Method for papilla positioning and stability control in endoscopic retrograde cholangiopancreatography (ERCP)

Abstract

A method for performing endoscopic surgery may include: viewing an image of the duodenal wall near a papilla using an endoscope; releasing fluid toward the papilla through a cannula of the endoscope while viewing the image; and inserting an instrument through an opening in the papilla after releasing the fluid. A system may include: an endoscope; a cannula system including a cannula extending through the endoscope; a fluid control system coupled to the cannula system, the fluid control system including a saline source and a cryoprotectant source; and a fluid activator configured to deliver at least one of saline and cryoprotectant through the cannula according to a user's judgment.

Description

Priority requirements

[0001] This application claims the benefit of priority to U.S. Provisional Patent Application No. 63 / 561,070, filed on March 4, 2024, the contents of which are incorporated herein by reference. Technical Field

[0002] This disclosure generally relates to medical devices, and more specifically, to endoscopes for imaging and / or providing access to various anatomical parts for therapeutic devices. Background Technology

[0003] Endoscopic retrograde cholangiopancreatography (ERCP) is a medical procedure that combines upper gastrointestinal (GI) endoscopy with X-rays to diagnose and treat problems with the bile ducts and pancreatic ducts. During the procedure, an endoscope is passed through the mouth, esophagus, stomach, and duodenum to reach the bile ducts. A small plastic tube, called a catheter, is then inserted through the endoscope into the bile duct. Contrast agent can be injected into the tube through the catheter, and X-rays are taken to show any blockages or other abnormalities.

[0004] ERCP can be used to treat problems with the bile duct and pancreatic duct, such as gallstones that form in the gallbladder and become stuck in the common bile duct, infections, acute pancreatitis, chronic pancreatitis, traumatic or surgical complications in the bile duct or pancreatic duct, pancreatic pseudocysts, tumors or cancers of the bile duct or pancreatic duct.

[0005] To access the common bile duct, the user first locates the main duodenal papilla, which includes the papillary opening. It is surrounded by a circular muscle called the sphincter of Oddi and receives a mixture of pancreatic enzymes and bile from the ampulla of Vater, which drains both the pancreatic duct and the biliary system. Summary of the Invention

[0006] This system includes technology to help users locate and access the opening of the main duodenal papilla when the papilla is in an abnormal condition.

[0007] In one example, a method for performing an endoscopic surgical procedure may include: using an endoscope to view an image of the duodenal wall near the papilla; releasing fluid toward the papilla through the cannula of the endoscope while viewing the image; and inserting an instrument through an opening in the papilla after releasing the fluid.

[0008] In one example, a device for stabilizing a papilla may include: a cannula extending through a duodenoscope configured to extend through the duodenum to reach a papilla within the duodenum; and a cryoprotectant container coupled to the cannula to deliver cryoprotectant through the cannula to the outer surface of the papilla and configured to stabilize the papilla.

[0009] In another example, the system may include: an endoscope; a cannula system including a cannula extending through the endoscope; a fluid control system coupled to the cannula system, the fluid control system including a saline source and a refrigerant source; and a fluid activator configured to deliver at least one of the saline and refrigerant through the cannula according to the user's judgment. Attached Figure Description

[0010] Figure 1 A schematic diagram of an endoscope system is shown, which includes an imaging and control system and an endoscope, such as a duodenoscope.

[0011] Figure 2 It shows Figure 1 A schematic diagram of an endoscope system, which includes an endoscope connected to a control unit of an imaging and control system.

[0012] Figure 3 A diagram showing a portion of the patient's duodenum and surrounding area is provided.

[0013] Figure 4 A schematic diagram of the distal portion of an endoscope, such as a duodenoscope, in the duodenum according to one embodiment is shown.

[0014] Figure 5 An embodiment is shown. Figure 4 A schematic diagram of an endoscope.

[0015] Figure 6 A schematic diagram of the distal portion of an endoscope, such as a duodenoscope, in the duodenum according to one embodiment is shown.

[0016] Figure 7 An embodiment is shown. Figure 6 A schematic diagram of an endoscope.

[0017] Figure 8 An embodiment is shown. Figure 6 Another schematic diagram of an endoscope.

[0018] Figure 9 A schematic diagram of a system for performing endoscopic surgery according to one embodiment is shown.

[0019] Figure 10 A method for performing endoscopic surgery according to one embodiment is shown.

[0020] Figure 11 This is a diagram of an AI system based on one implementation method. Detailed Implementation

[0021] Figure 1 and Figure 2 An example of a universal endoscope system is shown. Figure 1 This is a schematic diagram of the endoscope system 10, and Figure 2 This is a schematic diagram of an endoscope system 10, which includes an endoscope connected to a control unit of an imaging and control system. The endoscope system 10 may include an imaging and control system 12 and an endoscope 14. Figure 1 and Figure 2 The system described herein is an illustrative example of an endoscopic system suitable for use with the systems, apparatus, and methods described herein. According to some examples, endoscope 14 is capable of being inserted into an anatomical region for imaging and / or providing access for one or more sampling devices for biopsy or for one or more treatment devices for treating a disease condition associated with the anatomical region. Advantageously, endoscope 14 may engage with and be connected to an imaging and control system 12. In the illustrated example, endoscope 14 includes a duodenoscope, but other types of endoscopes may also be used with the features and teachings of this disclosure.

[0022] The imaging and control system 12 may include a controller 16, an output unit 18, an input unit 20, a light source 22, a fluid source 24, and a suction pump 26.

