Bending-adjustable catheter

Abstract

The invention discloses an adjustable bending catheter, and relates to the technical field of medical instruments, the adjustable bending catheter comprises an inner tube used for conveying preparations or instruments; the outer pipe is arranged outside the inner pipe in a sleeving mode, the inner pipe and the outer pipe are both provided with connecting ends located on the same side, and the connecting ends are used for being connected with different components of the handle; the axial supporting body is arranged on one side of the axis of the adjustable bent guide pipe and extends along the axis of the adjustable bent guide pipe; the axial supporting body is arranged at the end, away from the connecting end, of the outer pipe and fixedly connected with the end, away from the connecting end, of the inner pipe. The radial supporting body is arranged on the axial supporting body, and the radial supporting body is used for abutting against the side wall of the inner pipe for limiting; wherein the axial supporting body is provided with an extending direction from one end close to the connecting end to one end far away from the connecting end, and the flexibility of the axial supporting body is gradually increased in the extending direction of the axial supporting body. Bidirectional symmetrical bending adjustment of the adjustable catheter can be achieved, the bending angle is large, and the flexibility of bending adjustment of the adjustable catheter is improved.

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] Currently, most adjustable-bend catheters use a pull-wire control system, but this structure has the following technical drawbacks: First, the pull wire is prone to bending and breaking due to improper force control, and the tip is too rigid and lacks flexibility, making it difficult to adapt to complex vascular anatomy and increasing the risk of surgical complications; second, the bending angle is limited, and when faced with large-angle bends, the catheter cannot reach the target position, restricting the surgeon's operation; third, the directional control capability is poor, and the non-ideal bidirectional bending cannot meet the multi-directional operation requirements of complex and varied internal environments, resulting in limited surgical success rate, safety, efficiency, and applicability; fourth, because the pull wire needs to pass through a special channel, the catheter wall is relatively thick, making it difficult to achieve thin-walled miniaturization. For these reasons, there is an urgent need to develop a new type of adjustable-bend catheter. Summary of the Invention

[0003] The main objective of this invention is to provide an adjustable bendable conduit to solve the aforementioned technical problems.

[0004] To achieve the above objectives, the present invention provides an adjustable bendable conduit, comprising: Inner tube, used to deliver preparations or instruments; An outer tube is fitted over the inner tube. Both the inner tube and the outer tube have connecting ends on the same side. These connecting ends are used to connect to different parts of the handle. An axial support is provided on one side of the axis of the adjustable bend conduit and extends along the axis of the adjustable bend conduit; the axial support is provided on one end of the outer tube away from the connecting end and is fixedly connected to one end of the inner tube away from the connecting end. A radial support is disposed on the axial support, and the radial support is used to abut and limit the movement against the side wall of the inner tube; The axial support has an extending direction from one end near the connecting end to one end away from the connecting end, and the flexibility of the axial support increases in the extending direction of the axial support.

[0005] In one embodiment, the axial support decreases in size radially in the extending direction of the axial support body.

[0006] In one embodiment, the radial support is configured as an annular structure extending circumferentially along the adjustable bend conduit, wherein multiple annular structures are spaced apart axially along the adjustable bend conduit, and the annular structures are sleeved on the outside of the inner tube.

[0007] In one embodiment, the radial support has a width in the axial direction of the adjustable bend conduit, and the width dimension of the radial support remains constant or gradually varies in the axial direction of the extension of the axial support, and the spacing between every two adjacent annular structures remains constant or gradually varies.

[0008] In one embodiment, the radial support is configured as a helical spring, which extends along the extension direction of the axial support and is fixedly connected to both ends of the axial support, with the middle portion of the helical spring in close contact with the axial support; or, the radial support is configured as a flexible tube, which extends along the extension direction of the axial support and is fixedly connected to both ends of the axial support, with the middle portion of the flexible tube in close contact with the axial support.

[0009] In one embodiment, the outer wall of the axial support is provided with a plurality of protrusions, the protrusions extending radially along the adjustable bend conduit, and the plurality of protrusions being spaced apart axially along the adjustable bend conduit.

[0010] In one embodiment, the adjustable bendable conduit further includes a partition that covers at least one side of the axial support and the radial support, the partition being flexibly configured.

[0011] In one embodiment, the adjustable bend conduit further includes an adjusting member, which is rigidly disposed and movably disposed between the inner tube and the outer tube and slides along the axial direction of the adjustable bend conduit.

[0012] In one embodiment, the axial support has a hole structure with decreasing aperture in the extending direction of the axial support; and / or, In the extending direction of the axial support, the width of the axial support in the radial direction of the adjustable bend conduit remains unchanged.

[0013] In one embodiment, the axial support body has a first limiting section at one end away from the connecting end, the first limiting section having at least one connecting hole, and the inner tube at one end away from the connecting end is attached to the first limiting section and connected by one of the following methods: bonding, welding, and hot melting.

