An adjustable bend catheter

Abstract

This invention discloses an adjustable bending catheter, relating to the field of interventional medical device technology. It includes an inner tube, an outer tube, an adjusting support tube, and a handle. The inner tube includes a distally located curved section capable of bidirectional bending. A distally located internal control bending section extends outward from the outer tube. The outer tube is anchored via an anchoring structure. The distal end of the adjusting support tube is connected to the internal control bending section, and the distal end of the outer tube is fixed to the adjusting support tube. The elastic modulus of the adjusting support tube is less than that of the inner tube. The handle is equipped with an inner tube pushing component. When the outer tube is anchored to the inner wall of the blood vessel, an axial force is applied to the inner tube through the inner tube pushing component. The internal control bending section bends under the combined action of the axial force and the supporting force applied by the adjusting support tube. The distal end of the inner tube can achieve a large-angle bend. Combined with the overall rotation of the inner and outer tubes, the distal end of the inner tube can rotate in three-dimensional space, enabling the adjustable bending catheter to bend in any direction, thus facilitating passage through tortuous blood vessels.

Description

Technical Field

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

[0002] Adjustable bendable catheters are widely used medical devices in interventional procedures. They are primarily used to guide other medical devices (such as guidewires, catheters, and electronic components) or fluids into the body to reach the target site for diagnostic or therapeutic procedures. During the procedure, the operator needs to adjust the bendable catheter to adapt to complex anatomical structures and surgical pathways, thereby improving the safety and effectiveness of the surgery.

[0003] Existing adjustable catheters typically consist of a catheter body in the form of a thiocyanate tube or a serpentine tube, along with multiple traction wires. These traction wires are fixed to the catheter body, and bending is achieved by manipulating them. However, adjustable catheters using traction wires for bending are prone to problems such as traction wire breakage or connection failure between the traction wires and the catheter body. Summary of the Invention

[0004] In view of this, the purpose of the present invention is to provide an adjustable bendable catheter for interventional blood vessels, so as to solve the problems of easy breakage of the inner traction wire and easy connection failure between the traction wire and the catheter body in existing adjustable bendable catheters.

[0005] To solve the above-mentioned technical problems, the technical solution of the present invention is as follows:

[0006] An adjustable bendable conduit includes an inner tube, an outer tube, an adjustable bend support tube, and a handle. The inner tube passes through the inner lumen of the outer tube, and the proximal ends of both the inner tube and the outer tube are connected to the handle.

[0007] The inner tube includes a curved section located at the distal end. The wall of the curved section is provided with multiple inner tube deformation grooves. The multiple inner tube deformation grooves enable the curved section to bend in two opposite directions. The curved section includes an inner tube bending section extending outward from the distal opening of the outer tube.

[0008] The outer tube is provided with an anchoring structure that can expand or contract radially relative to the outer tube, and the anchoring structure can be anchored to the inner wall of the blood vessel in the expanded state;

[0009] The bending support pipe is sleeved on the outer periphery of the inner bending control section, the far end of the bending support pipe is connected to the far end of the inner bending control section, the pipe section of the outer pipe located at the far end of the anchoring structure is fixedly connected to the bending support pipe, and the elastic modulus of the bending support pipe is less than that of the inner pipe.

[0010] The handle is provided with an inner tube pusher for applying an axial force to the inner tube; when the outer tube is anchored to the inner wall of the blood vessel by the anchoring structure thereon, an axial force is applied to the inner tube by the inner tube pusher, and the inner tube bending section bends under the action of the axial force and the supporting force applied by the bending support tube, and the bending support tube bends along with the bending of the inner tube.

[0011] Furthermore, the outer tube is a double-lumen tube, the inner tube passes through the inner lumen of the double-lumen tube, and the outer tube is also provided with a balloon injection chamber. The anchoring structure is an anchoring balloon connected to the outer wall of the outer tube. The inner lumen of the anchoring balloon is connected to the balloon injection chamber, and the proximal end of the balloon injection chamber is provided with a balloon injection port.

[0012] Furthermore, the inner tube is a metal tube, the inner side of which is provided with a PTFE inner lining layer, and the outer side of which is provided with a polymer coating layer; the outer tube is a polymer double-lumen tube.

[0013] Furthermore, the bending support pipe includes:

[0014] The elastic tube is elastic in itself, with its distal end fixedly connected to the distal end of the inner tube bending section and its proximal end fixedly connected to the distal end of the outer tube.

[0015] The bending flat wire has its own elasticity, and its distal end is fixedly connected to the inner control bending section, and its proximal end is fixedly connected to the outer tube; the bending flat wire is located inside the elastic tube.

[0016] Furthermore, the elastic tube includes a polymer braided tube and a spring, the spring being embedded inside the polymer braided tube or fixed to the inner side of the polymer braided tube; the bending flat wire is a nickel-titanium alloy wire.

[0017] Furthermore, the handle includes:

[0018] handle body;

[0019] An outer tube fixing component is disposed inside the handle body and fixedly connected to the proximal end of the outer tube. The outer tube fixing component and the handle body are fixed in a relatively axial direction and rotate in a relatively circumferential direction.

[0020] An inner tube fixing member is disposed within the handle body and fixedly connected to the proximal end of the inner tube. The inner tube fixing member and the outer tube fixing member are kept in relative axial sliding and relative circumferential fixed arrangement. The inner tube pushing member is connected to the inner tube fixing member, and the inner tube pushing member applies an axial force to the inner tube through the inner tube fixing member.

[0021] An adjustment knob is connected to the far end of the handle body and fixedly connected to the outer tube fixing component, used to drive the outer tube fixing component to rotate around its own axis.

[0022] Furthermore, the bottom of the inner tube pusher is provided with an axial limiting block, and the proximal and distal ends of the handle body are provided with locking components for locking the axial limiting block so that the adjustable bendable guide tube is kept in the current bend state.

