Balloon dilatation catheter

Abstract

The utility model provides a balloon dilatation catheter. The balloon dilatation catheter comprises a catheter body, a blood flow tube and a balloon, the blood flow tube comprises a first tube body and a second tube body, the second tube body is located in the first tube body, the outer wall of one side of the second tube body is connected with the inner wall of one side of the first tube body, and a blood flow cavity is formed between the outer wall of the other side of the second tube body and the inner wall of the other side of the first tube body; the balloon is connected to the outer wall of the first tube body in a sleeving mode, and a filling cavity is formed between the balloon and the first tube body; the far end of the catheter body is inserted into the second catheter body, and a first medium cavity is formed between the far end of the catheter body and the second catheter body; and a through part for communicating the first medium cavity with the filling cavity is arranged at the joint of the first pipe body and the second pipe body. The balloon dilatation device can solve the problem of blood flow supply of a far-end blood vessel in the balloon dilatation period.

Description

Technical Field

[0001] The utility model relates to the technical field of medical devices, in particular to a balloon dilatation catheter. Background Art

[0002] Atherosclerosis refers to the thickening of the walls and narrowing of the arteries that supply blood to various organs such as the heart, brain and kidneys. It is the main cause of heart attacks and strokes, and the leading cause of death in the world. Currently, balloon products have been widely used in the interventional treatment of atherosclerosis through percutaneous transluminal angioplasty. These balloon products can be divided into pre-dilation balloons, post-dilation balloons, drug-coated balloons, etc. according to their functions.

[0003] Pre-dilation balloons are generally used for vascular calcification, severe stenosis, chronic total occlusion lesions and special treatments. Pre-dilation of the lesion site with a pre-dilation balloon can assess the nature of the lesion, estimate the difficulty of lesion treatment, and guide the formulation of subsequent strategies. In addition, pre-dilation treatment can partially relieve stenotic lesions, increase the success rate of subsequent stents passing through lesions, and reduce the damage of lesions to the stent coating.

[0004] Post-dilatation balloon is generally used for complex lesions, open lesions and in-stent lesions. Through post-treatment of stent implantation, it ensures the full expansion and adhesion of the stent, reduces thrombosis in the stent, and reduces the incidence of restenosis and revascularization rate after stent surgery.

[0005] As a new "implant-free" interventional treatment device, drug-coated balloons are coated with drugs on the balloon surface. After the balloon is filled, the surface drug coating separates from the balloon and adheres to the blood vessel wall to treat the diseased area. It can treat severe coronary artery lesions without leaving permanent implants in the blood vessels, avoid a series of problems caused by stent placement, and provide the possibility for diseased blood vessels to receive re-treatment, which has significant and unique advantages.

[0006] During the above-mentioned conventional balloon dilation, the blood vessels will be completely blocked to improve the wall adhesion effect and enhance the expected effect or drug transfer efficiency. However, the distal blood vessels of some patients cannot tolerate prolonged ischemia and cannot be dilated for a sufficient period of time. For pre-dilation balloons and post-dilation balloons, this will lead to poor treatment effects. For drug-coated balloons, the drug coating cannot be maximized and firmly transferred to the blood vessel wall, which not only reduces the drug concentration in the lesion area, but may also cause distal vascular embolism. In short, current conventional balloons still have limitations in the treatment of various lesions.

[0007] It should be noted that the information disclosed in the background technology section of the utility model is only intended to deepen the understanding of the general background technology of the utility model, and should not be regarded as an admission or suggestion in any form that the information constitutes prior art already known to those skilled in the art. Utility Model Content

[0008] The utility model aims to provide a balloon dilatation catheter, which can solve the problem of blood flow supply to the distal blood vessels during balloon dilatation.

[0009] To achieve the above-mentioned purpose, the utility model provides a balloon dilatation catheter, comprising a catheter body, a blood flow tube and a balloon, wherein the blood flow tube runs through the proximal end and the distal end of the balloon;

[0010] The blood flow tube comprises a first tube body and a second tube body, wherein the second tube body is located inside the first tube body, an outer wall on one side of the second tube body is connected to an inner wall on one side of the first tube body, and a blood flow cavity for blood flow to pass through is formed between the outer wall on the other side of the second tube body and the inner wall on the other side of the first tube body;

[0011] The balloon is sleeved on the outer wall of the first tube, and a filling cavity for accommodating a filling medium is provided between the balloon and the first tube;

[0012] The distal end of the catheter body is inserted into the second tube body, and a first medium cavity for allowing a filling medium to pass therethrough is provided between the distal end of the catheter body and the second tube body;

[0013] The connection between the first tube body and the second tube body has a through portion for connecting the first medium cavity and the filling cavity.

[0014] Optionally, an outer wall of one side of the second tube body is welded to an inner wall of one side of the first tube body, and a welding length between the second tube body and the first tube body is 2 mm to 6 mm, and the through portion includes at least one through hole provided at a welding point between the first tube body and the second tube body.

[0015] Optionally, the second tube body and the first tube body are an integral structure, and the through portion includes an open slit provided at a connection between the first tube body and the second tube body.

[0016] Optionally, the proximal end of the first tube body has a first sloped opening inclined toward the proximal end, and / or the distal end of the first tube body has a second sloped opening inclined toward the distal end.

[0017] Optionally, the catheter body includes an outer tube and an inner tube, the distal end of the outer tube is connected to the proximal end of the second tube body, the proximal end of the inner tube is located inside the distal end of the outer tube, the distal end of the inner tube is located inside the second tube body, the first medium cavity is provided between the inner tube and the second tube body, the second medium cavity is provided between the inner tube and the outer tube for allowing the filling medium to pass through, and the second medium cavity is connected to the first medium cavity.

