Systems and methods for treating strictures along the biliary and / or pancreatic ducts

Abstract

For example, a system and method for treating stenosis along the biliary tract and / or pancreatic duct are disclosed. An exemplary system may include a handle (12) having a base with a distal end region and a proximal end region. A length adjustment member (18) may be coupled to the handle. A length actuator (20) may be coupled to the distal end region of the handle. A catheter shaft (22) may be coupled to the handle. A steering mechanism may be coupled to the handle. The steering mechanism (24) may include an elongate steering member having a first end region coupled to the handle, a first body region extending along the catheter shaft, a loop region extending around the catheter shaft, a second body region extending along the catheter shaft, and a second end region coupled to the handle.

Description

Technical Field

[0001] The present disclosure relates to a medical device and a method for manufacturing a medical device. More particularly, the present disclosure relates to a medical device for treating stenosis along the biliary tract and / or pancreatic duct.

Background Art

[0002] A wide variety of medical devices have been developed for medical use. Some of these devices include guidewires, catheters, etc. These devices are manufactured by any one of a variety of different manufacturing methods and can be used according to any one of a variety of methods. Each of the known medical devices and methods has certain advantages and disadvantages. There is a continuing need to provide alternative medical devices and alternative methods for manufacturing and using medical devices.

Summary of the Invention

[0003] The present disclosure provides designs, materials, manufacturing methods, and alternative uses for medical devices. A system for treating stenosis is disclosed. The system includes a handle having a base with a proximal end region, a length adjustment member coupled to the handle and having a distal end configured to be attached to an endoscope, wherein the base is movable relative to the length adjustment member, a length actuator coupled to the handle and configured to allow a user to change the position of the base relative to the length adjustment member, a catheter shaft coupled to the base, and a steering mechanism coupled to the handle and configured to steer the catheter shaft. The steering mechanism includes an elongate steering member having a first end region coupled to the handle, a first body region extending along the catheter shaft, a loop region extending around the catheter shaft, a second body region extending along the catheter shaft, and a second end region coupled to the handle.

[0004] Alternatively or additionally to any one of the above embodiments, the elongate control member includes a control wire. Alternatively or additionally to any one of the above embodiments, the elongate control member includes a multi-filar control cable.

[0005] Alternatively or additionally to any one of the above embodiments, the first body region and the second body region extend adjacent to each other along the catheter shaft. Alternatively or additionally to any one of the above embodiments, the first body region, the second body region, or both extend along the outer surface of the catheter shaft.

[0006] Alternatively or additionally to any one of the above embodiments, the first body region, the second body region, or both extend through the wall of the catheter shaft. Alternatively or additionally to any one of the above embodiments, the first end region and the second end region of the elongate control member are connected to a control connector disposed within the handle.

[0007] Alternatively or additionally to any one of the above embodiments, the first end region and the second end region of the elongate control member extend in one or more loop configurations at the location of the control connector.

[0008] Alternatively or additionally to any one of the above embodiments, the first end region and the second end region of the elongate control member extend in an 8-shaped configuration at the location of the control connector.

[0009] Alternatively or additionally to any one of the above embodiments, the length actuator includes a depressible button. Alternatively or additionally to any one of the above embodiments, further comprising a needle attachment member detachably coupled to the proximal end region of the handle.

[0010] Alternatively or additionally to any one of the above embodiments, the needle attachment member further comprises a needle detachably connected thereto, the needle being configured to reach a position along the biliary tract and / or pancreatic duct through the tissue.

[0011] Alternatively or additionally to any one of the above embodiments, the catheter shaft includes a first channel, and a first body region extends through the first channel. Alternatively or additionally to any one of the above embodiments, the catheter shaft includes a second channel, and a second body region extends through the second channel.

[0012] Alternatively or additionally to any one of the above embodiments, the catheter shaft includes a first coil having a first pitch and a second coil having a second pitch different from the first pitch.