[0014] In the technical solution of this invention, the head of the inner tube is fixedly connected to the distal end of the axial support (i.e., the end furthest from the connecting end). Combined with the abutment and limiting of the radial support and the inner tube, the relative movement of the inner and outer tubes drives the axial support to bend and deform, thereby realizing the bending of the adjustable conduit. In addition, through the design of the axial support with increasing flexibility along the extension direction, the head end of the axial support (i.e., the end furthest from the connecting end) is easily bent and adjusted, while the end near the handle still maintains good support. During the application of force, due to the flexibility of the axial support from head to tail... As the diameter gradually decreases, the axial support gradually bends from head to tail, forming a near-circular curved profile. The bend is smoother and the angle is larger. When forces are applied in different directions, the bending direction of the adjustable catheter is opposite, achieving bidirectional symmetrical bending. In addition, since the above structure does not require an additional traction wire, the wall thickness of the catheter can be made thinner during manufacturing. The thin-walled design allows for a smaller outer diameter of the catheter, improving its flexibility and compliance, making it easier to pass through narrow blood vessels or cavities, and thus more easily reaching the small distal blood vessels in the human body. Attached Figure Description

[0015] To more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present invention. For those skilled in the art, other drawings can be obtained based on the structures shown in these drawings without creative effort.

[0016] Figure 1 This is a schematic diagram of the structure of the adjustable bendable conduit and the handle provided by the present invention; Figure 2 A cross-sectional schematic diagram of the adjustable bendable conduit provided by the present invention; Figure 3 This is a schematic diagram of the axial support region in one embodiment of the adjustable bendable conduit provided by the present invention. Figure 4 A schematic cross-sectional view of the inner and outer tubes in the adjustable bend conduit provided by the present invention; Figure 5 A schematic diagram of the adjustable bendable conduit provided by the present invention in a bent state; Figure 6 A schematic diagram of the adjustable bendable conduit provided by the present invention in another direction when in a bent state; Figure 7 This is a schematic diagram of the inner and outer tubes in a relative torsional state provided by the present invention. Figure 8 This is a schematic diagram of the adjustable catheter for adjusting the bending of the inferior trunk of the middle artery M2 provided by the present invention; Figure 9 This is a schematic diagram of the adjustable-bend catheter for super-selective treatment of the superior trunk of the M2 artery provided by the present invention; Figure 10 A schematic diagram of the windowsill effect; Figure 11 A schematic diagram illustrating how an adjustable bendable catheter can be used to deflect a support catheter toward the center of an artery. Figure 12 A schematic diagram of the axial support region in another embodiment of the adjustable bendable conduit provided by the present invention; Figure 13 A schematic diagram of the axial support region in another embodiment of the adjustable bendable conduit provided by the present invention; Figure 14 A cross-sectional schematic diagram of the region where the axial support body is located in another embodiment of the adjustable bendable conduit provided by the present invention; Figure 15 A cross-sectional schematic diagram of the region where the axial support body is located in another embodiment of the adjustable bendable conduit provided by the present invention; Figure 16 This is a schematic diagram of the adjusting component in the adjustable conduit provided by the present invention at different positions. Figure 17 A schematic diagram of the axial support region in another embodiment of the adjustable bendable conduit provided by the present invention; Figure 18 A schematic diagram of the structure of the first limiting section region in another embodiment of the adjustable bendable conduit provided by the present invention; Figure 19 This is a schematic diagram of the axial support region in another embodiment of the adjustable bendable conduit provided by the present invention.

[0017] Explanation of icon numbers: 10. Adjustable bendable conduit; 11. Connecting end; 12. Bending area; 20. Handle; 21. Control knob; 100. Inner tube; 110. First inner layer; 120. First intermediate layer; 130. First outer layer; 200. Outer tube; 210. Second inner layer; 220. Second intermediate layer; 230. Second outer layer; 300. Axial support; 310. Protrusion; 320. Hole structure; 330. First limiting section; 340. Second limiting section; 400. Radial support; 500. Spacer; 600. Adjusting element; 700. Hypoprene tube; 800. Imaging ring.

[0018] The realization of the objective, functional features and advantages of the present invention will be further explained in conjunction with the embodiments and with reference to the accompanying drawings. Detailed Implementation

[0019] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only a part of the embodiments of the present invention, and not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those of ordinary skill in the art without creative effort are within the scope of protection of the present invention.

[0020] It should be noted that if the embodiments of the present invention involve directional indicators (such as up, down, left, right, front, back, etc.), the directional indicators are only used to explain the relative positional relationship and movement of the components in a specific posture. If the specific posture changes, the directional indicators will also change accordingly.

[0021] Furthermore, if the embodiments of this invention involve descriptions such as "first" or "second," these descriptions are for descriptive purposes only and should not be construed as indicating or implying their relative importance or implicitly specifying the number of technical features indicated. Thus, a feature defined with "first" or "second" may explicitly or implicitly include at least one of those features. Additionally, the use of "and / or" or "and / or" throughout the text includes three parallel solutions. For example, "A and / or B" includes solution A, solution B, or a solution where both A and B are satisfied simultaneously. Furthermore, the technical solutions of the various embodiments can be combined with each other, but this must be based on the ability of those skilled in the art to implement them. When the combination of technical solutions is contradictory or impossible to implement, it should be considered that such a combination of technical solutions does not exist and is not within the scope of protection claimed by this invention.

