Dilation catheter

Abstract

The dilation catheter comprises a control wire, a control wire channel, a catheter head end, an elastic balloon, a catheter body and a handle, wherein the catheter head end, the elastic balloon, the catheter body and the handle are sequentially connected in the axial direction. The control wire channel sequentially penetrates through the elastic balloon, the tube body and the handle in the axial direction. The control wire is arranged in the control wire channel, and the far end is connected with the head end of the catheter; the elastic balloon is of a hollow structure and is composed of one or more elastic bodies. The near end of any elastic body is fixed to the far end of the catheter body, and the far end of any elastic body is connected with the near end of the catheter head end. When the control wire is pulled back after being stressed, the elastic body is driven to deform in the direction away from the axis of the elastic balloon, so that the elastic balloon is in a radial expansion state; when the control wire is loosened, the elastic body rebounds in the direction close to the axis of the elastic balloon. By means of the configuration, blood flow is not affected, the problem of hydraulic impact damage is avoided, repeated long-time expansion can be achieved, and more operability and better treatment effect can be provided.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to a dilatation catheter. Background Art

[0002] Acute vascular occlusive disease is now the main cause of death in the Chinese population, including acute myocardial infarction, cerebral infarction, peripheral arterial embolism, etc. When patients develop acute vascular occlusive disease, the preferred method is emergency interventional treatment to open the infarction-related blood vessels and then continue to perfuse the infarct area; however, during the emergency interventional treatment, directly opening the occluded blood vessels will cause further damage, which is called ischemia-reperfusion injury, leading to further damage to the organs in the infarct area. The traditional method of interventional treatment for acute vascular occlusive disease is to use intravascular guidewires and balloons to quickly open the acutely occluded blood vessels. However, after a large number of animal experiments and clinical experiments, it was found that the blood flow of the occluded blood vessels will suddenly continue to perfuse the distal myocardium, and the sudden recovery of energy and oxygen will lead to sudden changes in the intracellular environment and sudden imbalance of pH, thereby causing severe contraction and membrane damage of edematous cells, causing further necrosis of ischemic organs. In addition, the inner diameter of the inner lumen of the existing balloon catheter is too small. After the guide wire is inserted into the catheter, blood cannot flow smoothly. At the same time, when the balloon expands the lesion under high pressure, the inner lumen will collapse under the pressure inside the balloon and embrace the internal guide wire, thereby blocking blood flow.

[0003] There is a post-conditioning mode (ischemic postconditioning) to avoid ischemia-reperfusion injury. The specific operation method is to use a balloon to repeatedly expand and retract in the blood vessel, resulting in the blood flow in the blood vessel to be restored intermittently in a pulsed manner in an "all or nothing" manner, so that the ischemic area can adapt to the process of continuous reperfusion. Animal experiments have shown that this post-conditioning mode can partially alleviate ischemia-reperfusion injury. However, this "all or nothing" pulsed blood flow recovery may itself lead to ischemia-reperfusion injury. At the same time, the repeated expansion and retraction of the balloon may cause thrombus and plaque detachment, causing and aggravating the condition. Therefore, in current human experiments, most of the results obtained by this ischemic post-conditioning mode are negative.

[0004] Vascular stenosis and occlusion are diseases with high disability and mortality rates. For vascular diseases, especially arteriosclerosis, stenosis and occlusion, vascular lesion balloon dilatation and stent implantation technology are one of the main treatment methods, that is, an expandable balloon is sent to the lesion site, and the plaque is squeezed to the outside of the blood vessel by filling and expanding the balloon to expand the diameter of the vascular lumen, and finally a stent is implanted at the lesion site to support the lumen to achieve the purpose of treating vascular stenosis. However, the balloon needs to be expanded in the blood vessel for a long time, which may cause ischemia-reperfusion injury at the distal end of the lesion. Moreover, in clinical cases of vascular lesions in special parts, such as spontaneous or iatrogenic aortic dissection involving the openings of major branch arteries such as coronary arteries, renal arteries and common carotid arteries, patients may suffer from occlusion of important arterial trunks at any time, causing large-area blood supply obstruction to important organs such as the heart, kidneys, and brain, which is an extremely dangerous vascular critical disease that seriously endangers the patient's life safety. The above situation requires vascular surgery repair and / or artificial blood vessel replacement or large vascular stent surgery. However, the risk of trunk occlusion and sudden death during the diagnosis, transportation process and waiting for surgery is very high. In addition, for patients with severe stenosis and occlusion of the left main trunk and anterior descending branch, the clinical comprehensive judgment is that the efficacy of coronary artery bypass grafting is better than that of interventional treatment. Due to unstable plaques and large-area myocardial blood supply obstruction, patients are at high risk of acute large-area myocardial infarction, fatal arrhythmias and sudden death while waiting for emergency or elective surgery after diagnostic angiography. At present, in addition to drugs 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 severe stenosis of the coronary artery openings before receiving cardiac surgery coronary artery bypass grafting.

