An adjustable bend sheath assembly

Abstract

The present application relates to a kind of adjustable bending sheath tube assemblies, including adjustable bending pipe with adjustable bending pipe section and control structure, control structure includes adjusting pipe;Adjusting pipe includes a plurality of first circular arc segments that are connected head to tail and are distributed along the circumference of adjusting pipe, at least one first circular arc segment is different from the hardness of other first circular arc segment;Or, gap is extended along the axial direction on adjusting pipe, adjusting pipe includes at least one second circular arc segment, gap and second circular arc segment are distributed at different positions on the circumference of adjusting pipe;Adjusting pipe can rotate around the axis of adjustable bending pipe, to control the different positions on the circumference of adjusting pipe and the bending direction of adjustable bending pipe section are aligned, and adjustable bending pipe section and adjusting pipe can be bent synchronously, so that adjustable bending pipe can be bent with different bending radius.The above-mentioned adjustable bending sheath tube assembly is adjusted by adjusting the circumferential position of adjusting pipe, to adjust the bending radius and bending angle of adjustable bending pipe section, improve the applicability of the adjustable bending sheath tube assembly, facilitate to reach target position quickly.

Description

Technical Field

[0001] This invention relates to the technical field of medical devices, and more particularly to an adjustable bendable sheath assembly. Background Technology

[0002] This section provides only background information relevant to this disclosure and is not necessarily prior art.

[0003] Medical sheaths are used in minimally invasive interventional diagnostic and therapeutic surgeries to establish access, deliver or retrieve instruments, administer drugs, or drain bodily fluids. During clinical practice, the sheath needs to be adjusted to different shapes depending on the actual needs and the anatomical morphology of the target vessel. Adjustable sheaths, with their distally adjustable bendability, can quickly and reliably reach the target vessel, thus reducing surgical time.

[0004] Currently known adjustable sheaths for delivering medical devices include an adjusting tube and an adjusting wire. The distal end of the adjusting tube has an adjusting section, and the adjusting wire is located inside the wall of the adjusting tube and is used to control the deflection of the adjusting section. Moreover, the maximum bending angle and applicable blood vessel diameter of known adjustable sheaths are generally fixed.

[0005] However, in actual use, due to the differences in vascular structure among different patients at the same location (i.e., different vascular diameters), when the vascular diameter is smaller than the vascular diameter applicable to the bending sheath, the bending sheath will forcefully support the vascular wall, thereby enlarging the vascular diameter or changing the shape of the vascular. This will inevitably increase the difficulty of the surgical procedure, waste time in the process of bending and establishing the path, or cause damage to the patient's vascular. Summary of the Invention

[0006] Therefore, it is necessary to provide an adjustable bending sheath assembly that can control the bending radius and bending angle.

[0007] An adjustable bending sheath assembly includes an adjusting tube having an adjusting tube section, and a control structure including an adjusting tube.

[0008] The regulating tube includes several first arc segments that are connected end to end and distributed along the circumference of the regulating tube, wherein at least one of the first arc segments has a different hardness than the other first arc segments; or, the regulating tube has a gap extending along the axial direction, and the regulating tube includes at least one second arc segment, wherein the gap and the second arc segment are distributed at different positions along the circumference of the regulating tube.

[0009] The adjusting tube can rotate around the axis of the bending tube to control different positions of the adjusting tube in the circumferential direction to align with the bending direction of the bending tube segment, and the bending tube segment and the adjusting tube can bend synchronously, so that the bending tube can bend with different bending radii.

[0010] In the aforementioned adjustable bending sheath assembly, the bending section and the adjusting tube overlap radially to form an overlapping portion with adjustable bending degree. When the adjusting tube includes several first arc segments, at least one of the first arc segments has a different hardness than the other first arc segments. This drives the adjusting tube to rotate relative to the bending section around the axis of the bending tube, thereby aligning the position (effective bending portion) of the first arc segments with different hardness in the circumferential direction of the adjusting tube with the bending direction of the bending section. When the adjusting tube has an axially extending gap and includes at least one second arc segment, the adjusting tube is driven to rotate relative to the bending section around the axis of the bending tube, thereby aligning the portion with different hardness in the circumferential direction of the adjusting tube with the bending direction of the bending section.

