Multi-unit device for robotic manipulation of elongated surgical tools

Abstract

1. A robotic device for manipulating an array of a plurality of elongated surgical tools, comprising: a first unit and a second unit, each unit configured to receive at least one elongated surgical tool of the array, the elongated surgical tool received by the first unit being different from the elongated surgical tool received by the second unit, each unit including a drive assembly and a motor configured to actuate the drive assembly to move the at least one elongated surgical tool; and a coupler attached to the first unit and the second unit, the coupler configured to enable movement of at least one of the first and second units relative to the other by movement of two or more portions relative to each other while the elongated surgical tool remains in operative communication with the drive assembly in each of the first and second units.

Description

Technical Field

[0001] Cross - reference to Related Applications This application claims the benefit of priority of U.S. Provisional Patent Application No. 63 / 226,800, filed Jul. 29, 2021. The contents of this document are hereby incorporated by reference in their entirety into this specification.

Background Art

[0002] In some embodiments, the present invention relates to the robotic operation of elongated surgical tools, and more particularly, but not exclusively, to a multi - unit device configured to receive a pre - assembled array of tools and drive movement.

Summary of the Invention

[0003] According to aspects of some embodiments, a robotic device for manipulating an array of a plurality of elongated surgical tools, comprising a first activation unit and a second activation unit, each activation unit being configured to receive at least one elongated surgical tool of the array, the elongated surgical tool received by the first activation unit being different from the elongated surgical tool received by the second activation unit, each activation unit including a drive assembly and one or more motors configured to operate the drive assembly to move at least one elongated surgical tool, the first activation unit and the second activation unit, and a coupler attached to the first activation unit and the second activation unit, the coupler including two or more portions connected to each other, the coupler being configured, in each of the first and second activation units, to enable movement of at least one of the first and second activation units relative to the other activation unit by movement of the two or more portions relative to each other while the elongated surgical tool remains in an operable connection with the drive assembly.

[0004] In some embodiments, at least a first starter unit is attached to the coupler by a reversible fixture that allows for the replacement of the entire at least first starter unit.

[0005] In some embodiments, the coupler is configured to hold a first activation unit relative to a second activation unit in two or more spatial configurations.

[0006] In some embodiments, two or more spatial configurations include a vertical arrangement of a first starter unit relative to a second starter unit, where the major axes of the drive assemblies of the units are parallel to each other, and an inclined arrangement where the major axis of the drive assembly of the first starter unit extends at an angle with respect to the major axis of the drive assembly of the second starter unit.

[0007] In some embodiments, in each of the first and second activation units, there is no barrier between the drive assembly and the elongated surgical tool received within the activation unit.

[0008] In some embodiments, there is no barrier between the drive assembly and one or more motors in each of the starting units.

[0009] In some embodiments, one of at least two parts of the coupler is attached to a first starting unit, and the other of the at least two parts of the coupler is attached to a second starting unit.

[0010] In some embodiments, the movement of two or more parts of the coupling is spring-operated.

[0011] In some embodiments, the elongated surgical tool received in a first activation unit includes a guidewire, and the elongated surgical tool received in a second activation unit includes a microcatheter, the arrangement including a guidewire at least partially inserted into the lumen of the microcatheter.

[0012] In some embodiments, the drive assembly of the first activation unit is arranged to contact the guidewire when the guidewire is received into the first activation unit and to either move the guidewire linearly or rotate the guidewire, and the drive assembly of the second activation unit is arranged to contact the microcatheter when the microcatheter is received into the second activation unit and to move the microcatheter linearly.

[0013] In some embodiments, the second activation unit includes an attachment to the guiding catheter, and the microcatheter and guidewire array are at least partially inserted into the lumen of the guiding catheter.

[0014] In some embodiments, the second activation unit is slidably mounted on a platform, and the sliding movement of the second activation unit relative to the platform causes the attached guiding catheter to move linearly together with the inserted microcatheter and guidewire.

[0015] In some embodiments, the first starter unit is molded as a barrel, and the coupling holds the first starter unit vertically above the second starter unit.

[0016] In some embodiments, two or more parts of the coupling include lever portions and vertical rails connected to each other in the joint.

[0017] In some embodiments, the array of elongated surgical tools operated by the device includes a nested array in which an elongated surgical tool received by a first activation unit is at least partially introduced into the lumen of an elongated surgical tool received by a second activation unit.

[0018] In some embodiments, the elongated surgical tool received by the first activation unit includes a guidewire, and the elongated surgical tool received by the second activation unit includes a microcatheter.

[0019] According to aspects of several embodiments, there is a device for manipulating one or more elongated surgical tools, comprising: a stage defining a path into which at least one elongated surgical tool is received, the path being shaped to align the elongated surgical tool when it is received therein; and an actuation part being shaped and sized to be selectively mounted on the stage, the actuation part comprising a drive assembly and one or more motors configured to actuate the drive assembly, wherein when the actuation part is mounted on the stage, the drive assembly is positioned in contact with at least one elongated surgical tool, and the drive assembly is operable to move the at least one elongated surgical tool.

[0020] In some embodiments, the working part is formed as a cover for the stage, which is to be placed on the stage.

[0021] In some embodiments, the working part is shaped to surround the path.

[0022] In some embodiments, the device includes at least one interlock that, when locked, suppresses relative motion between the working part and the stage.

[0023] In some embodiments, the stage and the housing of the working part are similar in at least axial length.

[0024] In some embodiments, when the working part is mounted on a stage, the long axis of the drive assembly is parallel to the long axis of the path, and the axis extends along a similar vertical plane.

[0025] In some embodiments, the drive assembly includes a plurality of pairs of opposing wheels arranged adjacent to each other, and the longitudinal axis of the drive assembly extends along the space defined between each pair of opposing wheels.

[0026] According to aspects of some embodiments, a method of setting up a robotic device for operating one or more elongated surgical tools, the robotic device including at least a stage and an operating portion including one or more motors for actuating a drive assembly that moves at least one of the elongated surgical tools, the method comprising: placing at least one surgical tool on the stage such that the elongated surgical tool is aligned along the stage by a specified path; coupling the operating portion to the stage, the coupling positioning and contacting the drive assembly in alignment with the elongated surgical tool, the coupling including:

[0027] In some embodiments, the operating portion is configured as a cover of the stage, and the coupling includes closing the operating portion on the stage.

[0028] In some embodiments, the drive assembly includes a plurality of wheel pairs, and the coupling positions the wheel pairs such that the opposing wheels of each pair are disposed on both sides of the elongated surgical tool.

[0029] In some embodiments, the one or more elongated surgical tools include at least one of a guide wire, a microcatheter, and a guiding catheter.

[0030] In some embodiments, the method further includes assembling the one or more elongated surgical tools together as a nested array before placement and placing the nested array within the specified path.

[0031] In some embodiments, the method further includes introducing one or more elongated surgical tools into the patient's body before placement.

[0032] In some embodiments, the method further includes bringing the stage closer to the point of entry of one or more elongated surgical tools into the patient's body before placement and after introduction.

[0033] In some embodiments, the method further includes placing the adapter on at least one elongated surgical tool before placement, and placement includes inserting the adapter into a designated recess on the stage.

[0034] According to some embodiments, a method for effectively increasing the usable length of an elongated surgical tool operated by a robotic device including at least first and second units, wherein the elongated surgical tool extends from a fixture with the first unit, between the first and second units, and then through a designated path of the second unit, and the method is as follows: To confirm the need to increase the usable length of elongated surgical tools, A method is provided which includes maintaining an elongated surgical tool in an attached state with a first unit and keeping it within a designated path of a second unit, while bringing the attachment of the elongated surgical tool to the first unit closer to the point where the elongated surgical tool enters the designated path of the second tool, so that further segments of the elongated surgical tool can be made available for use.

[0035] In some embodiments, the method further includes advancing an elongated surgical tool further into the patient's body through a designated path.

[0036] In some embodiments, bringing them closer together involves changing the spatial configuration of the first unit relative to the second unit via a coupling connected to the first and second units.

[0037] In some embodiments, the modification involves moving the first unit from a vertical position relative to the second unit to an inclined or horizontal position relative to the second unit.

[0038] In some embodiments, the movement is spring-operated.

[0039] In some embodiments, the method includes remotely controlling the approach using a remote control device.

[0040] In some embodiments, confirmation includes one or more of the following: confirmation in response to a signal received from a controller of the robot device; confirmation in response to user input; and confirmation in response to instructions obtained by one or more sensors of the robot device.

[0041] According to some embodiments, a robotic device for manipulating an elongated surgical tool that can be inserted into a patient's body is provided, and the device is A long, narrow passage for receiving a long, narrow surgical tool, One or more motors, A drive assembly configured to move an elongated surgical tool when the tool is received into a path, the drive assembly being actuated by one or more motors, includes: The device includes an elongated path which comprises at least one axially offset portion that sets a controlled buckling position for the elongated surgical tool if the elongated surgical tool encounters resistance while being advanced within the patient's body.