[0005] In addition, the diameter and composition of the stenotic and occluded areas of the blood vessels are usually non-uniform, and the expansion of the conventional standard balloon results in non-uniform (axial and radial) expansion. The variability of the lesion composition (lesions can be composed of a mixture of hard and soft plaque materials) will lead to variability in the resistance to expansion along the lesion, and lead to over-expansion of the balloon in the area of ​​minimum resistance of the tube. The final result is that the standard balloon can apply excessive force to the lower resistance area of ​​the lesion, thereby causing trauma to the tube wall (e.g., dissection), and cannot apply enough force to the plaque area with resistance to achieve its effective expansion. If there is a balloon catheter that can achieve uniform circumferential opening for lesion tissue with uniform circumferential thickness in the blood vessel, and can achieve directional opening of thicker lesion tissue for lesion tissue with non-uniform circumferential thickness in the blood vessel, it will bring great clinical benefits.

[0006] Therefore, it is hoped to provide a dilatation catheter that can not only achieve directional rebound control, but also maintain normal blood flow during surgery, without having to worry about the risks caused by rupture of traditional polymer balloons. Summary of the invention

[0007] In view of this, the object of the present invention is to provide a dilatation catheter, which can realize the overall ejection and controllable directional ejection of the balloon without affecting blood flow, can maintain continuous blood infusion during surgery, and can avoid hydraulic shock injury problems, thereby providing more operability and better treatment effects.

[0008] To achieve the above-mentioned object, the present invention provides a dilatation catheter, comprising a control wire, a control wire channel, and a catheter head end, an elastic balloon, a tube body and a handle connected in sequence axially; the control wire channel sequentially penetrates the elastic balloon, the tube body and the handle in the axial direction; the control wire is at least partially arranged in the control wire channel, and the distal end is connected to the catheter head end;

[0009] The elastic balloon is 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 head end;

[0010] When the control wire is pulled back after being subjected to force, the elastic body is driven to deform in the axial direction away from the elastic balloon, so that the elastic balloon presents a radial expansion state; when the control wire is relaxed, the elastic body rebounds in the axial direction close to the elastic balloon.

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

[0012] Preferably, when the elastic balloon is composed of a plurality of the elastic bodies, the control wires are multiple, and the multiple control wires are arranged one-to-one with the multiple elastic bodies; the distal end of each of the elastic bodies is connected to the distal end of a corresponding control wire as a whole to form a distal joint; each of the distal joints is slidably connected to the proximal end of the catheter head end;

[0013] When a corresponding one of the control wires is pulled back after being subjected to force, it drives the corresponding one of the elastic bodies to deform in the axial direction away from the elastic balloon; when a corresponding one of the control wires is relaxed, it causes the corresponding one of the elastic bodies to rebound in the axial direction close to the elastic balloon.

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

[0015] Preferably, a limiting step is provided inside the proximal end of each blind hole, and a boss is provided at the distal end of each control wire, and the boss cooperates with the limiting step to prevent the distal end joint from detaching from the blind hole.

[0016] Preferably, there are a plurality of control wire channels, and the plurality of control wire channels are distributed at intervals along the circumference of the dilation catheter, and each control wire is arranged in a corresponding one of the control wire channels.

[0017] Preferably, when the elastic balloon is composed of a plurality of the elastic bodies, the plurality of the elastomers are distributed at intervals along the circumference of the elastic balloon, or the plurality of the elastomers are distributed crosswise with each other.

[0018] Preferably, the dilatation catheter further comprises a guidewire channel provided separately from the control wire channel, and the guidewire channel axially penetrates the dilatation catheter; alternatively, the catheter tip is configured as a guidewire structure.

[0019] Preferably, the dilatation catheter further comprises 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 a scale is provided on the proximal surface of the control wire.

[0020] Preferably, the locking member is an internal thread member, the proximal surface of the control wire is provided with an external thread, and the locking member cooperates 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] In the dilatation catheter provided by the present invention, since the elastic balloon itself is a hollow structure, it does not affect the blood flow after being expanded, thus avoiding ischemia-reperfusion injury at the distal end of the lesion and thrombosis caused by slow blood flow. Also, because the elastic balloon is different from the traditional polymer balloon, it saves operation time, and can also solve the problem of hydraulic shock injury caused by the rupture of the traditional polymer balloon, reducing the risk of surgery. In addition, the expansion direction and size of the elastic balloon can be controlled by the control wire, and can be repeatedly stimulated for a long time to prevent the lesion from rebounding after expansion. In particular, by directional rebound, directional expansion of the lesion tissue can be achieved, providing more operability for clinicians and providing better treatment effects for patients. In addition, there is no need to set a cavity for filling the polymer balloon in the tube body, so that the structure of the tube body can be simpler, the diameter is thinner, and the scope of application is wider.

