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

Abstract

A method for performing an endoscopy procedure can include viewing an image of a wall of a duodenum proximate a papilla using an endoscope, releasing through a cannula of the endoscope a fluid towards the papilla while viewing the image, and inserting an instrument through an opening of the papilla after releasing the fluid. A system can 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 source of saline and a source of a freezing agent, and a fluid activator, wherein the fluid activator is configured to deliver at least one of the saline and the freezing agent through the cannula at a user's discretion.

Description

METHOD FOR PAPILLA LOCATOR AND STABILITY CONTROL IN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP)PRIORITY CLAIM

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

[0002] The present disclosure relates generally to medical devices and more specifically, the present disclosure relates to endoscopes for imaging and / or providing passage of therapeutic devices toward various anatomical portions.BACKGROUND

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

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

[0005] To access the common bile duct, a user first finds the major duodenal papilla, which includes a papilla 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 biliary system.SUMMARY

[0006] The present system includes techniques to aid a user in finding and accessing the opening of the major duodenal papilla when the papilla is in an abnormal condition.

[0007] In one example, a method for performing an endoscopy procedure method can include viewing an image of a wall of a duodenum proximate a papilla using an endoscope, releasing through a cannula of the endoscope a fluid towards the papilla while viewing the image, and inserting an instrument through an opening of the papilla after releasing the fluid.

[0008] In one example, an apparatus for stabilizing a papilla can include a cannula extending through a duodenoscope configured for extending through a duodenum to reach a papilla within the duodenum, and a cryoprotectant container coupled to the cannula to deliver a cryoprotectant agent through the cannula against an outer surface of the papilla and configured to stabilize the papilla.

[0009] In another example, a system can 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 source of saline and a source of a freezing agent, and a fluid activator, wherein the fluid activator is configured to deliver at least one of the saline and the freezing agent through the cannula at a user’s discretion.BRIEF DESCRIPTION OF DRAWINGS

[0010] FIG. 1 shows a schematic diagram of an endoscopy system comprising an imaging and control system and an endoscope, such as duodenoscope.

[0011] FIG. 2 shows a schematic diagram of the endoscopy system of FIG. 1 comprising the endoscope connected to a control unit of the imaging and control system.

[0012] FIG. 3 shows a diagram of a portion of a duodenum and surrounding areas of a patient.

[0013] FIG. 4 shows a schematic view of a distal portion of an endoscope, such as a duodenoscope, within a duodenum, in accordance with one embodiment.

[0014] FIG. 5 shows a schematic view of the endoscope of FIG. 4, in accordance with one embodiment.

[0015] FIG. 6 shows a schematic view of a distal portion of an endoscope, such as a duodenoscope, within a duodenum, in accordance with one embodiment.

[0016] FIG. 7 shows a schematic view of the endoscope of FIG. 6, in accordance with one embodiment.

[0017] FIG. 8 shows another schematic view of the endoscope of FIG. 6, in accordance with one embodiment.

[0018] FIG. 9 shows a schematic view of a system for performing an endoscope procedure, in accordance with one embodiment.

[0019] FIG. 10 shows a method for performing an endoscopy procedure in accordance with one embodiment.

[0020] FIG. 11 is a diagram of an Al system, in accordance with one embodiment.DETAILED DESCRIPTION

[0021] FIGs 1 and 2 show an example of a general endoscopy system. FIG. l is a schematic diagram of endoscopy system 10, and FIG. 2 is a schematic diagram of the endoscopy system 10 including the endoscope connected to a control unit of the imaging and control system. The endoscopy system 10 can include an imaging and control system 12 and an endoscope 14. The system of FIGs 1 and 2 is an illustrative example of an endoscopy system suitable for use with the systems, devices and methods described herein. According to some examples, endoscope 14 can be insertable into an anatomical region for imaging and / or to provide passage of one or more sampling devices for biopsies, or one or more therapeutic devices for treatment of a disease state associated with the anatomical region. Endoscope 14 can, in advantageous aspects, interface with and connect to imaging and control system 12. In the illustrated example, endoscope 14 comprises a duodenoscope, though other types of endoscopes can be used with the features and teachings of the present disclosure.

[0022] Imaging and control system 12 can comprise controller 16, output unit 18, input unit 20, light source 22, fluid source 24 and suction pump 26.

[0023] Imaging and control system 12 can include various ports for coupling with endoscopy system 10. For example, controller 16 can include a data input / output port for receiving data from and communicating data to endoscope 14. Light source 22 can include an output port for transmitting light to endoscope 14, such as via a fiber optic link. Fluid source 24 can include a port for transmitting fluid to endoscope 14. Fluid source 24 can comprise a pump and a tank of fluid or can be connected to an external tank, vessel or storage unit. Suction pump 26 can comprise a port used to draw a vacuum from endoscope 14 to generate suction, such as for withdrawing fluid from the anatomical region into which endoscope 14 is inserted. Output unit 18 and input unit 20 can be used by an operator of endoscopy system 10 to control functions of endoscopy system 10 and view output of endoscope 14. Controller 16 can additionally be used to generate signals or other outputs from treating the anatomical region into which endoscope 14 is inserted. In examples, controller 16 can generate electricaloutput, acoustic output, a fluid output and the like for treating the anatomical region with, for example, cauterizing, cutting, freezing and the like.

