Guiding sheath and anchoring wire for cholangioscopic system

Abstract

A method for direct peroral cholangioscopy includes inserting an endoscope into a guiding sheath, inserting the guiding sheath and endoscope into the duodenum, extending a tissue retrieval device through the endoscope into the duodenum, extending a tether wire into the duodenum, collecting biological material with the tissue retrieval device, and withdrawing the cholangioscope and tissue retrieval device from the duodenum along the tether wire. A cholangioscopy system includes a steerable guiding sheath and a cholangioscope having a shaft extending to a distal end face for displacement within the steerable guiding sheath, a tool lumen extending along the shaft and exiting at the distal end face, an anchoring lumen entering the shaft between a proximal end portion and the distal end face and exiting at the distal end face, and an exchange lumen extending from the tool lumen to exterior of the shaft at the distal end face.

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit of priority to U.S. Provisional Patent Application No. 63 / 199,316, filed December 18, 2020, and U.S. Provisional Patent Application No. 63 / 213,849, filed June 23, 2021, the contents of which are incorporated by reference in their entireties herein.

[0002] The present disclosure relates generally to medical devices that include an elongate body configured to be inserted into an incision or opening in a patient's anatomy to provide a diagnostic or treatment procedure.

[0003] More particularly, the present disclosure relates to medical devices, such as endoscopes, that may be inserted into a patient's anatomy, such as with the aid of other devices, to facilitate the performance of a biological material removal process, such as by cutting sample tissue with forceps for subsequent analysis. [Background technology]

[0004] Endoscopes may be used for one or more of: 1) providing for the passage of therapeutic or other devices, such as tissue collection devices, to various anatomical portions, such as the gastrointestinal tract (e.g., esophagus, stomach, duodenum, pancreatic bile duct, intestines, colon, etc.), renal area (e.g., kidneys, ureters, bladder, urethra), and other internal organs (e.g., reproductive system, paranasal sinuses, submucosal areas, airways, etc.).

[0005] Conventional endoscopes may be involved in a variety of clinical diagnostic procedures including, for example, illuminating, imaging, detecting, and diagnosing one or more medical conditions; providing fluid delivery (e.g., saline or other preparations via fluid channels) to an anatomical region; providing passage of one or more therapeutic devices (e.g., via a working channel) to sample or treat an anatomical region; and providing an aspiration passage for collecting fluid (e.g., saline or other preparations).

[0006] In a conventional endoscope, the distal portion of the endoscope may be configured to support and orient a therapeutic device, such as with the use of an elevator. In some systems, two endoscopes may be configured to work together, with a first endoscope guiding a second endoscope being inserted with the aid of an elevator. Such a system may be useful for guiding an endoscope to anatomical locations inside the body that are difficult to reach. For example, some anatomical locations can only be accessed by an endoscope after insertion through a circuitous path.

[0007] One example of an endoscopic procedure is called endoscopic retrograde cholangiopancreatography, hereafter referred to as an "ERCP" procedure. In an ERCP procedure, an auxiliary scope (also called a daughter scope or cholangioscope) can be attached and advanced through the working channel of a "main scope" (also called a mother scope or duodenoscope). In addition, a tissue retrieval device used to remove sample material is inserted through the auxiliary scope. In this manner, the duodenoscope, auxiliary scope, and tissue retrieval device are successively inserted into progressively smaller lumens, making them progressively smaller and more difficult to navigate and perform interventions and procedures. [Prior art documents] [Patent documents]

[0008] [Patent Document 1] WO2011 / 140118A1 [Non-patent literature]

[0009] [Non-Patent Document 1] Direct Peroral Cholangioscopy by Mansour A. Parsi, MD, in the World Journal of Gastrointestinal Endoscopy, published online January 16, 2014 Summary of the Invention [Problem to be solved by the invention]

[0010] The inventors have recognized that problems to be solved with conventional medical devices, particularly endoscopes and duodenoscopes used to retrieve sample biological material, include, among others, 1) difficulties in navigating an endoscope and instruments inserted therein to locations within anatomical regions deep within a patient, 2) drawbacks associated with operating three instruments (e.g., a duodenoscope, a cholangioscope, a tissue removal device), such as the need for multiple skilled instrument operators, 3) increased time and associated costs due to the need to repeatedly remove and reinsert medical devices to obtain sufficient quality of sample material, and 4) difficulties in incorporating features (e.g., maneuverability and tissue collection features) into small diameter devices.

[0011] The inventors have recognized that such problems may be particularly present in duodenal endoscopy procedures, such as the ERCP procedure described above. Attempts have been made in recent times to address the deficiencies of ERCP procedures. Recent developments have involved the use of endoscopes in direct peroral cholangioscopy procedures, where the endoscope is advanced directly into the patient's mouth to reach the common bile duct. See, for example, the review in Direct Peroral Cholangioscopy by Mansour A. Parsi, MD, in the World Journal of Gastrointestinal Endoscopy, published online on January 16, 2014. However, such procedures are difficult to implement due to the inevitable looping of the endoscope created by guiding it through the pyloric sphincter of the stomach and the sphincter of the common bile duct (sphincter of Oddi). This looping of the endoscope can result in the inoperability of the endoscope due to binding, for example, the endoscope being curved too tightly to allow additional articulation. [Means for solving the problem]

[0012] The present disclosure can help provide solutions to these and other problems by providing systems, devices, and methods related to direct peroral cholangioscopy procedures, such as those that include a guiding sheath that can be placed over the endoscope to provide 1) direct secondary steering of the endoscope in addition to the endoscope's primary native steering capabilities, and 2) a rigid structure against which the endoscope can be pressed using its primary native steering capabilities to provide articulation of the endoscope, such that when the endoscope is positioned in the common bile duct, the native steering features of the endoscope remain operable to position a therapeutic device at a target tissue site (e.g., a site containing tissue to be treated or retrieved for analysis).

[0013] The present disclosure, as described herein, can thereby help solve the above-mentioned and other problems by, among other things, 1) increasing the ease of use of direct via-the-mouth cholangioscopy and ERCP systems (e.g., fewer operators, less skill required to navigate through the sphincter of Oddi / ampulla of Vater) and 2) increasing the dimensions of the treatment devices (e.g., increasing the volume of sample material collected with each insertion, reducing the number of times a tissue retrieval device needs to be inserted and reinserted into an anatomical structure).

[0014] In an example, a cholangioscopy system may include a guiding sheath and a cholangioscope. The guiding sheath may include a steerable lumen. The endoscope may include an elongate shaft extending between a proximal end portion and a distal end face, the elongate shaft configured for placement along the steerable lumen, a working tool lumen extending along the elongate shaft and exiting at the distal end face, an anchoring lumen entering the elongate shaft between the proximal end portion and the distal end portion and exiting the elongate shaft at the distal end face, and a non-axial lumen extending from the working tool lumen to an exterior of the elongate shaft at the distal end face.

[0015] In another example, a method of performing a direct peroral cholangioscopy procedure may include inserting an endoscope into a guiding sheath, inserting the guiding sheath and endoscope into the patient's duodenum, extending a tissue retrieval device through the endoscope and into the patient's common bile duct, extending a tether wire into the common bile duct, collecting biological material with the tissue retrieval device, and withdrawing the cholangioscope and tissue retrieval device from the common bile duct along the tether wire.

[0016] Additionally, the inventors have recognized that problems solved with traditional surgical procedures, such as duodenoscope procedures in the gastrointestinal system, may utilize follow-up procedures to address problems from the original procedure or to provide additional treatment. Multiple follow-up procedures are sometimes performed to provide ongoing treatment, etc., whereby the complex guiding and steering procedures described above are repeated two or more times.

[0017] The present disclosure provides a solution to these and other problems by providing an implantable device that can facilitate follow-up procedures. In particular, the implantable device can expedite follow-up procedures by providing rapid access to anatomical structures such as the duodenum and, in particular, the common bile duct. The re-entry device can include a stent that can include cutting capabilities that allow the stent to be implanted into an anatomical stricture. The implantable device can include a re-entry device that includes a tube, track, rail, guidewire, etc. that can provide a path through complex anatomical shapes to allow the procedure to follow a previously planned path. The re-entry device can allow a treatment device, such as a stent, to be inserted into the re-entry tube or slid over the re-entry guidewire, thereby eliminating the need for complex mother / daughter scopes, etc. The treatment device can be implanted into an anatomical structure to provide a one-time or ongoing treatment, such as pumping fluids, eradicating stones, etc.

[0018] In an example, a system for providing repeatable access to an anatomical area of ​​a patient may include a stent having a ring-shaped body and a re-entry track extending through the stent and may include an elongate body having proximal and distal ends extending from the ring-shaped body.

[0019] In another example, a method for implanting a treatment device in an anatomical structure may include the steps of implanting a stent at an anatomical opening, positioning a re-entry path extending from the stent into the anatomical passageway, sliding the treatment device along the re-entry path to position the treatment device in the anatomical passageway, and treating the anatomical structure with the treatment device. [Brief description of the drawings]

[0020] [Figure 1A] FIG. 1 is a schematic diagram of a direct oral cholangioscopic system including a guiding sheath, a cholangioscope, and a tissue retrieval device in a nested configuration. [Figure 1B] FIG. 1B is a schematic diagram of the direct oral cholangioscopic system of FIG. 1A in a disassembled state showing the guiding sheath and the internal lumen through the cholangioscope. [Diagram 2] FIG. 1C is a schematic diagram of the distal end portion of the guiding sheath, cholangioscope, and tissue retrieval device of FIGS. 1A and 1B. [Diagram 3] FIG. 1C is a schematic diagram of the cholangioscope of FIGS. 1A and 1B showing a schematic diagram of an imaging control system with a control unit connected to the cholangioscope. [Figure 4] FIG. 4 is a schematic diagram of the imaging control system of FIG. 3 connected to a cholangioscope. [Figure 5A] FIG. 5 is an end view of a camera module including optical and functional components suitable for use with the cholangioscope of FIGS. 1A-4. [Figure 5B] 5B is a cross-sectional view taken along plane 5B-5B of FIG. 5A showing components of the camera module. [Figure 6] FIG. 1C is a schematic diagram showing the guiding sheath and cholangioscope of FIGS. 1A and 1B inserted orally into a patient to reach the duodenum. [Figure 7] 7 is a schematic diagram showing the guiding sheath and cholangioscope of FIG. 6 positioned in the duodenum and a tissue retrieval device positioned in the common bile duct. [Figure 8] FIG. 13 is a perspective view of another example of a cholangioscope configured for use with the guiding sheath of the present disclosure. [Figure 9]FIG. 9 is an end view of the cholangioscope of FIG. 8 showing the tether wire lumen and the non-axial lumen. [Figure 10] FIG. 10 is a schematic diagram of a cross section taken along plane 10-10 of the cholangioscope of FIG. 9 showing the non-axial lumen. [Figure 11] FIG. 11 is a schematic diagram of a cross section taken along plane 11-11 of the cholangioscope of FIG. 9 showing the tether wire lumen. [Figure 12A] FIG. 9 is a schematic diagram of the cholangioscope of FIG. 8 inserted into the common bile duct with tether wires attached to tissue and a tissue retrieval device extended beyond the non-axial lumen. [Figure 12B] FIG. 9 is a schematic diagram of the cholangioscope of FIG. 8 being withdrawn from the common bile duct with tether wires attached to tissue and the tissue retrieval device bent to extend through the non-axial lumen. [Figure 13] FIG. 1 is a block diagram illustrating a method of retrieving a tissue sample from within a patient's common bile duct using a cholangioscope having a tethered wire lumen and a non-axial lumen. [Figure 14] FIG. 1 is a schematic diagram of the duodenum connected to the common bile duct via the duodenal papilla. [Figure 15] 15 is a schematic diagram of the duodenum of FIG. 14 with a stent of the present disclosure inserted into the duodenal papilla. [Figure 16A] FIG. 2 is a schematic diagram of a collapsed stent with an inflation balloon inserted and electrical leads extending therethrough. [Figure 16B] FIG. 16B is a schematic diagram of the stent of FIG. 16A in an expanded state with electrical leads in situ. [Figure 16C] FIG. 16C is a schematic diagram of the stent of FIG. 16B in an expanded state with electrical leads extending from the stent. [Figure 17] FIG. 2 is a schematic side view of a stent of the present application including electrical leads extending into a cylindrical mesh stent body. [Figure 18] 1 is a schematic side view of a stent of the present application including a mechanical cutting blade. [Figure 19] FIG. 19 is an end view of the stent of FIG. 18 showing the anchoring barbs. [Figure 20A] 1 is a schematic cross-sectional view of a magnetically active stent in a collapsed state. [Figure 20B] FIG. 20B is a schematic cross-sectional view of the magnetically active stent of FIG. 20A in an expanded state. [Figure 21] 20C is an example of a magnetic applicator configured to expand and contract the magnetically active stent of FIGS. 20A and 20B. [Figure 22] 1 is a schematic side view of a stent of the present application including an expandable elongate re-entry device. [Figure 23] FIG. 23 is an end view of the stent of FIG. 22 showing the lumen through the stent and the expandable re-entry device. [Figure 24] FIG. 24 is a schematic diagram of the stent of FIGS. 22 and 23 with an expandable elongate re-entry device in a deployed state. [Diagram 25] FIG. 1 is a side view of a stent of the present disclosure having an elongated re-entry device with infundibulum entry as it is deployed in the cystic duct. [Figure 26] FIG. 2 is a schematic side view of a stent comprising an elongate re-entry device including a distal stent. [Figure 27] FIG. 27 is a schematic side view of the duodenum and the stent of FIG. 26 deployed in the cystic and pancreatic ducts. [Figure 28] FIG. 1 is a schematic diagram of a duodenum having an implantable device of the present disclosure including an expandable and contractible pumping stent. [Figure 29A] 1 is a schematic side view of a stent configured to treat gallstones. [Figure 29B] FIG. 29B is a schematic end view of the gallstone treatment stent of FIG. 29A. [Diagram 30] FIG. 1 is a schematic diagram of a duodenum having an implantable device of the present disclosure including multiple monorail devices. [Diagram 31] FIG. 1 is a schematic diagram of a monorail with corkscrew moorings. [Figure 32A] FIG. 2 is a schematic diagram of a monorail with a first example of a deployable mooring in a collapsed state. [Figure 32B] FIG. 32B is a schematic diagram of the monorail of FIG. 32A with the deployable tether in an extended state. [Figure 33A] FIG. 13 is a schematic diagram of a monorail with a second example of a deployable mooring in a collapsed state. [Figure 33B] FIG. 33B is a schematic diagram of the monorail of FIG. 33A with the deployable tether in an extended state. [Diagram 34] FIG. 2 is a schematic diagram of a first example of an elongate deployable member with perforations. [Diagram 35] FIG. 2 is a schematic diagram of a first example of an elongate deployable member comprising a slit. [Diagram 36] 1 is a schematic diagram of a first example of an elongate deployable member with slits. [Figure 37] FIG. 2 is a schematic diagram of a first example of an elongate deployable member comprising a C-shaped reinforcement. [Figure 38] FIG. 2 is a schematic diagram of a first example of an elongate deployable member comprising a magnetic closure element. [Figure 39] FIG. 1 is a schematic perspective view of an elongated deployable member having a treatment device slid therethrough to expand the elongated deployable member. [Diagram 40] 1 is a block diagram illustrating a method of implanting a re-entry device of the present application having a treatment device. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0021] Figure 1A is a schematic diagram of a direct oral cholangioscopy system 100 with a guiding sheath 102, a cholangioscope 104, and a tissue retrieval device 106 in a nested configuration. Figure 1B is a schematic diagram of a direct oral cholangioscopy system 100 with a guiding sheath 102, a cholangioscope 104, and a tissue retrieval device 106 in a disassembled configuration. Figures 1A and 1B are considered together. Figures 1A and 1B are not necessarily drawn to scale and may be exaggerated in certain aspects for illustrative purposes.

[0022] The system 100 may include a guiding sheath 102, a cholangioscope 104, and a tissue retrieval device 106. The sheath 102 may include a shaft 108 and a control device 110, which may include a grip 112, a control knob 114, and a coupler 116 that may be connected to a control unit 16 (FIG. 4) via a cable 118. The cholangioscope 104, which is described in more detail with reference to FIGS. 3-5B, may include an elongated body 120 and a coupler 122 that may be connected to the control unit 16 via a cable 124. The tissue retrieval device 106 may include a shaft 126, a tissue separator 128, and a control device 130. The tissue separator 128 may include a hinge 132 and a separator 134.

[0023] Figure 1A shows a cholangioscope 104 nested within a sheath 102 and a tissue retrieval device 106 nested within the cholangioscope 104. Thus, as seen in Figure 1B, the sheath 102 can include a lumen 136 and the cholangioscope 104 can include a lumen 138.