[0018] Optionally, the inner tube has a guide wire cavity extending along its axial direction, and one side of the outer tube has a guide wire opening for allowing a guide wire to extend into the guide wire cavity.

[0019] Optionally, the area of ​​the inner tube located within the balloon has a development mark, and / or the proximal end of the outer tube has a catheter identification band.

[0020] Optionally, the outer tube includes a proximal outer tube and a distal outer tube, the proximal end of the distal outer tube is connected to the distal end of the proximal outer tube, and the distal end of the distal outer tube is connected to the proximal end of the second tube body.

[0021] Optionally, the balloon dilatation catheter further includes a connector and a diffusion stress tube, wherein the proximal end of the diffusion stress tube is connected to the distal end of the connector, and the distal end of the diffusion stress tube is connected to the proximal end of the catheter body.

[0022] Optionally, the balloon dilatation catheter further includes a head structure, and the distal end surface of the catheter body and the distal end surface of the second tube body are both connected to the proximal end of the head structure.

[0023] Optionally, the cross-section of the blood flow cavity is crescent-shaped.

[0024] Optionally, the diameter of the balloon is 2 mm to 4 mm.

[0025] Optionally, the length of the balloon is 10 mm to 40 mm.

[0026] Optionally, the outer diameter of the first tube is 0.7 mm to 1.5 mm.

[0027] Optionally, the wall thickness of the first tube body is 0.15 mm to 0.25 mm.

[0028] Optionally, the length of the first tube is 20 mm to 50 mm.

[0029] Optionally, the outer diameter of the second tube is 0.6 mm to 1 mm.

[0030] Optionally, the length of the second tube is 25 mm to 55 mm.

[0031] Optionally, the outer surface of the balloon has a drug coating.

[0032] Optionally, the material of the balloon is nylon, a block copolymer of polyamide and polyether, or thermoplastic polyurethane.

[0033] Compared with the prior art, the balloon dilatation catheter provided by the utility model has the following beneficial effects:

[0034] The balloon dilatation catheter provided by the utility model comprises a catheter body, a blood flow tube and a balloon, wherein the blood flow tube passes through the proximal end and the distal end of the balloon; the blood flow tube comprises a first tube body and a second tube body, wherein the second tube body is located in the first tube body, an outer wall on one side of the second tube body is connected to an inner wall on one side of the first tube body, and a blood flow cavity for blood flow to pass through is formed between an outer wall on the other side of the second tube body and an inner wall on the other side of the first tube body; the balloon is sleeved on the outer wall of the first tube body, and a filling cavity for accommodating a filling medium is provided between the balloon and the first tube body; the distal end of the catheter body is inserted into the second tube body, and a first medium cavity for filling medium to pass through is provided between the distal end of the catheter body and the second tube body; a through portion for connecting the first medium cavity with the filling cavity is provided at the connection between the first tube body and the second tube body. Therefore, the utility model can ensure that the proximal blood flow can reach the distal tissue before and after the balloon expansion by setting a blood flow tube having a blood flow cavity that penetrates the balloon at the distal end of the balloon dilatation catheter, thereby avoiding distal ischemia caused by the balloon expansion, thereby solving the problem that the existing conventional balloon completely blocks the blood vessels for a period of time during pre-expansion, post-expansion, and drug delivery, thereby reducing the treatment effect for some patients with poor tolerance to distal vascular ischemia. In addition, the utility model uses multiple tubes to nest to form multiple independent chambers, which ensures that each chamber plays a role while minimizing the traversable diameter of the balloon dilatation catheter. BRIEF DESCRIPTION OF THE DRAWINGS

[0035] Figure 1 A schematic diagram of the overall structure of a balloon dilatation catheter provided in one embodiment of the utility model;

[0036] Figure 2 A schematic structural diagram of the proximal end portion of a balloon dilatation catheter provided in one embodiment of the utility model;

[0037] Figure 3 A schematic diagram of the planar structure of the distal end portion of a balloon dilatation catheter provided in one embodiment of the utility model;

[0038] Figure 4 A schematic diagram of the three-dimensional structure of the distal end portion of a balloon dilatation catheter provided in one embodiment of the utility model;

[0039] Figure 5 A cross-sectional view of the distal end portion of a balloon dilatation catheter in an expanded state provided by an embodiment of the utility model;

[0040] Figure 6 A cross-sectional view of the proximal end portion of a balloon dilatation catheter in a folded state provided by an embodiment of the utility model;

[0041] Figure 7This is a blood flow diagram during the filling of a conventional balloon dilatation catheter;

[0042] Figure 8 A blood flow diagram during the filling period of a balloon dilatation catheter provided by an embodiment of the utility model;

[0043] Fig. 9 This is a schematic structural diagram of a blood flow tube in a balloon dilatation catheter provided in another embodiment of the utility model.