[0011] Therefore, when using the aforementioned adjustable bending sheath assembly, the user can adjust the bending radius and bending angle of the adjusting tube segment according to the patient's actual situation by adjusting the circumferential position of the adjusting tube. This effectively improves the applicability of the adjustable bending sheath assembly and facilitates its rapid arrival at the target position. At the same time, the controllable bending radius and bending angle not only effectively reduce the time required to establish vascular access during surgery but also reduce the damage to the patient's blood vessels during the establishment of vascular access. Attached Figure Description

[0012] To more clearly illustrate the technical solutions in the embodiments of the present invention, the accompanying drawings used in the description of the embodiments will be briefly introduced below. Obviously, the accompanying drawings described below are only some embodiments of the present invention. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0013] in:

[0014] Figure 1 This is a schematic diagram of the overall structure of the adjustable bending sheath assembly in one embodiment.

[0015] Figure 2 This is a schematic diagram of the structure of the distal end of the bend in one embodiment.

[0016] Figure 3 For the corresponding Figure 2 A sectional view after being cut along the central section line AA.

[0017] Figure 4 For the corresponding Figure 2 Enlarged view of a section of BB after partial cross-section.

[0018] Figure 5 This is a schematic diagram of the overall structure of the adjustable bending sheath assembly in another embodiment.

[0019] Figure 6This is a schematic diagram of the overall structure of the adjustable bending sheath assembly in another embodiment.

[0020] Figure 7 This is a schematic diagram of the structure of the remote portion of the control structure in one embodiment.

[0021] Figure 8 For the corresponding Figure 7 A sectional view after being cut along the center section line CC.

[0022] Figure 9 This is a schematic diagram of the structure of the remote portion of the control structure in another embodiment.

[0023] Figure 10 This is a schematic diagram of the structure of the remote portion of the control structure in another embodiment.

[0024] Figure 11 For the corresponding Figure 10 A sectional view after cutting along the center section line EE.

[0025] Figure 12 This is a schematic diagram of the structure of the remote portion of the control structure in another embodiment.

[0026] Figure 13 For the corresponding Figure 12 A sectional view after being cut along the center section line FF.

[0027] Figure 14 For the corresponding Figure 1 A cross-sectional view after being cut along the central section line HH.

[0028] Figure 15 For the corresponding Figure 14 A magnified view of part I in the middle.

[0029] Figure 16 This is a schematic diagram of the overall structure of the adjustable bending sheath assembly in another embodiment.

[0030] Figure 17 For the corresponding Figure 16 A sectional view after being cut along the central section line JJ.

[0031] Figure 18 For the corresponding Figure 17 A magnified view of part K in the middle. Detailed Implementation

[0032] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0033] In the description of the embodiments of the present invention, it should be noted that the terms "center," "upper," "lower," "left," "right," "vertical," "horizontal," "inner," and "outer," etc., indicating orientations or positional relationships based on the orientations or positional relationships shown in the accompanying drawings, are only for the convenience of describing the embodiments of the present invention and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation, and therefore should not be construed as a limitation on the embodiments of the present invention. Furthermore, the terms "first," "second," and "third" are used for descriptive purposes only and should not be construed as indicating or implying relative importance.

[0034] In the description of the embodiments of the present invention, it should be noted that, unless otherwise explicitly specified and limited, the terms "installation," "connection," and "linking" should be interpreted broadly. For example, they can refer to a fixed connection, a replaceable connection, or an integral connection; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; and they can refer to the internal connection of two components. Those skilled in the art can understand the specific meaning of the above terms in the embodiments of the present invention based on the specific circumstances.

[0035] In the field of interventional medical devices, the end of a medical device implanted in the human or animal body that is closer to the operator is generally called the "proximal end," and the end that is farther from the operator is called the "distal end." Based on this principle, the "proximal end" and "distal end" of any component of a medical device are defined. "Axial direction" generally refers to the length of the medical device during delivery, while "radial direction" generally refers to the direction of the medical device that is not parallel to its "axial direction." Based on this principle, the "axial direction" and "radial direction" of any component of a medical device are defined. "Circumferential direction" refers to the circumferential direction, that is, the axial direction surrounding a tubular structure or cylinder.

[0036] Please see Figure 1 This embodiment relates to an adjustable bending sheath assembly, which is mainly used in minimally invasive interventional diagnostic and therapeutic surgeries to establish channels, deliver or retrieve instruments, administer drugs, or drain bodily fluids. During use, the distal end of the adjustable bending sheath assembly can be adjusted to different shapes according to actual needs and the morphology of the target vessel, enabling it to quickly and reliably reach the target vessel location, thereby reducing surgical time.

