An adjustable bend catheter

Abstract

The application discloses a kind of adjustable bending catheters, including tube body, first reinforcing layer, second reinforcing layer and traction mechanism;The distal end portion of tube body is adjustable bending section, the rest is main body section;First reinforcing layer is correspondingly arranged in adjustable bending section and extends along the axial direction, second reinforcing layer is correspondingly arranged in main body section and extends along the axial direction, and traction mechanism is used to control the bending of adjustable bending section;At least one hooking structure is provided on one of first reinforcing layer and second reinforcing layer, and the other has at least one hooking space matched with the hooking structure, the hooking structure enters the hooking space, to realize the relative limit of first reinforcing layer and second reinforcing layer in the axial direction.The application solves the problem that it is difficult to simultaneously satisfy the reduction of the influence on main body section and the reduction of the risk of tensile fracture during bending in the prior art, thereby improving the reliability of the adjustable bending catheter.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and in particular to an adjustable bendable catheter. Background Technology

[0002] In the prior art, the adjustable bend catheter includes a proximal main segment and a distal adjustable bend segment. Since the adjustable bend segment is a continuation of the main segment, when the adjustable bend segment is bent or at a large bending angle or is subjected to the action of other instruments, it will inevitably affect the main segment, causing the main segment to undergo undesirable bending deformation and displacement. In turn, the main segment will affect the adjustable bend segment in turn, causing it to deviate from the ideal bending state.

[0003] To prevent the adjustable bend of the conduit from affecting the main body during bending, both the adjustable bend and the main body are reinforced with metal layers. For good bendability, existing technologies typically use the edges of the two metal reinforcing layers in contact, secured by a heat-fused adhesive film. While this method effectively reduces the impact of the adjustable bend on the main body during conduit bending, the connection between the two metal reinforcing layers is relatively weak. Furthermore, at larger bending angles, the adjustable bend is subjected to significant forces, which can easily cause breakage at the junction of the two metal reinforcing layers.

[0004] Based on the above, there is an urgent need for an adjustable bending guide tube that has minimal impact on the main body and can reduce the risk of tensile fracture. Summary of the Invention

[0005] In order to overcome at least one of the defects described in the prior art, the present invention provides an adjustable bending conduit that can solve the problem in the prior art that it is difficult to simultaneously reduce the impact on the main body section and reduce the risk of tensile fracture when adjusting the bending.

[0006] The technical solution adopted by this invention to solve its problem is:

[0007] An adjustable bending conduit includes a tube body, a first reinforcing layer, a second reinforcing layer, and a traction mechanism. The distal end of the tube body is divided into an adjustable bending section, and the remaining part is the main body section. The first reinforcing layer is correspondingly disposed within the adjustable bending section and extends axially, and the second reinforcing layer is correspondingly disposed within the main body section and extends axially. The traction mechanism is used to control the bending of the adjustable bending section. At least one hook structure is provided on one of the first reinforcing layer and the second reinforcing layer, and at least one hooking space that cooperates with the hook structure is provided on the other. The hook structure enters the hooking space to achieve relative axial positioning of the first reinforcing layer and the second reinforcing layer.

[0008] In summary, the adjustable bendable conduit provided by this invention has the following technical advantages:

[0009] This invention, through the provision of at least one hook structure on one of the first and second reinforcing layers and at least one hooking space cooperating with the hook structure on the other, achieves axial upper limit positioning of the first and second reinforcing layers, thereby reducing the risk of catheter breakage caused by opposing forces between the first and second reinforcing layers. Simultaneously, since the first and second reinforcing layers are not directly fixedly connected but are held within the hooking space by the hook structure, the impact of the adjustable bending segment on the main body segment during bending can be minimized. This reduces the impact of the adjustable bending segment on the main body segment, preventing undesirable bending deformation. Conversely, the main body segment has less impact on the adjustable bending segment, allowing the adjustable bending segment to approach and maintain an ideal bending state, thus improving the success rate of the surgery. Attached Figure Description

[0010] Figure 1 This is an application scenario diagram of the adjustable bending conduit provided in an embodiment of the present invention;

[0011] Figure 2 This is a schematic diagram of the adjustable bend conduit provided in an embodiment of the present invention;

[0012] Figure 3 This is a schematic diagram of the adjustable conduit provided in an embodiment of the present invention;

[0013] Figure 4 This is a cross-sectional schematic diagram of the adjustable bend section and the main body section in the adjustable bend conduit provided in an embodiment of the present invention;

[0014] Figure 5 for Figure 4 A magnified view of a portion of region A in the middle;

[0015] Figure 6 This is a schematic diagram of the first reinforcing layer and the hook structure in an embodiment of the present invention;

[0016] Figure 7 for Figure 6 A magnified view of a portion of region B in the middle;

[0017] Figure 8 This is a schematic diagram of the hook component in an embodiment of the present invention;

[0018] Figure 9 This is another structural schematic diagram of the hook component in an embodiment of the present invention;

[0019] Figure 10 This is a schematic diagram of the structure of the first reinforcing layer and the second reinforcing layer in an embodiment of the present invention;

[0020] Figure 11 for Figure 4 A cross-sectional view of CC.

[0021] Figure 12 This is another structural schematic diagram of the first and second reinforcing layers in an embodiment of the present invention;

[0022] Figure 13 This is another structural schematic diagram of the first reinforcing layer and the hook structure in an embodiment of the present invention;

[0023] Figure 14 for Figure 13 A magnified view of a portion of region D.