[0024] Endoscope 14 can comprise insertion section 28, functional section 30 and handle section 32, which can be coupled to cable section 34 and coupler section 36.

[0025] Insertion section 28 can extend distally from handle section 32 and cable section 34 can extend proximally from handle section 32. Insertion section 28 can be elongate and include a bending section, and a distal end to which functional section 30 can be attached. The bending section can be controllable (e.g., by control knob 38 on handle section 32) to maneuver the distal end through tortuous anatomical passageways (e.g., stomach, duodenum, kidney, ureter, etc.). Insertion section 28 can 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 section 30. The working channel can extend between handle section 32 and functional section 30. Additional functionalities, such as fluid passages, guide wires, and pull wires can also be provided by insertion section 28 (e.g., via suction or irrigation passageways, and the like).

[0026] Handle section 32 can comprise knob 38 as well as ports 40. Knob 38 can be coupled to a pull wire extending through insertion section 28. Ports 40 can be configured to couple various electrical cables, fluid tubes and the like to handle section 32 for coupling with insertion section 28.

[0027] Imaging and control system 12, according to examples, can be provided on a mobile platform (e.g., cart 41) with shelves for housing light source 22, suction pump 26, image processing unit 42, etc. Alternatively, several components of imaging and control system 12 shown in FIGS. 1 and 2 can be provided directly on endoscope 14 so as to make the endoscope “self-contained.”

[0028] Functional section 30 can comprise components for treating and diagnosing anatomy of a patient. Functional section 30 can comprise an imaging device, an illumination device and an elevator, as is described further below.

[0029] As shown in FIG. 2, the imaging and control system 12 can comprise controller 16, which can include or be coupled to image processing unit 42, treatment generator 44 and drive unit 46, as well as light source 22, input unit 20 and output unit 18.

[0030] Image processing unit 42 and light source 22 can each interface with endoscope 14 (e.g., at functional unit 30) by wired or wireless electrical connections. Imaging and control system 12 can accordingly illuminate an anatomical region, collect signals representing the anatomical region, process signals representing the anatomical region, and display imagesrepresenting the anatomical region on display unit 18. Imaging and control system 12 can include light source 22 to illuminate the anatomical region using light of desired spectrum (e.g., broadband white light, narrow-band imaging using preferred electromagnetic wavelengths, and the like). Imaging and control system 12 can connect (e.g., via an endoscope connector) to endoscope 14 for signal transmission (e.g., light output from light source, video signals from imaging system in the distal end, diagnostic and sensor signals, and the like).

[0031] Fluid source 24 can 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). Imaging and control system 12 can also include drive unit 46, which can be an optional component. Drive unit 46 can comprise a motorized drive for advancing a distal section of endoscope 14.

[0032] FIG. 3 shows a diagram of a portion of a duodenum D and surrounding areas of a patient. Duodenum D comprises an upper part of the small intestine. Duodenum D can comprise a wall 120 which includes a major duodenal papilla 132. A bile duct 124 and a pancreatic duct 126 join at the Ampulla of Vater 128, this empties through the papilla 132 at a papilla opening 130 which is surrounded by a circular muscle, the sphincter of Oddi 122. Bile duct 124 carries bile from the gallbladder and liver and empties the bile into the duodenum D. Pancreatic duct 126 carries pancreatic juice from the exocrine pancreas to the ampulla of Vater 128. Figure 3 shows what the major duodenal papilla 132 looks like in a normal anatomy. The papilla 132 has a small bump and appears rounded and the opening 130 is distinguishable from surrounding anatomy. In this situation, the papilla 132 would be easily located visually through an endoscope and the entry point identified. Furthermore, the shape of a typical papilla 132 can allow for easy insertion of an instrument therein. For example, some papilla 132 are squat in shape such that the instrument can be inserted therein without the papilla collapsing or folding over.

[0033] However, sometimes it can be very difficult to find the opening 130 and the papilla 132 because there is no bump present or the bump is very small. For example, sometimes the papilla 132 can be very flat and blend into wall 120 and the opening 130 of the papilla 132 can be very challenging to find. This causes procedural delay since it takes time to poke the wall surfaces 120 to locate the opening 130 of the papilla. Likewise, if the papilla 132 is too elongated, it can be difficult to insert an instrument therein, thereby also increasing difficulty and time in performing a procedure.

[0034] FIGs 4 and 5 show an apparatus configured to help aid the user when the papilla 132 is very flat and the opening 130 cannot be visually distinguished. FIGs 4 and 5 show schematic views of a distal portion of an endoscope 100, such as a duodenoscope, within the duodenum D, in accordance with one embodiment.

