Bendable medical apparatus having modular actuators

Abstract

An apparatus including a controller; a bendable device 200 having one or more bending segments, each bending segment being controlled by one or more control wires; and a modular actuator assembly with a plurality of modular actuator elements and a base, wherein each modular actuator element is removably attached to the base and is configured to drive a single control wire.

Description

TITLEBENDABLE MEDICAL APPARATUS HAVING MODULAR ACTUATORSCROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of priority from U.S. Provisional Application No. 63 / 603,043, filed November 27, 2023, which is hereby incorporated by reference herein in its entirety.Technical Field

[0002] The present disclosure relates generally to bendable medical devices and, more particularly to a continuum robot (also referred to as ‘snake’ or ‘snake system’) applicable to guide interventional tools and instruments, such as endoscopes and other tools, in medical procedures, wherein the bendable medical device incorporates a modular actuator element for easy replacement.Background Art

[0003] Minimally-invasive imaging, diagnostic, or therapeutic devices find use in image guided therapy to look inside a body. A flexible medical device or tool, such as a catheter, endoscope, colonoscope, bronchoscope, ablation device, or the like can carry out these types of medical procedures, where the medical device is inserted into a patient’s body and an instrument is passed through the tool to examine or treat an area inside the body. A bronchoscope is an endoscopic instrument to view inside the airways of a patient. Catheters and other medical tools can be inserted through a tool channel in the bronchoscope to provide a pathway to a target area in the patient for diagnosis, treatment, or the like.

[0004] A continuum robot, robotic and / or snake catheter assembly are exemplary medical arrangements or configurations that can implement the flexiblemedical device to carry out the medical procedures. These medical configurations typically have a rotational drive assembly to impart rotational movement to a guide wire of a steerable catheter, endoscope, or other medical device. The drive assembly is releasably connected to the catheter and a breakaway mechanism can be used so the drive assembly disconnects from the catheter in response to a breakaway force.

[0005] A snake catheter assembly may include a steerable catheter actuated with push-pull wires, a motorized actuator for driving catheter tip motions through the push-pull wires, and a controller that translates user / software commands into actuator motion.

[0006] Steerable catheters with push-pull wires have advantages over conventional steerable catheters to generate a large bending moment without contraction of the catheter along the axial direction. However, by actuating wires with both push and pull directions, tensile and contraction forces on the wires can lead to modes of failure including wire anchor fracturing (wire anchors being the bonding mechanism between the wire and the catheter tip), wire prolapse and protrusion, and excessive lateral bending force to internal tissues such as lung tissues or the like.

[0007] A continuum robot or snake includes a plurality of bending sections having a flexible structure, wherein the shape of the continuum robot is controlled by deforming the bending sections. The snake mainly has two advantages over existing robots including rigid links. The first advantage is that the snake can move along a curve in a narrow space or in an environment with scattered objects in which the rigid link robot may get stuck. The second advantage is that it is possible to operate the snake without damaging surrounding fragile elements because the snake has intrinsic flexibility.

[0008] In recent years, minimally invasive medical care, with which burden on the patient can be reduced and the quality of life (QOL) after the treatment or inspection can be improved, has been attracting attention. A surgery or inspectionusing an endoscope is a typical example of minimally invasive medical care. For example, a laparoscopic surgery7is advantageous over a conventional abdominal surgery in that it can be performed with a smaller surgical wound, which results in a shorter stay in the hospital and less damage to the appearance.

[0009] U.S. Patent Publication No. 20190015978 discloses a snake type catheter with an actuator that contains nine wire drivers to create bending in the catheter. These wire drivers are contained in a monolithic actuator structure that is assembled as a single unit.

[0010] The construction of snake type catheters such as U.S. Patent Publication No. 20190014978 incorporates a driving unit having actuators, which consist of nine wire driver axes that exist as a monolithic device. To elaborate, a single wire drive contains a motor, a translation mechanism (the leadscrew and nut), a linear bearing mechanism and a structural element that holds all of the components together.

[0011] As seen in FIG.14, the components of all the wire drivers are mounted to the same backbone structure. In having a monolithic structure that hold all nine wire drivers, a single axis or single axis component cannot be removed without disassembling the main strucuture and disturbing the other wire drivers. This means that the process of removing one wire driver or a component of a wire driver, requires dissassembly and misalignment of the other wire drivers. As all the compenents that make up the wire driver are connected to the same mainframe structure, in order to disconnect one, you must disconnect all nine.

[0012] This is is a manufacturing and repair burden, such that in order to remove a wire driver that may be experiencing issues or requires repair / replacement, the other eight wire drivers have to be compromised as well.SUMMARY

[0013] The present disclosure advantageously provides solutions to bendable medical devices that incorporate modular actuator elements for easy replacement. By doing so, the modular actuator elements and all wire drivers are removable and interchangeable with other modular actuator elements with single axis drivers, and swapping can be done without disturbing the other wire driver axes.

[0014] According to some embodiments, an apparatus can include a controller; a bendable device having one or more bending segments, each bending segment being controlled by one or more control wires; and a modular actuator assembly with a plurality of modular actuator elements and a base, wherein each modular actuator element is removably attached to the base and is configured to drive a single control wire.

[0015] The bendable device is configured to bend, rotate, or translate by pulling or pushing the one or more control wires by pulling or pushing the one or more control wires.

[0016] The base is configured as a regular polygon with a plurality of sides and a plurality of interior angles, wherein the each of the plurality of modular elements are removably mounted on a side and are equally spaced from each other. All of the sides are preferably equal, and all of the interior angles are preferably equal.

[0017] Each modular actuator element is configured for independent operation, wherein removal, substitution, or replacement of one modular actuator element from the modular actuator assembly has no operational effect on other modular actuator elements.

[0018] The bending segment has a length and may have a hollow cavity extending the length of the bending segment. A wall is formed about the hollow cavity. At least one control wire is slidably situated in the wall. Each modular actuator element may have a motor, a translation mechanism, a linear bearing, aforce sensor, a clamping mechanism, a structural element, at least one cooling element for each motor, and may have other components.

[0019] The apparatus may have a breakaway mechanism configured to releasably connect the bendable device from the modular actuator assembly. The bendable device disconnects from the modular actuator assembly in response to a breakaway force greater than a predetermined amount.

[0020] The apparatus may have a mainframe structure of the plurality of modular actuator elements, wherein the mainframe structure comprises a printed circuit board assembly.

[0021] The apparatus may be configured as a continuum robot, a snake robot, a snake robotic assembly, a snake endoscopic assembly, a snake robotic catheter assembly, or another configuration. The apparatus may be configured to carry out medical procedures including imaging, diagnostic, endoscopic, biopsy, therapeutic, surgical, or image guided therapy.

[0022] The endoscopic procedures include colonoscopy (bowel), gastroscopy(stomach), cystoscopy (bladder), bronchoscopy (airways of the lung), or laparoscopy (abdomen) procedures.

[0023] According to some embodiments, a continuum robot includes a controller; a bendable device having one or more bending segments, each bending segment being controlled by one or more control wires; and a modular actuator assembly with a plurality of modular actuator elements and a base, wherein each modular actuator element is removably attached to the base and is configured to drive a single control wire.

[0024] The bendable device is configured to bend, rotate, or translate by pulling or pushing the one or more control wires by pulling or pushing the one or more control wires.

[0025] The base is preferably configured as a regular polygon with a plurality of sides and a plurality of interior angles. Each of the plurality of modular elementsare removably mounted on a side and are equally spaced from each other. All of the sides may be equal, and all of the interior angles may be equal.

[0026] Each modular actuator element is configured for independent operation, wherein removal, substitution, or replacement of one modular actuator element from the modular actuator assembly has no operational effect on other modular actuator elements.

[0027] The bending segment has a length and may have a hollow cavity extending the length of the bending segment, wherein a wall is formed about the hollow cavity. At least one control wire is slidably situated in the wall.

[0028] Each modular actuator element may have a motor, a translation mechanism, a linear bearing, a force sensor, a clamping mechanism, a structural element, at least one cooling element for each motor, and may have other components.

[0029] The continuum robot may have a breakaway mechanism configured to releasably connect the bendable device from the modular actuator assembly. The bendable device may disconnect from the modular actuator assembly in response to a breakaway force greater than a predetermined amount.

[0030] The continuum robot may have a mainframe structure of the plurality of modular actuator elements, wherein the mainframe structure may include a PCBA.

[0031] The continuum robot may be a snake robot, a snake robotic assembly, a snake endoscopic assembly, or a snake robotic catheter assembly. The continuum robot may be configured to carry out medical procedures including imaging, diagnostic, endoscopic, biopsy, therapeutic, surgical, or image guided therapy. The endoscopic procedures may include colonoscopy (bowel), gastroscopy (stomach), cystoscopy (bladder), bronchoscopy (airways of the lung), laparoscopy (abdomen) procedures, and other procedures.