[0024] As discussed in more detail herein, the direct oral cholangioscopy system 100 can be configured to provide simplified navigation to the duodenum and common bile duct and allow for large sample sizes, thereby reducing procedural complexity and the number of times instruments are inserted into the duodenum and common bile duct to retrieve an adequate amount of tissue on which testing can be performed.

[0025] The shaft 108 of the guiding sheath 102 may include pull wires (140A, 140B in FIG. 2) that can be used to steer the guiding sheath 102. The control device 110 can be used to operate the guiding sheath 102, including the pull wires. For example, the gripper 112 can be grasped by an operator and the control knob 114 can be rotated to pull on one or both of the pull wires to add directionality to the shape of the shaft 108. Thus, the guiding sheath 102 can be used to affect the shape of the cholangioscope 104 that can be positioned inside the shaft 108. To that end, the shaft 108 can be made of a suitable material that is malleable enough to be oriented by the pull wires, but rigid enough to push the cholangioscope 104 off the shaft 108. In an example, the shaft 108 can be configured with sections having different stiffness, for example, to focus the ability of the shaft 108 to be steered in specific sections of the guiding sheath 102. For example, a distal end portion 139A of the shaft 108 (e.g., approximately the most distal 10-20 percent) can be configured to be more flexible than the remaining proximal portion 139B to allow a pull wire to pull the distal end of the shaft 108 at an acute angle (e.g., approximately 30-90 degrees), which may be useful when guiding the cholangioscope 104 from the duodenum 202 (FIG. 7) to the common bile duct 212 (FIG. 7). The segmentation of flexibility of the shaft 108 may provide the cholangioscope with stiffness in a more rigid portion proximal to the distal flexible portion, allowing the cholangioscope to more effectively use its inherent steering capabilities (e.g., without bending as described above). For example, the proximal portion 139B can have greater stiffness than the cholangioscope 104 so that when the cholangioscope 104 is manipulated, such as by tension in one or more pull wires 146A and 146B, the cholangioscope 104 can be pushed in a desired direction by pulling on the pull wires 146A and 146B.

[0026] The cholangioscope 104 can be configured as a fully functional endoscope, including maneuverability, guidance capabilities, imaging capabilities, fluid dispensing and withdrawal capabilities, and functionality (e.g., therapeutic and diagnostic) capabilities, as well as a passageway for other instruments. The functionality of the cholangioscope 104 is described in detail below with reference to the endoscope 14 of Figures 3 and 4, and is therefore shown only diagrammatically in Figures 1A and 1B.

[0027] The tissue retrieval device 106 may be configured as any suitable device configured to obtain a tissue sample from within a patient. However, the tissue retrieval device 106 may include components or devices for interaction with the patient, such as those configured to cut, slice, pluck, snip, punch, twist, or shear tissue. Specifically, the tissue retrieval device 106 may include any device suitable for removing tissue from a patient, such as a blade, punch, or auger. The tissue retrieval device 106 may be configured to physically separate a portion of the patient's tissue from other, larger portions of the patient's tissue. In an additional example, the tissue retrieval device 106 may be configured to only collect biological material from the patient that does not require physical separation, such as mucus or fluid. In the illustrated example, the tissue retrieval device 106 may include a forceps having a separator 134 configured as a sharp or serrated jaw pivotally connected at a hinge 132. However, tissue retrieval device 106 may be configured as a variety of devices capable of collecting biological material, such as punches, augers, blades, saws, etc. Although the term "tissue retrieval device" is used throughout this disclosure, tissue retrieval device 106 may alternatively or additionally comprise a biological material collection device, a biological material retrieval device, a tissue collection device, and a tissue retrieval device.

[0028] The tissue collection device 106 may be configured to retain a volume of collected biological material, such as tissue, such as between separators 134, such that the tissue collection device 106 can be configured to be withdrawn from the cholangioscope 104 to obtain the collected biological material, such as for diagnostic analysis. In other examples, the tissue collection device 106 may include a lumen through which the biological material can be withdrawn without having to withdraw the tissue collection device 106 from the cholangioscope 104.

[0029] The guiding sheath 102 can be configured as a simple tubular body with limited guidance capabilities that can be used to enhance the native guidance capabilities of the cholangioscope without increasing the size and complexity of the system components and procedure, thereby allowing the native guidance and imaging capabilities of the cholangioscope 104 to be used throughout the procedure. This eliminates the need for a mother duodenoscope, which requires a small sized cholangioscope, associated electronics, and associated skilled personnel. Thus, without a bulky fully functional duodenoscope, the diameter of the elongated body 120 of the cholangioscope 104 can be increased, thereby allowing for an associated increase in the size of the tissue retrieval device 106. Due to the simplicity of the guiding sheath 102, the guiding sheath 102 can be configured to be disposable.

[0030] 2 is a schematic diagram of the distal end portion of the guiding sheath 102, cholangioscope 104, and tissue retrieval device 106 of FIGS. 1A and 1B. The guiding sheath 102 may include a shaft 108 and a lumen 136. The cholangioscope 104 may include an elongate body 120 and a lumen 138. The tissue retrieval device 106 is additionally shown extending from the lumen 138. The tissue retrieval device 106 may include a shaft 126 and a tissue separator 128. FIG. 2 is not necessarily drawn to scale and may be exaggerated in certain aspects for illustrative purposes.

[0031] As shown, the guiding sheath 102, the cholangioscope 104, and the tissue retrieval device 106 may be configured to be inserted through a particular anatomical structure and to be nested within one another to maximize the size of the tissue retrieval device 106.

[0032] The guiding sheath 108 may have an outer diameter D1 configured for insertion into a patient's mouth 201 (FIG. 6). The guiding sheath 108 may be configured to be as large as a typical patient's anatomy would accommodate, such as the esophagus 206 (FIG. 6) and duodenum 202 (FIG. 6). Additionally, the guiding sheath 108 may be configured with different sizes to accommodate different sized human anatomy. In an example, D1 may range from approximately 10.0 mm to approximately 12.0 mm. In an additional example, D1 may range from approximately 8.0 mm to approximately 9.0 mm.

[0033] The lumen 136 of the guiding sheath 108 can have a diameter D2 and can be configured to be as large as possible while still allowing for the desired steerability of the guiding sheath 108, including flexibility, durability, and stiffness. The shaft 108 can have a thickness between D1 and D2 that is suitable for incorporating the pull wires 140A and 140B and other associated components, such as a pull ring. The control knob 114 (FIG. 1A) can be configured to tension the pull wires 140A and 140B to apply bending forces to the shaft 108, for example, to steer the guiding sheath 102 and to apply bending forces associated with the cholangioscope 104 as it is inserted into the lumen 136. However, in other examples, tether wires can be included within the lumen 136. In examples, given the simple structure of the guiding sheath 108, the guiding sheath 108 can be configured as a disposable item intended for a single use. In examples, D2 may range from approximately 9.0 mm to approximately 11.0 mm. In additional examples, D2 may range from approximately 8.0 mm to approximately 9.00 mm.

[0034] The cholangioscope 104 may have an outer diameter D3 configured for insertion into the lumen 136 of the guiding sheath 102. The cholangioscope 104 need not be configured to maximize the dimensions available from the diameter D2, but may be configured to utilize as much of the space in the lumen 136 as necessary to provide the cholangioscope with the desired capabilities. The elongate body 120 may be configured to slide freely within the lumen 136 without becoming stuck. In an example, D3 may range from approximately 8.0 mm to approximately 10.0 mm. In an additional example, D3 may range from approximately 4.0 mm to approximately 4.5 mm.

[0035] The lumen 138 of the cholangioscope 104 may have a diameter D4 and may be configured to allow for as much space as possible for the optical and other surgical components of the cholangioscope 104. Thereby, the lumen 138 may be configured to have one or more lumens 142 for other desired functionality of the cholangioscope 104. The lumen 142 may be configured to receive the components discussed with reference to FIGS. 5A and 5B, such as the optical transmitter 84, the wiring 88, and the fluid lines 89. Similarly, the lumen 138 may be configured to receive the pull wires 146A and 146B, which may be coupled to the knob 38 (FIG. 3) on the elongated body 120. In an example, D4 ​​may range from approximately 5.0 mm to approximately 6.0 mm. In an additional example, D4 ​​may range from approximately 2.0 mm to approximately 3.0 mm.

[0036] FIG. 3 is a schematic diagram of an endoscopic system 10 comprising an imaging control system 12 and an endoscope 14. The system of FIG. 3 is an illustrative example of an endoscopic system suitable for use with the systems, devices, and methods described herein, such as a direct oral cholangioscope system that may be used to obtain samples of tissue or other biological material removed from a patient for analysis or treatment of the patient. According to an example, the endoscope 14 may comprise the cholangioscope 104 of FIGS. 1A-2 and may be insertable into an anatomical region for imaging and / or to provide passage of one or more sampling devices for biopsy or one or more therapeutic devices for treatment of a medical condition associated with the anatomical region. The endoscope 14 advantageously interacts with and connects to the imaging control system 12. In the illustrated example, the endoscope 14 is an end-viewing cholangioscope, although other types of endoscopes may be used with the features and teachings of the present disclosure.

[0037] The imaging control system 12 may include a control unit 16, an output unit 18, an input unit 20, a light source unit 22, a fluid source 24, and a suction pump 26.

[0038] The imaging control system 12 may include various ports for coupling with the endoscopic system 10. For example, the control unit 16 may include input / output ports for receiving data from and transmitting data to the endoscope 14. The light source unit 22 may include an output port for transmitting light to the endoscope 14, such as via a fiber optic link. The fluid source 24 may include a port for sending fluid to the endoscope 14. The fluid source 24 may include a pump and tank of fluid, or may be connected to an external tank, container, or storage unit. The suction pump 26 may include a port used to draw a vacuum from the endoscope 14 to generate suction, such as to draw 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 an operator of the endoscopic system 10 to control the functions of the endoscopic system 10 and to view the output of the endoscope 14. The control unit 16 may additionally be used to generate signals or other outputs from treating the anatomical region into which the endoscope 14 is inserted. In examples, the control unit 16 may generate electrical outputs, acoustic outputs, fluid outputs, etc., for treating an anatomical region by, for example, cauterizing, cutting, freezing, etc.

[0039] Endoscope 14 may include an insertion section 28, a functional section 30, and a handle section 32, which may be connected to a cable section 34 and a connector section 36.

[0040] The insertion section 28 can extend distally from the handle section 32, and the cable section 34 can extend proximally from the handle section 32. The insertion section 28 can be elongated and can include a bending section and a distal end to which the functional section 30 can be attached. The bending section can be controllable (e.g., by pull wires 146A and 146B connected to control knobs 38 in the handle section 32) to steer the distal end through a tortuous anatomical passageway (e.g., stomach, duodenum, kidney, ureter, etc.). The insertion section 28 can be elongated and can also include one or more working channels (e.g., internal lumens) that can aid in the insertion of one or more treatment tools in the functional section 30, such as the tissue retrieval device 106 of FIGS. 1A and 1B. The working channels can extend between the handle section 32 and the functional section 30. Additional functions such as fluid passage, tether wires, and pull wires may also be provided by the insertion section 28 (eg, via aspiration or irrigation passages, etc.).

[0041] The handle section 32 may include a knob 38 as well as a port 40. The knob 38 may be coupled to pull wires 146A and 146B or other actuation mechanism extending through the insertion section 28 such that rotation of the knob 38 can cause bending of the functional section 30. The port 40 may be configured to couple various electrical cables, tether wires, auxiliary scopes, tissue collection devices of the present disclosure, fluid tubes, and the like, to the handle section 32 for connection with the insertion section 28. For example, a cholangioscope 104 may be fed into the endoscope 14 through one of the ports 40.

[0042] Imaging control system 12 may, by way of example, be mounted on a movable platform (e.g., cart 41) with shelves for housing light source unit 22, suction pump 26, image processing unit 42 (FIG. 4), etc. Alternatively, some components of imaging control system 12 shown in FIGs. 3 and 4 may be mounted directly to endoscope 14 to create a "self-contained" endoscope.

[0043] The functional area 30 may include components for treating and diagnosing a patient's anatomy. The functional area 30 may include imaging devices, lighting devices, and elevators, such as those further described with reference to Figures 5A and 5B. The functional area 30 may include imaging and lighting elements configured for viewing from an end, such as for viewing distally or axially beyond the functional area 30.

[0044] Figure 4 is a schematic diagram of the endoscopic system 10 of Figure 3 comprising an imaging control system 12 and an endoscope 14. Figure 4 shows generally the components of the imaging control system 12 coupled to the endoscope 14, which in the illustrated example comprises an end-view cholangioscope. The imaging control system 12 may comprise a control unit 16, which may comprise or be coupled to an image processing unit 42, a treatment generator 44 and a drive unit 46, as well as a light source unit 22, an input unit 20 and an output unit 18.

[0045] The image processing unit 42 and the light source unit 22 can each interact with the endoscope 14 (e.g., at the functional unit 30) by a wired or wireless electrical connection. Thus, the imaging control system 12 can illuminate the anatomical region, collect signals representative of the anatomical region, process the signals representative of the anatomical region, and display images representative of the anatomical region on the display unit 18. The imaging control system 12 can include the light source unit 22 to illuminate the anatomical region with light of a desired spectrum (e.g., broadband white light, narrowband imaging with preferred electromagnetic wavelengths, etc.). The imaging control system 12 can be connected to the endoscope 14 (e.g., via an endoscope connector) for signal transmission (e.g., light output from the light source, video signals from the imaging system at the distal end, sensor signals from a diagnostic device, etc.).

[0046] Fluid source 24 (FIG. 1) may be in communication with control unit 16 and may include one or more sources of air, saline, or other fluids, as well as associated fluid passages (e.g., air channels, irrigation channels, aspiration channels) and connectors (barb connectors, fluid seals, valves, etc.). Fluid source 24 may be utilized as actuation energy for the biasing or pressure application devices of the present disclosure. Imaging control system 12 may also include a drive unit 46, which may be an optional component. Drive unit 46 may include a motor drive for advancing a distal section of endoscope 14 as described at least in PCT Publication No. WO2011 / 140118A1, entitled “Rotate-to-Advance Catheterization System,” to Frassica et al., which is hereby incorporated by reference in its entirety.

[0047] 5A and 5B show an example of the functional area 30 of the cholangioscope 14 of FIG. 4. FIG. 5A shows an end view of the functional area 30, and FIG. 5B shows a cross-sectional view of the functional area 30 taken along cutting plane 5B-5B of FIG. 5A. FIG. 5A and FIG. 5B show a camera module 70 of an "end-viewing endoscope" (e.g., gastroscope, colonoscope, cholangioscope, etc.), respectively. In the end-viewing endoscope camera module 70, the illumination system and imaging system are positioned such that the viewing angle of the imaging system corresponds to a target anatomical structure located adjacent the end of the endoscope 14 and aligned with the central longitudinal axis A2 of the endoscope 14.

[0048] 5A and 5B, an end view endoscope camera module 70 may include a housing 72, a treatment unit 74, a fluid outlet 76, an illumination lens 78, and an objective lens 80. The housing 72 may include an end cap for the insertion section 28, thereby providing a seal for the lumen 82.

[0049] As can be seen in FIG. 5B, the insertion section 28 may include a lumen 82 through which various components may extend to connect the functional section 30 with the handle section 32. For example, the illumination lens 78 may be connected to an optical transmitter 84, which may comprise a fiber optic cable or cable bundle extending to the light source unit 22 (FIG. 4). Similarly, the objective lens 80 may be coupled to an imaging unit 87, which may be coupled to wiring 88. Also, the fluid outlets 76 may be coupled to fluid lines 89, which may comprise tubes extending to the fluid source 24 (FIG. 4). In an example, one of the fluid outlets 76 may include an inlet connected to a fluid line 89 configured for suction, such as connected to a vacuum, for the withdrawal of irrigation and flushing fluids. Other elongated elements, such as tubes, wires, cables, etc., may extend through the lumen 82 to connect the functional section 30 with components of the endoscope system 10, such as the suction pump 26 (FIG. 4) and the treatment generator 44 (FIG. 4). For example, the treatment unit 74 may include a wide diameter lumen to accommodate other treatment components, such as cutting and treatment devices, including the tissue retrieval device 106.

[0050] The endoscope camera module 70 may also include a light-sensitive element, such as a charge-coupled device ("CCD" sensor), or a complementary metal-oxide semiconductor ("CMOS") sensor. In either example, the imaging unit 87 may be coupled (e.g., via a wired or wireless connection) to the image processing unit 42 (FIG. 4) for transmitting signals (e.g., video signals) from the light-sensitive element representing an image to the image processing unit 42 for further display on a display device, such as the output unit 18. In various examples, the imaging control system 12 and the imaging unit 87 may be configured to provide an output at a desired resolution (e.g., at least 480p, at least 720p, at least 1080p, at least 4K UHD, etc.).