[0022] This application discloses an adjustable bendable conduit 10, comprising: Inner tube 100, used for delivering preparations or instruments; The outer tube 200 is sleeved on the outside of the inner tube 100. Both the inner tube 100 and the outer tube 200 have a connecting end 11 located on the same side. The connecting end 11 is used to connect to different parts of the handle 20. An axial support 300 is provided on one side of the axis of the adjustable bend conduit 10 and extends along the axis of the adjustable bend conduit 10; the axial support 300 is provided on the outer tube 200 at one end away from the connecting end 11, and is fixedly connected to the inner tube 100 at one end away from the connecting end 11. A radial support 400 is provided on the axial support 300, and the radial support 400 is used to abut and limit the movement against the side wall of the inner tube 100. The axial support 300 has an extending direction from one end near the connecting end 11 to the end away from the connecting end 11, and the flexibility of the axial support 300 increases in the extending direction of the axial support 300.

[0023] like Figures 1 to 18 Both the inner tube 100 and the outer tube 200 are hollow tubular structures made of multi-layered materials. The inner tube 100 has an inner cavity for delivering preparations or devices, and the outer tube 200 is fitted over the inner tube 100. In this design, the inner tube 100 consists of a three-layer structure: a first inner layer 110, a first intermediate layer 120, and a first outer layer 130. The first inner layer 110 is made of polytetrafluoroethylene (PTFE) to ensure that the inner cavity (the inside of the inner tube 100) is flat and smooth, facilitating the passage of preparations or devices. The first intermediate layer 120 can be made by braiding or winding metal wire to ensure that the inner tube 100 has sufficient strength. The first outer layer 130... Layer 130 is composed of a polymer composite material. The above three layers can be fused into a whole through rheological technology to ensure the integrity of the inner tube 100. Similarly, the outer tube 200 is also composed of a second inner layer 210, a second intermediate layer 220 and a second outer layer 230. The second inner layer 210 of the outer tube 200 is made of PTFE material to reduce friction when moving relative to the inner tube 100. The second intermediate layer 220 of the outer tube 200 is laser-cut from a metal tube (such as stainless steel or nickel-titanium alloy). The second outer layer 230 of the outer tube 200 is also composed of a polymer composite material. The above three layers are also fused into a whole through rheological technology. In addition, the first outer layer 130 of the inner tube 100 and the second outer layer 230 of the outer tube 200 can both be composed of polymer materials with different hardness. The hardness of the material decreases in the direction away from the handle 20, so as to ensure that the part connected to the handle 20 has sufficient support, while the end away from the handle 20 has sufficient softness and bending resistance to have a strong bending deformation ability, thereby minimizing the risk of tissue damage and improving the safety of the operation.

[0024] Furthermore, in this embodiment, the inner tube 100 or the outer tube 200 each has a connecting end 11 connected to the handle 20. An axial support 300 is provided at one end of the outer tube 200 away from the connecting end 11. The axial support 300 is offset from the central axis of the adjustable bend guide tube 10 and extends along the axial direction of the adjustable bend guide tube 10 away from the connecting end 11. To simplify the structure, the axial support 300 and the radial support 400 provided on the axial support 300 can be integrally formed with the outer tube 200. Specifically, the axial support 300 and the radial support 400 can be integrally formed with the middle layer of the outer tube 200 by laser cutting. In addition, the end of the axial support 300 away from the connecting end 11 can be fixedly connected to the inner tube 100. The fixing method can be any form such as welding or bonding. Furthermore, the radial support 400 can be a helical spring or flexible tubing extending around the inner tube 100. The radial support 400 wraps around the outside of the inner tube 100 and abuts against and limits its position against the outer wall of the inner tube 100. Alternatively, it is conceivable that the axial support 300 and the radial support 400 can also be used as a single component independent of the outer tube 200. The end of the axial support 300 near the connecting end 11 can be connected to the outer tube 200 by welding, bonding, or other methods. This not only simplifies the structural complexity of individual parts and reduces the difficulty and cost in the production process, but also achieves the same bending adjustment effect and performance as the aforementioned solutions. Since this solution is not fundamentally different from the aforementioned solutions in terms of technical implementation and effect, it will not be elaborated further here. In addition, the axial support 300 has a proximal end and a distal end in the axial direction, wherein the proximal end is the end closer to the handle 20 and the distal end is the end farther from the handle 20. Similarly, the inner tube 100 also has a proximal end and a distal end, with the proximal end of the inner tube 100 being the end closer to the handle 20 and the distal end of the inner tube 100 being the end farther from the handle 20. Figure 3 For example, in one embodiment, the distal end of the axial support 300 has a first limiting segment 330, and the proximal end of the axial support 300 has a second limiting segment 340. The first limiting segment 330 is fixedly connected to the distal end of the inner tube 100. The first limiting segment 330, the second limiting segment 340, and the area between them constitute the bending adjustment area 12. In addition, both the first limiting segment 330 and the second limiting segment 340 can fix the imaging ring 800. The fixing method can be heat fusion, bonding, welding, etc. After fixing, it is further fused with the second inner layer 210, the second intermediate layer 220, and the second outer layer 230 into a whole through rheological technology. During the operation, the imaging ring 800 allows the doctor to easily confirm the bending adjustment position and bending state of the adjustable catheter 10. With the above structure, the inner tube 100 and the outer tube 200 are driven to move relative to each other in the axial direction by rotating the control knob 21 of the handle 20 to achieve the bending of the bending area 12 of the adjustable bending conduit 10, and the entire rotation of the adjustable bending conduit 10 is achieved by rotating the entire handle 20.