[0023] Furthermore, the bending support tube is an intermediate tube coaxially arranged between the outer tube and the inner tube. The intermediate tube includes a bending section at the distal end. The wall of the bending section is provided with multiple bending grooves. The multiple bending grooves allow the bending section to bend in two opposite directions. The bending direction of the bending section is the same as that of the bending section of the inner tube. The distal end of the outer tube is fixed to the intermediate tube.

[0024] The outer periphery of the distal end of the inner control bend section is provided with a limiting groove, and the distal end of the intermediate pipe bend section is connected to an annular intermediate pipe limiting retaining ring. The inner diameter of the intermediate pipe limiting retaining ring is smaller than the inner diameter of the intermediate pipe bend section. The intermediate pipe limiting retaining ring extends into the limiting groove to limit the inner control bend section and the intermediate pipe bend section.

[0025] Furthermore, the limiting groove is a single-ring inclined annular groove, and the groove sidewall of the single-ring inclined annular groove includes a proximal groove sidewall and a distal groove sidewall. The farthest end of the proximal groove sidewall is defined as end face A, and the nearest end of the distal groove sidewall is defined as end face B. When the inner tube is subjected to an axial force toward the proximal end, the proximal end face of the intermediate tube limiting retaining ring abuts against the end face A. When the inner tube is subjected to an axial force toward the distal end, the distal end face of the intermediate tube limiting retaining ring abuts against the end face B.

[0026] Furthermore, the inner tube includes a distal segment located at the farthest end of the inner tube control bend section, a proximal oblique tube fixedly sleeved on the outer periphery of the distal segment with a beveled distal end face, and a distal oblique tube fixedly sleeved on the outer periphery of the distal segment with a beveled proximal end face. The outer wall surface of the distal segment forms the bottom wall of the single-ring inclined annular groove, the beveled surface of the proximal oblique tube forms the proximal groove sidewall of the single-ring inclined annular groove, and the beveled surface of the distal oblique tube forms the distal groove sidewall of the single-ring inclined annular groove.

[0027] Furthermore, the curved section of the intermediate tube is provided with a developing element.

[0028] Furthermore, the handle includes:

[0029] handle body;

[0030] An intermediate tube fixing component is disposed inside the handle body and fixedly connected to the proximal end of the intermediate tube. The intermediate tube fixing component and the handle body are fixed in a relatively axial direction and rotate in a relatively circumferential direction.

[0031] An inner tube fixing member is disposed within the handle body and fixedly connected to the proximal end of the inner tube. The inner tube fixing member and the intermediate tube fixing member are axially sliding and circumferentially fixed. An inner tube pushing member is connected to the inner tube fixing member, and the inner tube pushing member applies an axial force to the inner tube through the inner tube fixing member.

[0032] An outer tube fixing component is disposed inside the handle body and fixedly connected to the proximal end of the outer tube. The outer tube fixing component and the intermediate tube fixing component are kept in relative axial sliding and relative circumferential fixed arrangement.

[0033] An outer tube pusher is connected to the outer tube fixing member, and the outer tube pusher applies an axial force to the outer tube through the outer tube fixing member;

[0034] An adjustment knob is connected to the far end of the handle body and fixedly connected to the intermediate tube fixing component, used to drive the intermediate tube fixing component to rotate around its own axis.

[0035] Furthermore, the outer tube includes a deformable section serving as the anchoring structure, the deformable section being capable of radial expansion relative to the outer tube; the wall of the deformable section is provided with a plurality of strip-shaped cutting grooves arranged circumferentially around the outer tube, and a flexible connecting strip is formed between two adjacent circumferentially adjacent strip-shaped cutting grooves; when the distal end of the outer tube is fixed, an axial force towards the distal end is applied to the proximal end of the outer tube by the outer tube pusher, causing the plurality of connecting strips of the deformable section to undergo elastic bending deformation, and the deformable section expands radially outward relative to the outer tube after elastic deformation, thereby anchoring to the inner wall of the blood vessel.

[0036] Furthermore, the outer wall of the outer tube is provided with an outer tube covering layer. When the deformable segment elastically deforms and anchors to the inner wall of the blood vessel, the outer tube covering layer surrounding the deformable segment can block the blood vessel.

[0037] Furthermore, the openings of the plurality of inner tube deformation grooves are located on opposite sides of the inner tube, and the inner tube bending section bends in the two opposite directions with the grooves when subjected to force; the openings of the plurality of intermediate tube deformation grooves are located on opposite sides of the intermediate tube bending section, and the intermediate tube bending section bends in the two opposite directions with the grooves when subjected to force.

[0038] Furthermore, the inner tube bending section is provided with an inner tube limiting hole, and the intermediate tube bending section is provided with an intermediate tube limiting hole; when a limiting member passes through the inner tube limiting hole and the intermediate tube limiting hole, the openings of the multiple inner tube deformation grooves on the inner tube bending section and the openings of the multiple intermediate tube deformation grooves on the intermediate tube bending section are aligned.

[0039] The technical solution of this invention has the following advantages:

[0040] 1. The adjustable bendable catheter provided by this invention has an anchoring structure in the outer tube and the inner tube is designed to be longer than the outer tube, so that the distal end of the inner tube can be bent in both directions. The inner control bendable section extends outward from the distal opening of the outer tube, and a bendable support tube with an elastic modulus smaller than that of the inner tube is connected between the distal end of the outer tube and the distal end of the inner control bendable section. When this adjustable bendable catheter needs to be bent after intervention in a blood vessel, the outer tube is first anchored to the inner wall of the blood vessel through the anchoring structure. An axial force towards the proximal end is applied to the inner tube by the inner tube pusher on the handle. Under the action of this axial force and the support force applied by the bendable support tube, the inner control bendable section can bend in one bending direction defined by the inner tube bendable section. An axial force towards the distal end is applied to the inner tube by the inner tube pusher on the handle. Under the action of this axial force and the support force applied by the bendable support tube, the inner control bendable section can bend in the opposite bending direction defined by the inner tube bendable section, so that the inner control bendable section of the inner tube can achieve a maximum bend of 180°. In addition, the handle can also control the rotation of the inner and outer tubes as a whole, allowing the inner tube bend section to rotate in three-dimensional space, realizing the directional bending of the adjustable catheter, which can pass through various tortuous blood vessels and better meet the needs of clinical use. Attached Figure Description

[0041] To more clearly illustrate the specific embodiments of the present invention or the technical solutions in the prior art, the drawings used in the description of the specific embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are some embodiments of the present invention. For those skilled in the art, other drawings can be obtained from these drawings without creative effort.

