A dilating catheter

Abstract

The present application relates to a kind of dilating catheter, including steering wire, steering wire channel and axial sequential connection catheter head, elastic balloon, tube and handle;Steering wire channel is sequentially through elastic balloon, tube and handle along the axis;Steering wire is arranged in steering wire channel, and the distal end is connected with catheter head;Elastic balloon is hollow structure, and is made of one or more elastic body;The proximal end of any one elastic body is fixed with the distal end of tube, and the distal end of any one elastic body is connected with the proximal end of catheter head;When steering wire is pulled back after being stressed, it drives elastic body to deform towards the axis direction away from elastic balloon, so that elastic balloon presents radial expansion state;When steering wire is relaxed, it makes elastic body rebound towards the axis direction close to elastic balloon.So configure, it does not affect blood flow, also avoid the problem of hydraulic impact injury, and can be repeatedly expanded for a long time, can provide more operability, and better treatment effect.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and specifically to a dilation catheter. Background Technology

[0002] Acute vascular occlusive disease is currently a leading cause of death in the Chinese population, including acute myocardial infarction, cerebral infarction, and peripheral arterial embolism. The preferred treatment for patients with acute vascular occlusive disease is emergency interventional therapy to open the infarct-related vessel and then continuously perfuse the infarcted area. However, during emergency interventional therapy, directly opening the occluded vessel can cause further damage, known as ischemia-reperfusion injury, leading to further damage to organs in the infarcted area. The traditional interventional treatment for acute vascular occlusive disease uses an intravascular guidewire and balloon to rapidly open the acutely occluded vessel. However, extensive animal and clinical experiments have shown that the sudden restoration of blood flow to the occluded vessel, followed by sudden and continuous reperfusion to the distal myocardium, causes a sudden change in the intracellular environment and a sudden imbalance in pH, resulting in severe contraction and destruction of edematous cell membranes, leading to further necrosis of ischemic organs. Furthermore, the inner diameter of the existing balloon catheter is too small. After the guidewire is inserted into the catheter, blood flow cannot pass smoothly. At the same time, when the balloon expands the lesion under high pressure, the inner tube will collapse and encircle the guidewire due to the pressure inside the balloon, thereby blocking the passage of blood.

[0003] There is an ischemic postconditioning approach to avoid ischemia-reperfusion injury. This involves repeatedly expanding and contracting a balloon within the blood vessel, causing a pulsed, intermittent "all-or-nothing" restoration of blood flow, allowing the ischemic area to adapt to continuous reperfusion. Animal studies have demonstrated that this postconditioning approach can partially mitigate ischemia-reperfusion injury. However, this "all-or-nothing" pulsed blood flow restoration itself can potentially lead to ischemia-reperfusion injury. Furthermore, the repeated expansion and contraction of the balloon can cause thrombi and plaque detachment, triggering or exacerbating the condition. Therefore, current human trials using this ischemic postconditioning approach have largely yielded negative results.

[0004] Vascular stenosis and occlusion are diseases with high rates of disability and mortality. For vascular diseases, especially arteriosclerosis, stenosis, and occlusion, balloon angioplasty and stent implantation are among the main treatment methods. This involves delivering an expandable balloon to the lesion site, inflating and expanding the balloon to compress plaque and widen the vessel's lumen. A stent is then implanted at the lesion site to support the lumen and treat the stenosis. However, prolonged balloon expansion within the vessel can lead to ischemia-reperfusion injury distal to the lesion. Furthermore, in clinically significant cases of vascular lesions, such as spontaneous or iatrogenic aortic dissection involving the openings of major branches like the coronary arteries, renal arteries, and common carotid arteries, patients may experience occlusion of vital arterial trunks at any time, causing extensive blood supply obstruction to critical organs such as the heart, kidneys, and brain. This is an extremely dangerous and life-threatening vascular critical illness. Such cases require vascular repair and / or artificial vascular graft replacement or large-scale stenting surgery. However, the risk of trunk occlusion and sudden death during diagnosis, transport, and waiting for surgery is very high. Furthermore, for patients with severe stenosis and occlusion involving the left main coronary artery and the ostium of the left anterior descending artery, clinical assessment indicates that coronary artery bypass grafting (CABG) is more effective than interventional therapy. Due to plaque instability and large-area myocardial ischemia, patients have a high risk of acute large-area myocardial infarction, fatal arrhythmias, and sudden death while awaiting emergency or elective surgery after diagnostic angiography. Currently, aside from medications to reduce myocardial oxygen consumption, stabilize plaques, inhibit platelet function, and monitoring methods, there are no better measures to ensure coronary blood flow and continuous myocardial perfusion for patients with the aforementioned severe coronary artery ostial stenosis before undergoing cardiac surgery for CABG.