[0023] The imaging and control system 12 may include various ports for connection to the endoscope system 10. For example, the controller 16 may include data input / output ports for receiving data from and transmitting data to the endoscope 14. The light source 22 may include an output port for transmitting light to the endoscope 14, for example, via an optical fiber link. The fluid source 24 may include a port for transmitting fluid to the endoscope 14. The fluid source 24 may include a pump and a fluid tank, or may be connected to an external tank, container, or storage unit. The suction pump 26 may include a port for creating a vacuum from the endoscope 14 to generate suction, for example, to extract fluid from the anatomical region into which the endoscope 14 is inserted. The output unit 18 and the input unit 20 may be used by the operator of the endoscope system 10 to control the functions of the endoscope system 10 and to observe the output of the endoscope 14. The controller 16 may additionally be used to generate signals or other outputs based on the processing of the anatomical region into which the endoscope 14 is inserted. In the example, controller 16 can generate electrical output, acoustic output, fluid output, etc., for processing anatomical areas by means of, for example, cauterization, cutting, freezing, etc.

[0024] The endoscope 14 may include an insertion section 28, a functional section 30, and a handle section 32, which can be connected to a cable section 34 and a connector section 36.

[0025] Insertion segment 28 extends distally from handle segment 32, and cable segment 34 extends proximally from handle segment 32. Insertion segment 28 may be elongated and includes a bend and a distal end to which functional segment 30 may be attached. The bend may be controllable (e.g., via a control knob 38 on handle segment 32) to manipulate the distal end through tortuous anatomical pathways (e.g., stomach, duodenum, kidney, ureter, etc.). Insertion segment 28 may also include one or more working channels (e.g., internal lumens), which may be elongated and support the insertion of one or more therapeutic instruments of functional segment 30. Working channels may extend between handle segment 32 and functional segment 30. Additional functions such as fluid access, guide wires, and traction wires may also be provided by insertion segment 28 (e.g., via aspiration or flushing pathways, etc.).

[0026] The handle section 32 may include a knob 38 and a port 40. The knob 38 may be connected to a pull wire extending through the insertion section 28. The port 40 may be configured to connect various cables, fluid conduits, etc., to the handle section 32 for connection with the insertion section 28.

[0027] According to the example, the imaging and control system 12 can be mounted on a mobile platform (e.g., a trolley 41) having shelves for accommodating the light source 22, the suction pump 26, the image processing unit 42, etc. Alternatively, Figure 1 and Figure 2 Several components of the imaging and control system 12 shown can be directly mounted on the endoscope 14 so that the endoscope is "independent".

[0028] Functional section 30 may include components for processing and diagnosing the patient's anatomy. Functional section 30 may include an imaging device, an illumination device, and a lift, as further described below.

[0029] like Figure 2 As shown, the imaging and control system 12 may include a controller 16, a light source 22, an input unit 20, and an output unit 18. The controller 16 may include an image processing unit 42, a treatment generator 44, and a drive unit 46 or be connected to the image processing unit 42, the treatment generator 44, and the drive unit 46.

[0030] Image processing unit 42 and light source 22 can each be coupled to endoscope 14 via a wired or wireless connection (e.g., at functional unit 30). Imaging and control system 12 can thus illuminate the anatomical region, collect signals representing the anatomical region, process signals representing the anatomical region, and display an image representing the anatomical region on display unit 18. Imaging and control system 12 may include light source 22 to illuminate the anatomical region using light of a desired spectrum (e.g., broadband white light, narrowband imaging using preferred electromagnetic wavelengths, etc.). Imaging and control system 12 can be connected to endoscope 14 (e.g., via endoscope connector) for signal transmission (e.g., light output from the light source, video signals from the imaging system in the distal end, diagnostic and sensor signals, etc.).

[0031] Fluid source 24 may include one or more air sources, saline sources, or other fluid sources, as well as associated fluid pathways (e.g., air passages, flushing passages, suction passages) and connectors (barbed fittings, fluid seals, valves, etc.). Imaging and control system 12 may also include drive unit 46, which may be an optional component. Drive unit 46 may include a motorized actuator for advancing the distal segment of endoscope 14.

[0032] Figure 3 A diagram showing a portion of the duodenum D and its surrounding area is presented. The duodenum D comprises the upper portion of the small intestine. The duodenum D may include a wall 120, which includes a main duodenal papilla 132. The bile duct 124 and the pancreatic duct 126 converge at the ampulla of Vater 128, which empties through the papilla 132 at a papillary opening 130 surrounded by a circular muscle, namely the sphincter of Oddi 122. The bile duct 124 transports bile from the gallbladder and liver and empties bile into the duodenum D. The pancreatic duct 126 transports pancreatic juice from the exocrine pancreas to the ampulla of Vater 128. Figure 3 The appearance of the main duodenal papilla 132 in normal anatomy is shown. The papilla 132 has a small, rounded protuberance, and its opening 130 is distinguishable from the surrounding anatomical structures. In this configuration, the papilla 132 can be easily located visually via endoscopy, and the entry point can be identified. Furthermore, the typical shape of the papilla 132 allows for easy insertion of instruments. For example, some papillae 132 are short and stout in shape, allowing instruments to be inserted without causing the papilla to collapse or fold back.

[0033] However, sometimes it can be very difficult to locate the opening 130 and the nipple 132 because there is no protrusion or the protrusion is very small. For example, sometimes the nipple 132 may be very flat and fused into the wall 120, and the opening 130 of the nipple 132 may be very difficult to locate. This leads to surgical delays because time is needed to manipulate the wall surface 120 to locate the opening 130 of the nipple. Similarly, if the nipple 132 is too long and thin, it may be difficult to insert instruments, which also increases the difficulty and time required to perform the surgery.

