System and method for automatic closed-loop navigation and control of endoscopic surgical devices

Abstract

A surgical device is provided that includes a flexible member circularly wound in a housing. The surgical apparatus includes a processor configured to predict an expected path of the distal end and generate a control signal. An expected path is predicted based on at least one anatomical structure identified using data received from one or more sensors. An actuation unit of the surgical apparatus actuates three-dimensional movement of the distal end along the intended path based on the control signal.

Description

[0001] Cross-reference information

[0002] This application is a partial continuation of U.S. Patent Application No. 17 / 121,709, filed on December 14, 2020, entitled "SYSTEM AND METHOD FOR AUTOMATED INTUBATION", which is hereby incorporated by reference in its entirety. Technical Field

[0003] The present disclosure generally relates to an automated medical device, and more particularly, to a system and method for automated closed-loop navigation and control of an invasive surgical device. Background Art

[0004] Various surgical procedures involve implanting or inserting a medical device into a patient's body. Such devices are inserted or passed through a patient's body cavity or lumen for diagnosis and / or intervention at various internal body sites such as the upper, middle, or lower gastrointestinal (GI) tract, cardiovascular tract, trachea, urogenital tract, pulmonary airways, etc.

[0005] One such application of inserting an invasive device is colonoscopy, which is performed to examine the lower GI tract when passing through the anus, including the rectosigmoid colon, large intestine, and the distal portion of the small intestine. A doctor can use a cable-driven endoscope with an imaging device at the distal end to view the lumen of the lower GI tract. However, the length and natural direction changes of the lower GI tract make the colonoscopy procedure quite challenging. Therefore, performing colonoscopy requires a great deal of skill and training. Even with proper training, it may be difficult to effectively navigate through a patient's lower GI. Thus, there is a need for an effective and accurate method for controlling and navigating a device within a body cavity and lumen in a human body, such as the GI tract. Summary of the Invention

[0006] References to "one embodiment", "at least one embodiment", "an embodiment", "one example", "the example", "for example", etc. mean that the embodiment or example may include a particular feature, structure, characteristic, property, element, or limitation, but not every embodiment or example must include that particular feature, structure, characteristic, property, element, or limitation. Additionally, repeated use of the phrase "in an embodiment" does not necessarily refer to the same embodiment.

[0007] In one aspect of the present invention, an automatic closed-loop navigation and control system coupled to an invasive medical device is disclosed. The automatic 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, to identify structures associated with a patient's body cavity or lumen and to predict an expected path for inserting the invasive medical device into the patient's body. The processing circuit also generates a control signal based on the expected path and transmits it to at least one actuator unit to actuated the three-dimensional movement of the invasive medical device. Control systems related to colonoscopy that can be performed in an automatic and / or manual manner have been described. Similar systems and methods can be used and associated with any body cavity or lumen within the human body with some modifications.

[0008] In an exemplary embodiment of the present invention, the automatic colonoscopy system predicts one or more expected paths and generates a control signal for at least one actuator unit. The expected path is predicted based on data received from at least one imaging sensor. An overlay of the expected path and / or the identified anatomical structures is also displayed on the user interface, covering the data received by the user interface from the imaging sensor for effective guidance. If multiple expected paths are displayed, the user can select one or more paths and assign a rank to the trajectory. Throughout the process, information is provided to the user through the user interface, and the user is able to manually override the determined output regarding the expected path determined by the closed-loop navigation and control system, as described later in the detailed description. The manual override may trigger an audible or visual feedback asking the user to confirm the override. The rank between the manual control and the automatic control of the insufflation method can be changed in the settings or can be the default setting. Additionally, the overlay of the expected path can also be displayed on the user interface in the form of augmented reality and / or any other form that provides effective guidance to the user.

[0009] The instrument for the above procedure can be inserted through the instrument port such that the distal end of the instrument enters the instrument port and exits at the distal end of the flexible member. The processing circuit can predict the expected path of the instrument. The processing circuit can also generate a control signal and transmit it to the actuator unit to actuated the three-dimensional movement of the invasive medical device.

[0010] In a preferred embodiment, the closed-loop navigation and control system includes: a body; a bending portion; a flexible member that connects the body to the bending portion; a housing unit that is disposed on the bending portion and includes at least one imaging sensor; a circuit; a user interface; a disposable cover; an actuation unit for moving the distal end; and at least one actuation unit for actuating the three-dimensional movement of the flexible member. The length of the bending unit is variable and can range from almost at the tip of the flexible member to the entire flexible member. In other embodiments, the bending portion can be located within any part of the flexible member, which is determined by several factors including but not limited to the relevant use and the anatomical structure to be navigated.

[0011] The processing circuit can utilize a machine learning model and data received from a data source to identify structures related to the patient's body cavity, predict an expected path, generate a control signal, and transmit it to the actuation unit to actuate the three-dimensional movement of the invasive medical device. The expected path can be defined as the path along which the device can guide the invasive medical device once the movement starts. The generation of the machine learning model includes receiving or collecting training data in the form of a predetermined data set to train at least one neural network. The form of such a neural network used can be, but is not limited to, an object detector of a deep neural network based on edge implementation well-known in the art and / or any other algorithm. As is well-known to those skilled in the art, other forms of machine learning other than neural networks are alternatives.

[0012] The processing circuit can be used to predict the expected path for inserting the device based on at least one identified anatomical structure and generate a control signal. The processing circuit can also be used to identify anatomical structures using data received from the imaging sensor and at least one pre-trained machine learning model. The actuation unit can receive a control signal from the processing circuit to actuate the three-dimensional movement of the flexible member. The actuation unit can use the connection to the bending portion to actuate the bending movement of the flexible member in the X and Y planes. The actuation unit can also include a sliding mechanism to actuate the sliding movement of the flexible member in the Z plane by moving the bending portion and its associated actuation unit. Alternatively, the sliding mechanism can actuate the sliding movement of the distal end in the Z plane by direct contact or adjacency with the flexible member without moving the bending portion and its associated actuation unit.

[0013] In another aspect of the present invention, there is provided a method for automatically inserting an invasive medical device into a patient's body cavity or lumen, the method comprising inserting a curved portion and an invasive medical device disposed on the curved portion into the patient's body cavity or lumen. The method includes using an imaging sensor disposed on the curved portion to collect data and transmitting the collected data to a processing circuit to predict an expected path of insertion of the invasive medical device and generate a control signal. The control signal is then transmitted to at least one actuation unit to actuate three-dimensional movement of the invasive medical device. Preferably, the processing circuit predicts the expected path using the data transmitted from the imaging sensor based on the identification of at least one structure associated with the body cavity or lumen.

[0014] Other embodiments and preferred features of the present invention, as well as corresponding advantages, will become apparent from the following description and claims. BRIEF DESCRIPTION OF THE DRAWINGS

[0015] Aspects and embodiments of the present invention are better understood by reference to the following detailed description. The detailed description should be read in conjunction with the accompanying drawings for a better understanding of the present invention.

[0016] FIG. 1 illustrates an environment of a closed-loop navigation and control system according to an embodiment of the present disclosure.

[0017] FIG. 2a illustrates a robotic unit according to an embodiment of the present disclosure.

[0018] FIG. 2b illustrates a distal end of the robotic unit according to an embodiment of the present disclosure.

[0019] FIGS. 2c and 2d respectively illustrate a top view and a bottom view of a cover of the robotic unit of a closed first embodiment according to the present disclosure.

[0020] FIG. 3 illustrates a front view of an actuation unit of a robotic unit including a rack and pinion configuration according to an embodiment of the present disclosure.

[0021] FIG. 4a illustrates a robotic unit according to an alternative embodiment of the present disclosure.

[0022] FIG. 4b illustrates a front perspective view of a cover according to an alternative embodiment of the present disclosure.

[0023] FIG. 5 illustrates a detachable robotic unit according to an alternative embodiment of the present disclosure.

[0024] FIGS. 6a, 6b, and 6c illustrate a curved section of a robotic actuation mechanism including a robotic unit according to an embodiment of the present disclosure.

[0025] FIG. 6d illustrates a connection of the curved portion to the distal end according to an embodiment of the present disclosure.

[0026] FIG. 6e shows the angulation line in a robotic unit according to an embodiment of the present disclosure.

[0027] FIG. 7 shows a cross-sectional view of the internal circuit of a flexible component of a robotic unit according to an embodiment of the present disclosure.

[0028] FIG. 8 shows exemplary functional components of a proposed closed-loop navigation and control system according to an embodiment of the present disclosure.

[0029] FIG. 9 shows an exemplary implementation scenario of a closed-loop navigation and control system,

[0030] FIG. 10 shows a bushing coupling mechanism used in a robotic unit according to an embodiment of the present disclosure.

[0031] FIG. 11 shows different positions of a robotic unit around a patient according to an embodiment of the present disclosure. DETAILED DESCRIPTION

[0032] The present disclosure can be best understood with reference to the detailed drawings and detailed description set forth herein. Various embodiments have been discussed with reference to the drawings. However, those skilled in the art will readily understand that the detailed description provided herein with respect to the drawings is for explanatory purposes only, as the methods and systems can extend beyond the described embodiments. For example, the teachings presented and the requirements of a particular application can give rise to a variety of alternatives and suitable methods for implementing the functionality of any of the details described herein. Thus, in the following embodiments, any method can extend beyond certain implementation choices.

[0033] The methods of the present invention can be implemented by performing or implementing selected steps or tasks manually, automatically, or in combination. The term "method" refers to a manner, means, technique, and procedure for accomplishing a given task, including but not limited to those manners, means, techniques, and procedures known to practitioners in the field to which the present invention pertains or readily derivable from known manners, means, techniques, and procedures. The descriptions, examples, methods, and materials presented in the claims and the specification should not be construed as limiting but merely illustrative. Those skilled in the art will foresee many other possible variations within the purview of the techniques described herein.

[0034] In reading the description of the exemplary embodiments of the best mode of the present invention, hereinafter referred to as "exemplary embodiments" for brevity, the exemplary embodiments should be considered, in accordance with the inventor's belief, as the best mode of implementing the present invention at the time of filing the patent. Since those of ordinary skill in the art can recognize substantially equivalent structures or substantially equivalent actions and thus obtain the same result in the same or different ways, the exemplary embodiments should not be construed as limiting the present invention to one embodiment.