[0044] The reference numerals are described as follows:

[0045] Catheter body-100; outer tube-110; guide wire port-111; proximal outer tube-112; distal outer tube-113; inner tube-120; guide wire cavity-121; development mark-140; catheter identification band-150;

[0046] Blood flow tube-200; first tube body-210; first slope opening-211; second slope opening-212; second tube body-220; blood flow cavity-230; through portion-240;

[0047] Balloon - 300;

[0048] Filling chamber-410; first medium chamber-420;

[0049] Connecting piece-510; Diffusion stress tube-520; Head structure-530. DETAILED DESCRIPTION

[0050] The balloon dilatation catheter proposed by the utility model is further described in detail below in combination with the accompanying drawings and specific embodiments. According to the following description, the advantages and features of the utility model will be clearer. It should be noted that the accompanying drawings adopt a very simplified form and use non-precise proportions, which are only used to conveniently and clearly assist in explaining the purpose of the implementation of the utility model. In order to make the purpose, features and advantages of the utility model more obvious and easy to understand, please refer to the accompanying drawings. It should be noted that the structure, proportion, size, etc. illustrated in the accompanying drawings of this specification are only used to match the content disclosed in the specification for people familiar with this technology to understand and read, and are not used to limit the limiting conditions for the implementation of the utility model. Any modification of the structure, change of the proportional relationship or adjustment of the size, in the case of the same or similar effects and purposes that can be achieved by the utility model, should still fall within the scope of the technical content disclosed by the utility model. The specific design features of the utility model disclosed herein include, for example, specific size, direction, position and shape, which will be determined in part by the specific environment to be applied and used. Also, in the embodiments described below, sometimes the same reference numerals are used in common between different figures to represent the same parts or parts with the same functions, and their repeated descriptions are omitted. In this specification, similar reference numerals and letters are used to represent similar items, so once an item is defined in one figure, it does not need to be further discussed in subsequent figures. In addition, if the method described herein includes a series of steps, the order of these steps presented herein is not necessarily the only order in which these steps can be performed, and some of the steps described may be omitted and / or some other steps not described herein may be added to the method.

[0051] It should be noted that, in this article, relational terms such as first and second, etc. are only used to distinguish one entity or operation from another entity or operation, and do not necessarily require or imply any such actual relationship or order between these entities or operations, and cannot be understood as indicating or implying relative importance or implicitly indicating the number of technical features indicated. Moreover, the terms "include", "comprise" or any other variants thereof are intended to cover non-exclusive inclusion, so that a process, method, article or device including a series of elements includes not only those elements, but also other elements not explicitly listed, or also includes elements inherent to such process, method, article or device. In the absence of further restrictions, the elements defined by the sentence "including one..." do not exclude the existence of other identical elements in the process, method, article or device including the elements. The singular forms "a", "an" and "the" include plural referents, the term "or" is generally used in a sense including "and / or", the term "several" is generally used in a sense including "at least one", the term "at least two" is generally used in a sense including "two or more", and the term "plurality" is generally used in a sense including "at least two".

[0052] In the description of the present utility model, it should be understood that the terms "center", "longitudinal", "lateral", "length", "width", "thickness", "up", "down", "front", "back", "left", "right", "vertical", "horizontal", "top", "bottom", "inside", "outside", "axial", "radial", "circumferential" and the like indicate positions or positional relationships based on the positions or positional relationships shown in the drawings, and are only for the convenience of describing the present utility model and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as a limitation on the present utility model. In the description of the present utility model, unless otherwise clearly specified and limited, the terms "install", "connect", "connect", and "fix" 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 a direct connection or an indirect connection through an intermediate medium, it can be a connection between the inside of two elements or an interaction relationship between two elements. For ordinary technicians in this field, the specific meanings of the above terms in the present utility model can be understood according to specific circumstances. In addition, in the present utility model, unless otherwise clearly stipulated and limited, the first feature being "above" or "below" the second feature may include the first and second features being in direct contact, or may include the first and second features not being in direct contact but being in contact through another feature between them. Moreover, the first feature being "above", "above" and "above" the second feature includes the first feature being directly above and obliquely above the second feature, or simply means that the first feature is higher in level than the second feature. The first feature being "below", "below" and "below" the second feature includes the first feature being directly below and obliquely below the second feature, or simply means that the first feature is lower in level than the second feature.

[0053] The core idea of ​​the present invention is to provide a balloon dilatation catheter that can solve the problem of blood flow supply to the distal blood vessels during balloon dilatation.

[0054] Please refer to Figures 1 to 6 ,in, Figure 1 A schematic diagram of the overall structure of a balloon dilatation catheter provided in one embodiment of the utility model; Figure 2 A schematic structural diagram of the proximal end portion of a balloon dilatation catheter provided in one embodiment of the utility model; Figure 3 A schematic diagram of the planar structure of the distal end portion of a balloon dilatation catheter provided in one embodiment of the utility model; Figure 4 A schematic diagram of the three-dimensional structure of the distal end portion of a balloon dilatation catheter provided in one embodiment of the utility model; Figure 5 A cross-sectional view of the distal end portion of a balloon dilatation catheter in an expanded state provided by an embodiment of the utility model; Figure 6A cross-sectional view of the proximal end portion of a balloon dilatation catheter in a folded state provided by an embodiment of the utility model. Figures 1 to 6 As shown, the balloon dilatation catheter provided by the utility model includes a catheter body 100, a blood flow tube 200 and a balloon 300, wherein the blood flow tube 200 runs through the proximal end and the distal end of the balloon 300; the blood flow tube 200 includes a first tube body 210 and a second tube body 220, wherein the second tube body 220 is located inside the first tube body 210, an outer wall of one side of the second tube body 220 is connected to an inner wall of one side of the first tube body 210, and a blood flow cavity for blood flow to pass through is formed between the outer wall of the other side of the second tube body 220 and the inner wall of the other side of the first tube body 210 230; the balloon 300 is sleeved on the outer wall of the first tube body 210, and a filling cavity 410 for accommodating a filling medium is provided between the balloon 300 and the first tube body 210; the distal end of the catheter body 100 is inserted into the second tube body 220, and a first medium cavity 420 for allowing a filling medium to pass therethrough is provided between the distal end of the catheter body 100 and the second tube body 220; a through portion 240 for connecting the first medium cavity 420 with the filling cavity 410 is provided at the connection between the first tube body 210 and the second tube body 220. Therefore, the utility model, by setting a blood flow tube 200 penetrating the balloon 300 and having a blood flow cavity 230 at the distal end of the balloon dilatation catheter, can ensure that the proximal blood flow can reach the distal tissue before and after the balloon 300 is expanded (i.e., before and after filling), avoiding distal ischemia caused by the expansion of the balloon 300, thereby solving the problem that the existing conventional balloon 300 will completely block the blood vessel for a period of time during pre-expansion, post-expansion, and drug delivery, thereby reducing the treatment effect for some patients with poor tolerance to distal vascular ischemia. In addition, the utility model uses multiple tubes to nest to form multiple independent chambers, while ensuring that each chamber (including the first medium cavity 420, the filling cavity 410, the blood flow cavity 230, and the second medium cavity described below) plays a role, it also minimizes the traversable diameter of the balloon dilatation catheter. It should be noted that, as can be understood by those skilled in the art, the blood flow chamber 230 is separated from the first medium chamber 420 and the filling chamber 410, that is, the blood flow chamber 230 is neither connected to the first medium chamber 420 nor to the filling chamber 410.