[0023] In the dilatation catheter provided by the present invention, an elastic balloon is constructed by one or more elastomers, so that the overall expansion of the balloon can be achieved, and in particular, controllable directional expansion can be achieved. In this way, for diseased tissue with uneven circumferential thickness in the blood vessel, the elastomer at a certain position can be controlled by controlling the control wire, thereby implementing a directional expansion treatment method for the thicker diseased tissue, greatly improving the treatment effect. BRIEF DESCRIPTION OF THE DRAWINGS

[0024] The accompanying drawings are used to better understand the present invention and do not constitute an improper limitation of the present invention.

[0025] Figure 1 It is a schematic structural diagram of the dilatation catheter according to the first embodiment of the present invention, in which the elastic balloon is in an initial state (ie, a radially contracted state).

[0026] Figure 2 It is a cross-sectional view of the dilatation catheter according to the first embodiment of the present invention, and the elastic balloon shown in the figure is in an initial state.

[0027] Figure 3 4 is a cross-sectional view of the catheter tip according to the first embodiment of the present invention.

[0028] Figure 4 FIG. 1 is a schematic diagram of the structure of the elastic balloon in the initial state according to the first embodiment of the present invention, wherein Figure 4 (a) is the left view of the elastic balloon. Figure 4 (b) is a front view of the elastic balloon.

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

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

[0031] Figure 7 Schematic diagram of the structure of the control wire of the first embodiment of the present invention.

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

[0033] Fig. 9 It is a cross-sectional view of the elastic balloon according to the first embodiment of the present invention in a radially expanded state.

[0034] Fig.10 - is a left-side structural schematic diagram of the elastic balloon in the radially expanded state according to the second embodiment of the present invention.

[0035] Fig.11 It is a schematic diagram of the front structure of the elastic balloon in the radially expanded state according to the second embodiment of the present invention.

[0036] Fig.12 It is a cross-sectional view of the dilatation catheter according to the third embodiment of the present invention when the elastic balloon is in a radially expanded state.

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

[0038] Fig.14 FIG. 1 is a schematic structural diagram of a catheter tip end according to a third embodiment of the present invention, wherein Fig.14 (a) is the right view of the catheter tip. Fig.14 (b) is a cross-sectional view of the tube body.

[0039] Fig.15 FIG. 1 is a schematic diagram of the overall structure of the tube body and the handle of the third embodiment of the present invention, wherein Fig.15 (a) is a right side view when the tube body and the handle are formed as a whole. Fig.15 (b) is a cross-sectional view of the tube body and the handle formed as a whole.

[0040] Fig.16 Schematic diagram of the structure of the control wire of the third embodiment of the present invention.

[0041] Fig.17 It is a cross-sectional view of the dilatation catheter according to the fourth embodiment of the present invention when the elastic balloon is in a radially expanded state.

[0042] Fig.18 4 is a cross-sectional view of a catheter tip according to a fourth embodiment of the present invention.

[0043] Fig.19 FIG. 1 is a schematic diagram of the overall structure of the tube body and the handle according to the fourth embodiment of the present invention, wherein Fig.19 (a) is a left side view of the tube body and the handle formed as a whole. Fig.19 (b) is a front view when the tube body and the handle are formed as a whole.

[0044] Fig. 20 is a schematic structural diagram of a locking member according to a fourth embodiment of the present invention, wherein Fig. 20 (a) is the left side view of the locking part. Fig. 20 (b) is a cross-sectional view of the locking member.

[0045] Fig.21 Schematic diagram of the structure of the control wire according to the fourth embodiment of the present invention.