[0032] The present disclosure provides advantageous features regarding modularity, interchangeability, and cleanliness. The actuator modularity provides maintenance relief, reduces replacement expense, and operational efficiency. The actuator interchangeability provides operational flexibility, simplifies part substitution, and enhances utility.

[0033] Further features of the present disclosure will become apparent from the following description of exemplary embodiments with reference to the attached drawings, where like structure is indicated with like reference numerals.BRIEF DESCRIPTION OF THE DRAWINGS

[0034] FIG. 1 illustrates an imaging, continuum robot, endoscopic apparatus, or system according to some embodiments.

[0035] FIG. 2 is a schematic diagram of an imaging, continuum robot, endoscopic apparatus, or system according to some embodiments.

[0036] FIGs. 3Aand3B illustrate a catheter according to some embodiments.

[0037] FIGs. 4A and 4B illustrate bending of a catheter according to some embodiments.

[0038] FIG. 5 is a block diagram of an imaging, continuum robot, endoscopic apparatus, or system according to some embodiments.

[0039] FIG. 6 is a block diagram of a controller according to some embodiments.

[0040] FIG. 7 is a block diagram of a bendable medical device according to some embodiments.

[0041] FIGs. 8A, 8B, and 8C are schematic drawings of the bendable medical device according to some embodiments.

[0042] FIGs. 9 is a side perspective view of an exemplary wire driver according to some embodiments.

[0043] FIG. io is a side perspective view of an assembled actuator with multiple wire drivers according to some embodiments.

[0044] FIG. n illustrates a side perspective view of an actuator base with a single wire driver according to some embodiments.

[0045] FIG. 12 is a block diagram of a conventional snake type catheter.

[0046] FIG. 13 is a perspective view of a conventional snake type catheter.

[0047] FIG. 14 is a block diagram of a snake type catheter according to some embodiments.

[0048] FIG. 15 is a block diagram of a conventional monolithic actuator.

[0049] FIG. 16 is a block diagram of an actuator according to some embodiments.

[0050] Throughout the figures, the same reference numerals and characters, unless otherwise stated, are used to denote like features, elements, components or portions of the illustrated embodiments. In addition, reference numeral(s) including by the designation “ ’ “ (e.g. 12’ or 24’) signify secondary elements and / or references of the same nature and / or kind. Moreover, while the subject disclosure will now be described in detail with reference to the Figures, it is done so in connection with the illustrative embodiments. It is intended that changes and modifications can be made to the described embodiments without departing from the true scope and spirit of the subject disclosure as defined by the appended paragraphs.DESCRIPTION OF THE EMBODIMENTS

[0051] Various exemplary embodiments, features, and aspects of the disclosure that relate to bendable medical devices that incorporate modular actuator elements for easy replacement will be described below with reference to the drawings that may have different characteristics, advantages, disadvantages,performance parameters, or the like. The present disclosure is not limited to any particular configuration.

[0052] The present disclosure advantageously provides solutions to bendable medical devices that incorporate modular actuator elements for easy replacement. By doing so, the modular actuator elements and all wire drivers are removable and interchangeable with other modular actuator elements with single axis drivers, and swapping can be done without disturbing the other wire driver axes.

[0053] The present disclosure provides advantageous features regarding modularity, interchangeability, and cleanliness. The actuator modularity provides maintenance relief, reduces replacement expense, and operational efficiency. The actuator interchangeability provides operational flexibility, simplifies part substitution, and enhances utility.

[0054] Some embodiments functionally implement continuum robot, snake robot, snake robotic assembly, snake endoscopic assembly, snake robotic catheter assembly, or other arrangements or configurations that can implement a flexible device to carry out medical procedures including imaging, diagnostic, endoscopic, biopsy, therapeutic, surgical, image guided therapy, or other procedures. Endoscopic procedures include colonoscopy (bowel), gastroscopy (stomach), cystoscopy (bladder), bronchoscopy (airways of the lung), laparoscopy (abdomen), and other types of procedures.

[0055] In the following embodiments, bendable medical devices and configurations are described that incorporate modular actuator elements for easy replacement. The medical device is preferably a flexible device and can be a catheter, endoscope, colonoscope, bronchoscope, ablation device, or the like. The medical device can be used with various medical arrangements or configurations, such as a continuum robot, robotic or snake catheter assembly, or the like, to carry out medical procedures including imaging, diagnostic, endoscopic, biopsy, therapeutic, surgical, image guided therapy, or other procedures. Endoscopicprocedures include colonoscopy (bowel), gastroscopy (stomach), cystoscopy (bladder), bronchoscopy (airways of the lung), laparoscopy (abdomen), and other types of procedures.

[0056] Some embodiments functionally implement imaging modalities including CT (computed tomography), MRI (magnetic resonance imaging), IVUS (intravascular ultrasound), PET (positron emission tomography), X-ray imaging, optical coherence tomography (OCT), swept source OCT (SS-OCT), optical frequency domain imaging (OFDI), Fourier domain OCT (FD-OCT), time domain OCT (TD-OCT), multi-modality OCT (MMOCT), spectrally encoded endoscopy (SEE), other imaging modalities, combinations or hybrids thereof. Arrangements can also functionally implement light detection and ranging (LiDAR) configurations that are used to measure distances to remote targets. The present disclosure is not limited to any particular configuration.

[0057] Swept source OCT is an OCT technique of acquiring the spectral distribution of the interference light by time division, and spectral domain OCT is an OCT technique of acquiring the spectral distribution of the interference light by space division.

[0058] In continuum robot or snake robotic configurational embodiments, for example, a flexible device such as a catheter, endoscope, or the like, can be controlled to navigate, insert, retract, roll, articulate, or combinations thereof based on inputs received manually, semi-automatically, automatically or combinations thereof. The flexible device may be a medical device and can be inserted into an object, a patient for example, and an imaging instrument or tool may be passed through the medical device to examine or treat an area inside the object. The flexible device can include one or more wires or wire configurations including control wires, operation wires, drive wires, push wires, pull wires, push-pull wires, wire bundles, tendons, tendon wires, other wire configurations, or combinations thereof.

[0059] Such a flexible or medical arrangement may have an actuator with a motor or drive that may be configured as a rotational drive assembly to impart rotational movement to a driving wire or guidewire of a steerable catheter, endoscope, or other medical device. The drive wire can include one or more push- pull wires, control wires, drive wires, support wires, or other types of wires, and the drive assembly can drive bendable sections of the catheter by pushing and / or pulling the driving wires in a push / pull or insertion / pulling-out direction. Breakaway configurations according to some embodiments can be used so the drive assembly is releasably connected to the medical device and disconnects from the medical device in response to a coupling or breakaway force greater than a predetermined amount.

[0060] Controllable actuators can adjust the wires to adjust portions including the distal tip of the flexible device in any geometric or angular direction, e.g., up, down, left, right, translationally, rotationally, or combinations thereof.

[0061] Thus, to address such exemplary needs in the industry, a medical apparatus according to some embodiments of the present disclosure include a bendable body having a hollow cavity extending the length of the bendable body, and a wall formed about the hollow cavity. At least one control wire may be slidably situated in the wall, and an actuator for controlling the at least one control wire, wherein the actuator is modular.

[0062] According to some embodiments, an apparatus can include a controller; a bendable device having one or more bending segments, each bending segment being controlled by one or more control wires; and a modular actuator assembly with a plurality of modular actuator elements and a base, wherein each modular actuator element is removably attached to the base and is configured to drive a single control wire.

[0063] The bendable device is configured to bend, rotate, or translate by pulling or pushing the one or more control wires by pulling or pushing the one or more control wires.

[0064] The base is configured as a regular polygon with a plurality of sides and a plurality of interior angles, wherein the each of the plurality of modular elements are removably mounted on a side and are equally spaced from each other. All of the sides are preferably equal, and all of the interior angles are preferably equal.

[0065] Each modular actuator element is configured for independent operation, wherein removal, substitution, or replacement of one modular actuator element from the modular actuator assembly has no operational effect on other modular actuator elements.

[0066] The bending segment has a length and may have a hollow cavity extending the length of the bending segment. A wall is formed about the hollow cavity. At least one control wire is slidably situated in the wall. Each modular actuator element may have a motor, a translation mechanism, a linear bearing, a force sensor, a clamping mechanism, a structural element, at least one cooling element for each motor, and may have other components.

