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

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 a design, materials, manufacturing method, and alternative uses for a medical device. A system for treating stenosis is disclosed. The system includes a handle having a base with a proximal end region, a length adjustment member connected to the handle and having a distal end configured to be attached to an endoscope, where the base is movable relative to the length adjustment member, a length actuator connected 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 connected to the base, and a steering mechanism connected to the handle and configured to steer the catheter shaft. The steering mechanism includes an elongated steering member 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.

[0004] Alternatively or additionally to any one of the above embodiments, the elongated control member includes a control wire. Alternatively or in addition to any one of the above embodiments, the elongated control member includes a multi-filler 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 in addition to any one of the embodiments described above, the first body region, the second body region, or both extend along the outer surface of the catheter shaft.

[0006] Alternatively or in addition to any one of the embodiments described above, 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 embodiments described above, the first and second end regions of the elongated control member are connected to a control connector located within the handle.

[0007] Alternatively or additionally to any one of the embodiments described above, the first and second end regions of the elongated control member extend in one or more loops at the location of the control connector.

[0008] Alternatively or in addition to any one of the embodiments described above, the first and second end regions of the elongated control member extend in a figure-eight-like arrangement at the location of the control connector.

[0009] Alternatively or in addition to any one of the above embodiments, the length actuator includes a pressable button. Alternatively or additionally to any one of the above embodiments, the present invention further comprises a needle mounting member detachably connected to the proximal end region of the handle.

[0010] Alternatively or in addition to any one of the embodiments described above, the present invention further comprises a needle detachably connected to a needle attachment member, the needle configured to pass through tissue and reach a position along the biliary and / or pancreatic tract.

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

[0012] Alternatively or in addition to any one of the embodiments described above, 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 comprises 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 allow 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 elongated steering member connected to the steering actuator, 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 embodiments described above, the first and second end regions of the elongated control member are connected to a control actuator. Alternatively or in addition to any one of the embodiments described above, the first and second end regions of the elongated control member extend in one or more loop configurations adjacent to the control actuator.

[0015] Alternatively or additionally to any one of the embodiments described above, the first and second end regions of the elongated control member extend adjacent to the control actuator in an arrangement similar to a figure eight.

[0016] An endoscopic medical device assembly is disclosed. The endoscopic medical device assembly comprises a handle assembly including a handle and a length adjustment member; a length actuator connected to the handle assembly, configured to allow 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, configured to steer the catheter shaft; an elongated steering member connected to the steering actuator, 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; a needle attachment member detachably connected to the handle region; and a needle detachably connected to the needle attachment member, configured to pass through tissue and reach a position along the biliary and / or pancreatic tract.

[0017] The above summaries of some embodiments are not intended to describe each of the embodiments or any implementations disclosed in this disclosure. The following drawings and detailed description illustrate these embodiments in more detail. [Brief explanation of the drawing]

[0018] [Figure 1]A side view of an exemplary system for accessing the pancreatic duct and / or biliary tract. [Figure 2] A partial cross-sectional view of a portion of a handle assembly showing an exemplary operating mechanism. [Figure 3] A partial cross-sectional view of a portion of an exemplary catheter shaft. [Figure 4] A partial cross-sectional view of a portion of an exemplary catheter shaft. [Figure 5] A cross-sectional view taken along line 5-5 of FIG. 4. [Figure 6] A view showing an exemplary needle attachment member and an exemplary needle. [Figure 7] A view showing an exemplary needle attachment member coupled to an exemplary handle assembly. [Figure 8] A view showing a portion of an exemplary handle assembly. [Figure 9] A view showing a portion of an exemplary handle assembly. [Figure 10] A diagram schematically showing a part of the digestive system. [Figure 11] A diagram showing a method for accessing a stenosis according to the present disclosure. [Figure 12] A diagram showing a method for accessing a stenosis according to the present disclosure. [Figure 13] A diagram showing a method for accessing a stenosis according to the present disclosure. [Figure 14] A flowchart showing an exemplary method.