[0051] 6 illustrates the guiding sheath 102 and cholangioscope 104 of FIGS. 1A and 1B inserted orally into a patient 200 to reach the duodenum 202. The guiding sheath 102 can extend into the mouth 204, through the esophagus 206, and through the stomach 208 to reach the duodenum 202. Prior to reaching the intestine 210, the guiding sheath 102 can position the cholangioscope 104 adjacent to the common bile duct 212. The cholangioscope 104 can extend from the guiding sheath 102 to extend into the common bile duct 212. Steering features of the guiding sheath 102, such as pull wires 140A and 140B, can be used to facilitate guidance and bending of the cholangioscope 104 through the stomach 208 in addition to direct steering of the cholangioscope 104 via pull wires 146A and 146B. For example, navigation through the pyloric canal and pyloric sphincter can be difficult to navigate using only an endoscope. Thus, the guiding sheath 102 can be used to redirect or bend the elongated body 120 of the cholangioscope 104, or to reduce the amount of steering or bending of the elongated body 120 required by the pull wires 146A and 146B to facilitate crossing the pyloric sphincter. Additionally, once navigated through the pyloric sphincter, there is typically another turn in the opposite direction to enter the duodenum 202. Again, the steering capabilities of the guiding sheath 102, which may be relaxed after navigation through the pyloric sphincter, can again be used to redirect or bend the elongated body 120 of the cholangioscope 104 to reduce strain on the natural steering capabilities of the cholangioscope 104. Given the high degree of steering provided by the guiding sheath 102, the native steering capabilities of the cholangioscope 104 (e.g., pull wires 146A and 146B) can be maintained for steering the elongated body 120 to direct the tissue retrieval device 106 into the duodenum 202.

[0052] 7 is a schematic illustration of a distal portion of a guiding sheath 102 having a cholangioscope 104 and a tissue collection device 106 extending therefrom in accordance with the present disclosure. The guiding sheath 102 can be positioned in the duodenum 202, such as that described with reference to FIG.

[0053] The duodenum 202 may include a duct wall 214, a sphincter of Oddi 216, a common bile duct 212, and a main pancreatic duct 218. The duodenum 202 comprises an upper portion of the small intestine. The common bile duct 212 carries bile from the gallbladder and liver (not shown) and transfers the bile through the sphincter of Oddi 216 via a passageway 220 into the duodenum 202. The main pancreatic duct 218 carries pancreatic juice from the exocrine pancreas (not shown) to the common bile duct 212. It may sometimes be desirable to remove biological material, such as tissue, from the common bile duct 212 or pancreatic duct 218 to analyze the tissue, for example, to diagnose a patient's disease or disorder, such as cancer.

[0054] The cholangioscope 104 may be guided using the guiding sheath 102 such that the distal end of the cholangioscope 104 is positioned proximate the sphincter of Oddi 216. From there, the surgeon may operate the direct oral cholangioscope system 100 to extend the tissue retrieval device 106 from the cholangioscope 104 and into the common bile duct 212. The natural steering capabilities of the cholangioscope 104 may be used to turn the cholangioscope 104, which may then be approximately 90 degrees to face the sphincter of Oddi 216. In an example, the cholangioscope 104 may be advanced into the common bile duct 212. In either case, the tissue retrieval device 106 may be advanced from the cholangioscope 104 and steered, such as by the articulation of the cholangioscope 104 using the natural steering capabilities, to collect the target tissue within the common bile duct 212. Specifically, the cholangioscope 104 can be used to guide the tissue retrieval device 106 towards the gallbladder, liver, or other locations in the gastrointestinal system to perform various procedures. The surgeon can guide the tissue retrieval device 106 beyond the entrance 222 of the main pancreatic duct 218 and into the passageway 220 or into the entrance 222 of the common bile duct 212. The imaging capabilities of the cholangioscope (e.g., a camera) can be used to view the tissue retrieval device 106 to facilitate direct engagement with the target tissue.

[0055] In examples, the lumen 138 of the cholangioscope 104 can be used to deliver other devices to the duodenum 202 and common bile duct 212, instead of or in addition to the tissue retrieval device 106. The other devices may have their own functional capabilities, such as light sources, accessories, and biopsy channels for therapeutic procedures.

[0056] The biological material collected by the tissue collection device 106 can be removed from the patient, typically by removal of the tissue collection device 106 from the cholangioscope 104, so that the removed biological material can be analyzed to diagnose one or more conditions in the patient. According to some examples, the tissue collection device 106 may be suitable for removal of cancerous or pre-cancerous material (e.g., carcinoma, sarcoma, myeloma, leukemia, lymphoma, etc.), endometriosis evaluation, bile collecting duct biopsy, and the like.

[0057] As discussed herein, the size of a typical tissue retrieval device is limited by the size of the auxiliary scope, which itself is limited by the size of the duodenoscope. As such, a typical tissue retrieval device may be on the order of approximately 1.2 mm or less. However, with the disclosed device, the guiding sheath 102 may be configured as a simple device with a small thickness so that the working passage, such as the lumen 136, may be large compared to the working channel of the duodenoscope, which must additionally provide passage for imaging, illumination, and fluid capabilities. As such, with conventional devices, it may be difficult to obtain a tissue sample sized large enough to ensure accurate diagnosis without having to repeatedly remove and reinsert additional devices. However, with the disclosed system and device, for example, the lumen 138 is enlarged due to the small size of the guiding sheath 102, so that a tissue sample large enough can be obtained with a single insertion and removal of an additional device (e.g., tissue retrieval device 106).

[0058] Figure 8 is a perspective view of a cholangioscopy system 300 including a cholangioscope 302 and an anchoring wire 304 configured for use with the guiding sheath 102 of the present disclosure. Figure 9 is a view of the distal end of the cholangioscope 302 of Figure 8 showing the anchoring wire lumen 312 and the non-axial lumen 310 for the working tool lumen 308. Figures 8 and 9 are considered simultaneously.

[0059] As discussed in more detail below, the tether wire 304 can be used with the guiding sheath 102 to repeatedly insert the cholangioscope 302 into the patient's anatomy to retrieve multiple tissue samples. Specifically, after initial guidance of the cholangioscope 302 to a desired target tissue using the guiding sheath 102, the tether wire 304 can be used to tether the cholangioscope 302 to the target tissue or to tissue adjacent to the target tissue. The tissue retrieval device 106 can be inserted into the working tool lumen 308 to obtain tissue from the patient. The cholangioscope 302 and tissue retrieval device 106 can be withdrawn from the target tissue site, leaving the tether wire 304 and guiding sheath 102 in place. After the target tissue sample has been removed from the tissue retrieval device 106, the cholangioscope 302 can be easily guided back to the target tissue site using the guiding sheath 102 and tether wire 304.

[0060] 1A and 1B, the cholangioscope 302 may be positioned within the guiding sheath 102 for navigation through the anatomy. The cholangioscope 302 may include an elongate shaft 306, a working tool lumen 308, a non-axial lumen 310, an anchoring wire lumen 312, an objective lens 314, an illumination lens 316, a fluid outlet 320, a distal end surface 322, and a side surface 324.

[0061] The objective lens 314 may be configured similarly to the objective lens 80 of FIGS. 5A and 5B. The objective lens 314 may be configured to direct light toward the imaging unit to provide a digital image to the output unit 18. The illumination lens 316 may be configured similarly to the illumination lens 78 of FIGS. 5A and 5B. The illumination lens 316 may be configured to direct light from an optical transmitter, such as an optical transmitter receiving light from the light source unit 22, toward tissue distal to the distal end surface 322 to illuminate tissue for the guidance and tissue retrieval device 106. The fluid outlet 320 may be configured similarly to the fluid outlet 76 of FIGS. 5A and 5B. One or more fluid outlets 320 may be provided for delivering and retrieving fluids, such as by being coupled to a fluid source or a suction source. The elongated shaft 306 of the cholangioscope 302 may additionally be provided with steering capabilities, as described with reference to the cholangioscope 104. For example, elongate shaft 306 may include pull wires, such as pull wires 146A and 146B (FIG. 2), that may be coupled to an actuation device to impart a curvature to elongate shaft 306.

[0062] The working tool lumen 308 can be configured similarly to the lumen 138 of the endoscope 104 and can be configured to receive a working tool, such as the tissue retrieval device 106. The working tool lumen 308 can extend from the distal end surface 322 to a proximal portion of the elongate shaft 306. For example, the proximal end of the lumen 308 can be coupled to a port 40 ( FIG. 3 ) configured to allow a working tool to enter the elongate shaft 306. The cross-sectional area or diameter of the working tool lumen 308 can be sized to allow the tissue separator 128 to pass freely therethrough.

[0063] The non-axial lumen 310 may be connected to the work tool lumen 308. The non-axial lumen 310 may include an upper surface 326, a lower surface 328, and a proximal surface 330. The tether wire lumen 312 may include a distal opening 332, a proximal opening 334, and a shaft 336.

[0064] The non-axial lumen 310 may comprise a slot or slit in the distal end surface 322 of the elongate shaft 306 that connects the working tool lumen 308 to the side surface 324. In an example, the non-axial lumen 310 may be rectangular in shape such that the proximal surface 330 is flat or planar. The non-axial lumen 310 may be as thick or tall (with respect to the orientation of FIG. 8 ) as the shaft 126 of the tissue retrieval device 106 and as wide as the thickness between the side surface 324 and the working tool lumen 308. In an example, the non-axial lumen 310 may be as tall as the tissue separator 128 to allow the tissue separator 128 to pass laterally through the non-axial lumen 310. The non-axial lumen 310 may thereby extend not only through the material of the elongate shaft 306, but also through any coatings, reinforcing layers, etc. that extend through or along the elongate shaft 306. The non-axial lumen 310 can extend only along a distal portion of the elongate shaft 306, such as the distal-most 10 percent of the elongate shaft proximally from the distal end face 322. In an example, the non-axial lumen 310 can extend from approximately 2.0 mm to approximately 10.0 cm from the distal end face 322.

[0065] The tether wire 304 may comprise a cable 338 and an anchor 340. In the illustrated example, the anchor 328 may comprise a screw configured to be inserted into the patient's tissue proximate to where the tissue retrieval device 106 is desired to retrieve the target tissue. However, the anchor 340 may comprise any suitable device for attaching to, lodge in, or lodge against the soft tissue, such as a balloon. In other examples, the tether wire 304 may be used without the anchor 340 and the cable 338 may be blunted, such as having a ball attached to it.

[0066] The cable 338 may comprise a wire or wire rope that allows the cholangioscope to slide. The cable 338 may comprise one or more strands of a metal or polymeric material that is strong enough to be pushed through the anatomy and strong enough to ride other devices along the length of the tether wire 304. In an example, the cable 338 may be covered with a coating to facilitate sliding against other components and tissue. In an example, the cable 338 may simply comprise a long, thin member that can be inserted into the anatomy after the endoscope 302 is positioned, such as by pulling along with the cholangioscope 302 during the insertion process. In such a configuration, the tether 340 may be configured to hook into the opening 332 to facilitate being pulled by the cholangioscope 302. However, in other examples, the cable 338 may be configured as a steerable tether wire that is separately guided to the target tissue either before or after the cholangioscope 302 is guided to the target tissue site. Thus, the tether wire 304 can be guided to the target tissue and the cholangioscope 302 can follow by inserting the proximal end of the cable 338 into the opening 332, or the cholangioscope 302 can be guided to the target tissue and the tether wire 304 can be guided into the opening 334 and followed.

[0067] In an example, the cable 338 can be connected to a controller 354 (FIG. 12B) to facilitate movement of the tether wire 304. For example, the controller 354 can include a mechanism for controlling the advancement and retraction of the cable 338, such as a thumb wheel. The controller 354 can also be used to deploy or operate the tether 340. For example, the controller 354 can apply rotation to the cable 338 to drive the corkscrew tether into tissue, or can provide inflation pressure to the balloon via air or fluid pressure.

[0068] The tissue retrieval device 106 can be positioned within the working tool lumen 308 for insertion of the cholangioscope 302 into the anatomical structure and withdrawal of the cholangioscope 302. As discussed herein, the tissue separator 128 can be configured as a forceps or any other device suitable for separating, retrieving, or collecting a sample of biological material. The shaft 126 of the tissue retrieval device 106 can include a flexible body that allows the tissue separator 128 to angle from the elongated shaft 306 via bending through the non-axial lumen 310. The shaft 126 can additionally accommodate passage of a control feature, such as an actuation wire, to the tissue separator 128 to facilitate actuation of the tissue separator 128 to collect tissue.

[0069] FIG. 10 is a schematic diagram of a cross section taken along plane 10-10 of the cholangioscope 302 in FIG. 9 to show the non-axial lumen 310 connected to the working tool lumen 308. The cholangioscope 302 may include an elongated shaft 306, a distal end face 322, and a side face 324. The non-axial lumen 310 may include an upper face 326 (FIG. 10), a lower face 328, and a proximal face 330. The working tool lumen 308 may extend from proximal to distal end face 322 within the elongated shaft 306. As shown in FIG. 9, the working tool lumen 308 may include a circular lumen, although other shapes and cross sections may be used. As shown in FIG. 9, the non-axial lumen 310 may include a rectangular shape or cross section in the axial direction of the elongated shaft 306. 10, the non-axial lumen 310 may comprise a rectangular shape or cross-section in a direction transverse to the axial direction of the elongate shaft 306, as indicated by the flatness of the proximal face 330. However, the proximal face 330 may be curved between the side surface 324 and the working tool lumen 308, as indicated by line 356, or angled, as indicated by line 358, such that the non-axial lumen 310 can avoid having a sharp surface against which the shaft 126 of the tissue retrieval device 106 is configured to bend.

[0070] The non-axial lumen 310 can connect the working tool lumen 308 with both the distal end face 322 and the side face 324. Thus, as the cholangioscope 302 is withdrawn from the anatomy, the shaft 126 of the tissue retrieval device 106 can bend to position the tissue separator 128 out of the working tool lumen 308.

[0071] 11 is a schematic diagram of a cross section taken along plane 11-11 of the cholangioscope 302 in FIG. 9 to show the tether wire lumen 312. The cholangioscope 302 may include an elongate shaft 306, a distal end face 322, and a side face 324. The tether wire lumen 312 may include a distal opening 332 and a side opening 334.

[0072] The tether wire lumen 312 may include a passageway through the elongate shaft 306 to provide a shortcut from the distal end face 322 to the distal side 324 of the proximal end of the elongate shaft 306. The tether wire lumen 312 allows instruments to be inserted and anchored into the elongate shaft 306 without having to pass through the proximal end portion of the elongate shaft 306. Thus, the tether wire lumen 312 does not occupy space within the elongate shaft 306 of the cholangioscope 302 along the majority of the length of the elongate shaft 306. Thus, space within the elongate shaft 306 may be available for other functional components of the cholangioscope 302, such as imaging, illumination, and fluidics components. However, the tether wire lumen 312 may be long enough to provide a secure attachment of the tether wire 304 to the cable 338 to permit guidance of the distal portion of the elongate shaft 306 along the path of the tether wire 304. In examples, the tether wire lumen 312 may be shortened to provide a "point" connection. However, the tether wire lumen 312 may have a length to facilitate aligning the axis of the elongate shaft 306 with the axis of the cable 338.

[0073] In the illustrated example, the tether wire lumen 312 is configured to pass through the material of the elongate shaft 306 within the cylindrical footprint of the elongate shaft 306. Such a configuration is advantageous in conserving space within the elongate shaft 306, as discussed above, and provides a low profile shape at the distal end portion of the elongate shaft 306 to avoid snagging on the anatomy and the guiding sheath 102. However, in other examples, the tether wire lumen 312 may be provided outside the cylindrical footprint of the elongate shaft 306, such as on the exterior of the elongate shaft 306, such as by passing through a hook or clip attached to the elongate shaft 306 or through a protrusion of the material of the elongate shaft 306 that forms a hook, clip, or eyelet.

[0074] FIG. 12A is a schematic diagram of the cholangioscope 302 of FIG. 8 inserted into a tissue duct 350, an anchoring wire 304 attached to the tissue duct 350, and a tissue retrieval device 106 extended beyond the non-axial lumen 310.

[0075] The cholangioscope 302 can be guided into the tissue tract 350 using the steering capabilities of the guiding sheath 102 (FIGS. 1A-2) and the natural steering capabilities of the cholangioscope 302 (e.g., a pull wire). In examples, the tissue tract 350 can be the duodenum, common bile duct, pancreatic duct, or other tissue duct. Using the control device 354, the tether wire 304 can be inserted into the tissue tract 350 before, at the same time as, or after the cholangioscope 302. The tether wire 304 can be positioned with the cable 338 extending through the tether wire lumen 312 such that the distal end of the cable 338 protrudes from the tether wire lumen 312. Thus, the tether 340 can be positioned distal to the distal end surface 322 of the elongate shaft 306. The control device 354 can be used to engage the tether 340 with tissue to prevent displacement of the cable 338.