[0025] The following describes the bending process of the bending region 12 of the adjustable bending conduit 10: In the initial state, the inner tube 100 and the outer tube 200 are kept in a straight line. Figure 1 In a straight state, when the inner tube 100 and the outer tube 200 are aligned... Figure 5 When moving relative to the axial support 300 in the manner described in 5a, since the axial support 300 is not at the center of the adjustable bend conduit 10, the design of the axial support 300 causes the bending region 12 of the adjustable bend conduit 10 to have asymmetrical mechanical characteristics in the radial direction. At this time, the inner tube 100 applies pressure to the distal end of the axial support 300. Figure 5 The force in the direction of the arrow in 5a, such as Figure 5 In section 5b, because the axial support 300 provides support for the left side of the inner tube 100, while the right side of the inner tube 100 has no structural support, the inner tube 100 will bend to the right. During this process, the radial support 400 abuts against the outer wall of the inner tube 100 and is subjected to the bending force of the outer tube 200, causing the outer tube 200 to bend synchronously with the inner tube 100. When the outer tube 200 and the inner tube 100 are aligned... Figure 6 When moving relative to each other in the manner of 6a, such as Figure 6 As shown in 6b, since the axial support 300 provides support to the left side of the inner tube 100, the left side of the inner tube 100 will be difficult to move. However, the right side of the inner tube 100, lacking support, will push out to the right. Because the first limiting segment 330 of the axial support 300 is fixedly connected to the distal end of the inner tube 100, and under the constraint of the radial support 400, the inner tube 100 and the outer tube 200 will bend to the left. Thus, through the relative movement of the inner tube 100 and the outer tube 200 in different axial directions, the bending region 12 of the adjustable bending conduit 10 can bend in different directions, with the two directions being symmetrical, thereby achieving bidirectional symmetrical bending. Furthermore, the relative movement distance between the inner tube 100 and the outer tube 200 can result in different bending angles in the bending region 12 of the adjustable bending conduit 10, thereby achieving different bending amplitudes.

[0026] In addition to the above adjustment methods, the bending region 12 of the adjustable bending guide tube 10 in this solution can also be oscillated circumferentially along the bending region 12 of the adjustable bending guide tube 10; such as Figure 7 When the inner tube 100 moves axially relative to the outer tube 200 in a direction away from the connecting end 11, the bending area 12 of the adjustable conduit 10 will be in a position where... Figure 6 In the 6a bending state, press in this state Figure 7 When the inner tube 100 and the outer tube 200 are rotated counterclockwise, the bent portion of the inner tube 100 or the outer tube 200 will have an orientation towards Figure 7The adjustable bendable conduit 10 tends to swing to the right, but since the distal ends of both the inner tube 100 and the axial support 300 are fixed, the head end of the adjustable bendable conduit 10 will rotate to the right. The amplitude of the rotation is related to the angle of rotation of the inner tube 100 relative to the outer tube 200, thus enabling the circumferential swing of the bendable region 12 of the adjustable bendable conduit 10. Furthermore, it is conceivable that the inner tube 100 and the outer tube 200... Figure 7 Relative rotation in opposite directions allows the head end of the adjustable bendable conduit 10 to rotate to the left, thus enabling the bendable area 12 of the adjustable bendable conduit 10 to swing within a 360-degree range in the circumferential direction. Similarly, when the inner tube 100 moves axially relative to the outer tube 200 toward the connecting end 11, the bendable area 12 of the adjustable bendable conduit 10 will be in a position where... Figure 5 In the 5a bending state, when the inner tube 100 and the outer tube 200 rotate clockwise or counterclockwise relative to each other, the bending area 12 of the adjustable conduit 10 can also be in the bending state. Figure 5 It swings within a 360-degree range in the circumferential direction under the bending state of 5a.