[0067] The apparatus may have a breakaway mechanism configured to releasably connect the bendable device from the modular actuator assembly. The bendable device disconnects from the modular actuator assembly in response to a breakaway force greater than a predetermined amount.

[0068] The apparatus may have a mainframe structure of the plurality of modular actuator elements, wherein the mainframe structure comprises a printed circuit board assembly (PCBA).

[0069] The apparatus may be configured as a continuum robot, a snake robot, a snake robotic assembly, a snake endoscopic assembly, a snake robotic catheter assembly, or another configuration. The apparatus may be configured tocarry out medical procedures including imaging, diagnostic, endoscopic, biopsy, therapeutic, surgical, or image guided therapy.

[0070] The endoscopic procedures include colonoscopy (bowel), gastroscopy (stomach), cystoscopy (bladder), bronchoscopy (airways of the lung), or laparoscopy (abdomen) procedures.

[0071] A steerable catheter apparatus, configuration or arrangement is an exemplary configuration of the medical device according to some embodiments and can include a steerable catheter with a catheter tip actuated with push-pull wires, a motorized actuator for driving the catheter tip motions through the push-pull wires, a controller that translates user / software commands into actuator motion, and can include other elements or components. The catheter can have a proximal end near the actuator and a distal end near the catheter tip. Variations or other configurations of the medical device are within the scope of the present disclosure and are not limited to these arrangements.

[0072] The present disclosure advantageously provides solutions to bendable medical devices that incorporate modular actuator elements for easy replacement. By doing so, the modular actuator elements and all wire drivers are removable and interchangeable with other modular actuator elements with single axis drivers, and swapping can be done without disturbing the other wire driver axes.

[0073] Each modular actuator is configured as an independently replaceable drive for each control wire that allows substitution and replacement of individual drivers for each control wire that does not affect operation of other individual drives. Each individual drive may be provided separately and packaged in a sterile package to reduce contamination. Cooling elements may be provided to the individual motors.

[0074] The present disclosure provides advantageous features regarding modularity, interchangeability, and cleanliness. The actuator modularity provides maintenance relief, reduces replacement expense, and operational efficiency. Theactuator interchangeability provides operational flexibility, simplifies part substitution, and enhances utility.

[0075] < Robotic Catheter System >

[0076] A robotic catheter system 1000 according to some embodiments of the present disclosure is described in reference to FIG.i through FIG.6. FIG.i illustrates a simplified representation of a medical environment, such as an operating room, where the robotic catheter system 1000 can be used. FIG.2 illustrates a functional block diagram of the robotic catheter system 1000. FIGS. 3A and 3B represent a catheter 200 and FIGS.4A and 4B illustrate bending of the catheter 200. FIG.5 illustrates a logical block diagram of the robotic catheter system 1000. FIG.6 illustrates a block diagram of a controller 700 / 710. In this example, the system 1000 includes a system console 600 (computer cart) operatively connected to a steerable catheter 200 via a robotic platform 400. The robotic platform 400 includes one or more than one robotic arm 410 and a linear translation stage 420.

[0077] As shown in FIGs.i through 6, the robotic catheter system 1000 catheter may include one or more of the following: a display controller 710, a main display 500, a secondary display 510, a controller 700, an actuator 300, a continuum device 200 (also referred to herein as a “steerable catheter” or “an imaging device”), an operating portion 520, a camera or tracking sensor 270 (e.g., an electromagnetic (EM) tracking sensor), a catheter tip position / orientation / pose / state detector 320 (which may be optional (e.g., a camera may be used instead of the tracking sensor 270 and the position / state detector 320), and a rail or linear translation stage 420, which may be interconnected or combined together (for example, as shown in at least FIGs.i and 2). The system lOOO may include one or more processors, such as, but not limited to, a controller 700, a display controller 710, a CPU 720, a console orcomputer 600, any other processor or processors discussed herein, etc., that operate to execute a software program, to control the one or more adjustment, control, and / or smoothing technique(s) discussed herein, and to control display of a navigation screen on one or more displays 500, 510. The one or more processors (e.g., the system controller 700, the display controller 710, the CPU 720, the console or computer 600, or any other processor or processors discussed herein, etc.) may generate a three dimensional (3D) model of a structure (for example, a branching structure like airway of lungs of a patient, an object to be imaged, tissue to be imaged, or the like) based on images, such as, but not limited to, CT images, MRI images, etc. Alternatively, the 3D model may be received by the one or more processors (e.g., the system controller 700, the display controller 710, the CPU 720, the console or computer 600, any other processor or processors discussed herein, etc.) from another device. A two-dimensional (2D) model may be used instead of 3D model in one or more embodiments. The 2D or 3D model may be generated before a navigation starts. Alternatively, the 2D or 3D model may be generated in real-time (in parallel with the navigation). The robotic catheter system 1000 may implement various navigational techniques using, for example, a model of branching structure, a model of a route direct to a target, a model of a broad space, a model of a place or a space where an observation or a work is performed, or other modeling configurations by using the continuum robot 200.

[0078] In FIG.i, a user U (e.g., a physician) controls the robotic catheter system 1000 via a user interface unit (operation unit) to perform an intraluminal procedure on a patient P positioned on an operating table B. The user interface may include at least one of a main display 500 (a first user interface unit), a secondary display 510 (a second user interface unit), and a handheld controller 520 (a third user interface unit). The main display 500 may include, for example, a large display screen attached to the system console 600 or mounted on a wall of the operating room and maybe, for example, designed as part of the robotic catheter system 200or be part of the operating room equipment. Optionally, there is a secondary display 510 that is a compact (portable) display device configured to be removably attached to the robotic platform 400. Examples of the secondary display 710 may include a portable tablet computer, a mobile communication device (a cellphone), or other type of display.

[0079] The steerable catheter 200 is actuated via an actuator unit 300. The actuator unit 300 is removably attached to the linear translation stage 420 of the robotic platform 400. The handheld controller 520 may include a gamepad-like controller with a joystick having shift levers and / or push buttons. It may be a one-handed controller or a two-handed controller. The actuator unit 300 may be enclosed in a housing having a shape of a catheter handle. One or more access ports 226 are provided in or around the catheter handle. The access port 226 is used for inserting and / or withdrawing end effector tools and / or fluids when performing an interventional procedure of the patient P.

[0080] The robotic catheter system 1000 may include a system controller 700, a display controller 710, and a main display 500. The main display 500 may include a conventional display device such as a liquid crystal display (LCD), an organic light emitting display (OLED), a quantum dot display (QLED) or the like. The main display 500 may provide or display a graphic interface unit (GUI) configured to display one or more views. These views include a live view image 610, an intraoperative image 620, a preoperative image 630, and other procedural information 640. Other views may include a model view, a navigational information view, a composite view, and other views may be displayed. The live image view 610 may be an image from a camera at the tip of the catheter 200. This live image view 610 may also include, for example, information about the perception and navigation of the catheter 200. The preoperative image 630 may include pre-acquired 3D or 2D medical images of the patient acquired by conventional imaging modalities such as computer tomography (CT), magneticresonance imaging (MRI), ultrasound imaging, or other imaging modalities. The intraoperative image 620 may include images used for image guided procedure such images may be acquired by fluoroscopy or CT imaging modalities. The intraoperative image 620 may be augmented, combined, or correlated with information obtained from a sensor, camera image, or catheter data.

[0081] In various embodiments where a catheter tip tracking sensor 270 is used, the sensor 270 may be located at the distal end of the catheter 200. The catheter tip tracking sensor 270 may be, for example, an electromagnetic (EM) sensor. If an EM sensor is used, a catheter tip position detector 320 is included in the robotic catheter system 1000. The catheter tip position detector 320 may include an EM field generator operatively connected to the system controller 700. Suitable electromagnetic sensors for use with a steerable catheter are well-known and described, for example, in U.S. Patent No. 6,201,387 and International Publication W02020194212A1.

[0082] The display controller 710 may acquire position / orientation / navigation / pose / state (or other state) information of the continuum robot 200 from the system controller 700. Alternatively, the display controller 710 may acquire the position / orientation / navigation / pose / state (or other state) information directly from a tip position / orientation / navigation / pose / state (or other state) detector 270. Alternatively, a camera may be used instead of the tracking sensor 270 and the position detector 320 to determine and output detected positional / state information to the system controller 700. The continuum robot 200 may be a catheter device (e.g., a steerable catheter or probe device). The continuum robot 200 may be attachable / detachable to the actuator 300, and the continuum robot 200 may be disposable.