[0042] In some embodiments, the axially offset portion includes a curved portion that extends away from the major axis of the elongated path.

[0043] According to some embodiments, a robotic device for manipulating an elongated surgical tool that can be inserted into a patient's body, wherein the device is It includes an elongated pathway for receiving an elongated surgical tool, and the elongated pathway is One or more motors, A drive assembly configured to move an elongated surgical tool when the tool is received into a path, the drive assembly being actuated by one or more motors, The present invention provides an apparatus comprising one or more sensors positioned in or adjacent to an elongated path, each sensor configured to detect either or both contact between an elongated surgical tool and one or more walls of the path, and a force applied to one or more walls of the path by the elongated surgical tool.

[0044] In some embodiments, the elongated path includes an axially offset portion, and one or more sensors are positioned in or adjacent to the axially offset portion.

[0045] In some embodiments, the axially offset portion includes a curved portion.

[0046] In some embodiments, one or more sensors include pressure sensors.

[0047] In some embodiments, the robotic device includes a controller configured to receive instructions from one or more sensors and to activate one or more motors to move the elongated surgical tool by a drive assembly when one or more sensors detect contact and / or force applied by the elongated surgical tool.

[0048] In some embodiments, the controller is configured to retract the elongated surgical tool proximal to a position where resistance encountered by the distal end of the elongated surgical tool is avoided.

[0049] In some embodiments, the controller is configured to generate a warning to inform the user if the elongated surgical tool is buckling or bending.

[0050] According to some embodiments, a starting unit for operating a guide wire, Including the housing, the housing is A guide wire pre-loaded along a designated path inside the housing, One or more motors, A drive assembly configured to move a guide wire, the drive assembly being actuated by one or more motors, includes a drive assembly, The housing provides an activation unit which defines an external mounting fixture to a coupling molded and configured to hold the activation unit relative to at least a second activation unit.

[0051] In some embodiments, the drive assembly includes a plurality of wheel pairs positioned in contact with a guide wire, the rotation of the wheels causes the guide wire to move linearly, and the rotation of the drive assembly as a single unit causes the guide wire to rotate when the guide wire is held between opposing wheels of the plurality of wheel pairs.

[0052] In some embodiments, the housing is molded as a barrel, and the diameter of the barrel is sized according to the radius of rotation of the drive assembly as a single unit.

[0053] In some embodiments, the housing defines a fixture for handling the guide wire.

[0054] In some embodiments, a robotic device is provided, comprising: an activation unit as described herein, for example; a second activation unit; and a coupling comprising two or more rigid body parts whose positions relative to each other are adjustable, a first part configured to be attached to the first activation unit; and a second part configured to be attached to the second activation unit, wherein the movement of the rigid body parts relative to each other results in selective positioning of the first activation unit relative to the second activation unit.

[0055] In some embodiments, a second activation unit is configured to operate the microcatheter, and a guidewire is inserted at least partially into the lumen of the microcatheter.

[0056] Unless otherwise defined, all technical and / or scientific terms used herein have the same meaning as those generally understood by those skilled in the art to which the present invention pertains. Similar or equivalent methods and materials may be used in carrying out or testing embodiments of the present invention, but typical methods and / or materials are described below. In case of any conflict, the present specification, including definitions, shall prevail. Furthermore, materials, methods, and examples are illustrative and not necessarily intended to be limiting.

[0057] Implementation of the methods and / or systems of embodiments of the present invention may include performing or completing selected tasks manually, automatically, or in combination thereof. Furthermore, according to the actual instrumentation and equipment of embodiments of the methods and / or systems of the present invention, some selected tasks may be performed by hardware, software, firmware, or in combination thereof using an operating system.

[0058] For example, hardware for performing selected tasks according to embodiments of the present invention can be implemented as a chip or circuit. As software, selected tasks according to embodiments of the present invention can be implemented as a set of software instructions executed by a computer using any suitable operating system. In a typical embodiment of the present invention, one or more tasks according to a typical embodiment of the method and / or system described herein are performed by a data processor, such as a computing platform, for executing a set of instructions. Optionally, the data processor includes volatile memory for storing instructions and / or data, and / or non-volatile storage devices for storing instructions and / or data, such as magnetic hard disks and / or removable media. Optionally, network connectivity is also provided. A display and / or user input device, such as a keyboard or mouse, is also provided, optionally.

[0059] In this specification, several embodiments of the present invention will be described merely as examples with reference to the accompanying drawings. The drawings will now be given in detail, emphasizing that the illustrated details are intended to illustrate embodiments of the present invention as examples. In this regard, the description provided with the drawings will make it clear to those skilled in the art how embodiments of the present invention can be carried out. [Brief explanation of the drawing]

[0060] [Figure 1] This is a flowchart illustrating a method for preparing an array of elongated surgical tools according to several embodiments and loading the array onto a robotic device. [Figure 2a] This is a schematic block diagram of a robotic device for manipulating one or more elongated surgical tools, according to several embodiments. [Figure 2b] This is a schematic block diagram of a robotic device for manipulating one or more elongated surgical tools, according to several embodiments. [Figure 3]Figures a-b show different diagrams of a robotic device loaded with elongated surgical tools, according to several embodiments. [Figure 4] Figures 3a and 3b are partially disassembled assembly diagrams of the robotic device, showing a mobile drive assembly for an elongated surgical tool received within the robotic device, according to several embodiments. [Figure 5] Figures 3a and 3b show perspective views of the alignment stage at the base of the robotic device, which is equipped with an array of elongated surgical tools. [Figure 6] Figures a-b are partial diagrams of a positioning stage showing the positioning and fixing of a tool to the positioning stage via an adapter coupled to the tool, according to several embodiments. [Figure 7] This is a flowchart of methods for changing the spatial configuration of a robotic device according to several embodiments. [Figure 8] Figures a-c are side views of typical embodiments of robotic devices in vertical and inclined setups, according to several embodiments. [Figure 9] This is a flowchart of a method for detecting and / or controlling buckling and / or bending of an elongated surgical tool received at least partially within a robotic device, according to several embodiments. [Figure 10] Figures a-b schematically illustrate non-linear paths for elongated surgical tools in which buckling and / or bending of the tool is detected, according to several embodiments. [Figure 11] This is a partial cross-sectional view of a robotic device, including a non-linear path for an elongated surgical tool, according to several embodiments. [Figure 12a] This figure schematically illustrates attachments for robotic devices for manipulating one or more elongated surgical tools, according to several embodiments. [Figure 12b] This figure schematically illustrates attachments for robotic devices for manipulating one or more elongated surgical tools, according to several embodiments. [Figure 12c]This figure schematically illustrates attachments for robotic devices for manipulating one or more elongated surgical tools, according to several embodiments. [Figure 12d] This figure schematically illustrates attachments for robotic devices for manipulating one or more elongated surgical tools, according to several embodiments. [Modes for carrying out the invention]

[0061] In some embodiments, the present invention relates to the robotic manipulation of elongated surgical tools, and more particularly to a multi-unit device configured to receive a pre-assembled array of tools and drive their movement.

[0062] A broader aspect of several embodiments relates to the manipulation of an array of elongated surgical tools (e.g., a nested array of tools) by a device comprising multiple activation units. Each activation unit is configured to be coupled to at least one of the tools in the array and optionally drive its movement.

[0063] In some embodiments, an assembled array of tools (for example, including a guidewire at least partially received into the lumen of a microcatheter, and a guiding catheter at least partially received by the guidewire microcatheter array) is loaded onto a robotic device. In some embodiments, the device is shaped and configured such that the arrangement of the array aligns the tools with the device, and as a result, one or more drive assemblies of the device are then positioned to operably connect with the tools and move them (for example, to move the tools linearly and / or rotate the tools).

[0064] In some embodiments, the loading of the tool array onto the device occurs after one or more of the tools have been inserted into the patient's body, for example, after a guiding catheter has been introduced into the patient's body via an entry point and the tool array has been assembled, and only then is it loaded onto the device. Potential advantages of loading the tool(s) onto the device only at the same time as and / or after the tool(s) have been introduced at least partially into the patient's body may include the ability to selectively position the device relative to the patient's body, for example, to position it near the entry point once established.

[0065] In some embodiments, the device's multiple activation units include one or more units that connect to a tool(s) (e.g., a guidewire) that is optionally replaced or changed during a surgical procedure, while one or more other units connect to a tool(s) (e.g., a microcatheter and / or guiding catheter) that is optionally used throughout the procedure and is neither changed nor replaced. In some embodiments, the one or more units that connect to the changed tool(s) are interchangeable as a whole, for example, a unit that receives the guidewire and drives its movement is optionally replaced along with the guidewire. In some embodiments, for example, the guidewire is pre-loaded onto the unit so that pre-loading of the guidewire onto the unit is not required, and the unit (including the pre-loaded guidewire) can be assembled directly onto the system (e.g., attached to a coupling device and / or directly to other units).