[0027] This design allows for flexible adjustment of the bending state of the bending region 12 of the adjustable bending catheter 10 through the relative axial movement of the inner tube 100 and the outer tube 200, the relative circumferential rotation of the inner tube 100 and the outer tube 200, and the overall rotation of the adjustable bending catheter 10. Based on the above structure, the following will describe the usage of the adjustable bending catheter 10 within blood vessels: Figure 8 The diagram illustrates partial structures of the internal carotid artery, anterior cerebral artery, and middle cerebral artery (M1, superior M2 trunk, and inferior M2 trunk), without instrument guidance, such as... Figure 8 When the tip of the adjustable-bend catheter 10 reaches between the superior and inferior trunks of the middle artery M2, the relative axial positions of the inner tube 100 and the outer tube 200, as well as the overall rotation of the adjustable-bend catheter 10, can be adjusted so that the tip of the adjustable-bend catheter 10 bends towards the inferior trunk. After continuing to deliver the catheter, the adjustable-bend catheter 10 can enter the inferior trunk of the middle artery M2. Similarly, when the relative axial positions of the inner tube 100 and the outer tube 200 are adjusted in the opposite direction, and the adjustable-bend catheter 10 is rotated as a whole, the tip of the adjustable-bend catheter 10 can bend towards the superior trunk. After continuing to deliver the catheter, the adjustable-bend catheter 10 can enter the superior trunk of the middle artery M2. When the adjustable-bend catheter 10 is at different bifurcation positions, the above adjustments can be made so that the adjustable-bend catheter 10 can be pushed into different arterial branches and finally reach the surgical site.

[0028] Furthermore, the adjustable bendable conduit 10 in this solution can also be used to address the window sill effect problem. For example... Figure 10As shown, when the support catheter passes through the origin of branches such as the ophthalmic artery and posterior communicating artery with the assistance of a microcatheter, the relatively large gap between the two types of catheters can easily cause the tip of the support catheter to get stuck at the junction of the ophthalmic artery and be difficult to pass through. This phenomenon is known as the "windowsill effect." With the adjustable bendable catheter 10 in this solution, as... Figure 11 As shown, the adjustable-bend catheter 10 is placed inside the support catheter. By adjusting the relative axial movement of the inner tube 100 and outer tube 200 of the adjustable-bend catheter 10, the bending region 12 of the adjustable-bend catheter 10 can be adjusted. In the bent state of the bending region 12 of the adjustable-bend catheter 10, the tip of the support catheter can be deflected towards the center of the artery, thereby moving away from the ophthalmic artery junction, allowing the support catheter to smoothly follow the adjustable-bend catheter 10 forward.

[0029] Furthermore, in this design, the flexibility of the axial support 300 is specially designed. Along its extension direction, the flexibility of the axial support 300 increases (gradually softens). Specifically, this can be achieved by changing the cross-sectional area or material composition of the axial support 300. For example, the cross-sectional area of ​​the axial support 300 can decrease from the proximal end to the distal end. With this design, when the adjustable bending conduit 10 bends in the bending region 12, the increasing flexibility of the axial support 300 causes the region containing the axial support 300 to bend sequentially from the distal end to the proximal end, forming... Figure 5 and Figure 6 The semi-circular curved shape not only makes bending smoother but also allows for a larger bending angle, thus better adapting to the complex structure of blood vessels. It also ensures better support for the proximal end of the axial support 300, guaranteeing support for the inner tube 100 and other instruments. Through this solution, this application solves the problems of insufficient tip flexibility, limited bending angle, poor directional control, and thick wall thickness in existing adjustable-bend catheters 10. The progressively flexible design of the adjustable-bend catheter 10 and its bending region 12 provide sufficient flexibility, enabling it to better adapt to complex vascular structures and reducing the risk of damage to the vessel wall. Furthermore, the synergistic effect of the axial support 300 and the radial support 400 improves the bending ability and directional control precision of the adjustable-bend catheter 10, making it easier to reach the target position. This not only enhances surgical safety but also improves operational efficiency.

[0030] In addition, it is conceivable that the aforementioned axial support 300 is not limited to being installed on the outer tube 200. The axial support 300 and the radial support 400 can be integrated on the inner tube 100, and the bending direction and angle can be limited by the inner tube 100 applying a limit to the outer tube 200. This will not be elaborated here.

[0031] Furthermore, in the specific implementation of this scheme, when the inner tube 100 and the outer tube 200 move relative to each other along the axial direction, due to the design characteristics of the axial support 300, its flexibility gradually decreases from the distal end to the proximal end. This flexibility gradient causes the axial support 300 to gradually bend from the distal end to the proximal end when subjected to axial force. Specifically, as the inner tube 100 and the outer tube 200 undergo axial relative displacement, the bending region 12 of the adjustable conduit 10 gradually forms a circular bending profile, thus allowing for a wide range of bending angles to meet different application requirements. Moreover, when the relative movement directions of the outer tube 200 and the inner tube 100 are different, the bending direction of the axial support 300 will also change accordingly, specifically manifested as follows: Figure 5 The rightward bend and Figure 6 The adjustable bend curves to the left, allowing the bendable region 12 of the adjustable bendable catheter 10 to achieve bidirectional symmetrical bending, thus improving the flexibility and adaptability of the adjustable bendable catheter 10 in practical applications. Furthermore, since the above structure eliminates the need for an additional traction wire, the catheter wall can be made thinner during manufacturing. This thin-walled design allows for a smaller outer diameter of the adjustable bendable catheter 10, improving its flexibility and compliance, making it easier to pass through narrow blood vessels or cavities, and thus more easily reaching the small distal blood vessels in the human body.