[0083] FIG.1 illustrates the robotic catheter system 1000 includes the system controller 700 operatively connected to the display controller 710, which isconnected to the first display 500, the second display 510, and to the handheld controller 520. The system controller 700 is also connected to the actuator unit 300 via the robotic platform 400 or any component thereof, e.g., the robotic arm 410, or the rail or linear translation stage 420. The actuator unit 300 may include a plurality of motors 340 that control the plurality of drive wires 260. While six drive wires 260 are shown in FIG.2, the number of drive wires may be less than or more than six. These drive wires 260 travel through the steerable catheter 200. One or more access ports 226 may be located on the catheter 200, and may include an insertion / extraction detector. The catheter 200 may include a proximal section 248 located between the actuator 300 and the proximal bending section 252, where the drive wires 260 operate to actuate the proximal bending section 252. Three of the six drive wires 260 continue through the distal bending section 256 where they actuate this section and allow for a range of movement. FIG.2 shows two bendable sections 252 and 254, there may be three, four, or more bendable sections. In some embodiments, a single bending section may be provided, or alternatively, four or more bendable sections may be present in the catheter 200.

[0084] FIG. 3A shows an exemplary embodiment of a steerable catheter 200. The steerable catheter 200 includes a non-steerable proximal section 248, a steerable distal section 254, and a catheter tip 258. The proximal section 248 and distal bendable section 254, including bending segments 252 and 256, are joined to each other by a plurality of drive wires 260 arranged along the wall of the catheter. The proximal section 248 is configured with thru-holes or grooves or conduits to pass drive wires 160 from the distal section 254 to the actuator unit 300. The distal bendable section 254 is comprised of a plurality of bending segments including at least a distal segment 256, a middle segment 254, and a proximal segment 252. Each bending segment is bent by actuation of at least some of the plurality of drive wires 260 (driving members). The posture of the catheter 200 may be supported by non-illustrated supporting wires (support members) also arranged along the wallof the catheter 200 (see U.S. Patent Publication No. 20210308423). The proximal ends of drive wires 260 are connected to individual actuators or motors 244 of the actuator unit 300, while the distal ends of the drive wires 260 are selectively anchored to anchor members in the different bending segments of the distal bendable section 254.

[0085] Each bending segment is formed by a plurality of ring-shaped components (rings) with thru-holes, grooves, or conduits along the wall of the rings. The ring-shaped components are defined as wire-guiding members 262 or anchor members 264 depending on their function within the catheter. Anchor members 264 are ring-shaped components onto which the distal end of one or more drive wires 260 are attached. Wire-guiding members 262 are ring-shaped components through which some drive wires 260 slide through (without being attached thereto).

[0086] Detail “A” in FIG.3B illustrates an exemplary embodiment of a ring-shaped component (a wire-guiding member 262 or an anchor member 264). Each ring-shaped component includes a central opening which forms the tool channel 268, and plural conduits 266 (grooves, sub-channels, or thru-holes) arranged lengthwise equidistant from the central opening along the annular wall of each ring-shaped component. Inside the ring-shaped component, an inner cover such as is described in U.S. Patent Publication Nos. 20210369085 and 20220126060, may be included to provide a smooth inner channel and provide protection. The non-steerable proximal section 248 is a flexible tubular shaft and can be made of extruded polymer material. The tubular shaft of the proximal section 248 also has a central opening or tool channel 268 and plural conduits 266 along the wall of the shaft surrounding the tool channel 268. An outer sheath may cover the tubular shaft and the steerable section 254. In this manner, at least one tool channel 268 formed inside the steerable catheter 200 provides passage for an imaging device and / or end effector tools from the insertion port 226 to the distal end of the steerable catheter 200.

[0087] The actuator unit 300 includes one or more servo motors or piezoelectric actuators. The actuator unit 300 bends one or more of the bending segments of the catheter 200 by applying a pushing and / or pulling force to the drive wires 260. As shown in FIG. 3A, each of the three bendable segments of the steerable catheter 200 has a plurality of drive wires 260. If each bendable segment is actuated by three drive wires 260, the steerable catheter 200 has nine driving wires 260 arranged along the wall of the catheter. Each bendable segment of the catheter 200 is bent by the actuator unit 300 by pushing or pulling at least one of these nine drive wires 260. Force is applied to each individual drive wire 260 in order to manipulate / steer the catheter 200 to a desired pose. The actuator unit 300 assembled with steerable catheter 200 is mounted on robotic platform 400 or any component thereof, e.g., the robotic arm 410, the rail and / or the linear translation stage 420. The linear translation stage 420 may include a slider and a linear motor. In other words, the linear translation stage 420 is motorized, and can be controlled by the system controller 700 to insert and remove the steerable catheter 200 to / from the target, sample, or object, e.g., the patient, the patient’s bodily lumen, one or more airways, a lung, or the like) .

[0088] An imaging device 280 may be inserted through the tool channel 268 and includes an endoscope camera (videoscope) along with illumination optics (e.g., optical fibers or LEDs). The illumination optics provides light to irradiate the lumen and / or a lesion target which is a region of interest within the patient. End effector tools refer endoscopic surgical tools including clamps, graspers, scissors, staplers, ablation or biopsy needles, and other similar tools, which serve to manipulate body parts (organs or tumorous tissue) during examination or surgery. The imaging device 170 may be what is commonly known as a chip-on-tip camera and may be color or black-and-white.

[0089] In some embodiments, the tracking sensor 270 (e.g., an EM tracking sensor) may be attached to the catheter tip 258. In this embodiment, steerablecatheter 200 and the tracking sensor 270 may be tracked by the tip position detector 320. Specifically, the tip position detector 320 detects a position of the tracking sensor 270, and outputs the detected positional information to the system controller 700. The system controller 700 receives the positional information from the tip position detector 270, and continuously records and displays the position of the steerable catheter 200 with respect to the coordinate system of the target, sample, or object, e.g., the robotic arm, the rail and / or the linear translation stage 420. The system controller 700 controls the actuator unit 122 and the linear translation stage 420 in accordance with the manipulation commands input by the user U via one or more of the user interface units (the handheld controller 520, a GUI at the main display 500 or touchscreen buttons at the secondary display 510).

[0090] FIGS.4A and 4B show exemplary catheter tip manipulations by actuating one or more bending segments of the steerable catheter 200. As illustrated in FIG.4A, manipulating only the most distal segment 256 of the steerable section changes the position and orientation of the catheter tip 258. On the other hand, manipulating one or more bending segments (252 or 254) other than the most distal segment affects only the position of catheter tip 258, but does not affect the orientation of the catheter tip 258. In FIG.4A, actuation of distal segment 256 changes the catheter tip 258 from a position Pi having orientation 01, to a position P2 having orientation O2, to position P3 having orientation O3, to position P4 having orientation O4, etc. In FIG.4A, actuation of the middle segment 254 changes the position of catheter tip 258 from a position Pi having orientation 01 to a position P2 and position P3 having the same orientation 01. Here, it should be appreciated by those skilled in the art that exemplary catheter tip manipulations shown in FIGS.4A and 4B can be performed during catheter navigation (i.e., while inserting the catheter through tortuous anatomies). In the present disclosure, the exemplary catheter tip manipulations shown in FIGS.4A and4B apply namely to the targeting mode applied after the catheter tip has been navigated to a predetermined distance (a targeting distance) from the target.

[0091] The actuator 300 may proceed or retreat along a rail 420, e.g., to translate the actuator 300, the continuum robot / catheter 200, etc., and the actuator 300 and continuum robot 200 may proceed or retreat in and out of the patient’s body or other target, object, or specimen, e.g., tissue. As shown in FIG.3B, the catheter device 200 may include a plurality of driving backbones and may include a plurality of passive sliding backbones. In one or more embodiments, the catheter device 200 may include at least nine (9) driving backbones and at least six (6) passive sliding backbones. The catheter device 200 may include an atraumatic tip at the end of the distal section of the catheter device 200.

[0092] FIG.5 illustrates the system controller 700 executes software programs and controls the display controller 710 to display a navigation screen (e.g., a live view image 610) on the main display 500 and / or the secondary display 510. The display controller 710 may include a graphics processing unit (GPU) or a video display controller (VDC).

[0093] FIG.6 illustrates components of the system controller 700 and / or the display controller 710. The system controller 700 and the display controller 710 can be configured separately. Alternatively, the system controller 700 and the display controller 710 can be configured as one device. In either case, the system controller 700 and the display controller 100 may include substantially the same components. Specifically, the system controller 700 and display controller 710 may include a central processing unit (CPU 220), which may be comprised of one or more processors (microprocessors), a random access memory (RAM 730) module, an input / output (I / O 740) interface, a read only memory (ROM 710), and data storage memory (e.g., a hard disk drive (HDD 750) or solid state drive (SSD)).