[0035] The discussion of a species (or a particular item) involves the genus (item category) to which the species belongs and related species within that genus. Similarly, the description of a genus also involves species known in the art. Additionally, with the development of technology, many additional alternative ways of implementing aspects of the present invention can arise. Such improvements are included within their respective genera and should be considered functionally equivalent or structurally equivalent to the aspects shown or described.

[0036] Unless otherwise expressly stated, conjunctions (such as "or", "and", "including", or "comprising") shall be construed as inclusive rather than exclusive.

[0037] One of ordinary skill in the art should understand that various structures and devices are depicted in the block diagrams so as not to obscure the present invention. It should be noted that in the following discussion, unless otherwise specified, actions with similar names are performed in a similar manner.

[0038] The foregoing discussion and definitions are provided for purposes of clarification and are not restrictive. Unless otherwise indicated, words and phrases shall conform to their ordinary, straightforward meanings. The present disclosure generally relates to automated medical devices, and more particularly, to a system and method for automatically navigating an invasive medical device through a body cavity or lumen of a body.

[0039] 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 can include a processing circuit that receives data from at least one data source (such as an image sensor, a memory, or a database) to identify structures within a patient's body (such as a body cavity or lumen) and predict an expected path for inserting and navigating the invasive medical device within the patient's body. The processing circuit also generates a control signal based on the predicted expected path and transmits it to at least one actuation unit to actuate the invasive medical device in a three-dimensional manner for controlling the navigation and movement of the invasive medical device. The closed-loop navigation and control system related to colonoscopy can be performed in an automated and / or manual manner. Additionally, the closed-loop navigation and control system and method can be used for several other procedures within any body cavity or lumen within the human body with some modifications.

[0040] The data source may include one or more imaging sensors. Additionally, the sensors are such as 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, etc.) or other sensors known to those skilled in the art. In other embodiments, one or more sensors may be integrated into a custom-designed single sensor to reduce the size of the sensors. The data captured by the data source may also be captured based on differential absorption of monochromatic radiation (single wavelength or narrowband) or polychromatic radiation (having multiple wavelengths simultaneously) in the spectral range from ultraviolet to far infrared. The data may be static, single-point, or captured at a single time point, or may be dynamic or serial data and multiple time series or continuous data that can create a point cloud or video.

[0041] In an embodiment, a closed-loop navigation and control system can be used in diagnostic and interventional endoscopic procedures involving body cavities or lumens of the GI system, hepatobiliary system, respiratory system, male and female urogenital systems, cardiovascular system, and female reproductive system. In the GI system, the procedures can include, but are not limited to: esophagoscopy, rigid, transoral; diagnosis, including collection of specimens by brushing or lavage; esophagoscopy, rigid, transoral; single or multiple biopsies; esophagoscopy, flexible, transnasal; diagnosis, including collection of specimens by brushing or lavage; esophagoscopy, flexible, transnasal; single or multiple biopsies; esophagoscopy, flexible, transoral; diagnosis, including collection of specimens by brushing or lavage; esophagoscopy, flexible, transoral; single or multiple biopsies; esophagogastroduodenoscopy, flexible, transoral; diagnosis, including collection of specimens by brushing or lavage; esophagogastroduodenoscopy, flexible, transoral; single or multiple biopsies; small bowel endoscopy, enteroscopy beyond the second part of the duodenum, excluding the ileum; diagnosis, including collection of specimens by brushing or lavage; small bowel endoscopy, enteroscopy beyond the second part of the duodenum, excluding the ileum; single or multiple biopsies; small bowel endoscopy, enteroscopy beyond the second part of the duodenum, including the ileum; diagnosis, with or without collection of specimens by brushing or lavage; small bowel endoscopy, enteroscopy beyond the second part of the duodenum, including the ileum; single or multiple biopsies; ileostomy, via stoma; diagnosis, including collection of specimens by brushing or lavage during performance; ileostomy, via stoma; single or multiple biopsies; colonoscopy, via stoma; diagnosis, including collection of specimens by brushing or lavage; colonoscopy, via stoma; single or multiple biopsies; sigmoidoscopy, flexible; diagnosis, including collection of specimens by brushing or lavage; sigmoidoscopy, flexible; single or multiple biopsies; colonoscopy, flexible; diagnosis, including collection of specimens by brushing or lavage; colonoscopy, flexible; single or multiple biopsies; esophagoscopy, flexible, transoral; with endoscopic ultrasound; esophagogastroduodenoscopy, flexible, transoral; endoscopic ultrasound limited to the esophagus, stomach, or duodenum and adjacent structures; esophagogastroduodenoscopy, flexible, transoral; with endoscopic ultrasound, including the esophagus, stomach, and duodenum or surgically altered stomach, where the jejunum is examined distal to the anastomosis; colonoscopy, via stoma; with endoscopic ultrasound, limited to the sigmoid colon, descending colon, transverse colon, or ascending colon and cecum and adjacent structures; sigmoidoscopy, flexible; with endoscopic ultrasound; colonoscopy, flexible; endoscopic ultrasound limited to the rectum, sigmoid colon, descending colon, transverse colon, or ascending colon and cecum and adjacent structures; esophagoscopy, rigid, transoral; with balloon dilation (diameter less than 30 mm); esophagoscopy, rigid, transoral; insertion of a guidewire first, then dilation over the guidewire; esophagoscopy, flexible, transoral;Dilate the esophagus by retrograde passage of a balloon or dilator (including fluoroscopic guidance, if performed); Esophagoscopy, flexible, transoral; Dilate the esophagus with a balloon (30 mm or greater in diameter) (including fluoroscopic guidance, if performed); Esophagoscopy, flexible, transoral; Dilate the esophagus using an endoscope-mounted balloon (less than 30 mm in diameter); Esophagoscopy, flexible, transoral; Insert a guidewire first, then pass a dilator over the guidewire; Esophagogastroduodenoscopy, flexible, transoral; Dilate the esophagus with a balloon (30 mm or greater in diameter) (including fluoroscopic guidance, if performed); Esophagogastroduodenoscopy, flexible, transoral; Dilate gastric / duodenal strictures (e.g., balloon, bougie); Esophagogastroduodenoscopy, flexible, transoral; Insert a guidewire first, then pass a dilator over the guidewire through the esophagus; Esophagogastroduodenoscopy, flexible, transoral; Dilate the esophagus using an endoscope-mounted esophageal balloon; Ileostomy, via stoma; Dilate using an endoscope-mounted balloon; Colonoscopy, via stoma; Dilate using an endoscope-mounted balloon; Sigmoidoscopy, flexible; Dilate using an endoscope-mounted balloon; Esophagoscopy, rigid, transoral; Remove foreign body; Esophagoscopy, flexible, transoral; Remove foreign body; Esophagogastroduodenoscopy, flexible, transoral; Remove foreign body; Small bowel endoscopy, enteroscopy beyond the second part of the duodenum, excluding the ileum; Remove foreign body; Colonoscopy, via stoma; Remove foreign body; Sigmoidoscopy, flexible; Remove foreign body; Colonoscopy, flexible; Remove foreign body; Esophagoscopy, flexible, transoral; Excise tumor, polyp, or other lesion with a hot biopsy forceps; Esophagogastroduodenoscopy, flexible, transoral; Excise tumor, polyp, or other lesion with a hot biopsy forceps; Small bowel endoscopy, enteroscopy beyond the second part of the duodenum, excluding the ileum; Excise tumor, polyp, or other lesion with a hot biopsy forceps or bipolar electrocautery; Colonoscopy, via stoma; Excise tumor, polyp, or other lesion with a hot biopsy forceps; Sigmoidoscopy, flexible; Excise tumor, polyp, or other lesion with a hot biopsy forceps; Colonoscopy, flexible; Excise tumor, polyp, or other lesion with a hot biopsy forceps; Esophagoscopy, flexible, transoral; Excise tumor, polyp, or other lesion by snare technique; Esophagogastroduodenoscopy, flexible, transoral; Excise tumor, polyp, or other lesion by snare technique; Small bowel endoscopy, enteroscopy beyond the second part of the duodenum, excluding the ileum; Excise tumor, polyp, or other lesion by snare technique; Colonoscopy, via stoma; Excise tumor, polyp, or other lesion by snare technique; Sigmoidoscopy, flexible; Excise tumor, polyp, or other lesion by snare technique; Colonoscopy, flexible; Excise tumor, polyp, or other lesion by snare technique; Esophagoscopy, flexible, transoral; Ablate tumor, polyp, or other lesion (including before and after dilation and guidewire passage, if performed); Small bowel endoscopy, enteroscopy beyond the second part of the duodenum, excluding the ileum;Ablate tumors, polyps, or other lesions that are not easily removed with a hot biopsy forceps, bipolar cautery, or snare technique; colonoscopy, via stoma; ablate tumors, polyps, or other lesions (including before and after dilation and wire access, if performed); flexible sigmoidoscopy; ablate tumors, polyps, or other lesions (including before and after dilation and wire access, if performed); flexible colonoscopy; ablate tumors, polyps, or other lesions (including before and after dilation and wire access, if performed); small bowel endoscopy, enteroscopy beyond the second portion of the duodenum, excluding the ileum; ablate tumors, polyps, or other lesions that are not easily removed with a hot biopsy forceps, bipolar cautery, or snare technique; colonoscopy, via stoma; ablate tumors, polyps, or other lesions (including before and after dilation and wire access, if performed); flexible sigmoidoscopy; ablate tumors, polyps, or other lesions (including before and after dilation and wire access, if performed); flexible colonoscopy; ablate tumors, polyps, or other lesions (including before and after dilation and wire access, if performed); flexible esophagoscopy, via mouth; control bleeding by any method; flexible esophagogastroduodenoscopy, via mouth; control bleeding by any method; small bowel endoscopy, enteroscopy beyond the second portion of the duodenum, excluding the ileum; control bleeding (e.g., injection, bipolar cautery, monopolar cautery, laser, heater probe, stapler, plasma coagulator); small bowel endoscopy, enteroscopy beyond the second portion of the duodenum, including the ileum; control bleeding (such as injection, bipolar cautery, monopolar cautery, laser, heater probe, stapler, plasma coagulator); flexible sigmoidoscopy; control bleeding by any method; colonoscopy, via stoma; control bleeding by any method; flexible esophagoscopy, via mouth; esophageal variceal injection sclerotherapy; flexible esophagogastroduodenoscopy, via mouth; esophageal / gastric variceal injection sclerotherapy; flexible esophagoscopy, via mouth; esophageal variceal band ligation; flexible esophagogastroduodenoscopy, via mouth; esophageal / gastric variceal band ligation; flexible esophagoscopy, via mouth; place an endoscopic stent (including before and after dilation and wire access, if performed); flexible esophagogastroduodenoscopy, via mouth; place an endoscopic stent (including before and after dilation and wire access, if performed); small bowel endoscopy, enteroscopy beyond the second portion of the duodenum, excluding the ileum; endoscopic stent placement (including before dilation); small bowel endoscopy, enterostomy beyond the second portion of the duodenum, including the ileum; endoscopic stent placement (including before dilation); ileostomy, via stoma; place an endoscopic stent (including before and after dilation and wire access, if performed); flexible sigmoidoscopy; place an endoscopic stent (including before and after dilation and wire access, if performed); flexible colonoscopy; endoscopic stent placement (including before and after dilation and wire access, if performed);Esophagogastroduodenoscopy, flexible, via mouth; directional placement of percutaneous gastrostomy tube; small bowel endoscopy, enterostomy outside the second part of the duodenum, excluding ileum, placement of percutaneous jejunostomy tube; small bowel endoscopy, enterostomy outside the second part of the duodenum, excluding ileum, conversion of percutaneous gastrostomy tube to percutaneous jejunostomy tube, percutaneous replacement of gastrostomy or cecostomy (or other colon) tube under fluoroscopic guidance, including contrast injection; esophagoscopy, rigid, via mouth; directional submucosal injection of any substance; esophagoscopy, flexible, via mouth; directional submucosal injection of any substance; esophagogastroduodenoscopy, flexible, via mouth; directional submucosal injection of any substance; colonoscopy, via stoma; directional submucosal injection of any substance; sigmoidoscopy, flexible; directional submucosal injection of any substance; colonoscopy, flexible; directional submucosal injection of any substance; esophagoscopy, flexible, via mouth; endoscopic ultrasound-guided intramural or trans-wall fine needle aspiration / biopsy; esophagogastroduodenoscopy, flexible, via mouth; endoscopic ultrasound-guided intramural or trans-wall fine needle aspiration / biopsy (including endoscopic ultrasound examination limited to the esophagus, stomach or duodenum and adjacent structures); esophagogastroduodenoscopy, flexible, via mouth; endoscopic ultrasound-guided intramural or trans-wall fine needle aspiration / biopsy (including endoscopic ultrasound examination of the esophagus, stomach and duodenum or surgically altered stomach, where the jejunum is examined distal to the anastomosis); colonoscopy, via stoma; endoscopic ultrasound-guided intramural or trans-wall fine needle aspiration / biopsy, including endoscopic ultrasound examination limited to the sigmoid colon, descending colon, transverse colon or ascending colon and cecum and adjacent structures; sigmoidoscopy, flexible; endoscopic ultrasound-guided intramural or trans-wall fine needle aspiration / biopsy.;

