Systems and methods for treating strictures along biliary and / or pancreatic tracts

Abstract

Systems and methods for treating, for example, strictures along a biliary tract and / or pancreatic duct are disclosed. An example system can include a handle (14) having a base, a first carriage (26) translatable relative to the base, and a second carriage (24) translatable relative to the base. A sheath (16) can be coupled to the first carriage. The system can also include a catheter shaft (12) having a proximal region and a steerable distal region. The proximal region can be coupled to the second carriage. A needle can be releasably coupled to the handle. The needle can be configured to pass through tissue to a location along a biliary tract and / or pancreatic duct. The system can also include a steering member (44) having a first end coupled to the steerable distal region of the catheter shaft and a second end disposed adjacent the handle.

Description

[0001] Cross-references to related applications

[0002] This application claims the benefit and priority of U.S. Provisional Patent Application Serial No. 63 / 061,451, filed August 5, 2020, the disclosure of which is incorporated herein by reference. Technical Field

[0003] This invention relates to medical devices and methods for manufacturing medical devices. More particularly, this invention relates to medical devices for treating narrowings along the biliary tract and / or pancreatic tract. Background Technology

[0004] A wide variety of medical devices have been developed for medical use. Some of these devices include guidewires, catheters, etc. These devices are manufactured using a wide variety of different methods and can be used according to a wide variety of methods. Each of these medical devices and methods is known to have certain advantages and disadvantages. There is currently a need for alternative medical devices and alternative methods for manufacturing and using these devices. Summary of the Invention

[0005] This invention provides designs, materials, manufacturing methods, and alternatives for using medical devices. The invention discloses a system for treating strictures. The system includes: a handle having a base, a first slide translatably relative to the base, and a second slide translatably relative to the base; a sheath coupled to the first slide; a catheter shaft having a proximal region and a steerable distal region, the proximal region being coupled to the second slide; a needle releasably coupled to the handle, the needle being configured to penetrate tissue to a location along the biliary tract and / or pancreatic tract; and a steering member having a first end coupled to the steerable distal region of the catheter shaft and a second end disposed adjacent to the handle.

[0006] Alternatively or additionally for any of the above embodiments, the handle includes a first locking member for fixing the axial position of the first carriage relative to the base.

[0007] Alternatively or additionally, in any of the above embodiments, the handle includes a second locking member for securing the axial position of the second carriage relative to the base, relative to the first carriage, or both.

[0008] Alternatively or additionally, in any of the above embodiments, the handle includes a third locking member for fixing the axial position of the steering member relative to the base, relative to the second carriage, or both.

[0009] Alternatively or additionally for any of the above embodiments, the base includes a proximal connector, and the pin is secured to the proximal connector.

[0010] Alternatively or additionally for any of the above embodiments, the steering component includes a strip.

[0011] Alternatively or additionally, in any of the above embodiments, the conduit shaft has a cavity formed therein, and a steering member extends through the cavity.

[0012] Alternatively or additionally, for any of the above embodiments, at least a portion of the steering member extends along the outer surface of the guide shaft.

[0013] Alternatively or additionally, any of the above embodiments may also include a sleeve disposed along a portion of the steering member extending along the outer surface of the conduit shaft.

[0014] Alternatively or additionally, any of the above embodiments may also include an endoscope having a channel formed therein, wherein a catheter shaft is configured to extend within the channel.

[0015] This invention discloses a system for treating strictures. The system includes: a handle having a base, a first telescopic portion connected to the base, and a second telescopic portion connected to the base; a sheath connected to the first telescopic portion; a catheter shaft for access to the bile duct and / or pancreatic duct at a non-mastoid location, the catheter shaft having a guidewire lumen, a proximal region, and a steerable distal region, wherein the proximal region is connected to the second telescopic portion; a needle having a distal puncture region and a proximal region connected to a connector disposed along the handle, the distal puncture region needle being configured to penetrate tissue to access a location along the bile duct and / or pancreatic duct; a steering line having a distal end connected to the steerable distal region, an outer portion disposed along the outer surface of the catheter shaft, and a proximal end disposed adjacent to the handle; and a cannula disposed along the outer portion of the steering line.