[0005] Furthermore, the diameter and composition of stenotic and occluded areas of blood vessels are often non-uniform, and the inflation of a conventional standard balloon results in non-uniform (axial and radial) expansion. The variability in lesion composition (lesions can consist of a mixture of hard and soft plaque material) leads to variability in resistance to expansion along the lesion, resulting in over-inflation of the balloon in the region of least resistance within the vessel. As a result, a standard balloon can exert excessive force on areas of lower resistance in the lesion, thus causing trauma to the vessel wall (e.g., dissection), and cannot exert sufficient force on areas of resistance plaque to achieve effective dilation. A balloon catheter capable of achieving uniform circumferential expansion for lesions with uniform intravascular thickness, and targeted expansion for thicker lesions with non-uniform intravascular thickness, would offer significant clinical benefits.

[0006] Therefore, there is a need to provide a dilation catheter that can not only achieve directional pop-out control, but also maintain normal blood flow during the procedure, without the risk of rupture associated with traditional polymer balloons. Summary of the Invention

[0007] In view of this, the purpose of the present invention is to provide a dilation catheter that can achieve overall balloon opening and controllable directional opening without affecting blood flow, maintain continuous blood infusion during the procedure, and avoid hydraulic shock injury, thereby providing greater operability and better treatment results.

[0008] To achieve the above objectives, the present invention provides a dilation catheter, comprising a control wire, a control wire channel, and a catheter tip, an elastic balloon, a tubing body, and a handle connected sequentially along the axis; the control wire channel passes through the elastic balloon, the tubing body, and the handle sequentially along the axis; the control wire is at least partially disposed within the control wire channel, and its distal end is connected to the catheter tip.

[0009] The elastic balloon has a hollow structure and is composed of one or more elastic bodies; the proximal end of any one of the elastic bodies is fixed to the distal end of the tube body, and the distal end of any one of the elastic bodies is connected to the proximal end of the catheter tip.

[0010] When the control wire is pulled back under force, it causes the elastic body to deform in a direction away from the axis of the elastic bladder, so that the elastic bladder exhibits a radial expansion state; when the control wire is released, it causes the elastic body to rebound in a direction closer to the axis of the elastic bladder.

[0011] Preferably, when the elastic balloon is composed of one elastic body, the distal end of the elastic body is fixed to the proximal end of the catheter tip, and the distal end of the control wire is fixed to the proximal end of the catheter tip; or, when the elastic balloon is composed of multiple elastic bodies, the distal end of each elastic body is fixed to the proximal end of the catheter tip, and the distal end of one control wire is fixed to the proximal end of the catheter tip.

[0012] Preferably, when the elastic balloon is composed of multiple elastic bodies, there are multiple control wires, and the multiple control wires are arranged in a one-to-one correspondence with the multiple elastic bodies; the distal end of each elastic body is connected to the distal end of the corresponding control wire to form a distal joint; each distal joint is slidably connected to the proximal end of the catheter tip.

[0013] When the corresponding control wire is pulled back under force, it causes the corresponding elastic body to deform in a direction away from the axis of the elastic bladder; when the corresponding control wire is released, it causes the corresponding elastic body to rebound in a direction closer to the axis of the elastic bladder.

[0014] Preferably, the proximal end of the catheter tip is provided with a plurality of blind holes, and the plurality of blind holes are provided in a one-to-one correspondence with a plurality of distal engagement portions; each distal engagement portion is slidably disposed within a corresponding blind hole.

[0015] Preferably, each blind hole has a limiting step inside its proximal end, and each control wire has a boss at its distal end. The boss cooperates with the limiting step to prevent the distal end joint from disengaging from the blind hole.

[0016] Preferably, there are multiple control wire channels, which are distributed circumferentially along the expansion catheter, with each control wire arranged in a corresponding control wire channel.

[0017] Preferably, when the elastic balloon is composed of multiple elastic bodies, the multiple elastic bodies are distributed at intervals along the circumference of the elastic balloon, or the multiple elastic bodies are distributed in a crisscrossing manner.

[0018] Preferably, the dilation catheter further includes a guidewire channel separately disposed from the control wire channel, the guidewire channel axially penetrating the dilation catheter; or, the catheter tip is configured as a guidewire structure.

[0019] Preferably, the dilation catheter further includes a locking member disposed on the proximal side of the handle, the locking member being used to lock the control wire and the handle; and / or, the proximal surface of the control wire is provided with a scale.

[0020] Preferably, the locking member is an internally threaded member, and the proximal surface of the control screw is provided with an external thread, and the locking member engages with the external thread through the internal thread.

[0021] Compared with the prior art, the technical solution provided by the present invention has at least the following beneficial effects:

[0022] The dilation catheter provided by this invention features a hollow elastic balloon, which, upon expansion, does not impede blood flow, thus avoiding distal ischemia-reperfusion injury and thrombosis caused by slow blood flow. Unlike traditional polymer balloons, the elastic balloon saves surgical time and eliminates the hydraulic shock injury caused by the rupture of traditional polymer balloons, reducing surgical risks. Furthermore, the expansion direction and size of the elastic balloon can be controlled by a control wire, allowing for repeated, prolonged excitation to prevent rebound after lesion expansion. In particular, directional expansion enables targeted dilation of the lesion tissue, providing clinicians with greater operability and better treatment outcomes for patients. Additionally, the elimination of a cavity within the catheter for inflating the polymer balloon allows for a simpler catheter structure, a smaller diameter, and a wider range of applications.

