Medical device with an operable tip

Abstract

A medical device and method are disclosed. An exemplary medical device for accessing a body lumen along a bile duct and / or pancreatic duct 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 steerable by applying tension to one or more steering wires that extend between the distal tip and a handle at the proximal end of the medical device. The medical device may be a sphincterotome.

Description

Technical Field

[0001] The present application relates to medical devices, and methods for manufacturing and using these medical devices. More specifically, the present application relates to medical devices for accessing a body lumen along a bile duct and / or a pancreatic duct.

Background Art

[0002] For medical applications, such as endoscopic procedures, various in-vivo medical devices have been developed. Some of these devices include guidewires, catheters, catheter systems, and endoscopic instruments, etc. These devices can be manufactured via any one of a variety of different manufacturing methods and can be used according to any one of a variety of methods. Known medical devices and methods each have specific advantages and disadvantages. Therefore, alternative medical devices, as well as methods for manufacturing and using such medical devices, are still needed.

Summary of the Invention

[0003] The present disclosure provides options for the design, materials, manufacturing methods, and use of medical devices and medical systems. The medical device includes an elongate tube having a proximal end and a distal end configured to be guided toward an opening of a body lumen, a wire filament extending along the elongate tube, wherein a distal end of the wire filament is connected to the distal end of the elongate tube, a proximal portion of the wire filament extends at least partially along the elongate tube, a distal portion of the wire filament extends outside the elongate tube, the wire filament, a steerable distal tip extending distally from 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.

[0004] Alternatively or additionally to any one of the above examples, one or more steering wires extend from the handle to a manipulable distal tip, and adjustment of the handle creates tension in one or more of the one or more steering wires to adjust the position of the manipulable distal tip.

[0005] Alternatively or additionally to any one of the above examples, the handle includes a wire filament and an actuator connected to one or more steering wires. Alternatively or additionally to any one of the above examples, radial actuation of the actuator adjusts the position of the manipulable distal tip.

[0006] Alternatively or additionally to any one of the above examples, axial actuation of the actuator deflects the distal end of the elongate tube, and radial actuation of the actuator adjusts the radial position of the manipulable distal tip.

[0007] Alternatively or additionally to any one of the above examples, the actuator includes an operating element coupled to one or more steering wires and configured to adjust radially about a rotational joint.

[0008] Alternatively or additionally to any one of the above examples, one or more of the one or more steering wires extend through at least a portion of an elongate tube, the elongate tube including 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.

[0009] Alternatively or additionally to any one of the above examples, the one or more steering wires include at least three steering wires extending from the handle to a manipulable distal tip.

[0010] Alternatively or additionally to any one of the above examples, the radial adjustment of the handle with respect to the elongate tube is configured to adjust the position of the manipulable distal tip. Alternatively or additionally to any one of the above examples, the handle communicates with the proximal portion of the wire filament, and the axial adjustment of the handle with respect to the elongate tube is configured to flex the distal end of the elongate tube to expose the cut portion of the wire filament.

[0011] An exemplary system includes an endoscope having a proximal end with an axial opening, a distal end with a radial opening, and a working channel extending between the proximal end and the distal end, a guide wire, and a medical device that is extendable through the working channel and configured to be guided toward the opening of the body lumen. The medical device includes an elongate tube having a proximal end and a distal end, the distal end being configured to extend through the radial opening, a manipulable distal tip configured to extend through the radial opening, and a handle that mechanically communicates with the manipulable distal tip. The handle is configured to be adjusted to adjust the radial position of the manipulable distal tip.

[0012] Alternatively or additionally to any one of the above examples, the system may include one or more steering wires extending from the handle to the manipulable distal tip, and the adjustment of the handle creates tension in one or more of the one or more steering wires to adjust the radial position of the manipulable distal tip.

[0013] Alternatively or additionally to any one of the above examples, the handle includes an actuator connected to one or more steering wires, and the radial actuation of the actuator adjusts the radial position of the manipulable distal tip.

[0014] Alternatively or additionally to any one of the above examples, the actuating part includes an operating element coupled to one or more steering wires and configured to adjust radially around a rotary joint.

[0015] Alternatively or additionally to any one of the above examples, the medical device further comprises a wire filament extending along the elongate tube, the distal end of the wire filament being connected to the distal end of the elongate tube, the proximal portion of the wire filament extending at least partially along the elongate tube, and the distal portion of the wire filament extending outside the elongate tube.

[0016] An exemplary method of accessing a body lumen of a subject includes extending an endoscope having a working channel into the body lumen of the subject, extending an elongate tube having a distal end and a lumen through the working channel, guiding the distal end of the elongate tube through an opening of the body lumen, and maneuvering an operable distal tip forming the terminus of the elongate tube towards a tube located distal to the opening of the body lumen.

[0017] Alternatively or additionally to any one of the above examples, the step of maneuvering the operable distal tip includes radially adjusting a handle in communication with the operable distal tip to maneuver the operable distal tip towards the tube.

[0018] Alternatively or additionally to any one of the above examples, the step of maneuvering the operable distal tip includes radially adjusting at least a part of a handle in communication with the operable distal tip around a rotary joint to maneuver the operable distal tip towards the tube.

[0019] Alternatively or additionally to any one of the above examples, the method further includes extending a guide wire through the operable distal tip into the tube. Alternatively or additionally to any one of the above examples, the method further includes removing the elongate tube from the body lumen and the working channel of the endoscope while maintaining the guide wire within the tube, and inserting another elongate tube over the guide wire into the tube.

[0020] The above summary of some embodiments is not intended to describe every disclosed embodiment or every implementation of the present application.

Brief Description of the Drawings

[0021]

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Best Mode for Carrying Out the Invention

[0022] This application can be more fully understood by considering the following detailed description together with the accompanying drawings. Although various modifications and alternative forms are possible for the aspects of the present invention, the details are shown in the drawings by way of example and are described in detail. However, it should be understood that the intention is not to limit the aspects of the present invention to the specific embodiments described. On the contrary, the intention is to cover all improvements, equivalents, and alternatives included within the spirit and scope of the present invention.