[0034] Figure 4 and Figure 5 A device configured to assist the user when the nipple 132 is very flat and the opening 130 is not visually distinguishable is shown. Figure 4 and Figure 5 A schematic diagram of the distal portion of an endoscope 100, such as a duodenoscope, in the duodenum D according to one embodiment is shown.

[0035] Endoscope 100 is Figure 1 An example of an implementation of endoscope 14 is provided. Here, endoscope 100 may include an insertion section 102 and a functional section 104. Functional section 104 may include an opening 142 for extending cannula 160 to the outside of the device. Lifting section 140 may be located within the cavity defining opening 142 and configured to change the angle of an instrument, such as cannula 160, along the longitudinal axis of endoscope 100. Endoscope 100 may include a "side-viewing endoscope" (e.g., duodenoscope) camera module 150. In side-viewing endoscope camera module 150, illumination and imaging systems are positioned such that the viewing angle of the imaging system corresponds to a target anatomical structure laterally to the central longitudinal axis of endoscope 100.

[0036] The insertion section 102 may include a central lumen through which various components may extend to connect the functional section 104 and the handle section 32. Figure 1 Other elongated components, such as tubes, wires, and cables, can extend through the lumen to connect functional section 104 to components of the endoscope system 10, such as the suction pump 26 and the treatment generator 44.

[0037] The lifter 140 may include a means for moving an insertion through the insertion section 102, such as the cannula 160. In particular, the lifter 140 may be used to bend the cannula 160 (or other elongated instruments) at an angle relative to the longitudinal axis of the endoscope from the opening 142, thereby accessing the anatomical area adjacent to the side-viewing endoscope camera module 150.

[0038] The lift 140 may include a deflector disposed within a cavity of an opening 142 within a defining functional section 104. The deflector may be connected to a cable that extends to and connects to a handle section 32. The cable may be actuated, for example, by rotating a knob, pulling a lever, or pushing a button on the handle section 32. Movement of the cable may cause rotation of the deflector to move the lift 140 as needed, allowing the distal portion of the cannula 160 or other instrument to be removed from the endoscope through the opening 142.

[0039] The side-viewing endoscope camera module 150 may include optical components (e.g., objective lens, prism, imaging unit, wiring) for collecting image signals and light-emitting components (e.g., illumination lens, light emitter) for transmitting or generating light. The endoscope camera module 150 may also include a photosensitive element, such as a charge-coupled device (“CCD” sensor) or a complementary metal-oxide-semiconductor (“CMOS”) sensor. The camera module 150 may be coupled to the image processing unit 42 (e.g., via a wired or wireless connection). Figure 2 The signal (e.g., video signal) representing an image from the photosensitive element is transmitted to the image processing unit 42 and then displayed on a display, such as the output unit 18.

[0040] In this example, endoscope 100 will be used in a procedure involving the insertion of instruments through opening 130 of nipple 132. As noted, in Figure 4 and Figure 5 In the duodenum presented in the image, the opening 130 and the papilla 132 may be very difficult to locate because there is no protrusion. The papilla is very flat and fused into the wall 120, and the opening 130 of the papilla 132 may be very difficult to find visually, especially by imaging equipment. For example, because the opening 130 is very close to the wall 120, forces within the wall may have a tendency to close the opening 130.

[0041] Therefore, this embodiment includes an apparatus and method for locating such a flattened papilla and its opening 130. Here, an endoscope 100 (e.g., a duodenoscope) may be configured to extend through the duodenum D to reach the vicinity of the papillary opening 130 within the duodenum D. A cannula 160 may extend through the endoscope 100 and be configured to be inserted through the papillary opening 130 into the Vater ampulla 128.

[0042] Once the endoscope is positioned within the duodenum D near the papilla 132 and the papilla and its opening 130 are not identifiable, the cannula 160 can be extended at an angle from the endoscope using the lifter 140. A saline flow 164 can be dispensed through the cannula 160 at controlled pressure, as needed by the user, to deform the wall tissue of the wall 120. During this process, the saline flow 164 will deform the tissue and further expand the area near the papilla, allowing the user to visually identify the opening 130 of the papilla 132. See [link to procedure for identification] for details. Figure 4 And for the illustration of finding the nipple opening at 130°, see [the diagram]. Figure 5 Here, Figure 4 The diagram shows that the saline flow 164 is directed to the wall 120 adjacent to the nipple 132, so that the wall 120 is deflected inward, for example, away from the sleeve 160. Figure 5 It is shown that the saline flow 164 is directed to the wall 120 at or near the nipple 132 to overcome the forces within the wall 120 and open the nipple opening 130.

[0043] As will be discussed below, a saline container may be attached to the proximal portion of the cannula 160 to deliver a saline flow 164 through the cannula 160 to the wall 120 of the duodenum D. The amount and pressure of the delivered saline are configured to deform the wall. A lifter 140 may be used to guide the cannula 160, and the duodenoscope is configured to guide the saline along the outer wall of the duodenum D.

[0044] In some examples, the brine flow 164 may comprise a brine jet lasting from one to three seconds. The brine flow 164 may be delivered at low pressure, for example, approximately 1 psi to 5 psi, with a maximum of 10 psi. For example, a user may use just enough pressure to deform wall 120 and expand opening 130. The brine flow 164 may be continuous or an on / off jet. For example, a user may use a variable switch, such as a variable foot switch, to progressively decrease or increase the brine flow volume and / or pressure.

