Steerable wire system for medical devices

Abstract

A steerable medical device 102 includes a first wire 104 and a second wire 106. The first wire includes a first portion having a first width and a second portion having a second width. The second width is less than the first width. A distal end of the first wire is fixed relative to a distal end of the second wire. A proximal end of one or more of the first wire or the second wire is movable distally or proximally relative to the other of the first wire or the second wire to bend a distal portion of the steerable medical device.

Description

Cross-application of related applications

[0001] This application claims priority to U.S. Provisional Application No. 63 / 535777, filed on August 31, 2023, the entire contents of which are incorporated herein by reference. Technical Field

[0002] This disclosure relates generally to medical devices and related methods. Specifically, this disclosure relates to controllable leads and methods of using them. Background Technology

[0003] Sphincterotomy is a surgical procedure involving the cutting or transection of the sphincter muscle, commonly used in the gastrointestinal tract, urinary system, or other sites where sphincters are present. This technique is used to relieve obstructions, remove stones or foreign bodies, treat strictures, and provide better access for endoscopic procedures. For example, endoscopic retrograde cholangiopancreatography (ERCP) may involve sphincterotomy of the ampulla of Vater and the insertion of a guide into the bile duct and / or pancreatic duct. Currently, sphincterotomy is typically performed using rigid or semi-rigid scalpels and / or guides, which can present challenges in achieving precise guidance and control in complex anatomical structures.

[0004] Existing guides lack the flexibility and maneuverability required for the tortuous paths and narrow angles encountered in sphincterotomy. These limitations lead to increased surgical difficulty, prolonged operation time, and potential complications. Therefore, there is a need for an improved guide that enhances maneuverability while maintaining the necessary structural integrity to ensure optimal performance in a variety of clinical situations. Summary of the Invention

[0005] Examples of this disclosure relate to a manipulable medical device comprising a first wire and a second wire. The first wire may include a first portion having a first width and a second portion having a second width. The second width may be smaller than the first width. The distal end of the first wire may be fixed relative to the distal end of the second wire. The proximal end of one or more of the first or second wires may be movable distally or proximally relative to the other of the first or second wires to bend the distal portion of the manipulable medical device.

[0006] Any device disclosed herein may include any of the following features, either alone or in any combination thereof.

[0007] In other embodiments of the controllable medical device, the first portion may have a D-shaped cross-section or a circular cross-section.

[0008] In other embodiments of the controllable medical device, the central longitudinal axis of the first portion is offset from the central longitudinal axis of the second portion.

[0009] In other embodiments of the controllable medical device, the second line includes a third portion having a third width and a fourth portion having a fourth width. The fourth width may be smaller than the third width.

[0010] In other embodiments of the controllable medical device, the flat surface of the first portion may face the flat surface of the third portion.

[0011] In other embodiments of the controllable medical device, the flat line may be located between the flat surface of the first portion and the flat surface of the third portion.

[0012] In other embodiments of the operable medical device, the first, second, and third portions may be covered by a coating or sheath. The fourth portion may not be covered by a coating or sheath.

[0013] In other embodiments of the controllable medical device, the second line may have a uniform width along its entire length.

[0014] In other embodiments of the controllable medical device, the first line may further include a third portion having a third width. The second width may be smaller than the third width.

[0015] In other embodiments of the controllable medical device, the second part may be located between the first part and the third part.

[0016] In other embodiments of the controllable medical device, the first width may be approximately the same as the third width.

[0017] In other embodiments of the controllable medical device, the first line may include a tapered portion that gradually narrows between a first width and a second width.

[0018] Other embodiments of the controllable medical device may include a handle having an actuator configured as a proximal end of a first line of motion.

[0019] In other embodiments of the controllable medical device, the proximal end of the second wire may be fixed relative to the handle.

[0020] In other embodiments of the controllable medical device, the actuator may be configured to switch between a first configuration and a second configuration, in which the actuator is disengaged from the first wire and in which the actuator is engaged with the first wire in the second configuration.

[0021] In other embodiments, the controllable medical device may include a first line and a second line. The first line may include a first portion having a first width and a second portion having a second width. The second width may be smaller than the first width. The distance between the first portion of the first line and the second line may be smaller than the distance between the second portion of the first line and the second line. One or more of the first line or the second line may be movable distally or proximally relative to the other of the first line or the second line to bend the distal portion of the controllable medical device.

[0022] Any medical device disclosed herein may include any of the following features, either alone or in any combination thereof.

[0023] In other embodiments of the controllable medical device, the second line may include a third portion having a third width and a fourth portion having a fourth width. The fourth width may be smaller than the third width. The central longitudinal axis of the third portion may be offset from the central longitudinal axis of the fourth portion.

[0024] In other embodiments, the controllable medical device may include a first wire and a second wire. The cross-sectional width of the first wire may vary along its length, thereby changing the distance between the first wire and the second wire. The proximal end of one or more of the first or second wires may be moved distally or proximally relative to the other of the first or second wires to bend the distal portion of the controllable medical device.

[0025] Any medical device disclosed herein may include any of the following features, either alone or in any combination thereof.

[0026] In many other embodiments of the controllable medical device, the cross-sectional width of the second line may vary along its length.

[0027] In further embodiments of the controllable medical device, the central longitudinal axis of the first portion of the first line may be concentric with the central longitudinal axis of the second portion of the first line, and the central longitudinal axis of the first line may be offset from the central longitudinal axis of the combination of the first line and the second line.