[0066] Some embodiments relate to the alignment of at least one elongated surgical tool with respect to a device that controls its movement (specifically, with respect to a drive assembly of a device that connects to the tool and moves it).

[0067] In some embodiments, the activation unit of the device includes a stage molded to define a path for receiving a tool (or, in some embodiments, a nested array of tools), and when the tool is placed on the path, the tool is aligned by the path with respect to a portion of the stage (e.g., the length and / or width of the top surface of the stage). In some embodiments, the stage does not include components configured to move the tool (e.g., motors, drive assemblies), but rather functions as a mold on which the tool is mounted and molded so that the tool fits into a designated path. In some embodiments, the stage does not include power supply and / or electrical components. In some embodiments, the stage is relatively small and lightweight, potentially making it easier to position the stage in the desired location relative to the patient and / or other operating room equipment (e.g., operating table, imaging modality, etc.). In some embodiments, the stage itself can be brought closer to the ready assembly of tools before the assembly of elongated surgical tools is loaded onto the stage, and vice versa.

[0068] In some embodiments, the apparatus includes an actuation part that is mounted on a stage and selectively positioned, for example, the actuation part is formed as a cover that closes on the stage. The actuation part includes a drive assembly (and optionally one or more motors that actuate the drive assembly), and as a result, when the actuation part is mounted on the stage, the drive assembly is positioned to be operably coupled to a tool mounted on the stage. In an example, the tool is received in an elongated slot defined on the surface of the stage. When the actuation part is closed on the stage, the drive assembly of the actuation part is aligned with a designated path, for example, so that the long axis of the drive assembly is parallel to the path and approaches the path, allowing the drive assembly to contact the tool.

[0069] In some embodiments, the working part is placed on a stage, for example, positioned on the stage (vertically above the stage) so that gravity can easily position the working part.

[0070] In some embodiments, the working parts are positioned on the stage only after the stage has been selectively positioned (for example, by a physician or surgeon), so the activation components of the working parts (motor, power supply, etc.) are brought into a position where they can operate relative to the surgical tool only after the tool has been aligned by the stage.

[0071] In some embodiments, the stage defines one or more designated recesses into which an adapter(s) of a tool(s)(or array of tools) may be received. Optionally, the axial alignment and / or rotational direction of the tool with respect to a designated path may be obtained by positioning the adapter(s) (or part of the adapter(s), e.g., the Y-connector of the tool) within the designated recess(s).

[0072] Some embodiments relate to coordinating the spatial configuration of multiple units of a robotic device for manipulating one or more elongated surgical tools.

[0073] In some embodiments, two or more units of the apparatus are connected via a frame that includes a coupling, for example, at least two parts (e.g., a lever part and a vertical rail) that are movable relative to each other via a joint connection. In some embodiments, a first part of the coupling is attached to a first unit, and a second part of the coupling is attached to a second unit. When at least one of the parts is moved relative to the other, that part repositions the unit to which it is attached relative to the other unit. In the example, the first unit is moved from a vertical arrangement in which it is held, for example, above the second unit, to an inclined or horizontal arrangement relative to the second unit.

[0074] In some embodiments, changing the spatial position of a unit changes the relative position of the unit's drive assembly. For example, each unit includes a drive assembly comprising several pairs of wheels arranged adjacent to each other, with the long axis of the assembly defined by the space between the opposing wheels of each pair. Changing the spatial configuration of the device unit also changes the relative position of the long axes of the drive assembly, for example, from parallel (in the vertical alignment of the unit) to linearly aligned (in the horizontal alignment of the unit) or arranged at an angle to each other (in the inclined setup of the unit).

[0075] In some embodiments, the spatial configuration change is made while the tool(s) are each held by their respective units, and there is no need to remove the tools before the change, nor is there any loss of hold on the tools during or after the change. Optionally, the units are capable of continuing to move the tools even during the change itself.

[0076] In some embodiments, the coupler is adjustable to hold the units in multiple different spatial positions relative to each other. Optionally, one or more positions are spring-biased (for example, the coupler deforms from one position to another in response to spring action). In some embodiments, the coupler is configured to lock in a specific position to restrict the relative movement of the units at that position.

[0077] Aspects of several embodiments relate to increasing the usable length of a tool operated by a robotic device. In some embodiments, the increase in usable length is achieved by changing the spatial configuration of the device units. In an example, the units are moved closer to each other (or more specifically, the attachment point and / or entry position of the tool to the first unit is placed closer to the attachment point and / or entry position of the tool to the second unit). In some embodiments, the change in spatial configuration makes it possible for a shorter segment of the tool to extend between the two units (for example, compared to the length of the segment that extended between the units before the change in spatial configuration). This allows the robotic device to use (operate) an additional tool length, for example, to advance the additional tool length distally through a designated path of the units. Potential advantages of increasing the usable length of the tool may include, for example, the ability to change the spatial configuration of the device units (optionally, automatically when the need for a more usable tool length is identified) to advance the tool further within the body in situations where it is necessary to advance the distal end of a tool inserted into the body further.

[0078] Aspects of several embodiments relate to the control of the buckling or bending position of an elongated surgical tool operated by the device. In some embodiments, control of the position in which the tool bends or buckles (e.g., an axial position along the length of the tool and / or a position relative to a designated path of the device through which the tool passes) is achieved by guiding the tool through at least one axially offset position (e.g., a curved segment of a designated path). In some embodiments, the axially offset position includes a position located away from the straight axis of the path. In some embodiments, the tool may bend or buckle when it encounters resistance (e.g., by the distal tip of the tool pointing towards an obstruction in the patient's body, optionally). Since a tool segment traversing along an axially offset position of the path is likely to bend first (e.g., "more likely" to continue bending than a straight tool segment), the axially offset position sets the initial buckling or bending of the tool to that position.

[0079] Aspects of several embodiments relate to determining the state (e.g., buckling, bending) of an elongated surgical tool operated by the device by detecting contact and / or force applied by the tool to the wall(s) of a path in an axially offset (e.g., curved) segment of the path. In some embodiments, one or more sensors (e.g., force (e.g., pressure) sensors, contact sensors, proximity sensors) are located in or adjacent to the curved segment of the path and are configured to detect whether the tool passing through the curved segment is encountering resistance that causes the tool to bend or buckle, for example, at its distal end.

[0080] As used herein, the term “proximal” may refer to a device and / or tool part and / or direction that is further away from the patient’s body (e.g., further from the point of entry into the patient’s body). The term “distal” may refer to a device and / or tool part and / or direction that is closer to the patient’s body (e.g., further toward the point of entry into the patient’s body, optionally deeper within the point of entry, and / or further toward the target location within the patient’s body).

[0081] As used herein, “starting unit” or “unit” may optionally include a device part that is separable from one or more other device parts. In some embodiments, the unit is a tool receiving unit and includes a designated path for receiving, for example, an elongated surgical tool and / or a fixture for the elongated surgical tool (optionally, outside the unit). In some embodiments, the unit includes a housing (e.g., a box-shaped, barrel-shaped, and / or other shaped housing). The walls of the housing define an internal volume between them. In some embodiments, the internal volume accommodates a designated path (e.g., a slot, a recess, or any path) for receiving a segment of the surgical tool. In some embodiments, the internal volume accommodates one or more motors. In some embodiments, the internal volume accommodates one or more drive assemblies. A drive assembly includes, for example, a plurality of wheels configured to connect to and move the tool received in the path. In some embodiments, the unit includes one or more fixtures for the surgical tool (optionally, for a tool different from one received in the path). The mounting hardware is optionally located on the outside of the housing (for example, formed as a projection of the housing).

[0082] In some embodiments, the unit comprises two or more parts, for example, a first part configured to receive a tool (e.g., in a designated slot or recess) and a second part configured to actuate the movement of the tool when positioned in contact with the first part. In some embodiments, the first part defines a "mounting surface" for the tool and does not include a motor or power supply components, and optionally does not include electrical connections.

[0083] Before describing in detail at least one embodiment of the present invention, it should be understood that the present invention is not necessarily limited in its application to the construction details and array of components and / or methods described in the following description and / or illustrated in the drawings and / or examples. Other embodiments of the present invention are possible, and it can be carried out or implemented in various ways.

[0084] Before describing in detail at least one embodiment of the present invention, it should be understood that the present invention is not necessarily limited in its application to the details described or illustrated by the following description. Other embodiments of the present invention are possible, and it can be carried out or implemented in various ways.

[0085] Typical preparation of elongated surgical tools and loading them onto a robotic device. Next, referring to the drawings, Figure 1 is a flowchart of a method for preparing an array of elongated surgical tools according to several embodiments and loading the array onto a robotic device.

