CN115211968A

CN115211968A - Device for automatic insertion and manipulation of medical tools in body cavities

Info

Publication number: CN115211968A
Application number: CN202210391057.3A
Authority: CN
Inventors: 莎朗·西蒙; 博德·伊丹; 科夫曼·叶夫根尼; 肖哈姆·摩西; 柯恩·伊兰; 莫拉格·艾尔
Original assignee: Technology Research And Development Foundation Co ltd; Micro Robot Medical Co ltd
Current assignee: Technology Research And Development Foundation Co ltd; Micro Robot Medical Co ltd
Priority date: 2021-04-19
Filing date: 2022-04-14
Publication date: 2022-10-21
Also published as: JP2022165406A; CA3156099A1

Abstract

Disclosed is an apparatus for automated insertion and manipulation of medical tools within a body cavity, related to a small robotic device for driving the movement of two or more elongated surgical tools when the two or more elongated surgical tools are at least partially received within the device, the apparatus comprising: a housing comprising a plurality of walls defining a shared interior volume; within the shared internal volume, the housing contains: at least two internal pathways for receiving at least a portion of each of the two or more elongated surgical tools; a plurality of engines; and two or more tool actuation assemblies, each of which is configured at a location of one of the two or more internal pathways, driven by at least one of the plurality of motors, and each of which is configured to operably contact the elongated surgical tool for at least one of advancing, retracting, and/or rolling the elongated surgical tool.

Description

Device for automatic insertion and manipulation of medical tools in body cavities

Related application

The present application claims priority from U.S. continuation-in-part application 17/233,774, filed on.4/19/2021 and U.S. continuation-in-part application 17/678,070, filed on.2/23/2022, the contents of which are hereby incorporated by reference in their entirety as if fully set forth herein.

Technical field and background

The present invention, in some embodiments thereof, relates to the automatic actuation of a plurality of surgical tools inserted into a body cavity.

U.S. patent No. 10543047 discloses "a robotic instrument driver for a plurality of elongate members, including a first elongate member, and at least one manipulator mechanism configured to operate the first elongate member, and at least one articulation driver configured to articulate the first elongate member, which may be positioned on a bed and beside a patient contact point. The manipulator and articulation drive are positioned relative to each other a distance less than the insertable length of the first elongate member, fixed in position. "

Disclosure of Invention

According to an aspect of some embodiments, there is provided a small robotic device for driving movement of two or more elongated surgical tools when the two or more elongated surgical tools are at least partially received within the device, the device comprising:

a housing comprising a plurality of walls defining a shared interior volume; within the shared interior volume, the enclosure contains:

at least two internal pathways for receiving at least a portion of each of the two or more elongated surgical tools;

a plurality of engines;

two or more tool actuation assemblies, each of the two or more actuation assemblies configured at a location of one of the two or more internal paths; each of the two or more actuation assemblies is driven by at least one of the plurality of motors, each of the two or more actuation assemblies configured to operably contact at least one of the two or more elongated surgical tools for advancing, retracting, and/or rolling the at least one of the plurality of elongated surgical tools when the two or more elongated surgical tools are respectively at least partially received in the at least two internal pathways.

In some embodiments, the shared internal volume is free of internal barriers separating the plurality of engines from the two or more actuation assemblies.

In some embodiments, there is no wall, curtain, shroud, or sterility protection separating the plurality of motors from the two or more actuation assemblies.

In some embodiments, each of the two or more internal pathways extends through the internal volume between an inlet aperture and an outlet aperture disposed on opposing walls of the device housing and in communication with the internal volume.

In some embodiments, each of the plurality of actuation assemblies comprises a plurality of wheel pairs, each wheel pair comprising a set of opposing plurality of wheels configured to define the internal path therebetween.

In some embodiments, at least some of the opposing wheels are configured to rotate to advance and retract the elongated surgical tool within the internal path and to roll the elongated surgical tool about a long axis of the elongated surgical tool.

In some embodiments, the plurality of tool actuation assemblies are all confined within the plurality of walls of the housing, and wherein only a portion of the two or more elongated surgical tools, when received within the device, extend outwardly from the plurality of walls of the housing to a distance of at least 1 centimeter from the housing.

In some embodiments, at least one securing location is defined on the exterior of the plurality of walls of the housing for securing a proximal end of at least one of the two or more elongated surgical tools to the housing while a distal portion of the elongated surgical tool is received within the housing within one of the two or more internal pathways.

In some embodiments, the at least one fixed position is located at an exit aperture of the housing such that the elongated surgical tool exiting the interior volume through the exit aperture is introduced into a lumen of a proximal end of a second elongated surgical tool of the two or more elongated surgical tools, forming a telescoping configuration of the two elongated surgical tools.

In some embodiments, the at least one fixation location defines a cavity shaped and configured to receive a proximal handle of the at least one elongated surgical tool.

In some embodiments, the internal volume is less than 2800 centimeters ^3; and the device weighs less than 850 grams.

In some embodiments, the dimensions of the housing include a height less than 30 centimeters, a width less than 30 centimeters, a length less than 30 centimeters; each of the at least two internal pathways extends axially along the length.

In some embodiments, the two or more elongate surgical tools include a guidewire and a microcatheter, the guidewire configured to extend at least partially through a lumen of the microcatheter.

In some embodiments, the robotic device includes a controller configured to control the plurality of motors for driving the two or more actuating assemblies.

In some embodiments, the controller is remotely controlled by an external remote control device.

In some embodiments, when one or more of the two or more elongated surgical tools are received within the internal path, one or more of the two or more elongated surgical tools extend outward from the plurality of walls of the housing and form a curve outside of the device housing.

In some embodiments, each of the plurality of actuating assemblies includes a designated elongate shaft extending axially along at least a portion of a length of the internal path for the elongate surgical tool to extend through.

In some embodiments, the robotic device includes a third actuating assembly connected to the housing and actuated by a plurality of motors residing within the housing to move a third elongated surgical tool.

In some embodiments, a kit is provided, the kit comprising:

a robotic device, for example as described herein;

a guidewire for loading onto the device such that at least a portion of the guidewire extends along one of the at least two internal paths;

a microcatheter for loading onto the device such that at least a portion of the microcatheter extends along a second of the at least two internal pathways.

In some embodiments, there is provided a surgical system comprising:

a robotic device, for example as described herein;

an attachment unit for driving movement of a guide catheter, the attachment unit being mechanically connected to the housing of the robotic device.

According to an aspect of some embodiments, there is provided a small robotic device for driving and manipulating the motion of one or more elongated surgical tools, comprising:

at least one engine;

at least one tool moving element driven by the at least one motor, the tool moving element positioned and configured to operably contact a tool at least partially housed in the robotic device to advance, retract, and/or rotate the elongated surgical tool; and

a device housing shaped and dimensioned to encase the at least one motor and the at least one tool moving element.

In some embodiments, the at least one motor and the at least one tool moving element are confined within a plurality of walls of the housing, and wherein only the one or more elongated surgical tools extend outwardly from the plurality of walls of the housing when housed within the device.

In some embodiments, the walls of the housing define an internal volume of less than 2800 cm ^3, and wherein the weight of the device is less than 850 cm.

In some embodiments, the plurality of walls of the housing define at least one access aperture through which the elongated surgical tool is inserted into the device; and at least one exit hole through which the elongated surgical tool exits the device.

In some embodiments, the plurality of walls of the housing define at least two inlet apertures and at least two outlet apertures for at least two elongated surgical tools.

In some embodiments, the device includes an anchoring location for a proximal portion of the elongated surgical tool, wherein the anchoring location and an inlet aperture for the elongated surgical tool are aligned along a similar wall of the housing such that a length of the elongated surgical tool extends outwardly between the housing and the anchoring location and the inlet aperture, forming a U-shaped curve outside the housing.

In some embodiments, the housing includes a designated elongated shaft for the elongated surgical tool to extend therethrough, the at least one tool moving element being positioned adjacent to the shaft and projecting within the shaft to operatively contact the elongated surgical tool.

In some embodiments, the at least one tool moving element comprises a set of opposing wheels configured to rotate to advance or retract the elongated surgical tool within the shaft.

In some embodiments, the shaft is connected to a gear that, when rotated, rotates the shaft with at least one tool moving element and the tool received therein about the shaft long axis, thereby rolling the tool with the at least one tool moving element.

In some embodiments, an inner contour of the shaft is shaped to match an outer contour of the at least one tool moving element at their interface.

In some embodiments, the device comprises an anchoring position for a proximal portion of the elongated surgical tool, the anchoring position comprising a holder for holding a proximal portion of the elongated surgical tool while a distal portion of the elongated surgical tool is received within the designated elongated shaft.

In some embodiments, one of the plurality of motors is configured to drive rotation of the holder and the elongated shaft, thereby rolling the elongated surgical tool at two spaced apart locations along the length of the elongated surgical tool.

In some embodiments, a bottom wall of the housing is saddle-shaped.

In some embodiments, a bottom wall of the housing is flat.

In some embodiments, the dimensions of the housing include a height less than 30 centimeters, a width less than 30 centimeters, and a length less than 30 centimeters.

In some embodiments, the housing includes a tapered protrusion at the inlet aperture and/or the outlet aperture having a circular outer lip.

In some embodiments, the housing includes a removable or removable cover that provides access to the one or more elongated surgical tools loaded onto the device.

In some embodiments, the device is configured to drive and manipulate motion of at least one of a guidewire and a microcatheter.

According to an aspect of some embodiments, there is provided a surgical system comprising:

a robotic device, for example as described herein; and an attachment unit for driving movement of a guide catheter, the attachment unit being mechanically connected to the housing of the robotic device.

In some embodiments, the system includes a remote control device in communication with a controller of the robotic device.

In some embodiments, the system includes an imaging modality in communication with a controller of the robotic device.

According to an aspect of some embodiments, there is provided an assembly for driving linear and rotational movement of an elongated surgical tool, comprising:

a shaft including a slot in communication with a central lumen of the shaft, the lumen extending along the shaft length axis;

a set of wheels positioned opposite each other and aligned on either side of the slot, the wheels extending at least partially through the plurality of apertures in the elongated shaft and into the slot to contact an elongated surgical tool received therein;

a gear positioned and configured to rotate the shaft with the set of wheels about the shaft long axis when the gear is rotated.

In some embodiments, the gear is linearly aligned with the axis and coaxial with the shaft.

In some embodiments, the assembly includes a motor positioned and configured to drive rotation of the plurality of wheels, and the motor is positioned and configured to rotate with the shaft as the shaft rotates.

In some embodiments, the gear includes a slot on its circumference that is linearly aligned with the slot of the shaft.

In some embodiments, the inner walls of the shaft defining the central lumen have a profile that matches at least a portion of an outer profile of at least one of the wheels of the set of wheels.

In some embodiments, the assembly includes a motor transmission in contact with the gear and configured to rotate the gear.

In some embodiments, each of the set of the plurality of wheels is configured to lie on a plane substantially perpendicular to a plane defined by the slot.

In some embodiments, the set of multiple wheels rotates as the assembly rotates about the shaft long axis such that each wheel of the set of multiple wheels remains located on the plane substantially perpendicular to the plane defined by the slot.

According to an aspect of some embodiments, there is provided a method of operating at least one elongated surgical tool using a surgical robotic device, comprising:

providing a robotic device shaped and dimensioned to be placed adjacent to or on a surgical bed;

loading at least one elongated surgical tool onto the device;

controlling the robot device to operate the at least one elongated surgical tool through a remote control interface to perform a surgical procedure; and

treating the robotic device along with the at least one elongated surgical tool after the surgical procedure.

In some embodiments, the robotic device comprises:

one or more engines;

one or more tool moving elements driven by the one or more motors;

wherein loading brings the at least one elongated surgical tool into direct operable contact with the one or more tool moving elements, and the one or more tool moving elements into direct operable contact with the one or more motors.

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

In some embodiments, the method includes introducing the at least one elongated surgical tool into the body and allowing a plurality of bodily fluids to pass through the elongated surgical tool and into the robotic device.

providing a robotic device shaped and sized to be attached to a limb of a patient;

coupling the robotic device to a limb of the patient;

loading the at least one elongated surgical tool onto the device; and

controlling operation of the robotic device on the at least one elongated surgical tool to perform a surgical procedure.

In some embodiments, the limb is one of: the robotic device is coupled to a patient's leg of the thigh, and the robotic device is coupled to a patient's arm near the wrist.

In some embodiments, the method comprises forming an incision in the groin of the patient and introducing the at least one elongated surgical tool through the incision using the robotic device.

In some embodiments, coupling includes tying the robotic device to the limb.

According to an aspect of some embodiments, there is provided a method of controlling a usable length of an elongated surgical tool, comprising:

providing a robotic device comprising a housing;

loading the elongated surgical tool onto the robotic device such that the elongated surgical tool is held at a first position along the length of the elongated surgical tool and slidably held at a second position along the length of the elongated surgical tool; wherein a section of the tool extending between the first and second positions forms a curve; and

sliding the elongated surgical tool in the second position to shorten or lengthen a distance between a maximum point of the curve and the housing of the robotic device to control the length of the elongated surgical tool.

In some embodiments, the method includes controlling a length of a distal segment of the elongated surgical tool extending from the robotic device housing to a target point within the patient's body by shortening or lengthening.

According to an aspect of some embodiments, there is provided a small robotic device for driving and manipulating the motion of at least two elongated surgical tools, the device comprising:

a housing, comprising:

at least one engine;

at least two assemblies, each assembly configured to drive linear motion and/or rotation of one of the at least two elongated surgical tools, each assembly comprising a plurality of tool moving elements driven by the at least one motor or associated transmission;

wherein the housing defines a volume of less than 2800 cm 3 and weighs less than 850 cm.

According to an aspect of some embodiments, there is provided a small robotic device for driving and operating the motion of at least one elongated surgical tool, the device comprising:

a housing, comprising:

at least one engine;

a first tool moving element driven by the at least one motor, the tool moving element positioned and configured to operably contact an elongated surgical tool at least partially housed in the robotic device to advance or retract the elongated surgical tool; and

a second tool moving element driven by the at least one motor and configured to roll the elongated surgical tool about the long axis of the elongated surgical tool.

In some embodiments, the housing includes a shaft for the elongated surgical tool to extend through, the first tool moving element extending at least partially into the shaft to contact the elongated surgical tool.

In some embodiments, the inner walls of the shaft are contoured to match at least a portion of an outer contour of the first tool moving element.

In some embodiments, the first tool moving element comprises at least one pair of a plurality of wheels that advance or retract the elongated surgical tool depending on the direction of rotation of the wheels.

In some embodiments, the second tool moving element comprises a gear linearly aligned along the shaft and configured to rotate the shaft.

According to some embodiments, a plurality of advantageous medical devices for inserting and advancing a medical tool within a body lumen are provided, wherein the plurality of devices are configured to advance the medical tool in a linear and/or rotational motion. In some embodiments, the plurality of advantageous devices disclosed herein allow for the insertion and advancement of more than one medical tool, either individually or simultaneously, while being small in size, so as to be configured to fit on, or at least close 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 control. In some embodiments, systems are further provided that include the disclosed devices and methods of using the devices in various medical procedures.

According to some embodiments, there is provided a medical device for advancing and inserting a medical tool into a body cavity, the device being configured to be mounted on or positioned adjacent to the body of the subject and comprising: a housing configured for positioning the medical device on or near the body of the subject; at least one motion control unit comprising at least one linear actuator configured for linearly advancing the medical tool and at least one rotary actuator configured for rotating the medical tool; wherein the at least one rotary actuator and the at least one linear actuator are activated simultaneously and/or independently of each other.

According to some embodiments, the apparatus may further comprise a controller configured to activate the at least one linear actuator and the at least one rotary actuator. According to some embodiments, the controller may be configured to be manually operated by a user. According to some embodiments, the controller may be configured to receive a plurality of instructions from a processor. In some embodiments, the device may be autonomously controlled by a computer.

According to some embodiments, the at least one linear actuator and the at least one rotary actuator may have one or more universal actuators.

According to some embodiments, the at least one linear actuator may comprise an actuator selected from the group consisting of: a DC motor, an AC motor, a stepper motor, an electromagnetic actuator, a piezoelectric actuator, a pneumatic actuator, a hydraulic actuator, or any combination of the foregoing.

According to some embodiments, the at least one rotary actuator may comprise an actuator selected from the group consisting of: a DC motor, an AC motor, a stepper motor, an electromagnetic actuator, a piezoelectric actuator, a pneumatic actuator, a hydraulic actuator, or any combination of the preceding. 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.

According to some embodiments, the medical tool may be selected from the following: a guidewire, microcatheter, balloon catheter, guide catheter, stent placement catheter, embolic catheter, stent retrieval device, or the like, or any combination thereof.

According to some embodiments, the body cavity may be selected from a blood vessel, urethra and trachea, stomach anatomy, and the like. According to some embodiments, the apparatus may include more than one motion control unit, wherein 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 perform a separate or combined motion of the plurality of medical tools.

According to some embodiments, the device may comprise two motion control units, wherein a first motion control unit is configured to linearly advance and/or rotate a first medical tool and a second motion control unit is configured to linearly advance and/or rotate a second medical tool.

According to some embodiments, the first medical tool may be a guidewire and the second medical tool may be a catheter.

According to some embodiments, the first medical tool may be configured to be advanced through a lumen of the second medical tool.

According to some embodiments, the device may be further configured to allow control of the plurality of tip parameters of the medical tool.

According to some embodiments, the motion control unit may comprise at least two discs opposing each other along a portion of their outer circumference such that the medical tool can be placed in a space formed therebetween while maintaining at least partial contact with at least one of the plurality of discs, whereby the medical tool advances linearly as the plurality of discs spin. The surfaces of the outer peripheries of the plurality of disks may be rough, soft, smooth, coated, spongy, hydrophilic, hydrophobic or have other properties that may optimize the interaction with the medical tool. The plurality of drive disks may be assembled in such a way that the medical tool is not driven along a straight line, but along a curved path, allowing for higher drive forces and higher rotational moments.

According to some embodiments, the medical device may further comprise a power source.

According to some embodiments, the device may be configured to linearly advance the medical tool at a constant or varying rate (speed).

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

According to some embodiments, there is provided a system for inserting the medical tool into a body cavity, the system comprising: a medical device for inserting the medical tool into the body cavity, the device being configured for positioning on or near a body of a subject, and comprising: at least one motion control unit comprising at least one linear actuator configured for linearly advancing the medical tool and at least one rotary actuator configured for rotating the medical tool; a controller configured to activate the at least one linear actuator and the at least one rotary actuator, the controller configured to activate the at least one rotary actuator and the at least one linear actuator at least one of simultaneously and independently of each other; and a processor configured to provide the plurality of instructions to the controller.

According to some embodiments, the controller may be configured to be manually operated by a user.

According to some embodiments, the controller may comprise a plurality of activation buttons selected from the following: a plurality of push buttons, a plurality of slide buttons, a joystick, or any combination of the foregoing.

According to some embodiments, the systems disclosed herein are used to automatically insert and advance the medical tool into the body lumen during a medical procedure.