[0028] It should be understood that the above general description and the following detailed description are merely illustrative and explanatory, and do not limit the scope of the claimed disclosure. Attached Figure Description

[0029] The accompanying drawings, which are part of this specification, illustrate exemplary aspects of this disclosure and, together with the specification, serve to explain the principles of this disclosure.

[0030] Figure 1 The distal portion of the lead system of an exemplary medical device according to several aspects of this disclosure is shown.

[0031] Figure 2 Show Figure 1Further details regarding the implementation of the conductor system.

[0032] Figure 3 Show Figure 1 Further details regarding the implementation of the conductor system.

[0033] Figure 4 Show Figure 1 More details on the implementation of the conductor system.

[0034] Figure 5 Show Figure 1 More details on the implementation of the conductor system.

[0035] Figure 6 Show Figure 1 More details on the implementation of the conductor system.

[0036] Figures 7A to 7D Another embodiment of the conductor system is shown.

[0037] Figure 8 and Figure 9 Another embodiment of the conductor system is shown.

[0038] Figure 10 This illustrates yet another implementation of the conductor system.

[0039] Figure 11 This illustrates yet another implementation of the conductor system.

[0040] Figure 12A and Figure 12B This illustrates yet another implementation of the conductor system.

[0041] Figure 13 This illustrates yet another implementation of the conductor system.

[0042] Figures 14 to 17 This illustrates a control wire system, such as... Figure 1 The handle components of the wire system shown and their specific aspects. Detailed Implementation

[0043] This disclosure includes an example of a manipulable guide device and method specifically designed for sphincterotomy. The guide utilizes advanced materials, construction techniques, and control mechanisms, enabling precise and controllable guidance within the target anatomical structure. Its unique design allows for flexible movement along a tortuous path, thereby improving the accuracy, safety, and efficiency of sphincterotomy. However, it should be noted that the scope of this application is defined by the features listed in the claims and is not intended to remedy any particular deficiency.

[0044] The examples of this disclosure will now be described in detail with reference to the foregoing description and the accompanying drawings. Throughout the drawings, the same reference numerals are used wherever possible to refer to the same or similar parts.

[0045] In this document, "proximal" and "distal" are used to refer to the relative positions of components of an exemplary medical device. "Proximal" means a position relatively close to the outside of the object or close to a user, such as a medical professional, who holds or otherwise uses the medical device. Conversely, "distal" means a position relatively far from a medical professional or other user who holds or otherwise uses the medical device, or closer to the inside of the object. The terms "comprising," "having," "including," "containing," or variations thereof are intended to cover non-exclusive inclusion; therefore, an apparatus or method comprising a list of elements may include not only those elements but also other elements not expressly listed or inherent to it. Unless otherwise stated, the word "exemplary" means "example" rather than "ideal." The terms "about," "substantially," and "approximately" as used herein represent a range of values ​​within + / - 10% of the stated values.

[0046] Figure 1 A portion of a controllable lead system 102 (or simply "lead system 102") is shown, having a controllable distal tip segment 103 comprised of a first wire 104 and a second wire 106. Although the term "system" is used herein to refer to lead system 102, it should be understood that lead system 102 can be a single medical device. The first wire 104 and the second wire 106 can be D-shaped wires arranged in opposite directions, each wire having eccentric segments 108 and 110. Eccentric segments 108 and 110 can be length portions of wires whose width varies along their length, and can form a space 105 between the first wire 104 and the second wire 106, which allows relative movement between the wires. Relative movement can be caused by a user (e.g., a physician or other medical device operator) to move one of the first wires 104 or the second wire 106 longitudinally relative to the other, thereby causing the lead system 102 to move laterally / articulate within the lumen or other parts of the patient's anatomy (e.g., the gastrointestinal tract, urinary tract, veins, etc.) (as indicated by arrows 12, 14). See reference. Figures 1 to 6 A more detailed description of the conductor system is provided.

[0047] Figure 1A distal tip 112 is shown at the distal end 114 of the lead system 102. The lead system 102 also has a proximal portion 116 at its opposite end, which can be attached to one or more operating components (e.g., a handle assembly, which will be explained in more detail herein). Movement of the lead system 102, including relative movement between the first wire 104 and the second wire 106, can generally be performed at the proximal end of the lead system 102 (e.g., the proximal end of the proximal portion 116). Several aspects of the handle assembly 200 that can be used to control the lead system 102 will be described separately later.

[0048] Figure 2 and Figure 3 The first line 104 is shown separately. Any features described below for the first line 104 are also applicable to the second line 106. Unless otherwise stated, the same reference numerals apply to the first line 104 and the second line 106. As previously described, the first line 104 may include generally D-shaped portions (head 122 and proximal portion 123) having a flat surface 121 and an arcuate outer surface 125. At the head 122 and proximal portion 123, the cross-section of the line 104 perpendicular to its longitudinal axis may be generally D-shaped. In some embodiments, the cross-sectional shape of the outer surface 125 may be generally semi-circular. In other words, the head 122 and proximal portion 123 may resemble a typical circular line divided in half along the center of a circular line.

[0049] Wire 104 may include an eccentric segment 110 near its distal end 107. The eccentric segment 110 may have sufficient length between its distal end and the distal end 107 of wire 104 to form a head 122 at the distal end 107 of the first wire 104. In some embodiments, the length of the head 122 may be about 0.1 to 3.0 mm, about 0.1 to 10.0 mm, or other lengths. In some embodiments, the eccentric segment 110 may be removed by cutting, scraping, grinding, or otherwise removing a portion of the first wire 104. For example, as described above, the first wire 104 may be D-shaped overall before forming the eccentric segment 110. In some embodiments, the eccentric segment may be removed by laser cutting or grinding, or the wire may be formed by drawing or wire electrical discharge machining. Figure 3 The shape shown. In other embodiments, the first line 104, including the eccentric segment 110, may be formed via additive manufacturing. For example, in some embodiments, one or more portions of the line 104 may be attached by means of metal 3D printing, laser welding, brazing, or bonding to connect portions of different sizes.

