Systems and methods for automated closed-loop navigation and control of endoscopic surgical devices

Abstract

A surgical device is provided that includes a flexible portion annularly wound within a housing. The surgical device includes a processor configured to predict an intended path for the distal tip and generate a control signal. The intended path is predicted based on at least one anatomical structure recognized using data received from one or more sensors. An actuation unit of the surgical device actuates three-dimensional movement of the distal tip along the intended path based on the control signal.

Description

[Technical Field]

[0001] (Cross reference information) This application is a continuation-in-part of U.S. Patent Application No. 17 / 121,709, entitled "SYSTEM AND METHOD FOR AUTOMATED INTUBATION," filed December 14, 2020, which is incorporated herein by reference in its entirety.

[0002] TECHNICAL FIELD The present disclosure relates generally to automated medical devices, and more particularly to systems and methods for automated closed-loop navigation and control of invasive surgical devices. [Background technology]

[0003] Various surgical procedures involve the implantation or insertion of medical devices into or from a patient's body. Such devices are inserted into or through a patient's cavity or lumen for diagnostic and / or interventional purposes in various internal body regions, such as the upper, middle, or lower gastrointestinal (GI) tract, cardiovascular tract, trachea, genitourinary tract, pulmonary tract, etc.

[0004] One such application of invasive device insertion is colonoscopy, which is performed to examine the lower GI tract, including the rectosigmoid, large intestine, and distal portion of the small intestine, while passing through the anus. Physicians can visualize the lumen of the lower GI tract using a cable-driven endoscope with an imaging device at its distal end. However, the length and natural directional changes of the lower GI tract make the colonoscopy procedure quite challenging. Therefore, performing a colonoscopy requires significant skill and training. Even with proper training, efficiently navigating a patient's lower GI tract can be difficult. Therefore, an efficient and accurate means of controlling and navigating devices within cavities and lumens within the human body, such as the GI tract, is needed. Summary of the Invention

[0005] References to "one embodiment," "at least one embodiment," "an embodiment," "an example," "an example," "for example," etc., indicate that the embodiment or example may include a particular feature, structure, characteristic, property, element, or limitation, but not all embodiments or examples necessarily include that particular feature, structure, characteristic, property, element, or limitation. Moreover, repeated use of the phrase "in one embodiment" does not necessarily refer to the same embodiment.

[0006] In one aspect of the present invention, an automated closed-loop navigation and control system coupled to an invasive medical device is disclosed. The automated closed-loop navigation and control system may include a processing circuit that receives data from at least one data source, such as an image sensor, memory, or database, recognizes structures associated with a patient's cavity or lumen, and predicts an intended path for inserting the invasive medical device into the patient. The processing circuit further generates and communicates control signals based on the intended path to at least one actuation unit to actuate three-dimensional movement of the invasive medical device. Control systems associated with colonoscopy, which may be performed automatically and / or manually, have been described. Similar systems and methods may be used, with some modifications, in and in connection with any cavity or lumen within the human body.

[0007] In an exemplary embodiment of the present invention, an automated colonoscopy system predicts one or more intended paths and generates control signals for at least one actuation unit. The intended path is predicted based on data received from at least one imaging sensor. For effective guidance, an overlay of the intended path and / or recognized anatomical structures is also displayed on the user interface over the data received by the user interface from the imaging sensor. If multiple intended paths are displayed, the user can select one or more paths and assign trajectory priorities. Throughout this process, information is provided to the user through the user interface, and the user has the ability to manually override the output regarding the intended path determination determined by the closed-loop navigation and control system, as described below in the detailed description. Manual override may result in auditory or visual feedback prompting the user to confirm the override. The priority between manual and automatic control of insufflation can be changed in settings, and either can be the default setting. Additionally, the intended path overlay may be visualized on the user interface in the form of augmented reality and / or any other form that provides effective guidance to the user.

[0008] An instrument for the aforementioned procedure may be inserted through the instrument port such that the distal end of the instrument enters the instrument port and exits the distal end of the flexible section. The processing circuit may predict the intended path of the instrument. The processing circuit may generate and communicate control signals to the actuation unit to actuate three-dimensional movement of the invasive medical device.

[0009] In one preferred embodiment, the closed-loop navigation and control system includes a body, a bending section, a flexible section connecting the body with the bending section, a housing unit disposed on the bending section including at least one imaging sensor, circuitry, a user interface, a disposable cover, an actuation unit for moving the distal tip, and at least one actuation unit for actuating three-dimensional movement of the flexible section. The length of the bending unit is variable and can range from approximately the tip of the flexible section to the entire flexible section. In other embodiments, the bending section can be positioned within any portion of the flexible section, as determined by several factors, including, but not limited to, the anatomical structure that needs to be navigated and the associated application.

[0010] The processing circuitry can utilize the machine learning model in conjunction with data received from the data source to recognize structures associated with the patient's cavity, predict an intended path, and generate and communicate control signals to the actuation unit to actuate three-dimensional movement of the invasive medical device. The intended path may be defined as a path along which the device can guide the invasive medical device once movement is initiated. Generating the machine learning model involves receiving or collecting training data in the form of a predetermined data set to train at least one neural network. The form of the neural network used may be, but is not limited to, an edge-implemented deep neural net-based object detector and / or any other algorithm known in the art. Other forms of machine learning other than neural networks may be substituted, as is well known to those skilled in the art.

[0011] The processing circuitry can be utilized to predict an intended path for inserting the device based on at least one recognized anatomical structure and generate a control signal. The processing circuitry can also be utilized to recognize anatomical structures using data received from the imaging sensor and at least one pre-trained machine learning model. The actuation unit can receive control signals from the processing circuit to actuate three-dimensional movement of the flexible portion. The actuation unit can actuate bending movement of the flexible portion in the X and Y planes using a connection with the bending portion. The actuation unit can also include a sliding mechanism that actuates sliding movement of the flexible portion in the Z plane by moving the bending portion and its associated actuation unit. Alternatively, the sliding mechanism can actuate sliding movement of the distal end in the Z plane by direct contact or abutment with the flexible portion without displacing the bending portion and its associated actuation unit.

[0012] In another aspect of the present invention, a method for automatically inserting an invasive medical device into a cavity or lumen of a patient is provided, the method including inserting a bent portion and an invasive medical device disposed on the bent portion into the cavity or lumen of the patient. The method includes collecting data using an imaging sensor disposed on the bent portion and communicating the collected data to a processing circuit to predict an intended path of insertion of the invasive medical device and generate a control signal. The control signal is then communicated to at least one actuation unit to actuate three-dimensional movement of the invasive medical device. Preferably, the intended path is predicted by the processing circuit based on recognition of at least one structure associated with the cavity or lumen using data communicated from the imaging sensor.

[0013] Other embodiments and preferred features of the invention, together with corresponding advantages, will become apparent from the following description and claims. [Brief explanation of the drawings]

[0014] Various aspects and embodiments of the present invention are better understood by reference to the following detailed description. For a better understanding of the present invention, the detailed description should be read in conjunction with the drawings.

[0015] [Figure 1] 1 illustrates an environment for a closed-loop navigation and control system according to embodiments of the present disclosure.

[0016] [Figure 2A] 1 illustrates a robotic unit according to an embodiment of the present disclosure.

[0017] [Figure 2B] 1 illustrates a distal tip of a robotic unit according to an embodiment of the present disclosure.

[0018] [Figure 2C] 1 illustrates a top view of a cover encasing the robotic unit of the first embodiment, according to an embodiment of the present disclosure. FIG. [Figure 2D] FIG. 1 illustrates a bottom view of a cover encasing the robotic unit of the first embodiment, according to an embodiment of the present disclosure.

[0019] [Figure 3] 1 illustrates a close-up view of an actuation unit of a robotic unit including a rack and pinion configuration, according to an embodiment of the present disclosure.

[0020] [Figure 4A] 1 illustrates a robotic unit according to an alternative embodiment of the present disclosure.

[0021] [Figure 4B] FIG. 10 illustrates a front perspective view of a cover according to an alternative embodiment of the present disclosure.

[0022] [Figure 5] 1 illustrates a detachable robotic unit according to an alternative embodiment of the present disclosure.

[0023] [Figure 6A] 1 illustrates a flexure section including a robotic actuation mechanism of a robotic unit, according to an embodiment of the present disclosure. [Figure 6B] 1 illustrates a flexure section including a robotic actuation mechanism of a robotic unit, according to an embodiment of the present disclosure. [Figure 6C] 1 illustrates a flexure section including a robotic actuation mechanism of a robotic unit, according to an embodiment of the present disclosure.

[0024] [Figure 6D] 13 illustrates a connection to a distal end of a bend according to an embodiment of the present disclosure.

[0025] [Figure 6E] 13 illustrates an angulation wire in a robotic unit according to an embodiment of the present disclosure.

[0026] [Figure 7] 1 illustrates a cross-sectional view of the internal circuitry of the flexible portion of the robotic unit, according to an embodiment of the present disclosure.

[0027] [Figure 8] 1 illustrates exemplary functional components of a proposed closed-loop navigation and control system, according to certain embodiments of the present disclosure.

[0028] [Figure 9] 1 illustrates an exemplary implementation scenario of a closed-loop navigation and control system.

[0029] [Figure 10] 1 illustrates a bushing coupling mechanism used in a robotic unit, according to an embodiment of the present disclosure.

[0030] [Figure 11] 10A-10C illustrate various positions of the robotic unit around a patient according to an embodiment of the present disclosure. DETAILED DESCRIPTION OF THE INVENTION

[0031] The present disclosure is best understood with reference to the detailed figures and description set forth herein. Various embodiments are described with reference to the figures. However, those skilled in the art will readily appreciate that the detailed description provided herein with respect to the figures is for illustrative purposes only, as the methods and systems may extend beyond the described embodiments. For example, the teachings presented and the needs of a particular application may yield multiple alternatives and preferred approaches for implementing the functionality of any detail described herein. Thus, any approach may extend beyond the specific implementation selections in the following embodiments.

[0032] The methods of the present invention may be implemented by performing or carrying out selected steps or tasks manually, automatically, or in any combination. The term "method" refers to ways, means, techniques, and procedures for accomplishing a given task, including, but not limited to, ways, means, techniques, and procedures known to practitioners of the art to which the invention pertains or that can be readily developed from known ways, means, techniques, and procedures by such practitioners. The descriptions, examples, methods, and materials presented in the claims and the specification should be construed as illustrative only and not limiting. Those skilled in the art will envision many other possible variations on the techniques described herein.

[0033] When reading the description of an exemplary embodiment of the best mode of the invention (hereinafter referred to as "exemplary embodiment"), it should be understood that this exemplary embodiment is the best mode for practicing the invention according to the inventor's belief at the time of filing the patent application. An exemplary embodiment should not be construed as limiting the invention to one embodiment, as one skilled in the art can recognize that substantially equivalent structure or substantially equivalent acts can achieve the same result in the same or different manner.

[0034] A description of a species (or a particular item) refers to the genus (class of items) to which the species belongs and related species within this genus. Similarly, a description of a genus refers to the species as known in the art. Furthermore, as technology advances, numerous additional alternative means of achieving aspects of the invention may emerge. Such advances are incorporated into the respective genus and should be recognized as functionally equivalent or structurally equivalent to the embodiments shown or described.