[0023] For the following defined terms, these definitions apply unless different definitions are given elsewhere in the claims or in the specification. The configurations of the present disclosure are specifically described with reference to medical devices and systems (e.g., guidewires inserted near or through the papilla through an endoscopic device, accessory tools, and / or a duodenoscope) for selective access to the common bile duct (CBD) or pancreatic duct (PD), alignment with the CBD or PD, and / or cannulation of the CBD or PD during an endoscopic retrograde cholangiopancreatography (ERCP) procedure. However, it should be understood that such medical devices and systems can be used in various medical procedures that require guiding one or more accessory tools through the anatomical structures of tubes, lumens, blood vessels, or body lumens, including, for example, interventional radiology procedures, balloon angioplasty / angiography procedures, thrombolysis procedures, urological procedures, or gynecological procedures. The disclosed medical devices and systems can be inserted through various access points and approaches, such as percutaneous, endoscopic, laparoscopic, or some combination thereof.

[0024] In this specification, all numerical values are assumed to be modified by the term "about", whether or not explicitly indicated. The term "about" generally refers to a range of numerical values that a person of ordinary skill in the art would consider equivalent (e.g., having the same function or result) in the context of the numerical value. In many cases, the term "about" may include numerical values rounded to the nearest significant digit. Other uses of the term "about" (e.g., in contexts other than numerical values) are understood from the context of the specification and are considered to have the ordinary customary definition consistent therewith, unless otherwise specified.

[0025] The recitation of numerical ranges by endpoints includes all numerical values within that range including the endpoints (e.g., 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, 5). Although some appropriate dimensions, ranges, and / or values are disclosed for various components, features, and / or specifications, one of ordinary skill in the art induced by this specification will understand that the desired dimensions, ranges, and / or values may deviate from those explicitly disclosed.

[0026] As used in this specification and the appended claims, the singular forms "a", "an", and "the" include plural referents unless the context clearly dictates otherwise. As used in this specification and the appended claims, the term "or" is generally used in the sense including "and / or" unless the context clearly dictates otherwise. Note that for ease of understanding, given features disclosed within the disclosed embodiments, even if those features are in the plural or repeated, those features may be described in the singular. Unless otherwise noted, each instance of a feature may be included and / or encompassed by a single disclosure. For purposes of simplification and clarity, not all elements of the disclosure are necessarily shown in each figure or described in detail below. However, it will be understood that the following description may apply equally to any and / or all of the plurality of components, unless explicitly stated to the contrary. Additionally, for purposes of clarity, not all instances of some components or features are shown in each figure.

[0027] References to "one embodiment", "some embodiments", "other embodiments", etc. in this specification indicate that the described embodiments may include certain features, structures, or characteristics, but not all embodiments necessarily include such specific features, structures, or characteristics. Furthermore, such phrases do not necessarily refer to the same embodiment. Additionally, when a specific feature, structure, or characteristic is described in relation to an embodiment, it is within the knowledge of those skilled in the art to affect the specific feature, structure, or characteristic in relation to other embodiments, whether explicitly described or not, unless the contrary is clearly stated. That is, various individual elements described hereinafter can be combined or arranged with each other to form other additional embodiments or to complement and / or enhance the described embodiments as understood by those skilled in the art, even if not explicitly shown in a specific combination.

[0028] For purposes of clarity, a given numerical naming for identification (e.g., first, second, third, fourth, etc.) may be used throughout the specification and / or claims to name and / or distinguish variously described and / or claimed features. It should be understood that the numerical naming is not intended to be limiting and is merely illustrative. In some embodiments, substitutions and departures from previously used numerical naming conventions may be made for the sake of brevity and clarity. That is, a feature identified as the "first" element may later be referred to as the "second" element, "third" element, etc., or may be completely omitted, and / or different features may be referred to as the "first" element. The meaning and / or indication in each case will be apparent to a skilled practitioner.

[0029] The detailed description is intended to illustrate the disclosure and not to limit it. Those skilled in the art will recognize that the various elements described can be arranged in various combinations and configurations without departing from the scope of the invention. The detailed description shows exemplary embodiments of the invention.

[0030] As described herein, it is desirable for the distal tip of a medical device to have sufficient flexibility to effectively guide through a body lumen. For example, the flexible distal tip of a sphincterotome can facilitate guidance through narrow passages such as the Vater papilla, common bile duct, pancreatic duct, and / or other passages. In some cases, the flexible distal tip of a sphincterotome or other suitable medical device can facilitate manipulation of the sphincterotome within a target body lumen that is located adjacent to and / or has such structures as lesions, stones, or other formations located therein.

[0031] In some cases, the devices and methods disclosed herein can be useful for other purposes and can be useful for diagnostic or therapeutic procedures in the bile duct and / or pancreatic duct. Access to the pancreatobiliary system, such 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 useful for guidance in other parts of the body (e.g., the cardiovascular system, etc.).

[0032] Endoscopic retrograde cholangiopancreatography (ERCP) can be used, for example, to diagnose and treat conditions of the common bile duct, including gallstones, inflammatory strictures, leaks (e.g., due to trauma, surgery, etc.), and cancer. During an ERCP procedure, a physician can observe the interior of the stomach and / or duodenum through an endoscope. In many cases, this area can be visualized using X-rays by injecting dye (e.g., through the lumen of a sphincterotome or other device) into the ducts within the biliary system and pancreas. These procedures may require accessing and maintaining access to the Vater papilla, common bile duct, and / or pancreatic duct, which can be technically difficult, may require extensive training and practice to master, and may require one or more expensive instruments to perform.

[0033] During an ERCP procedure, several steps are generally performed while the patient is in a sedated and / or anesthetized state. For example, an endoscope or duodenoscope can be inserted through the mouth, down the esophagus, through the stomach and pylorus, and into the duodenum to a position at or near the Vater papilla, which is the opening of the common bile duct and pancreatic duct (also called the Vater dilatation). Due to the shape of the papilla and the angle at which the common bile duct and pancreatic duct contact the duodenal wall, the distal end of the endoscope or duodenoscope is generally positioned just beyond the papilla. Since the endoscope or duodenoscope is positioned beyond the papilla, the endoscopes or duodenoscopes commonly used in these procedures are typically side-viewing devices. This side-viewing feature allows an image to be obtained along the side of the distal tip rather than from the end of the endoscope. With such orientation, it may be possible for a clinician to obtain an image of the inner wall of the duodenum where the Vater papilla is located, even though the distal tip of the side-viewing device is positioned beyond the opening. Once the duodenal papilla or target area is visually located, an accessory medical device, such as a sphincterotome or other attached medical device, can be extended through a side opening or window of the endoscope or duodenoscope to facilitate access to the desired one of the common bile duct and pancreatic duct through the papilla.

