Apparatus for automatic insertion and operation of a medical tool within a body cavity
Patent Information
- Application Number
- CN202210391057.3
- Authority / Receiving Office
- CN · China
- Patent Type
- Patents(China)
- Current Assignee / Owner
- Priority Date
- 2022-02-23
- Filing Date
- 2022-04-14
- Publication Date
- 2026-09-08
- Estimated Expiration
- 2042-04-14
Smart Images
Figure CN115211968B_ABST
Abstract
Description
[0001] Related applications
[0002] This application claims priority to U.S. Partial Continuation Application No. 17 / 233,774, filed April 19, 2021, and U.S. Continuation Application No. 17 / 678,070, filed February 23, 2022, the contents of which are incorporated herein by reference in their entirety, as if fully set forth herein.
[0003] Technical Field and Background Technology
[0004] In some embodiments of the invention, the invention relates to the automatic actuation of multiple surgical instruments inserted into an integrated cavity.
[0005] U.S. Patent No. 10,543,047 discloses "a robotic instrument actuator for a plurality of elongated components, comprising a first elongated component, at least one manipulator mechanism configured to operate the first elongated component, and at least one articulation actuator configured to hinge the first elongated component, which can be positioned on a bed and next to a patient contact point. The manipulator and articulation actuator are positioned relative to each other at a distance smaller than the insertable length of the first elongated component, and are fixed in place." Summary of the Invention
[0006] According to one aspect of some embodiments, a small robotic device is provided for driving the movement of two or more elongated surgical instruments when the instruments are at least partially housed within the device, the device comprising:
[0007] An outer casing comprising a plurality of walls defining a shared internal volume; within the shared internal volume, the outer casing includes:
[0008] At least two internal paths for accommodating at least a portion of each of the two or more elongated surgical instruments;
[0009] Multiple engines;
[0010] Two or more tool actuation components, each of which is disposed at a location on one of the two or more internal paths; each of the two or more actuation components is driven by at least one of the plurality of motors, and each of the two or more actuation components is configured to operably contact at least one of the two or more elongated surgical tools when the two or more elongated surgical tools are at least partially received in the at least two internal paths, for advancing, retracting and / or rolling at least one of the plurality of elongated surgical tools.
[0011] In some embodiments, the shared internal volume does not have an internal barrier separating the plurality of engines from the two or more actuation components.
[0012] In some embodiments, there is no wall, curtain, shield, or sterile protection separating the plurality of engines from the two or more actuation components.
[0013] In some embodiments, each of the two or more internal paths extends through the internal volume between an inlet or an outlet, the inlet and the outlet being disposed on opposing walls of the device housing and communicating with the internal volume.
[0014] In some embodiments, each of the plurality of actuation components includes a plurality of wheel pairs, each wheel pair including a set of opposing plurality of wheels configured to define the internal path therebetween.
[0015] In some embodiments, at least some of the opposing plurality of wheels are configured to rotate to advance and retract the elongated surgical tool within the internal path and to cause the elongated surgical tool to roll about a long axis of the elongated surgical tool.
[0016] In some embodiments, the plurality of tool actuation components are all confined within the plurality of walls of the housing, and only a portion of the two or more elongated surgical tools, when housed within the device, extend outward from the plurality of walls of the housing at a distance of at least 1 cm from the housing.
[0017] In some embodiments, at least one fixing position is defined outside the plurality of walls of the housing for securing a proximal end of at least one of the two or more elongated surgical tools to the housing, while a more distal portion of the elongated surgical tool is housed within the housing, within one of the two or more internal paths.
[0018] In some embodiments, the at least one fixed position is located at an outlet hole of the housing, such that the elongated surgical tool exiting the internal volume through the outlet hole is introduced into a lumen at the proximal end of a second elongated surgical tool of the two or more elongated surgical tools, forming a telescopic configuration of the two elongated surgical tools.
[0019] In some embodiments, the at least one fixed location defines a cavity, the cavity being shaped and configured to receive a proximal handle of the at least one elongated surgical tool.
[0020] In some embodiments, the internal volume is less than 2800 cm³; and the weight of the device is less than 850 grams.
[0021] In some embodiments, the dimensions of the housing include a height less than 30 cm, a width less than 30 cm, and a length less than 30 cm; each of the at least two internal paths extends along the length axis.
[0022] In some embodiments, the two or more elongated surgical instruments include a guidewire and a microcatheter, the guidewire being configured to extend at least partially through a lumen of the microcatheter.
[0023] In some embodiments, the robotic device includes a controller configured to control the plurality of motors for driving the two or more actuation components.
[0024] In some embodiments, the controller is remotely controlled via an external remote control device.
[0025] In some embodiments, when one or more of the two or more elongated surgical tools are housed within the internal path, one or more of the two or more elongated surgical tools extend outward from the plurality of walls of the housing and form a curve outside the device housing.
[0026] In some embodiments, each of the plurality of actuation components includes a designated elongated shaft that extends axially along at least a portion of a length of the internal path for the elongated surgical tool to extend through.
[0027] In some embodiments, the robotic device includes a third actuation component connected to the housing and actuated by a plurality of motors residing within the housing to move a third elongated surgical tool.
[0028] In some embodiments, a set is provided, the set comprising:
[0029] For example, a robotic device as described in this article;
[0030] A guide wire is mounted onto the device such that at least a portion of the guide wire extends along one of the at least two internal paths;
[0031] A microcatheter for mounting onto the device such that at least a portion of the microcatheter extends along a second of the at least two internal paths.
[0032] In some embodiments, a surgical system is provided, the surgical system comprising:
[0033] For example, a robotic device as described in this article;
[0034] An additional unit for driving the movement of a guide tube, and said additional unit is mechanically connected to the housing of the robotic device.
[0035] According to one aspect of some embodiments, a small robotic device is provided for driving and manipulating the movement of one or more elongated surgical instruments, comprising:
[0036] At least one engine;
[0037] At least one tool moving element, driven by the at least one motor, is positioned and configured to operably contact a tool at least partially housed in the robotic device to advance, retract, and / or rotate the elongated surgical instrument; and
[0038] A housing for a device, the shape and size of which are designed to enclose the at least one engine and the at least one tool moving element.
[0039] In some embodiments, the at least one engine and the at least one tool moving element are confined within a plurality of walls of the housing, and wherein only the one or more elongated surgical tools extend outward from the plurality of walls of the housing when housed within the device.
[0040] In some embodiments, the plurality of walls of the housing define an internal volume of less than 2800 cm³, and the weight of the device is less than 850 grams.
[0041] In some embodiments, the plurality of walls of the housing define at least one inlet hole through which the elongated surgical instrument is inserted into the device; and at least one outlet hole through which the elongated surgical instrument is withdrawn from the device.
[0042] In some embodiments, the plurality of walls of the housing define at least two inlet holes and at least two outlet holes for at least two elongated surgical instruments.
[0043] In some embodiments, the device includes an anchoring position for a proximal portion of the elongated surgical tool, wherein the anchoring position and an inlet hole for the elongated surgical tool are aligned along a similar wall of the housing such that a section of the elongated surgical tool extends outward between the housing and the anchoring position and the inlet hole, forming a U-shaped curve outside the housing.
[0044] In some embodiments, the housing includes a designated elongated shaft for the elongated surgical tool to extend through, and the at least one tool moving element is positioned adjacent to and protrudes within the shaft to operably contact the elongated surgical tool.
[0045] In some embodiments, the at least one tool moving element includes a set of opposing plurality of wheels configured to rotate to advance or retract the elongated surgical tool within the shaft.
[0046] In some embodiments, the shaft is connected to a gear, which, when the gear rotates, causes the shaft, together with at least one tool moving element and the tool housed therein, to rotate about the long axis of the shaft, thereby causing the tool to roll together with the at least one tool moving element.
[0047] In some embodiments, the shape of an inner contour of the shaft is designed to match an outer contour of the at least one tool moving element at their interface.
[0048] In some embodiments, the device includes an anchoring position for a proximal portion of the elongated surgical tool, the anchoring position including a retainer for holding the proximal portion of the elongated surgical tool while a distal portion of the elongated surgical tool is housed within the designated elongated shaft.
[0049] In some embodiments, one of the plurality of motors is configured to drive rotation of the retainer and the elongated shaft, thereby rolling the elongated surgical tool at two spaced-apart locations along the length of the elongated surgical tool.
[0050] In some embodiments, one bottom wall of the housing is saddle-shaped.
[0051] In some embodiments, one bottom wall of the housing is flat.
[0052] In some embodiments, the dimensions of the housing include a height of less than 30 cm, a width of less than 30 cm, and a length of less than 30 cm.
[0053] In some embodiments, the housing includes a tapered protrusion with a circular outer lip at the inlet and / or outlet.
[0054] In some embodiments, the housing includes a removable or movable cover that provides access to the one or more elongated surgical instruments mounted on the device.
[0055] In some embodiments, the device is configured to drive and operate the movement of at least one of a guidewire and a microcatheter.
[0056] According to one aspect of some embodiments, a surgical system is provided, comprising:
[0057] For example, a robotic device as described herein; and an additional unit for driving the movement of a guide tube, the additional unit being mechanically connected to the housing of the robotic device.
[0058] In some embodiments, the system includes a remote control device that communicates with a controller of the robotic device.
[0059] In some embodiments, the system includes an imaging modality that communicates with a controller of the robotic device.
[0060] According to one aspect of some embodiments, an assembly is provided for driving linear and rotational motion of an elongated surgical instrument, comprising:
[0061] A shaft includes a groove communicating with a central cavity of the shaft, the cavity extending along the long axis of the shaft;
[0062] A set of multiple wheels, positioned relative to each other and aligned on both sides of the groove, the multiple wheels extending at least partially through multiple holes in the elongated shaft and into the groove to contact an elongated surgical tool housed therein;
[0063] A gear is positioned and configured such that, when rotated, it causes the shaft and a plurality of wheels of the assembly to rotate together about the long axis of the shaft.
[0064] In some embodiments, the gear is linearly aligned with the axis and coaxial with the axis.
[0065] In some embodiments, the component includes an engine positioned and configured to drive rotation of the plurality of wheels, and the engine is positioned and configured to rotate with the shaft as the shaft rotates.
[0066] In some embodiments, the gear includes a groove around itself that is linearly aligned with the groove on the shaft.
[0067] In some embodiments, the contours of a plurality of inner walls of the shaft defining the central lumen match at least a portion of the outer contour of at least one of the plurality of wheels in the group.
[0068] In some embodiments, the component includes an engine transmission that contacts the gear and is configured to rotate the gear.
[0069] In some embodiments, each of the plurality of wheels in the group is configured to lie on a plane substantially perpendicular to a plane defined by the groove.
[0070] In some embodiments, as the component rotates about the axial length axis, the plurality of wheels of the group rotate as well, such that each of the plurality of wheels of the group remains on the plane substantially perpendicular to the plane defined by the groove.
[0071] According to one aspect of some embodiments, a method is provided for operating at least one elongated surgical instrument using a surgical robotic device, comprising:
[0072] A robotic device is provided, the shape and size of which are designed to be placed near or on an operating table;
[0073] At least one elongated surgical instrument is loaded onto the device;
[0074] Controlling the robotic device via a remote control interface to operate the at least one elongated surgical instrument to perform a surgical procedure; and
[0075] The robotic device, along with the at least one elongated surgical instrument, is disposed of after the surgical procedure.
[0076] In some embodiments, the robotic device includes:
[0077] One or more engines;
[0078] One or more tool moving elements, driven by the one or more engines;
[0079] The loading process allows the at least one elongated surgical tool to be directly operably contacted with the one or more tool moving elements, and the one or more tool moving elements to be directly operably contacted with the one or more engines.
[0080] In some embodiments, the robotic device is not covered by a sterile curtain.
[0081] In some embodiments, the method includes introducing the at least one elongated surgical instrument into the body and allowing various bodily fluids to pass through the elongated surgical instrument and enter the robotic device.
[0082] According to one aspect of some embodiments, a method is provided for operating at least one elongated surgical instrument using a surgical robotic device, comprising:
[0083] A robotic device is provided, the shape and size of which are designed to be attached to a patient's limb;
[0084] The robotic device is attached to the patient's limb;
[0085] Loading the at least one elongated surgical instrument onto the device; and
[0086] Control the robotic device to operate the at least one elongated surgical tool to perform a surgical procedure.
[0087] In some embodiments, the limb is one of the following: a patient leg to which the robotic device is connected to the thigh, or a patient arm to which the robotic device is connected to the wrist.
[0088] In some embodiments, the method includes forming an incision in the patient's groin and using the robotic device to introduce at least one elongated surgical tool through the incision.
[0089] In some embodiments, the connection includes strapping the robotic device to the limb.
[0090] According to one aspect of some embodiments, a method for controlling an usable length of an elongated surgical tool is provided, comprising:
[0091] Provides a robotic device including a housing;
[0092] The elongated surgical tool is loaded onto the robotic device such that it is held at a first position along its length and slidably held at a second position along its length; wherein a section of the tool extending between the first and second positions forms a curve; and
[0093] The elongated surgical tool is slid in the second position to shorten or lengthen the distance between a maximum point of the curve and the outer shell of the robotic device, thereby controlling the length of the elongated surgical tool.
[0094] In some embodiments, the method includes controlling the length of a distal segment of the elongated surgical tool, which extends from the housing of the robotic device to a target point within the patient's body, by shortening or lengthening it.
[0095] According to one aspect of some embodiments, a small robotic device is provided for driving and manipulating the movement of at least two elongated surgical instruments, the device comprising:
[0096] An outer casing, comprising:
[0097] At least one engine;
[0098] At least two components, each configured to drive linear movement and / or rotation of one of the at least two elongated surgical instruments, each component including a plurality of tool moving elements driven by the at least one motor or associated transmission device;
[0099] The outer shell is defined as having a volume of less than 2800 cm³ and a weight of less than 850 grams.
[0100] According to one aspect of some embodiments, a small robotic device is provided for driving and manipulating the movement of at least one elongated surgical instrument, the device comprising:
[0101] An outer casing, comprising:
[0102] At least one engine;
[0103] A first tool moving element, driven by the at least one motor, is positioned and configured to operably contact an elongated surgical tool at least partially housed in the robotic device to advance or retract the elongated surgical tool; and
[0104] A second tool moving element, driven by the at least one motor, is configured to cause the elongated surgical tool to roll about the long axis of the elongated surgical tool.
[0105] In some embodiments, the housing includes a shaft through which the elongated surgical tool extends, and the first tool moving element extends at least partially into the shaft to contact the elongated surgical tool.
[0106] In some embodiments, the contours of a plurality of inner walls of the shaft match at least a portion of an outer contour of the first tool moving element.
[0107] In some embodiments, the first tool moving element includes at least one pair of multiple wheels that advance or retract the elongated surgical tool according to the rotation direction of the wheels.
[0108] In some embodiments, the second tool moving element includes a gear linearly aligned along the axis and configured to rotate the axis.
[0109] According to some embodiments, a plurality of advantageous medical devices are provided for inserting and advancing a medical instrument within a body cavity, wherein the plurality of devices are configured to advance the medical instrument with a linear and / or rotational motion. In some embodiments, the plurality of advantageous devices disclosed herein allow for the insertion and advancement of one or more medical instruments individually or simultaneously, while being small in size and thus configured to be mounted on, or at least close to, the subject's body. In some embodiments, the plurality of devices disclosed herein are configured to operate automatically and / or be manually controlled by a user using a remote control. In some embodiments, a plurality of systems are further provided including the plurality of devices disclosed herein and a plurality of methods for using the plurality of devices in various medical procedures.
[0110] According to some embodiments, a medical device is provided for advancing a medical instrument and inserting it into an integrated cavity, the device being configured to be mounted on or located near the body of a subject, and comprising: a housing configured to position the medical device on or near the body of the subject; at least one motion control unit including at least one linear actuator configured to linearly advance the medical instrument and at least one rotary actuator configured to rotate the medical instrument; wherein the at least one rotary actuator and the at least one linear actuator are activated simultaneously and / or independently of each other.
[0111] According to some embodiments, the device may further include a controller configured to activate at least one linear actuator and at least one rotary actuator. According to some embodiments, the controller may be configured to be manually operated by a user. According to some embodiments, the controller may be configured to receive multiple instructions from a processor. In some embodiments, the device may be autonomously controlled by a computer.
[0112] According to some embodiments, the at least one linear actuator and the at least one rotary actuator may have one or more universal actuators.
[0113] According to some embodiments, the at least one linear actuator may include an actuator selected from: a DC motor, an AC motor, a stepper motor, an electromagnetic actuator, a piezoelectric actuator, a pneumatic actuator, a hydraulic actuator, or any combination thereof.
[0114] According to some embodiments, the at least one rotary actuator may include an actuator selected from: a DC motor, an AC motor, a stepper motor, an electromagnetic actuator, a piezoelectric actuator, a pneumatic actuator, a hydraulic actuator, or any combination thereof. In some embodiments, the medical device is disposable. In some embodiments, the medical device is small in size. In some embodiments, the medical device is lightweight.
[0115] According to some embodiments, the medical tool may be selected from the following: a guidewire, a microcatheter, a balloon catheter, a guiding catheter, a stent placement catheter, an embolization catheter, a thrombectomy stent device, or any combination thereof.
[0116] According to some embodiments, the body cavity may be selected from a blood vessel, urethra and trachea, gastric anatomy, etc. According to some embodiments, the device may include one or more motion control units, wherein each control unit may be configured to linearly propel and / or rotate a separate medical instrument, or a combination of two or more motors may perform separate or combined movements of the multiple medical instruments.
[0117] According to some embodiments, the device may include two motion control units, wherein a first motion control unit is configured to linearly propel and / or rotate a first medical tool, and a second motion control unit is configured to linearly propel and / or rotate a second medical tool.
[0118] According to some embodiments, the first medical tool may be a guidewire, and the second medical tool may be a catheter.
[0119] According to some embodiments, the first medical tool may be configured to be advanced through a lumen of the second medical tool.
[0120] According to some embodiments, the device may also be configured to allow control of the plurality of tip parameters of the medical instrument.
[0121] According to some embodiments, the motion control unit may include at least two disks facing each other along a portion of its outer periphery, such that the medical tool can be placed in a space formed therebetween while maintaining at least partial contact with at least one of the disks, thereby enabling linear propulsion of the medical tool as the disks spin. The surfaces of the outer periphery of the disks may be rough, soft, smooth, coated, spongy, hydrophilic, hydrophobic, or have other properties that can optimize the interaction with the medical tool. The drive disks may be assembled in such a way that the medical tool is driven not along a straight line, but along a curved path, thereby allowing for higher driving forces and higher rotational torque.
[0122] According to some embodiments, the medical device may also include a power source.
[0123] According to some embodiments, the device can be configured to linearly propel the medical instrument at a constant or varying rate (speed).
[0124] According to some embodiments, the device can be configured to automatically insert and advance the medical instrument into the body cavity.
[0125] According to some embodiments, a system is provided for inserting a medical instrument into a body cavity, the system comprising: a medical device for inserting the medical instrument into the body cavity, the device being configured for positioning on or near a body of a subject, and comprising: at least one motion control unit including at least one linear actuator configured for linearly propelling the medical instrument and at least one rotary actuator configured for rotating the medical instrument; a controller configured to activate the at least one linear actuator and the at least one rotary actuator, the controller being configured to activate at least one of the at least one rotary actuator and the at least one linear actuator simultaneously and independently of each other; and a processor configured to provide the controller with a plurality of instructions.
[0126] According to some embodiments, the controller can be configured to be manually operated by a user.
[0127] According to some embodiments, the controller may include a plurality of start buttons selected from the following: a plurality of push buttons, a plurality of slide buttons, a joystick, or any combination thereof.
[0128] According to some embodiments, the system disclosed herein is used to automatically insert and advance the medical instrument into the body cavity during a medical procedure.
[0129] According to some embodiments, the medical procedure may include an intravascular procedure selected from coronary, peripheral and cerebral intravascular procedures, multiple gastric procedures, multiple urinary tract procedures and multiple respiratory procedures.
[0130] According to some embodiments, the system may also include or be configured to operate in conjunction with an imaging device. According to some embodiments, the imaging device may be selected from: X-ray devices, fluoroscopy, CT devices, cone-beam CT devices, CT fluoroscopy, MRI devices, and ultrasound devices. According to some embodiments, a method for inserting and advancing a medical instrument into a body cavity is provided, the method comprising: mounting and securing the medical device disclosed herein to a subject's body or positioning the medical device proximate to the subject's body, and advancing the medical device into the subject's body cavity. In some embodiments, the method is automatic (i.e., the advancement of the medical device is performed automatically by the medical device).
