System and method for robotic bronchoscopy

Abstract

An endoscopic robotic arm system and apparatus are provided. Devices and systems include various features that improve cost effectiveness and reduce complexity of manufacture and use. Disposable elongate members are described herein. The user interface device may also be adapted to user behavior and may be personalized.

Description

[0001] This application is a divisional application of the Chinese patent application with the application date of December 18, 2020, application number 202080097099.5, and invention name “System and method for robotic bronchoscopy” (the corresponding PCT application with the application date of December 18, 2020 and application number PCT / US2020 / 065999).

[0002] References

[0003] This application claims priority to U.S. Provisional Patent Application No. 62 / 950,740, filed December 19, 2019, which is incorporated herein by reference in its entirety. Background Art

[0004] Early diagnosis of lung cancer is crucial. The five-year survival rate for lung cancer is approximately 18%, significantly lower than the next three most common cancers: breast cancer (90%), colorectal cancer (65%), and prostate cancer (99%). In 2018, 142,000 deaths from lung cancer were recorded.

[0005] In general, the typical lung cancer diagnosis and surgical treatment process can vary significantly depending on the technology used by healthcare providers, clinical protocols, and clinical sites. Inconsistent processes can delay cancer diagnosis and also result in high costs for patients and the healthcare system. Summary of the Invention

[0006] The present invention recognizes the need for minimally invasive systems that allow surgical or diagnostic procedures to be performed with improved reliability and cost-effectiveness. The present disclosure provides systems and methods that allow standardized early lung cancer diagnosis and treatment at a reduced cost. The present disclosure provides accessible, more cost-effective methods and systems for the early diagnosis and treatment of cancer. In some embodiments of the present invention, at least a portion of the robotic bronchoscopy system is disposable. For example, the catheter portion can be designed to be disposable at a low cost while maintaining surgical performance capabilities and functionality. In addition, the provided robotic bronchoscopy system is designed to be able to access difficult-to-reach tissues such as the bronchi, lungs, etc. without introducing additional costs. It should be noted that the provided robotic system can be used for a variety of minimally invasive surgical procedures involving various types of tissues, including heart, bladder, and lung tissue, among other tissues.

[0007] According to some aspects of the present disclosure, a robotic endoscopic device is provided. The device may include a disposable elongated member comprising a proximal end and a distal end, with the proximal end removably attached to a robotic arm. The distal end includes a plurality of pull wires, and the pull wires are integrated with the wall of the elongated member. The elongated member may also be referred to as a bronchoscope, and the term "bronchoscope" may be used interchangeably throughout this specification.

[0008] In one aspect, a robotic endoscopic apparatus is provided, comprising: a disposable elongated member comprising: a proximal end and a distal end, wherein the proximal end is removably attached to a robotic arm via a handle, wherein the distal end is integrated with an imaging device, a position sensor, and an illumination device; and a bending section articulated by one or more pull wires.

[0009] In some embodiments, the distal end includes structure for receiving the imaging device, the position sensor, and the illumination device. In some embodiments, the imaging device, the position sensor, and the illumination device are arranged in a compact configuration. In some embodiments, the handle includes one or more components configured to process image data, provide power to the imaging device, the position sensor, and the illumination device, or establish communication with an external device.

[0010] In some embodiments, the handle includes an interface configured to couple the handle to an instrument drive mechanism attached to the robotic arm. In some cases, the interface includes an electrical interface and a mechanical interface. In some instances, the mechanical interface is configured to releasably couple the handle to the instrument drive mechanism. In some cases, the device also includes an anti-buckling mechanism having an alignment feature. For example, the alignment feature is configured to assist in alignment between the instrument drive mechanism and the anti-buckling mechanism. In some examples, the alignment feature includes a magnetic component, a laser, or a click button. In some examples, the anti-buckling mechanism includes a series of connected cylinders, each cylinder including a lip structure. In some instances, the lip structure of each cylinder has a retaining member with the same diameter.

[0011] In some embodiments, a robotic endoscopic system includes the robotic endoscopic device and a user interface device configured for a user to control the movement of the robotic endoscopic device. In some cases, the user interface device is personalized based on past user behavior. In some instances, the user interface device is personalized using a model trained using a machine learning algorithm. In some instances, the robotic endoscopic system further includes a display configured to display image data captured by the imaging device overlaid with a virtual rendering of one or more components. In some instances, the display of the virtual rendering of the one or more components is selectively enabled or disabled by the user.

[0012] In some embodiments, the handle and the disposable elongated member are both single-use. In some embodiments, the one or more pull wires are individually attached to the curved section according to a selected configuration mode. In some embodiments, control of the articulation of the robotic endoscopic device is based at least in part on a virtual mapping algorithm. In some cases, the virtual mapping algorithm maps the selected configuration mode to an updated configuration mode when the state of the one or more pull wires changes.

[0013] Additional aspects and advantages of the present disclosure will become readily apparent to those skilled in the art from the following detailed description, wherein only illustrative embodiments of the present disclosure are shown and described. As will be appreciated, the present disclosure is capable of other and different embodiments, and its several details are capable of modification in various obvious respects, all without departing from the present disclosure. Accordingly, the drawings and description are to be regarded as illustrative in nature and not restrictive.

[0014] Incorporation by reference

[0015] All publications, patents, and patent applications mentioned in this specification are herein incorporated by reference to the same extent as if each individual publication, patent, or patent application was specifically and individually indicated to be incorporated by reference. To the extent such incorporated by reference publications and patents or patent applications contradict the disclosure contained in this specification, this specification is intended to supersede and / or take precedence over any such conflicting material. BRIEF DESCRIPTION OF THE DRAWINGS

[0016] The novel features of the present invention are set forth with particularity in the appended claims. A better understanding of the features and advantages of the present invention may be obtained by reference to the following detailed description and accompanying drawings (also referred to herein as "drawings" and "figures") which set forth illustrative embodiments in which the principles of the invention are utilized, wherein:

[0017] Figure 1 An example workflow for standardized lung cancer diagnosis enabled by the robotic bronchoscopy system described herein is shown.

[0018] Figure 2A An example of a robotic bronchoscopy system according to some embodiments of the present invention is shown.

[0019] Figure 2B Different views of an example robotic bronchoscopy system are shown, according to some embodiments of the present invention.

[0020] Figure 3A An example of a fluoroscopic (tomosynthesis) imaging system is shown.

[0021] Figure 3BA C-arm fluoroscopic (tomosynthesis) imaging system is shown in different (rotational) postures when capturing images of a subject.

[0022] Figure 4A An example of a user interface for visualizing a virtual airway overlaid with an optimal path, the location of the catheter tip, and the location of a lesion is shown.

[0023] Figure 4B An example of a navigation view with enhanced information is shown.

[0024] Figure 4C An example of a navigation view with a virtual rendering of a user selection is shown.

[0025] Figure 4D An example of an endoluminal view is shown.

[0026] Figure 5 An example procedure interface module is shown that allows an operator or user to interact with a bronchoscope during a surgical procedure.

[0027] Figure 6A and Figure 6B An example of a treatment control module is shown.

[0028] Figure 7 Shown is an example of a robotic arm mounted on top of a robotic cart in a treatment control module.

[0029] Figure 8 An example of a robotic bronchoscope according to some embodiments of the present invention is shown.

[0030] Figure 9 An example of an instrument drive mechanism providing a mechanical interface to a handle portion of a robotic bronchoscope is shown, according to some embodiments of the present invention.

[0031] Figure 10 An example handle portion of a robotic bronchoscope according to some embodiments of the present invention is shown.

[0032] Figure 11 An example steerable catheter according to some embodiments of the present invention is shown.

[0033] Figure 12 An example distal portion of a catheter with integrated imaging and illumination is shown.

[0034] Figure 13 An example of a compact arrangement of multiple electronic components positioned at a distal portion of a catheter is shown, according to some embodiments of the present invention.

[0035] Figure 14 Examples of conventional and novel configurations of pull wires attached to a control ring structure are shown.

[0036] Figure 15 Various configurations of puller wires for a robotic catheter system are shown, according to some embodiments of the present invention.

[0037] Figure 16 An example of a guidewire with an inflatable tip is shown, according to some embodiments of the present invention.

[0038] Figure 17 Example anti-buckling mechanisms according to some embodiments of the present invention are shown.

[0039] Figure 18A The internal structure of an example anti-buckling mechanism according to some embodiments of the present invention is shown.

[0040] Figure 18B and Figure 18C An example of an assembly of an anti-buckling mechanism and a handle is shown.

[0041] Figure 18D An example of a scope handle and anti-buckling tube assembly with a side connection feature is shown.

[0042] Figure 18E An example of top loading the connected assembly of the anti-buckling tube and the mirror onto the instrument drive mechanism is shown.

[0043] Figure 18F An example of a patient-side connector and an IDM is shown.

[0044] Figure 18G Another example of an anti-buckling mechanism that is advanced to a target position via alignment between the patient-side connector and the IDM is shown.

[0045] Figure 18H and Figure 18I Examples of alignment features are shown.

[0046] Figure 19 An example of a user interface according to some embodiments of the present invention is shown.

[0047] Figure 20 An example of a neural network model for generating a control signal in response to a single user input is shown.

[0048] Figure 21A Shown is an example of a portable handle add-on module.

[0049] Figure 21B Various examples of robotic bronchoscopes used in conjunction with various systems, devices, and modules are shown.

[0050] Figure 22 An example portable robotic cone-beam CT is shown. DETAILED DESCRIPTION

[0051] Although various embodiments of the present invention have been shown and described herein, it will be readily understood by those skilled in the art that these embodiments are provided by way of example only. Many variations, modifications, and substitutions will occur to those skilled in the art without departing from the present invention. It will be understood that various alternatives to the embodiments of the present invention described herein may be employed.

[0052] While the exemplary embodiments will be primarily directed to bronchoscopy, those skilled in the art will understand that this is not intended to be limiting and that the devices described herein may be used in other therapeutic or diagnostic procedures and in other anatomical regions of a patient's body, such as the digestive system (including but not limited to the esophagus, liver, stomach, colon, urinary tract) or the respiratory system (including but not limited to the bronchi, lungs), as well as various other anatomical regions.