[0024] Icons: 1-Tube body, 11-Adjustable bend, 12-Main body, 13-Inner membrane tube, 14-Outer layer, 15-Slider, 16-Handle, 2-First reinforcing layer, 3-Second reinforcing layer, 4-Hook structure, 41-Hook component, 42-Strip component, 5-Hook space, 6-First connecting ring, 7-Second connecting ring, 8-Traction wire, 81-Threading tube, 9-Adjustable bend catheter, 10-Interventional instrument, 20-Braided ring. Detailed Implementation

[0025] To better understand and implement this invention, the technical solutions in the embodiments of this invention will be clearly and completely described below with reference to the accompanying drawings.

[0026] In the description of this invention, it should be noted that the terms "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings. They are only for the convenience of describing this 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. Therefore, they should not be construed as limitations on this invention.

[0027] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention pertains. The terminology used herein in the description of the invention is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention.

[0028] In the field of interventional medical devices, the proximal end refers to the end closer to the operator, while the distal end refers to the end farther from the operator; the axial direction refers to the direction parallel to the line connecting the center of the distal end and the center of the proximal end of the medical device; the radial direction refers to the direction along the diameter or radius, which is perpendicular to the axial direction; and the circumferential direction refers to the circumferential direction around the central axis. Those skilled in the art can understand the specific meaning of the above terms in this invention based on the specific circumstances.

[0029] To address the challenge of simultaneously minimizing the impact on the main body segment 12 and reducing the risk of tensile fracture during bending in existing technologies, this invention provides an adjustable-bend catheter 9 that can be applied in interventional procedures, such as for delivering instruments in minimally invasive surgery, and is particularly suitable for delivering mitral valve repair instruments.

[0030] Figure 1 Please refer to the following diagram for an application scenario of the adjustable bendable conduit 9 provided in this embodiment of the invention. Figure 1 For example, in mitral valve edge-to-edge repair, the adjustable catheter 9 can be used to deliver the interventional instrument 10 for delivering the valve clip to the mitral valve. After the valve clip extends from the interventional instrument 10, the anterior and posterior leaflets of the mitral valve are grasped by the relative opening and closing of the clamps of the valve clip, thereby achieving the purpose of fixing the leaflets and reducing mitral regurgitation.

[0031] The following describes an embodiment of the adjustable bendable conduit 9.

[0032] Example 1

[0033] Figure 2 This diagram illustrates the structure of the adjustable bendable conduit 9 provided in an embodiment of the present invention. Figure 3 This diagram illustrates the bending adjustment of the adjustable conduit 9 provided in an embodiment of the present invention. Figure 4 A cross-sectional schematic diagram of the adjustable bend section 11 and the main body section 12 of the adjustable bend conduit 9 is shown. Figure 5 It shows Figure 4 A magnified view of a portion of region A in the center. Please refer to this view as well. Figures 4-7 Embodiment 1 of the present invention provides an adjustable bending conduit 9, including a tube body 1, a first reinforcing layer 2, a second reinforcing layer 3, and a traction mechanism. The distal end of the tube body 1 is divided into an adjustable bending section 11, and the remaining part is the main body section 12; the first reinforcing layer 2 is correspondingly disposed within the adjustable bending section 11 and extends axially, and the second reinforcing layer 3 is correspondingly disposed within the main body section 12 and extends axially. The traction mechanism is used to control the bending of the adjustable bending section 11; at least one hooking structure 4 is provided on one of the first reinforcing layer 2 and the second reinforcing layer 3, and at least one hooking space 5 is provided on the other to cooperate with the hooking structure 4. The hooking structure 4 can enter the hooking space 5 to achieve relative axial positioning of the first reinforcing layer 2 and the second reinforcing layer 3.

[0034] It should be noted that, in Embodiment 1 of the present invention, at least one hook structure 4 is provided on one of the first reinforcing layer 2 and the second reinforcing layer 3, and at least one hook space 5 cooperating with the hook structure 4 is provided on the other, thereby limiting the first reinforcing layer 2 and the second reinforcing layer 3 relative to each other in the axial direction, thereby reducing the risk of breakage of the adjustable bend catheter 9 caused by the relative separation between the first reinforcing layer 2 and the second reinforcing layer 3; at the same time, since the first reinforcing layer 2 and the second reinforcing layer 3 are not directly fixedly connected, but are hooked in the hook space 5 by the hook structure 4, the influence of the adjustable bend segment 11 on the main body segment 12 during bending can be minimized, so that the main body segment 12 is less affected by the bending of the adjustable bend segment 11, thereby avoiding undesirable bending deformation of the main body segment 12. Conversely, the main body segment 12 has less influence on the adjustable bend segment 11, so that the adjustable bend segment 11 can approach and maintain an ideal bending state, improving the success rate of the surgery.

[0035] like Figure 4 , Figure 5 and Figure 10 As shown, in this embodiment, the hook structure 4 is disposed on the first reinforcing layer 2, the hook space 5 is disposed on the second reinforcing layer 3, the first reinforcing layer 2 and the second reinforcing layer 3 are sleeved on the outer side of the inner membrane tube 13, and the outer layer 14 wraps around and welds to the outer peripheral surface of the inner membrane tube 13, the outer peripheral surface of the first reinforcing layer 2 and the outer peripheral surface of the second reinforcing layer 3.