[0076] The tissue retrieval device 106 can be inserted into the tissue tract 350 together with the cholangioscope 302 or after the cholangioscope 302 is positioned in the tissue tract 350. The tissue retrieval device 106 can be extended from the working tool lumen 308 such that the tissue separator 128 protrudes from the working tool lumen 308. The tissue retrieval device 106 can be manipulated by the control device 130 to position the tissue separator 128 at a site of the target tissue in the tissue tract 350. In an example, the tissue retrieval device 106 can be fabricated from a transparent or translucent material that allows light to pass through so that the objective lens 80 can be viewed through the tissue retrieval device 106. Thus, opening the separator 134 to obtain tissue does not interfere with viewing of the target tissue site by the operator. Thus, the control device 130 can be operated to rotate the separator 134 at the hinge 132 (FIG. 1A) to remove the target tissue from the tissue tract 350. After the tissue separator 128 has obtained the tissue, the cholangioscope 302 can be withdrawn from the tissue tract 350, such as along with the tether wire 304.

[0077] FIG. 12B is a schematic diagram of the cholangioscope 302 of FIG. 8 being withdrawn from the tissue duct 350, the anchoring wire 304 remaining engaged with the tissue duct 350, and the tissue retrieval device 106 extending through the non-axial lumen 310 and bent to sever the tissue sample 352.

[0078] With the tissue separator 128 holding the tissue sample, the tissue retrieval device 106 can be retracted into the working tool lumen 308 such that the tissue separator 128 is within the elongate shaft 306. Thus, the tissue separator 128 can be protected during withdrawal of the cholangioscope 302. However, the cholangioscope 302 may be withdrawn with the tissue separator 128 extending from the working tool lumen 308.

[0079] The cholangioscope 302 can be retracted (to the left in FIG. 12B) out of the tissue tract 350. The tether 340 (FIG. 12A) can remain attached to the tissue tract 350 such that the cable 338 remains extended along a path from the target tissue site in the tissue tract 350 for exiting the patient's mouth during an oral procedure. The handle section 32 (FIG. 3) can be grasped to pull the cholangioscope 302 out of the tissue tract 350. Thus, the tissue retrieval device 106 can be pulled along with the cholangioscope 302. As the cholangioscope 302 is withdrawn from the patient, the most proximal portion (e.g., the handle section 32) will be displaced further and further from the patient. This can position the access for the working tool lumen 308 away from the operator of the cholangioscope 302. Thus, typically to retrieve tissue from the tissue separator 128, the operator must move to the location of the handle section 32 to either fully withdraw the tissue retrieval device 106 from the cholangioscope 302, which may potentially involve operator movement at the distance of the cholangioscope 302 and the tissue retrieval device 106, or advance the tissue retrieval device 106 forward until the tissue separator 128 protrudes from the working tool lumen 308, which may involve placing one hand of the operator at the handle section 32 and having the other hand sufficiently distal to the elongated shaft 306 to engage and release the tissue separator 128. Either of these options can create extra steps in the procedure and additional operator movement that may be difficult or inconvenient in the constraints of an operating room where tools are arranged in a compact and careful manner. However, with the present disclosure, the non-axial lumen 310 can facilitate quick and easy access to the tissue retrieval device 106 without requiring reorientation of the position of the tissue retrieval device 106 relative to the cholangioscope 302 or repositioning of the operator in the operating room. The shaft 126 can be bent to move the tissue separator 128 away from the elongate shaft 306. Specifically, the shaft 126 can be bent to position the tissue separator 128 in axial alignment with the side surface 324, in one example proximal to the distal end face 322. In an example, the shaft 126 can be bent approximately 90 degrees.Thus, the operator can remain positioned adjacent to the patient as the cholangioscope 302 is withdrawn and can easily manipulate the tissue separator 128 to access the sample tissue 352. For example, the tissue separator 128 can simply be grasped distally of the cholangioscope 302, pulled proximally through the non-axial lumen 310, and then finely manipulated to access the sample tissue 352. In an example, the controller 130 can be operated to move the separators 128 away from each other to release the sample tissue 352.

[0080] After the sample tissue 352 has been retrieved, the tissue separator 128 can be repositioned distally of the cholangioscope 302 and moved back into the working tool lumen 308, if desired. The cholangioscope 302 can then be moved back into the tissue tract 350 via sliding the elongate shaft 306 along the cable 338 to the target tissue site. The steering capabilities of the guiding sheath 102 and cholangioscope 302 can be used in conjunction with the tether wire 304 to facilitate movement of the cholangioscope 302 to the target tissue site. However, direct or unassisted steering of the cholangioscope 302 is not required due to the presence of the tether wire 304. At the target tissue site, the tissue separator 128 can be used again to obtain additional tissue samples to supplement the tissue sample 352. Thus, a sufficiently large amount of tissue can be obtained to perform one or more different types of tissue analyses without the difficulty of having to again navigate the cholangioscope unassisted through the duodenum and common bile duct.

[0081] 13 is a block diagram illustrating an example of a method 400 of collecting biological material from a patient using, for example, the direct oral cholangioscope system 300 of the present disclosure. The method 400 may encompass the use of the guiding sheath 102, the cholangioscope 302, and the tissue retrieval device 106 of FIGS. 8-12B.

[0082] At step 402, the cholangioscope 302 may be inserted into the guiding sheath 102. Specifically, the elongated shaft 306 of the cholangioscope 302 may be inserted into the lumen 136 of the guiding sheath 102. The cholangioscope 104 may be configured to slide freely within the guiding sheath 102 such that one can move relative to the other during and after insertion.

[0083] At step 404, the cholangioscope 302 and guiding sheath 102 may be navigated through the patient's anatomy. Specifically, the cholangioscope 302 and guiding sheath 102 may be inserted into the patient's mouth 204 and pushed down through the esophagus 206 and into the stomach 208 (see FIG. 6 ). The cholangioscope 302 and guiding sheath 102 may be steered to extend through the stomach 208 and into the duodenum 202.

[0084] At step 406, the cholangioscope 302 and guiding sheath 102 may be pushed into the duodenum 202. For example, the guiding sheath 102 may be steered, such as by using the control knob 114 to pull at least one of the pull wires 140A and 140B, to bend the cholangioscope 302 and exit the stomach 208 through the pyloric duct, thereby freeing control of the cholangioscope 302, such as the pull wires 146A and 146B, from the need to apply tension and / or compression to the elongated shaft 306, and further providing the cholangioscope 302 with steering capability for further use.

[0085] In step 408, the guiding sheath 102 can be adjusted, such as by using the control knob 114 to pull at least one of the pull wires 140A and 140B, to orient the distal end of the guiding sheath 102 towards the sphincter of Oddi 216, again preserving the native steering capabilities of the cholangioscope 302, such as pull wires 146A and 146B for later use. However, the pull wires 146A and 146B of the cholangioscope 302 can supplement the action of the pull wires 140A and 140B.

[0086] The cholangioscope 302 can be steered into the duodenum 202 using the pull wires 140A and 140B. The stiffness of the guiding sheath 102 can be used to allow the cholangioscope 302 to push out of the guiding sheath 102, if necessary, to achieve a desired shape for pointing towards and entering the duodenum 202. The cholangioscope 302 can be extended from the guiding sheath 102 to engage the sphincter of Oddi 216. In another example, the cholangioscope 302 can be extended from the guiding sheath 102 to enter the sphincter of Oddi 216.

[0087] In step 410, the tether wire 304 can be extended through the tether wire lumen 312 within the elongate shaft 306 of the cholangioscope 302. The tether wire 304 can be extended into the cholangioscope 302 before or after the cholangioscope 302 is placed in the anatomy. The tether wire 304 can be extended such that the tether portion 340 protrudes from the tether wire lumen 312. The tether portion 340 can then be deployed to engage tissue. As discussed, the tether portion 340 can be attached, adhered, or hooked to tissue to prevent or inhibit proximal displacement of the tether wire 304. A cable 338 can be extended through the tether wire lumen 312 to the proximal end of the cholangioscope 302 outside the elongate shaft 306 and can be connected, for example, to the handle section 32.

[0088] At step 412, the tissue retrieval device 106 can be inserted into and extended from the cholangioscope 302. A tissue separator 128 can extend from a distal end of the elongate shaft 306 to engage tissue in the common bile duct 212 beyond the sphincter of Oddi 216. In other examples, the tissue retrieval device 106, along with the guiding sheath 102 and cholangioscope 302, can be guided through the stomach 208 and duodenum 202.

[0089] At step 414, the target tissue may be collected using the tissue retrieval device 106. The target tissue may include tissue that is potentially diseased or that is otherwise indicative of a pathological condition in the patient. For example, the separator 134 may be manipulated from the control device 130 to engage the target tissue one or more times to separately collect the target tissue if necessary and store the target tissue. In an example, the tissue retrieval device 106 may be dimensioned large enough to collect a sufficient amount of biological material in one collection operation such that multiple insertions of the tissue retrieval device 106 may be avoided due to factors discussed herein. However, in the example of FIGS. 8-12B, the tissue retrieval device 106 may be dimensioned to any suitable volume and configured to be easily removed and reinserted into the anatomy without the need to re-perform navigation of the guiding sheath 102 and cholangioscope 302 to navigate the intricacies of the stomach 208 and common bile duct 212. For example, particularly if the forceps are substantially or partially fabricated from transparent materials and components, oversized forceps may be used that partially obstruct the imaging capabilities of the cholangioscope 302 when deployed outside the working tool lumen 308.

[0090] At step 416, the tissue retrieval device 106 is withdrawn into the working tool lumen 308 of the cholangioscope 302. The cholangioscope 302 can be withdrawn from the anatomy by sliding along the cable 338 so that the targeted tissue can be removed from the tissue separator 128. The tether 340 can remain attached or engaged to the tissue such that the tether wire 304 remains in place within the anatomy.

[0091] In step 418, the target tissue may be removed from the tissue separator 128. For example, the separator 134 may be widened to allow access to the separated target tissue.

[0092] The method 400 may then return to step 412 via reinserting the cholangioscope 302 and tissue collection device 106 into the anatomical structure in step 420 to collect additional material from the previous target tissue site or to collect additional material from a different target tissue site, or may continue to step 422 to complete the operation.

[0093] In step 422, the tether 304 may be removed from the patient, such as by disengaging the tether 340 from the tissue and then retracting the cable 338 from the anatomy.

[0094] In step 424 , the guiding sheath 102 may be removed from the patient, such as by withdrawing it from the esophagus 206 .

[0095] In step 426, the tissue collected from the patient may be analyzed, such as by being transported to a laboratory to be analyzed for the presence of diseased tissue, such as cancerous tissue.

[0096] In this manner, method 400 illustrates an example of a method for collecting biological material in multiple samples from an internal passageway of a patient such that a sufficient amount of tissue to perform analysis can be collected during a single patient procedure, thereby reducing or eliminating the need for subsequent patient procedures at a later time to obtain additional tissue. Method 400 may be performed using a cholangioscope having an anchoring system that includes an anchoring wire, an anchoring wire lumen, and a non-axial lumen for a working tool. The anchoring wire and the anchoring wire lumen can be used to guide the cholangioscope in and out of the patient's anatomy without the need to re-perform complex insertion and steering maneuvers. The anchoring wire can be attached only to the distal portion of the cholangioscope to avoid occupying space within the cholangioscope shaft. The non-axial lumen can be used to easily access tissue retrieval, collection, or separation devices at the distal end of the working tool without the need to fully withdraw the working tool from the cholangioscope. Thus, the direct oral cholangioscope system 300 of the present disclosure can facilitate efficient tissue collection from a patient, shortening procedure time and reducing the chance of the need for subsequent procedures.

[0097] FIG. 14 is a schematic diagram of a duodenum 500 connected to a common bile duct 502 via a duodenal papilla 504. The common bile duct 502 can branch into a pancreatic duct 506 and a cystic duct 508. The duodenal papilla 504 can include a sphincter of Oddi 510 (FIG. 15). The pancreatic duct 506 can lead to a pancreas 512. The cystic duct 508 can lead to a gallbladder 514. As previously discussed, it can be difficult to guide a surgical instrument into the duodenal papilla 504. It can also be difficult to guide a surgical instrument into the common bile duct 502 via insertion through the duodenal papilla 504. For example, the sphincter of Oddi 510 is a muscle that can control the flow of bile and pancreatic juices into the intestine. However, the muscle of the sphincter of Oddi 510 can make it difficult to enter the common bile duct 502. Therefore, it is common during medical procedures to cut the sphincter of Oddi 510 and enlarge the duodenal papilla 504 to allow easier access for instruments to the common bile duct 502.

[0098] 15 is a schematic diagram of the duodenum 500 of FIG. 14 with an implant 520 of the present disclosure inserted into the duodenal papilla 504. The implant 520 may comprise a body 522 that may comprise an annular cylinder that pushes the sphincter of Oddi 510 into an expanded state. The implant 520 may be delivered to the duodenum 500 in a collapsed state and then expanded to provide an entrance to the common bile duct 502. As discussed herein, the implant 520 may be used as a base to which other components may be mounted to facilitate, among other things, 1) operation of the implant 520, 2) performance of the procedure in which the implant 520 is implanted, and 3) performance of subsequent procedures.

[0099] FIG. 16A is a schematic diagram of a stent 530 having an inflatable balloon 532 inserted therein and leads 534A and 534B extending therethrough. FIG. 16A shows the stent 530 and balloon 532 in a collapsed state. The stent 530 may comprise a mesh body having an outer diameter 536 and an interior space 538. The leads 534A and 534B may extend from a distal end of the stent 530 through the mesh body and may extend proximally from the stent 530. The balloon 532 may comprise an inflatable bladder having an interior space 540 and a tube 542 extending from the interior space 540. The leads 534A and 534B and tube 542 may extend through a suitable insertion instrument, tube, or sheath that can be used to extend the stent 530 and balloon 532 through a working channel of a scope. In an example, the stent 530 and balloon 532 can be navigated into the duodenum 500 using any of the devices described herein. For example, the stent 530 and balloon 532 can be guided through the working channel 142 of the scope 104 (FIG. 2).

[0100] To push the stent 530 into the duodenal papilla 504, the sphincter of Oddi 510 (FIG. 2) may be cut to relax the tissue of the duodenal papilla 504 to facilitate insertion of the stent 530. The leads 534A and 534B may be powered via electrical current to provide tissue cutting via known electrosurgical techniques, as discussed in more detail below with reference to FIG. 16. The leads 534A and 534B may be connected to the control unit 16 (FIGS. 1A and 4). In an example, high frequency alternating current may be used to heat the tissue to the point of cauterization, thereby effecting separation from adjacent tissue. The duodenal papilla 504 may be cauterized to reach the sphincter of Oddi 510, thereby allowing the duodenal papilla 504 to receive the stent 530.

[0101] FIG. 16B is a schematic diagram of the stent 530 of FIG. 16A in an expanded state with electrical leads 534A and 534B being pulled back from the stent 530. The balloon 532 can be inflated to expand the stent 530 from diameter D1 to diameter D2. The leads 534A and 534B can be stiff to hold the stent 530 in the collapsed state of FIGS. 2 and 3 during the cutting procedure. However, the leads 534A and 534B can be pulled out of the stent 530 to allow expansion via inflation of the balloon 532. The balloon 532 can be inflated by the passage of pressurized air through the tube 542. The balloon 532 can thereby expand the interior space 538. The material of the stent 530 can stretch or deform to expand to the expanded state.

[0102] FIG. 16C is a schematic diagram of the stent 530 of FIG. 16B in an expanded state with electrical leads 534A and 534B pulled away from the stent 530. The material of the stent 530 can maintain its shape after the balloon 532 is deflated, thereby allowing the interior space 540 to be maintained at a diameter D2. Thus, the balloon 532 and the leads 534A and 534B can be withdrawn from the stent 530 and the patient through the working channel of the insertion device. As described below with reference to FIGS. 17-19, the stents of the present disclosure can be provided with various cutting capabilities. As described below with reference to FIGS. 20-39, the stents of the present application can be used to facilitate the performance of additional procedures at a later time, such as by providing a re-entry device that can quickly steer and / or guide an instrument back into the anatomy of the stent. Additionally, the re-entry device can be provided with a treatment device that can perform intermittent, ongoing, or on-demand treatment of the patient between treatments.

[0103] FIG. 17 is a schematic side view of a stent 550 of the present application including electrical leads 552A and 552B extending into a cylindrical mesh stent body 554. The electrical leads 552A and 552B may be connected to the control unit 16 (FIGS. 3 and 4). The stent body 554 may be made of multiple wires 556 interconnected or braided to form an interior space 558. The leads 552A and 552B may be braided into the wires 556. The control unit 16 may be configured to direct various forms of energy to the leads 552A and 552B to provide various functionality to the stent 550. In an example, the control unit 16 may provide direct or alternating current to the leads 552A and 552B. The electrical energy may be used to cut, coagulate, desiccate, or discharge tissue. Additionally, the electrical energy may be used to provide power to various devices mounted on or connected to the stent 550.