[0053] The embodiments disclosed herein can be combined in one or more of many ways to provide improved diagnosis and treatment to patients. For example, the disclosed embodiments can be combined with existing methods and devices to provide improved treatment, such as in combination with known methods of lung diagnosis, surgery, and surgery of other tissues and organs. It should be understood that any one or more structures and steps as described herein can be combined with any one or more additional structures and steps of the methods and devices as described herein, and the accompanying drawings and supporting text provide a description according to the embodiments.

[0054] Although the treatment plans and definitions for diagnostic or surgical procedures as described herein are presented in the context of pulmonary diagnosis or surgery, the methods and devices described herein can be used to treat any tissue of the body and any organ and blood vessel of the body, such as the brain, heart, lungs, intestines, eyes, skin, kidneys, liver, pancreas, stomach, uterus, ovaries, testicles, bladder, ears, nose, mouth, soft tissues such as bone marrow, adipose tissue, muscle, glandular and mucosal tissue, spinal and neural tissue, cartilage, hard biological tissues such as teeth, bones, etc., as well as body cavities and passages such as sinuses, ureters, colon, esophagus, lung passages, blood vessels and throat, etc.

[0055] Whenever the term "at least," "greater than," or "greater than or equal to" precedes the first value in a series of two or more values, the term "at least," "greater than," or "greater than or equal to" applies to every value in the series. For example, greater than or equal to 1, 2, or 3 is equivalent to greater than or equal to 1, greater than or equal to 2, or greater than or equal to 3.

[0056] Whenever the term "no more than," "less than," or "less than or equal to" precedes the first value in a series of two or more values, the term "no more than," "less than," or "less than or equal to" applies to every value in the series. For example, less than or equal to 3, 2, or 1 is equivalent to less than or equal to 3, less than or equal to 2, or less than or equal to 1.

[0057] As used herein, a processor includes one or more processors, for example, a single processor or multiple processors of a distributed processing system. A controller or processor as described herein generally includes a tangible medium for storing instructions for implementing the steps of a process, and the processor may include, for example, one or more of a central processing unit, a programmable array logic, a gate array logic, or a field programmable gate array. In some cases, one or more processors may be a programmable processor (e.g., a central processing unit (CPU) or a microcontroller), a digital signal processor (DSP), a field programmable gate array (FPGA), and / or one or more advanced RISC machine (ARM) processors. In some cases, one or more processors may be operably coupled to a non-transitory computer-readable medium. A non-transitory computer-readable medium may store logic, code, and / or program instructions that may be executed by one or more processor units to perform one or more steps. A non-transitory computer-readable medium may include one or more memory units (e.g., removable media or external storage such as an SD card or random access memory (RAM)). One or more methods or operations disclosed herein may be implemented in a hardware component or a combination of hardware and software (e.g., an ASIC, a special-purpose computer, or a general-purpose computer).

[0058] As used herein, the terms distal and proximal may generally refer to a position with reference to the device and may be as opposed to an anatomical reference. For example, a distal position of a bronchoscope or catheter may correspond to a proximal position of an elongated member of a patient, and a proximal position of a bronchoscope or catheter may correspond to a distal position of an elongated member of a patient.

[0059] The system as described herein comprises an elongated portion or elongated member, such as a catheter. Unless the context indicates otherwise, the terms "elongated member," "catheter," and "bronchoscope" are used interchangeably throughout the specification. The elongated member can be placed directly into a body cavity or body lumen. In some embodiments, the system may further comprise a support device such as a robotic manipulator (e.g., a robotic arm) to drive, support, position, or control the movement and / or operation of the elongated member. Alternatively or in addition, the support device may be a handheld device or may or may not include other control devices of the robotic system. In some embodiments, the system may further comprise peripheral devices and subsystems such as imaging systems that assist and / or facilitate navigation of the elongated member to a target site in the subject's body.

[0060] In some embodiments of the present disclosure, a robotic bronchoscopy system is provided for performing surgical or diagnostic procedures with improved performance at low cost. For example, the robotic bronchoscopy system can include a steerable catheter that can be completely disposable. This can beneficially reduce sterilization requirements that can be costly or difficult to perform, but sterilization or disinfection may not be effective. In addition, one challenge of bronchoscopy is reaching the upper lobes of the lungs while navigating through the airways. In some cases, the provided robotic bronchoscopy system can be designed to be able to navigate through airways with small curvatures in an autonomous or semi-autonomous manner. Alternatively, the robotic bronchoscopy system can be navigated by an operator using a control system with visual guidance.

[0061] Typical lung cancer diagnosis and surgical treatment processes can vary significantly depending on the technology used by healthcare providers, clinical protocols, and clinical sites. Inconsistent processes can lead to delays in early lung cancer diagnosis, high costs for healthcare systems and patients to diagnose and treat lung cancer, and a high risk of clinical and surgical complications. The provided robotic bronchoscopy system can allow for standardized early lung cancer diagnosis and treatment. Figure 1 An example workflow 100 is shown for standardized lung cancer diagnosis enabled by the robotic bronchoscopy system described herein.

[0062] like Figure 1 As shown, preoperative imaging can be performed to identify lesions. Any suitable imaging modality such as magnetic resonance imaging (MR), positron emission tomography (PET), X-ray, computed tomography (CT), and ultrasound can be used to identify lesions or regions of interest. For example, a patient suspected of lung cancer can be given a preoperative CT scan, and suspected lung nodules can be identified in the CT images. The preoperative imaging process can be performed before the bronchoscopy.

[0063] Then, the CT image can be analyzed to generate a map for guiding the navigation of the robotic bronchoscope during bronchoscopy. For example, the lesion or region of interest (ROI) can be segmented on the image. When the lung is imaged, the channel or path to the lesion can be highlighted on the reconstructed image to plan the navigation path. The reconstructed image can guide the navigation of the robotic bronchoscope to the target tissue or target site. In some cases, the navigation path can be pre-planned using 3D image data. For example, the catheter can be advanced toward the target site under the robotic control of the robotic bronchoscope system. The catheter can be turned or advanced toward the target site manually, autonomously, or semi-autonomously. In an example, the movement of the catheter can be image-guided so that the insertion and / or steering direction can be automatically controlled.

[0064] In some cases, due to patient movement or physical differences, the lesion location in preoperative imaging may not be accurate. In this case, the lesion location can be verified before a surgical procedure (e.g., a biopsy or treatment). The exact location of the lesion can be verified or updated with the aid of a robotic bronchoscopy system. For example, a bronchoscopy system can provide an interface with an imaging mode such as fluoroscopy to provide in vivo real-time imaging of the target site and surrounding area to locate the lesion. In an example, a C-arm or O-arm fluoroscopic imaging system can be used to generate a tomosynthesis image for verifying or updating the lesion location. When a surgical procedure such as a biopsy is performed, various surgical tools such as a biopsy tool, a brush, or forceps can be inserted into the working channel of the catheter to perform a biopsy or other surgical procedure manually or automatically.

[0065] Then, a sample of the lesion or any other target tissue can be obtained by a tool inserted through the working channel of the catheter. The system allows camera visualization to be maintained throughout the operation (including during the insertion of the tool through the working channel). In some cases, tissue samples can be quickly evaluated on site through a rapid on-site evaluation process to determine whether repeated tissue sampling is needed or to decide further actions. In some cases, the rapid on-site evaluation process can also provide a rapid analysis of the tissue sample to determine the following surgical treatment. For example, if the tissue sample is determined to be malignant as a result of the rapid on-site evaluation process, a manual or robotic treatment instrument can be inserted through the working channel of the robotic bronchoscope and endobronchial treatment of lung cancer is performed. This beneficially allows diagnosis and treatment to be performed in one course of treatment, thereby providing targeted, painless and rapid treatment of early-stage lung cancer.

[0066] Figure 2A and Figure 2B 2 shows an example of a robotic bronchoscopy system 200, 230 according to some embodiments of the present invention. Figure 2AAs shown, the robotic bronchoscopy system 200 may include a steerable catheter assembly 220 and a robotic support system 210 for supporting or carrying the steerable catheter assembly. The steerable catheter assembly may be a bronchoscope. In some embodiments, the steerable catheter assembly may be a single-use robotic bronchoscope. In some embodiments, the robotic bronchoscopy system 200 may include an instrument drive mechanism 213 attached to the arm of the robotic support system. The instrument drive mechanism may be provided by any suitable controller device (e.g., a handheld controller) that may or may not include a robotic system. The instrument drive mechanism may provide a mechanical interface and an electrical interface to the steerable catheter assembly 220. The mechanical interface may allow the steerable catheter assembly 220 to be releasably coupled to the instrument drive mechanism. For example, the handle portion of the steerable catheter assembly may be attached to the instrument drive mechanism via a quick installation / release device (such as a magnet and a spring-loaded level, etc.). In some cases, the steerable catheter assembly may be manually coupled to or released from the instrument drive mechanism without the use of tools.

[0067] The steerable catheter assembly 220 may include a handle portion 223 that may include components configured to process image data, provide power, or establish communication with other external devices. For example, the handle portion 223 may include circuits and communication elements that enable electrical communication between the steerable catheter assembly 220 and the instrument drive mechanism 213 and any other external system or device. In another example, the handle portion 223 may include circuit elements, such as a power supply for powering the electronic devices (e.g., camera and LED light) of the endoscope. In some cases, the handle portion may be in electrical communication with the instrument drive mechanism 213 via an electrical interface (e.g., a printed circuit board) so that image / video data and / or sensor data can be received by the communication module of the instrument drive mechanism and can be sent to other external devices / systems. Alternatively or in addition, the instrument drive mechanism 213 may only provide a mechanical interface. The handle portion may be in electrical communication with a modular wireless communication device or any other user device (e.g., a portable / handheld device or controller) for sending sensor data and / or receiving control signals. Details related to the handle portion are described later herein.