[0037] Please continue reading. Figure 1 In one embodiment, the adjustable bending sheath assembly includes a control handle 100 and an adjusting tube 200. The control handle 100 is connected to the proximal end of the adjusting tube 200. By controlling the distal end of the adjusting tube 200 at the proximal end using the control handle 100, it can quickly enter the curved target blood vessel location.

[0038] Please see Figure 2In one embodiment, the distal end of the bending pipe 200 is provided with a bending pipe section 210. It should be noted that the bending pipe section 210 is itself a portion of the bending pipe 200, and the hardness of this portion is lower than the hardness of other portions of the bending pipe 200. Thus, when the distal end of the bending pipe 200 is deflected, the bending pipe 200 will bend at the location of the bending pipe section 210, which is more conducive to the bending operation.

[0039] Please see Figure 2 and Figure 3 In one embodiment, the bending pipe 200 further includes: an inner pipe 220, an outer pipe 230, an intermediate layer 240, and a bending wire 250. The outer pipe 230 is sleeved on the outer wall of the inner pipe 220, and the intermediate layer 240 passes through the pipe wall of the outer pipe 230. The bending wire 250 is disposed within the pipe wall of the outer pipe 230 and is located between the intermediate layer 240 and the inner pipe 220. When the end of the bending wire 250 away from the bending pipe section 210 is pulled, the bending pipe section 210 can be driven to deflect, thereby achieving bending at the distal end of the bending pipe 200, that is, bending occurs at the bending pipe section 210.

[0040] In one embodiment, a through hole 231 is provided in the inner wall of the outer tube 230, and the through hole 231 extends along the axial direction of the outer tube 230 to form a cylindrical through channel. The bending wire 250 passes through the through hole 231.

[0041] In one embodiment, an inner membrane (not shown in the figure) is provided on the inner wall of the through hole 231. It should be noted that the inner membrane is made of a high-lubricity, low-friction polymer material. For example, polytetrafluoroethylene (PTFE), high-density polyethylene (HDPE), or polyimide (PI), etc., with a smooth inner surface, ensuring that the bending wire 250 passes smoothly through the inner surface of the inner membrane. The material of the bending wire 250 can be a material with a high Young's modulus, such as stainless steel, nickel-titanium alloy, cobalt-chromium alloy, etc., so that it is not easily deformed and elongated under tensile force. The bending wire 250 can be a single-strand wire structure or a multi-strand wire structure, preferably 3 strands and 5 strands. During assembly, the bending wire 250 is inserted into the through hole and arranged parallel to the axis of the inner layer tube 220. The distal end of the bending wire 250 is fixed to the intermediate layer 240 by welding or hanging, etc., and the proximal end of the bending wire 250 is connected to the control handle 100 (see...). Figure 1 In addition, the inner membrane can also protect the bending wire 250, so that the bending wire 250 will not lose its mobility due to being fixed inside the outer tube 230, so that the bending wire 250 can be pulled smoothly for easy bending.

[0042] In one embodiment, the inner tube 220 and the outer tube 230 are both made of polymer materials, and the intermediate layer 240 is a braided mesh tube or a spring tube. The inner tube 220, the outer tube 230, and the intermediate layer 240 are manufactured into an integral tubular structure through a hot-melt molding process.

[0043] In one embodiment, the inner tube 220 is made of a highly lubricating, low-friction polymer material, such as polytetrafluoroethylene (PTFE), high-density polyethylene (HDPE), or polyimide (PI). This design results in a smooth surface for the inner tube 220, allowing other instruments or liquids to pass smoothly through its inner cavity.

[0044] Please see Figure 2 and Figure 4 In one embodiment, the bending tube 200 further includes a developing ring 260 and a distal tube segment 270 located at the distal end of the bending tube segment 210. The developing ring 260 is disposed on the distal tube segment 270. In other embodiments, the developing ring 260 may also be disposed on the bending tube segment 210.

[0045] It is understood that the developing ring 260 may be provided only on the distal tube section 270; or only on the bending section 210; or partly on the distal tube section 270 and partly on the bending section 210. In this embodiment, the developing ring 260 is provided on the distal tube section 270.

[0046] Please continue reading. Figure 4 In one embodiment, the distal end of the bending wire 250 is fixed to the developing ring 260 by welding, hooking, or wrapping. Fixing the bending wire 250 to the developing ring 260 is more secure than fixing the distal end of the bending wire 250 to the intermediate layer 240 because the developing ring 260 has a larger surface area, allowing for a longer welding length, and the flat end face of the developing ring 260 ensures that hooking and wrapping do not slip. Alternatively, the bending wire 250 can be directly hooked to the developing ring 260 to avoid the adverse effects of welding.

