Modular robotic system for driving the movement of surgical tools

Abstract

1. A modular robotic surgical system comprising: a base; a plurality of tool receivers arranged as separate units, each tool receiver unit operable to move an elongated surgical tool received therein; a plurality of interface coupling pairs, each coupling pair including a first coupler as part of the base and a second coupler as part of each of the tool-receiver units; and a plurality of interface coupling pairs, each of the tool receiver units independently and interchangeably attachable to the base via the coupling pair.

Description

[Technical Field]

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

[0002] This application is also related to a co-filed, co-pending, and co-assigned PCT application entitled "ROBOTIC MANIPULATION OF A SURGICAL TOOL HANDLE" (Attorney Docket No. 83117), and a PCT application entitled "DEVICE FOR AUTOMATICALLY INSERTING AND MANIPULATING A MEDICAL TOOL INTO AND WITHIN A BODILY LUMEN" (Attorney Docket No. 83976), the contents of which are incorporated herein by reference in their entireties. [Background technology]

[0003] The present invention, in some embodiments thereof, relates to a modular robotic surgical system, and more particularly, but not exclusively, to a system for the manipulation of surgical tools received in separate tool-receiving units.

[0004] US Patent No. US10543047 discloses that "a robotic instrument driver for an elongated member includes a first elongated member, at least one manipulator mechanism configured to manipulate the first elongated member, and at least one articulating drive configured to articulate the first elongated member, and is positionable near a bed and a patient access location. The manipulator and articulating drive are positioned relative to each other at a distance less than the insertable length of the first elongated member and are fixed in position."

[0005] U.S. Patent No. US10524867 discloses that "an exemplary drive device may include a roller assembly and a roller support. The roller assembly may have a first continuous surface, a second continuous surface, an open configuration for receiving the elongated member, and a closed configuration for securing the elongated member to the roller assembly. The roller assembly provides axial movement of the elongated member along the first continuous surface and maintains contact with the elongated member during the axial movement. The roller support rotates the roller assembly about the second continuous surface and maintains contact with the roller support during rotational movement. The roller assembly and roller support provide axial and rotational movement, respectively, independent of each other."

[0006] US Patent No. US8480618 discloses that "a robotic catheter system is provided. The robotic catheter system includes a housing and a drive assembly coupled to the housing. The drive assembly is configured to impart movement to the catheter device. The catheter system includes a release structure that allows the drive assembly to be decoupled and removed from the housing without removing the catheter device from the patient." Summary of the Invention

[0007] According to some embodiments, there is provided a modular robotic surgical system including a base, a plurality of tool receivers arranged as separate units, each tool receiver unit operable to move an elongated surgical tool received therein, a plurality of interface coupling pairs, each coupling pair including a first coupler as part of the base and a second coupler as part of each of the tool-receiver units, each of the tool receiver units being independently and interchangeably attachable to the base via the coupling pair.

[0008] In some embodiments, each of the tool receiver units is configured to receive and drive the movement of only a single elongated surgical tool.

[0009] In some embodiments, the tool receiver units are shaped and sized to be mounted together on the base.

[0010] In some embodiments, each of the tool receiver units is configured to be mounted to the base and aligned with respect to the base and / or with respect to at least one other tool receiver unit via one or more of magnetic attraction, an interference fit coupling, or fasteners disposed external to the housing of each of the unit and the base.

[0011] In some embodiments, the base includes a housing that contains one or more motors.

[0012] In some embodiments, each of the tool receiver units comprises a slot configured to receive an elongated surgical tool and a plurality of tool movement elements disposed adjacent to the slot.

[0013] In some embodiments, the slot is elongated and extends along the longitudinal axis of the housing of the unit.

[0014] In some embodiments, the tool movement element includes a set of wheels positioned diametrically opposite the slot, the wheels positioned and configured to contact and move an elongated surgical tool received in the slot.

[0015] In some embodiments, the system includes at least two tool receiver units configured to be aligned parallel to one another such that an elongated surgical tool received in a first tool receiver unit is curved in a U-shape when it exits the first tool receiver unit and before it enters the second tool receiver unit.

[0016] In some embodiments, the system includes at least two tool receiver units, and a single elongated surgical tool is movable by the at least two tool receiver units.

[0017] In some embodiments, the first coupler comprises a mechanical coupler extending from within a housing of the base and the second coupler comprises a recess within the housing of each tool receiver unit from which the mechanical coupler extends, or vice versa.

[0018] In some embodiments, the mechanical coupler includes gears arranged and configured to drive movement of the tool movement element of each tool receiver unit in response to actuation of one or more motors in the base.

[0019] In some embodiments, the first coupler includes a protrusion and the second coupler includes a recess for receiving the protrusion, or vice versa.

[0020] In some embodiments, the first and second couplers include an interface electrical connection.

[0021] In some embodiments, the system includes two or more coupling pairs that are symmetrically aligned to allow attachment of at least one tool receiver unit and base in a first orientation and a second orientation, where in the second orientation the tool receiver unit is rotated 180 degrees relative to the first orientation.

[0022] In some embodiments, the elongated surgical tool is selected from the group of a guidewire, a microcatheter, a guide catheter, an intermediate catheter, or a "rapid exchange" catheter.

[0023] In some embodiments, the system includes at least one controller configured to coordinate actuation of tool movement elements configured on each of the plurality of units.

[0024] In some embodiments, the tool movement element drives one or both of the linear advancement and retraction of a tool received within the tool receiver unit, the rotation of a tool received within the tool receiver unit.

[0025] In some embodiments, the system further includes a remote control device, and the at least one controller is configured as part of the remote control device.

[0026] In some embodiments, at least one controller is integrated into one or more of the tool receiver units.

[0027] In some embodiments, each of the tool receiver units includes one or more sensors to indicate one or both of the presence of a tool in the tool receiver unit and the relative position of a tool received in the tool receiver unit.

[0028] In some embodiments, the system includes at least two tool receiver units mounted to a base, wherein in an assembled configuration, the tool receiver units do not protrude beyond an outer periphery defined by the base.

[0029] In some embodiments, the volume of the assembled system is 2500 cm 3 and the assembled system weighs less than 800 grams.

[0030] In some embodiments, the system further includes a mount on which the base rests, the base being slidable on the mount.

[0031] In some embodiments, in an assembled configuration, the system includes only a single tool receiver unit coupled to the base.

[0032] In some embodiments, in an assembled configuration, the system includes two or more tool receiver units coupled to a base.

[0033] In some embodiments, the one or more motors are selected from the group of DC motors, AC motors, stepper motors, electromagnetic actuators, piezoelectric actuators, pneumatic actuators, hydraulic actuators, or any combination thereof.

[0034] According to aspects of some embodiments, there is provided a method of assembling and operating a modular robotic surgical system, the method comprising: selecting a configuration of the system according to a surgical procedure to be performed; assembling the system by operably mounting at least one tool receiver unit configured to receive an elongated surgical tool on a base, the base including at least one motor configured to drive movement of the elongated surgical tool; positioning the assembled system relative to a patient; and performing the surgical procedure by controlling movement of the elongated surgical tool within the patient, the controlling including actuating at least one motor of the base.

[0035] In some embodiments, operably attaching includes operably attaching at least two tool receiver units to the base, each tool receiver unit configured to receive only a single elongated surgical tool, thereby performing a surgical procedure by controlling the movement of at least two elongated surgical instruments.

[0036] In some embodiments, controlling the movement includes controlling at least one of a linear movement of the elongated surgical tool, a rotational movement of the elongated surgical tool, and an actuation of a distal tip of the elongated surgical tool.

[0037] In some embodiments, the controlling is performed using a remote control device in wireless communication with the system.

[0038] In some embodiments, the method further comprises deploying a system including the tool receiver unit and the base at the end of the surgical procedure.

[0039] In some embodiments, the method includes adjusting the configuration of the system during a surgical procedure by removing or replacing at least one tool receiver unit.

[0040] In some embodiments, the elongated surgical tool is selected from the group of a guidewire, a microcatheter, an intermediate catheter, and a guide catheter.

[0041] In some embodiments, controlling includes automatically limiting or generating movement of at least one elongate surgical tool according to movement of at least one other elongate surgical tool.

[0042] In some embodiments, at least one tool receiver unit is provided pre-mounted on the base.

[0043] In some embodiments, operably attaching includes attaching at least one tool receiver unit in a selected orientation relative to the base.

[0044] In some embodiments, the method includes selecting between two orientations in which the tool receiver unit rotates 180 degrees relative to the base.

[0045] In some embodiments, operably attaching includes directly attaching the at least one tool receiver unit and the base without draping either the base or the at least one tool receiver unit.

[0046] According to an aspect of some embodiments, there is provided a tool receiver unit for use with a motor base, the tool receiver unit including: a first recess shaped and sized to receive a portion of an elongated surgical tool; one or more tool movement elements aligned adjacent to the first recess, the one or more tool movement elements configured to engage the elongated surgical tool to move the tool; and the one or more tool movement elements operably coupleable to the motor base.

[0047] In some embodiments, the tool receiver unit includes a housing that houses the tool moving element, the housing defining a second recess shaped and sized to receive the mechanical coupler of the base.

[0048] In some embodiments, the tool receiver unit includes a housing that houses the tool movement elements, the housing further comprising a mechanical coupler that protrudes from the housing for reception within the base.

[0049] In some embodiments, the tool receiver unit comprises a housing including a movable cover portion that covers the first recess.

[0050] In some embodiments, the elongated surgical tool is selected from the group of a guidewire, a microcatheter, an intermediate catheter, and a guide catheter.

[0051] In some embodiments, the tool movement element comprises a wheel configured for at least one of advancing and retracting the elongated surgical tool and rotating the elongated surgical tool.

[0052] In some embodiments, the first recess is elongate and defined along the elongate shaft, and the tool receiver unit is in operative communication with a motor that drives rotation of the shaft.

[0053] In some embodiments, the motor is configured in the base and the tool receiver unit includes slip rings that electrically couple the tool receiver unit to the base regardless of the rotational position of the shaft.

[0054] According to some embodiments, there is provided a modular robotic surgical system for use with a "rapid-exchange" catheter, the modular robotic surgical system including: a base including a housing containing one or more motors; a guidewire-receiving unit configured to be operably attached to the base such that movement of a guidewire received in the guidewire-receiving unit is controlled and driven by the one or more motors of the base; a rapid-exchange catheter-receiving unit configured to be operably attached to the base such that movement of a rapid-exchange guidewire received in the catheter-receiving unit is controlled and driven by the motors of the base; and a Y-junction shaped and sized to allow insertion of a guidewire into a lumen of the rapid-exchange catheter.

[0055] In some embodiments, the guidewire receiving unit and the rapid-exchange catheter receiving unit are independently engaged with the base.

[0056] According to an aspect of some embodiments, there is provided a modular robotic surgical system kit including, for example, a system as described above, and a plurality of elongated surgical tools for insertion into a plurality of tool receiver units, wherein the elongated surgical tools are selected from the group of guidewires, microcatheters, guide catheters, and intermediate catheters.

[0057] According to some embodiments, there is provided a modular robotic surgical system including a base, a plurality of tool receiver units arranged as separate units, each tool receiver unit operable to move an elongated surgical tool received therein, each of the tool receiver units operably attachable to the base and / or at least one other tool receiver unit, and at least two of the tool receiver units arranged to hold tools received therein in a parallel orientation to each other.

[0058] In some embodiments, each of the tool receiver units includes an elongated box-shaped housing.

