Bending-adjustable sheathing canal

Abstract

The invention belongs to the technical field of medical instruments, and particularly relates to a bending-adjustable sheathing canal which comprises a canal body and a traction wire, the canal body comprises a reinforcing layer and an outer layer which are sequentially bonded from inside to outside, and the canal body comprises a main body section arranged on the near-end side and a bending-adjustable section arranged on the far-end side. The reinforcing layer comprises a woven mesh pipe formed by overlapping at least two woven filaments, the woven mesh pipe is provided with a plurality of grid units, each grid unit is provided with a plurality of cross points, and each cross point is formed by overlapping two woven filaments; the far end of the traction wire is fixed with the adjustable bending section; wherein the reinforcing layer is provided with reinforcing areas extending in the axial direction at the adjustable bending section, and the reinforcing areas are staggered in the circumferential direction of the pipe body relative to the joint of the traction wire and the pipe body. Through the arrangement, when the bending adjusting section of the bending-adjustable sheathing canal is bent and passes through an instrument, the shape of the bending adjusting section can be maintained to ensure that the instrument is smoothly conveyed, so that the target position can be quickly aligned, the operation time is shortened, and the operation success rate is improved.

Description

Technical Field

[0001] The invention belongs to the technical field of medical devices, and particularly relates to an adjustable curved sheath tube. Background Art

[0002] Medical sheaths have been widely used in minimally invasive interventional diagnosis and treatment surgeries to establish channels, deliver or retrieve instruments, infuse drugs or remove body fluids, etc. Compared with ordinary sheaths, adjustable sheaths have a distal adjustable bending function. Through the free bending at the distal end, they can quickly and reliably reach the target lesion location to reduce the operation time.

[0003] The bending section of the adjustable sheath needs to be deformed and bent at different angles, so the hardness of the bending section needs to be smaller than that of the main section of the sheath. Figure 1 , Figure 1 This is the theoretical state. At this time, the sheath is adjusted to the branch blood vessel, and then the catheter / delivery system and other devices are delivered along the guide wire. However, in the actual bending process, when the device passes through the bending section, the bending section tends to straighten, and the harder traction wire will pull the softer bending section. The softer bending section will twist to the left and right due to stacking and other reasons, causing the bending sheath to move to the left and right ( Figure 1 The two sides (the vertical direction of the paper plane is the left and right sides) deviate from the predetermined branch vessel opening, causing the instrument to be unable to align with the branch vessel and difficult to enter the branch vessel smoothly.

[0004] Therefore, in view of the above shortcomings, the present invention is proposed. Summary of the invention

[0005] The purpose of the present invention is to provide an adjustable bending sheath tube to solve the problem in the prior art that the bending section of the adjustable bending sheath tube is twisted and deflected when conveying an instrument after being bent.

[0006] The present invention provides an adjustable bend sheath tube, comprising: a tube body, the tube body comprising a reinforcement layer and an outer layer bonded in sequence from the inside to the outside, the tube body comprising a main section arranged on the proximal side and an adjustable bend section arranged on the distal side, the reinforcement layer comprising a braided mesh tube composed of at least two overlapping braided wires, the braided mesh tube having a plurality of grid units, each grid unit having a plurality of intersections, each intersection being formed by the overlap of two braided wires; a traction wire, the distal end of which is fixed to the adjustable bend section; wherein the reinforcement layer has a reinforcement area extending axially at the adjustable bend section, and the reinforcement area is staggered with each other in the circumferential direction of the tube body relative to the connection between the traction wire and the tube body.

[0007] In a specific embodiment of the present invention, in the reinforcement area, at least some of the intersections of some of the grid units are fixedly connected.

[0008] In a specific embodiment of the present invention, the intersection is fixed by welding or bonding.

[0009] In a specific embodiment of the present invention, the intersection is fixed by anchor nails.

[0010] In a specific embodiment of the present invention, through holes are provided on the two braided wires at the intersection; the anchor comprises a cap and an insertion portion connected to each other, the insertion portion is inserted into the through hole so that the cap abuts against the braided wire, and the free end of the insertion portion is fixedly connected to the outer layer.

[0011] In a specific embodiment of the present invention, the two braided wires at the intersection are fixed by a cross fixing piece.

[0012] In a specific embodiment of the present invention, the cross fixing member includes a cross cover and a plug-in portion, the plug-in portion is four and is disposed at four ends of the same side of the cross cover, the cross cover is disposed at the intersection and the four plug-in portions are respectively plugged into the intersection gaps around the intersection; and / or

[0013] The cross fixing member is a flexible rope, and the flexible rope is wound around the intersection to form a cross knot to fix the two braided wires forming the intersection.

[0014] In a specific embodiment of the present invention, two intersection points in the grid unit where the connecting line is perpendicular to the axial direction of the tube body are connected by transverse ribs.

[0015] In a specific embodiment of the present invention, at least two intersections in the grid unit whose connecting lines are parallel to the axial direction of the tube body are connected by longitudinal ribs, and two adjacent intersections connected by the longitudinal ribs are located on the same grid unit or on different grid units.

[0016] In a specific embodiment of the present invention, the intersection points at the distal end and the intersection points at the proximal end of at least one column of mesh units of the braided mesh tube are connected by triangular connecting ribs, and the three vertices of the triangular connecting ribs are fixedly connected to three different intersection points respectively.

[0017] In a specific embodiment of the present invention, the transverse ribs, longitudinal ribs or triangular connecting ribs are metal wires, which are fixedly connected to the intersections; and / or the transverse ribs, longitudinal ribs or triangular connecting ribs are flexible ropes, which are fixedly connected to the intersections via knots.