[0034] Although not required, a fluid (e.g., a compressible fluid (compressed gas, air, nitrogen, carbon dioxide, etc.) and / or other suitable fluid) can be delivered to an opening of a body lumen (e.g., the ampulla of Vater) of a subject through a catheter (e.g., inserted through the subject as described above or otherwise inserted), a sphincterotome, and / or other elongate tubular device extending through an inserted endoscope, and / or other suitable elongate medical device. By applying the fluid to the opening, the opening can be at least partially dilated with the fluid before and / or during delivery of the catheter, sphincterotome, guidewire, etc. to a target anatomical structure or tissue (e.g., a duct or other suitable structure or tissue) at or distal to the opening of the body lumen, thereby facilitating identification and / or access to the body lumen. Some exemplary techniques and systems for using a fluid to insert a cannula into an opening of a body lumen are described in U.S. Patent Application Publication No. 2019 / 0380565, titled "Devices, Systems And Method For Accessing A Body Lumen," filed on June 13, 2019, which is incorporated herein by reference for all purposes.

[0035] Alternatively or additionally to using a fluid to open an opening of a body lumen, the opening can be manually opened by engaging the distal end or tip of an attached medical device with the papilla. Further, the attached medical device can be manipulated and / or an endoscope extending through the attached medical device can be manipulated to direct the attached medical device through the papilla into a desired one of the common bile duct and the pancreatic duct. Some exemplary techniques and systems for manipulating the distal tip of a medical device, such as a guidewire, to access a desired body lumen are described in U.S. Patent Application Publication No. 2015 / 0073391, titled "Medical Device With A Movable Tip," filed on September 11, 2014, which is incorporated herein by reference for all purposes.

[0036] Referring to the drawings, FIGS. 1 and 2 show selective cannula insertion during an ERCP procedure, which includes the guide wire 12 and / or an attached medical device 14 (e.g., an endoscopic accessory such as a sphincterotome, and / or other suitable attached medical device) passing toward, against, and / or through the body lumen such as the major papilla 16 (e.g., the dilated portion inlet) near the descending duodenum 18 to access the sphincter of Oddi 20. During the cannula insertion procedure, the distal portion of the medical device 22 (e.g., an endoscope, a duodenoscope, a guide catheter, etc.) can be disposed within the descending duodenum 18. The guide wire 12 and the attached medical device 14 can be advanced through the working channel (e.g., lumen) of the medical device 22 toward the major papilla 16. Additionally, the guide wire 12 and / or the attached medical device 14 can be pressed against the major papilla 16 and / or advanced through the major papilla 16 into one of the common bile duct 17 and the pancreatic duct 19.

[0037] Accessing the papilla 16, the common bile duct 17, and / or the pancreatic duct 19 can be difficult due to reasons such as the opening being small compared to the size (e.g., diameter or other size measurement) of many attached medical devices, the openings being closely located, the openings being completely collapsed / closed, the openings extending within the descending duodenum 18 at an angle where visual recognition and / or access can be difficult, and / or it being difficult to control the position of the distal tip of the attached medical device 14. Thus, medical professionals may be required to manually rotate the medical device 22 to adjust the attached medical device 14 in one direction, manipulate the attached medical device 14 and the guide wire 12 by pulling on the wire filament 30, and / or use an elevator and / or other suitable inclined plane within the distal end of the medical device 22 to better align or orient the attached medical device 14 and / or the guide wire 12 with respect to the medical device 22 and the openings of the papilla 16, the common bile duct 17, and / or the pancreatic duct 19. Difficult cannula insertion procedures where medical professionals fail to access the body lumen within a certain time limit or after a certain number of unsuccessful attempts can lead to significant post - procedure complications such as post - ERCP pancreatitis (PEP).

[0038] As described above, when a medical professional accesses a body lumen (e.g., a duct, papilla, common bile duct, pancreatic duct, etc.) by operating so as to press or insert a medical device attached to the opening of the body lumen, a compressive force may be applied to the wall of the opening of the body lumen. When the opening of the body lumen or the body lumen itself is compressed, buckling may occur as a phenomenon that can be described as the "accordion effect". Therefore, it is desirable to be able to control the distal tip of the attached medical device 14 so that the user can accurately access the opening of the papilla 16 and, after passing through the papilla 16, guide the attached medical device 14 and / or the guide wire 12 to a desired one of the common bile duct 17 and the pancreatic duct 19.

[0039] FIG. 3 schematically shows an exemplary system 24 for accessing a body lumen. In some cases, the system 24 may include an attached medical device 14 having a flexible elongated tube 26 in addition to other components. The tube 26 may have a proximal end 26a and a distal end 26b. The distal end 26b of the tube 26 has a distal tip 31 that extends distally of the distal end 36 of the wire filament 30 and may be configured to be directed toward and / or pass through the opening of the body lumen. The proximal end 26a of the tube 26 may be connected to, coupled to, or otherwise in communication with the handle 28.

[0040] 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 the fingers of the user that hold the attached medical device 14 when using the attached medical device 14 (e.g., receive two fingers), and a second portion 28b configured to receive the thumb of the user. In some cases, the second portion 28b of the handle 28 can be the actuating 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 attached medical device 14 as described herein or in other ways.

[0041] As schematically shown in FIG. 3, the first portion 28a of the handle 28 may have two finger holes configured to receive two fingers of the user, and the second portion 28b may have a thumb hole configured to receive the user's thumb. However, other configurations of the first and second portions 28a, 28b of the handle 28 are also contemplated. Although not essential, the handle 28 may be held and / or operated with one hand of the user, as shown.