[0013] An endoscopic medical device is disclosed. The endoscopic medical device includes a length adjustment member, a handle connected to the length adjustment member and movable relative to the length adjustment member, a length actuator connected to the handle and configured to enable a user to change the position of the handle relative to the length adjustment member, a catheter shaft connected to the handle, a steering actuator connected to the handle and configured to steer the catheter shaft, and an elongate steering member connected to the steering actuator and having a first end region connected to the handle, a first body region extending along the catheter shaft, a loop region extending around the catheter shaft, a second body region extending along the catheter shaft, and a second end region connected to the handle.

[0014] Alternatively or additionally to any one of the above embodiments, the first end region and the second end region of the elongate steering member are connected to the steering actuator. Alternatively or additionally to any one of the above embodiments, the first end region and the second end region of the elongate control member extend in one or more loop configurations adjacent to the control actuator.

[0015] Alternatively or additionally to any one of the above embodiments, the first end region and the second end region of the elongate control member extend in an 8 - shaped configuration adjacent to the control actuator.

[0016] An endoscopic medical device assembly is disclosed. The endoscopic medical device assembly includes a handle assembly including a handle and a length adjustment member, a length actuator coupled to the handle assembly and configured to enable a user to change the position of the handle relative to the length adjustment member, a catheter shaft coupled to the handle, a steering actuator coupled to the handle and configured to steer the catheter shaft, an elongate steering member coupled to the steering actuator and having a first end region coupled to the handle, a first body region extending along the catheter shaft, a loop region extending around the catheter shaft, a second body region extending along the catheter shaft, and a second end region coupled to the handle, a needle attachment member removably coupled to the handle region, and a needle removably coupled to the needle attachment member and configured to pass through tissue and reach a position along the biliary tract and / or pancreatic duct.

[0017] The above summary of some embodiments is not intended to describe every disclosed embodiment or every implementation of the present disclosure. The drawings and detailed description that follow illustrate these embodiments in more detail. BRIEF DESCRIPTION OF THE DRAWINGS

[0018]

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DETAILED DESCRIPTION OF THE INVENTION

[0019] The present disclosure can be more fully understood in view of the following detailed description in connection with the accompanying drawings. Although the present disclosure is suitable for various modifications and alternative forms, the details thereof are illustrated by way of example in the drawings and will be described in detail. However, it should be understood that the intention is not to limit the present invention to the specific embodiments described. On the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the present disclosure.

[0020] For the following defined terms, these definitions shall apply unless different definitions are provided in the claims or elsewhere in this specification. Any numerical value is assumed herein to be modified by the term "about" whether explicitly indicated or not. The term "about" generally refers to a range of numbers that a person of ordinary skill in the art would consider to be equivalent to the recited value (e.g., having the same function or result). In many instances, the term "about" may include numbers that are rounded to the nearest significant digit.

[0021] The recitation of numerical ranges 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). As used in this specification and the appended claims, the singular forms "a", "an", and "the" include plural referents unless the context clearly dictates otherwise. As used in this specification and the appended claims, the term "or" generally is employed in its sense including "and / or" unless the context clearly dictates otherwise.

[0022] References to "one embodiment", "some embodiments", "other embodiments", etc. in this specification are to be noted as indicating that the described embodiments may include one or more specific features, structures, and / or characteristics. However, such descriptions do not necessarily mean that all embodiments include that specific feature, structure, and / or characteristic. Also, when a specific feature, structure, and / or characteristic is described in relation to one embodiment, it should be understood that such feature, structure, and / or characteristic may be used in relation to other embodiments as well, whether explicitly described or not, unless otherwise clearly stated.

[0023] The following detailed description should be read with reference to the drawings in which like numerals are used for like elements in different drawings. The drawings, which are not necessarily to scale, depict exemplary embodiments and are not intended to limit the scope of the invention.