[0035] The endoscope 100 is an example of an implementation of the endoscope 14 of FIG. 1. Here, the endoscope 100 can include an insertion section 102 and a functional section 104. Functional section 104 can comprise an opening 142 for a cannula 160 to extend outside the device. An elevator portion 140 can be located within a cavity defining the opening 142 and is configured to change the angle of an instrument, such as the cannula 160, along a longitudinal axis of the endoscope 100. The endoscope 100 can include a “side-viewing endoscope” (e.g., duodenoscope) camera module 150. In the 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 anatomy lateral to central longitudinal axis of endoscope 100.

[0036] Insertion section 102 can comprise a central lumen through which various components can be extended to connect functional section 104 with handle section 32 (FIG. 1). Other elongate elements, e.g., tubes, wires, cables, can extend through the lumen to connect functional section 104 with components of endoscopy system 10, such as suction pump 26 and treatment generator 44.

[0037] The elevator 140 can include a mechanism for moving a device, such as the cannula 160, inserted through insertion section 102. In particular, the elevator 140 can be used to bend the cannula 160 (or other elongate instrument) out of the opening 142 at an angle relative to the longitudinal axis of the endoscope to thereby treat the anatomical region adjacent side-viewing endoscope camera module 150.

[0038] The elevator 140 can include a deflector that can be disposed in a cavity defining the opening 142 within the functional section 104. The deflector can be connected to a wire, which can extend and connect to handle section 32. The wire can be actuated, such as by rotating a knob, pulling a lever, or pushing a button on handle section 32. Movement of wire can cause rotation of the deflector to move the elevator 140 as desired to move the distal portion of the cannula 160, or other instrument, out of the endoscope through the opening 142.

[0039] The side-viewing endoscope camera module 150 can include optical components (e.g., objective lens, prism, imaging unit, wiring) for collection of image signals, lighting components (e.g., illumination lens, light transmitter) for transmission or generation of light.Endoscope camera module 150 can 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 can be coupled (e.g., via wired or wireless connections) to image processing unit 42 (FIG. 2) to transmit signals from the photosensitive element representing images (e.g., video signals) to image processing unit 42, in turn to be displayed on a display such as output unit 18.

[0040] In this example, the endoscope 100 is to be used for a procedure involving inserting an instrument through the opening 130 of the papilla 132. As noted, in the duodenum presented in FIGs 4 and 5, it can be very difficult to find the opening 130 and the papilla 132 because there is no bump present. The papilla is very flat and blends into wall 120 and the opening 130 of the papilla 132 can be very challenging to find visually, particularly through imaging equipment. For example, because the opening 130 is so close to wall 120, forces within wall can have a tendency to close opening 130.

[0041] Accordingly, this embodiment includes an apparatus and method for finding such a flat papilla and its opening 130. Here, the endoscope 100 (such as a duodenoscope) can be configured for extending though the duodenum D to reach proximate the papilla opening 130 within the duodenum D. The cannula 160 can extend through the endoscope 100 and is configured to be inserted through the papilla opening 130 into the Ampulla of Vater 128.

[0042] Once the endoscope is in place within the duodenum D proximate the location of the papilla 132 and the papilla and its opening 130 cannot be identified, the cannula 160 can be extended out of the scope at an angle using the elevator 140, and a stream of saline 164 can be dispensed through the cannula 160 at a controlled pressure as required by the user to deform the wall tissue of the wall 120. During this process, the stream of saline 164 will deform the tissue and expand the area proximate the papilla even more to allow the user to visibly identify the opening 130 of the papilla 132. See Fig. 4 for the process of identifying the location and Fig 5 for the illustration when the papilla opening 130 is found. Here, FIG. 4 shows stream of saline 164 being directed to wall 120 adjacent papilla 132 to deflect the wall 120 inward, e.g., away from cannula 160. FIG. 5 shows stream of saline 164 being directed to wall 120 at or close to papilla 132 to overcome forces within wall 120 and cause papilla opening 130 to open up.

[0043] As will be discussed below, a saline container can be coupled to a proximal portion of the cannula 160 to deliver the stream of saline 164 through the cannula 160 against the wall 120 of the duodenum D. The amount and pressure of the saline delivered is configured fordeforming the wall. The elevator 140 can be used to direct the cannula 160, and the duodenoscope is configured to direct the saline along the outer wall of the duodenum D.

[0044] In some examples, the stream of saline 164 can include a one second to a three second burst of saline. The stream of saline 164 can be delivered at a low pressure. For example, about 1 psi to 5 psi, up to 10 psi. For example, the user can use just enough pressure to deform the wall 120 and expand the opening 130. The stream of saline 164 can be continuous, or on / off bursts. The user can use a variable switch, such as a variable foot switch, to incrementally reduce or increase the saline flow volume and / or pressure, for example.