[0045] During operation, the saline stream 164 can be directed to various locations along the wall 120 until the opening 130 is dilated and identifiable. Thus, the user can use the lift 140 to move the endoscope 100 and cannula 160 to spray the saline stream 164 entirely around the proximal region of the nipple 132 until the opening 130 can be distinguished from the surrounding wall 120. The approximate or macroscopic location of the nipple 132 can be determined by the user's skill and judgment from the surrounding anatomy, and the saline stream 164 can be used to locate the precise or microscopic location of the nipple 132. As the wall 120 surrounding the opening 130 deforms, the opening 130 naturally dilates sufficiently to be visible through the endoscope. In some cases, the stream 164 may directly impact the opening 130, and the stream may force the opening 130 to open. Therefore, this method can use the direct or indirect impact of the stream 164 near the opening 130 to allow for visual identification of the opening.

[0046] In one method, the procedure may further include inserting a cannula 160 (or other instrument) through the opening 130 after the opening has been identified. As discussed below, the cannula 160 may be used to perform other procedures within the bile duct 124 and pancreatic duct 126.

[0047] Figures 6 to 8 The illustration depicts another potential problem that may arise during duodenoscopy. According to one implementation, Figure 6 A schematic diagram of the distal portion of the endoscope 100 within the duodenum D is shown. Figure 7 A schematic diagram of the endoscope 100 is shown, and Figure 8 Another schematic diagram of the endoscope 100 is shown.

[0048] In some cases, nipple 132 may have an extremely elongated portion of its raised tissue. This can pose a challenge for surgeons because the elongated portion of the raised tissue is soft and flexible, and cannulation through opening 130 causes the entire elongated portion to move away. In the case of an elongated portion of nipple 132, opening 130 can be easily identified because its shape allows for relaxation of the tissue surrounding it. However, the elongation makes the tissue supporting opening 130 fragile. Another problem is that repeated unsuccessful attempts to penetrate the opening can lead to trauma and inflammation of nipple 132.

[0049] In this example, the endoscope 100 has been inserted into the duodenum D and the opening 130 of the nipple 132 is visually located with the extremely elongated portion of the nipple 132.

[0050] Therefore, this system provides techniques and apparatus for stabilizing such elongated nipples 132. Specifically, this system proposes temporarily freezing the stalk and base of this type of nipple 132 to achieve stability and prevent unnecessary movement of the nipple 132 during attempts by the cannula 160, guide wire, or other instruments to penetrate the opening 130.

[0051] Therefore, this example provides a device for stabilizing nipple 132, the device including an endoscope 100 and a cannula 160 extending through the endoscope 100. As will be detailed below, a cryoprotectant container may be coupled to the cannula 160 to deliver cryoprotectant 170 through the cannula 160 to the outer surface of nipple 132, the outer surface including the basal surface 134 and / or lateral surface 136 of nipple 132. The cryoprotectant 170 may be applied in an amount required to temporarily freeze and stabilize nipple 132, thereby allowing instruments (such as the cannula 160) to be inserted through the opening 130.

[0052] Reference Figure 7 Functional section 104 may include a lifter 140 for guiding and aligning the cannula 160 to direct the cryoprotectant 170 to the base 134 and / or side 136 of the nipple 132, rather than the tip 138 of the nipple 132. By not freezing the tip region 138, the system allows the cannula 160 (or other instrument) to be inserted through the unfrozen opening 130 of the stabilized nipple 132, while the rest of the nipple 132 is temporarily frozen and stabilized. However, in some examples, the tip region 138 may be intentionally or unintentionally frozen, and a guide wire may be inserted therein until thawing occurs, at which point the cannula 160 can be inserted.

[0053] In some examples, cryoprotectant 170 may include a cryoprotectant. The cryoprotectant will not destroy or damage the papillary tissue as in cryogenic applications such as cryoablation, but rather temporarily freeze the tissue long enough for a cannula to enter the opening. A cryoprotectant is a compound that protects cells from damage during freezing and thawing. Cryoprotectants prevent the formation of ice crystals, which can damage cell membranes and components. The cryoprotectant may be similar to those used in cryopreservation, the process of preserving cells, tissues, and organs at low temperatures to maintain their viability. This process involves cooling cells to very low temperatures (-80°C to -196°C) and suspending their cellular metabolism, which preserves the cells for an unlimited amount of time.

[0054] In various embodiments, different types of cryoprotectants can be used in this system. For example, dimethyl sulfoxide (DMSO) is one of the most commonly used cryoprotectants in cryopreservation. It is a highly efficient cryoprotectant that can penetrate cell membranes and protect cells from damage during freezing and thawing. Other cryoprotectants may include glycerol and propylene glycol.

[0055] In some examples, the system may also use brine jet cleaning of the cannula 160 after dispensing the cryoprotectant 170, as the cryoprotectant 170 may cause blockage and residual cryoprotectant at the tip of the cannula 160. For example, since the cannula 160 can be used later to dispense contrast agent, the system may be designed to have an automated cleaning step after dispensing the cryoprotectant.

[0056] Therefore, when the nipple is slender and flexible, this system provides stability control by applying a cryoprotectant that will not damage or harm the tissue but will instead temporarily freeze and stabilize it.

[0057] In some implementations, one or more of the techniques discussed above can be used in the endoscopic system. For example, Figure 9 A schematic diagram of a system for performing endoscopic surgery according to one embodiment is shown.

[0058] The system may include an endoscope 100, such as a duodenoscope. As indicated, the endoscope may include a camera for the user to observe the wall and identify the nipple opening. The cannula system may include a cannula handle 200 for connecting a cannula 160 extending through the endoscope 100 to a fluid line 202 from a control unit 210. The control unit 210 is a fluid control system that may include one or more of a saline source 212 and a cryoprotectant source 214. The system may also include a fluid activator 216. The fluid activator 216 may be configured to deliver at least one of saline and / or cryoprotectant from the control unit 210 through the fluid line 202 and into and through the cannula 160, according to the user's discretion.

