Medical device with steerable tip

Abstract

Medical devices and methods are disclosed. An example medical device for accessing a body cavity along a biliary and / or pancreatic tract may include an elongate member having a distal end and a proximal end. The medical device may have a flexible distal tip. The flexible tip may be steered by applying tension to one or more steering wires extending between the distal tip and a handle located at a proximal end of the medical device. The medical device may be a sphincter.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims the benefit of U.S. Provisional Patent Application Serial No. 63 / 343,123, filed on May 18, 2022, the disclosure of which is incorporated herein by reference. Technical Field

[0003] The present invention relates to medical devices and methods for making and using these medical devices. More particularly, the present invention relates to medical devices for accessing a body cavity along the biliary and / or pancreatic tract. Background Art

[0004] A wide variety of intracorporeal medical devices have been developed for medical use, such as endoscopic surgery. Some of these devices include guidewires, catheters, catheter systems, endoscopic instruments, and the like. These devices are manufactured by any of a variety of different manufacturing methods and can be used according to any of a variety of methods. Each of the known medical devices and methods has certain advantages and disadvantages. There is a need to provide alternative medical devices and alternative methods for making and using medical devices. Summary of the invention

[0005] The present invention provides design, material, manufacturing method and use alternatives for medical devices and medical systems.

[0006] A medical device includes an elongated tube having a proximal end and a distal end, the distal end being configured to point toward an opening of a body cavity; a wire filament extending along the elongated tube, the distal end of the wire filament being connected to the distal end of the elongated tube, the proximal portion of the wire filament extending at least partially along the elongated tube, and the distal portion of the wire filament extending outside the elongated tube; a steerable distal tip extending distally of the distal end of the wire filament; and a handle in mechanical communication with the steerable distal tip. The handle is configured to be adjusted to control the position of the steerable distal tip in at least three directions.

[0007] Alternatively or additionally to any of the above examples, one or more steering wires extend from the handle to the steerable distal tip, and adjustment of the handle results in tension on one or more of the one or more steering wires to adjust the position of the steerable distal tip.

[0008] Alternatively or additionally to any of the above examples, the handle includes an actuation portion connected to the wire filament and the one or more steering wires.

[0009] Alternatively or additionally to any of the examples above, actuating the actuation portion in a radial direction adjusts the position of the steerable distal tip.

[0010] Alternatively or additionally to any of the above examples, actuating the actuation portion in an axial direction causes the distal end of the elongated tube to flex, and actuating the actuation portion in a radial direction adjusts a radial position of the steerable distal tip.

[0011] Alternatively or additionally to any of the above examples, the actuation portion includes a steering element coupled to the one or more steering lines and configured to be radially adjusted about the swivel joint.

[0012] Alternatively or additionally to any of the above examples, one or more of the steering wires extend through at least a portion of the elongated tube, and the elongated tube includes a first lumen for receiving a wire filament and one or more lumens each configured to receive one of the one or more steering wires.

[0013] Alternatively or additionally to any of the above examples, the one or more steering wires include at least three steering wires extending from the handle to the steerable distal tip.

[0014] Alternatively or additionally to any of the above examples, adjustment of the handle in a radial direction relative to the elongated tube is configured to adjust the position of the steerable distal tip.

[0015] Alternatively or additionally to any of the above examples, the handle is in communication with the proximal portion of the wire filament, and adjustment of the handle in the axial direction of the elongated tube is configured to flex the distal end of the elongated tube and expose the cut portion of the wire filament.

[0016] An example system includes an endoscope having a proximal end with an axial opening, a distal end with a radial opening, and a working channel extending therebetween; a guidewire; and a medical device that can extend through the working channel and is configured to be directed toward an opening of a body cavity, the medical device comprising an elongated tube having a proximal end and a distal end, the distal end being configured to extend through the radial opening; a steerable distal tip, the steerable distal tip being configured to extend through the radial opening; a handle in mechanical communication with the steerable distal tip; and wherein the handle is configured to be adjusted to adjust the radial position of the steerable distal tip.

[0017] Alternatively or additionally to any of the above examples, the system may include one or more steering wires extending from the handle to the steerable distal tip, and wherein adjustment of the handle causes tension on one or more of the one or more steering wires to adjust the radial position of the steerable distal tip.

[0018] Alternatively or additionally to any of the above examples, the handle includes an actuation portion connected to the one or more steering wires, and actuating the actuation portion in a radial direction adjusts the radial position of the steerable distal tip.

[0019] Alternatively or additionally to any of the above examples, the actuation portion includes a steering element coupled to the one or more steering lines and configured to be radially adjusted about the swivel joint.

[0020] Alternatively or additionally to any of the above examples, the medical device also includes a wire filament extending along the slender tube, the distal end of the wire filament is connected to the distal end of the slender tube, the proximal portion of the wire filament extends at least partially along the slender tube, and the distal portion of the wire filament extends outside the slender tube.

[0021] An example method of accessing a body cavity of a subject includes extending an endoscope having a working channel into the body cavity of the subject, extending an elongated tube having a distal end and a lumen through the working channel, directing the distal end of the elongated tube through an opening of the body cavity, and steering a steerable distal tip forming a terminal end of the elongated tube toward a catheter located distal to the body cavity opening.

[0022] Alternatively or additionally to any of the above examples, steering the steerable distal tip includes radially adjusting a handle in communication with the steerable distal tip to steer the steerable distal tip toward the catheter.

[0023] Alternatively or additionally to any of the above examples, steering the steerable distal tip includes radially adjusting at least a portion of a handle in communication with the steerable distal tip about a swivel joint to steer the steerable distal tip toward the catheter.

[0024] Alternatively or additionally to any of the above examples, the method further includes extending a guidewire through the steerable distal tip and into the catheter.

[0025] Alternatively or additionally to any of the above examples, the method further includes removing the elongated tube from the body cavity and the working channel of the endoscope while maintaining the guidewire in the catheter, and inserting another elongated tube over the guidewire and into the catheter.