[0018] The adjustable bend sheath provided by the present invention is provided with a reinforcement area extending axially in the adjustable bend section of the reinforcement layer of the tube body, so that the anti-extrusion and anti-extension capabilities of the corresponding position can be improved. In this way, when the adjustable bend section has a tendency to deform to the left or right side of the plane where the adjustable bend section is located after being bent, the reinforcement area will be pulled, so that the shape can be effectively maintained, that is, the adjustable bend sheath will not be twisted and deflected to the left or right side of the plane where the adjustable bend section is located after being bent. Through the above arrangement, during surgery, when the bending section of the adjustable bend sheath passes the instrument after being bent, the shape of the bending section can be maintained to ensure smooth transportation of the instrument, thereby achieving rapid alignment, shortening the operation time, and improving the success rate of the operation. BRIEF DESCRIPTION OF THE DRAWINGS

[0019] In order to more clearly illustrate the specific implementation methods of the present invention or the technical solutions in the prior art, the drawings required for use in the specific implementation methods or the description of the prior art will be briefly introduced below. Obviously, the drawings described below are some implementation methods of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying creative work.

[0020] Figure 1 It is a schematic diagram of the use status of the adjustable bending sheath tube under the theoretical state;

[0021] Figure 2 It is a front view of the adjustable bending sheath tube of the present invention;

[0022] Figure 3 A three-dimensional diagram of the adjustable bending sheath tube of the present invention;

[0023] Figure 4 It is a partial structural stereogram of the adjustable bending sheath tube of the present invention, wherein the outer layer of the adjustable bending sheath tube is removed;

[0024] Figure 5 It is a partial structural schematic diagram of an adjustable bending sheath tube according to Example 1 of the present invention, wherein the outer layer of the adjustable bending sheath tube is removed;

[0025] Figure 6 It is a partial structural schematic diagram of an adjustable bending sheath tube according to Example 1 of the present invention, wherein the outer layer of the adjustable bending sheath tube is removed;

[0026] Figure 7 It is a partial structural schematic diagram of an adjustable bending sheath tube according to Example 1 of the present invention, wherein the outer layer of the adjustable bending sheath tube is removed;

[0027] Figure 8 It is a partial structural schematic diagram of an adjustable bending sheath tube according to Example 2 of the present invention, wherein the outer layer of the adjustable bending sheath tube is removed;

[0028] Fig. 9This is a schematic diagram of the structure of the anchor in Example 2 of the present invention;

[0029] Fig.10 Schematic diagram of the connection between the anchor pin and the intersection of the grid unit in Example 2 of the present invention;

[0030] Fig.11 It is a partial structural schematic diagram of an adjustable bending sheath tube according to Example 3 of the present invention, wherein the outer layer of the adjustable bending sheath tube is removed;

[0031] Fig.12 This is a schematic diagram of the structure of a cross fixing member in Embodiment 3 of the present invention;

[0032] Fig.13 Schematic diagram of the connection between the cross fixing member and the intersection of the grid unit in Example 3 of the present invention;

[0033] Fig.14 Schematic diagram of the connection between the cross fixing member and the intersection of the grid unit in Example 4 of the present invention;

[0034] Fig.15 Schematic diagram of the connection between the cross fixing member and the intersection of the grid unit in Example 5 of the present invention;

[0035] Fig.16 Schematic diagram of the connection between the cross fixing member and the intersection of the grid unit in Example 6 of the present invention.

[0036] Description of reference numerals:

[0037] 100-Adjustable curved sheath;

[0038] 10-tube body, 11-adjustable bend section, 12-main section, 13-outer layer, 14-reinforcement layer, 15-inner layer, 16-TIP head, 17-braided mesh tube, 18-grid unit, 19-intersection point;

[0039] 20-traction mechanism, 21-traction wire, 22-traction wire tube, 23-traction ring;

[0040] 30-developing ring, 40-anchor nail, 41-cap, 42-insertion part; 50-cross fixing piece, 51-cross cover plate, 52-insertion part; 60-triangular connecting rib, 70-transverse rib, 80-longitudinal rib. DETAILED DESCRIPTION

[0041] The exemplary embodiments of the present invention will be described in more detail below with reference to the accompanying drawings. Although the exemplary embodiments of the present invention are shown in the accompanying drawings, it should be understood that the present invention can be implemented in various forms and should not be limited by the embodiments described herein. On the contrary, these embodiments are provided in order to enable a more thorough understanding of the present invention and to fully convey the scope of the present invention to those skilled in the art.

[0042] It should be understood that the terms used herein are only for the purpose of describing specific example embodiments and are not intended to be limiting. Unless the context clearly indicates otherwise, the singular forms "one", "an" and "said" as used herein may also be meant to include plural forms. The terms "include", "comprise", "contain", and "have" are inclusive, and therefore specify the existence of stated features, steps, operations, elements and / or parts, but do not exclude the existence or addition of one or more other features, steps, operations, elements, parts, and / or combinations thereof. The method steps, processes, and operations described herein are not interpreted as necessarily requiring them to be performed in the specific order described or illustrated, unless the execution order is clearly indicated. It should also be understood that additional or alternative steps may be used.

[0043] Although the terms first, second, third, etc. can be used in the text to describe multiple elements, components, regions, layers and / or sections, these elements, components, regions, layers and / or sections should not be limited by these terms. These terms can only be used to distinguish an element, component, region, layer or section from another region, layer or section. Unless the context clearly indicates, terms such as "first", "second" and other numerical terms do not imply order or sequence when used in the text. Therefore, the first element, component, region, layer or section discussed below can be referred to as the second element, component, region, layer or section without departing from the teaching of the example embodiments.

[0044] For ease of description, spatial relative terms may be used herein to describe the relationship of one element or feature relative to another element or feature as shown in the figure, such as "inside", "outside", "inner side", "outer side", "below", "below", "above", "above", etc. Such spatial relative terms are intended to include different orientations of the device in use or operation in addition to the orientation depicted in the figure. For example, if the device in the figure is turned over, then the elements described as "below other elements or features" or "below other elements or features" will subsequently be oriented as "above other elements or features" or "above other elements or features". Therefore, the example term "below..." can include both upper and lower orientations. The device can be oriented otherwise (rotated 90 degrees or in other directions) and the spatial relative descriptors used in the text are interpreted accordingly.