[0045] In operation, the stream of saline 164 can be directed at various locations along the wall 120 until the opening 130 is expanded and identified. Thus, the user can move the endoscope 100 and the cannula 160 using the elevator 140 to spray the stream of saline 164 all around the proximate area of the papilla 132 until the opening 130 is distinguishable from the surrounding wall 120. The general or macro-location of papilla 132 can be determined from the surrounding anatomy by the skill and judgement of the user and the stream of saline 164 can be used to find the precise or micro-location of papilla 132. As the wall 120 around the opening 130 deforms, the opening 130 naturally expands enough to be visible through the endoscope. In some instances, the stream 164 can hit the opening 130 directly and the stream forces the opening 130 open. Accordingly, the method can use either a direct or an indirect hit of the stream 164 proximate the opening 130 to allow for a visual determination of the opening.

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

[0047] FIGs 6-8 illustrate another problem that may occur when performing a duodenoscope procedure. FIG. 6 shows a schematic view of a distal portion of the endoscope 100, within the duodenum D, FIG. 7 shows a schematic view of the endoscope 100, and FIG. 8 shows another schematic view of the endoscope 100, in accordance with one embodiment.

[0048] In some cases, the papilla 132 may have an extreme elongation of the bump of the papilla 132. This situation can cause a challenge to the surgeon since the elongation of the bump tissue is soft and flexible, and penetrating the opening 130 with a cannula causes the whole elongation to move away. In cases of elongation of papilla 132, the opening 130 can be readily identified due to the shape of papilla 132 allowing the tissue surrounding opening130 to relax. However, the elongation results in facile tissue supporting the opening 130. Another issue is that multiple unsuccessful attempts to penetrate the opening can cause the papilla 132 to get traumatized and inflamed.

[0049] In this example, the endoscope 100 has been inserted in the duodenum D and the opening 130 of the papilla 132 is visually located with an extreme elongation of the papilla 132.

[0050] Accordingly, the present system provides a technique and apparatus for stabilizing such an elongated papilla 132. Specifically, the present system proposes to temporarily freeze the stem and the base of this type of papilla 132 to gain stability and prevent unnecessary movement of the papilla 132 during the attempt of the cannula 160, guidewire, or other instrument, to penetrate the opening 130.

[0051] Therefore, this example provides an apparatus for stabilizing the papilla 132 including the endoscope 100 and the cannula 160 extending though the endoscope 100. As will be detailed below, a freezing agent container can be coupled to the cannula 160 to deliver a freezing agent 170 through the cannula 160 against an outer surface of the papilla 132 including a base surface 134 and / or side surfaces 136 of the papilla 132. The freezing agent 170 can be applied in an amount necessary to temporarily freeze and stabilize the papilla 132 allowing an instrument (such as the cannula 160) to be inserted through the opening 130.

[0052] Referring to FIG. 7, the functional section 104 can include the elevator 140 to direct and aim the cannula 160 so as to direct the freezing agent 170 against the base 134 and / or sides 136 of papilla 132 and not a tip 138 of the papilla 132. By not freezing the tip area 138, the system allows the cannula 160 (or other instrument) to be inserted though the unfrozen opening 130 of the stabilized papilla 132, while the rest of the papilla 132 is temporarily frozen and stabilized. However, in some examples tip area 138 may be frozen either intentionally or unintentionally and a guidewire can be inserted therein until thawing occurs and at such time the cannula 160 can be inserted therein.

[0053] In some examples, the freezing agent 170 can include a cryoprotectant agent. A cryoprotectant agent will not kill or damage the papilla tissue as in cryogenics applications such as cryoablation, but instead temporarily freezes the tissue long enough to get the cannula in the opening. Cryoprotectants are chemical compounds that protect cells from damage during freezing and thawing. They prevent the formation of ice crystals that can damage the cell membrane and components. The cryoprotectant agent can be similar to what is used in cryopreservation - a process of preserving cells, tissues, and organs at low temperatures to maintain their viability. The process involves cooling the cells to very low temperatures (-80°C to -196°C) and suspending their cellular metabolism, which preserves the cells for an indefinite amount of time.

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

[0055] In some examples, the system can further purge the cannula 160 with a burst of saline after dispensing the freezing agent 170, since the freezing agent 170 can cause clogging and residual freezing at a tip of the cannula 160. Since the cannula 160 can be later used to dispense a contrasting media, for example, this system can be designed with an automatic purging step after the freezing agent is dispensed.

[0056] Accordingly, when a papilla is elongated and flexible the present system provides stability control by applying a freezing agent that will not kill or damage the tissue, but instead temporarily freezes and stabilizes the tissue.

[0057] In some embodiments, one or more of the techniques discussed above can be utilized in an endoscopy system. For example, FIG. 9 shows a schematic view of a system for performing an endoscope procedure, in accordance with one embodiment.