[0023] The dilation catheter provided by this invention uses one or more elastomers to construct an elastic balloon, which can achieve overall balloon opening, especially controllable directional opening. In this way, for lesions with uneven circumferential thickness within blood vessels, the elastomer at a certain position can be directionally controlled by the control wire, thereby implementing a directional opening treatment method for thicker lesions, which greatly improves the treatment effect. Attached Figure Description

[0024] The accompanying drawings are provided to better understand the invention and are not intended to unduly limit the scope of the invention. Wherein:

[0025] Figure 1 This is a schematic diagram of the dilation catheter according to the first embodiment of the present invention. The elastic balloon shown in the diagram is in the initial state (i.e., the radially contracted state).

[0026] Figure 2 This is a cross-sectional view of the dilation catheter according to the first embodiment of the present invention, with the elastic balloon in its initial state.

[0027] Figure 3 This is a cross-sectional view of the catheter tip according to the first embodiment of the present invention.

[0028] Figure 4 This is a schematic diagram of the elastic balloon in its initial state according to the first embodiment of the present invention, wherein... Figure 4 (a) in the image is the left view of the elastic balloon. Figure 4 (b) in the image is the front view of the elastic balloon.

[0029] Figure 5 This is a schematic diagram of the tube body according to the first embodiment of the present invention, wherein... Figure 5 (a) in the figure is the left view of the tube. Figure 5 (b) in the figure is a cross-sectional view of the tube.

[0030] Figure 6 This is a cross-sectional view of the handle according to the first embodiment of the present invention.

[0031] Figure 7 This is a schematic diagram of the control wire structure according to the first embodiment of the present invention.

[0032] Figure 8 This is a schematic diagram of the elastic balloon in the radially expanded state according to the first embodiment of the present invention.

[0033] Figure 9 This is a cross-sectional view of the elastic balloon of the first embodiment of the present invention in a radially open state.

[0034] Figure 10 - This is a schematic diagram of the left-side structure of the elastic balloon in the radially open state according to the second embodiment of the present invention.

[0035] Figure 11 This is a front view schematic diagram of the elastic balloon in the radially open state according to the second embodiment of the present invention.

[0036] Figure 12 This is a cross-sectional view of the dilation catheter of the third embodiment of the present invention with the elastic balloon in a radially open state.

[0037] Figure 13 This is a partial cross-sectional view of the catheter tip, elastic balloon, catheter body, and control wire according to the third embodiment of the present invention.

[0038] Figure 14 This is a schematic diagram of the catheter tip structure according to the third embodiment of the present invention, wherein... Figure 14 (a) in the image is a right view of the catheter tip. Figure 14 (b) in the figure is a cross-sectional view of the tube.

[0039] Figure 15 This is a schematic diagram of the overall structure of the tube body and handle according to the third embodiment of the present invention, wherein... Figure 15 (a) in the figure is a right view when the tube body and handle are formed as a whole. Figure 15 (b) is a cross-sectional view of the tube body and handle as a whole.

[0040] Figure 16 This is a schematic diagram of the control wire according to the third embodiment of the present invention.

[0041] Figure 17 This is a cross-sectional view of the dilation catheter of the fourth embodiment of the present invention with the elastic balloon in a radially open state.

[0042] Figure 18 This is a cross-sectional view of the catheter tip according to the fourth embodiment of the present invention.

[0043] Figure 19 This is a schematic diagram of the overall structure of the tube body and handle according to the fourth embodiment of the present invention, wherein... Figure 19 (a) is the left view when the tube and handle are formed as a whole. Figure 19 (b) is the front view when the tube and handle are formed as a whole.

[0044] Figure 20 This is a schematic diagram of the locking member according to the fourth embodiment of the present invention, wherein... Figure 20 (a) in the image is the left view of the locking element. Figure 20 (b) in the figure is a sectional view of the locking element.

[0045] Figure 21 This is a schematic diagram of the control wire according to the fourth embodiment of the present invention.

[0046] [The annotations in the attached figures are explained below]:

[0047] 1-Catheter tip; 101-Proximal annular end face; 2-Elastic balloon; 3-Tube body; 4-Handle; 5-Control wire; 7-Tapered section; 8-First channel; 9-Elastomer; 10-Inner lumen; 11-Second channel; 12-Third channel; 13-Handle; 14-Fourth channel; 15-Fifth channel; 16-Graduation; 17-Blind hole; 18-Limiting step; 19-Boss; 20-Guide head; 21-Core wire; 22-Sheath; 23-Locking element; 24-Internal threaded hole; 25-External thread; 59-Distal joint. Detailed Implementation

[0048] The following specific examples illustrate the implementation of the present invention. Those skilled in the art can easily understand other advantages and effects of the present invention from the content disclosed in this specification. The present invention can also be implemented or applied through other different specific embodiments, and various details in this specification can also be modified or changed based on different viewpoints and applications without departing from the spirit of the present invention. It should be noted that the illustrations provided in this embodiment are only schematic representations of the basic concept of the present invention. Therefore, the drawings only show components related to the present invention and are not drawn according to the actual number, shape, and size of components in the actual implementation. In the actual implementation, the type, quantity, and proportion of each component can be arbitrarily changed, and the component layout may also be more complex.