[0042] The second portion 28b of the handle 28 may be configured to be adjusted or manipulated to control the position of the distal end 26b of the elongate tube 26 and / or the wire filament 30. In some cases, the second portion 28b may be configured to be adjusted in the axial or longitudinal direction and the radial or rotational direction to adjust the position of the distal end 26b of the elongate tube 26 and / or the wire 30 in a plurality of directions.

[0043] The wire filament 30 extends along the elongate tube 26 and may be energized for the purpose of cutting tissue within the body of the subject. The wire filament 30 may have a proximal end (not shown) connected to the actuating portion 32 (e.g., the second portion 28b) of the handle 28 and a proximal portion that extends at least partially within the tube 26. The wire filament 30 may also have a distal portion 34 (e.g., a cutting portion) that extends outside the elongate tube 26, and the distal end 36 of the filament 30 may be connected to the distal end 26b of the elongate tube 26.

[0044] 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 actuating portion 32 of the handle 28 can be coupled to the wire filament 30 and can be operated to slide the wire filament 30 along the tube 26 (e.g., within the lumen of the tube 26). In one example, the actuating portion 32 of the handle 28 (e.g., the second portion 28b) is adjusted longitudinally relative to the first portion 28a of the handle 28 to apply tension to and / or relieve tension from the wire filament 30.

[0045] By sliding or adjusting the wire filament 30, the distal end 26b of the elongate tube 26 can move in response to the sliding of the wire filament 30. Accordingly, the actuating portion 32 of the handle 28 can be operated to control or adjust the position of the distal end 26b of the elongate tube 26, for example, to guide the distal end 26b to the opening of the body lumen. In some cases, when the tension applied to the wire filament 30 via the handle 28 is released, the wire filament 30 can return to a relaxed position or state due to the natural tension within the tube 26 and / or the wire filament 30 or the natural tension acting on the tube 26 and / or the wire filament 30.

[0046] In some cases, the wire filament 30 can be utilized to electrically sever or ablate tissue of a subject (e.g., to cut and cauterize tissue) and can function as a cautery wire. Accordingly, the handle 28 or other suitable portion of the medical device 22 can include an electrical connection 38 for an energy source (e.g., a radiofrequency energy source, etc.) to supply energy to the wire filament 30 and facilitate tissue cutting. When operating the actuating portion 32 of the handle 28 to adjust the position of the distal end 26b of the tube 26 and / or to utilize the wire filament 30 to cut tissue, the wire filament 30 can be spaced from the tube 26 and energized to enable cutting of tissue at the opening of the body lumen or tissue adjacent to the opening.

[0047] The distal tip 31 of the elongate tube can be flexible and can be configured to adjust in response to manipulation or adjustment of the control configuration at the proximal end of the attached medical device 14. The distal end 26b of the elongate tube 26 of the attached medical device 14 can be configured to bend or otherwise adjust in response to the actuation of the wire filament 30 or in response to advancing along another device (e.g., the elevator of an endoscope in the duodenum and / or other suitable device) that indicates the position of the elongate tube 26. However, such control or operation of the distal end 26b of the elongate tube 26 using the wire filament 30 is limited to adjustment in the direction of the wire filament 30 or in the direction provided by the distal end 26b advancing along another device and may lack the precise control required to access a desired body lumen (e.g., the common bile duct 17, the pancreatic duct 19, etc.). To enable precise control of the distal end of the attached medical device 14 while the attached medical device 14 is within the subject's body, the distal tip 31 is configured to be adjustable or maneuverable 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 attached medical device 14. Thus, the distal end 26b of the elongate tube 26 can be guided to the desired body lumen of the subject using more delicate manipulation of the distal tip 31 rather than by operating the elongate tube using the interaction with the wire filament 30 and / or other medical devices. The distal tip 31 can be a maneuverable distal tip.

[0048] The distal tip 31 can be formed from any suitable material configured to bend, deflect, or otherwise move in response to a force acting on the distal tip 31. In one example, the distal tip can be formed from a polyether block amide (PEBA, e.g., PEBAX® etc.), although this is not essential and other suitable materials are contemplated.

[0049] The position of the distal tip 31 can be controlled or adjusted in any suitable manner. In some cases, multiple wires, such as two wires, three wires, four wires, or any other suitable number of wires (e.g., multiple steering wires), may be utilized to enable control of the distal tip 31. While still being compatible with the existing configuration of the sphincterotome and / or other suitable attached medical device 14 used in an ERCP procedure, three or four wires can be used to provide appropriate and accurate control over the distal tip 31 to facilitate entry into the desired body lumen. In one example, four wires may be utilized to facilitate control of the position of the distal tip 31.

[0050] The wires used to control the distal tip 31 may have a distal end coupled to the distal tip 31, may extend through one or more lumens of the elongate tube 26 to the handle 28, and may have a proximal end coupled to an actuating portion 32 (e.g., the second portion 28b) of the handle 28. Two or more wires may extend through a single lumen of the elongate tube 26, but in one exemplary configuration, each of the multiple wires may extend through an individual lumen (e.g., a single lumen may be provided within the medical device 14 attached to each wire).

[0051] The distal end of the wire may be coupled to the distal tip 31 and / or the proximal end of the wire may be coupled to the actuating portion 32 of the handle 28 in any suitable manner. In one example, the wire may be adhered (e.g., by ultraviolet (UV) curing technology, crimping technology, and / or other suitable connection or bonding techniques) to the distal tip 31 and / or the actuating portion 32 of the handle 28.

[0052] In addition to the one or more lumens that extend and include the wires for controlling the position of the distal tip 31, the attached medical device 14 may include one or more other lumens that extend 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 lumens may have a distal opening that penetrates the distal tip 31 of the elongate tube 26.

[0053] In some cases, one of the one or more lumens of the elongate tube 26 may have a fluid connection for a fluid source (e.g., a pressurized fluid source 40 such as a CO 2 tank, a contrast agent source such as a syringe, etc.) at the proximal end. The lumen may be configured to supply fluid from the fluid source to the body lumen of the subject through an opening at the distal end 26b of the elongate tube 26.