[0059] In some embodiments, the plurality of tool receiver units includes at least two tool receiver units aligned to hold tools received therein along a similar longitudinal axis.

[0060] According to an aspect of some embodiments, there is provided a modular robotic surgical system including a base, a plurality of tool receiver units arranged as separate units, each unit operable to move an elongated surgical tool received therein, each of the units independently and interchangeably attachable to the base via an interface that communicates one or more of a mechanical drive for driving movement of the tool, power supply to one or more components of the unit that drive movement of the tool, and data for controlling movement of the tool by the unit.

[0061] According to some embodiments, there is provided a modular robotic surgical system comprising: a base including a housing containing one or more motors; a plurality of tool receiving units, each tool receiving unit comprising a housing that houses one or more tool movement elements and designated recesses in which a tool or segment of a tool is received, the recesses being positioned adjacent to the one or more tool movement elements; each tool receiving unit configured to be independently operably mounted to the base for actuation via the one or more motors of the base; and the tool movement elements for moving a tool received in the recess of the tool receiving unit.

[0062] Unless otherwise defined, all technical and / or scientific terms used herein have the same meaning as commonly understood by those skilled in the art to which this invention belongs. Although methods and materials similar or equivalent to those described herein can be used in the actual practice or testing of embodiments of the present invention, exemplary methods and materials are described below. In case of conflict, the patent specification, including definitions, will prevail. In addition, the materials, methods, and examples are illustrative only and are not necessarily intended to be limiting.

[0063] Implementation of the method and / or system of embodiments of the present invention may involve performing or completing selected tasks manually, automatically, or a combination thereof. Furthermore, depending on the actual equipment and implementation of the method and / or system embodiments of the present invention, some selected tasks may be performed by hardware, software, firmware, or a combination thereof using an operating system.

[0064] For example, hardware for performing selected tasks according to embodiments of the present invention may be implemented as a chip or circuit. As software, selected tasks according to embodiments of the present invention may be implemented as a plurality of software instructions executed by a computer using any suitable operating system. In exemplary embodiments of the present invention, one or more tasks according to exemplary embodiments of the methods and / or systems described herein are performed by a data processor, such as a computing platform for executing a plurality of instructions. Optionally, the data processor includes volatile memory for storing instructions and / or data, and / or non-volatile storage, e.g., a magnetic hard disk and / or removable media, for storing instructions and / or data. Optionally, a network connection is also provided. Optionally, a display and / or user input devices, such as a keyboard and / or mouse, are also provided.

[0065] Some embodiments of the invention are described herein, by way of example only, with reference to the accompanying drawings. Referring now in detail to the drawings, it is emphasized that the details shown are by way of example and are for the purpose of illustrating embodiments of the invention. In this regard, the description taken together with the drawings will make apparent to those skilled in the art how embodiments of the invention may be practiced. [Brief explanation of the drawings]

[0066] [Figure 1]1 is a flowchart of a general method of assembling and using a modular robotic surgical system, according to some embodiments. [Figure 2A] FIG. 1 is a schematic block diagram of a modular robotic surgical system, according to some embodiments. [Figure 2B] FIG. 1 is a schematic block diagram of a tool-receiving unit, according to some embodiments. [Figure 3] 1 illustrates an exemplary configuration of an assembled modular robotic surgical system, according to some embodiments. [Figure 4] 4A-B are isometric and side views of a modular robotic surgical system positioned relative to a patient, according to some embodiments. [Figure 5] 5A-B are side views (FIG. 5A) and exploded views (FIG. 5B) of a modular robotic surgical system including a guidewire unit, a microcatheter unit, and a guide catheter unit, according to some embodiments. [Figure 6-1] 6A-C show a guidewire-receiving unit with an open cover (FIGS. 6A, 6C) and a closed cover (FIG. 6B), according to some embodiments. [Figure 6-2] 6D-E illustrate a guidewire holder, according to some embodiments, shown in an isometric view (FIG. 6D) and a cross-sectional view (FIG. 6E). [Figure 7-1] 7A-E show various views of the base of a modular robotic surgical system, according to some embodiments. [Figure 7-2] 7F-G show various views of alternative base configurations for a modular robotic surgical system according to some embodiments, and FIG. 7H shows an example of a tool-receiving unit configured to engage with a base according to some embodiments. [Figure 8] 8A-D show attachment of a guidewire unit to a base resting on a mounting portion (FIGS. 8A-B) and attachment of a microcatheter unit to a base resting on a mounting portion (FIGS. 8C-D), according to some embodiments. [Figure 9] 9A-B are isometric views of an assembled modular robotic surgical system according to some embodiments, shown without a guidewire holder in FIG. 9A and with a guidewire holder protruding from the exit end of the guidewire-receiving unit in FIG. 9B. [Figure 10] 10A-B are isometric views of an assembled modular robotic surgical system shown without (FIG. 10A) and with (FIG. 10B) a tool inserted, according to some embodiments. [Figure 11] 11A-C show a guide catheter unit including a mechanism for linear movement of the guide catheter, according to some embodiments. [Figure 12-1] 12A-B show several views of a modular robotic surgical system configured to use a "rapid exchange" catheter, according to some embodiments. [Figure 12-2] 12C-D show several views of a modular robotic surgical system configured to use a "rapid exchange" catheter, according to some embodiments. [Figure 13] 13A-D are examples of remote control devices for controlling a modular robotic surgical system, according to some embodiments. [Figure 14] 14A-B schematically illustrate a guidewire, microcatheter, and guide catheter assembly, according to some embodiments. [Figure 15] 15A-D schematically illustrate various arrangements of the base and tool-receiving unit, according to some embodiments. [Figure 16] 16A-B show a slidable mount for a guide catheter unit, according to some embodiments. [Figure 17] 17A-B schematically illustrate a piezo actuation mechanism for linear translation and / or rotation of a surgical tool, according to some embodiments. [Figure 18]1 is a schematic diagram of a device capable of providing both linear and rotational motion to a surgical tool, according to some embodiments. DETAILED DESCRIPTION OF THE INVENTION

[0067] The present invention, in some embodiments thereof, relates to a modular robotic surgical system, and more particularly, but not exclusively, to a system for the manipulation of elongated surgical tools received within separate tool-receiving units.

[0068] A broad aspect of some embodiments relates to robotically manipulating elongated surgical tools using systems assembled and / or modified according to a surgical procedure.

[0069] In some embodiments, the configuration of the system is selected for use based on the type of surgical procedure being performed. The system can be pre-assembled and / or field assembled and installed by attaching only the tool-receiving units necessary to perform the procedure. Potential advantages of a built-to-order system may include simplified construction and operation, easy and fast setup, and a minimal system size.

[0070] In some embodiments, the assembled system is compact and occupies a relatively small volume (e.g., 2000 cm 3 Less than 2500cm 3 , 3500cm 3 , 5000cm 3 , 9000cm 3The system may be small (or intermediate, larger, or smaller volume), allowing the system to be located near the patient (such as near the surgical entry point into the body). Alternatively, the system may be attached directly to the patient, e.g., assembled to the patient's leg or arm, depending on the surgical entry point. In some embodiments, the system is small enough so as not to interfere with other operating room equipment, such as imaging modalities used during surgery. Optionally, the system has minimal or no floor and / or ceiling footprint.

[0071] Aspects of some embodiments relate to a system including a base and multiple tool-receiving units, each independently attachable to the base. In some embodiments, the units are interchangeable. In some embodiments, each unit is configured for quick connection (and disconnection) to and from the base. Optionally, the system is assembled on-site, e.g., immediately prior to surgery. In some embodiments, the configuration of the system can be adjusted even during surgery, e.g., by attaching or removing one or more tool-receiving units. Alternatively, the system is provided pre-assembled and ready to use, optionally pre-loaded with surgical tools.

[0072] In some embodiments, the interface between the tool-receiving unit and the base transmits mechanical power to drive tool movement. For example, the base includes one or more motors that drive the movement of tool movement elements (e.g., wheels) of the unit. Additionally or alternatively, the unit itself includes one or more integrated motors.

[0073] In some embodiments, the interface between the tool-receiving unit and the base electrically connects the unit and the base, such as for transferring power from the base to the unit.

[0074] In some embodiments, the interface between the tool-receiving unit and the base transfers data, such as data related to the control of the movement of the tool, optionally received at least in part from a general system controller (optionally from a remote control device).

[0075] In some embodiments, each unit is configured to receive an elongated surgical tool, e.g., an elongated intravascular surgical tool, e.g., a guidewire, microcatheter, guide catheter, midcatheter. In some embodiments, the unit includes a tool movement element that engages the tool upon insertion of the tool into the unit (e.g., into a designated recess in the unit housing) and is configured to move the tool, e.g., linearly advance and / or retract the tool, rotate the tool, manipulate the distal end of the tool, and / or otherwise navigate or manipulate the tool. In some embodiments, the tool movement element is actuated by motor(s) on the base. In some embodiments, each unit drives the movement of only a single tool. Optionally, multiple units drive the movement of the same single tool.

[0076] In some embodiments, the tool-receiving unit defines an interface for attachment to the base. In some embodiments, the base and unit are attached via an interface coupling pair including a first coupler as part of the unit and a second coupler as part of the base. The first and second couplers may be configured to transmit mechanical force, conduct electricity, and / or transmit data. In some embodiments, the first and second couplers define a shape at the interface between the unit and the base. For example, the first coupler is formed as a protrusion (optionally an element extending from the base) and the second coupler is formed as a recess in the unit into which the protrusion is received. In some embodiments, the coupling pair defines a mechanical engagement with a motor of the base. For example, in some embodiments, the motor (or a portion thereof) and / or a transmission element (e.g., a gear) protrude outward from the base and are received in a designated recess in the unit housing, where they are disposed in operative contact with a tool-moving element of the unit. In some embodiments, the interface includes an element for aligning the unit with the base. Alignment can be achieved, for example, by magnetic attraction, mechanical keying patterns, electronic engagement, and / or others. In some embodiments, the unit is mechanically locked to the base, for example, to prevent relative movement of the base and unit during use.

[0077] In some embodiments, the configuration of the system is optionally changed during operation, for example, by removal and / or replacement of one or more tool-receiving units. In some embodiments, one or more tools are removed or replaced during operation. In some embodiments, in the event of a unit malfunction, a particular unit can be removed (and optionally replaced) without requiring the removal or replacement of other system units.

[0078] In some embodiments, in an assembled system, the designated recess (eg, slot) in each unit where the tool is received remains accessible to the user in all system configurations.

[0079] In some embodiments, the system is controlled remotely, for example, via a remote control device. In some embodiments, actuation of tool movements in each unit is coordinated and controlled by a system controller. In some embodiments, the controller is configured to receive indications from one or more sensors configured in the unit and / or the base, the indications relating to one or more of the presence of a tool in the unit, the relative position of the tool, the tool movement performed, and the motor actuation performed.

[0080] Aspects of some embodiments relate to single-use robotic surgical systems. In some embodiments, the entire system (e.g., including the base and optionally the base attachment) is disposed of after use. Optionally, none of the system components (i.e., the tool-receiving unit and the base) are reusable. In some embodiments, the system is provided in a sterile package, optionally already assembled. In some embodiments, the electrical, mechanical, and electromechanical components of the system are provided sterile.

[0081] In some embodiments, during manufacturing, the system is pre-assembled to include the base and selected units, optionally configured according to surgical needs. Additionally or alternatively, the system is assembled on-site by a doctor / nurse, etc.