[0068] The steerable catheter assembly 220 may include a flexible, elongated member 211 coupled to a handle portion. In some embodiments, the flexible, elongated member may include a shaft, a steerable tip, and a steerable section. The steerable catheter assembly may be a single-use robotic bronchoscope. In some cases, only the elongated member may be disposable. In some cases, at least a portion of the elongated member (e.g., a shaft, a steerable tip, etc.) may be disposable. In some cases, the entire steerable catheter assembly 220 including the handle portion and the elongated member may be disposable. The flexible, elongated member and the handle portion are designed so that the entire steerable catheter assembly can be placed at low cost. Details relating to the flexible, elongated member and the steerable catheter assembly are described later herein.

[0069] In some embodiments, the provided bronchoscopic system may further include a user interface. As shown in example system 230, the bronchoscopic system may include a procedure interface module 231 (user console side) and / or a procedure control module 233 (patient and robot side). The procedure interface module may allow an operator or user to interact with the bronchoscope during a surgical procedure. In some embodiments, the procedure control module 233 may be a handheld controller. In some cases, the procedure control module may include a proprietary user input device and one or more additional elements that can be removably coupled to an existing user device to improve the user input experience. For example, a physical trackball or scroll wheel may replace or supplement the functionality of at least one virtual graphical element displayed on a graphical user interface (GUI) (e.g., navigation arrows displayed on a touchpad) by assigning functionality similar to the graphical element it replaces. Examples of user devices may include, but are not limited to, mobile devices, smartphones / cellular phones, tablet computers, personal digital assistants (PDAs), laptop computers or notebook computers, desktop computers, and media content players. Details regarding the user interface device and user console are described later herein.

[0070] Figure 2B Different views of the bronchoscope system are shown.The user console 231 can be mounted to the robotic support system 210. Alternatively or in addition, the user console or a portion of the user console (eg, the procedure interface module) can be mounted to a separate mobile cart.

[0071] Robotic intracavitary platform

[0072] In one aspect, a robotic intraluminal platform is provided. In some cases, the robotic intraluminal platform can be a bronchoscopy platform. The platform can be configured to perform Figure 1 One or more operations consistent with the method described in FIG3 to FIG3 Figure 7Various examples of robotic endoluminal platforms and components or subsystems thereof according to some embodiments of the present invention are shown. In some embodiments, the platform can include a robotic bronchoscopy system and one or more subsystems that can be used in conjunction with the robotic bronchoscopy system of the present disclosure.

[0073] In some embodiments, one or more subsystems may include an imaging system, such as a fluoroscopic (tomosynthesis) imaging system for providing real-time imaging of a target site (eg, including a lesion). Figure 3A An example of a fluoroscopic (tomosynthesis) imaging system 300 is shown. For example, a fluoroscopic (tomosynthesis) imaging system can be used in Figure 1 Accurate lesion position tracking or verification is performed before or during the surgical procedure. In some cases, the lesion position can be tracked based on position data related to a perspective (tomosynthesis) imaging system / station (e.g., a C-arm) and image data captured by the perspective (tomosynthesis) imaging system. The lesion position can be registered using the coordinate system of the robotic bronchoscopy system. The position or motion of the perspective (tomosynthesis) imaging system can be measured using any suitable motion / position sensor 310 such as an inertial measurement unit (IMU), one or more gyroscopes, velocity sensors, accelerometers, magnetometers, position sensors (e.g., global positioning system (GPS) sensors), visual sensors (e.g., imaging devices capable of detecting visible, infrared, or ultraviolet light, such as cameras), proximity or distance sensors (e.g., ultrasonic sensors, lidar, time of flight, or depth cameras), altitude sensors, attitude sensors (e.g., compasses), and / or field sensors (e.g., magnetometers, electromagnetic sensors, radio sensors). One or more sensors for tracking the motion and position of the fluoroscopic (tomosynthesis) imaging station may be positioned on the imaging station (such as a wall-mounted camera 320) or remotely from the imaging station. Figure 3B A C-arm fluoroscopic (tomosynthesis) imaging system is shown in different (rotational) poses when taking images of a subject. The various poses may be captured by one or more sensors as described above.

[0074] In some embodiments, the location of a lesion can be segmented in image data captured by a fluoroscopic (tomosynthesis) imaging system using a signal processing unit 330. One or more processors of the signal processing unit can be configured to further overlay the treatment location (e.g., lesion) on the real-time fluoroscopic image / video. For example, the processing unit can be configured to generate an enhancement layer that includes enhancement information, such as the location of the treatment location or target site. In some cases, the enhancement layer can also include graphical indicia indicating a path to the target site. The enhancement layer can be a substantially transparent image layer including one or more graphical elements (e.g., boxes, arrows, etc.). The enhancement layer can be superimposed on an optical view of an optical image or video stream captured by the fluoroscopic (tomosynthesis) imaging system and / or displayed on a display device. The transparency of the enhancement layer allows a user to view the optical image using the overlaid graphical elements. In some cases, both the segmented lesion image and the optimal navigation path of the elongated member to reach the lesion can be overlaid on the real-time tomosynthesis image. This can allow an operator or user to visualize the exact location of the lesion and the planned path of movement of the bronchoscope. In some cases, segmented and reconstructed images provided prior to operation of the systems described herein (eg, CT images described elsewhere) may be overlaid on the real-time image.

[0075] In some embodiments, one or more subsystems of the platform may include a navigation and positioning subsystem. The navigation and positioning subsystem may be configured to construct a virtual airway model based on preoperative images (e.g., preoperative CT images). The navigation and positioning subsystem may be configured to identify the segmented lesion location in the 3D rendered airway model, and based on the location of the lesion, the navigation and positioning subsystem may generate an optimal path from the main bronchus to the lesion at a recommended approach angle toward the lesion for surgical procedures (e.g., biopsy).

[0076] In a registration step before driving the bronchoscope to the target site, the system can align the rendered virtual view of the airway with the patient's airway. Image registration can include a single registration step or a combination of a single registration step and real-time sensory updates to the registration information. Once registered, all airways can be aligned with the preoperative rendered airways. During the driving of the robotic bronchoscope toward the target site, the position of the bronchoscope within the airway can be tracked and displayed. In some cases, a position sensor can be used to track the position of the bronchoscope relative to the airway. Other types of sensors (e.g., cameras) can also be used instead of or in combination with position sensors using sensor fusion technology. Position sensors such as electromagnetic (EM) sensors can be embedded at the distal tip of the catheter, and during surgery, an EM field generator can be positioned near the patient's torso. The EM field generator can locate the EM sensor position in 3D space, or can locate the EM sensor position and orientation in 5D or 6D space. This can provide visual guidance to the operator when driving the bronchoscope toward the target site.

[0077] Figure 4A An example of a user interface for visualizing a virtual airway 409 overlaid with an optimal path 403, the location of the catheter tip 401, and the location of the lesion 405 is shown. In this example, the location of the catheter tip is displayed in real time relative to the virtual airway model 409, providing a visual guide. Figure 4A As shown in the example of , during the actuation of the robotic bronchoscope, the optimal path 403 can be displayed and overlaid on the virtual airway model. As described above, the virtual airway model can be constructed based on the real-time perspective image / video (and the position data of the imaging system). In some cases, a view of the real-time perspective image / video 407 can also be displayed on the graphical user interface. In some cases, the user may also be granted real-time access to the camera view or image / video 411 captured by the bronchoscope.

[0078] In some embodiments, the user interface may further include a user device that allows the user to visualize a virtual rendering (e.g., an airway) and a real-time camera view as the device is navigated to a target during surgery. In some cases, the virtual rendering may be overlaid onto the real-time camera view and displayed on a display device. In some cases, the system may integrate with or utilize immersive technologies such as immersive, virtual reality (VR), and augmented reality (AR) systems to enable visualization of the virtual rendering.

[0079] For example, the user may be permitted to visualize overlays (e.g., pathways, targets, vasculature, other anatomical structures) on these views with or without the use of an augmented reality system to provide the user with information during the procedure. The system may also permit the user to select / control the display of overlays based on use case or user preference.

[0080] Figure 4B An example of a navigation view with enhanced information is shown. Figure 4B As shown, navigation view 420 may include at least a real-time camera view 421 overlaid with a virtual rendering (e.g., augmented reality information). The virtual rendering or overlay information may include multiple components, such as a virtual airway 423, a virtual lesion 424, a virtual planned path to the lesion 425, etc. The multiple virtual components may be visualized with or without a virtual / augmented reality device. The navigation view may also include a direction indicator 424 indicating the navigation direction (e.g., forward, up, down, back, left, right).

[0081] The provided system can advantageously allow a user to control the display of a virtual rendering based on user preferences. For example, a user can enable / disable the display of one or more components selected from a plurality of components. Figure 4C An example of a navigation view with a user-selected virtual rendering is shown. For example, the user can turn off the virtual rendering of the airway and view a live camera view overlaid with a selected virtual rendering of the lesion 424 and pathway 423. Figure 4D Examples of endoluminal views are shown. In example 440, a virtual lumen 426 can be displayed along with a planned path 427 and / or a virtual rendering of the vasculature 429. Similarly, a directional indicator 428 can be provided to the user within the view. In another example 441, the user can turn on the virtual rendering of the airway 429 and pleura 430, causing these virtual components to be overlaid on the endoluminal view. The user can toggle any selected component on and off at any time.

[0082] In some embodiments, one or more subsystems of the platform may include one or more treatment subsystems, such as manual or robotic instruments (e.g., biopsy needles, biopsy forceps, biopsy brushes) and / or manual or robotic treatment instruments (e.g., RF ablation instruments, cryogenic instruments, microwave instruments, etc.).