[0042] Figure 1 This is a schematic diagram of the overall structure of the adjustable bend conduit in Embodiment 1 of the present invention;

[0043] Figure 2 This is a schematic diagram of the inner and outer tubes before assembly in Embodiment 1 of the present invention;

[0044] Figure 3 This is a cross-sectional view of the outer tube in Embodiment 1 of the present invention;

[0045] Figure 4 This is a partial structural diagram of the distal end of the adjustable bend conduit in Embodiment 1 of the present invention;

[0046] Figure 5 This is a schematic diagram of the injection connector in Embodiment 1 of the present invention;

[0047] Figure 6 This is a three-dimensional structural diagram of the handle in Embodiment 1 of the present invention;

[0048] Figure 7 This is a front view of the handle in Embodiment 1 of the present invention;

[0049] Figure 8 This is a three-dimensional structural diagram of the handle when the upper shell of the handle is hidden in Embodiment 1 of the present invention;

[0050] Figure 9 for Figure 8 Top view;

[0051] Figure 10 This is a schematic diagram of the adjustable bendable conduit in Embodiment 1 of the present invention when the inner tube is subjected to a force toward the axial proximal end.

[0052] Figure 11 This is a schematic diagram of the adjustable bending conduit in Embodiment 1 of the present invention when the inner tube is subjected to a force toward the distal end of the axial direction.

[0053] Figure 12 This is a schematic diagram of the overall structure of the adjustable bend conduit in Embodiment 2 of the present invention;

[0054] Figure 13 This is a schematic diagram of the outer tube structure in Embodiment 2 of the present invention;

[0055] Figure 14 This is a schematic diagram of the first embodiment of the deformable section of the outer tube in Embodiment 2 of the present invention;

[0056] Figure 15 This is a schematic diagram of the second embodiment of the deformable section of the outer tube in Embodiment 2 of the present invention;

[0057] Figure 16 This is a schematic diagram of the inner tube structure in Embodiment 2 of the present invention;

[0058] Figure 17 This is a schematic diagram of the intermediate tube in Embodiment 2 of the present invention;

[0059] Figure 18 This is a schematic diagram of the connection structure between the inner tube and the intermediate tube in Embodiment 2 of the present invention;

[0060] Figure 19 This is a schematic diagram of the structure of the distal end of the inner tube in Embodiment 2 of the present invention;

[0061] Figure 20 This is a schematic diagram of the proximal oblique end tube in Embodiment 2 of the present invention;

[0062] Figure 21 This is a schematic diagram of the structure of the distal end of the intermediate tube in Embodiment 2 of the present invention;

[0063] Figure 22 This is a schematic diagram of the connection structure between the distal end of the inner tube and the distal end of the middle tube in Embodiment 2 of the present invention;

[0064] Figure 23 This is a schematic diagram of the developing element in Embodiment 2 of the present invention;

[0065] Figure 24 This is a schematic diagram of the overall structure of the handle in Embodiment 2 of the present invention;

[0066] Figure 25 This is a three-dimensional structural diagram of the handle when the upper shell of the handle is hidden in Embodiment 2 of the present invention;

[0067] Figure 26 This is a cross-sectional view of the handle in Embodiment 2 of the present invention;

[0068] Figure 27 This is a schematic diagram of the bending of the adjustable bendable conduit in Embodiment 2 of the present invention when the inner tube is subjected to a force toward the proximal end of the axial direction;

[0069] Figure 28 This is a schematic diagram of the bending of the adjustable bendable conduit in Embodiment 2 of the present invention when the inner tube is subjected to a force toward the distal end of the axial direction.

[0070] Explanation of reference numerals in the attached figures:

[0071] 100. Inner tube; 110. Inner tube bending section; 110a. Inner tube bending control section; 111. Inner tube deformation groove; 112. Inner tube limiting hole; 113. Limiting groove; 114. Distal section; 115. Proximal oblique tube; 116. Distal oblique tube;

[0072] 200. Outer tube; 210. Inner lumen; 220. Anchoring balloon; 230. Balloon injection chamber; 240. Deformable section; 241. First strip-shaped cutting groove; 242. Connecting strip; 243. Second strip-shaped cutting groove;

[0073] 300. Adjustable support tube; 310. Elastic tube; 311. Polymer braided tube; 312. Spring; 320. Adjustable flat wire;

[0074] 400. Handle; 410. Handle body; 411. Handle upper shell; 412. Handle lower shell; 420. Outer tube fixing component; 430. Inner tube fixing component; 440. Inner tube pushing component; 450. Adjustment knob; 460. Middle tube fixing component; 470. Outer tube pushing component;

[0075] 500. Infusion connector; 510. Balloon injection port; 520. External tube channel; 530. Limiting slider;

[0076] 600, intermediate tube; 610, bent section of intermediate tube; 611, deformation groove of intermediate tube; 612, limiting hole of intermediate tube; 613, limiting retaining ring of intermediate tube; 620, developing piece. Detailed Implementation

[0077] The technical solution of the present invention will now be clearly and completely described with reference to the accompanying drawings. Obviously, the described embodiments are only some, not all, of the embodiments of the present invention. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0078] In the description of this invention, it should be noted that, unless otherwise explicitly specified and limited, the terms "installation," "connection," and "linking" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral connection; they can refer to a direct connection or an indirect connection through an intermediate medium; and they can refer to the internal connection of two components. Those skilled in the art can understand the specific meaning of the above terms in this invention based on the specific circumstances. In the description of this invention, it should be understood that the terms "proximal" and "distal" throughout the text refer to near and far relative to the operator. In use, the end closer to the doctor or operator is the "proximal" end, i.e., the end where the operator is located, and the end farther from the doctor or operator is the "distal" end.