[0024] In endoscopy, frequent medical conditions occur in which patients present with abdominal pain, with or without associated jaundice. The cause is usually some type of obstruction in the biliary tree, which prevents the natural flow of bile from the proximal tree into the duodenum. The blockage can be the result of a gallstone formed in the lumen of the duct, or a tumor within the wall of the duct or adjacent tissue that impinges on the wall. When such a stenosis occurs, the duct proximal to the stenosis dilates, and the duct distal to the stenosis receives a reduced bile flow. To relieve the patient's symptoms, a gastroenterologist tries to find a way to resume the flow of bile from the proximal dilated duct into the duodenum. Some of the interventions expected to relieve the symptoms may include placing a stent in the stenosis to drain the proximal duct, removing the stone, and / or the like.

[0025] The most common method of placing a stent in a stricture is to perform an endoscopic retrograde cholangiopancreatography (ERCP). In ERCP, a side-viewing endoscope is placed at the site of the biliary papilla within the duodenum, and a guidewire is placed retrogradely through the papilla and across the stricture into the bile duct. Such a procedure can be difficult. For example, depending on the location, shape, and mechanism of the stricture, deep intubation into the proximal duct can be difficult, if not impossible. Further, when a physician attempts to access the bile duct, the physician may inadvertently insert a cannula into the pancreatic duct. Inadvertent intubation of the pancreatic duct can lead to complications such as pancreatitis. Devices and methods for addressing these and other problems, such as by utilizing an antegrade (e.g., non-papillary) stricture crossing, are disclosed herein.

[0026] FIG. 1 shows an exemplary system 10 for treating a stricture along a biliary and / or pancreatic duct. In at least some instances, system 10 is configured to be used with an endoscope for an antegrade stricture along a biliary and / or pancreatic duct (e.g., and / or with an endoscopic ultrasound device). As described in more detail herein, system 10 is advanced through at least a portion of a patient's gastrointestinal tract and used to pierce / puncture through the wall of the gastrointestinal tract and into the lumen / intralumen along the biliary and / or pancreatic duct, steered in a desired orientation, and then used to enable a suitable device to pass therethrough for intervention.

[0027] System 10 may include a handle or handle assembly 12. The handle assembly 12 may include a base 14 having a proximal end region 16. A length adjustment member 18 may be coupled to the handle assembly 12. For example, the length adjustment member 18 may be coupled to and movable relative to the base 14. In practice, a user can attach the length adjustment member 18 to an endoscope (e.g., as disclosed herein), and the handle assembly 12 (and / or the base 14) can be moved to manipulate a device (e.g., a catheter shaft, a needle, or both) relative to the length adjustment member 18 (and / or the endoscope). Generally, the length adjustment member 18 may be configured to adjust the length or “travel distance” of a device (e.g., a catheter shaft, a needle, or both) relative to the endoscope (e.g., the distance the device can be advanced from the endoscope towards a target site). A length adjustment actuator 20 may be coupled to the handle assembly 12. Generally, the length adjustment actuator 20 may be configured to enable a user to change the position of the handle assembly 12 (and / or the base 14) relative to the length adjustment member 18. In at least some instances, the length adjustment actuator 20 may take the form of a depressible button. In use, the length adjustment actuator 20 can be depressed to shift the base 14 relative to the length adjustment member 18. If the length adjustment member 18 is fixed to the endoscope and the base 14 is fixed to a device (e.g., a catheter shaft, a needle, or both), actuation of the length adjustment actuator 20 can shift (e.g., translate) the device relative to the endoscope. By releasing the length adjustment actuator 20, the length adjustment member 18 (and / or the endoscope) can be fixed relative to the base 14 (and / or the device). Some additional details regarding the length adjustment actuator 20 are disclosed herein.