[0083] In some embodiments, one or more subsystems of the platform may include a user console comprising a procedure interface module (user console side) and / or a procedure control module (patient and robot sides). Figure 5An example of a user console that allows an operator or user to interact with a bronchoscope during a surgical procedure is shown. As shown in example 510, the user console may include a treatment interface module that is configured to provide a user interface 511 that displays information related to the use of the bronchoscope, such as navigation information, user information (e.g., control parameters), robotic bronchoscopy camera views, etc. The user interface can be provided on a display. The display may be a touch screen, or may not be a touch screen. The display may be a light emitting diode (LED) screen, an organic light emitting diode (OLED) screen, a liquid crystal display (LCD) screen, a plasma screen, or any other type of screen. The display may be configured to show a user interface (UI) or a graphical user interface (GUI) presented by a software application (e.g., via an application programming interface (API) executed on the system).

[0084] In some embodiments, the user console may include a treatment control interface 511 and a treatment control module 503. The treatment control interface and the treatment control module may be separate, self-contained components. Alternatively or additionally, the treatment control interface and the treatment control module may be an integrated, single component. For example, the treatment control module may include a user input system 503 that communicates with the treatment interface module. Alternatively, the treatment control module may be a standalone system.

[0085] As shown in example 520, a user console or a component of a user console (e.g., a treatment interface module) can be mounted to a robotic support system 523. Alternatively or in addition, the user console or a component of a user console (e.g., a treatment interface module) can be mounted to a separate mobile cart 513. The mobile cart 513 can include various components such as a rechargeable power supply in electrical communication with a power strip that provides charging ports for portable electronic devices, converters, transformers, and surge protectors for multiple AC and DC outlets that serve as a power source for onboard equipment, including one or more computers that store specialized software for the treatment interface module.

[0086] In some embodiments, the treatment control module 503 may include, for example, a user interface handheld device that allows a physician to easily control a robotic endoscope (e.g., a bronchoscope). In some embodiments, the user input device or control device may be customized or personalized. Details regarding portable user interface devices / systems are described later herein. Alternatively or additionally, the treatment control module 503 may not be a portable device. For example, the treatment control module may be integrated into a robotic support system.

[0087] Figure 6A and Figure 6BAn example of a system with a treatment control system is shown. In some embodiments, the treatment control system may include or be integrated with a robotic support system 605, which includes a robotic arm 607, an instrument drive mechanism 609, a robotic control unit, and one or more peripheral devices such as an irrigation system 601 and a suction system 603. The robotic arm can initiate positioning of a robotic bronchoscope 611 or other robotic instrument. The instrument drive mechanism can be used to control the elongated member or robotic bronchoscope with two or more degrees of freedom (e.g., articulation). The irrigation system 601 and the suction system 603 can be located on a robotic arm base cart or any other part of the system. The irrigation system and the suction system can be connected to the working channel via a connector or Luer connector. The irrigation system can inject fluids such as saline, and the suction system can aspirate mucus, saline, or other materials from the airway. In some embodiments, the irrigation system and the suction system can be used with the aid of camera visualization.

[0088] Figure 7 An example of a robotic arm 710 mounted on top of a robotic cart in a treatment control system is shown. The robotic arm 710 can automatically position the catheter assembly to an initial position (e.g., an entry point) to access the target tissue. In some embodiments, the robotic arm can be moved passively by the operator. In this case, the operator can push the arm to any position and the arm moves compliantly. The robot can also be controlled in a compliant mode to improve human-robot interaction. For example, compliant motion control of robotics can employ collision avoidance strategies, and position force control can be designed to save unnecessary energy consumption while reducing the effects of possible collisions. In some embodiments, an instrument drive mechanism can be mounted to the robotic arm. The arm can have redundant degrees of freedom that allow its elbow to be algorithmically or passively moved into a configuration that is convenient for the operator.

[0089] Low-cost, single-use robotic bronchoscope

[0090] In one aspect of the present invention, a single-use robotic bronchoscope is provided. The robotic bronchoscope can be the same as the steerable catheter assembly described elsewhere herein. Conventional endoscopes can be complex in design and are typically designed to be reused after surgery, which requires thorough cleaning, disinfection, or sterilization after each surgery. Existing endoscopes are typically designed with complex structures to ensure that the endoscope can withstand the cleaning, disinfection, and sterilization processes. The provided robotic bronchoscope can be a single-use endoscope that can beneficially reduce cross-contamination and infection between patients. In some cases, the robotic bronchoscope can be delivered to the healthcare practitioner in pre-sterilized packaging and is intended to be disposed of after a single use.

[0091] Figures 8 to 10 An example of a robotic bronchoscope according to some embodiments of the present invention is shown. Figure 8 As shown, the robotic bronchoscope 820 may include a handle portion 813 and a flexible elongated member 811. In some embodiments, the flexible elongated member 811 may include a shaft, a steerable tip, and a steerable section. The robotic bronchoscope 820 may be the same as the steerable catheter assembly described in Figure 2. The robotic bronchoscope may be a single-use robotic endoscope. In some cases, only the catheter may be disposable. In some cases, at least a portion of the catheter may be disposable. In some cases, the entire robotic bronchoscope may be released from the instrument drive mechanism and may be disposed of. The bronchoscope may include different levels of stiffness along its axis to improve functional operation.

[0092] The robotic bronchoscope can be releasably coupled to an instrument drive mechanism 820. The instrument drive mechanism 820 can be mounted to an arm of a robotic support system or to any actuated support system as described elsewhere herein. The instrument drive mechanism can provide a mechanical interface and an electrical interface to the robotic bronchoscope 820. The mechanical interface can allow the robotic bronchoscope 820 to be releasably coupled to the instrument drive mechanism. For example, a handle portion of the robotic bronchoscope can be attached to the instrument drive mechanism via a quick-mount / release device (such as a magnet and a spring-loaded level, etc.). In some cases, the robotic bronchoscope can be manually coupled to or released from the instrument drive mechanism without the use of tools.

[0093] Figure 9 An example of an instrument drive mechanism 920 providing a mechanical interface to a handle portion 913 of a robotic bronchoscope is shown. As shown in the example, the instrument drive mechanism 920 can include a set of motors that are actuated to rotationally drive a set of pull wires of a catheter. The handle portion 913 of the catheter assembly can be mounted to the instrument drive mechanism so that its pulley assembly is driven by the set of motors. The number of pulleys can vary based on the pull wire configuration. In some cases, the catheter can be articulated using one, two, three, four, or more pull wires.

[0094] The handle portion can be designed to allow the robotic bronchoscope to be disposable at a reduced cost. For example, classic manual and robotic bronchoscopes can have a cable at the proximal end of the bronchoscope handle. The cable typically includes an illumination fiber, a camera video cable, and other sensor fibers or cables, such as EM sensors or shape sensing fibers, etc. Such complex cables may increase the cost of the bronchoscope. The provided robotic bronchoscope can have an optimized design so that simplified structure and components can be employed while maintaining mechanical and electrical functionality. In some cases, the handle portion of the robotic bronchoscope can employ a cable-free design while providing a mechanical / electrical interface to the catheter.

[0095] Figure 10 An example handle portion 1000 of a robotic bronchoscope according to some embodiments of the present invention is shown. In some cases, the handle portion 1000 can be a housing, or include components configured to process image data, provide power, or establish communication with other external devices. In some cases, the communication can be wireless communication. For example, the wireless communication can include Wi-Fi, radio communication, Bluetooth, IR communication, or other types of direct communication. Such wireless communication capabilities can allow the robotic bronchoscope to operate in a plug-and-play manner and can be conveniently disposed of after a single use. In some cases, the handle portion can include circuit elements, such as a power supply for powering electronic devices (e.g., a camera and LED light source) housed within the robotic bronchoscope or catheter.

[0096] The handle portion can be designed in conjunction with the catheter so that cables or optical fibers can be eliminated. For example, the catheter portion can be designed to have a single working channel that allows the instrument to pass through the robotic bronchoscope and low-cost electronic devices such as a tip chip camera, an illumination source such as a light-emitting diode (LED), and an EM sensor positioned at an optimal position according to the mechanical structure of the catheter. This can allow a simplified design of the handle portion. For example, by using LEDs for illumination, the termination at the handle portion can be based solely on electric welding or wire crimping. For example, the handle portion can include a proximal plate, wherein when the proximal plate is connected to the interface of the handle portion and an electrical connection to the instrument drive mechanism is established, the camera cable, LED cable, and EM sensor cable are terminated. As described above, the instrument drive mechanism is attached to the robot arm (robotic support system) and provides a mechanical interface and an electrical interface to the handle portion. This can advantageously improve assembly and implementation efficiency and simplify manufacturing process and cost. In some cases, the handle portion, together with the catheter, can be disposed of after a single use.

[0097] Single-use steerable catheter

[0098] Figure 11 An example steerable catheter 1100 according to some embodiments of the present invention is shown. In some embodiments, the catheter can have a substantially integral design, that is, one or more components can be integrated with the catheter, thereby simplifying the assembly and manufacturing process while maintaining the kinematic and dynamic performance of the steerable catheter. As shown in the example, the steerable catheter can include a slender member 1101 or a detection portion close to the tissue and / or area to be inspected. In some cases, the slender member 1101 may also be referred to as a catheter. The catheter 1101 may include internal structures such as a working channel 1103, thereby allowing tools as described elsewhere herein to be inserted through. In some cases, the working channel may have a size compatible with standard tools, such as a diameter of about 2 mm.

[0099] The catheter 1101 can be made of suitable materials to obtain desired flexibility or bending stiffness. In some cases, the material of the catheter can be selected so that it can maintain structural support to the internal structure (e.g., working channel) and is basically flexible (e.g., able to bend in all directions and orientations). For example, the catheter can be made of any suitable material such as urethane, vinyl (e.g., polyvinyl chloride), nylon (e.g., vestamid, grillamid), polyurethane, polyethylene, polypropylene, polycarbonate, polyester, silicone elastomer, acetate, etc. In some cases, the material can be a polymer material, a biocompatible polymer material, and the catheter can be flexible enough to advance through a path with a small curvature without causing pain to the object. In some cases, the catheter can include a sheath. The length of the sheath may be different from the length of the catheter. The sheath can be shorter than the catheter to provide desired support. Alternatively, the catheter can be basically a single-piece component.