[0050] The eccentric segment 110 may extend along one side of the first line 104, such as the side of the first line 104 opposite to the surface 121 (the portion of the outer surface 125 furthest from surface 121). Therefore, the eccentric segment 110 may be offset from the central longitudinal axis of the first line 104. In other words, the central longitudinal axis of the eccentric segment 110 may be parallel to but not coaxial with the central longitudinal axis of the first line 104. The flat surface 121 of the line 104 may be cut away from the line 104, leaving the eccentric segment 110.

[0051] The cross-section of the eccentric segment 110 may be generally flat. For example, the eccentric segment 110 may be strip-shaped. The length of the eccentric segment 110 may be approximately 10 mm to 100 mm. The eccentric segment 110 may gradually narrow towards the proximal side to a proximal portion 123, forming a tapered portion 127. In some examples, the tapered portion 127 may linearly narrow from the eccentric segment 110 to the proximal portion 123. The size and shape of the proximal portion 123 may be the same as the head 122 (e.g., D-shaped). The tapered portion 127 may help eliminate stress within the wire 104 and simplify the manufacturing process of the wire 104. Furthermore, in some embodiments, the flexibility of the flexible portion of the wire 104 may be measured according to the size / shape of the tapered portion 127. For example, different tapered profiles may result in different bending profiles of the wire 104 and allow for gradual changes in the radius of curvature. In some examples, the eccentric segment 110 may have a uniform shape between the distal end of the conical portion 127 and the proximal end of the head 122.

[0052] In some embodiments, the second wire 106 may be substantially similar to the first wire 104. When assembling the conductor system 102, the second wire 106 and the first wire 104 may be arranged in a mirror image across the central longitudinal axis of the conductor system 102. (Refer to...) Figure 1 and 4 The flat surfaces 120, 121 of the first wire 104 and the second wire 106 may be opposite each other at the head 122 and proximal portion 123 of the first wire 104 and the second wire 106. A space 105 (gap) may be formed between the first wire 104 and the second wire 106 along the eccentric segment 110 of the first wire 104 and the eccentric segment 108 of the second wire 106. The space 105 may be formed because the flat surfaces 120, 121 of the first wire 104 and the second wire 106 have been removed from the first wire along the eccentric segments 108 and 110. The space 105 allows relative movement between the first wire 104 and the second wire 106 along the eccentric segments 108, 110, enabling the steerable distal tip segment 103 to move left and right to manipulate the conductor system 102, as shown by arrows 12, 14. Figure 1 As shown in the figure and described below.

[0053] like Figure 3As shown, some embodiments of the lead system 102 may include one or more coatings, such as coating 130 on the surfaces of the first wire 104 and / or the second wire 106. For example, the eccentric segments 108, 110, the flat surface 121 of the first wire 104, the flat surface 120 of the second wire 106, or one or more other surfaces may be coated. For example, the flat surface 121 of the first wire 104 and the flat surface 120 of the second wire 106 may have a tungsten coating, which improves fluorescent visibility during medical procedures using the medical device.

[0054] Reference Figures 4 to 6 This further illustrates several aspects of the conductor system 102. Figure 4 A portion of a first wire 104 and a second wire 106 is shown. These two wires may meet at an intersection 124 between the flat surfaces of the portions of the conductor system 102 located near the eccentric segments 108, 110 (e.g., the proximal portion 116). In some embodiments, a flat wire 132 or other features (e.g., spacers) may be provided between the first wire 104 and the second wire 106, with the flat surfaces 120, 121 each contacting the flat wire 132. The flat wire 132 may be made of plastic, such as polyether block amide (PEBA), thermoplastic elastomer (TPE), polytetrafluoroethylene (PTFE), nylon, or other materials. In some embodiments, the flat wire 132 may be coated with a coating such as Nitinol, MP35N, or CoCr, or may be a stainless steel wire with a polymer coating that provides insulation. Compared to the direct contact between the flat surfaces of the first wire 104 and the second wire 106, the side of the flat wire 132 that contacts the flat surfaces of the first wire 104 and the second wire 106 may have a lower coefficient of friction. Furthermore, the flat surfaces of the first wire 104 and the second wire 106 that are not in contact with the flat wire 132 but are separated by the space created between the first wire 104 and the second wire 106 by the flat wire 132 can benefit from the additional space created between the flat surfaces due to the incorporation of the flat wire 132. Therefore, incorporating the flat wire 132 between the two parts of the conductor system 102 allows for better relative movement between the two wires, thereby improving control over the controllable distal tip segment 103 of the conductor system 102 and enhancing its maneuverability. In addition, the flat wire 132 can provide insulation between the two wires, which is particularly advantageous in embodiments where one or more wires are energized, as described in more detail below.

