Cholangioscope system guide sheath and anchoring line

Abstract

A method of direct peroral cholangioscopy includes inserting an endoscope into a guide sheath, inserting the guide sheath and endoscope into the duodenum, extending a tissue retrieval device through the endoscope into the duodenum, extending an anchor line into the duodenum, collecting biological matter using the tissue retrieval device, and withdrawing the cholangioscope and tissue retrieval device from the duodenum along the anchor line. A cholangioscopy system includes a steerable guide sheath and a cholangioscope including a shaft extending to a distal end face for displacement within the steerable guide sheath, a tool lumen extending along the shaft and exiting at the distal end face, an anchor line 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 an exterior of the shaft at the distal end face.

Description

[0001] This application is a divisional application of the invention patent application filed on November 9, 2021, with application number 202180084930.8 (PCT / US2021 / 058561) and entitled "Guiding Sheath and Anchoring Line for a Cholangioscopic System". Cross-references to related applications

[0002] 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 entire contents of which are incorporated herein by reference. Technical Field

[0003] This disclosure generally relates to medical devices comprising an elongated body configured to be inserted into an incision or opening in a patient’s anatomy to provide diagnostic or therapeutic procedures.

[0004] More specifically, this disclosure relates to medical devices, such as endoscopes, which can be inserted into a patient's anatomy, for example by means of another device, to facilitate the removal of biological material, such as by cutting sample tissue with forceps for later analysis. Background Technology

[0005] Endoscopes can be used for one or more of the following: 1) providing access to various anatomical parts via other devices, such as treatment devices or tissue collection devices, and 2) imaging such anatomical parts. Such anatomical parts may include the gastrointestinal tract (e.g., esophagus, stomach, duodenum, pancreaticobiliary duct, intestine, colon, etc.), the renal region (e.g., kidneys, ureter, bladder, urethra), and other internal organs (e.g., reproductive system, sinus cavities, submucosal regions, respiratory tract).

[0006] Conventional endoscopy can be used in a variety of clinical procedures, including, for example, illuminating, imaging, detecting, and diagnosing one or more disease states; providing fluid delivery toward an anatomical area (e.g., delivering saline or other preparations via a fluid channel); providing access to one or more treatment devices (e.g., via a working channel) for sampling or processing of the anatomical area; and providing aspiration access for collecting fluids (e.g., saline or other preparations).

[0007] In routine endoscopy, the distal portion of the endoscope can be configured to support and orient the treatment device, for example, using a lifter. In some systems, two endoscopes can be configured to work together, with the first endoscope guiding the second endoscope inserted within it using a lifter. Such systems can facilitate guiding endoscopes to hard-to-reach anatomical locations within the body. For example, some anatomical locations may only be accessible via endoscopy after insertion through a circuitous route.

[0008] An example of an endoscopic procedure is called endoscopic retrograde cholangiopancreatography (ERCP), hereinafter referred to as the "ERCP" procedure. In ERCP, an auxiliary endoscope (also called a daughter endoscope or cholangioscope) is attached and advanced through the working channel of the master endoscope (also called the mother endoscope or duodenoscope). Additionally, a tissue retrieval device for removing sample material is inserted through the auxiliary endoscope. Therefore, the duodenoscope, auxiliary endoscope, and tissue retrieval device become progressively smaller as they are inserted into progressively smaller lumens, making them more difficult to manipulate and perform interventions and treatments. Summary of the Invention

[0009] The inventors have recognized that the problems to be solved by conventional medical devices, and particularly endoscopes and duodenoscopes used for retrieving sample biological material, include, among other things: 1) difficulties in navigating the endoscope and instruments inserted into it to locations deep within the anatomical region of the patient's body; 2) disadvantages associated with operating three instruments (e.g., duodenoscope, cholangioscopy, tissue removal device), such as the need for multiple skilled instrument operators; 3) the increased time and associated costs of repeatedly removing and reinserting the medical device to obtain a sufficient quantity of sample material; and 4) the difficulty in incorporating features (e.g., maneuverability and tissue collection features) into small-diameter devices.

[0010] The inventors have recognized that such problems may be particularly present in duodenoscopy procedures, such as the aforementioned ERCP procedure. Recent attempts have been made to address the shortcomings of the ERCP procedure. Recent developments involve the use of endoscopes in direct peroral cholangioscopy procedures, in which the endoscope is advanced directly into the patient's mouth to reach the common bile duct. See, for example, the discussion in "Direct Peroral Cholangioscopy" by Dr. Mansour A. Parsi, published online in the World Journal of Gastrointestinal Endoscopy on January 16, 2014. However, such procedures are difficult to perform due to the looping of the endoscope created by navigating 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 lead to its inoperability due to constraints, such as the endoscope being bent too tightly to allow for other articulations.

[0011] This disclosure can help provide solutions to these and other problems by providing systems, devices, and methods related to direct transoral cholangioscopy procedures, such as those including a guide sheath, which can be placed on the endoscope to provide: 1) direct auxiliary maneuverability of the endoscope in addition to its primary inherent maneuverability, and 2) a rigid structure against which the endoscope can be pushed using its primary inherent maneuverability to provide articulation for the endoscope. Thus, when the endoscope is positioned in the common bile duct, the inherent maneuverability of the endoscope remains operable to position the treatment device at the target tissue site (e.g., the site where tissue to be treated or removed for analysis resides).

[0012] Therefore, this disclosure can help address the above and other problems by: 1) increasing the ease of use of direct transoral cholangioscopy and ERCP systems (e.g., fewer operators, less skill required to navigate through the sphincter of Oddi / Vater ampulla), and 2) increasing the size of the treatment device, among other things, as described herein (e.g., increasing the volume of sample material collected at each insertion, reducing the number of times the tissue removal device needs to be inserted and re-inserted into the anatomy).

[0013] In the example, the cholangioscopy system may include a guide sheath and a cholangioscope. The guide sheath may include a maneuverable lumen. The endoscope may include: an elongated shaft extending between a proximal end portion and a distal end face, the elongated shaft being configured for displacement along a steerable lumen; a working tool lumen extending along the elongated shaft and exiting at the distal end face; an anchoring line lumen entering the elongated shaft between the proximal and distal end portions and exiting the elongated shaft at the distal end face; and a non-axial lumen extending from the working tool lumen to the outside of the elongated shaft at the distal end face.

[0014] In another example, a method for performing a direct oral cholangioscopy procedure may include: inserting an endoscope into a guide sheath, inserting the guide sheath and endoscope into the patient's duodenum, extending a tissue retrieval device through the endoscope into the patient's common bile duct, extending an anchoring line into the common bile duct, collecting biological material using the tissue retrieval device, and retracting the cholangioscopy and tissue retrieval device from the common bile duct along the anchoring line.

[0015] Furthermore, the inventors have recognized that problems that can be addressed through conventional surgical procedures, such as duodenoscopy in the gastrointestinal system, sometimes require subsequent procedures to resolve issues arising from the original surgery or to provide additional treatment. Sometimes multiple subsequent procedures are performed, for example, to provide ongoing treatment. Therefore, the aforementioned complex navigation and manipulation procedures are repeated two or more times.

[0016] This disclosure provides a solution to these and other problems by offering an implantable device that facilitates subsequent procedures. In particular, the implantable device can expedite subsequent procedures by providing rapid access to anatomical structures, such as the duodenum and, especially, the common bile duct. The re-entry device may include a stent with cutting capabilities to allow implantation into anatomically constricted areas. The implantable device may include a re-entry device comprising tubes, tracks, guides, guide lines, etc., which can provide a path through complex anatomical geometry to allow procedures to follow previously drawn paths. The re-entry device can allow therapeutic devices, such as stents, to be inserted into the re-entry tube or slide along the re-entry guide line, thereby eliminating the need for complex master / daughter endoscopes, etc. The therapeutic device can be implanted into the anatomical structure to provide single-use or continuous treatment, such as fluid pumping, stone removal, etc.

[0017] In the example, a system for providing re-entry into a patient's anatomical region may include a stent comprising an annular body and a re-entry track extending through the stent, the re-entry track comprising an elongated body including a proximal end and a distal end extending from the annular body.

[0018] In another example, a method for implanting a treatment device into an anatomical structure may include: implanting a stent into an anatomical opening, positioning a reentry track extending from the stent into the anatomical pathway, sliding the treatment device along the reentry track to position the treatment device in the anatomical pathway, and treating the anatomical structure with the treatment device. Attached Figure Description

[0019] Figure 1A This is a schematic diagram of a direct oral cholangioscopy system, which includes a nested guide sheath, a cholangioscope, and a tissue retrieval device.

[0020] Figure 1B It is in a state of decomposition. Figure 1A A schematic diagram of a direct oral cholangioscopy system, showing the internal cavity passing through the guide sheath and the cholangioscope.

[0021] Figure 2 yes Figure 1A and Figure 1B A schematic diagram of the distal end portion of the guide sheath, cholangioscope, and tissue retrieval device.

[0022] Figure 3 yes Figure 1A and Figure 1B A schematic diagram of a cholangioscope, showing an imaging and control system including a control unit connected to the cholangioscope.

[0023] Figure 4 It is connected to the cholangioscope. Figure 3 A schematic diagram of the imaging and control system.

[0024] Figure 5A It includes being suitable for and Figures 1A to 4 An end view of the camera module, which is used with optical and functional components of a cholangioscope.

[0025] Figure 5B It is along Figure 5A The cross-sectional view taken from plane 5B–5B shows the components of the camera module.

[0026] Figure 6 The illustration shows an insertion into the patient's mouth to reach the duodenum. Figure 1A and Figure 1B A schematic diagram of the guide sheath and cholangioscope.

[0027] Figure 7 The diagram illustrates the location within the duodenum. Figure 6 A schematic diagram of the guide sheath, cholangioscope, and tissue retrieval device positioned in the common bile duct.

[0028] Figure 8This is a perspective view of another example of a cholangioscope constructed for use with the guide sheath of this disclosure.

[0029] Figure 9 yes Figure 8 The end view of the cholangioscope shows the anchoring line lumen and the non-axial lumen.

[0030] Figure 10 It is along Figure 9 A schematic cross-sectional view of the cholangioscope taken from plane 10-10, showing the non-axial cavity.

[0031] Figure 11 It is along Figure 9 A schematic cross-sectional view of the cholangioscope taken from plane 11-11, showing the anchoring line cavity.

[0032] Figure 12A It is inserted into the common bile duct Figure 8 A schematic diagram of a cholangioscope, an anchoring line attached to the tissue, and a tissue retrieval device extending beyond the non-axial lumen.

[0033] Figure 12B It is reabsorbed from the common bile duct. Figure 8 A schematic diagram of a cholangioscope, an anchoring line attached to the tissue, and a tissue retrieval device that is bent into a curve extending through a non-axial lumen.

[0034] Figure 13 This is a block diagram illustrating a method for retrieving tissue samples from a patient's common bile duct using a choledochoscope with an anchoring lumen and a non-axial lumen.

[0035] Figure 14 This is a schematic diagram of the duodenum, which connects to the common bile duct via the duodenal papilla.

[0036] Figure 15 It is a stent of this disclosure that is inserted into the duodenal papilla. Figure 14 A schematic diagram of the duodenum.

[0037] Figure 16A This is a schematic diagram of a stacked stent, which has an inflatable balloon inserted into the stent and electrical wires extending through the stent.

[0038] Figure 16B It is in a state of expansion. Figure 16A A schematic diagram of the support structure, in which the electrical wires are in their original positions.

[0039] Figure 16C It is in a state of expansion. Figure 16B A schematic diagram of the support structure, in which electrical wires are pulled away from the support structure.

[0040] Figure 17This is a schematic side view of the bracket of this application, which includes electrical wires extending into the cylindrical mesh bracket body.

[0041] Figure 18 This is a schematic side view of the bracket of this application, including the mechanically cut edges.

[0042] Figure 19 yes Figure 18 The end view of the bracket shows the anchoring barbs.

[0043] Figure 20A This is a schematic cross-sectional view of a magnetically actuated support in a collapsed state.

[0044] Figure 20B This is a schematic cross-sectional view of the magnetically actuated support in Figure 20 in an expanded state.

[0045] Figure 21 Describes the structure that makes Figure 20A and Figure 20B An example of a magnetic applicator that expands and contracts a magnetically actuated support.

[0046] Figure 22 This is a schematic side view of the support frame of the present application, which includes an extendable elongated reentry device.

[0047] Figure 23 yes Figure 22 An end view of the support, showing the cavity through the support and the extendable reentry device.

[0048] Figure 24 yes Figure 22 and Figure 23 A schematic diagram of the support structure, in which an extendable, elongated reentry device is deployed.

[0049] Figure 25 This is a side view of a stent disclosed herein, which has an elongated re-entry device with a funnel-shaped inlet deployed in the cystic duct.

[0050] Figure 26 This is a schematic side view of a support including an elongated reentry device, which includes a distal support.

[0051] Figure 27 It is deployed within the cystic duct and pancreatic duct. Figure 26 A schematic side view of the stent and duodenum.

[0052] Figure 28 This is a schematic diagram of the duodenum having an implantable device of the present disclosure, the implantable device including an expandable and retractable pumping stent.

[0053] Figure 29AThis is a schematic side view of a stent designed to treat gallstones.

[0054] Figure 29B yes Figure 29A A schematic end view of a gallstone treatment stent.

[0055] Figure 30 This is a schematic diagram of the duodenum having an implantable device comprising multiple monorail devices.

[0056] Figure 31 This is a schematic diagram of a monorail including a helical anchor.

[0057] Figure 32A This is a schematic diagram of a monorail, which includes a first example of a deployable anchor in a collapsed state.

[0058] Figure 32B yes Figure 32A A schematic diagram of a monorail, in which the deployable anchor is in an extended state.

[0059] Figure 33A This is a schematic diagram of a monorail, which includes a second example of a deployable anchor in a collapsed state.

[0060] Figure 33B yes Figure 33A A schematic diagram of a monorail, in which the deployable anchor is in an extended state.

[0061] Figure 34 This is a schematic diagram of a first example of a perforated, elongated deployable component.

[0062] Figure 35 This is a schematic diagram of a first example of an elongated deployable component including a slit.

[0063] Figure 36 This is a schematic diagram of a first example of an elongated deployable component including gaps.

[0064] Figure 37 This is a schematic diagram of a first example of an elongated deployable member including a C-shaped reinforcement.

[0065] Figure 38 This is a schematic diagram of a first example of an elongated deployable component including a magnetic enclosure element.

[0066] Figure 39 It is a schematic perspective view of an elongated deployable member with a treatment device that slides through the elongated deployable member to open the elongated deployable member.

[0067] Figure 40 This is a block diagram illustrating a method for implanting the re-entry device of this application, which has a therapeutic device. Detailed Implementation

[0068] Figure 1A This is a schematic diagram of a direct oral cholangioscopy system 100, in which the guide sheath 102, cholangioscope 104, and tissue retrieval device 106 are in a nested configuration. Figure 1B This is a schematic diagram of a direct oral cholangioscopy system 100, in which the guide sheath 102, cholangioscope 104, and tissue retrieval device 106 are in a disassembled configuration. Simultaneously, for... Figure 1A and Figure 1B Let's have a discussion. Figure 1A and Figure 1B It is not necessarily drawn to scale, and may be enlarged in some aspects for illustrative purposes.

[0069] System 100 may include a guide sheath 102, a cholangioscope 104, and a tissue retrieval device 106. Sheath 102 may include a shaft 108 and a control device 110. The control device 110 may include a gripper 112, a control knob 114, and a connector 116. The connector 116 can be connected to a control unit 16 via a cable 118. Figure 4 ). Reference Figures 3 to 5B The cholangioscope 104 is described in more detail. The cholangioscope 104 may include an elongated body 120 and a connector 122, which 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.

[0070] Figure 1A A cholangioscope 104 nested inside a sheath 102 and a tissue removal device 106 nested inside the cholangioscope 104 are shown. Therefore, as... Figure 1B As can be seen, the sheath 102 may include a cavity 136, and the cholangioscope 104 may include a cavity 138.

[0071] As discussed in more detail in this article, 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 surgical complexity and the number of times instruments need to be inserted into the duodenum and common bile duct to retrieve a sufficient amount of tissue for testing.