[0094] The ROM 750 and / or HDD 760 store the operating system (OS) software, and software programs for executing the functions of the robotic cathetersystem 1000 as a whole. The RAM 730 is used as a workspace memory. The CPU 120 executes the software programs developed in the RAM 130. The I / O 740 inputs, for example, positional information to the display controller 710, and outputs information for displaying the navigation screen to the one or more displays (main display 500 and / or secondary display 510). In the embodiments descried below, the navigation screen is a graphical user interface (GUI) generated by a software program but, it may also be generated by firmware, or a combination of software and firmware.

[0095] The system controller 700 may control the steerable catheter 200 based on any known kinematic algorithms applicable to continuum or snake-like catheter robots. For example, the system controller 700 controls the steerable catheter 200 based on an algorithm known as follow the leader (FTL) algorithm. By applying the FTL algorithm, the most distal segment 256 of the steerable catheter 200 is actively controlled with forward kinematic values, while the middle segment 254 and the proximal segment 252 (following sections) of the steerable catheter 200 move at a first position in the same way as the distal section moved at the first position or a second position near the first position.

[0096] The display controller 710 acquires position information of the steerable catheter 200 from system controller 700. Alternatively, the display controller 710 may acquire the position information directly from the tip position detector 320. The steerable catheter 200 may be a single-use or limited-use catheter device. In other words, the steerable catheter 200 can be attachable to, and detachable from, the actuator unit 300 to be disposable.

[0097] During a procedure, the display controller 710 can generate and output a live-view image or other view(s) or a navigation screen to the main display 500 and / or the secondary display 510 by executing pre-programmed software routines. This view can optionally be registered with a 3D model of a desired target (a branching structure) and the position information of at least aportion of the catheter 200 (e.g., position of the catheter tip 320). Upon completing navigation to a desired target, one or more end effector tools can be inserted through the access port at the proximal end of the catheter 200, and such tools can be guided through the tool channel of the catheter body to perform an intraluminal procedure from the distal end of the catheter 200.

[0098] The tool may be a medical tool such as an endoscope camera, forceps, a needle or other biopsy or ablation tools. In one embodiment, the tool may be described as an operation tool or working tool. The working tool is inserted or removed through the working tool access port. In the embodiments below, an embodiment of using a steerable catheter to guide a tool to a target is explained. The tool may include an endoscope camera or an end effector tool, which can be guided through a steerable catheter under the same principles. In a procedure there is usually a planning procedure, a registration procedure, a targeting procedure, and an operation procedure.

[0099] The display controller 700, may generate and output a navigation screen to the one or more displays 500, 510 based on the 2D / 3D model and the position / orientation / navigation / pose / state (or other state) information by executing the software. The navigation screen may indicate a current position / orientation / navigation / pose / state (or other state) of the continuum robot 200 on the 2D / 3D model. By using the navigation screen, a user may recognize the current position / orientation / navigation / pose / state (or other state) of the continuum robot 200 in the branching structure.

[0100] In one or more embodiments, the one or more processors, such as, but not limited to, the display controller 700 and / or the controller 710, may include, as shown in FIG.6, at least one central processing unit (CPU) 720, at least one random access memory (RAM) 730, at least one input and output (I / O) interface 740, at least one storage read only memory (ROM) 750, and at least one hard discdrive (HDD) 760. A solid state drive (SSD) may be used instead of HDD as the data storage.

[0101] The ROM 750 and / or HDD 760 operate to store the software in one or more embodiments. The RAM 730 may be used as a work memory. The CPU 720 may execute the software program developed in the RAM 730. The I / O 740 operates to input the positional (or other state) information to the display controller 700 (and / or any other processor discussed herein) and to output information for displaying the navigation screen to the one or more displays 500, 510. In the embodiments below, the navigation screen may be generated by the software program. In one or more other embodiments, the navigation screen may be generated by a firmware.

[0102] One or more devices or systems, such as the system 1000, may include a tip position / orientation / navigation / pose / state (or other state) detector 320 that operates to detect a position / orientation / navigation / pose / state (or other state) of the EM tracking sensor 270 and to output the detected positional (and / or other state) information to the controller 700 or 710.

[0103] The controller 700 may operate to receive the positional (or other state) information of the tip of the continuum robot 200 from the tip position / orientation / navigation / pose / state (or any other state discussed herein) detector 320. In one or more embodiments, the detector 320 maybe optional. For example, the tracking sensor 270 may be replaced by a camera. The controller 700 and / or the controller 710 operates to control the actuator 300 in accordance with the manipulation by a user (e.g., manually), and / or automatically (e.g., by a method or methods run by one or more processors using software, by the one or more processors, using automatic manipulation in combination with one or more manual manipulations or adjustments, etc.) via one or more operation / operating portions or operational controllers 520 (e.g., such as, but not limited to a joystick as shown in FIGS. 1-4). The one or more displays 500, 510 and / or operation portion oroperational controllers 520 may be used as a user interface 3000 (also referred to as a receiving device). The system 1000 may include, as an operation unit, the display 500 (e.g., such as, but not limited to, a large screen user interface with a touch panel, first user interface unit, etc.), the display 520 (e.g., such as, but not limited to, a compact user interface with a touch panel, a second user interface unit, etc.) and the operating portion 520 (e.g., such as, but not limited to, a joystick shaped user interface unit having shift lever / button, a third user interface unit, a gamepad, or other input device, etc.).

[0104] The controller 700 and / or the controller 710 (and / or any other processor discussed herein) may control the continuum robot 200 based on an algorithm known as follow the leader (FTL) algorithm. The FTL algorithm may be used in addition to the navigation planning and / or autonomous navigation features of the present disclosure. For example, by applying the FTL algorithm, the middle section and the proximal section (following sections) of the continuum robot 200 may move at a first position (or other state) in the same or similar way as the distal section moved at the first position (or other state) or a second position (or state) near the first position (or state). Similarly, the middle section and the distal section of the continuum robot 200 may move at a first position or state in the same / similar / approximately similar way as the proximal section moved at the first position or state or a second position or state near the first position (e.g., during removal of the continuum robot / catheter 200). The continuum robot / catheter 200 may be removed by automatically and / or manually moving along the same or similar, or approximately same or similar, path that the continuum robot / catheter 200 used to enter a target using the FTL algorithm, including, but not limited to, using FTL with the one or more adjustment, correction, state, and / or smoothing technique(s).

[0105] Any of the one or more processors, such as, but not limited to, the controller 700 and the display controller 710, may be configured separately. Asaforementioned, the display controller 710 may similarly include the CPU 720, RAM 730, I / O 740, ROM 750, and HDD 760 as shown diagrammatically in FIG.6, and may include other components. Alternatively, any of the one or more processors, such as, but not limited to, the controller 700 and the display controller 710, may be configured as one device (for example, the structural attributes of the controller 100 and the controller 102 may be combined into one controller or processor, such as, but not limited to, the one or more other processors discussed herein.

[0106] The system 1000 may include a tool channel 226 for a camera, biopsy tools, or other types of medical tools (as shown in FIG. 2). For example, the tool may be a medical tool, such as an endoscope, a forceps, a needle or other biopsy tools, etc. In one or more embodiments, the tool maybe described as an operation tool or working tool. The working tool may be inserted or removed through a working tool insertion slot 126, as shown in FIGS. 1 and 2.< Modular Actuator Assembly >

[0107] The subject innovation resolves the current issues in the art by employing an actuator designed to have a modular single axis in which a single wire driver is a fitted sub assembly that can be easily removed and interchanged. In this case the wire driver comprises a motor, a translation mechanism (leadscrew and nut), a linear bearing mechanism, a force sensor, a catheter wire engagement device (clamp), a discrete structural element, and may include other components. This structural element contains mounting provision to mount to the main actuator structural element (base) that aligns all nine axes true to each other.

[0108] The structural element is a mounting base or hub that may be configured as a polygon, preferably a regular polygon where all the sides of the polygon are equal, and all the interior angles are the same. FIG.16 illustrates an exemplary embodiment of a structural element base configured as a regular polygon- -with nine sides and interior angles of 140°, e.g., a nonagon or enneagon. The sides of the polygon are preferably equal so modular actuator elements having a control wire configured to actuate a segment of the of the bendable device are evenly spaced apart around the base. While the polygon is preferably a regular polygon, the polygon may have various other numbers of sides and interior angles, and other types of polygons may be used.

[0109] Each base contains an electronics breakout for the individual force sensor and motor connections that can be easily accessed. The single axis can be mounted to the main frame with easily accessible bolts and alignment can be done with pins and / or banking edges.

[0110] With this modular design, all wire drivers are removable and interchangeable with other single axis wire drivers, and swapping can be done so without disturbing the other wire driver axis.