According to some embodiments, the medical procedure may include an intravascular procedure selected from the group consisting of coronary, peripheral and cerebral intravascular procedures, gastric procedures, urinary tract procedures, and respiratory tract procedures.

According to some embodiments, the system may further comprise or be configured to operate with an imaging device. According to some embodiments, the imaging device may be selected from the following: an X-ray device, a fluoroscopic image, a CT device, a cone beam CT device, a CT fluoroscopic image, an MRI device, and an ultrasonic device. According to some embodiments, there is provided a method for inserting and advancing a medical tool into a body lumen, the method comprising: mounting and securing the medical device disclosed herein on or positioning the medical device in proximity to the body of a subject and advancing the medical tool into the body cavity of the subject. In some embodiments, the method is automated (i.e., advancement of the medical tool is performed automatically by the medical device).

According to some embodiments, there is provided a body-mountable medical device for inserting a medical tool into a body cavity, the device comprising: a housing configured for positioning on and securing to a body of a subject; at least one linear actuator configured for linearly advancing the medical tool; at least one rotary actuator configured for rotating the medical tool; a controller configured to activate the at least one linear actuator and the at least one rotary actuator; wherein the controller is configured to activate the at least one rotary actuator and the at least one linear actuator at least one of simultaneously and independently of each other.

According to some embodiments, the guide wire and microcatheter entering and exiting the device from the trailing and leading ends advantageously allow a microcatheter to be moved over the guide wire without the microcatheter actuation compromising the guide wire actuation.

Certain embodiments of the present disclosure may include some, all, or none of the above advantages. One or more other technical advantages may be readily apparent to one skilled in the art from the figures, descriptions, and claims included herein. Moreover, while specific advantages have been enumerated above, various embodiments may include all, some, or none of the enumerated advantages.

According to an aspect of some embodiments, there is provided a medical device for advancing and inserting a medical tool into a body lumen, comprising: a housing configured for positioning on or near a body of a subject and securing thereto; at least one motion control unit comprising at least one linear actuator configured for linearly advancing the medical tool and at least one rotary actuator configured for rotating the medical tool; wherein the at least one rotary actuator and the at least one linear actuator are activated simultaneously and/or independently of each other.

In some embodiments, the apparatus includes a controller configured to activate the at least one linear actuator and the at least one rotary actuator.

In some embodiments, the controller is configured to be manually operated by a user.

In some embodiments, the controller is configured to receive instructions from a processor.

In some embodiments, the at least one linear actuator and the at least one rotary actuator have one or more actuators in common.

In some embodiments, the at least one linear actuator comprises an actuator selected from the group consisting of: a DC motor, an AC motor, a stepper motor, an electromagnetic actuator, a piezoelectric actuator, a pneumatic actuator, a hydraulic actuator, or any combination of the preceding.

In some embodiments, the at least one rotary actuator comprises an actuator selected from the group consisting of: a DC motor, an AC motor, a stepper motor, an electromagnetic actuator, a piezoelectric actuator, a pneumatic actuator, a hydraulic actuator, or any combination of the foregoing.

In some embodiments, the medical device is disposable.

In some embodiments, the medical tool is selected from the following: a guidewire, a microcatheter, a balloon catheter, a guide catheter, a stent, a retrieval device, or any combination of the foregoing.

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

In some embodiments, the apparatus comprises more than one motion control unit, wherein each control unit is configured to linearly advance and/or rotate a separate medical tool.

In some embodiments, the apparatus comprises two motion control units, wherein a first motion control unit is configured to linearly advance and/or rotate a first medical tool and a second motion control unit is configured to linearly advance and/or rotate a second medical tool.

In some embodiments, the first medical tool is a guidewire and the second medical tool is a catheter.

In some embodiments, the first medical tool is configured to be advanced through a lumen of the second medical tool.

In some embodiments, the device is further configured to allow control of the plurality of tip parameters using an additional actuator of the medical tool.

In some embodiments, the motion control unit includes at least two discs opposing each other along a portion of an outer periphery thereof such that the medical tool can be placed in a space formed therebetween while maintaining at least partial contact with at least one of the plurality of wheels, whereby the medical tool advances linearly as the plurality of discs spin. In some embodiments, the device includes a power source.

In some embodiments, the device is configured to linearly advance the medical tool at a constant or varying rate (velocity).

In some embodiments, is configured to automatically insert and advance the medical tool into the body lumen.

According to an aspect of some embodiments, there is provided a system for inserting a medical tool into a body cavity, the system comprising: a medical device for inserting a medical tool into the body cavity, the device comprising: a housing configured for positioning on or near a body of a subject and securing thereto; at least one motion control unit comprising at least one linear actuator configured for linearly advancing the medical tool and at least one rotary actuator configured for rotating the medical tool; a controller configured to activate the at least one linear actuator and the at least one rotary actuator, the controller configured to activate the at least one rotary actuator and the at least one linear actuator at least one of simultaneously and independently of each other; and a processor configured to provide the plurality of instructions to the controller.

In some embodiments, the controller includes a plurality of activation buttons selected from the following: a plurality of push buttons, a plurality of slide buttons, a joystick, or any combination of the foregoing.

In some embodiments, the at least one linear actuator comprises an actuator selected from the group consisting of: a DC motor, an AC motor, a stepper motor, an electromagnetic actuator, a piezoelectric actuator, a pneumatic actuator, a hydraulic actuator, or any combination of the foregoing.

In some embodiments, the medical device is disposable.

In some embodiments, the medical tool is selected from the following: a guide wire, a microcatheter, a guide catheter and a balloon catheter.

In some embodiments, the body cavity is selected from a blood vessel, urethra, stomach, and trachea.

In some embodiments, the system comprises two motion control units, wherein a first motion control unit is configured to linearly advance and/or rotate a first medical tool and a second motion control unit is configured to linearly advance and/or rotate a second medical tool. In some embodiments, the first medical tool is a guidewire and the second medical tool is a catheter.

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

In some embodiments, the medical procedure is selected from the group consisting of coronary, peripheral and cerebral intravascular procedures, gastric procedures, multiple urinary tract procedures, and multiple respiratory tract procedures.

In some embodiments, the system further includes an imaging device.

In some embodiments, the imaging device is selected from the following: an X-ray device, a fluoroscopic image, a CT device, a cone beam CT device, a CT fluoroscopic image, an MRI device, and an ultrasonic device.

According to an aspect of some embodiments, there is provided a method for inserting and advancing a medical tool into a body lumen, the method comprising: positioning a medical device on or near a body of a subject, the device comprising: a housing configured for positioning and securing the medical device on or near a body of a subject; at least one motion control unit comprising at least one linear actuator configured for linearly advancing the medical tool and at least one rotary actuator configured for rotating the medical tool; wherein the at least one rotary actuator and the at least one linear actuator are activated simultaneously and/or independently of each other; and; advancing the medical tool into the body lumen of the subject.

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

In some embodiments, the advancing of the medical tool is performed automatically by the medical device.

According to an aspect of some embodiments, there is provided a medical device for inserting a medical tool into a body cavity, comprising: a housing configured for positioning on or near a body of a subject and securing thereto; at least one linear actuator configured for linearly advancing the medical tool; at least one rotary actuator configured for rotating the medical tool; a controller; configured to activate the at least one linear actuator and the at least one rotary actuator; wherein the controller is configured to activate the at least one rotary actuator and the at least one linear actuator at least one of simultaneously and independently of each other.

In some embodiments, the controller is configured to receive a plurality of instructions from a wireless remote control.

In some embodiments, the wireless remote control is a Wi-Fi remote control or a Bluetooth remote control.

In some embodiments, the at least one linear actuator and the at least one rotary actuator have one or more universal actuators.

In some embodiments, the at least one linear actuator comprises at least one piezoelectric actuator.

In some embodiments, the at least one rotary actuator comprises at least one piezoelectric actuator.

a housing comprising a plurality of walls defining an interior volume including at least two internal pathways for receiving the two or more elongated surgical tools

The shell encases:

a plurality of engines;

two or more tool actuation assemblies configured at a location of each of the two or more internal paths; the plurality of actuation assemblies are driven by a plurality of motors and are configured to operably contact an elongated surgical tool at least partially received in the internal path to at least one of advance, retract, and/or roll the elongated surgical tool.

In some embodiments, there is no internal barrier between the two or more internal pathways, such that the two or more tool actuation assemblies and the plurality of engines share the internal volume without separation therebetween.

In some embodiments, at least one securing location is defined on the exterior of the plurality of walls of the housing for securing a proximal end of an elongated surgical tool to the housing.

In some embodiments, the at least one fixation location is located at one of the plurality of exit holes such that an elongated surgical tool exiting the interior volume through the exit hole is directed into a lumen of a proximal end of a second elongated surgical tool, forming a telescoping configuration of the two tools.

In some embodiments, the at least one fixation location and one of the at least two inlet apertures are defined along the same wall of the housing such that an elongated surgical tool secured to the device at the at least one fixation location forms a curve prior to entering the interior volume through the at least one inlet aperture.

In some embodiments, the two or more internal pathways are parallel to each other and have a similar axial extent.

In some embodiments, a distance between major axes of the internal paths is less than 10 centimeters.

In some embodiments, the internal volume is less than 2800 cm ^3; and wherein the device has a weight of less than 850 grams.

In some embodiments, the plurality of engines comprises 3 to 5 engines.

In some embodiments, each of the plurality of actuation assemblies comprises:

a designated elongate shaft extending axially along at least a portion of a length of said internal path for said elongate surgical tool to extend therethrough; and

at least one pair of a plurality of wheels positioned proximate to and projecting within the shaft to operably contact the elongated surgical tool received within the shaft.

In some embodiments, the at least one pair of the plurality of wheels comprises a set of opposing plurality of wheels configured to rotate to advance or retract the elongated surgical tool within the shaft.

In some embodiments, the shaft is connected to a gear that, when rotated, rotates the shaft, along with the plurality of wheels and the elongated surgical tool received therein, about the shaft long axis, thereby rolling the elongated surgical tool.

In some embodiments, the dimensions of the housing include a height less than 30 centimeters, a width less than 30 centimeters, a length less than 30 centimeters; wherein each of the plurality of internal pathways extends axially along the length.

In some embodiments, at least one of the inlet apertures and/or at least one of the outlet apertures of the housing includes a tapered protrusion having a rounded outer lip.

In some embodiments, the housing includes a removable or removable cover that provides access to the one or more elongated surgical tools loaded onto the device and extending along at least a portion of the plurality of internal paths.

In some embodiments, the device is configured to drive movement of a guidewire and a microcatheter, the guidewire configured to extend at least partially through a lumen of the microcatheter.

In some embodiments, the apparatus includes a controller configured to control the plurality of motors for driving the two or more actuating assemblies.

In some embodiments, a kit is provided, the kit comprising: an apparatus such as described herein; a guidewire for loading onto the device such that at least a portion of the guidewire extends along one of the plurality of internal pathways; and a microcatheter for loading onto the device such that at least a portion of the microcatheter extends along a second one of the plurality of internal pathways.

In some embodiments, there is provided a surgical system, the system comprising: a robotic device such as described herein; and an attachment unit for driving movement of a guide catheter, the attachment unit being mechanically connected to the housing of the robotic device.

Unless defined otherwise, 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 belongs. Although any methods and materials similar or equivalent to those described herein can be used in the practice or testing of embodiments of the present invention, a variety of exemplary methods and/or materials are described below. In case of conflict, the patent specification, including definitions, will control. In addition, the materials, methods, and examples are illustrative only and not intended to be necessarily limiting.

Implementation of the method and/or system of various embodiments of the present invention may involve performing or completing selected tasks manually, automatically, or a combination thereof. Furthermore, the actual instrumentation and equipment according to the various embodiments of the method and/or system of the present invention may use an operating system to accomplish several selected tasks, either in hardware, software or firmware, or a combination of the foregoing.

For example, hardware for performing selected tasks according to embodiments of the invention may be implemented in a chip or a circuit. As software, selected tasks according to embodiments of the invention could be performed by software instructions being executed by a computer using any suitable operating system. In an exemplary embodiment of the invention, one or more tasks according to exemplary embodiments of the methods and/or systems described herein are performed by a data processor, such as a computing platform for executing instructions. Optionally, the data processor includes a volatile memory and/or a non-volatile memory for storing instructions and/or data, such as a magnetic hard disk and/or removable media for storing instructions and/or data. Optionally, a network connection is also provided. Optionally, a display and/or a user input device such as a keyboard or mouse are also provided.

Drawings

Some embodiments of the present invention are described herein by way of example only and with reference to the accompanying drawings, in which specific references are made to the drawings and it is stressed that the particulars shown are by way of example and for purposes of illustrative discussion of various embodiments of the present invention. Based on this, the figures and the description are combined to make the embodiment of the invention clear to the skilled person.

In the plurality of drawings:

fig. 1 shows a schematic view of a medical system including an insertion device secured to a body of a subject, in accordance with some embodiments;

figures 2A-2B show schematic perspective views (front and back, respectively) of an insertion device according to some embodiments;

figures 3A-3B show schematic perspective views of an insertion device according to some embodiments;

figures 4A-4B show schematic perspective cross-sectional views of the insertion device shown in figures 3A-3B according to some embodiments;

FIG. 5 shows a schematic perspective top view of a plurality of motion control units of an insertion device according to some embodiments;

FIG. 6A shows a schematic perspective view of an insertion device according to some embodiments;

FIG. 6B shows a perspective view of a motion control unit according to some embodiments;

FIG. 6C illustrates a side view of a motion control assembly according to some embodiments;

FIG. 7 shows a longitudinal cross-sectional view of a motion control assembly of FIG. 6C;

FIG. 8 schematically illustrates a motion control unit according to some embodiments;

fig. 9A-9B illustrate a mobile unit for linear advancement and/or rotational movement of a medical instrument, according to some embodiments. Fig. 9A schematically illustrates a piezoelectric actuation mechanism for linear translation of a medical tool, and fig. 9B schematically illustrates a piezoelectric actuation mechanism for rotating a medical tool, in accordance with some embodiments;

FIG. 10 depicts a schematic view of an exemplary device capable of imparting linear and rotational motion on a medical tool, in accordance with some embodiments;

FIG. 11 illustrates a motion control unit according to some embodiments;

FIG. 12 illustrates an assembly of multiple motion control units for controlling motion of more than one medical instrument, according to some embodiments;

FIG. 13 is a block diagram of a surgical robotic system according to some embodiments;

FIG. 14 is a flow diagram of a general method of using a surgical robotic device according to some embodiments;

FIG. 15 is a flow diagram of a method of loading a plurality of surgical tools onto the surgical robotic device, according to some embodiments;

fig. 16A-16D are various configurations of a robot of the surgical robotic system according to some embodiments;

fig. 17 is a schematic example of a screen interface associated with the surgical robotic system, according to some embodiments;

18A-18B are different views of a robotic device according to some embodiments;

19A-19B schematically illustrate a surgical robotic device including or attached to a guide catheter drive unit, according to some embodiments;

20A-20C are an example of a separate mechanism for the guide catheter drive unit, an example of a guide catheter drive unit housing, and an example of a guide catheter drive unit assembled to the robotic surgical system, according to some embodiments;

21A-21C illustrate mechanisms for actuating rotational (rolling) and/or linear motion of a tool actuated by the robotic surgical system, in accordance with some embodiments;

fig. 22 illustrates an exemplary configuration of mechanisms for driving movement of a guidewire according to some embodiments;

23A-23B are a schematic and a flow diagram relating to controlling a length and/or position of a tool by adjusting a bend portion of the tool, in accordance with some embodiments;

FIG. 24 illustrates a system configuration defining an arrangement of tools, in which a tool length may be adjusted, in accordance with some embodiments;

FIG. 25 schematically illustrates a plurality of tool movement drive mechanisms of the system according to some embodiments;

26A-26B are examples of a device configuration including resilient elements (e.g., springs) for selectively engaging tools received by the system, according to some embodiments;

fig. 27 is a schematic block diagram of a robotic device configured for manipulating two or more elongated surgical tools, according to some embodiments;

fig. 28 schematically illustrates a robotic device for manipulating a guidewire and a microcatheter, the guidewire extending at least partially within the microcatheter lumen, in accordance with some embodiments; and

fig. 29 schematically illustrates a robotic device for manipulating three or more elongated surgical tools configured for a telescopic configuration, in accordance with some embodiments.

Detailed Description

A broad aspect of some embodiments is directed to a small robotic device for manipulating the movement of a plurality of elongated intra-operative tools that extend and bend outside of the device housing. Some embodiments described herein relate to a robotic device adapted to manipulate structural, functional and/or design features of the tool using a small size that is not affected by the length of the tool being manipulated. In some embodiments, a plurality of characteristics (e.g., volume, weight) of the robotic device are determined solely by the electrical and mechanical components of the device, and not substantially by the plurality of tools being manipulated.

One aspect of some embodiments is directed to a small robotic device shaped and dimensioned to be mounted to a patient's body and/or a surgical bed. In some embodiments, the device has a volume less than 3000 cm ^3, 2800 cm ^3, 2500 cm ^3, or an intermediate, larger, or smaller volume. In some embodiments, the device has a weight of less than 1000 grams, 850 grams, 500 grams, or an intermediate, greater, or lesser weight.

In some embodiments, the device includes a plurality of actuation mechanisms for moving one or more elongated surgical tools (e.g., a guidewire, a microcatheter), e.g., for linearly advancing or retracting the tools, for rolling the tools. In some embodiments, a device housing encloses the plurality of actuation mechanisms, while walls of the housing define inlet and/or outlet holes and/or anchoring locations for the tool. In some embodiments, an anchoring location (e.g., a holder) at a proximal portion of the tool is connected to the housing, and an inlet aperture for a tool to the inside of the housing is aligned with each other along a similar horizontal or vertical axis, such that a tool segment extending between the anchoring location and the inlet aperture forms a curve outside the device housing. In some embodiments, an anchoring location and an access hole of the tool are defined in a similar face (or wall) of the device housing. In some embodiments, an inlet aperture and an outlet aperture for the same tool are disposed on opposing walls of the housing such that a tool entering the housing extends through the interior space defined by the housing to the outlet aperture.

In some embodiments, no portion of the device protrudes outward from the housing, and optionally, only the plurality of tools loaded onto the device extend outward from the housing.

In some embodiments, a maximum dimension of the robotic device housing (e.g., a width, a height in a box-shaped device) is a function of a distance between exit and entrance apertures of a tool that curves outside of the device. For example, the distance between the outlet and inlet holes may be set according to a minimum radius of curvature that the tool can withstand. In an example, a maximum dimension of the device housing is 2 to 6 times, 2 to 10 times, 2 to 5 times, or an intermediate, higher or lower multiple of a minimum radius of curvature of a tool manipulated by the device and bent outside the housing. A potential advantage of determining a device housing of a maximum size based on a minimum radius of curvature of a tool that bends upon exiting and re-entering the housing may include providing a small, minimum size housing. In one example, for a tool having a minimum radius of curvature X, a minimum distance between the entry and exit holes of the tool would be 2X. In this case, a wall of the housing into and out of which the tool enters and exits comprises a width of, for example, 2X, 2.1X, 3X, 5X or an intermediate, larger or smaller dimension.