[0016] Alternatively or additionally for any of the above embodiments, the handle includes a first locking member for fixing the axial position of the first telescopic portion relative to the base.

[0017] Alternatively or additionally, in any of the above embodiments, the handle includes a second locking member for fixing the axial position of the second telescopic portion relative to the first telescopic portion.

[0018] Alternatively or additionally, in any of the above embodiments, the handle includes a steering lock for fixing the axial position of the steering line relative to the base, relative to the second telescopic portion, or both.

[0019] Alternatively or additionally for any of the above embodiments, the turning line includes a strip line.

[0020] This invention discloses a method for traversing a stenosis. The method includes: advancing a catheter system through a patient's digestive tract to a location adjacent to a wall surface along the digestive tract; wherein the catheter system includes a catheter shaft and a needle; positioning the needle relative to the catheter shaft such that the distal end of the needle extends distally beyond the distal end of the catheter shaft; puncturing through the wall surface and entering an intraluminal location adjacent to the stenosis within the bile duct and / or pancreatic duct; removing the needle from the catheter system; and advancing a guidewire through the catheter shaft and beyond the stenosis.

[0021] Alternatively or additionally, along the wall surface of the digestive tract, the duodenal wall surface is included.

[0022] Alternatively or additionally, along the wall surface of the digestive tract, the stomach wall surface is included, in any of the above embodiments.

[0023] Alternatively or additionally for any of the above embodiments, puncture through the wall surface and into the intraluminal location adjacent to the stenosis within the bile duct and / or pancreatic duct includes puncturing the tissue between the wall surface and the adjacent intraluminal location within the bile duct and / or pancreatic duct.

[0024] Alternatively or additionally, in any of the above embodiments, the catheter shaft includes a steering member and further includes a component that steers the distal region of the catheter shaft relative to the stenosis.

[0025] The above overview of some embodiments is not intended to describe every disclosed embodiment or implementation of the invention. These embodiments are illustrated more specifically by way of example in the following figures and detailed descriptions. Attached Figure Description

[0026] The invention can be more fully understood by considering the following detailed description taken in conjunction with the accompanying drawings, in which:

[0027] Figure 1 This is a side view of the system according to the invention for accessing the pancreatic tract and / or bile duct;

[0028] Figure 2 This is a side view of the system according to the invention for accessing the pancreatic tract and / or bile duct;

[0029] Figure 3 This is a cross-sectional view of the system according to the invention for accessing the pancreatic tract and / or bile duct;

[0030] Figure 4 This is a cross-sectional view of the conduit shaft according to the present invention;

[0031] Figure 5 The duct shaft in a curved configuration according to the present invention is shown;

[0032] Figure 6Another conduit axis in a curved configuration according to the invention is shown;

[0033] Figure 7 A portion of the digestive system is depicted schematically;

[0034] Figures 8 to 10 A method for entering a narrow passage according to the present invention is shown;

[0035] Figure 11 This is a side view of a portion of an example handle according to the present invention.

[0036] While the invention is adaptable to various modifications and alternatives, its specific details have been shown by way of example in the accompanying drawings and will be described in more detail. However, it should be understood that it is not intended to limit the invention to the specific embodiments described. Rather, it is intended to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the invention. Detailed Implementation

[0037] For the purposes of the following definitions, unless otherwise specified in the claims of this specification or elsewhere, these definitions shall apply.

[0038] All numerical values ​​herein are assumed to be modified by the term "about," whether or not explicitly stated otherwise. The term "about" generally refers to a range of numbers that a person skilled in the art would consider equivalent to the referenced value (e.g., having the same function or result). In many cases, the term "about" may include numbers rounded to the nearest significant figure.

[0039] A description of a range of numbers represented by endpoints includes all numbers within that range (e.g., 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5).