[0049] Furthermore, while each embodiment described below possesses one or more technical features, this does not imply that users of the present invention must simultaneously implement all technical features in any embodiment, or can only separately implement some or all technical features in different embodiments. In other words, provided it is feasible, those skilled in the art can, based on the disclosure of the present invention and depending on design specifications or implementation requirements, selectively implement some or all technical features in any embodiment, or selectively implement a combination of some or all technical features in multiple embodiments, thereby increasing the flexibility in implementing the present invention.

[0050] As used herein, the singular forms “a,” “an,” and “the” include plural objects unless otherwise expressly indicated. As used herein, the term “or” is generally used to include the meaning of “and / or” unless otherwise expressly indicated, and the terms “installed,” “connected,” and “linked” should be interpreted broadly, for example, as a fixed connection, a detachable connection, or an integral connection. Connections can be mechanical or electrical. Connections can be direct or indirect through an intermediate medium, and can represent internal communication between two elements or an interaction between two elements. Those skilled in the art will understand the specific meaning of the above terms in this invention according to the specific circumstances.

[0051] To make the objectives, advantages, and features of the present invention clearer, the present invention will be further described in detail below with reference to the accompanying drawings. It should be noted that the drawings are all in a very simplified form and use non-precise proportions, and are only used to facilitate and clearly illustrate the objectives of the embodiments of the present invention. The same or similar reference numerals in the drawings represent the same or similar parts.

[0052] In this article, the terms "proximal" and "distal" refer to the relative orientation, position, and direction of the components or movements relative to each other from the perspective of the physician using the medical device. Although "proximal" and "distal" are not restrictive, "proximal" usually refers to the side of the medical device that is closer to the user during normal operation, while "distal" usually refers to the side that is farther away from the user.

[0053] The purpose of this invention is to provide a dilation catheter that can be used in interventional procedures throughout the human body, such as interventions in various blood vessels and various natural cavities (such as the trachea, esophagus, fallopian tubes, ureters, etc.). Therefore, the specific application scenarios are not limited.

[0054] The structure and function of each part of the dilation catheter will be described in detail below.

[0055] <First Embodiment>

[0056] Figure 1 This is a schematic diagram of the structure of a dilation catheter provided in Embodiment 1 of the present invention. Figure 2 for Figure 1 A cross-sectional view of the dilation catheter in the image.

[0057] like Figure 1 and Figure 2 As shown, the dilation catheter specifically includes a catheter tip 1, an elastic balloon 2, a tube body 3, a handle 4, and a control wire 5. The catheter tip 1, elastic balloon 2, tube body 3, and handle 4 are connected sequentially from distal to proximal. Furthermore, the control wire 5 passes through the handle 4, tube body 3, and elastic balloon 2 in sequence, with its distal end connected to the catheter tip 1. In this embodiment, the distal end of the control wire 5 is fixed to the proximal end of the catheter tip 1 to control the overall opening of the elastic balloon 2. More specifically, the dilation catheter in this embodiment also includes a control wire channel, which axially passes through the elastic balloon 2, tube body 3, and handle 4 in sequence. That is, the interiors of the elastic balloon 2, tube body 3, and handle 4 are all provided with structures for the control wire 5 to pass through, and the control wire 5 is at least partially arranged within the control wire channel. In the illustrated structure, the control wire channel includes a coaxial and axially connected inner cavity 10, a third channel 12, and a fifth channel 15.

[0058] The catheter tip 1, as the most distal part of the dilation catheter, provides excellent guidance, facilitating the placement of the dilation catheter to the target site. In some cases, the catheter tip 1 can also be visualized under X-ray to show the distal position of the dilation catheter. The proximal end of the catheter tip 1 is connected to the distal end of the elastic balloon 2. In this embodiment, the proximal end of the catheter tip 1 and the distal end of the elastic balloon 2 are fixedly connected, which can be achieved by adhesive bonding, laser welding, or integral molding.

[0059] The dilation catheter of this embodiment also has a guidewire channel that extends along its own axis and can be used in conjunction with a guidewire. Specifically, the guidewire channel includes a first channel 8, an inner lumen 10, a second channel 11, and a fourth channel 14 that are coaxial and sequentially connected in the axial direction. Preferably, the guidewire channel and the control wire channel are separately arranged.

[0060] Figure 3 The catheter tip 1 shown is a tubular structure with an axially extending first channel 8. A guidewire passes through the first channel 8. Furthermore, the distal end of the catheter tip 1 can be thinner than the proximal end; this thinning portion is called the taper section 7. The outer diameter of the taper section 7 gradually increases from the proximal end to the distal end, facilitating movement within blood vessels or cavities. In this embodiment, except for the taper section 7, the inner and outer diameters of the catheter tip 1 remain constant for a predetermined length starting from its proximal end, with the outer diameter gradually decreasing from the middle towards the distal end. When the catheter tip 1 is equipped with the taper section 7, the dilation catheter exhibits good flexibility and guidance at the distal end.