[0055] Reference Figure 5Multiple portions of the conductor system 102 may be covered by a sheath 134. For example, multiple portions of the first wire 104 and the second wire 106 may be covered within the sheath 134. The sheath 134 may be made of polytetrafluoroethylene (PTFE), polyether block amide (PEBA), silicone, nylon, fluoropolymers (e.g., fluoropolymers, PFA), other elastomers (ChronoSil, etc.), or other materials. For example, the sheath 134 may comprise a PTFE heat-shrinkable film with a silicone coating. In some examples, portions of the sheath 134 (e.g., portions formed of PTFE and / or other polymers) may be braided and / or woven. The sheath 134 may be heat-shrinkable onto the conductor system 102 and provides electrical and thermal insulation, as well as physical support, to hold the two wires 104, 106 in place, improving the maneuverability and performance of the conductor system 102.

[0056] Referring to Figure 6, a conductor system 102 is shown having a proximal sheath 134 and a distal sheath 136. The distal sheath 136 may be made of one or more different materials or have different characteristics from the proximal sheath 134. The distal sheath 136 may surround at least a portion of a steerable distal tip segment 103 of the conductor system 102. When the steerable distal tip segment 103 is moved left and right to guide the conductor system 102, the distal sheath 136 may cover the first wire 104 and the second wire 106 (which are usually covered by the distal sheath 136 and are therefore not shown). Figure 6 The sheath 134 and / or distal sheath 136 can be held in the desired position (e.g., wires 104 and 106 can be confined within the diameter / width of the sheath 136). In some embodiments, the distal sheath 136 can prevent unintended segmental bending between multiple portions of the first wire 104 and the second wire 106 (e.g., between eccentric segments 108 and 110) and can provide thermal and electrical insulation. The sheath 134 and / or the distal sheath 136 can have variable stiffness along their respective lengths, giving the conductor system 102 variable flexibility. In some examples, the stiffness of the sheath 136 can be relatively lower than that of the sheath 134, so that the distal tip segment 103 can be more flexible than the proximal portion of the conductor system 102. The increased flexibility of the distal tip segment 103 can facilitate deflection of the distal tip segment 103 (e.g., along eccentric segments 108 and 110).

[0057] Reference Figure 1 and Figure 6To deflect the distal tip segment 103, one or both of the wires 104 and 106 can be pulled proximally or otherwise tensioned. This can change the relative lengths of the wires 104 and 106 within the sheaths 134 and 136. For example, in a neutral configuration of the conductor system 102, the lengths of the wires 104 and 106 can be the same or approximately the same. When one of the wires 104 and 106 is moved proximally at its proximal end, that wire can be shorter relative to the other of the wires 104 and 106. For example, wire 104 can be moved proximally (tensioned) relative to wire 106. This can cause the conductor system 102 to... Figure 1 The direction of the bend indicated by arrow 14 (as shown) Figure 6 (As shown in the conductor system 102''). The conductor system 102 can be bent at the locations of eccentric segments 108, 110 because the flexibility of wires 104, 106 at eccentric segments 108, 110 is greater than at other parts of wires 104, 106. Similarly, wire 106 can be pulled (tensioned) proximally relative to wire 104, thereby causing it to... Figure 1 The direction of the arrow 12 is curved (as shown in the image). Figure 6 (As shown in the lead system 102'). Alternatively, only one of the lines 104 and 106 is movable. In such examples, line 104 or 106 can be moved proximally to deflect / bend the distal tip segment 103 in one direction indicated by arrow 12 or arrow 14, and can also be moved distally to deflect / bend the distal tip segment 103 in the other direction indicated by arrow 12 or arrow 14. Alternatively, only one of the lines 104 and 106 is movable. The relative shortening or lengthening of lines 104 and 106 relative to the other can deflect the distal tip segment 103. Thus, the lead system 102 is maneuverable. The maneuverability of the lead system 102 can facilitate, for example, access to different catheters in the pancreaticobiliary system.

[0058] Figures 7A to 7D An embodiment of the conductor system 300 is shown, having a first wire 302 and a second wire 304 connected at a distal tip segment 303, with a space 305 between the first wire 302 and the second wire 304. Unless otherwise specified herein, the first wire 302 and the second wire 304 may have any of the characteristics, features, and functions of other wires described herein. The first wire 302 and the second wire 304 may be covered by an outer sheath 334 and an inner sheath 336. Unless otherwise specified herein, the outer sheath 334 and the inner sheath 336 may have any of the characteristics, features, and functions of other sheaths described herein.

[0059] The outer sheath 334 is longitudinally movable relative to the length of the first line 302 and the second line 304, and multiple portions of the outer sheath 334 may have different characteristics along their length. For example, particularly referring to... Figure 7C and 7DThe outer sheath 334 may have high-stiffness segments 334a and low-stiffness segments 334b. Longitudinal movement of the outer sheath 334 may expose or cover portions of the first wire 302 and the second wire 304, and / or allow segments of varying stiffness to move relative to the first wire 302 and the second wire 304. Therefore, moving the outer sheath 334 can affect the maneuverability of the conductor system 300 by influencing the relative forces required to bend it at a maneuverable distal end of the conductor system. For example, moving the outer sheath 334 relative to the space 305 between the first wire 302 and the second wire 304 can affect the movement of the conductors. Moving the outer sheath 334 so that it no longer surrounds the space 305, or allowing the length of the lower-stiffness outer sheath 334 to surround the space 305, makes it easier to move the maneuverable conductor system 300 (i.e., to allow relative distal and proximal movement of the conductor system 300 between the first wire 302 and the second wire 304, as described herein with reference to an embodiment of conductor system 102). In other embodiments, the hardness of the outer sheath 334 may be sufficiently low at one or more of its portions (i.e., the outer sheath 334 may be sufficiently soft) so that the first line 302 and the second line 304 may move relative to each other when the outer sheath surrounds part or all of the first line 302 and the second line 304 at space 305.