In some embodiments, a minimum radius of curvature of an elongate tool comprises a maximum bend of the tool that still allows the tool to function, for example, to allow torque to be transmitted along the length of the tool. In some embodiments, a minimum radius of curvature for an elongate tool includes a bend in which the tool remains intact (e.g., undamaged).

In some embodiments, the exit and entry apertures from and to the housing are shaped to reduce or avoid friction between the tool and the edges of the aperture, for example, by circular lips having a tapered profile and/or the aperture. One potential advantage of forming a plurality of holes without sharp edges may include reducing frictional contact between the tool and the walls of the housing, which may reduce a risk of the tool wearing or tearing, particularly as the tool extends and bends outside the housing before re-entering the housing.

In some embodiments, a shape and/or size of the housing is determined by the mechanical and/or electrical components within the housing, such as an engine, engine transmission (e.g., gears), tool actuation mechanisms (e.g., tool moving elements, such as wheels). In some embodiments, the housing is sized as small as possible while still fully enclosing the plurality of mechanical components therein. Optionally, the plurality of mechanical components of the robotic device do not protrude outward from the housing. Optionally, no additional mechanical components from outside the housing are required to perform the actuation of the plurality of tools. In some embodiments, the housing is shaped and configured such that only the plurality of elongate surgical tools extend into and out of the housing. In some embodiments, extending out of the housing comprises extending away from a wall of the housing, e.g., at least 1 cm, at least 2 cm, at least 4 cm, or an intermediate, longer or shorter distance away from a wall through which the tool exits the housing. For example, a surgical tool, such as a guidewire or a microcatheter, is extended at least 1 cm away from the housing.

In some embodiments, components integral with the housing, such as protrusions defining lips of inlet and/or outlet ports of the housing, extend from the housing a distance of less than 1 cm, less than 0.5 cm, less than 0.3 cm, or an intermediate, longer or shorter distance.

In some embodiments, a housing of the robotic device is not limited to a particular orientation, e.g., such that the housing can be positioned in at least a first orientation and a second orientation, e.g., wherein the second orientation is at 90 degrees or 180 degrees from the first orientation. In some embodiments, there is a symmetry such that at least two opposing faces of the housing are similar in profile and size, allowing the device to be positioned in one of two "flipped" orientations.

In some embodiments, a plurality of pathways are defined through an interior volume of the device, wherein a plurality of actuation mechanisms for driving movement of a tool received within a pathway are disposed along the pathway. In some embodiments, a path extends between an inlet aperture to the interior volume of the device housing and an outlet aperture to the interior volume. In some embodiments, the plurality of inlet and outlet apertures are defined on opposing walls of the housing. In some embodiments, the apparatus includes a plurality of paths (e.g., 2, 3, 4,6 or intermediate, greater or lesser number of paths) for receiving a corresponding number of elongated surgical tools, each tool being received within a path. In some embodiments, the plurality of long axes of the plurality of paths are parallel. In some embodiments, multiple actuation mechanisms of multiple paths are aligned side-by-side and optionally extend along a similar axial extent. In some embodiments, there are no barriers (e.g., walls, shields, curtains, etc.) between the multiple actuation mechanisms of the multiple pathways, and the actuation mechanisms share a similar space.

An aspect of some embodiments is directed to a disposable robotic device for manipulating a plurality of elongated surgical tools. In some embodiments, the device is treated after the surgical procedure (optionally along with the plurality of tools operated by it). In some embodiments, the disposable device need not be covered with a sterile drape or cover. In some embodiments, no additional mechanical components are required to be operably connected to the disposable robotic device to drive and/or manipulate multiple tools loaded within the device. In some embodiments, the device provides packaging and pre-sterilization, optionally with one or more pre-loading means. Additionally or alternatively, a plurality of tools are loaded onto the device in the operating room.

In some embodiments, a tool loaded onto the device is in direct operative contact with one or more tool moving elements that manipulate it. In some embodiments, one or more tool moving elements are in direct operable contact with the one or more motors. In some embodiments, the one or more motors and one of the plurality of tool moving elements are enclosed in a single housing, and the housing is disposed along with its contents at the completion of the clinical procedure.

In some embodiments, multiple components of the robotic device, such as the multiple tool drive assemblies, and optionally the entire robotic device, are disposed of after use along with the multiple tools manipulated by the device. A potential advantage of a disposable device may include allowing the tools manipulated by the device to directly contact and/or reside in a similar shared volume with device components, including motion-driven components such as motors and/or transmission gears.

In some embodiments, there is no boundary element or barrier between the tool and its moving elements and/or drive motors within the housing. This is possible in some embodiments because the device is disposed of after use, thus avoiding the risk of contamination that may occur, for example, upon repeated use. Some potential advantages of an apparatus in which the loaded tool may directly contact tool moving elements of the apparatus (and/or other apparatus components, such as a motor) may include simplified use, potentially reduced loading time, and potentially improved mechanical engagement with the tool (e.g., because no "boundary" components are required), thereby reducing or avoiding unnecessary tool motions, such as slipping, twisting, or kinking of the tool.

In some embodiments, no sterile barrier is required between the plurality of device drive assemblies and the plurality of tools operated by the device. In some cases, the presence of the plurality of tools and the plurality of device drive assemblies in the same shared volume may mean that during operation, fluids (e.g., blood, salt) that are contacted by and/or flow within the tools may also come into contact with the plurality of device actuating components, however, since the devices are provided in a sterile state and do not require cleaning or re-sterilization after use, a contamination risk may be reduced or prevented.

In some embodiments, the device is made of a number of materials that are durable, lightweight, disposable, and optionally recyclable, such as plastic, aluminum, steel, copper, and/or other suitable metals.

One aspect of some embodiments relates to a dual function component in which linear and rotational movement (e.g., rolling) of an elongate tool occurs at a same physical location. In some embodiments, the assembly is configured for linearly moving the tool while the tool is being scrolled; or vice versa, the tool is rolled while it is moved linearly.

In some embodiments, the assembly comprises an elongate shaft having a central lumen in which the tool is received. A set of a plurality of wheels is positioned about the shaft and each of the plurality of wheels extends at least partially into the central lumen to operably contact the tool inside. In some embodiments, an engine driving rotation of the plurality of wheels is mounted adjacent to the plurality of wheels, e.g., below the axle. In some embodiments, rotation of the plurality of wheels pushes or retracts the tool, depending on the direction of rotation. In some embodiments, the motor driving rotation of the plurality of wheels is configured as part of the assembly. Alternatively, the driving force is transmitted to the plurality of wheels through an engine transmission.

In some embodiments, the inner walls of the shaft defining the central lumen are contoured to match an outer contour of at least some of the wheels. In this configuration, the central lumen extends into a space between the wheels, bringing the tool into close contact with the wheels. In one example, in a 4-wheel assembly, the inner walls of the shaft may be contoured to match at least one, two, three, or all four of the wheels at the central lumen segment closest to a point of contact where the tool contacts the wheels.

In some embodiments, a gear coaxial with the shaft is connected along the shaft and/or at a proximal or distal end of the shaft such that when the gear rotates, the shaft and wheel set rotate as a single unit through the gear, thereby rolling the tool (e.g., guidewire, steerable microcatheter) within the central lumen of the shaft.

A potential advantage of an assembly that drives linear and rotational motion of a tool at a same physical location (e.g., a particular physical location within the device housing and/or a particular location engaged with the tool) may include reducing or avoiding unwanted tool motion, such as sliding, kinking, twisting, which may occur, for example, if two spaced apart mechanisms drive linear and rotational motion, respectively, and the tool needs to extend between locations where the unwanted motion may occur. Another potential advantage is the compact design achieved by assigning two functions (e.g., rotation and advancement/retraction of the tool) to the same point.

One aspect of some embodiments pertains to using the same motor to drive rotation (roll) of an elongate tool at two spaced apart engagement locations along the length of the tool. In some embodiments, the tool is engaged by components that rotate the tool at the two or more points along the length of the tool, e.g., at a proximal portion of the tool (e.g., adjacent a handle of the tool), and at a distal portion. In an exemplary configuration, a first gear rotates a holder that holds a proximal portion of the tool; rotation of the first gear then rotates a second gear that is part of the linear motion assembly (such as described herein), wherein the second gear rotates a shaft in which a distal portion of the tool is received. In this configuration, actuation of a single motor drives rotation of the first and second gears, producing rotation (rolling) of the tool in two engaged positions.

A potential advantage of using a single motor to drive rotational motion at two spaced apart engagement locations along the length of the tool may include improved control of the tool, for example, where the actuation times and/or speeds and/or directions of the two motors would need to be synchronized to ensure that the tool rolls evenly along its length, as compared to using two different motors to drive rotation at the two locations.

In some embodiments, one or more tools manipulated by the device are engaged and manipulated only from their proximal portions (e.g., from a tool handle); while one or more additional tools are engaged at a remote section thereof (i.e., not from the tool handle).

An aspect of some embodiments relates to controlling a usable length of an elongated surgical tool by modifying a dimension of a curve of the tool external to the robotic device. In some embodiments, a tool manipulated by the device extends outside the housing in a curved manner (bend) one or more times. In some embodiments, the size of the curve expands or contracts as a length of a distal segment (e.g., a tool segment extending between an exit orifice of the device housing and a target in the patient's body) changes. In some embodiments, a tool enters and exits the device housing multiple times, forming more than one curve outside the housing. For example, a guidewire bends twice, once independently between a proximal handle and a distal portion, and a second time when received within a lumen of a curved microcatheter. In some embodiments, the curve is a "U" shaped curve, which may be modified, for example, by lengthening or shortening a distance of a maximum point of the "U" relative to the nearest wall of the device housing.

The present invention, according to some embodiments, relates to automated devices for inserting an elongated surgical medical tool into a body cavity, and more particularly to body-mountable automated devices for inserting elongated surgical medical tools, such as guidewires and microcatheters, into blood vessels.

Many medical procedures, such as catheterization for multiple diagnostic and/or therapeutic purposes, require the insertion of a catheter into multiple blood vessels and other multiple body cavities of the patient.

Typically, the physician first inserts a guidewire into an artery, such as the femoral artery or a vein, and guides it through the tortuous vasculature until it reaches the target, which may be the heart, an artery, a peripheral blood vessel, the brain, etc. Once properly positioned, the physician places a catheter over the guidewire and pushes the catheter until it also reaches the target. In some cases, the procedure requires the use of a small radius catheter, commonly referred to as a microcatheter. In this case, the physician may insert the microcatheter directly without the use of a guidewire. Manual insertion and guidance of guide wires/microcatheters through the tortuous vasculature is not only challenging for the physician, but can also be dangerous for the patient, as even subtle erratic movements can lead to accidental perforation of the vessel wall. In addition, multiple manual procedures require the physician and other medical personnel to be present in the procedure room during the entire procedure. Since most invasive procedures are performed under imaging (e.g., X-ray, CT, etc.), the medical personnel as well as the patient are exposed to radiation.

In recent years, a number of remotely operated automated (robotic) devices have been developed, however, a number of existing robotic devices are both cumbersome and expensive. Accordingly, there is a need for a small, inexpensive, and easy to use automated device for inserting multiple guide wires and/or multiple microcatheters into multiple body lumens, such as multiple blood vessels, and guiding therethrough to a target area.

According to some embodiments, the insertion device may include a power source. In some embodiments, the power source may be a battery, power supply, or the like. 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 supply may be directly or indirectly connected to a primary power source. In some embodiments, the insertion device may include one or more Printed Circuit Boards (PCBs) configured to relay/process/communicate a plurality of instructions and/or electrical connections between various components of the device.

According to some embodiments, the insertion device may allow linear and/or rotational advancement/movement of the medical instrument. In some embodiments, the insertion device may be configured to automatically advance the insertion device and/or further to automatically allow the rotational movement thereof by rotating the insertion device. In some embodiments, when the medical tool is a guidewire, the insertion device may allow control of the plurality of linear and/or rotational and/or tip parameters of the guidewire. In some embodiments, when the medical tool is a guidewire, the insertion device may allow for automatic and/or remote control of the plurality of linear and/or rotational and/or tip parameters of the guidewire. In some embodiments, the medical instrument may be preloaded onto the medical device prior to use in a medical procedure. In some embodiments, the medical instrument may be preloaded onto the medical device prior to being placed on the body of the subject.

According to some embodiments, an insertion device is provided that is configured to remotely and automatically linearly advance one or more medical tools (e.g., a guidewire and catheter) into and within a plurality of body lumens (e.g., a plurality of blood vessels) for a plurality of intravascular procedures, including coronary, peripheral, and cerebral intravascular procedures. In some embodiments, the insertion device is configured to further automatically and/or remotely control/allow the rotational movement of the one or more medical tools. In some embodiments, the insertion device is further configured to control a plurality of parameters of the one or more medical tools, such as tip stiffness. In some embodiments, the device is configured to control a force applied by a distal tip of the tool, for example, by controlling one or more of: the speed of advancement of the tool, a stiffness of the tool. Optionally, the tool is operated such that its distal tip applies a constant force or a varying force to a plurality of structures (e.g., tissue such as a vessel wall) encountered by the tip.

According to some embodiments, an insertion device is provided that is configured to remotely and automatically linearly advance one or more medical tools (e.g., a guidewire and catheter) into and within a plurality of body lumens for various intraluminal procedures. According to some embodiments, when the first tool is a guide wire and the second medical tool is a catheter, the insertion device may allow the plurality of linear, rotational and/or tip parameter controls of the guide wire, as well as the linear motion of the catheter (over the guide wire), and rotational motion thereof (relative to the insertion device).

According to some embodiments, the linear speed of advancement of the medical instrument may be within the range of about 0 to 100 millimeters per second or any plurality of subranges thereof. In some embodiments, the linear velocity of the medical instrument may be in the range of about 0 to 50 mm/sec, 1 to 100 mm/sec, 5 to 50 mm/sec, or intermediate, higher or lower velocities. The speed may be in constant and/or varying increments and may be adjustable (manually and/or automatically) during the procedure. In some embodiments, the speed may be in the range of about 0 to 25 mm/sec in increments of about 0.1 mm/sec. In some embodiments, the speed may be in the range of about 25 to 50 mm/sec in increments of about 1 mm/sec. In some embodiments, the position holding stability of the actuator is about 0.1 millimeters. According to some embodiments, the rotational movement may be anywhere within the range of 360 degrees.

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

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

According to some embodiments, the controller of the device may be a remote control. 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 allow control of the operation of the medical device. In some embodiments, the controller may be configured to allow control of the advancement of the medical instrument, including but not limited to: linear direction of advancement, speed of advancement, increment of advancement, rotational movement, degree of rotational movement, the like, or any combination of the foregoing. In some embodiments, the controller may include one or more operation buttons. In some embodiments, the plurality of buttons may include a plurality of pressure buttons, a plurality of slider buttons, a joystick, or the like, or any combination of the foregoing. In some embodiments, the system may have means for injecting a contrast agent into the lumen, e.g., the vasculature. The injection mechanism may be remotely operated, allowing the surgeon/physician to perform the entire procedure from a remote location. In some embodiments, the system, if used in the procedure, may be configured to control multiple linear and/or rotational movements of a guide catheter.

As referred to herein, a "robotic device" or "device" may refer to the device housing, including a plurality of mechanical and/or electrical components housed within the housing. In some embodiments, the "device" is not meant to encompass additional components or external components, such as a guide catheter drive unit (when externally coupled to the housing but not integrated therein), a fixture of the device, a remote control of the device, or the like.

As referred to herein, an "assembly" or "actuating assembly" may include tool moving elements, such as wheels, and/or a coupling for the tool, such as an elongate shaft that receives the tool. In some embodiments, an "assembly" or "actuation assembly" also includes one or more motors and/or transmissions (e.g., gears) that transmit forces from the one or more motors to outside the assembly.

Before explaining at least one embodiment of the invention in detail, it is to be understood that the invention is not necessarily limited in its application to the details of construction and the arrangement of the components and/or the methods set forth in the following description and/or illustrated in the drawings and/or the examples. The invention is capable of other embodiments or of being practiced or carried out in various ways.

Before explaining at least one embodiment of the invention in detail, it is to be understood that the invention is not necessarily limited in its application to the details set forth in the following description or illustrated by the examples. The invention is capable of other embodiments or of being practiced or carried out in various ways.

Referring to fig. 1, a schematic diagram of an exemplary medical system is shown, according to some embodiments. As shown in fig. 1, the system 2 includes a small body-mountable, automated insertion device 4 configured to insert a medical instrument, such as a guidewire 6, into a body cavity (e.g., a blood vessel) of a subject 8. According to some embodiments, the entry point may be selected from, but not limited to, in the groin (i.e., the femoral artery), arm (i.e., radial artery), or neck (i.e., jugular vein) of the patient, depending on the location of the target tissue (e.g., the heart, a peripheral blood vessel distal to the lower limb, brain, liver, etc.) and the purpose of the procedure. Thus, the position of the insertion device 4 on the patient's body can be varied. In the example shown in fig. 1, the device is connected to the patient's thigh to allow access to the patient's femoral artery. It will be appreciated that the device may additionally or alternatively be attached to the arm of the patient, or any other desired location on the patient's body, depending on the selected contact point. According to some embodiments, the device may be connected/mounted/secured to the patient's body using any suitable attachment element. For example, the device may be attached to the patient's body using a strap that can be pulled from the patient's leg onto his/her thigh. The strap may be flexible so that it extends around the circumference of the thigh, or it may be substantially rigid or semi-flexible and include a length adjustment mechanism. Alternatively, one or more straps may be wrapped directly around the patient's thighs. Such straps may be substantially rigid or semi-flexible, have a length adjustment mechanism, and are provided with connectors (e.g., buckles) at their opposite ends for securing the straps and securing them to the patient's thighs. The plurality of straps/straps may include one or more sensors, such as force sensors, disposed thereon.

According to some embodiments, the insertion device is not body-mountable, but is configured to be positioned proximate to the patient's body, e.g., using a robotic arm, a base structure configured to be secured to the patient bed, etc.

In some embodiments, the insertion device may be disposable, or partially disposable, such that some of its components are discarded and replaced between procedures, or completely disposable, once the procedure is completed, the entire insertion device is discarded, i.e., a single use device. In other embodiments, the insertion device may be reusable such that it may be reused with multiple new medical instruments (e.g., multiple guidewires and/or multiple catheters).

In some embodiments, the device may be configured such that it may be used to insert a plurality of different medical instruments having different lengths and diameters into a plurality of body lumens, including, for example, a guidewire, a catheter, a plurality of microcatheters, and the like. In some exemplary embodiments, without limitation, the device may be adapted to insert a Guidewire into a blood vessel, such as the Guidewire disclosed in commonly owned U.S. Pat. No. 9,586,029, entitled "Guidewire Having collecting selectable Stiff and Tip Curvature," and/or commonly owned U.S. patent application publication No. US 2018/214,675, entitled "Double centralized Guidewire," to Shekali et al, and incorporated herein by reference in its entirety.