[0059] Control unit 210 may be configured to accommodate receiving portions for brine source 212 and refrigerant source 214. For example, brine source 212 may include a pressurized brine container, such as a single-use container. Refrigerant source 214 may include, for example, a pressurized refrigerant container. Control unit may also include an air pressure inlet line 220, a pressure regulator, a two-way valve 222, and a shuttle valve 218, configured to control the dispensing of brine and / or refrigerant from control unit 210.

[0060] In one example, the fluid activator 216 may include a first foot switch 224 configured to activate a flow of saline solution from a saline source 212 and a second foot switch 226 configured to deliver refrigerant, coupled to the control unit 210. In one example, the first foot switch 224 may be configured to deliver a one-second saline flow jet when the foot switch 224 is momentarily activated. Alternatively, the first foot switch 224 may be configured to deliver a three-second saline flow jet when the foot switch 224 is activated for more than two seconds. The amount and duration of these deliveries can be varied as needed and can be programmed into the controller 228. Furthermore, the pressure of the saline flow can be varied. For example, the foot switch 224 may be a variable switch, wherein the more the foot switch 224 is activated or pressed deeper, the greater the pressure and flow rate of the delivered saline solution. As discussed above, in use, the fluid control system may be configured to deliver saline solution at a certain level and pressure through the cannula 160 to deform the duodenal wall and dilate the papillary opening, allowing the user to visually identify the location of the opening via an endoscope.

[0061] The second foot switch 226 can also be functionally connected to the control unit 210 to release cryoprotectant from the cryoprotectant source 214 and through the sleeve 160 when the foot switch 226 is activated. Thus, the fluid control system can be configured to deliver cryoprotectant through the sleeve 160 to the outer surface of the nipple to stabilize it. The foot switch 226 can be configured to allow the user to apply a brief, directional injection of cryoprotectant to the nipple, or in some examples, to distribute a stable flow of cryoprotectant. The user will use the lifter of the endoscope 100 and other controls to appropriately direct the flow to the desired location (the basal and / or lateral surfaces of the nipple) to stabilize the nipple tissue.

[0062] Furthermore, the fluid activator 216 or control unit 210 may include an electronic controller 228 that provides the desired operation and correct sequence of operations based on how the user activates the foot switches 224, 226. For example, the controller 228 may be configured to automatically provide a brine flushing flow after refrigerant has been used. Therefore, the brine source 212 can be used to flush the tubing with a brine flow after the refrigerant has been released. This is to prevent the tubing from potentially becoming clogged by the refrigerant.

[0063] The control unit 210 can be a standalone accessory unit, or it can be embedded in any system dedicated to a console that provides power / light source for the endoscope, or, for example, a laser console for lithotripsy.

[0064] Figure 10A method (300) for performing endoscopic surgery according to one embodiment is shown. Referring to the figures discussed above, the method (300) may include inserting an endoscope, such as a duodenoscope, into the duodenum and observing (310) an image of the duodenal wall at the duodenal papilla. While observing the image, the method may also include determining (320) based on the image whether the duodenal papilla is in an abnormal condition that makes it difficult for a cannula to pass through the opening of the papilla. If the papilla is in an abnormal condition, the method includes releasing (330) fluid through the cannula of the endoscope to alleviate the abnormal condition.

[0065] As discussed above, if the abnormality includes a flattened duodenal papilla that is not visible in the duodenal wall, the user can release a saline stream onto the duodenal wall to deform the wall until the opening is identified.

[0066] If the abnormality includes that the duodenal papilla is thin and flexible, the user can release a flow of cryoprotectant guided along the outer surface of the duodenal papilla to stabilize it.

[0067] Therefore, this system allows for the manipulation of the nipple to help the user insert the instrument into the nipple opening when the opening is difficult to find or the nipple is too long and flexible to allow easy access.

[0068] Figure 11 A schematic diagram of an exemplary computer-based clinical decision support system (CDSS) 400 is shown, configured to diagnose and recommend treatment based on images of the duodenal wall near the main duodenal papilla. In various embodiments, the CDSS 400 includes an input interface 410 and a user interface (UI) 440, through which patient-specific images of the duodenal wall near the main duodenal papilla are provided as input features to an artificial intelligence (AI) model 420. The AI ​​model 420 includes a processor performing inference operations, in which the images of the duodenal wall near the main duodenal papilla are applied to the AI ​​model to generate a diagnosis of the papilla condition, which is then communicated to a user, such as a clinician, via the user interface (UI) 440.

[0069] In some implementations, input interface 410 may be a direct data link between CDSS 400 and one or more medical devices, such as an endoscope camera, that generate at least some of the input features. For example, input interface 410 may transmit images directly to CDSS during treatment and / or diagnostic medical procedures. Additionally or alternatively, input interface 410 may be a classic user interface that facilitates interaction between a user and CDSS 400. For example, input interface 410 may support a user interface through which a user can manually input images or their descriptions. Additionally or alternatively, input interface 400 may provide CDSS 400 with access to databases and electronic patient records from which one or more input features can be extracted. In any of these cases, input interface 410 is configured to collect one or more subsequent input features associated with a particular patient at or before the time when CDSS 400 is used to assess whether the main duodenal papilla is abnormal and requires special treatment to access the papillary opening.

[0070] For example, a database may include multiple images and descriptions of a range of different nipples. The database may include a complete range from normal nipples to flat nipples to elongated nipples. These images can be categorized and entered into CDSS 400.

[0071] The input will also include a specific image of the wall of the currently diagnosed nipple.