[0060] Referring again to 7A to 7D, the inner sheath 336 may be an insulating sheath that insulates one or more of the first wire 302 and the second wire 304. The inner sheath 336 may surround all or part of the first wire 302 and the second wire 304. In particular, as... Figure 7A and 7B As shown, certain portions of the second thread 304 may be exposed from the inner sheath 336, for example, exposed portion 307. In some embodiments, one or more of the first thread 302 and the second thread 304 may be electrically energized, heated, or otherwise cause a skin cut. As the outer sheath 334 retracts proximally, the exposed portion 307 may extend away from the first thread 302 due to the relative movement between the threads when the user pushes the first thread 302 distally or pulls the second thread 304 proximally. The exposed portion 307 of the second thread 304 can cut the tissue of the object like a blade.

[0061] To prevent the second line 304 from moving away from the first line 302 when there is relative longitudinal movement between the two lines, the user can push the outer sheath 334 distally when there is relative longitudinal movement between the two lines, so that it surrounds the first line 302 and the second line 304. This prevents the second line 304 from extending away from the first line 302 and prevents the exposed portion 307 from acting as a blade or razor blade.

[0062] Figure 8 and Figure 9Another embodiment of the conductor system 140 is shown. Unless otherwise specified herein, the conductor system 140 may include any features of the conductor system 102. The conductor system 140 includes coated / sheathed wires 142 coated with a coating 145 and uncoated wires 144, separated by an eccentric portion 147, wherein wires 142 and 144 are not coupled together. Although the terms “coated” and “uncoated” are used herein, it should be understood that some portions of the coated wire 142 may be uncoated, and some portions of the uncoated wire 144 may be coated, as described below. Wires 142 and 144 may have any features of the wires 104 and 106 described above. For example, in some embodiments, wires 142 and 144 may have generally D-shaped heads (similar to...). Figure 1 The D-shaped head 122 (with any of its characteristics) and proximal portion (with any of the characteristics of proximal portion 123), and having an eccentric portion (with any of the characteristics of eccentric segment 108 or 110) extending between the head and the proximal portion. The eccentric portion of line 142 in Figure 8 and Figure 9 The line 142 may not be visible because it is covered by coating 145. In other embodiments, the coated line 142 and / or the uncoated line 144 may be generally flat lines.

[0063] Uncoated wire 144 may be partially coated along a portion of its length together with coated wire 142, and may be exposed from coating 145 or an opening in coating 145 distal to slit 141. In some examples, coating 145 may be provided on the proximal portions of wires 142, 144, and may be joined together as described above to form conductor system 102. Coating 145 may extend distally along coated wire 142, but may terminate along the length of uncoated wire 144, allowing uncoated wire 144 to move relative to coated wire 142. The junction 146 of wires 142, 144 may be uncoated, and wires 142 and 144 may be coupled to each other at the junction as described above.

[0064] The coating 145 on the coated wire 142 can be PTFE, silicone, PEBA, parylene, or other materials. In some embodiments, the coating can be heat-shrinked onto the wire. The coated wire 142 and the uncoated wire 144 can be soldered together or otherwise connected at a junction 146. Similar to wires 104 and 106, the uncoated wire 144 and the coated wire 142 can move relative to each other, thereby allowing one or the other to be pulled proximally or pushed distally to manipulate the conductor system 140. For example, as Figure 9As shown, the uncoated wire 144 can be pulled / tensioned proximally, shortening it relatively relative to the coated wire 142. This can cause the distal end 143 of the conductor system 140 to bend / deflect in the direction toward the side of the conductor system 140 with the uncoated wire 144. Alternatively, the uncoated wire 144 can be moved distally, lengthening it relatively relative to the coated wire 142. This can cause the distal end 143 to bend / deflect in the opposite direction (towards the side of the conductor system 140 with the coated wire 142).

[0065] Because the uncoated wire 144 is not coupled to the coated wire 142 along the eccentric portion 147, the uncoated wire 144 may separate from the coated wire 142 at the eccentric portion 147, forming a gap between the uncoated wire 144 and the coated wire 142. The curved, uncoated wire 144 may resemble the wire on a surgical instrument used to perform sphincterotomy. In some embodiments, the uncoated wire 144 may be energized (e.g., using an electrocautery current) and / or heated to perform sphincterotomy on the patient.

[0066] Figure 10 A conductor system 150 is shown, comprising a first wire 152 and a second wire 154. The first wire 152 may be a flat wire (e.g., a wire with a uniform diameter or uniform width along its entire length), and the second wire 154 may be... Figure 1 The first line 104 and / or the second line 106 are lines with similar properties. In some examples, the first line 152 may have a circular cross-sectional shape. In other examples, the first line 152 may have a flat cross-sectional shape, thus the first line 152 is strip-shaped.

[0067] The first wire 152 may be connected to the second wire 154 at a junction 156, which may be located at the head 151 of the first wire 152 (having any characteristics of the head 122) and the distal / distal portion of the second wire 154. A portion of the length of the wires 152 and 154 coupled to each other is sufficient to provide adequate strength to the conductor system 150 while allowing deflection of the conductor system 150 sufficiently close to the distal end 159 of the conductor system 150, as described below.