[0079] Example 1

[0080] like Figures 1-11 An adjustable bendable catheter is shown, comprising an inner tube 100, an outer tube 200, an adjustable support tube 300, a handle 400, and an infusion connector 500. The inner tube 100 passes through the inner lumen of the outer tube 200, and the proximal ends of both the inner tube 100 and the outer tube 200 are connected to the handle 400. The proximal end of the infusion connector 500 is connected to the handle 400, and the outer tube 200 passes through the inner lumen of the infusion connector 500.

[0081] like Figure 1 and Figure 2 As shown, the inner tube 100 is a metal tube with a PTFE liner on its inner side and a polymer coating on its outer side. The inner tube 100 includes a curved section 110 at its distal end, which is capable of bidirectional bending. Specifically, the wall of the curved section 110 is cut to form multiple inner tube deformation grooves, the openings of which are located on opposite sides of the inner tube 100. These grooves allow the curved section 110 to bend in two opposite directions with the grooves when subjected to force.

[0082] like Figure 1 , Figure 2 and Figure 4 As shown, the length of the inner tube 100 is greater than the length of the outer tube 200, and the inner tube bending section 110 includes an inner tube bending section 110a extending outward from the distal opening of the outer tube 200.

[0083] like Figure 2 and Figure 3 As shown, the outer tube 200 is a polymer double-lumen tube. The inner tube 200 has an inner lumen 210 and a balloon infusion chamber 230. The inner tube 100 passes through the inner lumen 210 of the outer tube 200. An anchoring balloon 220, capable of radial expansion or contraction relative to the outer tube 200, is connected to the outer wall of the outer tube 200. In the expanded state, the anchoring balloon 220 can be anchored to the inner wall of the blood vessel. The inner lumen of the anchoring balloon 220 communicates with the balloon infusion chamber 230. Combined with... Figure 5 As shown, the perfusion connector 500 has a balloon infusion port 510 and an outer tube channel 520. A limiting slider 530 is provided on the outer periphery of the outer tube channel 520. The perfusion connector 500 is fixedly connected to the handle 400 via the limiting slider 530. The outer tube 200 passes through the outer tube channel 520 and connects to the proximal end of the handle 400. The balloon infusion port 510 communicates with the proximal end of the balloon infusion chamber 230 within the outer tube 200. The medium can be injected into the inner lumen of the anchoring balloon 220 or flow out of the anchoring balloon 220 through the balloon infusion port 510 and the balloon infusion chamber 230. After inflation, the anchoring balloon 220 can anchor itself to the inner wall of the blood vessel. The anchoring balloon 220 is a compliant balloon.

[0084] During bending, the anchoring balloon 220 ensures the distal end of the outer tube 200 is fixed and positioned in the middle of the blood vessel, allowing for more precise bending of the distal end of the inner tube 100. During distal embolization, the anchoring balloon 220 temporarily blocks blood flow, preventing the embolic microspheres from being affected by blood flow and flowing to other healthy small blood vessels, thus avoiding vascular occlusion.

[0085] like Figure 1 and Figure 4 As shown, the bending support pipe 300 is sleeved on the outer periphery of the inner control bending section 110a, and the distal end of the bending support pipe 300 is connected to the distal end of the inner control bending section 110a. The section of the outer pipe 200 located at the distal end of the anchoring balloon 220 is fixedly connected to the bending support pipe 300. The elastic modulus of the bending support pipe 300 is less than that of the inner pipe 100.

[0086] like Figure 1 and Figure 4As shown, the bending support tube 300 includes an elastic tube 310 and a bending flat wire 320, with the bending flat wire 320 located inside the elastic tube 310. The bending flat wire 320 is made of nickel-titanium alloy and has its own resilience. A developing ring (not shown) is provided at the distal end of the inner control bending section 110a. The distal end of the bending flat wire 320 is welded to the position of the developing ring in the inner control bending section 110a, and the proximal end of the bending flat wire 320 is fixedly connected to the distal end of the outer tube 200. The elastic tube 310 is a polymer elastic tube with its own elasticity. The elastic tube 310 includes a polymer braided tube 311 and a spring 312. The spring 312 is embedded inside the polymer braided tube 311 or fixed to the inner side of the polymer braided tube 311. The distal end of the elastic tube 310 is fixedly connected to the distal end of the inner control bend section 110a, and the proximal end of the elastic tube 310 is fixedly connected to the distal end of the outer tube 200.

[0087] like Figure 1 , Figures 6-9As shown, the handle 400 includes a handle body 410, an outer tube fixing member 420, an inner tube fixing member 430, an inner tube pushing member 440, and an adjustment knob 450. The handle body 410 is formed by connecting an upper handle shell 411 and a lower handle shell 412. The outer tube fixing member 420 is located within the handle body 410 and is fixedly connected to the proximal end of the outer tube 200. The outer tube fixing member 420 and the handle body 410 are axially fixed and circumferentially rotatable. The inner tube fixing member 430 is located within the handle body 410 and is located near the proximal end of the outer tube fixing member 420. The inner tube fixing member 430 and the outer tube fixing member 420 are axially sliding and circumferentially fixed. The inner tube fixing member 430 is fixedly connected to the proximal end of the inner tube 100. The inner tube pusher 440 is connected to the inner tube fixing member 430 and slidably connected to a groove on the upper shell 411 of the handle. The inner tube pusher 440 applies an axial force to the inner tube 100 through the inner tube fixing member 430. The adjusting knob 450 is connected to the distal end of the handle body 410 and abuts against the distal end face of the handle body 410. The portion of the adjusting knob 450 extending into the outer tube fixing member 420 is fixedly connected to the outer tube fixing member 420. The adjusting knob 450 is used to drive the outer tube fixing member 420 to rotate around its own axis. The adjusting knob 450 has a groove that matches the outer tube fixing member 420. When the adjusting knob 450 rotates, it can drive the outer tube fixing member 420 and the outer tube 200 to rotate synchronously. The outer tube fixing member 420 has a groove that matches the inner tube fixing member 430, allowing the inner tube fixing member 430 to slide axially relative to the outer tube fixing member 420. Rotating the adjusting knob 450 rotates the outer tube fixing component 420, which in turn rotates the inner tube fixing component 430. This ensures that the inner tube 100 and outer tube 200 rotate synchronously within the blood vessel, assisting the adjustable catheter in entering the corresponding vascular channel. In some embodiments, the adjusting knob 450 and the outer tube fixing component 420 can be an integral structure. An axial force is applied to the inner tube 100 by the inner tube pusher 440, causing the inner tube bending section 110a to bend under the axial force and the supporting force applied by the adjusting flat wire 320. The adjusting support tube 300 bends along with the bending of the inner tube 100.