[0035] Unless expressly stated otherwise, conjunctions (such as "or," "and," "including," or "comprising") are to be construed in an inclusive rather than exclusive sense.

[0036] Those skilled in the art will appreciate that various structures and devices are depicted in block diagrams in order to avoid obscuring the invention, and that in the following description, similarly named acts are performed in similar manners unless otherwise noted.

[0037] The foregoing explanations and definitions are provided for purposes of clarity, not limitation. Unless otherwise indicated, words and phrases should be given their ordinary and plain meaning. This disclosure relates generally to automated medical devices, and more particularly to systems and methods for automatically navigating invasive surgical devices through body lumens or cavities.

[0038] In one aspect of the present invention, an automated closed-loop navigation and control system coupled to an invasive medical device is disclosed. The automated closed-loop navigation and control system may include a processing circuit that receives data from at least one data source, such as an image sensor, a memory, or a database, recognizes structures, such as cavities or lumens, within a patient, and predicts an intended path for insertion and navigation of the invasive medical device within the patient. The processing circuit further generates and transmits control signals based on the predicted intended path to at least one actuation unit to actuate the invasive medical device in three dimensions to control the navigation and movement of the invasive medical device. The closed-loop navigation and control system associated with colonoscopy may be performed automatically and / or manually. Additionally, the closed-loop navigation and control system and method may be utilized, with some modifications, within any cavity or lumen within the human body and for several other procedures.

[0039] The data source may include one or more imaging sensors, including, but not limited to, infrared cameras, acoustic sensors, microwave sensors, fiber optic shape sensors, photodetectors, mechanical sensors, such as pressure sensors, force sensors, proximity sensors, time-of-flight or LIDAR sensors, or other sensors known to those skilled in the art. In other embodiments, one or more sensors may be fused into a single, custom-designed sensor to reduce the size of the sensor. Data captured through the data source may be based on differential absorption of monochromatic (single wavelength or narrow band) or polychromatic (multiple wavelengths simultaneously) radiation ranging from the ultraviolet to the far-infrared spectrum. Data may be static, captured at a single point or a single time point, or may be dynamic or serial data, representing several sequences of time or continuous data that can create a point cloud or video.

[0040] In certain embodiments, the closed-loop navigation and control system may be used for diagnostic and interventional endoscopic procedures involving cavities or lumens of the GI system, hepatobiliary system, respiratory system, male and female genitourinary system, cardiovascular system, and female reproductive system. For the GI system, procedures include, but are not limited to, esophagoscopy, rigid, oral; diagnostic, with brushing or washing specimen collection; esophagoscopy, rigid, oral; with biopsy, one or more times; esophagoscopy, flexible, nasal; diagnostic, with brushing or washing specimen collection; esophagoscopy, flexible, nasal; with biopsy, one or more times; esophagoscopy, flexible, oral; diagnostic, with brushing or washing specimen collection; esophagoscopy, flexible, oral; with biopsy, one or more times; esophagogastroduodenoscopy, flexible, oral; diagnostic, with brushing or washing specimen collection Includes taking specimens by brushing or washing; Esophagogastroduodenoscopy, flexible, oral; With biopsy, one or more times; Small enteroscopy, enteroscopy beyond the second part of the duodenum, not including the ileum; Diagnostic, includes taking specimens by brushing or washing; Small enteroscopy, enteroscopy beyond the second part of the duodenum, not including the ileum; With biopsy, one or more times; Small enteroscopy, enteroscopy beyond the second part of the duodenum, including the ileum; Diagnostic, with or without taking specimens by brushing or washing; Small enteroscopy, enteroscopy beyond the second part of the duodenum, including the ileum; With biopsy, one or more times; Ileostomy, via stoma; Diagnostic, includes taking specimens by brushing or washing, if performed; Ileostomy , via stoma; with biopsy, one or more times; colonoscopy via stoma; diagnostic, including taking specimen by brushing or washing; colonoscopy via stoma; with biopsy, one or more times; sigmoidoscopy, flexible; diagnostic, including taking specimen by brushing or washing; sigmoidoscopy, flexible; with biopsy, one or more times; colonoscopy, flexible; diagnostic, including taking specimen by brushing or washing; Colonoscopy, flexible; with biopsy, one or more times; esophagoscopy, flexible, oral; endoscopic ultrasound; esophagogastroduodenoscopy, flexible, oral; endoscopic ultrasound limited to the esophagus, stomach, or duodenum and adjacent structures; esophagogastroduodenoscopy, flexible, oral; endoscopic ultrasound including either the esophagus, stomach, and duodenum, or a surgically modified stomach in which the jejunum distal to the anastomosis is examined; colonoscopy via a stoma;Endoscopic ultrasound limited to the sigmoid, descending, transverse, or ascending colon, and cecum, and adjacent structures; flexible sigmoidoscopy; endoscopic ultrasound; flexible colonoscopy; endoscopic ultrasound limited to the rectum, sigmoid, descending, transverse, or ascending colon, and cecum, and adjacent structures; rigid, oral esophagoscopy; with balloon dilation (less than 30 mm in diameter); rigid, oral esophagoscopy; with guidewire insertion followed by dilation over the guidewire; flexible, oral esophagoscopy; retrograde balloon or dilator dilation with esophageal dilation (including fluoroscopic guidance, if performed); flexible, oral esophagoscopy; with balloon (≥ 30 mm in diameter) dilation (if performed) including fluoroscopic guidance, if performed); esophagoscopy, flexible, oral; with endoscopic balloon dilation (<30 mm diameter); esophagoscopy, flexible, oral; with guidewire insertion followed by passage of a dilator over the guidewire; esophagogastroduodenoscopy, flexible, oral; with balloon (≥30 mm diameter) dilation of the esophagus (including fluoroscopic guidance, if performed); esophagogastroduodenoscopy, flexible, oral; with dilation of gastric / duodenal strictures (e.g., balloon, bougie); esophagogastroduodenoscopy, flexible, oral; with guidewire insertion followed by passage of a dilator in the esophagus over the guidewire; esophagogastroduodenoscopy, flexible, oral; with endoscopic balloon dilation of the esophagus; ileostomy , via stoma;with endoscopic balloon dilation;colonoscopy via stoma;with endoscopic balloon dilation;sigmoidoscopy, flexible;with endoscopic balloon dilation;esophagoscopy, rigid, oral;with removal of foreign body;esophagoscopy, flexible, oral;with removal of foreign body;esophagogastroduodenoscopy, flexible, oral;with removal of foreign body;enteroscopy beyond the second part of the duodenum, not including the ileum;with removal of foreign body;colonoscopy via stoma;with removal of foreign body;sigmoidoscopy, flexible;with removal of foreign body;colonoscopy, flexible;with removal of foreign body;esophagoscopy, flexible, oral;with removal of tumor, polyp, or other lesion with hot biopsy forceps;esophagogastroduodenoscopy, flexible, oral;with removal of tumor, polyp, or other lesion with hot biopsy forceps;Enteroscopy, enteroscopy beyond the second part of the duodenum, not including the ileum;with removal of tumors, polyps, or other lesions with hot biopsy forceps or bipolar cautery;colonoscopy via stoma;with removal of tumors, polyps, or other lesions with hot biopsy forceps;sigmoidoscopy, flexible;with removal of tumors, polyps, or other lesions with hot biopsy forceps;colonoscopy, flexible;with removal of tumors, polyps, or other lesions with hot biopsy forceps;esophagoscopy, flexible, oral;with removal of tumors, polyps, or other lesions with a snare technique; Esophagogastroduodenoscopy, flexible, oral; with removal of tumors, polyps, or other lesions by snare technique; small intestine endoscopy, enteroscopy beyond the second part of the duodenum, not including the ileum; with removal of tumors, polyps, or other lesions by snare technique; colonoscopy via stoma; with removal of tumors, polyps, or other lesions by snare technique; sigmoidoscopy, flexible; with removal of tumors, polyps, or other lesions by snare technique; colonoscopy flexible; with removal of tumors, polyps, or other lesions by snare technique; esophagoscopy, flexible, oral; involving ablation of tumors, polyps, or other lesions (including pre- and post-dilatation, and passage of a guidewire, if performed); enteroscopy, enteroscopy beyond the second part of the duodenum, not including the ileum; involving ablation of tumors, polyps, or other lesions not amenable to removal by hot biopsy forceps, bipolar cautery, or snare techniques; transstoma colonoscopy; involving ablation of tumors, polyps, or other lesions (including pre- and post-dilatation, and passage of a guidewire, if performed); sigmoidoscopy, Flexible; involving ablation of tumors, polyps, or other lesions (including pre- and post-dilatation, and passage of a guidewire, if performed); colonoscopy, flexible; involving ablation of tumors, polyps, or other lesions (including pre- and post-dilatation, and passage of a guidewire, if performed); enteroscopy of small bowel, enteroscopy beyond the second part of the duodenum, not including the ileum; involving ablation of tumors, polyps, or other lesions not amenable to removal by hot biopsy forceps, bipolar cautery, or snare techniques; colonoscopy via a stoma;with ablation of tumors, polyps, or other lesions (including pre- and post-dilatation, and passage of a guidewire, if performed); sigmoidoscopy, flexible; with ablation of tumors, polyps, or other lesions (including pre- and post-dilatation, and passage of a guidewire, if performed); colonoscopy, flexible; with ablation of tumors, polyps, or other lesions (including pre- and post-dilatation, and passage of a guidewire, if performed); esophagoscopy, flexible, oral; any method with controlled bleeding; esophagogastroduodenoscopy, flexible, oral; any method with controlled bleeding; small enteroscopy, enteroscopy beyond the second part of the duodenum, not including the ileum; with controlled bleeding (e.g., injection, bipolar cautery, monopolar cautery, laser, heater probe, stapler, plasma coagulator); small enteroscopy, enteroscopy beyond the second part of the duodenum, including the ileum; with controlled bleeding (e.g., injection, bipolar cautery, monopolar cautery , lasers, heater probes, staplers, coagulators); flexible sigmoidoscopy; with controlled bleeding, any method; transstoma colonoscopy; with controlled bleeding, any method; flexible oral esophagoscopy; with injection sclerosing of esophageal varices; flexible oral esophagogastroduodenoscopy; with injection sclerosing of esophageal / gastric varices; flexible oral esophagoscopy; with band ligation of esophageal varices; flexible oral esophagogastroduodenoscopy; with band ligation of esophageal / gastric varices; Esophagoscopy, flexible, oral; with endoscopic stent placement (including pre- and post-dilatation and passage of a guidewire, if performed); Esophagogastroduodenoscopy, flexible, oral; with endoscopic stent placement (including pre- and post-dilatation and passage of a guidewire, if performed); Enteroscopy, enteroscopy beyond the second part of the duodenum, not including the ileum; with endoscopic stent placement (including pre-dilatation); Enteroscopy, enteroscopy beyond the second part of the duodenum, including the ileum; with endoscopic stent placement (including pre-dilatation); Ileostomy, via stoma; with endoscopic stent placement (including pre- and post-dilatation and passage of a guidewire, if performed); Sigmoidoscopy, flexible; with endoscopic stent placement (including pre- and post-dilatation and passage of a guidewire, if performed); Colonoscopy, flexible;with endoscopic stent placement (including pre- and post-dilatation, if performed, and passage of a guidewire); esophagogastroduodenoscopy, flexible, oral; with directed placement of a percutaneous gastrostomy tube; enteroscopy, enterostomy beyond the second part of the duodenum, not including the ileum, with placement of a percutaneous jejunostomy tube; enteroscopy, enterostomy beyond the second part of the duodenum, not including the ileum , conversion of a percutaneous gastrostomy tube to a percutaneous jejunostomy tube, exchange of a percutaneous gastrostomy or cecostomy (or other colonic) tube, under fluoroscopic guidance, including contrast injection; esophagoscopy, rigid, oral; with directed submucosal injection of any substance; esophagoscopy, flexible, oral; with directed submucosal injection of any substance; esophagogastroduodenoscopy, flexible, oral; with directed submucosal injection of any substance; transstoma colonoscopy; with directed submucosal injection of any substance; sigmoidoscopy, flexible; with directed submucosal injection of any substance; colonoscopy, flexible; with directed submucosal injection of any substance; esophagoscopy, flexible, oral; with endoscopic ultrasound-guided intramural or transmural fine-needle aspiration / biopsy; esophagogastroduodenoscopy, flexible , oral; with endoscopic ultrasound-guided intramural or transmural fine-needle aspiration / biopsy (including endoscopic ultrasound limited to the esophagus, stomach, or duodenum, and adjacent structures); esophagogastroduodenoscopy, flexible, oral; with endoscopic ultrasound-guided intramural or transmural fine-needle aspiration / biopsy (including endoscopic ultrasound of either the esophagus, stomach, and duodenum, or a surgically modified stomach in which the jejunum distal to the anastomosis is examined); transstoma colonoscopy; including endoscopic ultrasound limited to the sigmoid, descending, transverse, or ascending colon, and cecum, and adjacent structures, with endoscopic ultrasound-guided intramural or transmural fine-needle aspiration / biopsy; sigmoidoscopy, flexible; with endoscopic ultrasound-guided intramural or transmural fine-needle aspiration / biopsy;