[0028] The handle assembly 12 may include a rotating member 19. Generally, the rotating member 19 may be used to operate the handle assembly 12 (and / or the base 14) relative to the length adjustment member 18. This may include rotation of the handle assembly 12 (and / or the base 14) relative to the length adjustment member 18. The handle assembly 12 may include an endoscope connector 21 that may be disposed adjacent to the rotating member 19. The endoscope connector 21 may enable the handle assembly 12 to be attached to an endoscope.

[0029] The catheter shaft 22 is coupled to the handle assembly 12 (and / or the base 14) and may be movable with the handle assembly 12. Generally, the catheter shaft 22 extends through a channel within the endoscope, exits the endoscope, passes through at least a portion of a patient's digestive tract, through the wall of the digestive tract, and extends into a lumen / duct along the biliary and / or pancreatic ducts (e.g., may include use of a needle or other "sharp" device), is maneuvered (e.g., curved, bent, and / or articulated) in a desired orientation, and is then configured to be used to enable a suitable device to pass through the catheter shaft 22 as part of an intervention. Some additional details regarding the catheter shaft 22 are disclosed herein.

[0030] In addition, the handle assembly 12 may include a steering mechanism 24. Generally, the steering mechanism 24 may be configured to steer the catheter shaft 22. The steering mechanism 24 may include a steering actuator 26, a steering connector 28 (e.g., generally disposed within the handle assembly 12, not shown in FIG. 1 but shown in FIG. 2), and a steering member 30. The steering actuator 26 may include a knob or button disposed along the handle assembly 12 (not shown in FIG. 1 but shown in FIG. 2). When actuated, the steering actuator 26 can operate the steering member 30 such that the catheter shaft 22 can be bent or curved. The steering member 30 may extend along the catheter shaft 22 and may take the form of one or more wires or cables (e.g., one or more multifilar cables) that couple to the steering actuator 26. In some instances, the steering member 30 may extend distally from the handle assembly 12 along the catheter shaft 22, loop around the distal end region of the catheter shaft 22, and extend proximally along the catheter shaft 22 toward the handle assembly 12 in the form of a single wire or cable (e.g., a single multifilar cable). The two ends of the cable steering member 30 may then be attached to the steering connector 28 as disclosed herein.

[0031] In some instances, the cable may be formed of or comprise a multifilar cable of a material such as tungsten (and / or other materials disclosed herein). In at least some instances, the multifilar cable may be desirable for several reasons. For example, the multifilar cable may have an increased resistance to elongation (e.g., as compared to a monofilament wire), an increase in flexibility, an increase in durability, combinations thereof, and / or similar properties.

[0032] Figure 2 shows the steering connector 28. Here, it can be understood that the steering connector 28 can take the form of a spool or spool member having a male thread 34. The end of the steering member 30 can be connected to the steering connector 28, for example, at one or more bolts or connectors 36. For example, if the steering member 30 takes the form of a single cable that extends along the catheter shaft 22, loops around the catheter shaft 22, and extends back to the steering connector 28, the ends of the cable can be fixed to the steering connector 28 at the location of the connector 36. In at least some instances, the steering member 30 can be looped around the connector 36 or, alternatively, can include one or more looped regions at the location of the connector 36 or adjacent to the connector 36. For example, the steering member 30 can be arranged in a figure-eight configuration around the connector 36. This configuration may be desirable for several reasons. For example, the looped or figure-eight arrangement can cause stress relief in the steering member 30 while also helping to reduce / minimize the possibility of forming weak points or pinch points.

[0033] The male thread 34 of the steering connector 28 can be threadably engaged with a threaded gear 38. A pair of arms 40 can extend through the steering connector 28 to another gear 42 that is engaged with the threaded gear 38. The arms 40 can extend through an opening in the base 14 of the handle assembly 12 such that the gear 42 can be engaged with the steering actuator 26. Thus, upon actuation of the steering actuator 26, the gear 42 rotates, and the rotation of the gear 42 can cause the threaded gear 38 to rotate. Due to the threaded relationship between the threaded gear 38 and the steering connector 28, rotation of the threaded gear 38 causes the steering connector 28 to translate within the handle assembly 12, and the steering member 30 extends or contracts to steer the catheter shaft 22 (e.g., to cause the catheter shaft 22 to curve or bend).

