound" or "at least one compound" may include a plurality of compounds including mixtures thereof.

[0335] Throughout this application, various embodiments of the present invention may be presented in a range format. It should be understood that the description in range format is for convenience and brevity only and should not be construed as an inflexible limitation on the scope of the present invention. Thus, a description of a range should be considered to specifically disclose all the possible sub-ranges within that range as well as individual numerical values. For example, a description of a range such as 1 to 6 should be considered to have sub-ranges such as 1 to 3, 1 to 4, 1 to 5, 2 to 4, 2 to 6, 3 to 6, etc., and individual numbers within that range, for example, 1, 2, 3, 4, 5, and 6, etc. This applies regardless of the width of the range.

[0336] Whenever a numerical range is recited herein, it is meant to include any recited number (fractional or integral) within the recited range. The phrase "range / range" where the first one indicates a number and the second one indicates a number, and "range / range" where the first one indicates the number "from" and the second one indicates a number, are used interchangeably herein and are meant to include the first and second recited numbers, as well as all decimals and integers therebetween.

[0337] As used herein, the term "method" refers to a method, means, technique, and procedure for accomplishing a given task, including, but not limited to, methods, means, techniques, and procedures known or readily developed from methods, means, techniques, and procedures known to practitioners in the fields of chemistry, pharmacology, biology, biochemistry, and medicine.

[0338] As used herein, the term "treating" includes eliminating, substantially inhibiting, slowing, or reversing the progression of a condition, substantially ameliorating the clinical or aesthetical symptoms of a condition, or substantially preventing the appearance of the clinical or aesthetical symptoms of a condition.

[0339] For clarity, it is understood that certain features of the invention described in the context of separate embodiments may be provided in combination in a single embodiment. Conversely, for brevity, various features of the invention described in the context of a single embodiment may be provided separately, or in any suitable sub-combination, or as appropriate in any other described embodiment of the invention. Specific features described in the context of various embodiments should not be regarded as essential features of those embodiments unless the embodiments are inoperable without those elements.

[0340] Although the invention has been described in connection with its specific embodiments, it is evident that many alternatives, modifications, and variations will be apparent to those skilled in the art. Accordingly, the invention is intended to embrace all such alternatives, modifications, and variations that fall within the spirit and broad scope of the appended claims.

[0341] All publications, patents, and patent applications mentioned herein are hereby incorporated by reference in their entirety, as if each individual publication, patent, or patent application was specifically and individually indicated to be incorporated by reference herein. Further, any reference or identification of a reference in this application should not be construed as an admission that such reference is available as prior art to the present invention. To the extent that section headings are used, they should not necessarily be construed as limiting. Additionally, any priority document of this application is hereby incorporated by reference in its entirety.

Claims

1. A small robot device for driving and operating the movement of at least one lengthening surgical tool, comprising a housing of the device that defines an internal volume, an assembly for linear movement and / or rotation of a lengthening surgical tool arranged in direct contact with the assembly, and one or more motors arranged and configured to operate the assembly, wherein there is no separation for maintaining sterility between the one or more motors and the assembly such that at least a segment of the lengthening surgical tool contacted by the assembly is located within the same internal volume as the one or more motors, wherein the housing of the device includes a fixing site for holding the proximal end of the lengthening surgical tool, wherein the fixing site is located outside the internal volume, A small robot device.

2. The small robot device comprises two or more motors arranged and configured to operate the assembly, The small robot device according to claim 1.

3. The one or more motors include at least a first motor configured to operate the linear movement of the lengthening surgical tool and a second motor configured to operate the rotation of the lengthening surgical tool, The small robot device according to claim 1.

4. The assembly includes a plurality of wheels arranged and configured to contact the lengthening surgical tool when at least a segment of the lengthening surgical tool is received within the internal volume, The small robot device according to claim 1.

5. The assembly includes an elongating shaft including a central lumen extending along the long axis of the shaft, wherein at least a segment of the lengthening surgical tool is received within the central lumen of the shaft, wherein the plurality of wheels project at least partially into the interior of the shaft so as to contact the lengthening surgical tool, The small robot device according to claim 4.

6. The one or more motors include a first motor that drives the rotation of the plurality of wheels, thereby linearly advancing or retracting the lengthening surgical tool, and a second motor that drives the rotation of the elongating shaft along the plurality of wheels about the long axis of the shaft, thereby rotating the lengthening surgical tool, The small robot device according to claim 5.

7. The assembly further includes a plurality of transmission gears configured between the one or more motors and the assembly, the plurality of transmission gears being located within the internal volume, The small robot device according to claim 1.

8. the plurality of transmission gears being configured to increase or decrease the speed of rotation generated by the one or more motors, The small robot device according to claim 7.

9. the plurality of wheels including a pair of opposing wheels, the segment of the at least one elongating surgical tool extending axially between the respective wheels of the pair, The small robot device according to claim 4.

10. the housing of the device including walls defining an inlet opening and an outlet opening for the elongating surgical tool, The small robot device according to claim 1.

11. the maximum dimension of the housing of the device being dimensioned according to the distance between the inlet opening and the outlet opening, measured across the internal volume, The small robot device according to claim 10.

12. The internal volume is less than 2800 cm ３ and the device being lighter than 850 grams, The small robot device according to claim 1.

13. the small robot device being provided in a sterilized package and being a disposable device, The small robot device according to claim 1.

14. the assembly including a slip ring that is coaxial with the elongating surgical tool when the elongating surgical tool is contacted by the assembly, the slip ring maintaining electrical contact with the one or more motors at all rotational positions of the assembly to supply power to the one or more motors, The small robot device according to claim 1.

15. the elongating surgical tool including a guide wire or a microcatheter, The small robot device according to claim 1.

16. the one or more motors being controlled by a remote controller, The small robot device according to claim 1.

17. A small robot device for driving and operating the movement of at least one elongating surgical tool, having a housing defining an internal volume, including a first motor and a second motor, and at least one tool movement element actuated by at least one of the first motor and the second motor, The tool movement element is arranged and configured to be at least partially received in the robotic device and operably contact the elongate surgical tool to move the elongate surgical tool. The first motor actuates the at least one tool movement element to linearly advance or retract the elongate surgical tool. The second motor actuates the at least one tool movement element to rotate the elongate surgical tool about its longitudinal axis. The housing includes a fixed portion for holding the proximal end of the elongate surgical tool. The fixed portion is located outside of the internal volume. Miniature robotic device.

Images