According to some embodiments, the system may further comprise a controller 10 for controlling the operation of the device, in particular the insertion and/or manipulation of the medical instrument (e.g. a guide wire and/or a catheter) towards the target (e.g. a heart chamber, an obstructed artery, etc.). The controller 10 may be coupled to the insertion device 4 via a wired or wireless connection and may be operated manually by a physician (e.g., the controller may be in the form of a joystick) or automatically using a proprietary software. In the latter case, the system may also include a computer 12, which may include at least one processor, user interface, and a display. The computer 12 may be a Personal Computer (PC), a laptop computer, a tablet computer, a smart phone, 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 more than one insertion device.

In some embodiments, the system 2 may also include, or may be used in conjunction with, an imaging device. The imaging modality used may be any of X-ray fluoroscopy, CT, cone-beam CT, CT fluoroscopy, MRI, ultrasound or any other suitable imaging modality. According to some embodiments, the insertion device is capable of linearly advancing the medical instrument within the body lumen. In some embodiments, the device may also be capable of rotating the medical instrument within the lumen instead of or in addition to linearly advancing the medical instrument. In some embodiments, the device may also be capable of rotating the medical instrument within the blood vessel separately and/or also simultaneously 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 the blood vessel. In some embodiments, the device may also be capable of rotating a guidewire and/or catheter within the vessel, instead of or in addition to linearly advancing the guidewire and/or catheter. In some embodiments, the device may also be capable of rotating a guidewire and/or catheter within the vessel separately and/or also simultaneously while linearly advancing the guidewire and/or catheter. According to some embodiments, as further exemplified herein, the insertion device is configured to allow the linear advancement of the medical instrument with the rotational movement thereof within the body lumen, further advantageously enabling the smooth movement of the medical instrument by utilizing one or more actuators without deforming the medical instrument (i.e., without creating tension or torsion along the length of the medical instrument). According to some embodiments, the linear and rotational motion of the medical instrument (e.g., a guidewire and/or microcatheter) may be generated by a plurality of separate actuators, or by one or more dual-purpose actuators configured to allow rotational and linear motion of the instrument, as further exemplified herein.

Reference is now made to fig. 2A-2B, which illustrate schematic perspective views (front and back, respectively) of an insertion device according to some embodiments. As shown in FIG. 2A, the insertion device includes a plurality of elements for advancing a first medical instrument (shown as guidewire 22) in a linear direction and optionally in a rotational direction (as indicated by the plurality of movement arrows). As shown in fig. 2A, the proximal end of the guidewire 22 may be secured to a dedicated retainer 34, which may further allow for control of a plurality of tip parameters of the guidewire 22, as described below. The guidewire 22 is advanced from a first opening 35 in the holder (at the front of the device 20), enters the insertion device 20 through a second opening 36, and exits the device 20 again from a different opening at the rear (dorsal) face of the device 20 (first rear opening (not shown)). The guidewire 22 may then re-enter the insertion device 20 through another opening at the rear face of the device 20, a second rear opening (not shown), and may re-exit the insertion device 20 from a third (front) opening 37, such that the distal end 24 of the guidewire 22, after exiting the third opening 37, may be configured for insertion into a body of a subject, and more particularly into a body lumen, such as a blood vessel.

In some embodiments, as shown in fig. 2A, the guidewire 22 exits the insertion device 20 into the lumen of a second medical instrument (shown as catheter 32) that may be connected/attached/coupled to the first posterior opening, reenters the insertion device 20 through the second posterior opening, and exits the front face of the insertion device 20 through the third anterior opening 37. In some embodiments, the second medical instrument is configured to be inserted into the body lumen. In some embodiments, the second medical instrument (e.g., catheter 32) may be inserted into the body lumen with the advancement of the first medical instrument (e.g., guidewire 22) through the automated medical device 20 and/or after the first medical instrument (e.g., guidewire 22). The above-described winding path of the guidewire 22 and/or the catheter 32 enables a consistent spatial arrangement (e.g., side-by-side) of the plurality of motion control units (as described below), thereby minimizing the overall size of the device. In some embodiments, the multiple paths (e.g., multiple axes) through which the multiple tools extend within the housing are aligned side-by-side and optionally parallel to one another. A lateral alignment in which the motion actuation mechanisms are positioned substantially side-by-side may provide a smaller device size, such as a thinner device width.

In some embodiments, the small size of the device allows for positioning the device on the body of the subject.

In some embodiments, the medical device 20 includes one or more actuators/elements configured to allow the linear and/or rotational movement/advancement of the medical instrument. In some embodiments, as shown in fig. 2A, the device 20 includes a first motion control unit 26, the first motion control unit 26 configured to allow linear and/or rotational motion of the guidewire 22. The first motion control unit 26 may include one or more actuators/motors that allow the motion of the guidewire 22, as described in further detail below. The apparatus 20 may further comprise a second motion control unit 28, said second motion control unit 28 being configured to allow linear and/or rotational motion of said catheter 32. The second motion control unit 28 may include one or more actuators/motors that allow the motion of the catheter 32, as described in further detail below.

Optionally, the device 20 may also include at least one additional motion control unit, for example, in the case where the guidewire comprises a hollow outer guidewire and an inner guidewire disposed within a lumen of the outer guidewire, as disclosed, for example, in U.S. patent application publication No. US 2018/214,675, supra. In this case, an additional motion control unit 29 may be used to allow control of the motion of the inner wire of the guide wire 22 relative to the outer wire of the guide wire 22 to control tip parameters of the guide wire 22, such as stiffness and/or curvature. The movement of the inner wire relative to the outer wire may be accomplished by an adjuster/slider 33 attached to the inner wire, a non-rotating nut 30 and a lead 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 lead screw 31, which in turn causes linear movement of the adjuster/slider 33 and the inner wire attached thereto. In some embodiments, the motion control unit 29 may cause the inner and outer wires of the guidewire 22 to have one or more of the following relative states: 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 translates proximally to be 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 plurality of distal tips of the inner and outer wires are aligned. In some embodiments, the rotation of the guidewire 22 and the retainer 34 to which it is attached at its proximal end may be controlled by the motion control unit 26. In some embodiments, to ensure that the retainer 34 rotates smoothly with the guidewire 22 to prevent twisting/kinking of the guidewire 22 (as the guidewire 22 may not be able to rotate relative to the retainer 34), the motion control unit 29 may include an additional actuator/motor, for example, coupled to the proximal end of the retainer 34, to further control the rotation of the retainer 34.

Referring now to FIG. 2B, a perspective rear view of the insertion device 20 is shown. As shown in fig. 2B, insertion device 20 includes a plurality of elements/units for advancing a first medical instrument (shown as guidewire 22) in a linear direction and optionally in a rotational direction (as indicated by the plurality of movement arrows). As shown in fig. 2B, the proximal end of the guidewire 22 may be secured to a dedicated retainer 34. The guidewire 22 may be advanced from the first opening 35 in the holder 34 (at the front of the device) to enter the insertion device 20 through a second opening (not shown in fig. 2B) and to re-exit the device 20 from a first rear opening 38 at the rear (dorsal) side of the device 20. The guidewire 22 may then re-enter the insertion device 20 through a second posterior opening 39 of the posterior side of the device 20 and then re-exit the insertion device 20 from a third (anterior) opening (not shown in fig. 2B), such that the distal end 24 of the guidewire 22, after exiting the third opening, may be configured for insertion into a body of a subject, and more particularly into a body lumen, such as a blood vessel.

In some embodiments, as shown in fig. 2B, the guidewire 22 may exit the insertion device 20 from the first posterior opening 38 into the lumen of a second, other medical instrument (shown as catheter 32) that may be connected/attached/integrated with the first posterior opening 38, reenter the insertion device 20 through the second posterior opening 39, and exit the front of the insertion device 20 through the third anterior opening. In some embodiments, the second medical instrument 32 is configured to be inserted into the body lumen. In some embodiments, the second medical instrument (e.g., catheter 32) may be inserted into the body lumen with advancement of the first medical instrument (e.g., guidewire 22) through the automated medical device and/or after the first medical instrument (e.g., guidewire 22).

Reference is now made to fig. 3A-3B, which illustrate schematic perspective top views of an insertion device according to some embodiments. As shown in FIG. 3A, the insertion device 50 includes a housing 52 and a top cover 53, which is shown in an open configuration. Further shown is a holder 54 that holds the proximal end of the guidewire 58 and, in some embodiments, may also allow for adjustment of the plurality of tip parameters of the guidewire 58. In some embodiments, the cap 53 is intended to allow access 14 to the retainer 54 so that the retainer 54, with the guidewire 58 attached thereto, can be inserted into the enclosure 52 and/or removed from the enclosure 52. As shown in fig. 3A, the guidewire 58 may be advanced from a first front opening 55 in the retainer 54 to enter the enclosure 52 through a second front opening 56 and re-exit the enclosure 52 from a first rear opening (not shown) at the rear of the enclosure. The guidewire 58 may then re-enter the enclosure through a second rear opening (not shown) on the rear face of the enclosure 52 and re-exit the enclosure 52 from a third front opening 57. In some embodiments, as shown in fig. 3A, the guidewire 58 exits the first rear opening of the enclosure 52 while being threaded into the lumen of another medical device (shown as a catheter 62) that may be connected/attached/coupled to the first rear opening, re-enters the enclosure 52 through the second rear opening, and exits the front face of the enclosure 52 through the third front opening 57. In some embodiments, the second medical instrument 62 is configured to be inserted into the body lumen. In some embodiments, the second medical instrument (e.g., catheter 62) may be inserted into the body lumen with the advancement of the first medical instrument (e.g., guidewire 58) through the automated medical device and/or after the first medical instrument (e.g., guidewire 58), i.e., the guidewire 58 may serve as a track on which the catheter 62 rides.

The above-described winding path of the guidewire 58 and/or the catheter 62 enables a consistent spatial configuration of the plurality of motion control units of the device 50, as described below, thereby minimizing the overall size of the device. In some embodiments, the small size of the device allows for positioning the device 50 on the body of the subject. In some embodiments, the medical device comprises one or more actuators/elements/units configured to allow the linear and/or rotational movement/advancement of the first and second medical instruments.

Referring to fig. 3B, the medical device of fig. 3A is schematically shown with the cap 53 and a top portion of the housing 52 removed. As shown in fig. 3B, the apparatus 50 may include a first motion control unit 66, the first motion control unit 66 configured to allow linear and/or rotational movement of the guidewire 58. The apparatus 50 may further comprise a second motion control unit 68, the second motion control unit 68 being configured to allow linear and/or rotational motion of the catheter. The first motion control unit 66 and the second motion control unit 68 may include one or more of the following: actuators/motors, gears, racks, shafts, rotating screws, respectively, allowing the movement (linear and/or rotational) of the guide wire and/or catheter, as described in further detail below. In some embodiments, the device 50 may include one or more additional motion control units. For example, where the guidewire is secured at its proximal end to a holder 54, the device 50 may also include a motion control unit having at least one motor/actuator and a gear 65 that controls the rotation of the holder 54 about its axis.

In the case where the guidewire 58 comprises a hollow outer wire and an inner wire disposed within the lumen of the outer wire, as shown in fig. 3B, the device may include an additional motion control unit comprising a non-rotating nut 63 attached to a regulator/slider 61 holding gas, which is rigidly attached to the proximal end of the inner wire, and a lead screw (not shown) threaded within the nut 63 to allow control of the movement of the inner wire relative to the outer wire to control the tip parameters of the guidewire (e.g., to adjust the stiffness and/or curvature thereof). Rotation of the lead screw by a motor/actuator (not shown) causes linear movement of the nut 63 along the length of the lead screw, which in turn causes linear movement of the adjuster/slider 61 and the inner wire attached thereto.

In some embodiments, the motion control unit may cause the inner wire and the outer wire of the guide wire to have one or more of the following relative states: 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 translates proximally so as to be disposed 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 plurality of distal tips of the inner and outer wires are aligned.

Reference is now made to fig. 4A-4B, which illustrate perspective views of cross-sections of the insertion device of fig. 3A-3B, in accordance with some embodiments. Fig. 4A shows a longitudinal cross-sectional view of the insertion device 50 (shown in fig. 3A-3B), taken at an on-line between the first motion control unit (66 in fig. 3B) and the second motion control unit (68 in fig. 3B). As shown in fig. 4A, the first motion control unit 66 includes at least one motor (shown as motor 75), a shaft 76 through which the first medical instrument (shown as guidewire 58) is moved. A plurality of gears (such as exemplary gear 78) are also shown. In addition, a moving element 80 is also indicated. As described in further detail below, motion element 80 includes at least two opposing disks/wheels/rings, one placed on top of and/or adjacent to the other with a space therebetween such that the medical device (shown as guidewire 58) is located in the space.

The back end opening 82 is further shown in fig. 4A, and the guidewire 58 may exit the device through the back end opening 82, such as into a catheter lumen configured to be connected to the back end opening. Referring now to FIG. 4B, a longitudinal cross-section of the first motion control unit 66 is shown.

As shown in fig. 4B, the motion element 80 includes two opposing spinning wheels/discs/rings (86A, 86B), one on top of the other and/or adjacent to the other with a space therebetween. In the space formed between the plurality of wheels, the guidewire 58 is positioned such that linear movement of the guidewire 58 within the shaft 76 toward the posterior opening 82 is facilitated when the plurality of wheels are spinning (e.g., actuated by various interconnected gears). By controlling the speed of the spinning, the advancement speed of the guidewire 58 can be controlled. In some embodiments, the motion control unit 66 and/or the motion element 80 may be rotated along a longitudinal axis, further allowing the rotational movement of the guidewire 58. In some embodiments, the plurality of wheels may be similar or different in size, shape, hardness, material, or composition.

As can be further observed in fig. 4A-4B, in some embodiments, an aperture through which a tool enters and/or exits the housing is configured to reduce friction between the tool and the plurality of walls of the housing. For example, the aperture 81 (through which the guidewire 48 re-enters the housing) defines a tapered protrusion ending in a rounded lip. A potential advantage of the housing having an aperture formed as a circle without sharp corners may include reducing friction between the tool and the walls of the housing, potentially reducing a risk of the tool tearing or wearing away (e.g., due to the tool rubbing against the walls). This may be particularly advantageous for devices such as those described herein, where the tool extends and bends outside of the housing, and thus may more easily contact the plurality of bore walls, for example, as compared to a tool held along only a single straight linear axis.

Referring now to fig. 5, a schematic perspective top view of a plurality of motion control units of an exemplary insertion device is shown, according to some embodiments. As shown in fig. 5, the insertion device 100 includes a plurality of motion control units. A first motion control unit 110 is configured to allow advancement of the guide wire 108 through which the guide wire 108 is inserted after being reinserted into the insertion device (as detailed above). A second motion control unit 120 is configured to allow a second medical tool (e.g., a catheter) to be advanced after the guidewire 108 reenters the insertion device while screwing into the lumen of the second medical tool (catheter) through a second posterior opening, toward the anterior face of the insertion device (through a corresponding anterior opening), as detailed above. A third optional motion control unit 102 is configured to allow control of the rotation of the holder 104, in the case of a holder 104 for holding the proximal end of the 30 guide wire 108, depending on the type of guide wire used, to prevent twisting/kinking/tangling of the guide wire 108 as it rotates.

As shown in fig. 5, the first motion control unit 110 may include a channel/shaft 113 through which the guide wire 108 passes and a motion element 114. Further shown is an engine 111 and one or more gears (representative gear 112 shown) that allow for controlling the operation of the motion control unit 110. The motion element 114 may include a rotating disk/ring/wheel 115 positioned in contact with the guidewire 108 so that the guidewire 108 may advance linearly along its path as it spins/rotates. The guide wire 108 may be pushed towards the rotating disk/ring/wheel 115 by a spring/screw pre-load pinion. In some embodiments, the guidewire is pushed to the rotating disk/ring/wheel 115 by a pair of spring/screw pre-load pinions.

As shown in fig. 5, facing the wheel 115 may be a groove that forms a bend in the guidewire 108. The built-in curvature in the guide wire pathway increases the perpendicular distance of the line of action of force from the axis of rotation, which distance would be equal to the radius of the guide wire if the guide wire followed a linear pathway, enabling a sufficient rotational moment (torque) to be exerted on the thin guide wire without having to exert a high positive force on the guide wire.

As further shown in fig. 5, the channel/shaft 113 may have an opening/slit 116 along its length to allow access to the guidewire 108 and further to allow placement/removal of the guidewire 108 as needed. In some embodiments, the first motion control unit 110 may be rotated about an axis (e.g., by the control of the plurality of actuators 118), thereby allowing the rotational motion of the guidewire 108 (and the holder 104). In case of an actuating rotational movement, the opening 113 may correspondingly face in the other direction.

As further shown in FIG. 5, the second motion control unit 120 includes at least one channel 123, the medical instrument passing through the channel 123, and a motion member 124. The motion element 124 may comprise a rotating disc/ring/wheel 125 that contacts the medical device (e.g., the catheter into which the guidewire is threaded) placed in the channel 123 so that the medical device may be advanced along its path as it rotates.

As shown in FIG. 5, the channel 123 may have an opening/slit 126 along its length to allow access to the medical instrument and further to allow placement/removal of the medical instrument when desired. In some embodiments, the second motion control unit 120 may be configured to rotate about its axis, thereby allowing the rotational motion of the second medical instrument (e.g., the catheter).

As further shown in fig. 5, the third alternative motion control unit 102 may include at least one gear 130 allowing the rotation of the holder 104. In some embodiments, where the guidewire 108 comprises a pair of concentric guidewires (i.e., an inner wire disposed within the lumen of an outer hollow wire), the device 100 may further include actuators/elements to allow control of the relative motion between the inner and outer wires of the guidewire to control parameters of the tip of the guidewire (e.g., the stiffness and/or curvature of the guidewire). In some embodiments, the device may include a non-rotating nut 103 attached to an adjuster/slider of the holder 104, rigidly attached to the proximal end of the inner wire, and a lead screw 105 threaded within the nut 103 to allow control of the movement of the inner wire relative to the outer wire, thereby controlling the tip parameters of the wire (e.g., adjusting the stiffness and/or curvature thereof). Rotation of the lead screw 105 causes linear movement of the nut 103 along the length of the lead screw 105, which in turn causes linear movement of the adjuster/slider and the inner wire attached thereto.

In some embodiments, the movement mechanism may cause one or more of the following relative states between the inner and outer wires of the guidewire: 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 translates proximally so as to be disposed within the outer wire (i.e., the distal tip of the outer wire extends beyond the 20 distal tip of the inner wire), and/or 3) the plurality of distal tips of the inner and outer wires are aligned.