[0082] Potential benefits of a single-use system may include reducing or eliminating the need to clean and / or sterilize components after use, reducing or eliminating the need to cover the system with a sterile cover (optionally eliminating the need to place a sterile drape over the system), reducing or preventing the risk of cross-contamination between patients, reducing preparation time, and simplifying follow-up cleaning.

[0083] In some embodiments, the motors of the system (such as the motor that drives the linear movement of the tool, the motor that drives the rotational movement of the tool, etc.) comprise DC motors, AC motors, stepper motors, electromagnetic actuators, piezoelectric actuators, pneumatic actuators, hydraulic actuators, or any combination thereof.

[0084] It should be noted that the dimensions and sizes listed herein are given by way of example only and should not be construed as limiting.

[0085] For example, it should be noted that the surgical tools described herein may include any elongated intraluminal tool for use in the human body, such as the vascular, urinary, lymphatic, respiratory, and digestive systems. The terms surgical tool, elongated tool, and intraluminal tool are generic and interchangeable terms to describe all of the above tools. Examples of such tools include guidewires, microcatheters, guide catheters, midcatheters, and rapid-exchange catheters, among others. In some embodiments, the tool is shaped and sized for insertion into a body lumen, including, for example, a blood vessel, a duct, a tube, and / or other lumen.

[0086] It should be noted that the terms "unit," "tool receiving unit," and "tool receiver unit," used interchangeably throughout this application, may refer to structures and / or mechanisms configured to engage, receive, hold, attach, and / or move an elongated surgical tool. In some embodiments, the "unit" includes a housing containing one or more of a tool movement element (e.g., wheel), a movement actuator (e.g., motor, motor transmission), a control component (e.g., controller, microprocessor, etc.), and a communication module.

[0087] Before describing at least one embodiment of the invention in detail, it is to be understood that the invention is not necessarily limited in this application to the details of construction and arrangement of components and / or methods set forth in the following description and / or illustrated in the drawings and / or examples. The invention is capable of other embodiments or of being practiced or carried out in various ways.

[0088] Before describing at least one embodiment of the present invention in detail, it is to be understood that the invention is not necessarily limited in its application to the details set forth in the following description or illustrated by way of examples. The invention is capable of other embodiments or of being practiced or carried out in various ways.

[0089] Referring now to the drawings, FIG. 1 is a flowchart of a general method of assembling and using a modular robotic surgical system, according to some embodiments.

[0090] In some embodiments, a decision to operate is made 101, for example, by a physician, surgeon, and / or other clinical personnel. In some embodiments, the operation is therapeutic. Additionally or alternatively, the operation is diagnostic.

[0091] In some embodiments, the procedure involves catheter insertion. In some embodiments, the procedure involves inserting one or more tools into and / or through the vascular system and / or into other non-vascular intraluminal structures. Example tools may include guidewires, microcatheters, rapid-exchange catheters, guide catheters, balloon catheters, stents or coils, ablation tools, midcatheters, aspiration catheters, ultrasound catheters, pressure catheters, and / or other tools. In some embodiments, the procedure is a through-lumen-based procedure. In some embodiments, the procedure is an over-the-wire-based procedure.

[0092] In some embodiments, a system configuration appropriate for a particular operation is selected 103. The configuration may be selected by the physician and / or in some embodiments automatically recommended by the system in response to input of, for example, the type of procedure and / or the anatomical location to be operated on and / or patient-specific data.

[0093] In some embodiments, the system configuration defines the type and / or number of tool-receiving unit(s) used depending on the type and / or number of tools required for the procedure. In some embodiments, the system configuration defines the alignment and / or positioning of the tool-receiving units relative to each other and / or to the system motor base. In some embodiments, the system configuration is selected according to the manner in which the tools received in the units will operate (e.g., a first tool is threaded into the lumen of another tool before the second tool is advanced).

[0094] In some embodiments, one or more tool-receiving units are assembled to the system base (105) according to a selected configuration. In some embodiments, assembly is by attaching one or more tool-receiving units to a surface of the base housing. In some embodiments, assembly includes positioning one or more tool-receiving units laterally relative to the base and / or below the base and / or in any other location where the tool-receiving units are operably coupled to the base. In some embodiments, assembly includes aligning components of the system, for example, aligning one or more units relative to the base and / or relative to each other. Alignment of components is aided by one or more of visual markings, mechanical interference elements (e.g., protrusions and respective recesses), magnetic attraction, snap-fit ​​mechanisms, sensors configured to indicate the position of the unit and / or the base, sensors configured to indicate the type of unit attached to the base (e.g., magnetic sensing, RFID, optical sensing, mechanical sensing, electrical sensing).

[0095] In some embodiments, the system is assembled by coupling one or more tool-receiving units to the base via a mechanical coupling. Optionally, the mechanical coupling includes an element extending from the housing of the base to the housing of the tool-receiving unit, or vice versa. In an example, a gear protrudes from the housing of the base that is received in a complementary recess formed in the housing of the tool-receiving unit. In some embodiments, the mechanical coupling is configured to lock the components of the system together, for example, locking the tool-receiving unit to the base and / or locking the tool-receiving units to each other.

[0096] In some embodiments, the assembled system is substantially block-shaped, e.g., having a square or rectangular compact configuration. Other configurations may include cylindrical configurations, rounded configurations. In some embodiments, the tool-receiving unit and / or the base do not include a housing. Optionally, a mechanical coupling is provided between the base and the tool-receiving unit by coupling at least one gear. Optionally, an electrical coupling is provided between the base and the tool-receiving unit, e.g., via wiring.

[0097] In some embodiments, the assembled system is positioned relative to the patient (107). In some embodiments, the system is attached to a surgical bed, for example, via fixation. In some embodiments, the system is attached to the patient, for example, attached to the patient's leg (e.g., thigh), the patient's arm, and / or other body part. Attaching the assembled system to the surgical bed and / or patient can be performed using straps, bands, rigid attachments, and / or other attachment means. In some embodiments, attachment to the bed is performed using a stand stabilized to the mattress, to the bed rails, and / or to the floor. The modular system can then be attached to the stand, for example, via a snap-fit ​​mechanism, magnetic means, straps (such as Velcro®), etc. In some embodiments, the stand is adjustable to accommodate use with patients of various sizes and / or different bed heights, etc. In some embodiments, when positioning the system, one or more of the height, body entry angle, alignment of the system relative to the patient, etc. are selected. The system may be positioned relative to the patient's body or parts thereof (eg, relative to the surgical entry site) and / or relative to the surgical bed and / or relative to other surgical room equipment, for example, relative to the imaging module.

[0098] In some embodiments, loading of the tool into the tool-receiving units (e.g., each unit receiving a single tool) is performed in the assembled system. In some embodiments, loading of the tool is performed after the system positioning is set. Alternatively, loading of the tool is performed before the system positioning is set. Optionally, the tool is pre-loaded into the unit. In an example, the unit is provided in a sterile package, already loaded with the tool.

[0099] In some embodiments, surgery is performed by controlling the movement of a surgical tool received within the unit via the system's user interface (109). Exemplary manipulations of the tool controlled by the system may include linear advancement and / or retraction of the tool, rotation of the tool (e.g., about the axis of the tool), twisting of the tool, angular orientation of the tool (e.g., by bending the distal end of the tool), articulation (e.g., at the distal tip of the tool), alteration of mechanical properties of the tool such as stiffness, etc., by controlling the distal tip structure or internal configuration from the proximal end of the tool.

[0100] In some embodiments, the user interface is configured on the modular system itself (e.g., as a screen and / or buttons and / or joystick attached to the system unit and / or base), and / or on a separate physician console, and / or on a separate remote control. Control signals can be communicated to the system via wired and / or wireless communications (e.g., network-based communications).

[0101] In some embodiments, the modular system or particular components thereof are disposed of after surgery (111). In some instances, the tool-receiving unit (along with any tools used) is discarded and the system base is reusable. In other instances, the system is discarded as a whole.

[0102] In some embodiments, the system is pre-packaged in an assembled configuration. Optionally, the assembled system is provided in multiple pre-assembled configurations, each suitable for a number of specific procedures. In use, a particular pre-packaged assembled configuration can be selected depending on the operation to be performed.

[0103] Additionally or alternatively, the configuration is selected and implemented in the operating room by assembling selected system components together (e.g., a base and a selected tool-receiving unit). In some embodiments, the system configuration is adjusted intraoperatively as needed. For example, a first phase of a procedure is performed with the system assembled in a first configuration, and a second phase of the procedure is performed with the system assembled in a second configuration that is different from the first configuration.

[0104] In some embodiments, certain tools and optionally their associated tool-receiving units are removed or replaced during surgery. In one example, in a "through-lumen" type procedure, the microcatheter can remain in place while the guidewire can be removed or replaced with a therapeutic tool, and in another example, in an "over-the-wire" procedure, the guidewire remains in place while the microcatheter is replaced with a therapeutic tool.

[0105] In some embodiments, for example, when a procedure requires advancement through the lumen of the catheter, the guidewire is retracted from the catheter lumen manually and / or by the system (e.g., by operating a quick retraction button). In some embodiments, the guidewire is retracted and optionally replaced with a new guidewire. Additionally or alternatively, the unit is replaced as a whole, including the guidewire.

[0106] In some embodiments, for example, in an "over the wire" procedure, the microcatheter is retracted so that the guidewire extends distally relative to the microcatheter, exposed and accessible. Optionally, the microcatheter is removed and optionally replaced.

[0107] FIG. 2A is a schematic block diagram of a modular robotic surgical system, according to some embodiments.

[0108] In some embodiments, the modular robotic system 201 is suitable for use in an operating room. Optionally, one or more system components (such as control components and optionally imaging components) are physically separated from the rest of the system and can be used remotely.

[0109] In some embodiments, system 201 includes multiple (e.g., 1, 2, 3, 4, 5, 10, 20, or any intermediate, greater or lesser number of tool-receiving units. In some embodiments, each unit is configured to receive a tool and move that tool. In some embodiments, each unit receives only a single tool. In some embodiments, movement of a single tool is actuated by a single unit. In some embodiments, movement of a single tool is actuated by two or more units.

[0110] In some embodiments, one or more specific tool receiving units are selected to perform an operation. Exemplary tool receiving units include the microcatheter unit 209, the guidewire unit 211, the guide catheter unit 213, and the intermediate catheter unit 215.

[0111] Each of the units may be configured to drive linear movement (e.g., advancement and / or retraction) of a tool received therein and / or to drive rotational movement (e.g., axial rotation) of a tool received therein. In some embodiments, linear and rotational movement are actuated simultaneously by the same unit. In some embodiments, a unit may be limited to a single type of movement (e.g., only driving linear movement, only driving rotational movement).

[0112] In some embodiments, each unit can be independently mounted to a base 203. In some embodiments, the base includes one or more actuators, such as one or more motors 205, and optionally a transmission mechanism 217. In some embodiments, when a unit is operably mounted to a base, the motor(s) of the base drive the moving elements (e.g., wheels, discs, rings) of the unit, which in turn move a tool received within the unit, e.g., move the tool linearly or rotate the tool. Additionally or alternatively, the unit includes one or more integrated motors housed within the unit housing.

[0113] In some embodiments, one or more tool-receiving units are configured to be mounted to and mechanically coupled to the base. In some embodiments, the units are mechanically coupled to and / or in direct contact with one or more other units. Alignment and attachment of the units to the base and / or one or more other units may be performed via one or more of magnetic attraction, snap-fit ​​interfaces, interference fit elements (e.g., protrusions and respective recesses), connectors (optionally configured to provide a visual and / or audio indication upon attachment), and / or other coupling mechanisms. In some embodiments, once the unit is placed in place (e.g., relative to the base), the unit is locked in place to prevent its movement.