[0040] As used in this specification and the appended claims, the singular forms “a,” “an,” and “the” include a plurality of indicators unless otherwise expressly indicated. As used in this specification and the appended claims, the term “or” is generally used to include “and / or” unless otherwise expressly indicated.

[0041] It should be noted that the embodiments described by references to "one embodiment," "some embodiments," "other embodiments," etc., in the specification may include one or more specific features, structures, and / or characteristics. However, such description does not necessarily imply that all embodiments include that specific feature, structure, and / or characteristic. Furthermore, when a specific feature, structure, and / or characteristic is described in connection with an embodiment, it should be understood that, whether explicitly described or not, such feature, structure, and / or characteristic may also be used in conjunction with other embodiments, unless expressly stated otherwise.

[0042] The following detailed description should be read with reference to the accompanying drawings, in which similar elements in different drawings have the same numbering. The drawings, which are not necessarily drawn to scale, depict illustrative embodiments and are not intended to limit the scope of the invention.

[0043] During endoscopy, a common symptom is abdominal pain with or without jaundice. The cause is usually some type of obstruction in the biliary tree, preventing bile from flowing naturally from the proximal tree into the duodenum. The obstruction may be due to bile duct stones lodged in the lumen of the duct or a tumor within the duct wall or impacting the wall from adjacent tissue. When this narrowing occurs, the duct dilates proximal to the narrowing, and the duct distal to the narrowing receives reduced bile flow. To alleviate the patient's symptoms, gastroenterologists attempt to find a way to restore bile flow from the proximal dilated duct into the duodenum. Some interventions envisioned to relieve symptoms may include placing a stent across the narrowing to drain the proximal duct, removing stones, etc.

[0044] The most common method for placing a stent across a stricture is to perform endoscopic retrograde cholangiopancreatography (ERCP), in which a lateral endoscope is placed at the location of the duodenal biliary papilla and, retrogradely, through the papilla and upward through the bile duct to place a guidewire across the stricture. This procedure can be challenging. For example, depending on the location, geometry, and mechanics of the stricture, deep cannulation of the proximal duct can be difficult or even impossible. Furthermore, when attempting to access the bile duct, the physician may inadvertently cannulate the pancreatic duct. Inadvertent cannulation of the pancreatic duct can lead to complications such as pancreatitis. This article discloses devices and methods for addressing these and other problems, for example, by utilizing antegrade (e.g., non-papillary) stricture traversal.

[0045] Figures 1 to 3An example system 10 for treating strictures along the biliary and / or pancreatic ducts is illustrated. In at least some cases, system 10 is configured for use with an endoscope (e.g., an endoscopic ultrasound device) for antegrade passage through strictures along the biliary and / or pancreatic ducts. System 10 can be understood as a cold (e.g., unpowered) access device that can be used for access to the biliary and / or pancreatic ducts from a non-mastoid location. As will be described in more detail herein, system 10 can be advanced through at least a portion of a patient's digestive tract to puncture / perforate the wall of the digestive tract and enter the lumen / duct along the biliary and / or pancreatic ducts, be steered to the desired orientation, and subsequently used to allow a suitable device to pass through it for intervention.

[0046] System 10 may include a catheter shaft 12 and a handle 14 coupled to the catheter shaft 12. A sheath 16 may be coupled to the handle 14. In at least some cases, the sheath 16 may be an inserter sheath or have functions similar to an inserter sheath. The sheath 16 may be formed of a relatively rigid material such as polyetheretherketone (PEEK). Other materials are also contemplated, including those disclosed herein. The handle 14 may include a first or proximal connector 20. In at least some cases, the proximal connector 20 may be used for securing a device relative to system 10. For example, a needle or sharp instrument 18 (in...) Figure 2 The needle / sharp instrument 18 (as depicted in the diagram) can be releasably secured to system 10. The needle / sharp instrument 18 may have a puncture and / or penetration distal end, allowing the needle / sharp instrument 18 to pass through tissue. The handle 14 may include a second or distal connector 22. In at least some cases, the distal connector 22, which may take the form of a Luer or other suitable connector, can be used to secure system 10 to the endoscope.