Best Mode for Carrying Out the Invention

[0019] The present disclosure can be more fully understood in view of the following detailed description in connection with the accompanying drawings. This disclosure is suitable for various modifications and alternative forms, the details of which are illustrated as examples in the drawings and will be described in detail thereafter. However, it should be understood that the intent is not to limit the invention to the specific embodiments described. Rather, the intent is to cover all modifications, equivalents, and alternatives that fall within the spirit and scope of this disclosure.

[0020] The following definitions of terms shall apply unless otherwise given in the claims or elsewhere in this specification. All figures, whether explicitly stated or not, are assumed in this specification to be modified by the term “approximately.” The term “approximately” generally refers to a range of figures that a person skilled in the art would consider equivalent to (e.g., having the same function or result as) the stated value. In many cases, the term “approximately” may include figures rounded to the nearest significant figure.

[0021] Numerical ranges indicated by endpoints include all numbers within that range (for example, 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5). Where used herein and in the appended claims, the singular forms “a,” “an,” and “the” include multiple references unless otherwise explicitly indicated herein. Where used herein and in the appended claims, the term “or” is generally adopted in its meaning including “and / or” unless otherwise explicitly indicated herein.

[0022] It should be noted that references in this specification to “one embodiment,” “several embodiments,” “other embodiments,” etc., indicate that the embodiments described may include one or more specific features, structures, and / or characteristics. However, such descriptions do not necessarily mean that all embodiments include those specific features, structures, and / or characteristics. Furthermore, if specific features, structures, and / or characteristics are described in relation to one embodiment, it should be understood that such features, structures, and / or characteristics may also be used in relation to other embodiments, whether explicitly described or not, unless otherwise explicitly stated.

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

[0024] During endoscopy, a frequent symptom is observed in patients presenting with abdominal pain, sometimes accompanied by jaundice, sometimes not. The etiology is usually some type of obstruction in the biliary tract, which prevents bile from flowing naturally from the proximal tract into the duodenum. This obstruction may result from gallstones formed in the lumen of the tract, or from tumors located within or adjacent to the wall of the tract. When such a stricture occurs, the proximal tract expands relative to the stricture, and the distal tract receives reduced bile flow relative to the stricture. To alleviate the patient's symptoms, gastroenterologists strive to find ways to restore bile flow from the proximal, expanded tract into the duodenum. Some anticipated interventions to alleviate symptoms may include placing a stent in the stricture to drain the proximal tract, removing stones, and / or similar actions.

[0025] The most common method for placing a stent in a stricture is endoscopic retrograde cholangiopancreatography (ERCP), in which a side-viewing endoscope is placed in the biliary papilla within the duodenum, and a guidewire is placed retrogradely across the stricture through the papilla to 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 may be difficult, if not impossible. Furthermore, when a physician attempts to access the bile duct, they may inadvertently insert a cannula into the pancreatic duct. Inadvertent intubation into the pancreatic duct can lead to complications such as pancreatitis. Devices and methods that address these and other problems, for example by utilizing antegrade (e.g., non-papillary) stricture crossings, are disclosed herein.