[0055] Specifically, the balloon dilatation catheter has a folded state and an expanded state (i.e., a filled state). When external gas or liquid (e.g., contrast fluid) is introduced into the balloon 300 to expand or inflate the balloon 300, the balloon dilatation catheter is in the expanded state. Figure 5 Before the balloon 300 is expanded or inflated, the balloon dilatation catheter is in a folded state, as shown in FIG. Figure 6Furthermore, during the folding and pressing process, the balloon 300 will not compress the blood flow tube 200 or cause it to deform, so that before and after the balloon 300 is expanded (ie before and after it is filled), it can be ensured that the proximal blood can flow to the distal tissue.

[0056] Please continue to refer to Figure 7 and Figure 8 ,in, Figure 7 This is a blood flow diagram during the filling of a conventional balloon dilatation catheter; Figure 8 A blood flow diagram during the filling period of a balloon dilatation catheter provided by an embodiment of the utility model. Figure 7 As shown, for a conventional balloon dilatation catheter, after the proximal blood flow reaches the filled part of the balloon 300, the proximal blood flow cannot further reach the distal tissue because the balloon 300 fits well with the blood vessel wall. Figure 8 As shown, during the filling period of the balloon dilatation catheter provided by the present invention, the blood flow cavity 230 formed between the first tube body 210 and the second tube body 220 provides a channel for blood flow, so that the proximal blood flow can further reach the distal tissue. It should be noted that, as can be understood by those skilled in the art, Figure 7 and Figure 8 The dashed arrows in the figure indicate the direction of blood flow.

[0057] Please continue to refer to Figure 5 and Figure 6 ,like Figure 5 and Figure 6 As shown, in some exemplary embodiments, the cross section (the cross section perpendicular to the axial direction) of the blood flow chamber 230 is crescent-shaped. Thus, the crescent-shaped blood flow chamber 230 allows blood flow at a larger angle along the circumference of the catheter to enter the blood flow chamber 230, maximizing the blood flow through the blood flow chamber 230 and avoiding the situation where the distal blood flow is blocked.

[0058] Please continue to refer to Figure 4 ,like Figure 4As shown, in some exemplary embodiments, the proximal end of the first tube body 210 has a first sloped opening 211 inclined toward the proximal end, and the distal end of the first tube body 210 has a second sloped opening 212 inclined toward the distal end. Thus, by providing the first sloped opening 211 at the proximal end of the first tube body 210 and the second sloped opening 212 at the distal end of the first tube body 210, not only can the blood flow entrance area be increased, so that part of the blood flow can enter the blood flow cavity 230 in a turbulent flow, which is conducive to the increase of blood flow, but also can be conducive to reducing the push resistance of the balloon dilatation catheter, so as to facilitate the delivery of the balloon dilatation catheter provided by the utility model to the lesion position in the blood vessel. It should be noted that, as can be understood by those skilled in the art, in some other embodiments, the second sloped opening 212 can also be provided only at the distal end of the first tube body 210, so as to reduce the push resistance of the balloon dilatation catheter; or the first sloped opening 211 can be provided only at the proximal end of the first tube body 210, so as to improve the blood flow.

[0059] Specifically, the first bevel opening 211 and the second bevel opening 212 can be formed by chamfering the proximal end and the distal end of the first tube 210. Of course, as those skilled in the art can understand, the first bevel opening 211 and the second bevel opening 212 can also be formed by other methods, which are not limited in the present invention.

[0060] Furthermore, the first bevel opening 211 may have an inclination angle of 45° to 60°, and the second bevel opening 212 may have an inclination angle of 45° to 60°. Thus, this angle setting can not only prevent the side walls of the first bevel opening 211 and the second bevel opening 212 from scratching the blood vessels, but also make the blood flow entrance area larger, further contributing to the improvement of blood flow.

[0061] In some exemplary embodiments, the material of the balloon 300 is nylon, a block copolymer of polyamide and polyether, or thermoplastic polyurethane. Thus, by using materials such as nylon, a block copolymer of polyamide and polyether (Pebax), or thermoplastic polyurethane (TPU) to make the balloon 300, the balloon dilatation catheter provided by the utility model can cope with different usage scenarios such as pre-dilatation, post-dilatation, and drug delivery.