[0026] The above summary of some embodiments is not intended to describe each disclosed embodiment or every implementation of the present invention. BRIEF DESCRIPTION OF THE DRAWINGS

[0027] The present invention may be more fully understood by considering the following detailed description taken in conjunction with the accompanying drawings, in which:

[0028] Figure 1 is a schematic diagram of an illustrative system for accessing an opening in a body cavity of a subject;

[0029] Figure 2 It is taken from circle 2 Figure 1 A schematic diagram of the system depicted in ;

[0030] Figure 3 is a schematic diagram of an illustrative system for entering a body cavity;

[0031] Figure 4 is a schematic cross-sectional view of an illustrative elongated tube of an accessory medical device;

[0032] Figure 5 is a schematic diagram of an illustrative system for accessing a body cavity of a subject in a method for accessing a body cavity;

[0033] Figures 6 to 9 is a schematic diagram of an illustrative system for accessing a body cavity of a subject that is used to access a body cavity;

[0034] Fig.10 is a schematic diagram of an illustrative method of using a system for accessing a body cavity; and

[0035] Fig.11 is a schematic diagram of an illustrative handle portion of an accessory medical device.

[0036] Although the present invention is suitable for various modifications and alternative forms, its specific details have been shown in the drawings by way of example and will be described in more detail. However, it should be understood that it is not intended to limit the present invention to the specific embodiments described. On the contrary, it is intended to cover all modifications, equivalents and substitutes that fall within the spirit and scope of the present invention. DETAILED DESCRIPTION

[0037] For the following defined terms, these definitions shall apply unless a different definition is given in the claims or elsewhere in this specification.

[0038] Although aspects of the present invention may be described with specific reference to medical devices and systems for selectively accessing, aligning and / or cannulating the common bile duct (CBD) or pancreatic duct (PD) during endoscopic retrograde cholangiopancreatography (ERCP) (e.g., endoscopic devices, accessory tools and / or guidewires inserted through a duodenoscope near or through the nipple, etc.), it should be understood that such medical devices and systems may be used in a variety of medical procedures that require navigation of one or more accessory tools through ductal, lumen, vascular or body cavity anatomical structures, including, for example, interventional radiology, balloon angioplasty / angiography, thrombolysis, urology or gynecology procedures, etc. The disclosed medical devices and systems may be inserted via different entry points and methods, for example, percutaneously, endoscopically, laparoscopically, or some combination thereof.

[0039] All numerical values ​​are assumed to be modified by the term "about" herein, whether or not explicitly indicated. In the context of numerical values, the term "about" generally refers to a numerical range that is considered by those skilled in the art to be equivalent to the quoted value (e.g., having the same function or result). In many cases, the term "about" may include numbers rounded to the nearest significant figure. Unless otherwise specified, the term "about" (e.g., in contexts other than numerical values) may be assumed to have its ordinary and customary definition, as understood and consistent with the context of this specification.

[0040] References to numerical ranges expressed by endpoints include all numbers within that range, including the endpoints (e.g., 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5). Although some suitable sizes, ranges, and / or values ​​are disclosed for various components, features, and / or specifications, those skilled in the art to which the present invention relates will appreciate that desired sizes, ranges, and / or values ​​can be derived from those explicitly disclosed.

[0041] As used in this specification and the appended claims, the singular forms "a", "an" and "the" include plural referents unless the content clearly indicates otherwise. As used in this specification and the appended claims, the term "or" is generally used in a sense that includes "and / or" unless the content clearly indicates otherwise. It should be noted that, for ease of understanding, certain features of the present invention may be described in the singular, even if those features may be plural or repeated in the disclosed embodiments. Each instance of a feature may include and / or contain a singular disclosure unless expressly indicated to the contrary. For simplicity and clarity, not all elements of the present invention will necessarily be shown in each figure or discussed in detail below. However, it should be understood that unless expressly stated to the contrary, the following discussion may apply equally to any and / or all of the components where there is more than one. Additionally, for clarity, all instances of some elements or features may not be shown in each figure.

[0042] It should be noted that references in the specification to "one embodiment", "some embodiments", "other embodiments", etc. indicate that the described embodiments may include a particular feature, structure, or characteristic, but each embodiment may not necessarily include the particular feature, structure, or characteristic. In addition, such phrases do not necessarily refer to the same embodiment. In addition, when a particular feature, structure, or characteristic is described in conjunction with one embodiment, whether or not explicitly described, it is within the knowledge of those skilled in the art to implement such feature, structure, or characteristic in conjunction with other embodiments, unless explicitly stated to the contrary. That is, the various individual elements described below, even if not explicitly shown in a particular combination, can still be considered to be combinable or arranged with each other to form other additional embodiments, or to supplement and / or enrich the described embodiments, as will be understood by those of ordinary skill in the art.

[0043] For the sake of clarity, certain identifying digital nomenclature (e.g., first, second, third, fourth, etc.) can be used throughout the specification and / or claims to name and / or distinguish various descriptions and / or claimed features. It is to be understood that the digital nomenclature is not intended to be limiting and is merely exemplary. In certain embodiments, for the sake of brevity and clarity, the digital nomenclature previously used can be changed and deviate from. That is, the feature identified as a "first" element can be referred to as a "second" element, a "third" element, etc., later, or can be omitted completely, and / or different features can be referred to as a "first" element. The meaning and / or name in each case will be apparent to the technician.

[0044] The detailed description is intended to illustrate, rather than limit, the present invention. Those skilled in the art will recognize that the various elements described may be arranged in various combinations and configurations without departing from the scope of the present invention. The detailed description describes example embodiments of the present invention.

[0045] As discussed herein, it may be desirable that the distal tip of a medical device be flexible in order to effectively navigate through a body cavity. For example, a flexible distal tip of a sphincterotomy device may be able to facilitate navigation through narrow passages, such as the papilla of Vater, the common bile duct, the pancreatic duct, and / or other passages. In some cases, a flexible distal tip of a sphincterotomy device or other suitable medical device may facilitate steering the sphincterotomy device into a target body cavity that is located proximal to a structure, such as a lesion, a stone, or other accumulation, and / or has such a structure located therein.

[0046] In some cases, the devices and methods disclosed herein can be used for diagnostic or therapeutic procedures of the bile duct and / or pancreatic tract, as well as for other purposes. Access to the pancreaticobiliary system as facilitated by the devices disclosed herein may be required to diagnose and / or treat various conditions, including but not limited to tumors, gallstones, infections, sclerosis, and pseudocysts. The devices disclosed herein can also be used to navigate in other parts of the body, such as the cardiovascular system, etc.