[0026] Figure 1 shows an exemplary system 10 for treating strictures along the biliary and / or pancreatic tracts. In at least some cases, system 10 is configured to be used with an endoscope (e.g., with an endoscopic ultrasound device) for antegrade strictures along the biliary and / or pancreatic tracts. As will be described in more detail herein, system 10 may be advanced through at least a portion of the patient's gastrointestinal tract and used to perforate / puncture through the wall of the gastrointestinal tract into the lumen / tubule along the biliary and / or pancreatic tract, maneuvered to a desired orientation, and then used to allow an appropriate device to pass through there 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 connected to the handle assembly 12. For example, the length adjustment member 18 may be connected to the base 14 and movable relative to the base 14. In practice, the user may attach the length adjustment member 18 to the endoscope (for example, as disclosed herein), and the handle assembly 12 (and / or base 14) may be moved relative to the length adjustment member 18 (and / or endoscope) to operate a device (e.g., a catheter shaft, a needle, or both). Generally, the length adjustment member 18 may be configured to adjust the length or "travel distance" (e.g., the distance the device can be advanced from the endoscope toward a target site) of a device (e.g., a catheter shaft, a needle, or both) relative to the endoscope. A length adjustment actuator 20 may be connected to the handle assembly 12. In general, the length adjustment actuator 20 may be configured to allow the user to change the position of the handle assembly 12 (and / or base 14) relative to the length adjustment member 18. In at least some cases, the length adjustment actuator 20 may take the form of a pressable button. When in use, the length adjustment actuator 20 can be pressed to shift the base 14 relative to the length adjustment member 18. If the length adjustment member 18 is fixed to an endoscope and the base 14 is fixed to a device (e.g., a catheter shaft, a needle, or both), the length adjustment actuator 20 can be activated to shift (e.g., translate) the device relative to the endoscope. By releasing the length adjustment actuator 20, the length adjustment member 18 (and / or endoscope) can be fixed relative to the base 14 (and / or device). Some additional details relating to 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 base 14) relative to a length adjustment member 18. This may involve rotation of the handle assembly 12 (and / or base 14) relative to the length adjustment member 18. The handle assembly 12 may include an endoscope connector 21 which may be located adjacent to the rotating member 19. The endoscope connector 21 may allow the handle assembly 12 to be attached to an endoscope.

[0029] The catheter shaft 22 is connected to the handle assembly 12 (and / or base 14) and may be movable together with the handle assembly 12. Generally, the catheter shaft 22 may be configured to extend through a channel within the endoscope, exit the endoscope, pass through at least a portion of the patient's gastrointestinal tract, through the wall of the gastrointestinal tract, and extend into the lumen / tubule along the biliary and / or pancreatic tract (which may include, for example, the use of a needle or other “sharp” device), be maneuvered to a desired orientation (e.g., curved, bent, and / or articulated), and then used to allow an appropriate device to pass through the catheter shaft 22 as part of an intervention. Some additional details relating to the catheter shaft 22 are disclosed herein.

[0030] The handle assembly 12 may also 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 (for example, generally located within the handle assembly 12 and not shown in Figure 1 but shown in Figure 2), and a steering member 30. The steering actuator 26 may include a knob or button located along the handle assembly 12 (not shown in Figure 1 but shown in Figure 2). The steering actuator 26 can operate the steering member 30 so that, when actuated, the catheter shaft 22 can be bent or curved. The steering member 30 may take the form of one or more wires or cables (e.g., one or more multifiller cables) that extend along the catheter shaft 22 and connect to the steering actuator 26. In some cases, the control member 30 takes the form of a single wire or cable (e.g., a single multifiller cable) that extends distally from the handle assembly 12 along the catheter shaft 22, forms a loop around the distal end region of the catheter shaft 22, and extends proximal toward the handle assembly 12 along the catheter shaft 22. The two ends of the cable control member 30 can then be attached to the control connector 28, as disclosed herein.

[0031] In some cases, the cable may be formed from or consist of a multifiller cable made of a material such as tungsten (and / or other materials disclosed herein). In at least some cases, multifiller cables may be desirable for several reasons. For example, multifiller cables may have increased resistance to elongation, increased flexibility, increased durability, a combination thereof, and / or similar properties (compared to, for example, monofilament wires).