[0072] The shaft 108 of the guide sleeve 102 may include a traction line ( Figure 2(140A, 140B) The traction line can be used to manipulate the guide sleeve 102. The control device 110 can be used to operate the guide sleeve 102, including operating the traction line. For example, the grip 112 can be grasped by the operator, and the control knob 114 can be rotated to pull one or both traction lines, thereby applying directionality to the shape of the shaft 108. Thus, the guide sleeve 102 can be used to influence the shape of the choledochoscope 104, which can be positioned inside the shaft 108. Thus, the shaft 108 can be made of a suitable material that is compliant enough to be oriented by the traction line, but rigid enough to allow the choledochoscope 104 to be pushed away from the shaft 108. In the example, the shaft 108 can be segmented to have different stiffnesses, for example, to concentrate the capability of the shaft 108 to be manipulated in specific sections of the guide sleeve 102. For example, the distal end portion 139A of shaft 108 (e.g., approximately the distal 10% to 20%) can be configured to be more flexible than the remaining proximal portion 139B, such that the traction cable can pull the distal end of shaft 108 at an acute angle (e.g., approximately 30 to 90 degrees), which can be used to insert the choledochoscope 104 from the duodenum 202 ( Figure 7 Guided to common bile duct 212 ( Figure 7 The flexible segmentation of axis 108 allows a more rigid portion adjacent to the distal flexible portion to provide reinforcement to the cholangioscope, allowing the cholangioscope to use its inherent maneuverability more effectively (e.g., without the restraints described above). For example, the proximal portion 139B can have a more rigidity than the cholangioscope 104, such that when the cholangioscope 104 is manipulated, for example by tightening one or more traction lines 146A and 146B, the cholangioscope 104 can be pushed in the desired direction by the pulling of the traction lines 146A and 146B.

[0073] The cholangioscope 104 can be configured as a full-function endoscope, possessing maneuverability, guidance capability, imaging capability, fluid distribution and retrieval capability, and functional (e.g., therapeutic and diagnostic) capabilities, as well as access for other instruments. See below for reference. Figure 3 and Figure 4 The endoscope 14 details the functionality of the choledochoscope 104, and therefore, only in Figure 1A and Figure 1B The functionality of the cholangioscope 104 is schematically illustrated in the diagram.

[0074] The tissue retrieval device 106 can be configured as any suitable device for obtaining tissue samples from a patient. However, the tissue retrieval device 106 may include components or devices for interacting with the patient, such as components or devices configured to cut, slice, pull, saw, pierce, twist, or auger the tissue. Specifically, the tissue retrieval device 106 may include any device suitable for removing tissue from the patient, such as a blade, punch, or auger. The tissue retrieval device 106 may be configured to physically separate portions of the patient's tissue from other, larger portions of the tissue within the patient's body. In other examples, the tissue retrieval device 106 may be configured to simply collect biological material, such as mucus or fluid, from the patient without requiring physical separation. In the illustrated example, the tissue retrieval device 106 may include clamps with a separator 134 configured as sharp or serrated jaws pivotally connected at a hinge 132. However, the tissue retrieval device 106 may be configured as a variety of devices capable of collecting biological material, such as the aforementioned punch, auger, blade, saw, etc. The term "tissue removal device" is used throughout this disclosure; however, tissue removal device 106 may alternatively or additionally include biological material collection device, biological material removal device, tissue collection device, and tissue removal device.

[0075] The tissue retrieval device 106 can be configured to, for example, maintain a volume of collected biological material, such as tissue, between the separators 134. Therefore, the tissue retrieval device 106 can be configured to be retrieved from the cholangioscope 104 to obtain the collected biological material, for example, for diagnostic analysis. In other examples, the tissue retrieval device 106 may include a lumen through which the biological material can be retrieved without having to retrieve the tissue retrieval device from the cholangioscope 104.

[0076] The guide sheath 102 can be constructed as a simple tubular body with limited navigation capabilities, which can be used to enhance the inherent navigation capabilities of the choledochoscope without increasing the size of system components or the complexity of the procedure, thereby allowing the inherent navigation and imaging capabilities of the choledochoscope 104 to be used throughout the entire procedure. Therefore, the need for a small choledochoscope, related electronic equipment, and related technicians can be eliminated. Thus, without the volume of a full-function duodenoscope, the diameter of the elongated body 120 of the choledochoscope 104 can be increased, thereby allowing a corresponding increase in the size of the tissue retrieval device 106. Due to the simplicity of the guide sheath 102, it can be constructed as a single-use device.

[0077] Figure 2 yes Figure 1A and Figure 1BA schematic diagram of the distal portions of the guide sheath 102, the cholangioscope 104, and the tissue retrieval device 106. The guide sheath 102 may include a shaft 108 and a lumen 136. The cholangioscope 104 may include an elongated body 120 and a lumen 138. The tissue retrieval device 106 is additionally shown as extending from the lumen 138. The tissue retrieval device 106 may include a shaft 126 and a tissue separator 128. Figure 2 It is not necessarily drawn to scale, and may be enlarged in some aspects for illustrative purposes.

[0078] As shown, the guide sheath 102, the cholangioscope 104, and the tissue retrieval device 106 can be configured to be inserted through a specific anatomical structure and nested within each other to maximize the size of the tissue retrieval device.

[0079] The guide sheath 102 may have an outer diameter D1, and the guide sheath is configured for insertion into the patient's oral cavity 204. Figure 6 In the ), the guide sheath 102 can be configured to conform to the anatomy of a typical patient who will receive the guide sheath, such as the esophagus 206 ( Figure 6 ) and duodenal 202 ( Figure 6 The guide sheath 102 can be configured to have different sizes to be compatible with different sizes of human anatomy. In the example, D1 can be in the range of about 10.0 mm to about 12.0 mm. In other examples, D1 can be in the range of about 8.0 mm to about 9.0 mm.

[0080] The cavity 136 of the guide sleeve 102 may have a diameter D2 and may be configured to be as large as feasible while taking into account the desired maneuverability, including flexibility, durability, and rigidity of the guide sleeve 102. The shaft 108 may have a thickness between D1 and D2 sufficient to accommodate the traction cables 140A and 140B and other related components, such as traction rings. Control knob 114 ( Figure 1A The guide sheath 102 can be configured to apply tension to the traction lines 140A and 140B to exert a bending force on the shaft 108, for example, when the cholangioscope 104 is inserted into the lumen 136, manipulating the guide sheath 102 and applying an associated bending force to the cholangioscope 104. However, in other examples, an anchoring line may be included within the lumen 136. In the examples, given the simple construction of the guide sheath 102, the guide sheath 102 can be configured as a single-use, disposable item. In the examples, D2 can range from about 9.0 mm to about 11.00 mm. In other examples, D2 can range from about 8.0 mm to about 9.00 mm.

[0081] The cholangioscope 104 may have an outer diameter D3, and is configured for insertion into the lumen 136 of the guide sheath 102. The cholangioscope 104 does not need to be configured to maximize the available size of the diameter D2, but can be configured to utilize as much space as possible in the lumen 136 as needed to provide the desired capabilities of the cholangioscope. The elongated body 120 can be configured to slide freely within the lumen 136 without restraint. In an example, D3 may range from about 8.0 mm to about 10.0 mm. In other examples, D3 may range from about 4.0 mm to about 4.5 mm.

[0082] The lumen 138 of the cholangioscope 104 may have a diameter D4, and the lumen 138 may be configured to be as large as feasible while taking into account the amount of space required for the optical components and other surgical components of the cholangioscope 104. Therefore, the lumen 138 may be configured to have one or more cavities 142 for other desired functions of the cholangioscope 104. The cavities 142 may be configured to receive references. Figure 5A and Figure 5B The components under discussion include, for example, the light emitter 84, wiring 88, and fluid lines 89. Similarly, cavity 138 can be configured to accommodate traction wires 146A and 146B, which can be connected to knob 38 in the elongated body 120. Figure 3 In the example, D4 ​​can be in the range of about 5.0 mm to about 6.0 mm. In other examples, D4 can be in the range of about 2.0 mm to about 3.0 mm.

[0083] Figure 3 This is a schematic diagram of an endoscopic examination system 10, including an imaging and control system 12 and an endoscope 14. Figure 3 The system described herein is an illustrative example of an endoscopic system suitable for use with the systems, apparatus, and methods described herein, such as a direct transoral cholangioscopy system, which can be used to obtain samples of tissue or other biological material removed from a patient for analysis or patient treatment. According to some examples, endoscope 14 may include... Figures 1A to 2 The endoscope 104 may be an endoscope capable of being inserted into an anatomical region for imaging and / or providing access for one or more sampling devices for biopsy or for one or more treatment devices for treating disease conditions associated with the anatomical region. Advantageously, the endoscope 14 may engage with and be connected to an imaging and control system 12. In the illustrated example, the endoscope 14 includes an endoscope, but other types of endoscopes may also be used with the features and teachings of this disclosure.

[0084] The imaging and 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.

[0085] The imaging and control system 12 may include various ports for connection to the endoscope 10. For example, the control unit 16 may include a data input / output port 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, for example, via an optical fiber link. The fluid source 24 may include a port for transmitting fluid to the endoscope 14. The fluid source 24 may include a pump and a fluid tank, or may be connected to an external tank, container, or storage unit. The suction pump 26 may include a port for creating a vacuum in the endoscope 14 to generate suction, for example, 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 the operator of the endoscope 10 to control the functions of the endoscope 10 and to view the output of the endoscope 14. The control unit 16 may additionally be used to generate signals or other outputs based on the processing of the anatomical region into which the endoscope 14 is inserted. In the example, the control unit 16 can generate electrical output, acoustic output, fluid output, etc., for use in treating anatomical areas by means of, for example, cauterization, cutting, freezing, etc.

[0086] The endoscope 14 may include an insertion section 28, a functional section 30, and a handle section 32. The endoscope 14 may be connected to a cable section 34 and a connector section 36.

[0087] Insertion segment 28 extends distally from handle segment 32, and cable segment 34 extends proximally from handle segment 32. Insertion segment 28 may be elongated and includes a curved segment and a distal end that can be attached to functional segment 30. The curved segment may be controllable (e.g., via traction cables 146A and 146B connected to control knob 38 on handle segment 32) to manipulate the distal end through tortuous anatomical pathways (e.g., stomach, duodenum, kidney, urinary catheter, etc.). Insertion segment 28 may also include one or more working channels (e.g., internal cavities), which may be elongated and support one or more therapeutic instruments of functional segment 30, such as... Figure 1A and Figure 1B The tissue removal device 106 is inserted. The working channel can extend between the handle section 32 and the functional section 30. Additional functions, such as fluid passages, anchor lines, and traction lines, can also be provided by the insertion section 28 (e.g., through suction or flushing passages).

[0088] The handle section 32 may include a knob 38 and a port 40. The knob 38 may be connected to traction wires 146A and 146B extending through the insertion section 28, or other actuating mechanisms, such that rotation of the knob 38 causes bending of the functional section 30. The port 40 may be configured to connect various cables, anchoring wires, auxiliary endoscopes, tissue collection devices of this disclosure, fluid tubing, etc., to the handle section 32 for connection with the insertion section 28. For example, a cholangioscope 104 may be fed into the endoscope 14 via one of the ports of the port 40.

[0089] According to the example, the imaging and control system 12 can be mounted on a mobile platform (e.g., a trolley 41) with shelves for accommodating the light source unit 22, the suction pump 26, and the imaging processing unit 42. Figure 4 ) etc. Alternatively, Figure 3 and Figure 4 Multiple components of the imaging and control system 12 shown can be directly mounted on the endoscope 14 to make the endoscope "independent".

[0090] Functional section 30 may include components for treating and diagnosing the patient's anatomy. Functional section 30 may include imaging devices, illumination devices, and lifts, such as for further reference... Figures 5A to 5B As described. Functional segment 30 may also include imaging and illumination components configured for end-view observation, such as observation at a distal end outside functional segment 30 or in the axial direction.

[0091] Figure 4 yes Figure 3 A schematic diagram of an endoscopic examination system 10, which includes an imaging and control system 12 and an endoscope 14. Figure 4 The components of an imaging and control system 12 connected to an endoscope 14, which in the illustrated example includes a terminal colonoscope, are schematically illustrated. The imaging and control system 12 may include a control unit 16, 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, wherein the control unit 16 may include an image processing unit 42 or be connected to an image processing unit 42.

[0092] Image processing unit 42 and light source unit 22 can each be coupled to endoscope 14 via a wired or wireless connection (e.g., at functional unit 30). Imaging and control system 12 can thus illuminate the anatomical region, collect signals representing the anatomical region, process signals representing the anatomical region, and display an image representing the anatomical region on display unit 18. Imaging and control system 12 may include light source unit 22 to illuminate the anatomical region using light of a desired spectrum (e.g., broadband white light, narrowband imaging using preferred electromagnetic wavelengths, etc.). Imaging and control system 12 can be connected to endoscope 14 (e.g., via endoscope connector) for signal transmission (e.g., light output from the light source, video signals from the imaging system in the distal end, diagnostic and sensor signals from diagnostic devices, etc.).

[0093] Fluid source 24 (FIG. 1) may be in communication with control unit 16 and may include one or more air sources, saline sources, or other fluid sources, as well as associated fluid pathways (e.g., air passages, flushing passages, suction passages) and connectors (barbed fittings, fluid seals, valves, etc.). Fluid source 24 may be used as activation energy for the biasing or pressure application device used in this disclosure. Imaging and control system 12 may also include drive unit 46, which may be an optional component. Drive unit 46 may include a motorized actuator for advancing the distal segment of endoscope 14, as described at least in PCT Publication No. WO 2011 / 140118 A1 entitled “Rotate-to-Advance Catheterization System” by Frassica et al., the entire contents of which are incorporated herein by reference.

[0094] Figures 5A to 5B The diagram shows... Figure 4 The first example of the functional section 30 of the endoscope 14. Figure 5A The illustration shows an end view of functional section 30, and Figure 5B The diagram illustrates along Figure 5A The cross-sectional view of the functional segment 30 cut from the cross-sectional plane 5B-5B. Figure 5A and Figure 5B Each illustration depicts an end-viewing endoscope (e.g., gastroscope, colonoscope, cholangioscope) camera module 70. In the end-viewing endoscope camera module 70, the illumination and imaging systems are positioned such that the observation angle of the imaging system corresponds to the target anatomical structure located near the end of the endoscope 14 and aligned with the central longitudinal axis A2 of the endoscope 14.

[0095] exist Figure 5A and Figure 5BIn this example, the end-viewing 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 to the cavity 82.

[0096] like Figure 5B As can be seen, the insertion section 28 may include a cavity 82, through which various components may extend to connect the functional section 30 and the handle section 32. Figure 4 ) connection. For example, illumination lens 78 can be connected to light emitter 84, which may include extensions to light source unit 22 ( Figure 4 ) fiber optic cables or cable bundles. Similarly, objective lens 80 can be connected to imaging unit 87, and imaging unit 87 can be connected to wiring 88. In addition, fluid outlet 76 can be connected to fluid line 89, and fluid line 89 may include extensions to fluid source 24 ( Figure 4 The fluid outlet 76 may include an inlet connected to a fluid line 89 configured for suction, such as connection to a vacuum, for recovering irrigation and flushing fluids. Other elongated elements such as tubes, wires, or cables may extend through the cavity 82 to connect the functional section 30 to components of the endoscope system 10, such as the suction pump 26. Figure 4 ) and treatment generator 44 ( Figure 4 (Connection). For example, treatment unit 74 may include a large-diameter cavity for receiving other treatment components, such as cutting devices and treatment devices including tissue removal device 106.

[0097] The endoscope camera module 70 may also include a photosensitive 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 to the image processing unit 42 (e.g., via a wired or wireless connection). Figure 4 The imaging and control system 12 and the imaging unit 87 can transmit signals representing an image (e.g., video signals) from the photosensitive element to the image processing unit 42, and then display them on a display, such as the output unit 18. In various examples, the imaging and control system 12 and the imaging unit 87 can be configured to provide output at a desired resolution suitable for an endoscopic examination procedure (e.g., at least 480p, at least 720p, at least 1080p, at least 4K UHD, etc.).