[0062] In some exemplary embodiments, the diameter of the balloon 300 is 2 mm to 4 mm, and the length of the balloon 300 is 10 mm to 40 mm. Thus, this size setting can further enable the balloon dilatation catheter provided by the utility model to cope with different usage scenarios such as pre-dilatation, post-dilatation, and drug delivery.

[0063] In some exemplary embodiments, the outer diameter of the first tube 210 is 0.7 mm to 1.5 mm, the wall thickness of the first tube 210 is 0.15 mm to 0.25 mm, and the length of the first tube 210 is 20 mm to 50 mm. Therefore, this size setting can not only ensure that the first tube 210 will not be compressed or deformed during the folding and pressing process of the balloon 300, so that the proximal blood flow can reach the distal tissue before and after the balloon 300 is expanded (i.e., before and after filling), but also ensure that within the use pressure range of the balloon 300, the first tube 210 will not collapse and deform, ensuring that the blood flow can pass normally.

[0064] Furthermore, the material of the first tube body 210 is nylon or a block copolymer of polyamide and polyether. Therefore, by using nylon or a block copolymer of polyamide and polyether (Pebax) to make the first tube body 210, it can be ensured that the first tube body 210 has sufficient strength to further ensure that the first tube body 210 will not be compressed or deformed during the folding and pressing process of the balloon 300, so that the proximal blood flow can reach the distal tissue before and after the balloon 300 is expanded (i.e. before and after filling).

[0065] In some exemplary embodiments, the outer diameter of the second tube 220 is 0.6 mm to 1 mm, and the length of the second tube 220 is 25 mm to 55 mm. Thus, this size setting can ensure that a crescent-shaped blood flow cavity 230 can be formed between the first tube 210 and the second tube 220, so that blood flow at a larger angle along the circumference of the catheter can enter the blood flow cavity 230.

[0066] Furthermore, the material of the first tube body 210 is nylon or a block copolymer of polyamide and polyether. Therefore, by using nylon or a block copolymer of polyamide and polyether (Pebax) to make the second tube body 220, it can be ensured that the second tube body 220 has sufficient strength to further ensure that the blood flow tube 200 will not be compressed or deformed during the folding and pressing process of the balloon 300, so that the proximal blood flow can flow to the distal tissue before and after the balloon 300 is expanded (i.e. before and after filling).

[0067] In some exemplary embodiments, the outer surface of the balloon 300 has a drug coating. Thus, the drug coating loaded on the outer surface of the balloon 300 can fully penetrate into the diseased blood vessel, effectively reducing the probability of intimal hyperplasia and reducing the elastic retraction of the blood vessel.

[0068] Specifically, the drug can be coated on the outer surface of the balloon 300 by electrostatic spraying, ultrasonic spraying or crystal self-growth, so as to form a drug coating on the outer surface of the balloon 300. Further, the drug coating can be a coating of only the drug, or a mixture coating of the drug and a carrier matrix. Further, the drug is one or more of rapamycin, rapamycin derivatives, paclitaxel, and paclitaxel derivatives. The carrier matrix can be one or more of iopromide, urea, polyethylene oxide, polylactic acid, etc.

[0069] In some exemplary embodiments, the outer wall of one side of the second tube body 220 is welded to the inner wall of one side of the first tube body 210, and the welding length between the second tube body 220 and the first tube body 210 is 2mm to 6mm, and the through portion 240 includes at least one through hole provided at the welding position between the first tube body 210 and the second tube body 220. Thus, by setting the first tube body 210 and the second tube body 220 as a split structure and connecting the outer wall of one side of the second tube body 220 to the inner wall of one side of the first tube body 210 by a welding method to form a blood flow tube 200 with a crescent-shaped vascular cavity, the production cost of the balloon dilatation catheter provided by the utility model can be reduced. In addition, by setting the welding length between the second tube body 220 and the first tube body 210 to 2mm to 6mm, it can be prevented that the push compliance of the balloon dilatation catheter provided by the utility model in the blood flow tube 200 section is affected by the excessive welding length. In addition, by opening at least one through hole at the welding point between the first tube body 210 and the second tube body 220 to form a through portion 240 for connecting the first medium cavity 420 and the filling cavity 410, air leakage can be effectively prevented.

[0070] It should be noted that, as can be understood by those skilled in the art, in some other embodiments, the outer wall of one side of the second tube body 220 can be connected to the inner wall of one side of the first tube body 210 by gluing or other connection methods. For details, please refer to the relevant technologies known to those skilled in the art, which will not be listed one by one here.

[0071] Furthermore, a fine needle may be used to punch holes at the welding point between the first tube body 210 and the second tube body 220 to obtain one or more through holes. Preferably, the through portion 240 includes a through hole to reduce process risk points. It should be noted that, as can be understood by those skilled in the art, the punching area (i.e., the through portion 240) should not exceed the edge of the welding seam to prevent air leakage.

[0072] Please continue to refer to Figure 1 ,like Figure 1As shown, in some exemplary embodiments, the catheter body 100 includes an outer tube 110 and an inner tube 120, the distal end of the outer tube 110 is connected to the proximal end of the second tube body 220, the proximal end of the inner tube 120 is located within the distal end of the outer tube 110, and the distal end of the inner tube 120 is located within the second tube body 220, the first medium cavity 420 is provided between the inner tube 120 and the second tube body 220, and the second medium cavity for allowing the filling medium to pass therethrough is provided between the inner tube 120 and the outer tube 110, and the second medium cavity is communicated with the first medium cavity 420. Thus, by setting the catheter body 100 to a double-layer structure including an outer tube 110 and an inner tube 120, not only can the balloon dilatation catheter provided by the utility model have good pushing performance, but also the external gas or liquid can be transported to the first medium cavity 420 through the second medium cavity formed by the gap between the inner tube 120 and the outer tube 110, and then transported to the filling cavity 410 through the through portion 240, so that the balloon 300 is filled as a whole. It should be noted that, as can be understood by those skilled in the art, the blood flow cavity 230 is also separated from the second medium cavity, that is, the blood flow cavity 230 is also not connected to the second medium cavity.