[0032] Figure 2 shows the control connector 28. Here, it can be understood that the control connector 28 may take the form of a spool or spool member having a male thread 34. The end of the control member 30 may be connected to the control connector 28, for example, by one or more bolts or connector 36. For example, if the control member 30 takes the form of a single cable that extends along the catheter shaft 22, forms a loop around the catheter shaft 22, and extends back to the control connector 28, the end of the cable may be fixed to the control connector 28 at the position of the connector 36. In at least some cases, the control member 30 may be loop-shaped around the connector 36, or otherwise may include one or more loop-shaped regions at or adjacent to the connector 36. For example, the control member 30 may be arranged in a figure-eight shape around the connector 36. This configuration may be desirable for several reasons. For example, a loop-shaped or figure-eight arrangement can help induce stress relaxation in the control member 30 while simultaneously reducing / minimizing the possibility of weak points or pinch points forming.

[0033] The male thread 34 of the control connector 28 can engage screwably with the threaded gear 38. A pair of arms 40 may extend through the control connector 28 to another gear 42 that engages with the threaded gear 38. The arms 40 may extend through an opening in the base 14 of the handle assembly 12 so that the gear 42 can engage with the control actuator 26. Thus, the operation of the control actuator 26 causes the gear 42 to rotate, and the rotation of the gear 42 causes the threaded gear 38 to rotate. Due to the threaded relationship between the threaded gear 38 and the control connector 28, the rotation of the threaded gear 38 causes the control connector 28 to move in parallel within the handle assembly 12, causing the control member 30 to extend or contract to control the catheter shaft 22 (for example, so that the catheter shaft 22 curves or bends).

[0034] In some cases, the control member limiter 43 may be positioned adjacent to the control connector 28. The control member limiter 43 may take the form of a bolt or screw or other threaded member that can engage with the control connector 28 (for example, if the control connector 28 is moved in parallel to engage with the control member limiter 43) and act as a physical barrier that can prevent further parallel movement of the control connector 28. This can help reduce the possibility of the control member 30 being overacted (e.g., including stretching, breakage, and / or other damage), the catheter shaft 22 being overacted, a combination thereof, and / or similar. In some cases, the control member limiter 43 may be adjustable. For example, if the control member limiter takes the form of a bolt or screw, the adjustment may include screwing the control member limiter 43 in deeper or shallower.

[0035] Figure 3 shows a control member 30 for the catheter shaft 22. The control member may include a first end region connected to the handle assembly 12 (for example, at the location of a control connector 28 as disclosed herein, or adjacent to it), 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 connected to the handle assembly 12 (for example, at the location of a control connector 28 as disclosed herein, or adjacent to it). The body regions 46 and 50 may extend adjacent to each other in a parallel arrangement. Parts of the control member 30 (e.g., body regions 46 and 50) may extend along the outer surface of the catheter shaft 22. In these and some other examples, parts of the control member 30 (e.g., body regions 46 and 50) may extend through the wall of the catheter shaft 22.

[0036] Figures 4 and 5 schematically show 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 arranged along the inner liner 54 (not shown in Figure 4, but shown in Figure 5). In some cases, coils 56, 58, and 60 may be separate individual coils. In other cases, one or more of the coils 56, 58, and 60 may be continuous with each other and / or 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, proximal or angled direction. The support member or braid 62 may be placed on top of the coils 56, 58, and 60.

[0037] A sleeve or jacket 64 may be positioned 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 with the ends of the braid 62 and which may help to keep the braid 62 intact. In some cases, the end regions 66a, 66b may contain nylon-12. In these cases and some other cases, the end regions 66a, 66b may contain 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 cases, the intermediate regions 68, 70 may contain relatively flexible polymer materials, such as polyether block amides. In some cases, the intermediate regions 68, 70 may have different durometers. For example, intermediate region 68 may contain 40D polyether block amide and intermediate region 70 may contain 55D polyether block amide. Other materials and durometers are also considered. The tip 71 may be located at or formed at the distal end of the catheter shaft 22.

[0038] As shown in Figure 5, one or more tubes or channels 74a, 74b may be formed within the catheter shaft 22. The channels 74a, 74b may be configured such that the main body regions 46, 50 of the maneuvering member 30 extend through the channels 74a, 74b. Generally, the channels 74a, 74b may be located beneath the braid 72. However, other positions are also conceivable.

