WIRE PUNCTURE OF STRICTURE FOR PANCREATICOBILIARY ACCESS

Systems, devices, and methods for endoscopic access to a target region in a patient pancreaticobiliary system from an entry site of a stricture is disclosed. The stricture can be opened up using an radio-frequency (RF)-based approach by delivering RF energy to a working head of a steerable elongate instrument positioned at the entry site, or a mechanical puncture-based approach by applying force to a working head made of material with substantial stiffness. A machine learning (ML) model can be trained to determine a proper pancreaticobiliary access method for the patient, such as between the RF-based approach and the mechanical puncture-based approach. At least a distal portion of the steerable elongate instrument can be advanced into the pancreaticobiliary region to perform a diagnostic or therapeutic operation therein.

FIELD OF THE DISCLOSURE

The present document relates generally to endoscopic systems, and more particularly to apparatus and methods for endoscopically accessing a pancreaticobiliary region of a patient to perform diagnostic or therapeutic operations therein.

BACKGROUND

Endoscopes have been used in a variety of clinical procedures, including, for example, illuminating, imaging, detecting and diagnosing one or more disease states, providing fluid delivery (e.g., saline or other preparations via a fluid channel) toward an anatomical region, providing passage (e.g., via a working channel) of one or more therapeutic devices or biological matter collection devices for sampling or treating an anatomical region, and providing suction passageways for collecting fluids (e.g., saline or other preparations), among other procedures. Examples of such anatomical region can include gastrointestinal tract (e.g., esophagus, stomach, duodenum, pancreaticobiliary duct, intestines, colon, and the like), renal area (e.g., kidney(s), ureter, bladder, urethra) and other internal organs (e.g., reproductive systems, sinus cavities, submucosal regions, respiratory tract), and the like.

Some endoscopes include a working channel through which an operator can perform suction, placement of diagnostic or therapeutic devices (e.g., a brush, a biopsy needle or forceps, a stent, a basket, or a balloon), or minimally invasive surgeries such as tissue sampling or removal of unwanted tissue (e.g., benign or malignant strictures) or foreign objects (e.g., calculi). Some endoscopes can be used with a laser or plasma system to deliver energy to an anatomical target (e.g., soft or hard tissue or calculi) to achieve desired treatment. For example, laser has been used in applications of tissue ablation, coagulation, vaporization, fragmentation, and lithotripsy to break down calculi in kidney, gallbladder, ureter, among other stone-forming regions, or to ablate large calculi into smaller fragments.

In conventional endoscopy, the distal portion of the endoscope can be configured for supporting and orienting a therapeutic device, such as with the use of an elevator. In some systems, two endoscopes can work together with a first endoscope guiding a second endoscope inserted therein with the aid of the elevator. Such systems can be helpful in guiding endoscopes to anatomic locations within the body that are difficult to reach. For example, some anatomic locations can only be accessed with an endoscope after insertion through a circuitous path.

Peroral cholangioscopy is a technique that permits direct endoscopic visualization, diagnosis, and treatment of various disorders of patient biliary and pancreatic ductal system using miniature endoscopes and catheters inserted through the accessory port of a duodenoscope. Peroral cholangioscopy can be performed by using a dedicated cholangioscope that is advanced through the accessory channel of a duodenoscope, as used in Endoscopic Retrograde Cholangio-Pancreatography (ERCP) procedures. ERCP is a technique that combines the use of endoscopy and fluoroscopy to diagnose and treat certain problems of the biliary or pancreatic ductal systems, including the liver, gallbladder, bile ducts, pancreas, or pancreatic duct. In ERCP, an cholangioscope (also referred to as an auxiliary scope, or a “daughter” scope) can be attached to and advanced through a working channel of a duodenoscope (also referred to as a main scope, or a “mother” scope). Typically, two separate endoscopists operate each of the “mother-daughter” scopes. Although biliary cannulation can be achieved directly with the tip of the cholangioscope, most endoscopists prefer cannulation over a guidewire. A tissue retrieval device can be inserted through the cholangioscope to retrieve biological matter (e.g., gallstones, bill duct stones, cancerous tissue) or to manage stricture or blockage in bile duct.

Peroral cholangioscopy can also be performed by inserting a small-diameter dedicated endoscope directly into the bile duct, such as in a Direct Per-Oral Cholangioscopy (DPOC) procedure. In DPOC, a slim endoscope (cholangioscope) can be inserted into patient mouth, pass through the upper GI tract, and enter into the common bile duct for visualization, diagnosis, and treatment of disorders of the biliary and pancreatic ductal systems.

Biliary stricture occurs when a portion of the bile duct abnormally gets smaller or narrower, which may be caused by damage (e.g., surgery) to the bile duct, passage of gallstones to the bile duct, infections of the bile duct, pancreatitis, or cancer in the bile duct or pancreas. Endoscopic stricture management generally involves placing a stricture management device to open or dilate the narrowed or obstructed portion of the duct. Devices used for pancreaticobiliary stricture management include, for example, dilating catheters, balloon dilators, and stents. Dilating catheters are tapered cylindrical tubes with a central channel, and may be passed over a guidewire through the accessory channel of the side-viewing duodenoscope. Wire-guided balloon dilators are used in the bile duct and the pancreatic duct, inflated with dilute contrast to facilitate visualization during ERCP. Pancreaticobiliary stents are self-expandable devices that can be passed through a working channel of an endoscope and inserted into the obstructed bile duct to open the stricture in ERCP.

SUMMARY

Endoscopic placement of stricture management devices in an obstructed or narrowed portion the pancreaticobiliary ductal system can be a complicated procedure. Conventionally, biliary endoscopic sphincterotomy is a prerequisite for placement of stricture management devices, calculi removal, tissue acquisition (e.g., biopsy), among other biliary interventions. Biliary endoscopic sphincterotomy (EST) generally refers to the cutting of the biliary sphincter and intraduodenal segment of the common bile duct following selective cannulation, using a high frequency current applied with a special knife, sphincterotome, inserted into the papilla. Biliary endoscopic sphincterotomy is either used solely for the treatment of diseases of the papilla of Vater, such as sphincter of Oddi dysfunction, or to facilitate subsequent therapeutic biliary interventions.

The operating physician's experience and dexterity play an important role in determining the success rate and patient outcome of endoscopic biliary procedures. Occasionally, biliary endoscopic sphincterotomy may be hampered by altered surgical anatomy or invasive tumors. With the duodenoscope designed to be stable in the duodenum, it can be more difficult to reach the duodenal papilla in surgically altered anatomy. Manipulation of the sphincterotome to achieve desired cutting can also be technically difficult in patients with altered anatomy of pancreaticobiliary system (e.g., the ampulla). Conventional endoscopic systems generally lack the capability of automated navigation guidance based on patient's unique anatomy. The endoscopic stricture management devices and techniques can be less effective for patients with altered surgical anatomy or invasive tumors, particularly when the operator has less experience with such devices and techniques.