[0036] Specifically, the inner membrane tube 13 is a flexible tube with an inner diameter between 3.9 mm and 5.4 mm. The inner membrane tube 13 can be made of thermoplastics such as polytetrafluoroethylene (PTFE), nylon, or fluorinated ethylene propylene copolymer (FEP). The outer layer 14 can be made of thermoplastic materials such as polyurethane polymer, block polyamide, or nylon. The outer layer 14 is coated and fused with the first reinforcing layer 2 and the second reinforcing layer 3 through a hot-melt process, and is combined with the outer peripheral surface of the inner membrane tube 13 to form the tube body 1.

[0037] Furthermore, the stiffness of the first reinforcing layer 2 is less than that of the second reinforcing layer 3, so that the adjustable bending section 11 is easier to bend, while the main body section 12 is less likely to bend, further reducing the impact of the adjustable bending section 11 on the main body section 12 during bending. The first reinforcing layer 2 and the second reinforcing layer 3 can be obtained by any method such as machining or laser cutting. The materials of the first reinforcing layer 2 and the second reinforcing layer 3 are not limited to fiber materials, but can include stainless steel, tungsten alloy, cobalt-chromium alloy, or nickel-titanium alloy, etc.

[0038] Figure 5 for Figure 4 A magnified view of a portion of region A in the middle. Figure 6This is a schematic diagram of the first reinforcing layer 2 and the hook structure 4 in an embodiment of the present invention; please refer to [link / reference]. Figure 5 and Figure 6 Each hook structure 4 includes at least one hook member 41, which extends radially relative to the first reinforcing layer 2 in which it is located, and at least a portion of the hook member 41 is radially capable of entering the hooking space 5 of the second reinforcing layer 3. Wherein, when the hook member 41 enters the hooking space 5, it contacts the second reinforcing layer 3; or, when the hook member 41 enters the hooking space 5, there is a gap between it and the second reinforcing layer 3 (that is, it does not contact the second reinforcing layer 3), and the outer layer 14 fills the gap.

[0039] For further information, please refer to [link / reference]. Figure 5 and Figure 6 Each hook structure 4 further includes at least one strip 42, the distal end of which is connected to the proximal end of the first reinforcing layer 2, and the proximal end of the strip 42 extends away from the first reinforcing layer 2, specifically extending axially along the tube body 1. Each strip 42 is provided with at least one hook 41, and the hook 41 protrudes radially relative to the strip 42. The hook 41 may protrude radially inward or radially outward relative to the strip 42.

[0040] It should be noted that by setting the strip 42, the distance between the near end of the first reinforcing layer 2 and the far end of the second reinforcing layer 3 can be increased; at the same time, the strip 42 is a linear structure and is relatively easy to bend, so the strip 42 is less likely to affect the second reinforcing layer 3 when bending, thereby reducing the impact of the adjustable bending section 11 on the main body section 12. In addition, setting the strip 42 makes it easy to process, and further makes it easier to process into the hook structure 4.

[0041] The material of the strip 42 can be made of thermoplastic plastics such as polytetrafluoroethylene (PTFE), polyethylene terephthalate (PET), and polyimide (PI), or it can be made of metal materials such as stainless steel and nickel-titanium.

[0042] Furthermore, the number of strips 42 is at least two, and the at least two strips 42 are evenly arranged in the circumferential direction so that the adjustable bending section 11 is subjected to uniform force in the circumferential direction when it is bent.

[0043] In this embodiment, please refer to Figure 7 The hook 41 protrudes radially outward relative to the strip 42 to reduce the overall thickness of the tube body 1. The hook 41 is a straight protrusion, meaning that the hook 41 extends vertically outward from the distal end or sidewall of the strip 42. In other embodiments, such as Figure 8 As shown, the hook 41 can also be L-shaped; such as Figure 9As shown, the hook 41 can also be in the shape of a "C".

[0044] It should be noted that in some other embodiments, the strip 42 may be unnecessary, and the hook 41 may be directly disposed on the proximal end of the first reinforcing layer 2 or on the outer peripheral surface of the first reinforcing layer 2.

[0045] Furthermore, please refer again. Figure 6 A first connecting ring 6 is also provided between the distal end of the strip 42 and the proximal end of the first reinforcing layer 2. It should be noted that the first connecting ring 6 can prevent the proximal end of the first reinforcing layer 2 from spreading or deforming. It can be understood that the first connecting ring 6 can be integrally cut with the first reinforcing layer 2 or the second reinforcing layer 3, or it can be fixedly connected to the first reinforcing layer 2 by means of bonding, welding, snap-fitting, etc.

[0046] Figure 10 A schematic diagram showing the connection relationship between the first reinforcing layer 2 and the second reinforcing layer 3 is provided. Please refer to [link / reference]. Figure 10 The first reinforcing layer 2 can be a spiral structure or a woven mesh structure, and the second reinforcing layer 3 can be a spiral structure or a woven mesh structure.

[0047] In this structure, the first reinforcing layer 2 is made of a first filament, and the second reinforcing layer 3 is made of a second filament. At least one of the cross-sectional area, density, and material stiffness of the second filament is greater than the corresponding cross-sectional area, density, or material stiffness of the first filament, such that the stiffness of the second reinforcing layer 3 is greater than the stiffness of the first reinforcing layer 2. For example, the density and material stiffness of the first and second filaments are the same, but the cross-sectional area of ​​the second filament is greater than that of the first filament. The density of the spiral structure refers to the number of spiral turns per unit length in the axial direction, while the density of the woven mesh structure refers to the number of filaments cut out per unit length in the axial direction.