Referring now to fig. 6A, a schematic perspective view of an exemplary insertion device is shown, in accordance with some embodiments. As shown in fig. 6A, the insertion device 150 may include a housing (shown as a translucent housing 158) that encases a plurality of motion control units 156, the plurality of motion control units 156 being configured for advancing a medical instrument (e.g., a guidewire 154) in a linear direction and optionally in rotational motion. As shown in fig. 6A, the proximal end of the guidewire 154 may be secured to a dedicated retainer 152, which may further allow for control of a plurality of tip parameters of the guidewire 154. The guidewire 154 may be advanced from the retainer 152 to enter the insertion device through an opening and re-exit the device from a different opening at the opposite side of the device. In some embodiments, the guidewire 154 may exit the insertion device 150 into the lumen of another medical instrument (e.g., a catheter) that may be connected/attached/bonded to an opening of the device.

Referring now to FIG. 6B, a perspective view of the motion control unit 156 is shown. As shown in fig. 6B, the motion control unit 156 may include a shaft/channel 162 through which the medical tool (e.g., guidewire 154) may be passed/advanced. The motion control unit 156 further includes a medical instrument linear drive (168) and optionally a rotational drive (164). The motion control unit 156 may also include a slip ring 160, the slip ring 160 configured to allow rotational motion. The motion control unit 156 may also include one or more rotating/spinning elements (e.g., wheels and gears) configured to mediate mechanical motion of various moving parts, as described in detail below. Referring now to FIG. 6C, a side view of the motion control unit 156 is shown. Shown in fig. 6C are the shaft 162, the guidewire 154, the rotary drive 164, and the slip ring 160.

Referring now to fig. 7, there is shown a longitudinal cross-sectional view of the linear drive 168 of the motion control unit shown in fig. 6C, substantially along the center of axis 162.

As shown in fig. 7, the linear drive 168 may include at least two rings/wheels/discs (170A, 170B), one placed/seated/positioned above the other with a limited space between them. The medical instrument (e.g., guidewire 154) is configured to pass through the tight space between

wheels

170A and 170B such that the guidewire at least partially in contact with both wheels advances linearly as the wheels spin/rotate.

In some embodiments, the wheels/rings/

discs

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, hardness, material, or form. In some embodiments, the space between the

wheels

170A and 170B is formed in a groove such that the medical instrument 154 is slightly bent to allow for better rotation of the medical instrument. A potential advantage of a built-in bend in the guide wire pathway may include increasing the perpendicular distance of the line of action of force from the axis of rotation (which would be equal to the radius of the guide wire if the guide wire followed a linear pathway), thus enabling a sufficient rotational moment (torque) to be applied on the thin guide wire without having to apply a high positive force on the guide wire.

Reference is now made to fig. 8, which schematically illustrates a motion control unit, in accordance with some embodiments. As shown in fig. 8, the motion control unit is configured to allow linear advancement and/or rotational motion of a medical instrument, such as a guidewire 202. In some embodiments, the medical instrument 202 may be advanced along a path defined, for example, by a channel or axis (shown as channel 204). To allow linear motion of the medical instrument 202, the motion control unit may contain a linear drive element 200, which may include two or more spin/rotation elements, shown in fig. 8 as wheels/discs/rings 206A and 206B.

As shown in fig. 8, the two wheels may be placed side by side with a tight space between them. The medical instrument 202 may be threaded between the two wheels such that it may pass under a first wheel 206A and over a second wheel 206B, forming an S-shape or substantially an S-shape. In this manner, since the medical instrument 202 is at least partially in contact with the two wheels, spinning/rotating the two wheels in opposite directions causes the instrument 202 to advance linearly. The relative spin directions of the

wheels

206A and 206B may determine the direction of the linear motion of the medical instrument 202.

In some embodiments, the motion control unit may further include a rotational drive element 210 that may allow rotation (e.g., in direction 212) of the linear drive element 200 and thus allow the medical instrument 202 to be wound therein. By using the medical instrument wrapped in an S-shaped path around the two wheels as detailed above, the medical instrument can rotate freely about its axis without slipping and without forming bends along its length. In some embodiments, the motion control unit is located/placed on a platform (shown as platform 214) to allow the unit to rotate freely.

Reference is now made to fig. 9A-9B, which illustrate a plurality of moving units for linear advancement and/or rotational movement of the medical instrument, in accordance with some embodiments. In some embodiments, as shown in fig. 9A-9B, linear and/or rotational motion of the guide wire may be generated by a plurality of piezoelectric actuators. The plurality of piezoelectric elements are comprised of a ceramic material that changes a plurality of its geometric dimensions as a function of the applied voltage. Piezoelectric elements can be activated at high frequencies, for example 50 to 150kHz, and they can generate relatively large forces which are linearly related to the degree of elongation (stroke) of the element. The use of piezoelectric actuators in an automated medical device is advantageous because their activation does not generate a magnetic field, which is undesirable in a number of medical applications. Furthermore, the plurality of piezoelectric actuators is MRI compatible. In some embodiments, other actuator types may be used, for example, multiple electromagnetic actuators (solenoids), multiple DC motors, multiple stepper motors, or multiple AC motors.

According to some embodiments, the insertion device may comprise two separate parts/units; a first part for generating linear motion (hereinafter also referred to as "linear part") and a second part for generating rotational motion (hereinafter also referred to as "rotational part") to allow each type of motion, i.e., linear and rotational, to be generated independently of the other. A combined motion, i.e. simultaneous rotation and linear propulsion, can be generated by activating the two parts in an orderly or alternating manner.

In some embodiments, the linear portion may be the form of an inchworm engine, and it may include three piezoelectric actuators, as shown in fig. 9A.

Piezoelectric actuators

301 and 303 are used to grasp the medical device 304 (e.g., a guidewire), which when energized, moves by extending (lengthening) and relaxing (shortening) along the vertical axis, and which when energized, moves by extending and shortening piezoelectric actuator 302 along the horizontal axis. In some embodiments, the piezoelectric actuators 301 and/or 303 may comprise a single actuator that, when extended, presses the guidewire 304 against a static element to grip the guidewire 304. In other embodiments, the piezoelectric actuators 301 and/or 303 are actually a pair of piezoelectric actuators positioned on opposite sides of the guidewire 304 such that both extend and relax to respectively grip and release the guidewire 304. The actuation process of the linear portion is a cyclic process. To move the instrument 304 from left to right, for example, the piezo actuator 303, in this example the forward clutch piezo, is first extended to grip the instrument, as shown in fig. 9A. Then the piezo actuator 302, the transverse piezo, is extended, causing the piezo actuator 1003 to move a small distance to the right along with the instrument. It is noted that the center of the piezoelectric actuator 302 is fixed so that its extension is left-right symmetric when the piezoelectric actuator 302 is energized. Since the piezo actuator 301 (in this example, the rear clutch piezo) is in a relaxed state at this stage of the process and does not grasp the instrument, the instrument grasped by the piezo actuator 303 moves to the right. Piezoelectric actuator 301 is then extended to grasp the instrument, and piezoelectric actuator 303 is then relaxed to release its grasp on the instrument. The piezoelectric actuator 302 is then released. Then, piezo actuator 303 is extended to re-grip the instrument, and then piezo actuator 301 relaxes.

As shown in fig. 9B, the rotating part/moving unit of the device may comprise a pair of

piezoelectric actuators

306, 307 contacting the instrument 308 on opposite sides, parallel to each other. Extending the two piezoelectric actuators in

opposite directions

309A and 309B causes the instrument to rotate. In some embodiments, as described above, at least one of the clutch piezo actuator/pairs, i.e., piezo actuator 301 and/or piezo actuator 303, may be part of the rotational portion of the device as well as the linear portion of the device. In other embodiments, an additional pair of piezoelectric actuators may be used to rotate the guidewire.

Referring now to FIG. 10, depicted is a diagram in accordance with someA schematic view of an exemplary device of an embodiment capable of imparting linear and rotational motion on a medical tool. In some embodiments, the linear motion may be achieved in an inchworm-like manner using

piezo motors

401, 402, and 403, substantially as described above with respect to fig. 9A-9B, but additional

piezo motors

404 and 405 are used as clutches that are moved toward and away from the medical tool (shown as guidewire 408) by piezo motor 403. To rotate the guide wire clockwise ("CW"), for example, piezoelectric motor 403 is relaxed/contracted, which moves

piezoelectric motors

404 and 405 toward the guide wire 408 until they grip the guide wire on opposite sides. The piezo motor 405 is then extended (moved down) while the piezo motor 404 is simultaneously relaxed/contracted (moved up), causing the guide wire to rotate. Next, piezo motor 401 is extended to grip the guide wire and piezo motor 403 is extended, releasing the grip on the guide wire by moving

piezo motors

404 and 405 away from the guide wire to their original positions. In alternative embodiments, an additional piezo motor may be coupled to one of

piezo motors

404 and 405 instead of piezo motor 403 to move it toward and away from the guidewire. In such an embodiment, rotation of the guidewire may be achieved by both

piezoelectric motors

404 and 405 extending (or contracting) in opposite directions. The piezoelectric actuators used may be manufactured, for example, by PI Ceramic GmbH, germany

A Monoolithic multilayered PZT activator. In some embodiments, the rotating the plurality of piezoelectric actuators may rotate the entire linear propulsion assembly.

Referring now to fig. 11, a motion control unit having two concentric circular components that can be rotated one relative to the other is shown, according to some embodiments. As shown in fig. 11, the motion control unit 500 includes a first motion control element 502 (e.g., a piezo motor), the first motion control element 502 configured to allow linear motion (advancement) of a medical instrument (e.g., guidewire 510) in any linear desired direction 505. The first motion control element 502 is secured to the inner concentric circular member 530 (see also fig. 12). The motion control unit 500 further comprises a second motion control element 504, said second motion control element 504 being configured to allow rotational motion of said first motion control element 502 by rotating said inner concentric circular component in any desired clockwise or counter-clockwise direction 507.

An alternative arrangement is further shown in fig. 11, in which the proximal end of the medical device is secured to a dedicated retainer 520. In some embodiments, for example, when the guidewire comprises a pair of concentric guidewires (i.e., an inner guidewire disposed within the lumen of an outer hollow guidewire), the holder may include a mechanism that allows for control of parameters of the medical device (e.g., tip compliance) that includes at least one adjuster/slider 503, the adjuster/slider 503 configured to linearly move the inner guidewire relative to the outer guidewire. Furthermore, there may be an additional motion control unit 506 allowing to control the rotation of the holder 520 with the instrument attached thereto.

Referring now to fig. 12, an assembly of multiple motion control units for controlling more than one medical instrument according to some embodiments is shown. As shown in fig. 12, motion control assembly 600 includes two separate

motion control units

602 and 604 that may be used in combination such that each unit is configured to allow actuation and control of the motion of a different medical instrument.

As shown in fig. 12, a first motion control unit 602 includes various motion elements that allow linear motion (advancement) and/or rotational motion of a first medical instrument, such as a guidewire 610, substantially as described above in detail with respect to fig. 11. A second motion control unit 604 includes various motion elements that allow linear (advancement) and/or rotational motion of a second medical instrument, such as microcatheter 612. In some embodiments, the motion (linear and/or rotational) of the first medical instrument 610 may be independent of the motion (linear and/or rotational) of the second medical instrument 612.

In some embodiments, the motions (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., a guidewire) may be passed through and advanced through the lumen of the second medical instrument (e.g., a catheter). According to some embodiments, any suitable actuator type may be used for any of the plurality of motion control units, devices, and systems disclosed herein, including but not limited to: a plurality of motors (e.g., a plurality of DC motors, a plurality of AC motors, a plurality of stepper motors, etc.), a plurality of electromagnetic actuators (solenoids), a plurality of piezoelectric actuators, a plurality of pneumatic actuators, a plurality of hydraulic actuators, etc.

Fig. 13 is a block diagram of a surgical robotic system according to some embodiments.

In some embodiments, a robotic system 1301 is adapted to an operating room. Optionally, one or more system components (e.g., control components, imaging components) are physically separate from the rest of the system and may be used remotely.

In some embodiments, system 1301 is configured to receive one or more surgical tools (e.g., a guidewire, a microcatheter, a guide catheter, an intermediate catheter, and/or other elongated surgical tools) and actuate movement of the plurality of tools.

In some embodiments, the system is configured to drive linear motion (e.g., advancement and/or retraction) of a tool received therein, and/or drive rotational motion (e.g., axial rotation) of a tool received therein. In some embodiments, the linear and rotational motions are actuated simultaneously.

In some embodiments, system 1301 includes a robotic device 1303 for driving motion of one or more tools. In some embodiments, the device 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 associated transmissions for the plurality of motors.

A plurality of tool moving elements 1317, such as a plurality of wheels, are configured to operably contact a tool received by the system to move the tool (e.g., advance, retract, rotate the tool). In some embodiments, the plurality of tool moving elements are driven directly (e.g., by contact) or indirectly (e.g., by one or more gears or other transmission means) by the plurality of motors 1305. It is believed that only some of the tool-moving elements are driven (directly or indirectly) by the plurality of engines, while other tool-moving elements move in response to the tool movement and/or in response to the motion of an engine-driven tool-moving element.

A controller 1307 configured to receive and/or send operational signals to a general control unit 1309 and/or receive and/or send operational signals from a general control unit 1309. The general control unit 1309 may be configured as a remote control, a control panel, a control unit physically attached to the system base, or a combination of the foregoing. In some embodiments, the controller 1307 is configured to coordinate manipulation (e.g., linear movement, rotation) of multiple tools received and operated by the robotic system.

The power supply 1311 includes, for example, a battery and/or connection for mains power.

Sensing device 1315, e.g., one or more sensors, configured to detect, e.g., whether a tool has been inserted; a relative position of the tool; a position of a plurality of tool moving assemblies (e.g., a plurality of wheels); actual movement of a plurality of tool moving assemblies (e.g., by a counter counting the number of wheel revolutions); a plurality of sensors for communicating with other system sensors and/or for other measurements and/or indications. In some embodiments, a plurality of sensors are configured to detect engine conditions, such as an engine position, an engine speed. Various types of sensors may be used, such as multiple optical sensors, multiple pressure sensors, multiple force measurement sensors, multiple speed sensors, sensors for detecting current, multiple flow sensors, multiple position sensors (e.g., multiple optical, magnetic, electrical position sensors). A memory 1313 storing, for example, a plurality of parameters relating to tool motion, such as speed of motion, rotation, translation, angle, deflection angle; indications obtained by one or more system sensors, such as a measurement of force acting on the tool, hardness of the tool; a plurality of parameters (e.g., heart rate, blood pressure, temperature, oxygenation level, and/or other sensed parameters) associated with the patient's body and sensed by the inserted plurality of tools.

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

In some embodiments, the robotic device is substantially block-shaped, e.g., having a box-shaped compact configuration. Other configurations may include a cylindrical configuration, a circular (e.g., spherical) configuration, a saddle shape, and/or others.

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. An imaging modality may include, for example, X-ray fluoroscopy, CT, cone-beam CT, CT fluoroscopy, MRI, ultrasound, or any other suitable imaging modality.

In some embodiments, the system 1301 comprises a fixation 1321 for placing the device 303 relative to the patient and/or relative to the operating bed. In some embodiments, the fixture comprises or is configured to attach to an adjustable fixture. Optionally, a height and/or angle and/or distance of the system relative to the patient (e.g. relative to the position of body entry) and/or relative to the bed is adjustable.

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

In some embodiments, the adapter defines a mechanical engagement between the one or more motors 1305 and one or more components that move the handle of the tool. For example, the adapter connects one or more motors or associated transmissions with a slider member of the handle that deflects the tool tip when slid; a knob member with a handle, said knob member causing said tool to roll when rotated; and/or with other handle components. Additionally or alternatively, the adaptor itself comprises one or more integrated motors for driving movement of the plurality of handle members.

Fig. 14 is a flow diagram of a general method of using a surgical robotic device according to some embodiments.

In some embodiments, an operational decision is made (1401), for example, by a physician, surgeon and/or other clinician. In some embodiments, the operation is for therapeutic purposes. Additionally or alternatively, the operation is for diagnostic purposes.

In some embodiments, the procedure involves catheterization. In some embodiments, the procedure involves inserting one or more tools into and/or through the vasculature and/or other non-vascular luminal structures. Examples of multiple tools may include: a guidewire, a microcatheter, a rapid exchange catheter, a guide catheter, a balloon catheter, a stent or coil, a plurality of ablation tools, an intermediate catheter, a suction catheter, an ultrasound waveguide, a pressure catheter, and/or other tools. In some embodiments, the operation is a lumen-based procedure. In some embodiments, the operation is a wireless-based procedure.

In some embodiments, the device is positioned relative to the patient (1403). In some embodiments, the device is mounted to the operating bed, for example, by a fixture. In some embodiments, the device is attached to the patient, e.g., mounted on the patient's leg (e.g., the thigh), the patient's arm, and/or other body part. Straps, a rigid mount, and/or other attachment devices may be used to attach the device to the operating bed and/or the patient.

In some embodiments, attachment to the bed is achieved using a brace that is stable relative to the mattress and/or the rails and/or the floor of the bed. The system may then be mounted on the bracket, for example, by a snap-fit mechanism, magnetic device, strap (e.g., velcro), and/or other means of attachment. In some embodiments, the support is adjustable so as to be able to be used with patients of various body sizes and/or different bed heights, etc. In some embodiments, when setting a position of the device, one or more of a height, an angle of entry into the body, and an alignment of the device relative to the patient is selected. The device position may be defined relative to the patient body or a part thereof (e.g. relative to the surgical access point) and/or relative to the operating bed and/or relative to other operating room equipment (e.g. relative to a plurality of imaging modules).

A potential advantage of attaching the device to the patient's body, such as to a limb and/or other body part (e.g., legs, arms (optionally the nose pack of the hand), neck, feet, etc.) may include that the device may be positioned closer to the entrance into the body. In such a configuration, a length of a tool segment extending between the device and the body may be reduced, potentially allowing more efficient use of a tool length. In some embodiments, the device is sufficiently dense to fit on top of a patient's limb, e.g., does not protrude laterally from the limb when the device is attached to the limb (e.g., the device is not sized to extend laterally from a patient's thigh).

In some embodiments, loading of the plurality of tools is performed (1405). In some embodiments, loading of the plurality of tools is performed after setting the device position (e.g., relative to the patient and/or relative to the couch); alternatively, the loading of the plurality of tools is performed before the setting of the device position. Optionally, one or more tools are preloaded onto the device, and optionally provided with the device. In one example, the device is provided in a sterile package while the tool or tools have been loaded. Additionally or alternatively, tools may be opened in the operating room and loaded onto the device, for example, by a nurse, technician, and/or other clinical personnel. In some embodiments, multiple tools are loaded and/or replaced during operation, for example, when switching from a navigation tool (e.g., a guidewire) to a treatment tool (e.g., an embolization tool, a catheter balloon, and/or other treatment tool).

In some embodiments, the apparatus is configured such that no shield (e.g., no physical separation of a wall, a wrap, a curtain) is present or required between the tool moving elements and the tool being loaded, e.g., such that direct contact is made between the tool and the plurality of tool moving elements (e.g., wheels, gears, and/or other actuators). Optionally, there is no need to cover with a sterile drape or other cover. For example, in a disposable device that is placed post-operatively, there is no need to cover the device and/or its specific components that contact the tools with a sterile cloth, since there are no permanent components. A potential advantage of a device in which the device is configured to directly engage the plurality of surgical tools without separation or draping may include a simpler, more efficient, time and/or cost effective preparation process and/or post-surgical cleaning process.