[0034] In some instances, the actuating member limiter 43 may be disposed adjacent to the actuating connector 28. The actuating member limiter 43 may engage the actuating connector 28 (e.g., when the actuating connector 28 is translated parallel such that it engages the actuating member limiter 43) and function as a physical barrier, such as a bolt or screw, that can prevent further translation of the actuating connector 28. This can help reduce the likelihood that the actuating member 30 is overactuated (which may include, for example, elongation, breakage, and / or other damage), the catheter shaft 22 is overactuated, combinations thereof, and / or the like. In some instances, the actuating member limiter 43 may be adjustable. For example, if the actuating member limiter takes the form of a bolt or screw, adjustment may include screwing the actuating member limiter 43 deeper or shallower.

[0035] Figure 3 shows the actuating member 30 with respect to the catheter shaft 22. The actuating member may include a first end region coupled to the handle assembly 12 (e.g., at the location of the actuating connector 28 as disclosed herein, or adjacent thereto), a first body region 46 extending along the catheter shaft 22, a loop region 48 extending around the catheter shaft 22, a second body region 50 extending along the catheter shaft 22, and a second end region coupled to the handle assembly 12 (e.g., at the location of the actuating connector 28 as disclosed herein, or adjacent thereto). The body regions 46, 50 may extend adjacent to each other in a parallel arrangement. A portion of the actuating member 30 (e.g., the body regions 46, 50) may extend along the outer surface of the catheter shaft 22. In some of these and other instances, a portion of the actuating member 30 (e.g., the body regions 46, 50) may extend through the wall of the catheter shaft 22.

[0036] Figures 4-5 schematically illustrate the catheter shaft 22. Here, it can be understood that the catheter shaft 22 may include an inner layer or liner 54. A number of different coiled sections including a first coil 56, a second coil 58, and a third coil 60 may be disposed along the inner liner 54 (not shown in FIG. 4 but shown in FIG. 5). In some instances, the coils 56, 58, 60 may be separate individual coils. In other examples, one or more of the coils 56, 58, 60 may be continuous with each other and / or may overlap each other. It can be understood that the winding direction and pitch may vary. For example, the first coil 56 may have a relatively dense or narrow pitch and a distally directed or angled winding direction. The second coil 58 may be wound in the same direction but may have a different, relatively loose or open pitch. The third coil 60 may be wound in a different, proximally directed, or angled direction. A support member or braid 62 may be disposed over the coils 56, 58, 60.

[0037] A sleeve or jacket 64 may be disposed to cover the braid 62. The jacket 64 may include end regions 66a, 66b. The end regions 66a, 66b may be relatively short regions configured to engage the ends of the braid 62 and may serve to keep the braid 62 intact. In some instances, the end regions 66a, 66b may include nylon-12. In some of these and other instances, the end regions 66a, 66b may include other materials such as those disclosed herein. The jacket 64 may also include one or more intermediate sections including a first intermediate region 68 and a second intermediate region 70. In some instances, the intermediate regions 68, 70 may include a relatively flexible polymeric material such as a polyether block amide. In some instances, the intermediate regions 68, 70 may have different durometers. For example, the intermediate region 68 may include 40D polyether block amide and the intermediate region 70 may include 55D polyether block amide. Other materials and durometers are also contemplated. The distal tip 71 may be disposed at or formed at the distal end of the catheter shaft 22.

[0038] As shown in FIG. 5, one or more tubes or channels 74a, 74b can be formed within the catheter shaft 22. The channels 74a, 74b can be configured such that the body regions 46, 50 of the steering member 30 extend through the channels 74a, 74b. Generally, the channels 74a, 74b can be disposed beneath the braid 72. However, other positions are contemplated.