[0098] Figure 6 The illustration shows the patient being inserted orally at 200 to reach the duodenum at 202. Figure 1A and Figure 1BA diagram of the guide sheath 102 and the choledochoscope 104. The guide sheath 102 can extend into the oral cavity 204, through the esophagus 206, and through the stomach 208 to reach the duodenum 202. Before reaching the intestine 210, the guide sheath 102 can position the choledochoscope 104 near the common bile duct 212. The choledochoscope 104 can be extended from the guide sheath 102 into the common bile duct 212. In addition to direct manipulation of the choledochoscope 104 via traction lines 146A and 146B, manipulation features of the guide sheath 102, such as traction lines 40A and 40B, can also be used to facilitate navigation and flexion of the choledochoscope 104 through the stomach 208. For example, navigation of the pyloric canal and pyloric sphincter may be difficult using only an endoscope. Therefore, the guide sheath 102 can be used to steer or bend the elongated body 120 of the choledochoscope 104, or to reduce the amount of manipulation or bending of the elongated body 120 required by the traction lines 146A and 146B to facilitate passage through the pyloric sphincter. Additionally, once navigation has passed through the pyloric sphincter, another turn in the opposite direction is typically for entry into the duodenum 202. Furthermore, the maneuverability of the guide sheath 102—which is released after passing through the pyloric sphincter—can again be used to steer or bend the elongated body 120 of the choledochoscope 104 to reduce the burden on the inherent maneuverability of the choledochoscope 104. Due to the enhanced maneuverability provided by the guide sheath 102, the inherent maneuverability of the choledochoscope 104 (e.g., traction lines 146A and 146B) can be preserved for maneuvering the elongated body 120 to guide the tissue retrieval device 106 into the duodenum 202.

[0099] Figure 7 This is a schematic diagram of the distal portion of a guide sheath 102 having a cholangioscope 104 and a tissue removal device 106 extending from the cholangioscope 104, according to the present disclosure. The guide sheath 102 can be positioned in the duodenum 202, for example, referring to... Figure 6 As described.

[0100] The duodenum 202 may include a ductal wall 214, a sphincter of Oddi 216, a common bile duct 212, and a main pancreatic duct 218. The duodenum 202 includes the upper portion of the small intestine. The common bile duct 212 carries bile from the gallbladder and liver (not shown) and empties it into the duodenum 202 via passage 220 through the sphincter of Oddi 216. The main pancreatic duct 218 transports pancreatic juice from the exocrine pancreas (not shown) to the common bile duct 212. Sometimes it may be desirable to remove biological material, such as tissue, from the common bile duct 212 or the main pancreatic duct 218 for tissue analysis, and thus, for example, to diagnose a patient's disease or discomfort, such as cancer.

[0101] The choledochoscope 104 can be guided using a guide sheath 102, positioning its distal end near the sphincter of Oddi 216. This allows the surgeon to manipulate the direct transoral choledochoscopy system 100 to extend the tissue retrieval device 106 from the choledochoscope 104 into the common bile duct 212. The inherent maneuverability of the choledochoscope 104 can be used to steer it toward the sphincter of Oddi 216, in some cases at an angle of approximately 90 degrees. In this example, the choledochoscope 104 can be advanced into the common bile duct 212. In either case, the tissue retrieval device 106 can be advanced from and manipulated from the choledochoscope 104, for example, by maneuvering it using its inherent maneuverability via the hinges of the choledochoscope 104, to collect target tissue within the common bile duct 212. Specifically, the choledochoscope 104 can be used to navigate the tissue retrieval device 106 toward other locations in the gallbladder, liver, or gastrointestinal system to perform various procedures. The surgeon can guide the tissue removal device 106 through the inlet 222 of the main pancreatic duct 218 and into the passage 220 of the common bile duct 212, or into the inlet 222. The imaging capabilities of a cholangioscope (e.g., a camera) can be used to visualize the tissue removal device 106 to facilitate direct contact with the target tissue.

[0102] In the example, the lumen 138 of the choledochoscope 104 can be used to deliver alternative tissue removal devices 106 or other devices attached to tissue removal devices 106 into the duodenum 202 and common bile duct 212. Other devices may have their own functional capabilities, such as light sources, accessories, and biopsy channels for treatment procedures.

[0103] Biological material collected by the tissue removal device 106 can typically be removed from the patient by removing it from the choledochoscope 104, allowing analysis of the removed biological material to diagnose one or more conditions in the patient. According to various examples, the tissue removal device 106 can be used to remove cancerous or precancerous material (e.g., carcinoma, sarcoma, myeloma, leukemia, lymphoma, etc.), for endometriosis assessment, bile duct biopsy, etc.

[0104] As described herein, the size of a typical tissue retrieval device is limited by the size of the auxiliary endoscope, which itself is limited by the size of the duodenoscope. Therefore, a typical tissue retrieval device can be on the order of approximately 1.2 mm or smaller. However, for the device of this disclosure, the guide sheath 102 can be constructed as a simple device, allowing for a small thickness, thus enabling the working channel, such as lumen 136, to be large compared to the working channel of the duodenoscope, which must provide additional channels for imaging, illumination, and fluid access. Therefore, with conventional devices, it may be difficult to obtain a sufficiently large tissue sample size to ensure accurate diagnosis without repeated removal and reinsertion of the auxiliary device. However, with the system and device of this disclosure, since lumen 138 is enlarged due to the small size of the guide sheath 102, a sufficiently large tissue sample size can be obtained with only a single insertion and removal of the auxiliary device (e.g., tissue retrieval device 106).

[0105] Figure 8 This is a perspective view of a cholangioscopy system 300, which includes a cholangioscope 302 configured for use with the guide sheath 102 of this disclosure and an anchoring line 304. Figure 9 yes Figure 8 A distal end view of the cholangioscope 302, showing the anchoring line cavity 312 and the non-axial cavity 310 for the working tool cavity 308. (Discussion follows.) Figure 8 and Figure 9 .

[0106] As discussed in more detail below, the anchoring line 304 can be used in conjunction with the guide sheath 102 to repeatedly insert the choledochoscope 302 into the patient's anatomy to obtain multiple tissue samples. Specifically, after initially guiding the choledochoscope 302 to the desired target tissue using the guide sheath 102, the anchoring line 304 can be used to anchor the choledochoscope 302 to the target tissue or to tissue near the target tissue. The tissue retrieval device 106 can be inserted into the working tool cavity 308 to obtain tissue from the patient. The choledochoscope 302 and the tissue retrieval device 106 can be withdrawn from the target tissue site while the anchoring line 304 and the guide sheath 102 remain in place. After removing the target tissue sample from the tissue retrieval device 106, the choledochoscope 302 can be easily guided back to the target tissue site using the guide sheath 102 and the anchoring line 304.

[0107] Similar to Figure 1A and Figure 1BThe choledochoscope 104 and choledochoscope 302 can be positioned within the guide sheath 102 for manipulation through anatomical structures. The choledochoscope 302 may include an elongated shaft 306, a working tool lumen 308, a non-axial lumen 310, an anchoring line lumen 312, an objective lens 314, an illumination lens 316, a fluid outlet 320, a distal end face 322, and a side surface 324.

[0108] Objective lens 314 can be configured to be similar to Figure 5A and Figure 5B The objective lens 80 is similar. Objective lens 314 can be configured to direct light toward the imaging unit to provide a digital image to output unit 18. Illumination lens 316 can be configured similarly to... Figure 5A and Figure 5B Illumination lens 78. Illumination lens 316 can be configured to direct light from a light emitter, such as a light emitter receiving light from light source unit 22, toward the distal end of tissue at distal end face 322, thereby illuminating the tissue for use in navigation and tissue removal device 106. Fluid outlet 320 can be configured to... Figure 5A and Figure 5B The fluid outlet 76 is similar. One or more fluid outlets 320 may be provided for delivering and recovering fluid, such as by coupling to a fluid source or aspiration source. The elongated shaft 306 of the cholangioscope 302 may be additionally provided with maneuverability as described with reference to the cholangioscope 104. For example, the elongated shaft 306 may include traction cables, such as traction cables 146A and 146B ( Figure 2 The traction line can be connected to the actuator to give the elongated shaft a curvature of 306.

[0109] The working tool cavity 308 can be configured similarly to the cavity 138 of the cholangioscope 104, and can be configured to receive a working tool, such as the tissue retrieval device 106. The working tool cavity 308 can extend from the distal end face 322 of the elongated shaft 306 to its proximal portion. For example, the proximal end of the cavity 308 can be connected to the port 40 (…). Figure 3 Port 40 is configured to allow the working tool to enter the elongated shaft 306. The cross-sectional area or diameter of the working tool cavity 308 may be sized to allow the tissue separator 128 to pass freely through the working tool cavity 308.

[0110] The non-axial cavity 310 can be connected to the working tool cavity 308. The non-axial cavity 310 may include an upper surface 326, a lower surface 328, and a proximal surface 330. The anchoring line cavity 312 may include a distal opening 332, a proximal opening 334, and a shaft 336.

[0111] The non-axial cavity 310 may include a slot or slit located at the distal end face 322 of the elongated shaft 306, which connects the working tool cavity 308 to the side surface 324. In the example, the non-axial cavity 310 may be rectangular in shape, such that the proximal surface 330 is flat or planar. The non-axial cavity 310 may be the same thickness or height as the shaft 126 of the tissue retrieval device 106 (see reference). Figure 8 The orientation of the non-axial cavity 310 (and its width) can be the same as the thickness between the side surface 324 and the working tool cavity 308. In the example, the non-axial cavity 310 can be as high as the tissue separator 128 to allow the tissue separator 128 to pass laterally through the non-axial cavity 310. Therefore, the non-axial cavity 310 can extend through the material of the elongated shaft 306 and any coatings, reinforcing layers, etc., thereby extending through or along the elongated shaft 306. The non-axial cavity 310 can extend only along the distal portion of the elongated shaft 306, such as the farthest 10% of the elongated shaft starting from the distal end face 322 and moving proximally. In the example, the non-axial cavity 310 can extend from about 2.0 mm to about 10.0 cm from the distal end face 322.

[0112] Anchor wire 304 may include cable 338 and anchor 340. In the illustrated example, anchor 340 may include a helical member configured to be inserted into the patient's tissue, with the tissue retrieval device 106 intended to retrieve target tissue near that tissue. However, anchor 340 may include any suitable device for attaching to, embedding in, or abutting against soft tissue, such as a balloon. In other examples, anchor wire 304 may be used without anchor 340, and cable 338 may be blunt, such as having a ball-shaped member attached thereto.

[0113] Cable 338 may include a line or cable over which a cholangioscope can slide. Cable 338 may include one or more strands of metal or polymer material that are strong enough to be pushed through an anatomical structure and allow other devices to travel along the length of anchor line 304. In an example, cable 338 may be coated to facilitate sliding against other components and tissues. In an example, cable 338 may simply include an elongated member that can be inserted into the anatomical structure after endoscope 302 is in place, for example, by being pulled into the anatomical structure together with cholangioscope 302 during the insertion process. In such a configuration, anchor 340 may be configured to be caught on opening 332 for easy pulling by cholangioscope 302. However, in other examples, cable 338 may be configured as a maneuverable anchor line to be individually navigated to the target tissue before or after cholangioscope 302 is navigated to the target tissue site. Therefore, the anchor wire 304 can be navigated to the target tissue and the cholangioscope 302 can follow it by inserting the proximal end of the cable 338 into the opening 332, or the cholangioscope 302 can be navigated to the target tissue and the anchor wire 304 can follow it by navigating to the opening 334.

[0114] In the example, cable 338 can be connected to controller 354 ( Figure 12B This facilitates the operation of the anchor wire 304. For example, the controller 354 may include a mechanism, such as a thumbwheel, for controlling the forward and backward movement of the cable 338. Additionally, the controller 354 may be used to deploy or operate the anchor 340. For example, the controller 354 may apply rotation to the cable 338 to allow the helical anchor to penetrate tissue, or it may provide inflation pressure to the balloon via air or fluid pressure.

[0115] The tissue retrieval device 106 can be positioned within the working tool cavity 308 for insertion of the cholangioscope 302 into anatomical structures and retraction of the cholangioscope 302. As discussed herein, the tissue separator 128 can be configured as forceps or any other device suitable for separating, retrieving, or collecting sample biological material. The shaft 126 of the tissue retrieval device 106 may include a flexible body that allows the tissue separator 128 to be angled away from the elongated shaft 306 by bending through the non-axial cavity 310. The shaft 126 may additionally provide space for control features, such as actuation lines, to pass through and reach the tissue separator 128 to facilitate actuation of the tissue separator 128 to collect tissue.

[0116] Figure 10 It is along Figure 9A schematic cross-sectional view of the cholangioscope 302 taken from plane 10-10 shows the non-axial cavity 310 connected to the working tool cavity 308. The cholangioscope 302 may include an elongated shaft 306, a distal end face 322, and a side surface 324. The non-axial cavity 310 may include an upper surface 326 ( Figure 10 The tooling cavity 308 extends from the proximal end of the elongated shaft 306 to the distal end face 322. (The text repeats itself here.) Figure 9 As shown, the tool cavity 308 may include a circular cavity; however, other shapes and cross-sections may also be used. For example... Figure 9 As also shown, the non-axial cavity 310 may have a rectangular shape or a rectangular cross-section in the axial direction of the elongated shaft 306. For example... Figure 10 As shown, the non-axial cavity 310 may have a rectangular shape or rectangular cross-section in a direction transverse to the axial direction of the elongated shaft 306, as indicated by the planarity of the proximal surface 330. However, the proximal surface 330 may be curved between the side surface 324 and the working tool cavity 308 as shown by line 356, or at an angle as shown by line 358, so that the non-axial cavity 310 can avoid having a sharp surface against which the shaft 126 of the tissue removal device 106 is configured to bend.

[0117] The non-axial cavity 310 can connect the working tool cavity 308 to both the distal end face 322 and the side surface 324. Therefore, when the cholangioscope 302 is withdrawn from the anatomical structure, the shaft 126 of the tissue retrieval device 106 can be bent to position the tissue separator 128 outside the working tool cavity 308.

[0118] Figure 11 It is along Figure 9 A schematic cross-sectional view of the cholangioscope 302 taken from plane 11-11 to show the anchoring lumen 312. The cholangioscope 302 may include an elongated shaft 306, a distal end face 322, and a side face 324. The anchoring lumen 312 may include a distal opening 332 and a side opening 334.

[0119] The anchoring lumen 312 may include a passage through the elongated shaft 306 to provide a shortcut from the distal end face 322 to the side surface 324 away from the proximal end of the elongated shaft 306. The anchoring lumen 312 allows instruments to enter and exit the elongated shaft 306 without having to pass through the proximal end portion of the elongated shaft 302. Therefore, the anchoring lumen 312 does not occupy space within the elongated shaft 306 of the cholangioscope 302 along a large portion of its length. The space within the elongated shaft 306 can thus be used for other functional components of the cholangioscope 302, such as imaging, illumination, and fluid control components. However, the anchoring lumen 312 may be long enough to provide a secure attachment to the cable 338 of the anchoring line 304, thereby allowing guidance of the distal portion of the elongated shaft 306 along the path of the anchoring line. In this example, the anchoring lumen 312 may be short to provide a “point” connection. However, the anchoring cavity 312 may have a length that facilitates alignment of the axis of the elongated shaft 306 with the axis of the cable 338.

[0120] In the illustrated example, the anchoring lumen 312 is configured to pass through the material of the elongated shaft 306 within the cylindrical coverage area of ​​the elongated shaft 306. As mentioned, this configuration is advantageous for saving space within the elongated shaft 306 and provides a low-profile shape for the distal end portion of the elongated shaft 306 to avoid hooking into anatomical structures and the guide sheath 102. However, in other examples, the anchoring lumen 312 may be located outside the cylindrical coverage area of ​​the elongated shaft 306, for example, on the exterior of the elongated shaft 306, such as by passing through a hook or clip attached to the elongated shaft 306, or through a protrusion forming a hook, clip, or eyelet in the material of the elongated shaft 306.