[0088] In some embodiments, the bottom of the inner tube pusher 440 is provided with an axial limiting block (not shown), and both the proximal and distal ends of the handle body 410 are provided with locking members for locking the axial limiting block to keep the adjustable bendable conduit in its current bent state. Specifically, the inner tube pusher 440 is a button, and the axial limiting block is a step protruding outward from the bottom of the button. When the button is pushed forward, it moves the inner tube 100 to the distal end. When the step of the button reaches the position of the locking member matching the upper shell 411 of the handle, the button is locked, and the bent state of the distal end of the inner tube 100 is fixed. Similarly, when the button is pushed backward, it moves the inner tube 100 to the proximal end. When the step of the button reaches the position of another locking member matching the upper shell 411 of the handle, the button is locked, and the bent state of the distal end of the inner tube 100 to the other side is fixed.

[0089] like Figure 10 and Figure 11 As shown, before bending, the outer tube 200 is anchored to the inner wall of the blood vessel via the anchoring balloon 220. (As indicated...) Figure 10 As shown, when the inner tube pusher 440 on the handle 400 applies an axial pulling force towards the proximal end to the inner tube 100, it can drive the inner tube 100 to move towards the proximal end. Since the inner tube control bend section 110a at the distal end of the inner tube 100 is fixed by the bending flat wire 320, the inner tube control bend section 110a will be supported by the bending flat wire 320. Due to the binding effect of the elastic tube 310 on the outside of the bending flat wire 320, the distal end of the bending flat wire 320 will drive the inner tube control bend section 110a to bend in a bending direction defined by the inner tube bend section 110. Similarly, as Figure 11 As shown, when the inner tube pusher 440 on the handle 400 applies an axial thrust toward the distal end to the inner tube 100, it can drive the inner tube 100 to move distally. Since the inner tube control bend segment 110a at the distal end of the inner tube 100 is fixed by the bending flat wire 320, the inner tube control bend segment 110a will be pulled by the bending flat wire 320. At the same time, the outer side of the bending flat wire 320 is restrained by the elastic tube 310, so that the distal end of the bending flat wire 320 will drive the inner tube control bend segment 110a to bend in the opposite direction defined by the inner tube bend segment 110; so that the distal end of the inner tube 100 can achieve a maximum bend of 180°. The adjustment knob 450 on the handle 400 can control the rotation of the inner tube 100 and the outer tube 200 as a whole, so that the distal end of the inner tube 100 can rotate in three-dimensional space, realizing the directional bend of the adjustable catheter, which can pass through various tortuous blood vessels and better meet the needs of clinical use.

[0090] Example 2

[0091] like Figures 12-28The adjustable bending conduit shown differs from Embodiment 1 in that the outer tube 200 is a polymer tube or a metal tube, and both the inner and outer layers of the inner tube 100 and the outer tube 200 are coated with polymer materials. The bending support tube 300 is an intermediate tube 600 coaxially disposed between the outer tube 200 and the inner tube 100. The proximal end of the intermediate tube 600 is connected to the handle 400, and the distal end of the outer tube 200 is fixed to the intermediate tube 600. The intermediate tube 600 is a bidirectionally bendable structure cut from a metal tube, and the elastic modulus of the inner tube 100 is greater than that of the intermediate tube 600. The anchoring structure on the outer tube 200 is formed by grooves cut into the tube body of the outer tube 200.

[0092] like Figure 13 , Figure 14 and Figure 15 As shown, the outer tube 200 includes a deformable section 240 as an anchoring structure. The deformable section 240 is part of the tube body of the outer tube 200 and can expand radially outward relative to the outer tube 200.

[0093] like Figure 14 As shown, in some embodiments of the deformable segment 240, the tube wall of the deformable segment 240 is provided with a plurality of first strip-shaped cutting grooves 241 arranged circumferentially around the outer tube 200, and the tube wall between two adjacent first strip-shaped cutting grooves 241 is a flexible first connecting strip 242. When the distal end of the outer tube 200 is fixed, an axial force towards the distal end is applied to the proximal end of the outer tube 200, causing the plurality of connecting strips 242 of the deformable segment 240 to undergo elastic bending deformation. After elastic deformation, the deformable segment 240 expands radially outward relative to the outer tube 200, thereby anchoring itself to the inner wall of the blood vessel. The outer wall of the outer tube 200 is provided with an outer tube covering layer. When the deformable segment 240 elastically deforms and anchors to the inner wall of the blood vessel, the outer tube covering layer surrounding the deformable segment 240 can block the blood vessel.

[0094] like Figure 15As shown, in some other embodiments of the deformable section 240, the tube wall of the deformable section 240 is provided with a plurality of first strip-shaped cutting grooves 241 arranged circumferentially around the outer tube 200. The tube wall between two adjacent first strip-shaped cutting grooves 241 is a flexible first connecting strip 242. The tube wall of the deformable section 240 is also provided with a pair of second strip-shaped cutting grooves 243 located at the proximal and distal ends of the first strip-shaped cutting grooves 241. The length of the pair of second strip-shaped cutting grooves 243 is shorter than the length of the first strip-shaped cutting grooves 241, and the gap between two adjacent second strip-shaped cutting grooves 243 is larger than the gap between two adjacent first strip-shaped cutting grooves 241. With this configuration, the deformable section 240 can deform gradually from both ends to the middle when subjected to force. The middle part of the deformable section 240 is more likely to bend at a large angle under force, and the shape stability of the deformable section 240 after bending deformation is better. It can be understood here that the cutting form of the strip cutting groove on the deformable section 240 is not limited to the two structural forms mentioned above, as long as the structural strength of a local section of the deformable section 240 itself is weakened and it can bend and deform under stress.