[0041] In certain embodiments, the cavity or lumen into which the invasive medical device may be inserted may be any natural or artificial cavity within the human body, including, but not limited to, the abdominal cavity, the orbit, the outer, middle, and inner ear (including associated lumens and cavities), the brain / cranial cavity, the vertebral / spinal cavity, the thoracic cavity, the peritoneal cavity, the pelvic cavity, the pleural cavity, the oral cavity, the nasal cavity, the laryngeal cavity, etc. The lumen may be any natural or artificial organ or structure within an organ system, including, but not limited to, the following organ systems: In the respiratory system, the lumen may include, but is not limited to, the continuous airways - nose, nasopharynx, larynx, trachea, left and right main bronchi, bronchi and bronchioles, alveoli, lung parenchyma, etc. In the gastrointestinal (GI) system, lumens can include, but are not limited to, the continuation of the GI tract—ostium, oropharynx, esophagus, stomach (including all distinct portions of the stomach), duodenum (including all distinct portions of the duodenum), small intestine (including all distinct portions of the small intestine), colon (including all distinct portions of the colon), sigmoid colon, rectum, anus, ileostomy, colostomy, etc. In the urinary system, lumens can include, but are not limited to, the continuation of the urinary tract—urethra (including all portions of the male and female urethra), vas deferens, bladder, ureters, renal pelvis, renal calyces, renal pyramids, and kidneys. In the cardiovascular system, lumens can include, but are not limited to, all ventricles, aorta (including all portions of the aorta), celiac artery, all arteries, all veins and capillaries, inferior vena cava, superior vena cava, etc. In the hepatopancreaticobiliary (HPB) system, lumens can include, but are not limited to, the continuous HPB ducts—liver, gallbladder, pancreas, and all associated ducts—hepatic duct, cystic duct, pancreatic duct, common bile duct, etc. In the female reproductive system, lumens can include, but are not limited to, the vagina, cervix, uterus, fallopian tubes, etc. Cavities or lumens can also include normal anatomical structures and landmarks within these organ systems, such as the veru montenum, ampulla of Vater, ileocecal junction, normal anatomical variations, and abnormal anatomical pathologies, such as polyps, tumors, diverticulitis, etc. Cavities or lumens may allow imaging of nearby structures with an endoscope and can be used for diagnostic and interventional procedures, such as transesophageal echocardiography, endoscopic ultrasound, endobronchial ultrasound, and other procedures known to those skilled in the art.

[0042] FIG. 1 illustrates an environment for a closed-loop navigation and control system 100 according to one embodiment of the present disclosure. In one embodiment, the closed-loop navigation and control system 100 may be provided within the body of a detachable robotic unit 104 or a stand (described below). The closed-loop navigation and control system 100 may include a control unit 102 that generates control signals transmitted to the detachable robotic unit 104. The detachable robotic unit 104 may include an imaging unit 112 and an actuation unit 114. In one embodiment, the control unit 102 may be connected to the detachable robotic unit 104 through a wired or wireless connection, or a combination of both. Thus, the detachable robotic unit 104 may be automatically operated by the control unit 102 based on feedback received from the imaging unit 112 and the sensor unit 116. Thus, a closed processing and control loop may be created based on inputs provided by the imaging unit 112 and processing performed by the control unit 102 to generate control signals for automatically controlling the movement of the detachable robotic unit 104 via the actuation unit 114.

[0043] In some embodiments, a wired or wireless network, or a combination thereof, may be implemented as one of different types of networks, such as an intranet, a local area network (LAN), a wide area network (WAN), Bluetooth, IEEE 802.11, the Internet, Wi-Fi, an LTE network, a CDMA network, etc. Furthermore, a wired or wireless network may be either a dedicated network or a shared network. A shared network represents an association of different types of networks that use various protocols, such as, for example, Hypertext Transfer Protocol (HTTP), Transmission Control Protocol / Internet Protocol (TCP / IP), Wireless Application Protocol (WAP), etc., to communicate with each other. Furthermore, a wired or wireless network may include various network devices, including routers, bridges, servers, computing devices, storage devices, etc.

[0044] In some embodiments, the closed-loop navigation and control system 100 may be electrically powered by electrical connections through power cables or rechargeable batteries provided to power the various components of the closed-loop navigation and control system 100. In some embodiments, the robotic unit 104 may be powered by the same or a different power cable of the control unit 102, or may have a separate power source in the form of a rechargeable battery for powering the robotic unit 104.

[0045] The control unit 102 includes one or more processors 108. The one or more processors 108 may be implemented as one or more microprocessors, microcomputers, single-board computers, microcontrollers, digital signal processors, central processing units, graphics processing units, logic circuits, and / or any device that manipulates data based on operational instructions. Among other functions, the one or more processors 108 are configured to fetch and execute computer-readable instructions stored in a memory 110 of the control unit 102. The memory 110 may store one or more computer-readable instructions or routines that can be fetched and executed to create or share data units via a network service. The memory 110 may include any non-transitory storage device, including, for example, volatile memory such as RAM, or non-volatile memory such as EPROM, flash memory, etc. In some embodiments, the control unit 102 may be connected to a cloud server that includes the one or more processors 108 and the memory 110 in the form of a cloud database. The one or more processors 108 may be configured to process data stored in a local memory 110 within the control unit 102 or in the form of a cloud database.

[0046] The control unit 102 may also include input / output devices 106. The input / output devices 106 may include various interfaces, such as interfaces for data input and output devices, and the like. The input / output devices 106 may facilitate input of instructions by a user 118 that communicates with the control unit 102. In some embodiments, the input / output devices 106 may be wirelessly connected to the control unit 102 through a wireless network interface, such as BLUETOOTH, infrared, or any other wireless radio communication interface known in the art. In some embodiments, the input / output devices 106 may be connected to communication paths for one or more components of the control unit 102 to facilitate transmission of input instructions and output results of data generated by various components, such as, but not limited to, the processor 108 and memory 110.

[0047] In one embodiment, the control unit 102 may be implemented on any computing device that can be automatically configured or controlled by a user 118 operating the closed-loop navigation and control system 100. Additionally, the user 118 may communicate with the control unit 102 through one or more user devices (not shown), which may be communicatively coupled to the control unit 102 through a wired or wireless connection or may be provided as one or more input / output devices 106. The user may be a healthcare provider and may be present during operation of a medical device that includes the closed-loop navigation and control system 100. In one embodiment, the user devices (not shown) may include a variety of computing systems, including, but not limited to, physical manipulation, touch-enabled computing devices, artificial intelligence (AI)-enabled interfaces, laptop computers, virtual reality / augmented reality / mixed reality (VR / augmented reality / AR / mixed reality)-enabled or integrated interfaces, desktop computers, notebooks, workstations, portable computers, personal digital assistants, handheld devices, joysticks, or mobile devices. In one embodiment, the input / output device 106 may be configured to receive input from a user 118 in the form of, but not limited to, touch, gaze, gestures, voice commands, and the like.

[0048] The robotic unit 104 may be removably connected to the control unit 102. The robotic unit 104 may have a variety of shapes and sizes and may be designed and selected for the cavity or lumen into which it is inserted. For example, the size and shape of a robotic unit 104 for a colonoscope or upper GI endoscope may be different from that used for a ureteroscope or bronchoscope, etc. In certain embodiments, the robotic unit 104 may also include a processing unit (not shown) for processing, such as sensor integration and independent functioning of one or more sensors, microcontrollers, motors, actuators, and other components provided within the robotic unit 104. The robotic unit 104 may also include attachment interfaces and channels for all external devices, including, but not limited to, other external surgical devices (not shown), external surgical instruments, energy devices (not shown), air insufflation devices (not shown), suction irrigation devices (not shown), ultrasound (not shown), and other imaging devices (not shown). The robotic unit 104 may comprise a combination of one or more disposable and reusable components (described below). In one embodiment, the robotic unit 104 may house a tube (described below), which may have different lengths and diameters corresponding to the cavity or lumen into which it is inserted. The tube of the robotic unit 104 may include a flexible section (described below), a bent section (described below), and a distal end (described below), which may be disposable or reusable.

[0049] The robotic unit 104 may be designed to have a variety of shapes and sizes. Furthermore, the robotic unit 104 may differ depending on the cavity or lumen for which the endoscope is designed. For example, the size and shape of the robotic unit 104 for a colonoscope or upper GI endoscope may be different from that for a ureteroscope or bronchoscope, etc. The robotic unit 104 may house a flexible section 204, the length and diameter of which may vary from cavity to cavity or lumen depending on what the endoscope is designed for.