[0114] In some embodiments, the base comprises power supply means 219, including, for example, a battery and / or connection means for a mains power source.

[0115] In some embodiments, the base comprises a communication module 221, for example for communicating with each of the tool receiving units and / or with a general control unit 223 of the system.

[0116] In some embodiments, the base includes an integrated controller 225. In some embodiments, the controller 225 receives and / or transmits operational signals to and from a general control unit 223. The general control unit 223 can be configured as a remote control, a console, a control unit physically attached to the system base, or a combination thereof. In some embodiments, the system controller(s) are configured to coordinate the operation (e.g., linear movement, rotation) of tools received in multiple tool-receiving units.

[0117] Optionally, the base includes a local user interface 227 configured, for example, as one or more buttons and / or a screen on the base housing.

[0118] Optionally, the base comprises a memory component 229. The memory 229 can store, for example, parameters related to tool movement, such as speed of movement, rotation, translation, angle, etc., indications obtained by one or more system sensors, such as measurements of forces acting on the tool, tool stiffness, etc., parameters related to the patient's body and sensed by the inserted tool (e.g., heart rate, blood pressure, temperature, oxygenation level, and / or other sensed parameters).

[0119] In some embodiments, system components include sensors (schematically shown as circles 231). Sensors integrated into the tool-receiving unit can be used, for example, to detect whether a tool has been inserted into the unit, the relative position of the tool, the position of the moving element (e.g., wheels), the actual movement of the moving element (e.g., by a counter counting wheel revolutions), communication with other system sensors, and / or other measurements and / or indications. Sensors integrated into the base can be used, for example, to detect the position of the motor, detect the rotational speed of the motor, detect whether the unit is attached to the base, and communicate with other system sensors. Various types of sensors can be used, such as optical sensors, pressure sensors, force measurement sensors, speed sensors, sensors for detecting current, flow sensors, position sensors (e.g., optical, magnetic, electrical position sensors), etc.

[0120] In some embodiments, system 201 includes a torquer unit 233 configured to affect rotational movement of a guidewire received within the guidewire unit. In some embodiments, torquer unit 233 actuates the distal tip of the guidewire, for example, controlling the curvature and / or orientation and / or stiffness of the distal tip of the guidewire. The torquer unit can actively control rotation of the guidewire and / or passively allow rotation in response to rotation by the guidewire-receiving unit. In some embodiments, the torquer unit is attached to a base.

[0121] In some embodiments, the system 201 includes an integrated imaging modality 237. Alternatively, the system is configured to be operatively connected to (e.g., in communication with) an existing imaging modality, which may include, for example, fluoroscopy, CT, cone-beam CT, CT fluoroscopy, MRI, ultrasound, or any other suitable imaging modality.

[0122] In some embodiments, the system 201 comprises a mount 239 for positioning the system (or components thereof) relative to the patient and / or relative to the operating table. In some embodiments, the mount includes or is configured to attach to an adjustable fixture. Optionally, the height and / or angle and / or distance of the system relative to the patient (e.g., relative to the body entry position) and / or relative to the bed is adjustable.

[0123] The system may be provided in a pre-assembled configuration ready for use, or alternatively may be assembled on-site.

[0124] Some example system configurations may include:

[0125] - Configuration including a guidewire unit and a microcatheter unit.

[0126] A configuration including a guidewire unit, a microcatheter unit, and a guide catheter unit.

[0127] A configuration including a microcatheter unit (optionally without a guidewire unit if the microcatheter itself is a steerable / deflectable microcatheter).

[0128] A configuration including a guidewire unit, a microcatheter unit, and an intermediate catheter unit (e.g., for use in vascular procedures). In an example, the intermediate catheter is used as an additional carrier to the microcatheter in a neurovascular procedure.

[0129] In an exemplary system configuration, the guidewire unit is configured to rotate the guidewire (optionally about the guidewire axis) and to linearly move (advance and retract) the guidewire, and the microcatheter unit is configured only to linearly move (advance and retract) the microcatheter (which receives the guidewire). In some embodiments, the microcatheter unit also drives the rotational movement of the microcatheter.

[0130] In exemplary uses, the guidewire-receiving unit and microcatheter-receiving unit are used in "through-lumen" procedures such as embolization (using coils, glue, beads, or other embolization tools), procedures in which localized drugs are delivered, and ablation procedures. In the embolization example, the guidewire can be retracted and then an embolization tool can be administered through the lumen of the microcatheter. In another example, a stent retriever and / or aspiration tool can be administered through the lumen of the microcatheter after retracting the guidewire.

[0131] In another exemplary use, a ballooning and / or stenting procedure is performed using a guidewire receiving unit (holding the guidewire) and a designated unit for a balloon catheter or stent catheter (holding the balloon / stent catheter).

[0132] FIG. 2B is a schematic block diagram of a tool-receiving unit, according to some embodiments.

[0133] In some embodiments, the tool receiving unit 251 comprises a housing 253 that houses components, for example, as described below.

[0134] In some embodiments, the tool receiving unit comprises a tool moving element 255, for example a wheel, constructed and arranged to engage a tool received within the unit.

[0135] In some embodiments, the tool-receiving unit comprises a base-engaging section 257. Optionally, the base-engaging section includes a recess into which a mechanical coupler protruding from the system base is received. Additionally or alternatively, the base-engaging section comprises a mechanical coupler that protrudes from the unit housing 253 and operably engages the base. In some embodiments, the mechanical coupler is a gear, wheel, motor, and / or other element shaped and configured to transmit force and / or drive movement of another component.

[0136] In some embodiments, the coupling between the unit and the base includes a magnetic coupling. In some embodiments, the coupling between the unit and the base includes an electrical coupling, for example, to enable power to be supplied to the unit (e.g., to the tool movement elements of the unit and / or other components that drive movement of the tool movement elements, such as motors). The electrical coupling may include, for example, slip rings, electrical connectors, relay circuits, and / or others.

[0137] In some embodiments, the tool movement elements are driven by a motor(s) on the base to which the unit is attached. Additionally or alternatively, the unit itself includes an integrated motor 263.

[0138] In some embodiments, the tool-receiving unit includes a tool-receiving port 259. Optionally, the port is configured as an elongated slot, e.g., extending along a longitudinal axis defined by the unit housing. In some embodiments, the slot is straight, e.g., extending along a longitudinal axis of the unit housing. Alternatively, the slot defines a serpentine or curved path, which can increase the contact surface area between the tool and the tool moving element (e.g., wheel), potentially improving traction.

[0139] In some embodiments, when the tool is inserted into the slot, a tool movement element engages the tool, for example an element configured as a wheel engages the tool, optionally in a diametrically opposed position, In some embodiments, the tool movement element is spring actuated, so that when the tool is inserted into the slot, the spring(s) press the element against the tool.

[0140] In some embodiments, the tool receiving unit is configured to receive tools of various diameters. For example, the guidewire receiving unit can be configured to receive guidewires with diameters between 0.18-0.25 mm, 0.5-1.14 mm, between 0.18-1.14 mm, or intermediate, larger, or smaller diameters. In some embodiments, spring-activated positioning of the tool moving element allows for the use of tools of various diameters.

[0141] In some embodiments, the tool-receiving unit includes at least one sensor 261. In an example, the sensor is configured to detect the presence of a tool received within the unit. Optionally, the sensor is configured to detect the presence of a tool within a second tool, e.g., the presence of a guidewire within a microcatheter. Optionally, the sensor is configured to detect the relative position of a tool received within the unit (e.g., detect the length of an elongated section of an advanced and / or retracted tool).

[0142] In some embodiments, the tool-receiving unit optionally includes its own controller 265 and communication means 267. Additionally or alternatively, the tool-receiving unit itself does not include any computational elements, and its components are controlled directly by the base controller(s) and / or by remote control(s) and / or other interfaces.

[0143] Optionally, the tool receiving unit is provided with its own power source, for example via a battery and / or a connection means to the mains power supply.

[0144] FIG. 3 illustrates an exemplary configuration of an assembled modular robotic surgical system, according to some embodiments.

[0145] In the example shown, the assembled system 301 includes the following components: a base 303, a guidewire receiving unit 305, a microcatheter receiving unit 307, a guide catheter receiving unit 309, a torquer unit 311, and a mounting portion 313 along which the base 303 can move linearly (e.g., by sliding).

[0146] In some embodiments, the guidewire-receiving unit 305 and the microcatheter-receiving unit 307 are each configured to be separately mounted to a housing on the base 303. In some embodiments, the unit housings are aligned with respect to the housing of the base, e.g., such that the unit housings do not extend beyond the perimeter of the base. Optionally, when the units are fully aligned with and optionally locked to the base, a compact box-shaped arrangement (e.g., having a rectangular or square cross-sectional profile) is formed. Alternatively, the assembled system includes a round cross-sectional profile.

[0147] In some embodiments, the assembled system is relatively small in size, e.g., height 325 less than 10 cm, 13 cm, 20 cm, or intermediate, longer or shorter; width 327 less than 7 cm, 12 cm, 15 cm, or intermediate, longer or shorter; length 329 less than 15 cm, 17 cm, 20 cm, or intermediate, longer or shorter when measured without the guide catheter unit; or length less than 18 cm, 25 cm, 30 cm, or intermediate, longer or shorter when measured with the guide catheter unit. In some embodiments, the assembled system is lightweight, e.g., weighing 400 grams or less, 600 grams, 900 grams, or intermediate, higher or lower. Potential advantages of a compact, lightweight system may include the ability to position the system in a variety of positions relative to the patient and / or the operating table, and even relative to the patient's body. Another potential advantage may include, for example, less interference with other operating room equipment, such as imaging modalities, compared to larger, bulkier systems. Another potential advantage is that the system may have no or minimal floor space and occupy no floor space.

[0148] In some embodiments, one or more units are mounted on the top surface of the base housing as shown. Additionally or alternatively, the units may be mounted on one or more other surfaces of the base, for example, the base may be positioned above the units, laterally adjacent to the units, or a combination thereof.

[0149] In some embodiments, torquer unit 311 is attached to a different side of the base housing than the sides to which units such as units 305 and 307 are attached. In some embodiments, the torquer unit affects movement of the distal tip of the guidewire. Alternatively, the torquer unit affects movement of the entire length of the guidewire.

[0150] In some embodiments, guide catheter receiving unit 309 extends distally from microcatheter receiving unit 307. In some embodiments, the connection between guide catheter receiving unit 309 and microcatheter receiving unit 307 includes junction 313 (optionally, a Y-junction). Optionally, the Y-junction allows for the injection of a material (e.g., a fluid), such as a contrast agent, into the lumen of guide catheter 315 received within the unit. Optionally, the Y-junction serves as a mechanical support.

[0151] It should be noted that in some embodiments, the Y-junction is generally located at the engagement point between the tools and / or at the tool opening, potentially providing continuous cleaning of the tool lumen, for example, to reduce or prevent the formation of blood clots inside the lumen.

[0152] In some embodiments, guide catheter receiving unit 309 optionally includes a rail 310 extending distally from joint 313, upon which a guide catheter held by the unit can move distally and / or proximally, e.g., 10 mm to 30 mm, 5 mm to 15 mm, 1 mm to 50 mm, or intermediate, longer, or shorter distances. In some embodiments, movement of the guide catheter along the rail is by a lead screw mechanism 302. In some embodiments, linear movement of the guide catheter is by movement along the rail and / or by axial translation of the entire assembled system, such as relative to the mounting. The range of linear movement can extend over the entire operable length of the guide catheter.