[0047] Endoscopic retrograde cholangiopancreatography (ERCP) can be used to diagnose and treat conditions of the common bile duct, including, for example, gallstones, inflammatory strictures, leaks (e.g., caused by trauma, surgery, etc.), and cancer. During an ERCP procedure, a physician can observe the interior of the stomach and / or duodenum through an endoscope. Typically, dye can be injected (e.g., via the lumen of a sphincterotomy or other device) into the ducts of the bile duct tree and pancreas so that the region can be viewed using X-rays. These procedures may require obtaining and maintaining access to the papilla of Vater, the common bile duct, and / or the pancreatic duct, which may be technically challenging, may require a lot of training and practice to gain proficiency, and may require one or more expensive tools to perform.

[0048] During an ERCP procedure, multiple steps are typically performed while the patient is often sedated and / or anesthetized. For example, an endoscope or duodenoscope can be inserted through the mouth, down the esophagus into the stomach, through the pylorus into the duodenum, to a position at or near the papilla of Vater (also known as the ampulla of Vater), which is the opening of the bile duct and pancreatic duct. Due to the shape of the papilla and the angle at which the bile duct and pancreatic duct meet the duodenal wall, the distal end of the endoscope or duodenoscope is typically placed slightly beyond the papilla. Due to this positioning beyond the papilla, the endoscopes or duodenoscopes typically used in these procedures are typically side-viewing devices. The side-view feature provides imaging along the outside side of the end, rather than from the end of the endoscope. This orientation can allow the clinician to obtain an image of the inner wall of the duodenum where the papilla of Vater is located, even if the distal end of the viewing device is beyond the opening. Once the target area in the papilla or duodenum is visually located, an accessory medical device, such as a sphincterotomy or other accessory medical device can be extended out of the side opening or window of the endoscope or duodenoscope to gain access through the papilla and into the desired one of the common bile duct and pancreatic duct.

[0049] Although not required, a fluid (e.g., a compressible fluid, such as a compressible gas, air, nitrogen, carbon dioxide, etc., and / or other suitable fluid) can be delivered to an opening (e.g., the papilla of Vater) of a body cavity of a subject via a catheter (e.g., inserted through a subject or otherwise inserted as discussed above), a sphincterotomy device, and / or other elongated tubular device extending through an insertion endoscope, and / or other suitable elongated medical device. Applying the fluid to the opening can facilitate identification and / or entry into the body cavity by at least partially enlarging the opening with the fluid before and / or during delivery of the catheter, sphincterotomy device, guidewire, etc. to a target anatomical structure or tissue at or distal to the body cavity opening. Some example techniques and systems for cannulating an opening of a body cavity using a fluid are described in U.S. Patent Application Publication No. 2019 / 0380565, filed on June 13, 2019, and entitled Apparatus, Systems, and Methods for Accessing a Body Cavity, which is incorporated herein by reference and for any and all purposes.

[0050] Alternatively or additionally to using a fluid to open the opening of a body cavity, the opening can be opened manually by engaging the distal end or tip of the accessory medical device with the nipple. In addition, the accessory medical device can be manipulated and / or the endoscope through which the accessory medical device extends can be manipulated to direct the accessory medical device through the nipple and into the desired one of the common bile duct and the pancreatic duct. Some example techniques and systems for manipulating the distal tip of a medical device to enter a desired body cavity are described in U.S. Patent Application Publication No. 2015 / 0073391, filed on September 11, 2014 and entitled Medical Device with a Removable Tip, which is incorporated herein by reference and for any and all purposes.

[0051] Turning to the attached figure, Figure 1 and Figure 2 A selective cannulation during an ERCP procedure is depicted, which includes a guidewire 12 and / or an accessory medical device 14 (e.g., an endoscopic accessory device, such as a sphincterotomy and / or other suitable accessory medical device) directed toward, against, and / or through a body cavity, such as a major papilla 16 (e.g., an ampulla inlet) near the descending duodenum 18 to access the sphincter of Oddi complex 20. During the cannulation procedure, a distal portion of a medical device 22 (e.g., an endoscope, a duodenoscope, a guide catheter, etc.) can be positioned within the descending duodenum 18. The guidewire 12 and the accessory medical device 14 can be advanced through a working channel (e.g., a lumen) of the medical device 22 toward the major papilla 16. Additionally, the guidewire 12 and / or the accessory medical device 14 can be advanced against and / or through the major papilla 16 to one of the common bile duct 17 and the pancreatic duct 19.

[0052] Accessing the papilla 16, common bile duct 17, and / or pancreatic duct 19 may be difficult because the opening is small compared to the size (e.g., diameter or other size measurement) of many accessory medical devices, the opening may be located in a tight location, the opening may be completely collapsed / closed, the opening may extend into the descending duodenum 18 at an angle that may be difficult to visualize and / or access, and / or it may be difficult to control the position of the distal tip of the accessory medical device 14. As a result, the medical professional may be required to manipulate the accessory medical device 14 and guidewire 12 by manually rotating the medical device 22, pulling the wire filament 30 to adjust the accessory medical device 14 in a single direction, and / or using an elevator and / or other suitable angled surface within the distal end of the medical device 22 in an attempt to better align or orient the accessory medical device 14 and / or guidewire 12 relative to the medical device 22 and the opening of the papilla 16, common bile duct 17, and / or pancreatic duct 19. Difficult cannulation procedures in which a medical professional is unable to access a body cavity within a certain time limit or after a certain number of unsuccessful attempts can result in significant post-operative complications, such as post-ERCP pancreatitis (PEP).

[0053] As discussed above, a medical professional may subject the walls of the body cavity opening to compressive forces by manipulating the accessory medical device against or into the body cavity opening to enter a body cavity. Compression of the body cavity opening or the body cavity itself may result in buckling, which may be referred to as an "accordion effect." Therefore, it is desirable to control the distal tip of the accessory medical device 14 so that the user can precisely enter the opening of the nipple 16 and, once through the nipple 16, direct the accessory medical device 14 and / or guidewire 12 to the desired one of the common bile duct 17 and pancreatic duct 19.

[0054] Figure 3 An illustrative system 24 for entering a body cavity is schematically depicted. In some cases, the system 24 may include, among other components, an accessory medical device 14 with a flexible elongated tube 26. The tube 26 may have a proximal end 26a and a distal end 26b. The distal end 26b of the tube 26 may have a distal tip 31 extending distally of the distal end of the wire filament 30 and may be configured to be directed toward and / or through an opening of the body cavity. The proximal end 26a of the tube 26 may be connected to, coupled to, or otherwise communicated with a handle 28.