[0047] Handle 14 may include a base 24, a first telescopic member or carriage 26 translatable relative to the base 24, and a second telescopic member or carriage 28 translatable relative to the base 24 (and / or translatable relative to the first carriage 26). The base 24 and carriages 26, 28 may be used to manipulate different parts of system 10 during intervention. For example, base 24 may be coupled / secured to an endoscope (e.g., distal connector 22 may be attached to the endoscope). It may be desirable to arrange sheath 16 relative to the endoscope. For example, it may be desirable to arrange sheath 16 such that it extends just beyond the lift of the endoscope. Handle 14 may be manipulated to adjust sheath 16. For example, proximal region 46 of sheath 16 may be coupled to the first carriage 26 (see, e.g., Figure 3 Therefore, the translation of the first carriage 26 relative to the base 24 adjusts the axial position of the sheath 16 relative to the base 24 (and / or the endoscope). In some cases, the first carriage 26 can be understood as a "length adjuster" for adjusting the length of the sheath 16 (e.g., relative to the base 24 and / or the endoscope).

[0048] The proximal region 48 of the catheter shaft 12 can be coupled to the second carriage 28. Therefore, translation of the second carriage 28 relative to the base 24 adjusts the axial position of the catheter shaft 12 relative to the base 24 (and / or the endoscope). Additionally, when the needle / sharp instrument 18 is coupled to the handle 14, the needle / sharp instrument 18 can be secured to the proximal connector 20. In some cases, the proximal connector 20 can be coupled to the second carriage 28. Therefore, when the needle / sharp instrument 18 is secured to the handle 14, translation of the second carriage 28 relative to the base 24 adjusts the axial position of both the catheter shaft 12 and the needle / sharp instrument 18 relative to the base 24 (and / or the endoscope). In some cases, the second carriage 28 can be understood as a "sharp instrument distancer" for adjusting the projection distance or length of the needle / sharp instrument 18 (e.g., relative to the base 24 and / or the endoscope).

[0049] The handle 14 may include several additional features. For example, a first stop member 30 may be provided along the base 24. The first stop member 30 may be in the form of a collar that can slide along the base 24. In at least some cases, the first stop member 30 may function as a stop or limiter that restricts how far the first carriage 26 can translate along the base 24. In use, the clinician can adjust the first stop member 30 to the desired position along the base 24. The base 24 may include visual markings or signs indicating the relative length / position of the sheath 16 to help the clinician determine the appropriate length / position of the first stop member 30. The first stop member 30 may include a first retaining screw 32. The retaining screw 32 may be used to secure the position of the first stop member 30 relative to the base 24.

[0050] The second stop member 34 may be disposed along the first slide 26. The second stop member 34 may be in the form of a collar that can slide along the first slide 26. In at least some cases, the second stop member 34 may function as a stop or limiter that restricts how far the second slide 28 can translate along the first slide 26. In use, clinicians can adjust the second stop member 34 to the desired position along the first slide 26. The first slide 26 may include visual markers or markings indicating the relative length / position of the catheter shaft 12 to help clinicians determine the appropriate length / position of the second stop member 34. The second stop member 34 may include a second fixing screw 36. The second fixing screw 36 may be used to fix the position of the second stop member 34 relative to the first slide 26.

[0051] The handle 14 may include a first locking member 38. The first locking member 38 may fix the axial position of the first carriage 26 relative to the base 24. In addition, the handle 14 may include a second locking member 40. The second locking member 40 may fix the axial position of the second carriage 26 relative to the first carriage 26 (and / or relative to the base 24).

[0052] Handle 14 may include a steering lock 42. The steering lock 42 may be in the form of a collar that can slide and translate along region 43 of handle 14. In at least some cases, the steering lock 42 may be coupled to a steering member or line 44 that is coupled to the conduit shaft 12 (e.g., as described in more detail herein). Translation of the steering lock 42 can actuate the steering line 44 to bend the conduit shaft 12. When the conduit shaft 12 is in the desired shape, a retaining screw 45 can be actuated to secure the steering lock 42 to handle 14 (e.g., to secure the steering lock 42 relative to the second carriage 28, base 24, or both), and thus secure the conduit shaft 12 in the desired shape.