[0045] In addition, it should be noted that in the field of interventional medical devices, the end of a medical device implanted in a human or animal body or a delivery system that delivers the medical device 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", and the "proximal end" and "distal end" of any component of a medical device or delivery system are defined based on this principle. "Axial" generally refers to the length direction of a medical device when it is being delivered, and "radial" generally refers to the direction of a medical device that is perpendicular to its "axial direction", and the "axial" and "radial" of any component of a medical device are defined based on this principle.

[0046] Since the existing adjustable sheath tube 100a is prone to twisting and deflection when conveying instruments after being bent, the present invention proposes an adjustable sheath tube 100, which aims to reduce the twisting and deflection of the adjustable bend section 11 after being bent, so as to achieve rapid alignment and shorten the operation time.

[0047] In view of the above, refer to Figure 2-16 The present invention provides an adjustable bend sheath tube 100, which includes a tube body 10 and a traction wire 21. Along the axial direction of the tube body 10, the tube body 10 includes a main section 12 arranged on the proximal side and an adjustable bend section 11 coaxially connected to the distal side of the main section 12; the traction wire 21 is arranged in the tube body 10 and extends axially to the adjustable bend section 11; wherein the tube body 10 has an axially extending reinforcement zone at the adjustable bend section 11, and the reinforcement zone and the traction wire 21 are staggered with each other in the circumferential direction of the tube body 10.

[0048] In the present invention, the tube body 10 has a reinforced area extending axially in the bending section, so that the anti-extrusion and anti-extension capabilities of the corresponding position can be improved. In this way, when the adjustable bending section 11 tends to deform to the left and right sides of the plane where the tube body 10 is located after bending, the reinforced area will be pulled, so that the shape can be effectively maintained and it is not easy to twist and deform to the opposite side, that is, the adjustable bending sheath tube 100 will not twist and deflect to the left and right sides of the plane where the tube body is located after bending. Therefore, during surgery, when the bending section of the adjustable bending sheath tube 100 is bent and passes the instrument, the shape of the bending section can be maintained to ensure smooth delivery of the instrument, thereby achieving rapid alignment, shortening the operation time, and improving the success rate of the operation.

[0049] In order to ensure the support strength of the sheath tube body 10 during the delivery process, and to ensure the effective bending of the distal end of the tube body 10 while minimizing the force intensity during the long-distance pulling of the distal end, in other embodiments, the hardness of the bending section is less than that of the main section. For example, the hardness of the bending section is between 20D and 50D, and the hardness of the main section 12 is between 60D and 80D.

[0050] In addition, refer to Figure 2-4As shown, the tube body 10 may also include a TIP head 16 coaxially docked at the distal end of the adjustable bend section 11. The hardness of the TIP head 16 is greater than the hardness of the bend adjustment section, so that the hardness of the distal end of the sheath is enhanced, which facilitates the adjustable bend sheath 100 to enter the blood vessel. Among them, in order to facilitate manufacturing, the hardness of the TIP head 16 is the same as the hardness of the main section 12. The axial edge of the distal end of the TIP head 16 is tilted inward, so that the distal end of the TIP head 16 is in a constricted shape, which not only facilitates guiding the tube body 10 into the blood vessel, but also avoids the prism-shaped structure of the distal edge of the TIP head 16 from causing damage to the blood vessel wall.

[0051] Furthermore, the adjustable bending sheath tube 100 further includes a developing ring 30 disposed at the distal end of the tube body 10, and the developing ring 30 can be developed under an X-ray device, and is used to accurately locate the position of the blood vessel in which the tube body 10 is located. Among them, when the TIP head 16 is not provided at the distal end of the adjustable bending section 11, the developing ring 30 is relatively fixed to the adjustable bending section 11. When the TIP head 16 is provided at the distal end of the bending adjustment section, the developing ring 30 can be relatively fixed to the TIP head 16.

[0052] Furthermore, the adjustable bend sheath tube 100 may also include a traction structure for bending the bend adjustment section of the tube body 10. The traction structure includes at least a traction wire 21. Among them, when the TIP head 16 is not provided at the distal end of the bend adjustment section, the distal end of the traction wire 21 is connected to the adjustable bend section 11, and the bending of the adjustable bend section 11 is achieved by pulling the proximal end of the traction wire 21. When the TIP head 16 is provided at the distal end of the adjustable bend section 11, the distal end of the traction wire 21 is connected to the TIP head 16, and the TIP head 16 drives the adjustable bend section 11 to bend by pulling the proximal end of the traction wire 21. When the traction wire 21 is released, under the action of the elastic restoring force, the distal end of the adjustable bend sheath tube 100 straightens, and recovers from the bent state to the axially straightened state.

[0053] It should be noted that, as one arrangement of the traction mechanism 20, the traction wire 21 can be arranged outside the tube body 10, and the distal end of the traction wire 21 can be connected to the outer wall of the tube body 10. As another arrangement of the traction mechanism 20, the traction wire 21 can be arranged in the inner wall of the tube body 10, and the distal end of the traction wire 21 can be connected to the inside of the tube body 10.

[0054] Furthermore, in order to facilitate the connection between the traction wire 21 and the tube body 10, the traction structure also includes a traction ring 23. Among them, when the distal end of the adjustable bend section 11 is not provided with a TIP head 16, the traction ring 23 is relatively fixed to the adjustable bend section 11, and the distal end of the traction wire 21 is connected to the traction ring 23, thereby realizing the connection between the distal end of the traction wire 21 and the adjustable bend section 11. When the distal end of the bend adjustment section is provided with a TIP head 16, the traction ring 23 is relatively fixed to the TIP head 16, and the distal end of the traction wire 21 is connected to the traction ring 23, thereby realizing the connection between the distal end of the traction wire 21 and the TIP head 16.

[0055] It should be noted that when the adjustable bending sheath tube 100 includes both the developing ring 30 and the traction ring 23, the developing ring 30 and the traction ring 23 are arranged side by side along the axial direction of the tube body 10. The developing ring 30 is located at the distal end of the traction ring 23.