The present disclosure describes alternative apparatus, devices, and methods for endoscopically accessing a target region in patient pancreaticobiliary system via an entry site at or around a stricture. According to one embodiment, a pancreaticobiliary access method comprises steps including navigating a steerable elongate instrument through a body cavity or channel toward a stricture adjacent to a target pancreaticobiliary region, delivering radio-frequency (RF) energy to an entry site of the stricture via a working head of the steerable elongate instrument to produce an opening sized to the pancreaticobiliary region. The entry site can be identified by applying an image of the stricture to a trained machine-learning (ML) model. At least a distal portion of the steerable elongate instrument can then be passed through the produced opening into the pancreaticobiliary region to perform a diagnostic or therapeutic operation therein.

According to another aspect of the present disclosure, a pancreaticobiliary access method comprises steps including navigating a steerable elongate instrument through a body cavity or channel toward a stricture adjacent to a target pancreaticobiliary region, positioning the working head of the steerable elongate instrument at an entry site of the stricture and applying a mechanical force thereto to produce an opening to the pancreaticobiliary region. The working head can be configured to achieve a higher amount of stiffness than other portions (e.g., the proximal portion) of the steerable elongate instrument as the working head approaches the stricture. The entry site can be identified by applying an image of the trained machine-learning (ML) model. At least a distal portion of the steerable elongate instrument can then be passed through the produced opening into the pancreaticobiliary region to perform a diagnostic or therapeutic operation therein.

According to another aspect of the present disclosure, an artificial intelligence (AI)-based decision system can select an appropriate pancreaticobiliary access approach for a patient, such as between an RF-based approach and a mechanical puncture-based approach, as described above catheter having a rigidized working head. A machine-learning (ML) model can be trained to identify an entry site at or around the stricture, and to determine a proper pancreaticobiliary access method for the patient, such as between the RF-based approach and the mechanical puncture-based approach.

Example 1 is a method for endoscopically accessing a pancreaticobiliary region of a patient, the method comprising: navigating a steerable elongate instrument through a body cavity or channel toward a stricture adjacent to the pancreaticobiliary region; delivering radio-frequency (RF) energy to an entry site of the stricture via a working head of the steerable elongate instrument to produce an opening to the pancreaticobiliary region; and passing at least a distal portion of the steerable elongate instrument through the produced opening into the pancreaticobiliary region to perform a diagnostic or therapeutic operation therein.

In Example 2, the subject matter of Example 1 optionally includes applying an image of the stricture to a trained machine-learning (ML) model to identify the entry site of the stricture.

In Example 3, the subject matter of any one or more of Examples 1-2 optionally includes the RF energy that can be applied to a stricture beside an ampulla of Vater to produce an opening to a common bile duct.

In Example 4, the subject matter of any one or more of Examples 1-3 optionally includes delivering the RF energy through an uncoiled wire portion on the working head of the steerable elongate instrument, the uncoiled wire portion electrically coupled to an RF power generator.

In Example 5, the subject matter of any one or more of Examples 1-4 optionally includes adjusting an RF energy delivered to the entry site of the stricture based at least on a characteristic of the stricture.

Example 6 is a method for accessing a pancreaticobiliary region of a patient, the method comprising: navigating a steerable elongate instrument through a body cavity or channel toward to a stricture adjacent to the pancreaticobiliary region, the steerable elongate instrument extended between a proximal portion and a distal portion, the distal portion including a working head configured to achieve a higher amount of stiffness than the proximal portion of the steerable elongate instrument as the working head approaches the stricture; positioning the working head of the steerable elongate instrument at an entry site of the stricture and applying a mechanical force thereto to produce an opening to the pancreaticobiliary region; and passing at least the distal portion of the steerable elongate instrument through the produced opening into the pancreaticobiliary region to perform diagnostic or therapeutic operation therein.

In Example 7, the subject matter of Example 6 optionally includes applying an image of the stricture to a trained machine-learning (ML) model to identify the entry site of the stricture.

In Example 8, the subject matter of any one or more of Examples 6-7 optionally includes the working head that can be made of material through a rigidization process.

In Example 9, the subject matter of any one or more of Examples 6-8 optionally includes the distal portion of the steerable elongate instrument that can be configured to have axially variable stiffness.

In Example 10, the subject matter of any one or more of Examples 6-9 optionally includes the steerable elongate instrument having the distal portion comprising struts spatially arranged to provide variable stiffness as the steerable elongate instrument changes its posture, including an increase in stiffness in response to a change from a bending posture to a straightening posture.

Example 11 is an endoscopic system, comprising: a steerable elongate instrument extended between a proximal portion and a distal portion, the distal portion including a working head configured to achieve a higher amount stiffness than other portions of the steerable elongate instrument as the working head approaches a stricture adjacent to a pancreaticobiliary region; and a controller configured to provide a control signal to an actuator to robotically facilitate navigation and manipulation of the steerable elongate instrument, including, via the actuator: position the working head of the steerable elongate instrument at an entry site of the stricture and apply a mechanical force thereto to produce an opening to the pancreaticobiliary region; and pass at least the distal portion of the steerable elongate instrument through the produced opening into the pancreaticobiliary region to perform a diagnostic or therapeutic operation therein.

In Example 12, the subject matter of Example 11 optionally includes a robot arm configured to detachably engage the steerable elongate instrument, and to automatically adjust position or navigation of the steerable elongate instrument via the actuator in response to the control signal.

In Example 13, the subject matter of any one or more of Examples 11-12 optionally includes the steerable elongate instrument that can be configured to be robotically positioned and navigated to a duodenal papilla or a portion of pancreaticobiliary system.

In Example 14, the subject matter of any one or more of Examples 11-13 optionally includes the working head that can be made of material through a rigidization process.

Example 15 is an endoscopic system, comprising: a steerable elongate instrument configured to be positioned and navigated in a patient anatomy; a controller configured to: receive an image of a stricture adjacent to a pancreaticobiliary region; and apply the received image of the stricture to at least one trained machine-learning (ML) model to identify an entry site of the stricture, and to determine a pancreaticobiliary access approach, between (i) an radio frequency (RF)-based approach and (ii) a mechanical puncture-based approach, to access the pancreaticobiliary region; and an output unit configured to provide the determined pancreaticobiliary access approach to a user.

In Example 16, the subject matter of Example 15 optionally includes the controller that can be further configured to: construct a training dataset comprising stored procedure data obtained from past endoscopic stricture management procedures on a plurality of patients using respective pancreaticobiliary access approaches including the RF-based approach or the mechanical puncture-based approach, the stored procedure data including (i) images of strictures of the plurality of patients and (ii) assessments of the pancreaticobiliary access approaches of the respective procedures; and train the ML model using the training dataset.