[0072] Based on one or more of the aforementioned input features, the processor uses AI model 420 to perform inference operations to generate diagnoses and suggested treatments based on images of the duodenal wall near the main duodenal papilla. For example, input interface 410 can feed a current image of the duodenal wall near the main duodenal papilla into the input layer of the AI ​​model, which propagates these input features to the output layer via the AI ​​model. The AI ​​model can provide a computer system with the ability to perform tasks without explicit programming by making inferences based on patterns discovered in data analysis. AI models explore the research and construction of algorithms (e.g., machine learning algorithms) that can learn from existing data and make predictions about new data. Such algorithms operate by building AI models from example training data to make data-driven predictions or decisions that are expressed as outputs or evaluations.

[0073] There are two common paradigms for machine learning (ML): supervised ML and unsupervised ML. Supervised ML uses prior knowledge (e.g., examples that correlate inputs with outputs or outcomes) to learn the relationship between inputs and outputs. The goal of supervised ML is to learn a function that best approximates the relationship between training inputs and outputs given some training data, so that the ML model can achieve the same relationship given an input to generate the corresponding output. Unsupervised ML trains the ML algorithm using information that is neither classified nor labeled, allowing the algorithm to operate on that information without guidance. Unsupervised ML is useful in exploratory analytics because it can automatically identify structures in the data.

[0074] Common tasks for supervised ML are classification and regression problems. Classification problems, also known as categorization problems, aim to classify items into one of several class values ​​(e.g., is the object an apple or an orange?). Regression algorithms aim to quantify some items (e.g., by assigning scores to values ​​of some inputs). 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).

[0075] Some common tasks in unsupervised ML include clustering, representation learning, and density estimation. Examples of commonly used unsupervised ML algorithms include K-means clustering, principal component analysis, and autoencoders.

[0076] Another type of machine learning is federated learning (also known as collaborative learning), which trains algorithms on multiple distributed devices that store local data without exchanging data. This approach differs from traditional centralized machine learning techniques, where all local datasets are uploaded to a single server. It also differs from more classic distributed methods, which typically assume that local data samples are uniformly distributed. Federated learning enables multiple participants to build general, robust machine learning models without sharing data, thus allowing for the resolution of critical issues such as data privacy, data security, data access permissions, and access to heterogeneous data.

[0077] In some examples, the AI ​​model can be trained continuously or periodically before the inference operation is performed by the processor. Then, during the inference operation, patient-specific input features provided to the AI ​​model can propagate from the input layer, through one or more hidden layers, and ultimately to the output layer, which corresponds to a diagnosis and recommended treatment based on an image of the duodenal wall near the main duodenum. For example, AI model 420 can determine that the current papilla is flat and a saline procedure should be used by comparing the current image with images in a database, or the AI ​​model can indicate that the papilla is elongated and a cryotherapy procedure should be used. These outputs can be accompanied by corresponding AI-generated confidence levels. In the example, images from the duodenoscope 100 can be analyzed in real time. The video output of the duodenoscope 100 presented on the output unit 18 can include markers, such as arrows or circles, that can be generated using the AI ​​model. The markers can be overlaid on the video image from the duodenoscope 100 to indicate to the user where to place the saline flow 164, cryotherapy 170, or cannula 160.

[0078] During and / or after the inference procedure, diagnoses and recommended treatments can be communicated to the user via a user interface (UI) and / or the endoscope can be automatically executed as recommended treatments. For example, an AI model can determine from the current image whether the duodenal papilla is in an abnormal condition that makes it difficult for the cannula to pass through the papilla opening, and suggest or automatically execute recommended treatments, such as saline treatment or cryotherapy as discussed above. Various annotations and examples

[0079] Example 1 may include or use the subject of, for example, a method for performing endoscopic surgery, the method comprising: viewing an image of the wall of the duodenum near the nipple using an endoscope; releasing fluid toward the nipple through a cannula of the endoscope while viewing the image; and inserting an instrument through an opening in the nipple after releasing the fluid.

[0080] Example 2 may include the subject matter of Example 1 or may optionally combine it with the subject matter of Example 1 to optionally include: determining, based on the image, whether the nipple is in an abnormal condition that makes it difficult for an instrument to pass through the opening of the nipple, and, if the nipple is in the abnormal condition, releasing fluid toward the nipple to alleviate the abnormal condition.

[0081] Example 3 may include the subject matter of Example 1 or 2, or may optionally combine it with the subject matter of Example 1 or 2, to optionally include: the nipple is flat and cannot be distinguished from the surrounding tissue in the wall of the duodenum, and the fluid released through the cannula includes a saline flow to the wall of the duodenum.

[0082] Example 4 may include the subject of one or any combination of Examples 1 to 3, or may optionally combine the subject of one or any combination of Examples 1 to 3, to optionally include: the brine flow comprising a brine jet of one to three seconds.

[0083] Example 5 may include the subject of one or any combination of Examples 1 to 4, or may optionally combine with the subject of one or any combination of Examples 1 to 4, to optionally include: the saltwater flow deforming the wall and expanding the opening.

[0084] Example 6 may include the subject of one or any combination of Examples 1 to 5, or may optionally combine the subject of one or any combination of Examples 1 to 5, to optionally include: the brine flow being directed to various locations along the wall until the opening is expanded and identified.

[0085] Example 7 may include the subject matter of one or any combination of Examples 1 to 6, or may optionally combine the subject matter of one or any combination of Examples 1 to 6, to optionally include: the nipple is elongated and flexible, and the fluid released through the cannula includes a cryoprotectant flow guided along the outer surface of the nipple to stabilize the nipple.

[0086] Example 8 may include the subject matter of one or any combination of Examples 1 to 7, or may optionally combine with the subject matter of one or any combination of Examples 1 to 7, to optionally include: the refrigerant includes a cryoprotectant type refrigerant.