[0086] In some embodiments, an array of elongated surgical tools (including, for example, guidewires, microcatheters, and guiding catheters) is prepared by a user (for example, a physician, surgeon, nurse, technician, and / or other clinical staff) before loading at least a portion of the array onto a robotic device that operates the movement of one or more tools in the array.

[0087] In some embodiments, at least a portion of the tool array is introduced into the patient's body before optionally loading the array onto a robotic device. For example, the distal segment of a guiding catheter is introduced into the patient's body, for example, via an entry point into the body (101). In some embodiments, the entry point may be selected from the patient's groin (i.e., femoral artery), arm (i.e., radial artery), or neck (i.e., jugular vein), without limitation, depending on the location of the target tissue (e.g., heart, peripheral blood vessels in the lower extremities, brain, liver, etc.) and the purpose of the procedure. In some embodiments, the tool(s) are introduced into the vascular lumen.

[0088] In some embodiments, an adapter (optionally including connectors to one or more other tools and / or devices and / or Y-connectors that allow injection of material into the lumen of the device) is assembled on the proximal end portion of the guiding catheter (103). In some embodiments, the adapter further includes one or more transmission elements, such as gears, which are configured to move (e.g., rotate) the tool that the adapter receives when in operable contact with one or more other transmission elements and / or in direct contact with a motor.

[0089] In some embodiments, the user then removes the guidewire (optionally, if removed from the sterile package) and inserts the guidewire into the lumen of the microcatheter (optionally, likewise removed from the sterile package) (105).

[0090] In some embodiments, at least the distal segment of the guidewire microcatheter array is optionally inserted into the lumen of the guiding catheter via the proximal end of the guiding catheter (107).

[0091] In some embodiments, once the user has completed setting up an assembly of elongated surgical tools, the user positions the robotic device's alignment stage near the tool assembly, optionally near the point of entry into the patient's body (109). In addition to or instead of this, the device's alignment stage is pre-positioned in such a location (for example, on or adjacent to the patient's bed when setting up the operating room). In some embodiments, the device includes a platform on which the alignment stage is mounted, and the platform (optionally together with the alignment stage) is positioned near the point of entry into the body. In some embodiments, the platform and mounting stage are selectively positioned relative to the patient's body after at least some (optionally, all) of the tool assembly has been introduced at least partially into the patient's body.

[0092] In some embodiments, the platform is mounted on an adjustable arm (or a generally adjustable rigid fixture) configured to hold the platform relative to the operating table and / or the patient. In some embodiments, one end of the arm is attached, for example, to the operating table, while the other end is connected to the platform.

[0093] In some embodiments, the user presses the segments and adapters of the guidewire microcatheter array onto designated recesses on the alignment stage (110). In some embodiments, the designated recesses for the segments of the guidewire microcatheter array are, for example, elongated recesses extending along the long axis of the alignment stage, and by positioning the array within the recesses, the segments of the array are optionally straightened so as to extend linearly along the stage. Optionally, the segments are positioned by the recesses relative to the alignment stage (for example, centered relative to the width of the stage).

[0094] In some embodiments, the guiding catheter is positioned such that its proximal end is facing or adjacent to the surface of the alignment stage facing the point of entry into the patient's body. In some embodiments, the guiding catheter adapter is positioned within the designated recess by moving the adapter linearly and / or moving the adapter laterally and / or rotating the adapter (without inducing rotation of the guiding catheter around the long axis of the guiding catheter) until the adapter is at least partially received within the designated recess.

[0095] In some embodiments, the user optionally secures the guidewire microcatheter array to the alignment stage while the segments are housed therein by, for example, closing the bridging element over a gap defined by a recess (111). Optionally, the bridging element is secured to the alignment stage via a plurality of snap-fit ​​connectors.

[0096] In some embodiments, once the array of tools is at least partially received within the alignment stage and optionally fixed therein, the user aligns the working parts of the device with the alignment stage (113).

[0097] In some embodiments, the actuarial part includes one or more motors and a drive assembly actuated by the one or more motors. In some embodiments, the drive assembly is configured to drive the linear and / or rotational motion of an array of tools(s) by, for example, a plurality of wheels configured and positioned to contact and move the tools. In some embodiments, the plurality of wheels of the drive assembly configured within the actuarial part are configured to contact segments of a guidewire microcatheter array received in a designated recess of an alignment stage and to move at least the microcatheters linearly (for example, to advance or retract the microcatheters).

[0098] In some embodiments, the working part is formed as a cover for the alignment portion that is selectively closed on the alignment stage. When the cover is closed, the drive assembly is positioned in operable contact with the segment of the tool array.

[0099] In some embodiments, the working parts do not necessarily form a topping cover for the alignment stage, but are formed, for example, as lateral connections to the alignment stage, bottom connections to the alignment stage, and / or other arrangements, suitable for enclosing and operably connecting to a plurality of surgical tools (optionally, a nested assembly of tools) mounted on the alignment stage.

[0100] For example, potential advantages of the device setup and loading methods described herein may include the ability for the user (e.g., a physician, surgeon) to position the device at a select location relative to the body's entry point, while assemble a nested arrangement of tools as is commonly done by choice, and only afterward load the arrangement onto the robotic device. Generally, the user sets up the tool assembly on or near the patient's bed and near the entry point into the body. Setting up the robotic device near the entry point into the patient's body may be potentially advantageous in the following ways: the usable tool length can be effectively extended; spatial and / or visual interference of the robotic device can be minimized; buckling of unconnected sections of the tool can be reduced or avoided; and the risk of failure due to connected sections of the tool can be reduced or avoided.

[0101] Multi-unit robotic device Figures 2a and 2b are schematic block diagrams of robotic devices for manipulating one or more elongated surgical tools, according to several embodiments.

[0102] In some embodiments, as schematically shown by Figure 2a, the robotic device 201 includes a plurality of units, for example, two, three, four, five, or a larger or smaller number of units. Each unit is configured to receive one or more elongated surgical tools and optionally drive movement (e.g., linear movement and / or rotational movement).

[0103] In some embodiments, the unit includes a housing that defines an internal volume, which includes a drive assembly (e.g., a set of wheels) that moves the tool, and one or more motors for operating the drive assembly. In some embodiments, the unit defines an elongated path from which at least a segment of the tool is received, and the drive assembly is positioned to operably contact the tool segment once it is received within the path.

[0104] In some embodiments, the device 201 includes a first unit 203 that receives and moves one or more elongated surgical tools that are changed during a surgical procedure. In some embodiments, the tool is replaced with another tool (for example, a guidewire is replaced with, for example, a removable coil system). In some embodiments, the tool is replaced with a similar tool (for example, a guidewire is replaced with a new guidewire). In some embodiments, the guidewire is retracted from the microcatheter to allow delivery of therapeutic agents such as beads, coils, or adhesives.

[0105] In some embodiments, when changing a tool, the tool is removed from the first unit and the new tool is inserted. Alternatively, the first unit as a whole (optionally including the tool) is replaced with a new first unit in which the new tool is received and / or previously housed. In some embodiments, the new tool is characterized by different features from the previous tool, such as a different stiffness level, the presence of a handle (e.g., within an operable guidewire / catheter), or the presence of a delivery lumen. In the example, replacing the first unit as a whole (including the tool) may be advantageous when changing a tool without a proximal handle to a tool with a proximal handle (e.g., an operable guidewire). The new unit is also optionally constructed to connect to (and optionally move) its handle.