[0046] [Description of reference numerals is as follows]:

[0047] 1-catheter head; 101-proximal annular end face; 2-elastic balloon; 3-tube body; 4-handle; 5-control wire; 7-taper section; 8-first channel; 9-elastic body; 10-inner cavity; 11-second channel; 12-third channel; 13-handle; 14-fourth channel; 15-fifth channel; 16-scale; 17-blind hole; 18-limiting step; 19-boss; 20-guide head; 21-core wire; 22-sheath; 23-locking piece; 24-inner thread hole; 25-external thread, 59-distal joint. DETAILED DESCRIPTION

[0048] The following is an explanation of the embodiments of the present invention by specific examples, and those skilled in the art can easily understand other advantages and effects of the present invention from the contents disclosed in this specification. The present invention can also be implemented or applied through other different specific embodiments, and the details in this specification can also be modified or changed in various ways based on different viewpoints and applications without departing from the spirit of the present invention. It should be noted that the illustrations provided in the present embodiment only illustrate the basic concept of the present invention in a schematic manner, and only the components related to the present invention are shown in the figure instead of being drawn according to the number, shape and size of the components in the actual implementation. The type, quantity and proportion of each component in the actual implementation can be a random change, and the component layout type may also be more complicated.

[0049] In addition, each embodiment of the following description has one or more technical features, but this does not mean that the user of the present invention must implement all the technical features in any embodiment at the same time, or can only implement part or all of the technical features in different embodiments separately. In other words, under the premise that implementation is possible, those skilled in the art can selectively implement part or all of the technical features in any embodiment according to the disclosure of the present invention and according to the design specifications or implementation requirements, or selectively implement a combination of part or all of the technical features in multiple embodiments, thereby increasing the flexibility of the implementation of the present invention.

[0050] As used in this specification, the singular forms "a", "an", and "the" include plural objects, unless the content clearly indicates otherwise. As used in this specification, the term "or" is generally used in a sense that includes "and / or", unless the content clearly indicates otherwise, and the terms "installed", "connected", and "connected" should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral connection. It can be a mechanical connection or an electrical connection. It can be directly connected or indirectly connected through an intermediate medium, and it can be a connection between the internal parts of two elements or an interaction relationship between two elements. For those of ordinary skill in the art, the specific meanings of the above terms in the present invention can be understood according to the specific circumstances.

[0051] In order to make the purpose, advantages and features of the present invention more clear, the present invention is further described in detail below with reference to the accompanying drawings. It should be noted that the drawings are all in very simplified form and in non-precise proportions, and are only used to conveniently and clearly assist in explaining the purpose of the embodiments of the present invention. The same or similar reference numerals in the drawings represent the same or similar components.

[0052] In this document, the terms "proximal" and "distal" refer to the relative orientation, relative position, and direction of components or actions relative to each other from the perspective of a doctor using the medical device. Although "proximal" and "distal" are not restrictive, "proximal" generally refers to the side of the medical device close to the user during normal operation, and "distal" generally refers to the side away from the user.

[0053] The purpose of the present invention is to provide a dilatation catheter that can be used for interventional surgery throughout the human body, for example, intervention in various blood vessels and intervention in various natural cavities (such as trachea, esophagus, fallopian tubes, ureters, etc.), so the specific application scenario is not limited.

[0054] The following is a detailed introduction to the structure and function of each part of the dilatation catheter.

[0055] <First Embodiment>

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

[0057] like Figure 1 and Figure 2 As shown, the dilatation catheter specifically includes a catheter head 1, an elastic balloon 2, a tubular body 3, a handle 4 and a control wire 5. Wherein, the catheter head 1, the elastic balloon 2, the tubular body 3 and the handle 4 are connected in sequence from the distal end to the proximal end. Moreover, the control wire 5 passes through the handle 4, the tubular body 3 and the elastic balloon 2 in sequence, and the distal end is connected to the catheter head 1. In the present embodiment, the distal end of the control wire 5 is fixed to the proximal end of the catheter head 1 to control the elastic balloon 2 to be ejected as a whole. In detail, the dilatation catheter of the present embodiment also includes a control wire channel, which runs through the elastic balloon 2, the tubular body 3 and the handle 4 in sequence along the axial direction, that is, the elastic balloon 2, the tubular body 3 and the handle 4 are all provided with a structure for the control wire 5 to pass through, and the control wire 5 is at least partially arranged in the control wire channel. In the structure shown in the figure, 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 farthest part of the dilatation catheter, can provide a good guiding effect, and facilitates guiding the dilatation catheter to the target site. In some cases, the catheter tip 1 can also be developed under X-ray irradiation to show the distal position of the dilatation 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 is fixedly connected to the distal end of the elastic balloon 2, and can be connected by glue bonding, laser welding or integrated molding.

[0059] The dilatation catheter of this embodiment also has a guidewire channel arranged along its axial direction, which can be used in conjunction with a guidewire. Specifically, the guidewire channel includes a first channel 8, an inner cavity 10, a second channel 11 and a fourth channel 14 which are coaxial and axially connected in sequence. Preferably, the guidewire channel is arranged separately from the control wire channel.