[0042] In an embodiment, the body cavity or lumen into which an invasive medical device can be inserted can be any natural or artificial body cavity within the human body, including but not limited to the abdominal cavity, orbit, external ear, middle ear and inner ear, including associated lumens and cavities, cranial cavity / cranial vault, spinal / vertebral cavity, thoracic cavity, peritoneal cavity, pelvic cavity, pleural cavity, oral cavity, nasal cavity, laryngeal cavity, etc. The lumen can be a structure within any natural or artificial organ or organ system, including but not limited to the following organ systems. In the respiratory system, the lumen can include but not limited to the continuous respiratory tract - nasal, nasopharynx, larynx, trachea, left and right main bronchi, bronchi and bronchioles, alveoli, lung parenchyma, etc. In the gastrointestinal (GI) system, the lumen can include but not limited to the continuous GI tract - oral cavity, oropharynx, esophagus, stomach (including all different parts of the stomach), duodenum (including all different parts of the duodenum), small intestine (including all different parts of the small intestine), colon (including all different parts of the colon), sigmoid colon, rectum, anus, ileostomy, colostomy, etc. In the urinary system, the lumen can include but not limited to the continuous urethra - urethra (including all parts of the male and female urethra), vas deferens, bladder, ureters, renal pelvis, calyces, renal pyramids and kidneys. In the cardiovascular system, the lumen can include but not limited to all chambers of the heart, aorta (including all parts of the aorta), celiac trunk, all arteries, all veins and capillaries, inferior vena cava and superior vena cava, etc. In the hepatopancreatobiliary (HPB) system, the lumen can include but not limited to the continuous HPB tract - liver, gallbladder, pancreas and all associated ducts - hepatic, cystic, pancreatic, common bile duct, etc. In the female reproductive system, the lumen can include but not limited to vagina, cervix, uterus, fallopian tubes, etc. The body cavity or lumen can also include normal anatomical structures and landmarks in these systems, such as seminal colliculus, ampulla of Vater, ileocecal junction, normal anatomical variations and abnormal anatomical pathologies (such as polyps, tumors, diverticula, etc.). The body cavity or lumen can enable imaging of structures near the 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.

[0043] FIG. 1 illustrates an environment of a closed-loop navigation and control system 100 according to an embodiment of the present disclosure. In one embodiment, the closed-loop navigation and control system 100 may be disposed in a body or a bracket (described later) of a detachable robot unit 104. The closed-loop navigation and control system 100 may include a control unit 102 that generates control signals that are transmitted to the detachable robot unit 104. The detachable robot unit 104 may include an imaging unit 112 and an actuation unit 114. In an embodiment, the control unit 102 may be connected to the detachable robot unit 104 by a wired connection, a wireless connection, or a combination of both. Accordingly, the detachable robot unit 104 may be automatically operated by the control unit 102 based on feedback received from the imaging unit 112 and a sensor unit 116. Thus, a closed loop of processing and control may be formed based on the input provided by the imaging unit 112 and the processing of the generated control signals by the control unit 102 to automatically control the movement of the detachable robot unit 104 via the actuation unit 114.

[0044] In an embodiment, a wired network, a 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. In addition, the wired network or the wireless network may be a private network or a shared network. A shared network represents a union of different types of networks that communicate with each other using various protocols (e.g., Hypertext Transfer Protocol (HTTP), Transmission Control Protocol / Internet Protocol (TCP / IP), Wireless Application Protocol (WAP), etc.). In addition, the wired network or the wireless network may include various network devices, including routers, bridges, servers, computing devices, storage devices, etc.

[0045] In an embodiment, the closed-loop navigation and control system 100 may be powered by an electrical connection via a power supply cable or a rechargeable battery that is provided to power the various components of the closed-loop navigation and control system 100. In an embodiment, the robot unit 104 may be powered by the same or a different power supply cable of the control unit 102, or may have a separate power source in the form of a rechargeable battery to power the robot unit 104.

[0046] 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, state machines, logic circuitry, and / or any device that manipulates signals based on operational instructions. Among other capabilities, the one or more processors 108 are configured to obtain and execute computer-readable instructions stored in the memory 110 of the control unit 102. The memory 110 may store one or more computer-readable instructions or routines that may be obtained 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 an embodiment, the control unit 102 may be connected to a cloud server that includes one or more processors 108 and a memory 110 in the form of a cloud database. The one or more processors 108 may be configured to process data stored in the control unit 102 or in the local memory 110 in the form of a cloud database.

[0047] The control unit 102 may also include input / output devices 106. The input / output devices 106 may include various interfaces, such as, for example, interfaces for data input and output devices, etc. The input / output devices 106 may facilitate a user 118 who communicates with the control unit 102 to input instructions. In an embodiment, the input / output devices 106 may be wirelessly connected to the control unit 102 via a wireless network interface (such as infrared or any other wireless radio communication known in the art). In an embodiment, the input / output devices 106 may be connected to the communication paths of one or more components of the control unit 102 to facilitate the transmission of input instructions and output the results of data generated by various components (such as, but not limited to, the processor 108 and the memory 110).

[0048] In an embodiment, the control unit 102 may be implemented in any computing device that may 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 via one or more user devices (not shown), which may be communicatively coupled to the control unit 102 via a wired or wireless connection or provided as one or more input / output devices 106. The user may be a healthcare provider who may be present during the operation of a medical device that includes the closed-loop navigation and control system 100. In an embodiment, the user device (not shown) may include various computing systems, including but not limited to physically manipulable, touch-enabled computing devices, artificial intelligence (AI)-enabled interfaces, laptop computers, virtual reality / augmented reality / mixed reality (VR / AR / MR)-enabled or integrated interfaces, desktop computers, notebooks, workstations, portable computers, personal digital assistants, handheld devices, joysticks, or mobile devices. In an embodiment, the input / output device 106 may be configured to receive inputs from the user 118 in forms including but not limited to touch, gaze, gestures, voice commands, etc.

[0049] The robotic unit 104 may be removably connected to the control unit 102. The robotic unit 104 may have different shapes and sizes and may be designed and selected for the body cavity or lumen into which it is to be inserted. For example, the size and shape of the robotic unit 104 for a colonoscope or upper GI endoscope may be different from those of the robotic unit for a ureteroscope or bronchoscope, etc. In an embodiment, the robotic unit 104 may also contain a processing unit (not shown) for handling sensor integration and independent functions for processing components such as one or more sensors, microcontrollers, motors, actuators, and other components provided in the robotic unit 104. The robotic unit 104 may also contain 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), insufflation devices (not shown), aspiration irrigation devices (not shown), ultrasound (not shown), and other imaging devices (not shown), etc. The robotic unit 104 may be considered a combination of one or more disposable components and reusable components (described later). In one embodiment, the robotic unit 104 may house a tube (described later), which may have different lengths and diameters corresponding to the body cavity or lumen into which it is to be inserted. The tube of the robotic unit 104 may include a flexible component (described later), a bending portion (described later), and a distal end (described later), which may be disposable or reusable.

[0050] The robotic unit 104 can be designed to have different shapes and sizes. Additionally, the robotic unit 104 can be different for each body cavity or lumen that the endoscope is designed for. For example, the size and shape of the robotic unit 104 for a colonoscope or upper GI endoscope may be different from that of a robotic unit for a ureteroscope or bronchoscope, etc. The robotic unit 104 can house the flexible member 204, which can have different lengths and diameters for each body cavity or lumen according to which the endoscope is designed.