[0068] Similar to lines 104 and 106, the second line 154 may include a tapered portion 153. The tapered portion 153 may gradually narrow along a taper distance 155 from the proximal portion 158 of the second line 154 to an eccentric portion 165. A space 157 may be formed between the first line 152 and the second line 154 along the eccentric portion 165 and the tapered portion 153. The space 157 may be formed because the second line 154 may extend along the flat surface 158a of the proximal portion 158 and the head 151 of the first line 152, and the second line 154 may be substantially tensioned so that it does not sag within the space 157.

[0069] Although not shown, it should be understood that the lead system 150 may include any of the sheaths / coatings described above. For example, the first wire 152 may resemble the uncoated wire 144, including an uncoated portion along the eccentric portion 165. The lead system 150 may also include any of the actuation mechanisms described above. In some examples, the proximal end of the first wire 152 may move proximally (pulled or tensioned) or distally (pushed or relaxed) to deflect the lead system 150, as described above for the previous lead systems.

[0070] Figure 11 Another embodiment of the conductor system 160 is shown. The conductor system 160 includes a first wire 164 and a second wire 166, separated by a spacer 168. The first wire 164 and the second wire 166 may be flat wires that converge at a junction 163 and effectively become a single wire 161 at the junction 163. Alternatively, wires 164 and 166 may be a single wire with its distal end bent / looped in place of the junction 163. The first wire 164 and the second wire 166 may have a generally flat cross-section, thus being generally strip-shaped. In some examples, wires 164 and 166 may be made of a material such as nitinol. The spacer 168 may be made of any suitable material, such as copper, plastic, stainless steel, silicon-coated nitinol, plastics such as polytetrafluoroethylene, nylon, or other materials.

[0071] The spacer 168 is generally cylindrical and may include multiple line guide mechanisms 169, each of which may include line guides 169a and 169b. Line guides 169a and 169b may be protrusions extending radially outward from the spacer 168. The distance between the line guides 169a and 169b may be slightly greater than the width of the lines 164 and 166. Lines 164 and 166 can be slidably accommodated between the line guides 169a and 169b. The spacer 168 may include two rows of line guide mechanisms 169, each row for its respective line 164 and 166. Each row of line guide mechanisms 169 may be arranged longitudinally along the outer surface of the spacer 168, so that the line segments drawn along the row of line guide mechanisms 169 can form a straight line. Any number of line guide mechanisms 169 may be used.

[0072] The wire guide mechanism 169 maintains the first wire 164 and the second wire 166 in proper position relative to each other and to the spacer 168. For example, the first wire 164 and the second wire 166 can be held on substantially opposite sides (diameterally opposite each other) of the spacer 168. Since the wire guide mechanism 169 can be arranged longitudinally along the spacer 168, the wires 164 and 166 can also be arranged longitudinally along the spacer 168. The wire guides 169a and 169b can be positioned at any point along the length of the spacer 168. The distal end of the spacer 168 can be sufficiently far from the junction 163 so that the first wire 164 and the second wire 166 can move longitudinally relative to each other, providing bending capability for both wires and giving the conductor system 160 maneuverability.

[0073] Lines 164 and 166 can move proximally and / or distally to deflect the conductor system 160. In some examples, both lines 164 and 166 can move actively; in other examples, only one of lines 164 and 166 can move actively. Due to the presence of spacer 168, lines 164 and 166 can be offset from the central longitudinal axis of the conductor system 160, which may be the central longitudinal axis of spacer 168. Therefore, pushing / pulling lines 164 and 166 can generate torque, causing the conductor system 160 to skew / deflect. In some examples, the conductor system 160 can be flexible distal to the spacer 168. In other examples, spacer 168 can have sufficient flexibility (and / or may include features such as slits) so that the conductor system 160 can be steerable in the portion where spacer 168 is located.

[0074] In some embodiments, the spacer 168 can be moved longitudinally relative to the junction 163 (i.e., the longitudinal distance between the distal end of the spacer and the junction 163 can be increased or decreased) to change the bending radius of the conductor system 160. A user can push or pull the spacer 168 and / or simultaneously push and pull the first wire 164 and / or the second wire 166 to change the distance between the junction 163 and one end of the spacer 168. When the distance between the spacer 168 and the junction 163 is relatively small, the bending radius of the conductor system 160 can be relatively small. When the distance between the spacer 168 and the junction is relatively large, the bending radius of the conductor system 160 can be relatively large.

[0075] The sheath 162 may surround all or part of the other components of the conductor system 160. The stiffness of the sheath 162 may vary along its length, and this variable stiffness may control the position and degree of bending of the conductor system 160. For example, a stiffer portion of the sheath is more difficult to bend than a less stiff portion. Relatively stiffer or less stiff portions may move forward or backward along the length of the sheath 162, or may be connected together, to control the mobility of the conductor system 160.

[0076] Figure 12A and 12B Several aspects of another embodiment of the conductor system 170 are shown. The conductor system 170 consists of a first wire 172a and a second wire 172b, which are surrounded by a sheath 171 and connected at a common end 178. The common end 178 may be a soldered end member soldered to the distal end 173 of the conductor system 170, connecting the first wire 172a and the second wire 172b. The distal end 173 may be opposite the proximal end 175 of the conductor system 170.

[0077] Figure 12B Line 172 is shown. Line 172 can serve as a first line 172a and a second line 172b. Line 172 may have a tapered portion 174, which gradually narrows towards its distal end 176. The distal end 176 of the tapered portion 174 may have a generally uniform diameter / width. The proximal portion 177 of the line 172, located near the tapered portion 174, may also have a generally uniform diameter / width. The diameter / width of the proximal portion 177 may be greater than that of the end portion 176, and the tapered portion 174 may gradually narrow from the larger width of the proximal portion 177 to the smaller width of the end portion 176. The tapered portion 174 may narrow symmetrically, such that the central longitudinal axis of the tapered portion and the end portion 176 is coaxial with the central longitudinal axis of the proximal portion 177. Alternatively, the tapered portion 174 may narrow eccentrically, such that the taper angle of the tapered portion 174 varies about its circumference.