[0048] Preferably, in this embodiment, the first reinforcing layer 2 has a spiral structure, and the second reinforcing layer 3 has a woven mesh structure. The woven mesh structure has a plurality of woven mesh holes, and each woven mesh hole constitutes a hooking space 5.

[0049] The woven mesh structure includes at least one braided wire, which interweaves to form multiple braided loops 20. Each braided loop 20 has a mesh opening, which can be understood as serving as a hooking space 5. The braided loops 20 of the woven mesh structure can form a circumferentially closed hooking space 5, achieving more stable axial positioning. The shape of the mesh opening can be circular, rhomboid, rectangular, semi-circular, pentagonal, hexagonal, etc. In this embodiment, the mesh opening is rhomboid. The braided wire of the woven mesh structure can be round or flat.

[0050] The spiral structure includes at least one spiral coil, which can be a round or flat wire. It can also be understood that the spiral structure has better bending capacity than the woven mesh structure, improving the adjustability of the adjustable bending section 11 and enabling more flexible bending. The woven mesh structure has better support performance than the spiral structure, thereby improving the deformation resistance of the main body section 12.

[0051] More specifically, the first reinforcing layer 2 uses a spiral structure formed by flat wires, and the second reinforcing layer 3 uses a woven mesh structure formed by round wires.

[0052] Please see Figure 10 In this embodiment, the woven mesh structure is formed by connecting multiple woven units sequentially along the axial direction. Each woven unit includes at least one woven loop 20 arranged circumferentially. In this embodiment, the axial length and circumferential width of each woven loop 20 are equal. In this embodiment, the axial length (i.e., the distance between woven nodes) of each woven loop 20 is between 0.2mm and 2.0mm. The above is only one example of a woven mesh structure. In other embodiments, the woven mesh structure may have different configurations.

[0053] In this embodiment, the number of hooks 41 is four. The distal end of the strip 42 is fixedly connected to the proximal end of the first connecting ring 6, and the other end extends axially away from the first connecting ring 6. The four strips 42 are arranged in a circumferential array along the first connecting ring 6, and each strip 42 is provided with one hook 41. In this embodiment, the hook 41 protrudes from the strip 42 toward the side away from the axis of the tube body 1. Each hook 41 has at least one abutting surface toward the distal end of the tube body 1. The abutting surfaces of the four hooks 41 respectively cooperate with the inner sidewall of their respective corresponding braided rings 20, thereby achieving axial relative positioning of the first reinforcing layer 2 and the second reinforcing layer 3.

[0054] It should be noted that the hook 41 is not limited to being located at the proximal end of the strip 42; the hook 41 can also be located at the middle or distal end of the strip 42.

[0055] In this embodiment, when multiple strips 42 are provided, the axial lengths of the multiple strips 42 are all the same, and the axial lengths of the strips 42 are set between 0.3mm and 6.1mm. Four hooks 41 are respectively provided at the proximal ends of the strips 42. The four hooks 41 enter the braided mesh (i.e., hooking space 5) formed by the braided ring 20 of the second reinforcing layer 3 along the radial direction of the strips 42 (which is also the radial direction of the tube body 1). When the hooks 41 enter the corresponding braided mesh, the abutting surface of the hooks 41 can contact the inner sidewall of the braided ring 20 or have a certain gap, the gap of which can be between 0.1mm and 1mm.

[0056] Preferably, the abutting surface of the hook 41 can contact the inner sidewall of the braided ring 20 or have a certain gap, thereby further increasing the independence between the first reinforcing layer 2 and the second reinforcing layer 3 and reducing the influence of the adjustable bending section 11 on the main body section 12 during bending.

[0057] In other embodiments, in order to adapt to different woven mesh structures and enable the hooking member 41 to achieve good axial positioning with the hooking space 5 of the second reinforcing layer 3, the axial lengths of the multiple strips 42 can also be set to be different, or partially the same and partially different.

[0058] In other embodiments, the hook 41 may also protrude radially inward relative to the strip 42, that is, the strip 42 extends from the hook 41 toward the axis of the tube body 1, that is, the hook 41 extends radially inward relative to the first reinforcing layer 2 in which it is located.

[0059] In other embodiments, some hook members 41 may protrude radially inward relative to the strip member 42 on which they are located, and some hook members 41 may protrude radially outward relative to the strip member 42 on which they are located, as long as the first reinforcing layer 2 and the second reinforcing layer 3 can be relatively limited in the axial direction.

[0060] In other embodiments, the number of strips 42 may be 1, 2, 3, or 5, etc., and the present invention does not limit this.

[0061] To prevent relative axial movement between the first reinforcing layer 2 and the second reinforcing layer 3 and to achieve stable axial positioning, the maximum distance from the hook member 41 radially to the centerline of the tube body 1 should be greater than the inner diameter of the second reinforcing layer 3. In this embodiment, the inner diameters of the first reinforcing layer 2 and the second reinforcing layer 3 are the same, and their inner diameters are between 4.0 mm and 5.5 mm. The maximum distance from the strip member 42 radially to the centerline of the tube body 1 is between 6 mm and 7 mm.