[0131] According to some embodiments, a body-mountable medical device is provided for inserting a medical instrument into an integrated cavity, the device comprising: a housing configured for positioning and securing to a body of a subject; at least one linear actuator configured for linearly advancing the medical instrument; at least one rotary actuator configured for rotating the medical instrument; and a controller configured to activate the at least one linear actuator and the at least one rotary actuator; wherein the controller is configured to activate at least one of the at least one rotary actuator and the at least one linear actuator simultaneously and independently of each other.
[0132] According to some embodiments, the guidewire and microcatheter entering and exiting the device from the rear and front ends advantageously allow a microcatheter to move on the guidewire without impairing the guidewire drive.
[0133] Some embodiments disclosed in this invention may include some, all, or none of the advantages described above. One or more other technical advantages will be apparent to those skilled in the art from the various figures, descriptions, and claims included herein. Furthermore, while several specific advantages have been listed above, various embodiments may include all, some, or none of the listed advantages.
[0134] According to one aspect of some embodiments, a medical device is provided for advancing a medical instrument and inserting it into an integrated cavity, comprising: a housing configured for positioning on or near a body of a subject and fixed thereon; at least one motion control unit including at least one linear actuator configured for linearly advancing the medical instrument and at least one rotary actuator configured for rotating the medical instrument; wherein the at least one rotary actuator and the at least one linear actuator are activated simultaneously and / or independently of each other.
[0135] In some embodiments, the apparatus includes a controller configured to activate the at least one linear actuator and the at least one rotary actuator.
[0136] In some embodiments, the controller is configured to be manually operated by a user.
[0137] In some embodiments, the controller is configured to receive a plurality of instructions from a processor.
[0138] In some embodiments, the at least one linear actuator and the at least one rotary actuator have one or more universal actuators.
[0139] In some embodiments, the at least one linear actuator comprises an actuator selected from: a DC motor, an AC motor, a stepper motor, an electromagnetic actuator, a piezoelectric actuator, a pneumatic actuator, a hydraulic actuator, or any combination thereof.
[0140] In some embodiments, the at least one rotary actuator comprises an actuator selected from: a DC motor, an AC motor, a stepper motor, an electromagnetic actuator, a piezoelectric actuator, a pneumatic actuator, a hydraulic actuator, or any combination thereof.
[0141] In some embodiments, the medical device is disposable.
[0142] In some embodiments, the medical instrument is selected from: a guidewire, a microcatheter, a balloon catheter, a guiding catheter, a stent, a retrieval device, or any combination thereof.
[0143] In some embodiments, the body cavity is selected from a blood vessel, urethra, trachea, and gastrointestinal tract.
[0144] In some embodiments, the device includes more than one motion control unit, wherein each control unit is configured to linearly propel and / or rotate a separate medical instrument.
[0145] In some embodiments, the device includes two motion control units, wherein a first motion control unit is configured to linearly propel and / or rotate a first medical tool, and a second motion control unit is configured to linearly propel and / or rotate a second medical tool.
[0146] In some embodiments, the first medical tool is a guidewire, and the second medical tool is a catheter.
[0147] In some embodiments, the first medical tool is configured to be advanced through a lumen of the second medical tool.
[0148] In some embodiments, the device is also configured to allow control of the plurality of tip parameters using additional actuators of the medical tool.
[0149] In some embodiments, the motion control unit includes at least two disks facing each other along a portion of its outer periphery, such that the medical instrument can be placed in a space formed therebetween while maintaining at least partial contact with at least one of the plurality of wheels, thereby enabling the medical instrument to propel linearly as the plurality of disks rotate. In some embodiments, the device includes a power source.
[0150] In some embodiments, the device is configured to propel the medical instrument linearly at a constant or varying rate (speed).
[0151] In some embodiments, the medical instrument is configured to be automatically inserted and advanced into the body cavity.
[0152] According to one aspect of some embodiments, a system for inserting a medical instrument into a body cavity is provided, the system comprising: a medical device for inserting the medical instrument into the body cavity, the device comprising: a housing configured for positioning on or near a body of a subject and fixed thereto; at least one motion control unit including at least one linear actuator configured for linearly advancing the medical instrument and at least one rotary actuator configured for rotating the medical instrument; a controller configured to activate the at least one linear actuator and the at least one rotary actuator, the controller being configured to activate at least one of the at least one rotary actuator and the at least one linear actuator simultaneously and independently of each other; and a processor configured to provide the controller with a plurality of instructions.
[0153] In some embodiments, the controller is configured to be manually operated by a user.
[0154] In some embodiments, the controller includes a plurality of start buttons selected from: a plurality of push buttons, a plurality of slide buttons, a joystick, or any combination thereof.
[0155] In some embodiments, the at least one linear actuator and the at least one rotary actuator have one or more universal actuators.
[0156] In some embodiments, the at least one linear actuator comprises an actuator selected from: a DC motor, an AC motor, a stepper motor, an electromagnetic actuator, a piezoelectric actuator, a pneumatic actuator, a hydraulic actuator, or any combination thereof.
[0157] In some embodiments, the at least one rotary actuator comprises an actuator selected from: a DC motor, an AC motor, a stepper motor, an electromagnetic actuator, a piezoelectric actuator, a pneumatic actuator, a hydraulic actuator, or any combination thereof.
[0158] In some embodiments, the medical device is disposable.
[0159] In some embodiments, the medical instrument is selected from the following: a guidewire, a microcatheter, a guiding catheter, and a balloon catheter.
[0160] In some embodiments, the body cavity is selected from a blood vessel, urethra, stomach, and trachea.
[0161] In some embodiments, the system includes two motion control units, wherein a first motion control unit is configured to linearly advance and / or rotate a first medical tool, and a second motion control unit is configured to linearly advance and / or rotate a second medical tool. In some embodiments, the first medical tool is a guidewire, and the second medical tool is a catheter.
[0162] In some embodiments, the system is configured to automatically insert and advance the medical instrument into the body cavity during a medical procedure.
[0163] In some embodiments, the medical procedure is selected from coronary artery, peripheral and cerebrovascular procedures, gastric procedures, multiple urinary tract procedures and multiple respiratory procedures.
[0164] In some embodiments, the system further includes an imaging device.
[0165] In some embodiments, the imaging device is selected from the following: X-ray device, fluorescence imaging, CT device, cone-beam CT device, CT fluorescence imaging, MRI device, and ultrasound device.
[0166] According to one aspect of some embodiments, a method is provided for inserting and advancing a medical device into a body cavity, the method comprising: positioning a medical device on or near a body of a subject, the device comprising: a housing configured to position and secure the medical device on or near a body of a subject; at least one motion control unit including at least one linear actuator configured to linearly advance the medical device and at least one rotary actuator configured to rotate the medical device; wherein the at least one rotary actuator and the at least one linear actuator are activated simultaneously and / or independently of each other; and advancing the medical device into the body cavity of the subject.
[0167] In some embodiments, the medical instrument is selected from the following: a guidewire, a microcatheter, a guiding catheter, and a balloon catheter.
[0168] In some embodiments, the body cavity is selected from a blood vessel, urethra, and trachea.
[0169] In some embodiments, the advancement of the medical tool is performed automatically by the medical device.
[0170] According to one aspect of some embodiments, a medical device is provided for inserting a medical instrument into an integrated cavity, comprising: a housing configured for positioning on or near a body of a subject and fixed thereto; at least one linear actuator configured for linearly advancing the medical instrument; at least one rotary actuator configured for rotating the medical instrument; a controller configured to activate the at least one linear actuator and the at least one rotary actuator; wherein the controller is configured to activate at least one of the at least one rotary actuator and the at least one linear actuator simultaneously and independently of each other.
[0171] In some embodiments, the controller is configured to be manually operated by a user.
[0172] In some embodiments, the controller is configured to receive a plurality of instructions from a processor.
[0173] In some embodiments, the controller is configured to receive multiple instructions from a wireless remote controller.
[0174] In some embodiments, the wireless remote control is a Wi-Fi remote control and a Bluetooth remote control.
[0175] In some embodiments, the at least one linear actuator and the at least one rotary actuator have one or more universal actuators.
[0176] In some embodiments, the at least one linear actuator comprises at least one piezoelectric actuator.
[0177] In some embodiments, the at least one rotary actuator comprises at least one piezoelectric actuator.
[0178] According to one aspect of some embodiments, a small robotic device is provided for driving the movement of two or more elongated surgical instruments when the instruments are at least partially housed within the device, the device comprising:
[0179] A housing comprising a plurality of walls defining an internal volume, the internal volume including at least two internal pathways for receiving the two or more elongated surgical instruments.
[0180] The outer shell encloses:
[0181] Multiple engines;
[0182] Two or more tool actuation components are configured at a location in each of the two or more internal paths; the plurality of actuation components are driven by a plurality of motors and configured to operably contact an elongated surgical tool at least partially housed in the internal path to advance, retract, and / or roll at least one of the elongated surgical tools.
[0183] In some embodiments, each of the two or more internal paths extends through the internal volume between an inlet port and an outlet port, the inlet port and the outlet port being disposed on opposing plurality of walls of the device housing and communicating with the internal volume.
[0184] In some embodiments, there are no internal barriers between the two or more internal paths, such that the two or more tool actuation components and the multiple engines all share the internal volume without separation between them.
[0185] In some embodiments, at least one fixing position is defined outside the plurality of walls of the housing for securing a proximal end of an elongated surgical tool to the housing.
[0186] In some embodiments, the at least one fixed position is located at one of the plurality of outlet holes, such that an elongated surgical tool exiting the internal volume through the outlet hole is guided into a lumen at a proximal end of a second elongated surgical tool, forming a telescopic configuration of the two tools.
[0187] In some embodiments, the at least one fixed position and one of the at least two inlet holes are defined along the same wall of the housing, such that an elongated surgical tool fixed to the device at the at least one fixed position forms a curve before entering the internal volume through the at least one inlet hole.
[0188] In some embodiments, the two or more internal paths are parallel to each other and have a similar axial range.
[0189] In some embodiments, the distance between the major axes of the plurality of internal paths is less than 10 cm.
[0190] In some embodiments, the plurality of tool actuation components are all confined within the plurality of walls of the housing, and only a portion of the two or more elongated surgical tools, when housed within the device, extend outward from the plurality of walls of the housing at a distance of at least 1 cm from the housing.
[0191] In some embodiments, the internal volume is less than 2800 cm³; and the weight of the device is less than 850 grams.
[0192] In some embodiments, the plurality of engines comprises 3 to 5 engines.
[0193] In some embodiments, each of the plurality of actuation components includes:
[0194] A designated elongated shaft, extending axially along at least a portion of a length of the internal path, for the elongated surgical instrument to extend through; and
[0195] At least one pair of multiple wheels are positioned close to and protrude within the shaft to operably contact the elongated surgical instrument housed within the shaft.
[0196] In some embodiments, each of the plurality of actuation components includes a plurality of wheel pairs, each wheel pair including a set of opposing plurality of wheels configured to define the internal path therebetween.
[0197] In some embodiments, the at least one pair of wheels comprises a set of opposing wheels configured to rotate to advance or retract the elongated surgical tool within the shaft.
[0198] In some embodiments, the shaft is connected to a gear, which, when the gear rotates, causes the shaft, together with the plurality of wheels and the elongated surgical tool housed therein, to rotate about the long axis of the shaft, thereby causing the elongated surgical tool to roll.
[0199] In some embodiments, the dimensions of the housing include a height less than 30 cm, a width less than 30 cm, and a length less than 30 cm; wherein each of the plurality of internal paths extends along the length axis.
[0200] In some embodiments, at least one of the inlet holes and / or at least one of the outlet holes of the housing includes a tapered protrusion having a circular outer lip.
[0201] In some embodiments, the housing includes a removable or movable cover that provides access to one or more elongated surgical instruments mounted on the device and extending along at least a portion of the plurality of internal paths.
[0202] In some embodiments, the device is configured to drive movement of a guidewire and a microcatheter, the guidewire being configured to extend at least partially through a lumen of the microcatheter.
[0203] In some embodiments, the apparatus includes a controller configured to control the plurality of engines for driving the two or more actuation components.
[0204] In some embodiments, the controller is remotely controlled via an external remote control device.
[0205] In some embodiments, a kit is provided comprising: a device, such as that described herein; a guidewire for mounting onto the device such that at least a portion of the guidewire extends along one of the plurality of internal paths; and a microcatheter for mounting onto the device such that at least a portion of the microcatheter extends along a second of the plurality of internal paths.
[0206] In some embodiments, a surgical system is provided, the system comprising: a robotic device, such as that described herein; and an additional unit for driving the movement of a guide catheter, the additional unit being mechanically connected to the housing of the robotic device.
[0207] Unless otherwise defined, all technical and / or scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention pertains. While many methods and materials similar to or equivalent to those described herein may be used in the practice or testing of various embodiments of the invention, several exemplary methods and / or materials are described below. In case of conflict, the patent specification (including multiple definitions) shall prevail. Furthermore, these materials, methods, and examples are illustrative only and are not necessarily limiting.
[0208] The implementation of the methods and / or systems described in various embodiments of the present invention may involve manually, automatically, or a combination thereof, performing or completing a plurality of selected tasks. Furthermore, in practical instruments and devices according to various embodiments of the methods and / or systems of the present invention, several selected tasks can be implemented using an operating system via hardware, software, or firmware, or a combination thereof.
[0209] For example, hardware for performing multiple selected tasks according to various embodiments of the present invention can be implemented on a single chip or circuit. As software, the multiple selected tasks according to various embodiments of the present invention can be implemented by multiple software instructions executed by a computer using any suitable operating system. In an exemplary embodiment of the present invention, one or more tasks of various exemplary embodiments of the methods and / or systems described herein are performed by a data processor, such as a computing platform for executing multiple instructions. Optionally, the data processor includes a volatile memory and / or a non-volatile memory for storing multiple instructions and / or data, such as a magnetic hard disk and / or a removable medium for storing multiple instructions and / or data. Optionally, a network connection is also provided. Optionally, a display and / or a user input device such as a keyboard or mouse is also provided. Attached Figure Description
[0210] Some embodiments of the present invention are described herein by way of example only and with reference to the accompanying drawings. The detailed description of the drawings and specific references emphasizes that the details shown are merely illustrative and are intended to illustrate the purpose of various embodiments of the present invention. Based on this, the accompanying drawings and description enable those skilled in the art to clearly implement various embodiments of the present invention.
[0211] In the aforementioned figures:
[0212] Figure 1 A schematic diagram of a medical system including an insertion device fixed to the body of a subject, according to some embodiments, is shown.
[0213] Figures 2A to 2B A schematic perspective view (front and rear, respectively) of an insertion device according to some embodiments is shown;
[0214] Figures 3A to 3B A schematic perspective view of an insertion device according to some embodiments is shown;
[0215] Figures 4A to 4B It shows some embodiments Figures 3A to 3B A schematic perspective cross-sectional view of the insertion device shown;
[0216] Figure 5 A schematic perspective top view of a plurality of motion control units of an insertion device according to some embodiments is shown;
[0217] Figure 6A A schematic perspective view of an insertion device according to some embodiments is shown;
[0218] Figure 6B A perspective view of a motion control unit according to some embodiments is shown;
[0219] Figure 6C A side view of a motion control assembly according to some embodiments is shown;
[0220] Figure 7 Showing Figure 6C A longitudinal cross-sectional view of a motion control component;
[0221] Figure 8 A motion control unit according to some embodiments is schematically shown;
[0222] Figures 9A to 9B A mobile unit for linear propulsion and / or rotational motion of a medical device is shown according to some embodiments. Figure 9A A piezoelectric actuation mechanism for linear translation of a medical instrument, according to some embodiments, is schematically shown. Figure 9BA piezoelectric actuation mechanism for rotating a medical tool is schematically shown according to some embodiments;
[0223] Figure 10 A schematic diagram of an exemplary device capable of applying linear and rotational motion on a medical instrument, according to some embodiments, is depicted;
[0224] Figure 11 A motion control unit according to some embodiments is shown;
[0225] Figure 12 A component of multiple motion control units for controlling the movement of more than one medical device, according to some embodiments, is shown;
[0226] Figure 13 This is a block diagram of a surgical robot system according to some embodiments;
[0227] Figure 14 This is a flowchart of a general method of using a surgical robot device according to some embodiments;
[0228] Figure 15 This is a flowchart of a method for loading multiple surgical tools onto a surgical robot device according to some embodiments;
[0229] Figures 16A to 16D Various configurations of a remote control device for a surgical robot system according to some embodiments;
[0230] Figure 17 This is an illustrative example of a screen interface associated with the surgical robot system according to some embodiments;
[0231] Figures 18A to 18B These are different views of a robotic device according to some embodiments;
[0232] Figures 19A to 19B A surgical robot device, including or attached to a guide catheter drive unit, is schematically shown according to some embodiments;
[0233] Figures 20A to 20C This is an example of a separate mechanism of the guide catheter drive unit according to some embodiments, an example of a guide catheter drive unit housing, and an example of a guide catheter drive unit assembled onto the robotic surgical system;
[0234] Figures 21A to 21C The diagram illustrates a mechanism, according to some embodiments, for driving the rotational (rolling) and / or linear motion of a tool actuated by the robotic surgical system;
[0235] Figure 22An exemplary configuration of multiple mechanisms for driving the movement of a guidewire according to some embodiments is shown;
[0236] Figures 23A to 23B This is a schematic diagram and a flowchart according to some embodiments regarding controlling the length and / or position of a tool by adjusting a curved portion of the tool;
[0237] Figure 24 A system configuration showing an arrangement of multiple tools according to some embodiments is illustrated, wherein the length of one tool can be adjusted;
[0238] Figure 25 The diagram schematically illustrates multiple tool movement drive mechanisms of the system according to some embodiments;
[0239] Figures 26A to 26B This is an example of a device configuration according to some embodiments, including multiple elastic elements (e.g., multiple springs) for selectively engaging multiple tools housed by the system;
[0240] Figure 27 This is a schematic block diagram of a robotic device configured to manipulate two or more elongated surgical instruments according to some embodiments;
[0241] Figure 28 A robotic device for manipulating a guidewire and a microcatheter, according to some embodiments, is schematically shown; the guidewire extending at least partially within the lumen of the microcatheter; and
[0242] Figure 29 A robotic device for manipulating three or more elongated surgical tools configured for a telescopic configuration is schematically shown according to some embodiments. Detailed Implementation
[0243] In some embodiments of the invention, the invention relates to the automatic actuation of multiple surgical instruments inserted into an integrated cavity.
[0244] A broad aspect of some embodiments relates to a small robotic device for manipulating the movement of a plurality of elongated intracavitary tools that extend and bend outside the device housing. Some embodiments described herein relate to a small-sized robotic device suitable for manipulating multiple structural, functional, and / or design features of the tools using a size unaffected by the length of the manipulated tools. In some embodiments, multiple characteristics of the robotic device (e.g., volume, weight) are determined solely by the electrical and mechanical components of the device, and not substantially by the plurality of manipulated tools.
[0245] One aspect of some embodiments relates to a small robotic device shaped and sized to be mounted on a patient's body and / or an operating table. In some embodiments, the device has a volume of less than 3000 cm³, 2800 cm³, 2500 cm³, or a medium, larger, or smaller volume. In some embodiments, the device has a weight of less than 1000 g, 850 g, 500 g, or a medium, larger, or smaller weight.
[0246] In some embodiments, the device includes a plurality of actuation mechanisms for moving one or more elongated surgical tools (e.g., a guidewire, a microcatheter), for example, for linearly advancing or retracting the tool, or for rolling the tool. In some embodiments, a device housing encloses the plurality of actuation mechanisms, and a plurality of walls of the housing define a plurality of inlet and / or outlet ports and / or a plurality of anchoring locations for the tools. In some embodiments, an anchoring location (e.g., a retainer) located at a proximal portion of the tool is connected to the housing, and an inlet port of a tool for access to the inner side of the housing is aligned with each other along a similar horizontal or vertical axis such that a tool segment extending between the anchoring location and the inlet port forms a curve outside the device housing. In some embodiments, an anchoring location and an inlet port of the tool are defined in a similar surface (or wall) of the device housing. In some embodiments, an inlet port and an outlet port for the same tool are configured on opposing walls of the housing such that a tool entering the housing extends through the internal space defined by the housing to reach the outlet port.