[0051] The robotic unit 104 can include an imaging unit 112, an actuation unit 114, and a sensor unit 116. The imaging unit 112 can include one or more imaging sensors that can capture images. The imaging unit 112 can be located at any position along the flexible member 204, or at any other position that can provide a panoramic image. In an embodiment, the image sensor can be placed at the distal end of the flexible member of the robotic unit 104. In an embodiment, the imaging unit 112 can be detached from the flexible member of the robotic unit 104. In an embodiment, the imaging unit 112 can be introduced through one or more channels through the flexible member of the robotic unit 104. In an embodiment, the image sensor may not be able to be directly placed at the optimal position due to engineering constraints, but can be placed elsewhere and connected to the optimal position. The imaging unit 112 can be connected to the optimal position using methods and techniques such as optical fibers, waveguides, and other forms of transmission media. In an embodiment, the imaging sensor can be placed at the proximal end of the flexible member (described later) and connected to the distal end via these methods. In an embodiment, the image sensors can be placed or aligned to have overlapping fields of view. The control unit 102 can generate a panoramic image by stitching together the images captured by each sensor of the imaging unit 112. In an embodiment, the panoramic image can be displayed on the display of the input / output device 106. Additionally, the panoramic image can be used to determine the intended path for operating the actuation unit 114, which in turn actuates the movement of the flexible member 204 of the robotic unit 104, as described in co-pending patent application PCT / US2021 / 062988, which is hereby incorporated by reference in its entirety. A custom sensor can be created by combining two or more imaging sensors into a single housing, and the data from the custom sensor can be used as a data source. In an embodiment, the imaging sensors can operate at any wavelength along the electromagnetic spectrum and non-electromagnetic spectrum, including but not limited to cameras, infrared cameras, ultraviolet sensors, acoustic sensors, microwave sensors, photodetectors, or other sensors known to those skilled in the art can also be used for the same purpose.

[0052] In addition, the flexible component of the robotic unit 104 may further include a sensor unit 116, which 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 may serve as data sources individually or in combination, and may provide data that can be used by the control unit 102 to generate control signals for the robotic unit 104.

[0053] In an embodiment, the panoramic view captured by the imaging unit 112 and the 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 later), which facilitates the movement of the flexible component of the robotic unit 104 within the patient's body along a predefined path that has been determined, superimposed, and verified. In an embodiment, the control signals from the control unit 102 are transmitted to the actuation unit 114 based on the predefined path. In an embodiment, the predefined path may be a path that will guide the movement of the flexible component of the robotic unit 104 once the movement begins.

[0054] In an embodiment of the present invention, the control unit 102, the input / output device 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 device 106, and the robotic unit 104 may be arranged separately from the body (not shown).

[0055] Figure 2a shows 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 contain a tubular flexible member 204 of the robotic unit 104 and an actuation unit 114. The flexible member 204 of the robotic unit 104 may have a distal end 206 and include an imaging unit 112, a sensor unit 116, and various other ports (not shown) for water, suction, flushing, blowing, illumination, etc. at the end. The actuation unit 114 and the housing 202 are configured to form a rack and pinion (as shown later). The teeth of the rack 208 may be arranged on the circumference or perimeter of the housing 202. The pinion (not shown) is attached to the Z motor 212 and rotates freely on the Z motor coupler axis. The pinion (not shown) rolls on the rack 208 and moves along the circumference or perimeter based on the power or actuation of the Z motor 212. The Z motor 212 is housed above the motor block 214 and moves from an initial starting position to an end position. The pinion (not shown) is attached to the end of the coupler shaft of the Z motor 212. The coupler shaft of the Z motor 212 passes through a hole in the sidewall 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 having teeth that interlock with the teeth of the rack 208. The rotation of the Z motor 212 coupler causes the pinion (not shown) to rotate, which in turn drives the movement of the flexible member 204 in the Z-axis. This movement of the flexible member 204 in the Z direction causes the flexible member 204 to be 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 an embodiment, the flexible member 204 may be attached to the motor block 214 at one end to connect to the housing 202. Additionally, the X and Y motors 218 may be attached to the same or opposite sides of the motor block 214. As seen in FIG. 2a, the motor block 214 may provide support for the X and Y motors 218 and the Z motor 212. In an embodiment, the X and Y motors 218 may be attached to the motor block 214 in such a way that the rack 208 is sandwiched between the X and Y motors 218. In an embodiment, limit switches (not shown) may be mounted to the Z motor 212 and the X and Y motors 218 or the motor block 214 to prevent the flexible member 204 from being over-inserted or over-retracted, and may enable initial calibration of the actuation unit 114. In an embodiment, limit switches (as described later) may also be placed along the rack 208 to provide additional position data on the Z-axis. The purpose of the limit switches may also be achieved by physical limiters that may limit the rotation of the X and Y motors 218 and prevent the motors from over-rotating. In an embodiment, electromagnetic sensors (not shown) and tracking sensors (not shown) may be used to confirm the extension or retraction of the flexible member 204, thereby forming a closed-loop system for winding and unwinding.

[0056] In a preferred embodiment, an automatic closed-loop navigation and control system 100 for an endoscopic surgical device (also referred to herein as robotic unit 104) includes a housing 202, a flexible member 204 that connects the housing 202 and is disposed on the housing 202. The housing 202 may include at least one imaging sensor, circuitry, a user interface, and an actuation unit 114 that actuates the three-dimensional movement of the distal end 206. The length of the flexible member 204 is variable and may include a bending portion (not shown) that is located at the end of the flexible member 204 or may completely cover the length of the flexible member 204. In other embodiments, the bending portion may be located within any portion of the flexible member 204, which is determined by several factors, including but not limited to the relevant use and the anatomical structure to be navigated. There may also be multiple bending portions within the flexible member 204.

[0057] 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 direction and the Y direction within the 2D movement plane to align the distal end 206 with the expected path. The 2D movement plane may be determined based on the panoramic image captured by the imaging unit 112. The control unit 102 may provide a set of coordinates of the expected path with which the distal end 206 is to be aligned. The determination of the set of coordinates of the expected path is described later in this disclosure. Those skilled in the art will find that it is reasonable to use other 2D coordinate systems other than X and Y, such as polar coordinates.

[0058] In an embodiment, a subsequent position can be determined based on the current position of the distal end 206 of the flexible member 204 and data received from one or more sensors of the imaging unit 112 and the sensor unit 116. In an embodiment, the determined subsequent position can be compared with an expected position along an expected path. Thus, if the subsequent position coincides with the expected position, a control signal can be generated to actuated the three-dimensional movement of the distal end 206 along the expected path. In the case where the subsequent position does not coincide with the expected position, an additional control signal can be generated by the control unit 102 to actuated the three-dimensional movement of the distal end back to the current position. In an embodiment, a user can manually operate the control unit 102 to actuated the robotic unit 104 such that the distal end 206 of the flexible member 204 overlaps with the expected position. In an embodiment, a plurality of subsequent positions can 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 can utilize machine learning algorithms to automatically actuated the robotic unit 104 such that, based on a comparison of the generated subsequent position of the distal end 206 with the expected position along the expected path, the distal end 206 of the flexible member 204 overlaps with the expected position. Thus, closed-loop control can be provided to actuated the bending portion of the flexible member 204 according to the determined expected path.

[0059] Based on the received set of coordinates of the expected path, the X and Y motors 218 actuated the corresponding angle adjustment cables that extend inside the flexible member 204 up to a robotic actuation mechanism (described later) disposed directly in front of the distal end 206. In an embodiment, four angle adjustment cables are provided, which can be actuated by the X and Y motors 218 to align the distal end 206 with the expected path.

[0060] In an embodiment, a surgical procedure involving the insertion of the flexible member 204 can be performed by extending the distal end 206 into a patient's body cavity or lumen. The flexible member 204 can be extended from a starting position into and through the body cavity or lumen by the Z motor 212. During the surgical procedure, when the flexible member 204 has been fully retracted from the housing 202, the physical barrier 220 can be removably attached to the housing 202. The physical barrier can be, but is not limited to, in the form of a sleeve removably attached to the housing that physically separates the flexible member from the housing. In an embodiment, the physical barrier can be disposable or reusable. In an embodiment, the flexible member can be, but is not limited to, a disposable drape or protective cover (not shown) that covers the flexible member 204. In an embodiment, the protective cover can form a barrier between the flexible member and body fluid and be made of a material that is possibly flexible, waterproof, impermeable, and transparent. The purpose of the disposable removable barrier 220 and the disposable sleeve or disposable drape is to provide an additional layer to prevent contamination of the robotic unit 104. The Z motor 212 can be actuated to retract the flexible member 204 and the distal end 206 in such a way that the flexible member 204 contacts only the disposable barrier. In an embodiment, the user can place or attach the barrier 220 onto the rack 208 slot around the circumference or perimeter of the housing 202. The barrier 220 will snap into place or be locked to the circumference of the housing 202 with a clamp or screw, or can be attached by methods known to those skilled in the art. In an embodiment, the cross-sectional shape of the flexible member 204 can be, but is not limited to, circular, oval, square, rectangular, etc. In an embodiment, the barrier 220 can be made of PVC, plastic, rubber, or a waterproof flexible material known in the art.

[0061] In an embodiment, the motor block 214 can have a convex guide rail (not shown) that can reduce friction when sliding on a concave guide rail on the rack 208, and vice versa. Importantly, the motor block 214 and the X and Y motors 218 move simultaneously because this will allow the X and Y motors 218 to travel along the circumference or perimeter of the housing 202. The X and Y motors 218 will need to travel such that the length of the angle adjustment cable (not shown) remains constant. This will allow the distal end 206 to move in a simplified three-dimensional manner. Those skilled in the art will also recognize that other three-dimensional coordinate schemes (such as radial coordinates, polar coordinates, cylindrical coordinates, and spherical coordinates) can be used instead of the x, y, and z coordinates described herein.

[0062] Figure 2b shows the distal end 206 of the robotic unit 104 according to an embodiment of the present disclosure. In an embodiment, the distal end 206 attached to the distal end of the flexible member 204 can include an instrument channel 222, an image sensor 224, an air / water channel 226, a visible light, UV, or IR light source 228, and other sensors 230.