[0058] The system can include the endoscope 100, such as a duodenoscope. As noted, the endoscope can include a camera for a user to view the wall and identify a papilla opening. The cannula system can include a cannula handle 200 to couple between the cannula 160, which extends through the endoscope 100, and a fluid line 202 coming from a control unit 210. The control unit 210 is a fluid control system that can include one or more of a source of saline 212 and a source of a freezing agent 214. The system can further include a fluid activator 216. The fluid activator 216 can be configured to deliver at least one of the saline and / or the freezing agent from the control unit 210 though the fluid line 202 and into the cannula 160 and through the cannula 160 at a user’s discretion.

[0059] The control unit 210 can be configured to house the receptacles for the source of saline 212 and the source of freezing agent 214. For example the source of saline 212 can include a pressurized saline container, such as a single use container. The source of freezing agent 214 can include a pressured cryoprotectant agent container for example. The control unit can further include an air pressure inlet line 220, a pressure regulator, 2-way valves 222, and a shuttle valve 218, structured and configured to control the dispensing of the saline and / or freezing agent from the control unit 210.

[0060] In one example, the fluid activator 216 can include a first footswitch 224 coupled to the control unit 210 which is configured to activate the saline stream from the source of saline 212 and a second footswitch 226 to deliver the freezing agent. In one example, the first footswitch 224 can be configured to deliver a one second burst of the saline stream when the footswitch 224 is momentarily activated. Also, the first footswitch 224 can be configured to deliver a three second burst of saline when the footswitch 224 is activated for more than two seconds. These amounts and times of delivery can be varied as needed and can be programmed into a controller 228. Further the pressure of the stream of saline can be varied. For example, the footswitch 224 can be a variable switch where the deeper the footswitch 224 is activated or pressed an increased pressure and flow of saline is delivered. As discussed above, in use the fluid control system can be configured to deliver the saline through the cannula 160 at a level and pressure to deform a wall of a duodenum and expand a papilla opening such that the user can visually identify a location of the opening through the endoscope.

[0061] The second foot switch 226 can also be functionally connected to the control unit 210 to release the cryoprotectant agent from the source of freezing agent 214 and through the cannula 160 when the foot switch 226 is activated. Thus, the fluid control system can be configured to deliver the freezing agent through the cannula 160 against an outside surface of a papilla to stabilize the papilla. The footswitch 226 can be configured to allow the user to apply short, directed burst of the cryoprotectant agent against the papilla, or in some examples a steady stream of the freezing agent can be distributed. The user will use the elevator and other control mechanisms of the endoscope 100 to properly direct the stream to the locations (the base and / or side surfaces of the papilla) where it is desired so as to stabilize the papilla tissue.

[0062] Further, the fluid activator 216 or the control unit 210 can include the electronic controller 228 that will provide the desired operation and the proper sequence of operation depending on how the user actives the footswitches 224, 226. For example, the controller 228 can be configured to automatically provide a purging stream of saline after the freezing agent has been used. Thus, the source of saline 212 can be used to purge the cannula line with a stream of saline after the freezing agent has been released. This is to prevent the potential clogging of the cannula line by the freezing agent.

[0063] This control unit 210 can be a stand-alone accessory unit or it can be embedded in any system dedicated to the console that provides the scope its power / light source, or the laser console for lithotripsy procedures, for example.

[0064] FIG. 10 shows a method (300) for performing an endoscopy procedure in accordance with one embodiment. Referring to the Figures discussed above, the method (300) can include inserting an endoscope, such as a duodenoscope, into a duodenum, and viewing an image (310) of a wall of the duodenum of a duodenal papilla. While viewing the image, the method can further include determining from the image (320) whether the duodenal papilla is in an abnormal condition such that entry of the cannula through an opening of the papilla is difficult. If the papilla is in the abnormal condition, the method includes releasing (330) through a cannula of the endoscope a fluid to alleviate the abnormal condition.

[0065] As discussed above, if the abnormal condition includes the duodenal papilla being flat and not visible in the wall of the duodenum, the user can release a stream of saline against the wall of the duodenum to deform the wall until the opening is identified.

[0066] If the abnormal condition includes the duodenal papilla being elongate and flexible, the user can release a stream of a freezing agent directed along an outer surface of the duodenal papilla to stabilize the duodenal papilla.

[0067] Accordingly, the present system allows for treating a papilla so as to help a user insert an instrument into an opening of the papilla when the opening is either hard to find or the papilla is too elongate and flexible to allow for easy entry.

[0068] FIG. 11 shows a schematic diagram of an exemplary computer-based clinical decision support system (CDSS) 400 that is configured to diagnose and suggest treatment based on images of a wall of a duodenum proximate the major duodenal papilla. In various embodiments, the CDSS 400 includes an input interface 410 through which the images of the wall of a duodenum proximate the major duodenal papilla which are specific to a patient are provided as input features to an artificial intelligence (Al) model 420, including a processor which performs an inference operation in which the images of the wall of a duodenum proximate the major duodenal papilla are applied to the Al model to generate a diagnosis of the condition of the papilla, and a user interface (UI) 440 through which diagnosis is communicated to a user, e.g., a clinician.