[0100] In some cases, the distal portion or tip of the catheter can be substantially flexible so that it can be diverted to one or more directions (e.g., pitch, yaw). In some embodiments, the catheter can have a variable bending stiffness along the longitudinal axis. For example, the catheter can include a plurality of segments with different bending stiffnesses (e.g., flexibility, semi-rigidity, and rigidity). The bending stiffness can be changed by selecting a material with different stiffness / hardness, changing the structure in different segments, adding additional support components, or any combination thereof. In some cases, the proximal end of the catheter does not need to be highly curved, so the proximal portion of the catheter can be enhanced with an additional mechanical structure (e.g., an additional material layer) to achieve greater bending stiffness. This design can provide support and stability for the catheter. In some cases, variable bending stiffness can be achieved by using different materials during catheter extrusion. This can advantageously allow different stiffness levels to be present along the axis of the catheter during the extrusion manufacturing process, without the need to additionally tighten or assemble different materials.

[0101] The distal portion of the catheter can be steered by one or more pull wires 1105. The distal portion of the catheter can be made of any suitable material such as a copolymer, polymer, metal or alloy so that it can be bent by the pull wire. In some embodiments, the proximal end or proximal portion of one or more pull wires 1105 can be operably coupled to various mechanisms (e.g., gears, pulleys, etc.) in the handle portion of the catheter assembly. The pull wire 1105 can be a metal wire, cable or thread, or it can be a polymer wire, cable or thread. The pull wire 1105 can also be made of natural or organic materials or fibers. The pull wire 1105 can be any type of suitable wire, cable or thread that can support various loads without deformation, significant deformation or breakage. The distal end or distal portion of one or more pull wires 1105 can be anchored or integrated into the distal portion of the catheter so that the control unit can apply force or tension to the distal portion by operating the pull wire, which can at least cause the distal portion of the catheter (e.g., the flexible section) to steer or articulate (e.g., upward, downward, in pitch, yaw or any direction therebetween).

[0102] As described above, the pull wire can be made of any suitable material such as stainless steel (e.g., SS316), metal, alloy, polymer, nylon, or a biocompatible material. The pull wire can be a wire, cable, or thread. In some embodiments, different pull wires can be made of different materials to change the load-bearing capacity of the pull wire. In some embodiments, different sections of the pull wire can be made of different materials to change the stiffness and / or load along the pull wire. In some embodiments, the pull wire can be used to transmit electrical signals.

[0103] The catheter can be sized so that one or more electronic components can be integrated into the catheter. For example, the outer diameter of the distal tip can be approximately 4 to 4.4 millimeters (mm), and the diameter of the working channel can be approximately 2 mm, so that one or more electronic components can be embedded in the wall of the catheter or in a gap in the catheter. However, it should be noted that, based on different applications, the outer diameter can be in any range less than 4 mm or greater than 4.4 mm, and the diameter of the working channel can be in any range depending on the tool size or specific application.

[0104] One or more electronic components may include an imaging device, an illumination device, or a sensor. In some embodiments, the imaging device may be a camera 1113. The imaging device may include optical elements and an image sensor for capturing image data. The image sensor may be configured to generate image data in response to a wavelength of light. Various image sensors may be used to capture image data, such as a complementary metal oxide semiconductor (CMOS) or a charge coupled device (CCD). The imaging device may be a low-cost camera. In some cases, the image sensor may be mounted on a circuit board. The circuit board may be an imaging printed circuit board (PCB). The PCB may include multiple electronic components for processing image signals. For example, the circuitry of a CCD sensor may include an A / D converter and an amplifier to amplify and convert the analog signal provided by the CCD sensor. Alternatively, the image sensor may be integrated with the amplifier and converter to convert the analog signal into a digital signal, thereby eliminating the need for a circuit board. In some cases, the output of the image sensor or circuit board may be image data (digital signal), which may be further processed by the camera circuitry or the camera's processor. In some cases, the image sensor may include an optical sensor array.

[0105] The lighting device can include one or more light sources 1111 located at the distal tip. The light source can be a light emitting diode (LED), an organic LED (OLED), quantum dots, or any other suitable light source. In some cases, the light source can be a miniaturized LED or dual-tone flash LED lighting for compact design.

[0106] The imaging device and the lighting device can be integrated into the catheter. For example, the distal portion of the catheter can include a suitable structure that matches at least the size of the imaging device and the lighting device. The imaging device and the lighting device can be embedded in the catheter. Figure 12 An example distal portion of a catheter with an integrated imaging device and lighting device is shown. A camera can be located in the distal portion. For example, the camera can be embedded in a cavity 1210 at the distal tip of the catheter. The cavity 1210 can be integrally formed with the distal portion of the cavity and can have dimensions that match the length / width of the camera so that the camera can not move relative to the catheter. The camera can be adjacent to the working channel 1220 of the catheter to provide a near-field view of the tissue or organ. In some cases, the posture or orientation of the imaging device can be controlled by controlling the rotational movement (e.g., rolling) of the catheter.

[0107] The power supply of the camera can be provided by a wired cable. In some cases, the cable line can be in a harness, providing power to the lighting element or other circuit at the distal tip of the camera and the catheter. The camera and / or light source can be supplied with power from a power supply placed in the handle portion via a wire, copper wire or via any other suitable device that runs through the length of the catheter. In some cases, the real-time image or video of the tissue or organ can be sent wirelessly to an external user interface or display. Wireless communication can be WiFi, Bluetooth, RF communication or other forms of communication. In some cases, the image or video captured by the camera can be broadcast to multiple devices or systems. In some cases, the image and / or video data from the camera can be sent to a processor located in the handle portion via a wire, copper wire or via any other suitable device along the length of the catheter. The image or video data can be sent to an external device / system via the wireless communication components in the handle portion. In some cases, the system can be designed so that no wire is visible to the operator or exposed to the operator.

[0108] In conventional endoscopy, illumination light can be provided by a fiber optic cable that transmits light from a light source located at the proximal end of the endoscope to the distal end of the robotic endoscope. In some embodiments of the present disclosure, a miniaturized LED light can be used and embedded in the distal portion of the catheter to reduce design complexity. In some cases, the distal portion can include a structure 1230 having dimensions that match the dimensions of the miniaturized LED light source. As shown in the illustrated example, two cavities 1230 can be integrally formed with the catheter to accommodate two LED light sources. For example, the outer diameter of the distal tip can be approximately 4 to 4.4 millimeters (mm), and the diameter of the working channel of the catheter can be approximately 2 mm, so that two LED light sources can be embedded in the distal end. The outer diameter can be within any range of less than 4 mm or greater than 4.4 mm, and the diameter of the working channel can be within any range depending on the tool size or specific application. Any number of light sources can be included. The internal structure of the distal portion can be designed to accommodate any number of light sources.

[0109] In some cases, each LED can be connected to a power cord that can extend to the proximal handle. In some embodiments, the LEDs can be soldered to separate power cords that are then bundled together to form a single strand. In some embodiments, the LEDs can be soldered to the pull wires that supply power. In other embodiments, the LEDs can be crimped or directly connected to a single pair of power wires. In some cases, a protective layer (such as a thin layer of biocompatible glue) can be applied to the front surface of the LED to provide protection while allowing light to be emitted. In some cases, an additional cover 1231 can be placed on the front end face of the distal tip to provide precise positioning of the LEDs and sufficient space for the glue. The cover 1231 can be made of a transparent material that matches the refractive index of the glue so that the illumination light is not blocked.

[0110] In some embodiments, one or more sensors may be embedded in the distal portion of the catheter. In conventional robotic bronchoscopes, sensors can be used to track the position of the tip, which is typically located at the distal tip, resulting in an increase in the size of the tip. Provided steerable catheters can bundle one or more electronic components to provide a compact design. In some cases, the illumination source and one or more position sensors can be combined into a bundle. Figure 13 An example of a compact configuration of electronic components disposed at the distal portion is shown. In some embodiments, a position sensor such as an electromagnetic (EM) sensor can be used to accurately track the position of the distal tip of the catheter. In some cases, one or more EM sensors 1310 can be disposed at the distal portion and can be placed adjacent to or behind an illumination light source 1320 (e.g., an LED) in a stereoscopic arrangement. An electromagnetic coil located at the distal end can be used in conjunction with an electromagnetic tracking system to detect the position and orientation of the distal end of the endoscope while the endoscope is disposed within an anatomical system. In some embodiments, the coil can be angled to provide sensitivity to electromagnetic fields along different axes, thereby giving the disclosed navigation system the ability to measure a full six degrees of freedom (i.e., three positional degrees of freedom and three angular degrees of freedom).

[0111] In some cases, the EM sensor and LED light source can form a bundle 1300. The power cables for the EM sensor can be bundled with the LED wires to provide reduced space and complexity. In some cases, stereo alignment can provide differential 5D measurements or fused 6D measurements, which allow accurate positioning and orientation sensing of the distal tip of the catheter. During this process, an EM field generator located next to, below, or above the patient's torso can position the EM sensor, thereby tracking the position of the catheter tip in real time.

[0112] Cable configuration and design

[0113] The robotic bronchoscope may include one or more pull wires for controlling articulation of the catheter. In conventional endoscopes, the distal ends or distal portions of the one or more pull wires may be anchored or mounted to a control ring such that manipulation of the pull wires by a control unit may apply a force or tension to the control ring, which may cause a particular segment or portion of the catheter (e.g., the distal segment) to steer or articulate (e.g., up, down, in pitch, yaw, or any direction therebetween). Figure 14 Examples of conventional configurations of pull wires 1413 attached to a control ring structure 1411 and the novel configuration 1420 of the present disclosure are shown. The control ring can be attached to the distal end of a catheter 1415. Typically, the tips of the pull wires are fused or welded to the control ring 1411, and the control ring can also be attached to the distal tip by welding. The welding process can be expensive, cumbersome, and complex. In addition, if one pull wire breaks or fails, the entire steering control function may be affected.