[0054] FIG. 3 shows a fluid source 40 coupled to the fluid port 41 of the attached 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., a syringe, etc.) may be coupled to the fluid port 41 in other suitable ways. In one example, a syringe containing a contrast agent may be coupled to the fluid port 41 via a luer lock connection and / or other suitable connection. The contrast agent may be delivered into the body lumen and used, for example, to temporarily improve imaging within the body lumen by 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 agent.

[0055] Another of the one or more lumens may be configured to receive the guide wire 12 and / or one or more other suitable medical devices usable with the attached medical device 14. Another lumen may extend at least partially along the tube 26 from the distal end 26b of the tube 26 (e.g., the opening of the distal tip 31) toward the proximal end 26a of the tube 26.

[0056] In some cases, the guidewire 12 or other suitable medical device extends through another lumen of the elongate tube 26 and exits proximally from the aperture port 46. The aperture port 46 can be disposed at the distal end of the handle 28 and / or one or more other suitable locations. In some cases, the aperture port 46 and the tube 26 can be configured to allow for rapid removal or replacement of the device by pulling the guidewire 12 and / or other suitable medical device out through the side of the tube 26, although this is not essential.

[0057] Figure 4 schematically shows a cross-sectional view of the elongate tube 26 and shows an example of one or more lumens extending through the elongate tube 26 taken at a location distal of the aperture port 46 and proximal of the distal end of the distal tip 31. Although other configurations are contemplated, the elongate tube 26 can include a plurality of steering wire lumens 50 (e.g., four steering wire lumens 50 as shown in FIG. 4, and / or other suitable number of steering wire lumens 50), one or more fluid lumens 51, one or more wire filament lumens 52, and one or more medical device lumens 53. As shown in FIG. 4, the elongate tube 26 can include four steering wire lumens 50 where each steering wire lumen is for an individual wire, a fluid lumen 51 where the fluid lumen 51 can be for pressurized fluid and / or contrast agent, a wire filament lumen 52 for the wire filament 30 connectable to the electrical connection 38, and a medical device lumen 53 for receiving a guidewire or other suitable medical device.

[0058] FIG. 5 shows an enlarged distal end of a system 24 having a medical device 22 disposed adjacent an opening 48 (e.g., an opening formed by the main papilla 16) of a body lumen (e.g., a body lumen formed by the sphincter of Oddi 20). As shown in FIG. 5, tension is applied to the wire filament 30 to bend the distal end 26b of the elongate tube 26 in a direction in which the wire filament 30 exits the medical device 22 through an opening 54 of the medical device 22. When the distal tip 31 enters the subject's body lumen through the opening 48, the position of the distal tip 31 of the elongate tube 26 is adjusted by operating the steering wire 56 (e.g., by selectively applying tension or applying tension in other ways), and the attached medical device 14 can be guided to enter the common bile duct 17 as it extends through the medical device 22. However, the steering wire 56 can be operated in one or more other suitable ways to guide the distal tip 31 to enter one or more other suitable body lumens (e.g., the pancreatic duct 19, etc.).

[0059] In some cases, the steering wire 56 can extend from the distal tip 31 to the handle 28 (e.g., to the actuating portion 32 of the handle 28 and / or other suitable portions of the handle). When configured in this way, the handle 28 can be adjusted or operated to create tension in one or more of the steering wires 56 to adjust the position of the distal tip 31.

[0060] FIGS. 6-9 schematically show the positions of the components of the system 24 when controlling the distal end 26b of the attached medical device 14 by adjustments made with the handle 28 to apply tension to the wire filament 30 and / or the steering wire 56. In FIG. 6, the handle 28 is schematically shown from a side perspective view. In FIGS. 7-9, the handle 28 is schematically shown in cross-section to facilitate showing the adjustment or movement of the actuating portion 32 that will adjust the distal end 26b of the elongate tube 26.

[0061] As shown in FIG. 6, the system 24 is disposed within the duodenum 18 of the subject, and the opening 54 of the medical device 22 is disposed in the vicinity of the opening 48 of the body lumen (e.g., slightly distal to the opening 48) adjacent to the major duodenal papilla 16 of the subject. Initially, the distal end 26b of the elongate tube 26 can be disposed within the medical device 22 adjacent to the papilla 16 with the second portion 28b of the handle 28 (e.g., the actuating portion 32 referred to as the second portion 28b of the handle 28 with respect to FIGS. 6-9) in a stationary or relaxed position relative to the first portion 28a of the handle 28.

[0062] FIG. 7 schematically shows the tension applied to the wire filament 30 by longitudinally adjusting the second portion 28b of the handle 28 (e.g., the actuating portion 32) in the direction of arrow L relative to the first portion 28a, whereby the distal end 26b of the elongate tube 26 is bent in the direction of the wire filament 30. Before, during, or after the tension is applied to the wire filament 30, the attached medical device 14 can be advanced distally relative to the medical device 22 such that the distal end 26b of the elongate tube 26 exits the opening 54 of the medical device 22 and the distal tip 31 approaches and / or enters the opening 48 of the papilla 16.

[0063] As shown in FIG. 7, the proximal end of the wire filament 30 can be coupled to the stem portion 60, and the steering wire 56 can be coupled to the joint 62 of the second portion 28b of the handle 28. Further, the configuration of the system 24 shown in FIGS. 6-9 can include four steering wires 56, although the schematic cross-sectional views of the handle 28 in FIGS. 7-9 show only three of the four steering wires 56 as one of the steering wires 56 can extend through an omitted portion of the handle 28.

[0064] As can be seen in the cross-sectional view of the handle 28 of FIG. 7, the operating portion 58 of the second portion 28b of the handle 28 can be coupled to the stem portion 60 of the second portion 28b via a joint 62 (e.g., a rotary joint or other suitable type of joint). When the second portion 28b of the handle 28 is adjusted longitudinally in the direction of arrow L, the joint 62 can enable both the longitudinal adjustment of the operating portion 58 and the stem portion 60 with respect to the first portion 28a of the handle 28.