[0056] In other exemplary embodiments, the traction structure further includes a traction wire tube 22. The traction wire tube 22 is disposed in the tube body 10, the traction wire 21 is passed through the traction wire tube 22 and can slide in the traction wire tube 22, and the distal end of the traction wire 21 passes through the pipeline to be connected to the adjustable bend 11 or the traction ring 23.

[0057] It should be noted that the traction structure and the configuration of the traction structure are not limited to the above, and can be configured according to actual needs, and can also be further optimized and improved on this basis.

[0058] For example, Figure 2-4 As shown, the pipe body 10 includes an inner layer 15, a reinforcement layer 14 and an outer layer 13 from the inside to the outside. Among them, since one, two or three of the inner layer 15, the reinforcement layer 14 and the outer layer 13 can be arranged in two sections with different hardness in the axial direction, their arrangement can achieve the purpose of adjusting the bending section. It should be noted that the pipe body 10 of this embodiment includes three layers, which is only exemplified based on the number of layers of the existing pipe body 10 structure and is not limited to this. For example, the number of layers of the pipe body 10 can also be set to two layers, three layers or more than three layers. However, no matter how many layers are set, the overall design concept of different hardness and setting a reinforcement area on the reinforcement layer 14 can refer to the three-layer setting method of this embodiment.

[0059] Correspondingly, since one, two or three of the inner layer 15, the reinforcement layer 14 and the outer layer 13 can be axially reinforced to form a reinforcement zone, their settings all achieve the purpose of strengthening the bending section. The settings of the specific reinforcement zones of the inner layer 15, the reinforcement layer 14 and the outer layer 13 in the three-layer structure are not fully exemplified here. This embodiment is only illustrated by taking the reinforcement zone provided in the reinforcement layer 14 as an example, and the settings of other layers or other two or three layers can refer to this embodiment. In addition, in this embodiment, the tube body 10 of this embodiment includes a TIP head 16, and the adjustable bending sheath tube 100 includes a traction mechanism 20 and a developing ring 30. That is, the adjustable bending sheath tube 100 of this embodiment includes a tube body 10 and a traction mechanism 20, and the tube body 10 includes a TIP head 16, an adjustable bending section 11 and a main section 12 connected in sequence from far to near, and the traction structure includes a traction ring 23, a traction wire tube 22 and a traction wire 21, and a developing ring 30 is also provided at the TIP head 16.

[0060] Specific, combined Figure 2-4The inner layer 15 is a PTFE tube, the reinforcing layer 14 is a spring tube and / or a braided mesh tube 17, and the outer layer 13 is a polymer tube. The PTFE tube is in the innermost layer 15 of the adjustable bending sheath tube 100, which extends the entire tube body 10 and provides a smooth inner cavity for the sheath tube, which is convenient for the delivery of other instruments. The traction ring 23 is made of stainless steel material, which is located at the TIP head 16 position of the sheath tube, and is sleeved on the outer wall of the PTFE tube together with the developing ring 30, and is coated inside the TIP head 16. The traction wire tube 22 is arranged in the cavity structure of the inner layer 15 and the reinforcing layer 14. The traction wire tube 22 can extend from the proximal end to the distal end of the adjustable bending sheath tube. The traction wire tube 22 can be made of PEBAX material, PTFE material, PU material, PEEK material, and stainless steel material. The outer wall of the traction wire tube 22 is respectively fitted with the outer wall of the inner layer 15 and the outer wall of the reinforcing layer 14. The traction wire 21 is made of stainless steel and is inserted into the traction wire tube 22 and can slide in the tube. The distal end of the traction wire 21 passes through the tube and is welded to the traction ring 23. The proximal end of the traction wire 21 extends to the proximal end of the main section 12 and is connected to the bending adjustment mechanism of the handle (not shown in the figure). The traction wire 21 can be pulled by adjusting the bending adjustment mechanism of the handle, and the traction wire 21 transmits the pulling force to the traction ring 23. Since the hardness of the bending adjustment section 11 is lower than that of the main section 12, the adjustable bending section 11 bends after being subjected to unilateral force, while the main section 12 will not bend, thereby achieving the effect of bending the distal end of the sheath.

[0061] The spring tube or / or braided mesh tube 17 of the reinforcing layer 14 is located in the middle layer and is made of stainless steel. When it is a spring tube, it is spiral. When it is a braided mesh tube 17, it is woven by stainless steel wire. The spiral spring tube or braided braided mesh tube 17 extends from the bending section to the tail end of the main section 12, is sleeved on the outer wall of the PTFE tube of the inner layer 15 and the traction wire tube 22, and is coated in the polymer tube of the outer layer 13, which strengthens the sheath tube. Among them, the reinforcing layer 14 in this embodiment includes a braided mesh tube 17 composed of at least two braided wires overlapping, and the braided mesh tube has a plurality of grid units, each grid unit has a plurality of intersections, and each intersection is formed by the overlap of two braided wires. The braided mesh tube 17 has a reinforced area extending along its axial direction at the adjustable bend section 11, so as to improve the anti-compression and anti-extension capabilities of the corresponding position. In this way, when the adjustable bend section 11 tends to deform to the left and right sides of the plane where the tube body 10 is located after being bent, the reinforced area will be pulled, so as to effectively maintain the shape and not easily twisted and deformed to the opposite side, so that the adjustable bend sheath tube 100 will not twist and deflect to the left and right sides of the plane where the tube body 10 is located after being bent.

[0062] Exemplarily, the number of reinforcement areas of the reinforcement layer 14 in the adjustable bend section 11 is two, and in any cross section of the tube body 10, the two reinforcement areas are symmetrical about the radial line connecting the traction wire 21 and the axis of the tube body. The reinforcement areas on both sides have the ability to resist compression and extension, so that when the bending section has a tendency to deform to one side, the reinforcement area on the other side will be pulled, and the two sides will restrain each other so as to effectively maintain the shape and not easily twist and deform, that is, the adjustable bend sheath 100 will not deflect to the left or right. Therefore, during surgery, when the bending section of the adjustable bend sheath 100 is bent and passed through the instrument, because the shape of the traction wire 21 on both sides of the radial direction is stable, the shape of the bending section can be better maintained to ensure the smooth delivery of the instrument, thereby achieving rapid alignment, shortening the operation time, and improving the success rate of the operation.