[0062] In this embodiment, the surface of the strip 42 closest to the axis of the tube body 1 is flush with the inner surface of the first connecting ring 6. The thickness of the strip 42 is less than the thickness of the first connecting ring 6, so that a step is formed between the surface of the strip 42 away from the axis of the tube body 1 and the outer surface of the first connecting ring 6. The second reinforcing layer 3 surrounds the outer periphery of the four strips 42. The inner surface of the second reinforcing layer 3 is in contact with or not in contact with the outer surface of the strip 42 (i.e., the surface away from the axis of the tube body 1), preferably not in contact (it can have a gap between 0.1mm and 0.2mm, and the outer layer 14 is fused in this gap), thereby further increasing the independence between the first reinforcing layer 2 and the second reinforcing layer 3, so as to further reduce the influence of the adjustable bending section 11 on the main body section 12 during bending. In addition, it is understandable that by setting the maximum radial distance from the side surface of the strip 42 away from the axis of the tube body 1 to the axis of the tube body 1 to be less than the radial distance from the outer surface of the first connecting ring 6 to the axis of the tube body 1, and since the second reinforcing layer 3 is arranged around the outer periphery of the strip 42, the overall thickness of the tube body 1 can be reduced.

[0063] The strip 42 can be integrally cut with the first connecting ring 6, or it can be fixedly connected together by means of bonding, welding, snap-fitting, etc.

[0064] More specifically, the thickness of the strip 42 is between 1 / 3 and 4 / 5 of the thickness of the first reinforcing layer 2, and more specifically, the thickness of the strip 42 is between 0.1 mm and 1.0 mm, and the thickness of the first connecting ring 6 is between 0.30 mm and 1.25 mm.

[0065] The hook part 41 can be integrally cut with the first connecting ring 6, or it can be fixedly connected together by means of bonding, welding, snap-fitting, etc.

[0066] In this embodiment, the strip 42 is provided with a hook 41 at least at its proximal end. In order to reduce the process flow, the hook 41 can be formed by bending or folding from the proximal end of the strip 42 toward the side away from the axis of the tube body 1.

[0067] In this embodiment, when the hook member 41 enters the hooking space 5, it comes into contact with the second reinforcing layer 3; or, when the hook member 41 enters the hooking space 5, there is a gap between it and the second reinforcing layer 3, and the outer layer 14 fills the gap. It can be understood that when the outer layer 14 heat-fuses the hooking structure 4, the first connecting ring 6, the first reinforcing layer 2, the second reinforcing layer 3, and the inner membrane tube 13 into one piece, it simultaneously fills the gap between the hook member 41 and the second reinforcing layer 3.

[0068] It should be noted that when the first reinforcing layer 2 and the second reinforcing layer 3 are simultaneously subjected to opposite tensile forces along the axial direction, the hook member 41 can directly abut against the second reinforcing layer 3, or indirectly abut against the second reinforcing layer 3 through the outer layer 14 filled between the hook member 41 and the second reinforcing layer 3. This can improve the tensile strength of the adjustable bending conduit 9 and prevent the first reinforcing layer 2 and the second reinforcing layer 3 from separating axially, thus preventing the adjustable bending conduit 9 from easily breaking in the first reinforcing layer 2 and the second reinforcing layer 3. It can also be understood that since the second reinforcing layer 3 is set as a braided mesh structure, when the main body section 12 undergoes torsional movement relative to the adjustable bending section 11, the torsional force of the main body section 12 can be transmitted through the hook member 41, thereby improving the torsional controllability of the adjustable bending conduit 9.

[0069] Figure 11 It shows Figure 4 A cross-sectional view of CC. Further details can be found in the following diagram. Figure 6 and Figure 11 A second connecting ring 7 is also fixedly installed at the far end of the first reinforcing layer 2. Combined with... Figure 2 , Figure 4 and Figure 11 The traction mechanism includes a handle 16 and at least one traction wire 8 that is movably inserted into the tube body 1. One end of the traction wire 8 is fixedly connected to the second connecting ring 7, and the other end of the traction wire 8 extends from the proximal end of the tube body 1 (that is, the proximal end of the main body section 12) and is connected to the handle 16.

[0070] The handle 16 is used to drive the traction wire 8 to move proximally relative to the tube body 1, which can cause the adjustable bend 11 with the first reinforcing layer 2 to bend. When the adjustable bend 11 bends, the first reinforcing layer 2 undergoes elastic deformation. After the adjustable bend 11 bends, the driving mechanism can also drive the traction wire 8 to move a certain distance distally relative to the tube body 1, or when the traction wire 8 releases its tension on the first connecting ring 6, the adjustable bend 11 returns to its natural state, for example, returns to a straight state. It can be understood that the second connecting ring 7 of Embodiment 1 of the present invention is located at the distal end of the first reinforcing layer 2, which not only prevents the first reinforcing layer 2 from spreading or deforming, but also acts as an anchoring element for the traction wire 8, thereby reducing the thickness of the tube body 1.

[0071] It should be noted that in some other embodiments, the first connecting ring 6 and / or the second connecting ring 7 may be optional, and the proximal and distal ends of the first reinforcing layer 2 and the second reinforcing layer 3 may be heat-treated at a high temperature of 100°C or heat-shrinked with a polymer heat-shrink film to prevent the proximal and distal ends of the first reinforcing layer 2 and the second reinforcing layer 3 from spreading out.