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

[0040] Figure 8 shows the length adjustment actuator 20. Here, it can be understood that the length adjustment actuator 20 includes an engagement region 80 having a projection 82. The projection 82 is configured to engage with 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 so that the projection 82 engages with one of the grooves 84. Generally, the spring 86 can bias the projection 82 of the engagement region 80 to engage with the groove 84. By pressing the length adjustment actuator 20, the biasing force is canceled out and the engagement region 80 is released from engagement with the groove 84.

[0041] Figure 9 shows a rotating member 19. It can be understood here that the rotating member 19 includes one or more torque limiters 88 and locking members 90. The torque limiters 88 may be used to prevent the rotating member 19 from rotating continuously relative to the handle assembly 12. For example, the torque limiters 88 may set a rotation range that sets the amount of rotation to an angle of less than 360 degrees. Once the rotation direction of the rotating member 19 is oriented in the desired direction, the locking members 90 can be activated 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., also known as the ampulla of Vater or simply the papilla) is located in the shown portion of the duodenum 174. The papilla 176 generally forms an opening through 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, connected to the gallbladder 188, also flows into the bile duct 180. Generally, endoscopic surgery or biliary surgery may involve advancing a medical device to the appropriate site along the biliary tree and then performing the appropriate intervention.

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

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

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

[0046] Figure 14 is a flowchart of an exemplary method. The method may include the step of positioning the endoscope 190 within the digestive system (e.g., the duodenum 174), as represented by box 200. A system similar to system 10 may be fixed to the endoscope 190 with the catheter shaft 22 extending through a channel (e.g., a 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 through the catheter shaft 22) may be advanced out of the endoscope 190, as represented by box 203. This may include the use of the elevator 192 of the endoscope 190 to guide the catheter shaft 22 toward the wall of the duodenum 174. The catheter shaft 22, having a needle / sharp 78 protruding from it, can then penetrate the wall of the duodenum 174 and advance through the tissue toward a target site, such as a luminal location within the common bile duct 180, as shown by box 204. Once the catheter shaft 22 is properly positioned, it can be steered to a desired orientation using the maneuvering mechanism 24, as shown by box 205. In at least some cases, it may be desirable to remove the needle / sharp 78 from the system 10 prior to maneuvering. Once the catheter shaft 22 is properly oriented, a device such as a guidewire 196 can advance through the catheter shaft 122 across the stenosis 194, as shown by box 206.

[0047] The catheter shaft 22 may be made from or otherwise made from metal, metal alloy, polymer (some examples of which are disclosed below), metal-polymer composites, ceramics, combinations thereof, and similar materials, or other suitable materials. Some examples of suitable polymers include polytetrafluoroethylene (PTFE), ethylene-tetrafluoroethylene (ETFE), fluoroethylene propylene (FEP), polyoxymethylene (POM, e.g., DELRIN® available from DuPont), polyether block esters, polyurethane (e.g., polyurethane 85A), polypropylene (PP), polyvinyl chloride (PVC), polyether esters (e.g., ARNITEL® available from DSM Engineering Plastics), ether or ester copolymers (e.g., butylene / poly(alkylene ether) phthalate and / or other polyester elastomers such as HYTREL® available from DuPont), polyamides (e.g., DURETHAN® or Elf available from Bayer). Available from Atochem: CRISTAMID®, elastomer polyamides, block polyamides / ethers, polyether block amides (PEBA, e.g., available under 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), polyetheretherketone (PEEK), polyimide (PI), polyetherimide (PEI), polyphenylene sulfide (PPS), polyphenylene oxide (PPO), polyparaphenylene terephthalamide (e.g., KEVLAR®), polysulfone, nylon, nylon-12 (EMS AmericanThe materials may include perfluoro(propyl vinyl ether) (PFA), ethylene vinyl alcohol, polyolefins, polystyrene, epoxy, polyvinylidene chloride (PVdC), poly(styrene-b-isobutylene-b-styrene) (e.g., SIBS and / or SIBS 50A), polycarbonates, ionomers, biocompatible polymers, other suitable materials, or mixtures, combinations, copolymers, polymer / metal composites, and the like. In some embodiments, the sheath may be formulated with liquid crystal polymer (LCP). For example, the mixture may contain up to about 6 percent LCP.