[0114] The provided robotic bronchoscope can include individually controlled pull wires, each of which is directly connected to the distal portion. As shown in example 1420, one or more pull wires 1423 can be attached to an integrally formed structure 1421 of the distal portion. For example, the integrally formed structure 1421 can be a groove molded with the distal tip. The groove can have a size or dimension that matches the size of the distal end 1421 of the pull wire so that the pull wire can be conveniently crimped at the distal end. This can advantageously improve assembly efficiency. In some instances, the pull wire can be rigidly fixed to the groove at the distal end so that the distal end of the pull wire is not allowed to move relative to the distal portion of the catheter.

[0115] The pull wire configuration can also provide improved reliability when steering the distal portion. For example, when each pull wire is individually connected to the distal portion and controlled individually, the articulation force can be dynamically adjusted based on different pull wire configurations. For example, the articulation force can be recalculated, and the control signal for controlling the pull wires can be dynamically adjusted based on the available pull wires in the event of a pull wire break.

[0116] The convenient assembly of the puller wires to the distal portion can also allow flexibility in designing the puller wire configuration. For example, the number or combination of puller wires can be dynamically selected or adjusted to meet different performance or design requirements. Figure 15 Various configurations of pull wires for a robotic catheter system are shown. In some embodiments, an integral structure (groove) for receiving the pull wires can be prefabricated. For example, four grooves can be formed integrally with the catheter, and one or more pull wires can be fixedly connected / crimped to one or more grooves selected from the plurality of grooves to form different configurations 1510, 1530. As shown in the examples, any number of grooves / slots or any given subset of grooves / slots can be selected to receive or couple to the pull wires at one end. In some cases, once a combination of grooves / grooves is selected to couple to corresponding pull wires, a pull wire configuration pattern can be formed, and a mapping relationship between the selected grooves / grooves and the pull wires can be sent to a control unit. A control signal can then be generated during articulation based on the mapping relationship to achieve the desired articulation force.

[0117] In another example, the prefabricated grooves can have various configurations. For example, the three-wire configuration 1520 can have three grooves spaced approximately 120° apart. In some cases, the virtual mapping algorithm can map the three-wire configuration to a four-wire configuration. The virtual mapping algorithm can also be used to update the new mapping relationship when one or more pull wires fail / break during operation. The virtual mapping algorithm maps the selected configuration mode to the updated configuration mode when the state of one or more pull wires changes. This integrated design of the pull wire configuration advantageously simplifies the assembly and manufacturing process while maintaining the kinematic and dynamic performance of the catheter.

[0118] Guidewire with inflatable tip

[0119] In some embodiments, a guidewire can be used during a bronchoscopic procedure. The guidewire is typically inserted well beyond the tip of the bronchoscope to first access the desired air passageway, and then the bronchoscope is allowed to slide over the guidewire into the selected passageway. Because the diameter of the guidewire is small compared to the diameter of the bronchoscope, the guidewire may not have sufficient stiffness and / or sufficient friction to anchor the guidewire within the air passageway.

[0120] The guidewires of the present disclosure may feature an expandable outer diameter at the tip. Figure 16 An example of a guide wire 1600 with an inflatable tip is shown. Guide wire 1601 can be inserted through the working channel of a catheter / bronchoscope to assist in navigating the air passages in the lungs. In some cases, the guide wire can extend beyond the tip of the catheter into the desired airway, and the catheter can then slide over the guide wire to reach the desired position. The inflatable tip can be implemented using various suitable methods. For example, an additional component 1603, such as an inflatable balloon, can be positioned at or near the distal end of the guide wire. The balloon can be connected to a balloon inflation source or pump via the working channel to inflate or deflate the balloon.

[0121] In some cases, the guide wire may include perforations. The diameter of the deflated balloon may be equal to the diameter of the elongated arm (e.g., a bronchoscope catheter). In some cases, the diameter of the deflated balloon may be slightly larger than the elongated arm. The guide wire may be able to move distally or proximally. The guide wire may be attached to an air pump to inject and extract air relative to the guide wire, thereby inflating and deflating the balloon, respectively. During the insertion of the guide wire into the airway, the balloon may remain deflated. When the correct position is reached, the balloon will be inflated by pumping in air. Once the bronchoscope reaches the desired forward position, the balloon can be deflated by pumping out air, which can allow the guide wire to move forward. In some embodiments, the inflatable tip can be made of a retractable mesh structure using materials such as shape memory alloys (SMAs), electroactive polymers (EAPs), and ferrofluids, and have their corresponding inflation and deflation control mechanisms. The anchoring element can have any other form to fix the anchoring of the guide wire. For example, the anchoring element can be a metal wire that can expand or contract radially. The anchoring element can be actuated by a sliding actuator that slides linearly to cause the anchoring element to change its position, and in particular, to deploy or return the anchoring element to a retracted position. The sliding action of the actuator can be translated into a change in the position (condition) of the anchoring element (e.g., the anchoring element deploys and radially expands to provide a structure to anchor the guidewire in place, or conversely, the anchoring element radially contracts and returns to a retracted state).

[0122] Anti-buckling device

[0123] In some embodiments, the catheter can be designed to be flexible. When the flexible portion of the catheter is inserted into the patient's body via the bronchoscope using an extension mechanism, one or more sections may bend or buckle. In this case, to prevent the catheter from buckling as the bronchoscope is advanced toward the patient, an anti-buckling mechanism can be coupled to the handle portion of the robotic bronchoscope to support the catheter. Although anti-buckling mechanisms such as telescoping mechanisms are known, the flexible portion of the catheter can still bend or buckle. Existing anti-buckling devices can include multiple cylindrical elements with openings at both ends. The diameters of the cylindrical elements can gradually increase. These cylindrical elements can be coupled together and can contract or expand within each other. The diameter of the cylinder with the smallest diameter is larger than the diameter of the elongated member, so that when the cylinder is extended, the elongated member can move forward. When the anti-buckling device is retracted or removed, the diameter difference prevents the catheter from being retrieved. However, the catheter can still bend in sections where the diameter of the telescoping mechanism is larger than the outer diameter of the catheter.

[0124] The present disclosure provides an improved anti-buckling mechanism for preventing buckling of an insertion shaft. Figure 17 An example anti-buckling mechanism 1700 according to some embodiments of the present invention is shown. Anti-buckling mechanism 1700 can be a retractable, extendable device with an internal mechanism for achieving anti-buckling of the catheter during insertion and removal. Anti-buckling mechanism 1700 can be removably connected to the handle portion of the robotic bronchoscope at one end and removably connected to a support surface 1701 at the other end. As shown in the example, the anti-buckling tube can be attached to a bracket on the instrument drive mechanism and can be removed and disposed of after the procedure via a quick-release mechanism. A support arm can be supported by a robotic mobile cart that supports the endotracheal tube mount and provides a support surface for the distal end of the anti-buckling tube to press against when compressed. The support arm can be controlled to rotate, translate vertically up and down, and / or can be an expanding and contracting boom arm, allowing it to be precisely positioned above the patient's mouth and attached to the endotracheal tube mount. Support arm positioning can be synchronized with the movement of the robotic arm, which can track the location of the catheter's entry point.

[0125] The anti-buckling mechanism can be designed with internal features to prevent the catheter from buckling. Figure 18AAn example of the internal structure of an anti-buckling mechanism according to some embodiments of the present invention is shown. In some cases, the anti-buckling mechanism can be a detachable device that can be disposed of after a single use. The anti-buckling device can include a plurality of cylinders 1801 with gradually decreasing cylindrical diameters. The cylinders can be assembled or connected concentrically along an axial axis. Each cylinder can be composed of a thin-walled cylinder 1801, a proximal end having an inner lip 1802, and a proximal closure 1803 having a clearance hole 1804 with a diameter slightly larger than that of the catheter / sheath. The diameter of the clearance holes of all cylinders can be the same so that the movement of the catheter can be limited relative to the anti-buckling device in the cross-sectional plane. The cylindrical element can also include an outer stop lip 1805 (i.e., a radial protrusion slightly larger than the outer diameter of the cylinder) and a stop 1806 at the distal opening of the cylindrical structure. In some embodiments, the proximal closure 1803 and the outer lip 1805 can be a single, integrated element. Alternatively, the proximal closure member 1803 and the outer lip 1805 can be assembled separately. In some embodiments, if the proximal closure member 1803 and the outer lip 1805 are a single, integral part, they can be in the form of a disc that is assembled to the proximal end of the cylindrical member. In some cases, the proximal closure member 1803 and the outer lip 1805 can be integrally formed with the cylindrical member. The inner lip and the outer stop lip can prevent the cylinder from disengaging during extension of the anti-buckling device.

[0126] A clearance hole located in the center of the proximal disc can allow the catheter to slide smoothly along the drive shaft and provide normal compression to prevent bending or buckling of the catheter when the telescope is extended. In some embodiments, the telescope can be filled with a pressurized viscous fluid (e.g., silicone oil, buffer solution) to prevent rapid buckling events during forceful insertion. Two attachment attachments (plates) can be provided at the distal and proximal ends of the entire anti-buckling device, with the proximal attachment plate fastened to the robotic arm. The distal plate can be attached to a fixture that is fastened to the patient's bed by additional features. In some embodiments, the fixture can be a post fastened to the bed, in which case no additional force is applied to the patient when the anti-buckling device is retracted. In other embodiments, the fixture can be a railing on the bed.

[0127] Figure 18B and Figure 18C An example of an assembly of an anti-buckling mechanism 1810 and a handle 1811 is shown. Figure 18B The anti-buckling mechanism is shown connected to the handle and in a retracted state, and Figure 18C The anti-buckling mechanism is shown fully extended.