[0069] In some embodiments, the input interface 410 may be a direct data link between the CDSS 400 and one or more medical devices that generate at least some of the input features, such as an endoscope camera. For example, the input interface 410 may transmit the images directly to the CDSS during a therapeutic and / or diagnostic medical procedure. Additionally, or alternatively, the input interface 410 may be a classical use interface that facilitates interaction between a user and the CDSS 400. For example, the input interface 410 may facilitate a user interface through which the user may manually enter the images ordescriptions thereof. Additionally, or alternatively, the input interface 400 may provide the CDSS 400 with access to a database and an electronic patient record from which one or more input features may be extracted. In any of these cases, the input interface 410 is configured to collect one or more of the following input features in association with a specific patient on or before a time at which the CDSS 400 is used to assess whether the major duodenal papilla is abnormal requiring special treatment so as to gain access to an opening of the papilla.

[0070] For example, the database can include a plurality of images and description of a range of different papillae. The database can include a full range from normal papillae to flat papillae, to elongate papillae. These images can be categorized and input into the CDSS 400.

[0071] The input will also include the specific image of the wall of the present papilla being diagnosed.

[0072] Based on one or more of the above input features, the processor performs an inference operation using the Al model 420 to generate diagnose and suggest treatment based on images of a wall of a duodenum proximate the major duodenal papilla. For example, input interface 410 may deliver the present image of the wall of a duodenum proximate the major duodenal papilla into the input layer of the Al model which propagates these input features through the Al model to an output layer. The Al model can provide a computer system the ability to perform tasks, without explicitly being programmed, by making inferences based on patterns found in the analysis of data. Al model explores the study and construction of algorithms (e.g., machine-learning algorithms) that may learn from existing data and make predictions about new data. Such algorithms operate by building an Al model from example training data in order to make data-driven predictions or decisions expressed as outputs or assessments.

[0073] There are two common modes for machine learning (ML): supervised ML and unsupervised ML. Supervised ML 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 ML 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 ML 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 ML is useful in exploratory analysis because it can automatically identify structure in data.

[0074] Common tasks for supervised ML are classification problems and regression problems. Classification problems, also referred to as categorization problems, aim at classifying items into one of several category values (for example, is this object an apple or an orange?). 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).

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

[0076] 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 machinelearning 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.

[0077] In some examples, the Al model may be trained continuously or periodically prior to performance of the inference operation by the processor. Then, during the inference operation, the patient specific input features provided to the Al model may be propagated from an input layer, through one or more hidden layers, and ultimately to an output layer that corresponds to the diagnose and suggest treatment based on images of a wall of a duodenum proximate the major duodenal. For example, the Al model 420 may determine from the present image compared to the images of the database that the present papilla is flat and that a saline procedure should be used, or the Al model may suggest that the papilla is elongate and that a freezing process should be used. These outputs can be accompanied by a corresponding Al generated confidence level. In examples, images from the duodenoscope 100 can be analyzed in real-time. Video output of duodenoscope 100 presented on output unit 18 can include indicia, such as arrows or circles, that can be generated from using the Al model. The indicia can be overlayed onto the video images from duodenoscope 100 to instruct a user where to place stream of saline 164 or freezing agent 170 or cannula 160.

[0078] During and / or subsequent to the inference operation, the diagnosis and suggested treatment may be communicated to the user via the user interface (UI) and / or automatically cause the endoscope to perform the suggested treatment. For example, the Al model can determine from the present image whether the duodenal papilla is in an abnormal condition such that entry of the cannula through an opening of the papilla is difficult, and suggest to the user, or automatically perform itself, a proposed treatment, such as a saline process or a freezing process, a discussed above.Various Notes & Examples

[0079] Example 1 can include or use subject matter such as a method for performing an endoscopy procedure including viewing an image of a wall of a duodenum proximate a papilla using an endoscope, releasing through a cannula of the endoscope a fluid towards the papilla while viewing the image, and inserting an instrument through an opening of the papilla after releasing the fluid.

[0080] Example 2 can include, or can optionally be combined with the subject matter of Example 1, to optionally include determining from the image whether the papilla is in an abnormal condition such that entry of an instrument through an opening of the papilla is difficult, and if the papilla is in the abnormal condition, releasing the fluid towards the papilla to alleviate the abnormal condition.

[0081] Example 3 can include, or can optionally be combined with the subject matter of Examples 1 or 2, to optionally include the papilla being flat and not distinguishable in the wall of the duodenum from surrounding tissue and the fluid released through the cannula includes a stream of saline against the wall of the duodenum.

[0082] Example 4 can include, or can optionally be combined with the subject matter of one or any combination of Examples 1 through 3 to optionally include the stream of saline includes a one second to a three second burst of saline.

[0083] Example 5 can include, or can optionally be combined with the subject matter of one or any combination of Examples 1 through 4 to optionally include the stream of saline deforming the wall and expanding the opening.

[0084] Example 6 can include, or can optionally be combined with the subject matter of one or any combination of Examples 1 through 5 to optionally include the stream of saline is directed at various locations along the wall until the opening is expanded and identified.