[0055] The handle 28 can be any suitable type of handle. In one example, the handle 28 can have a first portion 28a configured to receive a user's finger (e.g., two fingers) for holding the accessory medical device 14 with the accessory medical device 14, and a second portion 28b configured to receive a user's thumb. In some cases, the second portion 28b of the handle 28 can be the actuation portion 32 of the handle, and the user can adjust the second portion 28b relative to the first portion 28a to control the positioning of the distal end of the accessory medical device 14, as discussed herein or elsewhere.

[0056] like Figure 3 As schematically depicted in FIG, the first portion 28a of the handle 28 can have two finger holes configured to receive two fingers from a user; and the second portion 28b can have a thumb hole configured to receive a thumb from a user, but other configurations of the first and second portions 28a, 28b of the handle 28 are also contemplated. Although not required, as shown, the handle 28 can be held and / or operated by a user with a single hand.

[0057] The second portion 28b of the handle 28 can be configured to be adjusted or manipulated to control the position of the distal end 26b of the elongated tube 26 and / or the wire filament 30. In some cases, the second portion 28b can be configured to be adjusted axially or longitudinally and radially or rotationally to adjust the position of the distal end 26b of the elongated tube 26 and / or the wire filament 30 in multiple directions.

[0058] The wire filament 30 can extend along the elongated tube 26 and can be energized for cutting tissue in the subject. The wire filament 30 can have a proximal end (not shown) connected to an actuation portion 32 (e.g., second portion 28b) of the handle 28 and a proximal portion extending at least partially within the tube 26. The wire filament 30 can also have a distal portion 34 (e.g., a cutting portion) extending outside the elongated tube 26, and the distal end 36 of the filament 30 can be connected to the distal end 26b of the elongated tube 26.

[0059] The wire filament 30 can be received within the lumen of the tube 26 at least along the proximal portion of the filament 30 and can be configured to slide within the lumen. In some cases, the actuation portion 32 of the handle 28 can be coupled to the wire filament 30 and manipulated to slide the wire filament 30 along the tube 26 (e.g., within the lumen of the tube 26). In one example, the actuation portion 32 (e.g., the second portion 28b) of the handle 28 can be longitudinally adjusted relative to the first portion 28a of the handle 28 to apply tension to the wire filament 30 and / or remove tension from the wire filament 30.

[0060] Sliding or adjusting the wire filament 30 can cause the distal end 26b of the elongated tube 26 to move in response to the sliding of the wire filament 30. Thus, the actuation portion 32 of the handle 28 can be manipulated to control or adjust the position of the distal end 26b of the elongated tube 26, for example, to direct the distal end 26b toward the opening of the body cavity. In some cases, once the tension applied to the wire filament 30 via the handle 28 is released, the natural tension in or acting on the tube 26 and / or the wire 30 can cause the wire filament 30 to return to a relaxed position or state.

[0061] In some cases, the wire filament 30 can be used to electrically cut or remove tissue from a subject (e.g., cut and cauterize tissue) and can be considered a cautery wire. Therefore, the handle 28 or other suitable portion of the medical device 22 can include an electrical connection 38 for an energy source (e.g., radio frequency energy, etc.) to energize the wire filament 30 and facilitate cutting tissue. When the actuation portion 32 of the handle 28 is manipulated to adjust the position of the distal end 26b of the tube 26 and / or to cut tissue using the wire filament 30, the wire filament 30 can be spaced apart from the tube 26 and energized to facilitate cutting tissue at or near the body cavity opening.

[0062] The distal end 31 of the elongated tube may be flexible and configured to adjust in response to manipulation or adjustment of the control configuration at the proximal end of the accessory medical device 14. Although the distal end 26b of the elongated tube 26 of the accessory medical device 14 may be configured to bend or otherwise adjust in response to actuation of the wire filament 30 or in response to being advanced along another device that directs the position of the elongated tube 26 (e.g., an elevator of a duodenoscope and / or other suitable device), such control or manipulation of the distal end 26b of the elongated tube 26 using the wire filament 30 may be limited to adjustment in the direction of the wire filament 30 or in the direction provided by the distal end 26b that is advanced along another device and lacks the precise control required to enter a desired body cavity (e.g., the common bile duct 17, the pancreatic duct 19, etc.). To facilitate precise control of the distal end 14 of the accessory medical device while the device 14 is within the body of a subject, the distal tip 31 can be configured to be adjusted or steered in two or more directions (e.g., at least three directions, at least four directions, any desired direction, etc.) by control at the proximal end of the accessory medical device 14, so that the distal end 26b of the elongated tube 26 can be guided to a desired body cavity of the subject using finer manipulation of the distal tip 30 than can be obtained via manipulation of the elongated tube using the wire filament 30 and / or interaction with other medical devices. The distal tip 31 can be a steerable distal tip.

[0063] The distal tip 31 can be made of any suitable material that is configured to bend, deflect, or otherwise move in response to a force acting thereon. In one example, the distal tip can be made of polyether block amide (PEBA, e.g., ) is formed, but this is not required and other suitable materials can be envisioned.

[0064] The positioning of the distal tip 31 may be controlled or adjusted in any suitable manner. In some cases, multiple wires (e.g., steering wires), such as two wires, three wires, four wires, or another suitable number of wires, may be utilized to facilitate control of the distal tip 31. Three or four wires may be utilized to provide sufficient, precise control of the distal tip 31 to facilitate access to a desired body cavity while still fitting into existing forms of sphincterotomes used in ERCP procedures and / or other suitable accessory medical devices 14. In one example, four wires may be utilized to facilitate control of the position of the distal tip 31.

[0065] The wire for controlling the distal tip 31 can have a distal end coupled to the distal tip 31, can extend through one or more lumens of the elongated tube 26 to the handle 28, and can have a proximal end coupled to the actuation portion 32 (e.g., the second portion 28b) of the handle 28. Although two or more of the wires can extend through a single lumen of the elongated tube 26, in an example form, each of the wires can extend through a separate lumen (e.g., a single lumen can be provided in the accessory medical device 14 for each wire).

[0066] The distal end of the wire can be coupled to the distal tip 31 and / or the proximal end of the wire can be coupled to the actuation portion 32 of the handle 28 in any suitable manner. In one example, the wire can be coupled to the distal tip 31 and / or the actuation portion 32 of the handle 28 using bonding, for example, by ultraviolet (UV) curing techniques, crimping techniques, and / or other suitable connection or coupling techniques.