[0063] In an exemplary embodiment of the present invention, the flexible member 204 may include a shape sensor (not shown). The shape sensor may provide data related to the real-time position, orientation, velocity, rate, posture, and / or shape at the distal end and / or the flexible member 204. The shape sensor may include one or more optical fibers along the longitudinal axis of the flexible member 204, where it may be inserted or mounted externally via an instrument port, or may be temporarily or permanently located within the lumen of the flexible member 204. The one or more optical fibers may be single-core or may be multi-core. In an alternative embodiment, the one or more optical fibers may include fiber Bragg gratings (FBGs), which may provide data related to the strain along the length of the flexible member. In some embodiments, the same optical fiber may be used to provide strain data and connect the imaging sensor to its optimal position, as described above. The fiber optic 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 the procedure. During a surgical procedure such as, but not limited to, colonoscopy, these loops may include, but are not limited to, alpha loops, anti-alpha loops, transverse loops, n loops, gamma loops, etc. Since the risk of loop formation is predicted before the loop is formed, appropriate measures can be taken to avoid the formation of these loops. If loops are still formed, several methods known to those skilled in the art may be used, such as manual manipulation, shape locking on the tube, from flexible to rigid, a motorized pulling mechanism (not shown) from the distal end 206 of the flexible member 204, magnetic endoscopy imaging, etc.

[0064] The distal end 206 of the flexible member 204 may include one or more openings that are connected to one or more of the following: an intraluminal channel for an instrument, a source of monochromatic radiation (single wavelength or narrowband) or polychromatic radiation (multiple wavelengths simultaneously) in the ultraviolet to far-infrared spectral range, one or more image sensors of the imaging unit 112, then one or more connections to the image sensors, an opening leading to a channel for aspiration flushing, water spraying, insufflation, etc. In an alternative embodiment, the distal end may have additional ultrasound transducers, a source of monochromatic radiation (single wavelength or narrowband) or polychromatic radiation (multiple wavelengths simultaneously) in the ultraviolet to far-infrared spectral range, or other imaging components, or devices known to those skilled in the art.

[0065] Figures 2c and 2d respectively show a top view and a bottom view of the cover of the enclosed robotic unit 104 discussed above. Figure 2c shows a top view of the cover 232, which can be configured to accommodate the housing 202 and the disc shape of the robotic unit 104. The housing includes a U-shaped opening ridge 234 through which the distal end 206 of a surgical device such as an endoscope and the flexible member 204 extend outwardly from the housing 202. Figure 2d shows a bottom view of the cover 236 that includes the robotic unit 104 and the housing 202. In an embodiment, the cover 232 can include plugs and slots for power cables and / or battery compartments. Those skilled in the art will appreciate that the housing 202 and the cover 232 can be any three-dimensional shape capable of surrounding the robotic unit 104.

[0066] Figure 3 shows a close-up 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 whose teeth mesh with the teeth of the rack 208, where the pinion 302 passes through the rack 208 disposed on the circumference or perimeter of the housing 202. In an embodiment, the X and Y motors 218 are associated with the angular adjustment cable 304 using a mechanism such as but not limited to a chain and sprocket mechanism. In an embodiment, the Z motor 212 and the X and Y motors 218 can be associated with the flexible member 204 using other mechanisms. Limit switches 306 can be provided to provide physical limitations for the rotational movement of the X and Y motors 218 in the X coordinate and / or the Y coordinate.

[0067] Figure 4a shows a robotic unit 400 according to an alternative embodiment of the present disclosure. As shown in Figure 4a, a hub 402 holds a flexible member 204 including a distal end 206, and a removable barrier 420 is disposed on the circumference or perimeter of the hub 402. A disposable sleeve or disposable drape (not shown) may be applied over the top of the flexible member 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 is used to provide an additional layer to prevent 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 follower wheel 410 is movably connected to the drive wheel 406 by a belt or chain 412 in a pulley or sprocket arrangement. Those skilled in the art will know the method of connection between the follower wheel 410 and the drive wheel 406. In an embodiment, the drive wheel 406 and the follower wheel 410 may include sprockets or gears rotatably attached to each other by a chain to form a chain drive. Actuation of the Z motor 408 causes movement of the drive wheel 406. The drive wheel 406 is connected to the center of the hub 402, so when the drive wheel 406 rotates, the hub 402 rotates. The hub 402 may rotate in a clockwise or counterclockwise manner by one or more serrated guide wheels 414 to withdraw or retract the flexible member 204, and vice versa. Thus, the rotational movement of the hub 402 is converted into a linear movement of the flexible member 204. The flexible member 204 may be compressed between the serrated guide wheels 414 and a free-running wheel (not shown). The free-running wheel may have very low friction and will only rotate when a torque or force is applied thereto. It may also include serrations to increase the pressure on the flexible member 204. When the follower wheel 410 rotates, the serrated guide wheels 414 push the flexible member 204 out of the hub 402 or retract the flexible member into the hub. When the follower wheel 410 rotates counterclockwise, the serrated guide wheels 414 will rotate clockwise, and this movement will allow the distal end 206 to move forward. Importantly, the hub 402 and the follower wheel 410 rotate simultaneously. Additionally, the X and Y motors 416 also travel along the circumference or perimeter of the hub 402 and are attached to the proximal end of the flexible member 204. The X and Y motors 416 may move such that the length of an angle adjustment cable (not shown) remains constant. The Z motor 408 and the X and Y motors 416 together allow three-dimensional movement of the distal end 206. In an embodiment, the serrated guide wheels 414 may be directly driven by a separate motor (not shown). Those skilled in the art will know that the hub 402 and the cover 422 may have any three-dimensional shape.

[0068] Alternatively, the drive wheel 406 and the follower wheel 410 have a variety of different interconnect arrangements. The drive wheel 406 and the follower wheel 410 can be the same size and rotatably connected to the belt 412. In an embodiment, the drive wheel 406 and the follower wheel 410 can be of different sizes to increase or decrease the relative rotational speed of the follower wheel 410. In an alternative embodiment, the follower wheel 410 can be replaced by the Z motor 408, thus eliminating the requirement for the belt 412.

[0069] In a working embodiment, the flexible member 204 can be moved forward until the proximal end will reach a certain distance away from the follower wheel 410. The hub 402 can include one or more ridges or grooves 418 on the circumference or perimeter around which the flexible member 204 is wound. In an embodiment, the detachable barrier 420 is attached to the ridge 418. Once the surgical procedure is over, it is retracted into the hub 402 by inserting the flexible member 204 into the barrier 420. In an embodiment, the barrier 420 including the flexible member 204 and the distal end 206 can be detached from the hub 402. The flexible member 204 and the distal end 206 can be sterilized by removing them from the detachable barrier 420, which can then be discarded, and the distal end 206 will retract and slide on top of the detachable barrier 420. Once the distal end 206 reaches its starting position, the procedure can begin.

[0070] Figure 4b shows a front perspective view of the cover according to an alternative embodiment of the present disclosure. The cover 422 is a disc that surrounds the robotic unit 104 and the hub 402. The cover 422 includes an opening 424 through which the distal end 206 and the flexible member 204 extend during operation of the robotic unit 104.

[0071] FIG. 5 shows a detachable robot unit 104 according to an alternative embodiment 500 of the present disclosure. The detachable robot unit 104 of the current embodiment includes a first part 504 and a second part 506. The first part 504 includes a hub 502 that is attached to a left base 501 on the left side and to a right base 503 on the right side, and vice versa. The hub 502 can be a spool-shaped housing around which a flexible member 204 can be wound. The second part 506 is a driving and guiding unit for the flexible member and includes an automatic reverse screw 526, a lead screw nut 518, and a driving wheel 508 that can be attached to a driving wheel motor 510. In an embodiment, the guiding wheel 514 can be serrated. The driving wheel motor 510 can be attached to the first part 504. The Z motor 522 can be the same as the driving wheel motor 510. To drive the distal end 206 forward, the Z motor 522 will rotate the serrated guiding wheel 514, and at the same time the driving wheel 508 can be rotated by the driving wheel motor 510, which can rotate the driven wheel 512. The driving wheel 508 and the driven wheel 512 can be gears that are coupled together with a gear ratio of 1:1. Those skilled in the art will know the types of connections, such as gears, belts, chains, etc., and the gear ratio between the driving wheel 508 and the driven wheel 512. The movement of the driven wheel 512 can unwind the flexible member 204 and can push the distal end 206 outwards through the serrated guiding wheel 514. The flexible member 204 can be aligned by a distal end guide 524 attached to the top of the lead screw nut 518. The flexible member 204 can be compressed between the serrated guiding wheel 514 and the guiding wheel 520. The guiding wheel 520 can be a very low friction wheel and can rotate if any torque or force acts on it. The serrated guiding wheel 514 and the guiding wheel 520 can include serrations to increase the pressure on the flexible member 204. When the flexible member 204 is to be inserted or retracted, the Z motor 522 can rotate the serrated guiding wheel 514. The driving wheel motor 510 can rotate the driving wheel 508. The driving wheel 508 can rotate the adjacent driven wheel 512 and can have a gear ratio of 1:1. The driven wheel 512 can rotate the spool-shaped first part 504 to wind the flexible member 204 back onto the first part 504. During this action, the automatic reverse screw 526 will rotate freely while the ends do not move. This can cause the lead screw nut 518 to move along the same axis as the automatic reverse screw 526. The lead screw nut 518 can have threads that match the automatic reverse screw 526 and can be constrained on a linear track 516 at the opposite end. This can ensure that the lead screw nut 518 does not rotate. The lead screw nut 518 can have the ability to move with the same pitch as how the flexible member 204 winds back onto the hub 502 and moves back and forth on the automatic reverse screw 526. This can ensure that the flexible member 204 winds back onto the hub 502 as it is and helps with repeatability and non-entanglement.A disposable sleeve or disposable drape (not shown) may be applied over the top of the flexible member 204. The disposable sleeve or disposable drape is used to provide an additional layer to prevent contamination of the housing of the robotic unit 500.

[0072] Figures 6a, 6b, and 6c illustrate a bent portion of a robotic actuation mechanism including a robotic unit 104 in accordance with an embodiment of the present disclosure. The bent portion 600 is located at the distal end of the flexible member 204, just prior to the distal end 206. The bent portion 600 includes a plurality of individual vertebrae 602, 604 that are stacked on top of each other and may be connected by rivets 606, as shown in FIG. 6b. The distal portion of the bent section 608 may hold the distal end 206, which may include various sensors, a camera housing (not shown), etc. The vertebrae 602, 604 may be connected in such an arrangement to allow each vertebra 602, 604 to independently partially and / or fully rotate about the rivet 606. The rotational movement of each vertebra 602, 604 may enable the bent portion 600 to bend. The vertebrae 602, 604 may be connected to each other and may have eyelets 612 to allow angle adjustment cables to pass through them, where one end of the cable may be connected to the vertebra 604 at the most distal end of the bent portion 600. The articulating ends of each vertebra 602, 604 may include rounded corners 610 that may distribute stress during bending and reduce the load from the angle adjustment cables. The vertebrae 602, 604 may also include at least one eyelet 612 disposed on the inner perimeter of the circumference of each vertebra 602, 604. Cables from the actuation unit 114 may pass through the eyelets 612 to reach the connection point at the distal vertebra 604. The eyelets 612 may form a cross-section in the shape of a clover, thereby allowing the eyelets 612 to remain straight in each individual vertebra 602, 604 and maximizing the open interior volume of the vertebrae 602, 604. Aligning the eyelets 612 of adjacent vertebrae 602, 604 directly with each other and away from the rivet 606 may achieve a smoother transition during bending and may reduce the tensile load on the cables. Alternatively, a mesh or a combination of the above structure and a mesh, or other feasible arrangements known to those skilled in the art may be employed to achieve the same purpose.