[0087] Example 9 may include the subject of one or any combination of Examples 1 to 8, or may optionally combine with the subject of one or any combination of Examples 1 to 8, to optionally include: the outer surface of the nipple includes the base surface and the lateral surface of the nipple, and does not include the tip of the nipple near the opening.

[0088] Example 10 may include the subject of one or any combination of Examples 1 to 9, or may optionally combine with the subject of one or any combination of Examples 1 to 9, to optionally include: rinsing the sleeve with brine after dispensing the refrigerant.

[0089] Example 11 may include or use the subject of, for example, a device for stabilizing a nipple, the device comprising: a cannula extending through a duodenoscope configured to extend through the duodenum to reach a nipple within the duodenum; and a cryoprotectant container coupled to the cannula to deliver cryoprotectant through the cannula to the outer surface of the nipple and configured to stabilize the nipple.

[0090] Example 12 may include the subject matter of Example 11 or may optionally combine with the subject matter of Example 11 to optionally include: the amount of cryoprotectant delivered is configured for temporarily freezing the nipple.

[0091] Example 13 may include the subject matter of one or any combination of Examples 11 or 12, or may optionally combine the subject matter of one or any combination of Examples 11 or 12, to optionally include: a foot switch coupled to the cryoprotectant container to release the cryoprotectant from the cryoprotectant container and through the sleeve when the foot switch is activated.

[0092] Example 14 may include the subject matter of one or any combination of Examples 11 to 13, or may optionally combine the subject matter of one or any combination of Examples 11 to 13, to optionally include: a brine container coupled to the sleeve and configured to flush the sleeve with a brine flow after the cryoprotectant has been released.

[0093] Example 15 may include the subject matter of one or any combination of Examples 11 to 14, or may optionally combine the subject matter of one or any combination of Examples 11 to 14, to optionally include: a lifter for guiding the cannula, and the duodenoscope is configured to guide the cryoprotectant to the base of the papilla rather than the tip of the papilla.

[0094] Example 16 may include or use the subject of, for example, a system comprising: an endoscope; a cannula system including a cannula extending through the endoscope; a fluid control system coupled to the cannula system, the fluid control system including a saline source and a refrigerant source; and a fluid activator configured to deliver at least one of the saline and the refrigerant through the cannula based on a user's judgment.

[0095] Example 17 may include the subject matter of Example 16 or may optionally combine it with the subject matter of Example 16 to optionally include: the fluid control system is configured to deliver the saline solution horizontally through the cannula to deform the duodenal wall and dilate the papillary opening, enabling a user to identify the location of the papillary opening via the endoscope.

[0096] Example 18 may include the subject matter of one or any combination of Examples 16 to 17, or may optionally combine the subject matter of one or any combination of Examples 16 to 17, to optionally include: the fluid control system is configured to deliver the refrigerant to the outer surface of the nipple through the sleeve to stabilize the nipple.

[0097] Example 19 may include the subject of one or any combination of Examples 16 to 18, or may optionally combine with the subject of one or any combination of Examples 16 to 18, to optionally include: wherein, after the delivery of the refrigerant, the system is configured to deliver a brine jet to clean the sleeve.

[0098] Example 20 may include the subject matter of one or any combination of Examples 16 to 19, or may optionally combine with the subject matter of one or any combination of Examples 16 to 19, to optionally include: the refrigerant includes a cryoprotectant.

[0099] Example 21 may include the subject matter of one or any combination of Examples 16 to 20, or may optionally combine with the subject matter of one or any combination of Examples 16 to 20, to optionally include: a first foot switch for delivering the brine and a second foot switch for delivering the refrigerant.

[0100] Example 22 may include the subject of one or any combination of Examples 16 to 21, or may optionally combine with the subject of one or any combination of Examples 16 to 21, to optionally include: the first foot switch is configured to deliver a one-second spray of brine when the first foot switch is momentarily activated.

[0101] Example 23 may include the subject of one or any combination of Examples 16 to 22, or may optionally combine with the subject of one or any combination of Examples 16 to 22, to optionally include: the first foot switch is configured to deliver a three-second brine jet when the first foot switch is activated for more than two seconds.

[0102] Each of these non-restrictive examples can exist independently, or can be combined with one or more examples from other examples in various permutations or combinations.

[0103] The above detailed description includes reference to the accompanying drawings, which form part of the detailed description. The drawings illustrate, by way of illustration, specific embodiments in which the invention may be practiced. These embodiments are also referred to herein as “examples.” Such examples may include elements other than those shown or described. However, the inventors also contemplate examples in which only those elements shown or described are provided. Furthermore, the inventors contemplate examples using any combination or arrangement of those elements (or one or more aspects of those elements) shown or described with respect to a particular example (or one or more aspects of that particular example) or with respect to other examples shown or described herein (or one or more aspects of those other examples).

[0104] In the event of any inconsistency between the usage in this document and any other document incorporated by reference, the usage in this document shall prevail.

[0105] In this document, as is common in patent documents, the terms "a" or "one" are used to include one or more, regardless of any other instance or use of "at least one" or "one or more". In this document, unless otherwise indicated, the term "or" is used to refer to a non-exclusive "or", such that "A or B" includes "A but not B", "B but not A", and "A and B". In this document, the terms "comprising" and "in..." are used as concise equivalents to the corresponding terms "including" and "wherein". Furthermore, in the appended claims, the terms "comprising" and "including" are open-ended, meaning that a system, apparatus, article, composition, formulation, or process that includes elements other than those listed after this term in a claim is still considered to fall within the scope of that claim. Moreover, in the appended claims, the terms "first", "second", and "third", etc., are used only as illustrative marks and are not intended to impose numerical requirements on the objects of said terms.