[0048] Some examples of suitable metals and metal alloys include stainless steel 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, and nickel-chromium-molybdenum alloys (e.g., UNS:N06625 such as INCONEL® 625, UNS:N06022 such as HASTELLOY® C-22®, UNS:N10 such as HASTELLOY® C276®). 276, other nickel alloys such as other HASTELLOY® alloys and similar ones, nickel-copper alloys (e.g., UNS:N04400 such as MONEL® 400, NICKELVAC® 400, NICORROS® 400, and similar ones), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS:R30035 such as MP35-N® and similar ones), nickel-molybdenum alloys (e.g., HASTELLOY® ALLOY This includes UNS:N10665, such as B2 (trademark), 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 similar materials, cobalt-chromium alloys, cobalt-chromium-molybdenum alloys (e.g., UNS:R30003, such as ELGILOY®, PHYNOX®, and similar materials), platinum-enriched stainless steel, titanium, combinations thereof, and similar materials, or any other suitable material.

[0049] The specification of U.S. Patent Application Publication No. 2022 / 0040460 is incorporated herein by reference. It should be understood that this disclosure is illustrative in many respects. Modifications may be made in detail, particularly with respect to shape, size, and process arrangement, without departing from the scope of this disclosure. This may include, to an appropriate extent, the use of any feature of one exemplary embodiment in other embodiments. The scope of the invention is, of course, defined in the language expressing the appended claims.

Claims

1. A system for treating stenosis, A handle having a base with a proximal end region, A length adjustment member connected to the handle, the length adjustment member having a distal end configured to be attached to an endoscope, Here, the base is movable relative to the length adjustment member, A length actuator connected to the handle, configured to allow the user to change the position of the base relative to the length adjustment member, A catheter shaft connected to the base, A control mechanism connected to the handle, the control mechanism configured to control the catheter shaft, The control mechanism includes an elongated control member, the elongated control member having a first end region connected to the handle, a first body region extending along the first side of the catheter shaft, a loop region extending around the distal end region of the catheter shaft, a second body region extending along the first side of the catheter shaft, and a second end region connected to the handle.

2. The system according to claim 1, wherein the elongated control member includes a control wire.

3. The system according to claim 1, wherein the elongated control member includes a multifiller control cable.

4. The system according to any one of claims 1 to 3, wherein the first main body region and the second main body region extend adjacent to each other along the catheter shaft.

5. The system according to any one of claims 1 to 3, wherein the first main body region, the second main body region, or both extend along the outer surface of the catheter shaft.

6. The system according to any one of claims 1 to 3, wherein the first main body region, the second main body region, or both extend through the wall of the catheter shaft.

7. The system according to any one of claims 1 to 3, wherein the first end region and the second end region of the elongated control member are connected to a control connector located in the handle.

8. The system according to claim 7, wherein the first end region and the second end region of the elongated control member extend in one or more loop forms at the position of the control connector.

9. The system according to claim 7, wherein the first end region and the second end region of the elongated control member extend around the control connector in a figure-eight shape.

10. The system according to any one of claims 1 to 3, wherein the length actuator includes a pressable button.

11. The system according to any one of claims 1 to 3, further comprising a needle mounting member detachably connected to the proximal end region of the handle.

12. The system according to claim 11, further comprising a needle detachably connected to the needle attachment member, wherein the needle is configured to pass through tissue and reach a position along the biliary tract and / or pancreatic tract.

13. The system according to any one of claims 1 to 3, 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 3, 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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