[0073] Figure 6d illustrates the connection of the bent portion 600 to the distal end 206 in accordance with an embodiment of the present disclosure. The vertebrae 602, 604 are connected to the distal end 206 at the connection point 614.

[0074] Figure 6e shows the angulation line in a robotic unit according to an embodiment of the present disclosure. As shown in Figure 6e, it can be seen that the angulation line 616 passes through the flexible member 204 and further enters the bending portion 600. In an embodiment, there can be four angulation lines, and the four angulation lines can be placed 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 line 616 can be controlled by the X and Y motors to move them in the X and Y directions.

[0075] Figure 7 shows a cross-sectional view of the flexible member 204 of a robotic unit according to an embodiment of the present disclosure. As shown in Figure 7, it can be seen that four angulation lines 616 are arranged at 90 degrees to each other around the circumference of the flexible member 204. It can be seen that the flexible member 204 can include an outermost layer 702 made of any waterproof material. Next to the outermost layer 702, there can be a wire mesh 704 to increase the tensile strength of the flexible member 204. The flexible member 204 can surround an optical fiber 706, which can be connected to a light source (such as an LED) to illuminate the internal anatomical structure so that the imaging unit 112 can capture an image with appropriate illumination. The flexible member 204 can also include: a signal line 712 for transmitting signals from one or more sensors; and a line 716 for changing the thickness of the flexible member 204. In addition, the flexible member 204 can include a water spray channel 708 for flushing a certain area to provide an unobstructed passage for the distal end 206 to advance in a body cavity or lumen. In addition, the flexible member 204 can include an air channel 710.

[0076] Any collapsed passageway in a body cavity or lumen can be insufflated with a gas, such as CO2 gas, which can provide better visualization of the otherwise collapsed body cavity or lumen. In an embodiment, data received from a pressure sensor (not shown) can be combined with data received from an imaging sensor to form a closed-loop insufflation system that automatically achieves clear visualization of the body cavity or lumen. The air passage 710 can be used to blow air onto a region by discharging a gas such as CO2 gas. A pressure sensor (not shown) can be placed at the end of the distal end 206 or anywhere along the length of the air passage 710, including portions external to the flexible member 204. The pressure sensor can provide a digital or analog input to the robotic unit 104 or the control unit 102. The pressure of the insufflated gas can be monitored in real time based on the pressure sensor, and the amount of insufflated gas discharged can be controlled such that the pressure within the body cavity or lumen does not exceed or fall below a predefined threshold pressure level. Thus, any change in the pressure level can be tracked by the data received from the pressure sensor. The control unit 102 can utilize a machine learning model as well as the data received from the data source to identify an ideal insufflation level, which can be achieved when the data from the data source is within the predefined threshold pressure level. The predefined threshold pressure level can be determined based on a pre-trained data set. Once sufficient insufflation is achieved, a message will be sent to the control unit 102, which will then send a signal to automatically pause the further flow of the insufflated gas, thus forming a closed-loop insufflation system. Once sufficient insufflation is achieved and maintained at that pressure level, the pressure can be automatically increased or decreased as determined by closing the 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 can provide the user 118 with the ability to manually override the closed feedback loop output and manually control the pressure. In an embodiment, the manual override can trigger an audible or visual feedback requesting user confirmation of the override.

[0077] The processor 108 of the control unit 102 of the closed-loop navigation and control system 100 can utilize a machine learning model and data received from data sources or stored in the memory 110 to identify structures related to the patient's body cavity, predict an expected path, generate a control signal, and transmit it to the actuation unit 114 to actuate the three-dimensional movement of the invasive medical device of the robotic unit 104. By utilizing the machine learning model and data transmitted from the imaging unit 112 and the sensor unit 116, the control unit 102 can perform the prediction of the expected navigation path and the identification of structures related to the body cavity or lumen. The machine learning model is part of computer vision software 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 videos of the program into image files and labeling the anatomical structures on the image files. In an alternative embodiment, the generation of the machine learning model includes receiving or collecting training data in the form of a predetermined dataset to train at least one neural network. The predetermined dataset can be, but is not limited to, all of the above data sources. To achieve smooth real-time continuous tracking and navigation of the automatic closed-loop navigation and control system 100, the machine learning model can be optimized to execute faster on a single-board computing platform.

[0078] The control unit 102 can predict at least one new expected path. Once the distal end 206 of the flexible member 204 has reached the first position, the control unit 102 can generate or determine a second position along the expected path. The control unit 102 can continuously generate new positions for the distal end 206 of the flexible member 204 along the expected path based on data received from at least one imaging sensor of the imaging unit 112. The control unit 102 utilizes the machine learning model to compare the data of the actual movement of the distal end 206 of the flexible member 204 received from the imaging unit 112 with the expected movement of the distal end 206.

[0079] In an automatic closed-loop navigation and control system 100, an initial pre-programmed calibration sequence for the motor and the image unit or sensor unit can be indicated. The calibration sequence can be used to construct a Jacobian matrix. In an embodiment of the automatic closed-loop navigation and control system 100, it is a visual servo method, in which inverse kinematics can be used to move the robotic joints based on the change in the position of the desired target in the image coordinate system. The visual servo is implemented using the pseudo-inverse matrix of the Jacobian matrix. In other embodiments, it is a reference point minimum method, in which a gradient descent method can be utilized in response to a virtual potential field between the current position and the desired position in the image coordinate system. A desired position on the image coordinate system can be provided with the aim of moving the captured image of the current view of the robotic tool to the desired position by moving the robotic joints. This can be achieved by directly mapping the coordinates of the robot to the image coordinates. In other embodiments, laser-guided navigation with triangulation can be used for navigation within a body cavity or lumen. In other embodiments, force field tracking can be used, in which an actual force field such as (but not limited to) a mechanical force field or a magnetic force field is used to guide the robot along a desired path. In any embodiment, a form of proportional-integral-derivative controller can be used to smooth the tracking and approach the desired position.

[0080] FIG. 8 shows example functional components of the proposed closed-loop navigation and control system 100 according to an embodiment of the present disclosure. One or more processors 108 of FIG. 1 can enable various processing engines 800, such as a data receiving 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.

[0081] The data receiving engine 802 is configured to receive data from a data source. In an embodiment, the data source from which the data receiving engine 802 can receive data is the imaging unit 112, the actuation unit 114, the sensor unit 116, the input / output device 106, and the memory 110.

[0082] The image processing engine 804 can utilize the data received from the imaging sensor disposed in the imaging unit 112, and the processed data output from the image processing engine 804 can be displayed on the output user interface of the output device 106 to provide the user with a view of the lumen or body cavity of the patient. In an embodiment, the view can be a two-dimensional or three-dimensional panoramic view of the lumen or body cavity of the patient. In an embodiment, the view can be magnified.

[0083] Additionally, the object detection engine 806 can identify structures in the view created by the image processing engine 804. The generated view can include images that can be superimposed on the data received from the imaging sensor on the user interface in the form of a virtual envelope for effective visual guidance of the user.

[0084] During an invasive surgical procedure, a surgeon may accidentally damage one or more anatomical structures, such as but not limited to the ureters during a hysterectomy, the common bile duct during a cholecystectomy, and the iliac vessels and rectum during a prostatectomy, especially during their learning curve. The object detection engine 806 can detect such anatomical structures, and the navigation and collision control engine 808 can create a virtual envelope around such anatomical structures, which will depict such structures as being non - enterable and non - accessible, thus protecting them from accidental damage during the surgical procedure.

[0085] In an embodiment, the detected anatomical structures can ensure that a control output is determined subject to non - crossing or non - collision position constraints.

[0086] The navigation and collision control engine 808 can provide collision avoidance, which can be used to determine a navigation control and a virtual envelope around the detected anatomical structures that depicts the anatomical structures as no - go zones. When the distal end 206 of the flexible member 204 of the robotic unit 104 approaches these anatomical structures, it may be affected by a repulsive field F. This can be explained by sampling the computational time for image processing at 60 Hz to generate visual and simulated tactile feedback. The repulsive force "F" can be directly proportional to the approaching speed of the distal end 206 towards the virtual envelope and the reciprocal of the distance between the virtual envelope and the distal end 206, such that: F ∝ v / r. In an embodiment, "V" is the speed of the distal end 206, and "r" is the distance between the virtual envelope and the distal end 206.

[0087] Based on this principle, the algorithm implemented by the navigation and collision control engine 808 will be configured and its effectiveness can be tested in a virtual test environment of a surgical workspace created using tools such as but not limited to MATLAB: Natick, MRS. In an embodiment, a virtual test environment of the surgical workspace can be designed and a virtual robotic unit simulating the robotic unit 104 can be used in this virtual test environment to test the algorithm implemented by the navigation and collision control engine 808. Based on the determined algorithm efficiency, the algorithm can be integrated and implemented in the navigation and collision control engine 808. In an embodiment, the closed - loop navigation and control system 100 can be tested on non - living models, animal models, and based on its success, it can be made suitable for use with human subjects.

[0088] Stereo vision, depth, or distance can be used to detect obstacles. In the absence of stereo vision, the magnification of the object view (in terms of its extent on the image) can be related to the distance to the object, which can be used for approximate collision detection and avoidance. In an embodiment, the object detection engine 806 can utilize a machine learning model to process the data received from the data source to identify structures related to the patient's body cavity or lumen, or a pre-trained model can identify obstacles and determine no-go zones. The navigation and collision control engine 808 can utilize a machine learning model to process the data received from the data source to predict the expected path and follow the expected path so as to avoid the identified structures. The training of the machine learning model can involve receiving or collecting training data in the form of a predetermined data set to train at least one neural network. The form of such a neural network can be, but is not limited to, an object detector of a deep neural network based on edge implementation well known in the art. As is well known to those skilled in the art, other forms of machine learning models other than neural networks can be utilized. The predetermined data set can include, but is not limited to, images and videos, photon counts, temperature, position, distance, humidity, gas levels, fluid or enzyme levels, motility studies, pressure, force, etc.