[0111] The force sensor may include one or more or a combination of a processor, detection circuitry, memory, hardware, software, firmware, and can include other circuitry, elements, or components. The force sensor may be a plurality of sensors and acquires sensor information output from one or more sensors that detect force, motion, current position and movement of components interconnected with the apparatus 100. The sensor may include a multi-axis acceleration or accelerometer sensor and a multi-axis gyroscope sensor, may be a combination of an acceleration and gyroscope sensors, may include other sensors, and may be configured through the use of a piezoelectric transducer, a mechanical switch, a single axis accelerometer, a multi-axis accelerometer, or other types of configurations. The sensor can monitor, detect, measure, record, or store physical, operational, quantifiable data or other characteristic parameters of the apparatus 10 including one or more or a combination of a force, impact, shock, drop, fall, movement, acceleration, deceleration, velocity, rotation, temperature, pressure position, orientation, motion, or other types of data of the apparatus 10directionally in multiple axes, in a multi-dimensional manner, along the X-axis, Y-axis, Z-axis, or any combination thereof, and can generate sensor readings, information, data, a digital signal, an electronic signal, or other types of information corresponding to the detected state.

[0112] The continuum robot 200 can transmit or send the sensor reading data wirelessly or in a wired manner to a remote host or server. The sensor may be interrogated and can generate a sensor reading signal or information that can be processed in real time, stored, post processed at a later time, or combinations thereof. The information or data that is generated by the sensor can be processed, demodulated, filtered, or conditioned to remove noise or other types of signals. The sensor may include one or more or a combination of a force sensor, an acceleration, deceleration, or accelerometer sensor, a gyroscope sensor, a power sensor, a battery sensor, a proximity sensor, a motion sensor, a position sensor, a rotation sensor, a magnetic sensor, a barometric sensor, an illumination sensor, a pressure sensor, an angular position sensor, a temperature sensor, an altimeter sensor, an infrared sensor, a sound sensor, an air monitoring sensor, a piezoelectric sensor, a strain gauge sensor, a sound sensor, a vibration sensor, a depth sensor, and may include other types of sensors.

[0113] The medical device may be a catheter, endoscope, bronchoscope, colonoscope, gastroscope, laparoscope, arthroscope, cystoscope, endoscopic ultrasonography scope, aspiration scope, sheath, or other type of scope.

[0114] As a catheter, the medical device is configured as a long, thin, flexible tube or wire. The catheter is inserted in an object, such as a patient, for diagnosis, treatment, or other procedures. The catheter may be a steerable catheter that is manipulated by a mechanism which may be driven by operators or by one or more actuators. The distal tip may be controllable to deflect the tip by an interface including, for example, a remote control joystick, or the like. The steerable catheter can be configured, for example, as a single-section or multi-section tendon-drivencatheter, magnetic navigation catheter, soft material driven catheter, hybrid actuation catheter, or the like.

[0115] The catheter may include an inner sleeve, an outer sleeve movably coupled with the inner sleeve, a distal tip of the outer sleeve including an opening, one or more actuators connected to a proximal end of the outer sleeve and extended through one or more holes to a handle of the medical device, wherein the one or more actuators are individually removable from the medical device.

[0116] The medical device includes an actuator assembly with one or more modular actuators that are each interchangeable with the actuator assembly to facilitate at convenient replacement without undue effort. Consider a case where the actuator assembly includes a plurality of actuators and one or more of the plurality of actuators become operationally affected so as not to operate properly or malfunction. The modular configuration of each actuator facilitates convenient removal and replacement of the actuator from the actuator assembly. Treatment or repair of one actuator does not affect or hinder the operation of any of the other actuators. There is no interaction between each actuator with another actuator.

[0117] The catheter may be configured using various suitable materials including, for example, plastic, metal, steel, polyamide, polyurethane, polyolefin, polyethylene, polypropolene, nylon, polyester elastomer, polyether / block polyamide, PEBAX, Hytrel, Arnitel, fluor-polymer, polyether ether ketone (PEEK), polyethylene (PE), polyurethane, polyolefin copolymer (POC), tetrafluorethylene, polytetrafluorethylene (PTFE), combinations thereof, or other materials.

[0118] FIG.7 is a system block diagram of an exemplary bendable medical device system 1 incorporating various ancillary components intended to amass a complete medical system. The bendable medical device system i comprises a driving unit or actuator 2 (also referred to herein as a ‘driver’) for driving the wires, and having a base stage 28, a bendable medical device 3, a positioning cart 4, an operation console 5, having push-button, thumbstick, and / or joystick operationalconsole 5, and navigation software 6. The operation console 5 includes a user input device such as a push-button, thumbstick, and / or joystick. The operation console 5 also includes a processor for processing input from the user as well as input from sensors, etc. The processor further processes mapping between the input and the movement of the driver and movement of the base.

[0119] The navigation software 6 and the actuator 2 are communicatively coupled via a bus to transmit / receive data between each other. Moreover, the navigation software 6 is connected and may communicate with a CT scanner, a fluoroscope and an image server (not in Figure), which are ancillary components of the bendable medical device system 1. The image server may include, but is not limited to, a DICOM™ server connected to a medical imaging device including but not limited to a CT and / or MRI scanner and a fluoroscope. The navigation software 6 processes data provided by the actuator 2 and data provided by images stored on the image server, and / or images from the CT scanner and the fluoroscope in order to display images onto the image display.

[0120] The images from the CT scanner may be pre-operatively provided to navigation software 6. With navigation software, a clinical user creates an anatomical computer model from the images. In this particular embodiment, the anatomy is that of a lung with associated airways. From the chest images of the CT scanner, the clinical user can segment the lung airways for clinical treatments, such as biopsy. After generating the lung airway map, the user can also create plan to access the lesion for the biopsy. The plan includes the airways to insert and maneuver the bendable medical device 3 leading to the intended target, which in this example is a lesion.

[0121] The actuator 2 comprises a control circuitry. The control circuitry is communicatively-coupled with operation console 5. The actuator 2 is connected to the bendable medical device 3 so that the actuators in the actuator 2 operate the bendable medical device 3. Therefore, a clinical user can control the bendablemedical device 3 via the actuator 2. The actuator 2 is also physically connected to a positioning cart 4. The positioning cart 4 includes a positioning arm, and locates the actuator 2 and the bendable medical device 3 in the intended position with respect to the target / patient. The clinical user can insert, maneuver and retreat the bendable medical device 3 to perform medical procedures, here a biopsy in the lungs of the patient.

[0122] The bendable medical device 3 can be navigated to the lesion in the airways based on the plan by the clinical user’s operation. The bendable medical device 3 includes a hollow cavity for various tools (e.g. a biopsy tool). The bendable medical device 3 can guide the tool to the lesion of the patient. In one example, the clinical user can take a biopsy sample from the lesion with a biopsy tool.

[0123] FIGs.8A, 8B and 8C are schematic drawings of the bendable medical device 3, with FIG.8A detailing a perspective close-up view of the bendable medical device 3, and FIG.8B depicting a schematic drawing to explain the bendable segments of the bendable medical device 3. The bendable medical device 3 has a distal end 24 and a proximal end (in direction of arrow A), and comprises a proximal segment 19 and three bendable segments, which are the first, second, and third bendable segments 12, 13, 14, respectively (see FIG.8B).

[0124] The bendable segments 12, 13, 14, can independently bend and can form a shape with three independent curvatures, as seen in FIG.8B. The bendable medical device 3 includes a bendable body 7 with an inner diameter 30 and an outer diameter 32, which creates the cylindrical wall 8 of the bendable body 7, wherein the inner diameter 30 establishes a tool channel 18 (see FIG.8C). The wall 8 may house several lumens 26 intended to house one or more control wires (detailed below), wherein the lumens 26 are spaced a distance from one another creating at least one cavity 38 that greatly enhancing the bendable angle of the bendable segment 12, 13 and 14. The tool channel 18 is configured to extend the length of the bendable body 7, wherein the proximal part 19 of the bendable body 7 providesaccess to clinical users for inserting / retreating a medical tool. For example, a clinical user can insert and retrieve a biopsy tool trough the tool channel 18 to the distal end 24 of the bendable medical device 3. This may be accomplished after the bendable device 3 is inserted into the subject, or in unison with insertion / retreating the bendable device 3.