[0039] FIG. 6 shows a needle attachment member 76 configured to be removably coupled to the proximal end region of the handle assembly 12. A needle or sharp 78 can be removably fixed to the needle attachment member 76. For example, the needle attachment member 76 can include a collet, a set screw, and / or other mechanisms for fixing the needle 78 to the needle attachment member 76. A threaded stem 77 can extend from the needle attachment member 76. The stem 77 can enable the needle attachment member 76 to be fixed to the proximal end region 16 of the handle assembly 12 (as shown, for example, in FIG. 7).

[0040] FIG. 8 shows a length adjustment actuator 20. Here, it can be understood that the length adjustment actuator 20 includes an engagement region 80 having a protrusion 82. The protrusion 82 is configured to engage one of a plurality of grooves 84 formed in the length adjustment member 18. A biasing member or spring 86 can bias the engagement region 80 such that the protrusion 82 engages one of the grooves 84. Generally, the spring 86 can bias the protrusion 82 of the engagement region 80 to engage the groove 84. By depressing the length adjustment actuator 20, the biasing force is canceled and the engagement region 80 is released from engagement with the groove 84.

[0041] Figure 9 shows the rotating member 19. Here, it can be understood that the rotating member 19 includes one or more torque limiters 88 and a locking member 90. The torque limiter 88 can be used to prevent the rotating member 19 from continuously rotating relative to the handle assembly 12. For example, the torque limiter 88 can set a rotation range that sets the amount of rotation to an angle less than 360 degrees. When the rotation direction of the rotating member 19 is directed in the desired direction, the locking member 90 can be actuated to set / lock the rotation direction.

[0042] Figure 10 shows an overview of the biliary system or biliary tree. A portion of the duodenum 174 is shown. The papilla of Vater 176 (e.g., the enlarged portion of Vater or simply known as the papilla) is located at the shown portion of the duodenum 174. The papilla 176 generally forms an opening at which the pancreatic duct 178 and the common bile duct 180 can flow into the duodenum 174. The hepatic duct represented by reference numeral 182 is connected to the liver 184 and flows into the bile duct 180. Similarly, the cystic duct 186, which is connected to the gallbladder 188, also flows into the bile duct 180. Generally, endoscopic surgery or biliary surgery can include advancing a medical device to an appropriate site along the biliary tree and then performing an appropriate intervention.

[0043] System 10 can be used to access strictures along pancreatic duct 178 and / or common bile duct 180. For example, FIG. 11 shows an exemplary endoscope 190 disposed within duodenum 174. The present disclosure is not intended to be limited to disposing endoscope 190 within duodenum 174, and other sites including other parts of the digestive system including the stomach are contemplated. System 10 can be secured to endoscope 190 with catheter shaft 22 extending through a channel (e.g., a working channel) of endoscope 190, and handle assembly 12 can be manipulated to position catheter shaft 22. Catheter shaft 22 (e.g., having needle / sharp 78 extending therethrough) can be advanced out of endoscope 190. This can include use of elevator 192 of endoscope 190 to direct catheter shaft 22 toward the wall of duodenum 174. Catheter shaft 22 having needle / sharp 78 protruding therefrom can then penetrate the wall of duodenum 174 and advance through tissue toward a target site, e.g., a luminal location such as within common bile duct 180.

[0044] Once catheter shaft 22 is properly positioned, catheter shaft 22 can be maneuvered to a desired orientation using steering mechanism 24, as schematically shown in FIG. 12. In at least some instances, it may be desirable to remove needle / sharp 78 from system 10 prior to steering. Once catheter shaft 22 is oriented in the appropriate direction, a device such as guidewire 196 can be advanced through catheter shaft 122 and across stricture 194, as shown in FIG. 13.