[0121] Figure 12A It is inserted into the tissue tube 350 Figure 8 A schematic diagram of the cholangioscope 302, the anchoring line 304 attached to the tissue tube 350, and the tissue retrieval device 106 extending beyond the non-axial cavity 310.

[0122] Guide sleeve 102 can be used ( Figures 1A to 2 The choledochoscope 302 is guided to the tissue tube 350 by the manipulatory capabilities of the choledochoscope 302 and its inherent manipulatory capabilities (e.g., traction cable). In the example, the tissue tube 350 may include the duodenum, common bile duct, pancreatic duct, or other tissue tubes. The anchoring cable 304 can be inserted into the tissue tube 350 before, during, or after the choledochoscope 302 is used. The anchoring cable 304 can be positioned by extending a cable 338 through the anchoring cable lumen 312, such that the distal end of the cable 338 protrudes from the anchoring cable lumen 312. Thus, the anchor 340 can be positioned distal to the distal end face 322 of the elongated shaft 306. The controller 354 can be used to engage the anchor 340 with the tissue to prevent displacement of the cable 338.

[0123] The tissue retrieval device 106 can be inserted into the tissue tube 350 together with the cholangioscope 302, or after the cholangioscope 302 is positioned in the tissue tube 350. The tissue retrieval device 106 can extend from the working tool cavity 308 such that the tissue separator 128 protrudes from the working tool cavity 308. The tissue retrieval device 106 can be operated by the control device 130 to position the tissue separator 128 at the site of the target tissue within the tissue tube 350. In this example, the tissue retrieval device 106 can be made of a transparent or translucent material that allows light to pass through, so that the objective lens 80 can see through the tissue retrieval device 106. Therefore, opening the separator 134 to obtain the tissue will not obstruct the operator's observation of the target tissue site. The control device 130 can therefore be operated to allow the separator 134 to be positioned at the hinge 132 ( Figure 1A The endoscope 302 is rotated at the tissue tube 350 to remove the target tissue from the tissue tube 350. After the tissue is obtained by the tissue separator 128, the endoscope 302 can be retracted from the tissue tube 350, for example, along the anchor line 304.

[0124] Figure 12B It was recovered from Organization Management 350. Figure 8 A schematic diagram of a cholangioscope 302, an anchoring line 304 that remains engaged with a tissue tube 350, and a tissue retrieval device 106 that is bent to extend through a non-axial cavity 310 and release sample tissue 352.

[0125] With the tissue separator 128 holding the tissue sample, the tissue extraction device 106 can retract into the working tool cavity 308, such that the tissue separator 128 is located within the elongated shaft 306. Therefore, the tissue separator 128 can be protected during the retraction of the cholangioscope 302. However, the cholangioscope 302 can be retracted together with the tissue separator 128 extending from the working tool cavity 308.

[0126] The cholangioscope 302 can be retracted backward from the tissue canal 350 (in... Figure 12B (Move back to the left from the center). Anchor 340 ( Figure 12A The cable 338 can remain attached to the tissue tube 350, allowing it to extend along the path from the target tissue site in the tissue tube 350 to exit the patient's mouth during transoral surgery. Handle segment 32 ( Figure 3The choledochoscope 302 can be gripped to pull it from the tissue tube 350. Therefore, the tissue retrieval device 106 can be pulled along with the choledochoscope 302. As the choledochoscope 302 is withdrawn from the patient, the proximal portion (e.g., the handle segment 32) is displaced further away from the patient. This allows the inlet for the working tool lumen 308 to be positioned away from the operator. Therefore, typically, to retrieve tissue from the tissue separator 128, the operator will need to move to the position of the handle segment 32 to: fully withdraw the tissue retrieval device 106 from the choledochoscope 302, which may include the operator potentially moving the distance between the choledochoscope 302 and the tissue retrieval device 106; or advance the tissue retrieval device 106 forward to protrude the tissue separator 128 from the working tool lumen 308, which may include placing one of the operator's hands on the handle segment 32 and requiring the operator's other hand to be fully positioned at the distal end of the elongated shaft 306 to engage and open the tissue separator 128. Any of these options could introduce additional steps and operator movement during the procedure, which could be difficult or inconvenient in the context of an operating room arranged in a compact and delicate manner. However, for the purposes of this disclosure, the non-axial cavity 310 can facilitate quick and easy access to the tissue retrieval device 106 without requiring reorientation of the tissue retrieval device relative to the choledochoscope 302 or repositioning of the operator within the operating room. The shaft 126 can be bent to move the tissue separator 128 away from the elongated shaft 306. Specifically, the shaft 126 can be bent to position the tissue separator 128 axially alongside the lateral surface 324, and in some examples, proximal to the distal end face 322. In examples, the shaft 126 can be bent at approximately 90 degrees. Thus, the operator can remain positioned near the patient from whom the choledochoscope 302 is withdrawn and simply manipulate the tissue separator 128 to access the sample tissue 352. For example, the tissue separator 128 can be grasped distally at the end of the cholangioscope 302 and pulled proximally through the non-axial lumen 310, and then finely manipulated to access the sample tissue 352. In this example, the control device 130 can be operated to move the separators 128 away from each other to release the sample tissue 352.

[0127] After the sample tissue 352 is retrieved, the tissue separator 128 can be repositioned at the distal end of the cholangioscope 302 and retracted into the working tool cavity 308 if necessary. The cholangioscope 302 can then be moved back into the tissue tube 350 by sliding the elongated shaft 306 along the cable 338 to the target tissue site. The maneuverability of the guide sheath 102 and the cholangioscope 302 can be used in conjunction with the anchoring line 304 to facilitate movement of the cholangioscope 302 to the target tissue site. However, due to the presence of the anchoring line 304, there is no need for bare-metal or independent operation of the cholangioscope 302. Once at the target tissue site, the tissue separator 128 can be used again to obtain additional tissue samples to supplement the sample tissue 352. Therefore, a sufficient amount of tissue can be obtained to perform one or more different types of tissue analysis procedures without the difficulty of independently renavigating the cholangioscope through the duodenum and common bile duct.

[0128] Figure 13 This is a block diagram illustrating an example of a method 400 for collecting biological material from a patient using, for example, a direct transoral cholangioscopy system 300 of this disclosure. Method 400 may include... Figures 8 to 12B The use of the guide sheath 102, the cholangioscope 302 and the tissue removal device 106.

[0129] At step 402, the choledochoscope 302 can be inserted into the guide sheath 102. Specifically, the elongated shaft 306 of the choledochoscope 302 can be inserted into the cavity 136 of the guide sheath 102. The choledochoscope 104 can be configured to slide freely within the guide sheath 102, such that one can move relative to the other during and after insertion.

[0130] At step 404, the choledochoscope 302 and guide sheath 102 can be navigated through the patient's anatomy. Specifically, the choledochoscope 302 and guide sheath 102 can be inserted into the patient's oral cavity 204 and pushed downward through the esophagus 206 to reach the stomach 208 (see [link to relevant documentation]). Figure 6 The cholangioscope 302 and the guide sheath 102 can be manipulated to extend through the stomach 208 and into the duodenum 202.

[0131] At step 406, the choledochoscope 302 and the guide sheath 102 can be pushed into the duodenum 202. For example, the guide sheath 102 can be manipulated, for instance, by pulling at least one of the traction lines 140A and 140B using the control knob 114, to bend the choledochoscope 302 and exit the stomach 208 through the pyloric canal, thereby releasing control over the choledochoscope 302, such as the traction lines 146A and 146B, so that stretching and / or compression must be applied to the elongated shaft 306, thus further allowing the choledochoscope 302 to be maneuverable for other uses.

[0132] At step 408, the guide sheath 102 can be adjusted, for example by using control knob 114 to pull at least one of the traction lines 140A and 140B, to orient the distal end of the guide sheath 102 toward the sphincter of Oddi 216. This again preserves the inherent maneuverability of the choledochoscope 302, such as the traction lines 146A and 146B, for later use. However, the traction lines 146A and 146B of the choledochoscope 302 can supplement the function of the traction lines 140A and 140B.

[0133] The choledochoscope 302 can be manipulated into the duodenum 202 using traction lines 140A and 140B. The rigidity of the guide sheath 102 can be used to allow the choledochoscope 302 to be pushed away from the guide sheath 102 to achieve a desired geometry facing the duodenum 202 and entering the duodenum 202 when needed. The choledochoscope 302 can extend from the guide sheath 102 to engage the sphincter of Oddi 216. In other examples, the choledochoscope 302 can extend from the guide sheath 102 to penetrate the sphincter of Oddi 216.

[0134] At step 410, the anchoring wire 304 may be extended through an anchoring lumen 312 within the elongated shaft 306 of the cholangioscope 302. The anchoring wire 304 may be extended into the cholangioscope 302 before or after it has been placed in an anatomical structure. The anchoring wire 304 may be extended such that an anchor 340 protrudes from the anchoring lumen 312. The anchor 340 may then be deployed to engage tissue. As discussed, the anchor 340 may be attached to, adhere to, or abut against tissue insertion to prevent or inhibit proximal displacement of the anchoring wire 304. A cable 338 may extend through the anchoring lumen 312 to the proximal end of the cholangioscope 302, outside the elongated shaft 306, and may be connected, for example, to a handle segment 32.

[0135] At step 412, the tissue retrieval device 106 may be inserted into and extend from the cholangioscope 302. The tissue separator 128 may extend from the distal end of the elongated shaft 306 to engage tissue within the common bile duct 212 beyond the sphincter of Oddi 216. In other examples, the tissue retrieval device 106 may be guided together with the guide sheath 102 and the cholangioscope 302 through the stomach 208 and duodenum 202.

[0136] At step 414, the tissue retrieval device 106 can be used to collect the target tissue. The target tissue may include potentially diseased tissue or tissue that otherwise indicates a patient's condition. For example, the separator 134 can be manipulated by the control device 130 to engage the target tissue once or more, thereby collecting, separating, and storing the target tissue if necessary. In this example, due to the factors discussed herein, the tissue retrieval device 106 may be sized large enough to collect a sufficient volume of biological material in a single collection operation, thus avoiding multiple insertions of the tissue retrieval device 106. However, for Figures 8 to 12B For example, the tissue removal device 106 can be sized to any suitable capacity and can be configured to be easily removed and reinserted into the anatomical structure without having to re-perform the manipulation of the guide sheath 102 and the choledochoscope 302 to navigate through the complex stomach 208 and common bile duct 212. For example, oversized forceps can be used, which, when deployed outside the working tool cavity 308, particularly when the forceps are substantially or partially made of transparent material and components, partially obstruct the imaging capability of the choledochoscope 302.

[0137] At step 416, the tissue removal device 106 can be retracted into the working tool cavity 308 of the choledochoscope 302. The choledochoscope 302 can be retracted from the anatomical structure by sliding along the cable 338, allowing the target tissue to be removed from the tissue separator 128. The anchor 340 can remain attached to or engaged with the tissue, such that the anchor line 304 remains in place within the anatomical structure.

[0138] At step 418, the target tissue can be removed from the tissue separator 128. For example, the separator 134 can be opened to allow access to the separated target tissue.

[0139] Subsequently, method 400 may return to step 412 by reinserting the choledochoscope 302 and tissue retrieval device 106 into the anatomical structure at step 420 to collect additional material from the previous target tissue site or other material from a different target tissue site, or may continue to step 422 to complete the operation.

[0140] At step 422, anchor 304 can be removed from the patient, for example by disconnecting anchor 340 from the tissue and then retracting cable 338 from the anatomical structure.

[0141] At step 424, the guide sheath 102 can be removed from the patient, for example by retracting it from the esophagus 206.

[0142] At step 426, the tissue collected from the patient can be analyzed, for example by transporting the tissue to a laboratory to analyze the presence of diseased tissue, such as cancerous tissue.

[0143] Therefore, method 400 illustrates an example of a method for collecting biological material from a patient's internal access via multiple sampling, allowing a sufficient amount of tissue to be retrieved for analysis during a single patient procedure, thereby reducing or eliminating the need for additional tissue in subsequent patient procedures. Method 400 can be performed using a choledochoscope with an anchoring system comprising an anchoring line, an anchoring line lumen, and a non-axial lumen for the working tool. The anchoring line and anchoring line lumen can be used to guide the choledochoscope into and out of the patient's anatomy without having to perform complex insertion and repositioning operations again. The anchoring line can be attached only to the distal portion of the choledochoscope to avoid occupying space within the choledochoscope's axis. The non-axial lumen can be used to easily access the tissue retrieval, collection, or dissection device at the distal end of the working tool without having to completely retract the working tool from the choledochoscope. Therefore, the direct transoral choledochoscopy system 300 of this disclosure can facilitate efficient tissue collection from the patient, thereby reducing procedure time and the likelihood of needing subsequent procedures.

[0144] Figure 14 This is a schematic diagram of the duodenum 500, which connects to the common bile duct 502 via the duodenal papilla 504. The common bile duct 502 may branch into the pancreatic duct 506 and the cystic duct 508. The duodenal papilla 504 may include the sphincter of Oddi 510. Figure 15 The pancreatic duct 506 leads to the pancreas 512. The cystic duct 508 leads to the gallbladder 514. As mentioned above, navigation of surgical instruments to the duodenal papilla 504 can be difficult. Guiding surgical instruments through insertion into the common bile duct 502 via the duodenal papilla 504 can also be difficult. For example, the sphincter of Oddi 510 is a muscle that controls the flow of bile and pancreatic juice into the intestine. However, the muscle structure of the sphincter of Oddi 510 can make access to the common bile duct 502 difficult. Therefore, during medical procedures, the sphincter of Oddi 510 is often cut to widen the duodenal papilla 504 to allow easier access to the common bile duct 502.

[0145] Figure 15 It is an implant 520 of the present disclosure that is inserted into the duodenal papilla 504. Figure 14A schematic diagram of the duodenum 500. The implant 520 may include a body 522, which may include an annular cylindrical body that pushes the sphincter of Oddi 510 into an enlarged state. The implant 520 may be delivered to the duodenum 500 in a collapsed state and then enlarged to provide an entrance to the common bile duct 502. As described herein, the implant 520 may serve as a base for mounting other components to facilitate, among other things: 1) manipulating the implant 520, 2) performing the procedure for implanting the implant 520, and 3) performing subsequent procedures.

[0146] Figure 16A This is a schematic diagram of a stent 530, which has an inflatable balloon 532 inserted into the stent and wires 534A and 534B extending through the stent. Figure 16A A stent 530 and balloon 532 in a collapsed state are shown. The stent 530 may include a mesh body having an outer diameter 536 and an internal space 538. Leads 534A and 534B may extend from the distal end of the stent 530 through the mesh body and may extend from the stent 530 proximally. The balloon 532 may include an inflatable sac having an internal space 540 and a tube 542 extending from the inflatable sac. Leads 534A and 534B and tube 542 may extend through suitable insertion instruments, tubes, or sheaths that can be used to extend the stent 530 and balloon 532 through the working channel of the endoscope. In the example, any of the devices described herein can be used to navigate the stent 530 and balloon 532 to the duodenum 500. For example, the stent 530 and balloon 532 may be guided through the working channel 142 of the endoscope 104. Figure 2 ).

[0147] To push the stent 530 into the duodenal papilla 504, the Oddi sphincter 510 can be cut. Figure 2 This relaxes the tissue of the duodenal papilla 504, thereby facilitating the insertion of the stent 530. Leads 534A and 534B can be energized to provide tissue cutting via known electrosurgical techniques, as discussed in more detail below with reference to FIG16. Leads 534A and 534B can be connected to control unit 16 ( Figure 1A and Figure 4 In this example, high-frequency alternating current can be used to heat the tissue to a cauterization point, resulting in separation from adjacent tissue. The duodenal papilla 504 can be cauterized to reach the sphincter of Oddi 510. Therefore, the duodenal papilla 504 will receive the stent 530.

[0148] Figure 16B It is in a state of expansion. Figure 16AA schematic diagram of a support 530 is provided, wherein electrical conductors 534A and 534B are pulled backward from the support 530. A balloon 532 can inflate to expand the support 530 from diameter D1 to diameter D2. Conductors 534A and 534B can be rigid to hold the support 530 in place during the cutting process. Figure 2 and Figure 3 The stent 530 is in a collapsed state. However, wires 534A and 534B can be retracted from the stent 530 to allow expansion via the inflation of the balloon 532. The balloon 532 can be inflated by passing pressurized air through the tube 542. The balloon 532 thereby expands the internal space 538. The material of the stent 530 can be stretched or deformed to expand into the expanded state.