[0050] The robotic unit 104 may include an imaging unit 112, an actuation unit 114, and a sensor unit 116. The imaging unit 112 may include one or more imaging sensors that may capture images. The imaging unit 112 may be positioned anywhere along the flexible portion 204 or any other location that can provide a panoramic image. In some embodiments, the imaging sensor may be disposed at the distal end of the flexible portion of the robotic unit 104. In some embodiments, the imaging unit 112 may be detachable from the flexible portion of the robotic unit 104. In some embodiments, the imaging unit 112 may be introduced through one or more channels through the flexible portion of the robotic unit 104. In some embodiments, the image sensor may not be disposed directly in the optimal location due to engineering constraints and may be disposed elsewhere and connected to the optimal location. The imaging unit 112 may be connected to the optimal location using methods and techniques such as optical fiber, waveguides, and other forms of transmission media. In some embodiments, the imaging sensors may be disposed at the proximal end of the flexible portion (described below) and connected to the distal tip via these methods. In some embodiments, the image sensors may be disposed or aligned to have overlapping fields of view. The control unit 102 may generate a panoramic image by stitching together images captured by each sensor of the imaging unit 112. In some embodiments, the panoramic image may be displayed on a display of the input / output device 106. Furthermore, the panoramic image may be utilized to determine an intended path used to manipulate the actuation unit 114, which actuates the movement of the flexible portion 204 of the robotic unit 104, as described in co-pending patent application PCT / US2021 / 062988, which is incorporated herein by reference in its entirety. Custom sensors can be created by combining two or more imaging sensors into a single housing, and data from the custom sensors can be used as a data source.In certain embodiments, the imaging sensor may operate at any wavelength along the electromagnetic and non-electromagnetic spectrum, including, but not limited to, cameras, infrared cameras, ultraviolet sensors, acoustic sensors, microwave sensors, photodetectors, or others known to those skilled in the art may be employed to achieve the same purpose.

[0051] Additionally, the flexible portion of the robotic unit 104 may also include a sensor unit 116 that includes various sensors or combinations thereof, such as, but not limited to, time-of-flight sensors, temperature sensors, proximity sensors, pressure sensors, etc. The sensor unit 116 and the imaging unit 112, separately or in combination, may be data sources and may provide data that can be used by the control unit 102 to generate control signals for the robotic unit 104.

[0052] In one embodiment, the overview captured by the imaging unit 112 and data from the sensor unit 116 may be used by the control unit 102 to generate control signals that are transmitted to the actuation unit 114. The actuation unit 114 may include a robotic actuation mechanism (described below) that facilitates movement of the flexible part of the robotic unit 104 inside the patient's body according to a determined, overlaid, and confirmed intended path. In one embodiment, the control signals from the control unit 102 are transmitted to the actuation unit 114 based on the intended path. In one embodiment, the intended path may be a path along which the flexible part of the robotic unit 104 will be guided once the movement is initiated.

[0053] In one embodiment of the present invention, the control unit 102, the input / output devices 106, and the robotic unit 104 may be associated with a body (not shown). In an alternative embodiment of the present invention, the control unit 102, the input / output devices 106, and the robotic unit 104 may be located separately from the body (not shown).

[0054] FIG. 2A illustrates a robotic unit 104 according to an embodiment of the present disclosure. In one embodiment, the robotic unit 104 may include a housing 202. The housing 202 may include a tubular flexible portion 204 of the robotic unit 104 and an actuation unit 114. The flexible portion 204 of the robotic unit 104 has a distal end 206, which may include an imaging unit 112, a sensor unit 116, and various other ports (not shown) for water, suction, irrigation, air supply, lighting, etc. The actuation unit 114 and the housing 202 are configured to form a rack and pinion (described below). The teeth of the rack 208 may be located on the circumference or periphery of the housing 202. The pinion (not shown) is attached to a Z motor 212 and is free to rotate within the Z motor coupler shaft. The pinion (not shown) rotates on the rack 208 and moves along the circumference or periphery based on the power supply or actuation of the Z motor 212. The Z motor 212 is housed on the motor block 214 and moves from an initial home position to an end position. A pinion (not shown) is attached to the end of the Z motor 212 coupler shaft. The Z motor 212 coupler shaft passes through a hole in the side wall of the tunnel 210 of the motor block 214 that houses the pinion (not shown). The distal end of the pinion (not shown) is a gear with teeth that mesh with the teeth of the rack 208. Rotation of the Z motor 212 coupler rotates the pinion (not shown), which in turn drives movement of the flexible section 204 in the Z axis. This movement of the flexible section 204 in the Z direction results in the flexible section 204 being inserted or retracted in the Z direction. The speed of the Z motor 212 is controlled by a control signal received from the control unit 102 of FIG. 1 . In one embodiment, one end of the flexible section 204 may be attached to the motor block 214 and connected to the housing 202. Additionally, the X and Y motors 218 may be mounted on the same or opposite sides of the motor block 214. As seen in Figure 2A, the motor block 214 may provide support for the X and Y motors 218 and the Z motor 212. In one embodiment, the X and Y motors 218 may be mounted to the motor block 214 in such a way that the rack 208 is sandwiched between the X and Y motors 218.In some embodiments, limit switches (not shown) may be mounted on the Z motor 212 and the X and Y motors 218 or motor block 214 to prevent over-insertion or over-retraction of the flexible section 204 and may allow for initial calibration of the actuation unit 114; in some embodiments, limit switches (described below) may be disposed along the rack 208 to provide additional position data in the Z axis. The purpose of the limit switches may also be achieved by physical limiters that can limit the rotation of the X and Y motors 218 to prevent excessive rotation of the motors. In some embodiments, electromagnetic sensors (not shown) and tracking sensors (not shown) may be used to verify the extension or retraction of the flexible section 204, forming a closed-loop system for winding and unwinding.

[0055] In one preferred embodiment, the automated closed-loop navigation and control system 100 for an endoscopic surgical device, also referred to herein as a robotic unit 104, includes a housing 202 and a flexible section 204 disposed on the housing 202 and connecting the housing 202 to the flexible section 204. The housing 202 may include at least one imaging sensor, circuitry, a user interface, and an actuation unit 114 for actuating three-dimensional movement of the distal end 206. The length of the flexible section 204 is variable and may include a bend (not shown) at the tip of the flexible section 204 or may completely cover the length of the flexible section 204. In other embodiments, the bend may be located within any portion of the flexible section 204, as determined by several factors, including, but not limited to, the anatomy that needs to be navigated and the associated application. There may also be multiple bends within the flexible section 204.

[0056] The X and Y motors 218 may be actuated based on control signals received from the control unit 102. The X and Y motors 218 may navigate the movement of the distal end 206 in the X and Y directions within a 2D plane of motion to align the distal end 206 with the intended path. The 2D plane of motion may be determined based on a panoramic image captured by the imaging unit 112. The control unit 102 may provide a set of coordinates of the intended path along which the distal end 206 is aligned. Determining the set of coordinates of the intended path is described later in this disclosure. Those skilled in the art will recognize that it is reasonable to use a 2D coordinate system other than X and Y, for example, polar coordinates.

[0057] In one embodiment, a subsequent position may be determined based on the current position of the distal end 206 of the flexible portion 204 and data received from one or more sensors of the imaging unit 112 and the sensor unit 116. In one embodiment, the determined subsequent position may be compared to an intended position along the intended path. Thus, if the subsequent position matches the intended position, a control signal may be generated to actuate three-dimensional movement of the distal end 206 along the intended path. If the subsequent position does not match the intended position, a further control signal may be generated by the control unit 102 to actuate three-dimensional movement of the distal end back to the current position. In one embodiment, a user may manually operate the control unit 102 to actuate the robotic unit 104 so that the distal end 206 of the flexible portion 204 overlaps with the intended position. In one embodiment, multiple subsequent positions may be determined based on the current position and data received from the imaging unit 112 and the sensor unit 116. The closed-loop navigation and control system 100 may utilize a machine teaming algorithm to automatically actuate the robotic unit 104 so that the distal end 206 of the flexible portion 204 overlaps with the intended position based on a comparison of the generated subsequent positions of the distal end 206 with the intended position along the intended path. Thus, closed-loop control may be provided to actuate the bending portion of the flexible portion 204 according to the determined intended path.

[0058] Based on the received set of intended path coordinates, the X and Y motors 218 actuate corresponding angulation cables that extend within the flexible section 204 to a robotic actuation mechanism (described below) located just prior to the distal end 206. In one embodiment, four angulation cables are provided that can be actuated by the X and Y motors 218 to align the distal end 206 with the intended path.

[0059] In some embodiments, a surgical procedure involving insertion of flexible portion 204 may be performed by extending distal end 206 into a patient's cavity or lumen. Flexible portion 204 may be extended from a home position into and through the cavity or lumen by Z motor 212. During a surgical procedure, a physical barrier 220 may be removably attached to housing 202 when flexible portion 204 is fully withdrawn from housing 202. The physical barrier may be in the form of, but is not limited to, a sleeve removably attached to the housing that physically separates the flexible portion from the housing. In some embodiments, the physical barrier may be disposable or reusable. In some embodiments, the flexible portion may be, but is not limited to, a protective cover (not shown) or a disposable drape that covers flexible portion 204. In some embodiments, the protective cover may form a barrier between the flexible portion and bodily fluids and may be made of a material that may be soft, waterproof, impermeable, and transparent. The purpose of the disposable, removable barrier 220 and disposable sleeve or drape is to provide an additional layer of protection against contamination of the robotic unit 104. The Z motor 212 may be actuated to retract the flexible portion 204 and distal end 206 in a manner such that the flexible portion 204 contacts only the disposable barrier. In one embodiment, a user may place or attach the barrier 220 on a slot in the rack 208 around the circumference or periphery of the housing 202. The barrier 220 may snap into place or be clamped or screwed onto the circumference of the housing 202, or may be attached in any manner known to one skilled in the art. In one embodiment, the flexible portion 204 may have a cross-sectional shape, such as, but not limited to, a circle, an oval, a square, a rectangle, or the like. In one embodiment, the barrier 220 may be made of PVC, plastic, rubber, or any waterproof, flexible material known in the art.

[0060] In one embodiment, the motor block 214 may have male guide rails (not shown) that can reduce friction when sliding over female guide rails on the rack 208, or vice versa. It is important that the motor block 214 and the X and Y motors 218 move simultaneously because this allows the X and Y motors 218 to step along the circumference or periphery of the housing 202. The X and Y motors 218 will need to step such that the length of the angulation cables (not shown) remains constant. This allows for simplified movement of the distal end 206 in three dimensions. Those skilled in the art may also recognize that other three-dimensional coordinate schemes, such as radial, polar, cylindrical, and spherical, can be used in place of the x, y, and z coordinates described herein.

[0061] 2B illustrates the distal end 206 of the robotic unit 104, according to an embodiment of the present disclosure. In an embodiment, the distal end 206, which is attached to the distal end of the flexible section 204, may include an instrument channel 222, an image sensor 224, an air / water channel 226, a visible, UV, or IR light source 228, and other sensors 230.