In Example 17, the subject matter of any one or more of Examples 15-16 optionally includes the steerable elongate instrument that can include a catheter, a guide wire, or a guide sheath including a lumen to pass a stricture management device therethrough.

In Example 18, the subject matter of any one or more of Examples 15-17 optionally includes the steerable elongate instrument that can include an endoscope, the endoscope including an imaging sensor to generate the image of the stricture.

In Example 19, the subject matter of any one or more of Examples 15-18 optionally includes the steerable elongate instrument that can be extended between a proximal portion and a distal portion, the distal portion including a working head having a higher amount of stiffness than other portions of the steerable elongate instrument, wherein the working head is configured to, in response to a puncture force applied thereto, puncture the entry site of the stricture to produce an opening sized to pass at least the distal portion of the steerable elongate instrument therethrough.

In Example 20, the subject matter of any one or more of Examples 15-19 optionally includes the steerable elongate instrument that can include, at a distal portion thereof, a working head configured to be electrically coupled to an RF power generator and to deliver RF energy to the entry site of the stricture to produce an opening sized to pass at least the distal portion of the steerable elongate instrument therethrough.

The systems, devices, and methods described herein can improve pancreaticobiliary access particularly in patients with surgically altered or complicated anatomy or malignant biliary strictures. Compared to conventional endoscopic pancreaticobiliary access approach (e.g., sphincterotomy), the RF-based or mechanical puncture-based approach as described herein are more controllable and easier to operate, can reduce procedure complexity and shorten procedure time. The AI-based pancreaticobiliary access decision system can help avoid or reduce risks and complications associated with direct cutting (e.g., sphincterotomy). Overall ERCP procedure success rate can be improved, and the healthcare cost associated with complications and procedure failures can be reduced.

DETAILED DESCRIPTION

This document describes systems, devices, and methods for endoscopic access to a target region in a patient pancreaticobiliary system from an entry site of a stricture. The stricture can be opened up using an radio-frequency (RF)-based approach by delivering RF energy to a working head of a steerable elongate instrument positioned at the entry site, or a mechanical puncture-based approach by applying force to a working head made of material with substantial stiffness. A machine learning (ML) model can be trained to determine a proper pancreaticobiliary access method for the patient, such as between the RF-based approach and the mechanical puncture-based approach. At least a distal portion of the steerable elongate instrument can be advanced into the pancreaticobiliary region to perform a diagnostic or therapeutic operation therein.

FIG.1is a schematic diagram illustrating an example of an endoscopy system10for use in endoscopic procedures, such as an ERCP procedure. The system10comprises an imaging and control system12and an endoscope14. The endoscopy system10is an illustrative example of an endoscopy system suitable for patient diagnosis and/or treatment using the systems, devices and methods described herein, such as tethered and optically enhanced biological matter and tissue collection, retrieval and storage devices and biopsy instruments that can be used for obtaining samples of tissue or other biological matter to be removed from a patient for analysis or treatment of the patient. According to some examples, the endoscope14can be insertable into an anatomical region for imaging and/or to provide passage of or attachment to (e.g., via tethering) one or more sampling devices for biopsies, or one or more therapeutic devices for treatment of a disease state associated with the anatomical region.

The imaging and control system12can comprise a control unit16, an output unit18, an input unit20, a light source22, a fluid source24, and a suction pump26. The imaging and control system12can include various ports for coupling with endoscopy system10. For example, the control unit16can include a data input/output port for receiving data from and communicating data to the endoscope14. The light source22can include an output port for transmitting light to the endoscope14, such as via a fiber optic link. The fluid source24can comprise one or more sources of air, saline or other fluids, as well as associated fluid pathways (e.g., air channels, irrigation channels, suction channels) and connectors (barb fittings, fluid seals, valves and the like). The fluid source24can be in communication with the control unit16, and can transmit one or more sources of air or fluids to the endoscope14via a port. The fluid source24can comprise a pump and a tank of fluid or can be connected to an external tank, vessel or storage unit. The suction pump26can comprise a port used to draw a vacuum from the endoscope14to generate suction, such as for withdrawing fluid from the anatomical region into which the endoscope14is inserted.

The output unit18and the input unit20can be used by a human operator and/or a robotic operator of endoscopy system10to control functions of endoscopy system10and view output of endoscope14. In some examples, the control unit16can additionally be used to generate signals or other outputs for treating the anatomical region into which the endoscope14is inserted. Examples of such signals or outputs can include electrical output, acoustic output, a radio-frequency energy output, a fluid output and the like for treating the anatomical region with, for example, cauterizing, cutting, freezing and the like.

The endoscope14can interface with and connect to the imaging and control system12via a coupler section36. In the illustrated example, the endoscope14comprises a duodenoscope that may be use in a ERCP procedure, though other types of endoscopes can be used with the features and teachings of the present disclosure. The endoscope14can comprise an insertion section28, a functional section30, and a handle section32, which can be coupled to a cable section34and the coupler section36.

The insertion section28can extend distally from the handle section32, and the cable section34can extend proximally from the handle section32. The insertion section28can be elongate and include a bending section, and a distal end to which functional section30can be attached. The bending section can be controllable (e.g., by control knob38on the handle section32) to maneuver the distal end through tortuous anatomical passageways (e.g., stomach, duodenum, kidney, ureter, etc.). Insertion section28can also include one or more working channels (e.g., an internal lumen) that can be elongate and support insertion of one or more therapeutic tools of functional section30, such as a cholangioscope as shown inFIG.4. The working channel can extend between handle section32and functional section30. Additional functionalities, such as fluid passages, guidewires, and pull wires can also be provided by insertion section28(e.g., via suction or irrigation passageways, and the like).

The handle section32can comprise a control knob38and ports40. The ports40can be configured to couple various electrical cables, guidewires, auxiliary scopes, tissue collection devices of the present disclosure, fluid tubes and the like to handle section32for coupling with insertion section28. The control knob38can be coupled to a pull wire, or other actuation mechanisms, extending through insertion section28. The control knob38can be used by a user to manually advance or retreat the insertion section28of the endoscope14, and to adjust bending of a bending section at the distal end of the insertion section28. In some examples, an optional drive unit46(FIG.2) can be used to provide motorized drive for advancing a distal section of endoscope14under the control of the control unit16.

The imaging and control system12, according to examples, can be provided on a mobile platform (e.g., cart41) with shelves for housing light source22, suction pump26, image processing unit42(FIG.2), etc. Alternatively, several components of the imaging and control system12shown inFIGS.1and2can be provided directly on the endoscope14such that the endoscope is “self-contained.”