[0085] Example 7 can include, or can optionally be combined with the subject matter of one or any combination of Examples 1 through 6 to optionally include the papilla being elongate and flexible and the fluid released through the cannula includes a stream of a freezing agent directed along an outer surface of the papilla to stabilize the papilla.

[0086] Example 8 can include, or can optionally be combined with the subject matter of one or any combination of Examples 1 through 7 to optionally include the freezing agent includes a cryoprotectant freezing agent.

[0087] Example 9 can include, or can optionally be combined with the subject matter of one or any combination of Examples 1 through 8 to optionally include the outer surface of the papilla includes a base and side surfaces of the papilla and does not include a tip of the papilla proximate the opening.

[0088] Example 10 can include, or can optionally be combined with the subject matter of one or any combination of Examples 1 through 9 to optionally include purging the cannula with saline after dispensing the freezing agent.

[0089] Example 11 can include or use subject matter such as an apparatus for stabilizing a papilla, including a cannula extending through a duodenoscope configured for extending through a duodenum to reach a papilla within the duodenum, and a cryoprotectant container coupled to the cannula to deliver a cryoprotectant agent through the cannula against an outer surface of the papilla and configured to stabilize the papilla.

[0090] Example 12 can include, or can optionally be combined with the subject matter of Example 11 to optionally include an amount of the cryoprotectant agent delivered is configured for temporarily freezing the papilla.

[0091] Example 13 can include, or can optionally be combined with 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 agent from the cryoprotectant container and through the cannula when the foot switch is activated.

[0092] Example 14 can include, or can optionally be combined with the subject matter of one or any combination of Examples 11 through 13 to optionally include a saline container coupled to the cannula and configured to purge a line of the cannula with a stream of saline after the cryoprotectant agent has been released.

[0093] Example 15 can include, or can optionally be combined with the subject matter of one or any combination of Examples 11 through 14 to optionally include an elevator to direct the cannula, and the duodenoscope is configured to direct the cryoprotectant agent against a base of papilla and not a tip of the papilla.

[0094] Example 16 can include or use subject matter such a system including 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 source of saline and a source of a freezing agent, and a fluid activator, wherein the fluid activator is configured to deliver at least one of the saline and the freezing agent through the cannula at a user’s discretion.

[0095] Example 17 can include, or can optionally be combined with the subject matter of Example 16 to optionally include the fluid control system being configured to deliver the saline through the cannula at a level to deform a wall of a duodenum and expand a papilla opening such that a user can identify a location of the papilla opening through the endoscope.

[0096] Example 18 can include, or can optionally be combined with the subject matter of one or any combination of Examples 16 through 17 to optionally include the fluid control system being configured to deliver the freezing agent through the cannula against an outside surface of a papilla to stabilize the papilla.

[0097] Example 19 can include, or can optionally be combined with the subject matter of one or any combination of Examples 16 through 18 to optionally include, wherein after the freezing agent is delivered, the system is configured to deliver a burst of saline to purge the cannula.

[0098] Example 20 can include, or can optionally be combined with the subject matter of one or any combination of Examples 16 through 19 to optionally include the freezing agent includes a cryoprotectant.

[0099] Example 21 can include, or can optionally be combined with the subject matter of one or any combination of Examples 16 through 20 to optionally include a first footswitch to deliver the saline and a second footswitch to deliver the freezing agent.

[0100] Example 22 can include, or can optionally be combined with the subject matter of one or any combination of Examples 16 through 21 to optionally include the first footswitch being configured to deliver a one second burst of the saline when the first footswitch is momentarily activated.

[0101] Example 23 can include, or can optionally be combined with the subject matter of one or any combination of Examples 16 through 22 to optionally include the first footswitch being configured to deliver a three second burst of saline when the first footswitch is activated for more than two seconds.

[0102] Each of these non-limiting examples can stand on its own, or can be combined in various permutations or combinations with one or more of the other examples.

[0103] The above detailed description includes references to the accompanying drawings, which form a part of the detailed description. The drawings show, by way of illustration, specific embodiments in which the invention can be practiced. These embodiments are also referred to herein as “examples.” Such examples can include elements in addition to those shown or described. However, the present inventor also contemplates examples in which only those elements shown or described are provided. Moreover, the present inventor also contemplates examples using any combination or permutation of those elements shown or described (or one or more aspects thereof), either with respect to a particular example (or one or more aspects thereof), or with respect to other examples (or one or more aspects thereof) shown or described herein.

[0104] In the event of inconsistent usages between this document and any documents so incorporated by reference, the usage in this document controls.