[0128] In some cases, the systems and devices herein can allow for a simplified setup process for assembling the anti-buckling mechanism and the endoscope. For example, the anti-buckling mechanism and the endoscope handle can be assembled via a transverse connection between the anti-buckling mechanism and the endoscope handle, and the assembled parts can be top-loaded onto the instrument drive mechanism as a single part. This convenient assembly capability advantageously allows the endoscope handle and anti-buckling assembly to be coupled to the robotic arm regardless of the state and current position of the instrument drive mechanism. Figure 18D An example of a scope handle and anti-buckling tube assembly with side connection features is shown. Anti-buckling tube 1827 can be releasably connected to handle 1825 via side connection features 1821, 1823. A connector on scope handle 1821 can be laterally attached to a corresponding connector on anti-buckling mechanism 1823 to connect the two separate parts. In some cases, connectors can be located on both sides of the handle to connect to two connectors on the anti-buckling mechanism. Any suitable mechanism (button, pin, snap, magnet) can be used to releasably couple the anti-buckling tube to the handle. Figure 18E The assembled anti-buckling mechanism and handle are shown in .

[0129] Figure 18E An example is shown that allows a user to place the anti-buckling tube 1835 and the scope's connection assembly onto the instrument drive mechanism 1831 via the interface of the handle 1833. Assembling the scope and anti-buckling mechanism prior to loading onto the instrument drive mechanism can simplify the workflow.

[0130] The anti-buckling mechanism may require a relatively linear trajectory to travel. In some cases, this trajectory can be ensured via alignment between the anti-buckling mechanism in the collapsed state and the patient-side connector. Figure 18F An example of a patient-side connector 1841 and an IDM 1841 is shown. For example, the patient-side connector can be secured to a patient-side mount (e.g., attached to a patient bed). The alignment workflow can involve aligning a retracted anti-buckling mechanism 1845 with the patient-side connector with an alignment guide or feedback. For example, a user can be assisted by aligning the instrument drive mechanism (IDM) with the patient-side connector, and feedback (e.g., visual / tactile / audible feedback) can be provided to the user that the anti-buckling mechanism and the patient-side connector are properly aligned. Figure 18G Another example of an anti-buckling mechanism that is advanced to a target position via alignment between the patient-side connector and the IDM is shown.

[0131] In some cases, the alignment process can be performed using the IDM and the connector on the patient side of the anti-buckling mechanism before the anti-buckling mechanism is attached. Alternatively, the alignment process can be performed with the anti-buckling mechanism attached. Alignment features can include the use of click alignment, laser alignment, magnets, visual indicators, or tactile / auditory feedback. Figure 18HExamples of alignment features 1851, 1857 are shown. In the example shown, mechanical alignment features such as click buttons or magnets can be provided on the patient-side connector 1853 and the IDM 1855 to provide feedback indicators regarding alignment. For example, when alignment is complete, the click button or magnet can trigger a tactile, audible, or visual signal indicating proper alignment. In some cases, visual indicators such as colored dots / marks, grooves, ridges, etc. can be placed on the IDM to assist with alignment.

[0132] like Figure 18H As shown, the laser 1857 on the IDM can be used to aim at the patient side connector to ensure straight alignment with the patient side connector. Figure 18I As shown, the anti-buckling mechanism and magnets on the distal end of the patient-side connector can assist in alignment and provide visual / tactile feedback to the user that the components have been properly aligned.

[0133] User Interface

[0134] The user interface may include various devices such as a touch screen monitor, a joystick, a keyboard, and Figure 19 In some embodiments, the user may be able to navigate and / or control the motion of the robotic arm and the movement of the catheter using a user input device. The user input device may have any type of user interaction component, such as a button, a mouse, a joystick, a trackball, a touchpad, a pen, an image capture device, a motion capture device, a microphone, a touch screen, a handheld wrist gimbal, an exoskeleton glove, or other user interaction system such as a virtual reality system, an augmented reality system, or the like. In some cases, the user input device may be a stylus device that physically contacts a touch-sensitive display screen, and the user may control the robotic system by moving the stylus device across the display screen.

[0135] In some embodiments, the treatment control module may be a handheld controller 1930. The treatment control module may include proprietary, personalized, or customized user input devices. In some cases, one or more add-ons 1910 may be removably coupled to an existing user device 1920 to improve the user input experience of the treatment control module 1930. For example, one or more physical user input devices or add-ons 1920 (e.g., a trackball, joystick, or scroll wheel) may be coupled to a graphical user interface (GUI) 1910 located on the user device via tactile sensing or Bluetooth. For example, the trackball, joystick, or scroll wheel 1920 may replace or supplement the functionality of at least one virtual graphical element (e.g., navigation arrows, slider 1911) displayed on the graphical user interface (GUI) by assigning functionality similar to the graphical element it replaces. The add-on may be coupled to the GUI via physical contact on a touch screen, via an IO port, or via wired or wireless communication, so that user input received via the add-on can be mapped to input received by the virtual graphical element presented on the GUI. Examples of user devices may include, but are not limited to, mobile devices, smart phones / cellular phones, tablet computers, personal digital assistants (PDAs), laptop computers or notebook computers, desktop computers, media content players, etc. Details regarding user interface devices and user consoles are described later herein.

[0136] In another example, the user input device can be a camera (e.g., an imaging sensor located at the display), and the user input can include retinal information, such as the location the user is looking at. The user input is used to confirm the new alignment of the virtual component with the target position (e.g., by squeezing a trigger or pressing a button on a laparoscopic handheld controller, a voice command, etc.). The orientation of the virtual component (e.g., the rotational orientation of the axis) can be adjusted using a touchpad, trackball, or other suitable input on the laparoscopic handheld controller or other device (user device).

[0137] In some embodiments, a user may be allowed to personalize the user interface based on the user's personal preferences, such as handedness or speed of actuating a user interface device (e.g., speed of moving a lever on a joystick used to drive an elongated member of a robot forward or backward). Artificial intelligence methods, such as machine learning or deep learning, may be used to personalize the user interface device based on user behavior. As an example, machine learning methods may be used to learn based on user behavior, such as button usage, lever usage, frequency of button or lever usage, number of clicks, or speed of moving a lever on a joystick to adapt and become specialized. For example, the user interface may be adapted to use a combination of buttons or levers for a particular task based on the user's preferences for using those buttons and levers.

[0138] In some embodiments, the training data may include historical user interface interaction data or simulated data. The artificial intelligence algorithm may be trained to adapt to user behavior and interaction with the user interface.

[0139] In some embodiments, the training data can include historical user interface interaction data or simulated user interaction data as well as imaging and / or video data of the process as described elsewhere. The user interface interaction data can be time-stamped and annotated with respect to the real-time imaging data to distinguish specific user interactions while driving the elongated member. Having a combined training data set can allow the artificial intelligence algorithm to verify the user's experience level, in which case the user interface can not only adapt to the user's movements, but it can also assist in training the user through, for example, visual or audio messages to guide the user in driving the elongated member.

[0140] Various artificial intelligence models can be implemented, such as, but not limited to, neural networks. The artificial intelligence model can be a trained model or a trained machine learning algorithm. The machine learning algorithm can be any type of machine learning network, such as: support vector machine (SVM), naive Bayesian classifier, linear regression model, quantile regression model, logistic regression model, random forest, neural network, convolutional neural network (CNN), recurrent neural network (RNN), gradient boosting classifier or blocker, or another supervised or unsupervised machine learning algorithm (e.g., generative adversarial network (GAN), Cycle-GAN, etc.). Figure 20 An example of a neural network model for generating a control signal in response to a single user input is shown. Various types of neural networks can be used. The neural network can support deep learning. The neural network can be a convolutional deep neural network and / or a recurrent neural network using supervised or unsupervised training. In some embodiments, the neural network can support reinforcement learning.

[0141] The input to the neural network may include user interactions and behaviors with respect to user interface devices, such as Figure 20 The input may also include time-stamped real-time image and / or video data depicting the user's manipulation and actuation of the elongated member. The neural network may extract features from the input data that depict user preferences in various aspects of the user interface of the user interface device. For example, the user's preference for using buttons versus levers, the user's handedness, the speed at which the user moves the lever, etc.

[0142] The output layer of the neural network may include one or more output nodes. Each output node may represent a decision based on user behavior regarding interaction with the user interface device and actuation of the elongated member. The output may output the likelihood of different actions that the user can take. Based on the position of the elongated member, one or more actions may have a likelihood above a predetermined threshold. In some embodiments, based on real-time image data and the position of the tip of the elongated member, as well as the likelihood presented by the output of the neural network, visual and / or audio instructions may be displayed on a graphical user interface to guide the user in taking an action, such as stopping actuation of the elongated member, changing the actuation angle, accelerating or decelerating actuation, using a pull wire to bend the tip of the elongated member in a specific direction, and the like. The neural network may also personalize the functionality of elements of the user interface device, such as personalizing the use of certain touch buttons, push buttons, or levers on a joystick or any other user interface device.

[0143] The training dataset can be stored on local storage, such as local memory or a local server. It can also be stored on a remote dataset, such as a cloud server. Training can be performed online or offline. The training dataset can be updated in real time to improve the learning and functionality of the neural network.

[0144] In some cases, the platform can provide a deep learning model with continuous training or improvement after deployment. The deep learning model provided by the platform can be dynamically adjusted and adapted to different individuals and different surgical procedures over time. The predictive model provided by the platform can be continuously improved over time (e.g., during implementation, after deployment). This continuous training and improvement can be performed automatically with little user input or user intervention.

[0145] In some embodiments, the provided robotic intracavitary platform can adopt an edge intelligence paradigm, that is, data processing and prediction / inference are performed at the edge or edge gateway (e.g., bronchoscope, robotic system, user device), while the prediction model can be built, developed and trained on the cloud / data center and run on the user device or control device (e.g., hardware accelerator) for inference. In some cases, the deep learning model can be pre-trained on the cloud and sent to the user device, control system or edge computing system for implementation. In some cases, as new sensor data and user feedback are collected, the deep learning model can undergo continuous training. Continuous training can be performed on the cloud or server. In some cases, sensor data for updating the model for continuous training can be sent to the cloud, and the updated model (e.g., the parameters of the updated model) can be downloaded to a local or edge system (e.g., a bronchoscopy system, a robotic system, a user device, a software application of the bronchoscopy system) for implementation.