[0061] Continue to refer to Figure 3 In this embodiment, the distal end of the control wire 5 is fixed to the proximal annular end face 101 of the catheter tip 1, which can be achieved by adhesive bonding, laser welding, or other suitable fixing methods. Simultaneously, the proximal annular end face 101 of the catheter tip 1 is also fixed to the distal end of the elastic balloon 2.

[0062] Figures 1-2 , Figure 4 , Figures 8-9 In some embodiments shown, the elastic balloon 2 is composed of multiple elastic bodies 9 spaced apart along its circumference. These multiple elastic bodies 9 enclose a three-dimensional mesh-like perforated structure, meaning that a perforation is formed between any two adjacent elastic bodies 9 in the circumferential direction. In this case, the multiple elastic bodies 9 are arranged almost parallel to each other and do not overlap. Furthermore, the proximal end of each elastic body 9 is fixed to the distal end of the catheter body 3, and the distal end of each elastic body 9 is fixed to the proximal end of the catheter tip 1, thereby enabling the elastic balloon 2 to open as a whole, particularly effective for lesions with uniform circumferential thickness within blood vessels.

[0063] Understandably, such an elastic balloon 2 has Figure 1 and Figure 2 The radial contraction state shown (i.e., the initial state) also has Figure 8 and Figure 9The device exhibits a radially expanded state and can switch between a radially contracted state and a radially expanded state. It should be noted that the overall diameter of the elastic balloon 2 in this embodiment is variable, and those skilled in the art can set the diameter of the elastic balloon 2 according to actual needs.

[0064] like Figure 8 and Figure 9 As shown, because the elastic balloon 2 has a hollow structure, it does not affect blood flow after expansion, thus avoiding ischemia-reperfusion injury distal to the lesion and thrombosis caused by slow blood flow. Simultaneously, since the elastic balloon 2 does not use a traditional polymer balloon, there is no need for hydraulic media or other hydraulic equipment, saving surgical time and eliminating concerns about hydraulic shock injury caused by the rupture of a traditional polymer balloon, reducing surgical risks. Furthermore, there is no need to create a cavity within the tube 3 for inflating the polymer balloon, allowing for a simpler structure, a smaller diameter, and a wider range of applications for the tube 3.

[0065] The elastomer 9 is typically a rod-shaped structure capable of withstanding pressure and possessing good elasticity. The material of the elastomer 9 can be a medical-grade metallic material or a polymer material that is elastic and biocompatible. Preferably, the elastomer 9 is made of a shape memory alloy material. Alternatively, the elastomer 9 can be made of stainless steel, nickel-titanium alloy, cobalt-chromium alloy, polymer, or other suitable materials.

[0066] Furthermore, "multiple elastic bodies 9" refers to two or more elastic bodies 9. As shown in the figure, the elastic balloon 2 uses 18 elastic bodies 9. Of course, the number of elastic bodies 9 can be adjusted according to actual needs, and this application does not limit this.

[0067] In use, the control wire 5 directly pulls the catheter tip 1, driving it proximally. This compresses the entire elastic balloon 2 axially, causing multiple elastic bodies 9 to deform and bend under pressure, gradually expanding until the entire elastic balloon 2 is stretched outwards. In this situation, all elastic bodies 9 are simultaneously compressed and deformed, causing the elastic balloon 2 to expand circumferentially until it conforms to the lesion, achieving uniform circumferential expansion of the lesion tissue. To contract, the control wire 5 needs to be gradually released, allowing each elastic body 9 to rebound controllably.

[0068] Additionally, return to reference Figure 4 In this embodiment, the elastic balloon 2 has an axially through-hole cavity 10, which can be used with a guide wire. Of course, the control wire 5 can also pass through the cavity 10.

[0069] It should also be noted that in some other embodiments, the elastomer 9 can be a single piece (not shown), with its distal end fixed to the proximal end of the catheter tip 1 and its proximal end fixed to the distal end of the tube body 3. This structure allows for directional expansion of the elastic balloon 2 without requiring it to spring open in the entire circumferential direction, making the expansion direction of the elastic balloon 2 controllable and thus achieving directional expansion of the lesion tissue. This is particularly useful for lesions with uneven circumferential thickness within the blood vessel. When the elastic balloon 2 uses a single elastomer 9, the circumferential width of this single elastomer 9 can be adjusted and set according to the size of the lesion tissue to ensure effective expansion of the lesion tissue.

[0070] Figure 5 In the tube 3 shown, a second channel 11 and a third channel 12 are arranged along its own axial direction. The second channel 11 and the third channel 12 are two parallel and isolated channels. The second channel 11 is usually a central cavity, centrally located, to facilitate use with the guide wire, allowing the guide wire to pass through it. The third channel 12 facilitates the passage of the control wire 5. As a variation, the second channel 11 and the third channel 12 can be combined into one channel, that is, only the second channel 11 is retained. Preferably, the second channel 11 and the third channel 12 are arranged simultaneously in the tube 3 to prevent mutual interference between the control wire 5 and the guide wire.