[0153] In some embodiments, the sealer 312 is mounted in a position that prevents fluid from flowing proximally into the system unit.

[0154] In some embodiments, the guide catheter unit comprises a rotational actuator 314 (e.g., a gear) configured to axially rotate the guide catheter. Optionally, the rotation is driven by a motor integrated within the unit and / or by a gear interfaced with a system base that houses one or more motors.

[0155] In some embodiments, during surgery, the guide catheter is manually advanced to its final position and the guide catheter unit provides fine adjustment of the guide catheter's position by short linear advancements and / or retractions of the guide catheter.

[0156] In some embodiments, the tool receiving unit (e.g., 305, 307) includes a cover 317 sized and positioned to cover a tool received within the unit and optionally maintain retention of the tool within the unit (e.g., prevent the tool from being unintentionally withdrawn).

[0157] In some embodiments, the tool is loaded into the unit by inserting the tool into a designated slot, e.g., slot 318 of guidewire-receiving unit 305 and slot 319 of microcatheter-receiving unit. In some embodiments, the slots extend longitudinally across the face (optionally the top face) of the housing. In some embodiments, the slots are formed in longitudinal shaft 320. In some embodiments, loading is by manually grasping an elongated segment of the tool and feeding the elongated segment into the slot.

[0158] In some embodiments, one or more tool-moving elements, such as wheels (e.g., wheel 321 of unit 305 and wheel 322 of unit 307), contact the tool when it is fully received in the slot. In some embodiments, the wheels are positioned on opposite sides of the short dimension of the slot. Optionally, a spring-based mechanism (not shown) positions the wheels slightly away from the slot during tool insertion and then moves the wheels into operative engagement with a tool received in the slot. In some embodiments, opening cover 317 activates the spring-based mechanism to move the wheels away, and closing the cover moves the wheels into engagement with the tool.

[0159] Potential advantages of tool-loaded slots configured on the exterior surface of the tool-receiving unit housing, where the slots remain accessible even when the system is fully assembled, may include tools being easily inserted, removed, or replaced even during operation. For example, if manual manipulation of a tool is required during a procedure, the tool can be easily removed from the accessible slot without removing the tool from the patient's body.

[0160] Turning now to the tools operated by the system, in some embodiments, a guidewire 331 is manually inserted into the lumen of the microcatheter 335. In some embodiments, the free end of the guidewire 331 is received within the slot 317 of the guidewire receiving unit 305. Optionally, the proximal end of the guidewire is first inserted into the torquer unit 311, and then the guidewire is rotated (e.g., by a U-shaped curve) to fit within the slot 317, extending in a distal-to-proximal direction.

[0161] In some embodiments, the guidewire-receiving unit includes a holder 333 extending from the outlet end of the unit. Optionally, the holder comprises one or more sensors, such as an optical sensor, to indicate the presence of a guidewire (e.g., when a guidewire is in the holder, light is blocked by it, and when the guidewire is withdrawn, the light is no longer blocked; this change is then detected by the optical sensor). Other examples of sensors may include magnetic sensors, proximity (e.g., distance) sensors, membrane sensors configured to sense touch, proximity, friction, and / or others.

[0162] In some embodiments, upon exiting holder 333, the guidewire extends continuously into the lumen of microcatheter 335 into which it is pre-threaded. The microcatheter is then mounted within slot 319 of microcatheter receiving unit 307, extending proximally to distally across the slot and defining a U-shaped curve relative to the position of holder 333.

[0163] Next, at the distal end of the microcatheter unit, the microcatheter 335 (and the guidewire 331 extending therethrough) is threaded into the lumen of the guide catheter 315. The guide catheter (including the microcatheter and guidewire therein) can then be advanced into the patient's body, for example, into a blood vessel.

[0164] Potential advantages of "winding" a tool (e.g., a U-shaped curve of the tool whereby the tool enters the assembled system at a first end, exits the system at an opposite second end, then curves back and re-enters the system at the second end, then exits at the first end) may include the ability to align operating mechanisms (such as tool-receiving units) side-by-side (e.g., parallel to each other) to minimize the overall system dimensions.

[0165] Another potential advantage may include multiple "operating locations" per tool, as the tool passes through the system twice.

[0166] In some embodiments, following a curve means that the tool does not traverse the same exact path, but moves along a path adjacent (eg, parallel) to the first path.

[0167] In some embodiments, the guidewire is curved twice (e.g., first as it extends between the torquer unit and the slot in the guidewire receiving unit, and secondly as it exits the guidewire receiving unit and enters the microcatheter receiving unit (where the guidewire is within the lumen of the microcatheter).

[0168] In some embodiments, the microcatheter curves once between the exit of the guidewire-receiving unit and the entrance to the microcatheter-receiving unit.

[0169] In some embodiments, the microcatheter receiving unit comprises a microcatheter extension, which can be used to lengthen the microcatheter, for example, as a segment that extends in a curve between the exit of the guidewire receiving unit and the microcatheter receiving unit.

[0170] In some embodiments, during operation, wheel 321 linearly advances and / or retracts guidewire 331 by rolling the wheel. Optionally, the wheels are positioned to grip the guidewire between them. In some embodiments, shaft 320 is rotated (optionally, the wheels rotate with the shaft as a single assembly, changing the orientation of the wheels), causing rotation of the guidewire received within the slot. In some embodiments, the slot is shaped such that the guidewire received therein is centered relative to the shaft. In such a configuration, rotation of the shaft can rotate the guidewire about its longitudinal axis (which is coupled to the longitudinal axis of the shaft).

[0171] In some embodiments, a wheel 322 on the microcatheter receiving unit advances and / or retracts the microcatheter 335. In some embodiments, a mechanism such as a lead screw mechanism 302 on the guide catheter unit linearly advances and / or retracts the guide catheter.

[0172] In some embodiments, the wheel actuation of two or more units is controlled (e.g., by a system controller, optionally configured with a remote control device) to ensure that the tools move together, e.g., the guidewire moves together with the microcatheter, or alternatively, the tools do not move together (e.g., one tool advances while the other remains in place). In some embodiments, the rolls of wheel 322 of microcatheter-receiving unit 307 are counted (optionally to estimate the distance of advancement and / or retraction of the microcatheter), and then wheel 321 of the guidewire-receiving unit is rolled accordingly.

[0173] In an example, to advance only the microcatheter 335 without advancing the guidewire, wheel 322 is rotated to advance the microcatheter forward, while wheel 321 is rotated in the opposite direction to advance the guidewire backward.

[0174] In another example, when the entire system is moved (e.g., slid linearly at the mounting) to adjust the position of the guide catheter, the microcatheter can be driven linearly in the opposite direction to compensate for the movement.

[0175] In another example, injection of a material (e.g., contrast agent, medication, saline, and / or other fluids) into the lumen of the microcatheter may require rearward retraction of the guidewire due to the small size of the microcatheter lumen. In such a situation, prior to injection, wheel 321 can be actuated to retract the guidewire from within the lumen of the microcatheter.

[0176] 4A-B are isometric and side views of a modular robotic surgical system positioned relative to a patient, according to some embodiments.

[0177] In some embodiments, the assembled modular robotic system 401 (e.g., including a motor base and multiple tool receiving units, e.g., as described herein) is positioned relative to a patient 403, and optionally relative to a surgical body entry point. The entry point can be selected from, but is not limited to, the patient's groin (i.e., femoral artery), arm (i.e., radial artery), or neck (i.e., jugular vein).

[0178] In some embodiments, the system 401 is attached to a rigid fixture 405. In some embodiments, the fixture is placed on and / or restrained to the patient's body. Additionally or alternatively, the fixture is attached to the operating table.

[0179] In some embodiments, fixture 405 is adjustable to control one or more positioning parameters of system 401, such as height, angle (e.g., insertion angle into a body entry site), and distance from the patient (e.g., from the entry site). Optionally, fixture 405 includes rails along which system 401 can slide forward and / or backward toward and / or backward from the patient.

[0180] In some embodiments, the fasteners 405 are manually adjustable, for example, via a plurality of adjustable knobs 407 .

[0181] Potential advantages of a relatively small and compact system may include the ability to place the system relatively close to the patient (e.g., relative to the body entry point), for example, less than 2 cm, 3 cm, 5 cm, 10 cm from the entry point, or at intermediate, longer, or shorter distances.

[0182] 5A-B are side views (FIG. 5A) and exploded views (FIG. 5B) of a modular robotic surgical system including a guidewire unit, a microcatheter unit, and a guide catheter unit, according to some embodiments.

[0183] In the example shown, system 501 includes base 503, mounting portion 505, torquer unit 507, guidewire receiving unit 509, guidewire holder 511, microcatheter receiving unit 513, guide catheter receiving unit 514 including rail 515 and lead screw mechanism 517 for providing limited linear movement of the guide catheter, and Y-junction 519 for attaching the guide catheter receiving unit to base 503 and / or microcatheter receiving unit 513.

[0184] Also shown is a guidewire 521, a microcatheter 523 through which the guidewire is at least partially inserted, and a guide catheter 524 through which the guidewire and microcatheter assembly is at least partially inserted.

[0185] In some embodiments, the tool-receiving unit is operably coupled to the base. In some embodiments, the coupling is an interference coupling, e.g., a protrusion and a respective recess. In some embodiments, one or more mechanical elements (e.g., gears, transmission elements, etc.) and / or electrical couplings protrude from the housing of the base and are received within the housing of the unit, e.g., they operably engage with tool movement elements (e.g., wheels disposed adjacent to slots). Additionally or alternatively, one or more mechanical elements, e.g., gears, transmission elements, and / or electrical couplings protrude from the housing of the tool-receiving unit and are received within the housing of the base, e.g., they operably engage with gears of a motor.

[0186] In the example shown, a gear 525 and two protruding knobs 527, 528 of the motor extend upward from a top surface 529 of the housing of the base 503. The gears and / or knobs are then received in respective recesses formed in opposing (e.g., bottom) surfaces of the tool-receiving unit housing(s). For example, gear 525 and knob 527 fit within respective recesses in the housing of guidewire-receiving unit 509, and knob 528 fits within respective recesses (respective recesses not shown) in the housing of microcatheter-receiving unit 513. (As referred to herein, the gear can be defined as the “first coupler” of the interface coupling pair between the base and the unit, and the recesses in the unit can be defined as the “second coupler” of the interface coupling pair.) Some embodiments may include an opposite arrangement in which the unit includes a protruding element (first coupler) and the base defines a respective recess (second coupler). In some embodiments, the first and second couplers are symmetrically positioned about at least one corresponding axis of the unit and base, allowing the assembled unit to be attached and operated in one of two orientations 180 degrees from one another. For example, a first coupler including a protrusion extending from the base can be received within one of two respective second couplers positioned on opposite sides of the longitudinal axis or proximal and distal ends of the tool-receiving unit.

[0187] In some embodiments, the torquer unit 507 is attached to the base via a protrusion (e.g., a motor knob, not shown) extending from the side 531 of the base 503. In some embodiments, the motor driving rotation in the torquer unit is the same motor used to drive rotation of the guidewire in the guidewire-receiving unit.