[0149] Figure 16C It is in a state of expansion. Figure 16B A schematic diagram of stent 530 is shown, in which leads 534A and 534B are pulled away from stent 530. After balloon 532 deflates, the material of stent 530 can maintain its shape. Therefore, the internal space 540 can be maintained with a diameter D2. Thus, balloon 532, along with leads 534A and 534B, can be retrieved from stent 530 and the patient through the working channel of the insertion device. See below for reference. Figures 17 to 19 As described, the support of this application can be configured with various cutting capabilities. See Figures 20 to 20 below. Figure 39 As described, the stent of this application can be used, for example, by providing a re-entry device to facilitate the performance of other procedures at a later time point, which can accelerate the manipulation and / or navigation of instruments returning to the anatomical structure of the stent. Additionally, the re-entry device can be provided with a treatment device that can provide intermittent, continuous, or on-demand treatment to the patient between procedures.

[0150] Figure 17 This is a schematic side view of the bracket 550 of this application, which includes electrical wires 552A and 552B extending into the cylindrical mesh bracket body 554. Electrical wires 552A and 552B can be connected to the control unit 16. Figure 3 and Figure 4 The support body 554 may be composed of multiple wires 556 interconnected or braided to form the body 558. Wires 552A and 552B may be interwoven into the wires 556. The control unit 16 may be configured to direct various forms of energy to the wires 552A and 552B to provide various functions to the support 550. In this example, the control unit 16 may provide direct current or alternating current to the wires 552A and 552B. Electrical energy may be used for cutting, coagulating, drying, or cauterizing tissue. Additionally, electrical energy may be used to power various devices mounted on or connected to the support 550.

[0151] Leads 552A and 552B may include conductive wires, harnesses, or cables that can be attached to the body 558. In examples, leads 552A and 552B may be formed of copper, copper alloys, or other conductive metals and metal alloys. In examples, leads 552A and 552B may be made of bioresorbable materials that can naturally decompose into the body in which the stent 550 is deployed. Leads 552A and 552B may be attached to the body 558 in a fixed or deployable manner. For example, in embodiments where leads 552A and 552B are intended to be held within an implanted anatomical structure, leads 552A and 552B may be attached to the body 558. As disclosed herein, leads 552A and 552B can therefore be used to deliver treatment to a patient, such as via a pumping action or a stone ablation action. Leads 552A and 552B can therefore be soldered or fused to the body 558. In other examples, leads 552A and 552B may be woven into the material of the body 558. Body 558 may be made of a mesh material, such as strands of a biocompatible metal that can be braided into a ring-shaped tube that can contract or expand radially. In other examples, some or all of the other components of body 558 and the various devices and stents described herein may be radiopaque to facilitate observation, for example, in imaging, such as X-ray images and fluoroscopy, thereby facilitating guidance back to the location of the re-entry device described herein. In embodiments where leads 552A and 552B are intended to be retrieved from the patient after use, leads 552A and 552B may be releasably attached to body 558. In examples, leads 552A and 552B may be configured to be pulled proximally from body 558 through an anatomical structure. Thus, leads 552A and 552B may be detached from the braided material of body 558, or welded or fused attached leads 552A or 552B may be broken to detach leads 552A and 552B from body 558. The separated wires 552A and 552B can be removed from the anatomical structure or left in the anatomical structure for biodissolution.

[0152] Conductors 552A and 552B can be positioned such that the length of conductors 552A and 552B on the body 558, or a significant portion of the length of conductors 552A and 552B on the body 558, can contact tissue to provide the desired effect. Conductors 552A and 552B can be placed on the body 558 in different patterns, such as straight lines, wavy lines, and herringbone patterns. Conductors 552A and 552B can be positioned on the exterior of the body 558. As mentioned, conductors 552A and 552B can be used to cut tissue. In particular, conductors 552A and 552B can be used to cut the sphincter of Oddi 510 (… Figure 15This allows the bracket 550 to expand as disclosed herein. However, in other examples, wires 552A and 552B can be used to supply power to other devices or other functions of the bracket 550.

[0153] Figure 18 This is a schematic side view of the bracket 600 of this application, which includes multiple different mechanically cut edges disposed in the body 602. Figure 19 yes Figure 18 End view of bracket 600. Also discussed. Figure 18 and Figure 19 .

[0154] The mechanically cut edges may include an axial edge 604, circumferential edges 606A to 606F, and angled edges 608A to 608F. The bracket 600 may also include barbs 610A to 610D. Figure 19 Axial edges 604, circumferential edges 606A to 606F, and angled edges 608A to 608F can form repeating cutting pattern features along the circumferential direction on the support 600, for example, as... Figure 19 This can be seen from the text.

[0155] The mechanical cutting edge of the scaffold 600 can be used to cut tissues, such as the Oddi sphincter 510. Figure 15 This allows the stent 600 to expand, as disclosed herein.

[0156] The axial edge 604 may extend parallel to the central axis of the scaffold 600 and may include an edge configured to scrape, slice, or cut tissue when the scaffold 600 is rotated circumferentially along the central axis. The axial edge 604 may be configured to cut, for example, when rotating clockwise but not when rotating counterclockwise. Therefore, the axial edge 604 may be formed from a portion of the edge of a cut in the body 554.

[0157] Circumferential edges 606A to 606F may extend perpendicularly to the central axis of the scaffold 600 and may include edges configured to scrape, slice, or cut tissue when the scaffold 600 is pushed or pulled in the axial direction. Circumferential edges 606A to 606F may be configured to cut, for example, when pulled proximally but not when pushed distally. Therefore, circumferential edges 606A to 606F may be formed from a portion of the edge of an incision in the body 554.

[0158] Angled edges 608A to 608F may extend obliquely relative to the central axis of the scaffold 600 and may include edges configured to scrape, slice, or cut tissue as the scaffold 600 moves relative to tissue engaged with the scaffold 600. Angled edges 608A to 608F may be configured to cut, for example, when rotated in the circumferential direction along the central axis or pulled proximally, but not when pushed distally. Therefore, circumferential edges 606A to 606F may be formed from a portion of the edge of an incision in the body 554.

[0159] In the example, axial edge 604, circumferential edges 606A to 606F and angled edges 608A to 608F can be formed as a mesh metal plate attached to the body 602.

[0160] Figure 19 A stent 600 including barbs 610A to 610D is shown. Barbs 610A to 610D may include anchoring features to hold the stent 600 in place during placement. Barbs 610A to 610D may be located at one end of the body 602 to allow engagement with tissue after mechanical cutting. For example, barbs 610A to 610D may be located at the proximal end of the body 602 to allow the distal portion of the stent 600 to cut tissue via axial displacement before the barbs 610A to 610D are secured. In other examples, barbs 610A to 610D may be aligned axially along the body 602 rather than as shown. Figure 19 The body 602 is arranged circumferentially as shown to allow for cutting before the barbs 610A to 610D are fixed.

[0161] Figure 20A This is a schematic cross-sectional view of the magnetically actuated support device 630 in a collapsed state. Figure 20B It is in a state of expansion. Figure 20A A schematic cross-sectional view of the magnetically actuated support device 630. Figure 21 An example of a magnetic applicator 632 is depicted. It is also discussed... Figures 20A to 21 . Figure 20A and Figure 20B The device 630 may include Figure 15 Examples of implants 520, and may include Figures 16 to Figure 19 The cutting features.

[0162] Figure 20A and Figure 20B The illustration shows a radially expandable device 630, such as a stent, shunt, or plug. Device 630 can be removed after a period of time, remain permanently in the patient's body, or be biodegradable within the patient's body. Figure 20A and Figure 20BThe illustration shows a schematic cross-sectional view of the device 630 in the open and closed positions. Figure 21 The figure shows an applicator 632 for device 630.

[0163] In some cases, device 630 may be a stent, shunt, or plug for insertion into a patient access route. Device 630 may be a stent for maintaining patency of the patient access route, such as to allow fluid and debris to flow through the patient access route. Device 630 may be a shunt, for example, for an alternative route for the passage of blood or other bodily fluids. Device 630 may be a plug, for example, for preventing fluid flow through the access route.

[0164] Device 630 can be sized, shaped, or arranged for complete or partial insertion of dissecting tubes or openings, such as Figure 15 In the duodenal papilla 504.

[0165] Device 630 may include a deformable elongated tubular body 634, a sheath 636, and a plurality of magnetizable or magnetic elements 638. Device 630 may be placed or actuated by an applicator 632, which may include a guide wire 640 and a magnet 642. Magnet 642 may be configured to generate a magnetic field 644.

[0166] The tubular body 634 can extend from a proximal portion to a distal portion. The proximal portion can be used, for example, by a surgeon or physician performing a medical procedure using the device 630 to directly or indirectly hold, fix, or manipulate the device 630. Depending on the operator's needs, the proximal portion can optionally be connected to one or more clamps, handles, or guides. The distal portion can be configured for at least partial insertion into a patient's body cavity.

[0167] The deformable elongated tubular body 634 can be in a position Figure 20A The expansion state shown and Figure 20B The tubular body 634 is shown in its collapsed state. For example, in its expanded state, the tubular body 634 can have a diameter of about 0.5 mm to about 2.0 mm. In the expanded state, the tubular body 634 can be positioned against the inner wall of the body passage, for example, to help keep the passage open. In some cases, the expanded state can enlarge the body passage if needed. The expanded state of the tubular body 634 can have a relatively larger diameter than some other supports, for example, to allow fluid and debris to pass through the tubular body.

[0168] In the 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 collapse onto itself, for example, to form a shape whose diameter or other lateral dimensions can be smaller than the diameter or other lateral dimensions of a conventional stent or other stent. This allows for easy insertion into the patient's access by an operator.

[0169] The sheath 636 may include a compliant material extending between the distal and proximal portions of the tubular body 634 to form a tubular shape and define a cavity space, such as a longitudinal cavity in the tubular body 634. The sheath 636 may be made of a thin-walled polymer, such as polyethylene, silicone, or polyether block amide. In an example, the sheath 636 may have a thickness of about 0.051 mm to about 0.254 mm. In some cases, the sheath 636 may include more than one layer of material. The sheath 636 may have a Shore D hardness of about 0.005” to about 0.04”. The sheath 636 may define a cavity space with a diameter of about 1 mm to about 20 mm when in an expanded state, and a cavity space with a diameter less than about 2 mm when in a collapsed state. In an example, the ratio of the diameters in the expanded and collapsed states may be about 10:1. In an example, the ratio of the diameters in the expanded and collapsed states may be about 25:1. In an example, the ratio of the diameters in the expanded and collapsed states may be between about 10:1 and about 25:1. When in the collapsed state, the device 630 may be independently inserted into the patient access or inserted into a delivery sheath or housing, for example, to help maintain the collapsed state of the device 630 during insertion.

[0170] Magnetizable or magnetic element 638 may be embedded in, attached to, or coupled to sheath 636. Magnetic material may include materials that respond to changes in magnetic field and may include materials aligned with a particular magnetic field. Similarly, magnetizable material 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.

[0171] Magnetizable or magnetic elements 638 can be at least two magnetic or magnetizable elements located within the tubular body 634. In some cases, elements 638 can be a set of threads braided or woven around the core. In some cases, elements 638 can be selectively actuated. When magnetized or exposed to a magnetic field, the magnetizable or magnetic elements 638 can repel each other, thereby forcing the sheath 636 to open to a more expanded state. This can allow the sheath 636 to be magnetically disposed outward to the body passage wall. The magnetic repulsion between the magnetizable or magnetic elements 638 can allow, for example, the device 630 to suspend within the passage and / or help the device 630 to remain in the passage without the need for other fixing mechanisms, such as "braids," catches, clips, or other components. Conversely, in some cases, magnetic force can be used to keep the device in place and open within the passage.

[0172] In some cases, two, three, four, five or more magnetizable or magnetic elements 638 may be used in device 630. At least two magnetizable or magnetic elements 638 may be used to allow magnetic repulsion between these elements when actuated. The diameter or other lateral dimensions of device 630 in the expanded state can be controlled by manipulating the number and arrangement of the wires.

[0173] In device 630, the magnetizable or magnetic element 638 may be an elongated member and may extend along the length of the tubular body 634 from the distal to the proximal portion. The arrangement of the magnetizable or magnetic elements 638 around the circumferential or periphery of the sheath 636 may allow radial expansion when actuated to repel each other. In some cases, magnetic repulsion may be sufficient to induce conformal contact between device 630 and the wall defining the body cavity for housing device 630. In this case, the expanded state may have a circular cross-section or a non-uniform cross-section depending on the shape of the body cavity.

[0174] The magnetizable or magnetic element 638 may include wire, magnetic material, braided or interwoven strands, or other magnetic dipole sensing materials. The magnetizable or magnetic element 638 may be made of a variety of materials, such as magnetizable metals or composite materials, or one or more combinations thereof. In some cases, the magnetizable or magnetic element 638 may include a magnetic dipole element attached to the sheath 636.

[0175] The magnetizable or magnetic element 638 may extend longitudinally along part or all of the length of the tubular body 634, may extend radially along the tubular body 634, may coil around the tubular body 634, may be applied segmentally along the tubular body 634, or may perform one or more combinations thereof. The magnetizable or magnetic element 638 may also have different types, materials, and thicknesses to induce various magnetic fields, magnetic field responses, and magnetic repulsions depending on how the magnetizable or magnetic element 638 is actuated.

[0176] Figure 21 An example of a magnetic applicator 632 is depicted. The magnetic applicator 632 may include a lead wire 640 and a magnet 642, and may be affected by or configured to generate a magnetic field 644. The magnetic applicator 632 can be detached from the device 630, or be wholly or partially integrated with the device 630.

[0177] The magnetic applicator 632 may include a single component or multiple components, such as a guide wire 640 and a magnet 642. The magnetic applicator 632 may include, for example, an annular component, such as a magnet 642, configured to fit within or around a longitudinal cavity of the tubular body 634. In this case, the magnet 642 may be shaped to fit inside or outside the tubular body 634, and to fit into the tubular body 634 in a folded or expanded state.

[0178] The guide wire 640 can be attached to the magnet 642, for example, to allow manipulation of the magnet 642's placement within or near the device 630. This can, for example, allow the magnet 642 to increase or change the magnetic field interacting with the magnetizable or magnetic element 638 as the magnet is moved. For example, the magnetic applicator 632 can be pulled through the longitudinal cavity of the tubular body 634 to actuate the magnetizable or magnetic element 638 to help provide magnetic repulsion, thereby causing the tubular body 634 to remain in a more expanded state. This can be accomplished by an operator using the guide wire 640 to move the magnet 642.

[0179] In some cases, the magnetic applicator 632 can be pulled through the longitudinal cavity of the tubular body 634 to actuate the magnetizable or magnetic element 638, for example, to reduce magnetic repulsion, thereby causing the tubular body 634 to form a less expanded state. This can be accomplished by an operator using a guide wire 640 to move the magnet 642.

[0180] In the example, the magnetic applicator 632 can be inserted into the patient's passageway together with or simultaneously with the device 630. The magnetic applicator 632 can then be pulled out of the patient's passageway by the device 630 to magnetize the magnetizable or magnetic element 638 and to move the tubular body 634 from a collapsed state to an expanded state.

[0181] In this configuration, when the operator deems it time to remove device 630 from the patient access route, magnetic applicator 632 can be used to fold device 630 for easy removal. In some cases, magnetic applicator 632 may remain attached to device 630. In some cases, magnetic applicator 632 may be removed from device 630 during or after insertion into the patient access route. Magnetic applicator 632 may be reusable or disposable.

[0182] In certain situations, the magnetic applicator 632 can be used to alter the placement or expansion of the device 630. In such cases, if the operator deems the device 630 should be adjusted, for example, by indication of pain or discomfort from the patient, the magnetic applicator 632 can be inserted back into the device 630 or into the patient access area near the device 630. The magnetic applicator 632 can be used to partially or completely fold the device 630, allowing the operator to reposition the device. Once repositioning is complete, the device 630 can be re-expanded as needed using the magnetic applicator 632.