[0106] The method examples described herein may be implemented, at least in part, by a machine or computer. Some examples may include computer-readable or machine-readable media encoded with instructions operable to configure electronic devices to perform the methods described in the examples above. Implementations of such methods may include code, such as microcode, assembly language code, higher-level language code, etc. Such code may include computer-readable instructions for performing various methods. The code may form parts of a computer program product. Furthermore, in the examples, such as during execution or at other times, the code may be tangibly stored on one or more volatile, non-transitory, or non-volatile tangible computer-readable media. Examples of such tangible computer-readable media may include, but are not limited to, hard disks, removable disks, removable optical discs (e.g., compact discs and digital video discs), magnetic tape cartridges, memory cards or sticks, random access memory (RAM), read-only (ROM), etc.

[0107] The above description is intended to be illustrative and not restrictive. For example, the above examples (or one or more aspects of the above examples) can be used in combination with each other. For example, other embodiments can be used by those skilled in the art after consulting the above description. An abstract is provided to allow the reader to quickly determine the nature of the technical disclosure. The abstract is submitted on the understanding that it will not be used to interpret or limit the scope or meaning of the claims. Furthermore, in the above detailed description, various features can be combined together to simplify the disclosure. This should not be construed as meaning that any unclaimed disclosed features are necessary for any claim. Rather, the subject matter of the invention may lie in fewer than all features of a particular disclosed embodiment. Therefore, the appended claims are incorporated herein by way of example or embodiment, wherein each claim exists independently as a separate embodiment, and it is contemplated that such embodiments can be combined with each other in various combinations or arrangements. The scope of the invention should be determined by reference to the appended claims and the full scope of equivalents conferred by such claims.

Claims

1. A method for performing endoscopic surgery, the method comprising: Using an endoscope to observe images of the duodenal wall near the nipple; While observing the image, fluid is released toward the nipple through the cannula of the endoscope; as well as After the fluid is released, the instrument is inserted through the opening in the nipple.

2. The method of claim 1, further comprising determining, based on the image, whether the nipple is in an abnormal condition that makes it difficult for an instrument to pass through the opening of the nipple, and, if the nipple is in the abnormal condition, releasing fluid toward the nipple to alleviate the abnormal condition.

3. The method according to claim 2, wherein, The abnormal condition includes the nipple being flattened and indistinguishable from surrounding tissue within the wall of the duodenum, and the fluid released through the cannula including a saline flow onto the wall of the duodenum.

4. The method according to claim 3, wherein, The brine flow consists of brine jets lasting from one to three seconds.

5. The method according to claim 3, wherein, The saltwater flow deforms the wall and expands the opening.

6. The method according to claim 5, wherein, The brine flow is directed to various locations along the wall until the opening is expanded and identified.

7. The method according to claim 2, wherein, The abnormal condition includes the nipple being elongated and flexible, and the fluid released through the cannula including a cryoprotectant flow guided along the outer surface of the nipple to stabilize the nipple.

8. The method according to claim 7, wherein, The refrigerant includes cryoprotectant-type refrigerants.

9. The method according to claim 7, wherein, The outer surface of the nipple includes the base surface and the side surface of the nipple, but does not include the tip of the nipple near the opening.

10. The method of claim 7, further comprising rinsing the sleeve with brine after dispensing the refrigerant.

11. A device for stabilizing a nipple, the device comprising: A cannula extending through a duodenoscope, the duodenoscope being configured to extend through the duodenum to reach a papilla within the duodenum; as well as A cryoprotectant container, the cryoprotectant container being coupled to the sheath to deliver cryoprotectant through the sheath to the outer surface of the nipple, and configured to stabilize the nipple.

12. The device according to claim 11, wherein, The amount of cryoprotectant delivered is configured to temporarily freeze the nipple.

13. The device of claim 11, further comprising a foot switch connected to the cryoprotectant container to release the cryoprotectant from the cryoprotectant container and through the sleeve when the foot switch is activated.

14. The apparatus of claim 13, further comprising a brine container connected to the sleeve and configured to flush the sleeve's tubing with a brine flow after the cryoprotectant has been released.

15. The device according to claim 11, wherein, The duodenoscope includes a lifter for guiding the cannula, and the duodenoscope is configured to guide the cryoprotectant to the base of the papilla rather than the tip of the papilla.

16. A system comprising: Endoscope; A cannula system, the cannula system comprising a cannula extending through the endoscope; A fluid control system, connected to the casing system, includes a brine source and a refrigerant source; as well as A fluid activator, wherein the fluid activator is configured to deliver at least one of the brine and the refrigerant through the sleeve according to the user's judgment.

17. The system according to claim 16, wherein, The fluid control system is configured to deliver the saline solution through the cannula at a level that deforms the duodenal wall and dilates the papillary opening, allowing the user to identify the location of the papillary opening via the endoscope.

18. The system according to claim 16, wherein, The fluid control system is configured to deliver the refrigerant to the outer surface of the nipple through the sleeve to stabilize the nipple.

19. The system according to claim 18, wherein, After the refrigerant is delivered, the system is configured to deliver a brine jet to clean the casing.

20. The system according to claim 18, wherein, The refrigerant includes a cryoprotectant.

21. The system according to claim 16, wherein, The fluid activator includes a first foot switch for delivering the brine and a second foot switch for delivering the refrigerant.

22. The system according to claim 21, wherein, The first foot switch is configured to deliver a one-second spray of brine when the first foot switch is momentarily activated.

23. The system according to claim 22, wherein, The first foot switch is configured to deliver a three-second brine jet when the first foot switch is activated for more than two seconds.

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