[0188] In some embodiments, the tool-receiving units are coupled to one another. Optionally, the coupling is an operable coupling (e.g., including a motor or power transmission), and additionally or alternatively, the coupling is for system construction purposes, e.g., to lock the units in position relative to one another.

[0189] 6A-C show a guidewire-receiving unit with an open cover (FIGS. 6A, 6C) and a closed cover (FIG. 6B), according to some embodiments.

[0190] In some embodiments, a tool-receiving unit, such as guidewire-receiving unit 601, comprises a housing 603. In some embodiments, the housing is shaped and / or sized to be coupled to a base (not shown). Optionally, the length 605 of the unit housing as measured along the major axis (proximal-distal) is less than or equal to the length of the base; e.g., the length 605 is between 10 and 20 cm, 15 and 18 cm, 5 and 30 cm, or intermediate, longer, or shorter. Optionally, the width 607 of the unit as measured along an axis perpendicular to the major axis is less than or equal to the width of the base; e.g., the width 607 is between 4 and 12 cm, 3 and 10 cm, 2 and 15 cm, or intermediate, longer, or shorter. In certain embodiments, the width 607 is less than or equal to half the width of the base, e.g., to allow two units (e.g., a guidewire-receiving unit and a microcatheter-receiving unit) to fit together into the base.

[0191] In some embodiments, a single tool-receiving unit (eg, guidewire-receiving unit, microcatheter-receiving unit) weighs less than 400 grams, 300 grams, 700 grams, or an intermediate, higher, or lower weight.

[0192] In some embodiments, the housing 603 includes an elongated slot 609 in which a tool is received. Optionally, the slot extends along at least a portion of the long axis of the unit. In some embodiments, the slot is formed in a movable (e.g., rotatable) elongated shaft 604.

[0193] In some embodiments, the indents are formed at two opposite ends of the slot. Optionally, the indents allow for interlocking with another tool receiving unit, such as another linearly aligned unit.

[0194] In some embodiments, the housing 603 houses one or more tool movement elements, such as wheels 611. The tool movement elements are positioned to operatively contact a tool received within the unit, for example adjacent the slot (in this example, two wheels are positioned on opposite sides of the width of the slot).

[0195] In some embodiments, the tool segment inserted into the slot comprises a mid-portion of the tool (i.e., not the most proximal tool segment, not the most distal tool segment), e.g., a segment comprising between 20% and 80% of the total length of the tool. The length of the tool segment inserted into the slot may include, for example, 5%, 10%, 2%, 20%, or any intermediate, higher, or lower percentage of the total length of the tool, e.g., 10 cm for a tool up to 300 cm in length.

[0196] In some embodiments, the unit includes a cover 613 configured to cover the slot. In some embodiments, the cover is shaped to fit the unit without interfering with the movement of the tool movement elements. In this example, the cover 613 includes a semicircular protrusion 615 within which the wheel 611 moves freely. In some embodiments, the protrusion 615 allows the wheel to change orientation.

[0197] In some embodiments, as can be better seen in, for example, FIG. 6C, a rotatable gear 618 is configured on the end of the shaft 604, such that rotation of the gear 618 (e.g., by a gear extending from the base) causes the shaft and wheel to rotate as a single unit, thereby rotating the slot in which the guidewire is received.

[0198] In some embodiments, an integrated linear motor 616 is disposed below the wheel and configured to rotate the wheel to actuate linear movement of, for example, the guidewire. Optionally, an electrical coupling, such as by a slip ring, supplies current to the linear motor 616. The slip ring coupling can result in current being supplied to the linear motor 616 for each rotational position of the shaft (and guidewire).

[0199] In some embodiments, cover 613 includes an elongated protrusion 617 that aligns with the slot when the cover is closed to protect a tool received within the slot without impeding movement of the tool. In some embodiments, protrusion 617 allows shaft 604 to rotate freely about its axis, thereby rotating a guidewire received within the slot and gripped by the wheel.

[0200] In some embodiments (not shown), the unit includes two or more slots that can be loaded with a corresponding two or more guidewires. In such a configuration, the unit can include (or be attached to a connector that includes) a junction, such as a Y-junction. Optionally, two (or more) slots join at the junction, allowing the user to determine which guidewire will advance through the junction. In some embodiments, in a unit that includes two or more slots, each slot can be associated with its respective tool movement element (e.g., a wheel). Optionally, multiple tool movement elements may still be driven by the same motor or motors on the base (such as those used to drive a single-slot unit).

[0201] In some embodiments, two or more tool-receiving units of the same type (e.g., two guidewire-receiving units) can be used. Optionally, the units are aligned side-by-side. In such a configuration, a connector including a junction can be attached to both units at their outlet ends to guide attachment with the microcatheter, allowing the user to decide which tool (which unit) to advance further.

[0202] In some embodiments, two or more units drive the movement of the same single tool. In an example, a first unit includes a mechanism for advancing and / or retracting the tool, and a second unit includes a mechanism for axially rotating the same tool. In another example, the rotation of the tool (e.g., a guidewire) is actuated by both a wheel on the unit and another unit, such as a torquer unit (e.g., shown in FIG. 3).

[0203] Potential benefits of applying rotation from two separate points along the guidewire (e.g., one point on the torquer unit and another point on the guidewire receiving unit) may include improving traction and allowing better manipulation of the tool to induce rolling.

[0204] In some embodiments, the guidewire includes a handle at its proximal end that is received in the torquer unit and that is rotated to induce rolling of the guidewire, or the handle is left hanging so as not to interfere with applying rolling from another point along the guidewire.

[0205] 6D-E show a guidewire holder, according to some embodiments, shown in an isometric view (FIG. 6D) and a cross-sectional view (FIG. 6E).

[0206] In some embodiments, holder 651 is attached to the guidewire-receiving unit at the outlet end of the unit and defines a central channel 653 for the passage of a guidewire. In some embodiments, a catch 655 is attached to the exterior of the holder, which includes a sensor (schematically indicated by numeral 657) for determining whether a guidewire is within channel 653. Additionally or alternatively, a sensor can be incorporated inside the holder. Examples of sensors for providing an indication of whether a guidewire is received within the holder can include optical sensors, magnetic sensors, proximity sensors, etc.

[0207] In some embodiments, a rotatable knob 659 is configured at the outlet of the holder to tighten the microcatheter in place.

[0208] 7A-7E show various views of the base of a modular robotic surgical system, according to some embodiments.

[0209] Figure 7A is an isometric view of base 701 resting on mounting portion 703. Figure 7B is a view of the inner surface of the base of Figure 7A taken from the direction of the base's bottom surface. Figures 7C-7E are views of the inner surface of base 701, shown in different cross sections.

[0210] In some embodiments, one or more mechanical couplers, such as a motor gear or associated transmission, protrude from the base and engage the tool-receiving unit. In the example of FIG. 7A, the mechanical couplers include gear 705 for actuating rotational motion in the guidewire-receiving unit, motor 707 for actuating linear movement in the guidewire-receiving unit, and motor 709 for actuating linear movement in the microcatheter-receiving unit. In some embodiments, torquer unit 708, mounted, for example, on the side of the base, is configured to receive a guidewire proximal end or guidewire handle (e.g., to drive rotation of the guidewire). In FIG. 7B, the lower portions of motors 707 and 709 are shown. Also shown is motor 711, which rotates worm gear 713, which in turn rotates gear 705. Also shown is motor 715 for driving rotation in the torquer unit.

[0211] In some embodiments, as can be observed, for example, in Figure 7C, gears 705 extend in a plane that is substantially perpendicular to the plane of the top surface 706 of the base housing. Protruding mechanical couplers, such as gears, from the base housing (and / or from the unit housing) can in some cases be made possible by the system or parts thereof being single use and therefore having elements located outside the housings of the system's components (which in reusable systems can lead to contamination risks).

[0212] In some embodiments, the tool movement elements of a unit are driven by a designated motor of the base. Additionally or alternatively, the tool movement elements of multiple units are driven by the same motor of the base.

[0213] 7F-G show that in this example, base 721 does not include a motor for driving linear movement in the guidewire-receiving unit; instead, a motor is configured within the guidewire-receiving unit itself. In such a configuration, an electrical coupling 723 (shown schematically in FIG. 7G), for example in the form of a slip ring, is provided to supply electrical current to the motor within the unit.

[0214] FIG. 7H shows an example of a housing 731 of a tool-receiving unit configured to mate with a base, such as that shown in FIG. 7G, e.g., a guidewire-receiving unit. In some embodiments, as shown, the unit includes an element for attachment to the base. In some embodiments, the interface includes a recess 733 shaped and positioned to receive at least a portion of gear 705 therein when the unit is attached to the base. In some embodiments, the interface includes an electrical coupling 735 for connecting to electrical coupling 723 of the base. In some embodiments, the interface to the base is located on a face of the unit's housing opposite the slot in which the tool is received. Alternatively, the interface to the base can be located on a different face and / or multiple faces of the housing.

[0215] 8A-D show attachment of a guidewire unit 801 to a base 803 resting on a mounting portion 805 (FIGS. 8A-B) and attachment of a microcatheter unit 807 to a base 803 resting on a mounting portion 805 (FIGS. 8C-D), according to some embodiments.

[0216] As shown in this example, gear 809 protrudes from the base and is mounted inside the housing of guidewire unit 801 to drive rotation of the guidewire. Motor 811 protrudes from the base and is mounted inside the housing of guidewire unit 801 to drive linear movement of the guidewire. And motor 813 protrudes from the base and is mounted inside the housing of microcatheter unit 807 to drive linear movement of the microcatheter.

[0217] 9A-B are isometric views of an assembled modular robotic surgical system 901, according to some embodiments, shown without a guidewire holder in FIG. 9A and with a guidewire holder 905 protruding from the exit end of the guidewire-receiving unit in FIG. 9B.

[0218] In some embodiments, at the junction location (e.g., a Y-junction or a T-junction as shown), one or more selector knobs 904 are used to adjust the flow of fluid through the junction.

[0219] 10A-B are isometric views of an assembled modular robotic surgical system shown without (FIG. 10A) and with (FIG. 10B) a tool inserted, according to some embodiments.

[0220] In the example of FIGS. 10A-B, the assembled system 1001 includes the following system components:

[0221] The device includes a base 1003 baked onto the mounting portion 1002, a guidewire receiving unit 1005 and a microcatheter receiving unit 1007 (both units shown with their covers open) attached to the top surface of the base, a guidewire holder 1009 extending proximally from the outlet end of the guidewire receiving unit 1005 and connected at its proximal end to a junction (port) 1011 that allows for the injection of material into the lumen of the microcatheter, a guide catheter receiving unit 1013 extending distally from the microcatheter receiving unit 1007 and including a sealer 1015, an injection port 1017, and a rotary actuator (e.g., a motor and rotary gear 1019). In some embodiments, the junction (port) 1011 is integral with the receiving unit.

[0222] 11A-C show a guide catheter receiving unit 1101, according to some embodiments. In some embodiments, the guide catheter receiving unit includes a sealer 1103 that prevents fluid ingress in a proximal direction (e.g., into the system unit). In some embodiments, the guide catheter receiving unit includes a mechanism for linear movement of the guide catheter, e.g., a lead screw mechanism 1105. In some embodiments, a motor (e.g., a housing within the unit) actuates rotation of the lead screw, generating advancement (or retraction) of the guide catheter. The guide catheter is shown in various positions, from a proximal-most position (FIG. 11A) to a distal-most position (FIG. 11C). In some embodiments, the lead screw mechanism is configured to advance and / or retract the guide catheter a linear distance 1107 of 1-3 cm, 2-10 cm, 0.5-1 cm, or intermediate, longer, or shorter distances (see FIG. 11C).