[0073] Please continue to refer to Figure 1 , Figure 2 and Figure 5 ,like Figure 1 , Figure 2 and Figure 5 As shown, in some exemplary embodiments, the inner tube 120 has a guidewire cavity 121 extending along its axial direction, and one side of the outer tube 110 has a guidewire port 111 for allowing the guidewire to extend into the guidewire cavity 121. Thus, the guidewire port 111 and the guidewire cavity 121 can be used to pass the guidewire, so that the balloon dilatation catheter can move to the lesion area along the guidewire. Specifically, the balloon 300 is in a folded state and enters the lesion area along the guidewire. Subsequently, the filling medium such as contrast fluid or gas passes through the second medium cavity, the first medium cavity 420 and the through portion 240 in sequence to reach the filling cavity 410, so that the balloon 300 is filled as a whole and close to the target blood vessel wall. During the filling and pressure-maintaining period of the balloon 300, the proximal blood flow can still flow to the distal tissue through the reserved blood flow cavity 230.

[0074] Please continue to refer to Figure 1 ,like Figure 1 As shown, in some exemplary embodiments, the proximal end of the inner tube 120 extends out of the guide wire port 111. Thus, this arrangement can make it easier to insert the guide wire.

[0075] Please continue to refer to Figure 3 and Figure 4 ,like Figure 3 and Figure 4 As shown, in some exemplary embodiments, the region of the inner tube 120 located inside the balloon 300 has a developing mark 140. Thus, by providing the developing mark 140 in the region of the inner tube 120 located inside the balloon 300, the position of the balloon 300 can be imaged and positioned. Specifically, the developing mark 140 can be integrally formed with the inner tube 120, that is, a portion of the inner tube 120 is made of developing material, and the developing mark 140 can also be made separately from the inner tube 120, such as separately forming a developing ring, and then the developing ring is nested on the inner tube 120.

[0076] Furthermore, if Figure 3 and Figure 4 As shown, there are two development marks 140, one of which corresponds to the proximal position of the balloon 300, and the other corresponds to the distal position of the balloon 300. Thus, by providing two development marks 140, it is convenient to better locate the position of the balloon 300 through imaging.

[0077] Please continue to refer to Figure 1 and Figure 2 ,like Figure 1 and Figure 2 As shown, in some exemplary embodiments, the proximal end of the outer tube 110 has a catheter identification band 150. Thus, by providing the catheter identification band 150 at the proximal end of the outer tube 110, it can be used to mark the length of the balloon dilatation catheter entering the patient's body.

[0078] Please continue to refer to Figure 1 and Figure 2 ,like Figure 1 and Figure 2 As shown, in some exemplary embodiments, the outer tube 110 includes a proximal outer tube 112 and a distal outer tube 113, the proximal end of the distal outer tube 113 is connected to the distal end of the proximal outer tube 112, and the distal end of the distal outer tube 113 is connected to the proximal end of the second tube body 220. Thus, by setting the outer tube 110 to include a proximal outer tube 112 and a distal outer tube 113, the balloon dilatation catheter provided by the utility model can have good pushing performance as a whole, and at the same time have good torsion resistance, can smoothly pass through tortuous and small thin tubes, and has good retraction, which is conducive to multiple dilatations and shortens the operation time. Furthermore, the hardness of the proximal outer tube 112 is higher than the hardness of the distal outer tube 113, so as to further improve the pushing performance of the balloon dilatation catheter provided by the utility model.

[0079] Please continue to refer to Figure 1 and Figure 2 ,like Figure 1 and Figure 2 As shown, in some exemplary embodiments, the balloon dilatation catheter further includes a connector 510 and a diffusion stress tube 520, the proximal end of the diffusion stress tube 520 is connected to the distal end of the connector 510, and the distal end of the diffusion stress tube 520 is connected to the proximal end of the catheter body 100 (specifically, the proximal outer tube 112). Thus, by using the diffusion stress tube 520 to connect the connector 510 and the catheter body 100, the strength of the connection between the connector 510 and the catheter body 100 can be improved, effectively preventing the balloon 300 catheter provided by the utility model from breaking during use.

[0080] Please continue to refer to Figure 1 and Figure 3 ,like Figure 1 and Figure 3 As shown, in some exemplary embodiments, the balloon dilatation catheter further includes a head structure 530, and the distal end surface of the catheter body 100 and the distal end surface of the second tube body 220 are both connected to the proximal end of the head structure 530. Therefore, by providing the head structure 530 at the distal end of the balloon dilatation catheter, it can be used to pass through the diseased tissue.

[0081] Furthermore, if Figure 1 and Figure 3 As shown, in some exemplary embodiments, the diameter of the head structure 530 gradually decreases from the proximal end to the distal end. Thus, this arrangement can make it easier for the head structure 530 to pass through the diseased tissue.

[0082] The specific manufacturing process of the balloon dilatation catheter provided in this embodiment is described below.

[0083] First, a tube made of Pebax (a block copolymer of polyamide and polyether) or other materials, with an outer diameter of 0.6mm to 1mm, for example, 0.7mm, and a length of 25mm to 55mm, for example, 35mm, is used as the second tube body 220; then a tube made of nylon 12 or other materials, with an outer diameter of 0.7mm to 1.5mm, for example, 1.25mm, and a length of 20mm to 50mm, for example, 30mm, and a wall thickness of 0.15mm to 0.25mm, for example, 0.2mm, is used as the first tube body 210.