The functional section30can comprise components for treating and diagnosing anatomy of a patient. The functional section30can comprise an imaging device, an illumination device, and an elevator. The functional section30can further comprise optically enhanced biological matter and tissue collection and retrieval devices. For example, the functional section30can comprise one or more electrodes conductively connected to handle section32and functionally connected to the imaging and control system12to analyze biological matter in contact with the electrodes based on comparative biological data stored in the imaging and control system12. In other examples, the functional section30can directly incorporate tissue collectors.

In some examples, the endoscope14can be robotically controlled, such as by a robot arm attached thereto. The robot arm can automatically, or semi-automatically (e.g., with certain user manual control or commands), via an actuator, position and navigate an instrument such as the endoscope14(e.g., the functional section30and/or the insertion section28) of in the target anatomy, or position a device at a desired location with desired posture to facilitate an operation of an anatomical target, such as a stricture management device to open or dilate an obstructed or narrowed portion of the ductal system. In various embodiments, a controller can use artificial intelligence (AI) to determine cannulation and navigation parameters and/or tool operational parameters (e.g., position, angle, posture, force, and navigation path), and generate a control signal to the actuator of the robot arm to facilitate operation of such instrument or tools in accordance with the determined navigation and operational parameters in a robotically assisted procedure.

FIG.2is a schematic diagram of the endoscopy system10shown inFIG.1, which comprises the imaging and control system12and the endoscope14.FIG.2schematically illustrates components of the imaging and control system12coupled to the endoscope14, which in the illustrated example comprises a duodenoscope. The imaging and control system12can comprise a control unit16, which can include or be coupled to an image processing unit42, a treatment generator44, and a drive unit46, as well as the light source22, the input unit20, and the output unit18as discussed above with reference toFIG.1. The control unit16can comprise, or can be in communication with, a surgical instrument200comprising a device configured to engage tissue and collect and store a portion of that tissue and through which an imaging device (e.g., a camera) can view target tissue via inclusion of optically enhanced materials and components. The control unit16can be configured to activate an imaging device (e.g., a camera) at the functional section of the endoscope14to view target tissue distal of surgical instrument200and endoscopy system10, which can be fabricated of a translucent material to minimize the impacts of the camera being obstructed or partially obstructed by the tissue retrieval device. Likewise, the control unit16can be configured to activate the light source22to shine light on the surgical instrument200, which can include select components that are configured to reflect light in a particular manner, such as tissue cutters being enhanced with reflective particles.

The image processing unit42and the light source22can each interface with the endoscope14(e.g., at the functional section30) by wired or wireless electrical connections. The imaging and control system12can accordingly illuminate an anatomical region using the light source22, collect signals representing the anatomical region, process signals representing the anatomical region using the image processing unit42, and display images representing the anatomical region on the output unit18. The imaging and control system12can include the light source22to illuminate the anatomical region using light of desired spectrum (e.g., broadband white light, narrow-band imaging using preferred electromagnetic wavelengths, and the like). The imaging and control system12can connect (e.g., via an endoscope connector) to the endoscope14for signal transmission (e.g., light output from light source, video signals from the imaging device such as positioned at the distal portion of the endoscope14, diagnostic and sensor signals from a diagnostic device, and the like).

The treatment generator44can generate a treatment plan, which can be used by the control unit16to control the operation of the endoscope14, or to provide with the operating physician a guidance for maneuvering the endoscope14, during an endoscopic procedure. The treatment plan can include a pancreaticobiliary access plan for passing at least a portion of the endoscope14(or other steerable elongate instrument such as a catheter or a guidewire) into a target region of the pancreaticobiliary system to perform a diagnostic or therapeutic operation therein. Pancreaticobiliary access can be achieved by delivering radio-frequency (RF) energy to the stricture via a working head of the endoscope14, or by applying mechanical force to the stricture via a working head of sufficient stiffness at a distal portion of the endoscope14(or other steerable elongate instrument such as a catheter or a guidewire). In an example, the treatment generator44can use a trained machine-learning (ML) model to determine patient candidacy for RF-based pancreaticobiliary access approach such as based on an endoscopic image of the stricture. For non-candidates, mechanical puncture-based pancreaticobiliary access may be recommended to an operating physician. Examples of the RF-based or mechanical puncture-based approaches for pancreaticobiliary access are discussed below with reference toFIGS.5A-5B.

FIGS.3A-3Bare diagrams illustrating an example of peroral cholangioscopy performed via direct insertion of a cholangioscope324into the bile duct, as in a DPOC procedure, and a portion of patient anatomy where the procedure is performed. The cholangioscope324is nested inside of a guide sheath322, and inserted perorally into a patient to reach duodenum308. Duodenum308comprises an upper part of the small intestine. The guide sheath322can extend into mouth301, through esophagus306, through stomach307to reach the duodenum308. Before reaching intestines309, the guide sheath322can position the cholangioscope324proximate common bile duct312. The common bile duct312carries bile from the gallbladder305and liver304, and empties the bile into the duodenum308through sphincter of Oddi310(FIG.3B). The cholangioscope324can extend from guide sheath322to extend into common bile duct312. In some examples, steering features of guide sheath322(e.g., pull wire) can be used to facilitate navigating and bending of cholangioscope324through stomach307, in addition to direct steering of cholangioscope324via the pull wires. For example, navigation of the Pyloric canal and Pyloric sphincter can be difficult to navigate using only an endoscope. Thus, the guide sheath322can be used to turn or bend elongate body of cholangioscope324, or reduce the amount of steering or bending of the elongate body of the cholangioscope324required by pull wires, to facilitate traversing the Pyloric sphincter.

FIG.3Bis a schematic view of duodenum308connected to common bile duct312via duodenal papilla314. Common bile duct312can branch off into pancreatic duct316and gallbladder duct311. Duodenal papilla314can include sphincter of Oddi310that controls flow of bile and pancreatic juice into the intestine (duodenum). Pancreatic duct316can lead to pancreas303. Pancreatic duct316carries pancreatic juice from pancreas303to the common bile duct312. Gallbladder duct311can lead to gallbladder305. In some patients, it can be difficult to navigate surgical instruments to duodenal papilla314. It can also be difficult to navigate a surgical instrument into common bile duct312via insertion through duodenal papilla314. Therefore, it is common during medical procedures to cut sphincter of Oddi310to enlarge duodenal papilla314to allow for easier access of instrument into common bile duct312.

FIG.4is a diagram illustrating an example of mother-daughter endoscopes used in an ERCP procedure, and a portion of patient anatomy where the procedure is performed. The mother-daughter endoscopes comprise an auxiliary scope434(cholangioscope) attached to and advanced through a lumen432of a main scope400(duodenoscope). The auxiliary scope434can comprise a lumen436. The distal portion of the main scope400positioned in duodenum308comprises a functional module402, an insertion section module404, and a control module406. The control module406can include, or be coupled to, a controller408. Similar to the discussion above with respect toFIG.1, the control module406can include other components, such as those described with reference to endoscopy system10(FIG.1) and control unit16(FIG.2). Additionally, the control module406can comprise components for controlling an imaging device (e.g., a camera) and a light source connected to the auxiliary scope434, such as an imaging unit410, a lighting unit412and a power unit414. The main scope400can be configured similarly as endoscope14ofFIGS.1and2.