[0071] In addition, the handle 4 is mainly for the convenience of the user in gripping and operating the device. The handle 4 can be manufactured separately from the tube body 3 and then assembled, or the handle 4 can be integrally formed and connected to the tube body 4. The handle 4 is located at the proximal end of the tube body 3.

[0072] Figure 6 The handle 4 shown has a grip 13 for easy holding by the user. The shape of the grip 13 includes, but is not limited to, the shape shown in the figure; it can have various suitable shapes as long as it is easy to hold. Simultaneously, a fourth channel 14 and a fifth channel 15 are provided through the handle 4 along its own axial direction. Like the second channel 11 and the third channel 12, the fourth channel 14 and the fifth channel 15 are two parallel and isolated channels. The fourth channel 14 is usually a central cavity, centrally located, for easy use with the guide wire. The fifth channel 15 facilitates the passage of the control wire 5. The second channel 11 and the fourth channel 14 are coaxial and connected. The third channel 12 and the fifth channel 15 are coaxial and connected. Similarly, the fourth channel 14 and the fifth channel 15 can be merged into one channel, that is, only the fourth channel 14 needs to be retained. Preferably, the handle 4 has both the fourth channel 14 and the fifth channel 15.

[0073] Thus, in this embodiment, after the control wire 5 passes through the fifth channel 15, the third channel 12 and the lumen 10 in sequence, its distal end is connected to the proximal end of the catheter tip 1, while the guide wire passes through the fourth channel 14, the second channel 11, the lumen 10 and the first channel 8 in sequence.

[0074] Figure 7 A schematic diagram of the control wire 5 is shown. In some embodiments, the control wire 5 is essentially an elongated structure, and can be solid or hollow. There are no special requirements for the material of the control wire 5. Preferably, a scale 16 is provided on the proximal surface of the control wire 5 to indicate the stroke of the control wire 5, facilitating the determination of the degree of expansion of the elastic balloon 2, making operation more precise and convenient.

[0075] Return to reference Figure 1 and Figure 2 The proximal end of the control wire 5 can extend beyond the proximal end of the handle 4. Of course, in other cases, the proximal end of the control wire 5 can also be connected to the handle 4, and the control wire 5 can be controlled by the corresponding structure on the handle 4.

[0076] like Figure 8 and Figure 9 As shown, the working principle is as follows: the user holds the handle 4, keeps the tube body 3 stationary, and pulls the control wire 5 backward (see arrow indication, towards the proximal end). Under the pull of the control wire 5, the catheter tip 1 moves backward, thereby squeezing the elastic balloon 2 backward. This causes the multiple elastic bodies 9 on the elastic balloon 2 to gradually expand radially outward, resulting in elastic deformation and expansion of the elastic balloon 2 to a certain volume. Preferably, during the operation, the change in the scale 16 on the control wire 5 is used to determine the change in the diameter of the elastic balloon 2, thereby precisely controlling the expansion diameter of the elastic balloon 2 to ensure that the elastic balloon 2 can rupture calcified or fibrotic lesions on the inner wall of the blood vessel, thus achieving the clinical therapeutic effect.

[0077] <Second Embodiment>

[0078] The dilation catheter provided in this embodiment 2 has a basically the same structure as the dilation catheter provided in embodiment 1. The same parts will not be described again. The following only describes the differences.

[0079] like Figures 10-11 As shown in this second embodiment, the elastic balloon 2 is composed of multiple intersecting elastic bodies 9 forming a three-dimensional mesh-like hollow structure. Specifically, it can be cut or woven into shape. Similarly, the elastic balloon 2 gradually expands after being subjected to the axial compressive force when the catheter tip 1 moves proximally, and the shape of the intersecting mesh-like elastic bodies 9 becomes more uniform. This further disperses the compressive stress on calcified or fibrotic lesions in the human body or the inner wall of cavities, reducing impact damage to blood vessels or cavities and resulting in better clinical outcomes.

[0080] <Third Embodiment>

[0081] The dilation catheter provided in this embodiment is basically the same as the dilation catheter provided in embodiment one. The same parts will not be described again. The following only describes the differences.

[0082] like Figures 12 to 16 As shown, in this third embodiment, there are multiple control wires 5, meaning two or more, thus differing from the single control wire 5 in the first embodiment. Multiple control wires 5 are arranged in a one-to-one correspondence with multiple elastic bodies 9, so that each elastic body 9 is controlled by a corresponding control wire 5, and the control between them is independent and does not affect each other. The elastic balloon 2 achieves directional expansion due to the individual control of the elastic bodies 9. In this embodiment, the diameter of the elastic balloon 2 at different circumferential positions is variable, and the expansion direction and size are controllable circumferentially. It can be repeatedly activated for extended periods, allowing for directional expansion of lesions, providing clinicians with greater operability and offering patients better treatment outcomes.