[0084] Then, the inner wall of the first tube body 210 is welded to the outer wall of the second tube body 220 , and the welding length is 2 mm to 6 mm, for example, 4 mm. This step forms a nesting, thereby forming the blood flow cavity 230 .

[0085] A fine needle is then used to pierce holes at the welding point between the first tube body 210 and the second tube body 220 to obtain one or more through holes to form a through portion 240 .

[0086] Then, the balloon 300 is welded to both ends of the outer wall of the first tube 210. The balloon 300 is made of Pebax (block copolymer of polyamide and polyether) or other materials, with an outer diameter of 2mm to 4mm, such as 3mm, and a length of 10mm to 40mm, such as 20mm. This step forms a secondary nesting, thereby forming a filling cavity 410.

[0087] Then the proximal end of the second tube body 220 is connected to the distal outer tube 113, and the distal end of the second tube body 220 is connected and fixed to the inner tube 120 through the head structure 530, and the proximal end of the inner tube 120 is the entrance of the guide wire port 111. This step forms three nestings, the inner tube 120 is inside the guide wire cavity 121, the first medium cavity 420 is formed between the inner tube 120 and the second tube body 220, and the second medium cavity is formed between the inner tube 120 and the outer tube 110 (including the proximal outer tube 112 and the distal outer tube 113), and the first medium cavity 420 and the second medium cavity are connected front to back.

[0088] Please continue to refer to Fig. 9 , which is a schematic diagram of the structure of a blood flow tube 200 in a balloon dilatation catheter provided by another embodiment of the present invention. Fig. 9 As shown, the difference between the balloon dilatation catheter provided in this embodiment and the balloon dilatation catheter provided in the previous embodiment is that, in this embodiment, the second tube body 220 and the first tube body 210 are an integrated structure, and the through-portion 240 includes an open seam provided at the connection between the first tube body 210 and the second tube body 220. Therefore, by setting the second tube body 220 and the first tube body 210 as an integrated structure, the problems of reduced catheter flexibility and process instability caused by multiple welding can be reduced. By providing an open seam at the connection between the first tube body 210 and the second tube body 220 to form the through-portion 240, a larger through-portion 240 can be provided, so that the balloon 300 can be quickly filled and depressurized.

[0089] It should be noted that although Fig. 9 The first sloped opening 211 and the second sloped opening 212 of the first tube body 210 are not shown, but as those skilled in the art will appreciate, the first sloped opening 211 and the second sloped opening 212 can be formed by chamfering the proximal end and the distal end of the first tube body 210. Of course, as those skilled in the art will appreciate, the first sloped opening 211 and the second sloped opening 212 can also be formed by other methods, which are not limited in the present invention.

[0090] The specific manufacturing process of the balloon dilatation catheter provided in this embodiment is described below.

[0091] First, a double-lumen tube made of nylon 12 or other materials with an outer diameter of 0.7 mm to 1.5 mm, for example, 1.25 mm, and a length of 20 mm to 50 mm, for example, 30 mm, is obtained by co-extrusion. The double-lumen tube includes a first tube body 210 and a second tube body 220. The outer periphery of the second tube body 220 and the inner periphery of the first tube body 210 form a crescent-shaped chamber as a blood flow chamber 230. The inner cavity of the second tube body 220 (that is, the circular cavity of the double-lumen tube) and the inner tube 120 subsequently passing through it form a first medium cavity 420.

[0092] Then, a slit is cut on one side of the outer wall of the double-lumen tube (specifically, the side where the first tube body 210 and the second tube body 220 are connected) by laser to obtain an open slit to form a through portion 240, so that the first medium cavity 420 is connected to the subsequent filling cavity 410, but not to the crescent-shaped blood flow cavity 230, to prevent air leakage.

[0093] Then, a balloon 300 is welded to both ends of the outer wall of the double-lumen tube. The balloon 300 is made of Pebax (block copolymer of polyamide and polyether) or other materials, with an outer diameter of 2 mm to 4 mm, such as 3 mm, and a length of 10 mm to 40 mm, such as 20 mm. This step forms a filling cavity 410 .

[0094] Then, the proximal end of the second tube body 220 (i.e., the circular chamber) in the double-lumen tube is connected to the distal outer tube 113, and the distal end of the second tube body 220 (i.e., the circular chamber) in the double-lumen tube is connected and fixed to the inner tube 120 through the head structure 530. The proximal end of the inner tube 120 is the entrance of the guide wire port 111, and the interior of the inner tube 120 is the guide wire cavity 121. The inner tube 120 and the second tube body 220 (i.e., the circular chamber) in the double-lumen tube form a first medium cavity 420, and a second medium cavity is formed between the inner tube 120 and the outer tube 110 (including the proximal outer tube 112 and the distal outer tube 113), and the first medium cavity 420 and the second medium cavity are connected front to back.

[0095] Finally, the surface of the balloon 300 is coated with the everolimus drug coating by ultrasonic spraying, and then the balloon 300 segments are folded and pressed to obtain a balloon dilatation catheter.

[0096] In summary, compared with the prior art, the balloon dilatation catheter provided by the utility model has the following beneficial effects:

[0097] (1) The utility model sets a blood flow tube 200 penetrating the balloon 300 and having a blood flow cavity 230 at the distal end of the balloon dilatation catheter, thereby ensuring that blood can flow from the proximal end to the distal tissue before and after the balloon 300 is expanded, thereby avoiding distal ischemia caused by the expansion of the balloon 300, thereby solving the problem that the existing conventional balloon 300 will completely block the blood vessel for a period of time during pre-dilatation, post-dilatation, and drug delivery, thereby reducing the treatment effect for some patients with poor tolerance to distal vascular ischemia.