Alternatively, in some embodiments, the device (and/or selected components of the device, such as the tool moving assemblies) are at least partially covered by a sterile drape or sheath.

In some embodiments, the operation is performed by controlling the movement of the plurality of surgical tools received in the plurality of cells via a user interface of the device (1407). Exemplary operations of a plurality of tools controlled by the apparatus may include: linear advancement and/or retraction of a tool; rotation of a tool (e.g., rolling about the tool axis); a tool twist; angular orientation of a tool (e.g., by bending a distal tip of a tool); articulation (e.g., of a distal tip of a tool); for example, mechanical properties of a tool, such as stiffness, are changed by controlling a distal tip structure or internal configuration from a proximal end of the tool.

In some embodiments, manipulation of multiple tools is performed remotely. Optionally, the surgeon operates the system from a different room. Alternatively, the surgeon remains in the operating room and can operate the system while approaching or departing from the bed.

In some embodiments, manipulation of tools includes manipulation of tools attached to and/or inserted into one another and/or assembled in such a way that movement of one tool may affect another tool, for example, when a guidewire extends within a lumen of a microcatheter. In this case, controlling the motion may involve performing (by user control and/or automatic recognition of motion by the system) a "compensating" motion of the guide wire and/or microcatheter relative to each other, which may be desirable when both are driven together in a set of assembled configurations (e.g., when the guide wire is in the position of the plurality of tool moving elements of the unit in the microcatheter lumen, the tool is manipulated). In one example, it may be desirable to hold the guidewire in place without moving the guidewire with the microcatheter as the microcatheter is advanced or retracted. This may be performed, for example, by actuating the plurality of linear motion mechanisms of both tools but in opposite directions (e.g., advancing the microcatheter distally while actuating the guidewire mechanism in a manner that will retract the guidewire proximally). A potential advantage of the synchronized controlled movement of multiple tools used together (e.g., a guidewire extending within a lumen of a microcatheter) may include the ability to maintain one tool while advancing another, for example, by driving the multiple actuating mechanisms of the multiple tools in opposite directions-one tool will be advanced or retracted while another tool will effectively remain in place.

In some embodiments, the user interface is configured on the device itself (e.g., as a screen and/or buttons and/or a joystick attached to the system units and/or the base), and/or on a separate physician console, and/or on a separate remote control device. The plurality of control signals may be communicated to the device by wired and/or wireless communication, such as network-based communication.

In some embodiments, the device (e.g., the device controller) is programmed to include a loading mode for insertion and/or calibration of tools and/or the device motors; and performing an operational mode of the plurality of tool motions.

In some embodiments, the device or a number of specific components thereof are disposed of after operation (1409). Optionally, the device as a whole is disposed of, optionally including the plurality of tools loaded thereon.

Fig. 15 is a flow diagram of a method of loading a plurality of surgical tools onto the surgical robotic device, according to some embodiments.

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

In some embodiments, a proximal HANDLE OF a TOOL, such as a guidewire, is placed into engagement with a designated adapter or holder (150), such as in commonly-filed PCT patent application No. PCT/IL2020/051225, herein incorporated by reference.

In some embodiments, the guidewire is threaded (e.g., from the distal direction) in a designated axis of the guidewire drive mechanism of the robotic device (1507). At least a portion of the length of the guidewire exiting the shaft (present in the device housing) is then threaded into a lumen of a microcatheter (1509).

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

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

Then, in some embodiments, the one or more tools are introduced into the patient (1517) and manipulated using the device.

In an exemplary use, the robotic device is loaded with a guidewire and optionally a microcatheter. Optionally, a guide catheter (a distal portion thereof) is manually inserted into the patient. The robotic device is then placed near a proximal end of the guide catheter, and the guide catheter (optionally with a microcatheter of the guidewire received therein) is inserted into the lumen of the guide catheter. In some embodiments, the guide catheter lumen is inserted through a sealing element, which may be an integral part of the robotic device, or, alternatively, separate from the robotic device. Then, in some embodiments, the user connects the proximal end of the guide catheter to the robotic device. From this point forward, steering (e.g., linearly advancing/retracting and/or rotating) the guidewire and/or microcatheter within the lumen of the guide catheter and optionally as the guidewire and/or microcatheter exits the guide catheter (e.g., into a lumen of a blood vessel) can be performed robotically using the device (e.g., through a remote control interface). In some embodiments, linear advancement and/or retraction of the guide catheter, e.g., to some limited extent, is also performed using the robotic device.

Fig. 16A-16D are various configurations of a robot of the surgical robotic system, according to some embodiments.

In some embodiments, the remote control device is configured to be manually held by a user (e.g., a physician). Optionally, the remote control unit is lightweight and compact, and can be held by the user without obstructing the user's view of a plurality of visual aids, such as a screen that displays the results of the plurality of imaging during operation. In some embodiments, the remote control device includes one or more portions shaped to be grasped by the palm of the user's hand and/or engaged by a plurality of fingers of the user.

In some embodiments, the remote control device is in communication with the modular robotic system. In some embodiments, the communication is wireless, such as performed by wi-fi, infrared, bluetooth, RF, and/or other wireless modules.

In some embodiments, the remote control device includes or is in communication with a controller of the modular robotic system. In some embodiments, manipulation of a plurality of tools housed by the system is by the remote control device. Examples of the plurality of tool motions and/or other operational manipulations of the plurality of tools controlled by the remote control device may include: linear advancement and/or retraction of a tool; axial rotation of a tool; control of a tool distal tip; the speed of movement; control of a plurality of unique tool functions (e.g., inflation/deflation of a balloon in a balloon catheter, stent deployment and/or advancement), and/or other tool manipulations.

A number of other functions that may be controlled by the remote control include, for example: automatically injecting and passing a plurality of materials (e.g., a plurality of contrast agents, a plurality of wash solutions) through a tool lumen; linear and/or angular movement of the assembly system as a whole (e.g., sliding of the assembly system relative to a fixture); the system is safely stopped; on/off actuation of the system; providing power to the system or a plurality of specific components; and/or a plurality of other system functions.

Fig. 16A to 16B show a first example of a remote control device 1601, and fig. 16C to 16D show a second example of a remote control device 1603. In some embodiments, the device includes a plurality of interfaces in the form of one or more of the following: a plurality of buttons 1605, a plurality of joystick handles 1607, a plurality of handsliders 1609, a plurality of knobs 1611, and the like.

In some embodiments, the remote control device includes a screen, for example, for notifying a user of current controls and/or for receiving instructions from the user.

In some embodiments, the remote control device includes an interface (e.g., a button) for rapidly retracting a plurality of tools. Such an interface may be used in case of an emergency, device malfunction, etc. and/or for planned retraction of a tool, e.g. for replacing the tool with a new one.

In some embodiments, the remote control device is modular. Optionally, specific buttons and/or additional interfaces are selectively attached (and/or exposed to enable their use). For example, buttons for controlling the movement of a guide catheter (when a guide catheter receiving unit has been attached to the system) are only exposed for use when needed (e.g., positioned under a removable or movable cover). In another example, an interface for controlling the injection of materials through one or more system interfaces is attached to the remote control device and/or is not covered for use when needed.

The remote control may be operated at a location remote from the system. Optionally, the remote control is operated by a surgeon located in a different room. Optionally, the remote control is operated by a surgeon located in the operating room (close to the couch or remote from the couch).

In some embodiments, the remote control device may be configured as a screen interface, such as for a cell phone, tablet, computer, etc., as described below.

Fig. 17 is a schematic example of a screen interface associated with the surgical robotic system, according to some embodiments.

In some embodiments, a screen interface 1701 that communicates with the system may be used in addition to or instead of a remote control device such as described above. In some embodiments, the screen interface is configured for receiving data (e.g., from the device and/or from imaging device and/or from a physician and/or from a hospital system), presenting data, sending and/or receiving instructions to and from the robotic device, and/or others.

In some embodiments, the screen interface may be configured in a computer, laptop, tablet, as a cell phone application, and/or the like.

The user interface screen shown in this figure shows examples of functions and/or instructions associated with the robotic device operating the tools, including but not limited to: tool motion type (e.g., guidewire rolling, guidewire advancement/retraction, microcatheter advancement/retraction, guide catheter rolling, guide catheter advancement/retraction); guidewire tip control (e.g., guidewire tip deflection); tool speed and/or direction of motion (e.g., using a "turbo" mode to increase the speed, initiate rapid or partially rapid retraction); emergency stops (in case of device failure, medical emergency, etc.); in some embodiments, the emergency stop button stops power to the robotic device); controlling the movement of two (or more) tools together; custom control of tool motion, for example: control of accessories, including devices and/or accessories used with the system and/or tools, such as: injecting material through a port; inflating the saccule; expanding the stent; tip curvature; tool hardness.

Fig. 18A-18B are different views of a robotic device according to some embodiments.

In some embodiments, a robotic device 1801 is shaped and dimensioned to be located near the patient (e.g., attached to the bed) and/or on the patient, such as on a limb of a patient (e.g., on the patient's thigh). In the illustrated example, the device 1801 includes a dense housing 1802 having a saddle-shaped bottom 1803. Optionally, the saddle portion is shaped and sized to rest on a patient's limb, on a track of the bed, on a designated fixture (e.g., a fixture having a flat bottom for positioning on a flat surface, not shown), and/or the like. In some embodiments, a second portion 1805 of the housing extends from the saddle shaped bottom, the second portion housing one or more tool drive mechanisms.

In some embodiments, a guidewire is loaded onto the device 1801 as follows: in some embodiments, a proximal portion of the guidewire (e.g., a handle) is received within an accessible compartment 1807, optionally covered by a cover 1809 (compartment 1807 may also be referred to herein as an "adapter" or "retainer"). Optionally, manipulation of one or more guidewire handle components is performed within compartment 1807 by one or more pushers engaging the handle (e.g., a slider engaging the handle, a knob of the handle, and/or other handle components).

In some embodiments, a distal portion of the guidewire (adjacent the handle) exits compartment 1807 through aperture 1813. Next, in some embodiments, a distal portion of the guidewire (optionally, the distal-most end of the guidewire) is inserted into the device housing through an entry hole 1811, wherein the inserted guidewire is received within a designated shaft (not shown) of its drive mechanism. In some embodiments, the guidewire exits the housing again through aperture 1815, optionally from an opposite wall of the housing. In some embodiments, a location of the hole 1815 also serves as a fixation point for a proximal end of a microcatheter. Optionally, the microcatheter is threaded onto a knob 1817 and/or other suitable protrusion to secure to the housing. As the guidewire exits through aperture 1815, it is received in a lumen of the microcatheter.

In some embodiments, the microcatheter (with the guidewire extending inwardly) is bent (e.g., in a "U" shape) outside of the housing for insertion into a designated shaft of the microcatheter drive mechanism through an aperture 1819. The microcatheter (with the guidewire inside) then exits the housing through aperture 1820 on an opposite wall.

In some embodiments, the device housing is shaped and sized only to accommodate the plurality of tool drive mechanisms, independent of a plurality of tool size considerations, such as tool length, a tool width (e.g., diameter). Optionally, the housing protects the tool drive mechanism inside, while only the plurality of tools themselves remain visible and/or accessible outside the housing. Optionally, there is no visible drive mechanism. One potential advantage of such a configuration may include reducing a risk of damage to the plurality of tool drive mechanisms (e.g., due to unnecessary contact).

In some embodiments, a portion of a tool extending within the housing itself is less than 25%, 20%, 10%, 5% or an intermediate, greater or lesser percentage of the overall length of the tool. A potential advantage of a housing that houses the drive mechanisms and does not require a long portion of a tool to be received inside may include allowing for a relatively compact housing having small dimensions and/or small weight.

In some embodiments, the housing includes a removable or removable portion, such as a cover. Optionally, the cover is opened in case of an emergency and/or robot malfunction, e.g. manually releasing the tools. Alternatively, the lid is opened in the event that the plurality of tools need to be replaced.

In some embodiments, opening the cover automatically returns the device motors to an initial (home) position and/or orientation. Optionally, the actuating mechanisms of the tools, e.g. a designated shaft in which a tool is received, are rotated to align such that a slot extending along the shaft is facing upwards in the direction of the open lid. A potential advantage of automatically aligning the motors and/or tool shafts when opening the cover of the device housing may include easier access to adjust and/or remove a tool from its mechanism.

Exemplary dimensions of the upper portion 1805 of the device (without the saddle-shaped bottom, which may alternatively be formed as a flat surface) may include: an axial length 1821 less than 12 cm, a width 1823 less than 7 cm, and a height 1825 less than 9 cm.

In some embodiments, the housing 1802 is formed from a relatively light yet durable material, such as plastic, aluminum, composite materials. Optionally, the material is recyclable, so that a disposable device (e.g., a single use device) can be at least partially recycled.

Fig. 19A-19B schematically illustrate a surgical robotic device including or attached to a guide catheter drive unit, according to some embodiments.

Fig. 19A to 19B show a robot apparatus having housings of different shapes. Fig. 19A shows a robotic device housing 1900 such as described above in fig. 18A-18B, positioned on a fixture 1921 defining a flat surface. Fig. 19B shows a substantially box-shaped housing 1902 having a square or rectangular cross-sectional profile.

In some embodiments, a guide catheter drive mechanism 1901 is configured as a separate add-on unit that is configured to be operably coupled to the robotic device, e.g., to device housing 1903.

In some embodiments, the guide catheter drive unit is attached to the housing in a manner that presents a microcatheter of the housing (e.g., through aperture 1905) into a lumen of a guide catheter loaded onto the guide catheter unit. 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., by corresponding protrusions and recesses of the device housing and a housing of the guide catheter drive unit), a slide attachment (e.g., including a track 1906, e.g., as shown in fig. 19A).

In some embodiments, a track 1906 movably couples the guide catheter drive unit 1901 to one or more motors located within the housing of the device, e.g., such that a motor drives the back and forth motion of the unit for moving the guide catheter. In some embodiments, the guide catheter drive mechanism is configured to drive linear and/or rotational motion (i.e., rolling) of the guide catheter. In some embodiments, the guide catheter drive unit is configured to electrically connect with and receive a power supply from the robotic device. Alternatively, the guide catheter drive unit includes a separate power source (e.g., a battery).

In some embodiments, the guide catheter drive unit is connected to the robotic device by a plurality of mechanical connections, such as by a snap-fit connection, an interference fit connection, pins and sockets, and/or other suitable mechanical couplings.

Alternatively, in some embodiments, the guide catheter drive mechanism is located within the robotic device housing and forms an integral part of the robotic device.

In some embodiments, the guide catheter drive mechanism is configured for driving linear movement of the guide catheter over a selected distance range, e.g., advancing and/or retracting the catheter 3 cm, 5 cm, 10 cm or intermediate, longer or shorter distances. In some embodiments, this provides fine tuning of a position of a guide catheter previously inserted into the patient.

In some embodiments, to ensure that a microcatheter within the guide catheter moves with the guide catheter, the microcatheter drive mechanism is controlled to compensate for that motion, e.g., to drive the microcatheter in an opposite direction to the guide catheter. Optionally, a guidewire within the microcatheter moves with the microcatheter as a single unit and does not require independent actuation.

Fig. 20A-20C are an example of a separate mechanism for the guide catheter drive unit, an example of a guide catheter drive unit housing, and an example of a guide catheter drive unit assembled to the robotic surgical system, according to some embodiments.

In some embodiments, a guide catheter mechanism (see fig. 20A) includes one or more motors, such as a motor 2001 for driving linear motion and a motor 2003 for driving rotation. In some embodiments, a proximal portion of the guide catheter 2005 is attached at the connector 2009. In some embodiments, in operation, the motor 2001 rotates a lead screw 2007, which in turn advances or retracts the connector 2009, thereby advancing or retracting the guide catheter 2005. In some embodiments, motor 2003 moves linearly with connector 2009.

In some embodiments, activation of the motor 2003 rotates the connector 2009, thereby rotating (rolling) the guide catheter 2005.

Fig. 20B is an appearance of a guide catheter unit 2000. In some embodiments, the unit includes an elongated housing 2011 and the lead screw 2007 (e.g., as shown in fig. 20A) extends through the housing. In some embodiments, the housing contains one or more ports that open into the lumen of the guide catheter. For example, an injection port 2010 through which materials (e.g., liquid reagents, saline, etc.) may be injected into and through the lumen of the guide catheter.

In some embodiments, housing 2011 is shaped to attach to the robotic device. In one example, the housing defines a seat 2012, the seat 2012 can rest on and/or be at least partially coupled to the outer housing of the robotic device, such as by being received within a corresponding recess or notch defined at the robotic device housing.

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

As further shown in this example: a guidewire 2019 extends from a guidewire retainer 2021 into a designated shaft of the guidewire drive mechanism; the guidewire then exits the housing at 2025, which also serves as a fixation point for the microcatheter 2027, and the guidewire enters the microcatheter lumen. The microcatheter is then bent at 2029 to enter the device housing, being received within a designated shaft of the microcatheter drive mechanism. When the microcatheter (with the guidewire received therein) exits the housing, it is received within a lumen of the guide catheter 2005 held and manipulated by the guide catheter unit 2000.

Fig. 21A-21C illustrate mechanisms for actuating rotational (rolling) and/or linear motion of a tool actuated by the robotic surgical system, according to some embodiments.

In some embodiments, as shown in the exemplary mechanism of fig. 21A, a guide wire 2101 inserted into a designated shaft is engaged with at least a pair of drive wheels 2103 positioned opposite each other and contacting the guide wire passing therebetween. A motor 2105 for driving the linear motion of the tool drives the rotation of the plurality of wheels, which, depending on the direction of rotation, causes the guidewire to move axially in a proximal or distal direction.

In some embodiments, an engine 2107 is configured to drive the rotation of a first gear 2109, which first gear 2109 in turn interferes with a second gear 2111 (positioned near gear 2109 or on top of gear 2109), causing the second gear 2111 to rotate. In some embodiments, rotation of the second gear 2111 produces rotation of the assembly including the plurality of drive wheels 2103 and the linear motor 2105, thereby integrally rotating the assembly (with the guidewire held therein).

In some embodiments, as gear 2109 rotates, it rotates a holder 2121 for the guidewire, thereby rotating (rolling) the guidewire. Thus, in some embodiments, the rotation (rolling) of the guidewire occurs at two locations along the guidewire: a first position at the holder 2121 and a second position at the assembly comprising the drive wheels and linear motor, which is rotated as a unit with the guide wire. A potential advantage of rolling the guide wire at two locations along the guide wire, wherein optionally one location is shown close to the curve and the other location is away from the curve, may include reducing twisting of the guide wire during rolling, e.g. by driving rotation synchronously at both locations, optionally by a single motor performing the rolling motion at both locations.

A potential advantage of using the same single motor (e.g., motor 2107 moving gear 2109) to drive the guidewire in rotation at two locations along the length of the guidewire may include improved control over the guidewire roll, for example, as opposed to using multiple different motors at the two (or more) locations, which may require synchronization between the multiple motor directions and/or speeds and/or actuation timings. Another potential advantage of using a same single motor to drive rotation at two different guidewire length locations may include providing a more compact, smaller device housing.