[0063] Further, at any cross section of the tube body 10, the center angle of the reinforcement zone at any cross section of the tube body 10 is 0°-120°. For example, the center angle of the reinforcement zone at any cross section of the tube body 10 is 0°, 10°, 15°, 30°, 45°, 60°, 75°, 90°, 100°. Exemplarily, the center angle of the reinforcement zone at any cross section of the tube body 10 is 30°. Exemplarily, the center angle of the reinforcement zone at any cross section of the tube body 10 is 45°. The size of the center angle of the reinforcement zone at any cross section of the tube body 10 will affect the width of a single reinforcement zone, and the width of the reinforcement zone further affects the compression and extension strength and bending ability of the adjustable bend section 11 on that side. When the center angle of the reinforcement zone is within the above range, the reinforcement zone has an appropriate width and can simultaneously take into account the compression and extension strength and bending ability of the adjustable bend section 11, thereby improving the performance of the adjustable bend sheath tube 100.

[0064] Furthermore, in any cross section of the tube body 10, the central angle between the reinforcement zone and the traction wire 21 is 30°-120°. Exemplarily, the central angle between the reinforcement zone and the traction wire 21 is 30°, 45°, 60°, 70°, 90°, 100°, or any other angle between 30°-120°. Exemplarily, the central angle between the reinforcement zone and the traction wire 21 is 90°. In this way, the reinforcement zone is located on both sides of the adjustable bend sheath tube 100, which can reduce the impact on the bending ability of the adjustable bend section 11 while ensuring the anti-extrusion and anti-extension strength of the adjustable bend section 11 of the adjustable bend sheath tube 100.

[0065] Example 1

[0066] Reference Figure 5-7Based on the general design concept of the above-mentioned adjustable bending sheath tube 100, this embodiment exemplarily proposes a specific implementation of the adjustable bending sheath tube 100. As shown in the figure, the adjustable bending sheath tube 100 of this embodiment includes a tube body 10 and a traction wire 21, wherein the tube body 10 includes a braided mesh tube 17 and an outer layer 13 which are sequentially sleeved, and along the axial direction of the tube body 10, the tube body 10 includes a main body section 12 arranged on the proximal side and an adjustable bending section 11 arranged on the distal side, and the traction wire 21 is fixed to the adjustable bending section 11; wherein, at the adjustable bending section 11 of the braided mesh tube 17, at least part of the intersection points of the grid units 18 which are staggered with the traction wire 21 are fixedly connected, and the at least part of the grid units 18 extend along the axial direction of the tube body 10, thereby forming an axially extending reinforcement zone at the adjustable bending section 11 of the braided mesh tube 17, and the reinforcement zone and the traction wire 21 are staggered in the circumferential direction of the tube body 10.

[0067] Specifically, the grid unit 18 is formed into a rhombus or other shapes, such as a rectangle, a triangle, a trapezoid, and is woven by braided wires, and its size can be adjusted by the density of the braided wires. Exemplarily, this embodiment is described by taking the grid unit 18 as a rhombus as an example. The intersection 19 of the grid unit 18 is the common vertex of multiple adjacent rhombuses, and each grid unit 18 has 4 vertices, that is, it has 4 intersections 19.

[0068] In this embodiment, the two braided wires at the intersection 19 of the mesh unit 18 can be fixed by laser welding, resistance welding or other welding methods. In other embodiments, the intersection of the mesh unit 18 can also be fixed by bonding.

[0069] Exemplarily, at least part of the grid units 18 used to form the reinforcement zone are mainly distributed in one or more columns of the braided mesh tube 18. The central angle of a pair of vertices in the grid unit 18 whose connecting line is perpendicular to the axial direction of the tube body 10 at any cross section of the tube body 10 is the central angle of the grid unit 18 in this column. When the reinforcement zone includes only one column of grid units 18, the central angle of the grid unit 18 in this column is the central angle of the reinforcement zone at any cross section of the tube body 10. Further, in this embodiment, each reinforcement zone includes only one column of grid units 18.

[0070] Further, such as Figure 7 As shown, at the adjustable bend section 11, two braided wires are welded and connected at the intersection 19 of two rows of grid units 18 extending axially, and the two rows of grid units 18 are arranged on two opposite sides of the tube body 10 in the circumferential direction, and the central angle between each row of grid units 18 and the traction wire 21 is 90°.

[0071] Further, such as Figure 5 As shown, along the axial direction of the tube body 10, the two braided wires at all intersections 19 of each column of grid units 18 forming the reinforcement zone can be welded and connected. Figure 6As shown, in other embodiments, in each column of grid units 18 forming the reinforcement zone, the grid units 18 connected by two braided wires welded at the intersection 19 are arranged at intervals along the axial direction of the tube body 10 .

[0072] It should be noted that the fixing method at the intersection 19 of the grid unit 18 in this embodiment is mainly used for braided wires with circular cross-sections. Of course, braided wires with other cross-sections can also be applied to this embodiment.

[0073] In this embodiment, two reinforcement areas are arranged on the circumferential opposite sides of the braided mesh tube 17. The structures of the two reinforcement areas are basically the same and symmetrical about the line connecting the traction wire 21 and the axis of the tube body. When the bending section has a tendency to deform to one side, the reinforcement area on the other side will be pulled, and the two sides restrain each other so as to effectively maintain the shape and prevent it from being easily distorted and deformed, that is, the adjustable bending sheath tube 100 will not deflect to the left of the plane where the tube body is located after bending, and in two directions. Therefore, during surgery, when the bending section of the adjustable bending sheath tube 100 is bent and passes the instrument, the shape of the bending section can be well maintained to ensure smooth delivery of the instrument because the radial shapes of the traction wire 21 are stable, thereby achieving rapid alignment, shortening the operation time, and improving the success rate of the operation.