[0183] In the example, the magnetic applicator 632 can be inserted separately from the device 630 into the patient's access. In this case, the operator can insert the device 630 and then subsequently insert the magnetic applicator 632, thereby pulling the magnetic applicator 632 through the device to magnetize the magnetizable or magnetic element 638 and moving the device from a collapsed state to an expanded state. In some cases, the magnetic applicator can remain in the patient's body and be subsequently removed when the operator is ready to remove the device 630 from the patient's access.

[0184] The magnetic applicator 632 may allow an operator to manipulate the device 630 during insertion to modify or reposition the device 630 during removal, or a combination thereof.

[0185] Figure 22 This is a schematic side view of the support 650 of this application, which includes extendable elongated reentry devices 652A and 652B. Figure 23 yes Figure 22 End view of bracket 650. Also discussed. Figure 22 and Figure 23 The 650 bracket can be used in conjunction with reference. Figure 20A and Figure 20B Device 630 Figure 15 The implant 520 may include any of the features and components described in Figures 16 to 1990. Figure 19 The cutting features.

[0186] The support 650 may include a body 654 extending from a first end 656A to a second end 656B. The body 654 may be constructed of wire 658. The reentry device 652A may include an elongated tube 660A and an inlet element 662A. The reentry device 652B may include an elongated tube 660B and an inlet element 662B. Figure 23 As shown, the support 650 may define a cavity 664, and the tubes 660A and 660B may define cavities 666A and 666B.

[0187] Re-entry devices 652A and 652B can be configured to assist in guiding another elongated body through cavities 666A and 666B through the support 650 and into an anatomical structure distal to the support 650. Re-entry devices 652A and 652B may include flexible bodies that can pass through transitions between intersections of anatomical pathways. In an example, re-entry devices 652A and 652B may include tubes or guides fixedly or slidably attached to body 654. Re-entry devices 652A and 652B may extend proximally to body 654 to receive other components or instruments and may extend distally to body 654 to guide other components or instruments to a desired anatomical structure. In an example, the position of re-entry devices 652A and 652B relative to body 654 can be adjusted. In an example, the length of re-entry devices 652A and 652B may be adjustable.

[0188] In the example, re-entry devices 652A and 652B can be configured to receive an instrument from the duodenum 500, transfer the instrument into the duodenal papilla 504, guide the instrument through the body 654, and direct the instrument into one of the pancreatic duct 506 and the cystic duct 508. Therefore, it may not be necessary to manipulate or guide the instrument through such a pathway.

[0189] Reentry devices 652A and 652B may comprise flexible tubes made of polymers or other suitable biocompatible materials, such as Pebax® [e.g., polyether block amide or PEBA, which is a thermoplastic elastomer (TPE)], nylon, silicone, and urethane. Reentry devices 652A and 652B may have a telescopic structure to allow distal extension. In other examples, reentry devices 652A and 652B may be slidably attached to body 654, allowing adjustment of the lengths by which reentry devices 652A and 652B extend proximally and distally into body 654. Thus, reentry devices 652A and 652B may be mounted on a track or attached via rings or buckles. In examples, elongated tubes 660A and 660B may be configured to be released and removed from body 654 after use, leaving the scaffold 650 alone within the anatomical structure.

[0190] like Figure 23 As shown, the cross-sectional areas of cavities 666A and 666B can be smaller than that of cavity 664. Therefore, cavity 664 can freely accommodate other instruments. However, the ratio of the cross-sectional areas of cavities 666A and 666B to those of cavity 664 can vary depending on the performance capabilities required for different purposes.

[0191] Elongated tubes 660A and 660B may include cutting or stripping features, and references Figures 34 to 38The described openable cavity. Resection features may include axial segments of elongated tubes 660A and 660B that can be removed by a surgeon or operator to trim elongated tubes 660B and 660A to a desired length. Dissection features may include portions of elongated tubes 660A and 660B that can be dissected when no longer needed. For example, Figures 32A to 33B Sleeves 764 and 774 may include portions of elongated tubes 660A and 660B that can be stripped when anchors 762 and 772 are desired to be deployed.

[0192] Inlet elements 662A and 662B can be connected to the proximal ends of re-entry devices 652A and 652B, respectively. Inlet elements 662A and 662B can be configured to guide other components or instruments into elongated tubes 660A and 660B, respectively. In one example, inlet elements 662A and 662B may include funnels or funnel-shaped bodies configured to converge the distal ends of instruments and center them through re-entry devices 652A and 652B, respectively. In other examples, inlet elements 662A and 662B can be magnetic to pull instruments and devices into engagement with elongated tubes 660A and 660B. Inlet elements 662A and 662B may be provided with magnets of opposite polarity to keep them spaced apart from each other.

[0193] In other examples, the inlet elements 662A and 662B, and the elongated tubes 660A and 660B, may be threaded. Therefore, once the instrument or device is engaged with the inlet elements 662A and 662B, and the elongated tubes 660A and 660B, the instrument or device can be rotated to advance it through the inlet elements 662A and 662B, and the elongated tubes 660A and 660B. Such a feature is useful when it is difficult to advance the instrument or device by pushing alone due to the complex geometry of the path through anatomical structures, etc.

[0194] Reentry devices 652A and 652B are described as including tubes. However, other elongated bodies may also be used. For example, an elongated guide wire may be directly attached to the bracket 650. Alternatively, an elongated track may be attached to the bracket 650. The track may include an elongated body having a cross-section that allows the mating channel to slide along the track axially but prevents the channel from separating radially from the track. In the example, a track with a T-shaped cross-section may be used.

[0195] Figure 24 It has reentry devices 652A and 652B in a deployed state. Figure 22 and Figure 23A schematic diagram of the stent 650. Re-entry devices 652A and 652B can extend from the distal end of the body 654 to further position the distal ends of the re-entry devices 652A and 652B into the anatomical structure.

[0196] Reentry device 652A may have a guide wire 672 disposed therein, and reentry device 652B may have a guide wire 674 disposed therein. Guide wire 672 may have an anchor 676, and guide wire 674 may have an anchor 678. Anchors 676 and 678 may include means configured to attach to tissue. In an example, anchors 676 and 678 may include a helical device that can be rotated via guide wires 672 and 674. However, other types of anchors may also be used, such as those described above. Figures 32A to 33B The described anchor.

[0197] Guide wire 672 may extend into inlet element 662A to penetrate the distal end of tube 660A. Guide wire 674 may extend into inlet element 662B to penetrate the distal end of tube 660B. Guide wire 672 may be configured to position anchor 676 in an anatomical structure. Guide wire 674 may be configured to position anchor 678 in the same or different anatomical structures. Anchors 676 and 678 may be configured to attach to tissue to secure guide wires 672 and 674 to the tissue. (See reference...) Figures 32A to 33B As discussed, anchors 676 and 678 can be selectively deployed from pipes 660A and 660B. Therefore, other instruments, such as mirrors and pliers, can be guided to the positions of anchors 676 and 678 along guide lines 672 and 674.

[0198] Tubes 660A and 660B can have different lengths to reach different anatomical locations. For example, tube 660B can be longer than tube 660A, allowing tube 660B to reach the gallbladder 514 and tube 660A to reach the pancreas 512. Additionally, tubes 660A and 660B can be bent or twisted to extend through various anatomical canals to reach desired anatomical structures, such as… Figure 25 As shown. In the example, tubes 660A and 660B can be used to receive fluid from an organ, or to deliver fluid, such as a drug, to an organ or anatomical region via capillary action.

[0199] Figure 25 yes Figure 24A schematic diagram of a stent 650, wherein a re-entry device 652B is deployed from the stent to reach the cystic duct 508. The body 654 of the stent 650 can be positioned in the duodenal papilla 504 leading to the common bile duct 502. For simplicity, the re-entry device 652A is not shown. The tube 660B can be bent or flexed at an angle of approximately 90 degrees to extend along the duodenum 500 and then turn into the common bile duct 502. Thus, a device extending along the duodenum 500 can be pushed into the inlet element 662B to be guided along the tube 660B. Thus, the tube 660B can cause a device inserted therein to be turned to guide the device into the common bile duct 502. For example, a guide wire 674 can be drawn from an endoscope, such as endoscope 14 ( Figure 4 The guide wire 674 is deployed into the duodenum 500. It can be advanced forward near the inlet element 662B. The inlet element 662B can be magnetic to pull the guide wire 674 into the funnel-shaped entry channel. Once within the inlet element 662B, the guide wire 674 can be pushed along the tube 660B. The rigidity of the tube 660B is sufficient to deflect the guide wire 674 and push it through the tube 660B into the common bile duct 502 and the cystic duct 508. When the anchor 678 reaches the vicinity of the gallbladder 514 or the desired location within the gallbladder 514, the guide wire 674 can be rotated, for example, to allow the anchor 678 to penetrate into the tissue. Thus, the treatment device, such as a reference... Figures 26 to 29B The described treatment device and other devices can slide along the guide line 674 to reach the position of the anchor 678.

[0200] Figure 26 This is a schematic side view of a stent 690 including distal stents 692A and 692B. The stent 690 can be configured to... Figure 24 The stent 650 is similar but has additional distal stents 692A and 692B. Stent 692A may include a body 694A, and stent 692B may include a body 694B. Bodies 694A and 694B may be attached to tubes 660A and 660B, respectively, as illustrated. In other examples, bodies 694A and 694B may be slit to allow tubes 660A and 660B to pass through for distal deployment of tubes 660A and 660B. Bodies 694A and 694B may include annular bodies configured to enlarge or keep the anatomical tube open. Thus, stents 692A and 692B may allow larger stones to pass through the anatomical structure. Bodies 694A and 694B may be configured as any of the stents described herein, including those referenced. Figures 26 to 29B The described stent. In the example, bodies 694A and 694B may include an annular body that can fold during insertion and then expand upon positioning in the desired location to attach to and dilate the dissecting canal, the annular body including a reference Figures 20A to 21 The described annular body. In the example, bodies 694A and 694B may have a smaller diameter than the scaffold 690. In the example, bodies 694A and 694B may have different sizes for different anatomical locations, such as... Figure 27 As shown.

[0201] Figure 27 This is a schematic diagram of the 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 in the duodenal papilla 504 leading to the common bile duct 502. A tube 660B can extend from the stent 690 through the cystic duct 508 to reach the gallbladder 514. A tube 660A can extend from the stent 690 through the pancreatic duct 506 to reach the pancreas 512. Inlet elements 662A and 662B can be maintained within the duodenum 500 attached to tubes 660A and 660B, respectively, to facilitate the placement of guide wires or other instruments or devices through tubes 660A and 660B.

[0202] Stents 692A and 692B can be positioned within the outlet foramina of the gallbladder 514 and pancreas 512, respectively. Stents 692A and 692B allow gallstones and pancreatic stones to exit their respective organs more freely. In another example, stents 692A and 692B can be used to pump fluid from the gallbladder 514 and pancreas 512. For example, as shown in the reference... Figure 28 As described, stents 692A and 692B can be configured to expand and contract to expel fluid from the gallbladder 514 and pancreas 512. Additionally, stents 692A and 692B can be configured to generate a pressure differential, for example, via vibration, to allow the release or absorption of drugs. Furthermore, as described in reference... Figure 29A and Figure 29B As described, stents 692A and 692B can be configured to treat or bind stones to allow the stones to be metabolized or transported away from the anatomical structure.

[0203] Figure 28 It is with Figure 27 A schematic diagram of the duodenum 500 of stent 690, stent 690 including a therapeutic stent 694C connected via a tube 660C to a distal stent 692A. The therapeutic stent 694C can be positioned within an organ, such as the gallbladder 514 or the pancreas 512. The therapeutic stent 694C may be equipped with electrical leads, for example, as shown in the diagram. Figures 16A to 16C The described wires 534A and 534B and reference Figure 17 The described leads 552A and 552B. These leads allow the treatment stent 694C to be actively controlled. In other examples, the treatment stent 694C can be provided without stent 692A between stent 694C and stent 690 (e.g., stent 692A can be omitted).

[0204] In the example, the therapeutic stent 694C can be configured to expand and contract to provide a pumping effect. Therefore, the therapeutic stent 694C can be configured to pump fluid into or out of an organ, or to provide a pumping effect to an organ to, for example, stimulate the organ to produce a biofluid. In the example, the therapeutic stent 694C can be configured to expand and contract as described herein, such as by using magnetic actuation.

[0205] In other examples, the treatment holder 694C may be configured to provide heating via wires. In these examples, heating can be provided by resistance heating of the wires and the wires forming the treatment holder 694C. In other examples, heating can be provided by a heating element disposed on the holder 694C, which is powered by electricity supplied by the wires. In other examples, heating can be provided by induction heating, such as using... Figure 21 The magnetic applicator 632 provides the heating. In this example, heating can be provided by the vibration of the bracket 694C. The bracket 694C can be vibrated by ultrasound.

[0206] Heating of the treatment stent 694C can be used, for example, to provide a fluid effect by generating capillary action, to aspirate fluid through the stent 694C. Therefore, the stent 694C can be configured to expel fluid from the gallbladder 514 or pancreas 512. Heating can also deliver medication, for example, through tube 660C to the stent 694C, or apply medication as a coating to the stent 694C for evaporation into the tissue. Additionally, as described above, heating of the wire element can be used to perform cutting, ablation, etc.

[0207] Figure 29A This is a schematic side view of the stent 700 of this application, which is configured to handle biological materials such as gallstones and pancreatic stones. Figure 29B yes Figure 29A End view of the bracket 700. Also discussed. Figure 29A and Figure 29B .

[0208] In the example, the support 700 may include devices 702A and 702B in the body 706 and cutting edges 704A to 704F. Figure 29B As can be seen from the image, the bracket 700 may also include cutting elements 708A to 708D extending internally across the bracket 700, and anchors 710A to 710D.

[0209] Devices 702A and 702B can be configured to actively process biological material passing through the scaffold 700. In the example, the scaffold 700 may be provided with electrical wires, such as those shown in the reference diagram. Figures 16A to 16C The described wires 534A and 534B and reference Figure 17The described leads 552A and 552B. The leads allow the treatment stent 694C to be actively controlled. Devices 702A and 702B can be configured as rotary grinders to cut or grind stones entering the stent 700, for example, by abrasion or grinding. In the example, the surface of the stone can be shaped to facilitate visualization by imaging, for example, by causing the surface of the stone to echo. Therefore, stones larger than the inner diameter of the stent 700 can be ground to be accommodated within the stent 700, thereby allowing, for example, delivery out of the gallbladder 514.

[0210] In the example, devices 702A and 702B may have a coating or may emit a fluid that can dissolve gallstones.

[0211] In the example, devices 702A and 702B can be configured to emit laser beams that can dissolve or cut stones.

[0212] In the example, devices 702A and 702B can be configured to squeeze or compress stones to break them into smaller pieces.

[0213] In the example, the cutting edges 704A to 704F can trim or scrape the stone that has passed through the stent 700. Therefore, the stone can become smaller as it passes through the stent 700, allowing for easier biological processes such as dissolution or delivery away from the anatomical structure.

[0214] In the example, the cutting elements 708A to 708D may include wires that can be electrically actuated to cause heating or vibration. Thus, stones entering the stent 700 can be cut into smaller pieces to allow for easier bioprocessing. Vibration can be induced by an excitation frequency. In the example, an additional instrument may extend along the guide wire to vibrate or actuate the device. In other examples, the cutting elements 708A to 708D may be used to filter or sift large stones entering the stent 700 to prevent blockage. In such examples, the cutting elements 708A to 708D do not need to be configured to cut and do not need to be powered; instead, they may simply include wires to block free access to the stent 700. Such large stones can be removed by another procedure or by inserting an additional instrument into the stent 700.

[0215] Figure 30This is a schematic diagram of a duodenum 500 having an implantable device 750 of the present disclosure, the implantable device 750 including monorails 752A and 752B. The implantable device 750 may include a stent 754 through which monorails 752A and 752B can extend. The monorail device may include a wire or cable that extends proximally into the duodenum 500 from the stent 754 and distally into the pancreatic duct 506 and the cystic duct 508. The distal ends of monorails 752A and 752B may include anchors 756A and 756B, respectively.