[0089] The navigation and collision control engine 808 can generate and transmit control signals for the actuation unit 114 to actuate the three-dimensional movement of the robotic unit 104.

[0090] The navigation and collision control engine 808 can determine the expected path along which the robotic unit 104 can be guided. The expected path can be determined based on the output from the object detection engine 806 and the data received from the sensor unit 116. The processing circuit can also utilize at least one pre-trained machine learning model to identify the anatomical structure and the expected path using the data received by the data receiving engine 802.

[0091] In an embodiment, the machine learning model can be computer vision software used by various processing engines 802 to 812. The computer vision software can be developed by training one or more neural networks on a labeled image data set, where the labeled image data set is constructed by converting a collection of program videos into image files and labeling the anatomical structures on the image files. In an alternative embodiment, the generation of the machine learning model includes receiving or collecting training data in the form of a predetermined data set to train at least one neural network. The predetermined data set can also include, but is not limited to, any of the data sources as described above.

[0092] The user interface engine 810 may provide an interactive user interface on the input / output device 106 and may include a touch-sensitive display. In an embodiment, the display may show a view of the patient's internal anatomy, with the expected path and / or the identified VS overlaid thereon, to provide effective visual guidance to the user 118 through the interactive visual interface. In an embodiment, the depicted virtual envelope is overlaid on the VS for the user 118 to identify the VS.

[0093] In an embodiment, when the distal end 206 reaches an intersection in the channel where the channel may branch into several other branches, the user may provide a control signal to the actuation unit 114 by using one or more controls provided by the user interface engine 810 to select the expected path for the distal end 206 to traverse. In an 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 an embodiment, if multiple expected paths are detected, the user interface engine 810 may display a predetermined visual indication. The user 118 may use the appropriate visual indication to select the expected path. In an embodiment, the user interface engine 810 may display multiple trajectories from which the user 118 may select the expected path. Throughout the process, information is projected onto the display, and the user 118 may manually override the controls generated by the navigation and collision control engine 808 and the control unit 102. In an embodiment, the manual override may also trigger an auditory or visual feedback requesting the user to confirm the override in the form of an alert or notification. The hierarchy between manual control and automatic control may be predefined as a default setting based on training data and may be changed as required.

[0094] In an 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 laboratory results, but not limited to blood gas levels, glucose levels, air pressure detected in the lumen or body cavity, and other results known to those trained in the art.

[0095] In another embodiment, the user interface engine 810 may manually provide a control signal to the actuation unit 114 using multiple buttons (such as but not limited to up, down, left and right, insert and retract) to actuate the three-dimensional movement of the robotic unit 104. In an embodiment, the multiple buttons may enable the actuation of the actuation unit 114 by providing angular input, such as moving the distal end 206 at an angle of 30 degrees in the upper right direction. In an embodiment, the multiple buttons may be set as touch buttons arranged on the user interface to provide a manual actuation mode when needed by the user 118. If the user is not satisfied with the expected path determined by the control unit 102, the user may also use the multiple buttons to override the automatic actuation of the distal end 206.

[0096] In an embodiment, the other engine 812 can supplement the functions of other modules or the closed-loop navigation and control system 100 as needed.

[0097] FIG. 9 shows 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 shows a tower 902, a display 904, a user interface 906, and a cart 908 placed near the patient bed 910. In an embodiment, the tower 902 can include the display 904. The user interface 906 can be a touch-enabled tablet computer that can be used as the input / output device 106. The cart 908 can include one or more robotic arms (not shown) and a robotic unit 104 movably coupled to the one or more robotic arms.

[0098] In an embodiment, the tower 902 can further include a blowing device (not shown) that includes a gas cylinder 912 and an outlet tube connecting the gas cylinder 912 to the robotic unit 104. The tower 902 can include a suction container (not shown) for accommodating the inhaled material during suction. In addition, the suction container (not shown) can be connected to the suction channel 714 of the flexible member 204. Further, the tower 902 can include a fluid source (not shown) that can be used as a fluid source during flushing and can be connected to the water spraying channel 708 of the flexible member 204. The tower 902 can include various other operable energy systems known to those skilled in the art to power the electrical systems in the tower. In an embodiment, the tower 902, the cart 908, the robotic unit 104, and the tablet computer 906 can have separate power sources in the form of batteries or power supply cables, or can be powered by a common power source shared among each of them through power cables or other suitable means known in the art. The cart 908 and the tower 902 can be configured to stand freely on the floor and can include wheels below for positioning as needed. In an alternative embodiment, the cart 908 can be attached to the patient bed 910. In an alternative embodiment, the cart 908 can be attached to the ceiling or wall of the operating room.

[0099] In an embodiment, the cart 908 can include a physical attachment and communication interface with the robotic unit 104 (as shown in FIG. 10 described later). In an embodiment, the tower 902 and the cart 908 can include wheels for being movably placed near the user 118 and the patient for the user 118 to effectively and easily monitor the patient.

[0100] Each of the tablet computer 906, the cart 908, the robotic unit 104, and the tower 902 can be connected to each other via a wired or wireless connection. The tower 902 can further include one or more additional displays 904, and the one or more additional displays can also support touch.

[0101] FIG. 10 shows a bushing coupling mechanism used in a robotic unit according to an embodiment of the present disclosure. In an embodiment, a bushing coupler may be used to connect one or more robotic arms (not shown) of a cart 908 to one or more robotic units 104. In an embodiment, a robotic arm may be a type of robotic arm that may be controlled by a control unit 102 and may act similar to a human arm. A robotic arm may include linkages of such a manipulator, which may be connected by joints to allow rotational movement (such as in an articulated robot) or translational (linear) displacement. The linkages of the manipulator may be considered to form a kinematic chain. The end of the kinematic chain of the manipulator may be referred to as an end effector and may work similar to a human hand. The robotic unit 104 may be connected at an end or at any point along the robotic arm.

[0102] In an embodiment, a drive flange 1002 is attached to a Z motor of an actuation unit 114 of the robotic unit 104. A driven flange 1004 may be attached to one or more robotic arms (not shown) disposed on the cart 908. In an embodiment, the drive flange 1002 may be connected to the driven flange 1004 by connection means such as an electromagnetic connection or by nuts and bolts passing through connection notches 1006 and 1008.

[0103] FIG. 11 shows an example of some possible positions of the robotic unit 104 and the cart 908 around a patient 1108. This illustration is not an exclusive list of all possible procedures or positions around the patient 1108. In an embodiment, the cart 908 may be placed at position 1102 relative to the patient 1108 who is undergoing a procedure through the mouth or nose. In another embodiment, the cart 908 may be placed at position 1104 relative to the patient 1108 who is undergoing a trans-thoracic procedure or a procedure through the mouth or nose. In an embodiment, the cart 908 may be placed at position 1106 or 1110 relative to the patient 1108 who is undergoing a procedure through the urethra, vagina, or anus.

[0104] The present disclosure and the embodiments are intended to be considered as exemplary only, and the true scope of the disclosed embodiments is indicated by the following claims.

Claims

1. A surgical device, comprising: A housing; A flexible member having a distal end and wound around the housing; A processor configured to: Predict an expected path of the distal end of the flexible member; and Generate a control signal based on the expected path, wherein the expected path is predicted based on at least one anatomical structure identified using data received from one or more sensors; And An actuation unit configured to actuate a three-dimensional movement of the distal end of the flexible member along the expected path based on the control signal, the actuation unit comprising: An x-motor and a y-motor configured to actuate the distal end of the flexible member to bend and move towards the expected path in the x-plane and the y-plane; And A z-motor configured to wind the flexible member around the housing or unwind it from the housing such that the distal end of the flexible member passes through in the z-plane of the expected path.

2. The surgical device according to claim 1, wherein A machine learning model is used to identify the at least one anatomical structure, wherein the machine learning model is trained based on historical data regarding the identified multiple anatomical structures.

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

4. The surgical device according to claim 3, wherein, The processor is further configured to predict the expected path of the distal end of the flexible member to avoid the virtual envelope created corresponding to the determined at least one anatomical structure.

5. The surgical device according to claim 1, wherein, The actuation unit is further configured to constrain or limit the movement of the distal end of the flexible member when the distal end of the flexible member approaches the at least one anatomical structure.

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

7. The surgical device according to claim 1, wherein, The housing is further configured to accommodate a physical barrier that physically separates the flexible member from the housing, wherein the physical barrier is detachably attached to the housing and is disposable or reusable.

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

9. The surgical device according to claim 8, wherein, The processor is further configured to: Compare the generated subsequent position of the distal end with an expected position along the expected path, and Be configured as one of the following: If the subsequent position coincides with the expected position, generate the control signal to actuate the three-dimensional movement of the distal end along the expected path; or If the subsequent position does not coincide with the expected position, generate an additional control signal to actuate the three-dimensional movement of the distal end back to the current position.

10. The surgical device according to claim 9, wherein, The processor uses a machine learning model to compare the generated subsequent position of the distal end with the expected position along the expected path.

11. The surgical device according to claim 1, wherein the surgical device further comprises a protective cover configured to cover the flexible member and form a barrier between the flexible member and body fluid, and wherein the protective cover is made of a flexible, waterproof, impermeable, and transparent material.

12. The surgical device according to claim 1, wherein, The housing is in the shape of a disk.

13. The surgical device according to 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 member around the housing.

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

15. The surgical device according to claim 1, wherein, The housing includes a rack at the top portion, and a pinion attached to the z-motor rotates on the rack to unwind the flexible member from the housing.

16. The surgical device according to claim 15, wherein, The x-motor and y-motor rotate together with the z-motor.

17. The surgical device according to claim 1, wherein, The housing is in the shape of a reel.

18. The surgical device according to claim 17, wherein, The z-motor is attached to a serrated guide wheel, and the serrated guide wheel is attached to the flexible member, wherein the flexible member is sandwiched between the serrated guide wheel on one side and a freely rotatable wheel on the other side, so as to wind or unwind the flexible member around the reel-shaped housing.