Additionally or alternatively, rotation of gear 2109 does not directly rotate the guidewire (e.g., by not rotating retainer 2121), but rather facilitates rotation of the guidewire only from the point of the assembly rotated by gear 2111 (when gear 2111 is rotated by gear 2109).

In some embodiments, one or more slip rings are used to provide current to the plurality of motors regardless of a direction of current flow (e.g., direction of rotation) of the assembly. For example, a slip ring comprised of a roller bar 2117 and base 2119 is located at the attachment of the second gear 2111 to the drive wheels and linear motor components. In some embodiments, the slip ring maintains an electrical coupling with the linear motor so that the linear motor can be actuated regardless of the rotational direction of the assembly.

In another exemplary configuration, as shown in fig. 21B, a motor driving rotation and/or a gear 2113 transmitting rotation from the motor may be directly interconnected with the assembly of drive wheels and/or motor 2105 driving linear motion and/or with a shaft housing the tool. In one example, gear 2113 is positioned along a similar long axis as the assembly.

In some embodiments, gear 2113 is formed with a slot 2123, and the guidewire passes through slot 2123. Optionally, slot 2123 forms a direct extension of slot 2125 in a designated shaft 2127 that receives the guide wire. In some embodiments, the slot extends along a 5 degree, 10 degree, 20 degree arc around the gear. A potential advantage of a slot through the gear may include facilitating removal of the guidewire from the actuation mechanism.

Figure 21C is a cross-sectional view showing an actuation assembly including a shaft 2127 and a plurality of wheels 2103 that drive linear motion of the guidewire. In some embodiments, the shaft 2127 defines an elongate lumen 2129 in which the guide wire is received, the lumen communicating with the slot 2125. In some embodiments, the inner walls of shaft 2127 are configured to match a profile of the wheels (see, e.g., curvature 2128) such that a guidewire within lumen 2129 is guided into (and then out of) a pathway between the wheels. In some embodiments, lumen 2129 extends adjacent to the outer contours of the plurality of wheels to bring the guidewire directly between the plurality of wheels.

In some embodiments, the plurality of wheels 2103 are arranged (located) on a plane that is substantially perpendicular to a plane defined by the slot 2125. Alternatively, the plurality of wheels may be arranged in a plane parallel to a plane defined by the slot 2125.

One potential advantage of an axle configured to match a profile of the wheels may include improved control of the guidewire as it is advanced into (and out of) the pathway between the drive wheels. Another potential advantage may include reducing a risk of the guidewire slipping out and/or otherwise moving out of its intended path.

One potential advantage of an assembly that includes wheels for driving linear motion of the guidewire and is configured to rotate as a unit to produce rolling of the guidewire may include that linear motion may be performed during rolling motion (or vice versa). Another potential advantage of a dual motion assembly that drives linear and rotational motion at the same physical location (inside the robotic device) may include a reduction in slippage or other undesirable guidewire motion that may occur, for example, if two spaced apart mechanisms drive linear and rolling motion, respectively, the guidewire needs to extend between them. In spaced mechanisms where one mechanism drives rotation and another spaced mechanism drives linear motion, rotation of the guidewire may cause the guidewire to slide between the rotation mechanism and the linear motion mechanism (or vice versa-linear motion of the guidewire may cause it to slip from the rotation mechanism). Another disadvantage of separate spaced apart mechanisms is that friction may be caused at the idle point (i.e. friction is applied to a tool segment at a mechanism not currently in use), which may require some type of release mechanism that will disengage one mechanism when another mechanism is operated.

Fig. 22 illustrates an exemplary configuration of mechanisms for driving movement of a guidewire according to some embodiments.

In some embodiments, the guidewire rotation is performed by more than one mechanism. Optionally, two or more mechanisms engaging the guidewire are configured to cause rotation (rolling) of the guidewire. In this case, the two mechanisms are controlled in a synchronized manner, for example to ensure that the guide wire does not twist or kink.

In some embodiments, a guidewire proximal portion or handle is held within an adapter or holder 2201, adapted to produce rotation of the guidewire by rotation to rotate the handle as a whole, and/or by actuation of a handle component, such as a rotatable knob (not shown) that produces rotation (rolling) of the guidewire (optionally rolling of a distal tip of the guidewire). The guide wire extends from an axis 2203 along which the holder 2201 rotates until exiting the housing. As the guidewire enters the housing, it may pass through a second mechanism adapted to actuate rotation (also linear motion in this example). The second mechanism, such as one shown in fig. 21B, may be configured to actuate rotation (rolling) of the guidewire about an axis 2205 along which the guidewire extends along the axis 2205. Optionally, axis 2205 is parallel to axis 2203, defining multiple parallel paths in which tool actuation occurs. Alternatively, the multiple passes of the multiple tools defined along

axes

2205 and 2203 are non-parallel, e.g., angled inwardly or outwardly relative to each other.

In some embodiments, the mechanisms extend to a similar height and/or axial length so that they can be installed in a compact housing.

Fig. 23A-23B are a schematic and flow diagram relating to controlling a length and/or position of a tool by adjusting a curved portion of the tool, according to some embodiments.

In some embodiments, as schematically illustrated in fig. 23A, a tool 2301 manipulated by the robotic device 2302 engages two or more locations 2303, 2305 (along the length of the device) that are spaced apart from one another such that the extension of a segment 2307 of the tool between the two locations is adjustable (lengthened or shortened). In some embodiments, the

locations

2303, 2305 define multiple attachment points of the tool 2301 to the robotic device housing 2302, while the segment 2307 extends outside of the device (i.e., outside of the device housing).

In some embodiments, the

locations

2303, 2305 are arranged relative to one another in a manner that causes the segment 2307 to be bent or curved, e.g., a "U" shaped curvature as shown. In one example,

locations

2303 and 2305 are aligned side-by-side.

Alternatively,

locations

2303 and 2305 are not aligned side-by-side.

In some embodiments, to control a length of the tool, the curve (e.g., the "U" shape) is sized (e.g., expanded or contracted), changing a maximum distance 2309 between a peak of the curve and the housing of device 2302.

In some embodiments, a range of the curve (e.g., defined by a radius of curvature 2310) is set by linear motion of the tool (e.g., a range of advancement or retraction of the tool) and/or by manual loading of the tool, with a certain segment of the tool length loaded into the system. In some embodiments, the range of the curve depends on a total length of the tool.

In some embodiments, a distance 2312 between the tool and the plurality of attachment points of the housing is a function of a radius 2310 of curvature of the tool. Optionally, distance 2312 is twice the minimum radius at which the tool can bend to curvature.

In some embodiments, the dimensions of the housing 2302, e.g., a range of a wall of the housing in which the inlet and outlet apertures of the tool are formed, are sized according to the radius of curvature of the tool, e.g., at least twice a minimum radius of curvature of the tool, but not more than 5, 6, 8, 10 or intermediate, greater or lesser times the minimum radius of curvature of the tool for operation of the device.

In some embodiments, a maximum dimension of the housing (e.g., a width of the housing or a height of the housing) is between 5 to 10 centimeters, 8 to 20 centimeters, 12 to 40 centimeters, or intermediate, longer, or shorter.

In some embodiments, the device includes more than two engagement locations with the tool, allowing for multiple curves (e.g., "U" curves) to be formed between the locations.

One potential advantage of an apparatus that defines tool engagement positions such that the length of a tool segment extending between the positions is adjustable may include improved control over a length of the tool being manipulated. Optionally, a length of a distal-most tool segment, such as a segment extending between a posterior-most exit of the robotic device housing and a target point within the patient's body, is controlled, potentially allowing fine control over a tool distal tip position. In some embodiments, pushing the tool towards the target point inside the body reduces the size of the curve of the tool outside the housing, and vice versa: retracting the tool from the target point increases the size of the curve.

Another potential advantage of an apparatus that defines tool engagement positions such that the length of a tool segment extending between the positions is adjustable may include the ability to receive and manipulate multiple tools of various lengths.

Another potential advantage of a device defining tool engagement positions such that the length of a tool segment extending between the positions is adjustable may include the curved segment extending outside the device housing, potentially allowing a device to have a relatively small size (e.g., axial length) that is substantially unaffected by the length of the tool, thereby achieving a compact housing of small size.

The flow chart of FIG. 23B is an example of the mechanism described by the diagram of FIG. 23A. In some embodiments, a tool proximal end is secured to the robotic device (2321). For example, a handle of the tool is received and/or attached by a designated adapter or holder of the device. This attachment may be referred to as a first engagement position, such as described above. In some embodiments, a distal portion of the tool is screwed or inserted into the robotic device (2323). For example, a distal portion of the tool is threaded into a designated shaft of the steering mechanism (e.g., a guide wire is inserted to engage the plurality of tool moving wheels). This second attachment may be referred to as the second engagement position, e.g., as described above.

Next, optionally, a length of a tool segment extending between the fixed position of the tool proximal end and the engaged position of the tool (e.g., via the plurality of tool moving wheels) is adjusted (2325).

FIG. 24 illustrates a system configuration defining an arrangement of tools, in which a tool length may be adjusted, in accordance with some embodiments.

In the example shown, a robotic device 2401 including and/or coupled to a guide catheter unit 2403 is configured to receive and drive the following motions: a guidewire 2405, a microcatheter 2407 and a guide catheter 2409. In some embodiments, as shown in this example, the two "U" shaped

curves

2411 and 2413 are defined by a plurality of tools passing through the system: a curve 2411 of the guidewire alone, and a curve 2413 of the guidewire when the guidewire extends within the lumen of the curved microcatheter. In some embodiments, a change in a magnitude of curve 2413 causes the microcatheter and guidewire to move in unison at multiple stages away from the curve. In some embodiments, movement (advancement or retraction) of the microcatheter changes the size of curve 2413.

As can be observed in fig. 24, the device housing 2402 (i.e., the plurality of walls of the housing) defines a plurality of apertures through which the plurality of tools enter and/or exit the internal device space defined by the housing: in some embodiments, a proximal portion of the guidewire 2405 is anchored to the device at a retainer 2404; the guidewire then enters the housing at an aperture 2406 and exits through an aperture 2408, wherein the aperture 2408 is optionally located at an opposite wall of the housing from a wall defining the aperture 2406. In some embodiments, a proximal portion of the microcatheter 2407 is anchored to the device at a retainer 2410 where the guidewire is also received within the microcatheter lumen. Next, in some embodiments, the microcatheter enters the housing at an aperture 2412 and exits the housing at an aperture 2414, which is optionally disposed at an opposite wall of the housing from aperture 2412.

Fig. 25 schematically illustrates a plurality of tool movement drive mechanisms of the system according to some embodiments.

In some embodiments, as shown in this example, the plurality of tool movement mechanisms are arranged parallel to one another, e.g., side-by-side. A potential advantage of the multiple tool movement mechanisms being parallel to one another (and optionally aligned along a similar axial extent) may include that a tool extending through the multiple mechanisms may be adjustably curved, thereby providing variable tool lengths. A potential advantage of the multiple tool movement mechanisms being parallel to one another (and optionally aligned along a similar axial extent) may include that the device housing that houses these mechanisms may be kept at a relatively small, compact size, which is not determined by the actual length of the tool.

The plurality of tool movement mechanisms shown herein include a mechanism 2501 for holding and optionally rotating a guide wire 2502 (see, e.g., the description of fig. 21A); a mechanism 2503 for actuating linear translation of the guidewire, including, for example, a set of multiple wheels 2505; and a mechanism 2507 for actuating linear translation of a microcatheter 2508, including, for example, a set of multiple wheels 2509.

In some embodiments, guidewire rotation may be performed at one or both of

mechanisms

2501, 2503, optionally under synchronization (e.g., by a device controller).

Fig. 26A-26B are examples of a device configuration including resilient elements (e.g., springs) for selectively engaging tools received by the system, according to some embodiments.

In some embodiments, resilient elements (e.g., springs, straps) are positioned and configured to move (e.g., push) the drive wheels toward a tool received within the device, bringing the wheels into intimate contact with the tool. Additionally or alternatively, resilient elements are positioned and configured to move (e.g., push, center) a tool received within the device into operable contact with the drive wheels.

In the example shown, a spring 2601 is mounted on a lever 2603 that holds the drive wheels 2605 such that when a force is applied to the spring, the lever moves the wheels into contact with the tool. In some embodiments, force is applied to the spring by a closing or movement of a portion of the housing, such as a closing of a lid. In some embodiments, the spring is configured to retract the lever to move the plurality of wheels away from the tool, e.g., to allow removal of the tool. Optionally, when the cover (or other portion of the housing) is opened or otherwise moved, the spring is pulled up, thereby removing the plurality of wheels from the tool.

In some embodiments, the spring is pre-configured to apply a force selected for a particular tool or tool size (e.g., tool diameter), for example, positioning the plurality of wheels in contact with a tool of a particular thickness.

Fig. 27 is a schematic block diagram of a robotic device configured for manipulating two or more elongated surgical tools, according to some embodiments.

In some embodiments, walls of a housing 2701 of the robotic device define an interior volume 2703, at least two different paths, e.g., 2705, 2707, for the elongated surgical tool being defined in the interior volume 2703. In some embodiments, a passageway extends through the interior volume, such as between two opposing walls of the housing, such as wall 2709 and wall 2711. Optionally, the housing is shaped in an elongate form, for example having a substantially rectangular cross-sectional profile, and the plurality of paths extend along the length of the housing.

In some embodiments, each of the plurality of paths extends between an inlet aperture formed at the wall of the housing and an outlet aperture formed at an opposite wall of the housing. In the example shown, the path 2705 extends between an inlet aperture 2713 formed at the wall 2709 and an outlet aperture 2715 formed at the wall 2711; and path 2707 extends between an inlet opening 2717 formed at wall 2711 and an outlet opening 2719 formed at wall 2709.

In some embodiments, an aperture formed in a wall of the housing is shaped and/or sized according to the surgical tool passing therethrough. For example, a circular (e.g., circular) hole is sized to fit a cylindrical tool, such as a guidewire or microcatheter, wherein the hole diameter optionally does not exceed 5%, 10%, 25% or an intermediate, higher or smaller percentage of a diameter of the tool. In some embodiments, an aperture is sized to allow more than one tool to pass through. Optionally, the aperture profile is elliptical (e.g., ellipsoid), rectangular, slotted, and/or other shape. In some embodiments, a single elongated slot serves as a hole for both internal pathways.

In some embodiments, a single tool enters the interior volume of the housing through an entry aperture and exits the housing through a corresponding exit aperture. Additionally or alternatively, in some embodiments, a plurality of tools (e.g., 2 tools, such as a guidewire disposed within the lumen of a microcatheter) telescopically arranged together exit the housing through the same entry hole and together through a respective exit hole. Thus, in such an example, a first tool passes through a first internal path, exits the housing into the lumen of a second tool, and the telescoping assemblies of both tools pass through a second internal path. In some embodiments, the telescoping configuration of the plurality of tools occurs outside the housing after both tools have passed through their internal pathways, e.g., in the case of a rapid exchange catheter, which may be interconnected with the guidewire after each of the guidewire and the rapid exchange catheter have independently passed through their respective actuation assemblies located in the plurality of internal pathways.

In some embodiments, the plurality of paths extend in a similar plane, e.g., a similar horizontal plane, a similar vertical plane, a similar plane extending diagonally between the plurality of walls of the housing. In some embodiments, the plurality of paths extend along a plurality of parallel axes. A distance 2721 between the parallel axes may be, for example, between 3 and 12 cm, 2 and 10 cm, 5 and 9 cm or an intermediate, longer or shorter distance.

Alternatively, in some embodiments, the plurality of paths are non-parallel, e.g., one path extends directly between opposing walls, while another path takes a diagonal or other indirect path.

In some embodiments, the housing is sealed except for the plurality of aperture locations. Optionally, the housing includes a removable or removable cover or lid. In some embodiments, the housing is at least partially open, e.g., shaped as a box without a top surface.

In some embodiments, all components engaged with the tool to manipulate and/or drive movement of the tool are fully enclosed within the interior volume of the housing, and at least some of these components are positioned along the path defined for the tool. In some embodiments, these components include an actuation assembly, such as the plurality of tool moving elements described in fig. 21B-21C.

In some embodiments, as shown, a plurality of

motors

2722, 2723 are configured to drive the plurality of actuating assemblies, such as configured to drive a plurality of tool moving elements 2725 (e.g., wheels) of each assembly. In some embodiments, the engine and the plurality of tool moving elements are positioned along the path defined for the tool. In some embodiments, the multiple actuation assemblies of the two (or more) paths are aligned side-by-side. A potential advantage of the multiple actuation assemblies being aligned side-by-side may include allowing a short or minimum distance 2728 (optionally the device width or height) between opposing

walls

2733, 2735. In one example, distance 2728 is less than 15 centimeters, 12 centimeters, 10 centimeters, or an intermediate, longer, or shorter distance.

In some embodiments, the plurality of actuating assemblies of the two or more paths have a similar axial extent (or do not extend beyond a certain axial extent). A potential advantage of the multiple actuation components being positioned and/or sized relative to each other such that they do not extend beyond a certain axial extent may include that a distance 2730 between walls 2709 and 2711 (optionally the device length) may be maintained within a minimum axial extent required to contain the multiple motion drive components. In one example, distance 2730 is less than 10 centimeters, 7 centimeters, 12 centimeters, or an intermediate, longer, or shorter distance. In some embodiments, a plurality of

engines

2722, 2723 are also positioned within the axial extent of the plurality of actuating assemblies and proximate to the plurality of actuating assemblies to facilitate the compact design of the device. The ability to position the motor proximate to and potentially in contact with at least a portion of the plurality of actuation assemblies is provided, for example, because no barrier (e.g., sterility protection or shielding) is required between the actuation assemblies, the motor, and the surgical tool being manipulated.

In some embodiments, the plurality of actuation components of the two or more paths are positioned within the same, shared interior volume defined by the plurality of walls of the housing. In some embodiments, there are no barriers (e.g., inner walls, shrouds, curtains, etc.) between the plurality of motion-driving components of the two or more paths. In some embodiments, there are no barriers (e.g., interior walls, shields, curtains, etc.) between the actuation assemblies and the tools manipulated by them.

Alternatively, in some embodiments, a portion of a baffle or barrier is provided. For example, the device housing may include an inner wall or protrusion that does not completely obstruct the interior volume, thereby placing at least some regions of the multiple pathways in communication with one another.

In some embodiments, an actuation assembly of an internal path (e.g., an actuation assembly including a shaft in which a tool is received and/or a plurality of wheels that drive linear motion of the tool) is exposed to an actuation assembly of a different internal path (e.g., an adjacent path).

In some embodiments, multiple actuation assemblies of multiple paths are arranged and retained relative to each other on a chassis. Optionally, the chassis is exposed and open to its surroundings, e.g. no housing is provided.