[0247] In some embodiments, the device portion does not protrude outward from the housing, and optionally, only the plurality of tools mounted on the device extend outward from the housing.
[0248] In some embodiments, a maximum dimension of the robotic device housing (e.g., a width, a height in a box-shaped device) is a function of a distance between a plurality of exit and inlet holes of a tool bent outside the device. For example, the distance between the plurality of exit and inlet holes can be set according to a minimum radius of curvature that the tool can withstand. In one example, a maximum dimension of the device housing is a multiple of 2 to 6, 2 to 10, 2 to 5, or intermediate, higher, or lower than a minimum radius of curvature of a tool manipulated by the device and bent outside the housing. A potential advantage of determining a maximum size of the device housing based on a minimum radius of curvature of a tool bent when exiting and re-entering the housing can include providing a small, minimally sized housing. In one example, for a tool having a minimum radius of curvature X, a minimum distance between the plurality of inlet and exit holes of the tool would be 2X. In this case, a wall of the housing through which the tool enters and exits contains a width of, for example, 2X, 2.1X, 3X, 5X, or intermediate, larger, or smaller.
[0249] In some embodiments, a minimum radius of curvature of an elongated tool includes a maximum bend of the tool that still allows the tool to function, for example, allowing torque to be transmitted along the length of the tool. In some embodiments, a minimum radius of curvature of an elongated tool includes a bend that allows the tool to remain intact (e.g., undamaged).
[0250] In some embodiments, for example, the plurality of outlet and inlet holes of the housing, and the plurality of outlet and inlet holes of the housing, are shaped to reduce or avoid friction between the tool and the plurality of edges of the holes, for example by having a tapered profile and / or a circular lip of the holes. A potential advantage of forming a plurality of holes without sharp edges may include reducing frictional contact between the tool and the plurality of walls of the housing, which may reduce the risk of tool wear or tear, especially when the tool extends and bends outside the housing before entering the housing.
[0251] In some embodiments, the shape and / or size of the housing is determined by the plurality of mechanical and / or electrical components within the housing, such as a motor, a motor transmission (e.g., gears), and a plurality of tool actuation mechanisms (e.g., a plurality of tool moving elements, such as a plurality of wheels). In some embodiments, the housing is designed to be as small as possible while still completely enclosing the plurality of mechanical components. Optionally, the plurality of mechanical components of the robotic device do not protrude outward from the housing. Optionally, no additional mechanical components from outside the housing are required to actuate the plurality of tools. In some embodiments, the housing is shaped and configured such that only the plurality of elongated surgical tools extend into and out of the housing. In some embodiments, extending out of the housing includes a wall away from the housing, for example, a wall away from the tool exiting through the housing extending at least 1 cm, at least 2 cm, at least 4 cm, or a distance longer or shorter. For example, a surgical tool, such as a guidewire or a microcatheter, extends at least 1 cm away from the housing.
[0252] In some embodiments, multiple components integral with the housing, such as multiple protrusions of multiple lips defining multiple inlet holes and / or outlet holes of the housing, extend from the housing by a distance of less than 1 cm, less than 0.5 cm, less than 0.3 cm, or in between, a longer or shorter distance.
[0253] In some embodiments, the housing of the robotic device is not limited to a particular orientation; for example, the housing can be positioned in at least a first orientation and a second orientation, such that the second orientation is at 90 degrees or 180 degrees from the first orientation. In some embodiments, a symmetry exists such that at least two opposing faces of the housing are similar in outline and size, allowing the device to be positioned in one of two "flipped" orientations.
[0254] In some embodiments, multiple paths are defined through an internal volume of the device, wherein multiple actuating mechanisms for moving a tool housed within one path are configured along the path. In some embodiments, a path extends between an inlet or outlet opening into the internal volume of the device housing. In some embodiments, the multiple inlet and outlet openings are defined on opposing walls of the housing. In some embodiments, the device includes multiple paths (e.g., 2, 3, 4, 6, or a greater or lesser number of paths) for receiving a corresponding number of multiple elongated surgical tools, each tool being housed within a path. In some embodiments, the multiple long axes of the multiple paths are parallel. In some embodiments, the multiple actuating mechanisms of the multiple paths are aligned side-by-side and optionally extend along a similar axial range. In some embodiments, there are no barriers (e.g., walls, shields, curtains, etc.) between the multiple actuating mechanisms of the multiple paths, and the actuating mechanisms share a similar space.
[0255] One aspect of some embodiments relates to a disposable robotic device for manipulating multiple elongated surgical instruments. In some embodiments, the device is disposed of after the surgical procedure (optionally along with the multiple instruments operated by it). In some embodiments, the disposable device does not need to be covered with a sterile curtain or lid. In some embodiments, no additional mechanical components are required to be operatively connected to the disposable robotic device to drive and / or manipulate the multiple instruments loaded within the device. In some embodiments, the device is provided packaged and pre-sterilized, optionally with one or more pre-loaded instruments. Alternatively or additionally, multiple instruments are loaded onto the device in the operating room.
[0256] In some embodiments, a tool mounted on the device is in direct operative contact with one or more tool movement elements that operate it. In some embodiments, one or more tool movement elements are in direct operative contact with one or more motors. In some embodiments, the one or more motors and one of the plurality of tool movement elements are encapsulated in a single housing, and the housing, together with its contents, is disposed of upon completion of the clinical procedure.
[0257] In some embodiments, multiple components of the robotic device, such as the multiple tool drive assemblies, and optionally the entire robotic device, are disposed of after use along with the multiple tools operated by the device. A potential advantage of a disposable device may include allowing the multiple tools operated by the device to directly contact and / or reside in a similar shared volume with multiple motion drive components, including multiple motors and / or multiple transmission gears.
[0258] In some embodiments, there is no boundary component or barrier between the tool and its plurality of moving components and / or plurality of drive motors within the housing. This is feasible in some embodiments because the device is disposed of after use, thus avoiding the risk of contamination that may occur during reuse. Some potential advantages of a device in which the loaded tool can directly contact the plurality of tool moving elements (and / or other plurality of device components, such as motors) of the device may include simplified use, potentially reduced loading time, and potentially improved mechanical engagement with the tool (e.g., because no “boundary” component is required), thereby reducing or avoiding unwanted plurality of tool movements, such as slippage, twisting, or kinking of the tool.
[0259] In some embodiments, a sterile barrier is not required between the plurality of device actuation components and the plurality of tools operated by the devices. In some cases, the presence of the plurality of tools and the plurality of device actuation components in the same shared volume may mean that fluids (e.g., blood, salts) that come into contact with and / or flow within the tools may also come into contact with the plurality of device actuation components during operation; however, since the devices are provided in a sterile state and do not require cleaning or re-sterilization after use, a risk of contamination can be reduced or prevented.
[0260] In some embodiments, the device is made of a variety of durable, lightweight, disposable, and optionally recyclable materials, such as plastic, aluminum, steel, copper, and / or other suitable metals.
[0261] One aspect of some embodiments relates to a dual-function component in which linear motion and rotational motion (e.g., rolling) of an elongated tool occur at the same physical location. In some embodiments, the component is configured to linearly move the tool while it is being rolled, or vice versa, to roll the tool while it is being linearly moved.
[0262] In some embodiments, the assembly includes an elongated shaft having a central lumen in which the tool is housed. A plurality of wheels are positioned near the shaft, and each of the plurality of wheels extends at least partially into the central lumen to operably contact the internal tool. In some embodiments, a motor driving the rotation of the plurality of wheels is mounted near the plurality of wheels, for example, below the shaft. In some embodiments, the rotation of the plurality of wheels pushes or retracts the tool, depending on the direction of rotation. In some embodiments, the motor driving the rotation of the plurality of wheels is configured as part of the assembly. Alternatively, driving force is transmitted to the plurality of wheels via a motor transmission.
[0263] In some embodiments, the contours of the plurality of inner walls of the shaft defining the central lumen match the outer contours of at least some of the plurality of wheels. In this configuration, the central lumen extends into a space between the plurality of wheels, allowing the tool to come into close contact with the plurality of wheels. In one example, in a four-wheel assembly, the contours of the plurality of inner walls of the shaft may match at least one, two, three, or all four wheels in the central lumen segment closest to a point of contact where the tool contacts the plurality of wheels.
[0264] In some embodiments, a gear coaxial with the shaft is connected along the shaft and / or at a proximal or distal end of the shaft, such that when the gear rotates, the shaft and the gear assembly rotate as a single unit via the gear, thereby rolling the tool (e.g., guidewire, maneuverable microcatheter) within the central lumen of the shaft.
[0265] A potential advantage of an assembly that drives linear and rotational movement of a tool at the same physical location (e.g., a specific physical location within the housing of the device and / or a specific location where the tool engages) may include reducing or avoiding unwanted tool movements, such as possible slippage, kinking, or twisting, for example, if two spaced-apart mechanisms drive linear and rotational movements respectively, and the tool needs to extend between locations where such unwanted movements might occur. Another potential advantage is the compact design achieved by assigning two functions (e.g., rotation and advance / retraction of the tool) to the same location.
[0266] One aspect of some embodiments relates to using the same motor to drive the rotation (rolling) of an elongated tool at two spaced-apart engagement locations along the length of the tool. In some embodiments, the tool is engaged by multiple components that rotate the tool at two or more points along the length of the tool, for example, at a proximal portion of the tool (e.g., adjacent to a handle of the tool) and at a distal portion. In an exemplary configuration, a first gear rotates a retainer holding a proximal portion of the tool; then, the rotation of the first gear rotates a second gear, which is part of the linear motion assembly (e.g., as described herein), wherein the second gear rotates a shaft in which a distal portion of the tool is housed. In this configuration, actuation of a single motor drives the rotation of the first and second gears, producing rotation (rolling) of the tool at both engagement locations.
[0267] One potential advantage of using a single motor to drive rotational motion at two spaced-apart engagement locations along the length of the tool can include improved control of the tool, for example, compared to using two different motors to drive rotation at the two locations, where the actuation timing and / or speed and / or direction of the two motors would need to be synchronized to ensure that the tool rolls uniformly along its length.
[0268] In some embodiments, one or more tools operated by the device engage and operate only from their proximal portions (e.g., from a tool handle); while one or more additional tools engage at a more distal portion (i.e., not from the tool handle).
[0269] One aspect of some embodiments relates to controlling the usable length of an elongated surgical tool by modifying the size of a curve of the tool outside the robotic device. In some embodiments, a tool manipulated by the device extends into the housing in a curved manner (bending) one or more times. In some embodiments, the size of the curve expands or contracts as the length of a distal segment (e.g., a tool segment extending between an exit port of the device housing and a target within the patient's body) changes. In some embodiments, a tool enters and exits the device housing multiple times, forming more than one curve outside the housing. For example, a guidewire bends twice, once independently, optionally between a proximal handle and a distal portion, and a second time when it is received within a lumen of a curved microcatheter. In some embodiments, the curve is a "U"-shaped curve, which can be modified, for example, by lengthening or shortening the distance of the maximum point of the "U" relative to the nearest wall of the device housing.
[0270] According to some embodiments, the present invention relates to multiple automated devices for inserting a long surgical medical instrument into an integrated cavity, and more specifically to multiple body-mountable automated devices for inserting multiple long surgical medical instruments, such as multiple guidewires and multiple microcatheters, into multiple blood vessels.
[0271] Many medical procedures, such as catheterization for multiple diagnostic and / or therapeutic purposes, require inserting a catheter into multiple blood vessels and other body cavities of the patient.
[0272] Typically, the physician first inserts a guidewire into an artery, such as the femoral artery or a vein, and guides it through the tortuous vascular system until it reaches the target, which could be the heart, an artery, a peripheral vessel, the brain, etc. Once correctly positioned, the physician places a catheter on the guidewire and pushes the catheter until it also reaches the target. In some cases, the procedure requires the use of a small-radius catheter, often referred to as a microcatheter. In this case, the physician can insert the microcatheter directly without using a guidewire. Manually inserting and guiding multiple guidewires / microcatheters through the tortuous vascular system is not only challenging for the physician but can also be dangerous for the patient, as even multiple minute errors in movement can lead to accidental perforation of the vessel wall. Furthermore, multiple manual procedures require the physician and other medical personnel to be present in the procedure room throughout the entire procedure. Since most invasive procedures are performed under imaging (e.g., X-rays, CT scans, etc.), both the medical personnel and the patient are exposed to radiation.
[0273] Several remotely operated automated (robotic) devices have been developed in recent years; however, many existing robotic devices are both cumbersome and expensive. Therefore, there is a need for a small, inexpensive, and easy-to-use automated device for inserting multiple guidewires and / or multiple microcatheters into multiple body cavities, such as multiple blood vessels, and guiding them to a target area.
[0274] According to some embodiments, the insertion device may include a power source. In some embodiments, the power source may be a battery, a power supply, etc. In some embodiments, the battery is disposable. In some embodiments, the battery is reusable. In some embodiments, the battery is rechargeable. In some embodiments, the power supply may be directly or indirectly connected to a mains power source. In some embodiments, the insertion device may include one or more printed circuit boards (PCBs) configured to relay / process / transmit multiple instructions and / or electrical connections between various components of the device.
[0275] According to some embodiments, the insertion device may allow linear and / or rotational advancement / movement of the medical device. In some embodiments, the insertion device may be configured to automatically advance the insertion device and / or further automatically allow its rotational movement by rotating the insertion device. In some embodiments, when the medical tool is a guidewire, the insertion device may allow control of the plurality of linear and / or rotational and / or tip parameters of the guidewire. In some embodiments, when the medical tool is a guidewire, the insertion device may allow automatic and / or remote control of the plurality of linear and / or rotational and / or tip parameters of the guidewire. In some embodiments, the medical device may be preloaded onto the medical device prior to use in a medical procedure. In some embodiments, the medical device may be preloaded onto the medical device prior to placement on the subject's body.
[0276] According to some embodiments, an insertion device is provided, configured to remotely and automatically linearly advance one or more medical instruments (e.g., a guidewire and catheter) into multiple body cavities (e.g., multiple blood vessels) and within multiple body cavities (e.g., multiple blood vessels) for multiple intravascular procedures, including coronary, peripheral, and cerebrovascular procedures. In some embodiments, the insertion device is configured to further automatically and / or remotely control / permit the rotational movement of the one or more medical instruments. In some embodiments, the insertion device is also configured to control multiple parameters of the one or more medical instruments, such as tip stiffness. In some embodiments, the device is configured to control a force applied by a distal tip of the instrument, for example, by controlling one or more of the following: the advancement speed of the instrument, and a stiffness of the instrument. Optionally, the instrument is operated such that its distal tip applies a constant or varying force to multiple structures (e.g., a blood vessel wall) encountered by the tip.
[0277] According to some embodiments, an insertion device is provided, the insertion device being configured to remotely and automatically linearly advance one or more medical instruments (e.g., a guidewire and catheter) into and within multiple body cavities for various endocavitary procedures. According to some embodiments, when the first instrument is a guidewire and the second medical instrument is a catheter, the insertion device may allow control of the plurality of linear, rotational, and / or tip parameters of the guidewire, as well as the linear movement of the catheter (on the guidewire) and its rotational movement (relative to the insertion device).
[0278] According to some embodiments, the linear velocity of the advancement of the medical device can be within the range of about 0 to 100 mm / s or any of its sub-ranges. In some embodiments, the linear velocity of the medical device can be within the range of about 0 to 50 mm / s, 1 to 100 mm / s, 5 to 50 mm / s, or intermediate, higher, or lower speeds. In the procedure, the velocity can be constant and / or varying in increments and can be adjusted (manually and / or automatically). In some embodiments, the velocity can be within the range of about 0 to 25 mm / s in increments of about 0.1 mm / s. In some embodiments, the velocity can be within the range of about 25 to 50 mm / s in increments of about 1 mm / s. In some embodiments, the position of the actuator remains stable at about 0.1 mm. According to some embodiments, the rotational movement can be anywhere within the range of 360 degrees.
[0279] According to some embodiments, the rotational motion can be performed continuously within the 360-degree range. In some embodiments, the total number of rotations can be limited. In some embodiments, the total number of rotations can be limited to approximately 5 to 10 rotations in each direction from the neutral (starting) setting.
[0280] According to some embodiments, the rotational position resolution can be in increments of 1 to 5 degrees, 0.5 to 10 degrees, 0.1 to 1 degree, or intermediate, higher, or lower resolutions. In some exemplary embodiments, the rotational position resolution can be approximately + / - 2 degrees, + / - 1 degree, + / - 0.5 degrees, or intermediate, higher, or lower resolutions.
[0281] According to some embodiments, the controller of the device may be a remote control. In some embodiments, the controller of the device may be integrated with the device. In some embodiments, the controller of the device may be connected via wired or wireless means. In some embodiments, the controller may be configured to allow control of the operation of the medical device. In some embodiments, the controller may be configured to allow control of the advancement of the medical device, including but not limited to: linear direction of advancement, speed of advancement, increment of advancement, rotational movement, degree of rotational movement, etc., or any combination thereof. In some embodiments, the controller may include one or more operating buttons. In some embodiments, the plurality of buttons may include a plurality of pressure buttons, a plurality of slider buttons, a joystick, etc., or any combination thereof. In some embodiments, the system may have a device for injecting a contrast agent into the lumen, such as in the vascular system. The injection mechanism can be remotely operated, thereby allowing the surgeon / physician to perform the entire procedure from a remote location. In some embodiments, if used in the procedure, the system may be configured to control multiple linear and / or rotational movements of a guide catheter.
[0282] As mentioned herein, a “robotic device” or “device” may refer to the housing of the device, including a plurality of mechanical and / or electrical components housed within the housing. In some embodiments, the term “device” does not necessarily imply coverage of a plurality of additional or external components, such as a guide tube drive unit (when coupled externally to the housing but not integrated therein), a fixture of the device, a remote control of the device, etc.
[0283] As mentioned herein, an “assembly” or “actuation assembly” may include a plurality of tool moving elements, such as a plurality of wheels, and / or a coupling for the tool, such as an elongated shaft for receiving the tool. In some embodiments, an “assembly” or “actuation assembly” may further include one or more motors and / or transmission devices (e.g., a plurality of gears) that transmit force from one or more motors to the outside of the assembly.
[0284] Before explaining at least one embodiment of the invention in detail, it should be understood that the invention is not necessarily limited in its application to the details of the construction and configuration of the plurality of components and / or the plurality of methods set forth in the following description and / or illustrated in the plurality of drawings and / or the plurality of examples. The invention can be practiced or performed in other embodiments or in various ways.
[0285] Before explaining at least one embodiment of the invention in detail, it should be understood that the invention is not necessarily limited in its application to the details set forth in the following description or illustrated by the various examples. The invention can have other embodiments or can be practiced or performed in various ways.
[0286] refer to Figure 1 It shows a schematic diagram of an exemplary medical system according to some embodiments. Figure 1 As shown, system 2 includes a small, automated insertion device 4 that can be mounted on the body and is configured to insert a medical device, such as a guidewire 6, into a body cavity (e.g., a blood vessel) of a subject 8. According to some embodiments, the entry point may be selected from, but is not limited to, the groin (i.e., the femoral artery), arm (i.e., the radial artery), or neck (i.e., the jugular vein), depending on the location of the target tissue (e.g., the heart, a peripheral blood vessel of the lower extremity, the brain, the liver, etc.) and the purpose of the procedure. Therefore, the location of the insertion device 4 on the patient's body can vary. Figure 1 In the example shown, the device is attached to the patient's thigh to allow access to the patient's femoral artery. It is understood that the device may additionally or alternatively be attached to the patient's arm, or any other desired location on the patient's body, depending on the selected point of contact. According to some embodiments, the device can be attached / mounted / secured to the patient's body using any suitable attachment element. For example, the device can be attached to the patient's body using a strap that can be pulled from the patient's leg to his / her thigh. The strap can be flexible, so that it stretches according to the circumference of the thigh, or it can be substantially rigid or semi-flexible and include a length adjustment mechanism. Alternatively, one or more straps can be wrapped directly around the patient's thigh. Such straps can be substantially rigid or semi-flexible, have a length adjustment mechanism, and have multiple connectors (e.g., multiple buckles) at their opposite ends for fastening the straps and securing them to the patient's thigh. The multiple straps / straps may include one or more sensors, such as force sensors, disposed thereon.