[0053] Figure 4 This is a cross-sectional view of the catheter shaft 12. Several structural features can be shown here. For example, the catheter shaft 12 may include an inner layer 50, a reinforcing layer 52 (e.g., such as braid, coil, mesh, etc.), and an outer layer 54. The materials used for the various components of the catheter shaft 12 may include those disclosed herein. For example, the inner layer may include lubricating materials such as polytetrafluoroethylene (PTFE), fluorinated ethylene propylene (FEP), combinations thereof, and / or other materials disclosed herein. The reinforcing layer 52 may include stainless steel braid. The outer layer may include polyamide, polyether ester, nylon, combinations thereof, and / or other materials disclosed herein. In some cases, the material used for the catheter shaft 12 may vary along the length of the catheter shaft 12. This may allow the catheter shaft 12 to have greater flexibility near its distal end. In some cases, the catheter shaft 12 is formed of a single layer of material. In some cases, the catheter shaft 12 may include a tubular member having multiple slots formed therein. The slotted catheter shaft 12 may be formed of nickel-titanium alloy, stainless steel, etc. The outer sleeve can be set along the slotted guide shaft 12.

[0054] A guidewire and / or a pointed tube 56 (within which a lumen 58 is defined) may be disposed within the catheter shaft 12. The tube 56 may include an inner layer 60, a reinforcing layer 62 (e.g., such as braid, coil, mesh, etc.), and an outer layer 64. The construction of the tube 56 may be similar to or different from that of the catheter shaft 12. In some cases, the tube 56 is formed from a single layer of material. A diversion line assembly 66 may also be disposed within the catheter shaft 12. The diversion line assembly 66 may include a tubular member 68 having a lumen 70 defined therein and a diversion line 44 disposed within the lumen 70. In some cases, the diversion line 44 may be a strip. In other cases, the diversion line 44 may be a circular line or have a different shape.

[0055] As indicated herein, the steering line 44 can be actuated (e.g., by sliding the steering lock 42) to bend the catheter shaft 12. In some cases, the steering line 44 can be located inside the catheter shaft 12, such as... Figure 5 As depicted in [the text]. Alternatively, a portion of the turning line 44 may be positioned along the exterior of the conduit shaft 12. For example, Figure 6 The catheter shaft 112 is depicted, with a portion of the turning line 144 positioned along the exterior of the catheter shaft 112. In some cases, the cannula 172 may be positioned along the exterior, exposed portion of the turning line 144, which may help protect tissue from damage / cutting by the turning line 144 during use.

[0056] Figure 7 An overview of the biliary system or tree is shown. A portion of the duodenum 74 is shown. The Farther's papillae 76 (e.g., also called Farther's ampulla or simply papillae) are located in the shown portion of the duodenum 74. The papillae 76 typically form openings through which the pancreatic duct 78 and the common bile duct 80 can drain into the duodenum 74. The hepatic duct, indicated by reference numeral 82, connects to the liver 84 and drains into the bile duct 80. Similarly, the cystic duct 86, which connects to the gallbladder 88, also drains into the bile duct 80. Typically, endoscopic or biliary procedures may involve advancing a medical device along the biliary tree to the appropriate location and subsequently performing appropriate interventions.

[0057] System 10 can be used to access the stricture along the pancreatic duct 78 and / or common bile duct 80. For example, Figure 8 An example endoscope 90 positioned in the duodenum 74 is shown. The invention is not intended to be limited to positioning the endoscope 90 in the duodenum 74, as other locations are conceivable, including other parts of the digestive system, including the stomach. System 10 can be attached to endoscope 90, wherein a catheter shaft 12 extends through a channel (e.g., working channel) of endoscope 90, and a handle 14 can be manipulated to position the catheter shaft 12 and sheath 16 in the desired location. The catheter shaft 12 (e.g., having a needle / sharp instrument 18 extending therethrough) can be extended from endoscope 90. This may include using a lift 92 of endoscope 90 to guide the catheter shaft 12 toward the wall of duodenum 74. The catheter shaft 12, having the needle / sharp instrument 18 extending from it, can then pierce through the wall of duodenum 74 and be advanced toward a target location through tissue, such as a lumen, like within the common bile duct 80.