[0078] The first wire 172a and the second wire 172b may include tapered portions 174a and 174b corresponding to the tapered portion 174. Similarly, the first wire 172a and the second wire 172b may include end portions 176a and 176b and proximal portions 177a and 177b respectively corresponding to end portions 176 and proximal portions 177. The proximal portions 177a and 177b may be adjacent to each other, and the tapered portions 174a and 174b and the end portions 176a and 176b may be spaced apart from each other, so that there is a gap between the portions of the wires 172a and 172b on the distal side of the proximal ends of the tapered portions 174a and 174b. In some embodiments, one or more of the different portions may be concentric with one or more of the other portions. The common end 178 may be a component extending substantially perpendicular to the central longitudinal axis of the conductor system 170, thereby connecting the distal ends of the end portions 176a and 176b.

[0079] Therefore, the first wire 172a and the second wire 172b can each be offset from the central longitudinal axis of the conductor system 170 (e.g., parallel but not coaxial). The space between the first wire 172a and the second wire 172b allows them to move relative to each other, controlling the operation of the conductor system 170. For example, the first wire 172a and / or the second wire 172b can be moved proximally or distally (tensioned or relaxed) to deflect the conductor system 170, similar to the other conductor systems described above.

[0080] The stiffness of the sheath 171 can vary along its length, making some parts of the sheath 171 more flexible than others. Therefore, when the wiring system 170 is used for left-right control within the anatomy of an object, the sheath 171 can adjust the flexibility of the wiring system 170.

[0081] Figure 13 A conductor system 180 is shown, which includes wire 172 (having Figure 12B The wire 172 (with any characteristics of the wire 172) and the flat wire 182. The flat wire 182 may have any of the characteristics of the flat wires 142 and 144 described above. The flat wire 182 may have a flat cross-sectional shape, thus being strip-shaped. The wire 172 and the flat wire 182 may be coupled by an end member 184 having any of the characteristics of a common end 178. The end member 184 may be soldered to or otherwise coupled to the wire 172 and the flat wire 182 at the distal end 181 of the conductor system 180, opposite to the proximal end 183 of the conductor system 180. Although not shown, the wire 172 and the flat wire 182 may be surrounded by a sheath (having any of the characteristics of the sheath 171).

[0082] Along the proximal portion 177 of line 172, a flat line 182 may be adjacent to (e.g., in contact with) line 172. Along the tapered portion 174 and the end portion 176, the flat line 182 may be spaced apart from line 172. The end member 184 may maintain the distance between the flat line and the tapered portion 174 and the end portion 176 of line 172. The flat line 182 may be sufficiently taut and / or rigid to maintain the space between line 172 and the flat line 182.

[0083] In operation, wire 172 can be moved proximally (pulled) and / or distally (pushed) to shorten or lengthen the portion of wire 172 within the sheath (not shown) relative to flat wire 182. Therefore, conductor system 180 can be deflected similarly to conductor system 150, as described above.

[0084] Figures 14 to 17 A handle assembly 200 is shown that can be used with the various wiring systems described herein. Although Figures 14 to 17 The handle assembly 200 shown is for a conductor system with two opposing D-shaped wires, such as... Figures 1 to 6The wiring system 102 is described herein, but the operating principles described herein with respect to the handle assembly 200 are also applicable to other embodiments described herein.

[0085] Figure 14 A handle assembly 200 is shown, comprising a handle body 202. The handle assembly 200 may include an actuator, such as a slider or knob 204, slidably connected to the handle body 202 within a slot 214, and configured to switch between one or more configurations. The handle body 202 may be threadedly connected to a cap 206. D-shaped wires 208, 210 extend distally from a channel 212 in the cap 206. The channel 212 in the cap 206 may communicate with a lumen 213 in the handle body 202. Although not shown, the wires 208, 210 may be surrounded by a sheath, as described above.

[0086] Figure 15 A cross-sectional view of the handle body 202 is shown. The cap 206 can be connected to the handle body 202 at the threaded portion 224 of the cap 206 and the threaded portion 222 of the handle body 202. The collet 226 can be located within the lumen 213 of the handle body 202, such that the distal portion 215 of the collet 226 extends through the distal opening of the lumen 213 and reaches the distal end of the handle body 202 distally. The distal portion 215 of the collet can be accommodated within the cap 206.

[0087] Channel 212 may communicate with channel 220 of chuck 226. Channel 220 and channel 212 may be coaxial. One of the D-shaped wires 208 may extend through channels 212 and 220 and may move relative to chuck 226 in distal and proximal directions depending on the movement of knob 204, as will be described in detail later. Another D-shaped wire 210 may extend through channel 212 and may include a hypotube welded or crimped thereto. When cap 206 is screwed onto handle body 202, cap 206 may compress chuck 226, thereby clamping hypotube around wire 210 and securing wire 210 relative to chuck 226. Alternatively, wire 210 may be welded to a portion of chuck 226 or otherwise coupled to handle assembly 200 so that it cannot move relative to chuck 226 / handle body 202 in distal and proximal directions.