[0287] According to some embodiments, the insertion device is not mountable on the body, but is configured to be positioned close to the patient's body, for example, by using a robotic arm, or configured to be fixed to a basic structure on the patient's bed.
[0288] In some embodiments, the insertion device may be disposable, or partially disposable, such that some of its components are discarded and replaced between multiple procedures, or completely disposable, such that the entire insertion device is discarded once the procedure is completed; that is, a single-use device. In other embodiments, the insertion device may be reusable, such that it can be reused with multiple new medical devices (e.g., multiple guidewires and / or multiple catheters).
[0289] In some embodiments, the device may be configured to allow insertion of multiple different medical devices of varying lengths and diameters into multiple body cavities, including, for example, guidewires, catheters, multiple microcatheters, etc. In some exemplary embodiments, without limitation, the device may be adapted to insert a guidewire into a blood vessel, for example, the guidewire disclosed in commonly owned U.S. Patent No. 9,586,029, entitled “Guidewire Having Selectively Adjustable Stiffness and Tip Curvature,” and / or the commonly owned U.S. Patent Application No. 2018 / 214,675, entitled “Double Concentric Guidewire,” both belonging to Shekalim et al., and which are incorporated herein by reference in their entirety.
[0290] According to some embodiments, the system may further include a controller 10 for controlling the operation of the device, particularly the insertion and / or manipulation of the medical device (e.g., a guidewire and / or a catheter) toward the target (e.g., a heart chamber, an obstructed artery, etc.). The controller 10 may be coupled to the insertion device 4 via a wired or wireless connection and may be manually operated by a physician (e.g., the controller may be in the form of a joystick) or automatically operated using dedicated software. In the latter case, the system may further include a computer 12, which may include at least one processor, a user interface, and a display. The computer 12 may be a PC, a laptop, a tablet, a smartphone, or any other processor-based device. In some embodiments, the controller 10 is disposable. In some embodiments, the controller 10 is reusable. In some embodiments, the controller 10 is configured to interact / couple with more than one insertion device.
[0291] In some embodiments, the system 2 may further include an imaging device, or it may be used in conjunction with an imaging device. The imaging modality used may be any one of X-ray fluoroscopy, CT, cone-beam CT, CT fluoroscopy, MRI, ultrasound, or any other suitable imaging modality. According to some embodiments, the insertion device is capable of linearly advancing the medical device within the body cavity. In some embodiments, alternatively or in addition to linearly advancing the medical device, the device may also be capable of rotating the medical device within the lumen. In some embodiments, the device may also be capable of rotating the medical device alone and / or simultaneously, while linearly advancing the medical device, within the blood vessel. For example, in some exemplary embodiments, the insertion device may be capable of linearly advancing a guidewire and / or catheter within the blood vessel. In some embodiments, alternatively or in addition to linearly advancing the guidewire and / or catheter, the device may also be capable of rotating a guidewire and / or catheter within the blood vessel. In some embodiments, the device may also be capable of rotating a guidewire and / or catheter alone and / or simultaneously, while linearly advancing the guidewire and / or catheter, within the blood vessel. According to some embodiments, as further illustrated herein, the insertion device is configured to allow the linear advancement of the medical device within the body cavity with its rotational movement, further advantageously achieving the smooth movement of the medical device by utilizing one or more actuators without deforming the medical device (i.e., without creating tension or twisting along the length of the medical device). According to some embodiments, as further illustrated herein, the linear and rotational movements of the medical device (e.g., a guidewire and / or microcatheter) may be generated by multiple individual actuators, or by one or more dual-purpose actuators configured to allow rotational and linear movement of the device.
[0292] Now for reference Figures 2A to 2B It shows a schematic perspective view (front and rear, respectively) of an insertion device according to some embodiments. Figure 2A As shown, the insertion device includes multiple elements for advancing a first medical device (shown as guidewire 22) along a linear direction and optionally along a rotational direction (as indicated by the plurality of moving arrows). Figure 2AAs shown, the proximal end of the guidewire 22 can be secured to a dedicated retainer 34, which further allows control over multiple tip parameters of the guidewire 22, as described below. The guidewire 22 is advanced from a first opening 35 in the retainer (at the front of the device 20), enters the insertion device 20 through a second opening 36, and exits the device 20 again from a different opening (a first rear opening (not shown)) at the rear (dorsal) side of the device 20. The guidewire 22 can then re-enter the insertion device 20 through another opening at the rear of the device 20 (a second rear opening (not shown)), and can exit the insertion device 20 again from a third (anterior) opening 37, such that the distal end 24 of the guidewire 22, after exiting the third opening 37, can be configured for insertion into a subject's body, more specifically into a lumen, such as a blood vessel.
[0293] In some embodiments, such as Figure 2A As shown, the guidewire 22 exits the insertion device 20 and enters the lumen of a second medical device (shown as catheter 32), which can be connected / attached / combined with the first rear opening, re-enter the insertion device 20 through the second rear opening, and exit the front of the insertion device 20 through the third front opening 37. In some embodiments, the second medical device is configured to be inserted into the body cavity. In some embodiments, the second medical device (e.g., catheter 32) can be inserted into the body cavity together with the first medical device (e.g., guidewire 22) via the advancement of the automated medical device 20 and / or after the first medical device (e.g., guidewire 22). The aforementioned winding path of the guidewire 22 and / or the catheter 32 enables a consistent, close-spaced configuration (e.g., side-by-side) of the plurality of motion control units (described below), thereby minimizing the overall size of the device. In some embodiments, the plurality of tools extend through the housing via multiple paths (e.g., multiple axes) aligned side-by-side and optionally parallel to each other. The lateral alignment of the plurality of motion actuators, which are substantially positioned side by side, can provide a smaller device size, such as a thinner device width.
[0294] In some embodiments, the small size of the device allows it to be positioned on the subject's body.
[0295] In some embodiments, the medical device 20 includes one or more actuators / elements configured to allow the linear and / or rotational movement / propulsion of the medical device. In some embodiments, such as Figure 2AAs shown, the device 20 includes a first motion control unit 26 configured to allow linear and / or rotational movement of the guidewire 22. The first motion control unit 26 may include one or more actuators / motors to allow the movement of the guidewire 22, as further detailed below. The device 20 may also include a second motion control unit 28 configured to allow linear and / or rotational movement of the catheter 32. The second motion control unit 28 may include one or more actuators / motors to allow the movement of the catheter 32, as further detailed below.
[0296] Optionally, the device 20 may also include at least one additional motion control unit, for example, in the case where the guidewire comprises a hollow outer conductor and an inner conductor disposed within a lumen of the outer conductor, as disclosed, for example, in U.S. Patent Application No. 2018 / 214,675 published above. In this case, an additional motion control unit 29 can be used to allow control of the movement of the inner conductor of the guidewire 22 relative to the outer conductor of the guidewire 22 to control multiple tip parameters of the guidewire 22, such as stiffness and / or curvature. The movement of the inner conductor relative to the outer conductor can be achieved by an adjuster / slider 33 attached to the inner conductor, a non-rotating nut 30, and a lead screw 31 screwed therein. Rotation of the lead screw 31 by an engine / actuator causes the nut 30 to move linearly along the length of the lead screw 31, which in turn causes linear movement of the adjuster / slider 33 and the inner conductor attached thereto. In some embodiments, the motion control unit 29 may allow the inner and outer leads of the guidewire 22 to have one or more of the following relative states: 1) the distal tip of the inner lead extends distally beyond the distal tip of the outer lead; 2) the distal tip of the inner lead is translated proximally so that it lies within the outer lead (i.e., the distal tip of the outer lead extends beyond the distal tip of the inner lead); and / or 3) the plurality of distal tips of the inner and outer leads are aligned. In some embodiments, the rotation of the guidewire 22 and the retainer 34 to which it is attached at its proximal end may be controlled by the motion control unit 26. In some embodiments, to ensure that the retainer 34 rotates smoothly with the guidewire 22 to prevent the guidewire 22 from twisting / kinking (because the guidewire 22 may not be able to rotate relative to the retainer 34), the motion control unit 29 may include an additional actuator / motor, for example coupled to the proximal end of the retainer 34, to further control the rotation of the retainer 34.
[0297] Now for reference Figure 2BIt shows a perspective rear view of the insertion device 20. (See image below.) Figure 2B As shown, the insertion device 20 includes multiple elements / units for advancing a first medical device (shown as guidewire 22) along a linear direction and optionally along a rotational direction (as indicated by the plurality of moving arrows). Figure 2B As shown, the proximal end of the guidewire 22 can be secured to a dedicated retainer 34. The guidewire 22 can be advanced from the first opening 35 in the retainer 34 (at the front of the device) to pass through a second opening ( Figure 2B The guidewire 22 (not shown) enters the insertion device 20 and exits the device 20 again through a first rear opening 38 at the rear (back) side of the device 20. The guidewire 22 can then re-enter the insertion device 20 through a second rear opening 39 at the rear of the device 20, and then exit through a third (front) opening. Figure 2B (not shown) The insertion device 20 is re-extracted, such that the distal end 24 of the guidewire 22, after being withdrawn from the third opening, can be configured to be inserted into a subject's body, more specifically into an integral cavity, such as a blood vessel.
[0298] In some embodiments, such as Figure 2B As shown, the guidewire 22 can exit the insertion device 20 from the first rear opening 38 and enter the lumen of a second medical device (shown as catheter 32), which can be connected / attached / combined with the first rear opening 38, re-enter the insertion device 20 through the second rear opening 39, and exit the front of the insertion device 20 through the third front opening. In some embodiments, the second medical device 32 is configured to be inserted into the body cavity. In some embodiments, the second medical device (e.g., catheter 32) can be inserted into the body cavity together with the first medical device (e.g., guidewire 22) via the advancement of the automated medical device and / or after the first medical device (e.g., guidewire 22).
[0299] Now for reference Figures 3A to 3B It shows a schematic perspective top view of an insertion device according to some embodiments. For example... Figure 3A As shown, the insertion device 50 includes a housing 52 and a top cover 53, which is shown in an open configuration. A retainer 54 is further shown, which holds the proximal end of the guidewire 58 and, in some embodiments, may also allow adjustment of the plurality of tip parameters of the guidewire 58. In some embodiments, the top cover 53 is designed to allow contact 14 to the retainer 54 such that the retainer 54, together with the guidewire 58 attached thereto, can be inserted into and / or removed from the housing 52. Figure 3AAs shown, the guide wire 58 can be advanced from a first front opening 55 in the retainer 54 to enter the housing 52 through a second front opening 56, and re-exit the housing 52 from a first rear opening (not shown) at the rear of the housing. The guide wire 58 can then re-enter the housing through a second rear opening (not shown) on the back of the housing 52, and re-exit the housing 52 from a third front opening 57. In some embodiments, such as Figure 3A As shown, the guidewire 58 exits the first rear opening of the housing 52, is simultaneously screwed into the lumen of another medical device (shown as catheter 62) that can be connected / attached / combined with the first rear opening, re-enters the housing 52 through the second rear opening, and exits the front of the housing 52 through the third front opening 57. In some embodiments, the second medical device 62 is configured to be inserted into the body cavity. In some embodiments, the second medical device (e.g., catheter 62) may be inserted into the body cavity together with and / or after the first medical device (e.g., guidewire 58) via the advancement of the automated medical device, i.e., the guidewire 58 may serve as a track on which the catheter 62 is mounted.
[0300] The aforementioned winding path of the guidewire 58 and / or the catheter 62 enables a consistent, close-space configuration of the plurality of motion control units of the device 50, as described below, thereby minimizing the overall size of the device. In some embodiments, the small size of the device allows the device 50 to be positioned on the body of the subject. In some embodiments, the medical device includes one or more actuators / elements / units configured to allow the linear and / or rotational movements / propulsion of the first and second medical devices.
[0301] refer to Figure 3B It schematically shows Figure 3A The medical device wherein the top cover 53 and a top portion of the housing 52 are removed. Figure 3BAs shown, the device 50 may include a first motion control unit 66 configured to allow linear and / or rotational movement of the guidewire 58. The device 50 may also include a second motion control unit 68 configured to allow linear and / or rotational movement of the catheter. The first motion control unit 66 and the second motion control unit 68 may include one or more of the following: a plurality of actuators / motors, a plurality of gears, a plurality of racks, a plurality of shafts, and a plurality of rotating screws, respectively allowing the movement (linear and / or rotation) of the guidewire and / or catheter, as further detailed below. In some embodiments, the device 50 may include one or more additional motion control units. For example, when the guidewire is secured proximally to a retainer 54, the device 50 may also include a motion control unit having at least one motor / actuator and a gear 65 that controls the rotation of the retainer 54 about its axis.
[0302] like Figure 3B As shown, in the case where the guidewire 58 includes a hollow outer guidewire and an inner guidewire disposed within the lumen of the outer guidewire, the device may include an additional motion control unit comprising a non-rotating nut 63 attached to an adjuster / slider 61 of the holding gas, rigidly attached to the proximal end of the inner guidewire, and a lead screw (not shown) screwed into the nut 63 to allow control of the movement of the inner guidewire relative to the outer guidewire, thereby controlling the plurality of tip parameters of the guidewire (e.g., adjusting its stiffness and / or curvature). Rotation of the lead screw by an engine / actuator (not shown) causes linear movement of the nut 63 along the length of the lead screw, which in turn causes linear movement of the adjuster / slider 61 and the inner guidewire attached thereto.
[0303] In some embodiments, the motion control unit described above can cause the inner and outer leads of the guidewire to have one or more of the following relative states: 1) the distal tip of the inner lead extends distally beyond the distal tip of the outer lead; 2) the distal tip of the inner lead is translated proximally to be positioned within the outer lead (i.e., the distal tip of the outer lead extends beyond the distal tip of the inner lead); and / or 3) the plurality of distal tips of the inner and outer leads are aligned.
[0304] Now for reference Figures 4A to 4B It shows some embodiments Figures 3A to 3B A perspective view of the cross-section of the insertion device. Figure 4A The insertion device 50 is shown. Figures 3A-3BA longitudinal cross-sectional view of the first motion control unit (shown) Figure 3B 66) and the second motion control unit ( Figure 3B The online segment between 68 and 68 is extracted. For example... Figure 4A As shown, the first motion control unit 66 includes at least one motor (shown as motor 75) and a shaft 76 through which the first medical device (shown as guidewire 58) moves. Multiple gears (e.g., exemplary gear 78) are also shown. Furthermore, a motion element 80 is also indicated. As further detailed below, the motion element 80 includes at least two opposing discs / wheels / rings, one placed on top of and / or adjacent to the other, with a space between them such that the medical device (shown as guidewire 58) is positioned within this space.
[0305] Figure 4A The diagram further shows the rear end opening 82, through which the guidewire 58 can exit the device, for example, into a catheter lumen configured to connect to the rear end opening. (See now for further details.) Figure 4B It shows a longitudinal cross-section of the first motion control unit 66.
[0306] like Figure 4B As shown, the motion element 80 includes two opposing spinning wheels / discs / rings (86A, 86B), one placed on top of and / or adjacent to the other, with a space between them. Within the space formed between the wheels, a guide wire 58 is positioned such that the spinning of the wheels (e.g., actuated by various interconnected gears) facilitates linear movement of the guide wire 58 within the shaft 76 toward the rear opening 82. The advance speed of the guide wire 58 can be controlled by controlling the speed of the spinning. In some embodiments, the motion control unit 66 and / or the motion element 80 can rotate along a longitudinal axis, further allowing the rotational movement of the guide wire 58. In some embodiments, the size, shape, stiffness, material, or composition of the wheels may be similar or different.
[0307] As in Figures 4A to 4BAs can be further observed, in some embodiments, a tool is configured to reduce friction between the tool and the plurality of walls of the housing through an opening through which it enters and / or exits. For example, opening 81 (through which guidewire 48 re-enters the housing) defines a tapered protrusion ending with a rounded lip. A potential advantage of forming an opening in the housing as rounded and without sharp corners may include reduced friction between the tool and the plurality of walls of the housing, thereby potentially reducing the risk of tearing or wear of the tool (e.g., due to friction between the tool and the walls). This may be particularly advantageous for, for example, several devices described herein, where the tool extends and bends outside the housing and thus may more easily access the plurality of opening walls, for example, compared to a tool held only along a single straight linear axis.
[0308] Now for reference Figure 5 It shows a schematic perspective top view of a plurality of motion control units of an exemplary insertion device according to some embodiments. Figure 5 As shown, the insertion device 100 includes several motion control units. A first motion control unit 110 is configured to allow the advancement of the guidewire 108, which is inserted through the insertion device after being reinserted (as detailed above). A second motion control unit 120 is configured to allow the advancement of a second medical instrument (e.g., a catheter) after the guidewire 108 has re-entered the insertion device, while simultaneously screwing it into the lumen of the second medical instrument (catheter) through a second rear opening toward the front of the insertion device (through a corresponding front opening), as detailed above. A third optional motion control unit 102 is configured to allow control of the rotation of the retainer 104, depending on the type of guidewire used, in cases where the retainer 104 is used to hold the proximal end of the guidewire 108, thereby preventing the guidewire 108 from twisting / kinking / tangling during rotation.
[0309] like Figure 5 As shown, the first motion control unit 110 may include a channel / shaft 113 through which the guide wire 108 passes and a motion element 114. A motor 111 and one or more gears (a representative gear 112 is shown) are further shown, which allow control of the operation of the motion control unit 110. The motion element 114 may include a rotating disk / ring / wheel 115 positioned to contact the guide wire 108, so that the guide wire 108 can be linearly advanced along its path as it spins / rotates. The guide wire 108 may be pushed toward the rotating disk / ring / wheel 115 by a spring / screw preloaded pinion. In some embodiments, the guide wire is pushed toward the rotating disk / ring / wheel 115 by a pair of spring / screw preloaded pinions.
[0310] like Figure 5 As shown, the wheel 115 can be a groove, which forms a bend in the guide wire 108. This built-in bend in the guide wire path increases the perpendicular distance between the line of action of the force and the axis of rotation. If the guide wire follows a linear path, this distance will be equal to the radius of the guide wire, thereby enabling the application of a sufficient rotational torque on the thin guide wire without having to apply a high positive force to it.
[0311] like Figure 5 As further shown, the channel / axis 113 may have an opening / slit 116 along its length to allow contact with the guidewire 108 and further allow the guidewire 108 to be placed / removed as needed. In some embodiments, the first motion control unit 110 may rotate about an axis (e.g., by the control of a plurality of actuators 118), thereby allowing the rotational movement of the guidewire 108 (and the retainer 104). In the case of actuated rotational movement, the opening 113 may face in another direction accordingly.
[0312] like Figure 5 As further shown, the second motion control unit 120 includes at least one channel 123 through which the medical device passes, and a motion element 124. The motion element 124 may include a rotating disk / ring / wheel 125 that contacts the medical device (e.g., the catheter through which the guidewire is screwed) placed in the channel 123, so that the medical device can be advanced along its path as it rotates.
[0313] like Figure 5 As shown, the channel 123 may have an opening / slit 126 along its length to allow access to the medical device and further to allow placement / removal of the medical device when needed. In some embodiments, the second motion control unit 120 may be configured to rotate about its axis, thereby allowing the rotational movement of the second medical device (e.g., the catheter).
[0314] like Figure 5As further shown, the third optional motion control unit 102 may include at least one gear 130 to allow the rotation of the retainer 104. In some embodiments, where the guidewire 108 includes a double concentric guidewire (i.e., an inner guidewire disposed within the lumen of an outer hollow guidewire), the device 100 may further include a plurality of actuators / elements to allow control of the relative movement between the inner and outer guidewires of the guidewire to control a plurality of parameters of the tip of the guidewire (e.g., the stiffness and / or curvature of the guidewire). In some embodiments, the device may include a non-rotating nut 103 attached to an adjuster / slider of the retainer 104, rigidly attached to the proximal end of the inner guidewire, and a lead screw 105 screwed into the nut 103 to allow control of the movement of the inner guidewire relative to the outer guidewire, thereby controlling the plurality of tip parameters of the guidewire (e.g., adjusting its stiffness and / or curvature). The rotation of the lead screw 105 causes the nut 103 to move linearly along the length of the lead screw 105, which in turn causes linear movement of the adjuster / slider and the inner wire attached thereto.