In some embodiments, an actuation assembly of a path at least partially restricts movement of the tool within the internal path, e.g., restricts lateral movement of a tool received within the path. For example, movement of the tool beyond a plurality of imaginary limits defined by the elongate path is limited. In some embodiments, the tool is guided through the path, e.g., received in a slot of an elongated shaft (e.g., the shaft of an actuation assembly, e.g., shaft 2127, fig. 21B). Alternatively or additionally, the path is defined by a path created between pairs of opposing wheels.

In some embodiments, in addition to extending through the path, a tool engages the device at one or more additional fixed locations (also referred to herein as "fixed points," "joints"). In some embodiments, a fixed location includes a holder (e.g., 2727, 2729) located outside of the housing, inside of the housing, or partially inside and partially outside of the housing. In some embodiments, a fixed location couples a tool to the housing and/or one or more other tools. For example, at fixed location 2729, a first elongate surgical tool 2731 extending through pathway 2705 (e.g., a guide wire) enters a lumen of a second elongate surgical tool 2733 (e.g., a microcatheter), the second elongate surgical tool 2733 being coupled to the housing at fixed location 2729. In some embodiments, a proximal end of tool 2731 is coupled to the housing at fixed location 2727.

In some embodiments, fixed location 2727 is shaped and configured to receive a proximal handle of tool 2731, e.g., a handle that manipulates the distal portion of the tool in terms of bending and/or stiffness. In some embodiments, an additional motor (not shown) is configured to rotate tool 2731 through two positions, one of which is the handle of the tool (e.g., at fixed location 2727) and the other of which is a region remote from the tool. For example, an engine configured to rotate tool 2731 by rotating an actuation assembly associated with a portion of tool 2731 is also operably connected to the handle of the tool, optionally through a gear system. Thus, the engine is configured to simultaneously rotate the tool from these two different positions. One advantage of starting rolling movements by the same engine at two different positions along the tool may include enhancing the torque exerted on the tool and eliminating the risk of the tool slipping in its multiple gripping positions in the actuating assembly.

In some embodiments, a fixed location (e.g., 2727) of a tool and the housing and an inlet hole (e.g., 2713) for introducing the tool into the interior volume are located on a same wall of the housing, thereby forming a curve, such as a U-shaped curve, for a portion of the tool that is external to the housing. In some embodiments, for example, as described in fig. 23A-23B, the range of the U-shaped curve is dynamically adjustable. Optionally, linearly moving the tool (e.g., by the plurality of tool moving elements, e.g., a plurality of wheels) changes the extent of the U-shaped curve relative to the outside of the wall of the housing.

In some embodiments, the curve is defined along a path extending from and to the same wall of the device housing.

In the example shown, the housing includes a plurality of sharp corners and a plurality of straight-sided walls, but other configurations are contemplated including, for example, a plurality of rounded corners, a plurality of curved walls, etc.

In some embodiments, actuation of the actuation assembly of each of the plurality of paths (e.g., via an engine) is controlled by a controller 2735. In some embodiments, the components of each path are controlled independently, but in a synchronized manner.

In some embodiments, controller 2735 is remotely controlled by an external device, such as by a remote control device as described herein.

Fig. 28 schematically illustrates a robotic device for manipulating two or more elongated surgical tools configured for a telescopic configuration, such as in a non-limiting manner, a guidewire and a microcatheter, the first elongated tool extending at least partially within the lumen of the second elongated tool, in accordance with some embodiments.

In some embodiments, the robotic device 2801 comprises a housing 2803, the housing 2803 comprising a plurality of walls that form an internal volume 2805 therebetween. In some embodiments, two or more internal pathways extend inside the internal volume such that the

tools

2810, 2813 received and operated by the device extend at least partially along the multiple internal pathways.

In some embodiments, each of the plurality of internal pathways includes an actuation assembly positioned at a location of the pathway, e.g., extending axially along at least a portion of the pathway. In some embodiments, an actuation assembly (e.g., 2806, 2807) is configured for linearly moving the tool, e.g., one or more sets of wheels configured to advance and/or retract the tool. Alternatively or additionally, an actuating assembly (e.g., 2806) is configured for moving the tool in a rolling manner, such as by rotating a set of wheels that grip the tool therebetween.

In some embodiments, a plurality of actuating assemblies are operably coupled to a plurality of motors, such as

motors

2811, 2808, 2809. In some embodiments, the plurality of motors are configured for operating the plurality of actuating assemblies to produce linear motion of the plurality of tools received therein. Alternatively or additionally, the plurality of motors are configured to generate a rolling motion of the received tool, optionally by generating a rolling motion of the associated actuating assembly of the tool as a whole. For example, motor 2809 is operably connected to linear motion mechanism 2807, optionally through a gear system, and is configured to rotate linear motion mechanism 2807 with motor 2811, thereby rolling tool 2810, which tool 2810 is grasped within linear motion mechanism 2807. One potential advantage of rotating the entire linear motion mechanism with the tool is that the associated gear system is simplified and both linear and rolling motion can be performed simultaneously. In some embodiments, the motor 2811 rolls with the linear motion mechanism 2806 due to the absence of a sterile barrier between the plurality of motors and the plurality of actuation assemblies.

In the example shown, a first elongate surgical tool 2810 (e.g., a guidewire) extends along a first internal path, e.g., between an inlet orifice 2814 into the housing and an outlet orifice 2816 out of the housing.

In some embodiments, linear motion of the tool 2810 is driven by the motor 2811 and rolling of the tool 2810 is driven by the motor 2809, both of which are located and configured at a location of the internal path (e.g., along an imaginary axis defined by the path through the internal volume).

In some embodiments, the tool 2810 is telescopically received within a lumen of a second elongate surgical tool 2813 (e.g., a microcatheter) at the exit orifice 2816 of the housing where the tool 2810 exits. The tool 2813 then enters the housing at an inlet orifice 2815 and extends along a second internal path to an outlet orifice 2817, in which the tool 2810 extends.

In some embodiments, the linear motion of the tool 2813 is driven by an actuation assembly 2807.

In some embodiments, the actuation mechanism and the plurality of engines share the same internal volume without a barrier or other physical separation therebetween.

Fig. 29 schematically illustrates another example embodiment of the robotic device configured to receive three telescopically arranged elongated surgical tools, such as a guide wire, a microcatheter, and a guide catheter.

In some embodiments, robotic apparatus 2901 includes a housing 2903 having an interior volume 2905, wherein inlet aperture 2914 and outlet aperture 2916 define therebetween a first internal path for receiving a first elongated surgical tool 2910, and inlet aperture 2915 and outlet aperture 2917 define therebetween a second internal path for receiving a second elongated surgical tool 2913.

In some embodiments,

actuation assemblies

2906, 2907 are positioned along the plurality of internal paths and configured to contact the plurality of tools received therein for at least one of advancing, retracting, and/or rolling the tools. In some embodiments, a plurality of motors, such as

motors

2909, 2911 and 2908, are positioned proximate the plurality of internal pathways and are operably connected to the plurality of actuation assemblies. In some embodiments, the plurality of engines and the plurality of actuation assemblies are located within a same interior volume housing the plurality of internal pathways, e.g., there is no barrier blocking the air flow communication therebetween.

In some embodiments, only one motor is operably connected to an actuation assembly, exemplified by actuation assembly 2907 and motor 2908, which are operably connected to the actuation assembly to advance or retract elongated surgical tool 2913. In some embodiments, two or more motors are operably connected to an actuation assembly, such as actuation assembly 2906 and

motors

2909 and 2911. In this example,

motors

2909 and 2911 are operably connected to actuation assembly 2906 to advance, retract, and roll elongated surgical tool 2910. Optionally, motor 2909 rolls tool 2910 by rolling said complex 2904, wherein complex 2904 comprises at least actuating assembly 2906 and motor 2911.

In some embodiments, the proximal end of the elongated surgical tool 2910 is secured in a fixed position 2920. In some embodiments, the fixation location 2920 includes a protrusion configured to attach to a luer fitting (not shown) optionally present in the proximal end of the tool 2910. Alternatively, the fixed position 2920 comprises a cavity sized and shaped to receive a handle (not shown) optionally located at the proximal end of the tool 2910. In some embodiments, the proximal end of the tool 2910 is operably connected to an adapter 2950, in some embodiments the adapter 2950 rolls the tool about its longitudinal axis, for example, by rolling a proximal handle portion of the tool received at the adapter. In some embodiments, the motor operably connected to the adapter to cause the rolling motion is the same motor operably connected to the actuation assembly associated with the tool at a remote location. For example, as shown and illustrated by engine 2909, engine 2909 is operatively connected to adapter 2905 and at the same time operatively connected to complex 2904 to cause rolling actuation of tool 2910 from at least these two different positions.

In some embodiments, a U-shaped curve is formed in the tool 2910 between the fixation location 2920 and the inlet aperture 2914. In some embodiments, as the tool 2910 is moved linearly in the actuation assembly 2906, it advances or retracts the distal end 2930 of the tool 2910, optionally when a distal portion has been introduced into the patient. In some embodiments, as the tool 2910 is advanced or retracted, a distance between a maximum point of the U-shaped curve and the housing 2903 shortens or lengthens. One advantage of the U-shaped curve formed outside of housing 2903 is that the housing size need not accommodate this distance, and the device is capable of guiding a range of tool lengths independent of the size of the device.

In some embodiments, a fixed position of one elongate surgical tool is located at the exit aperture of another elongate surgical tool, as shown and illustrated by fixed point 2922, which overlaps exit aperture 2916, thereby causing elongate surgical tool 2910 to exit housing 2903 through exit aperture 2916 directly into the lumen of elongate surgical tool 2913 when tool 2913 is connected to fixed position 2922.

In some embodiments, a second U-shaped curve for tool 2910 and a first U-shaped curve for tool 2913 are formed between securing location 2922 and inlet aperture 2915. In some embodiments, as the distal end 2940 of the tool 2913 is advanced or retracted, both the tool 2910 and the tool 2913 move to lengthen or shorten the distance between the maximum point of the joint curve and the housing 2903. In some embodiments, when it is desired to linearly translate distal end 2940 (of tool 2913) without translating distal end 2930 (of tool 2910), engine 2911 linearly translates tool 2910 in an opposite direction to the translation of engine 2907, which affects both tools, effectively causing the distal end 2930 of tool 2910 to stand in place.

In some embodiments, an elongated surgical tool (e.g., a guide catheter or sheath) connected to a fixed position from outside of housing 2903 is configured to be operated by a plurality of motors located inside housing 2903, e.g., elongated surgical tool 2919 connected to fixed position 2917, and may be a linearly moving actuation assembly 2927 operably connected to motor 2928 and motor 2929 for linear and rolling motion, respectively. In some embodiments, actuation assembly 2927, along with

motors

2928 and 2929, are located in the same internal volume as

motors

2909, 2911, and 2908, and are located in the same internal volume as the

actuation assemblies

2906 and 2907 to which they are operably connected. In such exemplary embodiments, at least 5 motors are located within the same internal volume as the plurality of internal pathways of the plurality of elongated

surgical tools

2910 and 2913.

In some embodiments, fixation location 2924 overlaps with exit aperture 2917, such that the telescopically arranged elongate

surgical tools

2910 and 2913 exit housing 2903 through exit aperture 2917 directly into the lumen of elongate surgical tool 2919. In some embodiments, the actuation assembly 2927 is positioned along the same plurality of internal paths as the tool 2913.

As used herein, the various terms "insertion device" and "medical device", "robotic system", "device", "system", and the like may be used interchangeably. In some cases, a device is treated as part of a system.

As used herein, the terms "medical instrument" and "medical tool," "surgical tool," "elongated tool," and the like may be used interchangeably.

Although some examples described throughout this disclosure primarily pertain to inserting a guidewire into the patient's blood vessel, this is for simplicity reasons only, and the scope of the disclosure is not limited to devices for inserting multiple guidewires alone, but may include additional medical tools/instruments, such as microcatheters, balloon catheters, and the like. Further, the scope of the present disclosure is not limited to inserting multiple medical tools into multiple blood vessels, but may include inserting multiple medical tools into other body lumens, such as the urethra, gastrointestinal tract, and the trachea. In the description and claims of this application, the words "comprising" and "having" and their forms are not limited to the plurality of members of a list with which the words may be associated.

The various terms "comprising", "including", "having" and their various equivalents mean "including but not limited to".

The term "consisting of 8230 \ 8230; (consisting of)" means "including and limited to".

The term "consisting essentially of" 8230 "\8230%," 8230 "; composition (conforming) means that the composition, method or structure may comprise additional components, steps and/or portions only if the additional components, steps and/or portions do not materially alter the basic and novel characteristics of the claimed composition, method or structure.

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

Throughout this application, various embodiments of the invention may exist in a range of forms. It should be understood that the description in range format is merely for convenience and brevity and should not be construed as an inflexible limitation on the scope of the invention. Accordingly, the description of a range should be considered to have specifically disclosed all the possible subranges as well as individual numerical values within the range. For example, it is contemplated that a range description from 1 to 6 has specifically disclosed sub-ranges, such as from 1 to 3, from 1 to 4, from 1 to 5, from 2 to 4, from 2 to 6, from 3 to 6, etc., as well as individual numbers within the stated range, such as 1, 2, 3, 4, 5, and 6. This applies regardless of the scope.

Whenever a numerical range is indicated herein, it is meant to include any number (fractional or integer) recited within the indicated range. The phrases, a range between a first indicating number and a second indicating number, and a range of a first indicating number "to a second indicating number" are used interchangeably herein and are meant to include the first and second indicating numbers, as well as all fractions and integers therebetween.

The term "method" as used herein refers to means (manner), means (means), techniques (technique) and procedures (procedure) for accomplishing a specific task, including, but not limited to, those means, techniques and procedures which are known, or readily developed by practitioners of the chemical, pharmacological, biological, biochemical and medical arts from known means, techniques and procedures.

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

It is to be understood that certain features of the invention, which are, for clarity, described in the context of separate embodiments, may also be provided in combination in a single embodiment. Conversely, various features of the invention, which are, for brevity, described in the context of a single embodiment, may also be provided separately or in any suitable subcombination or in any other described embodiment suitable for the invention. The particular features described in the context of the various embodiments are not considered essential features of those embodiments, unless the embodiments are inoperative without those elements.

While the present invention has been described in conjunction with specific embodiments thereof, it is evident that many alternatives, modifications, and variations will be apparent to those skilled in the art. Accordingly, it is intended to embrace all such alternatives, modifications, and variations that fall within the scope of the included claims.

All publications, patents and patent applications mentioned in this specification are herein incorporated in their entirety by reference into the specification. To the same extent as if each individual publication, patent or patent application was specifically and individually indicated to be incorporated by reference herein. In addition, citation or identification of any reference shall not be construed as an admission that such reference is available as prior art to the present invention. The headings in this application are used herein to facilitate the understanding of this description and should not be construed as necessarily limiting. Further, any priority document of the present application is hereby incorporated by reference herein in its entirety.

Claims

1. A small robotic device for driving movement of two or more elongated surgical tools when the two or more elongated surgical tools are at least partially housed within the device, characterized by: the device includes:

a housing comprising a plurality of walls defining a shared interior volume; within the shared interior volume, the enclosure encloses:

at least two internal pathways for accommodating at least a portion of each of the two or more elongated surgical tools;

a plurality of engines;

two or more tool actuation assemblies, each of the two or more actuation assemblies configured at a location of one of the two or more internal paths; each of the two or more actuating assemblies is driven by at least one of the plurality of motors, each of the two or more actuating assemblies configured to operably contact at least one of the two or more elongated surgical tools for advancing, retracting, and/or rolling the at least one of the plurality of elongated surgical tools when the two or more elongated surgical tools are respectively at least partially received in the at least two internal paths.

2. The robotic device of claim 1, wherein: the shared internal volume is free of internal barriers separating the plurality of engines from the two or more actuation assemblies.

3. The robotic device of claim 2, wherein: the robotic device is free of walls, curtains, shields, or sterility protection separating the plurality of motors from the two or more actuation assemblies.

4. A robotic device according to any one of claims 1 to 3, wherein: each of the two or more internal pathways extends through the internal volume between an inlet aperture and an outlet aperture disposed on opposing walls of the device housing and in communication with the internal volume.

5. A robotic device according to any of claims 1 to 3, wherein: each of the plurality of actuating assemblies includes a plurality of wheel pairs, each wheel pair including a set of opposing wheels configured to define the internal path therebetween.

6. The robotic device of claim 5, wherein: at least some of the opposing wheels are configured to rotate to advance and retract the elongated surgical tool within the internal path and roll the elongated surgical tool about a long axis of the elongated surgical tool.

7. A robotic device according to any one of claims 1 to 3, wherein: the plurality of tool actuation assemblies are each confined within the plurality of walls of the housing, and wherein only a portion of the two or more elongated surgical tools, when received within the device, extend outwardly from the plurality of walls of the housing to a distance of at least 1 centimeter from the housing.

8. A robotic device according to any of claims 1 to 3, wherein: at least one securing location is defined on the exterior of the plurality of walls of the housing for securing a proximal end of at least one of the two or more elongated surgical tools to the housing while a distal portion of the elongated surgical tool is received within the housing within one of the two or more internal pathways.

9. The robotic device of claim 8, wherein: the at least one fixed position is located at an exit aperture of the housing such that the elongated surgical tool exiting the interior volume through the exit aperture is introduced into a lumen of a proximal end of a second elongated surgical tool of the two or more elongated surgical tools, forming a telescoping configuration of the two elongated surgical tools.

10. The robotic device of claim 8, wherein: the at least one securing location defines a cavity shaped and configured to receive a proximal handle of the at least one elongated surgical tool.

11. A robotic device according to any of claims 1 to 3, wherein: the internal volume is less than 2800 cm ^3; and wherein the device has a weight of less than 850 grams.

12. A robotic device according to any of claims 1 to 3, wherein: the dimensions of the housing include a height less than 30 cm, a width less than 30 cm, and a length less than 30 cm; each of the at least two internal pathways extends axially along the length.

13. The robotic device of claim 1, wherein: the two or more elongated surgical tools include a guidewire and a microcatheter, the guidewire configured to extend at least partially through a lumen of the microcatheter.

14. A robotic device according to any one of claims 1 to 3, wherein: the robotic device includes a controller configured to control the plurality of motors for driving the two or more actuating assemblies.

15. A robotic device according to claim 14, wherein: the controller is remotely controlled by an external remote control device.

16. A robotic device according to any one of claims 1 to 3, wherein: when one or more of the two or more elongated surgical tools are received within the internal path, one or more of the two or more elongated surgical tools extend outwardly from the plurality of walls of the housing and form a curve outside of the device housing.

17. A robotic device according to any of claims 1 to 3, wherein: each of the plurality of actuating elements includes a designated elongate shaft extending axially along at least a portion of a length of the internal path for the elongate surgical tool to extend therethrough.

18. A robotic device according to any of claims 1 to 3, wherein: the robotic device includes a third actuating assembly coupled to the housing and actuated by a plurality of motors residing within the housing to move a third elongated surgical tool.

19. A kit, comprising:

a robotic device according to claim 1;

20. A surgical system, comprising:

a robotic device according to claim 1;