[0095] Before bending, the intermediate tube 600 is kept in the same position in the axial direction. Since the distal end of the outer tube 200 is fixed to the intermediate tube 600, the axial position of the distal end of the outer tube 200 is also fixed at this time. A thrust is applied to the outer tube 200 towards the distal end through the handle 400. The multiple first connecting strips 242 of the deformable section 240 of the outer tube 200 bend and deform. After bending and deforming, the multiple first connecting strips 242 bulge outward, so that the deformable section 240 as a whole bulges outward radially relative to the outer diameter. Under the coating of the outer polymer material, the deformable section 240 in this state is spherical. The spherical deformable section 240 can be anchored to the inner wall of the blood vessel.

[0096] like Figure 12 , Figures 16-22 As shown, the inner tube 100 is a metal tube with a PTFE liner on its inner side and a polymer coating on its outer side. The inner tube 100 includes a curved section 110 at its distal end, which is capable of bidirectional bending. Specifically, the wall of the curved section 110 is cut to form multiple inner tube deformation grooves 111. The openings of these grooves are located on opposite sides of the inner tube 100, allowing the curved section 110 to bend in two opposite directions when subjected to force. The length of the inner tube 100 is greater than the length of the intermediate tube 600, and the length of the intermediate tube 600 is greater than the length of the outer tube 200. The intermediate tube 600 includes a curved section 610 located at the distal end, and the distal end of the curved section 610 extends outward from the distal opening of the outer tube 200. The inner tube 100 has a curved section 110a at the distal end that extends outward from the distal opening of the intermediate tube 600.

[0097] like Figure 19 and Figure 21 As shown, the wall of the intermediate tube bending section 610 is provided with multiple intermediate tube deformation grooves 611. The openings of the multiple intermediate tube deformation grooves 611 are located on opposite sides of the intermediate tube bending section 610. When subjected to force, the intermediate tube bending section 610 bends in the two opposite directions with the grooves. The bending direction of the intermediate tube bending section 610 is the same as the bending direction of the inner tube bending section 110. The cutting patterns of the inner tube bending section 110 and the intermediate tube bending section 610 include, but are not limited to, the forms shown in the above figures, as long as the cut inner tube bending section 110 and the intermediate tube bending section 610 can only bend in two opposite directions when subjected to force. The inner tube bending section 110 is provided with an inner tube limiting hole 112.

[0098] like Figure 16 , Figure 17 and Figure 18 As shown, the intermediate tube bending section 610 is provided with an intermediate tube limiting hole 612. During the assembly of the inner tube 100 and the intermediate tube 600, a limiting pin is passed through the inner tube limiting hole 112 and the intermediate tube limiting hole 612, so that the openings of the multiple inner tube deformation grooves 111 on the inner tube bending section 110 and the openings of the multiple intermediate tube deformation grooves 611 on the intermediate tube bending section 610 are aligned, and the bending direction of the intermediate tube bending section 610 is the same as that of the inner tube bending section 110. After the inner tube 100 and the intermediate tube 600 are assembled, the limiting pin can be removed.

[0099] Figures 16-22 As shown, a limiting groove 113 is provided on the outer periphery of the distal end of the inner control bend section 110a, and an annular intermediate pipe limiting retaining ring 613 is connected to the distal end of the intermediate pipe bend section 610. The outer diameter of the intermediate pipe limiting retaining ring 613 is the same as the outer diameter of the intermediate pipe bend section 610, and the inner diameter of the intermediate pipe limiting retaining ring 613 is smaller than the inner diameter of the intermediate pipe bend section 610. The intermediate pipe limiting retaining ring 613 extends into the limiting groove 113 to achieve step limiting of the inner control bend section 110a and the intermediate pipe bend section 610.

[0100] Figures 16-22As shown, the limiting groove 113 is a single-ring inclined annular groove, and the groove sidewall of the single-ring inclined annular groove includes a proximal groove sidewall located at the proximal end and a distal groove sidewall located at the distal end. The inner tube 100 includes a distal section 114 located at the farthest end of the inner control bend section 110a, a proximal oblique tube 115 fixedly sleeved on the outer periphery of the distal section 114 with a beveled distal end surface, and a distal oblique tube 116 fixedly sleeved on the outer periphery of the distal section 114 with a beveled proximal end surface. The distal section 114, the proximal oblique tube 115, and the distal oblique tube 116 are all cylindrical. The outer wall surface of the distal section 114 forms the bottom wall of the limiting groove 113, the oblique surface of the proximal oblique tube 115 forms the proximal groove sidewall of the limiting groove 113, and the oblique surface of the distal oblique tube 116 forms the distal groove sidewall of the limiting groove 113. Both the proximal beveled tube 115 and the distal beveled tube 116 are fixed to the outer periphery of the distal section 114 of the inner tube 100 by welding, bonding, or other methods. The farthest end of the proximal groove sidewall is defined as end face A, and the nearest end of the distal groove sidewall is defined as end face B. When the inner tube 100 is subjected to an axial force toward the proximal end, the proximal end face of the intermediate tube retaining ring 613 abuts against the end face A of the proximal beveled tube 115. When the inner tube 100 is subjected to an axial force toward the distal end, the distal end face of the intermediate tube retaining ring 613 abuts against the end face B of the distal beveled tube 116. The back-and-forth movement of the inner tube 100 will contact different beveled tubes, thereby bending the distal end of the inner tube 100.

[0101] like Figure 22 and Figure 23 As shown, the intermediate tube bending section 610 is equipped with a imaging element 620, which is welded to the intermediate tube 600. The imaging element 620 can be made of platinum-iridium alloy and is visible under X-ray. When the inner tube 100 is pushed distally, the inner tube bending section 110 bends towards the side of the marking rod of the imaging element 620; conversely, when the inner tube 100 is pushed proximally, the inner tube bending section 110 bends towards the other side of the marking rod of the imaging element 620. This guides the surgeon to predict the direction of bending during the adjustment, facilitating the surgical procedure.