[0074] In other embodiments, a reinforcement zone may be provided only on one side of the braided mesh tube 17. When the reinforcement zone is provided only on one side, it can also enhance the structural strength of the adjustable bending sheath tube 100 to prevent it from twisting and deforming and deflecting to the left and right directions during the bending process. In addition, there is no restriction on the number of traction wires 21. The traction wire 21 can be only one so that the adjustable bending sheath tube 100 is a unidirectional adjustable bending sheath tube 100, or it can be provided as two so that the adjustable bending sheath tube 100 is a bidirectional adjustable bending sheath tube 100. The present application does not restrict the number of reinforcement zones and the number of traction wires 21, as long as the reinforcement zones and the traction wires 21 are staggered from each other in the circumferential direction. In this embodiment, the reinforcement zone is provided by directly welding and fixing the intersection of the grid units of the braided mesh tube 17, and no other components need to be introduced. The structural changes to the entire adjustable bending sheath are small, and the other properties of the adjustable bending sheath are little affected. By locally setting a reinforcement area on the braided mesh tube 17, the structural strength of the braided mesh tube 17 is anisotropic in the circumferential direction, which prevents the device from twisting and deforming due to the low strength of the bending area when passing through after bending. The adjustable sheath can be accurately aligned with the branch blood vessel after bending and deliver the device to the target position.

[0075] Example 2

[0076] Reference Figure 8-10 The scheme of this embodiment is substantially the same as that of the embodiment 1, except that the fixing method of the intersection points 19 of the mesh units 18 of the braided mesh tube 17 is different.

[0077] In this embodiment, at the adjustable bend section 11 of the braided mesh tube 17, the intersection point 19 of at least part of the grid units 18 that are offset from the traction wire 21 is fixed by an anchor 40, and the at least part of the grid units 18 extends axially along the tube body 10, thereby forming an axially extending reinforcement zone at the adjustable bend section 11 of the braided mesh tube 17, and the reinforcement zone is offset from the traction wire 21 in the circumferential direction of the tube body 10.

[0078] Specifically, at least some of the grid units 18 have through holes on the two braided wires at the intersection 19, which can be formed by mechanical punching or laser drilling. The anchor 40 includes a cap 41 and an insertion portion 42 connected to each other, the insertion portion 42 is inserted into the through hole so that the cap 41 abuts against the braided wire, and the free end of the cap 41 or the insertion portion 42 is fixedly connected to the outer layer 13. The end surface of the insertion portion 42 away from the cap 41 is recessed toward the cap 41 to form at least one receiving groove (not shown).

[0079] In one embodiment, the free end of the insertion portion 42 of the anchor 40 is fixedly connected to the outer layer 13. At this time, the insertion portion 42 of the anchor 40 is inserted into the through hole at the intersection 19, and the free end is fixedly connected to the outer layer 13, and the cap 41 is arranged between the inner layer and the braided mesh tube 17. Specifically, when the outer layer 13 is formed, the polymer material will cover the entire braided mesh tube 17, and penetrate into the gap of the braided mesh tube 17 and the receiving groove of the insertion portion 42. On the one hand, by providing the receiving groove, the free end of the outer layer 13 and the insertion portion 12 can be better fixed; on the other hand, by introducing the rivet 40, the distance between the braided wire and the outer surface of the outer layer 13 can be increased, thereby not only reducing the risk of separation of the outer layer 13 and the insertion portion 42 during the bending process of the adjustable sheath, but also reducing the risk of the braided wire penetrating the outer layer 13 and irritating the blood vessel wall. In this embodiment, since the cap 41 of the anchor 40 is confined between the inner layer 15 and the braided mesh tube 17, and the free end of the insertion portion 42 is connected to the outer layer 13, the connection strength between the anchor 40 and the tube body 10 can be improved, and the connection of the anchor 40 can be made more secure.

[0080] In another embodiment, the cap 41 is fixedly connected to the outer layer 13. At this time, the insertion portion 42 of the anchor 40 is inserted from the outside of the braided mesh tube 17 into the through hole at the intersection 19, and the cap 41 is arranged between the braided mesh tube 17 and the outer layer. Specifically, when the outer layer 13 is formed, the polymer material will cover the entire braided mesh tube 17 and penetrate into the gap of the braided mesh tube 17, so as to achieve fixation with the cap 41. In this embodiment, since the anchor 40 is inserted from the outside of the braided mesh tube 17 into the through hole, the anchor 40 is easier to install.

[0081] In this embodiment, the fixing method at the intersection 19 of the grid unit 18 is mainly applied to braided wires with a flat cross-section.

[0082] Example 3

[0083] Reference Figure 11-13 The scheme of this embodiment is substantially the same as that of the embodiment 1, except that the fixing method of the intersection points 19 of the mesh units 18 of the braided mesh tube 17 is different.

[0084] In this embodiment, at the adjustable bend section 11 of the braided mesh tube 17, the intersection 19 of at least part of the grid units 18 that are offset from the traction wire 21 is fixed by a cross fixing piece 50, and the at least part of the grid units 18 extends along the axial direction of the tube body, thereby forming an axially extending reinforcement zone at the adjustable bend section 11 of the braided mesh tube 17, and the reinforcement zone is offset from the traction wire 21 in the circumferential direction of the tube body 10.

[0085] As a setting method of the cross fixing member 50, the cross fixing member 50 includes a cross cover plate 51 and a plug-in portion 52. There are four plug-in portions 52, which are respectively arranged at four ends of the same side of the cross cover plate 51. The cross cover plate 51 is arranged at the intersection 19 between the braided mesh tube 17 and the outer layer 13. The plug-in portions 52 are respectively inserted into the cross gaps at the intersection 19. The cross cover plate 51 is wrapped in the outer layer 13. Furthermore, the polymer layer of the outer layer 13 is fixed to the braided mesh tube 17 by thermal fusion, and the cross cover plate 51 is fixed between the braided mesh tube 17 and the outer layer 13.