[0106] Next, with reference to Figures 12a-12d, schematic diagrams of typical external fixtures according to some embodiments of the present invention are shown. In some embodiments, the first unit 203 includes an external fixture 1202 for a proximal handle of a tool (e.g., a proximal handle of an operable guide wire). In some embodiments, the fixture 1202 is configured on the outer wall of the unit's housing, for example, as shown in Figure 12a. In some embodiments, the fixture includes a housing sized and molded to satisfy one or more purposes: housing a proximal handle of a tool, housing a plurality of mechanisms configured to actuate the proximal handle of a tool, and optionally matching the shape of the first unit 203. Figure 12a shows the fixture 1202 mounted on the first unit 203. As can be seen from the figure, the first unit 203 includes an irregular shape, and therefore, optionally, the housing of the fixture 1202 includes a shape that matches the shape of the first unit 203. In some embodiments, a potential advantage of having a matching shape between the fixture 1202 and the first unit 203 is that space is saved when using the fixture 1202. Space is not always available where medical procedures are performed. Figures 12b and 12c show perspective views of the fixture 1202 having a housing that includes an irregular shape matching the shape of the first unit. For example, the top of the first unit 203 shown in Figure 12a includes a triangular shape. In some embodiments, the fixture includes a shape that matches the triangular shape of the top of the first unit 203. This shape resembles an inverted V, for example, as shown in Figures 12a, 12b, 12c, and 12d. In some embodiments, internal components are arranged inside the irregular shape of the fixture. For example, one side of the fixture (one "leg" of the V-shape) is used to house the mechanical components of the fixture, while the other side (the other "leg" of the V-shape) is used to house electronic equipment. This is illustrated, for example, in Figure 12d. In some embodiments, housing mechanical components on one side and electrical components on the other side is designed and / or optimized to reduce the size of the fixture.Next, with reference to Figure 12d, schematic diagrams of typical components and / or mechanisms located inside the fixture 1202 according to some embodiments of the present invention are shown. In some embodiments, as previously stated, the fixture 1202 includes a housing 1204. In some embodiments, inside the housing 1204 is a zone 1206 configured to receive the proximal handle of the tool 1208. In some embodiments, the fixture 1202 includes a first actuation mechanism 1210 (e.g., a worm screw mechanism) configured to actuate a slider (not shown) located within the proximal handle of the tool 1208. In some embodiments, the first actuation mechanism 1210 includes a motor 1212 configured to actuate the first actuation mechanism 1210. In some embodiments, the fixture 1202 includes a second actuation mechanism 1214 (e.g., a rotation mechanism) configured to rotate the proximal handle of the tool 1208 along its own longitudinal axis "X". In some embodiments, the second actuation mechanism 1214 includes a motor 1216 configured to actuate the second actuation mechanism 1208. In some embodiments, the fixture 1202 includes one or more power sources 1218 (e.g., one or more batteries) configured to supply the fixture 1202 with the necessary power. In some embodiments, an external power source is used to supply the fixture 1202 with the necessary power. In some embodiments, the fixture 1202 includes a circuit 1220 configured to control the overall operation of the fixture 1202. In some embodiments, the fixture 1202 includes communication means (e.g., Wi-Fi, Bluetooth, etc. (not shown)) configured to communicate with the circuit and connect the fixture 1202 to the rest of the system. This allows for coordination and / or synchronization of the operation between the fixture 1202 and the rest of the system. In some embodiments, the fixture is configured to actuate the tool by actinguating the proximal handle of the tool. In some embodiments, the fixture is configured to rotate the tool by rotating a handle located within the fixture.Alternatively, in some embodiments, the fixture moves with the tool, for example, rotating with the tool when the tool rotates with the drive assembly. Naturally, other mechanisms can be used within the fixture 1202 to give the tool different action.

[0107] In some embodiments, for example, if a tool without a handle is being used and a tool with a handle should be used next, the first unit is replaced with a different first unit that includes a fitting for a handle.

[0108] In some embodiments, the device 201 includes a second unit 205 that receives and moves one or more elongated tools used throughout the procedure without modification or replacement. In one example, the second unit receives and moves a microcatheter. Optionally, a portion of a guidewire received within the first unit 203 extends within the internal lumen of the microcatheter. In another example, the second unit functions in conjunction with a guiding catheter and moves the guiding catheter.

[0109] In some embodiments, the unit is configured to be attached externally to one or more tools (for example, externally to the unit housing). In one example, the first unit includes a fixture for connecting to a microcatheter (for example, to the proximal end of the microcatheter).

[0110] In some embodiments, a coupling interface 207 is present between the first unit and the second unit. In some embodiments, the coupling interface is configured to mechanically connect the first and second units, electrically connect the first and second units, transmit operative forces (e.g., from one or more motors) from one unit to the other, and transmit data (e.g., control signals, sensor readings, and / or others) from one unit to the other.

[0111] In some embodiments, the coupling interface includes a retainer, a coupling that extends between two units and holds them together. In some embodiments, the coupling includes a rigid fixture or frame that sets the relative positions of the units to each other and / or to the platform on which the device is mounted. In some embodiments, the coupling holds the units along a substantially vertical axis, for example, so that a first unit is held above a second unit. In some embodiments, the coupling includes a movable segment (e.g., a lever) that can be adjusted to set or correct the position of one unit relative to the other. In an example, the coupling is adjustable from a first position in which the first and second units are held along a vertical axis so that the first unit is held above the second unit, to a second position in which the first and second units are held along a horizontal axis (e.g., side by side), or the first unit is held at a certain angle (e.g., less than 180 degrees) relative to the second unit.

[0112] In some embodiments, the attachment of the coupling to the unit(s) is by mechanical fastening (e.g., including pins, clips, screw-in fasteners, snap-fit ​​fasteners), and / or other fastenings that connect the coupling to the unit, optionally, via other fastenings suitable for restricting relative movement of the unit, at least in the fastenings to the coupling.

[0113] In some embodiments, the coupling is formed as a frame including, for example, portions (e.g., rods, beams, etc.) that are molded and sized to fit the housing of the unit, extending along at least a portion of the wall of the unit housing.

[0114] In some embodiments, the coupling interface includes an electrical connection between the first and second units. Optionally, power is supplied from the second unit to the first unit. In the example, power is supplied via one or more slip rings that maintain electrical contact with the first unit in various rotational directions of the first unit (for example, when the first unit rotates as it rotates a tool) and / or in various positions of the first unit relative to the second unit. In addition to or instead of this, each unit is powered independently.

[0115] In some embodiments, the coupling interface is configured to transfer data between units, for example, via wired or wireless communication. In some embodiments, the transferred data includes control signals to synchronize the movement of tools by each unit, so that, for example, a guidewire operated by a first unit moves together with a microcatheter (which receives the guidewire) operated by a second unit.

[0116] In some embodiments, the robotic device is remotely controlled, for example, via a remote control device 209. In some embodiments, the remote control device includes a user interface (e.g., configured as a joystick, console, computer, etc.). From this interface, the user controls the operation of the device and / or receives input from the device (e.g., operational inputs, data obtained by device sensors, data obtained by device encoders, and / or other). The remote control device may be used locally with the robotic device, for example, when the user is in the operating room, or it may be used remotely, for example, when the user is in a different room.

[0117] In some embodiments, as shown in Figure 2b, for example, the first unit of the robotic device includes a barrel 251 from which the proximal segment of a tool, such as a guidewire 253, is received. In some embodiments, the barrel includes an external attachment for another tool, such as the proximal end of a microcatheter 255. In some embodiments, the guidewire extends from within the barrel into the lumen of the microcatheter. In some embodiments, the barrel houses one or more motors that actuate a drive assembly for linearly moving and / or rotating the guidewire. In some embodiments, the barrel rotates as a single piece when the guidewire is rotated, and the external housing of the barrel rotates as well, for example. Alternatively, at least a portion of the external housing of the barrel remains in place while the internal components of the barrel (such as the drive assembly and / or one or more motors) rotate.

[0118] In some embodiments, a second unit of the robotic device includes a base 257, which comprises at least: an alignment stage 259 on which a tool (e.g., a microcatheter 255) is mounted and aligned with a stage (e.g., arranged to be positioned along the long axis of the stage); and a working section 261 (such as one or more motors and drive assemblies) housing components for driving the movement of the tool mounted on the alignment stage.

[0119] In some embodiments, the actuation part is formed as a cover for the alignment stage. This can be closed on the alignment stage, thereby positioning the drive assembly in operable contact with the tool mounted on the alignment stage. In the example, the alignment stage and the actuation part are connected by a hinge. In some embodiments, the actuation part is completely removable from the alignment stage and can be mounted on the alignment stage (for example, as a lid, cap, or cover on the alignment stage).

[0120] In some embodiments, the alignment stage includes a fixture for one or more elongated tools (e.g., guiding catheter 263). In some embodiments, the working part includes a further drive assembly for moving (e.g., rotating and / or moving linearly) the proximal end portion of the guiding catheter. Alternatively or in addition to this, the guiding catheter is provided with an adapter which includes at least a portion of its drive assembly and includes, for example, gears for connecting to and functioning with a motor found in the working part and / or gears for connecting to a transmission element (e.g., a gear) connected to the motor.

[0121] In some embodiments, during use, the guidewire is operated in the barrel, the microcatheter (where the guidewire is received) is operated at the base, and optionally, the guiding catheter (where the guidewire-microcatheter array is received) is operated at the base. In some embodiments, one or more tools extend from a mounting point in one unit, optionally to the outside of the unit, and then into another unit. For example, a microcatheter extends from its attachment to the barrel (outside the barrel), and then into its designated recess in the alignment stage of the base. Optionally, the microcatheter curves along a path between the barrel and the base, forming, for example, a U-shaped curve.

[0122] In some embodiments, the base 257 is positioned on the platform 265. Optionally, the base is slidable relative to the platform. In some embodiments, linear movement of the guiding catheter is performed by sliding the base (optionally together with the barrel 251) relative to the platform (for example, back and forth along the long axis of the platform).

[0123] In some embodiments, the device units are coupled via a coupler 267, for example, the base and the barrel are connected by the coupler. In some embodiments, the position of at least one of the barrel and the base relative to the other can be adjusted by changing the coupler position and / or the coupler structure.