[0060] Figure 3 The catheter tip 1 shown is a tubular structure, and a first through passage 8 is axially provided. The guide wire passes through the first passage 8. In addition, the distal end of the catheter tip 1 can be thinner than the proximal end, and the thinned portion is called a tapered section 7. The outer diameter of the tapered section 7 gradually increases from the proximal end to the distal end, which is convenient for movement in a blood vessel or cavity. In this embodiment, except for the tapered section 7, the inner and outer diameters of the catheter tip 1 are constant for a specified length starting from its proximal end, and the outer diameter gradually decreases from the middle toward the distal end. When the catheter tip 1 is provided with the tapered section 7, the dilatation catheter has good flexibility and guidance at the distal end.

[0061] Continue to refer 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 head end 1, which can be fixed by glue bonding or laser welding or other suitable fixing methods. At the same time, the proximal annular end face 101 of the catheter head end 1 is also fixed to the distal end of the elastic balloon 2.

[0062] Figure 1-2 , Figure 4 , Figure 8-Figure 9 In some embodiments shown, the elastic balloon 2 is composed of a plurality of elastic bodies 9 distributed at intervals along the circumference of the elastic balloon 2, and the plurality of elastic bodies 9 enclose a three-dimensional mesh hollow structure, that is, a hollow is formed between any two adjacent elastic bodies 9 in the circumferential direction. At this time, the plurality of elastic bodies 9 are arranged almost in parallel and do not overlap each other. Moreover, the proximal end of each elastic body 9 is fixed to the distal end of the tube body 3, and the distal end of each elastic body 9 is fixed to the proximal end of the catheter head 1, so as to realize the overall opening of the elastic balloon 2, especially for the diseased tissue with uniform circumferential thickness in the blood vessel.

[0063] It is understandable that such elastic balloon 2 has Figure 1 and Figure 2 The radially contracted state (i.e., initial state) shown in FIG. Figure 8 and Fig. 9The elastic balloon 2 is in the radial expansion state shown, and can be switched between the radial contraction state and the radial expansion 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 Fig. 9 As shown, since the elastic balloon 2 is a hollow structure, it does not affect blood flow after being expanded, and can avoid ischemia-reperfusion injury at the distal end of the lesion and thrombosis caused by slow blood flow. At the same time, since the elastic balloon 2 no longer uses a traditional polymer balloon, there is no need to use hydraulic equipment such as hydraulic media, which not only saves surgical time, but also does not need to worry about hydraulic shock damage caused by the rupture of traditional polymer balloons, reducing surgical risks. In addition, there is no need to set a cavity for filling the polymer balloon in the tube body 3, so that the structure of the tube body 3 can be simpler, the diameter is thinner, and the scope of application is wider.

[0065] The elastomer 9 is usually a rod-shaped structure that can withstand pressure and has good elasticity. The material of the elastomer 9 can be selected from medical metal materials or polymer materials that are elastic and biocompatible. Preferably, the elastomer 9 is made of 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] In addition, multiple elastic bodies 9 refer 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] When in use, the catheter head end 1 is directly pulled by the control wire 5, driving the catheter head end 1 to move in the proximal direction, and then axially squeezing the entire elastic balloon 2, driving multiple elastic bodies 9 to deform and bend after being compressed, and gradually expand, and finally making the entire elastic balloon 2 appear to be stretched outward. In this case, all elastic bodies 9 are compressed, deformed and bent at the same time, so that the elastic balloon 2 is stimulated to expand in the entire circumferential direction until it fits the lesion, and the circumferential uniform expansion of the lesion tissue can be achieved. During contraction, it is necessary to gradually relax the control wire 5 so that each elastic body 9 can rebound in a controllable manner.

[0068] In addition, return reference Figure 4 In this embodiment, the elastic balloon 2 has an inner cavity 10 axially penetrating therethrough, and the inner cavity 10 can be used in conjunction with a guide wire. Of course, the control wire 5 can also pass through the inner cavity 10 .

[0069] It should also be noted that in some other embodiments, the elastic body 9 can be one (not shown), and only the distal end of the elastic body 9 is fixed to the proximal end of the catheter head 1, and the proximal end is fixed to the distal end of the tube body 3. Such a structure can achieve directional expansion of the elastic balloon 2 without the need to be ejected in the entire circumferential direction, so that the expansion direction of the elastic balloon 2 is controllable, thereby achieving directional expansion of the diseased tissue, which is especially aimed at the diseased tissue with uneven circumferential thickness in the blood vessel. When the elastic balloon 2 uses one elastic body 9, the width of the elastic body 9 in the circumferential direction can be adjusted and set according to the size of the diseased tissue to ensure that the diseased tissue can be effectively expanded.