[0058] Once the catheter shaft 12 is properly positioned, it can be redirected to the desired orientation using the redirection line 44, such as... Figure 9 The diagram is schematic. In at least some cases, it may be desirable to remove the needle / sharp instrument 18 from the system 10 before turning. Once the catheter shaft 12 is properly oriented, a device, such as a guidewire 96, can be advanced through the catheter shaft 12 and over the stenosis 94, as shown. Figure 10 As depicted in the text.

[0059] Figure 11This is a side view of a portion of handle 214, which may be part of a system similar to system 10. Handle 214 may be similar in form and function to handle 14. Handle 214 may include a rotary steering device / lock 242 coupled to handle 214 and steering line 44, rather than having a steering lock that slides along the handle. Rotation of steering device / lock 242 may actuate steering line 44 (e.g., and cause conduit shaft 12 to curve / bend).

[0060] Materials suitable for use in various components of system 10 may include those commonly associated with medical devices. For simplicity, the following discussion refers to catheter shaft 12. However, this is not intended to limit the devices and methods described herein, as the discussion can be applied to other similar tubular components and / or components of the tubular components and / or devices disclosed herein.

[0061] The conduit shaft 12 may be made of or otherwise comprised of metal, metal alloy, polymer (some examples of which are disclosed below), metal-polymer composite, ceramic, combinations thereof, or other suitable materials. Some examples of suitable polymers may include polytetrafluoroethylene (PTFE), ethylene tetrafluoroethylene (ETFE), fluorinated ethylene propylene (FEP), and polyoxymethylene (POM, e.g., available from DuPont). Polyether block esters, polyurethanes (e.g., polyurethane 85A), polypropylene (PP), polyvinyl chloride (PVC), and polyether esters (e.g., available from DSM Engineering Plastics) ), ether or ester copolymers (e.g., butene / poly(alkylene ether) phthalates and / or other polyester elastomers, such as those available from DuPont) ), polyamide (e.g., available from Bayer) Or it can be purchased from Elf Atochem. ), elastomer polyamide, block polyamide / ether, polyether block amide (PEBA, for example, can be listed by trade name) Purchased), ethylene vinyl acetate copolymer (EVA), silicone resin, polyethylene (PE), high-density polyethylene, low-density polyethylene, linear low-density polyethylene (e.g., Polyester, polybutylene terephthalate (PBT), polyethylene terephthalate (PET), polypropylene terephthalate, polyethylene naphthalate (PEN), polyetheretherketone (PEEK), polyimide (PI), polyetherimide (PEI), polyphenylene sulfide (PPS), polyphenylene ether (PPO), poly(p-phenylene terephthalamide) (e.g., Polysulfone, nylon, nylon-12 (such as those available from EMS American Grilon) Perfluoro(propyl vinyl ether) (PFA), ethylene vinyl alcohol, polyolefins, polystyrene, epoxy resins, polyvinylidene chloride (PVdC), poly(styrene-b-isobutylene-b-styrene) (e.g., SIBS and / or SIBS 50A), polycarbonate, ionomers, biocompatible polymers, other suitable materials or mixtures, combinations, copolymers, polymer / metal composites, etc. In some embodiments, the sheath may be blended with a liquid crystal polymer (LCP). For example, the blend may contain up to about 6% LCP.