[0047] Please see Figure 5 In one embodiment, the adjustable bending sheath assembly further includes a control structure 300. Specifically, the control structure 300 is sleeved on the bending tube 200 and is rotatable relative to the bending tube 200, thereby adjusting different circumferential positions of the adjusting tube 320 to align with the bending direction of the bending tube 200.

[0048] Please see Figure 6In one embodiment, the adjustable bending sheath assembly also includes a control structure 300, but the control structure 300 passes through the bending tube 200 and the control handle 100, and is rotatable relative to the bending tube 200. Furthermore, the proximal end of the control structure 300 extends beyond the control handle 100 and extends a certain distance to allow the user to directly and manually rotate the control structure 300 to align different circumferential positions of the control structure 300 with the bending direction of the bending tube 200.

[0049] It should be noted that, Figure 5 and Figure 6 The structure shown does not have any driving components. Instead, the user directly drives the control structure 300 to rotate relative to the bending tube 200 by directly contacting the control structure 300, thereby adjusting the position of the control structure 300 in the circumferential direction corresponding to the bending direction.

[0050] In one embodiment, the control structure 300 is rotatably and detachably inserted into the cavity of the bending tube 200; or, the control structure 300 is rotatably and detachably sleeved on the bending tube 200. Thus, the control structure 300 can be removed from the bending tube assembly as needed during use.

[0051] Please return Figure 1 In one embodiment, the adjustable bending sheath assembly further includes a control structure 300 and a drive structure 400. Specifically, the control structure 300 is movably assembled with the adjusting tube 200, and the proximal end of the control structure 300 is connected to the drive structure 400. It should be noted that the control structure 300 can rotate relative to the adjusting tube 200 about its axis under the action of the drive structure 400, thereby aligning different circumferential positions of the control structure 300 with the bending direction of the adjusting tube 200. In this embodiment, the control structure 300 is a sleeve movably fitted onto the adjusting tube 200, and the drive structure 400 is fixedly connected to the control structure 300. In other embodiments, the control structure 300 can be detachably assembled with the drive structure. The drive structure 400 and the control handle 100 can be fixedly connected, detachably connected, or the drive structure 400 and the control structure 300 can be unconnected.

[0052] In one embodiment, the drive structure 400 and the control structure 300 are not connected or are detachably connected. When the adjusting tube 330 is rotatably and detachably inserted into the cavity of the bending tube 200, the drive structure 400 is located on the proximal side of the control handle 100, and the proximal end of the control structure 300 passes through the control handle 100 and is detachably assembled with the drive structure 400. When the adjusting tube 330 is rotatably and detachably sleeved on the bending tube 200, the drive structure is located on the distal side of the control handle 100, the proximal end of the control structure 300 is connected to the drive structure 400, and the proximal end of the bending tube 200 passes through the drive structure 400 and extends to the control handle 100. Thus, when using this bending sheath assembly, the control structure 300 and the drive structure 400 can be removed together according to actual needs.

[0053] Please see Figure 1 , Figure 2 and Figure 7 In one embodiment, the control structure 300 includes a proximal portion 310, a distal portion 320, and an adjusting tube 330. The proximal end of the proximal portion 310 is connected to the drive structure 400. The distal portion 320 is located at the distal end of the adjusting tube 330 and is annular. The proximal end of the adjusting tube 330 is connected to the distal end of the proximal portion 310, and the distal end of the adjusting tube 330 is connected to the proximal end of the proximal portion 310. The adjusting tube 330 radially overlaps with the bending tube segment 210, and in the non-bending state, the adjusting tube 330 extends axially along the bending tube 200.

[0054] It should be noted that when the control structure 300 is driven to rotate around the axis of the bending pipe 200 by the drive structure 400, different positions of the adjusting pipe 330 in the circumferential direction are radially aligned or radially overlapped with the portion of the bending pipe section 210 on the small bend side, thereby adjusting the ease and radius of bending of the bending pipe section 210 on the small bend side. In other words, the adjusting pipe 330 is configured such that, when the same force is applied, different parts in the circumferential direction have different degrees of bending when bending on the small bend side. By selecting these different circumferential positions to be radially aligned with the small bend side of the bending pipe section 210, the degree of bending of the bending pipe section 210 can be adjusted, that is, the bending radius and bending angle can be adjusted.