19. A surgical device, comprising: a housing, the housing comprising: a top side; a bottom side disposed opposite to the top side; and a rack disposed on the top side; a flexible member wound along the circumference of the bottom side of the housing; a processor configured to: predict an expected path of a distal end of the flexible member; and generate a control signal based on the expected path, wherein the expected path is predicted based on at least one anatomical structure identified using data received from one or more sensors; and an actuation unit configured to actuate a three-dimensional movement of the distal end of the flexible member along the expected path based on the control signal, the actuation unit comprising: a z-motor connected to a pinion, wherein the z-motor is configured to move the pinion across the rack to wind or unwind the flexible member around the housing, such that the distal end of the flexible member retracts or extends by passing through in the z-plane of the expected path; and an x-motor and a y-motor configured to actuate the distal end of the flexible member to bend and move in the x-plane and y-plane towards the expected path, wherein the x-motor and y-motor move across the rack together with the z-motor.

20. The surgical device according to claim 19, wherein, The housing is in an oval or circular shape.

21. The surgical device according to claim 19, wherein, The identification of the anatomical structure includes using a machine learning model, and the machine learning model is trained based on historical data regarding a plurality of identified anatomical structures.

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

23. The surgical device according to claim 22, wherein, The processor is further configured to predict the expected path of the distal end of the flexible member to avoid the virtual envelope created corresponding to the determined anatomical structure.

24. The surgical device according to claim 19, wherein, The actuation unit is further configured to restrain or limit movement of the distal end of the flexible member when the distal end of the flexible member approaches the at least one anatomical structure.

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

26. The surgical device according to claim 19, wherein, The housing is further configured to accommodate a physical barrier that physically separates the flexible member from the housing, wherein the physical barrier is detachably attached to the housing and is disposable or reusable.

27. The surgical device according to claim 19, the surgical device further comprising a detachable barrier between the flexible member and the bottom side of the housing.

28. The surgical device according to claim 19, wherein, Generate the control signal for a subsequent position based on the current position of the distal end of the flexible member and data received from the one or more sensors.

29. The surgical device according to claim 28, wherein, The processor is further configured to: Compare the generated subsequent position of the distal end with an expected position along the expected path, and Is configured as one of the following: If the subsequent position coincides with the expected position, generate the control signal to actuate the three-dimensional movement of the distal end along the expected path; or If the subsequent position does not coincide with the expected position, generate an additional control signal to actuate the three-dimensional movement of the distal end back to the current position.

30. The surgical device according to claim 29, wherein, The processor uses a machine learning model to compare the generated subsequent position of the distal end with an expected position along the expected path.

31. The surgical device according to claim 19, the surgical device further comprising a protective cover configured to cover the flexible member and form a barrier between the flexible member and body fluid, wherein the protective cover is made of a flexible, waterproof, impermeable, and transparent material.

32. A surgical device, comprising: A disk-shaped hub, the disk-shaped hub comprising: A circumference; A flexible member wound along the circumference, the flexible member comprising: A distal end; A processor configured to: Predict an expected path of the distal end of the flexible member, and Generate a control signal based on the expected path, wherein the expected path is predicted based on at least one anatomical structure identified using data received from one or more sensors; and An actuation unit configured to actuate a three-dimensional movement of the distal end of the flexible member along the expected 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 follower wheel and the hub; A serrated guide wheel rotatably connected to the follower wheel, wherein rotation of the drive wheel causes the follower wheel, the hub, and the serrated guide wheel to rotate to wind the flexible member onto the hub or unwind the flexible member from the hub such that the distal end of the flexible member passes through in the z-plane of the expected path; An x-motor and a y-motor, the x-motor and the y-motor being configured to actuatingly move the distal end of the flexible member to bend in the x-plane and the y-plane towards the expected path. Wherein, the x-motor and the y-motor rotate along the circumference of the hub.

33. The surgical device according to claim 32, wherein, The cross-section of the hub is oval or circular.

34. The surgical device according to claim 32, wherein, The z-motor is disposed at the center of the housing to rotate the hub to wind the flexible member around the hub or unwind it from the hub.

35. The surgical device according to claim 32, wherein, The z-motor is attached to a serrated guide wheel, wherein the flexible member is clamped between the serrated guide wheel on one side and a guide on the other side.

36. The surgical device according to claim 32, wherein, The identification of the anatomical structure includes using a machine learning model, wherein the machine learning model is trained based on historical data regarding a plurality of identified anatomical structures.

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

39. The surgical device according to claim 32, wherein, The actuating unit is further configured to constrain or limit the movement of the distal end of the flexible member when the distal end of the flexible member approaches the at least one anatomical structure.

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

41. The surgical device according to claim 32, wherein, The hub is further configured to accommodate a physical barrier that physically separates the flexible member from the hub, wherein the physical barrier is detachably attached to the hub and is disposable or reusable.

42. The surgical device according to claim 32, wherein, Generate the control signal for the subsequent position based on the current position of the distal end of the flexible member and the data received from the one or more sensors.

43. The surgical device according to claim 42, wherein, The processor is further configured to: Compare the generated subsequent position of the distal end with the expected position along the expected path, and Is configured as one of the following: If the subsequent position is consistent with the expected position, generate the control signal to actuatingly move the distal end along the three-dimensional movement of the expected path; or If the subsequent position is inconsistent with the expected position, generate an additional control signal to actuatingly move the distal end back to the three-dimensional movement of the current position.

44. The surgical device according to claim 43, wherein, The processor uses a machine learning model to compare the generated subsequent position of the distal end with the expected position along the expected path.

45. The surgical device according to claim 32, the surgical device further comprising a protective cover configured to cover the flexible member and form a barrier between the flexible member and body fluid, wherein the protective cover is made of a flexible, waterproof, impermeable, and transparent material.

46. A surgical device, comprising: A hub in the shape of a reel; A flexible member including a distal end and wound around the hub; A processor configured to: Predict the expected path of the distal end of the flexible member, and Generate a control signal based on the expected path, wherein the expected path is predicted based on at least one anatomical structure identified using data received from one or more sensors; And A drive and guidance unit configured to guide and drive the flexible member by three-dimensional movement of the distal end of the flexible member along the expected path based on the control signal, the drive and guidance unit comprising: An x-motor and a y-motor attached to the hub and configured to actuate the distal end of the flexible member to bend and move towards the expected path in the x-plane and the y-plane; A drive motor configured to rotate a serrated guide wheel, wherein the serrated guide wheel is rotatably connected to a drive wheel and the hub, and wherein rotation of the serrated guide wheel rotates the hub to wind and unwind the flexible member on and from the hub such that the distal end of the flexible member passes through in the z-plane of the expected path.

47. The surgical device according to claim 46, wherein, The flexible member is sandwiched between the serrated guide wheel on one side and a guide on the other side.

48. The surgical device according to claim 46, wherein, Use a machine learning model to identify the at least one anatomical structure, wherein the machine learning model is trained based on historical data regarding the identified plurality of anatomical structures.

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

50. The surgical device according to claim 49, wherein, The processor is further configured to predict the expected path of the distal end of the flexible member to avoid the virtual envelope created corresponding to the determined at least one anatomical structure.

51. The surgical device according to claim 46, wherein, The drive and guidance unit is further configured to constrain or limit the movement of the distal end of the flexible member when the distal end of the flexible member approaches the at least one anatomical structure.

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

53. The surgical device according to claim 46, wherein, The hub is further configured to accommodate a physical barrier that physically separates the flexible member from the hub, wherein the physical barrier is detachably attached to the hub and is disposable or reusable.

54. The surgical device according to claim 46, wherein, Generate the control signal for a subsequent position based on the current position of the distal end of the flexible member and data received from the one or more sensors.

55. The surgical device according to claim 46, wherein, The processor is further configured to: Compare the generated subsequent position of the distal end with the expected position along the expected path, and Be configured as one of the following: If the subsequent position coincides with the expected position, generate the control signal to actuate the three-dimensional movement of the distal end along the expected path; or If the subsequent position does not coincide with the expected position, generate an additional control signal to actuate the three-dimensional movement of the distal end back to the current position.

56. The surgical device according to claim 55, wherein, The processor uses a machine learning model to compare the generated subsequent position of the distal end with the expected position along the expected path.

57. The surgical device according to claim 46, further comprising a protective cover configured to cover the flexible member and form a barrier between the flexible member and body fluid, wherein the protective cover is made of a flexible, waterproof, impermeable and transparent material.

58. A method for performing a surgical procedure, comprising: capturing data from one or more sensors; identifying at least one anatomical structure based on the captured data; predicting an expected path based on the at least one anatomical structure; generating a control signal based on the predicted expected path; and actuating a distal end of a flexible member of the surgical device in a three-dimensional manner along the predicted expected path based on the control signal, wherein the actuation of the flexible member comprises: actuating a z-motor to wind the flexible portion around or unwind it from a housing of the surgical device such that the flexible member passes through in a z-plane of the expected path; and actuating an x-motor and a y-motor to enable the distal end of the flexible member to bend and move in an x-plane and a y-plane toward the expected path.

59. The method according to claim 58, wherein, Using a machine learning model to identify the at least one anatomical structure, wherein the machine learning model is trained based on historical data regarding the identified multiple anatomical structures.

60. The surgical device according to claim 58, further comprising creating a virtual envelope corresponding to each of the determined one or more anatomical structures.

61. The method according to claim 60, wherein, Predicting the expected path of the distal end of the flexible member to avoid the virtual envelope created corresponding to the determined at least one anatomical structure.

62. The method according to claim 58, wherein The actuation of the distal end of the flexible member comprises: restricting or limiting the movement of the distal end of the flexible member when the distal end of the flexible member approaches the at least one anatomical structure.

63. The method according to claim 58, wherein, An endoscopic procedure of one of the gastrointestinal tract, urinary tract, respiratory tract, male or female urogenital tract, ear, nose, throat, brain, spinal cord, cardiovascular system, skeletal system, and nervous system can be performed using the method.

64. The method according to claim 58, wherein Generating the control signal for a subsequent position based on the current position of the distal end of the flexible member and the data received from the one or more sensors.

65. The method according to claim 64, the method further comprising: comparing the generated subsequent position of the distal end with an expected position along the expected path, and being configured as one of the following: if the subsequent position is consistent with the expected position, generating the control signal to actuate the three-dimensional movement of the distal end along the expected path; or if the subsequent position is inconsistent with the expected position, generating an additional control signal to actuate the three-dimensional movement of the distal end back to the current position.

66. The method according to claim 65, wherein Comparing the generated subsequent position of the distal end with the expected position along the expected path based on a machine learning model.