[0125] The bendable body 7 includes a set of first control wires 9a, 9b, 9c, a second set of control wires 10a, 10b, 10c, and a third set of control wires 11a, 11b, 11c (see FIGs.8A and 38C). The wall 8 houses the control wires 9a - 11c through the lumens 34, which are configured along longitudinal direction of the bendable body 7. The lumens 34 have fissures 36 for each wire, thus allowing for slidable movement of the control wires 9a - 11c along an axial direction of the bendable body. The control wires 9a - 11c may be terminated at the distal end of each bendable segment 12, 13 and 14, to form the three bendable groups, each with three wires each (a, b, c). The first control wires 9a, 9b, 9c are terminated at the distal end of the first bendable segment 12 with anchoring segments 15a, 15b, 15c, and are configured apart from each other by approximately 120 degrees within the wall 8. The first control wires 9a, 9b, 9c are connected to the actuator 2 at the proximal end of the wires 9a, 9b, 9c. The actuator 2 induces pushing or pulling forces to move the control wires 9a, 9b, 9c by actuating those wires, and bending the bendable body 7 from the distal end 24.

[0126] Similarly, the second set of control wires 10a, 10b, 10c are terminated at the distal end of the second bendable segment 13, using the anchoring segments 16a, 16b, 16c, and are connected to the actuator 2 at the proximal end. The second set of control wires 10a, 10b, 10c are also housed in the wall 8. The second set of control wires 10a, 10b, 10c can bend the bendable body 7 from the distal end of the second bendable segment 13.

[0127] In the same way, the third set of control wires 11a, 11b, 11c are also configured to bend the bendable body 7 at the third bendable segment 14, onceagain by inducing pushing or pulling, and by anchoring segment 17a, 17b, 17c, respectively, which are actuated at the distal end 24 of the control wires 11a, 11b, 11c by the actuator 2.

[0128] Accordingly, by pushing and pulling the set of control wires 9, 10, 11, the first, the second and the third bendable segments 12, 13, 14, respectively, individually bend the bendable medical device 3, in three dimensions.

[0129] Our attention will now turn to the actuator 2, and more specifically, to each wire driver 40, which are the modular element within the actuator 2 and their components.

[0130] FIG.9 provides a detailed look at a single wire driver 40, which includes a motor 42, a translation mechanism 44, linear bearing 46, a force sensor 48, and a clamping mechanism 50 for attachment to a control wire (9a-iic). A structural element 52 is the backbone of each wire driver 40 and both houses the components and allows for each wire driver 40 to attach to the actuator base 54. In addition, each wire driver 40 has a breakaway mechanism 56 and limit / home sensor 58.

[0131] The breakaway mechanism 56 serves as a safety mechanism consisting of a magnet and a ferromagnetic material that couple the motor side guide to the wire side guide. When a compressive breakaway threshold force is reached, that is greater than the magnetic force that couples the tractors together, the tractors decouple, isolating the force generated by the motor 42 from the wire guide 40. This prevents the actuator 2 from transmitting forces that may damage the catheter and / or harm the patient.

[0132] The limit / home sensors 58 comprise two separate sensors that detect light from a board. The sensors are mounted rigidly to the actuator stationary base, while the board is mounted rigidly to the moving tractor. The state of the sensor determines a home position, located in the center of travel, and a limit position, located at the positive and negative ends of travel.

[0133] The structural element 52 contains one or more mounting provision 60 to mount to the actuator base 54 that, in this embodiment, aligns all 9 wire drivers 40 true to each other. Each wire driver 40 contains an electronics breakout for the individual force sensor 48 and motor 42 connections that can be easily accessed. The wire driver 40 can be mounted to the actuator base 54 with an easily accessible fastener and alignment of the wire driver 40 may be accomplished by using pins and / or banking edges (not shown).

[0134] FIG.10 depict the actuator base 54 with a single wire driver 40 attached to better illustrate the actuator base structure 54 and attachment means to the wire driver 40. Also shown is the optional use of a printed circuit board assembly (PCBA) 60 for converting the electrical cables from all 9 wire drivers 40 in a tidy manner, into a single cable.

[0135] As seen in FIG.11, with this modular design, all wire drivers 40 are removable and interchangeable, and swapping can be done so without disturbing the other wire drivers 40.

[0136] FIGs.12-16 compare advantages of the present disclosure with conventional configurations.

[0137] FIG.12 illustrates a conventional snake type catheter with an actuator that contains nine wire drivers to create bending in the catheter, as shown in previously discussed U.S. Patent Publication No. 20190015978. These wire drivers are contained in a monolithic actuator structure that is assembled as a single unit.

[0138] The construction of snake type catheters such as U.S. Patent Publication No. 20190014978 incorporates a driving unit having actuators, which consist of nine wire driver axes that exist as a monolithic device. To elaborate, a single wire drive contains a motor, a translation mechanism (the leadscrew and nut), a linear bearing mechanism and a structural element that holds all of the components together.

[0139] As seen in FIG.13, the components of all the wire drivers are mounted to the same backbone structure. In having a monolithic structure that hold all nine wire drivers, a single axis or single axis component cannot be removed without disassembling the main strucuture and disturbing the other wire drivers. This means that the process of removing one wire driver or a component of a wire driver, requires dissassembly and misalignment of the other wire drivers. As all the components that make up the wire driver are connected to the same mainframe structure, in order to disconnect one, you must disconnect all nine.

[0140] This is is a manufacturing and repair burden, such that in order to remove a wire driver that may be experiencing issues or requires repair / replacement, the other eight wire drivers have to be compromised as well.

[0141] In contrast, the subject innovation of the present disclosure, as shown in FIG.14, boasts ease of assembly workflow: where individual wire drivers can be assembled, tested in validated as a standalone assembly.

[0142] In the current art, as shown in FIG. 15, the axis has to be tested in the fully assembled actuator state. If one axis fails, then the entire actuator has to be disassembled, compromising the assembly of the other axis.

[0143] The subject innovation shown in FIG. 16 resolves the current issues in the art by employing an actuator designed to have a modular single axis in which a single wire driver is a fitted sub assembly that can be easily removed and interchanged. In this case the wire driver comprises of a motor, a translation mechanism (leadscrew and nut), linear bearing mechanism, force sensor, catheter wire engagement device (clamp) and discrete structural element. This structural element contains mounting provision to mount to the main actuator structural element (base) that aligns all nine axes true to each other.

[0144] Each base contains an electronics breakout for the individual force sensor and motor connections that can be easily accessed. The single axis can bemounted to the main frame with easily accessible bolts and alignment can be done with pins and / or banking edges.

[0145] With this modular design, all wire drivers are removable and interchangeable with other single axis wire drivers, and swapping can be done so without disturbing the other wire driver axis.

[0146] Which in line also allows for ease of actuator repair: If one axis experiences failure, it can be removed without disturbing the other axis making it simple to replace. Since the wire drivers are fitted sub-assemblies they can easily be swapped. Since the single axis is a sub-assembly it can be tested and held in stock and installed into a system with minimal timing. In the case for the existing art, the entire single axis would have to be re-assembled at the time of repair instead of preemptively.

[0147] Finally, the subject innovation also allows the benefit of reducing or adding bending sections. This modular design makes it easy to simply remove wire drivers that are not need in alternative designs. For example, consider a catheter being used that has three bending sections with three wire drivers per section, and an application arises where two bending sections rather than three are desired. In a case where an application preferably includes two bending sections, three drivers can easily be removed to accommodate this.

[0148] The present disclosure advantageously provides solutions to bendable medical devices that incorporate modular actuator elements for easy replacement. By doing so, the modular actuator elements and all wire drivers are removable and interchangeable with other modular actuator elements with single axis drivers, and swapping can be done without disturbing the other wire driver axes.

[0149] The present disclosure provides advantageous features regarding modularity, interchangeability, and cleanliness. The actuator modularity provides maintenance relief, reduces replacement expense, and operational efficiency. Theactuator interchangeability provides operational flexibility, simplifies part substitution, and enhances utility.

[0150] According to some embodiments, an apparatus can include a controller; a bendable device having one or more bending segments, each bending segment being controlled by one or more control wires; and a modular actuator assembly with a plurality of modular actuator elements and a base, wherein each modular actuator element is removably attached to the base and is configured to drive a single control wire.

[0151] The bendable device is configured to bend, rotate, or translate by pulling or pushing the one or more control wires by pulling or pushing the one or more control wires.

[0152] The base is configured as a regular polygon with a plurality of sides and a plurality of interior angles, wherein the each of the plurality of modular elements are removably mounted on a side and are equally spaced from each other. All of the sides are preferably equal, and all of the interior angles are preferably equal.

[0153] Each modular actuator element is configured for independent operation, wherein removal, substitution, or replacement of one modular actuator element from the modular actuator assembly has no operational effect on other modular actuator elements.

[0154] The bending segment has a length and may have a hollow cavity extending the length of the bending segment. A wall is formed about the hollow cavity. At least one control wire is slidably situated in the wall. Each modular actuator element may have a motor, a translation mechanism, a linear bearing, a force sensor, a clamping mechanism, a structural element, at least one cooling element for each motor, and may have other components.