[0067] In addition to the one or more lumens in which the wires (if included) for controlling the position of the distal tip 31 extend, the accessory medical device 14 may include one or more other lumens extending from at least the proximal end 26a of the tube 26 to the distal end 26b of the tube 26. In some cases, one or more of the lumens may have a distal opening through the distal tip 31 of the elongated tube 26.

[0068] In some cases, a lumen in one or more lumens of the elongated tube 26 may have a fluid connection at the proximal end for a fluid source (e.g., a pressurized fluid source 40, such as a CO2 tank, a contrast fluid source, such as a syringe, etc.). The lumen may be configured to apply fluid from the fluid source to a body cavity of a subject through an opening at the distal end 26b of the elongated tube 26.

[0069] although Figure 3 A fluid source 40 is depicted coupled to a fluid port 41 of an accessory medical device 14 via a fluid tube 42 and a flow regulator 44, but the fluid source 40 and / or other suitable fluid sources (e.g., syringes, etc.) may be coupled to the fluid port 41 in other suitable ways. In one example, a syringe with a contrast fluid may be coupled to the fluid port 41 via a Luer lock connection and / or other suitable connection. Contrast media may be delivered into a body cavity and may be used to temporarily improve imaging of the interior of the body cavity by, for example, x-ray, computed tomography (CT) or magnetic resonance (MR) imaging, ultrasound, etc. Alternatively, separate lumens and separate fluid ports may be provided for each of the pressurized fluid and the contrast fluid.

[0070] Another lumen of the one or more lumens can be configured to receive a guidewire 12 and / or one or more other suitable medical devices that can be used with the accessory medical device 14. Another lumen can extend at least partially along the tube 26 from the distal end 26b of the tube 26 (e.g., the opening at the distal tip 31) toward the proximal end 26a of the tube 26.

[0071] In some cases, a guidewire 12 or other suitable medical device can extend through another lumen of the elongated tube 26 and extend proximally out of the orifice 46. The orifice 46 can be located at the distal end of the handle 28 and / or at one or more other suitable locations. In some cases, the orifice 46 and the tube 26 can be configured so that the guidewire 12 and / or other suitable medical device can be peeled off through the side of the tube 26 for quick removal or replacement of the device, but this is not required.

[0072] Figure 4 A cross-sectional view of the elongated tube 26 is schematically depicted, depicting one example of one or more lumens extending through the elongated tube 26 taken at a location distal to the orifice 46 and proximal to the distal end of the distal tip 31. The elongated tube 26 may include a plurality of steering line lumens 50 (e.g., such as Figure 4 The four steering line lumens 50 shown and / or other suitable number of steering line lumens 50), one or more fluid lumens 51, one or more wire filament lumens 52 and one or more medical device lumens 53. Figure 4 As depicted, the elongated tube 26 can include four steering wire lumens 50, each for a separate wire, a fluid lumen 51 that can be used for pressurized fluid and / or contrast fluid, a wire filament lumen 52 for a wire filament 30 that can be connected to an electrical connection 38, and a medical device lumen 53 for receiving a guidewire or other suitable medical device.

[0073] Figure 5The enlarged distal end of the system 24 is depicted with the medical device 22 positioned adjacent an opening 48 (e.g., the opening defined by the major papilla 16) of a body cavity (e.g., the body cavity defined by the sphincter of Oddi 20). Figure 5 As depicted, tension has been applied to the wire filament 30 to bend the distal end 26b of the elongated tube 26 in a direction in which the wire filament 30 exits the medical device 22 through the opening 54 of the medical device 22. As the distal tip 31 enters through the opening 48 and into the body cavity of the subject, the position of the distal tip 31 of the elongated tube 26 can be adjusted by manipulating (e.g., selectively tightening or otherwise applying tension to) the steering wire 56 and directed to enter the common bile duct 17 as the accessory medical device 14 extends through the medical device 22. However, the steering wire 56 can be manipulated in one or more other suitable manners to direct the distal tip 31 into one or more suitable body cavities (e.g., the pancreatic duct 19, etc.).

[0074] In some cases, steering wires 56 can extend from distal tip 31 to handle 28 (e.g., to actuation portion 32 of handle 28 and / or other suitable portion of handle). When so configured, handle 28 can be adjusted or manipulated to cause tension on one or more of steering wires 56 to adjust the position of distal tip 31.

[0075] Figures 6 to 9 The positions of the components of the system 24 are schematically depicted when the distal end 26b of the accessory medical device 14 is controlled by adjustments made at the handle 28 to apply tension to the wire filaments 30 and / or the steering wire 56. Figure 6 , the handle 28 is schematically depicted from a side perspective view. Figures 7 to 9 , the handle 28 is schematically depicted in a cross-sectional view to facilitate depicting adjustment or movement of the actuation portion 32 that results in adjustment of the distal end 26 b of the elongated tube 26 .

[0076] like Figure 6 As depicted in , system 24 is positioned within duodenum 18 of a subject, and opening 54 of medical device 22 has been positioned proximate to (e.g., slightly distal to) the subject's papilla 16 of Vater near body cavity opening 48. Initially, distal end 26b of elongated tube 26 may be positioned within medical device 22 proximate to papilla 16, with second portion 28b of handle 28 (e.g., actuation portion 32, with respect to Figures 6 to 9 Its second portion 28b), referred to as the handle 28, is in a rest or relaxed position relative to its first portion 28a.

[0077] Figure 7Schematically depicting the tension applied to the wire filament 30 by longitudinally adjusting the second portion 28b (e.g., the actuation portion 32) of the handle 28 relative to the first portion 28a in the direction of arrow L, which may cause the distal end 26b of the elongated tube 26 to bend in the direction of the wire filament 30. Before, simultaneously with, or after the tension is applied to the wire filament 30, the accessory medical device 14 can be advanced in a distal direction relative to the medical device 22 such that the distal end 26b of the elongated tube 26 can exit the opening 54 of the medical device 22 and the distal tip 31 can approach and / or enter the opening 48 at the nipple 16.

[0078] like Figure 7 As depicted, the proximal end of the wire filament 30 can be coupled to the rod portion 60, and the steering wire 56 can be coupled to the joint 62 of the second portion 28b of the handle 28. Figures 6 to 9 The configuration of the system 24 depicted in FIG. 2 may include four steering lines 56, but Figures 7 to 9 The schematic cross-sectional view of the handle 28 in FIG. 2 depicts only three of the four steering wires 56 because one of the steering wires 56 may extend through an omitted portion of the handle 28 .