The functional module402of the main scope400can comprise an elevator portion430. The auxiliary scope434can itself include functional components, such as camera lens437and a light lens (not illustrated) coupled to control module406, to facilitate navigation of the auxiliary scope434from the main scope400through the anatomy and to facilitate viewing of components extending from lumen432.

In ERCP, the auxiliary scope434can be guided into the sphincter of Oddi310. Therefrom, a surgeon operating the auxiliary scope434can navigate the auxiliary scope434through the lumen432of the main scope toward the gallbladder305, liver304, or other locations in the gastrointestinal system to perform various procedures. In some examples, the auxiliary scope434can be used to guide an additional device to the anatomy to obtain biological matter (e.g., tissue), such as by passage through or attachment to lumen436.

The biological sample matter can be removed from the patient, typically by removal of the additional device from the auxiliary device, so that the removed biological matter can be analyzed to diagnose one or more conditions of the patient. According to several examples, the mother-daughter endoscope assembly (including the main scope400and the auxiliary scope434) can include additional device features, such as forceps or an auger, for gathering and removing cancerous or pre-cancerous matter (e.g., carcinoma, sarcoma, myeloma, leukemia, lymphoma and the like), or performing endometriosis evaluation, biliary ductal biopsies, and the like.

The controller408can include, or be coupled to, a treatment plan generator460. The treatment plan generator460, which is an example of the treatment generator44as illustrated inFIG.2, can automatically generate a pancreaticobiliary access plan for passing at least a portion of the endoscope14(or other steerable elongate instrument such as a catheter or a guidewire) into the pancreaticobiliary system to perform a diagnostic or therapeutic operation therein.

The treatment plan generator460can generate alternative pancreaticobiliary access approaches that are easier to perform than conventional approaches such as direct cutting (e.g., sphincterotomy). One of such alternative approaches, also referred to as an RF-based approach, involves delivering RF energy to the stricture via a working head of the endoscope (or other steerable elongate instrument such as a catheter). Another alternative approach, also referred to as a mechanical puncture-based approach, involves applying mechanical force to the stricture via a working head of sufficient stiffness at a distal portion of the endoscope (or other steerable elongate instrument such as a catheter or a guidewire). The treatment plan generator460can include an AI-based access decision system462that can identify an entry site at or around a stricture, and to determine a proper pancreaticobiliary access method for the patient, such as between the RF-based approach and the mechanical puncture-based approach, based at least on images of the patient anatomy of interest. Images of the stricture and neighboring environment can be obtained from imaging studies, such as endoscopic images, X-ray images, fluoroscopy images, CT images, MRI images such as image obtained from Magnetic resonance cholangiopancreatography (MRCP), or endoscopic ultrasonography (EUS) images.

In an example, RF energy or mechanical force can be applied to an entry site of a stricture adjacent to duodenal papilla to gain pancreaticobiliary access therefrom. The AI-based access decision system462can use images of duodenal papilla (e.g., endoscopic images captured by an imaging device (e.g., a camera) of the endoscope, or images produced by other external imaging devices) to identify patient candidacy for the RF-based approach, or to recommend between the RF-based approach and the mechanical puncture-based approach.

The AI-based access decision system462can include an image processing unit463and at least one trained machine-learning (ML) model464. The image processing unit463can receive images of strictures at duodenal papilla and its surrounding environment acquired during an endoscopic procedure, and extract one or more geometric or morphological features from the image. The images or image features extracted therefrom can be applied to the at least one trained ML model464to automatically determine patient candidacy for the RF-based approach.

The at least one trained ML model464can have a neural network structure comprising an input layer, one or more hidden layers, and an output layer. To train the ML model, images or image features produced by the image processing unit463, optionally along with other input data (e.g., sensor signals indicative of anatomical characteristics of the stricture, patient general health status, etc.), can be fed into the input layer of the ML model, which propagates the input data or data features through one or more hidden layers to the output layer. The trained ML model464can provide the AI-based access decision system462with the ability to perform tasks, without explicitly being programmed, by making inferences based on patterns found in the analysis of data. The trained ML model464explores the study and construction of algorithms (e.g., ML algorithms) that may learn from existing data and make predictions about new data. Such algorithms operate by building the trained ML model464from training data in order to make data-driven predictions or decisions expressed as outputs or assessments.

The ML model may be trained using supervised learning or unsupervised learning. Supervised learning uses prior knowledge (e.g., examples that correlate inputs to outputs or outcomes) to learn the relationships between the inputs and the outputs. The goal of supervised learning is to learn a function that, given some training data, best approximates the relationship between the training inputs and outputs so that the ML model can implement the same relationships when given inputs to generate the corresponding outputs. Unsupervised learning is the training of an ML algorithm using information that is neither classified nor labeled, and allowing the algorithm to act on that information without guidance. Unsupervised learning is useful in exploratory analysis because it can automatically identify structure in data.

Common tasks for supervised learning are classification problems and regression problems. Classification problems, also referred to as categorization problems, aim at classifying items into one of several category values. Regression algorithms aim at quantifying some items (for example, by providing a score to the value of some input). Some examples of commonly used supervised-ML algorithms are Logistic Regression (LR), Naive-Bayes, Random Forest (RF), neural networks (NN), deep neural networks (DNN), matrix factorization, and Support Vector Machines (SVM). Examples of DNN include a convolutional neural network (CNN), a recurrent neural network (RNN), a deep belief network (DBN), or a hybrid neural network comprising two or more neural network models of different types or different model configurations.

Some common tasks for unsupervised learning include clustering, representation learning, and density estimation. Some examples of commonly used unsupervised learning algorithms are K-means clustering, principal component analysis, and autoencoders.

Another type of ML is federated learning (also known as collaborative learning) that trains an algorithm across multiple decentralized devices holding local data, without exchanging the data. This approach stands in contrast to traditional centralized machine-learning techniques where all the local datasets are uploaded to one server, as well as to more classical decentralized approaches which often assume that local data samples are identically distributed. Federated learning enables multiple actors to build a common, robust machine learning model without sharing data, thus allowing to address critical issues such as data privacy, data security, data access rights and access to heterogeneous data.