[0102] like Figure 24 , Figure 25 and Figure 26As shown, the handle 400 includes a handle body 410, an outer tube fixing member 420, a middle tube fixing member 460, an inner tube fixing member 430, an outer tube pushing member 470, and an adjustment knob 450. The handle body 410 is formed by connecting an upper handle shell 411 and a lower handle shell 412. The middle tube fixing member 460 is located within the handle body 410 and is fixedly connected to the proximal end of the middle tube 600. The middle tube fixing member 460 and the handle body 410 are fixed in a relatively axial direction and rotate in a relatively circumferential direction. The middle tube fixing member 460 can only rotate around its own axis between the upper handle shell 411 and the lower handle shell 412. The inner tube fixing member 430 is located within the handle body 410 and is located near the proximal end of the middle tube fixing member 460. The inner tube fixing member 430 and the middle tube fixing member 460 are slidably connected in a relatively axial direction and are fixed in a relatively circumferential direction. The inner tube fixing member 430 is fixedly connected to the proximal end of the inner tube 100. The inner tube pusher 440 is connected to the inner tube fixing member 430. The inner tube pusher 440 applies an axial force to the inner tube 100 through the inner tube fixing member 430. Under the constraint of the handle upper shell 411, the inner tube pusher 440 can only perform linear reciprocating motion along the axial direction of the handle 400. The outer tube fixing member 420 is located inside the handle body 410 and at the distal end of the intermediate tube fixing member 460. The outer tube fixing member 420 and the intermediate tube fixing member 460 maintain relative axial sliding and relative circumferential fixing. The outer tube fixing member 420 is fixedly connected to the proximal end of the outer tube 200. The outer tube pusher 470 is connected to the outer tube fixing member 420. The outer tube pusher 470 applies an axial force to the outer tube 200 through the outer tube fixing member 420. Under the constraint of the handle upper shell 411, the outer tube pusher 470 can only perform linear reciprocating motion along the axial direction of the handle 400. An adjustment knob 450 is fixedly connected to the distal end of the handle body 410. The portion of the adjustment knob 450 extending into the handle body 410 is fixedly connected to the intermediate tube fixing member 460. The adjustment knob 450 is used to drive the intermediate tube fixing member 460 to rotate around its own axis. The adjustment knob 450 has a groove that matches the intermediate tube fixing member 460, and the rotation of the adjustment knob 450 can drive the intermediate tube fixing member 460 to rotate. The intermediate tube fixing member 460 has a proximal sliding groove that matches the inner tube fixing member 430, allowing the inner tube fixing member 430 to slide axially relative to the intermediate tube fixing member 460; the intermediate tube fixing member 460 also has a distal sliding groove that matches the outer tube fixing member 420, allowing the outer tube fixing member 420 to slide axially relative to the intermediate tube fixing member 460. Rotating the adjustment knob 450 can drive the intermediate tube fixation component 460 to rotate. The intermediate tube fixation component 460 drives the inner tube fixation component 430 and the outer tube fixation component 420 to rotate, which in turn drives the inner tube 100, intermediate tube 600 and outer tube 200 to rotate synchronously in the blood vessel, assisting the adjustable bendable catheter to enter the corresponding blood vessel channel.

[0103] like Figure 24 , Figure 25 and Figure 26As shown, in some embodiments, the groove between the outer tube fixing member 420 and the adjusting knob 450 is tapered, with one end near the adjusting knob 450 being the smaller end and the other end being the larger end. The gradient change of the groove of the adjusting knob 450 ensures self-locking during pushing. The boss of the outer tube pusher 470 can form an interference fit with the groove of the adjusting knob 450, fixing the outer tube fixing member 420 at the pushed position and ensuring that the deformable section 240 of the outer tube 200 is stably in an expanded state.

[0104] like Figure 27 and Figure 28 As shown, before bending, the outer tube 200 is anchored to the inner wall of the blood vessel via its deformable section 240. (As indicated...) Figure 27 As shown, when an inner tube force F is applied to the inner tube 100 towards the proximal end, the intermediate tube retaining ring 613 and the proximal oblique tube 115 are in... Figure 27 At point A, the intermediate tube limiting retaining ring 613 and the intermediate tube bending section 610 are supported by the tip of the proximal oblique tube 115, causing the intermediate tube bending section 610 to deform and bend downwards, thereby causing the distal end of the entire adjustable bendable conduit to bend downwards. Figure 28 As shown, when an inner tube force F1 is applied to the inner tube 100 towards the distal end, the intermediate tube retaining ring 613 and the distal oblique tube 116 are in... Figure 28 When contact is made at point B, the intermediate tube limiting retaining ring 613 and the intermediate tube bending section 610 are supported by the tip of the distal oblique tube 116, causing the intermediate tube bending section 610 to deform and bend upward, thereby causing the distal end of the entire adjustable bendable conduit to bend upward.

[0105] During bending, the inner tube pusher 440 on the handle 400 applies an axial thrust toward the distal end to the inner tube 100, which can drive the inner tube 100 to move toward the distal end. Since the inner tube control bending section 110a at the distal end of the inner tube 100 is fixed by the intermediate tube limiting retaining ring 613, the inner tube control bending section 110a will be pulled by the intermediate tube limiting retaining ring 613, so that the intermediate tube limiting retaining ring 613 will drive the inner tube control bending section 110a to bend. Similarly, when an axial pulling force towards the proximal end is applied to the inner tube 100 by the inner tube pusher 440 on the handle 400, the inner tube 100 can be moved towards the proximal end. Since the inner tube control bend section 110a at the distal end of the inner tube 100 is fixed by the intermediate tube limiting retaining ring 613, it will be supported by the intermediate tube limiting retaining ring 613, so that the intermediate tube limiting retaining ring 613 will drive the inner tube control bend section 110a to bend in the opposite bending direction defined by the inner tube bending section 110; so that the distal end of the inner tube 100 can achieve a maximum bend of 180°.