[0104] The leads 552A and 552B may comprise conductive wires, wire bundles, or cables that may be attached to the body 554. In an example, the leads 552A and 552B may be made of copper, copper alloys, or other conductive metals and metal alloys. In an example, the leads 552A and 552B may be made of a bioabsorbable material that may naturally degrade into the body in which the stent 550 is deployed. The leads 552A and 552B may be attached to the body 554 in a fixed or deployable manner. For example, the leads 552A and 552B may be fixed to the body 554 for embodiments in which the leads 552A and 552B are intended to remain embedded in the anatomy. Thus, as disclosed herein, the leads 552A and 552B may be used to provide treatment to the patient, such as through pumping activities or stone ablation activities. Thus, the leads 552A and 552B may be welded or brazed to the body 554. In additional examples, the leads 552A and 552B can be woven into the material of the body 554. The body 554 can be made of a mesh material, such as strands of a biocompatible metal, that can be woven into an annular tube that can be radially contracted or expanded. In additional examples, the body 554, as well as some or all of the other components of the various devices and stents described herein, can be radiopaque to facilitate visibility in imaging, such as x-ray images and fluoroscopy, for example, to facilitate guidance back to the location of the re-entry devices described herein. In embodiments in which the leads 552A and 552B are intended to be withdrawn from the patient after use, the leads 552A and 552B can be releasably attached to the body 554. In an example, the leads 552A and 552B can be configured to be pulled proximally from the body 554 outside the anatomy. Thus, the leads 552A and 552B can be unraveled from the woven material of the body 554, or the welded or brazed attachment of the leads 552A and 552B can be broken to remove the leads 552A and 552B from the body 554.The detached leads 552A and 552B may be removed from the anatomy or may be left in place to biologically degrade.

[0105] The leads 552A and 552B may be positioned such that the length of the leads 552A and 552B in the body 554, or a substantial sum of the lengths of the leads 552A and 552B in the body 554, can contact tissue to provide a desired effect. The leads 552A and 552B may be arranged in different patterns in the body 554, such as straight, wavy, and jagged patterns. The leads 552A and 552B may be positioned outside the body 554. As previously described, the leads 552A and 552B may be used to cut tissue. Specifically, the leads 552A and 552B may be used to cut the sphincter of Oddi 510 (FIG. 15) to allow expansion of the stent 550, as disclosed herein. However, in other examples, the leads 552A and 552B may be used to provide power to other devices or other functions of the stent 550.

[0106] Figure 18A is a schematic side view of a stent 600 of the present application that includes a number of different mechanical cutting blades disposed on a body 602. Figure 18B is an end view of the stent 600 of Figure 18A. Figures 18A and 18B are considered simultaneously.

[0107] The mechanical cutting blades may include axial blades 604, circumferential blades 606A-606F, and angled blades 608A-608F. Stent 600 may further include anchors 610A-610D (FIG. 19). The axial blades 604, circumferential blades 606A-606F, and angled blades 608A-608F may form a pattern of cutting features in stent 600 that is repeated in the circumferential direction, for example, as seen in FIG.

[0108] The mechanical cutting blade of the stent 600 can be used to cut tissue, such as the sphincter of Oddi 510 (FIG. 15), to allow expansion of the stent 600 as disclosed herein.

[0109] The axial blade 604 can extend parallel to a central axis of the stent 600 and can comprise a blade configured to scrape, slicing, or cutting tissue when the stent 600 is rotated circumferentially along the central axis. The axial blade 604 can be configured, for example, to cut when rotated in a clockwise direction and not cut when rotated in a counterclockwise direction. The axial blade 604 can be formed from a portion of the edge of a cut in the body 602.

[0110] The circumferential blades 606A-606F can extend perpendicular to a central axis of the stent 600 and can comprise blades configured to scrape, slice, or cut tissue when the stent 600 is pushed or pulled in an axial direction. The circumferential blades 606A-606F can be configured, for example, to cut when pulled proximally and not cut when pushed distally. The circumferential blades 606A-606F can be formed from a portion of the edge of a cut in the body 602.

[0111] The oblique blades 608A-F can extend obliquely relative to a central axis of the stent 600 and can comprise blades configured to scrape, slice, or cut tissue when the stent 600 is moved relative to tissue engaged with the stent 600. The oblique blades 608A-F can be configured, for example, to cut when rotated circumferentially along the central axis or when pulled proximally and not cut when pushed distally. The oblique blades 608A-F can be formed from a portion of the edges of a cut in the body 602.

[0112] In an example, the axial blade 604, the circumferential blades 606A-606F, and the diagonal blades 608A-608F may be formed from metal plates that are attached to the mesh of the body 602.

[0113] FIG. 19 illustrates a stent 600 with barbs 610A-610D. The barbs 610A-610D may include anchoring features to hold the stent 600 in place once deployed. The barbs 610A-610D may be positioned at one end of the body 602 to allow engagement with tissue after a mechanical cutting blade is used. For example, the barbs 610A-610D may be positioned at a proximal end of the body 602 to allow a distal portion of the stent 600 to cut tissue via axial displacement before they are set. In other examples, the barbs 610A-610D may be aligned axially along the body 602 instead of circumferentially positioned as shown in FIG. 19 to allow cutting around the body 602 before they are set.

[0114] FIG 20A is a schematic cross-sectional view of the magnetically active stent device 630 in a collapsed state. FIG 20B is a schematic cross-sectional view of the magnetically active stent device 630 of FIG 20A in an expanded state. FIG 21 depicts an example of a magnetic applicator 632. FIG 20A-FIG 21 are considered simultaneously. The device 630 of FIG 20A and FIG 20B may comprise the example of the stent 520 of FIG 15 and may include the cutting features of FIG 16-FIG 19.

[0115] 20A and 20B show schematic diagrams of a device 630, such as a stent, shunt, or plug, capable of radial expansion. The device 630 may be removable after a period of time, may remain permanently in the patient, or may biodegrade within the patient. 20A and 20B show schematic cross-sectional views of the device 630 in open and closed positions. FIG. 21 shows an applicator 632 for the device 630.

[0116] In some cases, device 630 may be a stent, shunt, or plug for insertion into a passageway of a patient. Device 630 may be a stent to maintain patency of a passageway of a patient, such as to flush fluids and debris. Device 630 may be a shunt, such as to provide an alternative route for the passage of blood or other bodily fluids. Device 630 may be a plug, such as to prevent the flow of fluids through a passageway.

[0117] The device 630 may be sized, shaped, or positioned for complete or partial insertion into an anatomical canal or opening, such as the duodenal papilla 504 of FIG.

[0118] The device 630 may comprise a deformable elongated tubular body 634 with a sheath 636 and a plurality of magnetizable or magnetic elements 638. The device 630 may be positioned or actuated with an applicator 632, which may comprise a guidewire 640 and a magnet 642. The magnet 642 may be configured to generate a magnetic field 644.

[0119] The tubular body 634 can extend from a proximal portion to a distal portion. The proximal portion can be for holding, securing, or steering the device 630, directly or indirectly, such as by a surgeon or physician using the device 630 for a medical procedure. The proximal portion can optionally be connected to one or more grips, handles, or guidewires, as desired for an operator. The distal portion can be configured for at least partial insertion into a body lumen of a patient.

[0120] The deformable elongated tubular body 634 may be capable of an expanded state, as shown in FIG. 20A, and a collapsed state, as shown in FIG. 20B. In an example, in the expanded state, the tubular body 634 may have a diameter of about 0.5 mm to about 2.0 mm. In the expanded state, the tubular body 634 may be positioned against an inner wall of a body passageway, such as to help maintain patency of the passageway. In some cases, the expanded state may distend the body passageway, if desired. The expanded state of the tubular body 634 may have a relatively larger diameter than some other stents, such as to allow the passage of fluids and debris.

[0121] In an example, in the collapsed state, the tubular body 634 can have a diameter of about 0.5 mm to about 2.0 mm. In the collapsed state, the tubular body 634 can be collapsed upon itself, such as to create a shape with a diameter or other transverse dimension that may be smaller than conventional stents or other stents. This can allow for easy insertion by an operator into a patient's passageway.

[0122] The sheath 636 may include a compliant material extending between a distal portion and a proximal portion of the tubular body 634 that forms a tubular shape and defines a luminal space, such as a longitudinal lumen in the tubular body 634. The sheath 636 may be made from a thin-walled polymer, such as polyethylene, silicone, or polyether block amide. In examples, the sheath 634 may have a thickness of from about 0.051 mm to about 0.254 mm. In certain examples, the sheath 636 may include two or more layers of material. The sheath 636 may have a durometer hardness of about 0.005' to about 0.04" Shore D. The sheath 636 may define a luminal space with a diameter of about 1 mm to about 20 mm when in the expanded state and less than about 2 mm when in the collapsed state. In an example, the ratio of the diameter in the expanded state to the diameter in the collapsed state may be about 10:1. In an example, the ratio of the diameter in the expanded state to the diameter in the collapsed state may be about 25:1. In an example, the ratio of the diameter in the expanded state to the diameter in the collapsed state may be between about 10:1 and about 25:1. When in the collapsed state, the device 630 may be inserted into a passageway of a patient by itself or with a delivery sheath or shell that may help maintain the collapsed sheath during insertion, etc.

[0123] The magnetizable or magnetic element 638 may be embedded in, attached to, or coupled with the sheath 634. Magnetic materials may include materials that exhibit a response to changes in a magnetic field and may include materials that are aligned to a particular magnetic field. Similarly, magnetizable materials may include materials that can be magnetized and may include materials that are not yet magnetized but can be magnetized when exposed to a magnetic field.

[0124] The magnetizable or magnetic elements 638 can be at least two magnetic or magnetizable elements in the tubular body 634. In some cases, the elements 638 can be a group of wires woven or braided around a core material. In some cases, the elements 638 can be selectively actuated. When magnetized or exposed to a magnetic field, the magnetizable or magnetic elements 638 can repel each other, causing the sheath 636 to open to a more expanded state. This can cause the sheath 636 to magnetically position outwardly against the wall of the body passageway. The magnetic repulsion between the magnetizable or magnetic elements 638 can lock the device 630 in the passageway and / or facilitate retention of the device 630 in the passageway, such as without the need for other fastening mechanisms, such as "pigtail" clasps, clips, or other components. Instead, magnetic forces can be used in some cases to hold the device in place in the passageway and maintain patency.

[0125] In some cases, two, three, four, five, or more magnetizable or magnetic elements 638 can be used in the device 630. At least two magnetizable or magnetic elements 638 can be used to allow for magnetic repulsion between the elements when actuated. By manipulating the number and arrangement of wires, the diameter or lateral dimension of the device 630 in the expanded state can be controlled.

[0126] In device 630, magnetic element 638 may be a magnetizable or magnetic element that is an elongated member and may extend along the length of tubular body 634 from the distal portion to the proximal portion. The arrangement of magnetizable or magnetic elements 638 around or around the circumference of sheath 636 may allow for radial expansion when magnetizable or magnetic elements 638 are actuated to repel one another. In some cases, magnetic repulsion may be sufficient to provide conformal contact between device 630 and a wall defining a body lumen in which device 630 is disposed. In this case, the expanded state may have a circular cross-section or may have a non-uniform cross-section depending on the shape of the body lumen.

[0127] The magnetizable or magnetic element 638 may include a wire, a piece of magnetizable material, a braided or woven strand, or other magnetic dipole inducing material. The magnetizable or magnetic element 638 may be made from a variety of materials, such as a magnetizable metallic material or a composite material, or one or more combinations thereof. In some cases, the magnetizable or magnetic element 638 may comprise a magnetic dipole element secured to the sheath 636.

[0128] The magnetizable or magnetic element 638 may extend longitudinally along the length of the tubular body 634, extend radially along the tubular body 634, spiral around the tubular body 634, be applied in segments along the tubular body 634, or a combination or combinations thereof, over some or all of the length of the tubular body 634. The magnetizable or magnetic element 638 may additionally be of different types, materials, and thicknesses to induce a variety of different magnetic fields, magnetic field responses, and magnetic repulsions depending on how the magnetizable or magnetic element 638 is actuated.

[0129] 21 depicts an example of a magnetic applicator 632. The magnetic applicator 632 can include a guidewire 640 and a magnet 642 and can be influenced by or configured to generate a magnetic field 644. The magnetic applicator 632 can be detachable from the device 630 or can be fully or partially integrated with the device 630.

[0130] The magnetic applicator 632 may be a unitary piece or may include multiple pieces, such as a guidewire 640 and a magnet 642. The magnetic applicator 632 may include a ring, such as a magnet 642, configured to fit within or around the longitudinal lumen of the tubular body 634. In this case, the magnet 642 may be shaped to fit within or outside the tubular body 634 and may fit within the collapsed or expanded state of the tubular body 634.

[0131] The guidewire 640 can be attached to the magnet 642, such as to allow manipulation of the placement of the magnet 642 at or near the device 630. This can cause the magnet 642 to add to or change a magnetic field that interacts with the magnetizable or magnetic element 638, such as when the magnet is moved. For example, the magnetic applicator 632 can be drawn through the longitudinal lumen of the tubular body 634 to actuate the magnetizable or magnetic element 638 to help provide magnetic repulsion to keep the tubular body 634 in a more expanded state. This can be done by the operator using the guidewire 640 to move the magnet 638.

[0132] In some cases, the magnetic applicator 632 may be retracted through the longitudinal lumen of the tubular body 634 to actuate the magnetizable or magnetic element 638 to reduce magnetic repulsion and cause the tubular body 634 to assume a more unexpanded state. This can be done by the operator using a guidewire 640 to move the magnet 642.

[0133] In an example, the magnetic applicator 632 can be inserted into the patient's passageway along with or simultaneously with the device 630. The magnetic applicator 632 can then be withdrawn from the patient's passageway through the device 630 to magnetize the magnetizable or magnetic element 638 and move the tubular body 634 from the collapsed state to the expanded state.

[0134] In this case, when the operator deems it time to remove the device 630 from the patient's passageway, the magnetic applicator 632 can be used to collapse the device 630 for easy removal. In some cases, the magnetic applicator 632 can remain attached to the device 630. In some cases, the magnetic applicator 632 can be detached from the device 630 during or after insertion of the device 630 into the patient's passageway. The magnetic applicator 632 can be reusable or disposable.

[0135] In some cases, the magnetic applicator 632 can be used to change the positioning or expansion of the device 630. In that case, if the operator believes the device 630 should be adjusted, such as by the patient exhibiting pain or discomfort, the magnetic applicator 632 should be inserted back into the patient's passageway at or near the device 630. The magnetic applicator 632 can be used to collapse part or all of the device 630, allowing the operator to reposition the device. The device 630 can then be re-expanded as desired with the magnetic applicator 632 once repositioning is complete.

[0136] In an example, the magnetic applicator 632 can be inserted into the patient's passageway separately from the device 630. In that case, an operator can insert the device 630 followed by the magnetic applicator 632, pulling through the device to magnetize the magnetizable or magnetic element 638, moving the device from the collapsed state to the expanded state. In some cases, the magnetic applicator can remain with the patient and can be removed later when the operator is ready to remove the device 630 from the patient's passageway.

[0137] The magnetic applicator 632 can enable an operator to manipulate the device 630 during insertion of the device 630, during removal of the device 630 to update or reposition the placement of the device 630, or a combination thereof.

[0138] Figure 22 is a schematic side view of a stent 650 of the present application including expandable elongate re-entry devices 652A and 652B. Figure 23 is an end view of the stent 650 of Figure 22. Figures 22 and 23 are considered simultaneously. Stent 650 can incorporate any of the features and components described with reference to device 630 of Figures 20A and 20B and stent 520 of Figure 15, and can include the cutting features of Figures 16-19.

[0139] Stent 650 can include a body 654 extending from a first end 656A to a second end 656B. Body 654 can be made from a wire 658. Re-entry device 652A can include an elongate tube 660A and an entry element 662A. Re-entry device 652B can include an elongate tube 660B and an entry element 662B. As shown in FIG. 23B, stent 650 can define a lumen 664, and tubes 660A and 660B can define lumens 666A and 666B.

[0140] The re-entry devices 652A and 652B may be configured to help guide another elongate body through the stent 650 via the lumens 666A and 666B to an anatomical structure distal to the stent 650. The re-entry devices 652A and 652B may comprise a flexible body capable of traversing the transition between the intersections of the anatomical passageways. In an example, the re-entry devices 652A and 652B may comprise a tube or guidewire fixedly or slidably attached to the body 654. The re-entry devices 652A and 652B may extend proximally of the body 654 to receive other components or instruments and may extend distally of the body 654 to guide other components or instruments to a desired anatomical structure. In an example, the position of the re-entry devices 652A and 652B relative to the body 654 may be adjustable. In an example, the length of the re-entry devices 652A and 652B may be adjustable.