[0315] In some embodiments, the above-described motion mechanism may allow the inner and outer leads of the guidewire to have one or more of the following relative states: 1) the distal tip of the inner lead extends distally beyond the distal tip of the outer lead; 2) the distal tip of the inner lead is translated proximally to be positioned within the outer lead (i.e., the distal tip of the outer lead extends beyond the distal tip of the inner lead); and / or 3) the plurality of distal tips of the inner and outer leads are aligned.
[0316] Now for reference Figure 6A It shows a schematic perspective view of an exemplary insertion device according to some embodiments. Figure 6A As shown, the insertion device 150 may include a housing (shown as a translucent housing 158) that encloses a plurality of motion control units 156 configured to advance a medical device (e.g., a guidewire 154) in a linear direction and optionally in rotational motion. Figure 6AAs shown, the proximal end of the guidewire 154 can be secured to a dedicated retainer 152, which can further allow control over multiple tip parameters of the guidewire 154. The guidewire 154 can be advanced from the retainer 152 to enter the insertion device via an opening, and re-exit the device from a different opening on the opposite side of the device. In some embodiments, the guidewire 154 can exit the insertion device 150 into the lumen of another medical device (e.g., a catheter), which can be connected / attached / combined with an opening of the device.
[0317] Now for reference Figure 6B This shows a perspective view of the motion control unit 156. Figure 6B As shown, the motion control unit 156 may include a shaft / channel 162 through which the medical instrument (e.g., guidewire 154) can pass / advance. The motion control unit 156 also includes a medical device linear drive (168) and optionally a rotary drive (164). The motion control unit 156 may also include a slip ring 160 configured to allow rotational movement. The motion control unit 156 may also include one or more rotating / spinning elements (e.g., multiple wheels and multiple gears) configured to mediate the mechanical movement of various moving parts, as detailed below. Now refer to Figure 6C The image shows a side view of the motion control unit 156. Figure 6C The image shows shaft 162, guide wire 154, rotary drive 164, and slip ring 160.
[0318] Now for reference Figure 7 It shows Figure 6C The diagram shows a longitudinal cross-sectional view of the linear drive 168 of the motion control unit, substantially along the center of axis 162.
[0319] like Figure 7 As shown, the linear drive device 168 may include at least two rings / wheels / discs (170A, 170B), one placed / seaten / positioned on top of the other and having a finite space between them. The medical device (e.g., guidewire 154) is configured to advance linearly through the tight space between wheel 170A and wheel 170B, such that as the two wheels spin / rotate, the guidewire, which is at least partially in contact with both wheels, is linearly advanced.
[0320] In some embodiments, the wheels / rings / discs 170A and 170B may be identical in size, shape, composition, or form. In some embodiments, the wheels / rings / discs 170A and 170B may differ in size, shape, composition, hardness, material, or form. In some embodiments, the space between the wheels 170A and 170B is formed in a groove, causing the medical device 154 to be slightly curved to allow for better rotation of the medical device. A potential advantage of a built-in bend in the guidewire pathway may include increasing the perpendicular distance between the line of action of the force and the axis of rotation (which would be equal to the radius of the guidewire if the guidewire follows a linear path), thus enabling the application of a sufficient rotational torque on the thin guidewire without having to apply a high positive force to the guidewire.
[0321] Now for reference Figure 8 It schematically illustrates a motion control unit according to some embodiments. For example... Figure 8 As shown, the motion control unit is configured to allow linear forward and / or rotational movement of a medical device (e.g., a guidewire 202). In some embodiments, the medical device 202 may be advanced along a path defined, for example, by a channel or axis (shown as channel 204). To allow linear movement of the medical device 202, the motion control unit may include a linear drive element 200, which may include two or more spin / rotation elements. Figure 8 The display shows it as wheel / disc / ring 206A and 206B.
[0322] like Figure 8 As shown, the two wheels can be placed side by side, forming a tight space between them. The medical device 202 can be screwed between the two wheels so that it can pass under a first wheel 206A and over a second wheel 206B, thereby forming an S-shape or substantially an S-shape. In this way, since the medical device 202 is at least partially in contact with the two wheels, the opposite spin / rotation of the two wheels causes the device 202 to advance linearly. The relative spin directions of the wheels 206A and 206B determine the direction of the linear motion of the medical device 202.
[0323] In some embodiments, the motion control unit may further include a rotary drive element 210 that allows rotation of the linear drive element 200 (e.g., in direction 212) and thus allows the medical device 202 to be wound therein. By utilizing the medical device wound around the two wheels in an S-shaped path as detailed above, the medical device can rotate freely about its axis without slipping and without bending along its length. In some embodiments, the motion control unit is located / placed on a platform (shown as platform 214) to allow the unit to rotate freely.
[0324] Now for reference Figures 9A to 9B It illustrates multiple moving units for linear propulsion and / or rotational motion of the medical device according to some embodiments. In some embodiments, such as Figures 9A to 9B As shown, the linear and / or rotational motion of the guidewire can be generated by multiple piezoelectric actuators. These piezoelectric elements are composed of ceramic material, and their various geometries change as a function of the applied voltage. The multiple piezoelectric elements are capable of activation at multiple high frequencies, such as 50 to 150 kHz, and they can generate multiple relatively large forces that are linearly related to the degree of extension (stroke) of the elements. Using multiple piezoelectric actuators in an automated medical device is advantageous because their activation does not generate a magnetic field, which is undesirable in many medical applications. Furthermore, multiple piezoelectric actuators are compatible with MRI. In some embodiments, other actuator types can be used, such as multiple electromagnetic actuators (sowaries), multiple DC motors, multiple stepper motors, or multiple AC motors.
[0325] According to some embodiments, the insertion device may include two separate parts / units: a first part (hereinafter also referred to as the "linear part") for generating linear motion and a second part (hereinafter also referred to as the "rotational part") for generating rotational motion, so as to allow each type of motion, i.e., linear and rotational, to be generated independently of the other. A combined motion, i.e., simultaneous rotation and linear propulsion, can be generated by activating the two parts in an ordered or alternating manner.
[0326] In some embodiments, the linear portion may be in the form of a inchworm motor, and it may include three piezoelectric actuators, such as... Figure 9AAs shown. Piezoelectric actuators 301 and 303 are used to grip the medical device 304 (e.g., a guidewire), and movement is achieved by extending (lengthening) and relaxing (shortening) along the vertical axis when energized, and by piezoelectric actuator 302 extending and shortening along the horizontal axis when energized. In some embodiments, piezoelectric actuators 301 and / or 303 may include a single actuator that, when extended, presses the guidewire 304 against a static element to grip the guidewire 304. In other embodiments, piezoelectric actuators 301 and / or 303 are actually a pair of piezoelectric actuators positioned on opposite sides of the guidewire 304 such that both extend and relax to grip and release the guidewire 304, respectively. The actuation process of the linear portion is a cyclic process. To move the device 304 from left to right, for example, piezoelectric actuator 303, in this example, the forward clutch piezoelectric device, is first extended to grip the device, such as... Figure 9A As shown. Next, piezoelectric actuator 302, the lateral piezoelectric device, is extended, causing piezoelectric actuator 1003 to move a short distance to the right along with the device. It should be noted that the center of piezoelectric actuator 302 is fixed, such that its extended portion is symmetrical when piezoelectric actuator 302 is energized. Since piezoelectric actuator 301 (in this example, the rear clutch piezoelectric device) is in a relaxed state at this stage of the process and does not grip the device, the device gripped by piezoelectric actuator 303 moves to the right. Next, piezoelectric actuator 301 is extended to grip the device, and then piezoelectric actuator 303 relaxes to release its grip on the device. Next, piezoelectric actuator 302 is released. Next, piezoelectric actuator 303 is extended to re-grip the device, and then piezoelectric actuator 301 relaxes.
[0327] like Figure 9B As shown, the rotating portion / moving unit of the device may include a pair of piezoelectric actuators 306, 307 that contact the instrument 308 on opposite sides and are parallel to each other. Two piezoelectric actuators extending in opposite directions 309A and 309B cause the instrument to rotate. In some embodiments, as described above, at least one of the clutch piezoelectric actuators / pairs, i.e., piezoelectric actuator 301 and / or piezoelectric actuator 303, may be part of both the rotating portion and the linear portion of the device. In other embodiments, an additional pair of piezoelectric actuators may be used to rotate the guide wire.
[0328] Now for reference Figure 10 It depicts a schematic diagram of an exemplary device capable of applying linear and rotational motion on a medical instrument according to some embodiments. In some embodiments, the linear motion can be achieved in a inchworm-like manner using piezoelectric motors 401, 402, and 403, substantially as described above regarding... Figures 9A to 9B As described, however, additional piezoelectric motors 404 and 405 act as clutches, moving toward and away from the medical instrument (shown as guidewire 408) via piezoelectric motor 403. To rotate the guidewire clockwise (“CW”), for example, piezoelectric motor 403 is released / retracted, causing piezoelectric motors 404 and 405 to move toward the guidewire 408 until they grip the guidewire on opposite sides. Piezoelectric motor 405 is then extended (moved downwards) while piezoelectric motor 404 is simultaneously released / retracted (moved upwards), causing the guidewire to rotate. Next, piezoelectric motor 401 is extended to grip the guidewire, and piezoelectric motor 403 is extended to release the grip on the guidewire by moving piezoelectric motors 404 and 405 away from the guidewire to their original positions. In an alternative embodiment, an additional piezoelectric motor may be coupled to one of piezoelectric motors 404 and 405 instead of piezoelectric motor 403 to move it toward and away from the guide wire. In such an embodiment, rotation of the guide wire can be achieved by both piezoelectric motors 404 and 405 extending (or retracting) in opposite directions. The piezoelectric actuator used may be, for example, manufactured by PI Ceramic GmbH, Germany. Monolithic Multilayer PZT Actuator. In some embodiments, the rotating plurality of piezoelectric actuators can rotate the entire linear propulsion assembly.
[0329] Now for reference Figure 11 This illustrates a motion control unit with two concentric circular components, according to some embodiments, which can rotate one relative to the other. For example... Figure 11 As shown, the motion control unit 500 includes a first motion control element 502 (e.g., a piezoelectric motor) configured to allow a medical device (e.g., guidewire 510) to move (advance) linearly in any desired linear direction 505. The first motion control element 502 is fixed to the inner concentric circular component 530 (see also...). Figure 12 The motion control unit 500 also includes a second motion control element 504, which is configured to allow rotational movement of the first motion control element 502 by rotating the inner concentric circular member in any desired clockwise or counterclockwise direction 507.
[0330] Figure 11The image further shows an optional configuration in which the proximal end of the medical device is secured to a dedicated retainer 520. In some embodiments, such as when the guidewire comprises a biconcentric guidewire (i.e., an inner guidewire disposed within the lumen of an outer hollow guidewire), the retainer may include a mechanism that allows control of multiple parameters of the medical device (e.g., tip stress), comprising at least one adjuster / slide 503 configured to linearly move the inner guidewire relative to the outer guidewire. Additionally, an extra motion control unit 506 may be present, allowing control of the rotation of the retainer 520 and the device attached thereto.
[0331] Now for reference Figure 12 This illustrates a component of multiple motion control units for controlling more than one medical device, according to some embodiments. For example... Figure 12 As shown, the motion control assembly 600 includes two separate motion control units 602 and 604, which can be used together such that each unit is configured to allow actuation and control of the motion of a different medical device.
[0332] like Figure 12 As shown, a first motion control unit 602 includes various motion elements that allow linear (advancement) and / or rotational movement of a first medical device (e.g., guidewire 610), substantially as described above regarding Figure 11 As detailed herein, a second motion control unit 604 includes various motion elements that allow linear (advancement) and / or rotational movement of a second medical device (e.g., microcatheter 612). In some embodiments, the movement (linear and / or rotation) of the first medical device 610 may be independent of the movement (linear and / or rotation) of the second medical device 612.
[0333] In some embodiments, the movements (linear and / or rotations) of the first and second medical devices can be synchronized. In some exemplary embodiments, such as Figure 12 As shown, the first medical device (e.g., a guidewire) can pass through and advance through the lumen of the second medical device (e.g., a catheter). According to some embodiments, any suitable actuator type can be used in any of the plurality of motion control units, devices, and systems disclosed herein, including but not limited to: plurality of motors (e.g., plurality of DC motors, plurality of AC motors, plurality of stepper motors, etc.), plurality of electromagnetic actuators (sowaries), plurality of piezoelectric actuators, plurality of pneumatic actuators, plurality of hydraulic actuators, etc.
[0334] Figure 13 This is a block diagram of a surgical robot system according to some embodiments.
[0335] In some embodiments, a robotic system 1301 is adapted to an operating room. Optionally, one or more system components (e.g., multiple control components, multiple imaging components) are physically separate from the rest of the system and can be used remotely.
[0336] In some embodiments, system 1301 is configured to receive one or more surgical tools (e.g., a guidewire, a microcatheter, a guiding catheter, an intermediate catheter, and / or other elongated surgical tools) and actuate the movement of said tools.
[0337] In some embodiments, the system is configured to drive linear motion (e.g., advance and / or retract) of a tool housed therein, and / or drive rotational motion (e.g., axial rotation) of a tool housed therein. In some embodiments, linear and rotational motions are actuated simultaneously.
[0338] In some embodiments, system 1301 includes a robotic device 1303 for driving the movement of one or more tools. In some embodiments, the device is housed in and / or operatively connected to one or more of the following components:
[0339] One or more actuators, such as one or more engines 1305, and optionally associated transmissions of the plurality of engines.
[0340] Multiple tool moving elements 1317, such as multiple wheels, are configured to operably contact a tool housed by the system to move the tool (e.g., advance, retract, rotate the tool). In some embodiments, the multiple tool moving elements are driven directly (e.g., by contact) or indirectly (e.g., by one or more gears or other transmissions) by the multiple motors 1305. Alternatively, only some tool moving elements are driven by the multiple motors (directly or indirectly), while other tool moving elements move in response to movement of the tool and / or in response to movement of a motor-driven tool moving element.
[0341] A controller 1307 is configured to receive and / or send multiple operating signals to and / or receive and / or send multiple operating signals from a general-purpose control unit 1309. The general-purpose control unit 1309 may be configured as a remote control device, a control panel, a control unit physically attached to the system base, or a combination thereof. In some embodiments, the controller 1307 is configured to coordinate the manipulation (e.g., linear movement, rotation) of multiple tools housed and operated by the robotic system.
[0342] The power supply device 1311 includes, for example, a battery and / or a connection device for a main power source.
[0343] Sensing device 1315, for example, one or more sensors, configured to detect, for example, whether a tool has been inserted; a relative position of the tool; a position of multiple tool moving components (e.g., multiple wheels); actual movement of the multiple tool moving components (e.g., counting the number of wheel rotations by a counter); and multiple sensors for communication with other system sensors and / or for other measurements and / or indications. In some embodiments, the multiple sensors are configured to detect engine status, such as an engine position or an engine speed. Various types of sensors can be used, such as multiple optical sensors, multiple pressure sensors, multiple force measurement sensors, multiple speed sensors, sensors for detecting current, multiple flow sensors, and multiple position sensors (e.g., multiple optical, magnetic, and electrical position sensors). A memory 1313 stores, for example, multiple parameters related to tool movement, such as movement speed, rotation, translation, angle, and deflection angle; multiple indications obtained by one or more system sensors, such as a measurement of the force acting on the tool or the hardness of the tool; and multiple parameters related to the patient's body and sensed by the inserted multiple tools (e.g., heart rate, blood pressure, temperature, oxygenation level, and / or other sensed parameters).
[0344] In some embodiments, the robotic device (also referred to herein as an insertion device) is compact and small enough to minimize disturbance to operating room personnel (e.g., nurses, surgeons) and / or operating room equipment and / or the patient. In some embodiments, the device covers an area of less than 500 cm², 250 cm², 180 cm², or a medium, larger, or smaller area. In some embodiments, the device has a volume of less than 3500 cm³, 2800 cm³, 2000 cm³, or a medium, larger, or smaller volume. In some embodiments, the device has a weight of less than 1.5 kg, less than 1 kg, less than 800 g, less than 500 g, or a medium, higher, or lower weight.
[0345] In some embodiments, the robotic device is substantially blocky, for example, having a box-shaped dense configuration. Other configurations may include a cylindrical configuration, a circular (e.g., spherical) configuration, a saddle-shaped configuration, and / or others.
[0346] In some embodiments, system 1301 includes an integrated imaging modality 1319. Alternatively, the system is configured to be operatively attached to an existing imaging modality (e.g., to communicate with an existing imaging modality). An imaging modality may include, for example, X-ray fluoroscopy, CT, cone-beam CT, CT fluoroscopy, MRI, ultrasound, or any other suitable imaging modality.
[0347] In some embodiments, system 1301 includes a fastener 1321 for use relative to the patient and / or relative to the operating table placement device 303. In some embodiments, the fastener includes or is configured to be attached to an adjustable fixation device. Optionally, the system is adjustable relative to the patient (e.g., relative to the position the body enters) and / or relative to the bed in terms of height and / or angle and / or distance.
[0348] In some embodiments, system 1301 includes or is configured to engage an adapter 1323 for operatively engaging a proximal portion of a tool, such as a handle.
[0349] In some embodiments, the adapter defines a mechanical engagement between the one or more motors 1305 and one or more components of the handle that moves the tool. For example, the adapter connects one or more motors or associated transmissions to a sliding component of the handle that deflects the tool tip when slidable; a knob component of the handle that, when rotated, causes the tool to roll; and / or other handle components. Alternatively or additionally, the adapter itself includes one or more integrated motors for driving the movement of the plurality of handle components.
[0350] Figure 14 This is a flowchart of a general method of using a surgical robot device according to some embodiments.
[0351] In some embodiments, an operational decision (1401) is made, for example, by a physician, surgeon, and / or other clinical personnel. In some embodiments, the operation is for therapeutic purposes. Alternatively or additionally, the operation is for diagnostic purposes.
[0352] In some embodiments, the operation relates to catheter insertion. In some embodiments, the operation relates to inserting and / or passing one or more tools through the vascular system and / or other non-endovascular structures. Examples of multiple tools may include: a guidewire, a microcatheter, a rapid exchange catheter, a guiding catheter, a balloon catheter, a stent or coil, multiple resection tools, an intermediate catheter, a suction catheter, an ultrasound catheter, a pressure catheter, and / or other tools. In some embodiments, the operation is a percutaneous procedure. In some embodiments, the operation is a wireless procedure.
[0353] In some embodiments, the device is positioned relative to the patient (1403). In some embodiments, the device is mounted to the operating table, for example, via a fixation device. In some embodiments, the device is attached to the patient, for example, on the patient's leg (e.g., the thigh), the patient's arm, and / or other body parts. Multiple straps, multiple bands, a rigid fastener, and / or other attachment devices can be used to attach the device to the operating table and / or the patient.
[0354] In some embodiments, attachment to the bed is achieved using a support stable relative to the mattress and / or the bed rails and / or the floor. The system can then be mounted on the support, for example, via a snap-fit mechanism, magnetic device, strap (e.g., Velcro), and / or other means. In some embodiments, the support is adjustable to accommodate patients of various body types and / or different bed heights. In some embodiments, when setting a position for the device, one or more of a height, an angle of entry into the body, and alignment of the device relative to the patient are selected. The device position can be defined relative to the patient's body or a portion thereof (e.g., relative to the surgical entry point) and / or relative to the operating table and / or relative to other operating room equipment (e.g., relative to multiple imaging modules).
[0355] A potential advantage of attaching the device to the patient's body, such as to a limb and / or other body part (e.g., leg, arm (optionally the snuffbox of the hand), neck, foot, etc.), may include positioning the device closer to the entry point into the body. In such a configuration, the length of a tool segment extending between the device and the body can be reduced, potentially allowing for more efficient use of the tool's length. In some embodiments, the device is compact enough to be mounted on top of a patient's limb, for example, so that it does not protrude laterally from the limb when attached (e.g., the size of the device does not extend laterally from a patient's thigh).