[0083] In this way, the distal end of each elastic body 9 is joined to the distal end of the corresponding control wire 5 to form a single unit (see details). Figure 13 Detail A) is referred to as the distal junction 59. Each distal junction 59 is slidably connected to the proximal end of the catheter tip 1. The proximal end of each elastomer 9 remains fixed to the distal end of the tube body 3. In actual use, when the corresponding control wire 5 is pulled back under force, it directly causes the corresponding elastomer 9 to deform in a direction away from the axis of the elastic balloon 2; when the corresponding control wire 5 is released, it causes the corresponding elastomer 9 to rebound in a direction closer to the axis of the elastic balloon 2. Therefore, by selecting the control wire 5 in the corresponding direction of expansion, the expansion of the corresponding elastomer 9 can be controlled. Only one elastomer 9 can be expanded at a time, or multiple elastomers 9 can be expanded simultaneously. The operation of these elastomers 9 is independent.

[0084] Figure 13 and Figure 14 In this device, the proximal end of the catheter tip 1 is provided with multiple blind holes 17, which are distributed at intervals along the circumference of the catheter tip 1. Each blind hole 17 is provided with a corresponding distal junction 59. Each distal junction 59 slides within a corresponding blind hole 17, and the depth of the blind hole 17 can be adjusted and set according to actual needs.

[0085] To prevent the distal joint 59 from disengaging from the blind hole 17, preferably, a limiting step 18 is provided inside the proximal end of each blind hole 17 (see...). Figure 14 Meanwhile, each control wire 5 has a protrusion 19 at its distal end. Figure 16The boss 19 can cooperate with the limiting step 18 to prevent the distal joint 59 from disengaging from the blind hole 17. Of course, there are many ways to prevent the distal joint 59 from disengaging from the blind hole 17, including but not limited to the cooperation between the limiting step 18 and the boss 19. For example, some blocking structures or some elastic locking structures can be provided on the proximal exterior of the blind hole 17.

[0086] Preferably, the multiple control wires 5 are arranged separately, that is, there are multiple control wire channels, which are distributed at intervals along the circumference of the expansion catheter, and each control wire 5 is arranged in a corresponding control wire channel. Specifically, in this embodiment, multiple third channels 12 are arranged along the circumference of the tube body 3, and as shown in the figure. Figure 15 As shown, multiple fifth channels 15 are arranged around the handle 4, with the third channel 12 and the fifth channel 15 corresponding one-to-one.

[0087] The working principle of the dilation catheter in this embodiment is as follows: Figure 13 The middle arrow indicates that pulling a certain control wire 5 backward can only control the deformation of the elastic body 9 connected to it, so that the deformation of each elastic body 9 can be controlled individually. This allows for the adjustment of the directional, local and overall expansion mode of the elastic balloon 2, which is more in line with clinical needs.

[0088] in addition, Figure 10 and Figure 11 The elastic balloon 2 in the middle can also be controlled independently in the same way, but the specifics will not be explained further.

[0089] <Fourth Embodiment>

[0090] The dilation catheter provided in this embodiment is basically the same as the dilation catheter provided in the above embodiments. The same parts will not be described again. Only the differences will be described below.

[0091] like Figures 17 to 21 As shown, in addition to the catheter tip 1, elastic balloon 2, tube body 3, handle 4 and control wire 5, the dilation catheter in this embodiment also includes a locking member 23. The locking member 23 is mainly used to lock the elastic balloon 2 in the pop-out state to avoid manual operation.

[0092] The locking element 23 can lock the control screw 5 and the handle 4 by various means, such as clamping, pinning, threading, etc. Preferably, the locking element 23 is a knob with internal threads.

[0093] Detailed, such as Figure 20 As shown, the locking member 23 has an internally threaded hole 24. Meanwhile, as... Figure 21 As shown, the control screw 5 has an external thread 25. And refer to... Figure 17The locking element 23 is located on the proximal side of the handle 4, and can prevent the locking element 23 from moving distally through the handle 4. The locking element 23 engages with the external thread 25 on the control wire 5 through the internal threaded hole 24. When the control wire 5 is pulled proximally towards the catheter tip 1, the elastic balloon 2 can be adjusted and locked for an extended period of time, ensuring that calcified or fibrotic lesions in the human body are fully opened and do not rebound, which facilitates the user's operation and better meets clinical needs.

[0094] It should be understood that the implementation of the locking element 23 is applicable not only to the case where multiple elastic bodies 9 are simultaneously controlled to expand, but also to the case where a single elastic body 9 is independently controlled to expand in a directional manner, and is especially applicable to the scenario where there is only one control wire 5.

[0095] As a variant, such as Figure 17 As shown, the dilation catheter in this embodiment eliminates the guidewire channel and directly replaces the guidewire with the catheter tip 1. Specifically, the catheter tip 1 is configured as a guidewire structure, possessing the function of a guidewire. During use, there is no need to use an additional guidewire, simplifying the operation process.