[0055] It should also be noted that the regulating pipe 330 and the bending pipe section 210 can be bent synchronously, so that the bending pipe 200 has different bending radii. Furthermore, the thinner the regulating pipe 330 is, the better, provided that the bending radius of the bending pipe 200 can be adjusted. The regulating pipe 330 can be a simple single-layer pipe structure or a composite pipe structure formed by multiple layers.

[0056] In one embodiment, the control structure 300 may consist only of a proximal portion 310 and a bending tube 330, with the distal end of the proximal portion 310 connected to the proximal end of the bending tube 330.

[0057] Alternatively, the control structure 300 may consist only of a distal portion 320 and a bending tube 330, with the proximal end of the distal portion 320 connected to the distal end of the bending tube 330. The proximal end of the bending tube 330 extends toward and connects to the drive structure 400.

[0058] Please see Figure 7 and Figure 8 In one embodiment, the regulating tube 330 includes a plurality of first arc segments 331 connected end-to-end and distributed circumferentially along the regulating tube 330. At least one of the first arc segments 331 has a different hardness than the other first arc segments 331. Understandably, "end-to-end" in the above context refers to two opposite sides in the circumferential direction.

[0059] It is worth noting that the different hardness referred to in this embodiment can be caused by different materials, or by the same material but different thicknesses. Both of these solutions are within the scope of this embodiment.

[0060] Please see Figure 1 and Figure 7 In one embodiment, the drive structure 400 is provided with multiple marks (not shown in the figures) for indicating the circumferential position of the adjustment tube 330, and the multiple marks correspond one-to-one with several first arc segments 331. In this way, the position on the adjustment tube 330 corresponding to the small bend side can be determined in real time by the marks, which is convenient for the operator to adjust the position of the adjustment tube 330.

[0061] In one embodiment, the regulating tube 330 includes six first arc segments 331, each with a different hardness. The six first arc segments 331 are joined end-to-end in the circumferential direction by a heat-melting process to form a single tube.

[0062] It should be noted that the appendix Figure 8 The diagram shows different cross-sectional lines illustrating the first arc segments 331 with varying hardness. The tube body, formed from six segments of material with different hardnesses, exhibits at least six locations on the adjusting tube 330 with varying bending strengths when each segment of the first arc segment 331 is bent as a small bend. By aligning these six locations with varying bending strengths radially with the small bend of the adjusting tube segment 210 after bending, the bending strength of the adjusting tube 330 after overlapping with the adjusting tube segment 210 can be adjusted, thereby achieving adjustable bending degree of the adjusting tube 200. Furthermore, the number of first arc segments 331 included in the adjusting tube 330 can be determined according to requirements, and can be 3, 4, 5, etc. The size of each first arc segment 331 can be the same or different.

[0063] Please see Figure 9In one embodiment, the proximal cross-section and the distal cross-section of each of the first arc segments 331 included in the regulating tube 330 are not the same.

[0064] In one embodiment, the structures of the proximal portion 310 and the distal portion 320 are identical to those of the regulating tube 330. Specifically, both the proximal portion 310 and the distal portion 320 are composed of several first arc segments 331 connected end-to-end in the circumferential direction. Furthermore, at least one of these first arc segments 331 has a different hardness than the remaining first arc segments 331. For details, please refer to [reference needed]. Figure 1 With this configuration, the proximal portion 310, the distal portion 320, and the regulating tube 330 can be processed into a single tube body by heat fusion. In other embodiments, only the structure of the proximal portion 310 may be the same as that of the regulating tube 330, or only the structure of the distal portion 320 may be the same as that of the regulating tube 330.

[0065] Alternatively, in other embodiments, the proximal portion 310 and the distal portion 320 may be omitted, and the control structure 300 may consist only of the regulating tube 330.

[0066] Please see Figure 10 In one embodiment, the control structure 300 includes an adjusting tube 300 and a distal portion 320, wherein the adjusting tube 300 has a gap 301 extending axially along the adjusting tube 330. The adjusting tube 330 includes at least one second arcuate segment 332. The distal portion 320 is connected to the distal end of the second arcuate segment 332, and the distal portion 320 has an annular structure to prevent damage to the blood vessel wall from the distal end of the second arcuate segment 332 during bending.

[0067] Furthermore, the control structure 300 may also include a proximal portion 310, which is also annular, to facilitate connection of the proximal end of the control structure 300 to other components, or to facilitate operation of the control structure 300 at the proximal end.

[0068] It should be noted that there can be one or more second arc segments 332; when there are multiple second arc segments 332, the hardness of the multiple second arc segments 332 can be the same or different.