[0223] 12A-D show several views of a modular robotic surgical system 1201 configured to use a "rapid exchange" catheter, according to some embodiments.

[0224] In some embodiments, the modular system can be assembled for use with a rapid-exchange catheter. In such a configuration, the system is configured to drive the movement of the guidewire and microcatheter (separately from each other) until they reach the junction where they are joined.

[0225] In the example of FIGS. 12A-D, guidewire 1203 extends from torquer unit 1205 (which in this example is attached to the side of base 1207) into a designated slot in guidewire receiving unit 1209. A rapid-exchange microcatheter 1211 is independently placed within a designed slot in microcatheter receiving unit 1213. Both the microcatheter and guidewire are then advanced into channels in Y-junction 1215 and joined together at Y-junction joining point 1217. (Some embodiments may include a T-junction or any other configuration suitable for carrying tools through separate paths and then joining together at a more distal location.)

[0226] In some embodiments, the guidewire and microcatheter assembly is then advanced into the lumen of a guide catheter 1219 held by a guide catheter receiving unit 1221 .

[0227] Potential advantages of independently driving the movement of the guidewire and microcatheter may include the ability to control each separately until they reach a joining point. This may reduce the need to perform "compensatory" movements of the guidewire and / or microcatheter relative to one another, which may be required when both are driven together in an assembled configuration (such as when the guidewire is within the microcatheter lumen at the location of the tool movement element of the unit where the tool is manipulated). In systems configured for use with rapid-exchange catheters, manipulation of the tool (such as by the tool movement element of the unit) occurs proximal to the engagement of the guidewire and rapid-exchange catheter. This may allow each tool to be manipulated independently.

[0228] In general, another potential advantage of using a rapid-exchange catheter with a thinner, more proximal wire portion and a wider, more distal "lumen" portion may include that manipulating the thinner, more proximal wire portion may be easier than manipulating a standard microcatheter.

[0229] Another potential advantage of using a rapid-exchange catheter may include facilitating removal and / or replacement of a guidewire used with a rapid-exchange catheter, since configuration of the system for use with a rapid-exchange catheter does not require passing a guidewire during its withdrawal through the microcatheter receiving unit.

[0230] In some embodiments, there are two or more available configurations for attaching the unit to the base and / or other unit(s). Optionally, changing the attachment configuration also changes the function of the unit. In an example, the guidewire unit can be rotated 180 degrees (relative to the basic configuration in which a standard microcatheter is used with the guidewire) to accommodate a configuration in which the guidewire is used with a rapid-exchange catheter. In some embodiments, the unit can be rotated between available configurations about the linear axis of the unit (e.g., so that an end face of the unit that was previously facing proximally now faces distally, and vice versa).

[0231] Figure 12A shows an isometric view of the system, Figure 12B shows a rear view of the system (from proximal to distal), Figure 12C shows a top view of the system, and Figure 12D shows an enlarged view of the Y-junction 1215 and the guide catheter receiving unit 1221 extending distally from the Y-junction.

[0232] 13A-D are examples of remote control devices for controlling a modular robotic surgical system, according to some embodiments.

[0233] In some embodiments, the remote control is shaped to be held in the hand of a user, e.g., a physician. Optionally, the remote control is lightweight and small enough that the user can hold it during operation without obstructing the user's view of a visual aid, such as a screen showing imaging results. In some embodiments, the remote control includes one or more portions shaped to be grasped by the palm of a user's hand and / or engaged by a user's fingers.

[0234] In some embodiments, the remote control communicates with the modular robotic system, and in some embodiments, the communication is wireless, for example, via Wi-Fi, infrared, Bluetooth, RF, and / or other wireless modules.

[0235] In some embodiments, the remote controller includes or communicates with a controller of the modular robotic system. In some embodiments, manipulation of tools received by the system is performed via the remote controller. Examples of tool movement and / or other operational manipulation of tools controlled by the remote controller may include linear advancement and / or retraction of the tool, axial rotation of the tool, control of the distal tip of the tool, speed of movement, control of unique tool functions (e.g., inflation / deflation of a balloon in a balloon catheter, deployment and / or advancement of a stent), and / or other tool manipulation.

[0236] Other functions that can be controlled via the remote control include, for example, automatic injection of materials (e.g., contrast agents, irrigation fluids, etc.) into and through the tool lumens, linear and / or angular movement of the assembled system as a whole (e.g., sliding of the assembled system relative to the mounting), safety shutdown of the system, on / off activation of the system, supply of power to the system or specific components, and / or other system functions.

[0237] 13A-B show a first example of a remote control device 1301, and FIGS. 13C-D show a second example of a remote control device 1303. In some embodiments, the device includes an interface in the form of one or more of a push button 1305, a joystick handle 1307, a manual slider 1309, a rotary knob 1311, or the like.

[0238] In some embodiments, the remote control is modular. Optionally, specific buttons and / or add-on interfaces are selectively connected (and / or uncovered for use) depending on the selected system configuration. For example, buttons for controlling guide catheter movement (when a guide catheter receiving unit is attached to the system) are exposed for use only when needed (e.g., placed under a removable or movable cover). In another example, interfaces for controlling injection of material through one or more system interfaces are attached to the remote control and / or uncovered for use as needed.

[0239] The remote control can be operated remotely from the system, and optionally, the remote control can be operated by a surgeon in another room.

[0240] 14A-B schematically illustrate an assembly of a guidewire 1401, a microcatheter 1403, and a guide catheter 1405, according to some embodiments.

[0241] In some embodiments, guidewire 1401 is at least partially inserted into the lumen of microcatheter 1403 , and the assembled guidewire and microcatheter are then advanced into the lumen of guide catheter 1405 .

[0242] In some embodiments, the inner diameter of the microcatheter is only slightly larger than the outer diameter of the guidewire, e.g., about 0.0254 mm larger, 0.127 mm larger, 0.254 mm larger, or an intermediate, larger, or smaller size. In some embodiments, the inner diameter of the guide catheter is only slightly larger than the outer diameter of the microcatheter, e.g., about 0.05 mm larger, 0.01 mm larger, 0.1 mm larger, or an intermediate, larger, or smaller size.

[0243] Exemplary tool sizes may include: guidewires with a diameter of 0.18 to 1 mm; Microcatheters with a diameter of 2 to 3 FR, Guide catheters with diameters of 3 to 9FR.

[0244] 15A-D schematically illustrate various arrangements of the base and tool-receiving unit, according to some embodiments.

[0245] In some embodiments, one or more tool-receiving units 1501 are operably coupled to a base 1503. Optionally, the units are attached to a top surface of the base, e.g., as shown in Figure 15A; additionally or alternatively, the units are attached to a bottom surface of the base, e.g., as shown in Figure 15B; additionally or alternatively, the units are attached to a side of the base, e.g., as shown in Figure 15C; additionally or alternatively, the units are attached to an opposing surface, e.g., an opposing side, of the base, e.g., as shown in Figure 15D.

[0246] In some embodiments, the unit 1501 is aligned with respect to the base such that, for example, the unit does not protrude in cross section beyond three sides of the base (in the example of a rectangular / square cross section base).

[0247] In some embodiments, one or more of the magnets 1505, interference elements 1507 (e.g., protrusions received in respective recesses), and / or external connectors 1509 assist in aligning and / or coupling and / or locking the unit to the base. In some embodiments, the interference elements function as operating components of the system, such as gears and / or transmissions that transmit actuation forces from the base to the tool movement elements of the unit. In examples, mechanical couplers (e.g., gears) protrude from the base housing and extend into designated recesses in the unit housing. Additionally or alternatively, the mechanical couplers (e.g., gears) protrude from the unit housing and are received in designated recesses in the base.

[0248] In some embodiments, the base and unit include mechanical keying patterns and / or latches and / or snap-fit ​​features that securely attach the unit to the base and / or contribute to the alignment of the unit relative to the base.

[0249] In some embodiments, an electronic coupling 1511 is provided. Such coupling may include, for example, an electrical connection for supplying electrical current to components of the tool-receiving unit.

[0250] In some embodiments, identification of the unit is performed at the interface between the base and the unit, e.g., via an RFID tag that is read by the base, e.g., to ensure that the correct unit is attached to the base.

[0251] 16A-B show a slidable mount for a guide catheter unit, according to some embodiments.

[0252] In some embodiments, the modular units of the device are configured to be attached to each other and / or to the base via slidable mounts, for example mounts that include rails, optionally allowing the units to be moved closer to or further away from the base by sliding on the rails.

[0253] In the example shown, guide catheter unit 1601 is configured to attach to a base (see 1600 in FIG. 16A, 1602 in FIG. 16B) by sliding on rails 1606.

[0254] In some embodiments, as shown in this example, the base is configured to drive the movement of the guidewire 1607 and, optionally, the microcatheter 1609 in which the guidewire is received. In some embodiments, the microcatheter (with the guidewire extending therethrough) is received within the lumen of a guide catheter 1611, which is driven by a guide catheter unit.

[0255] In some embodiments, the guide catheter unit is attached to the base housing in such a way that a microcatheter present in the housing (e.g., via opening 1605) enters the lumen of a guide catheter loaded into the guide catheter unit.

[0256] In some embodiments, rail 1606 movably couples guide catheter unit 1601 to one or more motors disposed within the base housing, for example, such that the motors drive back and forth movement of the unit to move the guide catheter.

[0257] In some embodiments, the guide catheter unit is configured to drive linear and / or rotational (i.e., rolling) movement of the guide catheter. Optionally, the guide catheter drive mechanism is configured to drive linear movement of the guide catheter within a selected distance range, for example, to advance and / or retract the catheter a distance of 3 cm, 5 cm, 10 cm, or intermediate, longer, or shorter distances. In some embodiments, this provides fine adjustment of the position of a guide catheter previously inserted into a patient.

[0258] Figures 17A-B show a translation unit for linear advancement and / or rotational movement of a surgical tool, according to some embodiments. In some embodiments, as shown in Figures 17A-17B, the linear and / or rotational movement of the guidewire can be generated by a piezoelectric actuator or motor. The piezoelectric element is composed of a ceramic material that changes its geometric dimensions as a function of applied voltage. Piezoelectric elements may allow activation at high frequencies, such as 50-150 kHz, and can generate relatively large forces, which are linearly correlated with the degree of extension (stroke) of the element. Potential advantages of using piezoelectric actuators in automated medical instruments may include the fact that activation of the piezoelectric element does not generate a magnetic field, which is undesirable in some medical applications. Furthermore, piezoelectric actuators are MRI compatible. In some embodiments, other actuator (e.g., motor) types, such as electromagnetic actuators (solenoids), DC motors, stepper motors, or AC motors, can be used.

[0259] According to some embodiments, a robotic device may include two modules (mechanisms): a first module for generating linear movement and a second module for generating rotational movement. Optionally, each module can generate related types of movement, i.e., linear and rotational, independently of each other. In some embodiments, combined movement, i.e., simultaneous rotational and linear forward movement, may be generated by activating the two modules in an ordered or alternating manner.