[0356] In some embodiments, the loading of the plurality of tools is performed (1405). In some embodiments, the loading of the plurality of tools is performed after the device position is set (e.g., relative to the patient and / or relative to the bed); alternatively, the loading of the plurality of tools is performed before the device position is set. Optionally, one or more tools are pre-loaded onto the device and optionally provided with the device. In one example, the device is provided in a sterile package while one or more tools are loaded. Additionally or alternatively, for example, the plurality of tools are opened and loaded onto the device in the operating room by a nurse, technician, and / or other clinical personnel. In some embodiments, the plurality of tools are loaded and / or replaced during operation, for example, when switching from a navigation tool (e.g., a guidewire) to a treatment tool (e.g., an embolization tool, a catheter balloon, and / or other treatment tool).
[0357] In some embodiments, the device is constructed such that there is no or no cover (e.g., no physical separation of a wall, a wrap, or a curtain) between the tool moving elements and the loaded tools, for example, allowing direct contact between the tools and the plurality of tool moving elements (e.g., plurality of wheels, plurality of gears, and / or other actuators). Optionally, it is not necessary to cover with a sterile curtain or other cover. For example, in a disposable device placed after surgery, since there are no permanent parts, it is not necessary to cover the device and / or the various specific parts that contact the plurality of tools with a sterile drape. A potential advantage of a device configured to directly engage the plurality of surgical tools without separation or covering may include a simpler, more efficient, time-saving, and / or cost-effective preparation and / or postoperative cleaning process.
[0358] Alternatively, in some embodiments, the device (and / or selected components of the device, such as the multiple tool movement assemblies) is at least partially covered by a sterile curtain or sheath.
[0359] In some embodiments, operations (1407) are performed by controlling the movement of a plurality of surgical tools housed within the plurality of units via a user interface of the device. Exemplary operations of the plurality of tools controlled by the device may include: linear advance and / or retraction of a tool; rotation of a tool (e.g., rolling about the tool axis); twisting of a tool; angular orientation of a tool (e.g., by bending a distal tip of a tool); articulation (e.g., of a distal tip of a tool); for example, altering a plurality of mechanical properties of a tool, such as stiffness, by controlling a distal tip structure or internal configuration from a proximal end of the tool.
[0360] In some embodiments, the manipulation of multiple tools is performed remotely. Optionally, the surgeon operates the system from a different room. Alternatively, the surgeon remains in the operating room and can operate the system whether near or far from the bed.
[0361] In some embodiments, manipulation of multiple tools includes manipulating multiple tools that are attached and / or inserted into each other and / or assembled in a manner in which the movement of one tool may affect another tool, for example, when a guidewire is extended within a lumen of a microcatheter. In this case, controlling the movement may involve performing (through user control and / or by automatic recognition of movement by the system) “compensating” movements of the guidewire and / or microcatheter relative to each other, which may be necessary when both are driven together in an assembled configuration (e.g., when the tool is manipulated in the position of the multiple tool movement elements of the unit in the microcatheter lumen). In one example, when advancing or retracting the microcatheter, it may be desirable to hold the guidewire in place without moving the guidewire with the microcatheter. This can be performed, for example, by driving the multiple linear motion mechanisms of the two tools but in opposite directions (e.g., advancing the microcatheter distally while driving the guidewire mechanism in a manner that will retract the guidewire proximally). One potential advantage of the synchronized, controlled movement of multiple tools used together (e.g., a guidewire extending within a lumen of a microcatheter) may include the ability to hold one tool in place while advancing another, for example by multiple actuation mechanisms that drive the multiple tools in opposite directions—one tool will be advanced or retracted while the other tool will be effectively held in place.
[0362] In some embodiments, the user interface is configured on the device itself (e.g., as a screen and / or multiple buttons and / or a joystick attached to the multiple system units and / or the base), and / or on a separate physician console, and / or on a separate remote control. Multiple control signals can be transmitted to the device via wired and / or wireless communication (e.g., network-based communication).
[0363] In some embodiments, the device (e.g., the device controller) is programmed to include a loading mode for inserting and / or calibrating a plurality of tools and / or the plurality of device motors; and an operating mode for performing the movement of the plurality of tools.
[0364] In some embodiments, the device or its various specific components (1409) are disposed of after operation. Optionally, the device is disposed of as a whole, optionally including the various tools mounted thereon.
[0365] Figure 15This is a flowchart of a method for loading multiple surgical tools onto a surgical robot device according to some embodiments.
[0366] In some embodiments, a robotic device (1501) is provided, such as that described herein. In some embodiments, one or more elongated surgical instruments are provided, such as a guidewire, a microcatheter, a guiding catheter, a rapid exchange catheter, and / or other surgical instruments (1503).
[0367] In some embodiments, a proximal handle of a tool, such as a guidewire, is positioned to engage with a designated adapter or retainer (150), for example in the co-filed patent application entitled “ROBOTIC MANIPULATION OF A SURGICALTOOL HANDLE” (PCT patent application No. PCT / IL2020 / 051225), which is incorporated herein by reference.
[0368] In some embodiments, the guidewire (e.g., from the distal direction) is screwed into a designated shaft (1507) of the guidewire drive mechanism of the robotic device. Then, at least a portion of the guidewire length that has exited the shaft (present in the device housing) is screwed into a lumen of a microcatheter (1509).
[0369] In some embodiments, a proximal end of the microcatheter (not yet physically attached to the device) is secured to the device (1511) at an outlet port of the guidewire from the housing. Then, at least a portion of the length of the microcatheter (including the guidewire housed within) is screwed into a designated shaft (1513) of the microcatheter drive mechanism of the device. The microcatheter (along with the guidewire housed within) is then passed through a lumen (1515) of a guide catheter.
[0370] Optionally, the guide catheter is housed or engaged by a guide catheter drive mechanism, which may be externally operably coupled to the device housing, or alternatively integrated inside the device.
[0371] Then, in some embodiments, the one or more tools are introduced into the patient's body (1517) and manipulated using the device.
[0372] In one exemplary use, the robotic device is loaded with a guidewire and optionally a microcatheter. Optionally, a guide catheter (a distal portion thereof) is manually inserted into the patient. The robotic device is then positioned near a proximal end of the guide catheter, and the guide catheter (optionally together with a microcatheter housing the guidewire therein) is inserted into the lumen of the guide catheter. In some embodiments, the lumen of the guide catheter is inserted via a sealing element, which may be an integrated part of the robotic device or, alternatively, separate from the robotic device. Then, in some embodiments, the user connects the proximal end of the guide catheter to the robotic device. From this point onward, manipulation (e.g., linear advance / retraction and / or rotation) of the guidewire and / or the microcatheter within the lumen of the guide catheter and optionally as the guidewire and / or microcatheter exit the guide catheter (e.g., into a lumen of a blood vessel) can be performed robotically using the device (e.g., via a remote control interface). In some embodiments, the linear advancement and / or retraction of the guiding catheter, for example within a certain limited range, is also performed using the robotic device.
[0373] Figures 16A to 16D Various configurations of a remote control device for a surgical robot system according to some embodiments.
[0374] In some embodiments, the remote control device is shaped to be manually held by a user (e.g., a physician). Optionally, the remote control device is lightweight and small in size, allowing the user to hold it without obstructing their view of multiple visual aids, such as a screen displaying multiple imaging results during operation. In some embodiments, the remote control device includes one or more portions shaped to be grasped by the user's palm and / or engaged by multiple of the user's fingers.
[0375] In some embodiments, the remote control device communicates with the modular robot system. In some embodiments, the communication is wireless, for example, via Wi-Fi, infrared, Bluetooth, RF, and / or other wireless modules.
[0376] In some embodiments, the remote control device includes or communicates with a controller of the modular robotic system. In some embodiments, the manipulation of a plurality of tools housed in the system is performed via the remote control device. Examples of the movement of the plurality of tools controlled by the remote control device and / or other operational manipulations of the plurality of tools may include: linear advance and / or retraction of a tool; axial rotation of a tool; control of the distal tip of a tool; movement speed; control of multiple unique tool functions (e.g., inflation / deflation of a balloon in a balloon catheter, stent deployment and / or advance) and / or other tool manipulations.
[0377] Several other functions that can be controlled by the remote control device include, for example: automatically injecting multiple materials (e.g., multiple contrast agents, multiple washing solutions) through a tool lumen; linear and / or angular movement of the assembly system as a whole (e.g., sliding of the assembly system relative to a fixture); safe stopping of the system; on / off actuation of the system; supplying power to the system or multiple specific components; and / or multiple other system functions.
[0378] Figures 16A to 16B A first example of a remote control device 1601 is shown. Figures 16C to 16D A second example of a remote control device 1603 is shown. In some embodiments, the device includes multiple interfaces of one or more of the following forms: multiple buttons 1605, multiple joystick handles 1607, multiple manual sliders 1609, multiple knobs 1611, etc.
[0379] In some embodiments, the remote control device includes a screen, for example for notifying a user about current multiple controls and / or for receiving multiple instructions from the user.
[0380] In some embodiments, the remote control device includes an interface (e.g., a button) for quickly retracting multiple tools. This interface can be used in an emergency, device malfunction, or other similar situation, and / or for the planned retraction of a tool, such as for replacing the tool with a new one.
[0381] In some embodiments, the remote control device is modular. Optionally, multiple specific buttons and / or multiple additional interfaces are selectively attached (and / or exposed to enable their use). For example, multiple buttons for controlling the movement of a guide catheter (when a guide catheter receiving unit is attached to the system) are exposed for use only when needed (e.g., positioned under a removable or movable cap). In another example, an interface for controlling the injection of multiple materials through one or more system interfaces is attached to the remote control device and / or is available for use without a cap when needed.
[0382] The remote control device can be operated from a location away from the system. Optionally, the remote control device is operated by a surgeon located in a different room. Optionally, the remote control device is operated by a surgeon located in the operating room (near or away from the bed).
[0383] In some embodiments, the remote control device may be configured as a screen interface, such as for a mobile phone, tablet computer, computer, etc., as described below.
[0384] Figure 17This is an illustrative example of a screen interface associated with the surgical robot system according to some embodiments.
[0385] In some embodiments, a screen interface 1701 communicating with the system may be used, additionally or alternatively, as a remote control device, such as as described above. In some embodiments, the screen interface is configured to receive data (e.g., from the device and / or from an imaging device and / or from a physician and / or from a hospital system), present data, send and / or receive multiple instructions to and from the robotic device, and send and / or receive multiple instructions and / or other instructions from the robotic device.
[0386] In some embodiments, the screen interface may be configured in a computer, laptop, tablet computer, as a mobile application and / or others.
[0387] The user interface screen shown in this figure displays multiple examples of functions and / or instructions related to the operation of the multiple tools by the robotic device, including but not limited to: tool movement types (e.g., guidewire rolling, guidewire advance / retraction, microcatheter advance / retraction, guide catheter rolling, guide catheter advance / retraction); guidewire tip control (e.g., guidewire tip deflection); tool speed and / or direction of movement (e.g., using a "turbo" mode to increase the speed, initiating rapid or partially rapid retraction); emergency stop (in case of device failure, medical emergency, etc.; in some embodiments, the emergency stop button stops power supply to the robotic device); simultaneous control of the movement of two (or more) tools; customized control of tool movement, such as: control of multiple accessories, including multiple devices and / or multiple additional accessories used with the system and / or multiple tools, such as: material injection through a port; balloon inflation; stent expansion; tip curvature; tool stiffness.
[0388] Figures 18A to 18B These are different views of a robotic device according to some embodiments.
[0389] In some embodiments, a robotic device 1801 is shaped and sized to be located near the patient (e.g., attached to the bed) and / or on the patient, such as on a limb (e.g., on the patient's thigh). In the illustrated example, device 1801 includes a uniform housing 1802 having a saddle-shaped base 1803. Optionally, the saddle-shaped portion is shaped and sized to be able to be placed on a patient's limb, on a track of the bed, on a designated fixture (e.g., a fixture having a flat bottom for positioning on a flat surface, not shown), and / or others. In some embodiments, a second portion 1805 of the housing extends from the saddle-shaped base, the second portion accommodating one or more tool drive mechanisms.
[0390] In some embodiments, a guidewire is loaded onto the device 1801 as follows: In some embodiments, a proximal portion of the guidewire (e.g., a handle) is housed within an accessible compartment 1807, optionally covered by a cover 1809 (compartment 1807 may also be referred to herein as an "adapter" or "retainer"). Optionally, manipulation of one or more guidewire handle components within compartment 1807 is performed by one or more actuators engaging the handle (e.g., a slider engaging the handle, a knob of the handle, and / or other handle components).
[0391] In some embodiments, a distal portion of the guidewire (adjacent to the handle) exits the compartment 1807 through hole 1813. Then, in some embodiments, a distal portion of the guidewire (optionally, the most distal end of the guidewire) is inserted into the device housing through an inlet hole 1811, wherein the inserted guidewire is received within a designated shaft (not shown) of its drive mechanism. In some embodiments, the guidewire is withdrawn again from the housing through hole 1815, optionally from an opposing wall of the housing. In some embodiments, a location of hole 1815 also serves as a fixation point for a proximal end of a microcatheter. Optionally, the microcatheter is screwed onto a knob 1817 and / or other suitable protrusion to secure it to the housing. When the guidewire is withdrawn through hole 1815, it is received within a lumen of the microcatheter.
[0392] In some embodiments, the microcatheter (along with the inwardly extending guidewire) is bent (e.g., into a "U" shape) outside the housing to be inserted through a hole 1819 into a designated shaft of the microcatheter drive mechanism. The microcatheter (along with the internal guidewire) then exits the housing through a hole 1820 on an opposing wall.
[0393] In some embodiments, the shape and size of the device housing are solely for accommodating the plurality of tool drive mechanisms, unaffected by multiple tool size considerations, such as tool length or tool width (e.g., diameter). Optionally, the housing protects the internal tool drive mechanisms while only the plurality of tools themselves remain visible and / or accessible externally to the housing. Optionally, there are no visible drive mechanisms. A potential advantage of this configuration may include a reduced risk of damage to the plurality of tool drive mechanisms (e.g., due to unwanted contact).
[0394] In some embodiments, a portion of a tool extending within the housing itself is less than 25%, 20%, 10%, 5%, or an intermediate, larger, or smaller percentage of the total length of the tool. A potential advantage of a housing that accommodates the plurality of drive mechanisms and does not require housing a long portion of a tool within it may include allowing for a relatively compact housing with small size and / or light weight.
[0395] In some embodiments, the housing includes a removable or movable portion, such as a cover. Optionally, the cover can be opened in an emergency and / or robot malfunction, for example, to manually release the plurality of tools. Alternatively, the cover can be opened when it is necessary to replace the plurality of tools.
[0396] In some embodiments, opening the cover automatically returns the plurality of device motors to an initial (home) position and / or orientation. Optionally, the plurality of actuation mechanisms of the plurality of tools, for example, in which a designated shaft housing a tool, is rotated to align such that a groove extending along the shaft faces upward in the orientation of the opened cover. A potential advantage of automatically aligning the plurality of motors and / or the plurality of tool shafts when the cover of the device housing is opened may include easier access for adjusting and / or removing a tool from its mechanisms.
[0397] An exemplary dimension of the upper part 1805 of the device (without the saddle-shaped bottom, which can replace the terrain as a flat surface) may include: an axial length 1821 less than 12 cm, a width 1823 less than 7 cm, and a height 1825 less than 9 cm.
[0398] In some embodiments, the housing 1802 is formed of a relatively lightweight but durable material, such as plastic, aluminum, or composite material. Optionally, the material is recyclable, thereby allowing at least partial recycling of a disposed device (e.g., a single-use device).
[0399] Figures 19A to 19B A surgical robot device, including or attached to a guide catheter drive unit, is schematically shown according to some embodiments.
[0400] Figures 19A to 19B Robotic devices with different shaped shells are shown. Figure 19A The above shows examples such as Figures 18A to 18B The robot device housing 1900 described herein is located on a fixture 1921 that defines a flat surface. Figure 19B It shows a box-shaped shell 1902 with a square or rectangular cross-sectional profile.
[0401] In some embodiments, a guide tube drive mechanism 1901 is configured as a separate attachment unit, which is configured to be operatively coupled to the robotic device, for example, to the device housing 1903.
[0402] In some embodiments, the guide catheter drive unit is attached to the housing by means of a microcatheter present in the housing (e.g., through orifice 1905) entering a lumen of a guide catheter mounted on the guide catheter unit. In some embodiments, the attachment of the guide catheter unit to the housing is achieved through one or more of the following: an interference fit connector (e.g., through a plurality of corresponding protrusions and recesses of the device housing and a housing of the guide catheter drive unit), a sliding attachment (e.g., including a track 1906, such as...). Figure 19A (As shown).
[0403] In some embodiments, track 1906 movably couples the guide duct drive unit 1901 to one or more motors located within the housing of the device, for example, such that one motor drives reciprocating motion of the unit for moving the guide duct. In some embodiments, the guide duct drive mechanism is configured to drive linear and / or rotational motion (i.e., rolling) of the guide duct. In some embodiments, the guide duct drive unit is configured to be electrically connected to and receive power from the robotic device. Alternatively, the guide duct drive unit includes a separate power source (e.g., a battery).
[0404] In some embodiments, the guide tube drive unit is connected to the robot device via multiple mechanical connections, such as a snap-fit connection, an interference-fit connection, a pin and socket, and / or other suitable mechanical connectors.
[0405] Alternatively, in some embodiments, the guide tube drive mechanism is located within the housing of the robotic device and forms part of the robotic device.
[0406] In some embodiments, the guide catheter actuation mechanism is configured to drive the guide catheter linearly within a selected distance range, for example, advancing and / or retracting the catheter by 3 cm, 5 cm, 10 cm, or a distance that is intermediate, longer, or shorter. In some embodiments, this provides fine-tuning of the position of a guide catheter previously inserted into the patient.
[0407] In some embodiments, to ensure that a microcatheter within the guiding catheter moves together with the guiding catheter, the microcatheter actuation mechanism is controlled to compensate for that movement, for example, by driving the microcatheter to move in the opposite direction to the guiding catheter. Optionally, a guidewire within the microcatheter moves together with the microcatheter as a single unit and does not require independent actuation.
[0408] Figures 20A to 20C This is an example of a separate mechanism of the guide catheter drive unit according to some embodiments, an example of a guide catheter drive unit housing, and an example of a guide catheter drive unit assembled onto the robotic surgical system.
[0409] In some embodiments, a guiding catheter mechanism (see...) Figure 20A The device includes one or more motors, such as a motor 2001 for driving linear motion and a motor 2003 for driving rotation. In some embodiments, a proximal portion of the guide conduit 2005 is attached to a connector 2009. In some embodiments, during operation, the motor 2001 rotates a lead screw 2007, which in turn advances or retracts the connector 2009, thereby advancing or retracting the guide conduit 2005. In some embodiments, the motor 2003 moves linearly together with the connector 2009.
[0410] In some embodiments, starting the engine 2003 causes the connector 2009 to rotate, thereby rotating (rolling) the guide duct 2005.
[0411] Figure 20B This is an appearance of a guide tube unit 2000. In some embodiments, the unit includes an elongated housing 2011, and the guide screw 2007 (e.g.) Figure 20A (As shown) extends through the housing. In some embodiments, the housing includes one or more ports leading to the lumen of the guiding catheter. For example, an injection port 2010 through which multiple materials (e.g., multiple liquid reagents, saline, etc.) can be injected into and through the lumen of the guiding catheter.
[0412] In some embodiments, the housing 2011 is shaped to attach to the robotic device. In one example, the housing defines a support 2012 that can be abutted against or at least partially connected to the outer housing of the robotic device, for example by being received within a corresponding recess or notch defined in the housing of the robotic device.
[0413] Figure 20CThe guide catheter unit 2000 is shown connected to a robotic device 2013. In some embodiments, the guide catheter unit is coupled to an outer wall of the device housing 2015. Optionally, the guide catheter unit extends distally along the direction of insertion into the patient.
[0414] As further illustrated in this example: a guidewire 2019 extends from a guidewire holder 2021 into a designated axis of the guidewire drive mechanism; then the guidewire exits the housing at 2025, the housing also serving as a fixing point for the microcatheter 2027, and the guidewire enters the lumen of the microcatheter. Next, the microcatheter is bent at 2029 to enter the device housing and is housed within a designated axis of the microcatheter drive mechanism. When the microcatheter (along with the guidewire housed therein) exits the housing, it is housed within a lumen of the guidewire 2005, held and manipulated by the guidewire unit 2000.
[0415] Figures 21A to 21C The diagram illustrates a mechanism, according to some embodiments, for driving the rotation (rolling) and / or linear motion of a tool actuated by the robotic surgical system.