[0141] In examples, re-entry devices 652A and 652B may be configured to receive instruments from the duodenum 500, redirect the instruments to the duodenal papilla 504, direct the instruments through the body 654, and guide the instruments into one of the pancreatic duct 506 and the cystic duct 508. In that way, it may be unnecessary to steer or guide the instruments through such passageways.

[0142] The re-entry devices 652A and 652B may comprise flexible tubes fabricated from polymers such as Pebax® (polyether block amide or PEBA, which is a thermoplastic elastomer (TPE)) or suitable biocompatible materials, nylon, silicone, and urethane. The re-entry devices 652A and 652B may have a telescopic structure to allow distal extension. In an additional example, the re-entry devices 652A and 652B may be slidably attached to the body 654 such that the length of the re-entry devices 652A and 652B extending proximally and distally of the body 654 may be adjustable. Thus, the re-entry devices 652A and 652B may be mounted on rails or attached via hoops or clasps. In an example, the elongated tubes 660A and 660B may be configured to be released and removed from the body 654 after use to leave only the stent 650 in the anatomy.

[0143] The cross-sectional area of ​​lumens 666A and 666B compared to the cross-sectional area of ​​lumen 664 can be small, as shown in Figure 23, thereby leaving lumen 664 free to accommodate other instruments. However, the ratio of the cross-sectional area of ​​lumens 666A and 666B to the cross-sectional area of ​​lumen 664 can be varied depending on performance capabilities for different purposes.

[0144] The elongated tubes 660A and 660B may include detachment or peel-off features as well as openable lumens as described with reference to Figures 34-38B. Detachment features may comprise axial sections of the elongated tubes 660A and 660B that can be separated by a surgeon or operator to trim the elongated tubes 660A and 660B to a desired length. Peel-off features may comprise portions of the elongated tubes 660A and 660B that can be peeled off when no longer needed. For example, sleeves 764 and 774 of Figures 32A-33B may comprise portions of the elongated tubes 660A and 660B that can be peeled off when it is desired to deploy the anchors 762 and 772.

[0145] The entry elements 662A and 662B may be connected to the proximal ends of the re-entry devices 652A and 652B, respectively. The entry elements 662A and 662B may be configured to guide other components or instruments into the elongated tubes 660A and 660B, respectively. In an example, the entry elements 662A and 662B may comprise a funnel or funnel-shaped body configured to attract the distal end of an instrument and center said instrument with the re-entry devices 652A and 652B, respectively. In an additional example, the entry elements 662A and 662B may be magnetic to pull instruments and devices into engagement with the elongated tubes 660A and 660B. The entry elements 662A and 662B may be provided with magnets of opposite polarity to keep them apart from one another.

[0146] In an additional example, the entry elements 662A and 662B and the elongated tubes 660A and 660B may be threaded, such that once an instrument or device is engaged with the entry elements 662A and 662B and the elongated tubes 660A and 660B, the instrument or device may be rotated to advance the instrument or device therethrough. Such a feature may be useful when it is difficult to advance an instrument or device by pushing alone due to the complex geometry of a pathway through an anatomy, etc.

[0147] Re-entry devices 652A and 652B are described as comprising tubes. However, other elongate bodies can be used. For example, an elongate guidewire can be directly incorporated into stent 650. Alternatively, an elongate rail can be attached to stent 650. The rail can comprise an elongate body having a cross-section that allows a mating channel to slide axially along the rail, but prevents the channel from moving radially out of the rail. In an example, a rail having a t-shaped cross-section can be used.

[0148] Figure 24 is a schematic illustration of the stent 650 of Figures 22 and 23 with re-entry devices 652A and 652B in a deployed state. The re-entry devices 652A and 652B can be extended from the distal end of the body 654 to further position the distal ends into the anatomical structure.

[0149] Re-entry device 652A can have guidewire 672 disposed thereon, and re-entry device 652B can have guidewire 674 disposed thereon. Guidewire 672 can have anchoring portion 676, and guidewire 674 can have anchoring portion 678. Anchoring portions 676 and 678 can comprise devices configured to attach to tissue. In an example, anchoring portions 676 and 678 can comprise screw devices that can be rotated by guidewires 672 and 674. However, other types of anchoring portions may be used, such as those described with reference to FIGS. 32A-33B.

[0150] Guidewire 672 can be extended to entry device 662A to pass through the distal end of tube 660A. Guidewire 674 can be extended to entry device 662B to pass through the distal end of tube 660B. Guidewire 672 can be configured to position anchor 676 at an anatomical structure. Guidewire 674 can be configured to position anchor 678 at the same or a different anatomical structure. Tethers 676 and 678 can be configured to attach to tissue to secure guidewires 672 and 674 to tissue. As discussed with reference to FIGS. 32A-33B, anchors 676 and 678 can be selectively deployed from tubes 660A and 660B. Other instruments, such as scopes and forceps, can then be guided along guidewires 672 and 674 to the locations of anchors 676 and 678.

[0151] Tubes 660A and 660B can have different lengths to reach different anatomical locations. For example, tube 660B can be longer than tube 660A so that tube 660B can reach gallbladder 514 and tube 660A can reach pancreas 512. Tubes 660A and 660B can also be curved or bent to extend through various anatomical ducts to reach a desired anatomical structure, as shown in FIG. 25. In an example, tubes 660A and 660B can be used to receive fluids from an organ or can be used to provide fluids, such as medicines, to an organ or anatomical area via capillary action.

[0152] FIG. 25 is a schematic diagram of the stent 650 of FIG. 24 with a re-entry device 652B deployed to reach the cystic duct 508. The body 654 of the stent 650 can be positioned at the duodenal papilla 504 leading to the common bile duct 502. The re-entry device 652A is not shown for simplicity. The duct 660B can be bent or curved at approximately a 90 degree angle to extend along the duodenum 500 and then redirect into the common bile duct 502. A device extending along the duodenum 500 can be pushed into the entry device 662B to be guided along by the duct 660B. The duct 660B can thus redirect the device being inserted to guide it into the common bile duct 502. For example, a guidewire 674 can be deployed into the duodenum 500 from a scope, such as the scope 14 (FIG. 4). The guidewire 674 can be advanced forward in proximity to the entry device 662B, which can be magnetic to pull the guidewire 674 into the funnel-shaped entry passage. Once inside the entry device 662B, the guidewire 674 can be pushed along the duct 660B, whose stiffness can be sufficient to cause the guidewire 674 to turn and push through the duct 660B into the common bile duct 502 and cystic duct 508. When the anchor 678 reaches a desired location near or in the gallbladder 514, the guidewire 674 can be rotated, for example, to cause the anchor 678 to penetrate the tissue. Thereby, a treatment device, such as those described with reference to FIGS. 26-29B and others, can be slid along the guidewire 674 to reach the location of the anchor 678.

[0153] FIG. 26 is a schematic side view of a stent 690 including distal stents 692A and 692B. Stent 690 may be configured similarly to stent 650 of FIG. 24 with the addition of distal stents 692A and 692B. Stent 692A may include body 694A, and stent 692B may include body 694B. Bodies 694A and 694B may be attached to tubes 660A and 660B, respectively, as shown. In other examples, bodies 694A and 694B may be slid through tubes 660A and 660B for deployment distal to tubes 660A and 660B. Bodies 694A and 694B may include annular bodies configured to enlarge or hold open an anatomical tube. Thus, stents 692A and 692B may tolerate larger stones that would otherwise pass through the anatomical structure. Bodies 694A and 694B can be configured as any of the stents described herein, including those described with reference to Figures 26-29B. In an example, bodies 694A and 694B can comprise annular bodies that can be collapsed during insertion and then expanded when positioned at a desired location to attach to an anatomical vessel and expand the anatomical vessel, including those described with reference to Figures 20A-21. In an example, bodies 694A and 694B can have a smaller diameter than stent 690. In an example, bodies 694A and 694B can have different sizes for use in different anatomical locations, as shown in Figure 27.

[0154] 27 is a schematic illustration of a duodenum 500 with elongated re-entry devices 652A and 652B attached to a stent 690. The body 654 of the stent 690 can be positioned at the duodenal papilla 504 where it connects to the common bile duct 502. Duct 660B can extend from the stent 690 through the cystic duct 508 to the gallbladder 514. Duct 660A can extend from the stent 690 through the pancreatic duct 506 to the pancreas 512. The entry devices 662A and 662B can remain attached to the ducts 660A and 660B, respectively, within the duodenum 500 to facilitate placement of a guidewire or other instrument or device.

[0155] Stents 692A and 692B may be positioned in the exit orifices of the gallbladder 514 and pancreas 512, respectively. Stents 692A and 692B allow gallstones and pancreatic stones to pass more freely out of their respective organs. In additional examples, stents 692A and 692B may be used to pump fluid out of the gallbladder 514 and pancreas 512. For example, as described with reference to FIG. 28, stents 692A and 692B may be configured to expand and contract to push fluid out of the gallbladder 514 and pancreas 512. Stents 692A and 692B may also be configured to generate hydraulic pressure, such as via vibration, to allow for the release or absorption of drugs. Additionally, stents 692A and 692B may be configured to treat or engage stones to metabolize them or pass them out of the anatomy, as described with reference to FIGS. 29A and 29B.

[0156] FIG. 28 is a schematic diagram of the duodenum 500 with the stent 690 of FIG. 27, including the therapeutic stent 694C connected to the distal stent 692A via member 660C. The therapeutic stent 694C may be positioned inside an organ such as the gallbladder 514 or the pancreas 512. The therapeutic stent 694C may be provided with electrical leads, such as the leads 534A and 534B described with reference to FIGS. 16A-16C and the leads 552A and 552B described with reference to FIG. 17. The leads may allow active control of the therapeutic stent 694C. In additional examples, the therapeutic stent 694C may be provided without the stent 694A positioned between the stent 694C and the stent 690 (e.g., the stent 694A may be omitted).

[0157] In an example, the therapeutic stent 694C can be configured to expand and contract to provide pumping activity such that the therapeutic stent 694C can be configured to pump fluid into or out of an organ, or can provide pumping activity to an organ, for example, to stimulate the organ to produce biological fluids. In an example, the therapeutic stent 694C can be configured to expand and contract as described herein, such as using magnetic activation.

[0158] In an additional example, the therapeutic stent 694C may be configured to provide heating via the leads. In an example, heating may be provided by resistive heating of the leads and wires forming the body of the stent 694C. In an additional example, heating may be provided by a heating element on the stent 694C that is powered by electricity provided by the leads. In an additional example, heating may be provided by inductive heating, such as with the magnetic applicator 632 of FIG. 21. In an example, heating may be provided by vibration of the stent 694C. The stent 694C may be vibrated by ultrasound.

[0159] Heating the therapeutic stent 694C can be used to provide a fluid effect, such as by generating capillary action to draw fluid through the stent 694C. Thus, the stent 694C can be provided to flush fluid out of the gallbladder 514 or pancreas 512. Heating can also vaporize drugs delivered to the stent 694C, such as through the tube 660C, or provided on the stent 694C as a coating, into the tissue. Also, as previously discussed, heating the wire elements can be used to perform cutting, ablation, and the like.

[0160] Figure 29A is a schematic side view of a stent 700 of the present application configured to treat biological material, such as gallstones and pancreatic stones. Figure 29B is an end view of the stent 700 of Figure 29A. Figures 29A and 29B are considered together.

[0161] In the example, stent 700 may include devices 702A and 702B and cutting blades 704A-F on body 706. As seen in Figure 29B, stent 700 may further include cutting elements 708A-D extending across the interior of stent 700 and anchors 710A-D.

[0162] The devices 702A and 702B may be configured to actively process biological material passing through the stent 700. In an example, the stent 700 may be provided with electrical leads, such as the leads 534A and 534B described with reference to Figs. 16A-16C and the leads 552A and 552B described with reference to Fig. 17. The leads may allow active control of the stent 700. The devices 702A and 702B may be configured as rotary grinders to reduce or polish stones entering the stent 700, such as by ablation or polishing. In an example, the surface of the stone may be shaped to facilitate visualization by imaging, such as by making the stone surface echogenic. Thus, stones larger than the inner diameter of the stent 700 may be worn down until they fit within the stent 700, for example, to allow evacuation from the gallbladder 514.

[0163] In examples, devices 702A and 702B may have a coating or may emit a fluid that can dissolve gallstones.

[0164] In an example, devices 702A and 702B can be configured to emit a laser beam capable of melting or cutting stones.

[0165] In an example, devices 702A and 702B can be configured to crush or compress the stone to break it into smaller pieces.

[0166] In an example, the cutting blades 704A-704F can provide for reducing or cutting the stones passing through the stent 700. Thus, the stones can become smaller while passing through the stent 700 to allow easier biological processing, such as dissolving the anatomical structure or expelling the anatomical structure.

[0167] In an example, the cutting elements 708A-708D may comprise wires that can be electrically activated to produce heating or vibration. Thus, stones entering the stent 700 may be broken into smaller pieces to allow easier biological processing. The vibration may be triggered by an excitation frequency. In an example, an additional instrument may extend along the guidewire to produce vibrations or to activate devices, etc. In an additional example, the cutting elements 708A-708D may be used to filter or sieve larger sized stones from entering the stent 700 to prevent them from blocking the stent 700. In such an example, the cutting elements 708A-708D need not be configured or energized to cut, but may only comprise wires, etc., to prevent free passage into the stent 700. Such larger stones may be removed by other procedures or with additional instruments inserted into the stent 700.

[0168] 30 is a schematic diagram of a duodenum 500 having an implantable device 750 of the present disclosure including monorails 752A and 752B. The implantable device 750 may include a stent 754 through which the monorails 752A and 752B may extend. The monorail device may include wires or cables that may extend proximally of the stent 754 into the duodenum 500 and distally from the stent 754 to the pancreatic duct 506 and cystic duct 508. The distal ends of the monorails 752A and 752B may include tethers 756A and 756B, respectively.

[0169] The monorails 752A and 752B can be deployed using the elongated tubes 660A and 660B as described with reference to FIGS. 22-25. The monorails 752A and 752B can comprise devices that are installed in the anatomy to allow for the insertion of other devices without active steering and guidance. The monorails 752A and 752B can be left in the anatomy attached to the stent 750 after the procedure has been performed, or can be withdrawn from the stent 750. Thus, the monorails 752A and 752B can be configured to be bioabsorbable. In an example, the stent 750 and the monorails 752A and 752B can be inserted into the anatomy using an appropriate scope, such as by being guided through the working channel 142 (FIG. 2) of the scope 104.

[0170] 31 is a schematic diagram of a monorail 752A with a corkscrew tether 756A. The monorail 752A can comprise a wire or cable, and the tether 756A can comprise a portion of the wire or cable wound into a coil or helix. The tether 756A can be wound to have a thicker loop proximal to the monorail 752A that gets progressively smaller toward the distal end of the tether 756A and finally terminates at the tip of the monorail 752A. The tip of the monorail 752A at the distal end of the tether 756A can be circumferentially oriented such that rotation of the monorail 752A by an operator at the proximal end of the monorail 752A can cause the tip of the monorail 752A to penetrate tissue.

[0171] Figure 32A is a schematic diagram of a monorail 752A with deployable tethers 760 in a collapsed state. Figure 32B is a schematic diagram of the monorail 752A of Figure 32A with the deployable tethers 760 in an extended state. The tethers 760 can be deployed to expand in size and attach to tissue. Figures 32A and 32B are considered together.

[0172] The deployable tether 760 may comprise a tether 762 and a sleeve 764. The tether 762 may comprise a plurality of deformable leaflets 766A-766D. Each of the deformable leaflets 766A-766D may comprise a wire that is bent to have ends that are brought into proximity with one another to form a loop. Additionally, a distal portion of the loop may be curved outwardly from the end of the wire that forms the loop. The ends of the wire may be attached to the monorail 752A such that each of the wires may be curved. When covered by the sleeve 764, the curvature of the loop may be removed such that each of the leaflets 766A-766D may bear against the sleeve 764, as shown generally in FIG. 32A. However, when sleeve 764 is retracted proximally along monorail 752A, the wires forming each of leaflets 766A-766D can bend outwardly from monorail 752A, as shown diagrammatically in FIG. 32B, to engage tissue.

[0173] The sleeve 764 may comprise a tube that surrounds the tether 762 to reduce the outer diameter dimension of the deformable leaflets 766A-766D. The sleeve 764 may extend proximally along the length of the monorail 752A from the tether 762. In an example, the sleeve 764 may extend from the tether 762 all the way to an operator control at the proximal end. In an example, the sleeve 764 may be only long enough to surround the tether 762 and provide the desired compactness of the leaflets 766A-766D, and may be attached to an actuation wire that extends proximally to the operator control. Thus, either the proximal end of the sleeve 764 or a control wire attached to the sleeve 764 may be pulled proximally along the axis of the monorail 752A to release the leaflets 766A-766D.