[0072] Please see Figure 4 and Figure 11In this embodiment, the traction mechanism includes two traction wires 8. The distal end of each traction wire 8 is fixedly connected to the second connecting ring 7, and the proximal end of each traction wire 8 extends axially along the tube body 1 and protrudes from the proximal end of the main body segment 12. The traction wire 8 can slide axially within the tube body 1. The two traction wires 8 are arranged in a circumferential array along the second connecting ring 7, that is, the central angle corresponding to two adjacent traction wires 8 is 180 degrees. Pulling different traction wires 8 towards the proximal end can cause the adjustable bending segment 11 to bend in two different directions. That is, pulling one of the traction wires 8 towards the proximal end will cause the adjustable bending segment 11 to bend towards the side where one of the traction wires 8 is located.

[0073] Of course, in other implementations, the traction mechanism may include three or more traction wires 8, all of which are arranged in a circumferential array along the second connecting ring 7, so that the adjustable bending section 11 can be bent in three or more different directions.

[0074] More specifically, see Figure 11 The outer layer 14 is located outside the inner membrane tube 13, and the inner membrane tube 13, the first reinforcing layer 2, and the second reinforcing layer 3 are provided with threading tubes 81, the number of which is equal to the number of traction wires 8. The threading tubes 81 extend along the extension direction of the tube body 1, and the second connecting ring 7 is provided at the distal end of the threading tube 81. The inner cavity of the threading tube 81 forms a traction wire cavity along the axial direction of the tube body 1, and one traction wire 8 is correspondingly threaded into one traction wire cavity. The outer layer 14 fuses the first reinforcing layer 2, the second reinforcing layer 3, the connecting ring, the threading tube 81, and the inner membrane tube 13 into one unit. In this embodiment, the outer peripheral surface of the threading tube 81 is attached to the outer peripheral surface of the inner membrane tube 13 to reduce the thickness of the tube body 1.

[0075] More specifically, the inner diameter of the threading tube 81 can be set between 0.05mm and 0.3mm. The threading tube 81 can be made of thermoplastic plastics such as polytetrafluoroethylene (PTFE), polyethylene terephthalate (PET), and polyimide (PI), or it can be made of metal materials such as stainless steel and nickel-titanium. The distal end of the traction wire 8 and the second connecting ring 7 can be fixed by bonding, welding, or overlapping. In other embodiments, the threading tube 81 can also be located between the outer layer 14 and the first reinforcing layer 2 and the second reinforcing layer 3.

[0076] In this embodiment, there are two traction wires 8 and two corresponding threading tubes 81. These two threading tubes 81 are arranged in a circumferential array around the first connecting ring 6. A traction wire 8 is axially threaded through the traction wire cavity of each threading tube 81, and the distal end of each traction wire 8 is fixedly connected to the second connecting ring 7. The central angle between two adjacent threading tubes 81 is 180 degrees. The traction wire 8 can slide within the corresponding threading tube 81. Pulling the traction wire 8 in different threading tubes 81 towards their proximal ends can cause the adjustable bending section 11 to bend in two different directions.

[0077] Of course, in other implementations, depending on the number of traction wires 8 included in the traction mechanism, one, three or more wire-threading tubes 81 may be provided.

[0078] Specifically, the inner diameter of the first connecting ring 6 and / or the second connecting ring 7 ranges from 4.0mm to 5.5mm. The axial length of the first connecting ring 6 and / or the second connecting ring 7 ranges from 2.0mm to 5.0mm. The material of the second connecting ring 7 and / or the first connecting ring 6 can be stainless steel, platinum, gold, tungsten, tantalum, or other metals, or polymer materials such as polyimide (PI), polytetrafluoroethylene (PTFE), and polyethylene terephthalate (PET). When the second connecting ring 7 and / or the first connecting ring 6 are made of developing materials such as platinum, gold, or tantalum, the second connecting ring 7 and / or the first connecting ring 6 also have a developing function to observe the bending start and / or bending end positions of the adjustable bending section 11, and to determine whether the bending state of the adjustable bending section 11 has reached the expected level.

[0079] Further, please refer to Figure 2 The handle 16 has a drive mechanism, which includes several sliders 15. The proximal end of the traction wire 8 is fixedly connected to the corresponding slider 15. Each slider 15 slides axially, which can drive the corresponding traction wire 8 to slide. By pulling the slider 15 axially, the corresponding traction wire 8 pulls the second connecting ring 7, thus controlling the bending of the adjustable bending section 11. Please refer to [link to relevant documentation]. Figure 3 By pulling different sliders 15 toward the near end, the corresponding traction wires 8 can be moved toward the near end, so that the adjustable bending section 11 can bend in two different directions.

[0080] It is understandable that because the stiffness of the second reinforcing layer 3 is greater than that of the first reinforcing layer 2, the stiffness of the main body segment 12 is greater than that of the adjustable bending segment 11. Furthermore, the first reinforcing layer 2 and the second reinforcing layer 3 are not directly fixed together, but rather hooked by the hooking structure 4 within the hooking space 5 of the second reinforcing layer 3. This minimizes the impact of the adjustable bending segment 11 on the main body segment 12 during bending. When the traction wire 8 is pulled to bend the adjustable bending segment 11, its impact on the main body segment 12 is minimal, and the main body segment 12 remains essentially straight. Therefore, the main body segment 12 does not conversely affect the adjustable bending segment 11, allowing the adjustable bending segment 11 to achieve and maintain a relatively ideal bending state. When the first reinforcing layer 2 and the second reinforcing layer 3 are subjected to opposing forces, at least one radially outward-protruding hooking structure 4 is provided near the proximal end of the first reinforcing layer 2, effectively positioning the first reinforcing layer 2 and the second reinforcing layer 3 at their axial upper limits, thereby reducing the risk of relative fracture between the first reinforcing layer 2 and the second reinforcing layer 3.