[0032] like Figure 3 In another embodiment of this application, the axial support 300 decreases in size in the radial direction of the adjustable bend conduit 10 in the extending direction of the axial support 300.

[0033] The reduction in size can be achieved in several ways: for example, the width of the axial support 300 in the radial direction of the adjustable bend conduit 10 decreases in the extending direction of the axial support 300. The width of the axial support 300 at the proximal end near the handle 20 and the second limiting section 340 along the axial direction of the adjustable bend conduit 10 is preferably 0.4 mm to 1.4 mm, and the width of the axial support 300 at the distal end away from the handle 20 and near the first limiting section 330 along the axial direction of the adjustable bend conduit 10 is preferably 0.06 mm to 0.4 mm; or the material thickness of the axial support 300 decreases synchronously in the extending direction, which reduces the stiffness of the axial support 300 at the distal end, making it easier to bend, while providing sufficient support at the proximal end near the handle 20; such size changes can be achieved by using precision machining technology during manufacturing, such as laser cutting. Through the above technical solution, the distal end of the axial support 300 can be more flexible and more easily deformed, enabling the adjustable bendable catheter 10 to bend flexibly in complex vascular environments and improving the maneuverability of the adjustable bendable catheter 10.

[0034] In another embodiment of this application, the radial support 400 in the outer tube 200 is configured as an annular structure extending circumferentially along the adjustable bendable catheter 10, and the inner tube 100 is sleeved with the annular structure. The annular structure extends continuously circumferentially in the adjustable bendable catheter 10 to form a closed loop. The annular structure is fitted with the inner tube 100 with a clearance. The annular structure can be integrally formed on the axial support 300 to simplify the structure and improve overall strength. The annular structure is used to abut and limit the movement against the outer wall of the inner tube 100. Multiple annular structures can be spaced apart along the axial direction of the adjustable bendable catheter 10. Specifically, when the adjustable bendable catheter 10 is bent within the blood vessel, the continuous circumferential wrapping of multiple annular structures uniformly constrains the inner tube 100 radially, resulting in more uniform stress on the inner tube 100 and smoother bending. Furthermore, due to the spaced annular structures, the annular structures do not interfere with each other when the bending area 12 of the adjustable bendable catheter 10 achieves a large angle of bending, ensuring the smoothness and flexibility of the bending area 12 of the adjustable bendable catheter 10. At the same time, it forms a stable radial limit on the inner tube 100, preventing excessive local deformation in the area where the axial support 300 is located during bending, thus maintaining structural stability.

[0035] In another embodiment of this application, the radial support 400 has a width in the axial direction of the adjustable bend catheter 10. In the extending direction of the axial support 300, the width of the radial support 400 remains consistent or gradually varies, and the spacing between any two adjacent annular structures remains consistent or gradually varies. In one embodiment, the width of the radial support 400 in the axial direction of the adjustable bend catheter 10 is preferably 0.10 mm, and the spacing between adjacent radial supports 400 in the axial direction of the adjustable bend catheter 10 is preferably 0.10 mm to 0.15 mm, ensuring sufficient strength while preventing interference between adjacent radial supports 400. In another embodiment, the axial width of the radial support 400 may decrease linearly and gradually in the extending direction of the axial support 300. This results in a gradual decrease in the stiffness of the axial support 300 from proximal to distal end, making the distal end of the axial support 300, away from the handle 20, easier to bend, reducing resistance during bending, and further improving the maneuverability and flexibility of the adjustable bend catheter 10 in complex vascular environments. In another embodiment, the distance between adjacent radial supports 400 gradually decreases from the near end to the far end of the axial support 300, which also makes the axial support 300 easier to bend and reduces the resistance of the axial support 300 during the bending process. In addition, it is conceivable that the width of the radial support 400 and the spacing between adjacent radial supports 400 can be kept equal, and the designer can adjust the width and spacing according to the design requirements to meet the usage requirements.

[0036] In another embodiment of this application, the radial support 400 is configured as a helical spring or a flexible tube. When it is a flexible tube, it can be a low-hardness TPU tube. The radial support 400 only needs to be sleeved on the axial support 300. The two ends of the flexible tube and the two ends of the axial support 300 can be fixed by welding, bonding, or other methods, and the middle part of the flexible tube is tightly fitted with the axial support 300. When it is a helical spring, the helical spring extends along the extension direction of the axial support 300. The two ends of the helical spring are bonded or welded to the axial support 300, and the middle part is tightly fitted with the axial support 300. Figure 12 In this design, the axial support 300 is a rod-shaped structure. A helical spring or flexible tube can be sleeved on the axial support 300 and its two ends can be fixed to the two ends of the axial support 300 by welding or bonding. If it is a helical spring, its pitch allows the axial support 300 to deform when bent, and its elastic properties can also provide additional restoring force, making it easier for the bending area 12 of the adjustable conduit 10 to return to its initial straight state. In addition, the inner tube 100 can be inserted into the helical spring or flexible tube, and the helical spring or flexible tube can also provide a limit for the inner tube 100. In this way, while ensuring the radial limiting stability of the inner tube 100 and the outer tube 200, the structure of a single part is simplified.