[0086] Exemplarily, the free end of the plug-in portion 52 of the cross fixing member 50 is fixedly connected to the outer layer 13. At this time, the plug-in portion 52 of the cross fixing member 50 is inserted from the outside of the braided mesh tube 17 into the cross gap at the intersection 19, and the free end is fixedly connected to the outer layer 13, and the cross cover plate 51 is arranged between the inner layer 15 and the braided mesh tube 17. Specifically, when the outer layer 13 is formed, the polymer material will cover the entire braided mesh tube 17 and penetrate into the gap of the braided mesh tube 17, so as to achieve fixation with the free end of the plug-in portion 52. In this embodiment, since the cross cover plate 51 of the cross fixing member 50 is limited between the inner layer 15 and the braided mesh tube 17, and the free end of the plug-in portion 52 is connected to the outer layer 13, the connection strength between the cross fixing member 50 and the tube body 10 can be improved, and the connection of the cross fixing member 50 can be made more secure.

[0087] Exemplarily, the cross cover plate 51 is fixedly connected to the outer layer 13. At this time, the plug-in portion 52 of the cross fixing member 50 is inserted from the outside of the braided mesh tube 17 into the cross gap at the intersection 19, and the cross cover plate 51 is arranged between the braided mesh tube 17 and the outer layer 13. Specifically, when the outer layer 13 is formed, the polymer material will cover the entire braided mesh tube 17 and penetrate into the gap of the braided mesh tube 17, so as to achieve fixation with the cross cover plate 51. In this embodiment, since the cross fixing member 50 is inserted into the through hole from the outside of the braided mesh tube 17, the installation of the cross fixing member 50 is relatively convenient. In this embodiment, by setting the cross fixing member 50, the two braided wires that overlap to form the intersection are simultaneously bound to fix the intersection of the grid unit. The cross fixing member 50 has a large contact area with the two braided wires and simultaneously limits the four cross gaps around the intersection, which can stably achieve the fixation of the intersection.

[0088] As another arrangement of the cross fixing member 50, the cross fixing member 50 is a flexible rope, which is wound around the intersection 19 to form a cross knot to fix the two braided wires forming the intersection 19. In this way, a balance can be achieved between increasing hardness and maintaining flexibility, improving the bending efficiency and shortening the operation time.

[0089] Example 4

[0090] Reference Fig.14 The scheme of this embodiment is substantially the same as that of the embodiment 1, except that the fixing method of the intersection points 19 of the mesh units 18 of the braided mesh tube 17 is different.

[0091] In this embodiment, at the adjustable bend 11 of the braided mesh tube 17, the connecting line of at least part of the grid units 18 staggered with the traction wire 21 is perpendicular to the axial intersection 19 of the tube body 10 and connected by a transverse rib 70. The at least part of the grid units 18 extends along the axial direction of the tube body, thereby forming an axially extending reinforcement zone at the adjustable bend 11 of the braided mesh tube 17, and the reinforcement zone and the traction wire 21 are staggered in the circumferential direction of the tube body 10. The transverse rib 70 is arranged along the circumference of the braided mesh tube 17, and in the axial direction, in a vertical row of diamond units 18 in the reinforcement zone, adjacent diamond units 18 are provided with transverse ribs 70, and the transverse ribs 70 constitute the diagonal lines of the diamond units 18, thereby forming a plurality of relatively stable triangular structures, and improving the pulling performance of the reinforcement zone.

[0092] In this embodiment, the transverse rib 70 is made of metal material, preferably stainless steel, which is the same as the braided wire, and is fixedly connected to the intersection 19 by welding. Of course, in other embodiments, the transverse rib 70 can also be a flexible rope, which is wound around the intersection 19 to form a cross knot to fix the two braided wires forming the intersection 19.

[0093] Example 5

[0094] Reference Fig.15 The scheme of this embodiment is substantially the same as that of Embodiment 4, except that the fixing method of the intersection points 19 of the grid units 18 of the braided mesh tube 17 is different.

[0095] In this embodiment, at the adjustable bend 11 of the braided mesh tube 17, at least two intersections 19 in the mesh unit 18 whose connecting lines are parallel to the axial direction of the tube body 10 are connected by the longitudinal ribs 80, and the two adjacent intersections 19 connected by the longitudinal ribs 80 are located on the same mesh unit 18 or on different mesh units 18. A row of mesh units 18 connected by the longitudinal ribs 80 extends along the axial direction of the tube body 10, thereby forming an axially extending reinforcement area at the adjustable bend 11 of the braided mesh tube 17, and the two adjacent intersections 19 connected by the longitudinal ribs 80 are staggered with the traction wire 21 in the circumferential direction of the tube body 10.

[0096] Specifically, the intersections 19 of the longitudinal ribs 80 and the braided mesh tube 17 can be fixed by welding. Specifically, there are only two intersections 19 connected by the longitudinal ribs 80, and they are located at the intersections 19 at the proximal and distal ends of the adjustable curved section 11 of the braided mesh tube 17; there can also be multiple intersections 19 connected by the longitudinal ribs 80, and two adjacent intersections 19 connected by the longitudinal ribs 80 are located on the same mesh unit 18 or on different mesh units. Exemplarily, in order to improve the anti-extrusion and anti-twisting capabilities of the reinforced area, the intersections 19 on the entire row of mesh units are welded and fixed to the longitudinal ribs 80.

[0097] In this embodiment, not only the braided mesh tube 17 connected and reinforced by the longitudinal ribs 80 has the ability to resist compression and extension, but the longitudinal ribs 80 themselves also have the ability to resist compression and extension. Therefore, the strength is doubly improved, and the anti-compression and anti-extension effects are improved. In addition, the linear longitudinal ribs 80 will also have a better anti-extension effect.

[0098] In this embodiment, the longitudinal rib 80 is made of metal material, preferably stainless steel, which is the same as the braided wire. Of course, in other embodiments, the longitudinal rib 80 can also be a flexible rope, which is wound around the intersection 19 to form a cross knot to fix the two braided wires forming the intersection 19.