[0081] Example 2

[0082] The adjustable bendable conduit 9 in Example 2 is basically the same as that in Example 1, except that the hook structure 4 is disposed on the second reinforcing layer 3 and the hook space 5 is disposed on the first reinforcing layer 2.

[0083] like Figure 12 As shown, the second reinforcing layer 3 is provided with at least one hook structure 4. Each hook structure 4 includes at least one hook member 41, which extends radially relative to the second reinforcing layer 3. At least a portion of the hook member 41 can enter radially into the hook space 5 of the first reinforcing layer 2 to achieve relative axial positioning between the first reinforcing layer 2 and the second reinforcing layer 3. When the hook member 41 enters the hook space 5, it contacts the first reinforcing layer 2; or, when the hook member 41 enters the hook space 5, there is a gap between it and the first reinforcing layer 2, and the outer layer 14 fills this gap.

[0084] Furthermore, the hook structure 4 also includes at least one strip 42, the proximal end of which is connected to the proximal end of the second reinforcing layer 3, and the distal end of which extends away from the distal end of the second reinforcing layer 3, specifically extending axially along the tube body 1. Each strip 42 is provided with at least one hook 41, and the hook 41 protrudes radially relative to the strip 42. It can be understood that the hook 41 can protrude radially inward or radially outward relative to the strip 42.

[0085] To complement the above design, unlike Embodiment 1, the first connecting ring 6 is positioned between the proximal end of the strip 42 and the distal end of the second reinforcing layer 3 to prevent the proximal end of the second reinforcing layer 3 from spreading or deforming, while also facilitating connection with the hook structure 4. Continuing as... Figure 12 As shown, the first connecting ring 6 may not be provided at the proximal end of the first reinforcing layer 2. The proximal end of the first reinforcing layer 2 may be heat-treated at a high temperature of 100°C or heat-shrinked with a polymer heat-shrink film to prevent the proximal end of the first reinforcing layer 2 from spreading out.

[0086] Preferably, in order to ensure that the hooking member 41 of the hooking structure 4 of the second reinforcing layer 3 can be stably hooked in the hooking space 5 of the first reinforcing layer 2, while ensuring that the second reinforcing layer 3 has good resistance to deformation, in this embodiment, both the first reinforcing layer 2 and the second reinforcing layer 3 adopt a woven mesh structure.

[0087] Understandably, further details regarding the adjustable bendable conduit 9 in this embodiment can be found in the corresponding content of Embodiment 1, and will not be repeated here.

[0088] Example 3

[0089] Please see Figure 14The difference between Embodiment 3 and Embodiment 1 or Embodiment 2 is that: the number of hooks 41 disposed on the strip 42 is multiple, the multiple hooks 41 are spaced apart in the axial direction of the first strip 42, and the multiple hooks 41 can simultaneously enter one or more woven mesh holes (i.e. hooking space 5) of the first reinforcing layer 2 which is a woven mesh structure in the radial direction.

[0090] In this embodiment, at least one strip 42 includes two hooks 41. In other embodiments, the number of hooks 41 provided on the same strip 42 can be 3, 4, etc., and the present invention does not make a specific limitation in this regard.

[0091] It is understandable that by setting multiple hooks 41 on a strip 42, compared to setting only one hook 41 on a strip 42, the stability of the first reinforcing layer 2 and the second reinforcing layer 3 in the axial upper limit can be further enhanced, thereby providing better fracture resistance and torsional control.

[0092] In summary, the present invention provides an adjustable bendable conduit 9, which has at least the following advantages compared with the prior art:

[0093] (1) In this embodiment of the invention, at least one hook structure 4 is provided on one of the first reinforcing layer 2 and the second reinforcing layer 3, and at least one hook space 5 that cooperates with the hook structure 4 is provided on the other. This achieves the axial relative positioning of the first reinforcing layer 2 and the second reinforcing layer 3, thereby reducing the risk of breakage of the adjustable bend catheter 9 caused by opposite forces between the first reinforcing layer 2 and the second reinforcing layer 3. At the same time, since the first reinforcing layer 2 and the second reinforcing layer 3 are not directly fixedly connected, but are hooked in the hook space 5 by the hook structure 4, the influence of the adjustable bend segment 11 on the main body segment 12 during bending can be minimized. Thus, the main body segment 12 is less affected by the bending of the adjustable bend segment 11, thereby avoiding undesirable bending deformation of the main body segment 12. Conversely, the main body segment 12 has less influence on the adjustable bend segment 11, so the adjustable bend segment 11 can approach and maintain an ideal bending state, improving the success rate of the surgery.

[0094] (2) By setting the first connecting ring 6 and the second connecting ring 7, the first reinforcing layer 2 can be prevented from spreading or deforming. At the same time, the second connecting ring 7 is set at the far end of the first reinforcing layer 2, which can not only prevent the first reinforcing layer 2 from spreading or deforming, but also serve as an anchoring element for the traction wire 8, thereby reducing the overall thickness of the tube body 1.

[0095] (3) The hook structure 4 includes at least one strip 42 and at least one hook 41, with the hook 41 protruding radially from the strip 42. It can be understood that by setting the strip 42, the distance between the proximal end of the first reinforcing layer 2 and the distal end of the second reinforcing layer 3 is increased. At the same time, the strip 42 is easy to bend, so the first reinforcing layer 2 is less likely to affect the second reinforcing layer 3 when bending, thereby reducing the influence of the adjustable bending section 11 on the main body section 12. In addition, the strip 42 is easy to process, and it is even easier to process to form the hook structure 4.