[0037] like Figure 13 In another embodiment of this application, the outer wall of the axial support 300 is provided with a plurality of protrusions 310. The protrusions 310 extend radially along the adjustable bending conduit 10, and the plurality of protrusions 310 are spaced apart axially along the adjustable bending conduit 10. The radially extending shape of the protrusions 310 can be columnar protrusions, sheet-like protrusions, etc. The protrusions 310 are symmetrically arranged on both sides of the axial support 300 to form a paired structure, and multiple sets are spaced apart axially along the axial direction of the axial support 300. When the axial support 300 is subjected to torsional load, the radially extending protrusions 310 can resist torsional stress, thereby strengthening the ability of the axial support 300 to maintain its straight shape. The axially spaced protrusions 310 form a segmented rigid region in the axial support 300. While maintaining overall flexibility, it improves the torsional resistance of the bending region 12 of the adjustable bending conduit 10, ensures that the axial support 300 is always straight, and improves the stability of the bending shape when the bending region 12 of the adjustable bending conduit 10 is bent.

[0038] like Figure 14 In another embodiment of this application, the bending region 12 of the adjustable conduit 10 further includes a partition 500, which covers at least one side of the inner and outer sides of the axial support 300 and the radial support 400, and the partition 500 is flexibly configured.

[0039] The diaphragm 500 can cover the inner, outer, or both sides of the axial support 300 and radial support 400. The coverage area is selected based on the flexibility requirements of the bendable region 12 of the adjustable catheter 10, the bend position, or the vascular contact situation. The flexible material of the diaphragm 500 can be polyurethane or similar materials. The diaphragm 500 is integrally formed with the axial support 300 and radial support 400 through processes such as encapsulation and rheological molding. When the diaphragm 500 covers the outer side of the axial support 300 and radial support 400, a low-hardness TPU material can be used. This ensures the structural stability of the bendable region 12 and reduces friction with the vascular wall, enhancing surgical safety and operability. When the partition 500 covers the inner side of the axial support 300 and the radial support 400, the partition 500 can be made of PTFE material. In this case, the partition 500 can use the same material as the second inner layer 210. Since there is PTFE material on the inner side of the axial support 300 and the radial support 400, the friction force in the bending area 12 when the inner tube 100 and the outer tube 200 move relative to each other can be reduced, making the relative movement of the inner tube 100 and the outer tube 200 smoother. When the partition 500 exists on both the inner and outer sides of the axial support 300 and the radial support 400, the bonding between the partition 500 and the axial support 300 and the radial support 400 can be enhanced by the rheoforming process.

[0040] like Figure 15 In another embodiment of this application, the adjustable bendable conduit 10 further includes an adjusting member 600. The adjusting member 600 is rigidly disposed and movably disposed between the inner tube 100 and the outer tube 200, and moves along the axial direction of the adjustable bendable conduit 10. The adjusting member 600 may be made of metal wire or thin-walled metal tubing as a rigid material, and it may be disposed between the inner tube 100 and the outer tube 200, and move along the axial direction of the adjustable bendable conduit 10; specifically, as... Figure 16 As shown in the first figure, when the adjusting member 600 moves along the axial direction of the adjustable bending conduit 10 towards its head end, the length of the overlapping area of ​​the inner and outer tubes 200 covered by its rigid section increases. This overlapping area cannot bend due to the support of the rigid member, while the uncovered area retains its original flexibility. Therefore, the length of the adjustable bend in the bending area 12 decreases, and consequently, the bending radius of the bending area 12 decreases. Figure 16As shown in the second figure, when the adjusting member 600 is pulled to move away from the tip of the adjustable bending catheter 10 along the axial direction of the adjustable bending catheter 10, the length of the overlapping area of ​​the inner and outer tubes covered by its rigid section decreases, thereby increasing the length of the adjustable bending region 12 and thus increasing the bending radius of the adjustable bending region 12. In this way, the doctor can adjust the effective bending length and bending radius of the adjustable bending region 12 of the adjustable bending catheter 10 in real time according to the vascular morphology, improving the passability and directional control accuracy of the adjustable bending catheter 10 in complex vascular pathways.

[0041] like Figure 17 In another embodiment of this application, a hole structure 320 with decreasing aperture is provided on the axial support 300 in the extending direction of the axial support 300. The hole structure 320 can be formed by laser cutting. The aperture of the hole structure 320 decreases linearly or non-linearly along the extending direction of the axial support 300. Since the width of the axial support 300 near the connecting end 11 is relatively large, providing a hole structure 320 with a larger aperture at this location can reduce the stiffness at this location, thus further improving the flexibility of the near-end region of the axial support 300. The larger width of the axial support 300 near the connecting end 11 also better increases the support of the near-end region of the axial support 300, ensuring the bending shape during bending.