[0045] Materials that can be used for the various components of system 10 can include materials commonly associated with medical devices. For purposes of simplicity, the following discussion refers to catheter shaft 22. However, this is not intended to be limiting to the devices and methods described herein, as the discussion can apply to other similar tubular members and / or components or devices of tubular members disclosed herein.

[0046] FIG. 14 is a flowchart showing an exemplary method. The method may include placing an endoscope 190 within a digestive system (e.g., duodenum 174), as represented by box 200. A system similar to system 10 may be secured to the endoscope 190 with the catheter shaft 22 extending through a channel (e.g., working channel) of the endoscope 190, as represented by box 201. The handle assembly 12 may be operated to position the catheter shaft 22, as represented by box 202. The catheter shaft 22 (e.g., having a needle / sharp 78 extending therethrough) may be advanced out of the endoscope 190, as represented by box 203. This may include using the elevator 192 of the endoscope 190 to direct the catheter shaft 22 towards the wall of the duodenum 174. The catheter shaft 22 having the needle / sharp 78 protruding therefrom may then penetrate the wall of the duodenum 174 and advance through tissue towards a target site, e.g., a lumen location such as within the common bile duct 180, as represented by box 204. Once the catheter shaft 22 is properly positioned, the catheter shaft 22 may be steered to a desired orientation using the steering mechanism 24, as represented by box 205. In at least some instances, it may be desirable to remove the needle / sharp 78 from the system 10 prior to steering. Once the catheter shaft 22 is properly oriented, a device such as a guidewire 196 may be advanced through the catheter shaft 122 and past the stenosis 194, as represented by box 206.

[0047] The catheter shaft 22 is made of metal, metal alloy, polymer (some examples of which are disclosed below), metal-polymer composite, ceramics, combinations thereof, and the like, or other suitable materials, or may otherwise include the above. Some examples of suitable polymers are polytetrafluoroethylene (PTFE), ethylene-tetrafluoroethylene (ETFE), fluorinated ethylene propylene (FEP), polyoxymethylene (POM, e.g., DELRIN® available from DuPont), polyether-block ester, polyurethane (e.g., polyurethane 85A), polypropylene (PP), polyvinyl chloride (PVC), polyether-ester (e.g., ARNITEL® available from DSM Engineering Plastics), ether or ester-based copolymers (e.g., other polyester elastomers such as butylene / poly(alkylene ether) phthalate and / or HYTREL® available from DuPont), polyamide (e.g., DURETHAN® available from Bayer or CRISTAMID™ available from Elf Atochem), elastomeric polyamide, block polyamide / ether, polyether block amide (PEBA, e.g., available under the trade name PEBAX®), ethylene vinyl acetate copolymer (EVA), silicone, polyethylene (PE), high density polyethylene, low density polyethylene, linear low density polyethylene (e.g., REXELL™), polyester, polybutylene terephthalate (PBT), polyethylene terephthalate (PET), polytrimethylene terephthalate, polyethylene naphthalate (PEN), polyether ether ketone (PEEK), polyimide (PI), polyetherimide (PEI), polyphenylene sulfide (PPS), polyphenylene oxide (PPO), polyparaphenylene terephthalamide (e.g., KEVLAR®), polysulfone, nylon, nylon-12 (EMS AmericanThose available from Grilon such as GRILAMID®), perfluoro(propyl vinyl ether) (PFA), ethylene vinyl alcohol, polyolefin, polystyrene, epoxy, polyvinylidene chloride (PVdC), poly(styrene-b-isobutylene-b-styrene) (e.g., SIBS and / or SIBS 50A), polycarbonate, ionomer, biocompatible polymer, other suitable materials, or mixtures, combinations, copolymers, polymer / metal composites, and the like thereof may be included. In some embodiments, the sheath may be compounded with a liquid crystal polymer (LCP). For example, the mixture can contain up to about 6 percent LCP.