[0099] Example 6

[0100] Reference Fig.16 The scheme of this embodiment is substantially the same as that of Embodiment 4, except that the fixing method of the intersection points 19 of the grid units 18 of the braided mesh tube 17 is different.

[0101] In this embodiment, at the adjustable bend section 11 of the braided mesh tube 17, the intersection 19 at the distal end and the intersection 19 at the proximal end of at least one column of mesh units 18 of the braided mesh tube 17 are connected by a triangular connecting rib 60, and the three vertices of the triangular connecting rib 60 are respectively fixedly connected to three different intersections 19. The at least one column of mesh units 18 extends along the axial direction of the tube body 10, thereby forming an axially extending reinforcement zone at the adjustable bend section 11 of the braided mesh tube 17, and the reinforcement zone and the traction wire 21 are staggered in the circumferential direction of the tube body 10.

[0102] One vertex of the triangular connecting rib 60 is welded and fixed to the vertex of the mesh unit 18 at the far end of the adjustable bending section 11 of the braided mesh tube 17, and the other two vertices of the triangular connecting rib 60 are connected and fixed to the two opposite vertices of the mesh unit 18 at the proximal end of the braided mesh tube 17 adjustable bending section 11. In addition, the arrangement of the triangular connecting rib 60 makes the two overlapping wires at some intersections 19 in the triangular connecting rib 60 area, especially at some intersections 19 near the proximal side, not fixed together, and the circumferential size of the area with improved support performance on the distal side is smaller than that on the proximal side (the ribs extending along the circumferential direction of the triangular connecting rib 60 are arranged on the proximal side), thereby achieving a balance between the flexibility and support of the bending section. In this embodiment, not only does the braided mesh tube 17 itself, which is connected and strengthened by the triangular connecting rib 60, have the ability to resist compression and extension, but the triangular connecting rib 60 itself also has the ability to resist compression and extension. In addition, the triangle shape formed by the triangular connecting rib 60 itself also has a stable characteristic, so the strength of the enhanced area is tripled, and the compression and extension effect of the adjustable bending section 11 is better. In addition, since there are fewer fixing points between the triangular connecting ribs 60 and the braided mesh tube 17, the process is simpler and the cost is lower.

[0103] In this embodiment, the triangular connecting rib 60 is made of metal material, preferably stainless steel, which is the same as the braided wire. Of course, in other embodiments, the triangular connecting rib 60 can also be a flexible rope, which is wound around the intersection 19 to form a cross knot to fix the two braided wires forming the intersection 19.

[0104] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention, rather than to limit it. Although the present invention has been described in detail with reference to the aforementioned embodiments, those skilled in the art should understand that they can still modify the technical solutions described in the aforementioned embodiments, or replace some or all of the technical features therein with equivalents. However, these modifications or replacements do not cause the essence of the corresponding technical solutions to deviate from the scope of the technical solutions of the embodiments of the present invention.

Claims

1. An adjustable bending sheath tube, characterized in that: include: A tube body, the tube body comprising a reinforcement layer and an outer layer bonded in sequence from the inside to the outside, the tube body comprising a main body section arranged on the proximal side and an adjustable bending section arranged on the distal side, the reinforcement layer comprising a braided mesh tube formed by overlapping at least two braided wires, the braided mesh tube having a plurality of grid units, each grid unit having a plurality of intersections, each intersection being formed by overlapping two braided wires; A traction wire, whose distal end is fixed to the adjustable bend section; wherein the reinforcement layer has an axially extending reinforcement zone at the adjustable bend section, and the reinforcement zone is staggered relative to the connection between the traction wire and the tube body in the circumferential direction of the tube body.

2. The adjustable bending sheath tube according to claim 1, characterized in that: In the reinforcement area, at least some of the intersections of some of the grid units are fixedly connected to each other.

3. The adjustable bending sheath tube according to claim 2, characterized in that: The intersection is fixed by welding or bonding.

4. The adjustable bending sheath tube according to claim 2, characterized in that: The intersection is fixed by anchor nails.

5. The adjustable bending sheath tube according to claim 4, characterized in that: Through holes are provided on the two braided wires at the intersection; the anchor comprises a cap and an insertion portion connected to each other, the insertion portion is inserted into the through hole so that the cap abuts against the braided wire, and the free end of the insertion portion is fixedly connected to the outer layer.

6. The adjustable bending sheath tube according to claim 2, characterized in that: The two braided wires at the intersection are fixed by a cross fixing piece.

7. The adjustable bending sheath tube according to claim 6, characterized in that: The cross fixing member comprises a cross cover and a plug-in portion, wherein the plug-in portions are four and are respectively arranged at four ends of the same side of the cross cover, the cross cover is arranged at the intersection and the four plug-in portions are respectively plugged into the intersection gaps around the intersection; and / or The cross fixing member is a flexible rope, and the flexible rope is wound around the intersection to form a cross knot to fix the two braided wires forming the intersection.

8. The adjustable bending sheath tube according to claim 2, characterized in that: Two intersection points in the grid unit where the connecting line is perpendicular to the axial direction of the tube body are connected by transverse ribs.

9. The adjustable bending sheath tube according to claim 2, characterized in that: At least two intersections in the grid unit whose connecting lines are parallel to the axial direction of the tube body are connected by longitudinal ribs, and two adjacent intersections connected by the longitudinal ribs are located on the same grid unit or on different grid units.

10. The adjustable bending sheath tube according to claim 2, characterized in that: The intersection points at the distal end and the intersection points at the proximal end of at least one column of grid units of the braided mesh tube are connected by triangular connecting ribs, and the three vertices of the triangular connecting ribs are fixedly connected to three different intersection points respectively.

11. The adjustable bending sheath tube according to any one of claims 8 to 10, characterized in that: The transverse ribs, longitudinal ribs or triangular connecting ribs are metal wires, which are fixedly connected to the intersections; and / or the transverse ribs, longitudinal ribs or triangular connecting ribs are flexible ropes, which are fixedly connected to the intersections via rope knots.

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