[0042] like Figure 18 In another embodiment of this application, the first limiting segment 330 of the axial support 300 is provided with at least one connecting hole. The inner tube 100 is attached to the first limiting segment 330 and fixed by means of bonding, welding and hot melting. The first limiting segment 330 can be configured as having multiple circular or elliptical through holes arranged at intervals. The number of holes can be flexibly set. The presence of connecting holes can increase the contact area when the inner tube 100 and the first limiting segment 330 are connected, which helps to improve the fixing strength between the two.

[0043] like Figure 19 In another embodiment of this application, the width of the axial support 300 in the radial direction of the adjustable bending conduit 10 remains unchanged in the extending direction of the axial support 300. In this way, the stiffness of the axial support 300 at the proximal position can be effectively reduced, thereby making the adjustable bending conduit 10 have better smoothness at the proximal position of the bending region 12, improving the operational flexibility of the conduit, reducing resistance and friction during the bending process, and making the entire bending operation smoother and more efficient.

[0044] like Figure 3In another embodiment of this application, the second intermediate layer 220 on the outer tube 200 is configured as a hyaluronic acid tube 700, and the flexibility of the hyaluronic acid tube 700 increases in the direction close to the axial support rod. The increasing flexibility of the hyaluronic acid tube 700 can be achieved by changing the tube wall thickness or the density of the holes on the hyaluronic acid tube 700. By using the hyaluronic acid tube 700, the torque at the end of the handle 20 can be transmitted in real time to the head end of the bending area 12 of the adjustable bending guide tube 10, providing a 1:1 torque control feedback from the end of the handle 20 to the head end of the adjustable bending guide tube 10. Using the hyaluronic acid tube 700 can also improve the controllability, flexibility and bending resistance of the adjustable bending guide tube 10.

[0045] The above are merely exemplary embodiments of the present invention and do not limit the scope of the patent of the present invention. All equivalent structural transformations made using the contents of the present invention specification and drawings under the technical concept of the present invention, or direct / indirect applications in other related technical fields, are included within the scope of patent protection of the present invention.

Claims

1. An adjustable bend catheter, comprising: The adjustable bending catheter comprises: an inner tube for conveying a preparation or a device; an outer tube sleeved on the outer side of the inner tube, the inner tube and the outer tube both have a connecting end on the same side, which is used for connecting with different parts of a handle; an axial support body arranged on one side of the axial line of the adjustable bending catheter and extending along the axial line of the adjustable bending catheter; the axial support body is arranged on one end of the outer tube away from the connecting end and is fixedly connected with one end of the inner tube away from the connecting end; a radial support body arranged on the axial support body, which is used for abutting and limiting the side wall of the inner tube; wherein the axial support body has an extending direction from one end close to the connecting end to one end away from the connecting end, and the flexibility of the axial support body increases in the extending direction of the axial support body.

2. The steerable catheter of claim 1, wherein, In the extending direction of the axial support body, the size of the axial support body in the radial direction of the adjustable bending catheter decreases.

3. The steerable catheter of claim 1, wherein, The radial support body is configured as an annular structure extending along the circumferential direction of the adjustable bending catheter, and a plurality of annular structures are arranged at intervals in the axial direction of the adjustable bending catheter, and the annular structure is sleeved on the outer side of the inner tube.

4. The steerable catheter of claim 3, wherein, The radial support body has a width in the axial direction of the adjustable bending catheter, and the width of the radial support body remains unchanged or gradually changes in the extending direction of the axial support body, and the distance between every two adjacent annular structures remains unchanged or gradually changes.

5. The steerable catheter of claim 1, wherein, The radial support body is configured as a spiral spring extending along the extending direction of the axial support body, and the two ends of the spiral spring are fixedly connected with the axial support body, and the middle part of the spiral spring is in close contact with the axial support body; or the radial support body is configured as a flexible pipe material extending along the extending direction of the axial support body, and the two ends of the flexible pipe material are fixedly connected with the axial support body, and the middle part of the flexible pipe material is in close contact with the axial support body.

6. The steerable catheter of claim 1, wherein, The outer wall of the axial support body is provided with a plurality of protrusions extending in the radial direction of the adjustable bending catheter, and a plurality of protrusions are arranged at intervals in the axial direction of the adjustable bending catheter.

7. The steerable catheter of claim 1, wherein, The adjustable bending catheter further comprises a separation layer, which is wrapped on at least one side of the inner side and the outer side of the axial support body and the radial support body, and the separation layer is flexibly arranged.

8. The steerable catheter of claim 1, wherein, The adjustable bending catheter further comprises an adjusting member, which is rigidly arranged, movably arranged between the inner tube and the outer tube and slides along the axial direction of the adjustable bending catheter.

9. The steerable catheter of claim 1, wherein, In the extending direction of the axial support body, the axial support body is provided with a hole structure with a decreasing hole diameter; and / or, In the extending direction of the axial support body, the width of the axial support body in the radial direction of the adjustable bending catheter remains unchanged.

10. The steerable catheter of claim 1, wherein, One end of the axial support body away from the connecting end is provided with a first limiting section, the first limiting section is provided with at least one connecting hole, one end of the inner tube away from the connecting end is attached to the first limiting section and is connected by one of bonding, welding and hot melting.

Images