[0174] Figure 33A is a schematic diagram of a monorail 752A with deployable tethers 770 in a collapsed state. Figure 33B is a schematic diagram of the monorail 752A of Figure 33A with the deployable tethers 770 in an extended state. The tethers 770 can be deployed to expand in size and attach to tissue. Figures 33A and 33B are considered together.

[0175] The deployable tether 770 may comprise a tether 772 and a sleeve 774. The tether 772 may comprise a plurality of expandable members 776A-776D. Each of the expandable members 776A-776D may comprise a pointed protrusion extending from a base. The pointed protrusion may be biased radially outward from the base relative to a central axis of the monorail 752A. When covered by the sleeve 774, the pointed protrusion may be pushed closer to the monorail 752A, as shown diagrammatically in FIG. 33A. However, when the sleeve 774 is retracted proximally along the monorail 752A, the pointed protrusion may extend radially outward from the monorail 752A, as shown diagrammatically in FIG. 33B, to engage tissue.

[0176] The sleeve 774 may comprise a tube that surrounds the tether 772 to reduce the outer diameter dimension of the expandable members 776A-776D. The sleeve 774 may extend proximally along the length of the monorail 752A from the tether 772. In an example, the sleeve 774 may extend from the tether 772 all the way to an operator control at the proximal end. In an example, the sleeve 774 may be only long enough to surround the tether 772 and provide the desired compactness of the expandable members 776A-776D, and may be attached to an actuation wire that extends proximally to an operator control. Thus, either the proximal end of the sleeve 774 or the control wire attached to the sleeve 774 may be pulled proximally along the axis of the monorail 752A to release the members 776A-776D.

[0177] FIG. 34 is a schematic diagram of a deployable member 790 comprising an elongated shaft 792 comprising a lumen 794 and perforations 796. The deployable member 790 may comprise the tube 660A and 660B of FIG. 22, the sleeve 764 of FIG. 32A and 32B, or the sleeve 774 of FIG. 33A and 33B. The elongated shaft 792 may comprise a flexible member made of a polymer or another biocompatible material. The elongated shaft 792 may be made of a resilient material that may be deformed or bent when subjected to a load, but returns to its original shape when the load is removed. The perforations 796 may extend along the length of the elongated shaft 792 or along only selected portions of the shaft 792, such as portions positioned proximal to the anchor portions 762 (FIGS. 32A and 32B) and anchor portions 772 (FIGS. 33A and 33B). Perforations 796 may comprise a series of small notches extending through from the exterior of shaft 792 into lumen 794. Perforations 796 may cause shaft 792 to break open along the lines of perforations 796. Perforations 796 may thereby permit the passage of an object larger than the diameter of lumen 794 to pass through shaft 792. For example, an object may be pushed through lumen 794, breaking and separating perforations 796 along its path.

[0178] FIG. 35 is a schematic diagram of a deployable member 800 comprising an elongated shaft 802 comprising a lumen 804 and a slit 806. The deployable member 800 may comprise the tube 660A and 660B of FIG. 22, the sleeve 764 of FIG. 32A and 32B, or the sleeve 774 of FIG. 33A and 33B. The elongated shaft 802 may comprise a flexible member made of a polymer or other biocompatible material. The elongated shaft 802 may be made of a resilient material that may be deformed or bent when subjected to a load, but returns to its original shape when the load is removed. The slit 806 may extend along the length of the elongated shaft 802 or along only selected portions of the shaft 802, such as portions positioned proximal to the anchors 762 (FIGS. 32A and 32B) and anchors 772 (FIGS. 33A and 33B). Slit 806 may comprise a cut extending through from the exterior of shaft 802 into lumen 804. Slit 806 may cause shaft 802 to spread open along the line of slit 806. Slit 806 may thereby allow the passage of an object larger than the diameter of lumen 804 to pass through shaft 802. For example, an object may be pushed through lumen 804, spreading slit 806 apart along its path.

[0179] FIG. 36 is a schematic diagram of a deployable member 810 comprising an elongated shaft 812 comprising a lumen 814 and a gap 816. The deployable member 810 may comprise the tube 660A and 660B of FIG. 22, the sleeve 764 of FIG. 32A and 32B, or the sleeve 774 of FIG. 33A and 33B. The elongated shaft 812 may comprise a flexible member made of a polymer or another biocompatible material. The elongated shaft 812 may be made of a resilient material that may be deformed or bent when subjected to a load, but returns to its original shape when the load is removed. The gap 816 may extend along the length of the elongated shaft 812 or along only a selected portion of the shaft 812, such as the portion positioned proximal to the anchor portion 762 (FIG. 32A and 32B) and the anchor portion 772 (FIG. 33A and 33B). Gap 816 may comprise a cut that extends through from the exterior of shaft 812 into lumen 814. Gap 816 may cause shaft 812 to spread open along the line of gap 816. Gap 816 may thereby allow the passage of an object larger than the diameter of lumen 814 to pass through shaft 812. For example, an object may be pushed through lumen 814, spreading gap 816 apart along its path.

[0180] 37 is a schematic diagram of a deployable member 820 comprising an elongated shaft 822 comprising a lumen 824 and a gap 826. The gap 826 may comprise a plurality of magnetic members 828 and a metal strip 829. The magnetic members 828 may be attracted to the metal strip 829 via magnetic attraction. Thus, at rest, the magnetic members 828 may pull the end of the elongated shaft 822 along the gap 826 closed. However, when a device or object moves through the elongated shaft 822 that is larger than the lumen 824, the magnetic members 828 may be pushed away from the metal strip 829 to allow the device or object to pass. After the device or object has passed, the magnetic members 828 may be pulled back into engagement with the metal strip 829 via magnetic attraction.

[0181] 38 is a schematic diagram of a deployable member 830 comprising an elongate shaft 832 comprising a lumen 834 and a gap 836. A plurality of C-shaped reinforcements 838 may be disposed on the shaft 822 along the lumen 824. The C-shaped reinforcements 838 may be configured to be resilient such that they can deform to expand the C-shape under a load from within the lumen 834, but return to their original shape when the load is removed, thereby allowing devices or objects larger than the lumen 834 to pass through the shaft 832.

[0182] 39 is a schematic perspective view of the elongate deployable member 800 having a treatment device 840 slid therethrough to open the elongate deployment member 800. The treatment device 840 may comprise any of the devices described herein. In an example, the treatment device 840 may comprise a stent in a collapsed state. However, while in the collapsed state, the treatment device 840 may be larger than the lumen 804. Thereby, as the treatment device 840 passes along the slit 806, the opposing faces 842A and 842B of the shaft 802 may be spread apart to allow the treatment device 840 to pass therethrough.

[0183] FIG. 40 is a block diagram illustrating a method 900 for implementing a re-entry device of the present application having a treatment device.

[0184] At step 902, a stent may be implanted into the anatomical structure. For example, the stent 520 of FIG. 15 may be inserted into the duodenal papilla 504 in the duodenum 500. The stent 520 may be delivered to the duodenum 500 using any suitable delivery device, such as an endoscope. In an example, the stent 520 may be delivered using the direct oral cholangioscopy system 100 of FIGS. 1A and 1B.

[0185] At step 904, the tissue may be cut with a stent. For example, the stent 550 of FIG. 17 may be used to electrically cut the tissue, or the stent 600 of FIG. 18 and FIG. 19 may be used to cut the tissue. In an example, the sphincter of Oddi 510 may be cut to dilate the duodenal papilla 504 to accept the stent. Once in place, the stent may be anchored to the tissue, such as using anchors 610A-610D of FIG. 19.

[0186] The stent can be expanded at step 906. For example, the device 630 of Figures 20A and 20B can be expanded in the duodenal papilla 504 via magnetic action. In an additional example, the stent 530 can be expanded via a balloon 532.

[0187] At step 908, a re-entry track or device for the stent may be extended into the anatomical structure. In an example, re-entry devices 652A and 652B of FIG. 22 may be positioned in the anatomical duct adjacent to the stent. The ducts 660A and 660B may have proximal ends positioned in the duodenum 500 and distal ends positioned in the cystic duct 508 and pancreatic duct 506, respectively.

[0188] A guidewire may be inserted into the re-entry device at step 910. In an example, guidewire 674 (FIG. 24) may be positioned in vessel 660B and guidewire 672 (FIG. 24) may be positioned in vessel 660A.

[0189] The guidewire can be anchored to tissue at step 912. In examples, anchor 678 can be attached to the cystic duct 508 or gallbladder 514, and anchor 676 can be attached to the pancreatic duct 506 or pancreas 512. Also, the deployable or expandable anchors 760 and 770 of Figures 32A-33B can be used.

[0190] At step 914, a treatment device may be slid over the guidewire. For example, stents 692A and 692 of FIG. 27 may be slid over guidewires 674 and 672. Also, stents 694C (FIG. 28) and stents 700 (FIGS. 29A and 28B) may be slid over the guidewire into the anatomical structure to be treated.

[0191] At step 916, a lumen of the re-entry device may be opened to allow passage of the treatment device. For example, lumens 794, 804, 814, 824, and 834 of Figures 34-38 may be opened as the treatment device slides along the guidewire within the re-entry tube. After the treatment device has passed, the lumen may be closed using magnetic element 828 of Figure 37, c-shaped reinforcement 838 of Figure 38, or other means.

[0192] In step 918, the anatomical structure may be treated using a treatment device. As discussed herein, the treatment device may provide pumping, heating, drug delivery, vibration, ablation, stone destruction, and the like.

[0193] At step 920, the guidewires may be removed. For example, guidewires 674 and 672 may be withdrawn from re-entry tubes 660A and 660B. In additional examples, guidewires 674 and 672 may be left in the anatomy for use in a subsequent procedure or for biological resorption into the anatomy.

[0194] At step 922, the procedure may be completed. Specifically, unused components may be removed from the anatomy, and the access portals and incisions in the patient's anatomy may be closed to leave the re-entry components in the anatomy. A stent 520 (FIG. 15) as described herein and variations thereof may be left in the duodenal papilla 504. Also, the re-entry devices 652A and 652B may be left extended into the desired anatomical tract and redirected into the duodenum 500 to allow for later delivery of treatment devices, etc.

[0195] A follow-up procedure may be performed at step 924. The method 900 may return to step 910 to use a previously implanted re-entry device, such as by reopening the patient's anatomy and inserting a scope into the duodenum 500.

[0196] In step 926, the anatomical structure may be treated during follow-up treatment. The treatment performed in step 918 may be repeated, or additional or different treatments may be performed, including the use of treatment devices described herein.

[0197] In step 928, the follow-up procedure may be completed. Components or devices that are no longer in use may be removed from the patient, and components or devices that are intended for later use or for use during future procedures are closed off within the patient to facilitate later re-entry.

[0198] Various notes and examples Sheath for use with a guidewire for re-entry - Patent application Example 1 is a cholangioscopy system including a guiding sheath with a steerable lumen, an elongate shaft extending between a proximal end portion and a distal end face, the elongate shaft being configured for placement along the steerable lumen, a working tool lumen extending along the elongate shaft and exiting at the distal end face, an anchoring lumen entering the elongate shaft between the proximal end portion and the distal end face and exiting the elongate shaft at the distal end face, and an endoscope including a non-axial lumen extending from the working tool lumen to an exterior of the elongate shaft at the distal end face.

[0199] In Example 2, the subject matter of Example 1 optionally includes a tether wire extending through the tether wire lumen.

[0200] In Example 3, the subject matter of Example 2 optionally includes where the tether wire comprises an elongate cable and a tissue anchor positioned proximate a distal end of the tether wire.

[0201] In Example 4, the subject matter of any one or more of Examples 1-3 optionally includes a tissue retrieval device extendable from the working tool lumen.

[0202] In Example 5, the subject matter of Example 4 optionally includes the tissue retrieval device comprising a shaft that is elastically bendable from extending along the working tool lumen to extending along the working tool lumen into the non-axial lumen.

[0203] In Example 6, the subject matter of Example 5 optionally includes wherein the tissue retrieval device comprises forceps.

[0204] In Example 7, the subject matter of any one or more of Examples 1-6 optionally includes, in the distal end face, the non-axial bore includes a slit extending along the elongate shaft to intersect with the work tool bore.

[0205] In Example 8, the subject matter of Example 7 optionally includes a non-axial lumen extending through a side of the elongate shaft.

[0206] In Example 9, the subject matter of any one or more of Examples 1-8 optionally includes, wherein the non-axial lumen extends within the distal-most 10 percent of the length of the elongate shaft.

[0207] In Example 10, the subject matter of any one or more of Examples 1-9 optionally includes the endoscope including steering capabilities.

[0208] Example 11 is a method of performing a direct oral cholangioscopy procedure, the method including the steps of inserting an endoscope into a guiding sheath, inserting the guiding sheath and endoscope into the patient's duodenum, extending a tissue retrieval device through the endoscope and into the patient's common bile duct, extending a tether wire into the common bile duct, collecting biological material with the tissue retrieval device, and withdrawing the cholangioscope and tissue retrieval device from the common bile duct along the tether wire.

[0209] In Example 12, the subject matter of Example 11 optionally includes where inserting the guiding sheath and the endoscope into the patient's duodenum includes using the guiding sheath to steer the cholangioscope.

[0210] In Example 13, the subject matter of Example 12 optionally includes steering the cholangioscope using the cholangioscope's natural steering capabilities.

[0211] In Example 14, the subject matter of Example 13 optionally includes steering the cholangioscope by pushing away the guiding sheath.

[0212] In Example 15, the subject matter of any one or more of Examples 11-14 optionally includes extending the tether wire into the common bile duct by attaching the tether wire to tissue of the common bile duct.

[0213] In Example 16, the subject matter of any one or more of Examples 11-15 optionally includes the step of reinserting the cholangioscope into the common bile duct by sliding the cholangioscope along the tether wire.

[0214] In Example 17, the subject matter of Example 16 optionally includes removing tissue from the tissue collection device prior to reinserting the cholangioscope.

[0215] In Example 18, the subject matter of Example 17 optionally includes a step of positioning a distal portion of the tissue retrieval device within a non-axial lumen of the cholangioscope after the step of withdrawing the cholangioscope and tissue retrieval device from the common bile duct along the tether wire.

[0216] In Example 19, the subject matter of Example 18 optionally includes a step of positioning a distal portion of the tissue retrieval device within the non-axial lumen of the cholangioscope by bending a portion of a shaft of the tissue retrieval device extending from the working tool lumen to extend through the non-axial lumen.

[0217] In Example 20, the subject matter of Example 19 optionally includes wherein the non-axial lumen comprises a slot at the distal end of the cholangioscope connecting the working tool lumen to a side of the cholangioscope.

[0218] Stent-like devices for re-entry Example 1 is a system for providing repeatable access to an anatomical area of ​​a patient, the system comprising a stent having a ring-shaped body and a re-entry channel extending through the stent, the re-entry channel comprising an elongate body having proximal and distal ends extending from the ring-shaped body.

[0219] In Example 2, the subject matter of Example 1 optionally includes where the elongate body comprises a tubular body defining a lumen.

[0220] In Example 3, the subject matter of Example 2 optionally includes that the tubular body is openable.

[0221] In Example 4, the subject matter of Example 3 optionally includes wherein the tubular body comprises a slit extending along a length of the tubular body.

[0222] In Example 5, the subject matter of Example 4 optionally includes that the slit is closable.

[0223] In Example 6, the subject matter of Example 5 optionally includes the tubular body comprising a magnet positioned along the slit.

[0224] In Example 7, the subject matter of any one or more of Examples 5-6 optionally includes the tubular body comprising a spring configured to bias the slit toward the closed position.

[0225] In Example 8, the subject matter of any one or more of Examples 3-7 optionally includes, wherein the tubular body includes perforations extending along a length of the tubular body.

[0226] In Example 9, the subject matter of any one or more of Examples 2-8 optionally includes the tubular body comprising a thread extending along the lumen.

[0227] In Example 10, the subject matter of any one or more of Examples 2-9 optionally includes an access device attached to the proximal end of the tubular body.

[0228] In Example 11, the subject matter of Example 10 optionally includes wherein the access device comprises a funnel.

[0229] In Example 12, the subject matter of Example 11 optionally includes wherein the funnel includes an internal thread.

[0230] In Example 13, the subject matter of any one or more of Examples 11-12 optionally includes including that the funnel is magnetic.

[0231] In Example 14, the subject matter of any one or more of Examples 2-13 optionally includes a guidewire extending into the lumen of the tubular body and an anchor attached to a distal end portion of the guidewire.

[0232] In Example 15, the subject matter of Example 14 optionally includes wherein the anchoring portion comprises a screw.

[0233] In Example 16, the subject matter of any one or more of Examples 14-15 optionally includes an anchor portion comprising an expandable body, the anchor portion being capable of being retracted into a lumen of the tubular body to contract the expandable body and being capable of being extended from the lumen to expand the expandable body.

[0234] In Example 17, the subject matter of Example 16 optionally includes the expandable body comprising a plurality of bendable leaflets.