[0065] When the distal tip 31 enters the opening 48 and / or at one or more other suitable timings, the wire filament 30 can be utilized to cut or otherwise remove tissue from around the opening 48. In one example, energy can be applied to the wire filament 30 and, by rotating the attached medical device 14, the energized wire filament 30 can be brought into contact with the tissue around the opening 48. Other techniques can be utilized to remove tissue around the opening 48 using the wire filament 30.

[0066] FIG. 8 schematically shows an attached medical device 14 in which a wire filament 30 is under tension and an operating portion 58 of a second portion 28b (e.g., an actuating portion 32) of a handle 28 is coupled to a steering wire 56. The operating portion 58 can be rotated or manipulated in a radial direction of arrow R with respect 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 operating portion 58, and the resulting tension on the steering wire 56, cause the distal tip 31 to be displaced, as shown in FIG. 8, such that the guide wire 12 and the elongate tube 26 can be guided into the common bile duct 17. The operating portion 58 of the second portion 28b of the handle 28 is shown as adjusting the distal tip 31 toward the common bile duct 17, but the user can operate the operating 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, during, or after the distal tip 31 is guided into the common bile duct 17, and / or before, during, or after the operating portion 58 is operated, the attached medical device 14 and / or the guide wire 12 can be advanced distally relative to the medical device 22 such that the distal tip 31 and / or the guide wire 12 can approach and / or enter the common bile duct 17.

[0067] In some cases, a joint 62 that couples the operating portion 58 and the stem 60 can enable rotational and / or radial movement of the operating portion 58 with respect to the stem portion 60 along with longitudinal movement of the operating portion 58 having the stem portion 60 with respect to the first portion 28a of the handle 28. Other joint configurations are contemplated. In one example, the joint 62 between the operating portion 58 of the second portion 28b of the handle 28 and the stem portion 60 can be a ball socket joint. As shown in FIG. 8, the ball 64 of the ball socket joint can be part of the operating portion 58 and can communicate with the steering wire 56s, and the socket 66 can be part of the stem portion 60, although this is not essential and other configurations are contemplated.

[0068] FIG. 9 schematically shows the attached medical device 14 with the operating portion 58 of the second portion 28b of the handle 28 rotated or operated in the radial direction of arrow R with respect to the longitudinal axis of the handle 28. Further, with respect to FIGS. 7 and 8, the longitudinal force on the second portion 28b of the handle 28 in the direction of arrow L is released, and the wire filament 30 has returned to the relaxed state. As a result of the configuration of the second portion 28b of the handle 28, the wire filament 30 is no longer under tension and may be at a cutting position spaced from the elongate tube 26, but the distal tip 31 may be directed toward the common bile duct 17 by a radial adjustment of the operating portion 58 with respect to the stem portion 60 of the second portion 28b of the handle 28 in the direction of arrow R with respect to the longitudinal axis of the handle 28.

[0069] In some cases, it may be advantageous to control or adjust the distal tip 31 of the elongate tube 26 separately or independently from the remainder of the distal portion 26b of the elongate tube 26. In one example, fine adjustment of the distal tip 31 using the operating portion 58 of the handle 28 may, as described herein or otherwise, direct the attached medical device 14 and / or the guide wire 12 therein in a direction different from the bending of the elongate tube caused by applying tension to the wire filament 30 into the body lumen of the subject, and / or after the tension is released from the wire filament 30, it may be possible to direct or position the elongate tube 26 or the guide wire 12 extending therein toward the target body lumen.

[0070] In some cases, the elongate tube 26, the wire filament 30, the steering wire 56, and / or other components of the attached medical device 14 may be configured to return to a relaxed state when the force causing movement of the distal portion 26b of the elongate tube 26 is released from the handle 28. For example, the elongate tube 26, the wire filament 30, and / or the steering wire 56 may be formed from an elastic polymer, metal, and / or a combination of a polymeric material and a metallic material that allows the wire filament 30 and / or the steering wire 56 to return to the relaxed state.

[0071] Figure 10 is a schematic flow diagram of an exemplary technique 100 for accessing a subject's body lumen. In some cases, a system similar to the system 24 described above may be utilized to access the subject's body lumen. Technique 100 may be utilized to access the openings of other body lumens, but in one example, technique 100 may be utilized to access a desired one of the common bile duct and the pancreatic duct.

[0072] Exemplary technique 100 may include extending a medical device (e.g., medical device 22 such as an endoscope or a duodenoscope, and / or other suitable medical device) through a subject's body lumen (e.g., the duodenum or other suitable body lumen) (102). In some cases, the medical device may have a working channel configured to receive one or more accessory medical devices (e.g., accessory medical device 14 such as a sphincterotome, and / or other suitable accessory medical device). The medical device may be extended through the body lumen such that the opening of the medical device and / or the visualization lens of the medical device is positioned proximate to the target location (e.g., the ampulla of Vater or an associated opening). The working channel or lumen of the medical device may communicate with the opening of the medical device positioned proximate to the target location.

[0073] A elongate tube (e.g., elongate tube 26 and / or other suitable elongate tube) may be extended through the working channel of the medical device (104). In some cases, the elongate tube may be part of an accessory medical device such as a sphincterotome or other suitable accessory medical device. The elongate tube can be extended through the working channel in any suitable manner including, but not limited to, using rapid exchange techniques, over-the-wire techniques, etc. to pass the elongate tube through the working channel.

[0074] Furthermore, technique 100 may include guiding the distal end of the elongate tube toward and / or through an opening of a medical device in communication with the working channel to the opening of the target body lumen (106). The distal end of the elongate tube can be guided toward the opening of the target body lumen using any suitable technique. In one example, a ramp or other suitable elevator at the distal end of the working channel of the medical device can guide the distally advancing elongate tube toward and out of the opening in communication with the working channel and toward the opening of the target body lumen. Additionally or alternatively, in another example, by applying tension to a wire filament (e.g., wire filament 30 and / or other suitable wire filaments), the distal end of the elongate tube of the attached medical device can be bent in the direction of the wire filament and toward the opening of the body lumen. The tension can be applied to the wire filament in any suitable manner as described herein (e.g., by adjusting the actuator in the proximal longitudinal direction) or otherwise.