[0124] In some embodiments, the device unit includes a housing that defines an internal volume in which a drive assembly and / or one or more motors are housed. In some embodiments, when an elongated surgical tool is received into the unit, the tool extends into the internal volume in a space shared with the drive assembly and / or one or more motors. In some embodiments, once the tool is received in its path, it comes into direct contact with the drive assembly.

[0125] Next, with reference to Figures 3a and 3b, examples of robotic devices loaded with elongated surgical tools, according to several embodiments, are shown. Figure 4 shows a partially exploded assembly view of the robotic device showing the tool drive assembly. Figure 5 is a perspective view of the alignment stage at the base of the robotic device. Figures 6a and 6b are partial views of some embodiments of the alignment stage showing tool alignment and fixation, according to several embodiments.

[0126] A typical robotic device, as shown in Figure 3a, includes, for example, a barrel 301 from which a guidewire 303 is received, a base 305 comprising an alignment stage 307 and an operating part 309 from which a microcatheter 311 is received, a guiding catheter 313 coupled to and extending from the base, a platform 315 on which the base is movably positioned, and a coupling 317 (e.g., a frame) that holds the barrel and base relative to each other. A rear view of the device is shown in Figure 3b.

[0127] In the illustrated example, the barrel is stacked on the base and optionally maintained in such alignment using a coupling 317. In some embodiments, the coupling includes an L-shaped structure. The L-shaped structure includes, at least partially, a lever portion 319 that optionally extends over the top surface of the barrel along the length of the barrel, and a vertical rail 321 coupled to the lever and extending downward from the lever toward the base, with the vertical rail 321 coupled to the base. In some embodiments, the lever portion can move relative to the vertical rail, for example, via a hinge joint 318 between them (see Figure 3b). Thus, the angle at which the lever portion extends relative to the vertical rail is adjustable. Alternatively, in some embodiments, the lever portion is fixed to the vertical rail, and the two portions move together, for example, when adjusting the position of the barrel relative to the base.

[0128] In some embodiments, the coupling includes one or more adjustment interfaces, such as knobs 323, 325, etc. When rotated and / or pressed, these change the position of the lever portion relative to the vertical rail, or vice versa, for example, changing the relative position between the barrel and the base.

[0129] In some embodiments, the coupling 317 is molded and configured to enable: moving the barrel perpendicularly away from or toward the base; holding the barrel at a certain angle to the base; setting the axial (linear) position of the barrel relative to the base; and / or enabling the relative positioning of the barrel and the base in other ways.

[0130] Moving on to barrel 301, in some embodiments, the barrel includes a housing 327 (optionally, a cylindrical housing as shown in Figure 3a, for example). The housing 327 houses one or more motors (for example, as shown in Figure 4), such as a motor 329 for driving the linear movement of the guide wire and a motor 331 for driving the rotational movement of the guide wire. In some embodiments, one or more motors actuate a drive assembly 333, which includes, for example, a plurality of opposing wheels 335. The guide wire extends between the opposing wheels through a path defined by the plurality of wheel pairs. In some embodiments, when the wheels rotate (for example, actuated by the linear movement motor 329), the guide wire is moved linearly (for example, forward or backward). In some embodiments, when the drive assembly 333 rotates around the long axis of the drive assembly (for example, actuated by the rotational movement motor 331), the guide wire held between the wheels is rotated around its long axis.

[0131] Moving to the base 305, in some embodiments, the actuation part 309 includes one or more motors (for example, shown in Figure 4), such as a motor 337 that drives the linear movement of the microcatheter and a motor 339 that drives the rotation of the guiding catheter. In some embodiments, motor 337 acts on a drive assembly 341 that includes a plurality of opposing wheels 343. When the wheels 343 are rotated, they move the microcatheter linearly. In some embodiments, motor 339 acts on the rotation of a gear 342 which is part of the guiding catheter adapter 351 (best shown in Figures 5, 6a). As a result of the rotation of the gear, the guiding catheter rotates around its long axis. (In some embodiments, the linear movement of the guiding catheter is by the sliding movement of the base relative to the platform on which it is mounted).

[0132] In some embodiments, the base alignment stage 307 defines a designated recess 345 (see, for example, Figures 5, 6a). The recess 345 is formed, for example, as an elongated slot extending along at least a portion of the stage length for receiving a microcatheter. In some embodiments, another recess 347 is defined as a straight extension of the recess 345. The recess 347 is molded and sized to receive a guiding catheter Y-connector 344.

[0133] During use, in some embodiments, the user inserts a nested array of pre-prepared tools so that the microcatheter is positioned inside recess 345 and the guiding catheter Y-connector 344 is positioned inside recess 347. In some embodiments, the more proximal portion of the microcatheter extends between the barrel and the base, and the proximal end of the microcatheter is optionally attached to the barrel via connector 348 (a guidewire passing through the barrel enters the microcatheter lumen; see Figure 4). In some embodiments, the connector 348 is flexible (e.g., formed from an elastic or bendable material such as silicone or rubber), and as a result, optionally, the connector itself can bend along with the microcatheter as it curves along the path between the barrel and the base. Optionally, at least a portion of the connector is formed from a transparent material (e.g., so that the substance being injected through the connector is visible).

[0134] In some embodiments, the topography of the alignment stage is shaped to orient one or more tools into their designated recesses. In some embodiments, aligning and / or orienting the tools into their recesses and optionally in a selected (e.g., initial) rotational direction of the tools is facilitated by one or more protrusions and / or recesses of the alignment stage. For example, in some embodiments, to set the initial rotational direction of a guiding catheter, an adapter 351 of the guiding catheter (see Figures 5 and 6a) (e.g., including a Y-connector 344 or a T-connector, and optionally one or more gears such as a gear 342) is received into a designated recess 353 of the alignment stage (most commonly seen in Figure 5).

[0135] In some embodiments, the connector branch 354 extends at an angle to the long axis of the tool (or tool array), thereby positioning the tool along the long axis and / or width axis of the alignment stage by positioning the branch within its designated recess. Optionally, the branch is perpendicular to the long axis of the tool.

[0136] In some embodiments, the guiding catheter Y-connector 344 is secured in the recess 347 by inserting at least a portion of the adapter 351 (e.g., the Y-connector 344) into the recess 353, thereby reducing or preventing unintended movement of the guiding catheter (e.g., withdrawal). Optionally, the tool is centered relative to the alignment stage by inserting the Y-connector or a portion thereof (e.g., the branch 354) into the recess.

[0137] In addition to or instead of aligning the tools using tool connectors, in some embodiments, one or more stabilizing elements, such as rods or protrusions (not shown), are optionally placed (e.g., press-fitted and screwed in) on the array of tools before the array is placed on the alignment stage, and these stabilizing elements are then received into designated recesses of the alignment stage.

[0138] In some embodiments, the alignment stage defines a recess 359 (including, for example, a partial disk shape; see Figures 6a-b) in which the gear 342 of the guiding catheter adapter 351 is positioned.

[0139] In some embodiments, one or more fixing elements, such as a bridge 355 (see Figure 5), are positioned to hold a tool (e.g., a microcatheter) inside a recess, for example, to prevent the tool from being unintentionally pulled out of the recess.

[0140] Next, in some embodiments, the user positions the base actuation part 309 (see Figures 3a, 4) on the alignment stage so that the drive assembly 341 (see Figure 4) is aligned with the recess 345 (see Figure 5) (for example, by folding or otherwise positioning the actuation part on the alignment stage). In some embodiments, by closing the actuation part on the alignment stage, the wheel 343 (Figure 4) of the drive assembly is positioned diametrically opposed across the recess 345 (Figure 5), so that the wheel contacts the microcatheter received in the recess. In some embodiments, by closing the actuation part, the gear 349 (see Figure 4) coupled to the motor 339 is positioned to interfere with the gear 342, so that when gear 349 rotates, gear 342 rotates, thereby rotating the guiding catheter received in the alignment stage.

[0141] In some embodiments, the actuarial parts are configured to interlock with the alignment stage by, for example, an interlock 357 (see Figures 3a and 4). In this example, the interlock 357 includes a snap-fit ​​fixture. Optionally, the interlock 357 is configured to release a mechanical and / or electrical lock by closing, which, once released, allows the operation of, for example, a drive assembly moving a tool.

[0142] In some embodiments, as shown in Figure 3a, for example, the apparatus includes, for example, a light indicator 361 (e.g., a series of LED lights) located on the outside of the housing of one or more units. In some embodiments, the light indicator is configured to indicate one or more of the following: the receipt of the tool within the unit, the direction of linear movement of the tool, the speed of movement of the tool, unit malfunction, and the tool condition (e.g., buckling or bending).

[0143] Changing the spatial configuration of the robotic device Figure 7 is a flowchart illustrating methods for changing the spatial configuration of a robotic apparatus according to several embodiments.