[0098] (2) The utility model forms a plurality of independent chambers by nesting multiple tubes, thereby ensuring that each chamber functions as well as minimizing the traversable diameter of the balloon dilatation catheter.

[0099] (3) The crescent-shaped blood flow cavity 230 allows blood to flow into the blood flow cavity 230 at a larger angle along the circumference of the catheter, which not only maximizes the blood flow through the blood flow cavity 230 but also avoids the situation where the distal blood flow is blocked.

[0100] It should be noted that, in the description of this specification, the description with reference to the terms "one embodiment", "some embodiments", "example", "specific example", or "some examples" etc. means that the specific features, structures, materials or characteristics described in conjunction with the embodiment or example are included in at least one embodiment or example of the utility model. In this specification, the schematic representations of the above terms do not necessarily refer to the same embodiment or example. Moreover, the specific features, structures, materials or characteristics described may be combined in any one or more embodiments or examples in a suitable manner. In addition, those skilled in the art may combine and combine the different embodiments or examples described in this specification and the features of the different embodiments or examples, unless they are contradictory.

[0101] It should also be noted that the above description is only a description of the preferred embodiment of the utility model, and is not any limitation on the scope of the utility model. Any changes and modifications made by ordinary technicians in the field of the utility model based on the above disclosure content belong to the protection scope of the utility model. Obviously, technicians in this field can make various changes and modifications to the utility model without departing from the spirit and scope of the utility model. In this way, if these modifications and variations fall within the scope of the utility model and its equivalent technology, the utility model is also intended to include these modifications and variations.

Claims

1. A balloon dilatation catheter, characterized in that: It comprises a catheter body, a blood flow tube and a balloon, wherein the blood flow tube runs through the proximal end and the distal end of the balloon; The blood flow tube comprises a first tube body and a second tube body, wherein the second tube body is located inside the first tube body, an outer wall on one side of the second tube body is connected to an inner wall on one side of the first tube body, and a blood flow cavity for blood flow to pass through is formed between the outer wall on the other side of the second tube body and the inner wall on the other side of the first tube body; The balloon is sleeved on the outer wall of the first tube, and a filling cavity for accommodating a filling medium is provided between the balloon and the first tube; The distal end of the catheter body is inserted into the second tube body, and a first medium cavity for allowing a filling medium to pass therethrough is provided between the distal end of the catheter body and the second tube body; The connection between the first tube body and the second tube body has a through portion for connecting the first medium cavity and the filling cavity.

2. The balloon dilatation catheter according to claim 1, characterized in that: An outer wall of one side of the second tube body is welded to an inner wall of one side of the first tube body, and a welding length between the second tube body and the first tube body is 2 mm to 6 mm. The through portion includes at least one through hole provided at a welding point between the first tube body and the second tube body.

3. The balloon dilatation catheter according to claim 1, characterized in that: The second tube body and the first tube body are an integrated structure, and the through portion includes an open slit arranged at a connection between the first tube body and the second tube body.

4. The balloon dilatation catheter according to claim 1, characterized in that: The proximal end of the first tube body has a first sloped opening inclined toward the proximal end, and / or the distal end of the first tube body has a second sloped opening inclined toward the distal end.

5. The balloon dilatation catheter according to claim 1, characterized in that: The catheter body includes an outer tube and an inner tube, the distal end of the outer tube is connected to the proximal end of the second tube body, the proximal end of the inner tube is located inside the distal end of the outer tube, the distal end of the inner tube is located inside the second tube body, the first medium cavity is provided between the inner tube and the second tube body, the second medium cavity is provided between the inner tube and the outer tube for allowing the filling medium to pass through, and the second medium cavity is connected to the first medium cavity.

6. The balloon dilatation catheter according to claim 5, characterized in that: The inner tube is provided with a guide wire cavity extending along its axial direction, and one side of the outer tube is provided with a guide wire opening for allowing a guide wire to extend into the guide wire cavity.

7. The balloon dilatation catheter according to claim 5, characterized in that: The area of ​​the inner tube located inside the balloon has a visualization mark, and / or the proximal end of the outer tube has a catheter identification band.

8. The balloon dilatation catheter according to claim 5, characterized in that: The outer tube includes a proximal outer tube and a distal outer tube, the proximal end of the distal outer tube is connected to the distal end of the proximal outer tube, and the distal end of the distal outer tube is connected to the proximal end of the second tube body.

9. The balloon dilatation catheter according to claim 1, characterized in that: The balloon dilatation catheter also includes a head structure, and the distal end surface of the catheter body and the distal end surface of the second tube body are both connected to the proximal end of the head structure.

10. The balloon dilatation catheter according to claim 1, characterized in that: The balloon dilatation catheter also has at least one of the following technical features: The cross section of the blood flow cavity is arranged in a crescent shape; The diameter of the balloon is 2 mm to 4 mm; The length of the balloon is 10 mm to 40 mm; The outer diameter of the first tube is 0.7 mm to 1.5 mm; The wall thickness of the first tube body is 0.15 mm to 0.25 mm; The length of the first tube is 20 mm to 50 mm; The outer diameter of the second tube is 0.6 mm to 1 mm; The length of the second tube is 25 mm to 55 mm; The outer surface of the balloon has a drug coating; The material of the balloon is nylon, a block copolymer of polyamide and polyether, or thermoplastic polyurethane.

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