[0075] Once the distal tip of the elongate tube (e.g., distal tip 31 and / or other suitable distal tip) is disposed within the opening of the body lumen or to enable placement of the distal tip within the target body lumen, the steerable distal tip can be steered toward a tube located distal to the opening of the body lumen (108). In one example, when the distal tip is disposed within the opening of the sphincter of Oddi, the distal tip can be steered or controlled to be guided to the common bile duct or pancreatic duct distal to the opening of the sphincter by radially operating or adjusting an operating portion (e.g., operating portion 58 of the handle of the attached medical device or other suitable operating portion) to position the distal tip in a desired direction with respect to the target lumen.

[0076] When the distal tip is maneuvered toward a tube distal to the opening of the body lumen of the subject, a guide wire or other medical device can pass through the lumen of the elongate tube having an opening within the distal tip (e.g., within the terminus of the distal tip) and be disposed within the target tube or target lumen. The attached medical device can then be removed from the subject, and one or more other medical devices can be advanced over the disposed guide wire to perform one or more procedures on the subject at the target tube.

[0077] The operation or manipulation of the distal tip 31 of the attached medical device 14 is 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, although other suitable handle configurations configured to maneuver or position the distal tip 31 are contemplated. In one example, as schematically shown in FIG. 11, the handle 28 of the attached medical device 14 can utilize one or more dials or knobs to adjust the distal tip.

[0078] As shown in FIG. 11, the handle 28 can include a first knob 72, a second knob 74, and a third knob 76. FIG. 11 shows the first knob 72, the second knob 74, and the third knob 76 rotating about a common axis, which is not essential, and other configurations are contemplated.

[0079] Although not required, the first knob 72 and the second knob 74 may each be coupled to two wires that communicate with the distal tip 31 (or, alternatively, to a single continuous wire to which opposite ends of a single continuous wire are secured to the distal tip 31). When configured in this manner, each knob 72, 74 may be configured to control movement of the distal tip 31 in two opposite directions or otherwise manipulate it. For example, rotation of the first knob 72 in a first rotational direction may result in a first radial movement of the distal tip 31 in a first radial direction, rotation of the first knob in a second rotational direction opposite the first rotational direction may result in a second radial movement of the distal tip 31 in a second radial direction opposite the first radial direction, rotation of the second knob 74 in a first rotational direction may result in a third radial movement of the distal tip 31 in a third radial direction perpendicular to the first and second radial directions, and rotation of the second knob 74 in a second rotational direction may result in a fourth radial movement of the distal tip 31 in a fourth radial direction perpendicular to the first and second radial directions and opposite the third radial direction. By adjusting the first and second knobs 72, 74 in combination with each other, it may be possible to precisely position or manipulate the distal tip in many directions (potentially any desired direction through combinations of adjustments).

[0080] The third knob 76 may be coupled to the proximal end of the wire filament 30. Rotation of the third knob 76 in a first rotational direction may, as described herein and / or otherwise, apply tension to the wire filament 30 to effect bending of the distal end 26b of the elongate tube 26. Rotation of the third knob 76 in a second rotational direction may release the tension on the wire filament 30 to effect relaxation of the distal end 26b of the elongate tube 26. Other suitable configurations of the third knob 76 with respect to the wire filament 30 are contemplated.

[0081] The materials that can be used for various components of the presently disclosed system generally include those related to medical devices. For the sake of brevity, the following description will refer to the above-described system 24. However, this description is also applicable to other similar devices and at least one of the components of the devices disclosed herein, and is not intended to limit the devices and methods described herein.

[0082] System 24 and at least one of its components can be made from 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, mild steel, nickel-titanium alloys such as at least one of linear elastic Nitinol® and superelastic Nitinol®, nickel-chromium-molybdenum alloys (e.g., UNS:N06625 such as INCONEL® 625, UNS:N06022 such as HASTELLOY® C-22™, UNS:N10276 such as HASTELLOY® C276™, other HASTELLOY® alloys, etc.), nickel-copper alloys (e.g., UNS:N04400 such as MONEL® 400, NICKELVAC™ 400, NICORROS™ 400, etc.), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS:R30035 such as MP35-N™), nickel-molybdenum alloys (e.g., UNS:N10665 such as HASTELLOY® ALLOY B2™), other nickel-chromium alloys, other nickel-molybdenum alloys, other nickel-cobalt alloys, other nickel-iron alloys, other nickel-copper alloys, other nickel-tungsten or tungsten alloys such as other nickel alloys, cobalt-chromium alloys, cobalt-chromium-molybdenum alloys (e.g., UNS:R30003 such as ELGILOY®, PHYNOX®), platinum-enriched stainless steel, titanium, combinations thereof, etc., or any other suitable material.

[0083] Some examples of suitable polymers include polytetrafluoroethylene (PTFE), ethylene tetrafluoroethylene (ETFE), fluorinated ethylene propylene (FEP), polyoxymethylene (POM, e.g., DELRIN® available from DuPont), polyether block ester, polyurethane (e.g., polyurethane 85A), polypropylene (PP), polyvinyl chloride (PVC), polyether ester (e.g., ARNITEL® available from DSM Engineering Plastics), ether or ester copolymers (e.g., other polyester elastomers such as butylene / poly(alkylene ether) phthalate, HYTREL® available from DuPont), polyamide (e.g., DURETHAN® available from Bayer, CRISTAMID™ available from Elf Atochem), elastomeric polymer, block polyamide / ether, polyether block amide (PEBA, e.g., available under the trade name PEBAX®), ethylene vinyl acetate copolymer (EVA), silicone, polyethylene (PE), Marlex type high density polyethylene, Marlex type low density polyethylene, linear low density polyethylene (e.g., REXELL™), polyester, polybutylene terephthalate (PBT), polyethylene terephthalate (PET), polytrimethylene terephthalate, polyethylene naphthalate (PEN), polyether ether ketone (PEEK), polyimide (PI), polyether imide (PEI), polyphenylene sulfide (PPS), polyphenylene oxide (PPO), polyparaphenylene terephthalamide (e.g., KEVLAR®), polysulfone, nylon, nylon 12 (e.g., GRILAMID® available from EMS American Grilon), perfluoro(propyl vinyl ether) (PFA), ethylene vinyl alcohol, polyolefin, polystyrene, epoxy, polyvinylidene chloride (PVdC), poly(styrene-b-isobutylene-b-styrene) (e.g., SIBS and SIBSAt least one of 50A), polycarbonate, ionomer, biocompatible polymer, other suitable materials, or combinations, mixtures, copolymers, polymer / metal composites, etc. are included, but not limited thereto. In some embodiments, liquid crystal polymer (LCP) can be mixed into the sheath. For example, the mixture can contain up to about 6% LCP.