[0079] If you can Figure 7 As seen in the cross-sectional view of the handle 28 in FIG. 1 , the manipulation portion 58 of the second portion 28 b of the handle 28 can be coupled to the rod portion 60 of the second portion 28 b via a joint 62 (e.g., a swivel joint or other suitable type of joint). The joint 62 can facilitate longitudinal adjustment of the manipulation portion 58 and the rod portion 60 together relative to the first portion 28 a of the handle 28 when the second portion 28 b of the handle 28 is longitudinally adjusted in the direction of arrow L.

[0080] Once the distal tip 31 has entered the opening 48 and / or at one or more other suitable times, the wire filament 30 can be used to cut tissue or otherwise remove tissue from around the opening 48. In one example, energy can be applied to the wire filament 30, and the energized wire filament 30 can be brought into contact with tissue around the opening 48 by rotating the accessory medical device 14. Other techniques can be utilized to remove tissue around the opening 48 using the wire filament 30.

[0081] Figure 8The accessory medical device 14 is schematically depicted having tension on the wire filament 30 and the manipulation portion 58 of the second portion 28b of the handle 28 (e.g., the actuation portion 32) coupled to the steering wire 56, wherein the manipulation portion 58 can be rotated or manipulated in a radial direction of arrow R relative to the longitudinal axis of the handle 28 to apply tension to one or more steering wires 56. Such rotation and / or radial positioning of the manipulation portion 58 and the associated tension on the steering wire 56 can result in movement of the distal tip 31, as shown. Figure 8 , to direct the guidewire 12 and the elongated tube 26 into the common bile duct 17. Although the manipulation portion 58 of the second portion 28b of the handle 28 has been depicted as adjusting the distal tip 31 toward the common bile duct 17, the user can manipulate the manipulation portion 58 in one or more other suitable ways to direct the distal tip 31 in one or more other directions (e.g., toward the pancreatic duct 19 and / or other suitable ducts). Before, simultaneously with, or after directing the distal tip 31 toward the common bile duct 17 and / or manipulating the manipulation portion 58, the accessory medical device 14 and / or the guidewire 12 can be advanced in a distal direction relative to the medical device 22 so that the distal tip 31 and / or the guidewire 12 can approach and / or enter the common bile duct 17.

[0082] In some cases, the joint 62 coupling the manipulation portion 58 and the rod 60 can facilitate rotation and / or radial movement of the manipulation portion 58 relative to the rod portion 60, as well as longitudinal movement of the manipulation portion 58 and the rod portion 60 relative to the first portion 28a of the handle 28. Although other joint configurations are contemplated, in one example, the joint 62 between the manipulation portion 58 and the rod portion 60 of the second portion 28b of the handle 28 can be a ball joint. Figure 8 As depicted in FIG. 5 , the ball 64 of the ball joint may be part of the steering portion 58 and communicate with the steering line 56 s , while the socket 66 may be part of the rod portion 60 , but this is not required and other configurations are contemplated.

[0083] Fig. 9 The accessory medical device 14 is schematically depicted, wherein the manipulation portion 58 of the second portion 28b of the handle 28 is rotated or manipulated in the radial direction of the arrow R relative to the longitudinal axis of the handle 28. Figure 7 and Figure 8, the longitudinal force acting on the second portion 28b of the handle 28 in the direction of arrow L has been released, and the wire filament 30 has returned to a relaxed state. Due to the configuration of the second portion 28b of the handle 28, the wire filament 30 may no longer be tensioned and is in a cutting position, spaced away from the elongated tube 26, but due to the radial adjustment of the rod portion 60 of the manipulation portion 58 relative to the second portion 28b of the handle 28 in the direction of arrow R with respect to the longitudinal axis of the handle 28, the distal tip 31 can be directed toward the common bile duct 17.

[0084] In some cases, it may be advantageous to control or adjust the distal tip 31 of the elongated tube 26, either alone or separately from the rest of the distal portion 26b of the elongated tube 26. In one example, fine adjustment of the distal tip 31 using the manipulation portion 58 of the handle 28, as discussed herein or otherwise, may allow for directing the accessory medical device 14 and / or the guidewire 12 therein to a body cavity of a subject in a direction other than the bend in the elongated tube caused by tensioning the wire filament 30, and / or may facilitate directing or positioning the elongated tube 26 or the guidewire 12 extending therein toward a target body cavity after tension has been removed from the wire filament 30.

[0085] In some cases, the elongated tube 26, wire filaments 30, steering wire 56, and / or other components of the accessory medical device 14 can be configured to return to a relaxed state when the force causing the distal portion 26b of the elongated tube 26 to move is removed from the handle 28. For example, the elongated tube 26, wire filaments 30, and / or steering wire 56 can be formed of a resilient polymer, metal, and / or a combination of polymer and metal materials that facilitates the wire filaments 30 and / or steering wire 56 to return to a relaxed state.

[0086] Fig.10 1 is a schematic flow diagram of an illustrative technique 100 for accessing a body cavity of a subject. In some cases, a system similar to the system 24 discussed above can be utilized to access a body cavity of a subject. Although the technique 100 can be utilized to access openings of other body cavities, in one example, the technique 100 can also be utilized to access a desired one of the common bile duct and the pancreatic duct.

[0087] The illustrative technique 100 can include extending 102 a medical device (e.g., a medical device 22, such as an endoscope or duodenoscope and / or other suitable medical device) through a body cavity (e.g., the duodenum or other suitable body cavity) of a subject. In some cases, the medical device can have a working channel that is configured to receive one or more accessory medical devices (e.g., an accessory medical device 14, such as a sphincterotomy and / or other suitable accessory medical devices). The medical device can be extended through the body cavity so that an opening in the medical device and / or a visualization lens of the medical device is positioned proximate to a target location (e.g., a papilla of Vater or an opening associated therewith). The working channel or cavity of the medical device can be in communication with an opening of the medical device positioned proximate to the target location.

[0088] An elongated tube (e.g., elongated tube 26 and / or other suitable elongated tubes) can extend 104 through a working channel of a medical device. In some cases, the elongated tube can be part of an accessory medical device, such as a sphincterotomy or other suitable accessory medical device. The elongated tube can extend through the working channel in any suitable manner, including but not limited to passing the elongated tube through the working channel using a rapid exchange technique, an over-the-wire technique, etc.