[0216] You can use, as referenced Figures 22 to 25 The described elongated tubes 660A and 660B are used to deploy monorails 752A and 752B. Monorails 752A and 752B may include devices located within an anatomical structure to allow for the insertion of other devices without active manipulation and navigation. Monorails 752A and 752B may remain within the anatomical structure attached to the stent 754, or may be retrieved from the stent 754 after the procedure. Monorails 752A and 752B can therefore be configured to be bioresorbable. In the example, the stent 754 and monorails 752A and 752B may be used with a suitable endoscope, for example, through a working channel 142 guided through the endoscope 104. Figure 2 ) to be inserted into the anatomical structure.

[0217] Figure 31 This is a schematic diagram of a monorail 752A including a helical anchor 756A. The monorail 752A may include a wire or cable, and the anchor 756A may include a portion of the wire or cable wound into a coil or helix. The anchor 756A may be wound into a wider loop near the monorail 752A, which gradually narrows towards the distal end of the anchor 750A and finally terminates at the tip of the monorail 752A. The tip of the monorail 752A at the distal end of the anchor 756A may 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.

[0218] Figure 32A This is a schematic diagram of a monorail 752A including a deployable anchor 760 in a collapsed state. Figure 32B It features deployable anchors 760 in an extended state. Figure 32A A schematic diagram of the monorail 752A. Anchor 760 can be deployed in an enlarged form and attached to the tissue. (Discussion also follows.) Figure 32A and Figure 32B .

[0219] The deployable anchor 760 may include an anchor 762 and a sleeve 764. Anchor 762 may include a plurality of deformable protrusions 766A to 766D. Each of the deformable protrusions 766A to 766D may include a wire bent such that the ends of the wire are brought close together to form a loop. Additionally, the distal portion of the loop may be bent outward from the loop-forming end of the wire. The ends of the wire may be attached to a monorail 752A such that each wire can be bent. When covered by the sleeve 764, the curvature of the loop can be removed, allowing the wire forming each of the protrusions 766A to 766D to be bent as... Figure 32A As schematically illustrated, it abuts against monorail 752A. However, as sleeve 764 retracts proximally along monorail 752A, the lines forming protrusions 766A to 766D can be as shown in the diagram. Figure 32B As schematically illustrated, it bends outward from the monorail 752A to join the tissue.

[0220] Sleeve 764 may include a tubular member surrounding anchor 762 to reduce the outer diameter of deformable protrusions 766A to 766D. Sleeve 764 may extend proximally from anchor 762 along the length of monorail 752A. In an example, sleeve 764 may extend from anchor 762 all the way to an operator controller at the proximal end. In an example, sleeve 764 may be just long enough to surround anchor 762 and provide desired clamping to protrusions 766A to 766D, and may be attached to an actuation line extending proximally to the operator controller. Therefore, the proximal end of sleeve 764 or the control line attached to sleeve 764 may be pulled proximally along the axis of monorail 752A to release protrusions 766A to 766D.

[0221] Figure 33A This is a schematic diagram of a monorail 752A, which includes a deployable anchor 770 in a collapsed state. Figure 33B It features a deployable anchor 770 in an extended state. Figure 33A A schematic diagram of the monorail 752A. Anchor 770 can be deployed in an enlarged form and attached to the tissue. (Discussion also follows.) Figure 33A and Figure 33B .

[0222] The deployable anchor 770 may include an anchor 772 and a sleeve 774. The anchor 772 may include a plurality of extendable members 776A to 776D. Each of the extendable members 776A to 776D may include a pointed protrusion extending from a base. The pointed protrusion may be radially outwardly offset from the base relative to the central axis of the monorail 752A. When covered by the sleeve 774, the pointed protrusion may be as follows: Figure 33AAs schematically illustrated, it is pushed closer to the monorail 752A. However, as the sleeve 774 retracts proximally along the monorail 752A, the pointed protrusion can... Figure 33B As schematically illustrated, it extends radially outward from the monorail 752A to join the tissue.

[0223] Sleeve 774 may include a tubular member surrounding anchor 772 to reduce the outer diameter of extendable members 776A to 776D. Sleeve 774 may extend proximally from anchor 772 along the length of monorail 752A. In an example, sleeve 774 may extend from anchor 772 all the way to an operator controller at the proximal end. In an example, sleeve 774 may be just long enough to surround anchor 772 and provide desired clamping to extendable members 776A to 776D, and may be attached to an actuation line extending proximally to the operator controller. Thus, the proximal end of sleeve 774 or the control line attached to sleeve 774 may be pulled proximally along the axis of monorail 752A to release members 776A to 776D.

[0224] Figure 34 This is a schematic diagram of a deployable member 790 including an elongated shaft 792, which includes a cavity 794 and a through-hole 796. The deployable member 790 may include... Figure 22 Pipes 660A and 660B, Figure 32A and Figure 32B Sleeve 764 or Figure 33A and Figure 33B The sleeve 774. The elongated shaft 792 may include a flexible member made of a polymer or other biocompatible material. The elongated shaft 792 may be made of an elastic material that can deform or bend under load but will return to its original shape when the load is removed. The perforation 796 may extend along the length of the elongated shaft 792, or only along a selected portion of the shaft 792, such as at the anchor 762. Figure 32A and Figure 32B ) and anchor 772 ( Figure 33A and Figure 33B The perforation 796 may include a series of small cuts extending from the outside of the shaft 792 through into the cavity 794. The perforation 796 may allow the shaft 792 to suddenly open along the line of the perforation 796. Therefore, the perforation 796 may allow an object larger than the diameter of the cavity 794 to pass through the shaft 792. For example, an object may be pushed through the cavity 794, thereby causing the perforation 796 to break along that path.

[0225] Figure 35 This is a schematic diagram of a deployable member 800 including an elongated shaft 802, which includes a cavity 804 and a slit 806. The deployable member 800 may include... Figure 22Pipes 660A and 660B, Figure 32A and Figure 32B Sleeve 764 or Figure 33A and Figure 33B The sleeve 774. The elongated shaft 802 may include a flexible member made of a polymer or other biocompatible material. The elongated shaft 802 may be made of an elastic material that can deform or bend under load but will return to its original shape when the load is removed. The slit 806 may extend along the length of the elongated shaft 802, or only along a selected portion of the shaft 802, such as at the anchor 762. Figure 32A and Figure 32B ) and anchor 772 ( Figure 33A and Figure 33B The slit 806 may include a cut extending from the outside of the shaft 802 through into the cavity 804. The slit 806 may allow the shaft 802 to unfold along the line of the slit 806. Therefore, the slit 806 may allow an object larger than the diameter of the cavity 804 to pass through the shaft 802. For example, the object may be pushed through the cavity 804, thereby causing the slit 806 to unfold along that path.

[0226] Figure 36 This is a schematic diagram of a deployable member 810 including an elongated shaft 812, which includes a cavity 814 and a gap 816. The deployable member 810 may include... Figure 22 Pipes 660A and 660B, Figure 32A and Figure 32B Sleeve 764 or Figure 33A and Figure 33B The sleeve 774. The elongated shaft 812 may include a flexible member made of a polymer or other biocompatible material. The elongated shaft 812 may be made of an elastic material that can deform or bend under load but will return to its original shape when the load is removed. The gap 816 may extend along the length of the elongated shaft 812, or only along a selected portion of the shaft 812, such as at the anchor 762. Figure 32A and Figure 32B ) and anchor 772 ( Figure 33A and Figure 33B The portion extending near the shaft 812. The gap 816 may include a cutout extending from the outside of the shaft 812 through to the cavity 814. The gap 816 may allow the shaft 812 to unfold along the line of the gap 816. Therefore, the gap 816 may allow an object larger than the diameter of the cavity 814 to pass through the shaft 812. For example, an object may be pushed through the cavity 814, thereby causing the gap 816 to unfold along that path.

[0227] Figure 37This is a schematic diagram of a deployable member 820 including an elongated shaft 822, which includes a cavity 824 and a gap 826. The gap 826 may include a plurality of magnetic members 828 and a metal strip 829. The magnetic members 828 can be attracted to the metal strip 829 by magnetic force. Therefore, when stationary, the magnetic members 828 can pull the end of the elongated shaft 822 along the closed gap 826. However, when a device or object moves through the elongated shaft 822, which is larger than the cavity 824, the magnetic members 828 can 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 can be pulled back to engage with the metal strip 829 by magnetic attraction.

[0228] Figure 38 This is a schematic diagram of a deployable member 830 including an elongated shaft 832, which includes a cavity 834 and a gap 836. A plurality of C-shaped reinforcements 838 may be provided along the shaft 832 along the cavity 834. The C-shaped reinforcements 838 may be configured to be elastic, allowing them to deform under loads from within the cavity 834 to widen the C-shape, but to return to their original shape when the load is removed. Therefore, devices or objects larger than the cavity 834 can pass through the shaft 832.

[0229] Figure 39 This is a schematic perspective view of a deployable member 800 having a treatment device 840, which slides through the deployable member 800 to open the deployable member 800. The treatment device 840 may include any of the devices described herein. In an example, the treatment device 840 may include a support in a collapsed state. However, although in a collapsed state, the treatment device 840 may be larger than the cavity 804. Therefore, as the treatment device 840 passes along the slit 806, the opposing faces 842A and 842B of the shaft 802 may unfold to allow the treatment device 840 to pass through the shaft 802.

[0230] Figure 40 This is a block diagram illustrating a method 900 for implanting a re-entry device of the present application that has a therapeutic device.

[0231] At step 902, the scaffold can be inserted into the anatomical structure. For example, it can be... Figure 15 The implant 520 is inserted into the duodenal papilla 504 in the duodenum 500. Any suitable delivery device, such as an endoscope, can be used to deliver the implant 520 into the duodenum 500. In this example, it can be used... Figure 1A and Figure 1B The direct oral cholangioscopy system 100 is used to deliver the implant 520.

[0232] At step 904, a scaffold can be used to cut the tissue. For example, a scaffold can be used... Figure 17 The 550-watt scaffold can be used to cut tissue, or you can use... Figure 18 and Figure 19 The scaffold 600 is used to cut tissue. In the example, the Oddi sphincter 510 can be cut to allow the duodenal papilla 504 to dilate to receive the scaffold. Once inserted in place, the scaffold can be secured to the tissue, for example, by using... Figure 19 The barbs 610A to 610D are used to fix the tissue.

[0233] At step 906, the support can be expanded. For example, this can be achieved via magnetic force. Figure 20A and Figure 20B The device 630 expands within the duodenal papilla 504. In other examples, the stent 530 can be expanded via a balloon 532.

[0234] At step 908, the stent's re-entry track or re-entry device can extend into the anatomical structure. In the example, Figure 22 The re-entry devices 652A and 652B can be positioned adjacent to the stent within the anatomical tube. Tubes 660A and 660B can each have a proximal end positioned in the duodenum 500 and a distal end positioned in the cystic duct 508 and pancreatic duct 506, respectively.

[0235] At step 910, the guide wire can be inserted into the re-entry device. In the example, guide wire 674 ( Figure 24 ) can be positioned in tube 660B, and lead wire 672 ( Figure 24 It can be located in tube 660A.

[0236] At step 912, the guide wire can be anchored to the tissue. In the example, anchor 678 can be attached to the cystic duct 508 or the gallbladder 514, and anchor 676 can be attached to the pancreatic duct 506 or the pancreas 512. Alternatively, it can be used... Figures 32A to 33B Deployable or scalable anchors 760 and 770.

[0237] At step 914, the treatment device can be slid along the guide wire. For example, it can be... Figure 27 The supports 692A and 692 slide along the guide wires 674 and 672. Additionally, the support 694C ( Figure 28 ) and bracket 700 ( Figure 29A and Figure 29B The suture is cut along the guideline to the anatomical structure to be treated.

[0238] At step 916, the cavity of the re-entry device can be opened to allow the treatment device to pass through the cavity. For example, Figures 34 to 38Cavities 794, 804, 814, 824, and 834 can be opened as the treatment device slides along the guide wire inside the re-entry tube. After the treatment device has passed, it can be used... Figure 37 Magnetic component 828 Figure 38 The cavity is closed by using C-shaped reinforcement 838 or other means.

[0239] At step 918, a treatment device can be used to treat the anatomical structure. As described herein, the treatment device can provide pumping, heating, drug delivery, vibration, ablation, stone fragmentation, etc.

[0240] At step 920, the guide wires can be removed. For example, guide wires 674 and 672 can be retrieved from reentry tubes 660A and 660B. In other examples, guide wires 674 and 672 can be left within the anatomical structure for use in subsequent procedures or for bioabsorption into the anatomical structure.

[0241] At step 922, the procedure can be completed. Specifically, unused components can be removed from the anatomical structure, and the entry point and incision in the patient's anatomy can be closed to leave the re-entry component within the anatomy. The implant 520 described herein ( Figure 15 The re-entry devices 652A and 652B can remain in the duodenal papilla 504. In addition, the re-entry devices 652A and 652B can remain and extend into the desired anatomical tube and turn into the duodenum 500 to allow for the later delivery of therapeutic devices, etc.

[0242] At step 924, subsequent procedures can be performed. Method 900 can return to step 910 to use the previously implanted re-entry device, for example by reopening the patient's anatomy and inserting the endoscope into the duodenum 500.

[0243] At step 926, the anatomical structures can be treated during subsequent procedures. The treatment performed at step 918 can be repeated, or additional or different treatments can be performed, including treatments performed using the treatment device described herein.

[0244] At step 928, subsequent procedures can be completed. Unused parts or devices can be removed from the patient, and parts or devices intended for subsequent use or use during future surgeries can be enclosed in the patient for later re-entry.

[0245] Various notes and examples

[0246] Re-entry sheath used with the guide wire

[0247] Example 1 is a cholangioscopy system comprising: a guide sheath including a manipulable lumen; and an endoscope comprising: an elongated shaft extending between a proximal end portion and a distal end face, the elongated shaft being configured for displacement along the manipulable lumen; a working tool lumen extending along the elongated shaft and exiting at the distal end face; an anchoring line lumen entering the elongated shaft between the proximal end portion and the distal end face and exiting the elongated shaft at the distal end face; and a non-axial lumen extending from the working tool lumen to the outside of the elongated shaft at the distal end face.

[0248] In Example 2, the subject of Example 1 may optionally include an anchor line extending through the anchor line cavity.

[0249] In Example 3, the subject of Example 2 may optionally include, wherein the anchoring line comprises: a long cable; and an organization anchor located near the distal end of the anchoring line.

[0250] In Example 4, the subject of any or more of Examples 1 to 3 may optionally include a tissue removal device capable of extending from the working tool cavity.

[0251] In Example 5, the subject of Example 4 may optionally include a tissue removal device comprising a shaft extending along the working tool cavity and capable of elastically bending to extend along the working tool cavity and into a non-axial cavity.

[0252] In Example 6, the subject of Example 5 may optionally include a tissue removal device that includes forceps.

[0253] In Example 7, the subject of any or more of Examples 1 to 6 may optionally include a non-axial cavity that includes a slit at a distal end face that extends along an elongated axis to intersect with the working tool lumen.

[0254] In Example 8, the subject of Example 7 may optionally include a non-axial cavity extending through the side surface of the elongated shaft.

[0255] In Example 9, the subject of any or more of Examples 1 to 8 may optionally include a non-axial cavity extending within the far 10% of the length of the elongated shaft.

[0256] In Example 10, the subject of any or more of Examples 1 through 9 may optionally include an endoscope that is manipulative.

[0257] Example 11 is a method for performing a direct transoral cholangioscopy procedure, the method comprising: inserting an endoscope into a guide sheath; inserting the guide sheath and endoscope into the duodenum of a patient; extending a tissue retrieval device through the endoscope into the common bile duct of the patient; extending an anchoring line into the common bile duct; collecting biological material through the tissue retrieval device; and retracting the cholangioscopy and tissue retrieval device from the common bile duct along the anchoring line.

[0258] In Example 12, the subject matter of Example 11 optionally includes inserting a guide sheath and an endoscope into a patient's duodenum, including using the guide sheath to manipulate the choledochoscope.