The at least one trained ML model464may be trained using a training module included in the AI-based access decision system462. Alternatively, the training module can be implemented in a separate unit. To train a ML model, a training dataset can be constructed using past endoscopic procedure data. The past endoscopic procedure data can be stored in a database accessible by the AI-based access decision system462. The training data may include stored pancreaticobiliary access data obtained from past endoscopic stricture management procedures involving RF-based or mechanical puncture-based approaches to access pancreaticobiliary system on a plurality of patients. Examples of the stored past procedure data can include images of strictures at or around duodenal papilla obtained from the plurality of patients. The training data may additionally include pancreaticobiliary access approaches used in previous procedures (RF-based approach or the mechanical puncture-based approach), navigation parameters associated with the procedure (e.g., position, heading direction or angle, amount of protrusion, speed or force applied to the endoscope, or navigation path toward the stricture, among others), and assessment of outcomes of the procedures (e.g., success rate and patient complications).

In an example, the training data can be screened such that only data of procedures performed by certain physicians (such as those with substantially similar experience levels to the operating physician), and/or data of procedures on certain patients with special requirement (such as those with substantially similar anatomy or patient medical information to the present patient) are included in the training dataset. In an example, the training data can be screened based on a success rate of the procedure, including times of attempts before a successful cannulation or navigation, such that only data of procedures with a desirable success rate achieved within a specified number of attempts are included in the training dataset. In another example, the training data can be screened based on complication associated with the patients. In some examples, particularly in case of a small training dataset (such as due to data screening), the ML model can be trained to identify an entry site at or around a pancreaticobiliary stricture, and to determine a pancreaticobiliary access approach such as the RF-based approach or the mechanical puncture-based approach by extrapolating, interpolating, or bootstrapping the training data. The training of the ML model may be performed continuously or periodically, or in near real time as additional procedure data are made available. The training involves algorithmically adjusting one or more ML model parameters, until the ML model being trained satisfies a specified training convergence criterion.

The trained ML model can be validated, and implemented in the AI-based access decision system462. The AI-based access decision system462may apply an image of the stricture and the surrounding environment (or the image features such as generated by the image processing unit463), to the at least one trained ML model464to identify an entry site at or around the stricture, and to determine patient candidacy for the RF-based approach to gain pancreaticobiliary access. In some examples, a first ML model can be trained to identify an entry site at or around the stricture, and a different second ML model can be trained to determine patient candidacy for the RF-based approach to gain pancreaticobiliary access. In some examples, the AI-based access decision system462may generate a recommendation to the user of either RF-based approach or mechanical puncture-based approach for use in the procedure. In some examples, for the identified candidate suitable to be treated with the RF-based approach, the treatment plan generator460may identify characteristics of the strictures, such as by using images of the stricture or sensor data acquired by sensors associated with the RF catheter540. The controller408may adjust output of an RF power generator based at least on the identified characteristics of the stricture.

FIGS.5A-5Bare diagrams illustrating examples alternative endoscopic approaches to gain access to the pancreaticobiliary system (e.g., the common bile duct or the pancreatic duct) in the presence of strictures. Unlike conventional sphincterotomy which requires cutting of the biliary sphincter and intraduodenal segment of the common bile duct following selective cannulation, alternative pancreaticobiliary access approaches as illustrated inFIGS.5A-5Buse an RF catheter or a specialized puncture device (e.g., wire) to open up the stricture and gain access to the pancreaticobiliary region where diagnostic or therapeutic interventions can be performed.

FIG.5Aillustrates an example of a mechanical puncture-based approach for accessing a pancreaticobiliary region in a ERCP procedure. A puncture catheter520can be advanced alongside or via a channel of a flexible endoscope500(or other steerable elongate instrument such as a guidewire, a catheter, or a guide sheath), pass through the GI tract and exit to duodenal papilla511. Pancreaticobiliary stricture tissue513in the common bile duct or strictures at or around the duodenal papilla511may cause narrowing or obstruction that prevents direct access to the pancreaticobiliary system (e.g., common bile duct). The puncture catheter520can be extended from the endoscope500and advanced toward a target entry site at or around the pancreaticobiliary stricture tissue513, such as a portion of the duodenal papilla511or beside ampulla of Vater512. In an example, the entry site may be identified using an ML model, as discussed above with reference toFIG.4. A working head522, located at a distal portion of the puncture catheter520, can be positioned at the entry site. Mechanical force exerted manually (e.g., by the operating physician) or caused by a robotic apparatus (e.g., a robot arm), can be applied to the working head522to produce an opening sized to pass at least the distal portion of the puncture catheter520or other tools or tool delivery system into the pancreaticobiliary system (e.g., the common bile duct).

The working head522can be made of material having a higher amount of stiffness than the proximal portion of the puncture catheter520. The stiff working head can facilitate puncturing a hole at the entry site at or around the stricture without bending. The more compliant proximal portion can promote flexible movement of the puncture catheter520inside the working channel of the endoscope500. In an example, the distal portion of the puncture catheter520(including the working head522) can be made of material through a rigidization process. In an example, the distal portion including the working head522can be configured to have axially variable stiffness, such that the working head522can achieve a higher amount of stiffness as the working head approaches the stricture. In an example, at least the distal portion of the puncture catheter520comprises struts spatially arranged to provide variable stiffness as the distal portion of the puncture catheter520changes its posture. For example, when the distal portion of the puncture catheter520changes from a bending posture to a straightening posture, the structs change their spatially arrangement to provide an increased stiffness at the working head522. Such catheter posture-dependent stiffness allows for flexible motion of the puncture catheter520inside the working channel of the endoscope500and controllable and efficient puncturing at the entry site simply by straightening the working head522.

FIG.5Billustrates an example of an RF-based approach for accessing a pancreaticobiliary region in a ERCP procedure. During ERCP, an RF catheter540, coupled to an RF power generator, can be advanced alongside or via a channel of a flexible endoscope500(or other steerable elongate instrument such as a guidewire, a catheter, or a guide sheath), pass through the GI tract and exit to duodenal papilla511. In an example, the pancreaticobiliary stricture may present at or around the duodenal papilla511causing narrowing or obstruction therein that prevents direct access to the pancreaticobiliary system (e.g., common bile duct) through duodenal papilla511, as shown inFIG.5A. In another example, as shown inFIG.5B, pancreaticobiliary stricture tissue533may present at the ampulla of Vater or proximal portion of the common bile duct. The RF catheter540can be extended from the endoscope500towards a target entry site at or around the pancreaticobiliary stricture tissue533beside ampulla of Vater512or near the duodenal papilla511. In an example, the entry site may be identified using an ML model, as discussed above. RF energy, generated by the RF power generator, can be applied to electrodes disposed on a working head542at a distal portion of the RF catheter540. The working head542may be made of uncoiled metal wire of sufficient rigidity and geometric dimensions (e.g., small diameter) to facilitate flexible movement in the pancreaticobiliary anatomy and through the RF-treated stricture. The RF energy can ablate the tissue of contact to create a passageway for passing at least the distal portion of the RF catheter540or other tools or tool delivery system into a pancreaticobiliary region of interest, where therapeutic or diagnostic operations can be performed. In some examples, output of the RF power generator may be adjusted automatically based on the characteristics of the strictures, such as generated by the treatment plan generator460using images of the stricture or sensor data acquired by sensors associated with the RF catheter540, as described above with reference toFIG.4.