[0088] like Figure 15 As shown, knob 204 can move back and forth (towards and to the farthest side) within slot 214 as indicated by arrow 230, and can also move up and down (radially inwards and outwards) within slot 214 as indicated by arrow 232, to disengage from and engage with D-shaped line 208, as described below. (Refer to...) Figure 15 and Figure 16 The knob 204 includes a gripper 216. (As...) Figure 16As shown, the gripper 216 may have two walls 209 and 211 that gradually narrow outwards. The knob 204 may include two walls 217 and 219 that interact with the walls 209 and 211 of the gripper 216 when the knob 204 is pushed downwards / radially inwards, resulting in a wedge action on the gripper 216. The walls 209 and 211 of the knob 204 can push the walls 217 and 219 toward each other, causing them to grip line 208.

[0089] When the user moves knob 204 to an effective control position (e.g., pressing down / radially inward in the direction of arrow 232), gripper 216 and knob 204 can engage with each other by friction around the proximal portion of movable D-shaped line 208. Gripper 216 may not engage with D-shaped line 208 or D-shaped line 210 until the user presses knob 204. Therefore, when knob 204 is not pressed, any proximal / distal movement of knob 204 may not engage with line 208 (knob 204 can move relative to line 208 when not pressed down). After knob 204 is pressed down, knob 204 can move distally and proximally relative to handle assembly 200, thereby moving D-shaped line 208 distally and proximally relative to handle body 202.

[0090] Reference Figure 15 and Figure 16 Because the D-shaped wire 210 is fixed to the clamp 226 or another part of the handle assembly 200, its movement in the distal and proximal directions is suppressed, and in this embodiment, the D-shaped wire 210 does not move in the distal and proximal directions like the D-shaped wire 208. Therefore, movement of the knob 204 will produce relative distal and proximal movements between the D-shaped wire 208 and the D-shaped wire 210. This allows the wire system 102 to deflect according to the direction in which the user moves the knob 204 (e.g., ...). Figure 1 (As shown by arrows 12 and 14, the wires deflect left and right). More specifically, if the user moves the D-shaped wire 208 further away from the D-shaped wire 210 (i.e., moves the knob 204 further away from the cap 206), the twin-wire system tends to curl / bend away from the side of the axis with the D-shaped wire 208. Conversely, if the user moves the D-shaped wire 208 closer to the D-shaped wire 210 (i.e., moves the knob 204 away from the cap 206), the twin-wire system tends to curl / bend towards the side of the axis with the D-shaped wire 208.

[0091] Figure 17Port 228 in the proximal end of the handle body 202 is shown. Port 228 can be used, for example, to load one or more wires into the handle assembly 200. For example, one or both of D-shaped wires 208 and 210 can be loaded into port 228 and pushed through channel 220 in clamp 226 and channel 212 in cap 206. Alternatively, port 228 can also be used to deliver contrast agents or other reagents.

[0092] The embodiments disclosed herein are applicable to a variety of different medical or non-medical procedures. Furthermore, in practice, certain aspects of the embodiments may be selectively used in combination or removed without departing from the scope of this disclosure.

[0093] While the principles of this disclosure have been described herein with reference to examples of specific applications, it should be understood that this disclosure is not limited thereto. Those skilled in the art, upon encountering the teachings provided herein, will recognize that other modifications, applications, aspects, and equivalent substitutions fall within the scope of the aspects described herein. Therefore, this disclosure should not be considered as limited by the foregoing description.

Claims

1. A controllable medical device, comprising: First line; as well as Second line; The first line comprises a first portion having a first width and a second portion having a second width, wherein the second width is smaller than the first width. The distal end of the first line is fixed relative to the distal end of the second line, and The proximal end of one or more of the first or second lines can move distally or proximally relative to the other of the first or second lines to bend the distal portion of the controllable medical device.

2. The controllable medical device according to claim 1, wherein, The first part has a D-shaped cross-section or a circular cross-section.

3. The controllable medical device according to any one of claims 1 to 2, wherein the central longitudinal axis of the first portion is offset from the central longitudinal axis of the second portion.

4. The controllable medical device according to any one of claims 1 to 3, wherein the second line comprises a third portion having a third width and a fourth portion having a fourth width, wherein the fourth width is smaller than the third width.

5. The controllable medical device according to claim 4, wherein, The flat surface of the first part faces the flat surface of the third part.

6. The controllable medical device according to any one of claims 4 to 5, wherein the flat line is located between the flat surface of the first portion and the flat surface of the third portion.

7. The controllable medical device according to any one of claims 4 to 6, wherein the first portion, the second portion and the third portion are covered by a coating or a sheath, and wherein the fourth portion is not covered by the coating or the sheath.

8. The controllable medical device according to any one of claims 1 to 3, wherein the second line has a uniform width along its entire length.

9. The controllable medical device according to any one of claims 1 to 3, wherein the first line further comprises a third portion having a third width, and the second width is smaller than the third width.

10. The controllable medical device of claim 9, wherein the second portion is located between the first portion and the third portion.

11. The controllable medical device of claim 10, wherein the first width is substantially the same as the third width.

12. The controllable medical device according to any one of claims 1 to 11, wherein the first line includes a tapered portion that gradually narrows between the first width and the second width.

13. The operable medical device according to any one of claims 1 to 12, further comprising a handle having an actuator configured to move the proximal end of the first line.

14. The controllable medical device of claim 13, wherein the proximal end of the second wire is fixed relative to the handle.

15. The controllable medical device of claim 14, wherein the actuator is configured to switch between a first configuration and a second configuration, wherein in the first configuration the actuator is disengaged from the first wire, and in the second configuration the actuator is engaged with the first wire.

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