[0062] In an exemplary embodiment of the invention, the flexible portion 204 may include a shape sensor (not shown). The shape sensor may provide data related to the real-time position, orientation, speed, velocity, posture, and / or shape of the distal tip and / or flexible portion 204. The shape sensor may include one or more optical fibers along the longitudinal axis of the flexible portion 204, which may be inserted through an instrument port, mounted externally, or temporarily or permanently present within a lumen of the flexible portion 204. The one or more optical fibers may be single-core or multi-core. In an alternative embodiment, the one or more optical fibers may include a Fiber Bragg Grating (FBG), which may provide data related to strain along the length of the flexible portion. In some embodiments, the same fiber may be used to provide strain data and connect an imaging sensor to an optimal location as described above. The optical fiber shape sensor may also be a data source, and the control unit 102 may use machine learning models to predict and anticipate variable anatomical structures, including the formation of different types of loops, during a procedure. During a surgical procedure such as, but not limited to, a colonoscopy, these loops may include, but are not limited to, an alpha loop, a reverse alpha loop, a transverse loop, an n loop, a gamma loop, etc. The risk of loop formation can be predicted before a loop is formed so that appropriate measures can be taken to avoid the formation of these loops. If a loop still forms, several methods known to those skilled in the art may be used, such as manual manipulation, an overtube, a flexible-to-rigid shape lock, a motor-driven pull mechanism (not shown) from the distal end 206 of the flexible section 204, magnetic endoscopic imaging, etc.

[0063] The distal end 206 of the flexible section 204 may include one or more openings connected to one or more of an intraluminal channel for instrumentation, a source of monochromatic (single wavelength or narrow band) or polychromatic (multiple wavelengths simultaneously) radiation ranging from the ultraviolet to the far infrared spectrum, one or more image sensors of the imaging unit 112, and then one or more connections to the image sensors, openings to channels for suction irrigation, water jets, insufflation, etc. In alternative embodiments, the distal end may have additional ultrasound transducers, sources of monochromatic (single wavelength or narrow band) or polychromatic (multiple wavelengths simultaneously) radiation ranging from the ultraviolet to the far infrared spectrum, or other imaging components, or devices known to those skilled in the art.

[0064] 2C and 2D show top and bottom views, respectively, of a cover encasing the aforementioned robotic unit 104. FIG. 2C shows a top view of a cover 232, which may be provided in the shape of a circular disk, encasing the housing 202 and robotic unit 104. The housing includes a U-shaped opening ridge 234 through which the distal end 206 and flexible section 204 of a surgical device, such as an endoscope, extend outward from the housing 202. FIG. 2D shows a bottom view of the cover 236, including the robotic unit 104 and housing 202. In some embodiments, the cover 232 may include plug-ins and slots for a power cable and / or a battery compartment. Those skilled in the art will recognize that the housing 202 and cover 232 may be any three-dimensional shape capable of encasing the robotic unit 104.

[0065] 3 shows an expanded view of the actuation unit 114 of the robotic unit 104 including a rack-and-pinion configuration, according to an embodiment of the present disclosure. The pinion 302 is a gear with teeth that mesh with the teeth of the rack 208, where the pinion 302 traverses the rack 208, which is provided on the circumference or periphery of the housing 202. In an embodiment, the X and Y motors 218 are associated with the angulation cables 304 using mechanisms such as, but not limited to, chain and sprocket mechanisms. In an embodiment, the Z motor 212 and the X and Y motors 218 may be associated with the flexible section 204 using other mechanisms. Limit switches 306 may be provided to provide physical limits to the rotational movement of the X and Y motors 218 in the x and / or y coordinates.

[0066] FIG. 4A illustrates a robotic unit 400 according to an alternative embodiment of the present disclosure. As shown in FIG. 4A, a hub 402 holds the flexible portion 204, including the distal end 206, and a removable barrier 420 is provided around the circumference or periphery of the hub 402. A disposable sleeve or disposable drape (not shown) may be applied over the flexible portion 204. The purpose of the removable barrier 420 is similar to that of the single-use removable barrier 220 in the previous embodiment. The disposable sleeve or disposable drape provides an additional layer of protection against contamination of the housing of the robotic unit 400. The actuation unit 114 includes a Z-motor 408 connected to a drive wheel 406. A driven wheel 410 is movably connected to the drive wheel 406 through a belt or chain 412 in a pulley or sprocket wheel arrangement. Methods for connecting the driven wheel 410 and the drive wheel 406 will be known to those skilled in the art. In one embodiment, the drive wheel 406 and the driven wheel 410 may comprise sprocket wheels or gears rotatably attached to one another via a chain to form a chain drive. When the Z motor 408 is actuated, the drive wheel 406 moves as a result. The drive wheel 406 is connected to the center of the hub 402, so that when the drive wheel 406 rotates, the hub 402 rotates. The hub 402 may rotate clockwise or counterclockwise through one or more sawtooth guided wheels 414 to extend or retract the flexible section 204, or vice versa. Thus, rotational motion of the hub 402 is translated into linear motion of the flexible section 204. The flexible section 204 may be compressed between the sawtooth guided wheels 414 and a free-spinning wheel (not shown). The free-spinning wheel may have very low friction and rotate only when any torque is acting on it to force it. It may also include a serrated edge to increase pressure on the flexible section 204. As the driven wheel 410 rotates, the toothed guided wheel 414 pushes the flexible section 204 out of or back into the hub 402. As the driven wheel 410 rotates counterclockwise, the toothed guided wheel 414 rotates clockwise, which action allows the distal end 206 to move forward. It is important that the hub 402 and driven wheel 410 rotate simultaneously.Additionally, X and Y motors 416 also run along the circumference or periphery of the hub 402 and are attached to the proximal end of the flexible section 204. The X and Y motors 416 may move such that the length of the angulation cables (not shown) remains constant. Together, the Z motor 408 and the X and Y motors 416 enable three-dimensional movement of the distal end 206. In one embodiment, the sawtooth guide wheel 414 may be directly driven by a separate motor (not shown). One skilled in the art will know that the hub 402 and cover 422 may be any three-dimensional shape.

[0067] Alternatively, there are several different interconnection arrangements for drive wheel 406 and driven wheel 410. Drive wheel 406 and driven wheel 410 may have the same size and be rotatably connected to belt 412. In some embodiments, drive wheel 406 and driven wheel 410 may have different sizes to increase or decrease the relative rotational speed of driven wheel 410. In an alternative embodiment, driven wheel 410 may be replaced with Z motor 408, eliminating the need for belt 412.

[0068] In one practical embodiment, flexible segment 204 may move forward until its proximal end reaches a fixed distance from driven wheel 410. Hub 402 may include one or more ridges or grooves 418 on the circumference or periphery around which flexible segment 204 is wrapped. In one embodiment, a removable barrier 420 is attached to ridge 418. Once the surgical procedure is completed, flexible segment 204 is retracted into hub 402 by inserting it into barrier 420. In one embodiment, barrier 420, including flexible segment 204 and distal end 206, may be removed from hub 402. Flexible segment 204 and distal end 206 may be sterilized by removing them from removable barrier 420, which may then be discarded, and distal end 206 will retract, sliding over removable barrier 420. Once distal end 206 reaches its home position, the procedure can begin.

[0069] 4B shows a front perspective view of a cover according to an alternative embodiment of the present disclosure. The cover 422 is a circular disk that encases the robotic unit 104 and the hub 402. The cover 422 includes an opening 424 through which the distal end 206 and the flexible portion 204 exit during operation of the robotic unit 104.

[0070] FIG. 5 illustrates a detachable robot unit 104 according to an alternative embodiment 500 of the present disclosure. The detachable robot unit 104 of this embodiment includes a first portion 504 and a second portion 506. The first portion 504 includes a hub 502 attached to a left base 501 on the left side and a right base 503 on the right side, or vice versa. The hub 502 may be a spool-shaped housing around which the flexible portion 204 may be wound. The second portion 506 is a drive and guide unit for the flexible portion and includes a self-reversing screw 526, a lead screw nut 518, and a driver wheel 508 that may be attached to a driver wheel motor 510. In some embodiments, the guide wheel 514 may be sawtooth. The driver wheel motor 510 may be attached to the first portion 504. The Z motor 522 may be the same as the driver wheel motor 510. To drive the distal end 206 forward, the Z motor 522 rotates the sawtooth guide wheel 514, and simultaneously, the driver wheel 508 may be rotated by the driver wheel motor 510, which may rotate the driven wheel 512. The driver wheel 508 and the driven wheel 512 may be gears coupled to each other with a 1:1 gear ratio. The type of connection, such as gears, belts, chains, etc., and the gear ratio between the driver wheel 508 and the driven wheel 512, will be known to those skilled in the art. The movement of the driven wheel 512 may unwind the flexible section 204, pushing the distal end 206 outward through the sawtooth guide wheel 514. The flexible section 204 may be aligned by a distal end guide 524 mounted on a lead screw nut 518. The flexible section 204 may be compressed between the sawtooth guide wheel 514 and the guide wheel 520. Guide wheel 520 may be a very low friction wheel and may rotate when any torque or force is acting on it. Serrated guide wheel 514 and guide wheel 520 may include serrated edges to increase pressure on flexible section 204. As flexible section 204 is inserted or retracted, Z motor 522 may rotate sawtooth guide wheel 514. Driver wheel motor 510 may rotate driver wheel 508. Driver wheel 508 may rotate its adjacent driven wheel 512 and may have a 1:1 gear ratio.The driven wheel 512 may rotate the spool-shaped first portion 504, unwinding the flexible portion 204 onto the first portion 504. During this action, the self-reversing screw 526 will rotate freely without any end movement. This may allow the lead screw nut 518 to move in the same axis as the self-reversing screw 526. The lead screw nut 518 may have threads that match the self-reversing screw 526 and may be constrained on the linear rails 516 at both ends. This may ensure that the lead screw nut 518 does not rotate. The lead screw nut 518 may have the ability to move at the same pitch as the flexible portion 204 unwinds onto the hub 502 and may progress back and forth on the self-reversing screw 526. This may allow the flexible portion 204 to unwind back onto the hub 502, promoting repeatability and ensuring that entanglement does not occur. A disposable sleeve or disposable drape (not shown) may be applied over the flexible portion 204. The disposable sleeve or disposable drape provides an additional layer to prevent contamination of the housing of the robotic unit 500.

[0071] 6A, 6B, and 6C illustrate a flexure 600 including a robotic actuation mechanism of the robot unit 104, according to an embodiment of the present disclosure. The flexure 600 is located at the distal end of the flexible section 204, just before the distal end 206. The flexure 600 may include multiple independent vertebrae 602, 604 stacked on top of each other and connected by a rivet 606, as shown in FIG. 6B. The distal portion of the flexure section 608 may hold the distal end 206, which may include various sensors, camera housings (not shown), and the like. Connecting the vertebrae 602, 604 in such an arrangement may allow for partial and / or complete rotational movement of each vertebra 602, 604 independently about the rivet 606. The rotational movement of each vertebra 602, 604 may allow for bending of the flexure 600. The vertebrae 602, 604 may be connected to one another and may have eye loops 612 for threading angulation cables, where one end of the cable may be connected to the vertebra 604 at the distal-most end of the flexion section 600. The articulating end of each vertebra 602, 604 may include rounded corners 610 that may distribute stress during flexion and reduce load from the angulation cables. The vertebrae 602, 604 may also include at least one eye loop 612 located on the inner circumference of each vertebra 602, 604. A cable from the actuation unit 114 may pass through the eye loop 612 to reach a connection point at the distal vertebra 604. The eye loops 612 may form a cloverleaf-shaped cross section, which allows the eye loops 612 to remain straight throughout each individual vertebra 602, 604 and maximize the open internal volume of the vertebrae 602, 604. Aligning the eye loops 612 of adjacent vertebrae 602, 604 with each other and away from rivet 606 may allow for a smoother transition during flexion and may reduce cable tension loads. Alternatively, mesh, or a combination of mesh with the configurations described above, or other feasible arrangements known to those skilled in the art, may be employed to achieve the same purpose.