[0416] In some embodiments, such as Figure 21A As shown in the exemplary mechanism, a guide wire 2101 inserted into a designated shaft engages with at least one pair of drive wheels 2103 positioned opposite each other and contacting the guide wire passing between them. A motor 2105 for driving the linear motion of the tool drives the rotation of the plurality of wheels, which, depending on the direction of rotation, causes the guide wire to move axially in a proximal or distal direction.
[0417] In some embodiments, an engine 2107 is configured to drive rotation of a first gear 2109, which in turn interferes with a second gear 2111 (located near or on top of gear 2109), causing the second gear 2111 to rotate. In some embodiments, rotation of the second gear 2111 produces rotation of the assembly comprising the plurality of drive wheels 2103 and the linear engine 2105, thereby causing the assembly (along with the guide wire held therein) to rotate as a whole.
[0418] In some embodiments, when gear 2109 rotates, it causes a retainer 2121 of the guide wire to rotate, thereby causing the guide wire to rotate (roll). Therefore, in some embodiments, the rotation (rolling) of the guide wire occurs at two locations along the guide wire: a first location at the retainer 2121 and a second location at the assembly including the plurality of drive wheels and the linear motor—which rotates as a whole with the guide wire. A potential advantage of rolling the guide wire at two locations along the guide wire, where optionally one location is closer to the curve and the other is farther from the curve, can include reducing the twisting of the guide wire during rolling, for example, by synchronously driving rotation at both locations, optionally by performing the rolling motion at both locations via a single motor.
[0419] A potential advantage of using the same single motor (e.g., motor 2107 via moving gear 2109) to drive rotation of the guidewire at two locations along the guidewire length may include improved control over the guidewire roll, for example, compared to using multiple different motors at the two(or more) locations, which may require synchronization between the directions and / or speeds and / or actuation timings of the multiple motors. Another potential advantage of using the same single motor to drive rotation at two different guidewire length locations may include providing a more compact and smaller device housing.
[0420] Alternatively, rotation of gear 2109 does not directly rotate the guide wire (e.g., by non-rotating retainer 2121), but rather drives the rotation of the guide wire, which begins only from the point of rotation of the component by gear 2111 (when gear 2111 is rotated by gear 2109).
[0421] In some embodiments, one or more slip rings are used to supply current to the plurality of motors regardless of the current direction (e.g., rotation direction) of the component. For example, a slip ring consisting of a rolling bar 2117 and a base 2119 is located at the attachment point of the second gear 2111 to the plurality of drive wheels and the linear motor assembly. In some embodiments, the slip ring maintains an electrical coupling with the linear motor so that the linear motor can be actuated regardless of the rotation direction of the component.
[0422] In another exemplary structure, such as Figure 21B As shown, a drive engine and / or a gear 2113 that transmits rotation from the drive engine can directly interconnect with the assembly of the plurality of drive wheels and / or with the drive engine 2105 that drives linear motion and / or with a shaft housing the tool. In one example, the gear 2113 is positioned along a long axis similar to that of the assembly.
[0423] In some embodiments, gear 2113 has a groove 2123 through which the guide wire passes. Optionally, groove 2123 forms a groove 2125 extending directly within a designated shaft 2127 for receiving the guide wire. In some embodiments, the groove extends along a 5-degree, 10-degree, or 20-degree arc around the gear. A potential advantage of a groove passing through the gear may include facilitating removal of the guide wire from the actuation mechanism.
[0424] Figure 21C This is a cross-sectional view showing an actuation assembly comprising a shaft 2127 and a plurality of wheels 2103 that drive linear motion of the guidewire. In some embodiments, the shaft 2127 defines an elongated cavity 2129 for receiving the guidewire, the cavity communicating with a groove 2125. In some embodiments, a plurality of inner walls of the shaft 2127 are configured to conform to a profile of the plurality of wheels (see, for example, curvature 2128) such that a guidewire within the cavity 2129 is guided into (and then from) a pathway between the plurality of wheels. In some embodiments, the cavity 2129 extends near the outer profile of the plurality of wheels to bring the guidewire directly between the plurality of wheels.
[0425] In some embodiments, the plurality of wheels 2103 are arranged (located) on a plane substantially perpendicular to a plane defined by the groove 2125. Alternatively, the plurality of wheels may be arranged on a plane parallel to a plane defined by the groove 2125.
[0426] A potential advantage of configuring an shaft to match the profile of the plurality of wheels may include improved control of the guidewire as it is fed into (and withdrawn from) the path between the plurality of drive wheels. Another potential advantage may include reducing the risk of the guidewire slipping out and / or otherwise deviating from its intended path.
[0427] A potential advantage of an assembly including multiple wheels for driving the linear motion of the guidewire and configured to rotate as a whole to produce guidewire rolling can include the ability to perform linear motion during rolling motion (and vice versa). Another potential advantage of a dual-motion assembly driving linear motion and rotation in the same physical location (within the robotic device) can include reduced slippage or other potentially unwanted guidewire movements, for example, if two spaced-apart mechanisms drive linear and rolling motions respectively, the guidewire needs to extend between them. In spaced-apart mechanisms where one mechanism drives rotation and another spaced-apart mechanism drives linear motion, the rotation of the guidewire can cause it to slip between the rotating mechanism and the linear motion mechanism (and vice versa – the linear motion of the guidewire can cause it to slip out of the rotating mechanism). Another disadvantage of separate, spaced-apart mechanisms is the potential for friction to occur at idle points (i.e., friction being applied to a tool segment at a currently unused mechanism), which may require some type of release mechanism that disengages from one mechanism when the other is operated.
[0428] Figure 22 An exemplary configuration of a plurality of mechanisms for driving the movement of a guidewire according to some embodiments is shown.
[0429] In some embodiments, guidewire rotation is performed by more than one mechanism. Optionally, two or more mechanisms engaging the guidewire are configured to cause rotation (rolling) of the guidewire. In this case, the two mechanisms are controlled synchronously, for example to ensure that the guidewire is not twisted or kinked.
[0430] In some embodiments, a proximal portion of the guidewire or a handle is held within an adapter or retainer 2201, adapted to rotate the handle as a whole by rotation, and / or to generate rotation of the guidewire by actuating a handle component, such as a rotatable knob (not shown), which generates rotation (rolling) of the guidewire (optionally, rolling of a distal tip of the guidewire). The guidewire extends from the retainer 2201 along an axis 2203 of its rotation until exiting the housing. When the guidewire enters the housing, it can be actuated by a second mechanism adapted to rotate (also linearly in this example). The second mechanism, for example, is as follows: Figure 21B The mechanism shown can be configured to actuate the guidewire to rotate (roll) about an axis 2205 along which the guidewire extends. Optionally, axis 2205 is parallel to axis 2203, defining multiple parallel paths through which tool actuation occurs. Alternatively, the multiple paths of the tool defined along axes 2205 and 2203 are not parallel, for example, tilted inward or outward relative to each other.
[0431] In some embodiments, the plurality of mechanisms extend to a similar height and / or axial length, such that they can be mounted in a uniformly sealed housing.
[0432] Figures 23A to 23B This is a schematic diagram and a flowchart according to some embodiments regarding controlling the length and / or position of a tool by adjusting a curved portion of the tool.
[0433] In some embodiments, such as Figure 23A As schematically shown, a tool 2301 operated by the robotic device 2302 engages at two or more spaced-apart positions 2303, 2305 (along the length of the device), such that the extension of a segment 2307 of the tool between the two positions is adjustable (lengthened or shortened). In some embodiments, positions 2303, 2305 define multiple attachment points of the tool 2301 to the housing 2302 of the robotic device, while segment 2307 extends outside the device (i.e., outside the housing).
[0434] In some embodiments, positions 2303 and 2305 are arranged relative to each other in a manner that causes a bend or curvature in the segment 2307, for example, a "U"-shaped curvature as shown in the figure. In one example, positions 2303 and 2305 are aligned side by side.
[0435] Instead, positions 2303 and 2305 are not aligned side-by-side.
[0436] In some embodiments, in order to control a length of the tool, the size of the curve (e.g., the "U" shape) is changed (e.g., expanded or contracted), and a maximum distance 2309 between a peak of the curve and the housing of the device 2302 is changed.
[0437] In some embodiments, a range of the curve (e.g., defined by a radius 2310 of curvature) is set by the linear movement of the tool (e.g., a range of tool advance or retraction) and / or by manually loading the tool, wherein a segment of the tool's length is loaded into the system. In some embodiments, the range of the curve depends on a total length of the tool.
[0438] In some embodiments, a distance 2312 between the tool and the plurality of attachment points of the housing is a function of a radius 2310 of the curvature of the tool. Optionally, the distance 2312 is twice the minimum radius of curvature to which the tool can bend.
[0439] In some embodiments, the size of the housing 2302, such as a range of a wall of the housing forming the inlet and outlet holes of the tool, is determined according to the radius of the curvature of the tool, for example, at least twice a minimum radius of curvature of the tool, but not exceeding 5, 6, 8, 10, or an intermediate, larger, or smaller multiple of the minimum radius of curvature of the tool for operation of the device.
[0440] In some embodiments, a maximum dimension of the housing (e.g., a width or a height of the housing) is between 5 and 10 cm, 8 and 20 cm, 12 and 40 cm, or in between, longer or shorter.
[0441] In some embodiments, the device includes two or more engagement points with the tool, allowing multiple curves (e.g., "U"-shaped curves) to be formed between the locations.
[0442] A potential advantage of a device that defines tool engagement positions such that the length of a tool segment extending between said positions is adjustable may include improved control over the length of the manipulated tool. Optionally, controlling the length of a distal tool segment, such as a segment extending between the final exit of the robotic device housing and a target point within the patient's body, could potentially allow for fine control over the position of the distal tip of the tool. In some embodiments, pushing the tool toward the target point within the body reduces the size of the curve of the tool outside the housing, and vice versa: retracting the tool from the target point increases the size of the curve.
[0443] Another potential advantage of a device that defines tool engagement positions so that the length of a tool segment extending between said positions is adjustable may include the ability to receive and manipulate multiple tools of various lengths.
[0444] Another potential advantage of a device that defines the tool engagement position so that the length of a tool segment extending between the positions is adjustable may include the bending segment extending outside the device housing, potentially allowing a device to have a relatively small size (e.g., axial length) that is substantially unaffected by the tool length, thereby achieving a small-sized, uniformly sealed housing.
[0445] Figure 23B The flowchart mentioned above is from Figure 23AAn example of the mechanism described in the figure is shown. In some embodiments, a tool is proximal to the robotic device (2321). For example, a handle of the tool is received and / or attached by a designated adapter or retainer of the device. This attachment may be referred to as a first engagement position, for example as described above. In some embodiments, a distal portion of the tool is screwed into or inserted into the robotic device (2323). For example, a distal portion of the tool is screwed into a designated shaft of the manipulation mechanism (e.g., inserting a guide wire to engage with the plurality of tool movement wheels). This second attachment may be referred to as a second engagement position, for example as described above.
[0446] Next, optionally, the length of a tool segment extending between the fixed position at the proximal end of the tool and the engagement position of the tool (e.g., via the plurality of tool movement wheels) is adjusted (2325).
[0447] Figure 24 A system configuration is shown, which defines an arrangement of multiple tools according to some embodiments, wherein the length of one tool can be adjusted.
[0448] In the illustrated example, a robotic device 2401, including and / or coupled to a guide catheter unit 2403, is configured to receive and drive the movements of a guidewire 2405, a microcatheter 2407, and a guide catheter 2409. In some embodiments, as shown in this example, two U-shaped curves 2411 and 2413 are defined by multiple tools passing through the system: curve 2411 of the guidewire alone, and curve 2413 of the guidewire as it extends within the lumen of the curved microcatheter. In some embodiments, a change in the size of curve 2413 causes the microcatheter and guidewire to move together at multiple segments away from the curve. In some embodiments, movement (advancement or retraction) of the microcatheter changes the size of curve 2413.
[0449] As in Figure 24As can be observed, the device housing 2402 (i.e., the plurality of walls of the housing) defines a plurality of orifices through which the plurality of tools enter and / or exit the internal device space defined by the housing: In some embodiments, a proximal portion of a guidewire 2405 is anchored to the device at a retainer 2404; then, the guidewire enters the housing at an orifice 2406 and exits through an orifice 2408, wherein the orifice 2408 is optionally located on a wall of the housing opposite to the wall defining the orifice 2406. In some embodiments, a proximal portion of a microcatheter 2407 is anchored to the device at a retainer 2410, where the guidewire is also received within the lumen of the microcatheter. Next, in some embodiments, the microcatheter enters the housing at an orifice 2412 and exits the housing at an orifice 2414, the orifice being optionally located on a wall of the housing opposite to the orifice 2412.
[0450] Figure 25 The diagram schematically illustrates multiple tool movement drive mechanisms of the system according to some embodiments.
[0451] In some embodiments, as illustrated in the example, multiple tool moving mechanisms are arranged parallel to each other, for example, side by side. A potential advantage of having the multiple tool moving mechanisms parallel to each other (and optionally aligned along a similar axial range) may include that a tool extending through the multiple mechanisms can be adjusted to bend, thereby providing a variable tool length. A potential advantage of having the multiple tool moving mechanisms parallel to each other (and optionally aligned along a similar axial range) may include that the device housing housing these mechanisms can be kept in a relatively small, compact size, which is not determined by the actual length of the tool.
[0452] The plurality of tool movement mechanisms shown herein include a mechanism 2501 for holding and optionally rotating a guidewire 2502 (see, for example) Figure 21A (as described above); a mechanism 2503 for actuating linear translation of the guidewire, including, for example, a plurality of wheels 2505; and a mechanism 2507 for actuating linear translation of a microcatheter 2508, including, for example, a plurality of wheels 2509.
[0453] In some embodiments, guidewire rotation may be performed at one or both of mechanisms 2501, 2503, optionally in a synchronized manner (e.g., via a device controller).
[0454] Figures 26A to 26B This is an example of a device configuration according to some embodiments, including multiple elastic elements (e.g., multiple springs) for selectively engaging multiple tools housed by the system.
[0455] In some embodiments, a plurality of resilient elements (e.g., a plurality of springs, a plurality of strips) are positioned and configured to move (e.g., push) the plurality of drive wheels toward a tool housed within the device, bringing the plurality of wheels into close contact with the tool. Alternatively or additionally, a plurality of resilient elements are positioned and configured to move (e.g., push, center) a tool housed within the device, bringing it into operative contact with the plurality of drive wheels.
[0456] In the example shown, a spring 2601 is mounted on a lever 2603 that holds the plurality of drive wheels 2605, such that when a force is applied to the spring, the lever moves the plurality of wheels to contact the tool. In some embodiments, a force is applied to the spring by the closing or movement of a portion of the housing, such as the closing of a cover. In some embodiments, the spring is configured to retract the lever to move the plurality of wheels away from the tool, for example to allow removal of the tool. Optionally, the spring is pulled up when the cover (or other portion of the housing) is opened or otherwise moved, thereby removing the plurality of wheels from the tool.
[0457] In some embodiments, the spring is pre-configured to apply a force selected for a particular tool or tool size (e.g., tool diameter), for example, positioning the plurality of wheels in contact with a tool of a particular thickness.
[0458] Figure 27 This is a schematic block diagram of a robotic device configured to manipulate two or more elongated surgical tools according to some embodiments.
[0459] In some embodiments, a plurality of walls of a housing 2701 of the robotic device define an internal volume 2703, in which at least two distinct paths, such as 2705 and 2707, are defined for the elongated surgical instrument. In some embodiments, the pathways extend through the internal volume, for example, between two opposing walls of the housing, such as walls 2709 and 2711. Optionally, the housing is shaped into an elongated form, for example having a substantially rectangular cross-sectional profile, and the plurality of paths extend along the length of the housing.
[0460] In some embodiments, each of the plurality of paths extends between an inlet hole formed at one wall of the housing and an outlet hole formed at an opposite wall of the housing. In the example shown, path 2705 extends between an inlet hole 2713 formed at wall 2709 and an outlet hole 2715 formed at wall 2711; and path 2707 extends between an inlet hole 2717 formed at wall 2711 and an outlet hole 2719 formed at wall 2709.
[0461] In some embodiments, the shape and / or size of an opening formed in one wall of the housing is determined by the surgical instrument passing through it. For example, a circular (e.g., round) opening is designed to fit a cylindrical tool, such as a guidewire or microcatheter, wherein the diameter of the opening may optionally not exceed 5%, 10%, 25%, or an intermediate, higher, or lower percentage of a diameter of the tool. In some embodiments, an opening is designed to allow more than one tool to pass through. Optionally, the opening profile is elliptical (e.g., elliptical), rectangular, slotted, and / or other shapes. In some embodiments, a single elongated slot serves as an opening for two internal paths.
[0462] In some embodiments, a single tool enters the internal volume of the housing through an inlet port and exits the housing through a corresponding outlet port. Alternatively, in some embodiments, multiple telescopically arranged tools (e.g., two tools, such as a guidewire disposed within the lumen of a microcatheter) exit the housing together through the same inlet port and together through a respective outlet port. Thus, in such an example, a first tool exits the housing through a first internal path and enters the lumen of a second tool, and the telescopic components of both tools pass through a second internal path. In some embodiments, the telescopic configuration of the multiple tools occurs outside the housing after both tools have passed through their internal paths, for example, in the case of a quick-change catheter, which may intersect with the guidewire after each of the guidewire and the quick-change catheter has independently passed through their respective actuation components located in the multiple internal paths.
[0463] In some embodiments, the plurality of paths extend in a similar plane, for example, a similar horizontal plane, a similar vertical plane, and a similar plane extending diagonally between the plurality of walls of the housing. In some embodiments, the plurality of paths extend along a plurality of parallel axes. A distance 2721 between the plurality of parallel axes may be, for example, between 3 and 12 cm, 2 and 10 cm, 5 and 9 cm, or a distance longer or shorter.
[0464] Alternatively, in some embodiments, the plurality of paths are not parallel; for example, one path extends directly between multiple opposing walls, while another path takes a diagonal or other indirect route.
[0465] In some embodiments, the housing is sealed except for the locations of the plurality of openings. Optionally, the housing includes a removable or movable cover or lid. In some embodiments, the housing is at least partially open, for example, shaped as a box without a top surface.
[0466] In some embodiments, all components that engage with the tool to manipulate the tool and / or drive its movement are completely enclosed within the internal volume of the housing, and at least some of these components are positioned along the path defined for the tool. In some embodiments, these components include a moving assembly, such as... Figures 21B to 21C The plurality of tool moving elements described herein.
[0467] In some embodiments, as shown, a plurality of motors 2722, 2723 are configured to drive the plurality of actuation components, such as a plurality of tool moving elements 2725 (e.g., a plurality of wheels) of each component. In some embodiments, the motors and the plurality of tool moving elements are positioned along a path defined for the tool. In some embodiments, the plurality of actuation components of the two(or more) paths are aligned side-by-side. A potential advantage of the side-by-side alignment of the plurality of actuation components may include allowing a short or minimum distance 2728 (optionally the width or height of the device) between the opposing walls 2733, 2735. In one example, the distance 2728 is less than 15 cm, 12 cm, 10 cm, or a distance that is intermediate, longer, or shorter.
[0468] In some embodiments, the plurality of actuation components of the two or more paths have a similar axial range (or do not extend beyond a certain axial range). A potential advantage of the plurality of actuation components being positioned relative to each other and / or sized such that they do not extend beyond a certain axial range may include a distance 2730 between walls 2709 and 2711 (optionally the length of the device) being kept within a minimum axial range required to include the plurality of motion drive components. In one example, distance 2730 is less than 10 cm, 7 cm, 12 cm, or a distance in between, longer, or shorter. In some embodiments, a plurality of motors 2722, 2723 are also positioned within the axial range of the plurality of actuation components and close to the plurality of actuation components to facilitate the compact design of the device. The ability to position the motors close to and potentially in contact with at least a portion of the plurality of actuation components is provided, for example, because no barrier (e.g., sterile protection or shield) is required between the actuation components, the motors, and the manipulated surgical instrument.