[0069] Please see Figure 1 and Figure 10 In one embodiment, the drive structure 400 is provided with a plurality of marks (not shown in the figure) for indicating the circumferential position of the adjustment tube 330, and the plurality of marks correspond one-to-one with the gap 301 and the second arc segment 332.

[0070] Please see Figure 10 and Figure 11In one embodiment, a gap 301 is provided on the regulating tube 330. Multiple second arc segments 332 are provided, and the multiple second arc segments 332 are joined together in the circumferential direction to form an integral arc segment.

[0071] It should be noted that, Figure 11 The location of gap 301 is where the section line is not drawn. The regulating pipe 330 is subjected to the bending pipe section 210 (see...). Figure 2 When the regulating pipe 330 bends due to the force of the bending, there are two bends: a large bend and a small bend. When either the large or small bend is located at the gap 301, the hardness of the regulating pipe 330 at that bend can be considered to be 0. Thus, different parts of the regulating pipe 330 in the circumferential direction have different hardnesses. Furthermore, Figure 11 Different cross-sectional lines show the second arc segments 332 with different hardness. In this embodiment, the hardness of the multiple second arc segments 332 is different.

[0072] Please see Figure 12 and Figure 13 In one embodiment, the regulating pipe 330 is provided with three gaps 301, and correspondingly, three second arc segments 332 are also provided. The three gaps 301 and the three second arc segments 332 are alternately distributed in the circumferential direction of the regulating pipe 330. It should be noted that... Figure 13 Different cross-sectional lines indicate the second arc segments 332 with different hardnesses. The locations without cross-sectional lines are where gaps 301 are located. The number of gaps 301 can differ from the number of second arc segments 332, thus ensuring at least two second arc segments 332 are circumferentially connected. It should be noted that the terms "first" in "first arc segment 331" and "second" in "second arc segment 332" are merely used to distinguish arc segments described in different embodiments and do not indicate order, importance, or quantity. In embodiments including "second arc segment 332," the presence of "second arc segment 332" does not imply the presence of "first arc segment 331."

[0073] Please refer to it again. Figure 1 and Figure 14 In one embodiment, the control structure 300 is sleeved on the bending tube 200. The drive structure 400 is disposed on the distal end of the control handle 100, and the proximal end of the drive structure 400 is connected to the distal end of the control handle 100. The proximal end of the control structure 300 extends into the drive structure 400 and is connected to the proximal inner wall of the drive structure 400. In this embodiment, the control structure 300 only includes the adjusting tube 330, the proximal end of which extends into and is connected to the drive structure 400. In other embodiments, when the control structure 300 also includes a proximal portion 310, the proximal portion 310 extends into and is fixedly connected to the drive structure 400.

[0074] In one embodiment, the drive structure 400 includes a control body 410 and a connecting portion 420. The distal end face of the control body 410 is a conical or spherical surface, and the proximal end of the control body 410 is provided with an annular groove 411, which is used for rotatable connection with the distal end of the control handle 100. That is, after the control handle 100 is assembled with the annular groove 411, the drive structure 400 can rotate relative to the control handle 100, thereby driving the control structure 300 to rotate relative to the bending tube 200.

[0075] Please continue reading. Figure 1 and Figure 14 In one embodiment, the control handle 100 includes a main housing 110, a bending wire control member 120, and a bending wire connector 130. The main housing 110 is fitted onto the proximal end of the bending tube 200. The main housing 110 includes a head portion 111 having a first radial dimension and a cylindrical portion 112 having a second radial dimension. The cylindrical portion 112 is connected to the proximal side of the head portion 111, and the first radial dimension is larger than the second radial dimension for easy gripping by the user. The bending wire control member 120 is movably mounted on the main housing 110. The bending wire connector 130 is installed inside the bending wire control member 120 and passes through the bending tube 200, with the distal end of the bending wire connector 130 connected to the proximal end of the bending wire 250. It is worth noting that the bending wire control component 120 can move relative to the main housing 110 to control the bending wire connector 130 to tighten or loosen the bending wire 250, thereby controlling the deflection of the distal end of the bending tube 200.

[0076] In this embodiment, the distal end of the bending wire control member 120 is rotatably assembled with the head end portion 111, and the proximal end is rotatably assembled with the cylindrical portion 112. The radial dimension of the bending wire control member 120 is the same as the second radial dimension, so that when the bending wire 250 is not operated, the bending wire control member 120 and the cylindrical portion 112 form a larger grip portion for easy holding by the user, facilitating the user's operation of the drive structure 400 to rotate relative to the main housing 110. The radial dimension of the distal end of the head end portion 111 is the same as the radial dimension of the proximal end of the control member body 410. A locking portion 113 is provided on the head end portion 111 near the control body 410. The rotatable assembly of the drive structure 400 and the control handle 100 is achieved through the annular groove 411 and the locking portion 113.