[0084] In some embodiments, system 24 has some degree of compatibility with magnetic resonance imaging (MRI). For example, part or all of system 24 can be made of materials that do not substantially distort the image and do not generate substantial artifacts (i.e., gaps in the image). For example, certain ferromagnetic materials may not be suitable because they can generate artifacts in MRI images. Part or all of system 24 can also be made of materials that are imageable by an MRI device. Some materials that exhibit these properties include, for example, tungsten, cobalt-chromium-molybdenum alloys (e.g., UNS:R30003 such as ELGILOY®, PHYNOX®), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS:R30035 such as MP35-N™), Nitinol®, etc.

[0085] As described above, the tubular and / or elongate components of system 24 can include one or more tubular members in which slots can be formed. Various embodiments regarding the placement and configuration of the slots are contemplated. For example, in some embodiments, at least some, if not all, of the slots can be arranged at the same or a similar angle relative to the longitudinal axis of the tubular and / or elongate components of system 24. The slots can be arranged at a vertical or substantially vertical angle, or can be characterized as being arranged within a plane perpendicular to the longitudinal axis of the tubular and / or elongate components of system 24, or both. However, in other embodiments, the slots can be arranged at a non-vertical angle, or can be characterized as being arranged within a plane non-perpendicular to the longitudinal axis of the tubular and / or elongate components of system 24, or both. Also, a group of one or more slots can be arranged at an angle different from that of another group of one or more slots. The placement and configuration of the slots are applicable to the extent disclosed in U.S. Patent No. 7,914,467, which is hereby incorporated by reference in its entirety. Some exemplary embodiments regarding suitable micromachining methods and other cutting methods, and the structures for tubular members having slots and medical devices including the tubular members, are disclosed in U.S. Patent Application Publication No. 2003 / 0069522, U.S. Patent Application Publication No. 2004 / 0181174A2, U.S. Patent No. 6,766,720, and U.S. Patent No. 6,579,246, which are hereby incorporated by reference in their entirety. Some exemplary embodiments regarding etching processes are described in U.S. Patent No. 5,106,455, which is hereby incorporated by reference in its entirety. It should be noted that the method of manufacturing system 24 can include the step of forming slots in the tubular and / or elongate components of system 24 used in these or other manufacturing processes.

[0086] This application should be understood to be merely illustrative in many respects. Modifications can be made without departing from the scope of this application, particularly in terms of shape, size, and the arrangement of steps. This may include, to an appropriate extent, using any feature of one exemplary embodiment in other embodiments. The scope of the present invention is, of course, defined by the language of the appended claims.

Claims

1. A medical device, a long tubular member having a proximal end and a distal end configured to be directed toward an opening of a body lumen, a wire filament extending along the long tubular member, wherein a distal end of the wire filament is connected to the distal end of the long tubular member, a proximal portion of the wire filament extends at least partially along the long tubular member, and a distal portion of the wire filament extends outside the long tubular member, the wire filament; a manipulable distal tip extending distally from the distal end of the wire filament; a handle in mechanical communication with the manipulable distal tip, and the handle is configured to be adjusted to control the position of the manipulable distal tip in at least three directions. A medical device.

2. further comprising one or more steering wires extending from the handle to the manipulable distal tip, wherein adjustment of the handle creates tension in one or more of the one or more steering wires to adjust the position of the manipulable distal tip. The medical device according to claim 1.

3. The handle includes an actuating portion connected to the wire filament and the one or more steering wires. The medical device according to claim 2.

4. Radial actuation of the actuating portion adjusts the position of the manipulable distal tip. The medical device according to claim 3.

5. Axial actuation of the actuating portion deflects the distal end of the long tubular member, Radial actuation of the actuating portion adjusts the radial position of the manipulable distal tip. The medical device according to any one of claims 3 or 4.

6. The actuating portion includes an operating element coupled to the one or more steering wires and configured to be adjusted radially about a rotary joint. The medical device according to any one of claims 3 to 5.

7. One or more of the one or more steering wires extend through at least a portion of the long tubular member. The elongate 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, the medical device according to any one of claims 2 to 6.

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

9. Radial adjustment of the handle with respect to the elongate tube is configured to adjust the position of the steerable distal tip, the medical device according to any one of claims 1 to 8.

10. The handle communicates with the proximal portion of the wire filament, and axial adjustment of the handle with respect to the elongate tube is configured to flex the distal end of the elongate tube to expose the cut portion of the wire filament, the medical device according to any one of claims 1 to 9.

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 between the proximal end and the distal end; A guide wire; A medical device that can extend through the working channel and is configured to be guided toward an opening of a body lumen, the medical device comprising: An elongate tube having a proximal end and a distal end, the distal end 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; The handle is configured to be adjusted to adjust the radial position of the steerable distal tip, the system.

12. Further comprising one or more steering wires extending from the handle to the steerable distal tip; Adjustment of the handle causes tension in one or more of the one or more steering wires to adjust the radial position of the steerable distal tip, the system according to claim 11.

13. The handle includes an actuating part connected to the one or more steering wires, The system according to claim 12, wherein radial actuation of the actuating part adjusts the radial position of the steerable distal tip. **Claim 14** The system according to claim 13, wherein the actuating part includes an operating element coupled to the one or more steering wires and configured to adjust radially around a rotary joint. **Claim 15** The medical device further comprises a wire filament extending along the elongate tube, a distal end of the wire filament being connected to the distal end of the elongate tube, a proximal portion of the wire filament extending at least partially along the elongate tube, and a distal portion of the wire filament extending outside the elongate tube, the system according to any one of claims 11 to 14.

Images