[0089] In addition, technology 100 may include directing the distal end of the elongated tube 106 toward the opening of the medical device and / or directing the distal end of the elongated tube to reach the opening of the target body cavity through the opening of the medical device, the opening of the medical device being communicated with the working channel. Any suitable technology can be used to direct the distal end of the elongated tube toward the target body cavity. In one example, a ramp or other suitable lifter at the distal end of the working channel of the medical device can direct the elongated tube propelled distally toward the opening connected to the working channel and outwardly and toward the opening of the target body cavity. Additionally or alternatively, in another example, tension can be applied to a wire filament (e.g., wire filament 30 and / or other suitable wire filaments) so that the distal end of the elongated tube of the accessory medical device is bent in the direction of the wire filament and toward the opening of the body cavity. Tension can be applied to the wire filament in any suitable manner, as discussed herein (e.g., by adjusting the actuating portion in the longitudinal direction to the proximal side) or elsewhere.

[0090] Once the distal tip of the elongated tube (e.g., distal tip 31 and / or other suitable distal tip) has been positioned within the opening of the body cavity or to facilitate positioning the distal tip in the target body cavity, the steerable distal tip can be steered toward a catheter located distal to the opening of the body cavity 108. In one example, when the distal tip has been positioned in the opening at the papilla of Vater, the distal tip can be manipulated or controlled so as to be directed to the common bile duct or pancreatic duct located distal to the papilla opening by radially manipulating or adjusting a manipulation portion (e.g., manipulation portion 58 or other suitable manipulation portion of a handle of an accessory medical device) to position the distal tip in a desired direction relative to the target cavity.

[0091] Once the distal tip has been turned toward the catheter located distal to the subject's body cavity opening, a guidewire or other medical device can be passed through the lumen of the elongated tube having an opening in the distal tip (e.g., in its terminal end) and placed in the target catheter or cavity. The accessory medical device can then be removed from the subject, and one or more other medical devices can be advanced over the placed guidewire to facilitate performing one or more procedures on the subject in the target catheter.

[0092] Although manipulation or steering of the distal tip 31 of the accessory medical device 14 has been described herein with respect to actuating or manipulating the second portion 28b of the handle 28 relative to the first portion 28a of the handle, other suitable handle configurations configured to steer or position the distal tip 31 are also contemplated. Fig.11 As schematically depicted in FIG. 1 , the handle 28 of the accessory medical device 14 may utilize one or more dials or knobs to adjust the distal tip.

[0093] like Fig.11 As depicted in FIG. 1 , the handle 28 may include a first knob 72, a second knob 74, and a third knob 76. Fig.11 The first, second, and third knobs 72, 74, 76 are depicted rotating about a common axis, but this is not required and other configurations are contemplated.

[0094] Although not required, the first knob 72 and the second knob 74 can each be coupled to two wires in communication with the distal end 31 (or each coupled to a continuous wire, wherein both ends of the continuous wire are attached to the distal end 31). When so configured, each knob 72, 74 can be configured to control the movement of the distal end 31 in two opposite directions, or otherwise turn the distal end 31 in two opposite directions. For example, the rotation of the first knob 72 in a first rotational direction may cause the radial movement of the distal end 31 in a first radial direction, the rotation of the first knob in a second rotational direction opposite to the first rotational direction may cause the radial movement of the distal end 31 in a second radial direction opposite to the first radial direction, the rotation of the second knob 74 in the first rotational direction may cause the radial movement of the distal end 31 in a third radial direction perpendicular to the first and second radial directions, and the rotation of the second knob 74 in the second rotational direction may cause the radial movement of the distal end 31 in a fourth radial direction perpendicular to the first and second radial directions and opposite to the third radial direction. Adjustment of the first and second knobs 72, 74 in conjunction with one another may facilitate fine positioning or steering of the distal tip in a number of directions (possibly in any desired direction through a combination of adjustments).

[0095] The third knob 76 can be coupled to the proximal end of the wire filament 30. Rotation of the third knob 76 in a first rotational direction may result in applying tension on the wire filament 30 and bending the distal end 26b of the elongated tube 26, as discussed herein and / or elsewhere. Rotation of the third knob 76 in a second rotational direction may result in releasing tension on the wire filament 30 and loosening the distal end 26b of the elongated tube 26. Other suitable configurations of the third knob 76 relative to the wire filament 30 are contemplated.

[0096] Materials that can be used for the various components of the presently disclosed system can include those commonly associated with medical devices. For simplicity, the following discussion refers to the system 24 mentioned above. However, this is not intended to limit the devices and methods described herein, as the discussion can be applied to other similar devices and / or components of the devices disclosed herein.

[0097] System 24 and / or its components may be made of metals, metal alloys, polymers (some examples of which are disclosed below), metal-polymer composites, ceramics, combinations thereof, etc., or other suitable materials. Some examples of suitable metals and metal alloys include stainless steels, such as 304V, 304L, and 316LV stainless steels; low carbon steels; nickel-titanium alloys, such as linear elastic and / or superelastic nitinol; 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 ALLOY ), 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.

[0098] Some examples of suitable polymers may include, but are not limited to, polytetrafluoroethylene (PTFE), ethylene tetrafluoroethylene (ETFE), fluorinated ethylene propylene (FEP), polyoxyethylene (POM, e.g., commercially available from DuPont ), polyether block esters, polyurethanes (e.g., polyurethane 85A), polypropylene (PP), polyvinyl chloride (PVC), polyether esters (e.g., commercially available from DSMEngineering Plastics ), ether- or ester-based copolymers (e.g., butylene phthalate / poly(alkylene ether) and / or other polyester elastomers, such as those commercially available from DuPont ), polyamide (for example, commercially available from Bayer or commercially available from Elf Atochem ), elastomeric polyamides, block polyamide / ether, polyether block amide (PEBA, for example, available under the trade name commercially available), ethylene-vinyl acetate copolymer (EVA), silicone, polyethylene (PE), Marlex high-density polyethylene, Marlex low-density polyethylene, linear low-density polyethylene (e.g., ), polyester, polybutylene terephthalate (PBT), polyethylene terephthalate (PET), polytrimethylene terephthalate, polyethylene naphthalate (PEN), polyetheretherketone (PEEK), polyimide (PI), polyetherimide (PEI), polyphenylene sulfide (PPS), polyphenylene oxide (PPO), poly(p-phenylene terephthalamide) (e.g., ), polysulfone, nylon, nylon-12 (such as commercially 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., thereof. In some embodiments, the sheath can be mixed with a liquid crystal polymer (LCP). For example, the mixture can contain up to about 6% LCP.