[0155] The apparatus may have a breakaway mechanism configured to releasably connect the bendable device from the modular actuator assembly. Thebendable device disconnects from the modular actuator assembly in response to a breakaway force greater than a predetermined amount.

[0156] The apparatus may have a mainframe structure of the plurality of modular actuator elements, wherein the mainframe structure comprises a PCBA.

[0157] The apparatus may be configured as a continuum robot, a snake robot, a snake robotic assembly, a snake endoscopic assembly, a snake robotic catheter assembly, or another configuration. The apparatus may be configured to carry out medical procedures including imaging, diagnostic, endoscopic, biopsy, therapeutic, surgical, or image guided therapy.

[0158] The endoscopic procedures include colonoscopy (bowel), gastroscopy (stomach), cystoscopy (bladder), bronchoscopy (airways of the lung), or laparoscopy (abdomen) procedures.

[0159] According to some embodiments, a continuum robot includes a controller; a bendable device having one or more bending segments, each bending segment being controlled by one or more control wires; and a modular actuator assembly with a plurality of modular actuator elements and a base, wherein each modular actuator element is removably attached to the base and is configured to drive a single control wire.

[0160] The bendable device is configured to bend, rotate, or translate by pulling or pushing the one or more control wires by pulling or pushing the one or more control wires.

[0161] The base is preferably configured as a regular polygon with a plurality of sides and a plurality of interior angles. Each of the plurality of modular elements are removably mounted on a side and are equally spaced from each other. All of the sides may be equal, and all of the interior angles may be equal.

[0162] Each modular actuator element is configured for independent operation, wherein removal, substitution, or replacement of one modular actuatorelement from the modular actuator assembly has no operational effect on other modular actuator elements.

[0163] The bending segment has a length and may have a hollow cavity extending the length of the bending segment, wherein a wall is formed about the hollow cavity. At least one control wire is slidably situated in the wall.

[0164] Each modular actuator element may have a motor, a translation mechanism, a linear bearing, a force sensor, a clamping mechanism, a structural element, at least one cooling element for each motor, and may have other components.

[0165] The continuum robot may have a breakaway mechanism configured to releasably connect the bendable device from the modular actuator assembly. The bendable device may disconnect from the modular actuator assembly in response to a breakaway force greater than a predetermined amount.

[0166] The continuum robot may have a mainframe structure of the plurality of modular actuator elements, wherein the mainframe structure may include a PCBA.

[0167] The continuum robot maybe a snake robot, a snake robotic assembly, a snake endoscopic assembly, or a snake robotic catheter assembly. The continuum robot may be configured to carry out medical procedures including imaging, diagnostic, endoscopic, biopsy, therapeutic, surgical, or image guided therapy. The endoscopic procedures may include colonoscopy (bowel), gastroscopy (stomach), cystoscopy (bladder), bronchoscopy (airways of the lung), laparoscopy (abdomen) procedures, and other procedures.

[0168] While the present disclosure has been described with reference to exemplary embodiments, it is to be understood that the disclosure is not limited to the disclosed exemplary embodiments. The scope of the following claims is to be accorded the broadest interpretation so as to encompass all such modifications and equivalent structures and functions.

Claims

CLAIMS1. An apparatus comprising: a controller; a bendable device having one or more bending segments, each bending segment being controlled by one or more control wires; and a modular actuator assembly with a plurality of modular actuator elements and a base, wherein each modular actuator element is removably attached to the base and is configured to drive a single control wire.

2. The apparatus according to claim i, wherein the bendable device is configured to bend, rotate, or translate by pulling or pushing the one or more control wires.

3. The apparatus according to claim 1, wherein the bendable device is configured to bend, rotate, or translate by pulling or pushing the one or more control wires.

4. The apparatus according to claim 1, wherein the base is configured as a regular polygon with a plurality of sides and a plurality of interior angles.

5. The apparatus according to claim 4, wherein the each of the plurality of modular elements are removably mounted on a side and are equally spaced from each other.

6. The apparatus according to claim 4, wherein all of the sides are equal, and all of the interior angles are equal.7- The apparatus according to claim i, wherein each modular actuator element is configured for independent operation.

8. The apparatus according to claim 7, wherein removal, substitution, or replacement of one modular actuator element from the modular actuator assembly has no operational effect on other modular actuator elements.

9. The apparatus according to claim 1, wherein the bending segment has a length and comprises a hollow cavity extending the length of the bending segment10. The apparatus according to claim 9, wherein a wall is formed about the hollow cavity.

11. The apparatus according to claim 10, wherein at least one control wire is slidably situated in the wall.

12. The apparatus according to claim 1, wherein each modular actuator element comprises a motor, a translation mechanism, a linear bearing, a force sensor, a clamping mechanism, and a structural element.

13. The apparatus according to claim 12, further comprising at least one cooling element for each motor.

14. The apparatus according to claim 12, further comprising a breakaway mechanism configured to releasably connect the bendable device from the modular actuator assembly.

15. The apparatus according to claim 14, wherein the bendable device disconnects from the modular actuator assembly in response to a breakaway force greater than a predetermined amount.

16. The apparatus according to claim i, further comprising a mainframe structure of the plurality of modular actuator elements.

17. The apparatus according to claim 16, wherein the mainframe structure comprises a printed circuit board assembly (PCBA).

18. The apparatus according to claim 1, wherein the apparatus comprises a continuum robot, a snake robot, a snake robotic assembly, a snake endoscopic assembly, or a snake robotic catheter assembly.

19. The apparatus according to claim 1, wherein the apparatus is configured to carry out medical procedures including imaging, diagnostic, endoscopic, biopsy, therapeutic, surgical, or image guided therapy.

20. The apparatus according to claim 19, wherein the endoscopic procedures include colonoscopy (bowel), gastroscopy (stomach), cystoscopy (bladder), bronchoscopy (airways of the lung), or laparoscopy (abdomen) procedures.

21. A continuum robot comprising: a controller; a bendable device having one or more bending segments, each bending segment being controlled by one or more control wires; and a modular actuator assembly with a plurality of modular actuator elements and a base,wherein each modular actuator element is removably attached to the base and is configured to drive a single control wire.

22. The continuum robot according to claim 21, wherein the bendable device is configured to bend, rotate, or translate by pulling or pushing the one or more control wires.

23. The continuum robot according to claim 21, wherein the bendable device is configured to bend, rotate, or translate by pulling or pushing the one or more control wires.

24. The continuum robot according to claim 21, wherein the base is configured as a regular polygon with a plurality of sides and a plurality of interior angles.

25. The continuum robot according to claim 24, wherein the each of the plurality of modular elements are removably mounted on a side and are equally spaced from each other.

26. The continuum robot according to claim 24, wherein all of the sides are equal, and all of the interior angles are equal.

27. The continuum robot according to claim 21, wherein each modular actuator element is configured for independent operation.

28. The continuum robot according to claim 27, wherein removal, substitution, or replacement of one modular actuator element from the modular actuator assembly has no operational effect on other modular actuator elements.

29. The continuum robot according to claim 21, wherein the bending segment has a length and comprises a hollow cavity extending the length of the bending segment.

30. The continuum robot according to claim 29, wherein a wall is formed about the hollow cavity.

31. The continuum robot according to claim 30, wherein at least one control wire is slidably situated in the wall.

32. The continuum robot according to claim 21, wherein each modular actuator element comprises a motor, a translation mechanism, a linear bearing, a force sensor, a clamping mechanism, and a structural element.

33. The continuum robot according to claim 32, further comprising at least one cooling element for each motor.

34. The continuum robot according to claim 32, further comprising a breakaway mechanism configured to releasably connect the bendable device from the modular actuator assembly.

35. The continuum robot according to claim 34, wherein the bendable device disconnects from the modular actuator assembly in response to a breakaway force greater than a predetermined amount.

36. The continuum robot according to claim 21, further comprising a mainframe structure of the plurality of modular actuator elements.37- The continuum robot according to claim 36, wherein the mainframe structure comprises a printed circuit board assembly (PCBA).

38. The continuum robot according to claim 21, wherein the continuum robot comprises a snake robot, a snake robotic assembly, a snake endoscopic assembly, or a snake robotic catheter assembly.

39. The continuum robot according to claim 21, wherein the continuum robot is configured to carry out medical procedures including imaging, diagnostic, endoscopic, biopsy, therapeutic, surgical, or image guided therapy.

40. The continuum robot according to claim 29, wherein the endoscopic procedures include colonoscopy (bowel), gastroscopy (stomach), cystoscopy (bladder), bronchoscopy (airways of the lung), or laparoscopy (abdomen) procedures.

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