[0259] In Example 13, the subject of Example 12 may optionally include manipulating the cholangioscope using the inherent manipulative capabilities of the cholangioscope.

[0260] In Example 14, the subject of Example 13 may optionally include manipulating the choledochoscope by pushing away the guide sheath.

[0261] In Example 15, the subject matter of any or more of Examples 11 to 14 may optionally include extending the anchor line into the common bile duct by attaching the anchor line to the tissue of the common bile duct.

[0262] In Example 16, the subject matter of any or more of Examples 11 through 15 may optionally include reinserting a choledochoscope into the common bile duct by sliding the choledochoscope along the anchoring line.

[0263] In Example 17, the subject matter of Example 16 may optionally include removing tissue from the tissue removal device before reinsertion of the choledochoscope.

[0264] In Example 18, the subject matter of Example 17 may optionally include positioning the distal portion of the tissue retrieval device within the non-axial lumen of the cholangioscope after the cholangioscope and tissue retrieval device have been retracted from the common bile duct along the anchoring line.

[0265] In Example 19, the subject matter of Example 18 may optionally include positioning a distal portion of the tissue retrieval device within the non-axial cavity of the cholangioscope by bending a portion of the shaft of the tissue retrieval device extending from the working tool cavity into an extension through the non-axial cavity.

[0266] In Example 20, the subject matter of Example 19 may optionally include a non-axial cavity that includes a groove in the distal end of the cholangioscope that connects the working tool cavity to the side surface of the cholangioscope.

[0267] Support device for reentry

[0268] Example 1 is a system for providing reusable access to a patient's anatomical region, the system comprising: a stent including an annular body; and a reentry track extending through the stent, the reentry track including: an elongated body including a proximal end and a distal end extending from the annular body.

[0269] In Example 2, the subject of Example 1 may optionally include an elongated body, which includes a tubular body defining a cavity.

[0270] In Example 3, the subject of Example 2 may optionally include an openable tubular body.

[0271] In Example 4, the subject of Example 3 may optionally include a tubular body that includes a slit extending along the length of the tubular body.

[0272] In Example 5, the subject of Example 4 may optionally include a closable slit.

[0273] In Example 6, the subject of Example 5 may optionally include, wherein the tubular body includes a magnet positioned along the slit.

[0274] In Example 7, the subject of any or more of Examples 5 to 6 may optionally include a tubular body comprising a spring configured to bias the slit to a closed position.

[0275] In Example 8, the subject of any or more of Examples 3 to 7 may optionally include a tubular body comprising perforations extending along the length of the tubular body.

[0276] In Example 9, the subject of any or more of Examples 2 through 8 may optionally include a tubular body comprising threads extending along the cavity.

[0277] In Example 10, the subject of any or more of Examples 2 through 9 may optionally include an inlet element attached to the proximal end of the tubular body.

[0278] In Example 11, the subject of Example 10 may optionally include an inlet element that includes a funnel-shaped element.

[0279] In Example 12, the subject of Example 11 may optionally include a funnel-shaped element that includes internal threads.

[0280] In Example 13, the subject of any or more of Examples 11 to 12 may optionally include a magnetic funnel-shaped element.

[0281] In Example 14, the subject matter of any or more of Examples 2 to 13 may optionally include: a guide wire extending into the cavity of the tubular body; and an anchor attached to the distal end portion of the guide wire.

[0282] In Example 15, the subject of Example 14 may optionally include an anchor, which includes a helical element.

[0283] In Example 16, the subject matter of any or more of Examples 14 to 15 may optionally include an anchor that includes an expandable body, wherein the anchor can retract into a cavity of the tubular body to cause the expandable body to contract, and can extend from the cavity to allow the expandable body to expand.

[0284] In Example 17, the subject of Example 16 may optionally include an enlargeable body comprising a plurality of bendable protrusions.

[0285] In Example 18, the subject of any or more of Examples 16 to 17 may optionally include an enlargeable body that includes a plurality of extendable protrusions.

[0286] In Example 19, the subject of any or more of Examples 1 to 18 may optionally include an intervention device configured to move along the reentry trajectory.

[0287] In Example 20, the subject of Example 19 may optionally include an interventional device that includes a treatment stent.

[0288] In Example 21, the subject of Example 20 may optionally include a treatment stent constructed to provide a pumping effect in the anatomical region.

[0289] In Example 22, the subject of Example 21 may optionally include a therapeutic stent configured to expand and contract.

[0290] In Example 23, the subject matter of any or more of Examples 20 to 22 may optionally include a treatment stent device that includes a stone processor.

[0291] In Example 24, the subject of Example 23 may optionally include a stone processor configured to chemically treat stones.

[0292] In Example 25, the subject matter of any or more of Examples 23 to 24 may optionally include a stone processor configured to mechanically reduce the size of stones.

[0293] In Example 26, the subject matter of any or more of Examples 20 to 25 may optionally include a treatment stent configured to provide heating.

[0294] In Example 27, the subject of any or more of Examples 20 through 26 may optionally include a balloon positioned within a treatment stent.

[0295] In Example 28, the subject of any or more of Examples 1 through 27 may optionally include a scaffold configured to cut tissue.

[0296] In Example 29, the subject of Example 28 may optionally include a support that includes a mechanical cutting blade.

[0297] In Example 30, the subject of any or more of Examples 28 to 29 may optionally include a support that includes an electric cutting blade.

[0298] In Example 31, the subject of Example 30 may optionally include an electric cutting blade comprising a pair of electrical wires configured to be pulled out from a support after use.

[0299] In Example 32, the subject of any or more of Examples 1 to 31 may optionally include a selectively expandable scaffold.

[0300] In Example 33, the subject of Example 32 may optionally include: a plurality of magnets located on a support; and a magnetic applicator configured to move along the reentry track to magnetically expand the support.

[0301] Example 34 is a method for implanting a treatment device into an anatomical structure, the method comprising: implanting a stent into an anatomical opening; positioning a re-entry track extending from the stent into an anatomical pathway; sliding the treatment device along the re-entry track to position the treatment device in the anatomical pathway; and treating the anatomical structure with the treatment device.

[0302] In Example 35, the subject of Example 34 may optionally include inserting a scaffold into an anatomical opening by cutting tissue using a scaffold.

[0303] In Example 36, the subject of Example 35 may optionally include cutting tissue using a scaffold by using bipolar wire electrocautery.

[0304] In Example 37, the subject of Example 36 may optionally include removing bipolar wires from a support.

[0305] In Example 38, the subject matter of any or more of Examples 34 to 37 may optionally include inserting a stent into an anatomical opening by expanding the stent.

[0306] In Example 39, the subject of Example 38 may optionally include expanding the stent by magnetically expanding the stent.

[0307] In Example 40, the subject matter of any or more of Examples 34 through 39 may optionally include positioning a re-entry track extending from the stent into the anatomical pathway by positioning the tube within the anatomical pathway.

[0308] In Example 41, the subject of Example 40 may optionally include inserting a guide wire through a reentry track and into an anatomical pathway.

[0309] In Example 42, the subject matter of Example 41 may optionally include inserting a guide wire through the reentry track and into the anatomical pathway by attaching an anchor to the anatomical pathway.

[0310] In Example 43, the subject of Example 42 may optionally include attaching an anchor to an anatomical pathway by expanding the anchor to attach to the tissue.

[0311] In Example 44, the subject matter of Example 43 may optionally include expanding an anchor to attach to a tissue by pushing the expandable anchor out of the tube to allow the expandable anchor to expand.

[0312] In Example 45, the subject matter of any or more of Examples 41 to 44 may optionally include sliding the treatment device along a reentry track to position the treatment device in the anatomical pathway by sliding the treatment support along the guide line.

[0313] In Example 46, the subject matter of Example 45 may optionally include sliding a treatment stent along a guideline by opening the tube.

[0314] In Example 47, the subject of Example 46 may optionally include opening a tube by spreading out the gaps in the tube.

[0315] In Example 48, the subject matter of any or more of Examples 46 to 47 may optionally include opening the pipe by causing a perforation extending along the pipe to break.

[0316] In Example 49, the subject matter of any or more of Examples 46 to 48 may optionally include reclosing the tube via a magnetic sealing element.

[0317] In Example 50, the subject matter of any or more of Examples 46 to 49 may optionally include reclosing the tube via a resilient sealing element.

[0318] In Example 51, the subject matter of any or more of Examples 34 to 50 may optionally include treating an anatomical structure using a treatment device by pumping the anatomical structure to which the treatment device is deployed.

[0319] In Example 52, the subject of Example 51 may optionally include pumping the anatomical structure on which the treatment device is deployed by expanding and contracting the stent.

[0320] In Example 53, the subject matter of any or more of Examples 34 to 52 may optionally include treating the anatomical structure with a treatment device by processing the stones within the anatomical structure to facilitate passage through the treatment device.

[0321] In Example 54, the subject matter of Example 53 may optionally include processing stones within an anatomical structure to facilitate passage through a treatment device by chemically dissolving the stones.

[0322] In Example 55, the subject matter of any or more of Examples 53 to 54 may optionally include processing stones within an anatomical structure to facilitate passage through a treatment device by mechanically reducing the size of the stones.

[0323] In Example 56, the subject matter of any or more of Examples 34 to 55 may optionally include treating anatomical structures using a treatment device by heating the treatment device.

[0324] In Example 57, the subject of Example 56 may optionally include heating a treatment device via a vibration therapy device.

[0325] In Example 58, the subject matter of any or more of Examples 34 through 57 may optionally include inflating a balloon within the stent to expand the stent.

[0326] In Example 59, the subject matter of any or more of Examples 34 to 58 may optionally include sliding the treatment device along the reentry track by delivering the treatment device into the reentry track.

[0327] In Example 60, the subject matter of any or more of Examples 34 to 59 may optionally include screwing the treatment device into the reentry track.

[0328] In Example 61, the subject matter of any or more of Examples 34 to 60 may optionally include magnetically attracting the treatment device to the reentry orbit.

[0329] Each of these non-restricted examples can exist independently, or can be combined with one or more examples from other examples in various permutations or combinations.

[0330] The above detailed description includes references to the accompanying drawings, which form part of the detailed description. The drawings illustrate, by way of illustration, specific embodiments in which the invention may be practiced. These embodiments are also referred to herein as “examples.” Such examples may include elements other than those shown or described. However, the inventors also contemplate examples that provide only those elements shown or described. Furthermore, the inventors contemplate examples of any combination or arrangement of those elements (or one or more aspects of those elements) shown or described with respect to a particular example (or one or more aspects of that particular example) or with respect to other examples shown or described herein (or one or more aspects of those other examples).

[0331] In the event of any inconsistency between the usage in this document and any other document incorporated by reference, the usage in this document shall prevail.

[0332] In this document, as is common in patent documents, the term "a" or "one" is used to include one or more, independent of any other instance or use of "at least one" or "one or more". In this document, unless otherwise indicated, the term "or" is used to indicate a non-exclusive "or", such that "A or B" includes "A but not B", "B but not A", and "A and B". In this document, the terms "comprising" and "in..." are used as concise equivalents to the corresponding terms "including" and "wherein". Furthermore, in the appended claims, the terms "comprising" and "including" are open-ended, meaning that a system, apparatus, article, composition, formulation, or process that includes elements other than those listed after such terms in the claims is still considered to fall within the scope of the claims. Moreover, in the appended claims, the terms "first", "second", and "third", etc., are used only as designations and are not intended to impose numerical requirements on their objects.

[0333] The method examples described herein may be implemented, at least in part, by a machine or computer. Some examples may include computer-readable or machine-readable media encoded with instructions operable to configure electronic devices to perform the methods described in the examples above. Implementations of these methods may include code, such as microcode, assembly language code, higher-level language code, etc. Such code may include computer-readable instructions for performing various methods. The code may form parts of a computer program product. Furthermore, in the examples, such as during execution or at other times, the code may be tangibly stored on one or more volatile, non-transient, or non-volatile tangible computer-readable media. Examples of such tangible computer-readable media may include, but are not limited to: hard disks, removable disks, removable optical disks (e.g., compact disks and digital video disks), magnetic tape cartridges, memory cards or memory sticks, random access memory (RAM), read-only memory (ROM), etc.

[0334] The above description is intended to be illustrative and not restrictive. For example, the examples above (or one or more aspects of the examples) can be used in combination with each other. Other embodiments can be used by those skilled in the art upon review of the above description. An abstract is provided to allow the reader to quickly determine the nature of the technical disclosure. This abstract is submitted based on the understanding that it will not be used to interpret or limit the scope or meaning of the claims. Furthermore, in the specific embodiments described above, various features may be combined together to simplify the disclosure. This should not be construed as meaning that any unclaimed disclosed features are necessary for any claim. Rather, the subject matter of the invention may lie in fewer than all features of a particular disclosed embodiment. Therefore, the appended claims are incorporated herein by way of example or embodiment, wherein each claim is an independent, separate embodiment, and it is contemplated that these embodiments may be combined with each other in various combinations or arrangements. The scope of the invention should be determined by reference to the appended claims and the full scope of equivalents to which such claims are entitled.

Claims

1. A system for providing reusable access to a patient's anatomical region, the system comprising: The support includes an annular body; as well as A reentry track extending through the support, the reentry track comprising: an elongated body including a proximal end and a distal end extending from the annular body.

2. The system according to claim 1, wherein, The elongated body includes a tubular body that defines a cavity.

3. The system according to claim 2, wherein, The tubular body can be opened.

4. The system according to claim 3, wherein, The tubular body includes a slit extending along the length of the tubular body.

5. The system according to claim 4, wherein, The slit can be closed.

6. The system according to claim 5, wherein, The tubular body includes a magnet positioned along the slit.

7. The system according to claim 5, wherein, The tubular body includes a spring configured to bias the slit to a closed position.

8. The system according to claim 3, wherein, The tubular body includes perforations extending along the length of the tubular body.

9. The system according to claim 2, wherein, The tubular body includes threads extending along the cavity.

10. The system of claim 2, further comprising an inlet element attached to the proximal end of the tubular body.

11. The system according to claim 10, wherein, The inlet element includes a funnel-shaped component.

12. The system according to claim 11, wherein, The funnel-shaped component includes internal threads.

13. The system according to claim 11, wherein, The funnel-shaped element is magnetic.

14. The system according to claim 2, further comprising: A guide wire extending into the cavity of the tubular body; and an anchor attached to the distal end portion of the guide wire.

15. The system according to claim 14, wherein, The anchor includes a helical component.

16. The system according to claim 14, wherein, The anchor includes an expandable body, wherein the anchor can retract into a cavity of the tubular body to cause the expandable body to contract, and can extend from the cavity to allow the expandable body to expand.

17. The system according to claim 16, wherein, The magnifiable body includes multiple flexible protrusions.

18. The system according to claim 16, wherein, The magnifiable body includes multiple extendable protrusions.

19. The system of claim 1, further comprising an intervention device configured to move along the reentry trajectory.

20. The system according to claim 19, wherein, The interventional device includes a treatment stent.

21. The system according to claim 20, wherein, The treatment stent is configured to provide a pumping effect in the anatomical region.

22. The system according to claim 21, wherein, The treatment stent is designed to expand and contract.

23. The system according to claim 20, wherein, The treatment stent device includes a stone processor.

24. The system according to claim 23, wherein, The stone processor is designed to chemically treat stones.

25. The system according to claim 23, wherein, The stone processor is configured to mechanically reduce the size of the stones.

26. The system according to claim 20, wherein, The treatment stent is configured to provide heating.

27. The system of claim 20 further includes a balloon positioned within the treatment stent.

28. The system according to claim 1, wherein, The scaffold is constructed to cut tissue.

29. The system according to claim 28, wherein, The support includes mechanical cutting blades.

30. The system according to claim 28, wherein, The support includes an electric cutting blade.

31. The system according to claim 30, wherein, The electric cutting blade includes a pair of electrical wires configured to be pulled out from the support after use.

32. The system according to claim 1, wherein, The stent can be selectively expanded.

33. The system according to claim 32, further comprising: Multiple magnets, located on a support; as well as A magnetic applicator configured to move along the reentry track to magnetically expand the support.

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