[0077] Please see Figure 14In one embodiment, the bending wire control member 120 is provided with an internal threaded hole 101 extending along the axial direction of the bending tube 200. Correspondingly, the outer wall of the bending wire connector 130 is provided with an external thread 131 that matches the internal threaded hole 101. When the bending wire control member 120 rotates relative to the main housing 110 about the axis of the bending tube 200, it drives the bending wire connector 130 to move along the axial direction of the bending tube 200. The bending wire connector 130 is connected to the bending wire 250, and can control the tightening or loosening of the bending wire 250 during the movement of the bending wire connector 130.

[0078] Please see Figure 14 and Figure 15 When using the adjustable bending sheath assembly, the control structure 300 and the bending tube 200 are initially assembled on the control handle 100 and then inserted into the blood vessel. The bending wire connector 130 can be moved proximally to the control handle 100 by rotating the bending wire control component 120, causing the bending wire 250 within the bending tube 200 to be stretched and displaced, thus bending the bending tube segment 210 on the bending tube 200. When the bending radius and angle of the adjustable bending sheath assembly are not suitable for the current blood vessel structure, the rotatable drive structure 400 can be rotated to control the adjustment tube 330 to rotate relative to the bending tube 200, aligning different circumferential positions of the adjustment tube 330 with the bending direction of the bending tube 200, thereby adjusting the degree of bending of the bending tube segment 210 to suit blood vessel structures with different inner diameters or degrees of bending. For example, the point of minimum stiffness on the adjusting tube 330 can be aligned with the bending direction of the bending tube 200, thereby changing the bending strength at the overlap of the bending tube segment 210 and the adjusting tube 330, making the adjustable bending sheath assembly suitable for anatomical structures requiring greater bending.

[0079] Please see Figures 16 to 18 In one embodiment, the control structure 300 passes through the lumen of the bendable tube 200, and the bendable sheath assembly includes a drive structure 400. In this case, the drive structure 400 is not connected to the control handle 100, and the drive structure 400 is located on the proximal side of the control handle 100. The proximal end of the control structure 300 passes through the lumen of the bendable tube 200 and is connected to the drive structure 400.

[0080] In this embodiment, the control structure 300 further includes a proximal portion 310 and a distal portion 320. The proximal portion 310 and the distal portion 320 have the same structure, but differ from the structure of the regulating tube 330. The regulating tube 330 is formed by connecting six first arc segments 331, each with different hardness, end to end in the circumferential direction. The proximal portion 310, the distal portion 320, and the regulating tube 330 integrally form the control structure 300. It can be understood that in this embodiment where the control structure 300 passes through the bending tube 200, when the regulating tube 300 is a closed tube structure excluding the gap 301, the control structure 300 may also consist only of the regulating tube 330.

[0081] Please see Figure 17 In one embodiment, a guide wire channel 302 for the guide wire to pass through is provided inside the control structure 300 along its axial direction, and a corresponding through hole (not shown in the figure) communicating with the guide wire channel 302 is provided on the drive structure 400. It should be noted that the control structure 300 adopts a hollow cylindrical tube structure. The outer diameter of the control structure 300 is smaller than the inner diameter of the bending tube 200 to ensure that the control structure 300 can move freely within the cavity of the bending tube 200.

[0082] In one embodiment, the distal portion 320 is configured as a spherical shape to effectively prevent damage to the inner wall of the bending tube 200 when the control structure 300 moves within the lumen of the bending tube 200. The proximal end of the control structure 300 is connected to the drive structure 400, and the movement of the drive structure 400 does not interfere with the main housing 110.

[0083] Please continue reading. Figure 17 In one embodiment, a frustum 430 is provided on the side of the drive structure 400 near the main housing 110, and a cylindrical slot (not shown in the figure) is provided at the center of the frustum 430. The proximal end of the control structure 300 is inserted into the cylindrical slot to realize a detachable connection between the control structure 300 and the drive structure 400.

[0084] It should be noted that after assembly, the drive structure 400 can be detached from the near end of the control structure 300 as an independent component and reassembled as needed.