[0146] Portable handheld add-on module

[0147] The robotic bronchoscope is designed to work with a robotic platform. The electronic and mechanical movement of the catheter is controlled via the robotic platform. However, at the beginning of the operation, the doctor may need to manually inspect the main airway through the bronchoscope. The present disclosure provides a portable handle attachment module for the doctor to manually manipulate the bronchoscope without using a robotic support system. For example, the handle portion of the robotic bronchoscope can have a unified interface that allows the robotic bronchoscope to be releasably connected to the instrument drive mechanism, portable handle device, controller or user interface device, modular wireless communication device and various other devices of the robotic support system.

[0148] Below Figure 21A An example of a portable handle add-on module design is shown in . The module can have an electrical interface connected to a proximal plate within the handle. The electrical interface can include a signal connection. A plurality of matching mechanical pulleys can engage the active pulley of the handle. Two or more knobs can allow combined movement of all of the pulleys, thereby enabling the distal tip of the robotic bronchoscope to be articulated. The add-on module can be connected to the user interface via a wired connection, a wireless connection, or a combination of both. For example, a communication module such as a WiFi chip inside the module can broadcast video from the bronchoscope to multiple portable displays. The portable handle add-on module can include a power source such as a battery to provide backup power to the camera in addition to the cable in the handle. Alternatively or in addition, cable / wired communication can be used.

[0149] As described above, the robotic bronchoscope may be designed to interface with external devices in a plug-and-play manner. Figure 21BVarious examples of robotic bronchoscopes used in conjunction with various systems, devices, and modules are shown. In a first scenario 2110, a handle portion 2111 of a robotic bronchoscope can be connected to a portable handle attachment module 2117 via mechanical and electrical interfaces as described above. For example, the portable handle attachment module can provide a mechanical interface including a drive element (e.g., a motor) 2113, wherein the drive element 2113 is actuated to rotationally drive a set of pull wires of a catheter. In some cases, the portable handle attachment module 2117 can also provide an electrical interface 2115 that electrically communicates with a proximal plate in the handle portion 2111 for transmitting sensor data and / or control signals. In some embodiments, the same robotic bronchoscope 2121 can be releasably connected to and switched between a portable handle attachment module and a robotic support system, as shown in example 2120. The robotic bronchoscope can have a unified interface, allowing for convenient switching between the instrument drive mechanism 2123 and the portable handle attachment module 2117. In some embodiments, the instrument drive mechanism, the portable handle attachment module, or both can provide only a mechanical interface. As shown in scene 2130, a modular wireless communication device 2131 (e.g., a WiFi module) can be positioned and releasably coupled to a handle portion 2133 to expand the electrical communication capabilities of the robotic bronchoscope. For example, the modular wireless communication device 2131 (e.g., a WiFi module) can be in electrical communication with the handle portion for transmitting sensor data to an external device and / or receiving control signals from an external control system. This can advantageously allow the robotic bronchoscope to be used or integrated with existing robotic systems, user devices, or surgical systems, regardless of the electrical communication capabilities of the underlying systems.

[0150] Portable robotic cone-beam CT

[0151] Conventional cone-beam CT machines may have C- or O-shaped transmitter and receiver panels on the same mechanical structure. The connections between the transmitter and receiver panels can result in a large cone-beam CT machine. This oversized design limits use cases and takes up a significant amount of space in the rather cramped operating room.

[0152] This article describes a design to decouple the mechanical connection between the transmitter and receiver panels. Figure 22 An example portable robotic cone beam CT is shown. The transmitter and receiver panels can be mounted on two separate robotic arms, as shown in Figure 2. Figure 22 When used, both robots can move in the same coordinate system. The control algorithm ensures that both robots are moving in synchronized motion.

[0153] In addition, for patient gated motion (i.e., breathing), additional external sensors (i.e., IMU, EM, or image sensors) can be added to track the patient's motion. Sensors such as IMU, EM, or image sensors can be used to track the patient's position changes. Sensory signals can be used to command the two robotic arms. In some cases, one or both of the robotic arms may be moving to track the patient's motion, which essentially makes the transmitter and receiver stationary for the patient's motion in the region of interest (ROI) when tracking. The ROI may include a target site or target position that can be automatically determined by the system or manually determined by the doctor. Other mechanisms such as, but not limited to, external cameras and one or more trackers on the patient's body can also be used for tracking.

[0154] It will be understood by those skilled in the art that cone beam CT is a non-limiting example. The design described herein can be used with other imaging modalities, such as fluoroscopy, classical CT, and MRI.

[0155] The present invention provides embodiments including but not limited to the following:

[0156] 1. A robotic endoscope device comprising:

[0157] A disposable elongated member comprising:

[0158] a proximal end and a distal end, wherein the proximal end is removably attached to a robotic arm via a handle, wherein the distal end is integrated with an imaging device, a position sensor, and an illumination device; and

[0159] A curved section that is articulated by one or more tension wires.

[0160] 2. The robotic endoscopic apparatus of embodiment 1, wherein the distal end comprises a structure for receiving the imaging device, the position sensor, and the lighting device.

[0161] 3. The robotic endoscopic apparatus of embodiment 1, wherein the imaging device, the position sensor, and the lighting device are arranged in a compact configuration.

[0162] 4. The robotic endoscopic apparatus according to embodiment 1, wherein the handle includes one or more components configured to process image data, provide power to the imaging device, the position sensor, and the lighting device, or establish communication with an external device.

[0163] 5. The robotic endoscopic device of embodiment 1, wherein the handle comprises an interface configured to couple the handle to an instrument drive mechanism attached to the robotic arm.

[0164] 6. The robotic endoscopic device of embodiment 5, wherein the interface comprises an electrical interface and a mechanical interface.

[0165] 7. The robotic endoscopic device of embodiment 6, wherein the mechanical interface is configured to releasably couple the handle to the instrument drive mechanism.

[0166] 8. The robotic endoscopic device of embodiment 5, further comprising an anti-buckling mechanism having an alignment feature.

[0167] 9. The robotic endoscopic device of embodiment 8, wherein the alignment feature is configured to assist in alignment between the instrument drive mechanism and the anti-buckling mechanism.

[0168] 10. The robotic endoscopic device of embodiment 8, wherein the alignment feature comprises a magnetic component, a laser, or a click button.

[0169] 11. The robotic endoscopic device of embodiment 8, wherein the anti-buckling mechanism comprises a series of connected cylinders, each cylinder comprising a lip structure.

[0170] 12. The robotic endoscopic apparatus according to embodiment 11, wherein the lip structure of each cylinder has retainers of the same diameter.

[0171] 13. A robotic endoscope system, comprising the robotic endoscope apparatus according to embodiment 1 and a user interface device configured for a user to control the movement of the robotic endoscope apparatus.

[0172] 14. The robotic endoscopy system of embodiment 13, wherein the user interface device is personalized based on past user behavior.

[0173] 15. The robotic endoscope system according to embodiment 14, wherein the user interface device is personalized with the aid of a machine learning algorithm training model.

[0174] 16. The robotic endoscope system of embodiment 13, further comprising a display configured to display image data captured by the imaging device overlaid with a virtual rendering of one or more components.

[0175] 17. The robotic endoscopy system of embodiment 16, wherein display of the virtual rendering of the one or more components is selectively enabled or disabled by a user.

[0176] 18. The robotic endoscopic apparatus of embodiment 1, wherein said handle and said disposable elongated member are both single use.

[0177] 19. The robotic endoscopic device of embodiment 1, wherein the one or more pull wires are individually attached to the bending segments according to a selected configuration pattern.

[0178] 20. The robotic endoscopic device of embodiment 1, wherein control of articulation of the robotic endoscopic device is based at least in part on a virtual mapping algorithm.

[0179] 21. The robotic endoscopic device of embodiment 20, wherein the virtual mapping algorithm maps the selected configuration mode to an updated configuration mode when the state of the one or more pull wires changes.

[0180] Although preferred embodiments of the present invention have been shown and described herein, it will be readily understood by those skilled in the art that these embodiments are provided by way of example only. Without departing from the present invention, those skilled in the art will now appreciate that many variations, changes, and replacements may be employed. It should be understood that various alternatives to the embodiments of the present invention described herein may be employed in implementing the present invention. The following claims are intended to define the scope of the present invention, and methods and structures within the scope of these claims and their equivalents are intended to be covered thereby.

Claims

1. A robotic endoscope device comprising: A disposable elongated member comprising: a proximal end and a distal end, wherein the proximal end is removably attached to a robotic arm via a handle, wherein the distal end is integrated with an imaging device, a position sensor, and an illumination device; and A curved section that is articulated by one or more tension wires.

2. The robotic endoscopic apparatus of claim 1, wherein the distal end includes structure for receiving the imaging device, the position sensor, and the illumination device.

3. The robotic endoscopic apparatus according to claim 1, wherein the imaging device, the position sensor, and the lighting device are arranged in a compact configuration. 4 . The robotic endoscopic apparatus according to claim 1 , wherein the handle includes one or more components configured to process image data, provide power to the imaging device, the position sensor, and the lighting device, or establish communication with an external device. 5 . The robotic endoscopic device of claim 1 , wherein the handle comprises an interface configured to couple the handle to an instrument drive mechanism attached to the robotic arm. The robotic endoscopic device according to claim 5 , wherein the interface comprises an electrical interface and a mechanical interface.

7. The robotic endoscopic device of claim 6, wherein the mechanical interface is configured to releasably couple the handle to the instrument drive mechanism.

8. The robotic endoscopic apparatus of claim 5, further comprising an anti-buckling mechanism having an alignment feature.

9. The robotic endoscopic device of claim 8, wherein the alignment feature is configured to assist in alignment between the instrument drive mechanism and the anti-buckling mechanism. 10 . A robotic endoscope system comprising the robotic endoscope apparatus according to claim 1 and a user interface device configured for a user to control movement of the robotic endoscope apparatus.

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