[0469] In some embodiments, the plurality of actuating components of the two or more paths are positioned within the same, shared internal volume defined by the plurality of walls of the housing. In some embodiments, there are no barriers (e.g., plurality of inner walls, plurality of shields, plurality of curtains, etc.) between the plurality of motion drive components of the two or more paths. In some embodiments, there are no barriers (e.g., plurality of inner walls, plurality of shields, plurality of curtains, etc.) between the plurality of actuating components and the plurality of tools manipulated by them.
[0470] Alternatively, in some embodiments, a partition or barrier is provided for a portion of the space. For example, the device housing may include an inner wall or protrusion that does not completely block the internal volume, thereby allowing at least some areas of the plurality of paths to communicate with each other.
[0471] In some embodiments, a co-motion component of an internal path (e.g., a co-motion component including an axis in which a tool is housed and / or a plurality of wheels that drive the linear motion of the tool) is exposed to a co-motion component of a different internal path (e.g., an adjacent path).
[0472] In some embodiments, multiple actuation components of multiple paths are arranged relative to each other and held on a chassis. Optionally, the chassis is exposed and open to its surroundings, for example, without a housing.
[0473] In some embodiments, a synchronizing component of a path at least partially restricts the movement of the tool within the inner path, for example, restricting the lateral movement of a tool housed within the path. For example, the movement of the tool beyond a plurality of hypothetical limits defined by the elongated path is restricted. In some embodiments, the tool is guided through the path, for example, housed on an elongated axis (e.g., the axis of the synchronizing component, such as axis 2127). Figure 21B Within a slot. Alternatively or additionally, the path is defined by a pathway generated between multiple pairs of opposing wheels.
[0474] In some embodiments, in addition to extending through the path, a tool engages the device at one or more additional fixed locations (also referred to herein as "fixed points" or "engagements"). In some embodiments, a fixed location includes a retainer (e.g., 2727, 2729) located outside, inside, or partially inside and partially outside the housing. In some embodiments, a fixed location couples a tool to the housing and / or one or more other tools. For example, at fixed location 2729, a first elongated surgical tool 2731 extending through path 2705 (e.g., a guidewire) enters a lumen of a second elongated surgical tool 2733 (e.g., a microcatheter), which is coupled to the housing at fixed location 2729. In some embodiments, a proximal end of tool 2731 is coupled to the housing at fixed location 2727.
[0475] In some embodiments, a fixed position 2727 is shaped and configured to receive a proximal handle of a tool 2731, for example, a handle that manipulates the distal portion of the tool in terms of bending and / or stiffness. In some embodiments, an additional motor (not shown) is configured to rotate the tool 2731 through two positions, one at the handle of the tool (e.g., at the fixed position 2727) and the other at a region farther from the tool. For example, a motor configured to rotate the tool 2731 by rotating a matching actuation assembly associated with a portion of the tool 2731 may also be operatively connected to the handle of the tool, optionally via a gear system. Thus, the motor is configured to rotate the tool simultaneously from both of these different positions. One advantage of initiating rolling motion from the same motor at two different positions along the tool can include increased torque applied to the tool and elimination of the risk of the tool slipping in its multiple gripping positions within the actuation assembly.
[0476] In some embodiments, a tool is positioned at a fixed location (e.g., 2727) on the housing and an inlet (e.g., 2713) for introducing the tool into the internal volume, both on the same wall of the housing, such that a portion of the tool located outside the housing forms a curve, such as a U-shaped curve. In some embodiments, for example, as Figures 23A to 23B As described above, the range of the U-shaped curve is dynamically adjustable. Optionally, linearly moving the tool (e.g., via the plurality of tool movement elements, such as a plurality of wheels) changes the range of the U-shaped curve relative to the outer side of the wall of the housing.
[0477] In some embodiments, the curve is defined along a path extending from the same wall of the device housing and along a path extending to the same wall of the device housing.
[0478] In the example shown, the housing includes multiple sharp corners and multiple straight side walls, but other constructions are also possible, including, for example, multiple rounded corners, multiple curved walls, etc.
[0479] In some embodiments, the actuation of the actuation component of each of the plurality of paths (e.g., via a motor) is controlled by a controller 2735. In some embodiments, the plurality of components of each path are controlled independently, but in a synchronous manner.
[0480] In some embodiments, the controller 2735 is remotely controlled by an external device, such as a remote control device as described herein.
[0481] Figure 28 A robotic device for manipulating two or more elongated surgical tools according to some embodiments is schematically shown. The elongated surgical tools are configured for a telescopic configuration, such as in a non-limiting manner, including a guidewire and a microcatheter, with the first elongated tool extending at least partially within the lumen of the second elongated tool.
[0482] In some embodiments, the robotic device 2801 includes a housing 2803 comprising a plurality of walls that form an internal volume 2805 therebetween. In some embodiments, two or more internal paths extend within the internal volume such that tools 2810, 2813 received and operated by the device extend at least partially along the plurality of internal paths.
[0483] In some embodiments, each of the plurality of internal paths includes a co-actuating component positioned at a location on the path, for example, extending axially along at least a portion of the path. In some embodiments, the co-actuating component (e.g., 2806, 2807) is configured for linearly moving the tool, for example, a set or more sets of wheels configured to advance and / or retract the tool. Alternatively or additionally, the co-actuating component (e.g., 2806) is configured for moving the tool in a rolling manner, for example, by rotating a set of wheels that grip the tool between them.
[0484] In some embodiments, a plurality of actuation components are operatively coupled to a plurality of motors, such as motors 2811, 2808, and 2809. In some embodiments, the plurality of motors are configured to operate the plurality of actuation components to produce linear motion of the plurality of tools housed therein. Alternatively or additionally, the plurality of motors are configured to produce a rolling motion of the housed tool, optionally by producing a rolling motion of the associated actuation components of the tool as a whole. For example, motor 2809 is optionally operatively connected to linear motion mechanism 2807 via a gear system and is configured to rotate linear motion mechanism 2807 together with motor 2811, thereby rolling tool 2810, which is gripped within linear motion mechanism 2807. A potential advantage of rotating the entire linear motion mechanism together with the tool is that it simplifies the associated gear system and allows for both linear and rolling motions simultaneously. In some embodiments, motor 2811 is rolled together with linear motion mechanism 2806 because there is no sterile barrier between the plurality of motors and the plurality of actuation components.
[0485] In the example shown, a first elongated surgical tool 2810 (e.g., a guidewire) extends along a first internal path, for example, between an inlet port 2814 entering the housing and an outlet port 2816 exiting the housing.
[0486] In some embodiments, the linear movement of tool 2810 is driven by engine 2811, and the rolling of tool 2810 is driven by engine 2809, both of which are located and configured at a position on the internal path (e.g., along an imaginary axis defined by the path passing through the internal volume).
[0487] In some embodiments, the tool 2810 is retractably housed within a lumen of a second elongated surgical tool 2813 (e.g., a microcatheter) at the outlet port 2816 of the housing. The tool 2813 then enters the housing at an inlet port 2815 and extends along a second internal path to an outlet port 2817, in which the tool 2810 extends.
[0488] In some embodiments, the linear motion of the tool 2813 is driven by the actuation component 2807.
[0489] In some embodiments, the actuation mechanism and the plurality of engines share the same internal volume, and there are no barriers or other physical separations between them.
[0490] Figure 29Another exemplary embodiment of the robotic device is schematically shown, the robotic device being configured to receive three telescopically arranged elongated surgical tools, such as a guidewire, a microcatheter, and a guiding catheter.
[0491] In some embodiments, the robotic device 2901 includes a housing 2903 having an internal volume 2905, wherein an inlet port 2914 and an outlet port 2916 define a first internal path therebetween for receiving a first elongated surgical tool 2910, and an inlet port 2915 and an outlet port 2917 define a second internal path therebetween for receiving a second elongated surgical tool 2913.
[0492] In some embodiments, actuation components 2906, 2907 are positioned along the plurality of internal paths and configured to contact the plurality of tools housed therein for advancing, retracting, and / or rolling at least one of the tools. In some embodiments, a plurality of motors, such as motors 2909, 2911, and 2908, are positioned adjacent to the plurality of internal paths and operatively connected to the plurality of actuation components. In some embodiments, the plurality of motors and the plurality of actuation components are located within the same internal volume accommodating the plurality of internal paths, for example, without barriers obstructing airflow between them.
[0493] In some embodiments, only one engine is operatively connected to an actuation assembly, such as actuation assembly 2907 and engine 2908, which is operatively connected to the actuation assembly to advance or retract the long surgical tool 2913. In some embodiments, two or more engines are operatively connected to an actuation assembly, such as actuation assembly 2906 and engines 2909 and 2911. In this example, engines 2909 and 2911 are operatively connected to actuation assembly 2906 to advance, retract, and roll the long surgical tool 2910. Optionally, engine 2909 rolls the tool 2910 by rolling the composite 2904, wherein the composite 2904 includes at least actuation assembly 2906 and engine 2911.
[0494] In some embodiments, the proximal end of the elongated surgical tool 2910 is secured to a fixed position 2920. In some embodiments, the fixed position 2920 includes a protrusion configured to attach to a Luer connector (not shown) optionally present in the proximal end of the tool 2910. Alternatively, the fixed position 2920 includes a cavity sized and shaped to accommodate a handle (not shown) optionally located at the proximal end of the tool 2910. In some embodiments, the proximal end of the tool 2910 is operatively connected to an adapter 2950, which in some embodiments causes the tool to roll about its longitudinal axis, for example, by rolling a proximal handle portion of the tool housed at the adapter. In some embodiments, the motor operatively connected to the adapter to cause the rolling motion is the same as the motor operatively connected at a more distal location to the actuation assembly associated with the tool. For example, as shown and illustrated by means of engine 2909, engine 2909 is operatively connected to adapter 2905 and simultaneously operatively connected to composite 2904 to cause rolling actuation of tool 2910 from at least these two different positions.
[0495] In some embodiments, a U-shaped curve is formed in the tool 2910 between the fixed position 2920 and the inlet port 2914. In some embodiments, as the tool 2910 moves linearly in the actuation assembly 2906, it advances or retracts the distal end 2930 of the tool 2910, optionally when a distal portion has been introduced into the patient. In some embodiments, as the tool 2910 is advanced or retracted, a distance between a maximum point of the U-shaped curve and the housing 2903 shortens or lengthens. One advantage of forming the U-shaped curve outside the housing 2903 is that the size of the housing does not need to accommodate this distance, and the device can guide a range of tool lengths regardless of the size of the device.
[0496] In some embodiments, a fixed position of one elongated surgical tool is located at the exit hole of another elongated surgical tool, as shown and illustrated by fixed point 2922. The fixed point overlaps with the exit hole 2916, so that when tool 2913 is connected to fixed position 2922, elongated surgical tool 2910 exits the housing 2903 through exit hole 2916 and directly enters the lumen of elongated surgical tool 2913.
[0497] In some embodiments, a second U-shaped curve for tool 2910 and a first U-shaped curve for tool 2913 are formed between the fixed position 2922 and the inlet hole 2915. In some embodiments, when the distal end 2940 of tool 2913 is advanced or retracted, both tool 2910 and tool 2913 move to lengthen or shorten the distance between the maximum point of the combined curve and the housing 2903. In some embodiments, when it is desired to linearly translate the distal end 2940 of tool 2913 without translating the distal end 2930 of tool 2910, engine 2911 linearly translates tool 2910 in a direction opposite to the translation of engine 2907, which affects both tools, thereby effectively keeping the distal end 2930 of tool 2910 in place.
[0498] In some embodiments, an elongated surgical tool (e.g., a guide tube or sheath) connected from outside housing 2903 to a fixed location is configured to be operated by a plurality of motors located inside housing 2903, such as an elongated surgical tool 2919 connected to fixed location 2917, and may be a linearly movable actuator 2927 operably connected to motors 2928 and 2929 for linear and rolling motion, respectively. In some embodiments, actuator 2927, together with motors 2928 and 2929, is located in the same internal volume as motors 2909, 2911, and 2908, and in the same internal volume as actuators 2906 and 2907 to which they are operably connected. In such exemplary embodiments, at least five motors are located in the same internal volume as the plurality of internal paths of the plurality of elongated surgical tools 2910 and 2913.
[0499] In some embodiments, the fixed position 2924 overlaps with the outlet port 2917, such that the telescopically arranged elongated surgical tools 2910 and 2913 exit the housing 2903 through the outlet port 2917 and directly enter the lumen of the elongated surgical tool 2919. In some embodiments, the actuation assembly 2927 is positioned along the same plurality of internal paths as tool 2913.
[0500] As used herein, the terms “insertion device”, “medical device”, “robotic device”, “robotic system”, “device”, “system”, etc., are used interchangeably. In some cases, a device is treated as part of a system.
[0501] As used herein, the terms “medical device”, “medical tool”, “surgical tool”, “long tool”, etc., are used interchangeably.
[0502] While some examples described throughout this disclosure pertain primarily to the insertion of a guidewire into a patient's blood vessel, this is for simplicity only, and the scope of this disclosure is not limited to multiple devices for inserting multiple guidewires alone, but may include additional multiple medical tools / instruments, such as multiple microcatheters, multiple balloon catheters, etc. Furthermore, the scope of this disclosure is not limited to inserting multiple medical tools into multiple blood vessels, but may include inserting multiple medical tools into other body cavities, such as the urethra, gastrointestinal tract, and trachea. In the description and claims of this application, the words "comprising" and "having," and their various forms, are not limited to multiple members in a list that may be associated with the words.
[0503] The terms “comprise, comprising,” “include, including,” “having,” and their cognates mean “including but not limited to.”
[0504] The term "consisting of" means "including and limited to".
[0505] The term "consisting essentially of" means that the composition, method, or structure may include additional components, steps, and / or parts, provided that the additional components, steps, and / or parts do not substantially alter the claimed essential and novel features of the composition, method, or structure.
[0506] As used herein, the singular forms “a” and “the” include plural references unless the context clearly specifies otherwise. For example, the terms “a compound” or “at least one compound” can include multiple compounds, including mixtures thereof.
[0507] Throughout this application, various embodiments of the invention may exist in a range format. It should be understood that this range format is merely for convenience and brevity and should not be construed as a rigid limitation on the scope of the invention. Therefore, it should be assumed that the range description specifically discloses all possible sub-ranges and single numerical values within those ranges. For example, a range description from 1 to 6 should be assumed to specifically disclose sub-ranges such as from 1 to 3, from 1 to 4, from 1 to 5, from 2 to 4, from 2 to 6, from 3 to 6, etc., and single numbers within those ranges, such as 1, 2, 3, 4, 5, and 6. This applies regardless of the range.
[0508] Whenever a range of values is referred to herein, it means including any referenced number (fraction or integer) within the range referred to. The phrases “range between a first indicator number and a second indicator number” and “range from a first indicator number to a second indicator number” are interchangeable herein and refer to including the first and second indicator numbers, and all fractions and integers between them.
[0509] As used herein, the term "method" refers to the manner, means, technique, and procedure used to accomplish a particular task, including but not limited to those manner, means, techniques, and procedures that are known or can be readily developed by practitioners in the fields of chemistry, pharmacology, biology, biochemistry, and medicine from known manner, means, techniques, and procedures.
[0510] As used herein, the term "treating" includes eliminating, substantially inhibiting, slowing or reversing the progression of a condition, substantially improving the clinical or aesthetic symptoms of a condition, or substantially preventing the occurrence of the clinical or aesthetic symptoms of a condition.
[0511] It should be understood that certain features in this invention, described for clarity in the text of separate embodiments, may also be provided in combinations of a single embodiment. Conversely, for brevity, various features described in the text of a single embodiment may also be provided separately, in any suitable sub-combination, or in embodiments applicable to this invention. Specific features described in the text of various embodiments are not considered essential features of those embodiments unless the embodiment would not function without those elements.
[0512] While the invention has been described in conjunction with specific embodiments thereof, it will be apparent to those skilled in the art that many alternatives, modifications, and variations will be readily apparent. Therefore, it is intended to include all alternatives, modifications, and variations falling within the scope of the appended claims.
[0513] All publications, patents, and patent applications mentioned in this specification are incorporated herein by reference in their entirety, to the same extent as if each individual publication, patent, or patent application were specifically and individually identified and incorporated herein by reference. Furthermore, any references cited or indicated should not be construed as an admission that such references are prior art to the present invention. Heading portions in this application are used herein to facilitate understanding of the specification and should not be construed as necessary limitations. Additionally, any priority documents of this application are incorporated herein by reference in their entirety.
Claims
1. A small robotic device for driving the movement of two or more elongated surgical instruments when at least partially housed within the device, characterized in that: The device includes: An outer casing comprising a plurality of walls defining a shared internal volume; within the shared internal volume, the outer casing encloses: At least two internal paths for accommodating at least a portion of each of the two or more elongated surgical instruments; Multiple engines; Two or more tool actuation components, each of which is configured at a location on one of the two or more internal paths; Each of the two or more actuation components is driven by at least one of the plurality of engines, and each of the two or more actuation components is configured to operably contact at least one of the two or more elongated surgical tools when the two or more elongated surgical tools are at least partially received in the at least two internal paths, for advancing, retracting and / or rolling at least one of the plurality of elongated surgical tools. At least one of the fixing positions is defined outside the plurality of walls of the housing for securing a proximal end of at least one of the two or more elongated surgical tools to the housing, while a more distal portion of the elongated surgical tool is housed within the housing, within one of the two or more internal paths.
2. The robot device as described in claim 1, characterized in that: The plurality of engines are in direct contact with the two or more actuation components in the shared internal volume, and there are no internal barriers separating them.
3. The robot device as described in claim 2, characterized in that: The plurality of engines are in direct contact with the two or more actuation components in the shared internal volume, and there are no walls, curtains, shrouds or sterile protection separating them.
4. The robot device according to any one of claims 1 to 3, characterized in that: Each of the two or more internal paths extends through the internal volume between an inlet hole and an outlet hole, the inlet hole and the outlet hole being disposed on opposing walls of the device housing and communicating with the internal volume.
5. The robot device according to any one of claims 1 to 3, characterized in that: Each of the plurality of actuation components includes a plurality of wheelsets, each wheelset including a set of opposing wheels configured to define the internal path therebetween.
6. The robot device as described in claim 5, characterized in that: At least some of the opposing plurality of wheels are configured to rotate to advance and retract the elongated surgical tool within the internal path, and to cause the elongated surgical tool to roll about a long axis of the elongated surgical tool.
7. The robotic device according to any one of claims 1 to 3, characterized in that: The plurality of tool actuation components are all confined within the plurality of walls of the housing, and only a portion of the two or more elongated surgical tools, when housed within the device, extend outward from the plurality of walls of the housing at a distance of at least 1 cm from the housing.
8. The robotic device according to any one of claims 1 to 3, characterized in that: The internal volume is less than 2800 cm³; and the weight of the device is less than 850 grams.
9. The robotic device according to any one of claims 1 to 3, characterized in that: The dimensions of the outer casing include a height of less than 30 cm, a width of less than 30 cm, and a length of less than 30 cm; each of the at least two internal paths extends along the length axis.
10. The robot device as claimed in claim 1, characterized in that: The two or more elongated surgical instruments include a guidewire and a microcatheter, the guidewire being configured to extend at least partially through a lumen of the microcatheter.
11. The robotic device according to any one of claims 1 to 3, characterized in that: The robotic device includes a controller configured to control the plurality of motors used to drive the two or more actuation components.
12. The robot device as claimed in claim 11, characterized in that: The controller is remotely controlled via an external remote control device.
13. The robotic device according to any one of claims 1 to 3, characterized in that: When one or more of the two or more elongated surgical tools are housed within the internal path, one or more of the two or more elongated surgical tools extend outward from the plurality of walls of the housing and form a curve outside the device housing.
14. The robotic device according to any one of claims 1 to 3, characterized in that: Each of the plurality of actuation components includes a designated elongated shaft that extends axially along at least a portion of a length of the internal path for the elongated surgical tool to extend through.
15. The robotic device according to any one of claims 1 to 3, characterized in that: The robotic device includes a third actuation component connected to the housing and actuated by a plurality of motors residing within the housing to move a third elongated surgical instrument.
16. A set comprising: A robotic device according to claim 1; A guide wire is mounted onto the device such that at least a portion of the guide wire extends along one of the at least two internal paths; A microcatheter for mounting onto the device such that at least a portion of the microcatheter extends along a second of the at least two internal paths.
17. A surgical system comprising: A robotic device according to claim 1; An additional unit for driving the movement of a guide tube, and said additional unit is mechanically connected to the housing of the robotic device.
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