[0072] 6D illustrates the connection of flexure 600 to distal end 206, according to an embodiment of the present disclosure. Vertebrae 602, 604 are connected to distal end 206 at connection point 614.

[0073] 6E illustrates angulation wires within the robotic unit, according to an embodiment of the present disclosure. As shown in FIG. 6E, the angulation wires 616 can be seen passing through the flexible section 204 and further into the bending section 600. In an embodiment, there may be four angulation wires arranged at 90 degrees around the circumference of the robotic unit 104 and connected to the X and Y motors of the actuation unit 114 of the robotic unit 104. The movement of the angulation wires 616 may be controlled by the X and Y motors to move them in the X and Y directions.

[0074] FIG. 7 illustrates a cross-sectional view of the flexible portion 204 of the robotic unit, according to an embodiment of the present disclosure. As shown in FIG. 7 , four angulation wires 616 are seen arranged at 90 degrees to each other around the circumference of the flexible portion 204. It can be seen that the flexible portion 204 may include an outermost layer 702 made of any waterproof material. Next to the outermost layer 702, a steel wire mesh 704 may be present to improve the tensile strength of the flexible portion 204. The flexible portion 204 may encase an optical fiber 706, which may be connected to a light source, such as an LED, that illuminates the internal anatomy for the imaging unit 112 to capture images with appropriate illumination. The flexible portion 204 may further include a signal wire 712 for transmitting signals from one or more sensors and a wire 716 for varying the thickness of the flexible portion 204. Additionally, flexible portion 204 may include a water jet channel 708 for irrigating the area to provide a clear path for distal end 206 to travel within a cavity or lumen. Additionally, flexible portion 204 may include an air channel 710.

[0075] Any collapsed passages within a cavity or lumen may be insufflated with a gas, such as CO2 gas, to provide a better view of other collapsed cavities or lumens. In some embodiments, data received from a pressure sensor (not shown) may be combined with data received from an imaging sensor to create a closed-loop insufflation system that automatically achieves a clear view of the cavity or lumen. The air channel 710 may be used to insufflate the area by venting a gas, such as CO2 gas. A pressure sensor (not shown) may be disposed anywhere along the length of the air channel 710, including at the tip of the distal end 206 or on the outer portion of the flexible section 204. The pressure sensor may provide a digital or analog input to the robotic unit 104 or the control unit 102. The pressure of the insufflation gas may be monitored in real time based on the pressure sensor, and the amount of insufflation gas vented may be controlled so that the pressure within the cavity or lumen does not exceed or fall below a predefined threshold pressure level. Thus, any changes in pressure level may be tracked through data received from the pressure sensor. The control unit 102 may utilize a machine learning model in conjunction with data received from the data sources to identify an ideal insufflation level that can be achieved when the data from the data sources is within a predefined threshold pressure level. The predefined threshold pressure level may be determined based on a pre-trained data set. Once proper insufflation is achieved, that information is transmitted to the control unit 102, which will then transmit a signal to automatically pause further flow of insufflation gas, thus creating a closed-loop insufflation system. Once proper insufflation is achieved, that pressure level is maintained, and the pressure may automatically increase or decrease as determined through the closed feedback loop. Throughout the process, real-time pressure information is displayed on the user interface of the input / output device 106. Additionally, the user interface of the input / output device 106 may provide the user 118 with the ability to manually override the closed feedback loop output to manually control the pressure. In some embodiments, the manual override may result in auditory or visual feedback prompting the user to confirm the override.

[0076] The processor 108 of the control unit 102 of the closed-loop navigation and control system 100 can utilize machine learning models, together with data received from data sources or stored in the memory 110, to recognize structures associated with a patient's cavity, predict an intended path, and generate and transmit control signals to the actuation unit 114 to actuate three-dimensional movement of an invasive medical device in the robotic unit 104. The control unit 102 can utilize machine learning models, together with data transmitted from the imaging unit 112 and the sensor unit 116, to predict the intended path of navigation and recognize structures associated with a cavity or lumen. The machine learning models are portions of computer vision software developed by training one or more neural networks on labeled image datasets, where the labeled image datasets are constructed by converting a collection of procedural videos into image files and labeling anatomical structures on the image files. In an alternative embodiment, generating the machine learning models involves receiving or collecting training data in the form of a predetermined dataset to train at least one neural network. The predetermined data set may be, but is not limited to, all of the data sources mentioned above. To enable smooth real-time continuous tracking and navigation of the automated closed-loop navigation and control system 100, the machine learning models may be optimized to run faster on a single-board computing platform.

[0077] The control unit 102 may predict at least one new intended path. Once the distal end 206 of the flexible portion 204 reaches a first position, the control unit 102 may generate or determine a second position along the intended path. The control unit 102 may continually generate new positions for the distal end 206 of the flexible portion 204 along the intended path based on data received from at least one imaging sensor of the imaging unit 112. The control unit 102 utilizes machine learning models to compare data received from the imaging unit 112 of the actual movement of the distal end 206 of the flexible portion 204 with the intended movement of the distal end 206.

[0078] The automated closed-loop navigation and control system 100 may demonstrate an initial pre-programmed calibration sequence for the motors and the imaging or sensor unit. The calibration sequence may be used to construct a Jacobian matrix. In one embodiment of the automated closed-loop navigation and control system 100, a visual servoing method may be used in which inverse kinematics is used to move the robot joints based on changes in the position of a desired target in the image coordinate frame. A generalized inverse of the Jacobian matrix is ​​used to implement visual servoing. In another embodiment, a reference point minimum method may be used in which a steepest descent method is used according to a virtual potential field between a current position and a desired position in the image coordinate frame. A desired position in the image coordinate frame may be provided with the goal of moving a captured image of the current view of the robot's tool to the desired position by moving the robot joints. This may be performed by directly mapping the robot coordinates to the image coordinates. In another embodiment, laser-guided navigation using triangulation may be used to navigate within a cavity or lumen. In other embodiments, force field tracking may be used, where an actual force field, such as (but not limited to) mechanical or magnetic, guides the robot along a desired path. In any of these embodiments, a form of proportional-integral-derivative controller may be used to smooth the tracking and approach to the desired position.

[0079] 8 illustrates exemplary functional components of the proposed closed-loop navigation and control system 100, according to an embodiment of the present disclosure. The one or more processors 108 of FIG. 1 may enable various processing engines 800, such as a data reception engine 802, an image processing engine 804, an object detection engine 806, a navigation and collision control engine 808, a user interface engine 810, and other engines 812.

[0080] The data receiving engine 802 is configured to receive data from a data source. In an embodiment, the data receiving engine 802 may receive data from the imaging unit 112, the actuation unit 114, the sensor unit 116, the input / output device 106, and the memory 110.

[0081] The image processing engine 804 may utilize data received from an imaging sensor provided within the imaging unit 112, and the processed data output from the image processing engine 804 may be displayed on an output user interface of the output device 106 to provide a user with a view of the patient's lumen or cavity. In some embodiments, the view may be a two-dimensional or three-dimensional panoramic view of the patient's lumen or cavity. In some embodiments, the view may be magnified.

[0082] Additionally, the object detection engine 806 may recognize structures within the views created by the image processing engine 804. The generated views may include images that may be overlaid in the form of a virtual envelope onto the data received from the imaging sensor on the user interface for effective visual guidance to the user.

[0083] During an invasive surgical procedure, a surgeon, especially during their learning process, may accidentally injure one or more anatomical structures, such as, but not limited to, the ureter during a hysterectomy, the common bile duct during a cholecystectomy, and the iliac vessels and rectum during a prostatectomy. The object detection engine 806 may detect such anatomical structures, and the navigation and collision control engine 808 may create a virtual envelope around such structures that will indicate that such anatomical structures should be considered impenetrable and inaccessible, thereby preventing them from being accidentally damaged during the surgical procedure.

[0084] In an embodiment, the detected anatomical structures may ensure that the determination of the control outputs is subject to non-intersecting or non-colliding position constraints.

[0085] The navigation and collision control engine 808 may provide collision avoidance that may be utilized to determine a virtual envelope and navigation control around detected anatomical structures, indicating the anatomical structures as no-fly zones. When the distal end 206 of the flexible portion 204 of the robotic unit 104 approaches these anatomical structures, it may be subjected to a repulsion field F. This may be accounted for by sampling the computation time of the image processing at 60 Hz to generate visual and simulated thorough feedback. Repulsion force ! F' may be proportional to both the velocity of the distal tip 206 approaching the virtual envelope and the inverse of the distance between the virtual envelope and the distal tip 206, resulting in F v / r. In one embodiment, V is the velocity of the distal tip 206 and T' is the distance between the virtual envelope and the distal tip 206.

[0086] Based on this principle, algorithms implemented by the navigation and collision control engine 808 will be configured and their effectiveness may be tested in a virtual test environment of a surgical workspace created using tools such as, but not limited to, MATLAB®, Natick, MRS, etc. In one embodiment, a virtual test environment of a surgical workspace may be designed and the algorithms implemented by the navigation and collision control engine 808 may be tested in that virtual test environment using a simulated virtual robotic unit of the robotic unit 104. Based on the determined efficiency of the algorithms, the same may be integrated and implemented in the navigation and collision control engine 808. In one embodiment, the closed-loop navigation and control system 100 may be tested on non-living, animal models and, based on its success, may be made suitable for use on human subjects.

[0087] Obstacles may be detected using stereoscopic vision, depth, or distance. In the absence of stereoscopic vision, the magnification of an object's view, in terms of its extent on the image, may be correlated with the object's distance, which may be used to approximate collision detection and avoidance. In some embodiments, the object detection engine 806 may utilize machine learning models to process data received from data sources to recognize structures associated with a patient's cavities or lumens, or pre-trained models may identify obstacles and determine no-fly zones. The navigation and collision control engine 808 may utilize machine learning models to process data received from data sources to predict and navigate along an intended path while avoiding recognized structures. Training the machine learning models may involve receiving or collecting training data in the form of a predetermined data set to train at least one neural network. This form of neural network may be, but is not limited to, an edge-implemented deep neural net-based object detector, which is well known in the art. Other forms of machine learning models other than neural networks may be utilized, as is well known to those skilled in the art. The predetermined data sets may include, but are not limited to, images and videos, photon counts, temperature, position, distance, humidity, gas concentrations, liquid or enzyme volumes, motility studies, pressure, force, etc.

[0088] The navigation and collision control engine 808 may generate and communicate control signals for the actuation unit 114 to actuate the three-dimensional movement of the robotic unit 104.

[0089] The navigation and collision control engine 808 may determine an intended path along which the robotic unit 104 may be guided. The intended path may be determined based on output from the object detection engine 806 and data received from the sensor unit 116. The processing circuitry may utilize at least one pre-trained machine learning model to recognize anatomical structures and the intended path using the data received by the data reception engine 802.