[0144] In some embodiments, the need to change the spatial configuration of the apparatus is identified (701). Reasons for changing the spatial configuration of the apparatus may include: the need to provide or modify visual and / or physical access to imaging devices and / or other instruments used in procedures; the need to effectively extend the usable length of elongated surgical tools operated by the apparatus, as further described herein; the need to reposition the connector(s) of an elongated surgical tool, for example, the need to reposition the connector(s) of the tool relative to the apparatus and / or the patient to facilitate the injection of material through the connector(s).

[0145] In some embodiments, confirmation is performed automatically by the device, for example, in response to an instruction obtained by one or more sensors (such as an instruction that further tool length is needed), in response to a signal received from one or more encoders of the system, in response to a motor rotation count based on receiving a decision to release further tool length, and / or in response to other system instructions. In addition to or instead of this, confirmation is performed by the user of the device (for example, by visually detecting and / or tactilely sensing that further tool length is needed).

[0146] In some embodiments, the position of a first unit of the apparatus relative to at least a second unit is changed while a surgical tool is held in a predetermined position inside the apparatus unit, for example, while it is gripped by the wheels of the drive assembly within each unit (703). In some embodiments, the change in position is achieved by adjusting the couplings (e.g., frames) that connect the units to each other.

[0147] In some embodiments, the repositioning involves moving the first unit from a position where the first unit is held above the second unit (oriented perpendicular to the second unit) to a position where the first unit is held adjacent to the second unit (oriented horizontally to the second unit), or to a position that forms an angle with respect to the second unit (inclined setup).

[0148] As referred to herein, the position of a unit may include the position of the unit housing and / or refer to the longitudinal orientation defined by the drive assembly of the unit that contacts and optionally holds the tool. For example, in a vertical orientation of a unit, the drive assembly of the first unit may be aligned on a plane parallel to the plane of the drive assembly of the second unit; in a horizontal orientation of a unit, the drive assembly of the first unit may be aligned linearly with respect to the drive assembly of the second unit (for example, axially rearward with respect to the drive assembly of the second unit); and in an angular orientation of a unit, the drive assembly of the first unit may extend at an angle with respect to the drive assembly of the second unit (for example, at an angle of 1 to 179 degrees).

[0149] Optionally, in some embodiments, a change in spatial configuration makes further segments of the surgical tool operated by the device (e.g., guidewires and / or microcatheters) available for use by the device (705). For example, by positioning the first unit linearly behind the second unit, rather than directly above it, or at an angle less than 90 degrees relative to the second unit, the curved segment passing between the first and second units is now "shortened" and, optionally, the curve is avoided, so that further microcatheter and / or guidewire tool segments may become available for use. If further tool lengths become available for use, the tool can be advanced further, for example, further into the patient's body.

[0150] Figures 8a to 8c are side views of typical embodiments of robotic devices in vertical and inclined setups, according to several embodiments.

[0151] In some embodiments, for example as shown in Figure 8a, the barrel unit 801 is aligned perpendicularly to the base unit 803 so that the long axes of, for example, the drive assembly (not shown) of a surgical tool received and manipulated by the unit are parallel to each other. In some embodiments, a coupling 805 holds the two units relative to each other. In some embodiments, the coupling 805 includes a vertical rail 807 and a lever portion 809, which are coupled to each other at a joint 811 (e.g., a hinge or swivel joint). In some embodiments, with vertical alignment, a segment of the tool 813 (e.g., a microcatheter) extends along a path between units, from one curve to another. Potential advantages of vertical orientation of the units may include: providing available space (e.g., external volume of the unit) for changing the curvature of the tool, for example, optionally, for extending or shortening the curving tool segment based on the use of the tool inside a patient; and minimizing spatial interference of the device as a whole.

[0152] In some embodiments, as shown in the examples in Figures 8b-c, the barrel unit 801 is moved and held in an inclined position relative to the base unit 803. In some embodiments, the coupling 805 is adjusted by changing the angle α of the lever portion 809 with respect to the vertical rail from, for example, an acute or right angle in the vertical alignment of the unit to an obtuse angle (e.g., 90-180 degrees) in the inclined setup.

[0153] In some embodiments, the relative orientation of the units is maintained by a biasing component. In one example, the coupling 805 includes a spring (for example, in a lever portion not shown) and when the spring is released, the lever portion is elastically recoiled by the spring, changing the orientation of the units from vertical to inclined.

[0154] In some embodiments, a change in spatial configuration shortens the length of the segment of tool 813 extending between units, for example, by changing from a curved path (e.g., as shown in Figure 8a) to a substantially straight path (e.g., as shown in Figure 8c). In the example, the length of the segment passing between units (outside the housing of the units) is shortened by at least 20%, 40%, 70%, or an intermediate, greater or smaller amount of change in the spatial device configuration.

[0155] In some embodiments, the minimum length of the segments extending between units is determined by the rigid proximal portion of the tool (e.g., a microcatheter) (e.g., the portion where the connector and / or luer are formed, and / or the portion where the catheter is provided at the more rigid proximal end).

[0156] In some embodiments, the use of soft and / or flexible connectors may not be so restrictive when changing the length of a curved segment and / or otherwise altering the path the tool takes outside the unit housing. For example, in a vertical configuration of units where the tool curves between units, soft and / or flexible connectors may allow shorter tool segments to extend between units.

[0157] In some embodiments, changes to the spatial configuration are controlled remotely, for example, via a remote control device of the system.

[0158] Detection and control of curvature and / or buckling of elongated surgical tools Figure 9 is a flowchart of a method for detecting and / or controlling buckling and / or bending of an elongated surgical tool received at least partially within a robotic device, according to several embodiments.

[0159] In some embodiments, the robotic device defines at least one non-linear (i.e., curved) path through which an elongated surgical tool passes (901). In some embodiments, the path is mostly straight (e.g., straight along 60%, 80%, 95%, or an intermediate, longer or shorter proportion of its length) but includes axially offset positions that extend away from the major axis of the path. In some embodiments, the axially offset positions include curved portions.

[0160] In some embodiments, the curved portion forces the tool to curve as it passes through the curve, and as a result, the direction and / or axial position (along the tool length) that causes the tool to buckle when, for example, the distal end of the tool hits an obstacle (e.g., by encountering tissue or other structures inside a patient's body) is set by the curved path. In some embodiments, the tool segment extending through the curved path is freely stationary within the curve and is not restricted by, for example, any structural element, so the segment can bend freely, especially when the distal end of the tool encounters an obstacle.

[0161] In some embodiments, one or more sensors located in or adjacent to a curved path are configured to detect buckling and / or bending of a tool by, for example, detecting a force (e.g., pressure) applied by the tool on one or more sensors located in a curve of a path defined within the robotic device (903).

[0162] In some embodiments, when a force (e.g., pressure) applied by the tool to one or more sensors is detected, the user is notified about the state of the tool (905), for example, that the tool is encountering resistance at its distal end. Such notification may be given by visible and / or audible and / or tactile indications (e.g., vibration of the remote control) on the robotic device and / or its remote control. In some embodiments, the system control device is configured to generate notifications about tool conditions such as buckling or bending.

[0163] In some embodiments, optionally, the tool is automatically retracted to a position more proximal to which an obstacle at the distal end of the tool is avoided (for example, by acting on the drive assembly to retract the tool linearly backward) (907).

[0164] Figures 10a and 10b schematically illustrate non-linear paths for elongated surgical tools in which buckling and / or bending of the tool is detected, according to several embodiments.

[0165] In some embodiments, the tool 1001 is received within a path 1003 of a robotic apparatus that includes one or more curved portions 1005. In some embodiments, the tool is freely stationary within at least one of the curved portions, and is not limited to that.

[0166] In some embodiments, during use, for example as shown in Figure 10b, if the tool 1001 encounters an obstacle 1009 at, for example, the distal end 1007 of the tool, the curved portion sets the direction of the curve of the tool as the more proximal portion of the tool extending within the curved portion is pressed against the inner wall 1011 of the path.

[0167] In some embodiments, the curved portion includes, for example, one or more sensors 1013 located on the inner wall of the path, which detect contact and / or force (e.g., pressure) applied by the tool when the tool is pressed against the wall as a result of the curvature.

[0168] Figure 11 is a cross-sectional view of a typical portion of a robotic device that includes a non-linear path to an elongated surgical tool, as illustrated and illustrated in Figures 10a and 10b, according to several embodiments.