[0070] Figure 5 In the tubular body 3 shown, the tubular body 3 is provided with a second channel 11 and a third channel 12 that are connected along its own axial direction. The second channel 11 and the third channel 12 are two channels that are arranged side by side and isolated from each other. The second channel 11 is usually a central cavity, which is centrally arranged to facilitate the use with a guide wire so that the guide wire passes therethrough. The third channel 12 facilitates the passage of the control wire 5 therethrough. 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 simultaneously arranged in the tubular body 3 to prevent the control wire 5 and the guide wire from interfering with each other.

[0071] In addition, the handle 4 is mainly convenient for the user to hold and operate. The handle 4 can be assembled after being manufactured separately from the tube body 3, or the handle 4 and the tube body 4 are integrally formed and connected. The handle 4 is arranged at the proximal end of the tube body 3.

[0072] Figure 6 In the handle 4 shown, the handle 4 has a grip 13, which is convenient for the user to hold. The shape of the grip 13 includes but is not limited to that shown in the figure, and it can have various suitable shapes as long as it is convenient to hold. At the same time, the handle 4 is provided with a fourth channel 14 and a fifth channel 15 that are connected 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 channels that are side by side and isolated from each other. The fourth channel 14 is usually a central cavity, which is centrally arranged for easy use with a guide wire. The fifth channel 15 is convenient for the manipulation wire 5 to pass through it. 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 is retained. Preferably, the fourth channel 14 and the fifth channel 15 are simultaneously arranged in the handle 4.

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

[0074] Figure 7 The schematic diagram of the structure of the control wire 5 is shown. In some embodiments, the control wire 5 is substantially an elongated structure, which can be solid or hollow. There is no special requirement for the material of the control wire 5. Preferably, a scale 16 is provided on the proximal surface of the control wire 5 to display the stroke of the control wire 5, so as to facilitate the determination of the expansion degree of the elastic balloon 2, and make the operation more accurate 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 is controlled by the corresponding structure on the handle 4.

[0076] like Figure 8 and Fig. 9 As shown, the working principle is that the user holds the handle 4, keeps the tube body 3 still, and pulls the control wire 5 backward (see the arrow, toward the proximal direction). Under the pulling of the control wire 5, the catheter head end 1 moves backward, thereby squeezing the elastic balloon 2 backward, driving the multiple elastic bodies 9 on the elastic balloon 2 to gradually expand radially outward and undergo elastic deformation, so that the elastic balloon 2 expands to a certain volume. Preferably, during the control process, the change in the diameter of the elastic balloon 2 is determined by the change in the scale 16 on the control wire 5, and then the expansion diameter of the elastic balloon 2 is accurately controlled to ensure that the elastic balloon 2 can break the calcified lesions or fibrotic lesion tissues on the inner wall of the blood vessel, thereby achieving a clinical treatment effect.

[0077] <Second Embodiment>

[0078] The structure of the dilatation catheter provided in the second embodiment is substantially the same as that of the dilatation catheter provided in the first embodiment, and the same parts will not be described again, and only the differences will be described below.

[0079] like Figure 10-11 As shown, in the second embodiment, the elastic balloon 2 is formed by a plurality of elastic bodies 9 intersecting each other into a three-dimensional mesh hollow structure, which can be cut or woven into shape. Similarly, the elastic balloon 2 is gradually expanded after receiving the axial squeezing force when the catheter head end 1 moves toward the proximal end, and the mesh-shaped cross-elastic bodies 9 are more uniformly deformed, and the compressive stress generated on the calcified lesions or fibrotic lesions on the inner wall of the human body or the cavity is more dispersed, reducing the impact damage to the human blood vessels or cavities, and having a better clinical effect.

[0080] <Third Embodiment>

[0081] The dilatation catheter provided in the third embodiment is substantially the same as the dilatation catheter provided in the first embodiment, and the same parts will not be described again, and only the differences will be described below.

[0082] like Figures 12 to 16 As shown, in the third embodiment, there are multiple control wires 5, and multiple means two or more, which is different from the single control wire 5 in the first embodiment. The multiple control wires 5 are arranged in a one-to-one correspondence with the multiple elastic bodies 9, so that each elastic body 9 is controlled by a corresponding control wire 5, and the control between them is operated independently without affecting each other. The elastic balloon 2 can achieve directional expansion due to the separate control of the elastic body 9. The diameter of the elastic balloon 2 at different circumferential positions of the present embodiment is variable, and the expansion direction and size are controllable in the circumferential direction, and it can be repeatedly stimulated for a long time, and the lesion can be directionally expanded, which provides more operability for clinicians and can provide better treatment effects for patients.