[0235] In Example 18, the subject matter of any one or more of Examples 16-17 optionally includes wherein the expandable body comprises a plurality of extendable projections.

[0236] In Example 19, the subject matter of any one or more of Examples 1-18 optionally includes an interventional device configured to move along the re-entry path.

[0237] In Example 20, the subject matter of Example 19 optionally includes wherein the interventional device comprises a treatment stent.

[0238] In Example 21, the subject matter of Example 20 optionally includes the treatment stent being configured to provide pumping activity in the anatomical area.

[0239] In Example 22, the subject matter of Example 21 optionally includes the treatment stent being configured to expand and contract.

[0240] In Example 23, the subject matter of any one or more of Examples 20-22 optionally includes that the treatment stent device comprises a stone treatment device.

[0241] In Example 24, the subject matter of Example 23 optionally includes wherein the stone treatment device is configured to chemically treat the stone.

[0242] In Example 25, the subject matter of any one or more of Examples 23-24 optionally includes the stone treatment device being configured to mechanically reduce a size of the stone.

[0243] In Example 26, the subject matter of any one or more of Examples 20-25 optionally includes the treatment stent being configured to provide heating.

[0244] In Example 27, the subject matter of any one or more of Examples 20-26 optionally includes a balloon positioned within the treatment stent.

[0245] In Example 28, the subject matter of any one or more of Examples 1-27 optionally includes the stent being configured to cut tissue.

[0246] In Example 29, the subject matter of Example 28 optionally includes the stent comprising a mechanical cutting blade.

[0247] In Example 30, the subject matter of any one or more of Examples 28-29 optionally includes the stent comprising an electrical cutting blade.

[0248] In Example 31, the subject matter of Example 30 optionally includes the electrical cutting blade comprising a pair of electrical leads configured to be withdrawn from the stent after use.

[0249] In Example 32, the subject matter of any one or more of Examples 1-31 optionally includes the stent being selectively expandable.

[0250] In Example 33, the subject matter of Example 32 optionally includes a plurality of magnets positioned on the stent and a magnetic applicator configured to move along the re-entry path to magnetically expand the stent.

[0251] Example 34 is a method for implanting a treatment device in an anatomical structure, the method including the steps of implanting a stent at an anatomical opening, positioning a re-entry path extending from the stent into the anatomical passageway, sliding the treatment device along the re-entry path to position the treatment device in the anatomical passageway, and treating the anatomical structure with the treatment device.

[0252] In Example 35, the subject matter of Example 34 optionally includes the step of implanting the stent in the anatomical opening by cutting tissue with the stent.

[0253] In Example 36, the subject matter of Example 35 optionally includes cutting the tissue with the stent by electrically cutting the tissue with a bipolar lead.

[0254] In Example 37, the subject matter of Example 36 optionally includes the step of detaching the bipolar lead from the stent.

[0255] In Example 38, the subject matter of any one or more of Examples 34-37 optionally includes the step of expanding the stent to implant the stent in the anatomical opening.

[0256] In Example 39, the subject matter of Example 38 optionally includes expanding the stent by magnetically expanding the stent.

[0257] In Example 40, the subject matter of any one or more of Examples 34-39 optionally includes a step of positioning a re-entry pathway extending from the stent into the anatomical passage by positioning a tube in the anatomical passage.

[0258] In Example 41, the subject matter of Example 40 optionally includes inserting a guidewire through the re-entry pathway into the anatomical passageway.

[0259] In Example 42, the subject matter of Example 41 optionally includes inserting a guidewire into the anatomical passageway through the re-entry pathway by attaching an anchor to the anatomical passageway.

[0260] In Example 43, the subject matter of Example 42 optionally includes attaching the anchoring portion to the anatomical passage by expanding the anchoring portion to attach to the tissue.

[0261] In Example 44, the subject matter of Example 43 optionally includes the step of expanding the tether for attachment to tissue by pushing the expandable tether out of the tube to expand the expandable tether.

[0262] In Example 45, the subject matter of any one or more of Examples 41-44 optionally includes a step of sliding the treatment device along the re-entry path to position the treatment device in the anatomical passageway by sliding the treatment stent along the guidewire.

[0263] In Example 46, the subject matter of Example 45 optionally includes the step of opening the vessel to allow a treatment stent to slide over the guidewire.

[0264] In Example 47, the subject matter of Example 46 optionally includes opening the tube by widening a gap in the tube.

[0265] In Example 48, the subject matter of any one or more of Examples 46-47 optionally includes opening the tube by breaking a perforation extending along the tube.

[0266] In Example 49, the subject matter of any one or more of Examples 46-48 optionally includes reclosing the tube via a magnetic closure element.

[0267] In Example 50, the subject matter of any one or more of Examples 46-49 optionally includes reclosing the tube via an elastic closure element.

[0268] In Example 51, the subject matter of any one or more of Examples 34-50 optionally includes a step of treating the anatomical structure with the treatment device by pumping into the anatomical structure into which the treatment device is deployed.

[0269] In Example 52, the subject matter of Example 51 optionally includes pumping the anatomical structure in which the treatment device is deployed by expanding and contracting a stent.

[0270] In Example 53, the subject matter of any one or more of Examples 34-52 optionally includes a step of treating the anatomical structure with the treatment device by treating a stone in the anatomical structure to facilitate passage through the treatment device.

[0271] In Example 54, the subject matter of Example 53 optionally includes treating the stone in the anatomical structure to facilitate passage of the stone through the treatment device by chemically dissolving the stone.

[0272] In Example 55, the subject matter of any one or more of Examples 53-54 optionally includes a step of treating a stone in an anatomical structure to mechanically reduce a size of the stone to facilitate passage through the treatment device.

[0273] In Example 56, the subject matter of any one or more of Examples 34-55 optionally includes treating the anatomical structure with the treatment device by heating the treatment device.

[0274] In Example 57, the subject matter of Example 56 optionally includes heating the treatment device by vibrating the treatment device.

[0275] In Example 58, the subject matter of any one or more of Examples 34-57 optionally includes the step of inflating a balloon within the stent to expand the stent.

[0276] In Example 59, the subject matter of any one or more of Examples 34-58 optionally includes a step of sliding the treatment device along the re-entry path by funneling the treatment device into the re-entry path.

[0277] In Example 60, the subject matter of any one or more of Examples 34-59 optionally includes a step of twisting the treatment device into the re-entry path.

[0278] In Example 61, the subject matter of any one or more of Examples 34-60 optionally includes magnetically attracting the treatment device into the re-entry path.

[0279] 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.

[0280] The above detailed description includes references to the accompanying drawings, which may form a part of the detailed description. The drawings show, by way of example, specific embodiments in which the invention may be practiced. These embodiments are also referred to herein as "examples." These examples may include elements in addition to those shown or described. However, the inventors also contemplate examples in which only the elements shown or described are provided. Furthermore, the inventors also contemplate examples using any combination or permutation of the elements shown or described (or one or more aspects thereof) with respect to either the specific example (or one or more aspects thereof) or any other example (or one or more aspects thereof) shown or described herein.

[0281] In the event of a conflicting usage between this document and any document incorporated by reference, the usage in this document will control.

[0282] The terms "a" or "an" are used herein to include one or more, as is common in patent literature, independently of any other instance or use of "at least one" or "one or more." The term "or" is used herein to refer non-exclusively to "A or B," including "A but not B," "B but not A," and "A and B," unless otherwise indicated. The terms "including" and "in which" are used herein as the plain English equivalents of the respective terms "comprising" and "wherein." Also, in the following claims, the terms "including" and "comprising" are intended to be open-ended, i.e., a system, device, article, composition, formulation, or process that includes elements in addition to the elements listed after such term in a claim is still deemed to be within the scope of that claim. Moreover, in the following claims, terms such as "first," "second," and "third," are used merely as labels and are not intended to impose numerical requirements on their objects.

[0283] Examples of the methods described herein can be implemented, at least in part, on a machine or computer. Some examples can include computer-readable or machine-readable media encoded with instructions operable to configure an electronic device to implement the methods as described in the previous examples. Such method implementations can include code, such as microcode, assembly language code, or high-level language code. Such code can include computer-readable instructions for implementing various methods. The code may form part of a computer program product. Further, in examples, the code can be tangibly stored in one or more volatile, non-transitory, or non-volatile 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 digital video disks), magnetic cassettes, memory cards or sticks, random access memory (RAM), and read-only memory (ROM).

[0284] The foregoing description is intended to be illustrative, not limiting. For example, the examples of the foregoing description (or one or more aspects thereof) can be used in combination with each other. Other embodiments may be used by those of ordinary skill in the art upon review of the foregoing description. The Abstract is provided to allow the reader to quickly ascertain the nature of the disclosure of the present technology. The Abstract 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 construed as intending that an unclaimed disclosed feature is essential to any claim. Rather, the subject matter of the present invention may lie in less than all features of a specific disclosed embodiment. Thus, the following claims are hereby incorporated into the detailed description as an example or embodiment, 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 present invention should be determined with reference to the appended claims, along with the full scope of equivalents to which such claims are entitled. [Explanation of symbols]

[0285] 10 Endoscope System 12 Imaging control system 14 Endoscopes, scopes 16 Control Unit 18 Output unit, display unit 20 Input Units 22 Light source unit 24 Fluid source 26 Suction Pump 28 Insertion Area 30 Functional Areas, Functional Units 32 Handle Area 34 Cable Area 36 coupler area 38 Knob 40 Ports 41 Cart 42 Image Processing Unit 44 Treatment Generation Device 46 Drive unit 70 Camera Module 72 Case 74 Treatment Unit 76 Fluid outlet 78 Lighting Lens 80 Objective Lens 82 Lumen 84 Optical Transmitter 88 Wiring 89 Fluid Line 100 Direct oral cholangioscopic system 102 Guide sheath 104 Bile Duct Scope, Endoscope, Scope 106 Tissue recovery device, tissue collection device 108 Shaft, guide sheath 110 Control Device 112 Gripping part 114 Control Knob 116 Coupler 118 Cable 120 Long and thin body 122 Coupler 124 Cable 126 Shaft 128 Tissue separation body 130 Control Device 132 Hinge 134 Separate body 136 Lumen of sheath 102 138 Lumen of cholangioscope 104 139A Distal end portion 139B Proximal part 140A, 140B Pull Wire 142 Lumen 146A, 146B Pull Wire 200 patients 201 mouth 202 Duodenum 204 mouth 206 Esophagus 208 Stomach 210 Intestines 212 Common bile duct 214 Conduit wall 216 Sphincter of Oddi 218 Main pancreatic duct 220 Aisle 222 Entrance 300 Direct oral cholangioscopic system 302 Cholangioscope 304 Mooring Wire 306 Long and thin shaft 308 Work tool bore 310 Non-axial lumen 312 Mooring wire lumen 314 Objective Lens 316 Lighting Lens 320 fluid outlet 322 Distal surface 324 Side 326 Top 328 Bottom surface 330 Proximal surface 332 Distal opening 334 Proximal opening, lateral opening 336 Shaft 338 Cable 340 Mooring 350 tissue tube 352 Sample tissue, tissue samples 354 Control device 356, 358 line 500 Duodenum 502 Common bile duct 504 Duodenal papilla 506 Pancreatic duct 508 Cystic duct 510 Sphincter of Oddi 512 Pancreas 514 Gallbladder 520 Implants, stents 522 Main unit 530 Stent 532 Inflatable Balloon 534A, 534B Electrical Leads 536 Outer diameter 538 Interior Space 540 Interior Space 542 tube 550 Stent 552A, 552B Electrical Leads 554 Mesh stent body 556 Wire 558 Interior Space 600 stents 602 Main unit 604 Axial Blade 606A, 606B, 606C, 606D, 606E, 606F Circumferential blades 608A, 608B, 608C, 608D, 608E, 608F Beveled blade 610A, 610B, 610C, 610D Mooring parts, spines 630 Stent Device 632 Magnetic applicator 634 Tubular body, sheath 636 Sheath 638 Magnetizable or magnetic elements, magnets 640 Guidewire 642 Magnet 644 Magnetic field 650 Stent 652A, 652B Re-entry Device 654 Main unit 656A First End 656B Second end 658 Wire 660A, 660B Long thin tube 660C Component 662A, 662B Ingress element, ingress device 664 Lumen of stent 650 666A, 666B Lumen of tube 672, 674 Guide wire 676, 678 Mooring section 690 Stent 692A, 692B Distal Stent 694A, 694B main body 694C Therapeutic stents 700 stents 702A, 702B Devices 706 Main unit 704A, 704B, 704C, 704D, 704E, 704F cutting blade 708A, 708B, 708C, 708D cutting elements 710A, 710B, 710C, 710D Moorings 750 Implantable Devices 752A, 752B Monorail 756A, 756B Moorings 760 Deployable Moorings 762 Mooring 764 Sleeve 766A~766D Lobule 770 Deployable Moorings 772 Mooring 774 Sleeve 776A, 776B, 776C, 776D Expandable members 790 Deployable Members 792 Long and thin shaft 794 Lumen 796 Perforated line 800 Deployable Members 802 Long and thin shaft 804 Lumen 806 Slit 810 Deployable members 812 Long and thin shaft 814 Lumen 816 Gap 820 Deployable Members 822 Long and thin shaft 824 Lumen 826 Gap 828 Magnetic materials 829 Metal Strips 830 Deployable members 832 Long and thin shaft 834 Lumen 836 Gap 838 C-shaped reinforcement 840 Treatment Device D1 Outer diameter of guide sheath 108 D2 Diameter of bore 136 D1, D2 Diameter of stent 530 D3 Outer diameter of cholangioscope 104 D4 Diameter of bore 138 A2 Center longitudinal axis

Claims

1. A guide sheath having an inner lumen and flexibility adapted for steering; an elongate shaft extending between a proximal end of the elongate shaft and a distal end of the elongate shaft, the distal end having a distal end surface, the elongate shaft being configured for placement along the lumen; a work tool lumen extending along the interior of said elongate shaft and having an exit opening at said distal end face; a tether wire lumen having a side opening into an outer surface of the elongate shaft between a proximal end face and the distal end face, the tether wire lumen having a distal opening at the distal end face; a non-axial bore extending to the distal end face of the elongate shaft for connecting the work tool bore to the exterior of the elongate shaft; An endoscope comprising: A cholangioscopy system comprising:

2. The cholangioscopy system of claim 1 , further comprising a tether wire extending through the tether wire lumen.

3. The mooring wire is A long thin cable and a tissue anchor positioned proximate a distal end of the anchor wire; and The cholangioscopy system of claim 2 .

4. The cholangioscopy system of claim 1 , further comprising a tissue retrieval device extendable from the working tool lumen.

5. 5. The cholangioscopy system of claim 4, wherein the tissue retrieval device comprises a shaft that is elastically bendable from extending along the working tool lumen to extending along the working tool lumen into the non-axial lumen.

6. The cholangioscopy system of claim 5 , wherein the tissue retrieval device comprises a forceps.

7. 2. The cholangioscopy system of claim 1, wherein the non-axial lumen comprises a slit disposed in the distal end face, the slit extending along the elongate shaft and extending from an exterior of the elongate shaft to the working tool lumen.

8. The cholangioscopy system of claim 7 , wherein the non-axial lumen extends through a side of the elongate shaft.

9. The cholangioscopy system of claim 1 , wherein the non-axial lumen extends within the distal-most 10 percent of the length of the elongate shaft.

10. The cholangioscopy system of claim 1 , wherein the endoscope includes steering capabilities.

11. 1. A method of assembling an endoscopic system for performance of a direct oral cholangioscopy procedure, comprising: inserting an endoscope into a guiding sheath, the guiding sheath and the endoscope configured for insertion into the duodenum and common bile duct of a patient; extending a tissue retrieval device through the endoscope; extending a tether wire into the interior of the endoscope; Including, the tissue collection device is configured to collect biological material; The endoscope and the tissue retrieval device are configured to be withdrawn from the common bile duct along the tether wire. method.

12. The method of claim 11 , wherein the guiding sheath is configured to steer the endoscope.

13. The method of claim 12 , wherein the endoscope's natural steering capabilities are configured to steer the endoscope.

14. The method of claim 13 , wherein the endoscope is configured to be steered by pushing away the guiding sheath.

15. The method of claim 11 , wherein the anchoring wire is configured to be attached to tissue.

16. The method of claim 11, wherein the endoscope is configured to be reinserted into the endoscope by sliding the endoscope along the tether wire.

17. The method of claim 16 , wherein the tissue collection device is configured such that tissue is removed therefrom after it has been collected.

18. The method of claim 17, wherein a distal portion of the tissue retrieval device is configured to be positioned within a non-axial lumen of the endoscope.

19. The method of claim 18, wherein a portion of the shaft of the tissue retrieval device extends from the work tool lumen and is configured to bend as it extends through the non-axial lumen.

20. 20. The method of claim 19, wherein the non-axial lumen comprises a slot at a distal end of the endoscope connecting the work tool lumen to a side of the endoscope.

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