[0048] Some examples of suitable metals and metal alloys include stainless steels such as 304V stainless steel, 304L stainless steel, and 316LV stainless steel, mild steel, nickel-titanium alloys such as linear elastic and / or superelastic nitinol, nickel-chromium-molybdenum alloys (e.g., UNS:N06625 such as INCONEL® 625, UNS:N06022 such as HASTELLOY® C-22®, UNS:N10276 such as HASTELLOY® C276™, other HASTELLOY® alloys, and the like), other nickel alloys, nickel-copper alloys (e.g., UNS:N04400 such as MONEL® 400, NICKELVAC™ 400, NICORROS® 400, and the like), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS:R30035 such as MP35-N™ and the like), nickel-molybdenum alloys (e.g., UNS:N10665 such as HASTELLOY® ALLOY B2™), 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, and the like, cobalt-chromium alloys, cobalt-chromium-molybdenum alloys (e.g., UNS:R30003 such as ELGILOY®, PHYNOX®, and the like), platinum-enriched stainless steel, titanium, combinations thereof, and the like, or any other suitable material.

[0049] U.S. Patent Application Publication No. 2022 / 0040460 is incorporated herein by reference. It should be understood that the present disclosure is, in many respects, only illustrative. Specifically, changes may be made without departing from the scope of the present disclosure, particularly with respect to shape, size, and the arrangement of steps. This may include the use of any of the features of one exemplary embodiment in other embodiments within a suitable range. The scope of the present invention is, of course, defined in the language in which the appended claims are expressed.

Claims

**Claim 1** A system for treating stenosis, comprising a handle having a base with a proximal end region, a length adjustment member coupled to the handle, the length adjustment member having a distal end configured to be attached to an endoscope, wherein the base is movable relative to the length adjustment member, a length actuator coupled to the handle, the length actuator configured to enable a user to change the position of the base relative to the length adjustment member, a catheter shaft coupled to the base, and a steering mechanism coupled to the handle, the steering mechanism configured to steer the catheter shaft, wherein the steering mechanism includes an elongate steering member having a first end region coupled to the handle, a first body region extending along the catheter shaft, a loop region extending around the catheter shaft, a second body region extending along the catheter shaft, and a second end region coupled to the handle. **Claim 2** The system of claim 1, wherein the elongate steering member includes a steering wire. **Claim 3** The system of claim 1 or 2, wherein the elongate steering member includes a multifilar steering cable. **Claim 4** The system according to any one of claims 1 to 3, wherein the first body region and the second body region extend adjacent to each other along the catheter shaft. **Claim 5** The system according to any one of claims 1 to 4, wherein the first body region, the second body region, or both extend along an outer surface of the catheter shaft. **Claim 6** The system according to any one of claims 1 to 5, wherein the first body region, the second body region, or both extend through a wall of the catheter shaft. **Claim 7** The system according to any one of claims 1 to 6, wherein the first end region and the second end region of the elongate steering member are coupled to a steering connector disposed within the handle. **Claim 8** The system of claim 7, wherein the first end region and the second end region of the elongate steering member extend in one or more loop configurations at a location of the steering connector. **Claim 9** The system according to claim 7 or 8, wherein the first end region and the second end region of the elongate control member extend in an 8-shaped configuration at the position of the control connector.

10. The system according to any one of claims 1 to 9, wherein the length actuator includes a depressible button.

11. The system according to any one of claims 1 to 10, further comprising a needle attachment member removably coupled to the proximal end region of the handle.

12. The system according to claim 11, further comprising a needle removably coupled to the needle attachment member, the needle being configured to reach a position along the biliary tract and / or pancreatic duct by passing through tissue.

13. The system according to any one of claims 1 to 12, wherein the catheter shaft includes a first channel, and the first body region extends through the first channel.

14. The system according to claim 13, wherein the catheter shaft includes a second channel, and the second body region extends through the second channel.

15. The system according to any one of claims 1 to 14, wherein the catheter shaft includes a first coil having a first pitch and a second coil having a second pitch different from the first pitch.

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