[0106] In summary, the adjustable-bend catheter provided by this invention has an inner tube 100 that is longer than the outer tube 200. The distal end of the inner tube 100 has an internal bend-controlling segment 110a that extends outward from the distal opening of the outer tube 200. A bend-adjusting support tube 300 or intermediate tube 600 with an elastic modulus less than that of the inner tube 100 is connected between the distal end of the outer tube 200 and the distal end of the internal bend-controlling segment 110a. An anchoring balloon 220 or a deformable segment 240 is provided in the outer tube 200. When this adjustable-bend catheter needs to be bent after intervention in a blood vessel, the outer tube 200 is first anchored to the inner wall of the blood vessel via the anchoring balloon 220 or the deformable segment 240. An axial force towards the proximal end is applied to the inner tube 100 by the inner tube pusher 440. Under the action of this axial force and the supporting force applied by the bending flat wire 320 or the intermediate tube limiting ring 613, the inner tube bending section 110a can bend in one bending direction defined by the inner tube bending section 110. An axial force towards the distal end is applied to the inner tube 100 by the inner tube pusher 440. Under the action of this axial force and the supporting force applied by the bending flat wire 320 or the intermediate tube limiting ring 613, the inner tube bending section 110a can bend in the opposite bending direction defined by the inner tube bending section 110, allowing the inner tube 100's inner bending section 110a to achieve a maximum bending angle of 180°. Furthermore, the adjustment knob 450 can also control the rotation of the entire adjustable catheter, allowing the inner bending section 110a to rotate in three-dimensional space, achieving directional bending of the adjustable catheter. This allows it to navigate through various tortuous blood vessels, better meeting clinical needs. This adjustable-bend catheter design simplifies the structure of traditional pull-wire adjustable-bend catheters, reduces the risk of failure, and enables bidirectional bending functionality. Simultaneously, the outer tube 200 is equipped with a deformable section 240, which better anchors the catheter within the blood vessel during use, improving the bending effect and stability.

[0107] Obviously, the above embodiments are merely illustrative examples for clear explanation and are not intended to limit the implementation. Those skilled in the art will recognize that other variations or modifications can be made based on the above description. It is neither necessary nor possible to exhaustively list all possible implementations here. However, obvious variations or modifications derived therefrom are still within the scope of protection of this invention.

Claims

1. An adjustable bendable conduit, characterized in that, It includes an inner tube (100), an outer tube (200), a bending support tube (300), and a handle (400). The inner tube (100) passes through the inner cavity of the outer tube (200), and the proximal ends of both the inner tube (100) and the outer tube (200) are connected to the handle (400). The inner tube (100) includes an inner tube bending section (110) located at the distal end. The inner tube bending section (110) has a plurality of inner tube deformation grooves on its wall. The plurality of inner tube deformation grooves enable the inner tube bending section (110) to bend in two opposite directions. The inner tube bending section (110) includes an inner tube bending section (110a) extending outward from the distal opening of the outer tube (200). The outer tube (200) is provided with an anchoring structure that can expand or contract radially relative to the outer tube (200), and the anchoring structure can be anchored to the inner wall of the blood vessel in the expanded state; The bending support pipe (300) is sleeved on the outer periphery of the inner bending control section (110a). The distal end of the bending support pipe (300) is connected to the distal end of the inner bending control section (110a). The distal end of the outer pipe (200) is fixedly connected to the bending support pipe (300). The elastic modulus of the bending support pipe (300) is less than that of the inner pipe (100). The handle (400) is provided with an inner tube pusher (440) for applying an axial force to the inner tube (100); when the outer tube (200) is anchored to the inner wall of the blood vessel by the anchoring structure thereon, an axial force is applied to the inner tube (100) by the inner tube pusher (440), and the inner tube bending section (110a) bends under the action of the axial force and the supporting force applied by the bending support tube (300); The bending support tube (300) includes: The elastic tube (310) is elastic in itself, and its distal end is fixedly connected to the distal end of the inner control bend section (110a), and its proximal end is fixedly connected to the distal end of the outer tube (200). The bending flat wire (320) has its own elasticity. Its distal end is fixedly connected to the inner control bending section (110a), and its proximal end is fixedly connected to the outer tube (200). The bending flat wire (320) is located inside the elastic tube (310).

2. The adjustable bendable conduit according to claim 1, characterized in that, The outer tube (200) is a double-lumen tube, and the inner tube (100) passes through the inner lumen (210) of the double-lumen tube. The outer tube (200) is also provided with a balloon injection chamber (230). The anchoring structure is an anchoring balloon (220) connected to the outer wall of the outer tube (200). The inner lumen of the anchoring balloon (220) is connected to the balloon injection chamber (230). The proximal end of the balloon injection chamber (230) is provided with a balloon injection port (510).

3. The adjustable bendable conduit according to claim 2, characterized in that, The handle (400) includes: handle body(410); An outer tube fixing member (420) is disposed inside the handle body (410) and fixedly connected to the proximal end of the outer tube (200). The outer tube fixing member (420) and the handle body (410) are fixed in relative axial direction and rotate relative to each other. An inner tube fixing member (430) is disposed inside the handle body (410) and fixedly connected to the proximal end of the inner tube (100). The inner tube fixing member (430) and the outer tube fixing member (420) are axially sliding and circumferentially fixed. The inner tube pushing member (440) is connected to the inner tube fixing member (430). The inner tube pushing member (440) applies an axial force to the inner tube (100) through the inner tube fixing member (430). An adjustment knob (450) is connected to the far end of the handle body (410) and fixedly connected to the outer tube fixing member (420), and is used to drive the outer tube fixing member (420) to rotate around its own axis.

4. The adjustable bendable conduit according to claim 1, characterized in that, The bottom of the inner tube pusher (440) is provided with an axial limiting block, and the proximal and distal ends of the handle (400) are provided with locking elements for locking the axial limiting block so that the adjustable bendable conduit is kept in the current bend state.

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