[0096] Figure 18 In this embodiment, the catheter tip 1 includes a guide head 20, a core wire 21, and a sheath 22. The sheath 22 can be a sheath or a polymer cannula. The core wire 21 has a constant outer diameter for a predetermined length starting from its proximal end, and gradually decreases in diameter towards the distal end from the middle, with the rate of decrease remaining constant or varying. Preferably, the core wire 21 consists of a first variable diameter section, a tapered section 7, and a first constant diameter section from the distal end to the proximal end, with the taper of the first variable diameter section being smaller than the taper of the tapered section 7. Alternatively, such a core wire 21 may not be present; for example, a constant diameter section may be provided between adjacent variable diameter sections, or the farthest position of the core wire 21 may be a constant diameter section. This is also within the scope of the present invention.

[0097] The guide head 20 is fixed to the distal end of the core wire 21. It is relatively soft and smooth, which can reduce damage to the tissue.

[0098] The sheath 22 is a component in which the wire is wound into a spiral shape and is provided to cover the distal portion of the core wire 21. The sheath 22 is preferably made of a metallic material, such as stainless steel, a superelastic alloy, a cobalt alloy, gold, tungsten, or a combination of multiple materials. By providing such a sheath 22, the pushing resistance can be reduced, thereby improving the operability of the dilation catheter.

[0099] In this embodiment, the dilation catheter, with the aforementioned catheter tip 1, eliminates the guidewire channel; that is, the first channel 8 is eliminated from the catheter tip 1, the second channel 11 is eliminated from the tube body 3, and the fourth channel 14 is eliminated from the handle 4. Therefore, during use, it is not necessary to use a guidewire, simplifying the surgical procedure.

[0100] While the present invention has been disclosed above, it is not limited thereto. Those skilled in the art can make various modifications and variations to the present invention without departing from its spirit and scope. Therefore, if such modifications and variations fall within the scope of the present invention specification and its equivalents, the present invention also intends to include such modifications and variations.

Claims

1. A dilation catheter, characterized in that, The expansion catheter comprises a control wire, a control wire channel, a catheter head end, an elastic balloon, a tube body and a handle connected in sequence along an axial direction, the control wire channel penetrates through the elastic balloon, the tube body and the handle along the axial direction; The control wire is arranged at least partially in the control wire channel, and a distal end of the control wire is connected with the catheter head end; the elastic balloon is a hollow structure; The elastic balloon is composed of one elastic body, a distal end of the elastic body is fixed with a proximal end of the catheter head end, and a distal end of the control wire is fixed with the proximal end of the catheter head end; when the control wire is pulled back under stress, the elastic body is deformed towards a direction away from an axis of the elastic balloon, so that the elastic balloon is in a radial expansion state; when the control wire is released, the elastic body rebounds towards a direction close to the axis of the elastic balloon; Alternatively, the elastic balloon is composed of a plurality of elastic bodies, and the control wire is also a plurality of control wires, the plurality of control wires and the plurality of elastic bodies are arranged one by one in a corresponding manner; a distal end of each elastic body is connected with a distal end of a corresponding control wire as a whole, and forms a distal end joint; each distal end joint is slidingly connected with the proximal end of the catheter head end; when a corresponding control wire is pulled back under stress, the corresponding elastic body is deformed towards a direction away from the axis of the elastic balloon; when the corresponding control wire is released, the corresponding elastic body rebounds towards a direction close to the axis of the elastic balloon.

2. The dilation catheter of claim 1, wherein, When the elastic balloon is composed of a plurality of elastic bodies, the proximal end of the catheter head end is provided with a plurality of blind holes, and the plurality of blind holes and the plurality of distal end joints are arranged one by one in a corresponding manner; each distal end joint is slidingly arranged in a corresponding blind hole.

3. The dilation catheter of claim 2, wherein, A limiting step is arranged inside a proximal end of each blind hole, and a boss is arranged at a distal end of each control wire, the boss cooperates with the limiting step to prevent the distal end joint from being separated from the blind hole.

4. The dilation catheter of claim 1, wherein, When the elastic balloon is composed of a plurality of elastic bodies, the control wire channel is a plurality of control wire channels, the plurality of control wire channels are distributed in a spaced manner along a circumferential direction of the expansion catheter, and each control wire is arranged in a corresponding control wire channel.

5. The dilation catheter of claim 1, wherein, When the elastic balloon is composed of a plurality of elastic bodies, the plurality of elastic bodies are distributed in a spaced manner along a circumferential direction of the elastic balloon, or the plurality of elastic bodies are distributed in a crossing manner.

6. The dilation catheter of claim 1, wherein, The expansion catheter further comprises a guide wire channel arranged separately from the control wire channel, the guide wire channel penetrates through the expansion catheter along an axial direction; or the catheter head end is configured as a guide wire structure.

7. The dilation catheter of claim 1, wherein, The expansion catheter further comprises a locking member arranged on a proximal end side of the handle, the locking member is used for locking the control wire and the handle; and / or a proximal end surface of the control wire is provided with a scale.

8. The dilation catheter of claim 7, wherein, The locking member is an internal thread member, a proximal end surface of the control wire is provided with an external thread, and the locking member cooperates with the external thread through the internal thread.

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