[0096] (4) By setting the radial distance from the side surface of the strip 42 away from the axis of the tube body 1 to the axis of the tube body 1 to be less than the radial distance from the outer surface of the first connecting ring 6 to the axis of the tube body 1, the second reinforcing layer 3 is surrounded around the outer periphery of the strip 42 to reduce the overall thickness of the tube body 1.

[0097] (5) Each strip 42 has multiple hooks 41, and the multiple hooks 41 can simultaneously enter one or more woven mesh holes of the first reinforcing layer 2, which is a woven mesh structure, in the radial direction, which can further strengthen the axial stability between the first reinforcing layer 2 and the second reinforcing layer 3, thereby providing better fracture resistance.

[0098] The technical means disclosed in this invention are not limited to those disclosed in the above embodiments, but also include technical solutions composed of any combination of the above technical features. It should be noted that those skilled in the art can make various improvements and modifications without departing from the principles of this invention, and these improvements and modifications are also considered within the scope of protection of this invention.

Claims

1. An adjustable bendable conduit, characterized in that, Includes the tube body, the first reinforcing layer, the second reinforcing layer, and the traction mechanism; The distal end of the tube is divided into an adjustable bend section, and the remaining part is the main body section; the first reinforcing layer is correspondingly disposed in the adjustable bend section and extends axially, the second reinforcing layer is correspondingly disposed in the main body section and extends axially, and the traction mechanism is used to control the bending of the adjustable bend section. One of the first reinforcing layer and the second reinforcing layer is provided with at least one hook structure, and the other has at least one hook space that cooperates with the hook structure. The hook structure enters the hook space to achieve relative axial positioning of the first reinforcing layer and the second reinforcing layer.

2. The adjustable bendable conduit as described in claim 1, characterized in that, Each of the hook structures includes at least one hook member that extends radially relative to the first or second reinforcing layer in which it is located, and at least a portion of the hook member is capable of radially entering the hook space.

3. The adjustable bendable conduit as described in claim 2, characterized in that, Each of the hook structures further includes a strip; the distal end of the strip is connected to the proximal end of the first reinforcing layer, and the proximal end of the strip extends away from the proximal end of the first reinforcing layer; or the proximal end of the strip is connected to the distal end of the second reinforcing layer, and the distal end of the strip extends away from the distal end of the second reinforcing layer. Each of the strips is provided with at least one hook, and the hook protrudes radially relative to the strip.

4. The adjustable bendable conduit as described in claim 3, characterized in that, The tube body includes an inner membrane tube and an outer layer. The first reinforcing layer and the second reinforcing layer are sleeved on the outer membrane tube. The outer layer wraps around and fuses the inner membrane tube, the first reinforcing layer and the second reinforcing layer. When the hooking member enters the hooking space, it comes into contact with the second reinforcing layer; or, when the hooking member enters the hooking space, there is a gap between it and the second reinforcing layer, and the outer layer fills the gap.

5. The adjustable bendable conduit as described in claim 3, characterized in that, The hook protrudes radially outward relative to the strip.

6. The adjustable bendable conduit as described in claim 2, characterized in that, The hook can be straight, C-shaped, or L-shaped.

7. The adjustable bendable conduit as described in claim 3, characterized in that, A first connecting ring is connected between the proximal end of the strip and the proximal end of the first reinforcing layer; or a first connecting ring is connected between the distal end of the strip and the distal end of the second reinforcing layer.

8. The adjustable bendable conduit as described in claim 3, characterized in that, The number of strips is multiple, and the multiple strips are evenly arranged circumferentially.

9. The adjustable bendable conduit as described in claim 1, characterized in that, The stiffness of the first reinforcing layer is less than that of the second reinforcing layer.

10. The adjustable bendable conduit as described in claim 9, characterized in that, The first reinforcing layer is made of a first filament, and the second reinforcing layer is made of a second filament. At least one of the cross-sectional area, density, and material stiffness of the second filament is greater than the corresponding cross-sectional area, density, and material stiffness of the first filament, so that the stiffness of the second reinforcing layer is greater than the stiffness of the first reinforcing layer.

11. The adjustable bendable conduit as described in claim 3, characterized in that, The first reinforcing layer has a spiral structure or a woven mesh structure, and the second reinforcing layer has a spiral structure or a woven mesh structure.

12. The adjustable bendable conduit as described in claim 11, characterized in that, The first reinforcing layer has a spiral structure, and the second reinforcing layer has a woven mesh structure. The woven mesh structure has a plurality of woven mesh holes, and each woven mesh hole constitutes a hooking space.

13. The adjustable bendable conduit as described in claim 12, characterized in that, The at least one strip includes at least one first strip, and the number of hooks disposed on the first strip is multiple. The multiple hooks are spaced apart in the axial direction of the first strip, and the multiple hooks can simultaneously enter one or more mesh holes of the woven mesh structure radially.

14. The adjustable bendable conduit as described in claim 1, characterized in that, A second connecting ring is fixedly provided at the distal end of the first reinforcing layer. The traction mechanism includes at least one traction wire that is movably inserted into the tube body. One end of the traction wire is fixedly connected to the second connecting ring, and the other end extends from the proximal end of the main body section.

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