[0260] In some embodiments, the linear module may be in the form of an inchworm motor, which may include, for example, three piezo actuators, as shown in FIG. 17A. Piezo actuators 1701 and 1703 are used to grip a tool 1704 (e.g., a guidewire) by extending (lengthening) and relaxing (retracting) along a vertical axis when powered, while motion is achieved by piezo actuator 1702, which extends and retracts along a horizontal axis when powered. In some embodiments, piezo actuators 1701 and / or 1703 may comprise a single actuator that pushes guidewire 1704 against a static element to grip guidewire 1704 as it lengthens. In other embodiments, piezo actuators 1701 and / or 1703 are effectively a pair of piezo actuators positioned on opposite sides of guidewire 1704, extending and relaxing to grip and release guidewire 1704, respectively.

[0261] In some embodiments, the actuation process for the linear portion is a cyclic process. To move tool 1704 from left to right, for example, piezo actuator 1703, which in this example is the front clutch piezo, is first extended to grip the tool, for example, as shown in FIG. 17A. Next, piezo actuator 1702, the lateral piezo, is extended, causing piezo actuator 1703 to move a small distance to the right, along with the tool.

[0262] Note that in some embodiments, the center of piezo actuator 1702 is fixed, so that when power is supplied to piezo actuator 1702, its extension is symmetrical on both the left and right sides. At this stage in the process, piezo actuator 1701, which in this example is the rear clutch piezo, is in a relaxed state and is not gripping the tool, so the tool gripped by piezo actuator 1703 moves to the right. Next, piezo actuator 1701 is extended to grip the tool, followed by piezo actuator 1703 relaxing, releasing its grip on the tool. Next, piezo actuator 1702 is relaxed. Next, piezo actuator 1703 is extended to grip the tool again, followed by piezo actuator 1701 relaxing.

[0263] 17B, ​​the rotation module of the device can include a pair of piezo actuators 1706, 1707 that are parallel to each other and contact opposite sides of a tool 1708. In some embodiments, extending the two piezo actuators in opposite directions 1709A and 1709B causes the tool to rotate.

[0264] In some embodiments, at least one of the clutch piezo actuators / pairs, i.e., piezo actuator 1701 and / or piezo actuator 1703, may be part of the rotational module of the device as well as the linear module of the device, as described above. In other embodiments, an additional pair of piezo actuators may be used to rotate the guidewire.

[0265] Reference is now made to FIG. 18, which shows a schematic diagram of an exemplary device capable of imparting both linear and rotational motion to a medical instrument, according to some embodiments.

[0266] In some embodiments, linear motion can be achieved essentially in an inchworm fashion using piezo motors 1801, 1802, and 1803, as described above with respect to Figures 17A-17B. Additional piezo motors 1804 and 1805 are provided to act as clutches to move piezo motor 1803 toward or away from the medical tool (shown as guidewire 408). In some embodiments, for example, to rotate the guidewire clockwise ("CW"), piezo motor 1803 is relaxed / retracted, moving piezo motors 1804 and 1805 toward guidewire 1808 until they grip the guidewire on opposite sides. Then, piezo motor 1805 is extended (moved downward) and piezo motor 1804 is simultaneously relaxed / retracted (moved upward), rotating the guidewire. Piezo motor 1801 is then extended to grip the guidewire, and piezo motor 1803 is extended to release its grip on the guidewire by moving piezo motors 1804 and 1805 back to their original positions, away from the guidewire.

[0267] In alternative embodiments, an additional piezo motor can be coupled to one of piezo motors 1804 and 1805 in place of piezo motor 1803 to move toward or away from the guidewire. In such embodiments, rotation of the guidewire can be achieved by both piezo motors 1804 and 1805 extending (or retracting) in opposite directions. The piezo actuator utilized can be, for example, a PICMA® Monolithic Multilayer PZT Actuator manufactured by PI Ceramic GmbH of Germany. In some embodiments, the rotary piezo actuator can rotate the entire linear advancement assembly.

[0268] The words "comprises," "comprising," "includes," "including," "having," and their combinations mean "including but not limited to."

[0269] The term "consisting of" means "including and limited to."

[0270] The term "consisting essentially of" means that a composition, method, or structure may include additional ingredients, steps, and / or components, but only if the additional ingredients, steps, and / or components do not materially alter the basic and novel characteristics of the claimed composition, method, or structure.

[0271] As used herein, the singular forms "a," "an," and "the" include plural references unless the context clearly indicates otherwise. For example, the terms "a compound" or "at least one compound" can include multiple compounds, including mixtures thereof.

[0272] Throughout this application, various embodiments of the invention may be presented in a range format. It should be understood that the description in range format is merely for convenience and brevity and should not be construed as an inflexible limitation on the scope of the invention. Accordingly, the description of a range should be considered to have specifically disclosed all possible subranges and individual numerical values ​​within that range. For example, description of a range such as 1 to 6 should be considered to have specifically disclosed subranges such as 1 to 3, 1 to 4, 1 to 5, 2 to 4, 2 to 6, 3 to 6, etc., and individual numerical values ​​within that range, e.g., 1, 2, 3, 4, 5, and 6. This applies regardless of the breadth of the range.

[0273] Whenever a numerical range is given herein, it is meant to include any recited number (fractional or integer) within the stated range. The phrases "ranging between" a first designator number and a second designator number, and the phrase "ranging from" a first designator number "to" a second designator number, are used interchangeably herein and are meant to include the first and second designators and all fractional and integer numbers therebetween.

[0274] As used herein, the term "method" refers to methods, means, techniques, and procedures for accomplishing a given task, including, but not limited to, methods, means, techniques, and procedures that are known or that can be readily developed from known methods, means, techniques, and procedures by those skilled in chemistry, pharmacology, biology, biochemistry, and medicine.

[0275] As used herein, the term "treating" includes negating, substantially inhibiting, slowing, or reversing the progression of a condition, substantially ameliorating the clinical or cosmetic symptoms of a condition, or substantially preventing the appearance of clinical or cosmetic symptoms of a condition.

[0276] It is understood that certain features of the invention that are, for clarity, described in the context of separate embodiments, can also be provided in combination in a single embodiment. Conversely, various features of the invention that are, for brevity, described in the context of a single embodiment, can also be provided separately or in any suitable subcombination, or as preferred in any other described embodiment of the invention. Particular features described in the context of various embodiments should not be considered essential features of those embodiments, unless the embodiment cannot function without those elements.

[0277] It is the intention of the applicants (applicants) that all publications, patents, and patent applications mentioned herein be incorporated by reference in their entirety, as if each individual publication, patent, or patent application was specifically and individually indicated to be incorporated by reference herein. Furthermore, citation or identification of any reference in this application should not be construed as an admission that the reference is available as prior art to the application. Section headings, if used, should not be construed as necessarily limiting. Additionally, any priority document(s) of this application are incorporated by reference herein in their entirety.

Claims

1. 1. A modular robotic surgical system for manipulation of at least first and second elongated surgical tools, the elongated surgical tools being flexible and configured for insertion into a body, the system comprising: one or more tool receiver units arranged as separate units, each tool receiver unit operable to move the first and second elongated surgical tools when partially received in the tool receiver unit such that the first and second elongated surgical tools are axially movable within a respective housing of the one or more tool receiver units; a base, wherein each of the one or more tool receiver units is configured to be mounted on the base, and the one or more tool receiver units are configured to be juxtaposed and aligned parallel to one another on the base; Including, each of the tool receiver units is independently and replaceably attachable to the base via a mechanical coupling interface that communicates one or more of: a drive force for driving movement of the first and second elongated surgical tools received in each of the one or more tool receiver units; a power supply to one or more components of each of the one or more tool receiver units that drive movement of the first and second elongated surgical tools received in each of the one or more tool receiver units; and data for controlling movement of the first and second elongated surgical tools received in the tool receiver units; the base comprises one or more motors configured to actuate the one or more tool receiver units via the mechanical coupling interface to manipulate the at least first and second elongated surgical tools; the modular robotic surgical system includes a guide catheter receiving unit coupled to and extending distally from one of the one or more tool receiver units; the guide catheter receiving unit includes a rotational actuator configured to axially rotate a guide catheter retained in the guide catheter receiving unit; Rotation is driven by a motor contained within the guide catheter receiving unit and / or a gear engaging a motor in the base. The modular robotic surgical system.

2. 2. The system of claim 1, wherein one tool receiver unit of the one or more tool receiver units defines a recess for the first elongated surgical tool that is parallel to a recess for the second elongated surgical tool defined by another tool receiver unit of the one or more tool receiver units.

3. The system of claim 1 , wherein the one or more tool receiver units are mountable to a surface of a housing of the base.

4. 10. The system of claim 1, further comprising a slidable mount including a rail, wherein a tool receiver unit of the one or more tool receiver units is connected to the base via the slidable mount and configured to slide linearly on the rail.

5. The system of claim 3 , wherein the mechanical coupling interface comprises an interface fit in which a protrusion extending from the housing of the base is received in a recess defined in the housing of each of the one or more tool receiver units.

6. The system of claim 5 , wherein the protrusion comprises a transmission gear that transmits force from the one or more motors of the base to the tool receiver unit.

7. each of the tool receiver units and the base includes a slot-shaped recess for receiving the first or second elongated surgical tool, and a plurality of tool moving elements disposed adjacent the slot-shaped recess; The system of claim 1 , wherein the slot is elongated and extends along the length of the housing of each of the tool receiver units.

8. 8. The system of claim 7, wherein the tool movement element includes a set of wheels positioned diametrically opposite the slot-shaped recess, the wheels arranged and configured to contact the first or second elongated surgical tool when received within the slot-shaped recess and to linearly move the first and second elongated surgical tools, respectively.

9. 9. The system of claim 8, wherein each of the one or more tool receiver units comprises a motor configured to drive the plurality of tool moving elements for internal engagement with the at least first and second elongated surgical tools.

10. 2. The system of claim 1, comprising at least two tool receiver units configured to be aligned parallel to each other and to the base so that the first elongated surgical tool received in one of the at least two tool receiver units curves in a U-shape when it exits the first tool receiver unit and before it enters the second tool receiver unit or the base.

11. 2. The system of claim 1, comprising at least two tool receiver units, wherein the first elongated surgical tool is received in both of the at least two tool receiver units or in at least one of the two tool receiver units and the base.

12. The system of claim 1 , wherein the mechanical coupling interface comprises an interface electrical contact.

13. The system of claim 1 , wherein the elongated surgical tool is selected from the group of a guidewire, a microcatheter, a guide catheter, an intermediate catheter, and a "rapid exchange" catheter.

14. The system of claim 1 , further comprising at least one controller configured to coordinate actuation of tool movement elements configured on the one or more tool receiver units and the base.

15. The system of claim 14 , wherein the system further comprises a remote control device configured to communicate with the at least one controller.

16. The system of claim 1 , wherein the one or more tool receiver units and the base are configured to wirelessly communicate with each other.

17. 2. The system of claim 1, wherein the base and each of the one or more tool receiver units include one or more sensors for indicating the presence of the first and second elongated surgical tools and / or the relative positions of the first and second elongated surgical tools relative to each other and / or the housing.

18. 10. The system of claim 1, wherein a total volume of the one or more tool receiver units when attached to the base is less than 2500 cm and a total weight of the one or more tool receiver units when attached to the base is less than 800 grams.

19. The system of claim 1 , wherein the first and second elongated surgical tools received within the system are held in a parallel orientation with respect to one another by the base and the one or more tool receiver units.

20. The system of claim 1 , wherein the housing of the base is also configured to receive the first elongated surgical tool when the first elongated surgical tool is received within the tool receiver unit.

21. 21. The system of claim 20, wherein the base is removably coupled to a mounting stand or placed directly on a surgical bed, and the housing of the at least one tool receiver unit is connected to the housing of the base.

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