FIG.6is a flow chart illustrating an example method600for accessing a pancreaticobiliary region of a patient to perform diagnostic or therapeutic operations therein. The pancreaticobiliary access can be achieved using either a mechanical puncture-based approach such as that described above with reference toFIG.5A, or a radio frequency (RF)-based approach such as that described above with reference toFIG.5B.

At610, a steerable elongate instrument can be navigated through a body cavity or channel, such as portion of patient GI tract including the mouth, the esophagus, the stomach, and the duodenum, as illustrated inFIGS.5A-5B. Examples of the steerable elongate instrument may include an elongate portion of an flexible endoscope, a guidewire, a catheter, or a guide sheath. The steerable elongate instrument can be advanced toward to a stricture adjacent to a pancreaticobiliary region, such as a stricture at or around the duodenal papilla as shown inFIG.5A, or a stricture at the ampulla of Vater or proximal portion of the common bile duct as shown inFIG.5B.

At620, a pancreaticobiliary access approach can be determined, such as between an RF-based approach and a mechanical puncture-based approach. The RF-based approach involves applying RF energy, provided by a RF power generator, to an entry site at or around the stricture via a working head of the steerable elongate instrument to produce an opening to the pancreaticobiliary region. The mechanical puncture-based approach involves applying mechanical force to a working head of the steerable elongate instrument positioned at the entry site at or around the stricture to create an opening sized to pass at least the distal portion of the steerable elongate instrument therethrough and into the pancreaticobiliary region.

The entry site can be identified automatically based at least on images of the stricture and neighboring environment, which can be obtained from imaging studies before or during the procedure. Examples of the images can include endoscopic images (e.g., image from cholangioscopy), X-ray images, fluoroscopy images, CT images, MRI images such as image obtained from Magnetic resonance cholangiopancreatography (MRCP), or endoscopic ultrasonography (EUS) images. In an example, the entry site can be identified using artificial intelligence (AI) or machine learning (ML), such as by the AI-based access decision system462as described above with reference toFIG.4.

In an example, a ML model can be trained using a training dataset including stored pancreaticobiliary access data obtained from past endoscopic stricture management procedures involving RF-based or mechanical puncture-based pancreaticobiliary access approaches on a plurality of patients. Examples of the stored past procedure data can include images of strictures at or around duodenal papilla obtained from the plurality of patients. The training data may additionally include pancreaticobiliary access approaches used in previous procedures (RF-based approach or the mechanical puncture-based approach), navigation parameters associated with the procedure (e.g., position, heading direction or angle, amount of protrusion, speed or force applied to the endoscope, or navigation path toward the stricture, among others), and assessment of outcomes of the procedures (e.g., success rate and patient complications). The trained ML model can be used to identify an entry site at or around the stricture to receive RF energy or puncture force, and to identify patient candidacy for RF-based approach. For non-candidates, mechanical puncture-based approach may be recommended.

At630, a working head of the steerable elongate instrument can be positioned at the identified entry site of a stricture adjacent to a pancreaticobiliary region to produce an opening to the pancreaticobiliary region in accordance with pancreaticobiliary access approach determined at620. If an RF-based approach is selected at620, then RF energy can be delivered to the entry cite of the stricture via the working head of the steerable elongate instrument (e.g., the RF catheter540as shown inFIG.5B). In an example, the working head may be made of uncoiled metal wire of sufficient rigidity and geometric dimensions (e.g., small diameter) to facilitate flexible movement in the pancreaticobiliary anatomy and through the RF-treated stricture. The RF energy can ablate the tissue of contact to create a passageway for passing at least the distal portion of the steerable elongate instrument or other tools or tool delivery system into pancreaticobiliary region of interest. In some examples, output of the RF power generator may be adjusted automatically based on the characteristics of the strictures.

If a mechanical puncture-based approach is selected at620, then mechanical force may be applied to the working head of the steerable elongate instrument (e.g., the puncture catheter520as shown inFIG.5A). Mechanical force can by exerted manually (e.g., by the operating physician), or caused by a robotic apparatus (e.g., a robot arm). An opening can be created at the entry site of the stricture sized to pass at least the distal portion of the steerable elongate instrument or other tools or tool delivery system into pancreaticobiliary region of interest. In some examples, the working head can be made of material having a higher amount of stiffness than the proximal portion of the puncture catheter. The stiff working head can facilitate puncturing a hole at the entry site at or around the stricture without bending. The more compliant proximal portion can promote flexible movement of the puncture catheter inside the working channel of the endoscope. In an example, the working head can be made of material through a rigidization process. In an example, the distal portion (including the working head) can be configured to have axially variable stiffness, such that the working head can achieve a higher amount of stiffness as the working head approaches the stricture. In an example, at least the distal portion of the puncture catheter comprises struts spatially arranged to provide variable stiffness as the distal portion of the puncture catheter changes its posture. Such catheter posture-dependent stiffness allows for flexible motion of the puncture catheter inside the working channel of the endoscope and controllable and efficient puncturing at the entry site simply by straightening the working head.

At640, at least a distal portion of the steerable elongate instrument can be passed through the opening created at630(either via the RF-based approach or the mechanical puncture-based approach), and into the pancreaticobiliary region, where a diagnostic or therapeutic operation can be performed.

FIG.7illustrates generally a block diagram of an example machine700upon which any one or more of the techniques (e.g., methodologies) discussed herein may perform. Portions of this description may apply to the computing framework of various portions of the treatment plan generator460, such as the AI-based access decision system462.

Machine (e.g., computer system)700may include a hardware processor702(e.g., a central processing unit (CPU), a graphics processing unit (GPU), a hardware processor core, or any combination thereof), a main memory704and a static memory706, some or all of which may communicate with each other via an interlink (e.g., bus)708. The machine700may further include a display unit710(e.g., a raster display, vector display, holographic display, etc.), an alphanumeric input device712(e.g., a keyboard), and a user interface (UI) navigation device714(e.g., a mouse). In an example, the display unit710, input device712and UI navigation device714may be a touch screen display. The machine700may additionally include a storage device (e.g., drive unit)716, a signal generation device718(e.g., a speaker), a network interface device720, and one or more sensors721, such as a global positioning system (GPS) sensor, compass, accelerometer, or other sensors. The machine700may include an output controller728, such as a serial (e.g., universal serial bus (USB), parallel, or other wired or wireless (e.g., infrared (IR), near field communication (NFC), etc.) connection to communicate or control one or more peripheral devices (e.g., a printer, card reader, etc.).