[0105] In this document, the terms “a” or “an” are used, as is common in patent documents, to include one or more than one, independent of any other instances or usages of “at least one” or “one or more.” In this document, the term “or” is used to refer to a nonexclusive or, such that “A or B” includes “A but not B,” “B but not A,” and “A and B,” unless otherwise indicated. In this document, the terms “including” and “in which” are used as the plain- English equivalents of the respective terms “comprising” and “wherein.” Also, in the following claims, the terms “including” and “comprising” are open-ended, that is, a system, device, article, composition, formulation, or process that includes elements in addition to those listed after such a term in a claim are still deemed to fall within the scope of that claim. Moreover, in the following claims, the terms “first,” “second,” and “third,” etc. are used merely as labels, and are not intended to impose numerical requirements on their objects.

[0106] Method examples described herein can be machine or computer-implemented at least in part. Some examples can include a computer-readable medium or machine-readable medium encoded with instructions operable to configure an electronic device to perform methods as described in the above examples. An implementation of such methods can include code, such as microcode, assembly language code, a higher-level language code, or the like. Such code can include computer readable instructions for performing various methods. The code may form portions of computer program products. Further, in an example, the code can be tangibly stored on one or more volatile, non-transitory, or nonvolatile tangible computer-readable media, such as during execution or at other times. Examples of these tangible computer-readable media can include, but are not limited to, hard disks, removable magnetic disks, removable optical disks (e.g., compact disks and digitalvideo disks), magnetic cassettes, memory cards or sticks, random access memories (RAMs), read only memories (ROMs), and the like.

[0107] 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 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.

Claims

THE CLAIMED INVENTION IS:

1. A method for performing an endoscopy procedure, the method comprising: viewing an image of a wall of a duodenum proximate a papilla using an endoscope; releasing through a cannula of the endoscope a fluid towards the papilla while viewing the image; and inserting an instrument through an opening of the papilla after releasing the fluid.

2. The method of claim 1, further including determining from the image whether the papilla is in an abnormal condition such that entry of an instrument through an opening of the papilla is difficult, and if the papilla is in the abnormal condition, releasing the fluid towards the papilla to alleviate the abnormal condition.

3. The method of claim 2, wherein the abnormal condition includes the papilla being flat and not distinguishable in the wall of the duodenum from surrounding tissue and the fluid released through the cannula includes a stream of saline against the wall of the duodenum.

4. The method of claim 3, wherein the stream of saline includes a one second to a three second burst of saline.

5. The method of claim 3, wherein the stream of saline deforms the wall and expands the opening.

6. The method of claim 5, wherein the stream of saline is directed at various locations along the wall until the opening is expanded and identified.

7. The method of claim 2, wherein the abnormal condition includes the papilla being elongate and flexible and the fluid released through the cannula includes a stream of a freezing agent directed along an outer surface of the papilla to stabilize the papilla.

8. The method of claim 7, wherein the freezing agent includes a cryoprotectant freezing agent.

9. The method of claim 7, wherein the outer surface of the papilla includes a base and side surfaces of the papilla and does not include a tip of the papilla proximate the opening.

10. The method of claim 7, further including purging the cannula with saline after dispensing the freezing agent.

11. An apparatus for stabilizing a papilla, the apparatus comprising: a cannula extending through a duodenoscope configured for extending through a duodenum to reach a papilla within the duodenum; and a cryoprotectant container coupled to the cannula to deliver a cryoprotectant agent through the cannula against an outer surface of the papilla and configured to stabilize the papilla.

12. The apparatus of claim 11, wherein an amount of the cryoprotectant agent delivered is configured for temporarily freezing the papilla.

13. The apparatus of claim 11, further including a foot switch coupled to the cryoprotectant container to release the cryoprotectant agent from the cryoprotectant container and through the cannula when the foot switch is activated.

14. The apparatus of claim 13, further including a saline container coupled to the cannula and configured to purge a line of the cannula with a stream of saline after the cryoprotectant agent has been released.

15. The apparatus of claim 11, wherein the duodenoscope includes an elevator to direct the cannula, and the duodenoscope is configured to direct the cryoprotectant agent against a base of papilla and not a tip of the papilla.

16. 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 source of saline and a source of a freezing agent; anda fluid activator, wherein the fluid activator is configured to deliver at least one of the saline and the freezing agent through the cannula at a user’s discretion.

17. The system of claim 16, wherein the fluid control system is configured to deliver the saline through the cannula at a level to deform a wall of a duodenum and expand a papilla opening such that a user can identify a location of the papilla opening through the endoscope.

18. The system of claim 16, wherein the fluid control system is configured to deliver the freezing agent through the cannula against an outside surface of a papilla to stabilize the papilla.

19. The system of claim 18, wherein after the freezing agent is delivered, the system is configured to deliver a burst of saline to purge the cannula.

20. The system of claim 18, wherein the freezing agent includes a cryoprotectant.

21. The system of claim 16, wherein the fluid activator includes a first footswitch to deliver the saline and a second footswitch to deliver the freezing agent.

22. The system of claim 21, wherein the first footswitch is configured to deliver a one second burst of the saline when the first footswitch is momentarily activated.

23. The system of claim 22, wherein the first footswitch is configured to deliver a three second burst of saline when the first footswitch is activated for more than two seconds.

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