[0085] Please see Figure 17 In this embodiment, the head portion 111 includes a head and a tail, with the distal end of the bending wire control member 120 connected to the head and the proximal end connected to the tail. At this time, the cylindrical portion 112 can be fully held by the user, facilitating the user's manipulation of the bending wire control member 120 and the drive structure 400 relative to the main housing 110. It should be noted that the outer surface of the head can be a conical surface or a spherical surface.

[0086] The technical features of the above embodiments can be combined in any way. For the sake of brevity, not all possible combinations of the technical features in the above embodiments are described. However, as long as there is no contradiction in the combination of these technical features, they should be considered to be within the scope of this specification.

[0087] The above description discloses only preferred embodiments of the present invention and should not be construed as limiting the scope of the present invention. Therefore, equivalent variations made in accordance with the claims of the present invention are still within the scope of the present invention.

Claims

1. An adjustable bend sheath assembly comprising an adjustable bend tube having an adjustable bend tube segment, characterized by, The control structure comprises an adjusting tube which is sleeved on or penetrated in the bending tube; The adjusting tube comprises a plurality of first circular arc segments which are connected end to end and distributed along the circumference of the adjusting tube, wherein at least one of the first circular arc segments has a different hardness from the other first circular arc segments; or, the adjusting tube is provided with gaps extending along the axial direction, and the adjusting tube comprises at least one second circular arc segment, wherein the gaps and the second circular arc segment are distributed at different positions along the circumference of the adjusting tube; The adjusting tube can rotate around the axis of the bending tube to control different positions along the circumference of the adjusting tube to align with the bending direction of the bending tube segment, and the bending tube segment and the adjusting tube can be bent synchronously so that the bending tube can be bent at different bending radii.

2. The adjustable bend sheath assembly of claim 1, wherein, The hardness of the plurality of first circular arc segments is different, and the adjusting tube is an integral tube body formed by the plurality of first circular arc segments connected end to end along the circumference.

3. The adjustable bend sheath assembly of claim 1, wherein, The gaps are provided in plurality, and the second circular arc segments are provided in plurality in correspondence, and the plurality of gaps and the plurality of second circular arc segments are alternately distributed along the circumference of the adjusting tube.

4. The adjustable bend sheath assembly of claim 3, wherein, The hardness of the plurality of second circular arc segments is the same, or at least one of the second circular arc segments has a different hardness from the other second circular arc segments.

5. The adjustable bend sheath assembly of any of claims 1-4, wherein, The control structure further comprises: a proximal end portion connected to the proximal end of the adjusting tube; and / or a distal end portion connected to the distal end of the adjusting tube, and the distal end portion can move synchronously with the distal end of the adjusting tube when the adjusting tube is bent.

6. The adjustable bend sheath assembly of claim 5, wherein, When the adjusting tube is provided with gaps extending along the axial direction, the adjusting tube comprises at least one second circular arc segment, and the gaps and the second circular arc segment are distributed at different positions along the circumference of the adjusting tube, the control structure further comprises the distal end portion, and the distal end portion is annular.

7. The adjustable bend sheath assembly of claim 1, wherein, Further comprising: a driving structure connected to the proximal end of the adjusting tube, and the driving structure can drive the adjusting tube to rotate around the axis of the bending tube.

8. The adjustable bend sheath assembly of claim 7, wherein, The driving structure is provided with a plurality of marks for indicating the circumferential position of the adjusting tube, and the plurality of marks correspond to the plurality of first circular arc segments one by one; or, the plurality of marks correspond to the gaps and the second circular arc segments one by one.

9. The adjustable bend sheath assembly of claim 7, wherein, The adjustable bending sheath assembly further comprises a control handle connected to the proximal end of the bending tube; when the adjusting tube is rotatably and detachably penetrated in the lumen of the bending tube, the driving structure is located on the proximal end side of the control handle, and the proximal end of the adjusting tube penetrates out of the proximal end of the control handle and is connected to the driving structure; when the adjusting tube is rotatably sleeved on the bending tube, the proximal end of the driving structure is connected to the distal end of the control handle or the driving structure is not connected to the control handle, and the bending tube penetrates through the driving structure and extends to the control handle.

10. The adjustable bend sheath assembly of claim 9, wherein, The side wall of the bending pipe is provided with a bending wire, and the control handle comprises a main shell, a bending wire control member and a bending wire connecting member; the main shell is sleeved on the proximal end of the bending pipe; the bending wire control member is installed on the main shell; the bending wire connecting member is installed in the interior of the bending wire control member, and the bending wire connecting member is connected with the proximal end of the bending wire; the bending wire control member can move relative to the main shell to control the bending wire connecting member to tighten or loosen the bending wire.

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