The storage device716may include a machine readable medium722on which is stored one or more sets of data structures or instructions724(e.g., software) embodying or utilized by any one or more of the techniques or functions described herein. The instructions724may also reside, completely or at least partially, within the main memory704, within static memory706, or within the hardware processor702during execution thereof by the machine700. In an example, one or any combination of the hardware processor702, the main memory704, the static memory706, or the storage device716may constitute machine readable media.

Additional Notes

The above description is intended to be illustrative, and not restrictive. For example, the above-described examples (or one or more aspects thereof) may be used in combination with each other. Other embodiments can be used, such as by one of ordinary skill in the art upon reviewing the above description. The Abstract is provided to comply with 37 C.F.R. § 1.72(b), to allow the reader to quickly ascertain the nature of the technical disclosure. It is submitted with the understanding that it will not be used to interpret or limit the scope or meaning of the claims. Also, in the above Detailed Description, various features may be grouped together to streamline the disclosure. This should not be interpreted as intending that an unclaimed disclosed feature is essential to any claim. Rather, inventive subject matter may lie in less than all features of a particular disclosed embodiment. Thus, the following claims are hereby incorporated into the Detailed Description as examples or embodiments, with each claim standing on its own as a separate embodiment, and it is contemplated that such embodiments can be combined with each other in various combinations or permutations. The scope of the invention should be determined with reference to the appended claims, along with the full scope of equivalents to which such claims are entitled.1. A method for endoscopically accessing a pancreaticobiliary region of a patient, the method comprising:navigating a steerable elongate instrument through a body cavity or channel toward a stricture adjacent to the pancreaticobiliary region;delivering radio-frequency (RF) energy to an entry site of the stricture via a working head of the steerable elongate instrument to produce an opening to the pancreaticobiliary region; andpassing at least a distal portion of the steerable elongate instrument through the produced opening into the pancreaticobiliary region to perform a diagnostic or therapeutic operation therein.2. The method of example 1, further comprising applying an image of the stricture to a trained machine-learning (ML) model to identify the entry site of the stricture.3. The method of any of examples 1-2, wherein the RF energy is applied to a stricture beside an ampulla of Vater to produce an opening to a common bile duct.4. The method of any of examples 1-3, wherein delivering the RF energy is through an uncoiled wire portion on the working head of the steerable elongate instrument, the uncoiled wire portion electrically coupled to an RF power generator.5. The method of any of examples 1-4, comprising adjusting an RF energy delivered to the entry site of the stricture based at least on a characteristic of the stricture.6. A method for accessing a pancreaticobiliary region of a patient, the method comprising:navigating a steerable elongate instrument through a body cavity or channel toward to a stricture adjacent to the pancreaticobiliary region, the steerable elongate instrument extended between a proximal portion and a distal portion, the distal portion including a working head configured to achieve a higher amount of stiffness than the proximal portion of the steerable elongate instrument as the working head approaches the stricture;positioning the working head of the steerable elongate instrument at an entry site of the stricture and applying a mechanical force thereto to produce an opening to the pancreaticobiliary region; andpassing at least the distal portion of the steerable elongate instrument through the produced opening into the pancreaticobiliary region to perform diagnostic or therapeutic operation therein.7. The method of examples 6, further comprising applying an image of the stricture to a trained machine-learning (ML) model to identify the entry site of the stricture.8. The method of any of examples 6-7, wherein the working head is made of material through a rigidization process.9. The method of any of examples 6-8, wherein the distal portion of the steerable elongate instrument is configured to have axially variable stiffness.10. The method of any of examples 6-9, wherein the distal portion of the steerable elongate instrument comprises struts spatially arranged to provide variable stiffness as the steerable elongate instrument changes its posture, including an increase in stiffness in response to a change from a bending posture to a straightening posture.11. An endoscopic system, comprising:a steerable elongate instrument extended between a proximal portion and a distal portion, the distal portion including a working head configured to achieve a higher amount stiffness than other portions of the steerable elongate instrument as the working head approaches a stricture adjacent to a pancreaticobiliary region; anda controller configured to provide a control signal to an actuator to robotically facilitate navigation and manipulation of the steerable elongate instrument, including, via the actuator:position the working head of the steerable elongate instrument at an entry site of the stricture and apply a mechanical force thereto to produce an opening to the pancreaticobiliary region; andpass at least the distal portion of the steerable elongate instrument through the produced opening into the pancreaticobiliary region to perform a diagnostic or therapeutic operation therein.12. The endoscopic system of example 11, comprising a robot arm configured to detachably engage the steerable elongate instrument, and to automatically adjust position or navigation of the steerable elongate instrument via the actuator in response to the control signal.13. The endoscopic system of any of examples 11-12, wherein the steerable elongate instrument is configured to be robotically positioned and navigated to a duodenal papilla or a portion of pancreaticobiliary system.14. The endoscopic system of any of examples 11-13, wherein the working head is made of material through a rigidization process.15. An endoscopic system, comprising:a steerable elongate instrument configured to be positioned and navigated in a patient anatomy;a controller configured to:receive an image of a stricture adjacent to a pancreaticobiliary region; andapply the received image of the stricture to at least one trained machine-learning (ML) model to identify an entry site of the stricture, and to determine a pancreaticobiliary access approach, between (i) an radio frequency (RF)-based approach and (ii) a mechanical puncture-based approach, to access the pancreaticobiliary region; and an output unit configured to provide the determined pancreaticobiliary access approach to a user.16. The endoscopic system of example 15, wherein the controller is further configured to:construct a training dataset comprising stored procedure data obtained from past endoscopic stricture management procedures on a plurality of patients using respective pancreaticobiliary access approaches including the RF-based approach or the mechanical puncture-based approach, the stored procedure data including (i) images of strictures of the plurality of patients and (ii) assessments of the pancreaticobiliary access approaches of the respective procedures; andtrain the ML model using the training dataset.17. The endoscopic system of any of examples 15-16, wherein the steerable elongate instrument includes a catheter, a guide wire, or a guide sheath including a lumen to pass a stricture management device therethrough.18. The endoscopic system of any of examples 15-17, wherein the steerable elongate instrument includes an endoscope, the endoscope including an imaging sensor to generate the image of the stricture.19. The endoscopic system of any of examples 15-18, wherein the steerable elongate instrument is extended between a proximal portion and a distal portion, the distal portion including a working head having a higher amount of stiffness than other portions of the steerable elongate instrument,wherein the working head is configured to, in response to a puncture force applied thereto, puncture the entry site of the stricture to produce an opening sized to pass at least the distal portion of the steerable elongate instrument therethrough.20. The endoscopic system of claim any of examples 15-19, wherein the steerable elongate instrument includes, at a distal portion thereof, a working head configured to be electrically coupled to an RF power generator and to deliver RF energy to the entry site of the stricture to produce an opening sized to pass at least the distal portion of the steerable elongate instrument therethrough.