[0099] In some embodiments, a degree of magnetic resonance imaging (MRI) compatibility is imparted to system 24. For example, system 24 or portions thereof may be made of materials that do not substantially distort images and create a large number of artifacts (i.e., gaps in the image). For example, certain ferromagnetic materials may be unsuitable because they may create artifacts in MRI images. System 24 or portions thereof may also be made of materials that can be imaged by MRI machines. Some materials that exhibit these properties include, for example, tungsten, cobalt-chromium-molybdenum alloys (e.g., UNS: R30003, such as etc.), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS: R30035, such as etc.), Nitinol, etc.

[0100] As implied above, the tubular and / or elongated components of the system 24 may include one or more tubular members, which may have a slot formed therein. Various embodiments of the arrangement and configuration of the slots can be envisioned. For example, in some embodiments, at least some (if not all) of the slots are arranged at the same or similar angle relative to the longitudinal axis of the tubular and / or elongated components of the system 24. The slots can be arranged at a vertical or substantially vertical angle, and / or can be characterized as being arranged in a plane orthogonal to the longitudinal axis of the tubular and / or elongated components of the system 24. However, in other embodiments, the slots can be arranged at a non-vertical angle, and / or can be characterized as being arranged in a plane not orthogonal to the longitudinal axis of the tubular components of the system 24. Additionally, one or more slots of one group can be arranged at different angles relative to one or more slots of another group. Within the applicable scope, the distribution and / or configuration of the slots can also include any of those disclosed in U.S. Patent Publication No. US7,914,467, the entire disclosure of which is incorporated herein by reference. Some example embodiments of suitable micromachining methods and other cutting methods, as well as structures for tubular members including slots and medical devices including tubular members, are disclosed in U.S. Patent Publication Nos. 2003 / 0069522 and 2004 / 0181174-A2; and U.S. Patent Nos. 6,766,720; and 6,579,246, the entire disclosures of which are incorporated herein by reference. Some examples of etching processes are described in U.S. Patent No. 5,106,455, the entire disclosure of which is incorporated herein by reference. It should be noted that the method for manufacturing system 24 can include forming slots in tubular or elongated members of system 24 using these or other manufacturing steps.

[0101] It should be understood that the present invention is in many respects merely illustrative. Changes may be made in details, particularly in matters of arrangement of shape, size and steps, without exceeding the scope of the present invention. To the extent appropriate, this may include using any of the features of an example embodiment used in other embodiments. Of course, the scope of the present invention is defined by the language of the appended claims.

Claims

1. A medical device comprising: an elongated tube having a proximal end and a distal end, the distal end being configured to point toward an opening of the body cavity; a wire filament extending along the elongated tube, a distal end of the wire filament connected to the distal end of the elongated tube, a proximal portion of the wire filament extending at least partially along the elongated tube, and a distal portion of the wire filament extending outside of the elongated tube; a steerable distal tip extending distally of the distal end of the wire filament; as well as a handle in mechanical communication with the steerable distal tip; as well as Wherein the handle is configured to be adjusted to control the position of the steerable distal tip in at least three directions.

2. The medical device according to claim 1, further comprising: one or more steering wires extending from the handle to the steerable distal tip; as well as Wherein adjustment of the handle generates tension on one or more of the one or more steering wires to adjust the position of the steerable distal tip.

3. The medical device of claim 2, wherein the handle comprises an actuation portion connected to the wire filament and the one or more steering wires.

4. The medical device of claim 3, wherein actuating the actuation portion in a radial direction adjusts the position of the steerable distal tip.

5. The medical device according to claim 3 or claim 4, wherein: actuating the actuation portion in an axial direction causes the distal end of the elongated tube to flex; as well as Actuating the actuation portion in a radial direction adjusts the radial position of the steerable distal tip.

6. The medical device of any one of claims 3 to 5, wherein the actuation portion comprises a steering element coupled to the one or more steering wires and configured to be radially adjusted about a swivel joint.

7. The medical device according to any one of claims 2 to 6, wherein: The one or more of the steering lines extend through at least a portion of the elongated tube; and The elongated tube includes a first lumen for receiving the wire filament and one or more lumens each configured to receive one of the one or more steering wires.

8. The medical device of any one of claims 2 to 7, wherein the one or more steering wires include at least three steering wires extending from the handle to the steerable distal tip.

9. The medical device of any one of claims 1 to 8, wherein adjustment of the handle in a radial direction relative to the elongated tube is configured to adjust the position of the steerable distal tip.

10. The medical device according to any one of claims 1 to 9, wherein the handle is connected to the proximal portion of the wire filament, and adjustment of the handle in the axial direction of the slender tube is configured to flex the distal end of the slender tube and expose the cut portion of the wire filament.

11. A system comprising: an endoscope having a proximal end with an axial opening, a distal end with a radial opening, and a working channel extending therebetween; Guidewire; as well as A medical device, the medical device being extendable through the working channel and being configured to be directed toward an opening of a body cavity, the medical device comprising: an elongated tube having a proximal end and a distal end, the distal end being configured to extend through the radial opening; a steerable distal tip configured to extend through the radial opening; a handle in mechanical communication with the steerable distal tip; and Wherein the handle is configured to be adjusted to adjust the radial position of the steerable distal tip.

12. The system according to claim 11, further comprising: one or more steering wires extending from the handle to the steerable distal tip; as well as Wherein adjustment of the handle generates tension on one or more of the steering wires to adjust the radial position of the steerable distal tip.

13. The system of claim 12, wherein: The handle includes an actuation portion connected to the one or more steering lines; and Actuating the actuation portion in a radial direction adjusts the radial position of the steerable distal tip.

14. The system of claim 13, wherein the actuation portion includes a steering element coupled to the one or more steering lines and configured to be radially adjusted about a swivel joint.

15. A system according to any one of claims 11 to 14, wherein the medical device further comprises a wire filament extending along the elongated tube, a distal end of the wire filament being connected to the distal end of the elongated tube, a proximal portion of the wire filament extending at least partially along the elongated tube, and a distal portion of the wire filament extending outside the elongated tube.

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