[0090] In one embodiment, the machine learning model may be computer vision software utilized by the various processing engines 802-812. The computer vision software may be developed by training one or more neural networks on a labeled image dataset, where the labeled image dataset is constructed by converting a collection of procedural videos into image files and labeling anatomical structures on the image files. In an alternative embodiment, generating the machine learning model involves receiving or collecting training data in the form of a predetermined dataset to train at least one neural network. The predetermined dataset may include, but is not limited to, any of the data sources discussed above.

[0091] The user interface engine 810 may provide an interactive user interface on the input / output device 106, which may include a touch-sensitive display. In an embodiment, the display may display a view of the patient's internal anatomy with an overlay of the recognized VS and / or intended path to provide effective visual guidance to the user 118 through the interactive visual interface. In an embodiment, a virtual envelope is shown as an overlay on the VS for the user 118 to identify the VS.

[0092] In one embodiment, when the distal end 206 reaches a path intersection where the path may branch into several other branches, the user may provide control signals to the actuation unit 114 to select an intended path to be traversed by the distal end 206 by using one or more controls provided by the user interface engine 810. In one embodiment, the one or more controls may be provided in the form of augmented reality and / or any other form that may provide effective visual guidance to the user 118. In one embodiment, the user interface engine 810 may display a predetermined visual indication when multiple intended paths are detected. The user 118 may select an intended path of choice using the appropriate visual indication. In one embodiment, the user interface engine 810 may display multiple trajectories, and the user 118 may select an intended path from among these trajectories. Throughout this process, information is projected on the display, and the user 118 may manually override controls generated by the navigation and collision control engine 808 and the control unit 102. In some embodiments, manual override may result in auditory or visual feedback in the form of an alarm or notification asking the user to confirm the override. The priority between manual and automatic control may be predefined as a default setting based on training data and may be changed as needed.

[0093] In one embodiment, the user interface engine 810 may provide real-time vital information of the patient, such as, but not limited to, pulse and heart rate, temperature, blood pressure; and other test results (including, but not limited to, blood gas levels, blood glucose levels, detected air pressure within a lumen or cavity), and other results that a state-of-the-art trained human would be aware of.

[0094] In another embodiment, the user interface engine 810 may provide control signals to the actuation unit 114 to manually actuate three-dimensional movement of the robotic unit 104 using multiple buttons, such as, but not limited to, up, down, left and right, insert and retract. In some embodiments, the multiple buttons may enable actuation of the actuation unit 114 by providing an angular input, such as moving the distal end 206 at a 30-degree angle in an up and right direction, and in some embodiments, the multiple buttons may be provided as touch buttons located on the user interface to provide a manual actuation mode if desired by the user 118. The user may also use the multiple buttons to override automatic actuation of the distal end 206 if the user is not satisfied with the intended path determined by the control unit 102.

[0095] In some embodiments, other engines 812 may complement other modules or functionality of the closed-loop navigation and control system 100 as needed.

[0096] 9 illustrates an exemplary implementation scenario of the closed-loop navigation and control system 100 according to an embodiment of the present disclosure. The exemplary scenario 900 illustrates a tower 902, a display 904, a user interface 906, and a cart 908 disposed near a patient's bed 910. In an embodiment, the tower 902 may include the display 904. The user interface 906 may be a touch-enabled tablet that may serve as the input / output device 106. The cart 908 may include one or more robotic arms (not shown) and a robotic unit 104 movably coupled to the one or more robotic arms.

[0097] In some embodiments, the tower 902 may further include an air supply (not shown) including a gas cylinder 912 and an exhaust line for connecting the gas cylinder 912 to the robotic unit 104. The tower 902 may include a suction container (not shown) for receiving material sucked in during suction. The suction container (not shown) may further be connected to the suction channel 714 of the flexible portion 204. The tower 902 may further include a fluid source (not shown) that may serve as a fluid source during cleaning and may be connected to the water jet channel 708 of the flexible portion 204. The tower 902 may include various other operable energy systems known to those skilled in the art for powering electrical systems within the tower. In some embodiments, the tower 902, cart 908, robotic unit 104, and tablet 906 may have separate power sources in the form of batteries or power cables, or may be powered by a common power source shared among them through an electrical cable or other suitable means known in the art. The cart 908 and tower 902 may be configured to stand free on the floor and may include wheels on the bottom so that they can be positioned as needed. In an alternative embodiment, the cart 908 may be attached to the patient's bed 910. In alternative embodiments, the cart 908 may be attached to the ceiling or wall of the operating room.

[0098] In some embodiments, the cart 908 may include a physical attachment and communication interface (shown in FIG. 10 , described below) with the robotic unit 104. In some embodiments, the tower 902 and cart 908 may include wheels that allow them to be movably positioned near the user 118 and the patient for the user 118 to effectively and easily monitor the patient.

[0099] The tablet 906, cart 908, robotic unit 104, and tower 902 may each be connected to one another via a wired or wireless connection. The tower 902 may also include one or more additional displays 904, which may be touch-enabled.

[0100] FIG. 10 illustrates a bushing coupling mechanism used in a robotic unit, according to an embodiment of the present disclosure. In an embodiment, the bushing coupling may be used to connect one or more robotic arms (not shown) of the cart 908 to one or more robotic units 104. In an embodiment, the robotic arm may be a type of mechanical arm that may be controlled by the control unit 102 and may function similarly to a human arm. The robotic arm may include manipulator links that may be connected at joints that allow either rotational movement (e.g., in an articulated robot) or translational (linear) displacement. The manipulator links may be considered to form a kinematic chain. The end of the manipulator kinematic chain may be called an end effector and may act similarly to a human hand. The robotic unit 104 may be connected at any point or end along the robotic arm.

[0101] In one embodiment, the driver flange 1002 of the Z motor of the actuation unit 114 of the robotic unit 104. The driven flange 1004 may be attached to one or more robotic arms (not shown) mounted on the cart 908. In one embodiment, the driver flange 1002 may be connected to the driven flange 1004 through a connection means such as an electromagnetic connection or a nut and bolt passing through connection notches 1006 and 1008.

[0102] 11 shows examples of some possible positions of the robotic unit 104 and cart 908 around a patient 1108. This diagram is not an exhaustive list of all possible procedures or positions around the patient 1108. In one embodiment, the cart 908 may be disposed at position 1102 for a patient 1108 undergoing a procedure through the mouth or nose. In another embodiment, the cart 908 may be disposed at position 1104 for a patient 1108 undergoing a transthoracic procedure through the mouth or nose. In one embodiment, the cart 908 may be disposed at positions 1106 or 1110 for a patient 1108 undergoing a procedure through the urethra, vagina, or anus.

[0103] It is intended that the disclosure and examples be considered as exemplary only, with the true scope of the disclosed embodiments being indicated by the following claims.

Claims

1. housing; a flexible section having a distal end and wrapped over the housing; predicting an intended path for the distal end of the flexible section; and generating a control signal based on the intended path, wherein the intended path is predicted based on at least one anatomical structure recognized using data received from one or more sensors. a processor configured to: an actuation unit configured to actuate three-dimensional movement of the distal end of the flexible section along the intended path based on the control signal, the actuation unit comprising: x and y motors configured to actuate bending movement of the distal end of the flexible section to the intended path in the x and y planes; and a z-motor configured to wind or unwind the flexible section from the housing such that the distal end of the flexible section traverses the z-plane of the intended path. having A surgical device comprising:

2. The surgical device of claim 1 , wherein the at least one anatomical structure is recognized using a machine learning model, the machine learning model being trained based on historical data regarding a plurality of recognized anatomical structures.

3. The surgical device of claim 1 , wherein the processor is further configured to create a virtual envelope corresponding to the recognized at least one anatomical structure.

4. The surgical device of claim 3 , wherein the processor is further configured to predict the intended path for the distal end of the flexible section to avoid the created virtual envelope corresponding to the recognized at least one anatomical structure.

5. The surgical device of claim 1 , wherein the actuation unit is further configured to inhibit or limit the three-dimensional movement of the distal end of the flexible portion when the distal end of the flexible portion approaches the at least one anatomical structure.

6. 10. The surgical device of claim 1, wherein the surgical device is configured to perform an endoscopic procedure of one of the gastrointestinal tract, urinary tract, respiratory tract, male or female genitourinary tract, ear, nose, throat, brain, spinal cord, cardiovascular system, skeletal system, or nervous system.

7. The surgical device of claim 1 , wherein the housing is further configured to contain a physical barrier that physically separates the flexible portion from the housing, the physical barrier being removably attached to the housing and being disposable or reusable.

8. The surgical device of claim 1 , wherein the control signal for a subsequent position is generated based on a current position of the distal end of the flexible section and the data received from the one or more sensors.

9. The processor further comprises: configured to compare the generated subsequent position of the distal end with an intended position along the intended path; generating the control signal to actuate the three-dimensional movement of the distal end along the intended path when the subsequent position coincides with the intended position; or generating a further control signal to actuate the three-dimensional movement of the distal tip back to the current position if the subsequent position does not match the intended position. configured to perform one of the following: The surgical device of claim 8.

10. The surgical device of claim 9 , wherein the processor utilizes a machine learning model to compare the generated subsequent positions of the distal end to intended positions along the intended path.

11. 10. The surgical device of claim 1, further comprising a protective cover configured to cover the flexible portion and form a barrier between the flexible portion and bodily fluids, wherein the protective cover is made of a flexible, waterproof, impermeable, and transparent material.

12. The surgical device of claim 1 , wherein the housing is disk-shaped.

13. The surgical device of claim 12 , wherein the z-motor is disposed at the center of the disk-shaped housing to rotate the housing to wind or unwind the flexible section from the housing.

14. The surgical device of claim 13 , wherein the x and y motors rotate simultaneously with the disk-shaped housing.

15. The surgical device of claim 1 , wherein the housing has a rack on top on which a pinion attached to the z-motor rotates to unwind the flexible section from the housing.

16. The surgical device of claim 15 , wherein the x and y motors rotate together with the z motor.

17. The surgical device of claim 1 , wherein the housing is spool-shaped.

18. 18. The surgical device of claim 17, wherein the z-motor is attached to a toothed guide wheel attached to the flexible section, the flexible section being sandwiched between the toothed guide wheel on one side and a freely rotatable wheel on the other side, and the flexible section being wound or unwound from the spool-shaped housing.

19. Top surface; a bottom surface disposed opposite the top surface; and a rack provided on the top surface a housing having a flexible portion wrapped around the circumference of the bottom surface of the housing; predicting an intended path for the distal end of the flexible section; and generating a control signal based on the intended path; wherein the intended path is predicted based on at least one anatomical structure recognized using data received from one or more sensors. a processor configured to: an actuation unit configured to actuate three-dimensional movement of the distal end of the flexible section along the intended path based on the control signal, the actuation unit comprising: a z-motor connected to a pinion, wherein the z-motor is configured to traverse the pinion on the rack while winding or unwinding the flexible section from the housing such that the distal end of the flexible section retracts or extends by traversing the z-plane of the intended path; and x and y motors configured to actuate bending movement of the distal end of the flexible section to the intended path in the x and y planes; wherein the x and y motors traverse along the rack together with the z motor; having A surgical device comprising:

20. The surgical device of claim 19 , wherein the housing is oval or circular in shape.

21. The surgical device of claim 19, wherein the recognition of the anatomical structure includes using a machine learning model, the machine learning model being trained based on historical data relating to a plurality of recognized anatomical structures.