[0169] In some embodiments, a path 1101 defined within a unit of the robotic apparatus (for example, a barrel unit of the apparatus shown and illustrated in Figure 3a) extends through a drive assembly 1103 into a space defined, for example, by one or more wheels 1105 of the drive assembly, and optionally continues to form a curved portion 1107 distal to the drive assembly. In some embodiments, the curved portion is defined by an internal wall 1109 of the unit, for example, by a curve, bump, or protrusion within the wall. In some embodiments, one or more sensors 1111 (e.g., a pressure sensor, proximity sensor, contact sensor) are located in or adjacent to the curved portion to detect whether a tool (e.g., a guide wire in the barrel unit example) is pressed toward or against the wall of the path in the curve.

[0170] The terms "comprises," "comprising," "includes," "including," and "having," as well as their cognates, all mean "to include without limitation."

[0171] The term "~consisting of" means "to include and be limited to."

[0172] The terms “essentially consisting of” mean that a composition, method, or structure may include further components, steps, and / or parts, provided that these further components, steps, and / or parts do not substantially alter the basic and novel properties of the claimed composition, method, or structure.

[0173] As used herein, unless the context clearly indicates otherwise, the singular forms "a," "an," and "the" include references to the plural. For example, the terms "compound" or "at least one compound" may include multiple compounds, including mixtures thereof.

[0174] Throughout this application, various embodiments of the invention may be presented in range form. It should be understood that descriptions in range form are for convenience and simplicity only and should not be interpreted as an irrevocable limitation to the scope of the invention. Therefore, range descriptions should be considered to specifically disclose all possible subranges, as well as the individual numerical values ​​within those ranges. For example, a range description such as 1-6 should be considered to specifically disclose subranges such as 1-3, 1-4, 1-5, 2-4, 2-6, 3-6, as well as the individual digits within those ranges, such as 1, 2, 3, 4, 5, and 6. This applies regardless of the breadth of the range.

[0175] Whenever a numerical range is indicated herein, it is intended to include any cited digits (fractions or integers) within that range. The phrases "extending / extending the range" of the first and second indicated numbers, and "from" the first indicated number to the second indicated number, are used interchangeably herein and are intended to include the first and second indicated numbers and all fractional and integer digits between them.

[0176] As used herein, the term “method” means methods, means, techniques, and procedures for accomplishing a given task. This includes, for example, methods, means, techniques, and procedures that are known to practitioners of the arts of chemistry, pharmacology, biology, biochemistry, and medicine, or that can be readily developed from manners, means, techniques, and procedures known to practitioners.

[0177] As used herein, the term “to treat” includes disabling, substantially inhibiting, delaying, or reversing the progression of a condition, substantially improving the clinical or aesthetic symptoms of a condition, or substantially preventing the appearance of the clinical or aesthetic symptoms of a condition.

[0178] For clarity, it is understood that certain features of the present invention described in the context of separate embodiments may be combined in a single embodiment. Conversely, for simplicity, various features of the present invention described in the context of a single embodiment may be provided separately, in any preferred subset, or as preferred in any other described embodiment of the present invention. Certain features described in the context of various embodiments should not be considered essential features of those embodiments unless the embodiments would be unable to operate without those elements.

[0179] It is the applicant's(s) intent that all publications, patents, and patent applications referenced herein are incorporated by reference in their entirety as if each individual publication, patent, or patent application were specifically and individually indicated when it is mentioned that it is incorporated by reference herein. In addition, where any reference is cited or specified in this application, it should not be construed as an admission that such reference is available as prior art of the present invention. Section headings, to the extent that they are used, should not necessarily be construed as limitations. In addition, any priority document(s) of this application are incorporated by reference herein, in their entirety.

Claims

1. A robotic device for manipulating an array of multiple elongated surgical tools, A first activation unit and a second activation unit, each activation unit configured to receive at least one elongated surgical tool in the array, wherein the elongated surgical tool received by the first activation unit is different from the elongated surgical tool received by the second activation unit, and each activation unit includes a drive assembly and one or more motors configured to actuate the drive assembly to move the at least one elongated surgical tool, A coupling attached to the first and second activation units, the coupling comprising two or more parts connected to each other, the coupling configured such that the movement of the two or more parts relative to each other allows at least one of the first and second activation units to move relative to each other, and the coupling maintains in each of the first and second activation units that the elongated surgical tool remains operably connected to the drive assembly, The movement of at least one of the first and second starting units relative to each other is characterized by rearranging from a vertical arrangement in which the first starting unit is held above the second starting unit to an inclined arrangement in which the first starting unit is held at an angle to the second starting unit, or to a horizontal arrangement in which it is linearly aligned with the second starting unit. The rearrangement includes changing the direction of movement of the elongated surgical tool in the first activation unit, which was opposite to the direction of movement of the elongated surgical tool in the second activation unit in the vertical arrangement, so that the directions of movement coincide in the horizontal arrangement or the inclined arrangement. In the vertical arrangement, the passage of the elongated surgical tool from the first activation unit to the second activation unit is characterized by the elongated surgical tool forming a U-shaped curved path, while in the horizontal arrangement or the inclined arrangement, the passage of the elongated surgical tool from the first activation unit to the second activation unit is characterized by the elongated surgical tool forming a straight path.

2. The robotic apparatus according to claim 1, wherein at least the first starting unit is attached to the coupler by a reversible fixture that allows at least the first starting unit to be replaced as a whole.

3. The robot apparatus according to claim 1, wherein the coupling is configured to hold the first starting unit relative to the second starting unit in two or more spatial configurations.

4. The robot apparatus according to claim 3, wherein the two or more spatial configurations include a vertical arrangement in which the first starting unit is positioned relative to the second starting unit, such that the major axes of the drive assemblies of each unit are parallel to each other, and an inclined arrangement in which the major axis of the drive assemblies of the first starting unit extends at a certain angle with respect to the major axis of the drive assemblies of the second starting unit.

5. The robotic apparatus according to claim 1, wherein in each of the first and second activation units, there is no barrier between the drive assembly and the elongated surgical tool received in the activation unit.

6. The robot apparatus according to claim 1, wherein in each of the starting units, there is no barrier between the drive assembly and the one or more motors.

7. The robot apparatus according to claim 1, wherein one of the at least two parts of the coupler is attached to the first starting unit, and the other of the at least two parts of the coupler is attached to the second starting unit.

8. The robotic device according to claim 1, wherein the movement of the two or more parts of the coupling is spring-operated.

9. The robot device according to claim 8, wherein when the spring is released, the lever portion of the two or more portions springs elastically, thereby changing the orientation of the first starting unit and the second starting unit.

10. The robotic apparatus according to claim 1, wherein the elongated surgical tool received in the first activation unit includes a guidewire, and the elongated surgical tool received in the second activation unit includes a microcatheter, and the arrangement includes the guidewire at least partially inserted into the lumen of the microcatheter.

11. The robotic apparatus according to claim 10, wherein the drive assembly of the first activation unit is arranged to contact the guide wire when the guide wire is received into the first activation unit and to perform one or both of the following: to move the guide wire linearly and / or rotate the guide wire, and the drive assembly of the second activation unit is arranged to contact the microcatheter when the microcatheter is received into the second activation unit and to move the microcatheter linearly.

12. The robotic apparatus according to claim 10, wherein the second activation unit includes an attachment to a guiding catheter, and the microcatheter and guidewire array are at least partially inserted into the lumen of the guiding catheter.

13. The robotic apparatus according to claim 12, wherein the second activation unit is slidably mounted on a platform, and the sliding movement of the second activation unit relative to the platform causes the attached guiding catheter to move linearly together with the inserted microcatheter and guidewire.

14. The robotic apparatus according to claim 1, wherein the first starter unit is formed as a barrel, and the coupling holds the first starter unit vertically above the second starter unit.

15. The robot device according to claim 1, wherein the two or more parts of the coupling include lever portions and vertical rails connected to each other in the joint.

16. The robot apparatus according to claim 15, wherein at least a portion of the lever portion extends along the length of the first starting unit, the vertical rail extends downward from the lever portion toward the second starting unit, and the lever portion and the vertical rail are configured to hold the first starting unit and the second starting unit toward each other.

17. The robotic apparatus according to claim 1, wherein the arrangement of the plurality of elongated surgical tools operated by the apparatus includes a nested arrangement, and the elongated surgical tools received by the first activation unit are at least partially introduced into the lumen of the elongated surgical tools received by the second activation unit.

18. The robotic apparatus according to claim 16, wherein the elongated surgical tool received by the first activation unit includes a guide wire, and the elongated surgical tool received by the second activation unit includes a microcatheter.

19. The robotic apparatus according to claim 1, wherein the transition of the elongated surgical tool from the U-shaped curved path to the straight path shortens the length of the elongated surgical tool extending from the first activation unit to the second activation unit, thereby making the additional length of the elongated surgical tool available.

20. The robotic apparatus according to claim 1, characterized in that the movement of at least one of the first and second activation units relative to each other is performed while the elongated surgical tools in the array remain held by the first and second activation units, respectively, and there is no need to remove the elongated surgical tools before the movement, and the holding of the elongated surgical tools is not lost during or after the movement.

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