[0062] Some examples of suitable metals and metal alloys include stainless steels such as 304V, 304L, and 316LV stainless steels; mild steels; nickel-titanium alloys such as linearly elastic and / or hyperelastic nickel-titanium alloys; other nickel alloys such as nickel-chromium-molybdenum alloys (e.g., UNS: N06625, such as...). 625, UNS: N06022, such as UNS: N10276, such as other alloys, etc.), nickel-copper alloys (e.g., UNS: N04400, such as...) 400 400 400, etc.), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS: R30035, such as...). (etc.), nickel-molybdenum alloys (e.g., UNS: N10665, such as...) Other nickel-chromium alloys, other nickel-molybdenum alloys, other nickel-cobalt alloys, other nickel-iron alloys, other nickel-copper alloys, other nickel-tungsten or tungsten alloys, etc.; cobalt-chromium alloys; cobalt-chromium-molybdenum alloys (e.g., UNS: R30003, such as...). (etc.); platinum-rich stainless steel; titanium; combinations thereof; etc. or any other suitable material.

[0063] It should be understood that the present invention is merely illustrative in many respects. Changes may be made in details, particularly in terms of shape, size, and arrangement of steps, without departing from the scope of the invention. To the appropriate extent, this may include the use of any of the features of an example embodiment used in other embodiments. Of course, the scope of the invention is defined by the language of the appended claims.

Claims

1. A system for treating stenosis, the system comprising: A handle having a base, a first carriage translatable relative to the base, and a second carriage translatable relative to the base; Sheath, the sheath being connected to the first carriage; A catheter shaft having a proximal region and a steerable distal region, the proximal region being coupled to the second carriage; A needle, releasably coupled to the handle, the needle being configured to penetrate tissue to a location along the bile duct and / or pancreatic duct; A steering member having a first end coupled to the steerable distal region of the guide shaft and a second end disposed adjacent to the handle; The handle includes a third locking member for fixing the axial position of the steering member relative to the base, relative to the second carriage, or both.

2. The system according to claim 1, wherein, The handle includes a first locking member for fixing the axial position of the first carriage relative to the base.

3. The system according to claim 1, wherein, The handle includes a second locking member for fixing the axial position of the second carriage relative to the base, relative to the first carriage, or both.

4. The system according to any one of claims 1 to 3, wherein, The handle includes a proximal connector, and the pin is secured to the proximal connector.

5. The system according to any one of claims 1 to 3, wherein, The steering component includes a strip.

6. The system according to any one of claims 1 to 3, wherein, The conduit shaft has a cavity formed therein, and the steering member extends through the cavity.

7. The system according to claim 6, wherein, At least a portion of the steering member extends along the outer surface of the guide shaft.

8. The system of claim 7, further comprising a sleeve disposed along the portion of the steering member extending along the outer surface of the conduit axis.

9. The system according to any one of claims 1 to 3, further comprising an endoscope having a channel formed therein, wherein, The conduit shaft is configured to extend within the channel.

10. A system for treating stenosis, the system comprising: A handle having a base, a first telescopic portion connected to the base, and a second telescopic portion connected to the base; Sheath, the sheath being connected to the first telescopic portion; A catheter shaft for accessing the bile duct and / or pancreatic duct from a non-mastoid location, the catheter shaft having a guidewire lumen, a proximal region, and a steerable distal region; The proximal region is connected to the second telescopic portion; A needle having a distal puncture region and a proximal region connected to a connector disposed along the handle, the distal puncture region being configured to penetrate tissue to a location along the bile duct and / or pancreatic duct. A steering line having a distal end connected to the steerable distal region, an external portion disposed along the outer surface of the conduit axis, and a proximal end disposed adjacent to the handle; A sleeve, the sleeve being disposed along the outer portion of the turning line; and A steering lock is configured to fix the axial position of the steering line relative to the base, relative to the second telescopic portion, or relative to both, wherein actuation of the steering lock actuates the steering line by axial displacement of the steering lock to bend the guide shaft.

11. The system according to claim 10, wherein, The handle includes a first locking member for fixing the axial position of the first telescopic portion relative to the base.

12. The system according to any one of claims 10 to 11, wherein, The handle includes a second locking member for fixing the axial position of the second telescopic portion relative to the first telescopic portion.

13. The system according to claim 10, wherein, The turning line includes a strip line.

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