22. The surgical device of claim 19, wherein the processor is further configured to create a virtual envelope corresponding to each of the recognized anatomical structures.

23. 23. The surgical device of claim 22, wherein the processor is further configured to predict the intended path for the distal end of the flexible section to avoid the created virtual envelope corresponding to the recognized anatomical structure.

24. 20. The surgical device of claim 19, wherein the actuation unit is further configured to inhibit or limit the three-dimensional movement of the distal end of the flexible portion when the distal end of the flexible portion approaches the at least one anatomical structure.

25. 20. The surgical device of claim 19, wherein the surgical device is configured to perform an endoscopic procedure of one of the gastrointestinal tract, urinary tract, respiratory tract, male or female genitourinary tract, ear, nose, throat, brain, spinal cord, cardiovascular system, skeletal system, or nervous system.

26. 20. The surgical device of claim 19, wherein the housing is further configured to contain a physical barrier that physically separates the flexible portion from the housing, the physical barrier being removably attached to the housing and being disposable or reusable.

27. The surgical device of claim 19, further comprising a removable barrier between the flexible portion and the bottom surface of the housing.

28. 20. The surgical device of claim 19, wherein the control signal for a subsequent position is generated based on a current position of the distal end of the flexible section and the data received from the one or more sensors.

29. The processor further comprises: configured to compare the generated subsequent position of the distal end with an intended position along the intended path; generating the control signal to actuate the three-dimensional movement of the distal end along the intended path when the subsequent position coincides with the intended position; or generating a further control signal to actuate the three-dimensional movement of the distal tip back to the current position if the subsequent position does not match the intended position. configured to perform one of the following:

30. The surgical device of claim 28.

30. 30. The surgical device of claim 29, wherein the processor utilizes a machine learning model to compare the generated subsequent positions of the distal end to intended positions along the intended path.

31. 20. The surgical device of claim 19, further comprising a protective cover configured to cover the flexible portion and form a barrier between the flexible portion and bodily fluids, wherein the protective cover is made of a flexible, waterproof, impermeable, and transparent material.

32. circumference a disc-shaped hub having The flexible portion is wound around the circumference. Distal end having predicting an intended path for the distal end of the flexible section; and generating a control signal based on the intended path. wherein the intended path is predicted based on at least one anatomical structure recognized using data received from one or more sensors. a processor configured to: an actuation unit configured to actuate three-dimensional movement of the distal end of the flexible section along the intended path based on the control signal, the actuation unit comprising: a z-motor connected to a drive wheel, wherein the drive wheel is rotatably connected to a driven wheel and the hub; a sawtooth guide wheel rotatably connected to the driven wheel; wherein rotation of the drive wheel rotates the driven wheel, the hub, and the toothed guide wheel to wind or unwind the flexible section from the hub such that the distal end of the flexible section traverses the z-plane of the intended path; x and y motors configured to actuate bending movement of the distal end of the flexible section to the intended path in the x and y planes; wherein the x and y motors rotate along the circumference of the hub; have, A surgical device comprising:

33. 33. The surgical device of claim 32, wherein the hub has an oval or circular cross section.

34. 33. The surgical device of claim 32, wherein the z-motor is disposed at a center of a housing of the surgical device to rotate the hub to wind or unwind the flexible section from the hub.

35. 33. The surgical device of claim 32, wherein the z-motor is attached to the toothed guide wheel, and the flexible section is sandwiched between the toothed guide wheel on one side and a guide on the other side.

36. The surgical device of claim 32, wherein the recognition of the anatomical structure includes using a machine learning model, the machine learning model being trained based on historical data for a plurality of recognized anatomical structures.

37. The surgical device of claim 32, wherein the processor is further configured to create a virtual envelope corresponding to each of the at least one determined anatomical structure.

38. 38. The surgical device of claim 37, wherein the processor is further configured to predict the intended path for the distal end of the flexible section to avoid the created virtual envelope corresponding to the determined anatomical structure.

39. 33. The surgical device of claim 32, wherein the actuation unit is further configured to inhibit or limit the three-dimensional movement of the distal end of the flexible portion when the distal end of the flexible portion approaches the at least one anatomical structure.

40. 33. The surgical device of claim 32, wherein the surgical device is configured to perform an endoscopic procedure of one of the gastrointestinal tract, urinary tract, respiratory tract, male or female genitourinary tract, ear, nose, throat, brain, spinal cord, cardiovascular system, skeletal system, or nervous system.

41. 33. The surgical device of claim 32, wherein the hub is further configured to house a physical barrier that physically separates the flexible portion from the hub, the physical barrier being removably attached to the hub and being disposable or reusable.

42. 33. The surgical device of claim 32, wherein the control signal for a subsequent position is generated based on a current position of the distal end of the flexible section and the data received from the one or more sensors.

43. The processor further comprises: configured to compare the generated subsequent position of the distal end with an intended position along the intended path; generating the control signal to actuate the three-dimensional movement of the distal end along the intended path when the subsequent position coincides with the intended position; or generating a further control signal to actuate the three-dimensional movement of the distal tip back to the current position if the subsequent position does not match the intended position. configured to perform one of the following:

43. The surgical device of claim 42.

44. 44. The surgical device of claim 43, wherein the processor utilizes a machine learning model to compare the generated subsequent positions of the distal end to intended positions along the intended path.

45. 33. The surgical device of claim 32, further comprising a protective cover configured to cover the flexible portion and form a barrier between the flexible portion and bodily fluids, wherein the protective cover is made of a soft, waterproof, impermeable, and highly transparent material.

46. Spool-shaped hub; a flexible section having a distal end and wrapped onto the hub; predicting an intended path for the distal end of the flexible section; and generating a control signal based on the intended path, wherein the intended path is predicted based on at least one anatomical structure recognized using data received from one or more sensors. a processor configured to: a drive and guide unit configured to guide and drive the flexible section by actuating three-dimensional movement of the distal end of the flexible section along the intended path based on the control signal, the drive and guide unit comprising: x and y motors attached to the hub and configured to actuate bending movement of the distal end of the flexible section to the intended path in the x and y planes; a driver motor configured to rotate a sawtooth guide wheel, wherein the sawtooth guide wheel is rotatably connected to a drive wheel and the hub, and wherein the rotation of the sawtooth guide wheel rotates the hub to wind and unwind the flexible section from the hub such that the distal end of the flexible section traverses within the z-plane of the intended path; having A surgical device comprising:

47. 47. The surgical device of claim 46, wherein the flexible portion is sandwiched between the toothed guide wheel on one side and a guide on the other side.

48. 47. The surgical device of claim 46, wherein the at least one anatomical structure is recognized using a machine learning model, the machine learning model being trained based on historical data regarding a plurality of recognized anatomical structures.

49. 49. The surgical device of claim 48, wherein the processor is further configured to create a virtual envelope corresponding to each of the recognized at least one anatomical structure.

50. 50. The surgical device of claim 49, wherein the processor is further configured to predict the intended path for the distal end of the flexible section to avoid the created virtual envelope corresponding to the recognized at least one anatomical structure.

51. 47. The surgical device of claim 46, wherein the drive and guide unit is further configured to inhibit or limit the three-dimensional movement of the distal end of the flexible segment when the distal end of the flexible segment approaches the at least one anatomical structure.

52. 47. The surgical device of claim 46, wherein the surgical device is configured to perform an endoscopic procedure of one of the gastrointestinal tract, urinary tract, respiratory tract, male or female genitourinary tract, ear, nose, throat, brain, spinal cord, cardiovascular system, skeletal system, or nervous system.

53. 47. The surgical device of claim 46, wherein the hub is further configured to house a physical barrier that physically separates the flexible portion from the hub, the physical barrier being removably attached to the hub and being disposable or reusable.

54. 47. The surgical device of claim 46, wherein the control signal for a subsequent position is generated based on a current position of the distal end of the flexible section and the data received from the one or more sensors.

55. The processor further comprises: configured to compare the generated subsequent positions of the distal end with an intended position along the intended path; generating the control signal to actuate the three-dimensional movement of the distal end along the intended path when the subsequent position coincides with the intended position; or generating a further control signal to actuate the three-dimensional movement of the distal tip back to a current position if the subsequent position does not match the intended position; configured to perform one of the following:

47. The surgical device of claim 46.

56. 56. The surgical device of claim 55, wherein the processor utilizes a machine learning model to compare the generated subsequent positions of the distal end to intended positions along the intended path.

57. 47. The surgical device of claim 46, further comprising a protective cover configured to cover the flexible portion and form a barrier between the flexible portion and bodily fluids, wherein the protective cover is made of a flexible, waterproof, impermeable, and transparent material.

58. capturing data from one or more sensors; recognizing at least one anatomical structure based on the captured data; predicting an intended path based on the at least one anatomical structure; generating a control signal based on the predicted intended path; and actuating a distal end of a flexible section of a surgical device three-dimensionally along the predicted intended path based on the control signal, wherein the actuating the flexible section comprises: activating a z-motor to wind or unwind the flexible section from a housing of the surgical device so that the flexible section traverses the intended path in the z-plane; and activating x- and y-motors to enable bending movement of the distal end of the flexible section to the intended path in the x- and y-planes. having 1. A method of performing a surgical procedure, comprising:

59. 60. The method of claim 58, wherein the at least one anatomical structure is recognized using a machine learning model, the machine learning model being trained based on historical data regarding a plurality of recognized anatomical structures.

60. 60. The method of claim 58, further comprising creating a virtual envelope corresponding to each of the recognized one or more anatomical structures.

61. 61. The method of claim 60, wherein the intended path for the distal end of the flexible section is predicted to avoid the created virtual envelope corresponding to the recognized at least one anatomical structure.

62. 59. The method of claim 58, wherein the actuating the distal end of the flexible section comprises inhibiting or limiting the three-dimensional movement of the distal end of the flexible section when the distal end of the flexible section approaches the at least one anatomical structure.

63. 59. The method of claim 58, wherein the method can be utilized to perform an endoscopic procedure of one of the gastrointestinal tract, urinary tract, respiratory tract, male or female genitourinary tract, ear, nose, throat, brain, spinal cord, cardiovascular system, skeletal system, or nervous system.

64. 59. The method of claim 58, wherein the control signal for a subsequent position is generated based on a current position of the distal end of the flexible section and the data received from the one or more sensors.

65. comparing the generated subsequent position of the distal end to an intended position along the intended path; and generating the control signal to actuate the three-dimensional movement of the distal end along the intended path when the subsequent position coincides with the intended position; or generating a further control signal to actuate the three-dimensional movement of the distal tip back to the current position if the subsequent position does not match the intended position. one of 65. The method of claim 64, further comprising:

66. 66. The method of claim 65, wherein the comparing the generated subsequent positions of the distal end to an intended position along the intended path is based on a machine learning model.

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