[0083] In this way, the distal end of each elastic body 9 is joined to the distal end of a corresponding control wire 5 as a whole (see Fig.13 A), and is called a distal joint 59. Each distal joint 59 is slidably connected to the proximal end of the catheter head end 1. The proximal end of each elastomer 9 is still fixed to the distal end of the tube body 3. In actual use, when a corresponding control wire 5 is pulled back after being subjected to force, it directly drives a corresponding elastomer 9 to deform in the axial direction away from the elastic balloon 2; when a corresponding control wire 5 is relaxed, the corresponding elastomer 9 rebounds in the axial direction close to the elastic balloon 2. Therefore, if expansion is required in which direction, the control wire 5 in the corresponding direction is selected to control the expansion of the corresponding elastomer 9. Only one elastomer 9 can be expanded at a time, or multiple elastomers 9 can be expanded at the same time, and the operations between these elastomers 9 are independent.

[0084] Fig.13 and Fig.14 In the embodiment, the proximal end of the catheter head end 1 is provided with a plurality of blind holes 17, and the plurality of blind holes 17 are distributed at intervals along the circumference of the catheter head end 1, and the plurality of blind holes 17 and the plurality of distal end joints 59 are provided one by one. Each distal end joint 59 is slidably disposed in 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 engaging portion 59 from being separated from the blind hole 17, preferably, a limiting step 18 is provided inside the proximal end of each blind hole 17 (see Fig.14 ), and at the same time, a boss 19 is provided at the distal end of each control wire 5 ( Fig.16), the boss 19 can cooperate with the limiting step 18 to prevent the distal engaging portion 59 from escaping from the blind hole 17. Of course, there are many ways to limit the distal engaging portion 59 from escaping 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 can be set outside the proximal end of the blind hole 17, or some elastic locking structures can be set.

[0086] Preferably, the plurality of control wires 5 are arranged separately, that is, the aforementioned control wire channels are multiple, and the plurality of control wire channels are spaced apart along the circumference of the dilatation catheter, and each control wire 5 is arranged in a corresponding control wire channel. Specifically in this embodiment, the plurality of third channels 12 are arranged along the circumference of the tube body 3, and as Fig.15 As shown, a plurality of fifth channels 15 are arranged along the circumference of the handle 4 , and the third channels 12 and the fifth channels 15 correspond one to one.

[0087] The working principle of the dilatation catheter of this embodiment is as follows: Fig.13 The middle arrow indicates that pulling a certain control wire 5 backward can only control the deformation of the elastomer 9 connected to it, so that the deformation of each elastomer 9 can be controlled individually, thereby realizing 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, Fig.10 and Fig.11 The elastic balloon 2 in the apparatus can also be individually controlled in the same manner, and the details will not be described in detail.

[0089] <Fourth Embodiment>

[0090] The dilatation catheter provided in the fourth embodiment is substantially the same as the dilatation catheter provided in the above embodiments, and the same parts will not be described again, and only the differences will be described below.

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

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

[0093] Detailed, such as Fig. 20 As shown, the locking member 23 has an internal threaded hole 24. Fig.21 As shown, the control wire 5 has an external thread 25. Fig.17The locking member 23 is arranged on the proximal side of the handle 4, and the handle 4 can be used to prevent the locking member 23 from moving in the distal direction. The locking member 23 cooperates with the external thread 25 on the control wire 5 through the internal thread hole 24. When the control wire 5 is forced to pull the catheter head 1 in the proximal direction, the elastic balloon 2 can be adjusted and locked for a long time to ensure that the calcified lesions or fibrotic lesions in the human body are fully opened without rebounding, and the operation of the user is convenient, which is more in line with clinical needs.

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

[0095] As a variation, Fig.17 As shown, the dilatation catheter of this embodiment cancels the guidewire channel, and directly replaces the guidewire with the catheter head end 1. Specifically, the catheter head end 1 is set as a guidewire structure, which has the function of a guidewire. When in use, no additional guidewire is needed, simplifying the operation process.

[0096] Fig.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 sleeve. The outer diameter of the core wire 21 is constant for a specified length starting from its proximal end, and the outer diameter gradually decreases toward the distal end from the middle, and the reduction amplitude can remain unchanged or change. Preferably, the core wire 21 is a first variable diameter section, a tapered section 7 and a first constant diameter section from the distal end to the proximal end, and the taper of the first variable diameter section is smaller than the taper of the tapered section 7. In addition, it is also possible not to have such a core wire 21, for example, a constant diameter section is set between adjacent variable diameter sections, or the farthest position of the core wire 21 is a constant diameter section. This situation 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 and is relatively soft and smooth, thus reducing damage to tissues.

[0098] The sheath 22 is a component in which a wire is wound into a spiral shape, and is provided in a manner to cover the distal end side portion of the core wire 21. The sheath 22 is preferably made of a metal material, for example, stainless steel, superelastic alloy, cobalt alloy, gold, tungsten, etc., or a combination of multiple materials. By providing such a sheath 22, the push resistance can be reduced, and the operability of the dilatation catheter can be improved.

[0099] In the case of the dilatation catheter of this embodiment having the catheter head end 1, the guide wire channel is cancelled, that is, the catheter head end 1 cancels the first channel 8, while the tube body 3 also cancels the second channel 11, and the handle 4 cancels the fourth channel 14. Therefore, when in use, it is not necessary to use with a guide wire, simplifying the surgical operation process.

[0100] Although the present invention is disclosed as above, it is not limited thereto. Those skilled in the art may make various changes and modifications to the present invention without departing from the spirit and scope of the present invention. Thus, if these modifications and variations of the present invention fall within the scope of the present invention specification and its equivalent technology, the present invention is also intended to include these modifications and variations.

Claims

1. A dilatation catheter, characterized in that: It comprises a control wire, a control wire channel, and a catheter head end, an elastic balloon, a tube body and a handle which are connected in sequence in the axial direction; the control wire channel passes through the elastic balloon, the tube body and the handle in sequence in the axial direction; The control wire is at least partially arranged in the control wire channel, and the distal end is connected to the catheter head end; The elastic balloon is 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 head end; When the control wire is pulled back after being subjected to force, the elastic body is driven to deform in a direction away from the axis of the elastic balloon, so that the elastic balloon is in a radially expanded state; When the control wire is relaxed, the elastic body rebounds toward the axial direction close to the elastic balloon.

2. The dilatation catheter according to claim 1, characterized in that When the elastic balloon is composed of one elastomer, the distal end of one elastomer is fixed to the proximal end of the catheter head, and the distal end of the control wire is fixed to the proximal end of the catheter head; or, when the elastic balloon is composed of multiple elastomers, the distal end of each elastomer is fixed to the proximal end of the catheter head, and the distal end of one control wire is fixed to the proximal end of the catheter head.

3. The dilatation catheter according to claim 1, characterized in that When the elastic balloon is composed of a plurality of elastic bodies, there are a plurality of control wires, and the plurality of control wires are arranged in a one-to-one correspondence with the plurality of elastic bodies; the distal end of each elastic body is connected to the distal end of a corresponding control wire as a whole to form a distal joint; each distal joint is slidably connected to the proximal end of the catheter head end; When a corresponding one of the control wires is pulled back after being subjected to force, it drives the corresponding one of the elastic bodies to deform in the axial direction away from the elastic balloon; when a corresponding one of the control wires is relaxed, it causes the corresponding one of the elastic bodies to rebound in the axial direction close to the elastic balloon.

4. The dilatation catheter according to claim 3, characterized in that The proximal end of the catheter head end is provided with a plurality of blind holes, and the plurality of blind holes are arranged in one-to-one correspondence with the plurality of distal end joints; each of the distal end joints is slidably arranged in a corresponding one of the blind holes.

5. The dilatation catheter according to claim 4, characterized in that A limiting step is provided inside the proximal end of each blind hole, and a boss is provided at the distal end of each control wire, and the boss cooperates with the limiting step to prevent the distal end joint from detaching from the blind hole.

6. The dilatation catheter according to claim 3, characterized in that: There are a plurality of control wire channels, and the plurality of control wire channels are distributed at intervals along the circumference of the dilation catheter, and each control wire is arranged in a corresponding one of the control wire channels.

7. The dilatation catheter according to any one of claims 1 to 3, characterized in that: When the elastic balloon is composed of a plurality of the elastic bodies, the plurality of the elastic bodies are distributed at intervals along the circumference of the elastic balloon, or the plurality of the elastic bodies are distributed crosswise with each other.

8. The dilatation catheter according to any one of claims 1 to 3, characterized in that: The dilatation catheter further comprises a guidewire channel which is separately arranged from the control wire channel, and the guidewire channel axially penetrates the dilatation catheter; or, the catheter head end is configured as a guidewire structure.

9. The dilatation catheter according to any one of claims 1 to 3, characterized in that: The dilatation catheter further comprises 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 a scale is provided on the proximal surface of the control wire.

10. The dilatation catheter according to claim 9, characterized in that The locking piece is an internal thread piece, the proximal surface of the control wire is provided with an external thread, and the locking piece cooperates with the external thread through the internal thread.

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